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CERTIFIED PROFESSIONAL IN HEALTH CARE QUALITY AND HEALTH CARE


QUALITY HAND BOOK

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Ruby Med Plus
Dr. Shoeb Ahmed Ilyas
BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant

CPHQ Exam Notes

CPHQ EXAM TRAINING MANUAL


Ruby Med Plus Training Institute. E-MAIL:
drshoeb_2k@yahoo.com/ shoebilyas@gmail.com
Mobile: +917032771303 /+919666148506

Dr.Shoeb Ahmed Ilyas BS, BDS, MPH, MS (GH),


MS( PSY), MS (Biotech), MHA, EMSRHS, M.Phil
(HHSM), PGDMLE, MHRM, F.H.T.A., F.M.S.P.I.,
Cert. in Health Economics.

1/3/2017

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Dr. Shoeb Ahmed Ilyas
BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant

CPHQ EXAM NOTES


Seven Pillars of Quality

1. Efficacy
This deals with a controlled environment and examines what is possible. It sets an upper
boundary for quality and establishes the ideal to which all should aspire. However, as we know,
the real world is very different to the laboratory. It is likely that the less control that is exerted
over the environment; the less probable it is that practitioners are able to meet these standards.

2. Effectiveness
The second pillar of quality is "effectiveness" i.e. to what extent does the service achieve its
intended outcomes in a real world environment? Social, economic and individual factors
influence the selection of quality indicators. Various indicators have been developed such as cost
effective, socially effective and individually effective although the way in which they are
measured is not always universally agreed.

3. Efficiency
The third pillar of quality is "efficiency". This examines the extent to which scarce resources are
used to derive the greatest benefits with the least waste. This is usually measured by examining
the ratio between the costs and benefits of a service and comparing these with others who are
providing the same or similar services. This measure is typically used by socio-economic forces
seeking to select a service which will result in reduced costs. The assumption is made that the
benefit stays the same, an assumption that is frequently not tested.

4. Acceptability
The fourth pillar is acceptability. This concentrates on the usefulness of the service to the patient
and its perceived impact on his/ her quality of life. It takes into consideration patient preferences

2
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BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
regarding access to the service (e.g. advice), relationship with health service providers (egg trust,
confidentiality), the amenities in which the service is provided and the cost utility relationship.

5. Optimality
The fifth pillar is optimality. From the point of view of society and the economic system, it is
necessary to ensure that the optimum allocation of resources is achieved relative to the benefits
derived from the services provided. Techniques such as cost benefit analysis and marginal
costing are used to identify the optimum point of resource allocation: benefits. Quality indicators
are usually of a global socio-economic nature. Neither the individual service provider nor patient
is concerned with these indicators. However, data collection starts at the interface between the
two and these desires for maximal rather than optimal benefits may adversely influence the
selection of appropriate indicators.

6. Equity
The sixth pillar is equity. Society is concerned that every person should receive equal treatment,
or at best fair treatment. Equity is compromised when the quality of service or even the range of
services is determined by the patient's ability to pay for the service. Since third party payers play
a significant role in the health care system, equity would be affected by the extent to which a
third party payer includes a fee for the service in the benefits that it offers it members.

7. Legitimacy
The seventh and final pillar is legitimacy. This is similar to the concept of acceptability except
that "the preferences and values for legitimacy are expressed through a societal rather than an
individual perspective". Clearly, society requires evidence upon which to make these judgments.

3
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Dr. Shoeb Ahmed Ilyas
BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
Management and Leadership

Strategic
The Certified Professional in Healthcare Quality (CPHQ) has a unique and broad responsibility
in an organization. The CPHQ promotes and supports quality assurance, safety, and effective
healthcare. The quality professional must have the expertise to design, implement, and evaluate
process improvement activities. The CPHQ must:
• Develop data collection and measurement procedures in order to evaluate outcomes.

• Provide education for administration and staff.

• Coordinate activities related to licensure, accreditation, standards, and regulations.

• Provide leadership as an agent of change within the organization.

• Identify organizational needs and opportunities for improvement.

• Prepare organization-wide plans, including quality management, patient safety, utilization and
risk management.

• Document activities and provide summary reports to leadership and the governing board.

• Facilitate interdisciplinary participation and teams.

• Differentiate a variety of organizational needs.

Leadership values
Leadership must be consistent, and succeeds by providing staff with direction and guidance that
shows by example, explaining why things need to be done, rather than directing how this must be
achieved. A good leader fosters values by focusing on the right way to do things, rather than on
errors or poor performance. By engaging staff in all parts of the process, a leader engenders a
sense of commitment in the staff. Commitment cannot be achieved through rules, regulation,
threats, and criticism. A good leader must demonstrate integrity, welcome diversity, be open-

4
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Dr. Shoeb Ahmed Ilyas
BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
minded, and search for competence. While a leader must have a thorough understanding of the
organization/facility and its work, he or she must be able to perceive holistically. The leader
must motivate others by providing structure, order, and able decision-making. The leader must
both learn and teach in order to create positive change.

Motivating staff:
An organization’s leaders must understand staff’s motivation to increase productivity and
improve performance. Leaders who use active listening discover the strengths of individuals and
groups within their organization. Leaders who provide positive reinforcement and rewards,
expect excellence, and remove barriers to employee involvement in the work process enable their
employees to feel empowered, recognized and acknowledged as valuable. Leaders must base
their responses on actual assessment, rather than preconceived ideas or biases. The four greatest
motivators for employees are:

Autonomy: Allowing people to use their ideas.

Salary: Providing adequate compensation for work done.

Recognition: Appreciating the efforts that employees put forth.

Respect: Listening to ideas.

Types of leaders:
Charismatic: The charismatic leader depends on personal charm to influence people, and is very
persuasive. However, charismatic leaders have limited effectiveness because they make
followers of employees, and relate to one group, rather than the organization as a whole.

Bureaucratic: The bureaucrat follows the organization’s rules exactly and expects everyone else
to do so. Bureaucrats are most effective in handling cash flow or managing work in dangerous
work environments. Bureaucrats may engender respect, but are not conducive to change or
creativity.

5
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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
Autocratic: The autocrat makes decisions independently, and strictly enforces rules. Team
members often feel left out of the decision-making process and may not be supportive.
Autocratic leaders are most effective in crisis situations, but may have difficulty gaining staff
commitment for routine work.

Consultative: The consultant presents a decision to staff, and welcomes their input and
questions, although the original decision rarely changes. Consultative leadership is most
effective when gaining the support of staff is critical to the success of proposed changes.

Leadership styles:
Participatory: A participatory style means the leader presents a potential decision and then
makes the final decision based on input from individual employees or teams. Participatory
leadership is time-consuming and may result in compromises that are not wholly satisfactory to
either management or staff, but participation motivates employees, who feel their expertise is
valued.

Democratic: A democratic style means the leader presents a problem and asks individual
employees or teams to arrive at a solution, although the leader usually makes the final decision.
Democratic leadership may delay decision-making, but employees and teams are often more
committed to the solutions because of their input.

Laissez-faire (free rein): A laissez-faire style means the leader exerts indirect control, allowing
employees/ teams to make decisions independently, with little interference. Laissez-faire may be
effective leadership if the teams are highly skilled and strongly motivated, but in many cases
laissez-faire leadership is the product of poor management skills and little is accomplished
because of lack of direction.

Time management techniques:


Time management is an important function of leaders, who must not only manage their own
time, but must also model time management, and schedule others’ time effectively.

Steps for effective time management are:

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BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
Plan: Create goals. Establish schedules for yearly, monthly, and daily activities. Plan each day
in advance.

Create a task list: Update your task list daily, including routine tasks, so that all can be
completed.

Prioritize: Rank the order in which tasks are to be accomplished, beginning with high priority
items.

Minimize paper handling: Try to handle a paper or task once only, instead of shuffling it about
and dealing with it repeatedly.

Use time effectively: Avoid wasted time by starting meetings on schedule, and ask a timekeeper
to monitor the time and announce when the time is up. Work efficiently, paying attention to
necessary details.

Delegate: Determine which tasks can be delegated to others, and do not micromanage them.

Use computer technology: Avoid paper when possible. Keep calendars and lists on the
computer for easy updating. Use e-mail and the Internet.

Avoid procrastination: Just do it.

Organizational culture
Organizational culture comprises the attitudes, beliefs, and behaviors of those involved in the
organization. The physical environment and the organizational structure strongly impact culture.
Culture involves shared assumptions about behavior and working together in an organization.
To facilitate change within an organization, the leader must understand its basic underlying
values, and change the organizational culture, along with changing processes and procedures.
The four basic types of organizational cultures are:

Stable learning cultures, where people exercise skills and advance over time.

Independent cultures, in which people have valued skills that are easily transferable to other
organizations.
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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
Group cultures, in which there is strong identification and emphasis on seniority.

Insecure cultures, with frequent staff layoffs and reorganizations.

To facilitate changes in the organizational culture, the leader must foster a commitment to
excellence at all levels, create opportunities for involvement, and empower staff. Management
must be flexible, encourage team building, and systems-thinking across the organization.

Organizational ethics:
Organizational ethics is the value system at work within an organization. While almost all
healthcare organizations have a written Code of Ethics, an ethical organization embodies that
code within all processes, including:

• A code of right conduct governing staff relationships with patients and the public.

• Recognition of the patient’s right to quality care and respect for personal religious beliefs,
culture, and psychosocial values.

• Transparency in disclosure of information, and accountability.

• Adherence to regulations and best practices.

• Recognition of the need to empower staff and patients.

• Leadership without intimidation or fear tactics.

• Standard, open guidelines for organ donation, procurement, and research projects.

• Maintenance of a bioethics committee to provide guidance related to ethical issues in


healthcare.

Organization-wide strategic planning:


Organization-wide strategic planning requires that an organization examines its needs,
community, and customers and establishes goals for the near future (2—4 years) and the
extended future (10—15 years). Strategic planning must be based on assessments, both internal

8
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Dr. Shoeb Ahmed Ilyas
BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
and external, to determine the present courses of action, needed changes, priorities, and
methodologies to effect change. The focus of strategic planning must be on development of
services. The organization identifies customer needs, develops services, and then markets those
services. Organization-wide strategic planning includes:

• Collecting data and doing an external analysis of customer needs in relation to regulations and
demographics.

• Analyzing internal services and functions.

• Identifying and understanding key issues, including the strengths and weaknesses of the
organization, potential opportunities, and negative impacts.

• Developing revised mission and vision statements that identify core values.

• Establishing specific goals and objectives, based on findings.

Strategic quality planning


Strategic quality planning to promote performance improvement must begin at the top level of
management, with a commitment to facilitate change at all levels, and to provide the financial
resources that make these changes possible. Every strategic quality plan begins with a clear
definition of quality as it applies to customers, and relates this to the organization’s mission and
vision statements, goals, and objectives. Processes are redesigned to achieve quality.
Organizational performance measurements are modified to ensure regulatory compliance. Total
quality management (TQM) is at the center of all planning. An organization-wide model for
quality performance must be used that includes at least the following:

• Assessment

• Planning

• Implementation

• Evaluation of continuous improvement

9
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Dr. Shoeb Ahmed Ilyas
BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
The planning process must be documented, and must contain an action plan that ensures
ongoing evaluation of progress.

Customer needs and satisfaction


Customer needs and satisfaction can be difficult to define because they are very individualized.
Build an assessment of satisfaction, including opportunities for feedback, into any strategic plan.
Patients are your external customers. Patients want to avoid complications and regain their health
without worrying about a plan. Your internal customers include:

• Hospital administrators, who want a cost-effective plan, increased productivity, and reduced
liability.

• Physicians, who want to provide positive outcomes for patients, and your assistance in
providing care.

• Nurses, who wants a practical, efficient plan that can be implemented without increasing their
workload.

• Environmental Services workers want a plan that relates to the resources available in each
department.

• Accreditation agencies want a plan providing documented proof of your organization’s


compliance with accreditation standards.

• Communities/community agencies want a plan that meets the needs of the various populations
they represent.

• Insurance companies want a cost-saving plan.

• Suppliers want a profitable, efficient plan.

Organizational mission statement:


The mission statement of an organization reflects the current status of the organization and
describes, in broad terms, the purpose of the organization and its role in the community.

10
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Dr. Shoeb Ahmed Ilyas
BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
Develop the mission statement in response to data and program analysis, and with input from all
members of the organization. The mission statement identifies the organization or program,
states its function, and outlines its purpose and strategy of the program, for example:

Hospital X is a collaborative group of professionals, physicians, administrators, nurses, and


support staff. The mission of Hospital X is to promote the health and safety of its patients,
visitors, and staff, and to provide outstanding quality health care services to (name the
community).

The mission statement should in some way include a commitment to quality and patient care,
and the need to serve the community. In many cases, the mission statement is followed by
detailed explanations, which may include statements of organizational values, philosophy, and
history.

Goals and objectives: Goals and objectives support the mission and vision statements, so
complete them at the same time to determine if the mission and vision statements can be
realized, and explain how that will happen. Goals should be achievable aims, essentially end
results, developed for specific units of the organization or the organization in general, focusing
on improving performance. An example of a specific goal is:

“The Neonatal Intensive Care Unit will reduce surgical site infections by 30% less than 2014
levels.”

In healthcare quality management, the goals must be based on knowledge about functions and
processes within the organization, and prioritized accordingly, as part of achieving positive
patient outcomes. Objectives are the measurable steps taken to achieve goals, and in the case of
infections, an objective might include:

“An Infection Control practitioner will audit antibiotic use and the Physicians’ Internal Medicine
Committee will establish an antibiotic prophylaxis protocol within 6 months.”

Objectives must be measurable, and include a timeline, and identify who is responsible for
achieving the objective.

11
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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
Customers
A customer is a receiver. Internal customers are those directly involved in product or healthcare
delivery, such as the Board of Directors, administrators, clerical staff, nurses, medical support
staff, physicians, Human Resources personnel, plant managers, pharmacists, and volunteer staff.
Consider in-patients as your internal customers. Internal customers need others in the work
environment to provide some type of product or service in order for them to function, and they,
in turn, provide a product or service to others, so each internal customer is also a supplier.
Vertical customer/supplier relationships, such as between administration and nursing staff, are
sometimes more obvious than the equally important horizontal relationships, such as between
floor nurses, which involve cooperative measures to ensure that quality care is provided.
Identify these types of important horizontal relationships, such as between floor nurses, which
involve cooperative measures to ensure that quality care is provided. Identify these types of
customer/supplier relationships in your strategic plan to help increase internal awareness and
improve methods of meeting the various customers’ needs.

External customer/supplier relationships:

External customer-supplier relationships are critical to an organization because these customers


are those that receive products or services supplied the organization’s workers. External
customers include outpatients and their families, private physicians, vendors, insurance
companies, government regulatory agencies, lawyers, and others in the community. In-patients
are internal customers. As with internal customers, each external customer is both a receiver of
products or services and a supplier. For example, a regulatory agency provides regulations and
guidelines as a supplier, and then receives reports in return as a customer. This symbiotic
relationship must be clearly understood by the CPHQ, because the external customer-supplier
relationship is one over which the organization often has less direct control, so identification of
the customers’ needs through surveys, interviews, focus groups, research, and brainstorming can
help to clarify and improve these relationships.

Performance measures
Balanced scorecard:

12
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BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
The balanced scorecard (designed by Kaplan and Norton) is based on the strategic plan, and
provides performance measures in relation to the mission and vision statements, and goals and
objectives. A balanced scorecard includes not only the traditional financial information, but also
includes data about customers, internal processes, and education/learning. Each organization can
select measures that help to determine if the organization is on track in meeting its goals. These
measures may include:

• Customers: Types of customers and customer satisfaction.

• Finances/business operations: Financial data may include funding and cost-benefit analysis.

• Clinical outcomes: Complications, infection rates, inpatient and outpatient data, and
compliance with regulatory standards.

• Education/learning: In-service training, continuing education, assessment of learning and


utilization of new skills, research.

• Community: Ongoing needs.

• Growth: Innovative programs.

If the scorecard is adequately balanced, it will reflect both the needs and priorities of the
organization itself, and also those of the community and customers it serves.

Dashboard:
A digital dashboard, like the dashboard in a car, provides an overview of an organization. A
dashboard is an easy to access and read computer program that integrates a variety of
performance measures or key indicators into one display, usually with graphs or charts. It might
include data regarding patient satisfaction, infection rates, financial status, or any other
measurement that is important to assess performance. The dashboard provides a running picture
of the status of the department or organization at any point in time, and may be updated as
desired — daily, weekly, or monthly. An organization-wide dashboard provides numerous
benefits:

13
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BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
• Broad involvement of all departments.

• A consistent and easy to understand visual representation of data.

• Identification of negative findings or trends so that they can be corrected.

• Availability of detailed reports.

• Effective measurements that demonstrate the degree of efficiency.

• Assistance with making informed decisions.

Core measures:
The Joint Commission has established core measures to determine if healthcare institutions are
in compliance with current standards. The core measures involve a series of questions that are
answered either “yes” or “no” to indicate if an action was completed. Currently, the Joint
Commission’s core measures relate to the following conditions:
• Acute myocardial infarction (MI)

• Heart failure

• Pneumonia

• Pregnancy and related conditions

• Surgical infection prevention

• Cardiac

• Venous thromboembolism

For each condition, questions relate to whether or not standard care was provided, such as giving
an Aspirin for those patients with an acute MI. This data is public and provides useful
information about these particular standards, but does not necessarily reflect the overall quality
of care. Core measurements alone are not adequate performance measures, but must be
considered along with other indicators.

14
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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
Lines of authority and accountability
The Joint Commission has established leadership standards that apply to healthcare
organizations and help to establish management’s lines of authority and accountability. Under
these standards, leadership comprises the governing body, the Chief Executive Officer, senior
managers, department leaders, leaders (both elected and appointed) of staff or departments, the
Nursing Executive, and other nurse leaders. The governing body is ultimately responsible for all
patient care rendered by all types of practitioners (physicians, nurses, laboratory staff, and
support staff) within and under the jurisdiction of the organization. The governing body must
clearly outline the lines of authority and accountability for others in management positions.
Each level of management must establish performance standards and performance
measurements, so that accountability becomes transparent, and is based on data that can be used
to drive changes when needed, to bring about improved outcomes.

Nursing role:
Nurses, especially those in leadership positions, have a responsibility to assist others with
professional leadership and accountability within the healthcare team and community.
Collaboration requires an ongoing commitment that includes mentoring, coaching, and teaching
others. Nursing must be involved in the following:

• Making decisions at all levels of an organization/ facility.

• Taking an active role in strategic planning.

• Assuming responsibility for standards of nursing care.

• Assessing and selecting equipment, supplies, and electronic information systems.

• Assisting with planning for utilization of resources.

• Analyzing all decisions with respect to patient outcomes.

• Supporting staff education and development, including training for management positions, and
offering opportunities to acquire continuing education hours.

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• Facilitating access to research and both internal and external resources.

• Allowing staff members time to consider their place in the organization and in their own
practices.

Performance improvement models


A number of different performance improvement models have been developed over the - 29 -
years. Evaluating and applying these models are part of strategic management and quality
healthcare. Some medical organizations use a single approach, but many combine models in
various ways in order to meet their specific needs. Those in leadership roles must understand
how these models can facilitate change, so that they choose elements that are appropriate for the
needs of their organization and to those who will work with the model.

All the various models share some like elements:


• The models focus on continuous improvement and are planned, systematic, collaborative, and
apply to the entire organization.

• They all focus on identifying problems, collecting data, assessing current performance,
instituting actions for change, assessing changes, team development, and use of data.

In order for any model or eclectic elements from different models to be effective, there must be
cooperation and consensus across the organization.

PDCA performance improvement model:


Plan-Do-Check-Act (PDCA or Shewhart cycle) is a method of continuous quality improvement.
PDCA is simple and understandable; however, it may be difficult to maintain this cycle
consistently because of lack of focus and commitment. PDCA is more suited to solving specific
problems, rather than organization-wide problems:

Plan: Identify, analyze and define the problem. Set goals and establish a process that
coordinates with leadership. Brainstorm extensively. Use Ishikawa fishbone diagrams to identify
problematic processes and list current process steps. Collect data and analyze the root cause.

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Do: Generate multiple solutions. Select one or more and then implement the first solution on a
trial basis.

Check: Gather and analyze data to determine the effectiveness of the first solution. If effective,
then continue to Act; if not, return to Plan and pick a different solution.

(Study may replace Check: PDSA.)

Act: Identify changes that need to be accomplished to fully implement the solution. Adopt the
solution and continue to monitor results, while picking another improvement project.

FOCUS performance improvement model:


Find, organize, clarify, uncover, and start (FOCUS) is a performance improvment model:

• Find: Identify a problem by looking at the organization and attempting to determine what isn’t
working well or what is wrong.

• Organize: Identify the people who understand the problem or process and create a team to
work on improving performance.

• Clarify: Utilize brainstorming techniques, such as Ishikawa fishbone diagrams, to determine


what is involved in solving the problem.

• Uncover: Analyze the situation to determine the reason the problem has arisen or why a
process is unsuccessful.

• Start: Determine where to begin the change process.

FOCUS, by itself, is an incomplete process and is primarily used as a means to identify a


problem, rather than a means to find the solution. FOCUS is usually combined with PDCA
(FOCUS-PDCA), so it becomes a 9-step process, but beginning with FOCUS refines the
problem, resulting in better outcomes.

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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
Accelerated rapid-cycle change model:
The accelerated rapid-cycle change approach is a response to rapid changes in healthcare
delivery and radical re-engineering. There are four areas of concern:

• Models for rapid-cycle change: The goal is doubling or tripling the rate of quality
improvement by modifying and accelerating traditional methods. Teams focus on generating
and testing solutions, rather than analysis.

• Pre-work: Assigned personnel prepare problem statements, graphic demonstrations of data,


flowcharts, and a literature review. Team members are identified.

• Team creation: Rapid action teams (RATs, or rapid acceleration, or rapid achievement) are
created to facilitate quick change.

• Team meetings and work flow are done over 6 weeks:

• Week 1: Review information. Clarify quality improvement opportunities. Identify key


customers, waste, and benchmarks.

• Week 2: Review customer requirements. Perform a cost/benefit analysis of the solution with
test data.

• Week 3: Complete the solution’s design. Plan its implementation. Conduct pilot tests.

• Week 4—5: Test, train, analyze, and make changes as needed.

• Week 6: Implement the solution.

Xerox 10-step benchmarking model


Benchmarking is an ongoing process of measuring your practice, service, or product results
against your competitors’ or industry standards. Xerox Corporation developed the 10-step
benchmarking model. You need to know how efficient others’ processes are, and search their
data for ways to improve your processes. There are four phases in benchmarking:

Planning, analysis, integration, and action. The 10 steps are:

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• Your benchmark targets.

• Similar organizations/units/providers with which to compare data.

• Determine and initiate methods of data collection.

• Evaluate your current performance level and deficits.

• Project a vision of your future performance.

• Communicate your findings and reach a group agreement.

• Recommend changes, based on benchmarking data.

• Develop specific action plans for your objectives.

• Implement actions and adjust them as necessary, based on monitoring of the process.

• Update your benchmarks based on the latest data.

This basic benchmarking model is often modified. It can be shortened to 7 steps, or extended to
11 steps, depending on the needs of the organization. Benchmarking is often used to improve
cash flow, as healthcare becomes more competitive, and to compare infection rates.

Ernst and Young’s 7-step “IMPROVE” model:


The Ernst and Young 7-step IMPROVE model is a simplified model that is effective for teams
who are already experienced with quality improvement processes and data collection. The basic
steps for the IMPROVE model are:

• Identify: Select a problem and evaluate your current performance.

• Measure: Determine its impact on internal and external customers through evaluation of dates
and other information.

• Prioritize: Identify all possible causes for the problem and prioritize it.

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• Research: Assess and evaluate the problem, including a root cause analysis.

• Outline: Determine all possible solutions to the problem and develop an action plan to
implement appropriate solutions.

• Validate: Establish a monitoring system after implementation to validate the effectiveness of a


solution.

• Execute: Continue to fully implement the solutions and standardize them, while continuing to
monitor efficiency.

Organizational Dynamics “FADE” cycle performance improvement model


Organizational Dynamics, a consulting firm, developed a four-phase FADE performance cycle
for quality improvement. The FADE model uses outputs and inputs. The output from one phase
serves as the input for the next. The phases are:

• Focus: Hold brainstorming sessions to create a list of problems. Select one problem. Define
the problem, analyze its impact completely, and generate a problem statement (output).

• Analyze: Collect baseline data, identify patterns, and gather general information about factors
that influence the problem or outcomes. Make charts and diagrams (output), such as Pareto,
fishbones, and flowcharts.

• Develop: Generate a list of possible solutions and choose one solution. Create an action plan
for implementation (output).

• Execute: Develop support and commitment for the proposed solution through presentations.
Put the plan into effect. Monitor the plan’s impact to ensure that the plan is effective.

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Juran quality improvement process (QIP) model:
Joseph Juran’s quality improvement process (QIP) is a four-step model, focusing on quality
control. QIP is based on quality planning, control, and improvement. The steps to the QIP
process are:

• Organize your project by listing and prioritizing problems, and identifying a team.

• Diagnose: Analyze the problems and then formulate theories related to their root cause. Test
your theories.

• Remediate: Consider various alternative solutions. Design and implement specific solutions
and controls. Address institutional resistance to change. As you identify the causes of problems
and remediate them, processes should improve.

• Hold: Evaluate performance and monitor the control system in order to maintain your gains.

AHIMA process improvement model:


The American Health Information Management Association’s process improvement model for
performance improvement is a consensus-building method with 11 steps, which are:

• Create a list of opportunities for improvement through brainstorming and prioritize the list,
choosing one on which to focus the project.

• Create the quality improvement team, who will facilitate the improvement process.

• Analyze problems related to the process.

• Create a speculative list of causes as a beginning point.

• Test assumptions.

• Perform root cause analysis to identify specific causes related to problems.

• Consider a number of alternative solutions.

• Design possible solutions and controls.

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• Reach consensus by addressing resistance to change through education, in-service training, and
presentations.

• Implement solutions and controls.

• Evaluate performance.

Six Sigma performance improvement model:


Six Sigma® is a performance improvement model developed by Motorola to improve its
business practices and increase its profits. The Six Sigma® model has been adapted to many
types of businesses, including healthcare. Six Sigma® is a data-driven performance model that
aims to eliminate “defects” in processes that involve products or services. The goal is to achieve
Six Sigma, meaning no more than 3.4 defects in every 1 million opportunities.

The focus is on continuous improvement, with the customer’s perception as key, so that the
customer defines that which is “critical to quality” (CTQ). Two different types of improvement
projects may be employed: DMAIC (define, measure, analyze, improve, control) for existing
processes or products that need improvement and DMADV (define, measure, analyze, design,
verify) for development of new, high-quality processes or products. Both DMAIC and DMADV
utilize trained personnel to execute the plans. Six Sigma® personnel have martial arts titles:
Green belts and black belts execute programs, and master black belts supervise programs.

Use in healthcare
The first project type for Six Sigma® is DMAIC (define, measure, analyze, improve, control),
which is used when existing healthcare processes or products need quality improvement:

• Define costs and benefits that will be achieved when the changes are instituted. Develop a list
of customer needs, based on complaints and requests.

• Measure input, process, and output. Collect baseline data. Perform a cost analysis. Calculate
the sigma rating.

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• Analyze root or other causes of current defects. Use data to confirm your analysis. Uncover
steps in processes that are counterproductive.

• Improve by creating potential solutions. Develop and pilot plans. Measure the results.
Determine the cost savings and other benefits to customers.

• Control the work processes by standardizing them. Monitor the system by linking performance
measures to a balanced scorecard. Create processes for updating procedures, disseminating
reports, and recommending future processes.

Lean-Six Sigma performance improvement model:


Lean-Six Sigma is a performance improvement model that combines Six-Sigma with concepts of
“lean” thinking by focusing process improvement on strategic goals, rather than on a project-by-
project basis. A Lean-Six program is driven by strong senior leadership, who outline long-term
goals and strategies to employees. Physicians are an important part of the Lean-Six process, and
must be included and engaged. The basis of Lean-Six is to reduce errors and waste within the
organization through continuous learning and rapid change. Lean-Six has four characteristics:

• Long-term goals with strategies in place for 1—3 year periods.

• Performance improvement is the underlying belief system.

• Cost reduction through quality increase, supported by statistics evaluating the cost of
inefficiency.

• Incorporation of improvement methodology, such as DMAIC, PDCA, or other methods.

National and international quality models


There is an increasing need for both national and international excellence/quality models, so that
best practices and standardizations can be shared. Existing models include:

• The Joint Commission Standards for Improvement of Organizational performance, where


voluntary compliance leads to accreditation.

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• The National Committee for Quality Assurance (NCQA) management improvement process.

• The Baldrige Award Criteria for Process Management and Results, an evaluation process that
provides excellent performance assessment.

• The International Standards Organization (ISO) standard for quality management (9001:2000),
which requires a strategic approach to process improvement through quality planning and
supportive data.

• United States Federal Quality Improvement Programs, which help organizations remain in
compliance with these complex Federal mandates regarding Medicare:

• Healthcare Quality Improvement Program (HCQIP)

• Quality Improvement Organization (QIO) projects

• Quality Improvement System for Managed Care (QISMC)

Healthcare facilities participate in these models to: Obtain accreditation; comply with Medicare
or other Federal programs regulations; gain feedback; or gain prestige.

Voluntary accreditation processes

Accreditation is a primary requirement for most healthcare organizations, because it establishes


that the organization is committed to standards based on evaluation. General accreditation is
usually done by either:

• The Joint Commission, which accredits more than 20,000 healthcare programs, both nationally
and internationally. It is the primary accrediting agency in the United States, so accreditation by
the Joint Commission indicates a commitment to improving care and provides information about
compliance with core measures.

• The Healthcare Facilities Accreditation Program of the American Osteopathic Association,


which also accredits many healthcare programs, including acute care, ambulatory care,
rehabilitation centers and substance abuse centers, behavioral care centers, and critical access
hospitals. It provides guidelines for patient safety initiatives, and reports common deficiencies.
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A healthcare organization may also seek accreditation by agencies with a narrower focus to
demonstrate excellence in a particular area, such as the Intersocietal Commission for the
Accreditation of Echocardiography Laboratories (ICAEL). Leadership and staff must determine
what type of ccreditation is most appropriate, based on the programs they offer, and their
commitment to improving standards.

Obtaining accreditation:
Your institution performs a self-assessment to ensure it complies with standards related to patient
care, safety issues, and performance-based core measures (comparative measurements).
Surveyors perform a peer review to assess compliance. They scrutinize:

• Documents (e.g., policies & procedures manuals).

• Medical records.

• Standards implementation measures.

• Integration of performance measurement data.

• Service and support systems.

Surveyors visit your institution for an accreditation evaluation. They inspect, observe, and
interview staff in person. The surveyors release their final report, which may:

• Renew an accreditation.

• Make a Conditional Accreditation (CA) or Preliminary Denial of Accreditation (PDA) if there


are infractions.

• Make a Denial of Accreditation (DA) if circumstances pose a threat to staff, the public, or
patients.

Your institution may appeal for reconsideration of the surveyors’ adverse decision within 60
days. Surveyors conduct a second visit for CA institutions to ensure that infractions are

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corrected. If appeal is denied, your institution can request a formal hearing by the FDA to
demonstrate its compliance through documentation or interviews.

Performance improvement plans


To develop a performance improvement plan, follow these steps:

• Design the process: Choose an approach that focuses on quality planning, control, and
improvement. Assemble a team. Establish a process based on data. Identify your customers.
Assess your rganization’s ability to implement a plan. Include training needs and resources in the
initial design.

• Design the plan: Plan strategically for organization-wide participation and collaborative
activities, which may be department or discipline-specific, or interdisciplinary. Make your plan
consistent with the organization’s vision and mission statements, and its goals and objectives.
Include performance expectations and measurements.

• Plan for implementation: Write the plan, including: A definition of quality; standards of care;
guidelines for patient safety; benchmarks; and outcome measurements.

Educate leadership and staff.

Issues to resolve:
You must resolve these issues to develop a performance improvement plan:

• Leadership roles: Delineate the roles of the key leaders in writing, beginning at the highest
level (such as the Chief Executive Officer), so that their responsibilities are clear.

• Terminology related to quality: Use consistent terminology in all documents and activities.
Decide whether to refer to quality management (QM), quality resource management (QRM),
continuous quality improvement (CQI) or some other acronym.

• Accountability structure: Determine who will sit on the quality council. Its members set
priorities regarding staff time, finances, and resources, and ensure accountability. The quality
council should be one structure, which may require the integration of existing bodies, or the

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creation of a new entity. The quality council oversees the plan, reports to the governing board,
and communicates with leaders at all levels.

Paperwork:

• Create a flow chart: Include the complete organizational structure, with all the participating
councils, teams, and lines of authority and communication. Provide a copy for all team members.

• Integrate policies, statements, and plans: Update documentation across your organization,
so that all use the same terminology (e.g., customers or consumers, public or non-staff). Make a
consistent glossary of definitions.

• Link goals with performance improvement activities: All performance activities must
reference your organization’s specific strategic goals or objectives, and its mission and vision
statements. If there is a disparity, then either the vision and mission statements must be adjusted,
or the focus of your improvement activities must be changed. The mission and vision statements
are central to quality healthcare planning. Plan all activities with the intention of meeting
established goals and objectives.

Functions and models:


Functions are the specialized activities of a system. Functions include not only patient care, but
also governance, management, and support. If you focus on function, rather than individual
departments, it integrates services and makes patient care the priority, rather than the
departmental processes themselves. Identify functions by analyzing patient tracers, performance
measures, cost data, reviews, and claims data.

Model (or methodology): The guide for your performance improvement plan, such as FOCUS,
PDCA, 10-Step Benchmarking, QIP, or Six Sigma. Review all models and pick the one that best
meets the needs of your organization and will be accepted by all interested parties. Part of your
decision relates to available resources and the degree of commitment your organization has to
performance improvement.

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Reporting and team structures:
Your performance improvement plan requires you to:

• Establish a reporting structure and calendar: Performance improvement activities are


usually reported on a monthly basis, or another regular, frequent schedule. Distribute a detailed
written report and present a synopsis at team and management meetings. Remind the directors
and managers to disseminate the monthly report through staff meetings. Post a calendar, which
clearly indicates a proposed timeline for improvements, and lists regular meetings times.

• Determine the team structures: A number of different teams may be necessary, depending
on the model you chose. Assign the teams very specific functions, such as patient assessment,
clinical improvement, and operations improvement. Determine which teams should be
interdisciplinary, which teams should be department-specific, and who should be included.

Writing a performance improvement plan:

Document every performance improvement plan in writing. Tailor your written plan to its
purpose. It may be brief if it is intended primarily as a teaching tool to guide staff, but if it is
intended as a tool for implementation, it must be a comprehensive document that outlines in
detail all of the different aspects of the performance improvement plan. A detailed plan must
include a:

• Statement of commitment

• Clear outline of authority and responsibility

• Explanation of the infrastructure

• Outline of the flow of information

Your organization may require a written plan for its state licensure or participation in federal
plans. Obtain a copy of the specific state and federal requirements, and ensure your plan
corresponds to them exactly. The goals and objective of your quality plan must clearly relate to
the organization’s overall strategic goals and objectives. Outline the structure and design of

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leadership and teams, and delineate their responsibilities. Get approvals from all interested
parties, and keep the originals on file with the document.

Educational needs and team training:

Your performance improvement plan must:

• Address the specific educational needs of leaders and staff: Decide who requires education.
State the educational needs of each group of participants, and what your organization can
appropriately provide. List the means for providing this education.

For example, your organization can provide on-site computer training during regular work hours,
but staff must renew their CPR and First Aid certification off-site, in their own time, through an
independent third party provider, like Red Cross.

Create an executive summary and detailed plan for all those in leadership positions, beginning
with the governing board, so they thoroughly understand the performance improvement plan, its
data collection, measurement, and analysis.

• Plan for training teams: Relate general training to team structure, team functions, and team
leadership. Ensure the individual team members get training for their specific roles, so teams
work consistently.

Financial benefits:
A quality performance improvement plan should not only improve functions (including patient
care), but must show a financial benefit to the organization if it is to gain support of the
governing board. Complete a cost-benefit analysis to demonstrate potential savings or income for
each aspect of your action plan. For example, if bar coding will be used to decrease medication
errors, thereby reducing complications and shortening hospital stay, then potential savings exist.
Provide specific, measurable goals in your improvement plan to facilitate calculation of financial
benefits. As the plan is implemented, include a financial benefit section in your monthly written
report, because this provides tangible evidence of the plan’s success. Summarize the financial

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benefits in graphs and charts, because a visual demonstration is a more effective way to
communicate than text alone.

Facilitating change within the healthcare system


Facilitating change within a healthcare organization requires the creation of a common vision
for care, and begins with the organization creating teams to work collaboratively and focus on
serving the customers. Achieving a common vision requires a true collaborative effort:

• Include all levels of staff across the organization, encompassing nursing and all other
positions.

• Build consensus through discussions, in-service training, and team meetings, so diverse
viewpoints converge.

• Value staff creativity and provide encouragement during your facilitation process.

• Post the common vision statement so it is accessible to all staff.

• Recognize that a common vision is an organic concept that evolves over time, requiring
regular re-evaluation and changes as needed, so it continues to reflect the needs of the
organization, patients, families, and staff.

Barriers to system change:


Barriers can include: Identification with role, feelings of victimization, relying on past
experience, autocratic views, failure to adapt, and weak consensus. Barriers to system change
can arise at the individual, departmental, or administrative levels because of:

• Identification with role rather than purpose: People see themselves from the perspective of
their role in the system, as nurse or physician, and are not able to step outside their preconceived
ideas to view situations holistically or to accept the roles of others. They may lack the ability to
look at situations as human beings first and professionals second.

• Feelings of victimization: People may blame the organization or the leadership for personal
shortcomings, or feel that there is nothing that they can do to improve or change situations. A

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feeling of victimization may permeate an institution to the point that meaningful communication
cannot take place, and people are closed to change.

• Relying on past experience: New directions require new solutions, so being mired in the past
or relying solely on past experience can prevent progress.

• Autocratic views: Autocrats feel that their perceptions and practices are the only ones that are
acceptable, and often have a narrow focus, so that they cannot view the system as a whole, but
focus on short-term outcomes. They fail to see that there are many aspects to a problem,
affecting many parts of the healthcare system.

• Failure to adapt: Change is difficult for many individuals and institutions, but the medical
world is changing rapidly, and this requires adaptability. Those who fail to adapt may feel
threatened by changes and unsure of their ability to relearn new concepts, principles, and
procedures.

• Weak consensus: Groups that arrive at an easy or weak consensus without delving into
important issues may delude themselves into believing that they have solved problems, which
remain fixed and are often ignored, rather than moving forward to resolution.

Operational

Performance oversight group


The performance oversight group is often referred to as the quality council, steering council, or
quality management committee. The governing board establishes the performance oversight
group to coordinate all performance improvement activities. The group is usually drawn from
administrative leaders, medical staff, and key personnel in various departments. The chairperson
of the group is usually appointed by the President or Chief Executive Officer of the organization,
and is approved by the medical staff and governing board. Part of your role as facilitator is to:

• Inform the governing board of the need for the group.

• Cost the group’s activities.

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• Develop a preliminary list of group responsibilities.

• Match those responsibilities with the skills, knowledge, work roles, and vision of potential
group members.

• Schedule regular meetings for the group, ranging from twice monthly to 10 times yearly.

• Report the group’s activities regularly to the governing board.

• Document the group’s performance improvement activities.

• Maintain confidentiality of patient and practitioner information, in accordance with HIPPA


regulations.

Group members’ responsibilities:


The performance oversight group has tremendous influence over the success of a performance
improvement plan, so potential group members must be aware of their responsibilities and
willing to participate. Disseminate preliminary information about performance improvement at
meetings held to discuss the issues. The responsibilities of the performance oversight group are
to:

• Develop, modify, and approve the performance improvement plan.

• Establish priorities for initiatives, based on patient impact, data, and organizational objectives.

• Select the types of teams needed, establish teams, and supervise them.

• Plan methodologies to support action plans.

• Review aggregate data, measurements of performance, and periodic summaries from teams.

• Establish a confidential peer review policy.

• Establish educational and training programs as needed.

• Supervise a budget and make budgetary recommendations.

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• Evaluate the effectiveness of performance activities.

• Provide summaries of achievement activities and progress toward goals.

Performance improvement team


A performance improvement team is a group of people working together to achieve a goal, like
writing a clinical action plan. Performance improvement activities almost always involve a team
or teams of staff because of the complexity of healthcare organizations.

Rarely is one department solely responsible for outcomes, except in very specialized work.
Tracer methodology is a method that looks at the continuum of care a patient receives from
admission to post-discharge. When you determine the composition of the performance
improvement team, use tracer methodology to ensure there is at least one representative from all
groups that participate in patient care on the team. Teamwork requires a considerable time and
training commitment. Performance improvement initiatives require teams to:

• Improve outcomes through a common purpose.

• Utilize staff expertise.

• Contribute various perspectives.

• Facilitate a participative management style.

• Improve acceptance of processes that impact work practice.

• Manage complexity, where many participants are involved in outcomes.

• Increase organization-wide acceptance of change.

• Combat resistance to change.

Advantages:

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The advantages of developing performance improvement teams are:
• Individual: Team members have the opportunity to develop new skills, share their expertise,
utilize their creativity, increase their personal autonomy, influence decisions, and improve their
job satisfaction. Working in teams often increases the team members’ respect for other
disciplines and members.

Administrative: The organization’s administration benefits when it has increased flexibility to


facilitate, rather than direct. Delegating performance improvement to teams means administrators
have fewer time constraints, increased staff support, better utilization of skills, and improved
productivity. Utilizing teams frees administrators from many time-consuming tasks, allowing
for better overall management.

Organization-wide: The organization benefits by more continuity, customer satisfaction, cost


efficiency, improved productivity, more efficient accountability, decreased staff turnover, and an
improved ability to deal with staff turnover. Teams benefit the entire organization because they
are more suited to dealing with complexity than individuals.

Team structure:

The appropriate team structure is very important in performance improvement because creating a
team does not, in itself, assure teamwork. The team must be comprised of individuals whose
skills omplement each other, and who have a shared purpose, because outcomes depend on the
collaborative efforts of the group, rather than individuals within the group. Accordingly, the
collective team is accountable for outcomes, rather than individuals. When creating teams,
consider these important elements:

• Size: Teams with less than 10 members are most effective.

• Skills: Team members should have complementary skills that encompass the technical,
problem solving, decision-making, and interpersonal aspects of the problem.

• Performance goals: Allow teams a degree of autonomy to produce action plans for
performance improvement, based on strategic goals and objectives.

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• Unified approach: Create the teams according to the model of performance improvement you
have chosen, but allow them some flexibility in working together.

• Accountability: Make the team members collectively accountable, rather than individually
accountable.

Cross-functional team:
Cross-functional teams are sometimes called interdisciplinary. Cross-functional teams are
comprised of individuals with various skill levels or from different disciplines, who work
together to accomplish one or more functions. An ad hoc team operates for a short time to
accomplish specific goals. A permanent team is a regular part of continuous performance
improvement. Cross-functional teams are particularly useful when you need to:

• Develop new processes.

• Implement organization-wide performance changes or technology.

• Control costs and increase the cost-benefit ratio.

• Deal with problems or performance activities that cross disciplines.

• Access a broad range of expertise and skills.

To ensure the success of your performance improvement activities:

• Select team members with the correct mix of abilities.

• Clearly outline the roles for the team members and the expected outcomes. •

Provide adequate training to assist cross-functional team members in working together as a unit.

Self-directed work team:


Self-directed work teams are groups of individuals working together to achieve a common goal,
such as improving a process or producing a product. While the members may be trained cross-

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functionally, they usually have individual functions within the group. Usually, the teams have an
assigned task or tasks for which they are accountable, but have the authority to manage the
functions on their own, and make decisions without the direction of the administration. As with
other types of teams, self-directed work teams may be ad hoc or permanent. Their degree of
autonomy varies from one organization to another.

Self-directed work teams may do the following:

• Plan and establish priorities.

• Organize and manage budgets.

• Manage work schedules and assignments.

• Engage in problem-solving activities and make corrections.

• Monitor and evaluate performance.

• Coordinate with other teams or individuals.

• Chose or hire team members.

Facilitator and team leader:

There are a number of key roles within a performance improvement team, and selecting the best-
suited candidate to fill each role greatly influences the effectiveness of the team.

The first two key roles are:

• Facilitator (Master Black belt in Six Sigma®): The facilitator is not a member of the team,
but rather consults with or coaches the team members, helps to build team skills, and keeps the
team focused. The facilitator may: Provide training; assist the team leader or team members;
receive input from team members; evaluate consensus; provide feedback; and summarize
outcomes.

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• Team leader (Black belt in Six Sigma®): This team leader is a member of the team who
provides direction, but is not individually responsible for decision-making, or the overall
effectiveness of the team’s efforts. Often, team leaders are middle managers that coach, rather
than direct, members of the team. The team leader may: Prepare and conduct meetings; assign
activities; evaluate progress; coordinate with other teams; communicate with the facilitator; and
document meetings and activities.

Member and secretary/recorder:


There are a number of key roles within a performance improvement team, and selecting the best-
suited candidate to fill each role greatly influences the effectiveness of the team.

The third and fourth key roles are:

• Team member (Green belt in Six Sigma®): The team member is a critical part of the team
because this person does much of the actual hands-on activities related to team responsibilities.
The team member: Attends all meetings; provides input for the agenda; assists the team leader;
shares expertise; communicates with other team members; completes specific assignments;
proposes projects; measures; collects data; and recommends actions.

• Secretary/recorder: The Secretary is responsible for keeping minutes and creating other
reports or documents as needed by the team. This position may become the responsibility of one
person, or may be done on a rotating basis by various team members. Careful documentation
and reporting is a necessary function of teams, so that their progress can be evaluated and reports
disseminated to management.

Timekeeper and sponsor:

There are a number of key roles within a performance improvement team, and selecting the best-
suited candidate to fill each role greatly influences the effectiveness of the team.

The fifth and sixth key roles are:

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• Timekeeper: The timekeeper monitors the time spent in meetings and keeps people on track,
so that meeting times are well spent, and do not exceed scheduled times. This position is often
rotated among team members.

• Sponsor (champion): The sponsor may be the quality council as a whole, or a key leader with
an interest in the particular activities of a team. The sponsor is not involved in the day-to-day
activity of the group, but receives regular reports regarding the team’s activities. The sponsor
reviews the team’s efforts and may provide guidance or direction. The sponsor maintains overall
responsibility and accountability for the team effort, and has a primary role in the selection of
projects and other members of the team. The sponsor ensures that all interested parties are
informed, monitors decisions and activities, and has the authority to implement changes.

Champions and process owners:

Champions are those individuals with a particular passion for or interest in the activities of a
performance improvement team, and are often instrumental in the creation and formation of the
teams themselves, choosing the basic function of the team and the team members. Because
members of organizations very often resist change, the champion has a pivotal role in providing
leadership. The process champion (also called a sponsor) is often a member of upper
management, who has the authority to make decisions, and the ability to communicate with top
management and the governing board. Champions can exist at different levels, so there may be
clinical champions or patient safety champions — individuals who have made an effort to be
informed and to promote performance improvement. Process owners, on the other hand, are
usually the team leaders, who are actively involved in supervising and/or carrying out the
functions and activities of the team. Process owners are often key managers with knowledge and
commitment to improvement.

Monitoring consultants

Many organizations hire consultants to facilitate or lead teams or to provide specific services for
performance improvement. The CPHQ selects a consultant based on networking,

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recommendations, advertising, references, telephone interviews, presentations, personal
interviews, and proposals. The CPHQ must select the correct consultant, to ensure that:

• Quality and patient safety are not compromised.

• The goals, needs, and budget of the project are met.

The duties of the CPHQ are to:


• Make a clear, itemized list of goals for the project.

• Provide an organizational chart to the consultant, which clearly defines the lines of authority in
relationship to the consultant.

• Create an itemized job description for the consultant.

• Specify time frames and deadlines in the consulting contract.

• Include confidentiality agreements and specific work requirements in the contract.

Once the consultant is hired, the CPHQ supervises the consultant’s activities, to ensure that the
consultant adheres to the job description and provides valued service to the organization.

Objective performance measures


The development of objective performance measures is critical to monitoring performance
improvement. Most organizations have many types of data, but often it is not in a usable form
for performance improvement. Identify your data needs first. Categories of performance
measures include those needed for:

• Strategic planning (specific to the organization)

• Regulations (to meet state or federal requirements)

• Contractual agreements (as in managed care)

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Consider all three of these categories when developing performance measures, to avoid
duplication, and to ensure that the data collected will evaluate the effectiveness of the
organization. The data provided should directly relate to functions and processes.

Basically, you require two types of measurements:

• Outcomes, which show how the organization is performing and whether or not goals are being
achieved. For example, data may measure mortality rates in a Neonatal Intensive Care Unit.

• Processes, which show if the organizational systems/functions are working effectively. For
example, data may measure compliance with core measures for accreditation.

Selecting performance measures:

Below are areas of concern when selecting performance measures:

• Responsibility for selection: Each team should select appropriate performance measures.
There may be a number of different teams selecting measures for different levels, such as
organization-wide data, as opposed to departmental data. These teams are usually
interdisciplinary and members have training or expertise in utilizing performance measures.

• Clear understanding: Functions, processes, and variables that may affect outcomes require
standardized language, a glossary, and consistent training.

• Identification of purpose and utilization: Data may be used to assess quality, or for
accountability, or for research.

• Review and inventory: You must have current, available data within the organization’s
databases to determine what can be utilized.

• Measures: Determine the numerators, denominators, and measures that will be used. Assess
the measures for their reliability and validity, and document your findings. Post the definitions,
and list reasons for their choice and references for each measure.

Triggers:

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Triggers are mechanisms or signals within data that indicate when further analysis or prioritizing
must be done, such as case reviews or root-cause analysis. Select triggers for each measure of
performance.

• Data Triggers:

• Sentinel events: An unexpected death or major impairment lasting at least two weeks, which
occurs because of a deficiency in a process or system.

• Adverse events (AE): An unintended, unfavorable, iatrogenic occurrence that is life-


threatening, or requires in-patent hospitalization, or extends the patient’s length of stay, or causes
a birth defect or lasting disability.

• Performance rate: A pre-established level of performance in a particular measure.

• Rate change: A pre-established change over a specified time period.

• Difference between groups: A pattern of disparity between specified groups.

• Specified upper and lower control limits about a mean: Guardrails establish an acceptable
range of variation, usually set by standard deviation methods.

• External Triggers

• Feedback from staff, internal and external customers.

• Strategic planning initiatives, Practice guidelines.

• Benchmarks, Research.

Written risk management plans

The written risk management plan, while not required by accreditation agencies, is usually
required by liability insurers. Your written plan must include:

• Statement of purpose: Outline your organization’s general policy of risk management, such
as patient safety guidelines or financial risk reductions.

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• Goals: Make goals specific and measurable.

• Program scope: Include linkages with other programs.

• Lines of authority: Begin with the governing board and end with employees.

Outline the responsibilities at each level.

• Policies: Include confidentiality (HIPPA) and conflict of interest policies.

• Data sources and referrals: Outline the types of measures your organization uses.

• Documentation/reporting: Clarify who is responsible for reporting. List the frequency of


reports.

• Activities integration

• Evaluation of program: Note the method and frequency of evaluation.

• Charts and Diagrams: Attach flow charts, organizational charts, and pertinent diagrams to the
written risk management plan.

Survey processes
Survey processes include accreditation, licensure, and contractual requirements. The CPHQ is
responsible for coordinating survey processes. Your goals as coordinator are to ensure that:

• All necessary data is collected

• The proper format is used

• The most cost-efficient method is used

In some cases, electronic data sources are incompatible, making it impossible to transfer data,
and the costs of new software can be considerable. Take a thorough inventory of all
performance measures and data collected across the organization:

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• Send a data inventory questionnaire to all departments, requesting information about their
types of data and reasons for its collection.

• Organize the inventory results according to:

• Core measures

• Outcomes

• Processes Definitions of the data types, storage methods, job titles of persons responsible for
collections, and legal uses of the data.

• Match a complete list of all required measures against the inventory to verify compliance. It is
at this point that duplications or deficiencies should become evident.

Survey readiness:
As the survey processes coordinator, you must ensure that your organization is in a constant state
of survey readiness through:

• Identification of Leadership: Ask the governing board to identify an administrative team and
clinical leaders who will assume the responsibility for continuous readiness.

• Monitoring: When the Board assigns appropriate interdisciplinary teams to monitor readiness,
ensure those responsible meet four times yearly to review your organization’s compliance with
standards.

• Structure and Activities: Document the type of administrative and team structure used for
survey readiness, including team activities and responsibilities.

• Tracer Methodology and Performance Measures: Conduct some form of mock survey or
self-assessment regularly. Evaluate performance measures and intervene as necessary.

• Information and Communication: Distribute standards and guidelines to leaders for


reference. Flag changes in standards for them. Review the surveyors’ reports for the last two full
surveys to determine if previous recommendations have been instituted. Communicate

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compliance standards to staff in various media, including your corporate intranet, newsletters,
and in-service training sessions.

Licensure

While accreditation processes are voluntary, licensure is mandatory, usually through the State
Department of Health Services. Hospitals and laboratories must comply with state and federal
laws and regulations in order to be licensed. Managed care organizations are usually licensed by
other state departments, such as the Department of Insurance. There are a number of different
types of licenses, and these vary slightly from one state to another:

• Acute medical and psychiatric hospitals

• Ambulatory surgical centers

• Skilled nursing facilities and sub-acute care centers

• Long-term care facilities

• Home health care agencies

• Hospice agencies

• Assisted living programs

• Residential programs for the behaviorally, mentally, and developmentally disabled

Organizations that use beds or staffing in non-compliant ways risk losing their licenses.
Licenses specify the number of patient beds, the types of patients, and staffing provisions, which
vary from state to state.

Cost analysis for performance improvement

Cost-benefit analysis:
A cost-benefit analysis uses the average cost of an event and the cost of an intervention to
demonstrate savings. For example:

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• According to the CDC, a surgical site infection caused by Staphylococcus aureus results in an
average of 12 additional days of hospitalization and costs $27,000. (In actuality, the cost varies
widely from one institution to another, so use local data if it benefits your case.) If your
institution averages 10 surgical site infections annually, the cost is 10 x $27,000 = $270,000
annually.

If the proposed interventions include:

• New software for surveillance ($10,000)

• An additional staff person ($65,000 salary + $15,000 benefits)

• Increased staff education, including materials ($2000)

Then the total intervention cost would be $10,000 + $65,000 +$15,000 + $2000 = $92,000.00.

If the goal were to decrease infections by 50%, to 5 infections per year, the savings would be 5 x
$27,000 = $135,000.

Subtract the intervention cost from the savings to obtain the annual cost benefit:

$135,000 - $92,000 = $43,000.

Management and Leadership

It consists of twenty one items which includes:


Strategic in which the applicant learns about development of leadership values and commitment
to quality, program /project development and evaluation enterprise risk management, prevention
and control, new service lines, assessment, development, and design of the organization’s quality
culture, participate in organization-wide strategic planning, quality improvement activities with
strategic goals, customer/supplier relationships, developing an organizational vision and mission
statement, performance measures/key performance/quality indicators, into strategic planning for
the organization.

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Operational
The second to learn is Operational in which included are the establishment of a performance/
quality improvement oversight group such as organizational values and commitment to staff,
Interact with external quality consultants, Coordinate survey processes.

Information Management

Covering thirty one percent and includes the sub topics as:

Design and Data Collection

This includes the confidentiality of performance/quality improvement records and reports,


information for committee meetings, epidemiological principles in data collection and analysis,
customer needs and expectations, coordinate data inventory listing activities, Perform or
coordinate data definition activities, data collection methodology.

Measurement and Analysis in which included are use of process analysis tools to display data,
basic statistical techniques to present data common and special cause variation, random
variation, trend analysis, Interpret data to support decision making.

Communication in which included are Interact with staff regarding quality issues, Compile and
write performance/quality improvement reports, promote the dissemination of
performance/quality improvement information within the organization, Participate in public
reporting activities such as organizational transparency, website content, ensuring accuracy,
communication with accrediting and regulatory bodies.

Quality Measurement and Improvement

covers forty five items that includes the objectives of Planning that covers establishment of
priorities for performance/quality improvement activities, development of performance/quality
improvement action plans and projects, program development, evaluation, planning, projects,
and activities, development or selection of process and outcome measures, evaluation/selection

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of evidence-based practice guidelines standing orders or as guidelines for physician ordering
practice, the development of clinical/critical pathways or guidelines, evaluating the readiness to
apply for external quality awards, survey readiness for accrediting and regulatory bodies.

Improving Healthcare Using Toyota Lean Production Methods.


 There are a number of “obstacles” in your way on the CPHQ test. Among these are
answering questions, finishing in time, and mastering test-taking strategies.

 All must be executed on the day of the test at peak performance, or your score will suffer.

 The CPHQ is a mental marathon that has a large impact on your future.

 Wear a watch to the CPHQ Test. At the beginning of the test, check the time (or start a
chronometer on your watch to count the minutes), and check the time after each passage
or every few questions to make sure you are “on schedule.”

 For the computerized test an onscreen clock display will keep track of your remaining
time, but it may be easier for you to monitor your pace based on how many minutes have
been used, rather than how many minutes remain.

 If you are forced to speed up, do it efficiently. Usually one or more answer choices can
be eliminated without too much difficulty. Above all, don’t panic.

 Don’t speed up and just begin guessing at random choices. By pacing yourself, and
continually monitoring your progress against the clock or your watch, you will always
know exactly how far ahead or behind you are with your available time.

 If you find that you are one minute behind on the test, don’t skip one question without
spending any time on it, just to catch back up. Once you catch back up, you can continue
working each problem at your normal pace.

 Furthermore, don’t dwell on the problems that you were rushed on. If a problem was
taking up too much time and you made a hurried guess, it must be difficult.

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 The difficult questions are the ones you are most likely to miss anyway, so it isn’t big
loss. It is better to end with more time than you need than to run out of time. You can
always go back and work the problems that you skipped.

 If you have time left over, as you review the skipped questions, start at the earliest
skipped question, spend at most another minute, and then move on to the next skipped
question.

 Lastly, sometimes it is beneficial to slow down if you are constantly getting ahead of
time.

 You are always more likely to catch a careless mistake by working more slowly than
quickly, and among very high-scoring test takers (those who are likely to have lots of
time left over), careless errors affect the score more than mastery of material.

 You probably know that guessing is a good idea on the CPHQ test- unlike other
standardized tests, there is no penalty for getting a wrong answer.

 Even if you have no idea about a question, you still have a 20-25% chance of getting it
right.

 Most test takers do not understand the impact that proper guessing can have on their
score. Unless you score extremely high, guessing will significantly contribute to your
final score.

 This test intentionally writes deceptive answer choices that “look” right. A test taker has
no idea about a question, so picks the “best looking” answer, which is often wrong. The
monkey has no idea what looks well and what doesn’t, so will consistently be lucky about
20-25% of the time.

 Test takers will eliminate answer choices from the guessing pool based on a hunch or
intuition. Simple but correct answers often get excluded, leaving a 0% chance of being
correct. The monkey has no clue, and often gets lucky with the best choice.

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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
 Find a good source for practice tests.

 If you are willing to make a larger time investment, consider using more than one study
guide- often the different approaches of multiple authors will help you “get” difficult
concepts.

 Take a practice test with no time constraints, with all study helps “open book.” Take your
time with questions and focus on applying strategies.

 Take a practice test with time constraints, with all guides "open book."

 Take a final practice test with no open material and time limits

 Since you have to pay a registration fee each time you take the CPHQ exam, don’t take it
as a “practice” test. Feel free to take sample tests on your own, but when you go to take
the CPHQ exam, be prepared, be focused, and do your best the first time!

 Everyone knows that time is money. There is no need to spend too much of your time or
too little of your time preparing for the CPHQ exam.

 You should only spend as much of your precious time preparing as is necessary for you
to pass it.

 Everyone knows that time is money. There is no need to spend too much of your time or
too little of your time preparing for the CPHQ exam.

 You should only spend as much of your precious time preparing as is necessary for you
to pass it.

TOP 20 TEST TAKING TIPS


1. Carefully follow all the test registration procedures

2. Know the test directions, duration, topics, question types, how many

3. questions

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4. Setup a flexible study schedule at least 3-4 weeks before test day

5. Study during the time of day you are most alert, relaxed, and stress free

6. Maximize your learning style; visual learner use visual study aids, auditory learner use
auditory study aids

7. Focus on your weakest knowledge base

8. Find a study partner to review with and help clarify questions

9. Practice, practice, practice

10. Get a good night’s sleep; don’t try to cram the night before the test

11. Eat a well balanced meal

12. Know the exact physical location of the testing site; drive the route to the site prior to test
day

13. Bring a set of ear plugs; the testing center could be noisy

14. Wear comfortable, loose fitting, layered clothing to the testing center; prepare for it to be
either cold or hot during the test

15. Bring at least 2 current forms of ID to the testing center

General Strategies
16. Eliminate the obviously wrong answer choices, then guess the first remaining choice

17. Pace yourself; don’t rush, but keep working and move on if you get stuck

18. Maintain a positive attitude even if the test is going poorly

19. Keep your first answer unless you are positive it is wrong

20. Check your work, don’t make a careless mistake

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21. The most important thing you can do is to ignore your fears and jump into the test
immediately- do not be overwhelmed by any strange-sounding terms.

22. You have to jump into the test like jumping into a pool- all at once is the easiest way.

MAKE PREDICTIONS
 As you read and understand the question, try to guess what the answer will be.

 Remember that several of the answer choices are wrong, and once you begin reading
them, your mind will immediately become cluttered with answer choices designed to
throw you off.

 Your mind is typically the most focused immediately after you have read the question
and digested its contents.

 If you can, try to predict what the correct answer will be. You may be surprised at what
you can predict.

 Quickly scan the choices and see if your prediction is in the listed answer choices. If it is,
then you can be quite confident that you have the right answer.

 It still won’t hurt to check the other answer choices, but most of the time, you’ve got it!

Answer the Question


 It may seem obvious to only pick answer choices that answer the question, but the test
writers can create some excellent answer choices that are wrong.

 Don’t pick an answer just because it sounds right, or you believe it to be true. It MUST
answer the question.

 Once you’ve made your selection, always go back and check it against the question and
make sure that you didn’t misread the question, and the answer choice does answer the
question posed.

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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
Valid Information
 Don’t discount any of the information provided in the question. Every piece of
information may be necessary to determine the correct answer.

 None of the information in the question is there to throw you off (while the answer
choices will certainly have information to throw you off). If two seemingly unrelated
topics are discussed, don’t ignore either. You can be confident there is a relationship, or it
wouldn’t be included in the question, and you are probably going to have to determine
what that relationship to find the answer is.

Eliminate Answers
 Eliminate choices as soon as you realize they are wrong. But be careful! Make sure you
consider all of the possible answer choices.

 Just because one appears right, doesn’t mean that the next one won’t be even better! The
test writers will usually put more than one good answer choice for every question, so read
all of them.

 Doesn’t worry if you are stuck between two that seem right. By getting down to just two
remaining possible choices, your odds are now 50/50.

 Rather than wasting too much time, play the odds. You are guessing, but guessing wisely,
because you’ve been able to knock out some of the answer choices that you know are
wrong. If you are eliminating choices and realize that the last answer choice you are left
with is also obviously wrong, don’t panic. Start over and consider each choice again.

 There may easily be something that you missed the first time and will realize on the
second pass.

Tough Questions
 If you are stumped on a problem or it appears too hard or too difficult, don’t waste time.
Move on! Remember though, if you can quickly check for obviously incorrect answer
choices, your chances of guessing correctly are greatly improved.

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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
 Before you completely give up, at least try to knock out a couple of possible answers.

 Eliminate what you can and then guess at the remaining answer choices before moving
on.

Brainstorm
 If you get stuck on a difficult question, spend a few seconds quickly brainstorming. Run
through the complete list of possible answer choices.

 Look at each choice and ask yourself, "Could this answer the question satisfactorily?"

 Go through each answer choice and consider it independently of the other.

 By systematically going through all possibilities, you may find something that you would
otherwise overlook. Remember that when you get stuck, it’s important to try to keep
moving.

Read Carefully
 Understand the problem.

 Read the question and answer choices carefully.

 Don’t miss the question because you misread the terms.

 You have plenty of time to read each question thoroughly and make sure you understand
what is being asked.

 Yet a happy medium must be attained, so don’t waste too much time.

 You must read carefully, but efficiently.

New Information
 Correct answer choices will rarely have completely new information included.

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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
 Answer choices typically are straightforward reflections of the material asked about and
will directly relate to the question. If a new piece of information is included in an answer
choice that doesn't even seem to relate to the topic being as ked about, then that answer
choice is likely incorrect.

 All of the information needed to answer the question is usually provided for you, and so
you should not have to make guesses that are unsupported or choose answer choices that
require unknown information that cannot be reasoned on its own.

Time Management
 On technical questions, don’t get lost on the technical terms. Don’t spend too much time
on any one question. If you don’t know what a term means, then since you don’t have a
dictionary, odds are you aren’t going to get much further.

 You should immediately recognize terms as whether or not you know them.

 If you don’t, work with the other clues that you have, the other answer choices and terms
provided, but don’t waste too much time trying to figure out a difficult term.

Contextual Clues
 Look for contextual clues. An answer can be right but not correct.

 The contextual clues will help you find the answer that is most right and is correct.

 Understand the context in which a phrase or statement is made.

 This will help you make important distinctions.

Don’t Panic
 Panicking will not answer any questions for you. Therefore, it isn’t helpful.

 When you first see the question, if your mind goes blank, take a deep breath.

 Force yourself to mechanically go through the steps of solving the problem and using the
strategies you've learned.

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Pace Yourself
 Don’t get clock fever. It’s easy to be overwhelmed when you’re looking at a page full of
questions, your mind is full of random thoughts and feeling confused, and the clock is
ticking down faster than you would like.

 Calm down and maintain the pace that you have set for yourself. As long as you are on
track by monitoring your pace, you are guaranteed to have enough time for yourself.

 When you get to the last few minutes of the test, it may seem like you won’t have enough
time left, but if you only have as many questions as you should have left at that point,
then you’re right on track!

Answer Selection
 The best way to pick an answer choice is to eliminate all of those that are wrong, until
only one is left and confirm that is the correct answer. Sometimes though an answer
choice may immediately look right. Be careful!

 Take a second to make sure that the other choices are not equally obvious.

 Don’t make a hasty mistake. There are only two times that you should stop before
checking other answers.

 First is when you are positive that the answer choice you have selected is correct. Second
is when time is almost out and you have to make a quick guess!

Check Your Work

 Since you will probably not know every term listed and the answer to every question, it is
important that you get credit for the ones that you do know.

 Don’t miss any questions through careless mistakes. If at all possible, try to take a second
to look back over your answer selection and make sure you’ve selected the correct

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answer choice and haven’t made a costly careless mistake (such as marking an answer
choice that you didn’t mean to mark).

 This quick double check should more than pay for itself in caught mistakes for the time it
costs.

Beware of Directly Quoted Answers


 Sometimes an answer choice will repeat word for word a portion of the question or
reference section.

 However, beware of such exact duplication – it may be a trap! More than likely, the
correct choice will paraphrase or summarize a point, rather than being exactly the same
wording.

Extreme Statements
 Avoid wild answers that throw out highly controversial ideas that are proclaimed as
established fact. An answer choice that states the “process should used in certain
situations, if…” is much more likely to be correct than one that states the “process should
be discontinued completely.”

 The first is a calm rational statement and doesn’t even make a definitive,
uncompromising stance, using a hedge word “if” to provide wiggle room, whereas the
second choice is a radical idea and far more extreme.

Healthcare Quality Concepts


• Quality means doing the right things right the first time.

• Quality can be said to be, at least in part, compliance with standards. Standards are
created when experts are able to understand what the right things are and how the right
things are best achieved based on Research and Clinical Evidence

• When recipients of care define quality, they judge whether or not the right things are
done in ways that meet their own needs and expectations.

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• The Institute of Medicine defines quality as:

"The degree to which health care services for individuals and populations
increase the probability of desired health outcomes and are consistent with current
professional knowledge of best practice."

Three Aspects of Quality


• Measurable Quality

• Appreciative Quality

• Perceptive Quality

Measurable Quality
• Can be defined objectively as compliance with, or adherence to standards.

• Clinically, these standards may take the form of practice parameters or protocols, or
they may establish acceptable expectations for patient and organizational outcomes.

• Standards serve as guidelines for excellence.

Appreciative Quality
• Is the comprehension and appraisal of excellence beyond minimal standards and criteria.

• Requires the judgments of skilled, experienced practitioners and sensitive, caring


persons.

• Peer review bodies rely on the judgments of like professionals in determining the quality
or non-quality of specific patient-practitioner interactions.

Perceptive Quality
• Is the degree of excellence which is perceived by the recipient or the observer of care
rather than by the provider of care.

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• Is generally based more on the degree of caring expressed by physicians, nurses, and
other staff than on the physical environment and technical competence.

Q The perception of quality by a patient receiving care in an ambulatory healthcare center


is influenced most by

a. the physical environment.

b. caring staff and physician.

c. new technology.

d. the physician's technical competence.

Dimensions of Quality

Appropriateness
The degree to which the care/intervention is relevant to the patient's clinical needs, given the
current state of knowledge.

Availability
The degree to which appropriate care/intervention is obtainable to meet the patient's
needs.

Competency
The practitioner's ability to produce both the health and satisfaction of customers. The
degree to which the practitioner adheres to professional and/or organizational standards of care
and practice.(Not a JCAHO dimension)

Continuity
The coordination of needed healthcare services for a patient or specified population
among all practitioners and across all involved organizations over time.

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Effectiveness
The degree to which care is provided in the correct manner, given the current state of
knowledge, to achieve the desired or projected outcome(s) for the individual.

Efficacy
The potential, capacity, or capability to produce the desired effect or outcome, as already
shown, e.g., through scientific research (evidence-based) findings.

Efficiency
The relationship between the outcomes (results of care) and the resources used to deliver
care.

Respect and Caring


The degree to which those providing services do so with sensitivity for the individual's
needs, expectations, and individual differences, and the degree to which the individual or a
designee is involved in his or her own care decisions.

Safety
The degree to which the risk of an intervention ... and risk in the care environment are
reduced for a patient and other persons including health care practitioners.

Timeliness
The degree to which needed care and services are "provided to the patient at the most
beneficial or necessary time.

The "appropriateness" of care is:

a. primarily a focus of utilization management

b. a key dimension of quality care.

c. equivalent to "case management”.

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d. the degree to which healthcare services are coherent & unbroken.

A medication is ordered for a diabetic patient its capacity to improve health status, as a
dimension of quality or performance, is its:

a. effectiveness.

b. potential.

c. appropriateness.

d. efficacy.

That dimension of quality/ performance that is dependent upon evaluation by the


recipients and/ or observers of care is:

a. respect/caring.

b. safety.

c. continuity.

d. availability.

If, in the continuous quality improvement process, we increase our emphasis on customer
satisfaction and outcomes of care, which two dimensions of quality/improvement must be
incorporated into all quality management activities?

a. availability and respect/caring.

b. respect/caring and competency.

c. effectiveness and respect/caring.

d. continuity and competency.

Quality Management Trilogy


• Quality Planning

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• Quality Control

• Quality Improvement

Quality Planning includes:

• Identifying and tracking customers, their needs and expectations.

• Designing new or redesigning systems, services, or functions based on customer


needs and expectations.

• Identifying function and process issues critical to effective outcomes; and


developing new processes capable of achieving the desired outcome.

• Setting quality improvement objectives based on strategic goals.

Quality Control/Measurement includes:

• Developing process and outcome performance measures.

• Measuring actual performance and variance from expected.

• Summarizing data and performing initial assessment/ analysis.

• Measuring and describing process variability.

• Measuring and tracking outcomes of populations.

• Performing intensive assessment as data dictates.

• Providing accurate, timely feedback.

• Using the data to manage, evaluate effectiveness, maintain Quality Improvement


gains, and facilitate Quality Planning.

Quality Improvement includes:


• Collaboratively studying and improving selected existing processes and outcomes
in governance, management, clinical, and support activities;

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• Analyzing causes of process failure, dysfunction, and/or inefficiency;

• Systematically developing optimal solutions to chronic problems;

• Analyzing data/information for better or best practice.

The Quality Management Cycle, based on Juran's Quality Trilogy (quality planning,
quality control, quality improvement)

a. excludes the lab's activities to monitor equipment.

b. requires a departmentalized approach to quality management.

c. encompasses only the non clinical aspects of QM.

d. incorporates information from strategic planning.

That function in the Juran Quality Management Cycle that includes the initial analysis of
data/information is

a. quality planning.

b. quality initiatives.

c. quality control/measurement.

d. quality improvement.

Quality Management Principles


• Leadership commitment is the Key.

• Focus on systems not on individuals.

• All decisions are based on information derived from reliable data.

• Quality is what is perceived by the customer as quality.

• Quality management is preventive and proactive not reactive or a quick fix.

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• Quality empowers people; it does not police them.

• The modern approach to quality is thoroughly grounded in scientific and statistical


thinking.

• Total employee involvement is critical.

• Sound customer-supplier relationships are absolutely necessary for sound quality


management.

• Productive work is accomplished through effective structure and efficient processes.

• Defects in quality come from problems in processes. Understanding the variability of


processes is a key to improving quality.

• Quality measurement should focus on the most vital processes.

• Poor quality is costly.

The major difference between traditional "quality assurance" activities and the expanded
quality improvement/performance improvement activities is the QI/PI focus on

a. people and competency.

b. analysis of data.

c. performance measures.

d. systems and processes.

In the transition from quality assurance to quality management/quality improvement,


which of the following emphases has resulted in the most significant benefit?

a. Focusing primarily on process rather than individual performance

b. Focusing on organization wide rather than clinical processes

c. Organizing activities around patient flow rather than department or discipline

d. Initiating more prospective rather than retrospective improvement efforts

Structure, Process, and Outcome


Structure: is the arrangement of parts of a care system or elements that facilitate care; the care
environment; evidence of the organization's ability to provide care to patients, e.g.:

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• Resources

• Equipment

• Numbers of staff

• Qualifications/credentials of staff

• Work space

Process: refers to the procedures, methods, means, or sequence of steps for providing or
delivering care and producing outcomes. In other words, processes are activities that act on an
"input" from a "supplier" to produce an "output" for a "customer" e.g.

• Clinical Processes

• Care Delivery Processes

• Administrative and Management Processes

Outcome: refers to the results of care, adverse or beneficial e.g.

Clinical:
• Short-term results of specific treatments and procedures

• Complications - Adverse events - Mortality

Functional:
• Long-term health status

• Activities of daily living (ADL) status

Perceived:
• - Patient/family satisfaction

Monitoring the specific organization and content requirements of a medical record


system is a review of which focus?

a. Outcome of care

b. Process of care

c. Structure of care

d. Administration of care
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Monitoring phlebitis associated with IV insertions by nurses in the Surgical Intensive Care
Unit addresses which focus?

a. Outcome of care

b. Process of care

c. Structure of care

d. Administrative procedure

Which of the following best describes the successful outcome of the quality improvement
process?

a. Customer satisfaction

b. Enhanced communication

c. Employee empowerment

d. Improved statistical data

What is the most important relationship between structure, process, and outcome as types
of indicators of quality?

a. Interdependent: Structure directly affects both process and outcome.

b. Causal: Structure leads to process and process leads to outcome.

c. Relational: Useful for comparisons, but not causal

d. There is no relationship; they are categories used to group indicators.

Review of the timeliness of high risk screening for diabetes addresses which focus?

a. Outcome of care

b. Process of care

c. Structure of care

d. Administrative procedure

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The Concept of Process Variation
Variation is "change or deviation in form, condition, appearance, extent, etc., from a former or
usual state, or from an assumed standard." "Variation" generally refers to the whole process or a
step in the process.

Variance is "a changing or tendency to change; degree of change or difference; divergence;


discrepancy." This term generally refers to specific data or information.

Clinical Variation
• Variation in clinical practice has been defended in the past as the "art" of medicine.

• In fact, variation can be either positive or negative.

• In healthcare quality, we tend to think of variation as negative or adverse, based on the


quality assurance case-specific review tradition.

• Sometimes the art of medicine creates a "best practice," which we now try to capture and
replicate as part of quality improvement process.

Process Variation
1. Common Causes

Random or common cause:


• Intrinsic to the process itself;

• naturally occurring inliers.

“Example: patient response to medication will always vary, within the cohort of patients and
even for one patient over time.“

• Common causes" refer to situations, usually within patient care systems and processes
(within the normal, bell-shaped curve) that are more ongoing, chronic, and persistent.

• These common causes contribute to the "normal range of variation" within a process.

• The goal of quality improvement is not to eliminate, but to reduce variation in a process
enough to produce and sustain "stability. “

• Common causes may also contribute to what are considered to be the less than desirable
parts of a process.

• Usually finding and resolving common causes of problems or variation is more time-
consuming and may be more difficult for departments, services,

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• The resolution of common causes of problems is often considered to be key, however, to
continuous, incremental improvement of the quality of care and services rendered to
patients

2. Special Cause
• Special cause:

• Extrinsic to the usual process;

• related to identifiable patient or clinical characteristics,

• Idiosyncratic practice patterns, or other factors that can be tracked ("assigned") to


root causes.

• "Special causes" refer to sentinel events, one-time occurrences, or other unique,


out-of-the-ordinary circumstances that give rise to a variation from what is
normally expected.

• Special causes are usually more easily identified and resolved, either by departments or
QI teams.

• Special causes account for the majority of what we call "outliers"-those problems that
occur in the "tails" of a normal, bell-shaped curve representing a particular process.

Statistical Process Control


• Walter Stewart’s causes of variation led him to develop a methodology to chart the
process and quickly determine when a process is "out of control.

• This ongoing measurement and analysis is known as "statistical process control (SPC)."

• As long as assignable or special causes of variation exist, we cannot make accurate


predictions about process performance and probable outcome.

• Once assignable causes are eliminated, we can call the process "stable" and can measure
the "capability of the process" by rates of deficiencies or rates of achievement of desired
outcomes.

• At this point we have the data we need to perform the in-depth analysis that leads to
improvement. [See also "Statistical Process Control" and Control Chart in "Graphic
Representations of Comparison Data,"

The Pareto Principle:


Prioritizing Variation

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• Joseph Juan noted that approximately 80% of observed variation in processes was
generally caused by only 20% of the process inputs.

• He called this phenomenon the "Pareto Principle,"

• The "80%" and "20%" are relative figures, representing relationship, not absolute
calculations.

• In prioritizing for quality improvement, it makes sense to identify and focus on those
20% of process issues that make up 80% of the variation.

Juran calls this prioritized 20% the "vital few.

Examples of application of the Pareto Principle


• 20% of the possible reasons for dissatisfaction with an ambulatory clinic are responsible
for 80% of the recorded dissatisfaction on the survey, enabling the QI team to prioritize
improvement efforts..

• 80% of a physician's practice or a hospital's admissions is accounted for by 20% of the


classes of diagnoses providing a focus for practice guidelines and disease management..

• 20% of a healthcare organization's patients account for 80% of the case managers' time,
again providing data for prioritizing the development of clinical paths and disease
management protocols.

"Common causes" of problems in processes refer to?

a. one-time situations.

b. temporary situations.

c. acute situations.

d. chronic situations

Applying the Pareto Principle in quality improvement is?

a. prioritizing process issues.

b. tracking and measuring process effectiveness.

c. providing meaningful data to support strategic objectives.

d. prioritizing patient outcome issues.

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Special cause variation is to the process?

a. random, extrinsic, outlier.

b. assignable, intrinsic, noise.

c. random, inlier, identifiable.

d. assignable, extrinsic, outlier.

When common cause process variation is identified, the goal of quality improvement is to

a. promote compliance with established procedure or protocol.

b. eliminate the variation.

c. improve practitioner competency.

d. reduce variation sufficiently to produce stability.

After first describing the problem, the best way to look at "patterns of behavior" over time
is to use?

a. storytelling and "The Five Whys."

b. brainstorming and constructing gap hypotheses.

c. line graphs and story telling.

d. Pareto charts and brainstorming.

In statistical process control, it is important to first?

a. eliminate assignable causes of variation.

b. eliminate random causes of variation.

c. prioritize causes of variation.

d. eliminate all causes of variation.

The Concept of Outcomes Management


• “Outcomes Management" refers to a "technology of patient experience designed to help
patients, payers, and providers make rational medical care-related choices based on
better insight into the effect of these choices on the patient's life" [Ellwood, 1988].

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• The resulting data, called outcome measures, are measures of performance.

Outcomes management should consist of


• A common language of health outcomes, understood by patients;.

• A national reference database containing information and analysis on clinical, financial,


and health outcomes, estimating:-

• Relationships between medical interventions and health outcomes –

• Relationships between health outcomes and money spent.

• Opportunity for decision-makers to access analysis relevant in making choices.

Outcomes management depends on the following four developing techniques


1. Practitioner reliance on standards and guidelines in selecting appropriate interventions

2. Routine and systematic measurement of the functioning and well-being of patients, along
with disease-specific clinical outcomes, at appropriate time intervals

3. Pooling of clinical and outcome data on a massive scale

4. Analysis and dissemination of results (outcomes) from the segment of the database
pertinent to the concerns of each decision maker

The task of setting up an ambulatory care setting QM/QI program that focuses on
"outcomes" as a measure of treatment effectiveness is difficult because:?

a. the patient remains in control of treatment.

b. patient care outcomes are determined by the payer.

c. there are no required medical records.

d. expected outcomes for ambulatory conditions are too obvious.

The centerpiece of "outcomes management" in healthcare is?

a. the measurement of the patient's functionality and quality of life.

b. morbidity and mortality.

c. data reliability.

d. financial impact.

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System Thinking
• A body of principles, methods, and tools focused on the interrelatedness of forces in
systems operating for a common purpose.-

• The belief that the behavior of all systems follows certain common principles, the nature
of which can be discovered, articulated, understood, and used to make change.

• According to David Mc Camus, former chairman and CEO of Xerox Canada, systems
thinking "requires 'peripheral vision': the ability to pay attention to the world as if through
a wide-angle, not a telephoto lens, so you can see how your actions interrelate with other
areas of activity"

Definitions

• System: perceived whole whose elements 'hang together' because they continually affect
each other over time and operate toward a common purpose"

• Systemic structure: Not just the organizational chart, but the pattern of interrelationships
among all key components of the system:

• Process flows-

• Attitudes and perceptions-

• Quality of products and services –

• Ways in which decisions are made –

• Hierarchy, and

• Systemic structures may be visible or invisible, built consciously or


unconsciously based on choices and decisions made over time.

• Interrelationships are discovered by asking the question: "What happens if it (process,


perception, attitude, task, etc.) changes?"

Steps in Systems Thinking


1. Describe the problem (one that is chronic, limited in scope, with a known history) as
accurately as possible, without jumping to conclusions.

2. Tell the story; build the model, providing as many divergent ideas as possible.

3. Ask the question: "How did we-through our thinking, processes, practices, procedures-
contribute to or create the circumstances, good and bad, that we now face?
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4. Look for causality:-causal relationships between events or patterns of behavior

5. Apply an "Archetype" or pattern of performance to fill in gaps in thinking and construct


consistent hypotheses about the governing forces in systems.

6. Determine strategies for solution and their ramifications.

7. Redesign the system. You know you have a good intervention when you can see the long-
term pattern of behavior shift qualitatively

Customer Satisfaction
• Customer/supplier Relationships

• Customer needs & expectations

• Measurable characteristics of the process agreed to

Guiding principles of good customer service

Identify Customers
• Internal

• Nursing

• Pharmacy

• Laboratory

External

Patients

Physicians

Community

Regulatory

Payers

Tools Used To Identify Customers & Their Needs


• Identify Customers:

• Wheel & Spoke” “Sundial”

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• Customer lists by type e.g. internal & external

• Customer lists by categories e.g.:

• Patients & families

• Practitioners / clinicians

• Suppliers / Vendors

• Provider organizations ….etc

• Identify Customer needs:

• Surveys

• Assigned interviews

• Focus groups

• Research

Brainstorming

Guiding Principles of Good Customer Service


• Pay attention to your customer's needs; a successful, long-term relationship with your
customer is built day by day

• Own your customer's problem as if it were your problem

• Be courteous to your customer

• Be positive about all aspects of your relationship with your customer

• Show through every action that your customer is important to you

• Distinguish your product or service through the quality of its delivery to the customer

• Turn a loss into a win by providing prompt and courteous attention to your customer
when your product or service fails; remedy the situation through effective service

• Look at all situations through the eyes of your customer, see your product or service as if
for the first time

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• Every job, with all its tasks, decisions, and responsibilities, is important, since every
action affects the customer

• Only the customer's perception of your product or service counts for quality

Healthcare Customer Expectations in the 21st Century


• Healthcare customers provide the perceptive quality

• Both internal and external customers tend to focus on how services meet their perceived
needs and whether their expected outcomes are met.

• Patients add the degree of caring associated with the service and the outcome of the care
related to their sense of well-being and quality of life to the interpretive mix.

Expectations from Leadership


• Leadership integrity before dollars;.

• Leadership sensitivity to needs for:

• More personalization and genuine attention;

• More time for physician caring and compassion.

• Leadership involvement in the local community.

• Leadership attention to the organization's financial health to assure high quality clinicians
and technology

Expectations from Healthcare Delivery


• More attention to the empowered, informed customer/patient more apt to challenge
"doctor's orders”

• Reduced hassle, more convenience;

• More practitioner time (lack of time perceived as disrespect);- Child-centered orientation;

• Acceptance and coverage of "alternative" approaches.

Expectations from Healthcare System


• Choice of physician and treatment

• Optimizing prevention

• Access for all


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• High quality and cost control

• Up-to-date technology for diagnosis and treatment

The Healthcare Customer Focus


• Being truly committed to delivering value to patients and other customers;.

• Listening to and communicating with patients and other customers;.

• Seeking customer feedback and insight for strategic initiatives and quality improvement
activities;

• Identifying and addressing true needs and value-based expectations;.

• Committing to long-term, rather than quarterly (shareholder) business results; .

• Optimizing treatment patterns and outcomes for cohorts of similar patients:-

• Clinical

• Functional

• Enhancing the performance of internal processes to benefit:-

• Patients-

• Vendors

• All who work there.

• Respecting patient confidentiality/ privacy and security needs;.

• Responding timely to practitioners', providers', and purchasers' appropriate requests for


information;.

• Building trust, respect, and loyalty in relationships.

In developing a program to evaluate the effectiveness of physician care, a primary care


clinic would select which one of the following indicators?

The patients will express overall satisfaction with clinic facilities.

b. The contract lab will provide results within 24 hours of sample delivery.

c. The staff complies with all infection control policies and procedures.

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d. Newly diagnosed hypertensive patients are controlled within 6 months.

HealthCare Delivery Settings


Emergency care is:

• Designated hospital trauma centers,

• Emergency department of hospitals,

• Urgent care centers or

• “in the filed” by paramedical personnel

Acute inpatient (hospital) care


• Intensive/critical care

• Urgent, elective or rehabilitative care considered unsafe as outpatient depending on:

• Type of diagnostic or therapeutic procedure or

• Patient condition including need for daily physician visit & 24 hour nursing care

Urgent care for immediate care for urgent or emergent conditions not requiring treatment at a
fully equipped (level I) emergency or trauma center.

Ambulatory care including

• Primary care,

• Specialty care, &

• Ambulatory surgery centers providing outpatient services only

• “in-store health clinics” opened in pharmacy & retail chains generally staffed by nurse
practitioners offering patients fast access to routine medical services.

• Home care providing certain treatments, services & nursing care in the patient’s home

• Hospice care providing psychological, medical & nursing care to the terminally ill & their
families, either in outpatient or non acute inpatient settings.

• Transitional, sub acute & skilled care provide medically necessary nursing services
requiring licensed professionals or professional oversight that must be provided daily &
for therapeutic purposes at a stage of care between acute hospital & custodial.

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• Assisted Living is group residential setting providing or coordinating personal & health-
related services & 24 hours supervision & assistance.

• Long term care is Custodial or supportive nursing services that do not require skilled,
licensed professional intervention.

• Behavioral Health & substance abuse programs: are

• Partial hospitalization or :”nonresidential” including day or evening treatment.

• Crisis stabilization in the home

• Residential.

• Wellness & community health are centers provide special training, education &
monitoring for certain healthcare needs such as stop-smoking, weight control, stress
reduction programs or for certain patient group “with leukemia”

Patient safety
Look-Alike, Sound-Alike Medication Names

Patient Identification Communication during Patient Handovers

Performance of Correct Procedure at Correct Body Site –Control of Concentrated Electrolyte


Solutions – Assuring Medication Accuracy at Transitions in Care

Quality Assurance in Health care

Components of Quality Care:


 Safe

 Effective

 Patient Centred

 Efficient

 Equitable

 Timely

 Quality Assurance is that set of activities that are carried out to previously Set Standards
to monitor and improve Performance so that the care provided is as effective and as safe
as possible.

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 Component of Quality Management that ensures the Right things are being done- based
on Standards and Established Goals.

 Systematic Process of checking if a Healthcare Service is meeting Specified


Requirements

 Helps reduce waste and unnecessary activities and improve Service Delivery

Quality Assessment Methods

System Performance
Health Priorities, System Planning, Financing and Resource Allocation done at National Level &
Global Level.

General Environment of the Country, Legislation & Other Regulatory Mechanisms, Professional
Recognition and Overall Quality Management.

Institutional and Clinical Performance

External Assessment
 ISO, Accreditation, Licensing, EFQM, Peer Review

Internal Self-assessment
 Patients Rights, Risk Management, Clinical Governance, Clinical Audit, Performance
Indicators & Benchmarking

4 Tenets of Quality Assurance:


• Oriented toward meeting the needs and expectations of the Patients and other Users.

• Focused on systems and processes.

• Use data to analyse service delivery processes.

• Encourage a team approach to Problem Solving and Quality Improvement.

Developments in Quality Assurance:

• 1859- Florence Nightingale introduced the first standards in nursing care during the
Crimean War

• 1913-American College of Surgeons(ACS)- Minimum Standards for Hospitals

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• 1951-Joint Commission- ACS , American College of Physicians, American Hospital
Association, Canadian Medical Association, American Medical Association

 1966-Avedis Donabedian- ‘Evaluating the Quality of Medical Care’

Structure| Process | Outcome


 1998- International Society for Quality in Healthcare (ISQUA) ALPHA Program

 2004-WHO- World Alliance for Patient Safety

Quality: Degree of the realisation of the reasons that the Patient has come to the care hospital
e.g. patient comes to Hospital for an Operation.

Safety: Results which are not the reasons for the Patient coming e.g. ‘not catching an
infection’ and he is implicitly confident he will not run the risk of this happening.

Quality Improvements:
Hospitals have taken steps to reduce medical errors and injuries.

Examples:

 Computerized prescriptions: 81% decrease in errors.

 Including pharmacist in medical team: 78% decrease in preventable drug


reactions.

 Team training in delivery of babies: 50% decrease in harmful outcomes — such


as brain damage — in premature deliveries.

Source: Journal of the American Medical Association

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Classification of Medical Errors-

Near Miss: is defined as an act could have harmed the patient but did not do so as a result of:

Chance e.g. patient received a contraindicated drug but did not experience an adverse drug
reaction

Prevention e.g. a potentially lethal over-dose was prescribed, but a nurse identified the error
before administering the medication

Mitigation e.g., a lethal drug overdose was administered but discovered early and countered with
an antidote.

Adverse Events cause harm to patients—causing a large number of injury, disability, and death.

Errors of Commission
• Prescribing a medication that has a potentially fatal interaction with another drug the
patient is taking.

Errors of Omission
• Failing to prescribe a medication from which the patient would likely have benefited,
which may pose an even greater threat to health?

Why Do Errors Occur—Some Obstacles


 Workload fluctuations

 Interruptions

 Fatigue

 Multi-tasking

 Failure to follow up

 Poor handoffs

 Not following protocol & standard operating procedures

 Poor Leadership

 Breakdown in Communication

 Breakdown in Teamwork

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 Losing track of Objectives

 Excessive professional courtesy

 Complacency

 High-risk phase

 Task (target) fixation

Team Strategies & Tools to Enhance Performance & Patient Safety

Quality Assurance ensures Safety by assessing:


 Adverse Event Reporting

 Patient Safety Culture

 Leadership Support of Patient Safety

 Adverse Event Analysis

 Adverse Event Prevention

 Communication and Feedback

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 Patient Involvement in Care

 Environment of Care

Accreditation Standards:
 Hospital has a Patient Safety Program

 Hospital Risk Management Program

 Specific Prevention Programs

 Transfusion Safety Program

 Procedures for identifying Patients Correctly

 Conducts Periodic Patient Safety Training

 Effective Communication Techniques

 Ensures Safety of High-Alert Medications

 Ensures Correct-Site, Correct-Procedure, Correct-Patient Surgery

 Procedures for reducing Health Care–Associated Infections

 Hand Hygiene Standards

 Reduce Patient Harm Resulting from Falls

 Conducts Risk Management & Infection Prevention for Healthcare Professionals

 Hospital has Procedures for handling, storage, preparation & distribution of foodstuffs

 Ensures Radiation Safety


Ensures Injection Safety

QUALITY ASSURANCE
Quality assurance is a range of activities (including review, evaluation, surveillance, and
appraisal and monitoring) which collectively comprise the intelligence gathering arm of quality
assurance.
These are: - * Quality consists of doing those things necessary to meet & exceed the needs &
expectations of those we serve & doing those right things right every time.

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Review is the process of critical reflection used by clinicians wishing to assess their own (or their
peers) performance

Audit is the activity of review when conducted on a continuous and routine basis.

Evaluation is one-off assessment of the impact of a service on indices of health

Surveillance is routinely repeated evaluation

Appraisal is ad hoc data collection and analysis by management in relation to health care
delivery

Monitoring is ongoing appraisal

WHAT IS QUALITY?
 Quality is not a number but is a function of positive perception.

 Quality, simplistically, means that a product should meet one‟s requirement.

 Quality is the inherent characteristic & distinctive attribute that makes a product different
from others.

 Ensures conformity to requirement.

 Products & services should be essentially free from defects, there by becoming cost
effective.

 Quality consists of doing those things necessary to meet &exceed the needs &
expectations of those we serve & doing those right things right every time.

 It is the result of good intention, sincere effort, intelligent thinking and skillful execution.

 All dimensions like accessibility, appropriateness, continuity, effectiveness & efficiency


must be given equal importance in quality.

QUALITY MANAGEMENT
It is a holistic approach to the art of managing quality output considering together the people,
process and products rather than independent factors and driven towards the objective with
effective &efficient performance output”.

QUALITY REQUIREMENTS
1. Customer participation in QM

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2. Leadership for the steering of quality

3. Personnel as a prerequisite for high quality;

4. QM for preventive as well other activities;

5. Management of processes as a basis for QM;

6. Information as a basis for the continuous enhancement of quality;

7. Systematization of QM;

8. Feed back and detailed recommendations;

9. Quality criteria support quality management;

To provide care as per


• Accessibility

• Social Equity established norms

• Affordability

• Effective public

• Doing the right thing resource utilization

• Prompt attention

• Doing it the right way

• Standardized care

• Doing it right the first

• Less waiting time

• Cost contentment time

• Receiving the right

•Satisfaction of both

• Doing it on time service for their use provider and receiver without exceeding cost

• Being satisfied that their

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• Fruitful outcome

• Availability of needs have been met

• Profit margin adequate resources

• Early cure and return to

• Satisfaction with the work final outcome

• Being treated with

• Helps in improving integrity, courtesy and skills, efficiency and respect experience.

DIMENTIONS OF QUALITY
Joint commission on Accreditation of Health care organizations (JCAHO) has described the
following criteria’s as quality dimensions (safety, effectiveness, efficiency, timeliness, efficacy
and equity Respect and caring, availability, appropriateness), RESPECT AND SAFETY
TIMELINESS CARING EFFICACY EFFECTIVENESS EFFICIENCY APPROPRIATENES
CONTINUITY AVAILABILITY S/ EQUITY

Reduction in ADVANTAGE OF QUALITY

• Improved care wastage

• Shorter lead times– Better team spirit

• Better relationship with– Less staff conflict, customer’s enhanced job

• Reduced cost, increased satisfaction profit– Increased efficiency

• Improved systems and– Confidence to standardized procedures clients,

• Better workmanship,– less customer • Guaranteed quality complaints,– lower rejection rates,
less rework

PARTS OF THE QUALITY SYSTEM


Organization Personnel Equipment Process Purchasing Control Information (QC & EQA) &
Inventory & Specimen Management. Management nt Documents Occurrence Management
Assessment & Records nt Process Customer Facilities & Improvement Service Safety CDC.

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Patients •Inventory Methods • Physiologic •Equipment •Coordination parameters •Supplies
•Physician orders •Functional status •Training •Nursing Care •Environment •Ancillary staff OUT
COME •Housekeeping •Transport • Patient Satisfaction •Cost.

A. INPUT: Input is what we invest inputs are the various needs and resources that projects can
draw upon as it sets out to accomplish its work. Inputs include resources like manpower, data,
and money and materials.

B. PROCESS: Process is the ensemble of activities of planning, implementing and monitoring


the performance of an activity. Process manipulates the inputs to get the output. It includes
functions, actions, and operations. Process management is the application of knowledge, skills,
tools, techniques, and systems to define, visualize, measure, control, report and improve
processes with the goal to meet customer requirements.

C. OUTPUT: Outputs, are the results of processes, which include products, information, and
reports. It disseminates (output) data and information and provides a feedback mechanism to
meet an objective. Outputs are the results of processes.

D. OUTCOME

•It is the Impact of a process.

•It may be a level of performance, or achievement.

•It may be associated with the process, or the output.

reduction, Product appreciation or client satisfaction.

- Short Term (learning: awareness, knowledge, skills, motivations)


Medium Term (action: behavior, practice, decisions, policies) Long Term (consequences: social,
economic, environmental etc.)

COMPONENTS OF QUALITY SYSTEM


1. INPUTS

•Adequate buildings and working space

•Necessary equipments always available and functioning

•Necessary medications and medical supplies always available

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•personnel

•Anybody who touches the patient or a relevant process in the system:-Departments, physicians,
clerks, pharmacy, nursing, OT, ICU, care technicians, phlebotomist, patient transport,
administration

2. PROCESSES

All those affecting relevant aspects of patient care:-Clinical decision making, order writing,
admission intake, medication delivery, direct patient care, discharge planning, communication,
discharge follow-up, etc

OUTPUT
•Which are the end result of the process:- Physiologic parameters, (Meeting standards )functional
status, (Efficiency, Effectiveness, Quality)

OUTCOME This is the end result of the output Patient satisfaction Cost

QUALITY SYSTEM
Quality does not happen by chance

Quality needs to be systematically developed with objective planning, staff involvement and
considering patient need.

DEVELOPING A QUALITY SYSTEM

QUALITY SYSTEM

STAGE 1
Chief executive of the firm should commit to quality assurance by declaring quality policy e.g.
„Towards total customer satisfaction

‟Make formal statement of the objectives e.g. „ To achieve ISO 9002certification in 18 months

‟Organizing management structure and defining responsibilities following the above activities

STAGE 2 –Examine and review the existing internal documentation, activities and procedures
prior to preparation of quality manual and quality procedures i.e. quality system

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STAGE 3 –Apply general quality procedures to specific contracts when the quality system is
completed and fully approved internally. Staff should be familiar with quality assurance and
understand their roles but training is required.

STAGE 4 –Prepare quality plans and additional quality procedures for specific contracts.

STAGE 5 –Apply quality plans to specific contracts. Training may be necessary.

STAGE 6 –Internal and external audit of quality system; review periodically all quality manuals
and procedures.

QUALITY MANAGEMENT
It is a holistic approach to the art of managing quality output considering together the people,
process and products rather than independent factors and driven towards the objective with
effective & efficient performance output.

ELEMENTS OF QUALITY MANAGEMENT


Errors in the hospital are invariably due to system failure in85% of cases (Edward Deming).

Only 15% are attributed to people‟s performance.

Therefore attention should be given on bad system than bad people.

Improvement of systemic errors can be done by:-

Commitment of TOP Management,

Active support of Middle management.

Education and training of staff.

Formation of quality management team.

Developing Quality culture in the work place.

Making aware all staff about the goal and objective of the organisation.

Developing quality policy and quality manual.

Developing Standard Operating Procedure for all areas (SOP)

Good Hospital Information System (HIS).

Formulation of criteria’s and Standards for measuring activities.

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Constant monitoring and Supervision and feed back.

Introducing Medical Audit System.

Rectification of errors and Evaluation.

External quality control.

QUALITY MANAGEMENT vs. TQM Quality element Previous state (Traditional)

Total Quality Management : Definition Product oriented Customer oriented Priorities Second to
service and Cost First among the equals of service and cost Decisions Short term Long term

Source: Basterfieldet al, 2002 pp3)

Emphasis on Detection Prevention Errors Operations System Responsibility Quality Control


Every one Problem solving Managers Teams Procurement Price Life cycle costs, partnership
Manager‟s Role Plan, assign, control and Delegate, coach, facilitate and enforce mentor

• Inadequate financing

Large gap between demand &investment supply

• No regionalization of Med

• Lack of motivation, misuse &care policy pilferage.

• No strict referral system • Poor budgetary planning

• Political and beaurocrate •Unionism internal conflicts interference

• Lack of latest gadgets

• Lack of regular re-orientation

• Poor handling of

• Training in advancement of grievances/complaints technology

• Lack of standing guidelines/procedures

• Evaluation of care from patient/relatives

QUALITY DEMAND
(Four elements of quality service)

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Customer satisfaction continuity commitment in improvement of staff quality expectation of
patient and staff

Emphasis Detection Prevention Errors Operations System Responsibility Quality Control Every
one Problem solving Managers Teams Procurement Price Life cycle costs, partnership
Manager’s Role Plan, assign, control and Delegate, coach, facilitate and enforce mentor.

Which approaches could be used to improve quality and patient safety in hospitals?
Increasing resources: increasing the financing, personnel, facilities or equipment used in a
hospital or health system, with the aim of treating more patients or treating the same number
faster, better and at lower cost-per-person. Large-scale reorganization or financial reform:
changing the structure of a hospital or health system so as to facilitate better decision-making or
use of resources. Changes in financing methods are made as a way of improving quality.

Strengthening management: improving quality by increasing management responsibilities,


authority or competencies. It is sometimes used as part of other types of strategy. Standards and
guidelines: formulating standards of what is expected from health providers, communicating,
providing training in, and enforcing the standards. Examples are the United Kingdom’s national
standards frameworks (8), the Zambian national technical standards, and clinical practice
guidelines for various health conditions (9). Most medical and clinical audits fall within this
category (10), as well as some approaches called “quality assurance” (11) and “clinical
pathways” (12).

Patient empowerment and rights: giving patients a voice, for example through complaints
systems or patient satisfaction questionnaires, as well as publicizing what patients have a right to
expect. There may also be methods to strengthen patient power through legal entitlement,
advocacy or other institutions, such as a right to treatment within 30 minutes of arriving at an
emergency room.

Quality management system: defines responsibilities for quality and puts into place the
structures and systems to ensure it. The International Organization for Standardization (ISO)
issues guidelines to design quality management systems.

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Quality assessment and accreditation, internal or external: There are many assessment systems
the best known in Europe is the European Foundation for Quality Management system, based on
the American Baldridge Award system. A related strategy is voluntary or compulsory external
quality assessment by a third-party peer review organization, or governmental body. This may or
may not involve issuing formal accreditation. Accreditation systems differ in which aspects of
hospital operations are assessed and whether quality outcomes are considered in the assessment .

Total quality management (TQM) and continuous quality improvement (CQI): TQM is a set of
principles and methods applied in many different ways, originating from organization-wide
industrial quality programmes. This strategy focuses on attention of personnel and on providing
the best patient experience and outcomes.

Quality tools are used by multidisciplinary teams of workers to make changes, and the approach
is generally thought to require strong management leadership. It is based on a view that quality
problems are more often due to poor organization than to individual faults. CQI is the same as
TQM in most literature, although it sometimes refers to a concentration on multidisciplinary
project teams analyzing work processes and using repeated cycles of testing small changes.

Quality collaborative:
The strategy is to bring together project teams from many different hospitals. The teams typically
meet every 3 months over 9 months to learn and apply quality methods and to report their
progress. It was devised to provide an economical way to learn models of effective practice and
quality methods, to stimulate enthusiasm and get faster results than are usually obtained by
CQI/TQM strategies.

Re-engineering: uses some of the TQM methods, but includes a more radical redesign of
“production processes” than the TQM approach, which normally involves small-scale and
incrementally tested changes.

Quality indicator comparison: seeks to motivate patients, clinicians and others to use
information about quality to make improvements, but is not prescriptive. It can be used by one
hospital taking part in a comparative data gathering programme or as a voluntary or compulsory

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strategy for hospitals in an area to collect and report the same data. Some comparison systems
are public and promoted to encourage both patients and providers to take action to improve
quality.

Benchmarking: uses comparative information about quality with additional methods to help
providers decide how to improve quality. There are specific methods for identifying,
documenting and applying the best practices.

Risk management and safety: identifies high risk procedures or situations that put the hospital at
financial risk from patient claims. It includes methods for diagnosing causes of adverse events.
Patient safety strategies often include risk management and a wide range of methods from other
industries for collecting and analyzing adverse event or near miss reports with a view to
prevention.

Decision-makers should be aware that the same strategy applied in a different place may well
yield different results, even if fully implemented. Attention needs to be paid to financial, cultural
and other conditions surrounding implementation. 4. Having chosen one type of quality strategy,
one should review it regularly and adapt it to changing situations and the responses of the
interested personnel. Efforts should be made to assess whether any lack of results is due to the
wrong strategy, poor implementation, or the time required for results to become measurable.
Close monitoring using a range of types of information can assist this assessment. 5. It is
possible that applying a consistent quality strategy over time is more likely to be effective than
changing to another approach. Flexibility without sudden radical change appears to be important.
“It ain’t what you do; it’s the way that you do it.”

What is Quality?
The quality of technical care consists in the application of medical science and technology in a
way that maximizes its benefits to health without correspondingly increasing its risks. The
degree of quality is, therefore, the extent to which the care provided is expected to achieve the
most favorable balance of risks and benefits. - Avedis Donabedian, M.D., 1980.

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Total quality management: Doing the right thing right, right away.

To the ordinary person, quality is how good something is. This may be a service e.g. canteen
service or a product eg. wrist watch. A person's judgement about a service or product depends on
what he expects of it or from it. Some of the words used to describe quality are: Beautiful or
attractive Durable Meeting standards Healthy Value for money although different words are used
to explain quality, we would define it as the extent to which a product or service satisfies a
person or a group i.e. how much satisfaction the person gets from the service.

When we say quality of care, we mean healthcare activities that we in the medical, nursing,
laboratory fields etc. perform daily to benefit our patients without causing harm to them. Quality
of Care demands that we pay attention to the needs of patients and clients. We also have to use
methods that have been tested to be safe, affordable and can reduce deaths, illness and disability.
Furthermore, we are expected to practice according to set standards as laid down by clinical
guidelines and protocols.

With Quality of Care we do the right things at the right time. We see to patients promptly, make
the right diagnosis and give the right treatment. With quality of care we keep on improving on
our standard of services till excellence is attained.

Dimensions of Quality: QA activities may address one or more dimensions, such as technical
competence, access to services, effectiveness, interpersonal relations, efficiency, continuity,
safety, and amenities.

1. Technical Competence
Technical competence refers to the skills, capability, and actual performance of health providers,
managers, and support staff. Technical competence relates to how well providers execute
practice guidelines and standards in terms of dependability, accuracy, reliability, and
consistency. This dimension is relevant for both clinical and nonclinical services. For health
providers, it includes clinical skills related to preventive care, diagnosis, treatment, and health

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counseling. Competence in health management requires skills in supervision, training, and
problem solving. The requisite skills of support staff depend on individual job descriptions.

A lack of technical competence can range from minor deviations from standard procedures to
major errors that decrease effectiveness or jeopardize patient safety. Technical competence as an
indicator of quality assurance implies that we should have adequate knowledge and skills to
carry out our functions in order to provide quality service. E.g. one must go to a nursing school
and pass the nursing examinations before she can work as a nurse. Even though we are no longer
in school, we have to continue to update our knowledge by reading health books and attending
in-service training workshops etc.

As health professionals, we should also know our limits, that is, know what we can do and what
we cannot do. With respect to what we cannot do, we are expected to refer them to other centers
or personnel who are more competent to handle them. Our practice should also be guided by laid
down standards and guidelines e.g. Standard Treatment Guideline.

Access to Services:
Access means that health care services are unrestricted by geographic, economic, social, cultural,
organizational, or linguistic barriers. Geographic access may be measured by modes of
transportation, distance, travel time, and any other physical barriers that could keep the client
from receiving care. Economic access refers to the affordability of products and services for
clients. Social or cultural access relates to service acceptability within the context of the client’s
cultural values, beliefs, and attitudes. For example, family planning services may not be accepted
if they are offered in a way that is inconsistent with the local culture. Organizational access
refers to the extent to which services are conveniently organized for prospective clients, and
encompasses issues such as clinic hours and appointment systems, waiting time, and the mode of
service delivery. For example, the lack of evening clinics may reduce organizational access for
day laborers. Where travel is difficult, lack of home visits or village-based services may create
an access problem. Linguistic access means that the services are available in the local language
or a dialect in which the client is fluent.

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Access refers to the ability of the individual to obtain health services. Some of the factors that
can affect access are: a) Distance: e.g. where health facility is sited far away or it is difficult to
get transport to the facility access to quality health care becomes a problem. b) Financial: e.g.
where people cannot pay for the services provided. c) Culture, beliefs and values: The services
provided may not be in line with the culture, beliefs and values of some people.

Equity:
Quality services should be provided to all people who need them, be they poor, children, adults,
old people, pregnant women, disabled etc. Quality services should be available in all parts of the
country, in villages, towns and cities.

Effectiveness:
The quality of health services depends on the effectiveness of service delivery norms and
clinical guidelines. Assessing the dimension of effectiveness answers the questions, Does the
procedure or treatment, when correctly applied, lead to the desired results? and Is the
recommended treatment the most technologically appropriate for the setting in which it is
delivered? Effectiveness is an important dimension of quality at the central level, where norms
and specifications are defined. Effectiveness issues should also be considered at the local level,
where managers decide how to carry out norms and how to adapt them to local conditions. When
selecting standards, relative risks should be considered. For example, more frequent use of
cesarean section might be warranted in a population with many high risk pregnancies, despite the
associated risks. To determine this strategy’s effectiveness, the procedure’s potential harm must
be compared with its potential net benefits.

We are interested in the type of care that produces positive change in the patient's health or
quality of life. We therefore use treatments that are known to be effective, for example, giving a
child with diarrhea Oral Rehydration Salt (ORS)

Efficiency:
The efficiency of health services is an important dimension of quality because it affects product
and service affordability and because health care resources are usually limited. Efficient services

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provide optimal rather than maximum care to the patient and community; they provide the
greatest benefit within the resources available. Efficiency demands that necessary or appropriate
care is provided. Poor care resulting from ineffective norms or incorrect delivery should be
minimized or eliminated. In this way, quality can be improved while reducing costs. Harmful
care, besides causing unnecessary risk and patient discomfort, is often expensive and time-
consuming to correct. It would be misleading, however, to imply that quality improvements
never require additional resources. But by analyzing efficiency, health program managers may
select the most cost-effective intervention.

Efficiency is the provision of high quality care at the lowest possible cost. We are expected to
make the best use of resources and avoid waste of our scarce resources. We waste resources by :
prescribing unnecessary drugs stocking more drugs than is required and making them expire
buying supplies and equipment we do not use What happens when we stock more drugs than is
required?

Continuity:
Continuity means that the client receives the complete range of health services that he or she
needs, without interruption, cessation, or unnecessary repetition of diagnosis or treatment.
Services must be offered on an ongoing basis. The client must have access to routine and
preventive care provided by a health worker who knows his or her medical history. A client must
also have access to timely referral for specialized services and to complete follow-up care.
Continuity is sometimes achieved by ensuring that the client always sees the same primary care
provider; in other situations, it is achieved by keeping accurate medical records so that a new
provider knows the patient’s history and can build upon and complement the diagnosis and
treatment of previous providers. The absence of continuity can compromise effectiveness,
decrease efficiency, and reduce the quality of interpersonal relations.

Continuity means that the client gets the full range of health services he/she needs, and that when
the case is beyond us, we refer him/her to the right level for further care. Continuity may be
achieved by the patient seeing the same primary health care worker or by keeping accurate health
records so that another staff can have adequate information to follow up the patient.

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Safety:
As a dimension of quality, safety means minimizing the risks of injury, infection, harmful side
effects, or other dangers related to service delivery. Safety involves the provider as well as the
patient. For example, safety is an important dimension of quality for blood transfusions,
especially since the advent of AIDS. Patients must be protected from infection, and health
workers who handle blood and needles must be protected by safety procedures. Additional safety
issues related to blood transfusions include maintaining aseptic conditions and using proper
techniques for transfusing blood. While safety may seem most important when complex clinical
services are provided, there are safety concerns in the provision of basic health services as well.
For example, health center waiting rooms can put clients at risk of infection from other patients
if risk-reducing measures are not taken. If a health worker does not provide proper instruction on
the preparation of oral rehydration solution (ORS), a mother may administer to her child ORS
containing a dangerously high concentration of salt.

Safety means that when providing health services, we reduce to the barest minimum injuries,
infections, harmful side effects and other dangers to clients and to staff. In providing quality
care, we should not put the patient's life at risk. For example, we should not give unsafe blood to
patients and thereby infect them with HIV/AIDS.

Amenities:
Amenities refer to the features of health services that do not directly relate to clinical
effectiveness but may enhance the client’s satisfaction and willingness to return to the facility for
subsequent health care needs. Amenities are also important because they may affect the client’s
expectations about and confidence in other aspects of the service or product. Where cost
recovery is a consideration, amenities may enhance the client’s willingness to pay for services.
Amenities relate to the physical appearance of facilities, personnel, and materials; as well as to
comfort, cleanliness, and privacy. Other amenities may include features that make the wait more
pleasant such as music, educational or recreational videos, and reading materials. While some
amenities -- clean, accessible restrooms; and privacy curtains in examination rooms -- are

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considered luxuries in most LDC health care settings, they are nevertheless important for
attracting and retaining clients and for ensuring continuity and coverage.

These are features that can be provided by our health facilities to make life comfortable and
pleasant for clients. They contribute to clients' satisfaction and make clients willing to use our
services. For example, comfortable seats, television set, music, educational materials, educative
video films, etc. at the OPD and wards.

Interpersonal Relations:
The dimension of interpersonal relations refers to the interaction between providers and clients,
managers and health care providers, and the health team and the community. Good interpersonal
relations establish trust and credibility through demonstrations of respect, confidentiality,
courtesy, responsiveness, and empathy. Effective listening and communication are also
important. Sound interpersonal relations contribute to effective health counseling and to a
positive rapport with patients. Inadequate interpersonal relations can reduce the effectiveness of
a technically competent health service. Patients who are poorly treated may be less likely to heed
the health care provider’s recommendations, or may avoid seeking care.

It refers to the relationship between us and our clients and communities, between health mangers
and their staff. We should: show respect to our clients; feel for our patients; not be rude or shout
at them; not disclose information we get from patients to other people. These will bring about
good relations and trust between the clients/communities and us. Clients consider good
interpersonal relationship as an important component of quality of care.

Perspectives on the Meaning of Quality?


What does quality of health care mean for the communities and clients that depend on it, the
clinicians who provide it, and the managers and administrators who oversee it?

The health staff, health manager, clients and communities are all stakeholders in service delivery.
Each of these groups may expect different things from health services.

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The Client For the clients and communities served by health care facilities, quality care meets
their perceived needs, and is delivered courteously and on time. In sum, the client wants services
that effectively relieve symptoms and prevent illness. The client’s perspective is very important
because satisfied clients often are more likely to comply with treatment and to continue to use
primary health services. Thus, the dimensions of quality that relate to client satisfaction affect the
health and well-being of the community. Patients and communities often focus on effectiveness,
accessibility, interpersonal relations, continuity, and amenities as the most important dimensions
of quality. However, it is important to note that communities do not always fully understand their
health service needs-- especially for preventive services--and cannot adequately assess technical
competence. Health providers must learn about their community’s health status and health
service needs, educate the community about basic health services, and involve it in defining how
care is to be most effectively delivered. Which decisions should be made by health professionals
and which should be made by the community? Where does the technical domain begin and end?
This is a subjective and value-laden area that requires an ongoing dialogue between health
workers and the community. Answering these questions requires a relationship of trust and two
way communication between the parties.

Research done in various parts of the country shows that our patients/clients want services that:
are delivered on time by friendly and respectful staff; are safe, produce positive result and that
they can afford; provide them with adequate information about their condition and treatment;
provide them with all the drugs they need; give privacy are within their reach (distance) and
given in a language they can understand.

The Health Service Provider:


From the provider’s perspective, quality care implies that he or she has the skills, resources, and
conditions necessary to improve the health status of the patient and the community, according to
current technical standards and available resources. The provider’s commitment and motivation
depend on the ability to carry out his or her duties in an ideal or optimal way. Providers tend to
focus on technical competence, effectiveness, and safety. Key questions for providers may be:
How many patients are providers expected to see per hour? What laboratory services are

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available to them, and how accurate, efficient, and reliable are they? What referral systems are in
place when specialty services or higher technologies are needed? Are the physical working
conditions adequate and sanitary, ensuring the privacy of patients and a professional
environment? Does the pharmacy have a reliable supply of all the needed medicines? Are there
opportunities for continuing medical education? Just as the health care system must respond to
the patients’ perspectives and demands, it must also respond to the needs and requirements of the
health care provider. In this sense, health care providers can be thought of as the health care
system’s internal clients. They need and expect effective and efficient technical, administrative,
and support services in providing high-quality care.

The health provider can provide quality care if he/she has: adequate knowledge and skills enough
resources- staff, drugs, supplies, equipment and transport etc safe and clean workplace
opportunity to regularly improve himself/herself. is well paid and rewarded for good work.

The Health Care Manager Quality care requires that managers are rarely involved in delivering
patient care, although the quality of patient care is central to everything they do. The varied
demands of supervision and financial and logistic management present many unexpected
challenges and crises. This can leave a manager without a clear sense of priorities or purpose.
Focusing on the various dimensions of quality can help to set administrative priorities. Health
care managers must provide for the needs and demands of both providers and patients. Also, they
must be responsible stewards of the resources entrusted to them by the government, private
entities, and the community. Health care managers must consider the needs of multiple clients in
addressing questions about resource allocation, fee schedules, staffing patterns, and management
practices. The multidimensional concept of quality presented here is particularly helpful to
managers who tend to feel that access, effectiveness, technical competence, and efficiency are
the most important dimensions of quality.

The health care manager sees quality care as: managing efficiently the resources of the health
facility. Health staff achieving set targets. Health staff being regularly supported and supervised.
Having adequate and competent staff to provide care. staff being disciplined. providing enough
resources for work.

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Quality of care can also be seen from the inputs, processes and outcome of service delivery. We
have to address these together to improve on quality. Most of the time we only complain about
lack of inputs without also looking at how we do things or activities that we carry out.

Inputs These are materials needed to provide care. Examples include staff, drugs, buildings and
equipment.

Process This refers to what is done and the way things are done. An example is the activities for
outpatient care. The patient has to make a card, go to the screening table for his/her temperature
and blood pressure to be taken. He/she then goes to the consulting room after which he/she goes
to the dispensary for drugs.

Output/Outcome It is the results we get out of health service delivery. For example, is the client
satisfied with the service he/she gets after visiting our facility? Has there been a decrease in
outpatient attendance?

Answers to the two questions are indications of output/ outcome of our health service delivery

What is Quality Assurance?


Dr. Donabedian broadly defines it as all the arrangements and activities that are meant to
safeguard, maintain, and promote the quality of care.4 Drs. Ruelas and Frenk, who have
conducted extensive QA work in Mexico, define it as a systematic process for closing the gap
between actual performance and the desirable outcomes. . . .

According to Dr. Heather Palmer, a QA expert in U.S. ambulatory care, it is a process of


measuring quality, analyzing the deficiencies discovered, and taking action to improve
performance followed by measuring quality again to determine whether improvement has been
achieved. It is a systematic, cyclic activity using standards of measurement.6 Dr. Donald
Berwick, a U.S.-based clinician, is working to apply principles of continuous quality
improvement (CQI) to health services. This approach to QA is an integrated organizational
approach for meeting client needs and expectations involving both management and staff while
improving processes and services using quantitative techniques and analytical tools. According

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to Berwick, it is . . . a systematic managerial transformation designed to address the needs and
opportunities of all organizations as they try to cope with increasing change, complexity and
tension within their environments.

Quality Assurance is a set of activities that are planned for, carried out systematically or in an
orderly manner and continuously to improve quality of care. It involves: The setting of
standards? Monitoring to see if there is a gap between what is being done now and what is
expected; and addressing the gap on a regular basis (quality improvement).

Quality Assurance encourages health workers to examine the services they provide, assess their
own work and come out with what they can do with the limited resources to improve the quality
of care. For supervisors and managers, QA calls for change from the status of an inspector to that
of a facilitator, and expects the health workers to identify and solve problems. Quality Assurance
also requires that health workers understand the needs of patients and their communities in order
to provide for them. Quality Assurance requires active support and commitment from leaders at
the national, regional, district, sub-district levels and in the health facilities.

In essence, quality assurance is that set of activities that are carried out to set standards and to
monitor and improve performance so that the care provided is as effective and as safe as
possible.

After 1985, WHO and several projects such as PRICOR and CCCD began using systems
analysis and facility assessments to assess the quality of care.

Principles of Quality Assurance


There are five basic principles of quality assurance. These principles, as stated below, clearly
show what QA is intended for.

1. Quality Assurance is oriented towards meeting the needs and expectations of our clients 2.
Quality Assurance focuses on systems and processes 3. Quality Assurance uses data to analyze
service delivery 4. Quality Assurance encourages the use of teams in problem solving and

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quality improvement 5. Quality Assurance uses effective communication to improve service
delivery

The Four Tenets of Quality Assurance s


Quality Assurance is oriented toward meeting the needs and expectations of the patient and
the community. Quality assurance requires a commitment to finding out what patients and the
community need, want, and expect from the health services. The health team must work with
communities to meet service demand and to promote acceptance of needed preventive services.
Subsequent program planning and quality improvement efforts should be evaluated according to
these needs and expectations. Quality assurance also requires that health workers’ professional
needs and expectations be met.

Quality assurance focuses on systems and processes. By focusing on the analysis of service
delivery processes, activities, and tasks as well as outcomes, quality assurance approaches allow
health care providers and managers to develop an in-depth understanding of a problem and to
address its root causes. Rather than merely treating the symptoms of a quality-related problem,
quality assurance seeks to find a cure. In the advanced stages of a QA program, the health center
team can go even further by analyzing processes to prevent problems before they occur.

Quality assurance uses data to analyze service delivery processes. Simple quantitative
approaches to problem analysis and monitoring are another important aspect of quality
improvement. Data-oriented methods allow the QA team to test its theories about root causes;
effective problem solving should be based on facts, not assumptions.

Quality assurance encourages a team approach to problem solving and quality improvement.

Participatory approaches offer two advantages. First, the technical product is likely to be of
higher quality because each team member brings unique perspective and insight to the quality
improvement effort. Collaboration facilitates a thorough problem analysis and makes
development of a feasible solution more likely. Second, staff members are more likely to accept
and support changes that they helped to develop. Thus, participation in quality improvement
builds consensus and reduces resistance to change.

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If an organization desires a comprehensive approach, a QA initiative can be developed as a
component of a general management improvement effort or a total quality management system.

The Quality Assurance Process


Some U.S. models include the quality assurance cycle used by Palmer in ambulatory care
settings; the 10-step process developed by the Joint Commission on Accreditation of Health Care
Organizations; and CQI which applies total quality management to health services. The QAP
quality improvement model attempts to integrate the strengths of the various models into a
simple, logical process for planning and implementing QA activities. Consistent with earlier
models, QAP’s quality improvement model defines norms, conducts an assessment, works with
health care providers in a participatory fashion, takes action based on the assessment, and
monitors results. Perhaps most important, it puts forth a replicable process for improving the
quality of health care service delivery. This process can, over time, be integrated into ongoing
program management.

QAP's Quality Assurance Process


In practice, QA is a cyclical, iterative process that must be applied flexibly to meet the needs of a
specific program. The process may begin with a comprehensive effort to define standards and
norms as described in Steps 1-3, or it may start with small-scale quality improvement activities
(Steps 5-10). Alternatively, the process may begin with monitoring (Step 4). Some teams may
even choose to simultaneously begin in two places. For instance, comprehensive monitoring and
focused problem solving may start as a coordinated, parallel effort.

1. Planning for Quality Assurance:


This first step prepares an organization to carry out QA activities. Planning begins with a review
of the organization’s scope of care to determine which services should be addressed. For most
organizations, it is impossible to improve quality in all areas at once. Instead, QA activities are
initiated in a few critical areas. High-priority, high-volume, or problem-prone services are often
selected for special attention at the start of a QA program. Once organizational leaders have
decided where the QA effort will begin, they must select a quality improvement approach. They

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may focus on monitoring desired or adverse outcomes, or they may study service delivery and
support processes to determine areas for improvement. Another component of planning is
assigning responsibilities for the QA activities. This may entail forming a QA committee or an
ad hoc team responsible for initial QA activities. If the program mission is unclear or
unresponsive to community needs, or if overall planning in an organization is weak, in-depth
strategic planning might be required. Strategic planning begins with defining the organization’s
mission. The next step is to assess the opportunities and constraints in the external environment
as well as the organization’s internal strengths and weaknesses. Strategic planning produces a
clear vision of what the organization must do to achieve its mission in the light of its
environment. The organization can then determine QA priorities based on the program mission
and vision.

2. Setting Standards and Specifications

To provide consistently high-quality services, an organization must translate its programmatic


goals and objectives into operational procedures. In its widest sense, a “standard” is a statement
of the quality that is expected. Under the broad rubric of standards there are practice guidelines
or clinical protocols, administrative procedures or standard operating procedures, product
specifications, and performance standards.

Practice guidelines, sometimes called clinical protocols or practice parameters, define how
clinical processes such as antenatal care are carried out. Guidelines are defined as
“systematically developed statements to assist practitioner and patient decisions about
appropriate health care for specific clinical circumstances.”

Administrative procedures, sometimes


Called standard operating procedures, define routine nonclinical processes. Specifications
usually pertain to product characteristics or material inputs such as drugs or technical equipment
related to health service delivery.

Performance standards are specific criteria used to measure the outcome of service delivery and
the activities that support it. They are also used to measure compliance with guidelines. These

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standards differ from guidelines or standard operating procedures; they are designed to evaluate
practice rather than to assist practitioners and patients. Standards have been defined as
“authoritative statements of (1) minimum levels of acceptable performance or results, (2)
excellent levels of performance or results, or (3) the range of acceptable performance or results.”

Standards can be related to the care process by measuring health outcomes or guideline
compliance. While health outcomes are sometimes difficult and costly to measure, it is often
possible to monitor intermediate outcomes such as utilization or coverage in assessing program
effectiveness. Performance standards form the core of the monitoring system, as discussed in
StEP-4

Guidelines, standard operating procedures, and performance standards should be developed for
both clinical and management areas. They should reflect the perspectives of their com-munities
and health care specialists. Both perspectives are essential to ensure the effectiveness of planned
activities and their accessibility and acceptability to the community. Program staff should
periodically review and revise guidelines and standard procedures.

For some programs, setting standards and specifications involves a simple review of current
guidelines and standard operating procedures to ensure that they are up-to-date. For others, it
may be important to develop consensus among professionals to ensure support. Others may
require creating new guidelines and standards. In such cases, some widely accepted re-sources
are available. For example, WHO helps in defining service delivery protocols appropriate for
health centers and small hospitals in developing countries? The PRICOR Project developed
clinical guidelines for use in primary health care in developing countries. The PRICOR
Thesaurus sets forth guidelines for seven child survival services: immunization, oral rehydration
therapy, prenatal care, family planning, growth monitoring, treatment of acute respiratory
infections, and malaria. The project also developed guidelines in seven management areas:
planning, supervision, training, logistics, financial management, management information
systems, and community organization. In sum, the Thesaurus is a useful reference for setting
standards.

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Health workers at all levels should participate in developing guidelines and setting standards.
Because health workers often understand local conditions better than high-level managers, the
resulting guidelines are likely to be more appropriate and effective. Also, staff participation will
generate commitment to quality because health workers are more likely to implement and
support an effort that they have helped to develop. Finally, staff members are more likely to
accept QA activities if they have been involved in defining quality. Their standards will become
the measure for judging the quality of their services.

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Communicating Guidelines and Standards
Once practice guidelines, standard operating procedures, and performance standards have been
defined, it is essential that staff members communicate and promote their use. This will ensure
that each health worker, supervisor, manager, and support person understands what is expected
of him or her. This is particularly important if ongoing training and supervision have been weak
or if guidelines and procedures have recently changed. Assessing quality before communicating
expectations can lead to erroneously blaming individuals for poor performance when fault
actually lies with systemic deficiencies. Additionally, QA efforts that begin with a surprise
examination are likely to cause suspicion rather than support.

Managers and the health center team share a mutual responsibility for quality; the notion of this
partnership should be communicated along with guidelines and standards. A dialogue about
guidelines and standards can take place in the context of supervision, training, or other channels.
Activities that communicate guidelines and standards include developing job descriptions,
translating performance guidelines into job aids, developing and conducting training programs,
holding formal conferences or informal presentations about new procedures, providing on-the-
job training through supervisory activities, and informing providers of changes in protocols
through administrative announcements.

Monitoring Quality
Monitoring is the routine collection and review of data that helps to assess whether program
norms are being followed or whether outcomes are improved. By monitoring key indicators,
managers and supervisors can determine whether the services delivered follow the prescribed
practices and achieve the desired results. QA involves a new process orientation that has
profound implications for monitoring and collecting data in LDCs. Outcome measures alone, or
other service statistics that are generally part of LDC monitoring systems, offer limited
Guidance in problem solving. Detailed assessment of processes through special comprehensive
studies or routine assessments can provide useful information about specific service delivery
problems.

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The monitoring system is central to a QA program. Unfortunately, existing data collection


systems in many developing countries can be difficult to use for QA. At some point, existing
monitoring systems may require redesign. However this is not recommended as an initial
activity; it is likely to be very time consuming and to meet resistance. It is often better to involve
program staff members in using data to solve problems (see Steps 5-11) and to work with them
in redesigning their system.

Designing (or redesigning) a monitoring system requires translating statements about expected
quality into measurable indicators. It also demands setting performance thresholds, selecting
information sources, designing a system for collecting data and compiling results, and carrying
out monitoring activities. (Each of these activities is briefly discussed below.) It is important to
define which data are to be used at the various levels in the system. For example, a front-line
supervisor may collect a great deal of information about service quality and delivery, but may
summarize only some of this information for higher-level managers.

Generally, all levels of staff should be involved in designing a monitoring system so that
everyone receives all necessary information.

Selecting indicators: An indicator is a measurable characteristic of actual system performance


that determines the extent to which desired outcomes are achieved, or the degree to which
guidelines and standard operating procedures are adhered. Indicators are used to monitor the
quality or appropriateness of important clinical and management activities. It is unnecessary to
choose an indicator for every standard or specification. The number of indicators should be
minimized when assessing key processes and identifying potential problem areas.

Setting thresholds: Thresholds define a program’s acceptable performance levels, as measured


by indicators, at a given point in time. They allow program staff to detect potential problems or
areas for improvement. Performance thresholds can be based on clinical or medical knowledge
of risks or on what is operationally feasible.

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For example, some immunization programs set 80 percent coverage as a threshold.
The acceptable level of performance is relative and should be revised as conditions and priorities
change. The role of thresholds is to trigger action when the monitored indicators suggest
inadequate program performance. Performance thresholds are not needed in all cases and should
be set only after consultation with program staff.
It is important to note the potential drawbacks of using thresholds in a quality improvement
effort. Rather than encouraging continual improvement, using thresholds may give the mistaken
impression that some errors are acceptable and that, Once met, there is no need for further
improvement.
In spite of these potential drawbacks, performance thresholds, used correctly, can help teams to
set priorities and can promote gradual improvement.

Selecting information sources: Because many organizations already collect data, the first
information source to examine is the existing information systems. Some-times it is possible to
make a minor change that would provide information without major efforts. Other information
sources include suggestion boxes, complaint registers, clinical records, health center registers,
interviews, facility review, and job performance observations. Because monitoring is a routine
exercise, additional data collection should be kept to a minimum. It is especially important to
minimize the burden of data collection on peripheral health workers. Generally, health workers
should not be asked to collect data that they cannot use in their work. Data that are used at the
local level and then compiled for higher-level managers are more likely to provide a basis for a
constructive dialogue between health workers and managers about problems and priorities.

Designing a system for collecting and compiling data: It is important to specify who will collect
and compile the data, determine the frequency of collection and compilation, and develop a
mechanism and schedule for disseminating the results.
This system should be developed with staff participation at all levels, and it should
be periodically reviewed. Over time, staff members should become adept at self-
monitoring, relying less on district- and central-level managers.

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Implementing the monitoring activities:
Once the system has been designed and responsibility has been assigned, data collection and
compilation can begin. During the initial phase of a monitoring system, health workers will need
assistance in collecting and using data. This support is essential if monitoring is to serve as a
screening tool. Rather than constantly monitoring all activities, monitoring systems might use an
index of activities or tracer conditions that cover various program dimensions. For example, a
program manager could monitor immunization, hypertension, and treatment of pneumonia.
Together, these tracer conditions might cover preventive services and management of chronic
and acute illness, encompassing both child and adult care. Eventually, the conditions monitored
should be rotated or modified to meet the community’s changing needs. They should also
expand with the QA effort.
It is important to limit the monitoring system by emphasizing the collection and use of only
essential data.

Systems analysis is another assessment method that can be used to identify service delivery
problems. The service quality assessment technique originally applied to LDC primary health
care by PRICOR consists of a comprehensive assessment of standard procedures and health
worker performance. It is based primarily on observing actual or simulated performance.

Such systems analyses can be carried out as a baseline in identifying and measuring major
problems before a QA program is launched. They can also be carried out periodically, in whole
or in part, to evaluate general improvement and to prove the validity of program
institutionalization.

Identifying Problems and Selecting Opportunities for Improvement Program managers can
identify quality improvement opportunities by monitoring and evalu-
ating activities. With effective monitoring systems, health programs can conduct special
community or patient surveys or comprehensive assessments such as PRICOR II’s systems
analysis methodology.

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These studies highlight specific service delivery problems requiring attention. Other means
include soliciting suggestions from health workers, performing system process analyses,
reviewing patient feedback or complaints, and generating ideas through brainstorming or other
group techniques. Employing a participatory approach to problem identification offers several
advantages. First, the quality of the assessment and preliminary analysis is likely to be superior
because those who are directly involved with the processes are participating. Second, staff
members are more likely to contribute and to cooperate if they are involved in identifying
problems.

Once a health facility team has identified several problems, it should set quality improvement
priorities by choosing one or two problem areas on which to focus.

Selection criteria will vary from program to program. Two important principles should guide
this process. The criteria should reflect team, not individual, priorities. They should also be
explicit so that the decision-making process is as objective and as thorough as possible. Criteria
might include the technical feasibility of addressing the problem, the potential impact of
improving quality on the population’s health, or the adequacy of the necessary available
resources.

PRICOR II’s quality improvement work in developing countries resulted in some noteworthy
insights about priority setting. First, the problem must be within the scope of responsibility and
authority of those carrying out the QA effort. Trying to change something that is outside local
control is a frustrating experience that has little hope for success. In the same vein, it is often
preferable to begin QA efforts by focusing on a smaller, manageable problem rather than on a
large, complex one. Tackling a solvable problem encourages confidence in the QA process.

Teams can select priorities using various group decision-making techniques such as ranking and
voting exercises or decision matrices that consider several criteria in the priority-setting process.

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Defining the Problem


Having selected a problem, the team must define it operationally--as a gap between actual
performance and performance as prescribed by guidelines and standards. The problem
statement should identify the problem and how it manifests itself. It should clearly state where
the problem begins and ends, and how to recognize when the problem is solved.

Developing a problem statement is a crucial step in the QA process, and its apparent simplicity is
deceptive. Often, the initial formulation of a problem will include only the cause of a problem
“we don’t have a laboratory”--or its premature solution--“we need more staff.” Sometimes
problems are too general to permit concrete, incremental action--“we don’t work as a team.”

Problem statements also may err by focusing on blame rather than on the problem description--
“nurses are not willing to be polite to patients.” Problems should explicitly relate to the quality
of services or the health of the population. They should refer to specific processes or activities
so that the improvement effort is well focused and measurable.

Problem definition is an iterative process: as team members attempt to define a problem, they
will be forced to rethink many of their steps. They may decide to narrow the problem or choose
to address one cause of a multifaceted problem. While defining a concrete operational problem,
team members are likely to vacillate between large, unmanageable problems and the smaller one
that they are trying to define. They may even feel that the discrete operational problem they are
defining is not worth addressing because it is such a small part of the wider problem. It is
important for a team to take the time to develop clarity about the
Problem and consensus about its importance. Without these ingredients, the QA effort will stall.

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Choosing a Team
Once a health facility staff has employed a participatory approach to selecting and defining a
problem, it should assign a small team to address the specific problem.

The team will analyze the problem, develop a quality improvement plan, and implement and
evaluate the quality improvement effort. The team should comprise those who are involved
with, contribute inputs or resources to, and/or benefit from the activity or activities in which the
problem occurs. This ensures the involvement of those most knowledgeable about the process.

Learning to work effectively as a team is a challenging and continuous process. Health center
teams often will need training in basic skills related to planning and facilitating meetings,
communicating effectively, making group decisions, and resolving conflict. Building a high
performance team takes time, requiring patience and persistence.

Analyzing and Studying the Problem to Identify the Root Cause


Achieving a meaningful and sustainable quality improvement effort depends on understanding
the problem and its root causes. Given the complexity of health service delivery, clearly
identifying root causes requires systematic, in-depth analysis.
Analytical tools such as system modeling, flow charting, and cause-and-effect diagrams can be
used to analyze a process or problem. (See box below.) Once several potential causes are
identified, the team should determine which ones are the most damaging, since two or three
causes may be responsible for up to 80 percent of quality problems. By addressing these critical
causes, a problem solving team can realize significant improvement with minimal effort.

Analytical tools alone will not always provide enough information. A problem-solving team
may need to conduct an in-depth examination. Such studies can be based on clinical record
reviews, health center register data, staff or patient interviews, service delivery observations, or
any combination of the above. These studies must go beyond documenting the problem; they
should examine root causes.

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At this stage, problem-solving teams often employ some basic statistical tools. These may
include check sheets, histograms, scatter grams, pareto charts, run charts, and control charts. (See
box below.) The check sheet is a data collection tool used in assessing variables related to a
specific process. The resultant data can be presented in a histogram that assesses the extent of
variation, in a distribution scatter gram that indicate trends, or in a pareto chart that classifies
problems according to cause in descending order of importance. Run charts make it easy to
monitor change in a process over time. Control charts help to monitor variation and provide
clues that can help to identify the type of variation. Some causes are inherent to the process,
while others have their roots outside the process.

Developing Solutions and Actions for Quality Improvement


The problem-solving team should now be ready to develop and evaluate potential solutions.
Unless the procedure in question is the sole responsibility of an individual, developing solutions
should be a team effort. It may be necessary to involve personnel responsible for processes
related to the root cause.

Solutions to quality problems or quality improvement activities can take several forms. A
solution may be very straightforward: it may be as simple as reminding staff about clinical
guidelines through supervision or focused in-service training. Solutions may also take the form
of job aids such as wall charts and checklists. They become part of the process that provides
information and checks at the point of service delivery, thereby reducing error or variation.
Often, solutions and improvements are rooted in management systems related to supervision,
training, and logistics.

Some problems, however, are more difficult to solve because they require procedural redesign.
This should be considered if the team determines that there is no existing process in the problem
area or that the defined process is not responsive to the clients’ needs and expectations. In such

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cases, tools such as flowcharts and design matrices can be very helpful in designing solutions
that build on the strengths of existing practices and take client requirements into account.

Problem-solving teams are encouraged to think creatively and to generate a variety of solution
options. Choices among potential solutions should be based on an examination of the option’s
potential costs and effectiveness. Teams may employ techniques such as multiple criteria utility
assessment or multivoting to help them in evaluating solutions and making a decision. The team
also should gauge potential opposition to change and develop a plan to minimize resistance.

Implementing and Evaluating Quality Improvement Efforts


Implementing quality improvement requires careful planning. The team must determine the
necessary resources and time frame and decide who will be responsible for implementation. It
must also decide whether implementation should begin with a pilot test in a limited area or
should be launched on a larger scale. A pilot project is merited if the solution requires
substantial resources or if there is considerable uncertainty about the solution’s potential
effectiveness.
The team should select indicators to evaluate whether the solution was implemented correctly
and whether it resolved the problem it was designed to address. In-depth monitoring should
begin when the quality improvement plan is implemented. It should continue until either the
solution is proven effective and sustainable, or the solution is proven ineffective and is
abandoned or modified. When a solution is effective, the teams should continue limited
monitoring. Teams should modify solutions as needed and should fully document results and
lessons learned.

Once the solution has proved to be effective, program managers should codify and disseminate
the new process so that others can learn from the experience. The QA team should also make
plans to identify a new problem, either through a team process or through data generated by an
existing monitoring system. The team may then repeat the quality improvement cycle.

Building a Quality Assurance Program


A QA program is a comprehensive set of quality assessment and improvement activities that is
incorporated into an organization’s routine management functions. As health care organizations
learn more about the QA process, they are likely to discover that some of their current activities
are related to quality improvement. In fact, most organizations already do some type of QA.
These existing activities provide a foundation upon which to build a comprehensive QA

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program. The previous section describes how program managers and staff can conduct quality-
related activities more thoroughly. The following section discusses how QA can
be permanently integrated into health program management in developing countries.

There are two distinct approaches to building a QA program. The first is the comprehensive QA
strategy; the second is the problem-oriented strategy. The two approaches are contrasted here to
provide an overview of the wide range of strategic options available to program managers. In
practice, most organizations will want to combine these approaches as they introduce quality
assurance.

In the comprehensive approach, QA policies, procedures, and processes are implemented


simultaneously, starting at the top and moving down the organizational structure. A
comprehensive approach typically begins with a thorough review of standards and specifications.

This may be followed by an assessment of health care and support services. This assessment
may be conducted through an existing management information system or through a monitoring
system specifically developed to measure service quality. Start-up also includes an extensive
training effort to strengthen technical competencies and to impart quality improvement
knowledge and skills.

Comprehensive service quality assessments are useful in countries where information systems
are inadequate. Systems analysis allows managers to use interviews and observation to assess
primary health care services and their associated support activities. Priority areas for quality
improvement can be identified based on the results of comprehensive monitoring or systems
analysis. The comprehensive approach works best when there is a commitment throughout the
system to addressing quality of care and when organizations have the neces-
sary resources to implement a QA program on a large scale.

The problem-oriented approach to QA emphasizes practical, small-scale, quality-related


activities that produce incremental quality improvements. Rather than carrying out a
comprehensive assessment, individuals or teams focus on a single problem that is important to
them.

In this model, comprehensive assessment and monitoring are de-emphasized in favor of


immediate action. This is based on the assumption that monitoring systems and a more
systematic approach can be developed over time once problem solving has become part of the
organizational culture. Often, the problem-oriented approach is introduced early at a few clinics
rather than throughout the organization. This allows an organization to modify and adapt the
problem-solving strategy before wider implementation.
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With careful planning, problem-orientation can evolve into a more comprehensive approach.
Eventually, all types of services can be covered by the QA effort and a simple monitoring system
can be emplaced. It is also important to note that a comprehensive approach can benefit from
some small-scale, problem-oriented activities. One danger of an exclusively comprehensive
approach is that staff at all levels may grow impatient with the tedious process of setting up
systems and of participating in training activities that do not yield immediate, concrete results.
Potential resistance can be averted by conducting small-scale, quality improvement activities that
demonstrate quick, short-term outcomes. Also, these results can
be incorporated into training efforts, thus providing local examples of QA.

There is no recipe for developing a QA program. It is a creative process that requires flexibility
in order to adapt to a given health program’s unique features. This section describes key
activities that are usually carried out in building a QA program. Most of the key activities
described take place concurrently, and many must be continually renegotiated as the program
evolves and conditions change.

Key Activities in the Development of a Quality Assurance Program


Foster commitment to quality
Conduct a preliminary review of QA-related activities
Develop the purpose and vision for the QA effort
Determine level and scope of initial QA activities
Assign responsibility for QA
Allocate resources for QA
Develop a written QA plan
Strengthen QA skills and critical management systems
Disseminate QA activities
Manage change

A QA program may be developed gradually through a carefully planned, phased process, or it


may be implemented in one step as part of a fundamental organizational change. A gradual,
phased approach is frequently appropriate for organizations with rudimentary management
systems.

Foster Commitment to Quality Building a permanent QA program requires the early support of
top- and mid-level managers. Over time, this commitment to QA should be shared by all staff
and reflected in the organization’s mission, purpose, and procedures. The process of fostering

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and developing commitment is not an isolated activity; it must continue throughout the life of a
project and at all levels of the organization.

Commitment is developed by raising awareness and by fostering a dialogue among top-level


managers. This can be done through awareness-raising seminars, special planning meetings, or
one-to-one discussions with an organization’s leaders. During the awareness-raising process,
basic concepts are introduced that relate to quality and quality assessment and improvement
methods. Discussing the importance of quality and presenting empirical information about
quality problems at the local level can also foster commitment.

Conduct a Preliminary Review of Quality-Related Activities


Before introducing new QA activities, it is important to conduct an initial review of the
organization and to develop a general description of the existing system. This review will allow
the new QA effort to build on existing strengths.

QA efforts will likely be sustained if they are built into the existing system in a logical way. For
example, an existing supervisory system that monitors compliance with technical norms is a
logical place to begin QA activities. Failing to recognize such an opportunity can result in turf
battles between managers and in confusion among service providers. One important function of
the initial assessment is to determine the best place in the organization to launch a QA initiative.

This preliminary analysis can include the following:


Review of the program’s clinical and managerial standards or norms. Are they technically
sound? Are they appropriate for local conditions? Are they complete? Are they up-to-date?
Are they available to staff?

Assessment of the quality of service currently provided, and patient and community satisfaction
with the services.
Review of the supervisory system and related management activities to determine which type of
QA is already in place. What problems are faced by supervisors? Are they able to solve them?

Examination of the management information system. Consider the scope, validity, sensitivity,
specificity, and reliability of the indicators currently being monitored. Are data used for
management and decision making? Could the existing data be used to support

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QA program?
Review of existing training capacity. Could training be carried out by the organization or would
outside help be needed? Do current training programs include skills that could be used in QA?

Study of the organizational structure. Profile the organization’s lines of communication and
authority. Who is doing QA now? Who should be doing QA?
s Assessment of the adequacy of facilities, logistics, and equipment.

Different approaches can be used to conduct a preliminary assessment. Depending on the


resources available, the assessment can be a comprehensive study. It may include collecting new
data or a rapid assessment based on available data and the expert opinion of key informants.

Develop the Purpose and Vision for the Quality Assurance


Effort Building commitment to QA within an organization requires that top managers and their
staff share an overall vision of quality improvement. The purpose of a vision statement is to
build consensus between managers and to set boundaries for the QA effort. The vision statement
will help staff at all levels to understand how their day-to-day work relates to quality
improvement. It can be developed through a variety of consensus-building techniques that can
be employed by the senior management team. The vision statement should be developed at the
QA effort’s outset and revised periodically if there are strategic changes in the organization or if
there is a significant staff turnover.

Determine Level and Scope of Initial Quality Assurance Activities


The level and scope of initial QA activities depend on the resources available, the
implementation time frame, and the receptivity of management and program staff to the idea of
QA. An organization must also consider external political factors.

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A QA effort can be implemented at the national, regional, and district level or within a single
health facility. Where services are organized as vertical programs, one program may be the
focus of initial QA activities.

An organization must also use a small-scale effort such as a pilot study or series of demostration
projects in testing QA strategies and in learning more about their local application.

Small-scale efforts are often attractive to managers because they offer progress at little risk, and
because successful programs can be replicated or expanded. Unfortunately, it is frequently
difficult to replicate developed models, often because the demonstration sites have advantages
over the rest of the organization.

Assign Responsibility for Quality Assurance


To ensure continuity, accountability for QA activities must be clear, and QA must be a
prominent organizational emphasis. In some organizations a single person may be responsible
for QA, while in others it may be the domain of quality committees. Occasionally, an existing
committee or management body will take on responsibility for QA, integrating it into the general
management structure. In others, a QA program will be established whose role is defined in
relation to other departments. The titles of those responsible for QA should denote a facilitative
rather than a directive role; they might be called quality coordinators, coaches, or
advisors. QA coordinators and the QA committee are responsible for monitoring and supporting
QA activities, providing technical assistance to teams, assigning staff to develop indicators, and
facilitating communication about QA issues between top-level management and staff.

Develop a Written Quality Assurance Plan


A QA plan is a written document that describes the program objectives and scope, defines lines
of responsibility and authority, and puts forth implementation strategies. The plan should help

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staff members to relate quality goals and objectives to their routine activities. It should also be a
living document that is regularly referred to and revised.

Strengthen Quality Assurance Skills and Critical Management Systems


QA activities are an important part of management and may occasionally be reformulated into a
total quality management system. In general, however, QA efforts will focus more narrowly on
three critical management systems: supervision, training, and management information systems.
Special effort should be made to strengthen these systems as a QA program develops.

Organizations should develop supervision systems that not only evaluate and manage activities,
but also support health workers through a process of professional growth. In the long term, this
approach can lead to self-managed, self-directed individual and collective work. While this may
seem difficult, it is necessary since many health providers in developing countries work at the
periphery without daily supervision. Supervisors can take the lead in QA efforts by providing an
example of participatory leadership and problem-solving skills;
Over time, health workers can initiate quality improvement activities. Methods for self-
management and concurrent QA such as health worker and supervisor self-assessments and other
job aids can be introduced by the supervisor to improve performance.

The training system should incorporate competency-based training for specific routine tasks,
including service delivery, counseling, and health education, as well as for management support
services. Besides improving training in skill areas essential for high-quality services, the training
capacity should be developed and expanded to include such QA skills as problem solving,
evaluation, and teamwork.
It is also important to revise the management information system so that it serves as an effective
QA monitoring system. This can be done early or late in the QA process, when managers and
staff have an idea of what information they need and how to use it more effectively. Resistance
to change in this area may be easier to manage after the QA program has achieved some initial
successes.

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What Is A Standard?
The term standard is used very often but its meaning is not understood by most people. A
Standard is a statement of expected level of quality. It states clearly the inputs required
delivering a service, how things should be done (process) and what the output or outcome should
be. When we compare what is expected in the standards to what we do, we shall be able to
identify any quality gaps and then make plans to improve upon it.

Types of Standards
In carrying out any health activity there are three stages that are followed. We need inputs
(resources), we should also define clearly how things are going to be done (processes) and know
what results to expect (outcome).
Standards must therefore be set for each of the three areas.

Input Standards
Input or structure standards define the resources that must be supplied for the activities to be
carried out e.g., the physical structure, people, equipment and materials. For example to provide
outpatient services we need a building with a number of rooms for consultation, treatment,
laboratory etc. We also need trained nurses, medical assistants or doctors and equipment like
thermometers, weighing scales, sphygmomanometers

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Process Standards
Process standards describe the tasks or steps that must be carried out until the activity is
completed. In the example of outpatient services, the steps include, registration, recording of
temperature and weight, consultation and collection of drugs.
Output/ Outcome Standards Output/ Outcome standards describe the outputs or results of the
activities carried out. For example - the number of patients seen at the OPD. There are a number
of standards that have been developed by the Ghana Health Service and some of us have been
trained in their use. A few examples are: Integrated Management of Childhood Illness (IMCI)
case management guidelines Malaria case management guidelines Tuberculosis case
management guidelines Reproductive health policy and standards and guidelines.

Uses of Standards The use of standards will ensure quality care and reduce the differences in
managing patients among prescribers. It will also get value for money.

Standards are used to: Define quality Determine, inputs, processes and outcomes, and Develop
indicators to monitor quality. Let's examine an example of standards for antenatal care using the
three (3) areas namely, input, process and outcome as illustration Input standards These are
measured in terms of quality of physical structure, equipment, supplies and staff. Physical
structure the antenatal clinic should have a reception and waiting area with adequate seating for
women. A separate examination room for history and examination. Equipment and supplies
Standing scale with Height measure Sphygmomanometer Maternal health records Fetoscope
Dipstick for urinalysis Measuring tape Examination table Immunization equipments Laboratory
for basic tests Drugs- Folic acid, Iron, anti-malarials

Process standards: These are written out in the: National Reproductive Health Policy, Standards
and Protocols Laboratory standard operating procedures; and Medical records procedures.
Output/ Outcome standards Pregnant women will attend at least four times during pregnancy.
Ninety percent (90%) of women attending antenatal clinic will report satisfaction with care given
(client survey).

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How Do Staff Get To Know About Standards? When standards have been developed, staff
should be made aware of them so that they can be used to improve quality of care. There are
several methods that can be used depending on what has been developed. They include: Training
of health workers (in service and on the job training) Launching of the standard Seminars/
conferences developing job aids Support supervision. When standards have been well
communicated, the health worker knows the standards; he/she accepts them and changes his or
her practice accordingly.

Standards define what level of quality we should be expecting. It states the inputs required
delivering a service, how things should be done (processes) and what the outcome should be.
Standards enable us develop indicators so that the level of quality can be measured and
monitored.

MONITORING AND SUPERVISION

What Is Monitoring? In order to assess whether we are making any improvement in quality of
service delivery, we need to do regular monitoring. It is important for us to understand what is
meant by the term 'monitoring'. Monitoring is the collection, analysis and interpretation of data
in order to assess whether we are making any progress towards achieving our set targets or
improving quality. Data for monitoring quality may be from the routine data that we collect in
the facilities and in the communities, for example OPD attendance and immunization coverage.
It may also be data that is collected from time to time to follow our performance on selected
indicators, for example patient waiting time, drug availability.

Another aspect of quality monitoring is to check if we are keeping to standards, protocols or


guidelines. For example a health centre may compare the treatment of Malaria with agreed
standards of treatment. What is the Importance of Monitoring Quality of Care? Monitoring helps
us to identify gaps in quality of our health care delivery. It provides lessons to learn from as we

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progress with our implementation. It tells us if we are making progress in improving quality of
care. Monitoring therefore helps us to identify problems with the implementation of our plans so
as to take the necessary steps in order to achieve our targets.

Methods for Monitoring Quality of Care


There are many methods of monitoring quality. The common ones include: Review of routine
health information. For example, Health Management Information System data on OPD
attendance, In-patient admissions and deaths, Immunisation coverage. Client satisfaction
surveys. Patients complaints system. Critical incidents -Adverse events. Mystery clients
Supervision We shall now discuss each of these quality-monitoring methods.

Client Satisfaction Survey


This is a good way of getting the clients' views on our services. It tells us what the client's
expect from our health services. By telling us their expectations and making suggestions, clients
are indirectly participating in the decision making process of the facility. It promotes services
that are sensitive to the needs of the client.
Preparation for the survey: It is important to prepare very well before starting any client
satisfaction survey. The quality assurance team should: Identify the objective of the survey. We
need to be clear about what we want to achieve at the end of the survey. It is only when we get
our objectives right that we can know the relevant data to collect. Develop your questionnaire.
There is currently an existing questionnaire on satisfaction, which is widely used by health
facilities. You may have to translate the questionnaire into the local language. This should be
done and agreed upon before the interviews are conducted. Determine the number of people to
be interviewed (sample size). It is recommended that a minimum of 50 clients are interviewed in
a clinic or health centre survey. Select and train the interviewers on how to conduct the
interviews. The interviewers should not be known to the clients.

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When do we collect the data?
Information should be collected from clients when they are about to leave the facility. This is
called the EXIT interview.

How do we collect the data?


These are the measures that should be taken when conducting exit interviews. Spread data
collection over two weeks or over a period of 10 days. (5 per day from Monday to Friday) Select
patients randomly. You will have to decide whether you will select every 3rd person or 4th
person or 5th person in that order. Number your questionnaires in consecutive order. (1,2,3,4,5)
Before interviewing the client, introduce yourself and seek his consent. Explain briefly why you
are carrying out the survey (to help improve on services for clients) Let the same person
interview the clients to ensure that questions are asked the same way. The interviewer should not
be in uniform. Do not influence the client's responses.
Data Analysis and Report Writing. After gathering the information from the clients, you analyse
and present your findings using a simple data entry form. For example assuming that 25 out of
50 clients interviewed said that they were seen in less than 1 hour then the % of Clients seen
within 1 hour is: 25/50 x 100 =50% The % obtained for all the indicators are displayed
graphically for interpretation.

Clients Complaints System This is another way clients can inform you about the services that are
being provided without doing a survey.

There are several complaints system but the most common and simple ones are: 1. The use of
complaints/suggestions box. 2. The use of client complaints desk.

Complaints /Suggestions
A complaint box as the name suggests, involves placing a clearly labelled box at an open place
e.g. the reception. Attached to the box is a pen and paper, which clients will use to write down

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their complaints and suggestions. There should be a person responsible for emptying the box,
analyzing the complaints and reporting on findings regularly to management for action.

When using the complaint box, the following should be noted:


1. It should be possible to not identify those who make the complaints; else it would scare off
clients or patients who would like to complain about the quality of services.
2. Prompt investigations should be carried out and feedback given to clients who provide their
address.
3. Staff should not sit by the box.

There are some problems that relate to the use of the complaints box. Among them are the
following:
1. The box may not be opened for very long periods.
2. People may write about things that are not related to the quality of service.
3. They may also use it to make accusations against health workers.
4. It is not useful in an area where a large number of the clients are illiterates.

Client Information and Complaints Desk

A client Information and Complaint Desk/Centre is normally located at a place that is accessible
to clients. A well-trained staff with good interpersonal skills should be in charge of the desk. She
or he is responsible for giving the necessary information and direction to clients, listening to their
complaints, documenting them and following up on complaints. Most often complainants have
the opportunity of receiving feedback on the spot. Some of the complaints may need further
investigation. It is important that feed-back is given to the complainant after investigations have
been conducted and where the facility is in the wrong, apology should be rendered. The records
of the complaints should be reviewed regularly and feedback given to management and staff.

Records Review: This is the collection and analysis of information from existing records and
reports. The routine data we collect from the Health Management Information System (HMIS) is

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an important source of information for monitoring quality. We should take interest in analyzing
the data and use it to improve quality in our facilities. For example, analyzing trends in
immunization coverage can show us whether we are meeting our set target. We can also review
patient records to see if prescribers are complying with standards, protocols and guidelines.

Review of Adverse Incidences


Adverse incidences are unusual incidents that occur in the course of duty at the work place e.g. a
person collapsing after an injection, adverse events following immunization. Such an event
should be well documented and thoroughly reviewed immediately after it has occurred with a
view to putting in measures to prevent similar occurrences in the future. The process involves a
systematic review of all records on the incident. If you are unable to undertake the review, you
should consult your supervisor to support you do it.

Mystery Client
In this approach, the institution engages the services of an individual called the mystery client
who visits the health facility and pretends to be receiving health care services in the facility.
Without attracting attention, he or she observes, assesses and at times experiences the quality of
services rendered by the staff to clients. The mystery client then reports his or her findings to the
institution for analysis. The nature of the task of the mystery client requires that he or she must
be confident, accurate and reliable. He or she must also have good memory in order to reproduce
what was observed and experienced in an unbiased manner after the process.

Supervision
Supervision is a process of guiding, helping and teaching health workers at their workplace to
perform better. It involves a two-way communication between the one supervising (supervisor)
and the one being supervised (supervisee). Adequate preparation should be made in terms of
planning and budgeting before the visits. At the end of the visit, the supervisor should make time

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to discuss with staff their findings and agree on what actions to take to improve on performance.
A report must be written by the supervisor and feedback sent to the staff.

There are various types of supervision and three are described below:
1. Facilitative Supervision: It is also called supportive supervision because the supervisor does
not see himself as an inspector looking over the shoulders of his subordinates for faults. Instead,
he sees himself as part of the quality team guiding the staff to identify their weaknesses and gaps
in quality of service delivery. Together with the supervisee, they develop appropriate solutions to
improve on their performance.
2. Inspectorate type: The supervision here focuses on finding faults and has minimal
interaction. It therefore leaves little or no learning experience to the one being supervised.
Self- assessment or peer-based supervision: This is where the supervisor's role is indirect. It is
the type of supervision where staff belonging to the same team or professional group sets up a
system whereby they meet regularly to discuss their own performance with little or no external
role. Monitoring is the way to determine how much progress we are making towards achieving
our set objectives. In this chapter, we have come to understand that quality monitoring involves
the collection, analysis and interpretation of data to know where we are in quality of our service
delivery. Data for monitoring quality may be obtained from routine HMIS data, reports or
periodic data from surveys i.e. patient satisfaction surveys. We have also discussed the various
types of supervision. We have also learnt about other methods for monitoring quality. As we
implement quality assurance, let us remember to use the data we collect to improve the quality of
our services, which is one of the five principles of quality.

TOOLS FOR MONITORING

Indicators
You need to use Indicators to make monitoring meaningful. An indicator can be defined simply
as the yardstick by which you measure progress. Indicators are derived from standards.
Depending on what you set out to do, you may select indicators that will help you measure them.

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We can categorise Indicators for monitoring quality into Client and Professional perspectives.
Client-defined indicators are those derived from the clients expectations and professional
indicators are those derived from professional standards.

Indicators for Monitoring Quality on Patient Satisfaction (OPD)


1. Proportion of patients seen promptly
2. Proportion of patients seen without an unnecessary delay
3. Proportion of patients examined by the Doctor
4. Proportion of patients told about the diagnosis
5. Proportion of patients given instructions about how to take their treatment
6. Proportion of patients told whether or not to return
7. Proportion of patients having privacy during consultation
8. Proportion of patients receiving all drugs prescribed
9. Proportion of patients perceiving staff attitude to be very good
10. Proportion of patients perceiving clinic to be clean
11. Proportion of patients seeking emergency treatment in the past 6 months who were seen
promptly
12. Proportion of patients feeling very satisfied with their visit
13. Proportion of thirty (30) essential drugs in stock.

Examples of routine indicators: Number of OPD attendance? Percentage of children under 1


year who have completed their Immunization coverage? Number of injection abscess?
Percentage drug availability? Number of supervised deliveries ? Number of drugs prescribed for
a patient In addition to the above, the QA team can also use indicators that look at how we
manage patients. We have standard guidelines for the management of diseases like Malaria and
Diarrhoea in children under 5 years. Indicators that have been developed from these guidelines
include: ? Proportion of children weighed at OPD ? Proportion of children whose temperatures
were taken ? Proportion of children who were diagnosed as having Malaria and prescribed oral

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chloroquine or artesunate-amodiaquine. ? Proportion of children who were diagnosed as having
diarrhoea and given ORS.

Tools for Collecting Data and Use of Information


Before you set out to collect data for monitoring the progress of your QA, you need to agree on
how you are going to collect the data. The common tools used for data collection during
monitoring are? Checklist? Observational guide? Questionnaires? A combination of all the 3.

Checklist
Checklist contains the important information you will need to collect to assist you monitor
quality in your facility. It lists out the important points that should guide you to ask the necessary
questions and make the required observations.

Observational Guide
It is a list of key points that will guide you to observe the important activities that you need to
take note of. We can use this method to assess staff attitude at the OPD by observing how
patients are handled by health staff at the various points during OPD consultation. We can also
use observational guide to assess how sick children are managed at the OPD by sitting in the
consulting room and quietly observing the process of consultation using for instance, a sample
observation guide at appendix 1C. The rating scale provided with the guide gives the result of
observation a numerical value.

Questionnaire
A questionnaire is a useful tool containing questions on key issues that you want to know about.
There are several types of questionnaires. A few of them are stated below: Structured
questionnaire: This provides possible answers for the one being interviewed to choose from. ?

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Open-ended questionnaire: The one being interviewed is encouraged to come out with his or her
own answers. ? Semi-structured questionnaire: This combines both structured and openended.

Dissemination of Information on Quality Assurance


The importance of gathering information about quality is to improve our services. People are
more likely to use the information when they understand it, hence the need for creative ways to
disseminate it. It is important to discuss your findings first with management before presenting
them to the general staff body and the community.

Find below some guidelines for dissemination:

Findings from monitoring should be presented in a very clear manner so that staff can easily
understand. Findings should be presented as absolute figures; proportions or percentages;
pictorial form e.g. line graph, bar chart, pie chart and histograms. ? Always remember that after
initial discussion of your findings with management, you would have to follow it up with a
written report so that they can take action where necessary. ? Findings should be displayed on
staff notice boards. ? Always remember to hold staff durbars to inform them about your findings.
? The findings and the proposed solutions should be shared with clients and the community. The
use of audiovisual equipments like the video will make your message clearer.

QUALITY IMPROVEMENT

Quality Assurance Cycle


The QA cycle is a guide that can be followed to continuously improve quality of our health
services. It has different stages and by going through them, the QA team can follow the cycle to
assess, monitor and improve the quality of care we give to the clients. You can start from any
stage of the cycle but have to complete it once you start. Just be simple, practical and creative in
your approach.

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Steps in the quality assurance cycle what then are the main steps in the QA Cycle and how can
they be used to improve quality?

Plan for Quality


We do planning in our everyday lives and in our facilities also. It is equally important to plan for
QA. Planning for quality is not an individual task but should be done by the whole QA team. It is
the task of this team to carefully plan activities that will facilitate the implementation of QA
activities in your facility. A budget should be prepared with the plans so that resources are
committed for quality assurance. The activities should be well organized, systematically carried
out and properly coordinated.

Review Standards
We need standards to check whether our activities meet client and professional expectations.
Standards are usually set at the national level but can be adapted for the lower levels. Protocols
and Guidelines can also help us to improve the quality of our services. Make a list of some of the
guidelines and protocols available at your facility.

Communicate Standards
Communication plays a very important role in QA. Whatever decision the team takes must be
well understood by all members and properly communicated to other staff. It is important to
communicate these standards set by the facility to all members of staff. For example all
prescribers in the facility should know about existing guidelines and protocols and comply
accordingly. Each facility has its own effective way to communicate information to the staff.
Examples include meetings and durbars. What other examples do you have?

Monitor the Use of Standards Once we have our standards, protocols and guidelines in place,
we then monitor to see whether we are adhering to them or not. For example, we can always

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check to see whether the temperature is taken and recorded for malaria cases. The main aim of
monitoring is to check whether or not we are complying with standards.

Identify and Prioritize Problems


In our facilities, some of the problem areas are related to patient satisfaction, poor prescription
habits, infection control practices etc. Since we cannot solve all the problems at the same time,
there will be the need to prioritize. We can determine the priority problem areas as well as
opportunities for improvement. It may be helpful to first select the simple ones that we have
resources to solve. Once we see results of our activities, we are encouraged to do more.

Define the Problem


Once the problem areas have been identified, we try to define them. We state them as problems.
What does this mean? Consider the following two statements about the state of the clinic
compound: ? The compound is dirty because patients litter the place and the few laborers are
lazy ? 45% of patients complain the compound is very dirty. In the above example the actual
problem is the very dirty compound. The size of the problem is that 45% of patients complain
about it. A good problem statement does not assign reason or blames people. The second
statement obviously better defines the problem.

Analyze the Problem


Every problem has got its underlying causes. We therefore analyze to find the root causes to the
problem. Simple methods for problem analysis include Brainstorming, But Why and Tree
diagram.

The root cause of the problem in this case is the absence of dustbins. The situation may differ in
your work place. There is therefore the need to carefully analyze the problem in order to get to

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the root cause. In brainstorming, the QA team freely talks about the problem until they discover
the root causes. The problem can also be presented as a tree with its causes representing the roots

Suggest/Develop Solutions
After analyzing the problem, the team should suggest ways of correcting the problem. Again,
this can be done through brainstorming to gather a lot of possible solutions. You can also find
out how other facilities have addressed similar problems. Some problems are easy to solve while
others are difficult. The solution you choose should be practicable and within your available
resources (money, material and human) once you get to the root causes, it becomes easy to
suggest possible solution. Usually the root causes and the suggested solutions are like the two
sides of a coin. In the above example, the suggested solution is to provide dustbins.
Implement Solution. First develop action plan. The action plan spells out the activities to be
undertaken based on the solutions, persons responsible, time frame for each activity, resources
required, expected output and how monitored. It is helpful to assign people to specific tasks even
though we all work on the problem as a team. The person responsible should be clear about the
task and the time to report to the team. Remember the saying that everybody's business is
nobody's business. Always remember to make people responsible!

Example of an Action Plan Clinic: Aboabo Health Center Problem: 15% patients
complained the clinic is not very clean.
Objective: To reduce the proportion of patients who complain that the clinic is not very clean
from 15% to 10% by the end of December 2004.
Period of implementation: July- December 2004
The action plan should be implemented within an agreed time period. During the implementation
period indicators should be monitored to see if we are achieving our goal before the final
evaluation. A Gantt chart may be of help in the monitoring of activities.

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Evaluate.
At the end of the agreed period we check to see whether we have achieved our goal. In the above
example, we find out in December 2004 whether we have succeeded to reduce the proportion of
patients who complain that the clinic is not very clean from 15% to 10%. In so doing we improve
the quality of state of cleanliness from the patient's view substantially. You will have to conduct
another patient satisfaction survey and compare results to see how far you have improved. Then
the cycle continues.

IMPLEMENTING QUALITY ASSURANCE IN A FACILITY

Steps in the Implementation of QA in A Facility


To effectively implement a QA system in a facility, there are certain basic steps to be considered.
Some of these steps can be carried out at the same time. It will be helpful to review each step
periodically to ensure that the implementation process is continuous.
The steps involve the need to:
1. Form a multidisciplinary quality action team
2. Create awareness among staff
3. Review present state quality
4. Develop/adapt written guidelines
5. Carry out QA training
6. Apply skills to continuously improve your performance
7. Share results periodically with other staff and clients 8. Hold regular QA meetings to plan and
review performance

Form a Multidisciplinary QA Team


Teamwork is key to successful QA implementation at the facility level. Each member of staff has
a special role to play just as a rainbow has many colors. The team should be multidisciplinary eg.
Pharmacy, laboratory, Nurses, Records etc be represented. There is the need to ensure that the

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members are committed to work. The team shall be responsible for the implementation of QA at
the facility.

Create Awareness among Staff


It is important that every member of staff (from the lowest to the highest) understands and
appreciates the QA concept. A system to create awareness include staff durbars, departmental
meetings etc. Awareness creation should continue until quality becomes part of normal routine
work.

Review the Present State of Quality Performance


At the facility. Before you can take any meaningful step to improve quality, you need to know
your present state of quality performance in your institution. How can this be achieved? You can
get information from normal routine records, results of patient satisfaction survey etc. You then
determine where you want to focus and improve performance.

Develop Written Guidelines / Standards


The team at this time looks at how to improve quality according to approved standards and
guidelines. Existing guidelines can be obtained from National or Regional levels. They can be
adapted or new ones developed. The most important thing is that all the standards and guidelines
are communicated to staff.

Conduct Training For QA Team And Other Staff.


A start up training is conducted for QA team members. This training will cover broad areas on
QA principles; setting up process and overall strategies in QA management. The team should be
confident enough to initiate QA process in the facility after the training. Subsequently, there will
be the need to train other members of staff. There should also be a system for systematic and
continuous education.

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Apply Skills To Improve QA.

At this point, the QA team should be in the position to apply the knowledge and skills acquired
to confidently initiate the QA program in the facility. It is usually advisable to start small with
indicators which are easy to monitor and see results e.g. Patient satisfaction survey. You may
then expand to other areas based on what the team decides.

Share QA Results With Other Staff and Patients.


It is important to share the results of QA performance with other members of staff. This will help
to create more awareness, increase commitment and deepen sense of ownership among staff. For
example, Performance can be presented using bar charts at staff durbar. Other creative ways can
be explored to disseminate information to clients eg using patient information desk.

Hold Regular QA Review Meetings Once you have initiated the process of implementing QA in
your institution, there is the need to meet regularly and review your performance as a team. You
can achieve this by holding regular QA meetings. Keep minutes of meetings for reference and
may be used to develop action plan . Remember to appoint a Chairman and a Secretary.

The role of the Health Care Manager in QA


The Health Care Manager plays a central role in the successful implementation of the QA
program. There is the need for the manager to personally show interest and inspire other staff.
The manager may play some of the following roles among others: Lead the staff to cultivate
Quality culture in the facility. Ensure that the QA Team meets as scheduled. Provide logistics to
implement QA in the institution Encourage training to develop staff Develop incentive system
and strategies to motivate staff. ? ? ? ? ? It is of no use to receive training in QA and not putting
into practice. Management commitment is very important for successful QA implementation.

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What the Leadership stands for I always want to improve my services even with the little
resources I have. I always look for creative ways to improve my services through teamwork.
Above all I always make sure my services meet professional standards and to the very best taste
of my clients. I always aim at excellence. QA

MANAGING CHANGE IN QUALITY ASSURANCE

Types of Change in an Organization


Various types of change can occur in a health facility or organization. Change can be described
as being imposed when there is a directive to initiate change from somewhere else. An example
is when the Director General directs institutions to implement QA. A health facility on its own
can initiate change by reorganizing the way things are done or puts in place measures to improve
its performance. An example is the management and staff of a facility decides to initiate change
in order to establish a QA program.
Change can be described as necessary when an organization whose survival is being threatened
by circumstances, undergoes major changes to ensure its survival. An example is the
privatization of a public health facility that is performing poorly.

Reactions to Change People react to change in different ways.


These include? Those who will welcome change? Those who will be indifferent to change?
Those who will oppose change

Reasons Why People Welcome Change? Some people welcome change because: ? They want to
be free from the boredom of their work. Possibly, they feel they are being marginally utilized and
thus are looking out for more challenging opportunities. ? They expect to enjoy better conditions
of service? They expect the fall of someone's “kingdom”. This occurs at the workplace when
some staff feel others have undue advantages over them in terms of access to resources and

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privileges and the change is likely to affect the privileged negatively? They expect recognition
from the change- and opportunity to be involved more in the organization's activities.

Reasons People Are Indifferent To Change People are indifferent to change because; ? They
have heard of it all, being said before, and it never happened? They see that systems and cultures
are entrenched for such long periods- the organization hardly undergoes any change

Reasons Why People Oppose Change People resist change because? They want to guard their
own interests. The change threatens to deprive them of their position and privileges ? There is
misunderstanding and lack of trust. This occurs when the reasons for the change, the implications
and benefits are not explained to them? They may have to acquire new skills and behaviors
which they may find difficult to learn.
Strategies for Managing Change in QA the under listed/following strategies can be used to
manage change in your facility. ? Share ideas and discuss the need for change with all staff who
will be involved in the change process. This calls for frequent dialogues through staff durbars,
meetings, group discussions etc.? Use methods aimed at effecting changes in attitudes, values
and skills eg conferences, study tours to sites of best QA practice to introduce and clarify new
concepts and share experiences.

Ways to Minimize Resistance When Implementing Change The following is suggestions as to


how you can minimize resistance to the implementation of QA in your facility. ? Show strong
commitment and leadership? Involve all staff- do not leave it to a privileged few? Provide data
for the need to change to all staff? Communicate the change message effectively and
continuously, listen and act upon concerns from the staff? Allay fears of staff- use consultations,
discussions workshops etc? Look for consensus decisions, encourage those likely to be affected
to suggest solutions? Do not initiate too many activities at a time? Be transparent? Encourage
innovations? Involve staff in standards setting? Monitor performance and provide feedback to
staff.

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PATIENT DEFINED INDICATORS

INDICATOR 1: Proportion of patients seen promptly. Number of patients saying they were seen
in 2 hours or less x 100 Number of patients interviewed

INDICATOR 2: Proportion of patients seen without an unnecessary delay Number of patients


saying they were seen without a delay x 100 Number of patients interviewed

INDICATOR 3: Proportion of patients examined by the Doctor/ Medical Assistant (MA)


Number of patients examined by the MA x 100 Number of patients interviewed

INDICATOR 4: Proportion of patients told the diagnosis. Number of patients told diagnosis x
100 Number of patients interviewed

INDICATOR 5: Proportion of patients given instructions about their illness from the MA.
Number of patients given instructions by the MA x 100 Number of patients interviewed

INDICATOR 6: Proportion of patients told whether to return. Number of patients told whether
or not to return x 100 Number of patients interviewed

INDICATOR 7: Proportion of patients having privacy during consultation Number of patients


having privacy during consultation x 100 Number of patients interviewed

INDICATOR 8: Proportion of patients receiving all drugs prescribed. The number of patients
interviewed who received all drugs x 100 Number of patients interviewed
INDICATOR 9: Proportion of patients understanding instructions from the Pharmacist Number
of patients who understood pharmacy instructions x 100 Number of patients interviewed

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INDICATOR 10: Proportion of patients perceiving staff attitude to be very good Number of
patients saying staff attitude is very good x 100 Number of patients interviewed

INDICATOR 11: Proportion of patients perceiving clinic to be clean. Number of patients saying
clinic is very clean x 100 Number of patients interviewed

INDICATOR 12: Proportion of those seeking emergency treatment in previous 6 months who
were seen promptly. Number of patients saying they were seen promptly during emergency x
100 Number of patients who answered question 12.

INDICATOR 13. Proportion of patients feeling very satisfied with their visit. Number of patients
saying they were very satisfied x 100 Number of patients interviewed

TERMINOLOGY
Access: The extent to which users can reach and obtain service. Action Plan: A timetable of
activities planned for a given period of time which indicates inputs required, the processes
involved and the outcomes expected.

Adverse incidence: An occurrence that deviates from the normal, such as accidents occurring in
the course of duty at the workplace.

Amenities: The physical features of a service that facilitates the delivery and use of the service.
Checklist: A list of items and conditions expected to be present.
Client: User of a product or service. Clients may be internal, that is, among the providers
themselves, or external, that is, outside the providers.
Clinical Audit: A systemic process whereby clinicians critically examine their practice against
agreed standards and modify their practice where indicated, in order to improve the delivery and
outcomes of patient care.

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Communication: A process by which a message is passed from a sender to a receiver. The
components of effective communication are the sender, the message, the channel, the receiver
and feedback from the receiver to the sender.

Confidentiality: Protection of information from persons who are not expected to have access to
it.

Continuity of services: Ability of the client to receive the complete package of services that he
needs from the service provision system over time, without interruption or cessation.

Customer: used interchangeable with Client.

Effectiveness: The ability of a process to produce the anticipated desirable effects. Efficiency:
Carrying out an activity or process with the least waste of time, effort and resources

Equity: Fairness in the distribution of services. Evaluation: Assessment of the outcome of a set
of processes in relation to the set objectives. Expectation: What is seen as being satisfactory?

Facilitative supervision: Overseeing the performance of a task in such a way as to promote


learning

Gantt chart: A chart showing when activities begin and end Guideline: Direction on how an
activity may be carried out. Impact: The lasting effects of an activity or set of activities.
Indicator: A yardstick used to measure the level of quality.
Input: The set of people and things that are needed to carry out an activity. Interpersonal
relations: Relationship between users and providers and among providers.
Models of quality: The different angles from which one can define, monitor, measure and
improve quality.
Monitoring: Continuing assessment of the progress made in the implementation of a plan or
activity, with recommendations for modification of methods of as appropriate.

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Mortality meeting: A meeting of health staff to examine deaths that have occurred in the facility
over a period of time.

Observational guide: A list of the essential points that have to be noted when observing an
activity.

Outcome: The ultimate effect of an activity or set of activities.

Output: The immediate result of an activity.


Perception: Expression of what is experienced Perspective: Approach or point of view Privacy:
The state of not being seen or heard by a person not expected to do so. (Compare privacy)

Problem: The gap between the present level and the expected level of quality.

Process: The actual performance of an activity or set of activities. Protocol: Strict direction on
how to perform an activity. (Compare guideline)

Quality: The degree to which a product or service meets the expectations of an individual or a
group.
Quality Assurance: A planned systematic approach for continuously monitoring, measuring and
improving quality of health services, with available resources, to meet the expectations of both
users and providers.

Quality Assurance Cycle: The steps in the implementation of quality assurance.

Questionnaire: A set of questions that help to measure the quality structures, processes and
outcomes.

Safety: The degree to which a service is free from risks to the user and provider.

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Specifications: Guidelines that specify the characteristics of a product or material input like
equipment or supplies used in health care delivery.

Stakeholder: A person or group of persons that has vested interest in a particular thing Standard:
Explicit statement of expected quality.

Structure: The set of people and things needed to carry out an activity, as well as how well they
are organised to achieve results.

Supplier: The person who provides a good or service.

Technical competence: The extent to which health professional are able to apply knowledge and
skills to produce professionally acceptable results.

Definition of Quality
 Meeting the needs and exceeding the expectations of those we serve
 Delivering all and only the care that the patient and family needs

“Definition” of Improvement
 It is NOT…
 yelling at people to work harder, faster, or safer
 creating order sets or protocols and then failing to monitor their use or effect
 traditional Quality Assurance
 research (but they can co-exist nicely)
Principle OF QUALITY :
Improvement Requires Change

Every system is perfectly designed to achieve exactly the results it gets


To improve the system, change the system…

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Principle #2:
Less is more

You cannot destroy productivity


When changing the system, keep it simple

Understanding Change in the Hospital Atmosphere


 Change = not just doing something different, but engineering something different
 at least one step in at least one process
 Hospital Atmosphere = hospitals tend to be viscous, complex systems with default levels
of performance
change engineered to improve performance can be a foreign concept - or even overtly resisted.

A Common Strategy Which Commonly Fails:


 Experts design a comprehensive protocol using EBM over several months
 Protocol is presented as a finished, stand alone product
 Customization of protocol is discouraged
 Compliance depends on vigilance and hard work
 Monitoring for success or failure is the exception to the rule (with failures coming to light
after patients are harmed)
 Flawed implementation leads to repetitive efforts down the road

High-Reliability Strategies Commonly Succeed:


 Build a “decision aide” or reminder into the system
 Make the desired action the default action (not doing the desired action requires opting
out)
 Build redundancy into responsibilities (e.g. if one person in the chain overlooks it,
someone else will catch it)
 Schedule steps to occur at known intervals or events
 Standardize a process so that deviation feels weird
 Take advantage of work habits or reliable patterns of behavior

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 Build at least one - if not more - of these high-reliability strategies into any changed
process.
Change engineered to drive improvement depends on…
 Workplace Culture: personnel must be receptive to change
 Awareness: administrative and medical staffs must care about
performance and support its improvement through change
 Evidence: local experts must identify which research to translate into
practice
 Experience: a skilled team must choose, implement, and follow up
changes to ensure:
1) improvement efforts are ongoing and yielding better performance
2) Productivity is preserved

AWARENESS OF THE LOCAL PERFORMANCE GAP


Patient
Medical Staff
Administrative Support

EXPERIENCE WITH SIMILAR IMPROVEMENT EFFORTS


Hospitalist Quality Officer
Multidisciplinary Team Members
Success Stories From Other Institutions

EVIDENCE TO TRANSLATE INTO PRACTICE


“Bedside” Teaching
Didactic Teaching Sessions
Local Expertise in Disease Literature

WORKPLACE CULTURE READY TO ACCEPT CHANGE


Task Load
Culture of Improvement

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Culture of Negative Expectations

Three types of team members…


1) Team Leader
2) Team Facilitator
3) Process Owners (members with operational, hands-on fundamental knowledge of the process)

Team Leader…
 schedules and chairs team meetings
 sets the agenda (printed at each meeting)
 records team activities (working documents in binder)
 reports to management (Steering Team)
 often a member of Steering Team

Team Facilitator…
 owns the team process (enforces ground rules)
 technical expert on QI theory and tools
 assists Team Leader
 teaches while doing, within team

Process Owners…
 chosen for fundamental knowledge
 will help implement
 should become leaders (so choose wisely)

Team Ground Rules…


 All team members and opinions are equal
 Team members will speak freely and in turn
– We will listen attentively to others
– Each must be heard

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– No one may dominate
 Problems will be discussed, analyzed, or attacked (not people)
 All agreements are kept unless renegotiated
 Once we agree, we will speak with "One Voice" (especially after leaving the meeting)
 Honesty before cohesiveness
 Consensus vs. democracy: each gets his say, not his way
 Silence equals agreement
 Members will attend regularly
 Meetings will start and end on time

Hospitals have two dynamic levels impacting performance:


1) Processes
 tasks performed in series or in parallel, impacting patient care and
potentially patient outcomes
 all those affecting relevant aspects of patient care
 clinical decision making, order writing, admission intake, medication
delivery, direct patient care, discharge planning, PCP communication,
discharge follow-up, etc

2) Personnel
 skilled people with hearts and minds, with variable levels of attention,
time, and expertise
– anybody who touches the patient or a relevant process in the system
 departments, physicians, clerks, pharmacy, nursing, RT, PT/OT/ST, care
technicians, phlebotomist, patient transport, administration
 What?
– is the right thing to do?
– will make the system more effective?

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Cause-and-Effect Diagram
Sometimes also called a ‘fishbone’ or Ishikawa diagram graphically displays list of possible
factors, focused on one topic or objective
used to quickly organize and categorize ideas during a brainstorming session, often as an
interactive part of the session itself (the added organization can help produce balanced ideas
during a brainstorming session)

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Will the team target ‘all’ patients in the inpatient bell curve, or just a sub-group considered ‘at-
risk’ (depicted in the outlying tail)? Is the quality of inpatient care which is not in the tail
somehow ‘acceptable?’

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If the team can identify and define an inpatient sub-group ‘at-risk,’ then improvement efforts
could conceivably focus just on these ‘at-risk’ patients - this is similar to traditional Quality
Assurance. Note that even if tail events are eliminated, the quality of care for the rest of the
inpatient population (depicted by the unchanged position and shape of the bell curve) does not
improve at all. While the mean does move toward better care, this is due only to eliminating
statistical outliers.

If the team identifies a performance gap applicable to a wider patient population, the team may
design changes in processes with the potential for dramatic effect: improvement and

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standardization in processes reduces variation (narrows the curve) and raises quality of care for
all (shifts entire curve toward better care). This radical change is what defines Quality
Improvement.

Pareto Chart
• graphical display of the relative weights or frequencies of competing events, choices, or
options
• a bar chart, sorted from greatest to smallest, that summarizes the relative frequencies of
events, choices, or options within a class
• often includes a cumulative total line
• used to focus within a broad category containing many choices, based on factual or
opinion-based information
• can combine factors that contribute to each item's practical significance

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Sketching Processes or Flow:

Macro Process Maps

Decision Flow Diagrams

Decision Flow Diagram:

Run Charts
 Our brains understand graphics better than tables
 Tabular information doesn’t convey trends over time very well
 Keep it simple
 In center of horizontal axis place: baseline mean performance

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 In center of vertical axis place: implementation point
 Can add upper and lower control limits, but usually not needed

The Multidisicplinary Team Asks “How?”


 How? can you make it easy to do the right thing?
You cannot destroy productivity.

Changes must maintain, or enhance, workplace efficiency or balance


You must devote as much attention to fitting changes into clinical work flow as you do to the
evidence-based guideline

Changes must be blended into the flow of clinical care


Important variables to consider: staffing, training, supplies, physical layout, information flow,
and educational materials.

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CLINICAL PROCESS IMPROVEMENT
The key issue in quality planning is to know that such national standards and practice guidelines
exist and are available for use by organizations in treating patients and establishing performance
measures.
 The improvement of performance in clinical processes is more complex than
improvements in governance, management, or support processes.
 One of the key issues is the addition of the patient as a variable as supplier, processor,
and customer.
 Other issues include the more interdisciplinary nature of these processes,
epidemiological differences between individual patients and patient populations, the
constantly changing technology and research, and the differences in practitioner training
and experience.
 Clinical standards, clinical practice guidelines, clinical pathways, and adjustments for
severity and complexity of patient illness and injury offer "state of the art" support.
 All such guidelines are considered, in quality improvement language,
"specifications of process" or "specifications of care,” based on the best scientific
evidence of effectiveness combined with expert opinion.
 They describe "typical" treatment for "typical" patients and provide a framework for
discussing patterns of care for cohorts of patients (patients with similar risk, co
morbidity, severity of illness, and expected outcomes).

Definitions and description

Standard of Care: "A standard of care defines the type of care/service and outcome that the
patient can expect from the healthcare encounter.
" [Healthcare Quality Certification Board]

Standard of Practice: "A standard of practice establishes an acceptable level of performance."


[Healthcare Quality Certification Board] Standards of practice are broad, generalized
statements of expected practitioner performance, behavior, or patient care intervention that are

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accepted in the community or nationally. They should not be confused with "practice
guidelines,” which are very specific to patient management of a particular condition.

Clinical Practice Guideline (CPG):


The National Guideline Clearinghouse [www.guideline.gov] employs the definition developed
by the Institute of Medicine (IOM):
Clinical practice guidelines are systematically developed statements to assist practitioner and
patient decisions about appropriate health care for specific clinical circumstances.

Evidence-Based Medicine (EBM):


 Most clinical practice guidelines (CPGs) are now based upon evidence-based
medicine, defined as the "conscientious, explicit, and judicious use of current best
evidence in making decisions about the care of individual patients.
 The practice of evidence-based medicine means integrating individual clinical experience
with the best available external clinical evidence from systematic research." [Sackett, et
al, "Evidence-Based Medicine: What It Is and What It Isn't," BMJ, 1996]
 A great resource: "Evidence-based Practice," Health Sciences Library, McMasters
University, Canada, www-hsl.mcmaster.ca/ebm/

Standards of Care for PHYSICIANS


 For physicians, standards of care are now best known as clinical practice guidelines.
Clinical "algorithms" and "practice parameters" also fall within this framework. A
clinical algorithm is a diagram of a guideline, making a step-by-step decision tree.
 Clinical practice guidelines generally are produced by medical specialty
associations, relevant professional societies, public or private
organizations, or government agencies, or result from a collaborative effort.
 Practice guidelines approved by national professional groups provide clinical rationale
for clinical pathways and performance measures and should be available through the

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quality professional (Quality Resource Center). We must know where the good resources
and data sources are.

Standards of Patient Care for Nursing


 The Joint Commission uses the term ‘nursing standards of patient care"
in Standard NR.3.10, 2005 CAMH.
 Nursing policies and procedures; nursing standards of patient care, treatment, and
services; and standards of nursing practice are established by the nurse executive,
registered nurses, and other designated nursing staff members, defined in writing, and
accessible to nurses in written or electronic format [NR.3.10, EP 1 & 3].}
 The Standards of Nursing Practice content, first developed by the American Nurses
Association in 1973, were revised most recently in 2004.
 They consist of:
 six "Standards of Practice" (care) and
 nine "Standards of Professional Performance," along
 with measurement criteria for each standard that are applicable in any setting
 Source: Nursing: Scope and Standards of Practice, ANA, 2004].

 The ANA Standards of Practice actually "describe a competent level of nursing care" ,
demonstrated through the nursing process:
 Assessment
 Diagnosis
 Outcomes identification
 Planning
 Implementation (coordination of care, health teaching and health promotion,
consultation, prescriptive authority)
 Evaluation
 In performance measurement, important aspects of nursing care are easily adapted from
the established nursing standards, as are performance measures.

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 The ANA Standards of Professional Performance cover nine key areas:
 Quality of practice,
 education,
 professional practice evaluation,
 collegiality,
 collaboration,
 ethics,
 research,
 resource utilization, and
 leadership.

The Quality of Practice standards says:


 The registered nurse systematically enhances the quality and effectiveness of nursing
practice." Measurement criteria include:
 Documenting in a responsible, accountable, ethical manner;
 Using QI results to initiate changes in nursing practice and the delivery system;
 Using creativity and innovation in nursing practice to improve care delivery;
 Incorporates new knowledge for change if desired outcomes are not achieved;
 Participates in quality improvement activities.

Clinical Practice Guideline Development


 National practice guidelines offer solid baseline information for the develop of
organization-specific clinical pathways (clinical
management plans).
 Practice guidelines help in the development of clinical algorithms to support clinical
pathways.
 For example, physicians can support the effectiveness of a clinical pathway forventilator-
dependent patients by developing an acceptable weaning protocol or algorithm.

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 Another example is physician development of algorithms for the prescription of
appropriate antibiotics, based on infectious agent, for patients with pneumonia who are
being treated by the team in accordance with a pneumonia clinical pathway

 Clinical practice guidelines are developed and released by the then U.S. federal Agency
for Health Care Policy and Research (AHCPR), now called the Agency for Healthcare
Research and Quality (AHRQ), www.ahrq.gov, between 1992 and 1996.
 They included both a clinician' reference guide and a patient's guide
and were widely covered in the lay press.
 The distribution of most guidelines was discontinued May 2001, since they are now
considered to be out of date. The 16 discontinued guidelines are available only in an
electronic archive: www.ahrq.gov/clinic/cpgarchv.htm.
 The three guidelines still current—Pressure Ulcers in Adults, Pressure Ulcer Treatment,
and Cardiac Rehabilitation—are available at www.guideline.gov .
 The AHRQ now supports development efforts by others and sponsors the National
Guidelines Clearinghouse (NGC™), at www.guideline.gov.
 The NGC™, a partnership effort involving AHRQ, America's Health Insurance Plans
(AHIP) and the American Medical Association (AMA), is a publicly available electronic
repository for guidelines and related materials that have been reviewed and updated
within the last five years by more than 300 organizations.
 As of July 2006, the repository covers guidelines under:
 1742 Diseases;
 160 Mental Disorders
 Treatment/Intervention: 958 Chemicals and Drugs; 1524 Analytical, Diagnostic, and
Therapeutic Techniques and Equipment (surgical, anesthesia, diagnosis/ therapeutics,
investigative, dentistry, equipment/supplies); 197 behavioral

The Integration of Standards into Practice and Performance Appraisal


 Physicians are increasingly being called on to use clinical guidelines.

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 Scientific studies support their use; resistance to “cookbook medicine” is fading out.
 External groups from Leapfrog to the American Heart Association to NCQA and JCAHO
are incorporating adherence to guidelines into PI.
 Physicians are more apt to use them, with medicine becoming more complex, as long as
leaders believe in them and they are readily available at the point of care.
 Standards of care, clinical practice guidelines, and clinical paths are used increasingly to
generate performance measures/indicators for ongoing quality management activities.
 The emphasis in quality improvement is on the processes of delivering care, but we
cannot ignore significant findings related to the care and practice of individual
practitioners.
 Performance measure results are the basis of the growing pay-for-performance bonus-
payment programs
 The results of quality management activities, including adherence to standards, are
documented and reviewed in conjunction with the reappraisal of all independent
practitioners with delineated clinical privileges (physicians, psychologists, dentists,
podiatrists, allied health professionals/limited license practitioners) that occurs generally
every two years in hospitals, large medical groups, staff model HMOs, etc
 The results of quality management activities within the organization may
also be incorporated into the performance evaluation process of at least the other clinical
staff or those who directly contact patients (nurses, therapists, technicians, medical
assistants, health aides, etc.), along with non-clinical staff, as organization performance
monitoring progressively includes more governance, management, and support functions
and performance measures based on standards.
 One of the most valuable aspects of this integration is the inclusion of positive findings.

Clinical pathway and clinical algorithm development


 A clinical path is a patient management strategy and tool describing the key events in
the process of care for a given diagnosis or condition that the healthcare team determines
are most likely to result in positive outcomes.

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 The path describes what interventions an average patient might require, but allows the
physician to change, delete, or add interventions to meet each patient's needs.
 In this sense a clinical path serves as a patient management plan, but it is not a standard
of care.
Steps in Clinical Path Development
 Prioritizing and defining the patient population/group;
 Identifying the "categories" of care to be included, as applicable, e.g.:
 Consults
 Lab Diagnostic Evaluation
 Radiology Diagnostic Evaluation
 Other Diagnostic Evaluation
 Treatments (can be broken out by service)
 Nursing care (can be separate or under treatments)
 Medications
 Nutrition
 Activity
 Teaching
 Discharge/transition plan
 Psychosocial
 Expected progress/outcome (for each day of care or objective)

 Identifying, for the designated diagnosis, procedure, or condition, the levels and number
of days of care or visits to be included (e.g., preadmission/emergent, day one through day
five, skilled or home health, etc.);
 Outlining anticipated care requirements and outcomes for each level/day of care objective
and category, using existing data or medical record review;

 Testing the accuracy of the clinical path while care is being rendered, redesigning as
necessary to reduce potential for unnecessary variation;

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 Identifying, documenting, and tracking variances over time, looking for better practice
and continuing redesign as necessary, or introducing other process improvements to
further reduce variation.

ADJUSTING FOR SEVERITY/COMPLEXITY OF ILLNESS


 Severity of Illness" is the degree of risk of immediate death or permanent loss of
function due to a disease.
 Clinical findings are used to assign a severity rating, ranging from “no risk” (0) to
“death” (5), depending on the system.
 A "Severity of Illness" System is computerized measurement which adjusts
ICD-9-CM diagnosis codes and/or DRG designation for hospitalized patients based on
the severity or extent of the illness treated.
 "Complexity of Illness" is the designation given to subclasses of illness, based on
complications and co-morbidities, in the DRG Refinements project undertaken by HCFA
(now CMS) and Yale University.
 The goal of all severity of illness or complexity of illness systems is to
group patients into homogeneous categories that reflect the extent or seriousness of
the disease process.

Examples of Available Severity/Complexity of Illness Systems


 Acuity Index Method (AIM), distributed by IAMETER, Inc. (www.iameter.com)
 Severity ratings are based on a full year of discharge data for hospitals and procedure
data for hospital outpatient surgical services.
 APACHE (Acute Physiology and Chronic Health Evaluation),
distributed by Apache Medical Systems, Inc. (www.apache-msi.com)
 This system provides different severity-adjusted software to trend patients and predict
need for critical care, "heart care," and acute care, and analyze clinical and financial
outcomes.

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 3M APR-DRGs (All Patient Refined—Diagnosis
Related Groups), a combination of the Yale R-DRGs (DRG Refinements) and another
then HCFA/3M project called AP-DRGs (All Patient DRGs), which modified DRGs for
non-Medicare patients.
 Distributed by HIS Systems, 3M APR-DRGs adjusts patient
data for severity of illness and risk of mortality.
 (www.3m.com/market/healthcare/his/us/product,
 Complexity of Illness Subcategories for APR-DRGs:
 Minor
 Moderate
 Major
 Extreme
 Atlas, distributed by Cardinal Health (originally "MedisGroups," by MediQual Systems,
Inc.), uses concurrent clinical findings and patient encounter data with severity-
adjustment algorithms to track patients through the continuum of care.
(www.mediqual.com/products/atlasoutcomes.asp )

Development of Effective Clinical Pathway System


The following issues must be addressed:
 The focus diagnoses, procedures, and/or conditions must be
identified, hopefully by organization leaders, based on accurate, in-
depth analysis of available data:
 Long term, determine the percentage of the patient
population to be included;
 Patient groups may be selected on the basis of high volume, high cost, high risk,
or problem-prone data;
 In addition to the above data, leaders should seek to identify those diagnoses,
procedures, and conditions that have wide variability in processes (management
by opinion, not standard) and obviously need a new process designed to bring the
clinical system under control.

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 The clinical path must be developed by a team consisting at
the least of all those who provide direct care to the
identified patient group;
 The clinical path that is developed should not change clinical staffing requirements;
 The clinical path should consider the entire episode of illness, outlining care requirements
for each care discipline and each level of care, including ambulatory, inpatient/alternative
delivery, and aftercare.

Clinical Pathway Analysis


 Truly effective clinical path analysis will require computerization.
 There is currently such a vast score and mix of variations from the path that hand tallying and
analyzing is tedious and inadequate for long-term aggregation;
 Many variations from clinical paths stem simply from the fact that:
 Patients are all different; and
 The paths probably do not truly represent "best" practice, and modifications to the
path are necessary (to stabilize the process) as the first step in reducing variation.

The Value of Clinical Pathways

Clinical (or critical) paths (or pathways) are developed by interdisciplinary teams, in
conjunction with physicians, as a way to:
 Identify the important functions, care processes, and needed services connected with
a particular diagnosis (e.g., diabetes), procedure (e.g., total joint replacement), diagnosis-
related group or other prospective payment reimbursement group, or condition (e.g.,
ventilator-dependent) for each expected day of care in the hospital or for each stated
objective in primary care or home care;
 Describe patient, material, and information flow for given diseases/conditions;
 Establish a clear mechanism—focused on the patient and not a department/service—to
"manage" the patient through the system;

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 Support the organization's identified important direct patient care
processes prioritized for improvement, particularly those that are Strategic Quality
Initiatives;
 Link expected care, based on incorporation of appropriate practice guidelines and
standards of care, with the nursing or interdisciplinary care plan;
 Track significant variations from the path case by case
(concurrently) and over time (in aggregate), to improve care by
modifying the path, improving associated processes of care, establishing better or best
practices, etc.; [See Chapter V, Information Management, for more detail re. variance
analysis]
 Vertically integrate care at all levels from primary care through the acute inpatient
period to post discharge care and maintenance of function;
 Communicate care expectations to patients and families and involve them actively and
concretely in the care.

Clinical paths can facilitate quality management activities by:


 During development, collecting information about current
patient management practices and identifying improvement opportunities;
 Improving processes, e.g.:
 Timely patient assessment for discharge needs;
 Availability of supplies and equipment;
 Timely performance of therapies and procedures.
 Improving communications, e.g., orders, transports, consultations, discharge;
 Reducing variation in physician practice patterns;
 Offering flow-charted information to QI Teams for the selected
diagnoses, procedures, and conditions and ongoing variance tracking after QI actions
have been implemented;
 Providing the basis for ongoing, as well as special, monitoring of diagnoses, procedures,
and conditions. Chart review can be performed, concurrently or retrospectively, using
the clinical path as the patient management tool.

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 Clinical paths facilitate implementation of capitated managed care contracts by:
 Predicting preadmission/pre-procedure visits, length of stay, resource
use, aftercare, and expected outcomes for specific diagnoses, procedures, and
conditions for use in marketing and negotiating with employers, HMOs, and other
healthcare purchasers; and
 Focusing the attention of all care providers on maximizing each visit or day of
care for the patient, that operationalizes concerns about costs per visit or day of
care, effective use of resources, and progress toward meeting stated patient care
objectives.

Accreditation
 Both JCAHO and NCQA require the selection and implementation of clinical
practice guidelines, along with evaluation of their effectiveness, based on the
organization's mission, priorities, and patient populations.

The Joint Commission Standards 2007


 LD.5.10 The hospital considers clinical practice guidelines when designing or improving
processes, as appropriate.
 LD.5.20 When clinical practice guidelines are used, the leaders identify criteria for their
selection and implementation.
 LD.5.30 Appropriate leaders, practitioners, and health care professionals in the hospital
review and approve clinical practice guidelines selected for implementation.
 LD.5.40 The leaders evaluate the outcomes related to use of clinical practice guidelines
and determine steps to improve processes.
 Standard D.5.10

The hospital considers clinical practice guidelines when designing or improving


processes, as appropriate
 Rationale for LD.5.10

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 Clinical practice guidelines can improve the quality, utilization, and value of
health care services.
 Clinical practice guidelines help practitioners and patients in making decisions about
preventing,
 diagnosing, treating, and managing selected conditions. Clinical practice guidelines can
also be used in designing clinical processes or checking the design of existing processes.
The leaders may
 consider sources of clinical practice guidelines such as the Agency for
Healthcare Research and
 Quality, National Guideline Clearinghouse, and professional organizations.
 Element of Performance for LD.5.10
 The leaders have considered the use of clinical practice guidelines in designing or
improving processes.
Standard LD.5.20
When clinical practice guidelines are used, the leaders identify criteria for their
selection and implementation.
 Rationale for LD.5.20
 Selecting and implementing clinical practice guidelines that are appropriate
to the hospital are critical. The leaders set criteria to guide the selection and
implementation of clinical practice guidelines that are consistent with the hospital’s
mission and priorities.
 The leaders also consider the steps and changes or variations needed to encourage use,
dissemination, and implementation of chosen guidelines throughout the hospital. This
includes staff communication, training, implementation,
 Feedback, and evaluation.
 Elements of Performance for LD.5.20
 1. When guidelines are used, the leaders have identified criteria to guide the
selection and implementation of guidelines.
 2. The hospital manages, evaluates, and learns from variation.

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Standard LD.5.30
Appropriate leaders, practitioners, and health care professionals in the hospital review
and approve clinical practice guidelines selected for implementation
 Rationale for LD.5.30
 To be successfully implemented, clinical practice guidelines should be reviewed, revised,
or
 adapted by the providers using them and approved by the hospital’s leaders.
 Element of Performance for LD.5.30
 1. Appropriate hospital leaders have reviewed and approved the clinical practice
guidelines selected for use.
 Standard LD.5.40

The leaders evaluate the outcomes related to use of clinical practice guidelines and
determine steps to improve processes
 Rationale for LD.5.40
 To fully benefit from the use of clinical practice guidelines, the outcomes of
patients treated usingclinical practice guidelines are evaluated, and refinements
are made to how the guidelines areused, if necessary.
 Element of Performance for LD.5.40
 Clinical practice guidelines are monitored and reviewed for effectiveness and are
modified as necessary
Frequently Asked Questions
What are guidelines?

 a. Recommendations for the performance or exclusion of specific


procedures or services derived through a rigorous methodological
approach that includes the following:
1. Determination of appropriate criteria, such as effectiveness, efficacy, population benefit, or
patient satisfaction; and

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2. Literature review to determine the strength of the evidence (based in part on study design)
in relation to these criteria.
 b. Guidelines are frequently displayed in the form of an algorithm. An algorithm is a set
of rules for solving a problem in a finite number of steps. Typically, a clinical algorithm
diagrams a guideline into a step-by-step decision-tree.
 What are the main characteristics of a high-quality Clinical Practice Guideline

Characteristics of a good guideline include:


 Validity - Correctly interpreting available evidence, so that when
followed, valid guidelines lead to improvements in health.
 Reproducibility - Given the same evidence another guideline group produces similar
recommendations.
 Reliability - Given the same clinical circumstances another health professional applies
them similarly.
 Clinical Applicability - Target population is defined in accordance with scientific
evidence.
 Clinical Flexibility - Guidelines identify exceptions and indicate how patient preferences
are to be incorporated in decision making.

 Cost effectiveness - Guidelines lead to improvements in health at acceptable costs.


 Clarity - Guidelines use precise definitions, unambiguous language, and user-friendly
formats.
 Multidisciplinary Process - All key disciplines and interests (including patients)
contribute to guideline development.
 Scheduled Review - Guidelines state when and how they are to be reviewed.
 Documentation - Guidelines record participants, assumptions, and methods; and link
recommendations to available evidence.

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What is a clinical algorithm?
 Typically, a clinical algorithm diagrams a guideline into a step-by-step decision-tree.

What is the reason for putting the guideline into an algorithm?


 The algorithmic format allows clinicians to follow a linear approach to critical clinical
information needed at the major decision points in the disease management process and
stepwise evaluation and management strategies that include the following:
 Ordered sequence of steps of care
 Required observations to be made
 Decisions to be considered
 Actions to be taken
 It is recognized, however, that clinical practice often requires a nonlinear
approach and must always reflect the unique clinical issues in an individual
patient-clinician situation.

Do clinical algorithms limit clinical thinking?


 On the contrary, it may be argued that using a specific approach to solving a
clinical problem is essential to proper clinical decision making and may increase the
clinician's ability to recognize unusual problems.

What are Clinical Pathways?


 Clinical Pathways are clinical management plans that organize, sequence, and specify
timing for the major patient care activities and interventions of the entire interdisciplinary
team for a particular diagnosis or procedure.
 Clinical pathways define key processes and events in the day-to-day management of care.
 They differ from guidelines, as defined by VHA, by focusing on the quality and
efficiency of care after decisions have already been made to perform the procedure or
service.

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 They are almost always locally developed based upon a broader guideline and may be
included as a part of the clinical record.
 Variance from the pathway along with causes of variance should be documented.
decision-tree.
 Where did the guidelines come from?
 Clinical practice guidelines initially evolved in response to studies
demonstrating significant variations in risk-adjusted practice patterns and costs.
Researchers hypothesized that establishing criteria for the appropriate use of procedures and
services might decrease inappropriate utilization and improve patient outcomes.
 Professional societies, health care policy groups, non-profit disease-oriented
organizations, and government-appointed panels were among those who responded by
publishing position papers, efficacy reports, practice policies, and other forms of advice
to practitioners.
 While definitive evidence is not yet available, these clinical practice guidelines appear to
be having an appreciable impact on medical care.

How can I be sure that a clinical guideline is based on scientific evidence?

 The literature search is followed by critical analysis of the literature, primarily


by the clinical experts.
 To promote an evidence-type approach, the quality of evidence is rated using a
hierarchical rating scheme.
 The value of a hierarchical rating scheme is that it provides a systematic means for
evaluating the scientific basis for health care service (3).

Performance Improvement Tools Identify Problem

How to Identify the Problem


 Is it a real problem?

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 Do we have enough reliable data to prove that it is a problem?
 What is the scope of the problem?
 Who are the Stakeholders?
 What is the impact of this problem on Patient Care?
 Is the solution within the scope of the team?

How to Write a Problem Statement


 A good problem statement
 Should be:
 specific
 measurable
 supported by data
 objective
 And should not:
 include any causes or solutions or blame anybody

Brainstorming
Definition:
 Brainstorming is a structured group process used to create as many ideas as possible in as
short a time as possible, e.g., one session, and to elicit both individual and group
creativity.

Structured Brainstorming:
 Everyone in the group gives an idea in rotation or passes until the next round.

Unstructured Brainstorming:
 Everyone in the group gives ideas as they come to mind.

Brainstorming
 Lists generated may relate to:
 Problems or topics
 Components of a process
 Indicators, criteria, elements for data collection
Possible solutions Structure

Five Steps of Brainstorming


 Define the subject and direction of the session;
 Allow time for initial, individual thought;

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 Establish a time limit for the entire session;
 Request ideas according to the predetermined structure; keep circling the issue
until all ideas are recorded
 Clarify all ideas generated to assure accuracy and understanding.

What can be done to improve employee morale?

Affinity Diagram

Definition:
 An affinity diagram is an organizational tool most often used at the beginning of a team's
work to organize large volumes of ideas or issues into major categories.
 The ideas may have come from the group's initial brainstorming session.
 "Affinity" means close relationship or connection, or similarity of structure;
 When developing an Affinity Diagram, it is most important to determine the primary
issue and major related subgroups in order to grasp the appropriate relationships, links, or
connections.
Steps:
 Define the primary issue, using neutral, broad language;
 Brainstorm - use cards or adhesive notes which can be moved and sorted;
 Display in random fashion all ideas for the team (on a wall or table);

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 Each team member participates in sorting the ideas into major groupings -- in
silence and quickly, without discussion and without time for contemplation --
until team consensus is reached;
 Discuss the major groupings and create a concise title for each grouping;
 Draw the affinity diagram, based on major groupings, linking all ideas related to
each grouping.
Display the Generated Ideas
Issues in Implementing Continuous Process Improvement

Sort Ideas into Related Groups


Issues in Implementing Continuous Process Improvement

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Create Header Cards
Issues in Implementing Continuous Process Improvement

Finished Affinity Diagram

Prioritization Matrix

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Definition:
 A Prioritization matrix is a tool used to select one option from a group of alternatives, be
they problems or solutions.
 It promotes objective decision making.
 Steps:
 Limit the list of options (of problems or solutions) to no more than eight (8);
 Select the criteria against which each option will be rated, stated in either positive
or negative terms, but not both;
 Determine the weight (relative value) of each criterion; perhaps some are more
important to meet than others;

 Select a scoring method, e.g.:


 Point system:
 From 5 = Very important to 0 = Unimportant
 Yes/No system: Criteria Met? Y=Yes; N=No
 Check mark: Box checked if criteria met
 + or - system:
 + = Important/criteria met
 - = Unimportant/criteria not met
 Determine the desired score, what number of criteria must be met, etc. for the option to
remain under consideration;
 Prepare the matrix with options down the left side and criteria/total score column across
the top.

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Flow Charts

Definition:
 A flowchart is a pictorial representation displaying the:
 Actual sequence of steps and their inter-relationships in a specific process in order
to identify hand-off (appropriate and inappropriate), inefficiencies, redundancies,
inspections, and waiting steps; and/or
 Ideal sequence of steps, once the actual process is known.
Symbols Used in Flowcharts

 Use when:
 Identifying and describing a current process
 Questioning whether there is a process
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 Questioning whether actual process meets current policy/procedure
 Analyzing problems to determine causes
 Redesigning the process as part of the action
 Designing a new process
Linear Flowchart Example

Levels of Flowcharts

 Steps:
 Determine the boundaries (the start and stop points) of the process under review.
 Brainstorm to identify all activities and decision points in the process;
 Place all activities and decision points in sequence, paying attention to seeming
repetitions, disconnection's, etc.;
 Design the flowchart, placing:

 each activity in a box (square or rectangle)


 each decision in a diamond,
 ovals or circles for the start and stop points,
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 connecting arrows indicating the flow.
 If there is more than one "output" arrow from an activity box, it probably requires
a decision diamond;

 Analyze the flowchart, looking for process "glitches": inefficiencies, omissions/gaps,


redundancies, barriers, etc.
 Also look for the smooth parts of the process to use as models or "best practices" for
improvement;
 Decide whether to correct steps within the current process, design a new process, or do
corrections first, then redesign in the future.
Interpreting a Flowchart
 Step 1 - Examine each process step
Bottlenecks? Poorly defined steps? Ineffective sequence? Delays? Weak
links?
 Step 2 - Examine each decision symbol
Can this step be eliminated?
 Step 3 - Examine each rework loop
Can it be shortened or eliminated?
 Step 4 - Examine each activity symbol
Does the step add value for the end-user?

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Cause–and Effect “Fish-Bone”

“Ishikawa”Diagram

Cause-and-effect Diagram
 The cause-and-effect diagram is a tool generally used to gather all possible causes as an
overview,
 The ultimate goal being to uncover the root cause(es) of a problem.
 The specific problem is usually stated as a negative outcome ("effect") of a process, e.g.,
late transfer of patients from the inpatient facility to skilled nursing facilities.
 The diagram is a visualization of relationships between the outcome of a particular
system or process, the major categories of that system or process (the main branches),
and causes and subcauses (sub-branches off main branches).
Steps
 Start with the outcome (problem statement) on the right of the paper, halfway down;
draw a horizontal line across the middle of the paper with an arrow pointing to the
outcome;

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Basic Layout of
Cause and Effect Diagrams

 Link the major categories (representing process and structure) to the outcome with
diagonal lines angled from the horizontal line away from the outcome;
 Brainstorm to identify possible main causes of the negative outcome and link each to one
of the major categories, using horizontal lines (parallel to the main outcome line)
touching the appropriate diagonal line;
 Identify any possible subcauses of main causes by using the "Five-Why" technique
described earlier in this Chapter, linking these to the main cause lines;
 Evaluate the draft diagram as a team to determine the accuracy of the placement of issues
and lines;
 Once the diagram seems appropriate to the team, further evaluate for: Obvious
improvement options;
 Causes already resolved or eliminated; Causes easily resolved or eliminated;
 Issues raised which require more in-depth assessment to be understood, to
 determine significance, etc.;
 Use whatever statistical tools are necessary to collect data, draw accurate conclusions,
and pursue appropriate solutions.
 It is very important to study the relative frequencies of the different causes before acting
to change the process.

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Pareto
 Bar chart arranged in descending order of height from left to right
 Bars on left relatively more important than those on right

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 Separates the "vital few" from the "useful many" (Pareto Principle)

Constructing the Pareto Chart


 Step 1 Choose a Problem to Study
 Step 2 Choose Categories
 Step 3 Select a Unit of Measure
 Step 4 Choose a Time Period
 Step 5 Gather Data
 Step 6 Compare Data
 Step 7 Construct the Chart
 Step 8 Show Cumulative Percents
 Step 9 Interpret the Results
 Key Success Behaviors
 Clarify the data collection plan
 Collect data consistently
 Use consistent legend and format
 Explore Pareto variations
 Key Success Behaviors
 Clarify the data collection plan
 Collect data consistently
 Use consistent legend and format
 Explore Pareto variations

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Force Field Analysis


 Definition: Force field analysis is used by the team when a proposed solution to a
problem will require significant change, and it is important to analyze the potential
impact and chances of success.
This technique was developed to look at both the "driving forces", which move a situation
toward change, and the "restraining forces" that block the movement. If no change occurs, it is
because the opposing forces are equal, or the restraining forces are too strong
Steps:
 List in two groups all the driving and restraining forces affecting a desired change;
 Discuss the overall value of the proposed change;
 Come to team consensus about priorities for effecting change;
Include in the planned solution, actions to diminish or eliminate the restraining forces.

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 When a team has a number of potential solutions to a problem, selection grids can be
used to help them decide which ones to implement.
 Selection Grids can assist the team in evaluating potential solutions against agreed upon
Criteria.
 In some cases , some criteria may be more important than others. In that event, the team
can weigh those criteria more heavily in the scoring process.
 See Prioritization Matrix for more details

Action Planning
 Once the team selects a solution, an action plan need to be developed.
 Action plans at a minimum identifies:
 what to be done? (deliverables)
 How a certain task will be done?( implementation Strategies)
 who will do it?( R)
 Time Frame
 A mean of verification that a certain task has been done
 The team leader is responsible of monitoring the implementation process.

Implementation
 Implement on a Pilot basis
 Collect Data to check Effectiveness and Effeciency of the solution.
 Make sure it is the right solution.
 Declare success and share the story
 Get a Buy In from Stakeholders
 Get ready for a wider scale of Implementation
 Get ready to replicate your experience in other areas or other projects

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Is it the Right Solution
 Prior to maintaining any remedy make sure you have the right solution.
 Ensure support from formal and informal leaders
 Make the Remedy part of day to day management.
 Issue policies, procedures, or guidelines to facilitate the implementation process.
 Educate Staff and prepare them for the upcoming change
 Monitor the impact of the solution on performance over time

Monitoring the Impact


 Collect data using data collection tools.
 Conduct surveys
 Analyze data, transform data into information
 Present your data using line, Bar and Pie Charts
 Study Common/Special Cause Variations
 Use Control Charts

Process Variation
 Variation is "change or deviation in form, condition, appearance, extent, etc., from a
former or usual state, or from an assumed standard." "Variation" generally refers to the
whole process or a step in the process.
 Variance is "a changing or tendency to change; degree of change or difference;
divergence; discrepancy." This term generally refers to specific data or information.

Clinical Variation
 Variation in clinical practice has been defended in the past as the "art" of medicine.
 In fact, variation can be either positive or negative.
 In healthcare quality, we tend to think of variation as negative or adverse, based on the
quality assurance case-specific review tradition.
 Sometimes the art of medicine creates a "best practice," which we now try to capture and
replicate as part of quality improvement process.
 Random or common cause:
 Intrinsic to the process itself;
 naturally occurring inliers.
 " Example: patient response to medication will always vary, within the cohort of
patients and even for one patient over time.“
 Common causes" refer to situations, usually within patient care systems and processes
(within the normal, bell-shaped curve) that are more ongoing, chronic, and persistent.

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 These common causes contribute to the "normal range of variation" within a process.
 The goal of quality improvement is not to eliminate, but to reduce variation in a process
enough to produce and sustain "stability.“
 Common causes may also contribute to what are considered to be the less than desirable
parts of a process.
 Usually finding and resolving common causes of problems or variation is more time-
consuming and may be more difficult for departments, services.
 The resolution of common causes of problems is often considered to be key, however, to
continuous, incremental improvement of the quality of care and services rendered to
patients.
 Special cause:
 Extrinsic to the usual process;
 related to identifiable patient or clinical characteristics,
 idiosyncratic practice patterns, or other factors that can be tracked ("assigned") to
root causes.
 "Special causes" refer to sentinel events, one-time occurrences, or other unique, out-of-
the-ordinary circumstances that give rise to a variation from what is normally expected.
 Special causes are usually more easily identified and resolved, either by departments or
QI teams.
 Special causes account for the majority of what we call "outliers"-those problems that
occur in the "tails" of a normal, bell-shaped curve representing a particular process.

Root cause analysis


 When variation is inherent in the process and a reduction of the variation is desired, the
root cause of the variation must be identified to eliminate tampering with the effective
components of the process.
 This is a requirement of the Joint Commission in response to sentinel events.
 To start with, potential causes of the variation should be identified.
 An interdisciplinary team very familiar with the process should utilize brainstorming,
flowcharting, and/or cause-and-effect diagrams or some other process to determine these
potential causes. The second step is to verify the potential causes by collecting data
concerning the process.
 After the data are collected and analyzed utilizing the PI tools the actual causes of the
variation (or at least the most probable causes) can be identified.
 The following areas should be addressed in the analysis:
 human factors—communications and information management systems.
 human factors—training.
 human factors—fatigue/scheduling.
 environment factors.
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 equipment factors.
 rules, policies, procedures.
 leadership systems and culture (White, 2004).
 At this point, the team should develop and implement an action plan designed to
eliminate or minimize the root cause(s) of the variation.

Statistical Process Control (SPC)


 Walter Shewhart's causes of variation led him to develop a methodology to chart the
process and quickly determine when a process is "out of control.
 This ongoing measurement and analysis is known as "statistical process control (SPC)."
 As long as assignable or special causes of variation exist, we cannot make accurate
predictions about process performance and probable outcome.
 Once assignable causes are eliminated, we can call the process "stable" and can measure
the "capability of the process" by rates of deficiencies or rates of achievement of desired
outcomes.
 At this point we have the data we need to perform the in-depth analysis that leads to
improvement.
 Allows management to determine a range of random variation that always occurs in a
process. SPC describes two types of causes of random variation: common cause and
special cause.

Run Charts
 Run or trend charts are graphic displays of data points over time.
 Run charts are control charts without the control limits.
 Their name comes from the fact that the user is looking for trends in the data or
significant number of data points going in one direction or on one side of the average.
 Trends generally indicate a statistically important event that needs further analysis. Resist
the tendency to see every variation in the data as significant by waiting to interpret the
results until at least 10 (or even better, 20) data points have been plotted.
 As indicated in this example, it is best not to analyze data too frequently. For instance,
looking at monthly data when quarterly data may more accurately reflect trends over
time.

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How to construct
1. Draw vertical and horizontal axes.
2. Label the vertical axis with the indicator or the variable and determine the scale.
3. Label the horizontal axis horizontal axis with the unit of time or sequence for which the data
were collected.
4. Plot the data points.
5. Connect the data points.
6. Determine the mean of the plotted numbers and draw a mean line on the graph.
7. Label the chart and name the source of the data, date and the author.
When to use
 To display variation.
 To detect the presence or absence of special causes.
 To observe the effects of a process improvement.
 Communicate process performance.
 Analyze data for patterns.
 Assess process stability.

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Control Charts

 Control charts are run charts to which control limits have been added above and below
the center line (mean).

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 These lines are calculated from the data and show the range of variation in the output of a
process.
 Generally, upper and lower control limits (UCL and LCL) are statistically determined by
adding and subtracting three standard deviations to or from the mean.
 Assuming a normal distribution, and no special cause variation, 99% of the data points
would be expected to fall between the upper and lower control limits.

Types of Control Charts


 There are many type of control charts for both variable and attributes data. These include:
 Variables data: 1 and range chart; median and range chart; x and s chart; XmR,
chart; moving average chart
 Attributes data: P chart; NP chart; U chart; and C chart.
 One common chart presents the individual values (X) and calculates the limits based on
the moving range (mR); this is the XmR chart.
 The XmR chart is used when data are obtained on a periodic basis, such as once a day or
once a week, as is common in quality management activities.

How to construct
. Construct chart as you would a run or trend chart.
2. Calculate control limits according to the appropriate statistical formula or via computer
program.
3. Plot the control limits on the chart and examine the data for variation as described below.

When to use
 To distinguish variation from common and special causes.
 To assist with eliminating special cause variation.
 To observe effects of a process improvement.
Performance Improvement Approach
FOCUS-PDCA
Shewhart Cycle

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In the 1920s, Walter Shewhart, a statistician at Bell Telephone Laboratories, developed the
Shewhart cycle, known as Plan, Do, Check, Act (PDCA).

Plan
Question the capacity or capability of a process. Pose theories on how to improve the process
and predict measurable outcomes.
Do
Make changes on an experimental, pilot basis.
Check
Measure outcomes compared to predicted outcomes.
Act
Implement the changes on a broad scale (Gaucher & Coffey,1991).

The Tradiotnal PDCA Model

Deming Cycle
• The PDCA cycle was later adapted by Deming as the Plan, Do, Study, Act (PDSA) cycle;
therefore, it also is referred to as the Deming Cycle, or the Deming Wheel.

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F.O.C.U.S
→ Find an improvement project (initiative):
– Review related standards & documents
– Analysis of collected data
– Identify problems & desired outcomes
→ Organize ad hoc (task force) team:
– Identify & involve stakeholders (e.g. physicians, nurses, administrative …etc)
– Cover all related departments to the improvement initiative
– Select team members who best do or know the process to be improved
→ Clarify current process & desired outcomes:
– Fully understand the current process by all team member
– Draw flow chart to clarify the process variation/problem
– Collect data from all affected areas relevant to process & desired outcomes
→ Understand Process Variation, Root Causes & Desired Outcomes:
– Identify tools needed to describe & analyze process variation, root causes &
desired outcomes
– Obtain Information from benchmark, best practice ..etc
– Identify all possible solutions to achieve the desired outcome
→ Select the best practice procedure:
– Analyze alternative solutions related to process improvement
– Choose the best solution that will achieve desired outcome
– Develop approval with a summary of required information about expected
outcomes, resources needed, time-frame, responsibilities ..etc

P.D.C.A
→ Plan for improvement project (initiative):
– Assign tasks with agreed criteria checklist & set time frame

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–Allocate resources, determine responsibilities & gain support from all who will be
affected by implementation.
– Establish monitoring system to collect necessary data to keep project on the track
→ Do the improvement project:
– Implement the best solution stated in FOCUS process.
– Empower all people involved by training, education & moral support.
– Collect data & update checklist
→ Check the results
– If the desired outcome is obtained & lead expected improvement.
– Compare data collected from FOCUS process with that during DO
– Check for any unexpected, undesired consequences or outcomes
→ Act to hold gains or re-adjust FOCUS-PDC
– If improvement initiative is reaches; standardize the process, adjust documents &
empower people
– If improvement initiative is not reached, repeat FOCUS-PDCA cycle
– For both situations, continue to monitor the process to identify further
improvement.

IHI Model
→ Process Improvement Model (PDSA)

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The Collaborative Approach
→ The IHI developed the “collaborative” approach, termed the “Breakthrough Series,” to
bring about rapid cycle improvements.
→ Fundamental to the collaborative approach is the acceptance of a model and
establishment of infrastructure through which collaborating organizations can identify
and prioritize aims for improvement and gain access to methods, tools, and materials that
will enable them to conduct sophisticated, evidence-based quality improvement activities
that they could not conduct individually.
→ The key elements of success are enlisting a broad range of “partners,” utilizing evidence-
based practice to improve quality of care, and developing toolkits that contain essential
information and resources for change.
→ At the cores of the collaborative approach are PDCA cycles that build on incremental
improvements.
→ The real benefits to organizations that participate in the Breakthrough Series are that they
can learn from other organizations’ successes and failures.
→ The spread is fostered through learning sessions in which organizations share their
experiences.
→ The IHI approach also can be adapted to a single organization (the work begins in a few
units or teams and then is spread to other units and, eventually, the entire organization).

Quality Measurement
Why measuring?
What are we measuring?
Measurement Tools
Indicator Development
Data Collection

Why Measuring?
Measurement is the scientific way to :
• Know that there is a problem,
• Know the size of the problem
• Identify trends overtime

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• Identify special cause and common cause variations
• Know the success or the failure of the pilot intervention
• Monitor progress
• Learn about Patient/Client Satisfaction
• Learn about Employee satisfaction
• Monitor Staff productivity
• Ensure that Performance Improvement is sustained

What Are We Measuring?


• In Quality, we measure:
– Structure
– Process
– Outcome
Measurement Tools
• Indicators
• Surveys
• Data collection Sheets
• Expert Opinion (qualitative)

What is an Indicator?
• Indicators are reliable and valid measures used to screen/assess organizational and
practitioner performance issues, but not direct measures of quality
Attributes of Performance Measures
• Well defined
• Objective
• Measurable (reliable and valid)
• Comparative and
• Graphically displayed
Types Of Indicators
• Outcome Indicator measures what happens or does not happen as the result of a process
or processes;
• Process Indicator measures a discrete activity that is carried out to provide care or service
• Structure indicator measures the inputs to the process and resources allocated to provide
care
Types Of Indicators

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• Rate-based Indicators assess an event for which a certain proportion (same population) of
the events that occur in a time period represent expected care, or service, e.g.:
# of patients experiencing a specified event during a particular procedure /Total # of
patients having the specified procedure
• Sentinel Event Indicators assess serious or significant events that require further
investigation for each occurrence, e.g., "All patients who expire during coronary
angioplasty."

Required Performance Measures


• Clinical
• Functional
• Service
• Financial
• Organizational/operational

Indicator Development Process


1. Identification of important organizational functions (based on the scope of care and
services):
In clinical care areas: High volume, High risk, Low volume/high risk, Problem-prone
In service delivery: High volume, Problem-prone, High cost; resource intensive,
Complex/interdisciplinary
2. Identification of the scope of care or service within each function.
3. Identification of processes that have the significant impact on patient outcomes.
4. Development of preliminary set of indicators.
5. Identification of factors explaining potential or expected variation in performance.
6. Development of information set for each indicator.

The Information Set for Indicators


• Indicator statement
• Definition of terms
• Rationale for choice
• Dimensions of quality being assessed

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• Definition of patient populations included
• Definition of data elements for each indicator, including both numerator and denominator
when appropriate;

Types of Data Collection Tools


• Data Sheet or Work Sheet: Form for recording data; requires subsequent processing for
analysis and interpretation;
• Check sheet: Form for recording data; designed to facilitate interpretation directly from
form;
• Survey : Form for getting input from a large group;
Types of Data Collection Tools
• Interview or Focus Group: Questionnaire format; can be open-ended discussion to obtain
input from people;
• Download: Automated retrieval from a computerized data source.

Surveys
Surveys are methods by which we can measure customer satisfaction, get feedback on written
materials and oral presentations, gauge attitudes and much more.

How to Develop a Survey


• Know your audience
• Remember who will be answering your survey and imagine how they might interpret the
questions you are asking.
• KISS (Keep It Short and Simple), People tend not to answer lengthy surveys.
• Be direct. Ask exactly what you want to know.
• Make your statements or questions neutral. If you state your question in a negative
manner, you may be swaying the respondent.

Customer Survey
• Use of customer surveys
• Purposes for measuring

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• Monitoring customer satisfaction
• Hints for customer surveys
• Customer focus groups

Data Collection
When To Use Data Collection:
• To define or identify a problem
• To measure current functioning
• To monitor progress
• To measure the effects of change
Before beginning to collect data, you should consider the following questions:
• What do you want to know?
• Where will you get the information?
• Who will be a part of the data collection process?
• How will you collect the data with a minimum of effort and chance of error?
• What will you do with the data you collect?
• How will it impact operations or practice?
• How will it improve services?
• If you cannot come up with valid, rational and practical answers to these questions you
may want to re-think expending valuable resources in collecting data.
• Your answers will help you in designing data collection so that you get the information
you need to accomplish your goals.

Potential Quality Data Sources


Internal Sources
• Patient/client records
• Occurrence reports/summaries
• Ongoing quality control/measurement summaries
• Patient surveys, interviews, questionnaires
• Staff surveys

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• Direct observation
• Clinical reports/profiles (pharmacy, lab, blood bank, etc.)
• Infection control reports
• Demographics/registration data
• Indexes, registers, and logs
• Medication records
Clinical review findings,
– Operative/other procedure
– Medical record review
– Medication use
– Blood/blood component use
– Pharmacy and therapeutics function
– Mortality reports
– Functional outcome status
– Risk management/claims reports
– Utilization management reports
– Safety reports
– Autopsy reports
– Case mix reports
– Financial reports
– Staff research reports

Potential Quality Data Sources


External Sources
• Reference databases/performance measure systems/ compilations
• Maryland Quality Indicator Project
• Accreditation reports
• State inspection/licensure reports
• Third party payer and employer reports
• HCFA reports

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• PRO reports
• Registry reports
• CDC reports
• Research projects/literature (e.g., MEDLINE)
• Clinical protocols, guidelines, and practice parameters (medical colleges and boards;
• National Guideline Clearinghouse
• State/regional/national rates and thresholds
• Comparative report cards

INPATIENT INDICATORS (IMPLEMENTED IN 1986)


1 Hospital acquired infections
2 Surgical wound infections
3 Inpatient mortality
4 Neonatal mortality
5 Perioperative mortality
6 Caesarean sections
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7 Unplanned readmissions
8 Unplanned admissions after ambulatory procedures
9 Unplanned returns to an intensive care unit 10 Unplanned returns to the operating theatre

OUTPATIENT OR DAY CASE INDICATORS


Al Unplanned return to accident and emergency within 72 hours
A2 Patients in accident and emergency more than six hours
A3 Discrepancy between initial and final reports on x ray films requiring a change in patient
management
A4 Patients leaving accident and emergency before completion of treatment
A5 Cancellation of day case procedure on the day of the procedure

Improve the quality of care Improve data quality Encourage changes in clinical practice which
improve quality of care Increase debate on quality between clinicians and managers Increase
understanding of the concept of quality of care Stimulate discussion about data quality between
clinicians and managers Encourage collaboration between hospitals participating in the project
Maintain and encourage units to participate

PATH
PATH is a performance assessment system designed by the World Health Organization to
support hospitals in defining quality improvement strategies, questioning their own results and
translating them into actions for improvement.
By participating in PATH, hospitals join a network that shares a number of core values such as
transparency, openness and collaboration, and continuous improvement. Hospitals recognize that
performance management is complex and needs to be addressed by the strategic decision-makers
within hospitals as well as on the operational level by all hospital staff. The PATH system goes
beyond the traditional professional divisions such as financial performance vs. clinical
effectiveness, taking a more comprehensive approach to hospital performance within a

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framework comprising six dimensions: clinical effectiveness, efficiency, staff orientation,
responsive governance, safety and patient centeredness. For each dimension, indicators were
selected based on their importance and usefulness, potential impact and burden of data
collection.

The internal assessment tool provided by the PATH system was not designed and developed
neither for punitive action nor for external accountability.
Starting with performance measurement, PATH encourages hospitals to learn about their
strengths and weaknesses and initiate improvement activities that ultimately help them to fulfill
their mission. To reach their strategic goals, hospitals need an integrated system to monitor
progress against a set of performance indicators linked to these goals. PATH is able to provide
such a system and can help produce a new image of the participating institutions as it not only
includes a performance measurement tool, but also focuses on the interpretation of results within
the strategic local context of each hospital as well as within the hospital network, especially at
country level. PATH also offers an opportunity for international benchmarking based on e.g.
hospitals' specialties, types or geographical locations, to mention just a few possible options.
In this context, PATH helps hospitals identify best practices in the field through a network of
hospitals as it facilitates contacts between the participants (both hospitals and providers) in order
to initiate learning activities.

The Performance Assessment Tool for Quality Improvement in Hospitals (PATH) was initiated
by the WHO Regional Office for Europe in 2003. The PATH system was created by a group of
international experts based on an extensive literature review and a survey of the importance,
usefulness and data availability of potential indicators in 20 European countries. The PATH
prototype was pilot tested by 66 hospitals in 5 different countries between February 2004 and
March 2006: 4 countries in the European region (Belgium, Denmark, France, Slovakia) and 2
countries outside the region (South Africa/Kwazulu-Natal and Canada/Ontario). Using the
experience of Country Coordinators and hospitals, PATH launched a second wave of data
collection with a slightly revised indicator set, starting in 2006. Thus in PATH II, 140 hospitals

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from 9 different countries committed themselves to change for improvement, collected data on
17 indicators and shared experience with other hospitals.

A Sequence of Steps for Improvement. The toolkit offers a general guide to using improvement
methods, with a particular focus on the QIs. As laid out in the following sections, the complete
improvement process includes a sequence of steps in which you will set priorities and plan for
performance improvements on the QIs, implement improvement strategies, and sustain
improvements achieved:

Determining Readiness To Change.


Applying QIs to the Hospital Data.
Identifying Priorities for Quality Improvement.
Implementing Improvements.
Monitoring Progress for Sustainable Improvement.
Analyzing Return on Investment.
Using Other Resources.

Utilization Management
Definition:
In the early 1980s, the American Hospital Association defined Utilization Management
as the planning, organizing, directing, and controlling of the healthcare product in a cost-
effective manner while maintaining quality of patient care and contributing to the overall goals
of the institution.
 Utilization management is an organization wide, interdisciplinary approach to balancing
cost, quality, and risk concerns in the provision of patient care.
 It is an expansion of traditional utilization review activities to encompass the
management of all available healthcare resources and include all management staff.

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 Purpose: To both identify and resolve problems that cause or result in either deficient or
excessive resource utilization and inefficient delivery of care.
 Medical Necessity---a service or treatment that is appropriate and consistent with
diagnosis and standards of practice and is needed by the patient.
 RIGHT CARE
 RIGHT PLACE
 RIGHT TIME
 MOST COST EFFECTIVE

Components Of Utilization Management


 Utilization Review/Assessment
 Evaluation of specific cases, patterns, and trends indicating overutilization
 Underutilization of level of care or resources even with evidence of medical necessity
 Misutilization: Inefficiencies, e.g., in scheduling of tests/treatments or use of other
resources; wrong treatment, e.g., wrong antibiotic, based on test information or
miscommunication.
 Intervention to prevent or resolve utilization problems adversely affecting the balance
between cost-effectiveness, quality, and minimized risk in care delivery

Effective Utilization Management Requirements


 Top-level commitment
 Recognition that utilization management is a part of, not separate from, the overall
quality management and organization wide performance improvement.
 Use of healthcare industry-accepted objective criteria
 Involvement of treating physicians
 Appropriate, effective review processes
 Coordination with disease management, demand management, and case management
programs;

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 Efficient mechanisms for referral to medical directors, physician advisors, committees,
and/or administration as appropriate.
 Processes for identifying problem trends, cases, practitioners, or departments.
 Applicability to all patients regardless of payer.
 Objective, timely information, as concurrent as possible.
 Effective communication and education skills and systems.
 A computerized information system.

Factors Contributing To Utilization Problems


 Historically, a retrospective payment system encouraging resource consumption
 The lack of appropriate community services at all levels of care.
 Defensive medicine due to fear of malpractice suits;
Unrealistic consumer expectations.
 The lack of actual cost awareness by physicians and professional staff;
 Ordering tests and services out of habit.
 Inefficient scheduling of tests, services, and reports.
 The lack of direct financial incentives to physicians for proper resource utilization
 Processes Involved:
 Clinical necessity of treatment or procedure
 Clinical necessity of acute level of care
 Appropriateness of hospital admission, including possible required pre-
authorization;
 Appropriateness of resource use.
 Data involved
 Concurrent (generally case-specific)
 Periodic (aggregated, pattern/trend)
 Age/disability groups
 Diagnoses/DRGs/procedures
 Complications/problems/risk factors -Levels of care
 Treatment or practice patterns

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Integration with Quality Management
 Utilization review and management are integral parts of the organization wide quality
management program.
 Utilization management evaluates the impact of cost containment activities on the quality
of patient care and helps to determine the point at which quality may be compromised. .
 Utilization management shares the interest of quality management in review of ancillary
and other resource use, which is most effective when identifying patterns retrospectively,
using accumulated data and interdisciplinary team input, rather than attempting time- and
staff-intensive concurrent review.
 Utilization management shares the interest of quality management in Concurrent
monitoring of all aspects of patient care, utilizing an interdisciplinary approach which
encourages integration of quality review, utilization review, risk control, and infection
surveillance systems.

RISK MANAGEMENT
Risk: The possibility of loss or injury; a dangerous element or factor.
Management: The act or art of conducting or supervising something or the judicious use of
means to accomplish an end.
Risk in Healthcare: The probability that something undesirable will happen. It implies the need
for avoidance.

 A formal attempt to control liability, prevent financial loss, and protect the financial
assets of the organization;
 The reduction or elimination of potential financial loss due to damage, theft,
misplacement of property, or patient injury (potentially compensable events)
 The prevention of, and/or the identification, evaluation, and treatment of, financial loss.

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The Goal of Risk Management

 The goal of risk management in any organization is to protect the organization from the
financial losses which may arise as a result of the risks to which it is exposed.
 A risk manager accomplishes this goal by applying the risk management process in the
organization in which she or he functions.

Risk Management
Basic Functions
 Maintenance & monitoring of effective incident reporting & occurrence screening
program
 Claims management
 Policy review, credentialing, contract review, internal reporting, and education
 Collaboration with Safety Officer
 Collaboration with financial office
 Regulatory compliance
 Risk Management plan establishment
Risk Control
 Definition: process of minimizing loss once risk occurred
 Techniques
 incident reporting
 occurrence screening
 claims management handling
Risk Prevention
 Contract Review
 Internal and External Reporting
 Education
 Policy review
 Informed Consent
 Medical Record Confidentiality

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 Credentialing
 Compliance with Country/State/Local law
 Safety Management
Risk Financing
 What is risk financing?
 Methods of risk financing
 Risk retention: pay for losses from within organization
 Risk transfer: pay for losses from outside organization

Governance Oversight Responsibilities

 To authorize and support the development and implementation of an effective Risk


Management Program;
 To know how risk is addressed by the organization:
 To know how the risk management and quality management programs interact,
 including the involvement of physicians;
 To ensure that antitrust laws are followed;
 To know and monitor the areas of organizational risk

Professional Liability
Physicians/independent Practitioners
 Liabilities of Lack of documentation of treatment;
 Inadequate work-up (based on accepted standards);
 Acts of others (e.g., nurses) if exercising control
 Failure to attend or follow up;
 Mistaken identity (along with the institution);
 Misdiagnosis, if based on inadequate examination and testing;
 Wrong diagnosis followed by improper treatment causing injury;
 Treatment outside field of competence;

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 Abandonment (neglect or failure to follow up after the acute stage of illness--unilateral
termination of the physician-patient relationship without notice to the patient);
 Failure to obtain informed consent;
 Failure to seek consultation or refer to a medical/ surgical specialist;
 Use of unprecedented procedures, unless approved by a respectable minority of medical
opinion;
 Failure to order diagnostic tests which are considered to be a "matter of common
knowledge";
 Failure to obtain results of diagnostic tests ordered;
 Infections resulting from failure to utilize proper procedures /precautions;
 Aggravation and/or activation of a preexisting condition if injury results;
Premature dismissal or discharge

Professional Liability
Nurses
 Administration of drugs inconsistent with prevailing statutes, nurse practice acts, or
institutional policies;
 Failure to follow physician/independent practitioner orders;
 Failure to report significant changes in a patient's condition;
 Failure to take correct verbal or telephone orders;
 Operating room sponge/instrument miscounts; -Patient burns;
 Patient falls;
 Failure to report defective equipment;
 Failure to follow established nursing procedures;
 Negligent handling of patient valuables.
The Concept of Negligence
 Negligence means lack of proper care:
 "Proper care" is based on a defined standard established by law to protect others against
harm;
 In medical malpractice "proper care" is judged by peers;

215
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 "Reasonable care" means there is both a rationale for doing and for not doing, and the
rationale is the basis for decision making.
 Negligent conduct (based on set standards and under like circumstances and training) is
 Doing what a reasonable person would not do;
 Failure to do what a reasonable person would do: --- Exercise reasonable
care
 Protect or assist another
 Gross negligence: failure to act if there is known or suspected risk resulting in adverse
impact or death;
 Contributory negligence: a plaintiffs proven contribution to his/her own harm.

Burden of Proof for Negligence


(all elements must be proven)

 Duty:The healthcare institution having custody of a patient must:


 Ensure a safe transaction
 Protect from foreseeable harm
 Protect from malpractice
 Breach of duty, based on policies or procedures (advertised standards of care) or
"reasonable" standards of care set by law, regulations, or peers;
 Measurable harm (injury);
 Causation: The breach of duty caused the injury.

Risk Management As An Organizationwide Performance Improvement Process


 Integration with Quality Management
 Risk management is considered by most references to be one key component of the giant
quality management umbrella.
 Risk management needs good outcomes; good outcomes require good quality
management.

216
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 Effective risk management programs emphasize "harm prevention" for patients, visitors,
and staff more than financial loss.
 The emphasis of Ql on improving processes is a great boon to the ongoing prevention and
reduction efforts of risk management.
 Joint Commission standards require information and communication links between RM
and QM.
 A comprehensive QM/RM system is designed to gather and evaluate important
information on all undesirable events or trends, and use professional time and resources
efficiently, with minimal duplication.
 It is well known that the longer the length of stay for a patient in a hospital, the higher the
risk of a nosocomial or iatrogenic event
 Cost, quality, and risk issues in healthcare organizations cannot be separated.
 Risk Management is one of those important governance and management activities that
the Joint Commission readdressed in 1994 under the Performance Improvement,
Leadership, and Information Management Standards for hospitals.

QM and RM share
 A commitment to eliminate or reduce problems in patient care
 Concern for harm and loss prevention
 Need for analysis of related data
 Incidents/occurrences
 Continuous performance measures (indicators) Special study results
 Patient feedback measures
 Patient, visitor, and staff complaints
 Surveillance: infection, safety, security

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Integration of Risk with Quality Management
 Risk management is considered by most references to be one key component of the giant
quality management umbrella.
 Risk management needs good outcomes; good outcomes require good quality
management.
 Effective risk management programs emphasize "harm prevention" for patients, visitors,
and staff more than financial loss.

 A comprehensive QM/RM system is designed to gather and evaluate important


information on all undesirable events or trends, and use professional time and resources
efficiently, with minimal duplication.

The Basics of Healthcare Failure Mode and Effect Analysis


Failure Mode and Effects Analysis (FM EA) is:-
• A team-based prospective quality improvement tool;-
• A prospective assessment that identifies and improves steps in a process
toreasonably ensure a safe and clinically desirable outcome [NCPS];-
• A systematic mechanism to identify and prevent product and process failures
before they occur
• Failure: The condition or fact of not achieving the desired end; insufficient or
nonperformance [The American Heritage Dictionary]; the inability to function in the
desired manner..
• Failure mode: Different ways that a process or sub-process can fail to function or fail to
provide the desired result; an undesirable variation in a process.
• Effect: The adverse consequence(s) of a failure mode that the patient or other customers
might experience.
• Cause: The means by which a step in the process might result in a failure mode.
• Hazard: An activity or condition posing threat of harm.

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• Occurrence/frequency or probability: Rating the likelihood that the failure mode will
occur by assigning a frequency/occurrence score, knowing that the more steps in a
process, the more likely the probability of not performing well.
• Severity: Rating the degree of adverse effect or outcome relative to patient, visitor, staff,
equipment or facility, and fire.
• Detectability: Rating the likelihood that current control measures will detect the failure
mode or its cause.
• Criticality index: The determination of the seriousness of a potential failure mode effect
on patients or other customers, computed from the occurrence, severity, and detectability
ratings.
• Risk Priority Number (RPN): The mathematical product of occurrence, and detectability
ratings: RPN = (S) X (0) X (D). intervention are based on this ranking method.
• Control measure: A barrier (physical or administrative) that substantially reduces the
likelihood of an adverse event occurring.
FMEA Steps for Healthcare
Step1: Define the purpose and scope of the FMEA
• The scope of the FMEA, including which aspects the team is responsible for(e.g.,
performing analysis, making recommendations for improvement, implementing
recommendations, etc.), must be clearly defined;
• The process or service under review must be fully described.

Step:2: Assemble the team


• The team is chartered for the specific FMEA, is ad hoc rather than permanent, and
will probably disband afte'r the project is completed.
• The team is interdisciplinary, representing all affected areas:
• Those closest to the process;
• Subject-area experts, e.g., finance; QI/PI, UM, RM; infection control,
depending on type of process.
• The team leader or facilitator/advisor must understand FMEA concept and\
process;

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• Just-in-time FMEA training is necessary for all team members;
• A recorder must be assigned to document the process.

Step 3: Describe and understand the process


• As a team, create a detailed flowchart of the process or service, perhaps starting with
self-sticking notes;
• Consecutively number each process step to identify the step with the remaining
work to be documented on the FMEA Worksheet;
• If the process is complex, identify the step or steps that will be the focus. Prioritizing
makes the project manageable and better ensures success;
• Identify all sub-processes under each block (step) on the flowchart and consecutively
letter these as sub-steps (e.g., 1 a, 1 b.. Ad, etc.);
• Create a permanent document of the numbered/lettered process steps and sub-steps.
Flowcharting software is very helpful.

Step 4: Brainstorm potential failure modes-


• As a team, list all potential failure modes for each sub-step or step;
• Brainstorming should include a review of the major categories of variation, such as the 5
Ps (people, provisions, policies, procedures, place); 5 Ms (manpower, materials,
machines, methods, management); or simply people, process, equipment, environment;
• Affinity diagramming may be helpful to organize the brainstorming process, using the
same major categories of variation
• Consecutively number each failure, linked to the applicable sub-step or step (e.g., 1
a(1), 1 a(2), 1 b(3).. .5d(1 0), etc.);--
• Record each failure mode on the FMEA Worksheet under the applicable process step or
sub-step.

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Step 5: Identify the potential cause(s) of each failure mode
• Use the same 5 Ps or 5 Ms in a cause-and-effect diagram to focus on potential causes for
each failure mode; other tools include a full root cause analysis and/or use of the "Five
Whys"
• Thinking through various causes helps determine probability of failure and provides
information regarding severity of the failure mode and effective corrective actions;
• Record the potential causes on the FMEA Worksheet.
Step 6: List potential effects of each failure mode-
• Identify the potential adverse outcome(s) of the failure mode if it occurs;
• Answer the question, "What happens to the patient or other customers if this failure mode
occurs?".

Step 7: Assign a severity rating for each effect-


• A severity scale, traditionally ranging from 1 - 10, is based on possible adverse
outcomes/effects that would be determined in Step 6, e.g.:
• Slight annoyance to patient/other customer; may affect the system (1)
• Moderate system problem; may affect the patient (2,3)
• Major system problem; may affect the patient (4,5)
• Minor injury to patient/other customer (6)
• Major injury to patient/other customer (7)
• Terminal injury or death to patient/other customer (8,9,10)
Step 8: Assign a frequency/occurrence rating for each failure mode-
A frequency/occurrence scale, traditionally ranging from 1 - 10, quantifies the likelihood and
probability of failure mode occurrence within a specified time period (perhaps a year),
Step 9: Assign a detection rating to each failure mode-
A detection scale, traditionally ranging from 1 - 10, quantifies the likelihood and probability of
recognizing the hazard/error or failure mode prior to any adverse effect.

Step 10: Calculate the Risk Priority Number (RPN) for each failure model effect
• RPN = occurrence rating (O) X severity rating (S) X detection rating (D);

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• The RPN provides a "criticality index," a way to rank and prioritize the failure modes and
associated effects, determining which are high risk and warrant corrective action.

Step 11: Take action to eliminate or reduce the high-risk failure modes
• Brainstorm actions-control measures-that will control or eliminate the identified high-risk
failure modes;
• Place the control measure (physical or administrative barrier) at the earliest feasible point
in the process:
• Multiple control measures may be placed in the process to control a single hazard or
failure mode;
• A control measure may be used more than one time in the process.
• Identify a person responsible for coordinating implementation of the action:
• Ensure that top leadership concurs with the recommendations;
• Pilot test before full implementation

Step 12: Identify performance measures to monitor the effectiveness of the redesigned process-
• The action should reduce the criticality index by:
• Decreasing the severity of effects;
• Decreasing the likelihood of occurrence;
• Increasing the probability of detection.
• Each of these components of the RPN, as well as the recalculated total, provides
measures of outcome.

Clinical Risk Management


 Risk: The possibility of loss or injury; a dangerous element or factor.
 Management: The act or art of conducting or supervising something or the judicious use
of means to accomplish an end.
 Risk in Healthcare: The probability that something undesirable will happen. It implies the
need for avoidance.

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Risk Management in Healthcare
 A formal attempt to control liability, prevent financial loss, and protect the financial
assets of the organization;
 The reduction or elimination of potential financial loss due to damage, theft,
misplacement of property, or patient injury (potentially compensable events)
 The prevention of, and/or the identification, evaluation, and treatment of, financial loss.

The Goal Of Risk Management


 The goal of risk management in any organization is to protect the organization from the
financial losses which may arise as a result of the risks to which it is exposed.
 A risk manager accomplishes this goal by applying the risk management process in the
organization in which she or he functions.

Risk Management Basic Functions

 Maintenance & monitoring of effective incident reporting & occurrence screening


program
 Claims management
 Policy review, credentialing, contract review, internal reporting, and education
 Collaboration with Safety Officer
 Collaboration with financial office
 Regulatory compliance
 Risk Management plan establishment

Risk Control
 Definition: process of minimizing loss once risk occurred
 Techniques
 incident reporting
 occurrence screening
 claims management handling

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Risk Prevention
 Contract Review
 Internal and External Reporting
 Education
 Policy review
 Informed Consent
 Medical Record Confidentiality
 Credentialing
 Compliance with Country/State/Local law
 Safety Management

Risk Financing
 What is risk financing?
 Methods of risk financing
 Risk retention: pay for losses from within organization
 Risk transfer: pay for losses from outside organization

Governance Oversight Responsibilities


 To authorize and support the development and implementation of an effective Risk
Management Program;
 To know how risk is addressed by the organization:
 To know how the risk management and quality management programs interact,
 including the involvement of physicians;
 To ensure that antitrust laws are followed;
 To know and monitor the areas of organizational risk

Professional Liability
Physicians/independent Practitioners
 Liabilities of Lack of documentation of treatment;
 Inadequate work-up (based on accepted standards);

224
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 Acts of others (e.g., nurses) if exercising control
 Failure to attend or follow up;
 Mistaken identity (along with the institution);
 Misdiagnosis, if based on inadequate examination and testing;
 Wrong diagnosis followed by improper treatment causing injury;
 Treatment outside field of competence;
 Abandonment (neglect or failure to follow up after the acute stage of illness--unilateral
termination of the physician-patient relationship without notice to the patient);
 Failure to obtain informed consent;
 Failure to seek consultation or refer to a medical/ surgical specialist;
 Use of unprecedented procedures, unless approved by a respectable minority of medical
opinion;
 Failure to order diagnostic tests which are considered to be a "matter of common
knowledge";
 Failure to obtain results of diagnostic tests ordered;
 Infections resulting from failure to utilize proper procedures /precautions;
 Aggravation and/or activation of a preexisting condition if injury results;
 Premature dismissal or discharge.

Professional Liability Nurses


 Administration of drugs inconsistent with prevailing statutes, nurse practice acts, or
institutional policies;
 Failure to follow physician/independent practitioner orders;
 Failure to report significant changes in a patient's condition;
 Failure to take correct verbal or telephone orders;
 Operating room sponge/instrument miscounts; -Patient burns;
 Patient falls;
 Failure to report defective equipment;
 Failure to follow established nursing procedures;

225
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BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
 Negligent handling of patient valuables.

The Concept of Negligence


 Negligence means lack of proper care:
 "Proper care" is based on a defined standard established by law to protect others against
harm;
 In medical malpractice "proper care" is judged by peers;
 "Reasonable care" means there is both a rationale for doing and for not doing, and the
rationale is the basis for decision making.
 Negligent conduct (based on set standards and under like circumstances and training) is
 Doing what a reasonable person would not do;
 Failure to do what a reasonable person would do: --- Exercise reasonable
care
 Protect or assist another
 Gross negligence: failure to act if there is known or suspected risk resulting in adverse
impact or death;
 Contributory negligence: a plaintiffs proven contribution to his/her own harm.

Burden of Proof for Negligence


(all elements must be proven)

Duty:The healthcare institution having custody of a patient must:


 Ensure a safe transaction
 Protect from foreseeable harm
 Protect from malpractice
 Breach of duty, based on policies or procedures (advertised standards of care) or
"reasonable" standards of care set by law, regulations, or peers;
 Measurable harm (injury);
 Causation: The breach of duty caused the injury.

226
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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
Risk Management As An Organizationwide Performance Improvement Process
 Integration with Quality Management
 Risk management is considered by most references to be one key component of the giant
quality management umbrella.
 Risk management needs good outcomes; good outcomes require good quality
management.
 Effective risk management programs emphasize "harm prevention" for patients, visitors,
and staff more than financial loss.

Risk Management As An Organization wide Performance Improvement Process

 The emphasis of Ql on improving processes is a great boon to the ongoing prevention and
reduction efforts of risk management.
 Joint Commission standards require information and communication links between RM
and QM.
 A comprehensive QM/RM system is designed to gather and evaluate important
information on all undesirable events or trends, and use professional time and resources
efficiently, with minimal duplication.
 It is well known that the longer the length of stay for a patient in a hospital, the higher the
risk of a nosocomial or iatrogenic event
 Cost, quality, and risk issues in healthcare organizations cannot be separated.
 Risk Management is one of those important governance and management activities that
the Joint Commission readdressed in 1994 under the Performance Improvement,
Leadership, and Information Management Standards for hospitals.

QM and RM share
 A commitment to eliminate or reduce problems in patient care
 Concern for harm and loss prevention
 Need for analysis of related data

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 Incidents/occurrences
 Continuous performance measures (indicators) Special study results
 Patient feedback measures
 Patient, visitor, and staff complaints
 Surveillance: infection, safety, security

Integration of Risk with Quality Management

 Risk management is considered by most references to be one key component of the giant
quality management umbrella.
 Risk management needs good outcomes; good outcomes require good quality
management.
 Effective risk management programs emphasize "harm prevention" for patients, visitors,
and staff more than financial loss.
 A comprehensive QM/RM system is designed to gather and evaluate important
information on all undesirable events or trends, and use professional time and resources
efficiently, with minimal duplication.

Care Coordination
 Care coordination involves management of the delivery of services to both the individual
patient/client (case management) and selected populations.
 Continuity of Care means the coordination of needed healthcare services for a patient or
specified population among all practitioners and across all involved provider
organizations over time

Case Management
 Case Management refers to the clinical and administrative coordination and integration of
all phases of a patient's or client's care, including the identification and orchestration of all
necessary healthcare resources, in acute, outpatient, and community-based settings

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 It is a process encouraging interdisciplinary, proactive, or point-of-service intervention by
clinical practitioners; case management/UM, social services, and quality management staff;
and leaders to promote and provide quality, cost-effective patient care through an entire
episode of illness;

Essential Components
 Assessment and planning
 Coordination and referral
 Coordination of treatment
 Monitoring of processes

The General Purposes of Case Management


 Organizing and coordinating services and resources to meet an individual's healthcare
needs;
 Ensuring appropriate use of the healthcare system;
 Providing and managing episodes of care for patients
 Providing quality care along a continuum;
 Decreasing fragmentation of care across many settings;
 Enhancing clients' quality of life
 Containing costs.

Case Management Models


 Reimbursement based-- control cost and coordinate services
 Institution based---usually found in hospitals, home care agencies, or nursing homes
 Social Service based---found in the social welfare arena
 Private management based--employed by patients or their families to provide life
planning of finances and healthcare.

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Essential Features of a Case Management Program
 Established methods of screening/ targeting/ identifying appropriate patients/ clients, e.g.
- Predetermined diagnoses
- Multiple hospital admissions or ED visits
 Comprehensive individual assessment and diagnosis procedures;
 Care plan development, including service planning, resource identification, and linkage
of patients/clients to needed services;
 Care plan/service implementation and coordination; Monitoring of service delivery;
 Thorough documentation and reporting of activities;
 A method of reassessing patient/client status and evaluating service outcomes;
 Patient advocacy approach.

Disease Management
 Disease Management" refers to the management of chronic disorders across the
continuum of care
 Diseases are selected on the basis of:
Chronicity
High costs of care over time
High patient volume
Treatment by both primary care and specialist physicians
Wide variance in practice patterns
Significant potential for patient involvement

 Use of practice guidelines and clinical pathways


 Use of appropriate specialist as PCP for some chronic diseases
 Patient/family education/ Provider education
 Outpatient drug management
 Physician buy-in and support
 Triage protocols

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 Risk assessment tools aimed at primary, secondary, and tertiary prevention
 Group visits in place of individual visits

Discharge Planning
 Component of Utilization Management
 Begins upon admission
 Moves the patient through the system
 effectively
 efficiently
 Requires an organizational focus

Implementing Discharge Planning Programs


 Critical to utilization program
 Methods of patient identification
 pre-certification
 diagnoses
 Additional roles
 Legal considerations

Implementing Patient Advocacy Program


 Systematic problem solving
 Basic patient rights
 Management of concerns, inquiries, complaints
 Processing complaints
 Tracking and trending

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Managed Care
 An integral part of patient care processes in every healthcare organization:
 The balance of cost, quality & risk issues & systems in a competitive healthcare
environment
 An integrated clinical/financial approach to patient care management & service
delivery
 A transfer of information, of consensus, across, in, & through services and
settings
 Vertical & horizontal integration of patient care

Demand Management
 The term “demand” stems from the concept of supply & demand
 In the past healthcare marketing focused on the supply side (provider): “Do you want
what I have to offer?”
 Now, the demand side (patient/member) now asks: “Do you have help & resources to
meet my need?”
 In managed care, “demand management” involves the use of decision and behavior
support systems to appropriately influence individual patients’/members’ decisions about
whether, when, where, & how to access medical services.
 Demand management incorporates tele-service technologies, triage, algorithm-driven
care guidelines & provider database.

Demand Management
Support Systems
 Telephone 24 hour “call centers” or hotlines
 Easy-to-access health & resource information
 Self-care books & other communications
 Group & individual education programs

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 Lifestyle & stress management
 Patient/member counseling
 Sophisticated information systems
 Physician approval of protocols, algorithm.

Demand Management
Services
 Manage utilization
 Improve access to needed care (Timelines & appropriate level
 Link consumers of care to all appropriate information & care options
 Track/monitor patients’ conditions
 Enhance patient/member health education & participation in care
 Provide data to better address the needs of members & patients and to make strategic
decisions about benefits.
 Link demand, enrollment, claims, clinical & provider profiling database

Performance Measurement and Improvement – Evaluation


Evaluating Team Performance
• Goal Clarity
• Leadership and Participation
• Conflict Patterns
• Communication Behaviors
• Decision-Making
• Organizational Support
• Points to cover in annual evaluation of team
• Original problem
• Goals
• Activities

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• Results
• Resources
• Communication
• Boundaries
• Members
• Authority
• Roles
• Time

Performance/Productivity Reports
Definition
• Productivity is 'that balance between all factors of production that will give the greatest
output for the smallest effort' (Peter F. Drucker).
• Productivity refers to all the resources that go into making a product or delivering a
service.
• Financially, productivity equals the unit costs of all the outputs (direct staff, supplies,
equipment, energy, and other overhead costs) needed to produce specific services.
• Under PPS or any type of pre-negotiated payment system, the management challenge is
to control the unit costs of individual services.

Reducing costs:
• Unit costs (costs per unit of service, including physician contribution); -Staffing ratios;
• Space allocation and function/service appropriateness;
• Delays and other process variances;
• Cost-benefit analysis reports;
• Supply inventory (Excessive? Competitive bidding? Shared purchasing agreements?).

Increasing efficiency
• Units of input and output associated with revenues and expenses;
• Staff competency/work quality based on performance measures; -Turn-around times;

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• Productivity standards (quantifiable) as part of a merit system or performance appraisal
approach;
• Equipment appropriateness and effectiveness (both existing and proposed).

Analysis of Customer Satisfaction


• Survey tool
• Analyzing Scores
• Interpreting Data
• Common analysis mistakes

Physician Profiles
• Intent of profiles
• Use of profiles
• Items included in profile
• Integration into department profiles
• Profiles and reappointment tracking forms

Risk Management
Trend Analysis
• Trending to identify potential losses early
– Liability claims
– Incident reports
– Patient complaints, etc.
• Trending of losses essential

Customer Satisfaction Complaint Tracking:


• Types of complaints
• Complaint tracking forms
• Aggregated complaint data
• Recognition of the complaint

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Clinical Case Management Trend Analysis


• Data for timely and appropriate patient management and treatment
• Identification of clinical outcomes to be trended/analyzed

EXAMPLES of outcome
• patient cooperation with assessment
• completion of testing in a timely manner
• treatment goals defined
• patient compliance with the treatment plan
• improvement in physical, physiological, or psychological functioning
• verbalization or demonstration of an understanding of medications, equipment, disease,
or complications improved scores or rating scales (e.g. Glasglow Coma Scale, Beck’s.)

Surveillance, Prevention, and Control of Infection

 The goal of the surveillance, prevention, and control of infection function* is to identify
and reduce the risks of acquiring and transmitting infections among patients, employees,
physicians and other licensed independent practitioners, contract service workers,
volunteers, students, and visitors.
 All hospitals run the risk of nosocomial infections-that is, infections acquired in the
hospital-as well as infections brought into the hospital.
 These infections may be endemic (common cause) or epidemic (special cause), and they
may affect patients, and health care workers and others who come into contact with
patients.
 Surveillance, prevention, and control of infection covers a broad range of processes and
activities, both in direct patient care and in patient care support, that are coordinated and
carried out by the hospital.

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 This function also links with external organization support systems to reduce the risk of
infection from the environment, including food and water sources.
 Infection: “An illness produced by a microorganism or other infectious agent”
 Nosocomial: “An infection acquired by an individual while receiving care or services in
the health care organization.”
 Endemic: “Habitual presence or usual prevalence in a geographic area”.
 Epidemic: “Outbreak or in excess of normal expectancy and derived from a common
source”
 Epidemiologically significant infection: "An outbreak in a community or region of a
group of similar infections that is statistically in excess of normal expectations.”

Scope of the Function:


 Evidence of Goal Achievement: Reduced nosocomial infection rates.
 Inclusive of activities at the direct patient care level and at the patient care support level
to reduce risks for nosocomial infections;
 Coordination of all activities related to the surveillance, prevention, and control of
nosocomial infections;
 Linkages with support systems to reduce the risks of infection from the environment,
including food and water sources.

Joint Commission Standards Hospital


 Since 1990, the Joint Commission Hospital Infection Control Standards have become less
rigid, reflecting state-of-the-art infection control practices.
 They permit types of surveillance other than 100% ("whole house"). Increased emphasis
has been placed on prevention and control of infection.
 A few standards were deleted in 1992, particularly those that were very detailed and
prescriptive
 The requirement for a separate Infection Control Committee was deleted in 1995. The
function may be structured under a team, its own committee, or another committee.

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The Infection Control Process


 The organization uses a coordinated process to reduce the risks of endemic and epidemic
nosocomial infections in patients and health care workers.[IC.1]
 The infection control process is managed by one or more qualified individuals.[C.1.1]
 The hospital's infection control process is based on sound epidemiologic principles and
research on nosocomial infection.

 The specific program for controlling infection may differ from hospital to hospital,
depending on factors such as:
 the hospital's geographic location;
 patient volume;
 patient population served;
 hospital's clinical focus; and
 number of employees.

 The hospital's infection control program addresses issues defined by that hospital to be
epidemiologically important.
 Depending on the hospital, these may include:
 device-related infections, especially those associated with intravascular devices,
ventilators, and tube feeding;
 surgical site infections;
 nosocomial infections in special care units;

 infections caused by organisms that are antibiotic-resistant or in other ways


epidemiologically important;
 nosocomial tuberculosis and other communicable diseases, especially vaccine-
preventable infections; and
 infections in neonates.

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Case Finding and Reporting
 Case findings and identification of demographically important nosocomial infections
provide surveillance data. [IC.2]
 The hospital reports, when appropriate, information about infections both internally and
to public health agencies.[IC.3]
 The hospital takes action to prevent or reduce the risk of nosocomial infections in
patients, employees, and visitors. [IC.4]
The hospital takes action to control outbreaks of nosocomial infections when they are
identified.[IC.5]

 The hospital's infection control process is comprehensive, encompassing both patient care
and employee health services.
 The mechanisms that support this process are based on current scientific knowledge,
accepted practice guidelines, and applicable law and regulation.
 They address the infection issues that are epidemiologically important to the hospital.

Aim of the Infection Control Process


 The hospital's infection control process is designed to lower the risks and to improve the
(proportional) rates or (numerical) trends of epidemiologically significant infections.
[IC.6]
 Management systems support the infection control process. [IC.6.1]
 The infection control process includes at least one activity aimed at preventing the
transmission of epidemiologically significant infections between patients and
staff.[IC.6.2]
 The infection control process is integrated with the hospital's overall process for
assessing and improving organization performance.
 The hospital tracks risks, rates, and trends in nosocomial infections.
 It uses this information to improve its prevention and control activities and to reduce
nosocomial infection rates to the lowest possible levels.

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 The infection control program works with the employee health program to reduce the
transmission of infections, including vaccine-preventable infections, from patients to staff
and from staff to patients.
 Management systems, including staff and data systems, help the hospital achieve these
objectives.
 The specific role of management systems depends on the hospital's infection control
process. Generally, they support activities such as data analysis, interpretation, and
presentation of findings.

Integrated Delivery Systems:

"The ideal integrated healthcare System is an optimally configured and operated healthcare
corporation designed to maximize market share by providing a full range of cost-effective, high-
quality health services to attract patients and employers."

Types of integration in healthcare systems


Horizontal: Multi-institutional entities with coordinated functions, activities, or operating units
that are at the same stage or segment of the continuum of care, e.g., hospital, long term care, or
home health systems.

Vertical: A network of entities that provide and coordinate healthcare to a defined population
across the entire continuum of care: prevention, ambulatory, acute, sub-acute, and perhaps rehab
and/or long term.

"Vertical integration" of healthcare delivery systems includes:


 A geographically determined marketplace;

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 Determination of functions common among all or most of the provider organizations,
e.g., marketing;
 Setting of priority strategic goals, e.g., illness prevention;
 Strong, motivated board leadership working with executive leaders;
 Community and local involvement in determination of service needs;
 Common financial incentives;
 Ideally, integration of physician credentialing, privileging functions, etc.

Integrated delivery system (IDS)


 An [integrated] delivery system is a network of organizations that provides or arranges
to provide a coordinated continuum of services to a defined population and is willing to
be held fiscally and clinically accountable for the health status of that population.
 It owns or has a close relationship with an insurance product.
 It also has linkages with broad-based public health and social services and may serve as
the 'umbrella' or catalyst for community care networks."

Degrees of system integration


 The legal relationship of the entities in the IDS affects the degree to which each
organization's success is dependent upon the success of the others:
Affiliations are the loosest alliances and may not involve any financial risk-sharing;
Partnerships or joint ventures represent middle-ground relationships and usually share risks
and rewards;
Mergers and acquisitions require that all participating organizations function as a single entity.

Evaluating Clinical Integration:


 Clinical integration of patient care services, rather than corporate restructuring per se or
administrative and management reengineering, is what generally will result in the most
significant cost savings, improvements in quality of care, and patient satisfaction.

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 The progress of an IDS toward achieving clinical integration among operating units
can be analyzed according to four criteria, once they are developed as performance
measures:
1. Coordination of clinical processes and services;
2. Avoidance of unnecessary duplication of clinical facilities and services;
3. Appropriate sharing of clinical services and facilities; and
4. Achievement of cost-effective care, as predefined.

A "SEAMLESS" CONTINUUM OF CARE


In the ideal healthcare system, care is delivered in an integrated, uninterrupted, or "seamless"
flow.
Definition
An integrated, client-oriented system of care composed of both services and integrating
mechanisms that guides and tracks clients over time through a comprehensive array of health,
mental health, and social services spanning all levels of intensity of care.

Components of a "Seamless Continuum of Care"

Aligned payment and incentive systems:

• Centralized payment function;


• Clearly defined benefit package for enrolled populations;
• Financial compensation, other rewards, and performance appraisal processes
• linked to system-wide CLINICAL objectives for improving or maintaining the
health status of enrolled populations.
Integrated administrative/management infrastructure:

• Financial planning and resource allocation (financial structure);


• Information system support;

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• Human resource development;
• Planning and marketing; and
• Quality management and improvement.

Population-based needs assessment:
• Realistic evaluation of community healthcare needs;
• Community-based and employer-based surveys;
• Integration of primary data with currently available reference and comparative
data.

Appropriate breadth of services and providers:


- Required services determined by identified need: prevention, primary care, acute care,
chronic care, rehabilitative/restorative care, and supportive care;
- Provider units owned or under contractual agreements

Appropriate geographic distribution and proximity:


• Adequate access to services;
• "One-stop shopping" to the extent possible.

 Technology management system:


 Cost/benefit analyses of various technologies compared to the needs of the
assessed population served;
 Coordination by outsourcing or sharing technology and adopting value-
enhancing technology (lower-cost treatment alternatives with good outcomes
 Patient care management system—critical elements:
 Access to information on outcomes and clinical effectiveness (Per Donabedian,
you can assume process is adequate if outcomes are good);

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 Development of clinical care protocols and practice guidelines, based on
reference and comparative data (the most accurate way to get at best practices);
 Use of continuous improvement processes [CQI] to enhance outcomes and reduce
ineffective practice variations (making a better or best practice common practice);
 Development of clinical information systems as the database upon which to
improve care;

Active case management:


 Provided by a multidisciplinary team of healthcare professionals;
 "Headed by a primary care professional to oversee the coordination of care
delivery for a patient across settings and over time"

The Foundation for Building an Integrated Continuum of Care

Four Essential Principles


1. Integration of financing and payment sources, at the level of the individual case, the
individual provider entity, or the broader community;
2. Common records or shared data systems; the creation and maintenance of a communications
system and common language among all providing care to the client;

3. Someone in charge of integrating services— a case manager, "although precise definitions


of case management are subject to considerable controversy, as is the even less consequential
question of which profession is best suited to provide case managers."
4. Effective multidisciplinary teamwork and the development of the necessary mechanisms to
assure that such teamwork occurs.

INTEGRATION
Integration Is the Key
 To benefit from the Results of Performance Improvement
 To move from just compliance with the standards to be the Benchmark

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 To the Road from Good to Great
 Incremental change Vs. breakthroughs

 To benefit from the Results of Performance Improvement


 To move from just compliance with the standards to be the Benchmark
 To the Road from Good to Great
 Incremental change Vs. breakthroughs

Integrating Data Analysis into Performance Improvement


 Prioritization of data collection
 An Integrated Information system is essential for effective and efficient data collection
 Data Analysis to make decision about priorities for performance Improvement
 Coordination the flow of information within the organization
 Information for decision making

Integrating the results of Quality Reviews into the performance Improvement process

Results of Patient Satisfaction surveys


 Trending Patient complaints
 Time to dissatisfied customers
 In depth Analysis for reasons of dissatisfaction
 Setting priorities for PI based on results
 Impalement the FOCUS-PDCA Approach on priorities
 After the check phase, Act to integrate solutions into the Practice of the organization

Integrating findings from Medical committee Quality Reviews into Performance Improvement
 Medical assessment and treatment of clients
 Use of medications

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 Use of blood/blood components
 Use of invasive procedures
 Use of clinical practice patterns
 Significant departure from patterns of practice
 Use of Results in Re-credentialing and re-appointment

Risk Management As An Organizationwide Performance Improvement Process


 The emphasis of Ql on improving processes is a great boom to the ongoing prevention
and reduction efforts of risk management.
 Joint Commission standards require information and communication links between RM
and QM.
 A comprehensive QM/RM system is designed to gather and evaluate important
information on all undesirable events or trends, and use professional time and resources
efficiently, with minimal duplication.
 It is well known that the longer the length of stay for a patient in a hospital, the higher the
risk of a nosocomial or iatrogenic event
 Cost, quality, and risk issues in healthcare organizations cannot be separated.
 Risk Management is one of those important governance and management activities that
the Joint Commission readdressed in 1994 under the Performance Improvement,
Leadership, and Information Management Standards for hospitals.

QM and RM share
 A commitment to eliminate or reduce problems in patient care
 Concern for harm and loss prevention
 Need for analysis of related data
 Incidents/occurrences

 Continuous performance measures (indicators) Special study results


 Patient feedback measures

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 Patient, visitor, and staff complaints
 Surveillance: infection, safety, security

Integration of Risk with Quality Management


 Risk management is considered by most references to be one key component of the giant
quality management umbrella.
 Risk management needs good outcomes; good outcomes require good quality
management.
 Effective risk management programs emphasize "harm prevention" for patients, visitors,
and staff more than financial loss.
 A comprehensive QM/RM system is designed to gather and evaluate important
information on all undesirable events or trends, and use professional time and resources
efficiently, with minimal duplication.
 Utilization review and management are integral parts of the organizationwide quality
management program.

 Utilization management evaluates the impact of cost containment activities on the quality
of patient care and helps to determine the point at which quality may be compromised. .
 Utilization management shares the interest of quality management in review of ancillary
and other resource use, which is most effective when identifying patterns retrospectively,
using accumulated data and interdisciplinary team input, rather than attempting time- and
staff-intensive concurrent review.

 Utilization management shares the interest of quality management in Concurrent


monitoring of all aspects of patient care, utilizing an interdisciplinary approach which
encourages integration of quality review, utilization review, risk control, and infection
surveillance systems.

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Integration of Infection Control with Quality Management
 Integrating results of surveillance into PI initiatives
 Adopting best practice in infection control and prevention into day to day practice
 Quality initiatives to reduce sepsis, surgical site infection, ventilator site infection and
septicemia

Integration of Case Management with Quality Management


 Case managers report cases of increased LOS to Quality
 Denial cases are referred to peer Review
 Integration of case management with patient advocacy programs
Integrating results of case coordination into multidisciplinary approach of patient care

Integrating Results from Sentinel Events and Alerts


 Root Case Analysis and Action Plans
 Implement and check of the effectiveness of the action plan
 Make barriers part of the system
 Response to alerts

Integrating Results into Policies and Procedures


 Adopting best practice into day to day business
 Implementing evidence Based leadership
 Integrating results of PI into policies
 Adopting recommendations in Sentinel event alerts
 Polices for Pt safety in response to patient safety goals

Integrating Patient Safety Goals


 Make them the standard of care
 Resurces
 Follow up

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 Pt Safety Rounds
 Leadership commitment

Integrating Results into Bylaws


 Appraisal system
 Job description
 Training and orientation
 Compliance
 Safety measures

The Integration of Standards into Practice and Performance Appraisal


 Physicians are increasingly being called on to use clinical guidelines.
 Scientific studies support their use; resistance to “cookbook medicine” is fading out.
 External groups from Leapfrog to the American Heart Association to NCQA and JCAHO
are incorporating adherence to guidelines into PI.
 Physicians are more apt to use them, with medicine becoming more complex, as long as
leaders believe in them and they are readily available at the point of care.
 Standards of care, clinical practice guidelines, and clinical paths are used
increasingly to generate performance measures/indicators for ongoing
quality management activities.

 The emphasis in quality improvement is on the processes of delivering care, but we


cannot ignore significant findings related to the care and practice of individual
practitioners.
 Performance measure results are the basis of the growing pay-for-performance bonus-
payment programs
 The results of quality management activities, including adherence to
standards, are documented and reviewed in conjunction with the reappraisal of all
independent practitioners with delineated clinical privileges (physicians, psychologists,

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dentists, podiatrists, allied health professionals/limited license practitioners) that occurs
generally every two years in hospitals, large medical groups, staff model HMOs, etc
 The results of quality management activities within the organization may also be
incorporated into the performance evaluation process of at least the other clinical staff or
those who directly contact patients (nurses, therapists, technicians, medical assistants,
health aides, etc.), along with non-clinical staff, as organization performance monitoring
progressively includes more governance, management, and support functions and
performance measures based on standards.
 One of the most valuable aspects of this integration is the inclusion of positive findings.

Integration of Results from PI Teams

 Think Globally and act locally


 Importance of coordination
 Eliminate duplication and re-do
 Integrate results into the big picture
 Integrate results into policies and procedures

System Integration
 Role of Information System in Integration
 Building Institutional memory
 Integration of processes within the system
 Team collaboration and coordination

Supplier – Processor – customer relationship

Role of Governance and Leadership in Integration


 Linking Quality to strategic Planning

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 Quality is the way the organization doing business Integrating Quality into day to
day business
 Part of the mission statement
 Quality is everyone's responsibility
 Precipitation and not just blessing performance improvement activates

Quality Planning
 Listen to the customer
 Voice of the community
 Integrating best practice in management
 Integrating data from SWOT Analysis

 Resource allocation
 Make part of the system
 Rewards
 Bylaws
 Approval for credentialing
 Enforcement of Pt safety measures ( RED Rules)
 Support to UM
 Support to RM
Listen to the Voice of the Customer

Barriers to Integration
 Lack of Supervision
 No enforcement for Compliance
 Weak Leadership commitment
 High Rate of Turn over
 Lack of documentation

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 Lack of Medical staff commitment and buy In
 Lack of Resurces to continue
 Lack of incentives
 No consuequcxes for non- compliance

Quality Reviews
 Peer Review
 Medical Record Review
 Blood Review
 Utilization Review
 Drug Utilization Reviews
 Surgical and Procedure Case Review
 Mortality Review
 MSET/Code Blue Review
 Sentinel Events Review

Types of Review

 Retrospective: Review is performed after care has been rendered. It offers a complete
picture of services provided, timeliness, and patient outcomes and findings can be
compared to costs of care.
 Focused:Review for a predetermined reason is concentrated on a select sample of cases
or data elements.
 Prospective: The medical need for care is assessed before care is rendered "medical
necessity”
 Concurrent: Review is performed at the onset of, and during care, for medical necessity,
appropriateness of care and service, or any of the other dimensions of performance

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The Multi-Level Review Process

 1st Level (Monitoring):


 Criteria-based data collection and summarization
 2nd Level (Analysis):
 Initial analysis of data/information, confirmation of variations, or more intensive
review
 3rd Level (Analysis/improvement) :
 QI Team, Medical Staff Department or Section Chair (hospital) Medical Director

The Multi-Level Review Process

 4th Level (improvement/Design) : -


 Quality Council
 5th Level (Re-monitoring/Reanalysis)
 QI Team/Committee/Task Force

Case-Specific Review Process

 Quality control/measurement of today, especially in a managed care environment, must


provide aggregated data to measure performance over time, based on the screening of
activities using well-defined and constructed measures (indicators).

 Any case-specific review (review involving intensive analysis of the medical/ clinical
record) should be triggered from the indicator data, should focus in areas of concern, and
should be as concurrent as possible.

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What is Peer Review?
 Peer review can be simply defined as follows:
 “Helping each physician to be the best he or she can be.”
 Peer review is a systematic, structured way to evaluate physician performance
which includes: Technical quality of care, quality of service, resource utilization,
peer and co-worker relationships, and contributions to the hospital and medical
staff.
Peer:
 A peer is defined as a physician, Physicians Assistant or Certified Registered Nurse
Anesthetists in the same specialty or professional practice or related specialty as the
professional whose services are being reviewed.
 Reviewable Circumstances: Criteria/indicators/screens and/or special studies specifically
for the purpose of assuring appropriate care of the patient.
Data Sources:
 Criteria review, Quality of Care Issue Resolution process, Staff or Patient Relations
Issues, Utilization Review, Medical Record Suspension and Clinical Pertinence,
Medication Errors/Event Description Forms, Autopsy Review, Drug Usage Review,
Blood Usage Review, Procedure/Surgical Case Review, Resource Utilization, special
studies.
Focused Review:
 If during the criteria/peer review process, a pattern emerges or significant variation from
medical standards of care has been identified for a particular physician, the Department
Chair/Section Chief may elect to conduct a broader review of that physician’s cases.

External Review:
 A review of cases done by practitioners outside the facility when the review involves a
specialty with a limited number of physicians in that specialty and/or an anticipated
conflict of interest.

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Peer Review Process
 Why do I have to do it?
 How do I do it?
 What happens to the information?
 What if I have to take action?
 What if performance does not change?

Why do I have to do it?


 Medical staff leaders are obligated by by-laws to:
 continuously review the quality of care of practitioners in their departments
 take action on identified issues or concerns
 make recommendations concerning re-appointment to the staff based on the
results of peer review monitoring and evaluation.
How do I do it?
 developing indicators
 designing studies
 collecting data and presenting results
 developing action plans
 tracking and trending

 In general, there are three types of peer review information that can be collected for
departmental review:
 Rules and general principles of medicine
 Unusual (usually adverse) events
 Performance improvement data
 Rules/General Principles of Medicine

 Usually data comes from blood use, drug use, medical record, utilization, or procedure
review;

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 These reviews are generally conducted by special medical staff committees convened for
that purpose.
 Physicians establish the guidelines for the reviews (what constitutes “appropriate”, etc.)
 Physicians who are at variance may be asked to respond in writing to the variance (this is
at the committees’ discretion).
Examples
 Failure to write a post op note after surgery (medical records)
 Prescribing FFP at variance to established guidelines (blood use)

 Administering gentamycin without checking blood levels appropriately (drug use)


 Performing a laminectomy without documentation of indications for procedure
(procedure review)

 Chairmen need to be involved directly with these reviews if:


 a physician in their department is chronically breaking the rules (based on trended
data)
 the “rule breaking” resulted in a serious (adverse) event or outcome
 a physician in their department refuses to respond to requests from the committee
for explanation of variance.
Unusual Events
 Data for this comes from two sources:
 Department established criteria screens (mortality, unplanned re-admissions, un-
planned return to surgery, dental injury during intubation, other morbidity's, etc.)
 Sentinel event (or near miss) investigations

 Department established screens are generally reviewed in the department’s quality


meeting.
 The chairmen may need to take action if: there was a serious adverse outcome or
significant breach of medical protocol OR if there is an undesirable pattern or trend.

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 Issues from sentinel event investigations are brought to the chairmen by the Quality
Consultant and/or Risk Manager and generally require action or follow-up.

Performance Improvement Rates

 Performance improvement data is derived from those areas which a department selects to
study to look for opportunities to improve.
 The results will show which physicians are performing within the established guidelines
and which are not.

 Example: The Department of Family Practice wants to study antibiotic use for
pneumonia. The department defines what constitutes appropriate use based on current
literature. A study is done of physician practice based on retrospective data:

What happens to the information?


 All types of reviews are “scored” on a one to four scale - one being no deviation from
accepted standards of care, four being significant deviation.
 Information from all reviews (both positive and negative) is stored by the Quality
department in confidential files.
 Information is released to the chairmen:
 at time of re-appointment
 if an undesirable pattern or trend is emerging
at the chairman’s request
 Information can only be released to the chairman, chairman’s designee, or medical staff
officer.
 At time of re-appointment, chairmen should expect to see a physician-specific summary
of all the peer review data collected during the past two year appointment period
including (but not limited to):

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 volume of activity, meeting attendance, performance improvement rates, rules/
general principles review, unusual events review, compliments and complaints
(from staff and patients).

What if the chairman needs to take action?


 Praise in public, chastise in private
 Consider using a focused review committee to verify problem/concern
 Constantly refer to the data
 Be specific
 Offer the physician the opportunity to improve/ change voluntarily
 Be collegial and helpful
 Be specific about recommendations; give a timeline
 Follow-up to see if change has occurred

What if the chairman needs to take action?


 Possible actions:
 Additional training and education
 Voluntarily relinquishing a privilege (permanently or until further training
received)
 Behavior change
 Using a mentor or proctor

What if performance doesn’t change?


 Corrective action is the last resort.
 Involve quality and hospital legal counsel
 Follow by-laws

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Medical Record Review

Patient-specific Data/Information Standards


 The organization defines, captures, analyses, transforms, transmits, and reports patient-
specific data and information related to care processes and outcomes
 The organization initiates and maintains a medical record for every individual assessed or
treated.
 Only authorized individuals make entries in medical records.

 The medical record contains sufficient information to identify the patient, support the
diagnosis, justify the treatment, document the course and results, and promote continuity
of care among healthcare providers.

Confidentiality, Security, and Integrity


 Confidentiality, security, and integrity of data and information are maintained.
 Collection, storage, and retrieval systems are designed to allow timely and easy use of
data and information without compromising its security and confidentiality.
 Records and information are protected against loss, destruction, tampering, and
unauthorized access or use.

Uniformity, Standardization & Data Assessment

Uniform data definitions and data capture methods are used whenever possible
 Minimum data sets, data definitions, codes, classifications, and terminology are
standardized whenever possible.
 The hospital collects data in a timely, economic, and efficient manner and with the degree
of accuracy, completeness, and discrimination necessary for their intended use.

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Contents of the Medical Record

Each medical record contains at least the following


 Patient information and authorized representative;
 Legal status, for mental health services;
 Emergency care prior to arrival;
 Record and findings of the patient assessment;
 Conclusions/impressions from history and physical;
 Diagnosis or diagnostic impression;
 Reason(s) for admission or treatment;
 Goals of treatment and treatment plan;
 Evidence of known advance directives;
 Evidence of informed consent if required;
 Diagnostic and therapeutic orders;
 All diagnostic and therapeutic procedures/tests performed and results;
 All operative and other invasive procedures performed;
All progress notes;

 All reassessments;
 Clinical observations;
 Response to care provided;
 Consultation reports;
 Every medication ordered/prescribed for inpatients;
 Each medication dispensed/prescribed for ambulatory patient or inpatient on discharge;
 Every dose of medication administered and any adverse drug reaction;

 All relevant diagnoses;


 Any referrals/communications to external/internal care providers and community
agencies;

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 Conclusions at termination of hospitalization;
 Discharge instructions to the patient and family; and
 Clinical resumes and discharge summaries, a final progress note, or transfer summary.

The Discharge Summary


 The discharge summary contains the following information
 Reason for hospitalization;
 Significant findings;
 Procedures performed and treatment rendered;
 Condition on discharge; and
 Specific instructions.

Pre- Operative and Operative Documentation


 operative or other procedures and the use of anesthesia.
 Preoperative diagnosis
 Operative reports dictated or written immediately after surgery, including
 Primary surgeons and assistants;
 Findings;
 Technical procedures used;
 Specimens removed;
Postoperative diagnosis

Postoperative documentation
 Postoperative documentation, including
 Vital signs and level of consciousness;
 Medications and blood;
 Unusual events or postoperative complications;
 ID of nursing care providers;
 Discharge from PACU by LIP or by Relevant Discharge Criteria.

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Emergency Care
 When emergency, urgent, or immediate care is provided,….the medical record
documents
 Time and means of arrival;
 Patients left against medical advise( AMA);
 Conclusions, including:
 Final disposition;
 Condition at discharge;
 Instructions for follow-up care.
 Copy of record available to follow-up practitioner or medical organization.

Verbal Orders
 Verbal orders of authorized individuals are accepted and transcribed by qualified
personnel who are identified by title or category in the medical staff rules and regulations
 Dated and identified by names of individuals giving, receiving, and implementing the
orders;
 Authenticated by the prescribing practitioner within the specified time period
when required by state or federal law or regulation.

Entries & Authentication


 Every medical record entry is dated, its author identified, and, when necessary,
authenticated.
 Entries made only by authorized individuals;
 Entries authenticated only by the author to verify they are complete, accurate, and final
 Entries authenticated by written signature or initials, rubber stamp, or computer
"signatures" or codes, faxed signatures.

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 Entries requiring authentication identified in policy, including at least H & P, operative
reports, consultation, and discharge summaries.

 The [organization] can quickly assemble and have access to all relevant information from
components of a patient's record, when the patient is admitted or is seen for ambulatory
or emergency care.
 The medical record, computer system, or organization policy indicates when part of the
record has been filed elsewhere.

Purposes Of The Medical Record

 Continuity of Care:
 To serve as a basis for planning patient care and for continuity in the evaluation of
the patient's condition and treatment;
 To furnish documentary evidence of the course of the patient's medical
evaluation, treatment, and change in condition during the care episode.
 Communication Among Practitioners:
 To document communication between the practitioner responsible for the patient
and any other healthcare professional who contributes to the patient's care.
 Legal Protection:
 To assist in protecting the legal interest of the patient, the organization, and the
practitioner responsible for the patient.
 Data:
 To provide data for use in continuing education, in research, and in quality
measurement, assessment, and improvement.

 Identify of the patient:


 Identification data
 Summary of psychosocial needs appropriate to patient age

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 Support for the diagnosis:
 Medical history
 Reports of relevant physical examinations
 Diagnostic orders
 Justification for treatment:
 Evidence of appropriate informed consent
 Therapeutic orders
 Clinical observations
Purposes Of The Medical Record
 Documentation of the course and results of:
 Therapy
 Procedures and tests
 Conclusions at termination of treatment or evaluation

Medical Record Completion

Requirements for Hospital

 History and Physical:


 Within 24 hours after admission. May be done within 30 days prior to admission.
For a readmission within 30 days for the same or related condition, an interval H
& P is adequate if the original is available
 Verbal orders:
 Signed within 24 hours
 Informed Consent: Evidence of compliance with requirements stated in the
organization's policy and consistent with any legal requirements
 Reports:

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 (lab, radiology, pathology, anesthesia, nuclear medicine, and diagnostic and
treatment procedures) [Time limit for results, within 24 hours if possible, no
longer in standards];

 Clinical Resume:
 (Discharge Summary): 30-day time limit in conjunction with the completion of
the record [Most institutions require it within 2 weeks];

 Discharge instructions:
 must include physical activity, medications, diet, and follow-up care;

 A final Progress Note:


 is acceptable instead of discharge summary if LOS is less than 48 hours for
uncomplicated conditions, normal newborns, and uncomplicated deliveries;
 Deaths:
 include reason for admission, findings, course, and events leading to death;

 Autopsy Report:
 provisional anatomic diagnoses within 3 days; complete report within 60 days.
History & Physical/Assessment Requirements
 Must be completed by a physician/LIP within 24 hours of admission.
 If completed by a Physician’s Assistant, Medical Student, Nurse Practitioner, or Mid-
wife: must be counter-signed by supervising physician.
 May be dictated or LEGIBLY written on the H&P form.

Medical history and physicals


(for in-patient admissions)

 Must contain or address the following elements:


 History of current illness

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 Current medications
 Significant past medical history
 Social history (may indicate “non-contributory)
 Family history (may indicate “non-contributory”)
 Review of systems and physical exam
 Plan of care

Surgical/invasive Procedure History And Physicals


(For In- Or Out- Patients)

 Must be complete and on the chart PRIOR to surgery/procedure.


 May bring copy from office chart.
 May be completed up to 30 days prior to surgery; if more than 30 days old CANNOT be
updated.
 If completed by a Physician’s Assistant, Medical Student, Nurse Practitioner, or Mid-
wife: MUST be counter-signed by supervising physician.
 If completed by a physician who is NOT a member of the medical staff, SURGEON
MUST WRITE “Reviewed by” and sign and date.
 If more than 7 days old: Please review and note any updates or changes, sign and date. If
no changes, write “No change since previous exam” and sign and date. This must be done
to meet CMS (HCFA) requirements.

 Must contain or address the following elements:


 Indications for surgery/procedure (significant history)
 Current medications
 Social history (may indicate as “non-contributory”)
 Family history (may indicate as “non-contributory”)
 Review of systems and physical exam (at a minimum, must include assessment of heart,
lungs, neuro status, and surgical site.)
 Plan of care

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 If completed by the surgeon/physician performing procedure, may be used to indicate


informed consent discussion. Must include notation of discussion of RISKS, BENEFITS,
and ALTERNATIVES.

Special Required Assessment/documentation Prior To Administration Of Moderate


Sedation
 Physician H&P (not more than 30 days old; if more than 7 days old, noted and signed as
described above)
 Informed Consent

Special Required Assessment/documentation Prior To Administration Of Moderate


Sedation
 Documentation of risk classification (ASA), current medications, previous adverse
reactions to sedation or anesthesia, pre-anesthesia assessment of heart, lungs, and neuro
status, and plan for moderate sedation – SIGNED BY THE PHYSICIAN. This should be
documented on the moderate sedation form or procedure/endoscopy record.

 Documentation of evaluation of patient immediately prior to administration of moderate


sedation medications (may be done by RN). First set of vitals IS acceptable as long as it
is done prior to the administration of sedation and is clearly documented as such.

The Medical Record as a Review Tool


 Continuity of care delivery;
 Completeness, timeliness, and legibility to assure: Adequacy as a legal document;
 Compliance with medical staff bylaws, rules, regulations; accreditation, state, and federal
requirements.
 Appropriateness of orders, tests, and treatments;

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 Medical necessity and appropriateness of hospital and skilled/sub-acute level of care
 Variance and outcome monitoring based on clinical paths or practice, guidelines;
 Timeliness of care delivery;
 Adequacy of the medical record as a clinical, communicative record;

 Medical records are reviewed on an ongoing basis for completeness and timeliness of
information, and action is taken to improve the quality and timeliness of documentation
that impacts patient care
 A representative sample of records is included in the review process

Type of Record Review


 Open Record Review
 Closed Record Review
 19 Element Review

Open Record Review


 Prospective review
 Usually done by staff
 Allows for immediate feedback to staff

Closed Record Review


 Usually done by a multi-disciplinary team
 Allows for “practice” in finding information that will be gathered during the real JCAHO
record review
 Allows for compilation of a list of “good” charts

19 Element Review

 Review must address timeliness and completeness of each element

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 A portion of the 19 elements can be reviewed at each quarterly review provided all 19
elements are reviewed annually.
 If an element is reviewed annually the surveyors will want to see the last three years
worth of data
 Before the survey the organization completes the Summary Review Sheet, indicating at
least quarterly findings for the review of each item as part of the ongoing medical record
review process as well as performance improvement activities initiated to address
findings if appropriate.
 Identification data
 Medical History:
 chief complaint
 present illness
 past medical history
 family history
 social history
 inventory by body system

 Age appropriate psycho-social assessment


 Report of relevant physical examinations
 H&P Conclusions or impressions
 Physician Plan of Care
 Diagnostic and therapeutic orders
 Informed Consent
 Clinical observations

 Progress notes
 Consult reports
 Operative/Invasive Procedure Reports
 Reports from diagnostic or therapeutic procedures
 Records of donation and receipt of transplants and/or implants

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 Final diagnosis
 Conclusions at termination of hospitalization

 Discharge Instructions
 Discharge summaries
Results of autopsies

Surgical and Procedure Case Review


 Organization-wide clinical review processes has become the responsibility of the
organization, not a department or the medical staff,
 The Joint Commission standards for hospitals require that many clinical review activities
considered important to patient outcomes be monitored as organization-wide.

 The use of operative, other invasive, and noninvasive procedures that place patients at
risk is considered one of them

Who Is Conducting Surgical Case Review?


 The Hospital forms a multidisciplinary Committee that has at a minimum representatives
from:
 Surgery
 Anesthesia
 Pathology/Lab
 Surgical Services
Other Systems as appropriate
 The Committee decides on the frequency of meetings
 Every year the committee decides on the number and kind of studies to be conducted.
 A principal investigator is assigned to each study.

 Quality department assists in developing the data collection tool.

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 The Quality Consultant in collaboration with the Principal Investigator identify the
appropriateness criteria
 A team is assigned to collect the data.
 The Quality consultant assists in presenting and analyzing the data
 The committee reviews the results and make recommendations for improvement.
 The Chair of the committee shares the results and the recommendations with the quality
council.
 Actions are taken according to the type of recommendation

Selection of Cases for


Surgical and Procedure Case Review
 Selection of specific procedures, diagnoses or DRGS, is based on high volume,
substantial risk to patients, or potential problem; then measurement of one or more
processes in order to improve performance of the clinical function, Or
 Selection of one or more of the processes to be monitored; then review of relevant
procedures, diagnoses, DRGS, medications, etc.;

Prioritization

 The organization prioritizes those procedures that pose considerable risk to patients.
 Procedures may carry risk of complications or expose the patient to unnecessary risk if
 performed when not indicated,
 not performed when indicated, or
 performed poorly or incorrectly.
Joint Commission sampling recommendation
 100% review may be necessary for low-volume activities (< 30 cases per quarter) or to
establish a baseline for future sampling;

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 Sampling of 5% of high-volume activities, if the average number of cases per quarter is >
600;
 Sampling of at least 30 cases of lower volume activities, if the average number per
quarter is < 600.

What are we reviewing?


 In general, the processes to be reviewed fall into the following categories:
 Indications/appropriateness
 Preparation/dispensing
 Administration/performance
 Monitoring effects
 Patient education [operative/invasive]

Selection of the Patient


 H&P
 Chief Complaint
 Present Illness
 Past History
 Social History
 Family History
 Physical Exam
 Impression
Appropriateness of Care
 Diagnostic Data
 Met Surgical / Procedure Indicator
Informed Consent
 Consent Signed
 Risk & Benefits Discussed
 Potential Complications Discussed
 Blood & Blood Products Discussed

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Preparation & Monitoring of the Patient


 Immediate PreOp Anesthesia Assessment
 Mental Status
 Neuro Status
 Anesthesia Plan of Care
 Anesthesia Procedure Monitoring
 Post Operative Anesthesia Evaluation
 ASA Score
Wound Classification

Immediate Post Op Care


 Procedure Time in Minutes
 Operative Note
 Operative Report

PACU Assessment & Monitoring


 PACU Pre-Admission Assessment by MD
 PACU Monitoring
 PACU Discharge Assessment / MD
 Discharge Aldrete Score
If Conscious Sedation used, escorted?

Post Procedure Unit Care

 Nursing Plan of Care


 Post Procedure Instruction given to Patient
 Patient Signs He Understand D/C Instructions

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Blood Use Analysis


 Estimated Blood Loss
 Overall Units Transfused
 Units Crossmatched
 RBC's Transfused
 CT Ratio
 Autologous Transfused

Pathology Results
 Same Pre/Post Pathology Results
 Autopsy Class I
 Autopsy Class II
 Autopsy Class III
 Autopsy Class IV
 Autopsy Class V

Financial Outcomes
 ALOS
 Average Payment
 Average Direct Cost
 Average Net Income

Patient Satisfaction Outcomes


 MD Explains Diagnosis
 MD Explains Treatment Options
 MD Spends Time Answering Questions

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 Total Combined MD Score

Examples of screens for monitoring and analysis include


 Deaths
 Unexpected neoplasms
 Unplanned returns to surgery
 Major discrepancies or patterns of discrepancies between pre- and post-operative
diagnoses, including those identified during the pathologic review of specimens;
 Significant adverse events associated with anesthesia use.

Medication Usage Review

Medication Use
 Processes Involved
 Prescribing/ordering medication;
 Preparing and dispensing;
 Administering;
 Monitoring effects on patients.

 Disciplines Involved:
 Pharmacy;
 Nursing;
 Management and administrative staff;
 Other clinical areas as necessary;
 Medical staff/peers, as applicable, must review when the individual licensed
practitioner with clinical privileges becomes the focus.
Selection of Medications for Monitoring and Analysis Include:
 Significant medication errors
 Significant adverse drug reactions

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 Those known or suspected to present a significant risk to patients;
 Those whose use is known or suspected to be problem-prone;

 Those given to high-risk patients;


 Those identified through other indicators;
 Those with significantly high cost;
 Those needing validation of therapeutic effectiveness.

Blood and Blood Component Use

The Scope of Review


 Blood utilization review can be divided into two major categories
 Direct monitoring of physician ordering practices and transfusion effectiveness
 Evaluation of processes involved in the transfusion process, including informed
consent and the preparation, dispensing, and administration of blood components.
Blood and Blood Component Use
 Processes Involved:
 Ordering of appropriate blood components
 Distributing, handling, and dispensing
 Administering;
 Monitoring effects on patients.
 Disciplines Involved:
 Medical staff/physicians, as applicable;
 Transfusion service;
 Nursing;
 Departments/services using blood;
 Management and administrative staff.

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Direct Monitoring of Physician Ordering
Practices and Transfusion Effectiveness

 These reviews should use the predetermined transfusion practice guidelines established
by the Transfusion Committee and include a sufficient number of patients to identify
patterns that require more intensive evaluation.
 Universal review of all transfusions is indicated when components are used in low
volume or when a baseline of practice is being established.
 For high-volume blood components that have previously been reviewed and practice is in
accordance with accepted parameters, audits can be performed on a representative sample
and an appropriate proportion of transfusions.
 Transfusion on all services, including outpatient services, should be included in the
review, preferably in approximate proportion to their use of blood.

 Cases in which the need for transfusion is not evident can be referred to the Transfusion
Committee for review by a physician.
 Specific components used in high volume or components thought or known to be
problematic should be reviewed first.
 Alternatively, a specific disease or pathologic process could be selected first and then the
relevant components used for treatment reviewed.

 Monitoring of all transfusion reactions, post-transfusions infections, and other adverse


events of transfusion affecting all inpatients and outpatients is required to ensure
recognition of any problems in the delivery of transfusion services.

Evaluation of Processes Involved in the Preparation, Dispensing, and


Administration of Blood Components

 Topics that have recently been of interest to JCAHO inspectors include:

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 the adequacy of the blood supply available to the hospital,
 the timeliness of delivery of emergency orders,
 the presence of informed consent documentation in the patient record.
 Other potential topics for study include the use of blood warmers, pumps, or other
equipment used in the administration of blood; therapeutic hemapheresis; therapeutic
phlebotomy; perioperative blood recovery; and the use of satellite blood storage areas
such as the operating room or trauma center.
 Measurers to assess whether patients are being under-transfused should also be
considered for inclusion in the review process.

Blood and Blood Component Use


 Selection of Blood/Blood Components for Monitoring and Analysis Include:
 All confirmed transfusion reactions (Mandatory)
 Those most important to patient outcomes;
 Those with highest volume or risk;
 Those with access/availability problems, etc.
The Review Process
 Data must be collected , tabulated and analyzed at regular specified times to determine
the number and type of variations from the transfusion guidelines and to evaluate the
effectiveness of the various processes involved in the ordering and administration of
blood components
 Peer review is used to assess whether deviations from the transfusion guidelines are
clinically justified.
 If variations are identified, correspondence is sent to the physician who ordered the blood
component asking for more information

 The data generated from the review process should be analyzed to determine
inappropriate trends
 When deficiencies are identified , plans of corrective should be formulated
 The action is determined according to the type of the variation

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 After a suitable interval , follow up assessment is conducted to determine whether
improvement occurred.

Blood Usage Review Sheet


Factor 8 or 9 - packed cells - fresh frozen plasma - platelets
Cryoprecipitate – autologous - consent present

Hx. Number DC Date Physician Diagnosis/Procedure Component Labs Pre Labs Post Presence of
Consent

Example of Transfusion Criteria for Adults

INOVA FAIR OAKS HOSPITAL


 Transfusion of RBC’s (Including Autologous, Direct Donor, Irradiated, Washed)
 Anemia: Adult Hgb <8 or Hct. <25.
 Surgical blood loss of 750cc. or more.
 Crystalloids are preferred as the primary therapy in clinical shock.

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 Current chemotherapy patient: Hgb.< 8 or Hct.< 25.
 Heart disease (CV disease, heart surgery or hypertension): according to physician
judgement.
 Significantly symptomatic: Hct. between 25 and 30 (not meeting with other criteria)
reason must be well documented.

 Transfusion of Platelets:
 Single, Random, Irradiated (Adults)
 Treatment of bleeding due to thrombocytopenia with platelet count less than
50,000 or the presence of functionally abnormal platelets.
 For bleeding patients associated with bone marrow hypoplasia due to
chemotherapy, tumor invasion or primary aplasia with platelet count less than
10,000.
 Actively bleeding patient <50,000.
 Single donor platelets are preferred over random donor platelets.

 Transfusion of RBC’s (Including Autologous, Direct Donor, Irradiated, Washed)


 Anemia: Adult Hgb <8 or Hct. <25.
 Surgical blood loss of 750cc. or more.
 Crystalloids are preferred as the primary therapy in clinical shock.
 Current chemotherapy patient: Hgb.< 8 or Hct.< 25.
 Heart disease (CV disease, heart surgery or hypertension): according to physician
judgement.
 Significantly symptomatic: Hct. between 25 and 30 (not meeting with other
criteria) reason must be well documented.
 Transfusion of Platelets:
 Single, Random, Irradiated (Adults)
 Treatment of bleeding due to thrombocytopenia with platelet count less than
50,000 or the presence of functionally abnormal platelets.

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 For bleeding patients associated with bone marrow hypoplasia due to
chemotherapy, tumor invasion or primary aplasia with platelet count less than
10,000.
 Actively bleeding patient <50,000.
 Single donor platelets are preferred over random donor platelets.
 Transfusion of Cryoprecipitate (Adult)
 Hypofibrinogenemia
 DIC with or without hypofibrinogenemia.
 Local use to wound as fibrinogen glue. Tisseel (Baxter) is available.
 Transfusion of Clotting Factor Concentrates (Adults)
 Coagulation defect correction (a specific defect must be documented by abnormal
coagulation studies or previous diagnosis.)
 Factor VIII for: hemophilia
 Use concentrates for Factor IX and FFP for Factor II, VII, and X.
 Severe or variant forms of Von Willebrand’s disease.
 For life threatening bleeding due to vitamin K deficiency or excessive Coumadin,
use FFP or Vitamin K.
 Transfusion of Fresh Frozen Plasma (Adults)
 Prothrombin time greater than 3 seconds beyond upper limit of normal range or
PTT greater than 50 seconds.
 Previously known diagnosis of deficiencies of Factors II, V, VII, X, XI, XIII.
 Reversal of Coumadin effect: if immediate hemostasis is required to stop
bleeding or for emergency surgery or invasive procedure.
 Thrombotic thrombocytopenia purpura (TTP).

Mortality Review
 Mortality review is a hospital medical staff process not specifically delineated in Joint
Commission standards, but it is nevertheless an integral part of quality management
activities of each medical staff department/service.
 The review also involves nursing and other clinical services as appropriate.

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Utilization Management Activities

 Data involved:
 Concurrent (generally case-specific)
 Periodic (aggregated, pattern/trend)
 Age/disability groups
 Diagnoses/DRGs/procedures
 Complications/problems/risk factors
 Levels of care
 Treatment or practice patterns

Responsibilities of UM Staff
 Establish rapport and liaison relationships with physicians/practitioners;
 Establish and/or perform utilization review for primary and specialist care, outpatient
procedures, admission, continued stay, resource use, next level of care, readiness for
discharge/aftercare, including screening for aftercare and health maintenance needs;
 Identify utilization, patient care, and potential liability problems;
 Conduct ongoing quality and risk monitoring or special studies as appropriate, including
outcome studies to determine improved or maintained health status;
 Refer organizational systems issues to the appropriate QI team or department/service and
participate as needed;
 Refer continuity of care issues to the case manager, care coordinator, discharge
planner/transition manager,or other appropriate staff,

 Refer physician-related issues concerning quality, utilization, or liability to the medical


director, physician advisor, or appropriate committee or department chair, as applicable,
for review and decision;
 Issue denials, e.g., benefit coverage or treatment authorization denials, based on job and
payer requirements;

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 Assist with problem resolution and reevaluation as appropriate;
 Coordinate the review requirements of all external review entities, managed care
contracts, self-insured employers, insurers, fiscal intermediaries, and state and federal
agencies;
 Refer to and/or coordinate UM Committee and applicable QI team activities; Document
all activities and outcomes.

Integration with Quality Management


 Utilization review and management are integral parts of the organizationwide quality
management program.
 Utilization management evaluates the impact of cost containment activities on the quality
of patient care and helps to determine the point at which quality may be compromised. .
 Continuous quality improvement through interdisciplinary team measurement,
assessment, and improvement of patient care delivery processes and services resulting in
enhanced quality and reduced cost and risk (resource management).
 Practitioner Profiling:
 An activity summary that coordinates information from all review areas including
utilization (LOS, denials, appeals, etc.), and provides one objective basis for
reappraisal and re-privileging.
Documentation of routine MSET Cart
 Documentation of routine MSET cart and defibrillator checks will be kept on the MSET
cart or in a designated area.
 Routine cart and defibrillator checks will include validation of:
 Adult MSET Carts
 Monitor/ defibrillator is plugged in
 Adequate paper in the monitor/defibrillator
 Monitor/defibrillator cables present (ECG and if installed, pulse oxymeter)
 Completion of defibrillator test as indicated by manufacturers guidelines
 Date/time indicated on display is correct
 Cart lock is intact

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 Cart signature form is present and indicates expiration date of next drug, IV
solution and Intubation tray.
 Dates not expired
 Electrodes present on top of cart
 Saline pads present on top of cart
 Quick-combo pads present on top of cart
 Ambu bag present
 Portable oxygen tank , regulator and key are present
 Oxygen in tank is full (at least 2,000 psi)
 To be Completed by ACLS Responder/ Critical Care Nurse in Collaboration with
Physician in Charge
 Not a permanent part of the medical record
MSET CRITIQUE
DATE: ________________
LOCATION: _________________ (Nursing Unit)
Was announcement loud with location within one minute? pYes
pNo
And beeped within one minute? pYes pNo
RESPONDERS (Please Circle)

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EQUIPMENT PROBLEM (S)

COMMUNICATION

CLINICAL INTERVENTIONS
Indicate any Problem and Describe
p CPR
p Intubation
p IV Access
p Defibrillation

Initial Review by Critical Care Director

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Concerns Identified (describe)
p Actions Taken

SENTINEL EVENTS
Example of Sentinel Events
 Unanticipated death or major loss of function, unrelated to natural course of illness or
underlying condition;
 Patient suicide during round-the-clock care;
 Infant abduction or discharge to wrong family;
 Rape;
 Hemolytic transfusion reaction involving major blood group incompatibilities;
 Surgery on wrong patient or body part.

Responding to a Sentinel Event


 The organization is expected to:
 Conduct immediate investigation;
 Determine whether or not to self-report a reviewable event (those identified above) to
the Joint Commission within 5 days.
 If the Joint Commission becomes aware of a reviewable event by other means,
documentation of investigation and intervention is required.
 Respond appropriately to all defined sentinel events:
 Prepare a thorough and credible root cause analysis (RCA) and action plan;

 The Action plan should include:


 Strategies to reduce risk of recurrence;
 Responsibility for implementation and oversight;
 Pilot testing as appropriate;
 Time lines for testing and full implementation;
 Strategies for monitoring the effectiveness of actions taken.

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 Provide RCA and action plan without patient or care giver names to Joint Commission
for review within 45 calendar days of known occurrence if self- reported or otherwise
known to Joint Commission;

Root Cause Analysis


 Event:
 An occurrence that is either deemed to be, or results in, a significant problem or
is a "near miss" (almost happened)
Root Cause Analysis Process
 Significant/Sentinel Event Occurs/Notification
 Define Problem/Collect Initial Data
 Perform Task/Process Analysis
 Perform Change/Difference Analysis
 Perform Control Barrier Analysis

 Begin Cause and Effect Analysis/Conduct Interviews


 Determine Root Causes
 Ask the "Why?" question(Five Whys)
 Develop/recommend Changes/Actions
 Develop an action plan for implementation of change
Report Conclusions

Accreditation

How Accreditation Improves


Quality of Care and Patient Outcomes
 Accreditation is a process in which an entity, separate and distinct from the health care
organization, usually nongovernmental, assesses the health care organization to
determine if it meets a set of requirements designed to improve quality of care.

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 Accreditation is often a voluntary process in which organizations choose to participate,
rather than one required by law and regulation.

 Accreditation standards are usually regarded as optimal and achievable.

 Accreditation provides a visible commitment by an organization to improve the quality


of patient care, ensure a safe environment, and continually work to reduce risks to
patients and staff.

 Accreditation has gained worldwide attention as an effective quality evaluation and


management tool.

Accreditation Is Not an Alternative to Licensure


 Licensure is a process by which a governmental authority grants permission to an
individual practitioner or health care organization to operate or to engage in an
occupation or profession.

 Licensure regulations are generally established to ensure that an organization or


individual meets minimum standards to protect public health and safety

Accreditation Is Not Certification


 Certification is a process by which an authorized body, either a governmental or non-
governmental organization, evaluates and recognizes either an individual or an
organization as meeting pre-determined requirements or criteria.
 Although the terms accreditation and certification are often used interchangeably,
accreditation usually applies only to organizations, while certification may apply to
individuals, as well as to organizations.

The major purposes of accreditation


 Improve the quality of health care by establishing optimal achievement goals in meeting
standards for health care organizations

 Stimulate and improve the integration and management of health services

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 Establish a comparative database of health care organizations able to meet selected
structure, process, and outcome standards or criteria

 Reduce health care costs by focusing on increased efficiency and effectiveness of


services

 Provide education and consultation to health care organizations, managers, and health
professionals on quality improvement strategies and “best practices” in health care

 Strengthen the public’s confidence in the quality of health care, and

 Reduce risks associated with injury and infections for patients and staff

Motivations To Participate In Accreditation Programs


 Motivations to participate in accreditation include:.

 True commitment to improvement in quality of patient care and services .

 Willingness to be held accountable/to be compared to like organizations.

 Enhancing confidence of the public/consumers.

 Condition of payment

 Requirement for contracting to provide services and receive reimbursement

 Requirement for residency programs in academic medical centers

The Accreditation Process


 Accreditation can be considered the following step in the quality assurance process in
healthcare.

 It consists of a more comprehensive review of the competencies of the organization to


deliver reliable quality outputs or achieve desired results.

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 The accreditation process consists of a combination of self and external organizational
assessments based on pre-established standards.

 Accreditation focuses on continuous improvement strategies and achievement of optimal


quality standards rather than adherence to minimal standards intended to assure public
safety.

 Accreditation standards are typically developed by a consensus of health care experts

 Standards are published and reviewed and revised periodically in order to stay current
with the state-of-the-art thinking about health care quality, advances in technology and
treatments, and changes in health policy.

Joint Commission International Standards


 Joint Commission International has four international accreditation programs:

 Hospitals,

 Medical transport organizations (emergency and non-emergency),

 Clinical laboratories, and

 Care continuum (chronic care, rehabilitation, and end of life care).

 They comprise sets of standards for JCI accreditation of individual health facilities and
support organizations in multiple countries

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Organization of JCI Standards

JCI Standards Are Organized Into: "functional chapters" around those functions found to be
common to all healthcare organizations.

Patient-Centered Standards:-

Access to Care and Continuity of Care –

Patient and Family Rights-

Assessment of Patients

Care of Patients-

Patient and Family Education

Health Care Organization Management Standards:-


 Quality Improvement and Patient Safety –

 Prevention and Control of Infections-

 Governance, Leadership, and Direction –

 Facility Management and Safety-

 Staff Qualifications and Education-

 Management of Information

Quality Improvement And Patient Safety Standards


 Comprehensive approach, including:-
 Designing new clinical and managerial processes well;-
 Monitoring how well processes work through indicator data collection;
 Analyzing the data; and-
 Implementing and sustaining changes resulting in improvement

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 Both QI and patient safety programs:-
 Are leadership driven;-
 Seek to change the organization's culture;-
 Proactively identify and reduce risk and variation;
 Use data to focus on priority issues; and-
 Seek to demonstrate sustainable improvements.

Compliance With Standards

 Standards in healthcare accreditation have become or are becoming more practical in the
sense of:

 Assessing actual performance ("performance-based") rather than capacity to


perform;.

 Focusing on:- Processes and outcomes, not simply structure;

 Patient care issues related to quality and safety;-

 The organization's efforts to manage patient care and to support process


improvements that result in good patient outcomes.
 Most agencies will accredit an organization if it is in "substantial" or "full" compliance
(expectations met) with the standards overall, even if not with each individual standard.

Assessment of Compliance
 Most accreditation agencies use one or more of the following means to assess compliance
with applicable standards:
 Review of documents that demonstrate compliance;
 Onsite observations by surveyors;.
 Verbal information gained by surveyors through interviews;
 Examples of standards implementation;.
 Review of medical/health records;.

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 Assessment of service/support systems;
Integration of performance measure data in scoring

 If a surveyor finds any condition existing that poses a threat to public or patient health or
safety, the surveyor may notify the chief executive officer of the organization and
recommend denial of accreditation.
 Any recommendation of denial is reviewed by the accrediting agency before a final
decision is made.
 The organization is offered an opportunity to discuss areas of noncompliance, to submit
documentation to demonstrate compliance or progress, and, with some accrediting
agencies, to request a face-to-face interview or even a "validation" resurvey.
The New JCAHO Accreditation Process
 A new accreditation process called "Shared Visions-New Pathways" became effective in
January 2004.
 It is intended to shift the focus from survey preparation to continuous improvement
 The vision shared with healthcare organizations, oversight bodies, and the public is to:
"bridge what has been called a gap or chasm between the current state of health care and
the potential for safer, higher quality care"

"New Pathways" Are Approaches That Include:.


 Consolidation of the standards within and across all accreditation programs;
 A required mid-cycle (15 to 18 months from last triennial survey) self assessment,
called Periodic Performance Review, to evaluate compliance and develop a Plan
of Correction that will be validated during the triennial on-site survey
 Priority Focus Process:
 Pre-survey review of organization-specific data, including Periodic Performance
Review information, ORYX core measures, previous recommendations,
demographic data on types and volume of services, complaints, and sentinel
events.

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On-site standards evaluation

 On-site standards evaluation related to the care experience of actual patients, using new
Tracer Methodology to identify types of patients and processes more at risk (safety and
quality issues) in the specific organization;

 Active engagement of physicians and other direct caregivers in the accreditation process;

 Revision of individual organization Quality Reports to include more performance


information, once performance measurement (core measure) data has been integrated into
the accreditation process (under development).

Understanding and Using the Tracer Methodology in Organizational Assessment

Follow Patient’s Care Journey

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Patient Care Tracer Methodology
 Dynamic process surveyors are piloting during on-site survey process in 2006

 Follow patients through organization’s processes/services

 Processes as seen through patient’s eyes and experience of the organization

 Analysis of systems for providing care, treatment or service

 Focus on execution/ delivery of care

Goals of Tracer Methodology


 Evaluate care provided to patients

 Evaluate processes established within organizations

 Establish and maintain continual survey readiness

 Perform effective QI and PI activities

 Increase staff participation in QI and PI activities

Objectives of Tracer Activity


 Follow entire course of care and services provided to the patient

 Assess relationships among disciplines and important functions

 Evaluate performance of processes provided to the patient

 Evaluate the integration of

 JCI standards

 Organizational processes

 Care and services provided

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Types of Tracers
 Individual Patient Tracers

 Follow actual care across the continuum

 Individual (Patient) System Tracers

 Data Use, medication management, infection control

 Follow an element of a system through the organization

 Environment of care – under consideration

 Evaluation approach that JCI surveyors are piloting during the on-site accreditation
survey in 2006

 Follows or “traces” patients through the organization’s processes and services and
then branches out to assess how well standards were met

 The individual tracer supports a surveyor’s review of critical organizational functions in


the context of the care and services provided to individuals.

 For any given care recipient, a surveyor can assess how the care recipient experienced
elements of many different processes, systems, and structures.

System Tracer Analysis


 Manual systems / checks

 Multiple places for same data

 Variation in processes

 Lack of standardization

 No mechanism for timely communication

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 Transfer / transition points

Complex systems / processes

Accreditation Survey Preparation and Preparedness


Get the TEAM Ready

 Establish on-going interdisciplinary teams (or utilize appropriate existing teams) at each
site or for each important function) to meet at least quarterly, reviewing compliance with
appropriate standards, improvements, policies, etc..

 Identify a medical/professional staff, or medical group team of clinical leaders who will
be in authority at the time of the surveyor will be required to participate as medical
directors, department chairs, etc.

 The quality, utilization, and risk managers need to work with the medical staff/group
coordinator to review compliance with applicable standards and report to the selected
leadership team

Remain Current with Standards


 Distribute the current Standards and Guidelines, with any other appropriate
explanatory material

 Annually identify any changes in standards and evaluate need for associated change in
organization policy, quality/performance improvement strategy, department! service
policies/procedures, documentation, etc..

 Annually identify any changes in survey process, such as how the increased emphasis
on patient safety will be addressed in any required pre-survey documentation and on-site.

Remain Current with Standards


 Remain current on patient safety issues-standards, national reporting requirements,
National Patient Safety Goals (JCAHO), media-and track organizationwide
understanding, readiness, compliance, documentation.

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 Remain current on compliance with organization ethics and anti-fraud policies.

 Review the previous two full survey reports, as well as any interim random survey
reports, looking for areas of vulnerability in the organization (patterns). Previous
recommendations will be focus areas for surveyors in future surveys..

 Review any focused survey reports and any written progress reports submitted
subsequent to corrective action plans. Did the corrective action take place and is it still
in place and effective?

The Review Process


 Review current organizational concerns, data, etc. to compare current compliance with
the past and to identify any new compliance issues, including National Patient Safety
Goals.

 Review the current status of all quality management/performance improvement activities,


organizationwide, functional, and departmental, to ascertain the impact of improvements
made, based on continuous measurement and analysis.

 Review minutes and other records of teams and committees, as well as medical staff
departments, if applicable, looking for missed improvement opportunities (while there is
still time to do something).

 Review the previous year's quality management/performance improvement program


evaluation report. Are approved recommendations being implemented?

 Review the current year's quality management/quality improvement plan, objectives, and
any Strategic Quality Initiatives. Are the objectives/initiatives being achieved? In
progress?

 If it is planned to have an outside pre-survey performed, be certain that it is timed to


allow the maximum time possible for implementation of recommendations and, if at all
possible, incorporates all standards that will be in effect at the time of the actual survey
wherever applicable.
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 Review and revise all policies and procedures associated with the standards.

 Be certain that the policies are organizationwide or system-wide as appropriate and, most
importantly, that all policies and procedures dealing with the same system, function, or
process are consistent across all settings and areas of the organization

 Review the QM/PI processes, approved approach, and team activities and determine any
revisions or modifications, or develop a new process if appropriate.

 Be certain that the organizationwide QM/PI approach is understood and is utilized for all
quality planning and quality improvement activities.

 For patient safety, review the program description and program components and track
data, analysis, reporting, action

 Review all QM/PI communication, reporting, and feedback processes and improve as
appropriate.

 Review credentials process and files for licensed independent practitioners (LIPs) for
timeliness, completeness, and current competency status

 Review human resource process and files for documentation of timely orientation and
completion and maintenance of current competencies.

Periodic Self-assessment/Pre-survey Prep


 A planned self-assessment process will encourage continued standards compliance and
survey preparedness.

 JCAHO requires a mid-cycle self assessment (Periodic Performance Review), to evaluate


compliance and develop a Plan of Correction that will be validated during the triennial
on-site survey;

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Who is conducting the PPR

 The administrative team is the most effective in performing periodic walk-around


inspections of all settings, departments, and services, focusing on selected standards each
time. If non-compliance issues arise, decisions can be made on the spot.

 A good alternative or addition to the walk-around is to establish interview focus groups


for each important function or category of standards and each organizationwide required
review process

The Focus of PPR


 Focus on correcting any noncompliance issues or completing improvement activities
discovered or discussed during previous focus surveys, walk-around, or interviews.

 Provide a grid or log sheet that outlines, for each standard, where/in what form
appropriate documentation may be found to prove compliance

 This log will serve the administrative and clinical teams, but also will provide support to
each person who will need to participate in the survey

Communications and Information


 Consider organizationwide information/communication improvements that make
compliance easier, e.g.,

 Putting policy and procedure manuals and forms on line;

 Providing an organizationwide compliance calendar with review dates,


plan/report due dates, etc.;

 Computer sign-on screen

 QI/PI or survey tips, reminders;

 Frequent emails to staff concerning relevant standards, Progress reports,

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 Compliance needs, etc.

 Get the network rolling: Have each manager contact all colleagues with surveys in the
same accreditation year to learn what specific issues tend to be the focus. This is
necessary to understand as clearly as possible surveyor interpretation of standards...

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Get Organized and Take Action

 Begin organizing a binder, with detailed table of contents, for each function or category
of standards, depending on the accreditation agency and process, utilizing all available
instructions from the agency.

 Delegate any pre-survey recommendations to the appropriate manager, team leader,


committee chair, or staff and establish accountability for follow-through, including
person's) responsible and time frames or actual deadlines.

 List all improvement activities in an organized, systematic way, utilizing a singular


documentation system and forms if at all possible.

 All quality improvement efforts that impact the LIPs should be included, even if actions
were taken by another area and reported back.

 There should be evidence of LIP participation on at least some of the interdisciplinary QI,
strategic initiative, or best practice teams.

 Provide specific pre-survey orientation to all potential interview teams, QI teams that
might be participating, and staff regarding focus of questions and where to locate
references or call for answers.

 Unit managers and physicians whose patients are included in ORYX core measure data
should know what the data says about their processes (OB, Nsy, ED, ICU, CCU, units
treating AMI, pneumonia)

Educate, Educate, Educate


 Educate/update each medical staff department chair, officer, medical director, or medical
group:

 Previous compliance issues in their area and current status,

 Current standards and any changes since the last survey;

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 Current monitoring/data collection, analysis, and improvement processes for their
area;

 All quality improvement successes within at least the last 12 months.

 Educate all who should know about each pertinent improvement impacting their role,
department/service, and care and service provision.

 Educate all staff concerning the impending survey process, its importance, staff roles and
responsibilities, important policies/procedures, etc. E-mail is an excellent way to
distribute such information.

 Each person should have in hand the log indicating where all appropriate documentation
is located for each applicable standard for which that person is responsible and should be
familiar with those binders of information or electronic files pertinent to each person's
responsibilities....

THE JOINT COMMISSION ONSITE PROCESS


Announced Surveys.

 Full onsite surveys are scheduled every three years and are predictable, announced, and
based on :

 Current standards

 Review of current compliance in previously non-compliant areas,

 Pre-survey review of organization-specific data,

 Periodic performance review (PPR),

 Complaints, sentinel events, ORYX core measures, and CMS data.

 Surveyors include, at a minimum, a physician, nurse, and administrative surveyor.

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 Other surveyors are added, depending on the types of services provided, e.g., ambulatory,
mental health, chemical dependency, rehab, etc.

 Full surveys are now three to five days in length for hospitals, depending on the size of
the facility and the number and types of sites and services provided.

 The length of survey in ambulatory, long term, home care, and behavioral health care
depends on the number of services and sites.

 Part of the survey may be conducted during evening, night, or weekend shifts if 24-hour
care is provided.

Unscheduled and Unannounced Surveys


 An unscheduled survey-announced or unannounced-may be performed if the Joint
Commission becomes aware of potentially serious patient care or safety issues or has
other valid reasons for survey in an accredited organization.

 Beginning in January 2006, all triennial surveys will be unannounced.

 In 2004 and 2005, organizations may voluntarily agree to an unannounced triennial


survey.

 The best way to prepare for any accreditation survey is to remain in compliance with all
appropriate standards all the time: called "survey preparedness" or "ongoing compliance."

Accreditation Survey Process


Survey Team

• In order to make an accreditation decision concerning a health care organization’s ability


to meet published performance standards, a team of trained peer reviewers or surveyors
conducts an on-site evaluation of the organization.

• This Team usually formed of:

– A physician

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– A Nurse

An administrator

Types of Surveys

• Depending on the accreditation program’s design and policies, these on-site evaluations
or surveys may be conducted with advance notice to the organization, or may be
unannounced.

• There are advantages and disadvantages to both approaches.

• When the health care organization is advised of the survey dates, it can ensure that its key
managers and staff are present and available to participate in the process, thus promoting
optimal opportunities for consultation and education with the survey team.

• On the other hand, when the organization knows the exact dates that the team is
scheduled, there may be a tendency for the organization to invest in a last-minute effort to
“look good” for the survey, such as an extra cleaning of the facility, thus making it more
difficult for the survey team to determine the usual practices and operations.

• Regardless of the approach used in scheduling the on-site evaluation, a well-trained and
thorough survey team will look beyond surface appearances to determine if the health
care organization meets a wide range of patient care and organizational standards.

• Surveyors typically employ a variety of evaluation strategies to determine if the health


care organization meets standards related to key systems and functions, such as:

• patient care,

• infection control,

• management of the environment,

• human resource management, and

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• quality assurance.

Typical Evaluation Approaches Used in Conducting an Accreditation Survey


• Most health care accrediting bodies use a variety of evaluation approaches during the on-
site survey in order to determine the health care organization’s compliance or
performance with applicable structure, process, and outcome standards. These include:

– Leadership interviews

– Clinical and support staff interviews

– Patient and family interviews

– Observation of patient care and services provided

– Review of patients’ medical records

– Building tour and observation of patient care areas, building facilities, equipment
management, and diagnostic testing services.

– Review of written documents such as policies and procedures, orientation and


training plans and documents, budgets, and quality assurance plans

– Evaluation of the organization’s achievement of specific outcome measures (e.g.,


immunization rates, hospital-acquired infection rates, patient satisfaction) through
a review and discussion of monitoring and improvement activities,

Document Review
• The survey team may review written documents (e.g., operational plans and budgets,
clinical policies and procedures, or standard operating procedures for conducting certain
laboratory tests).

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Interviews
• Surveyors will frequently interview organizational leaders, clinicians, employees, and
patients in order to determine the organization’s performance and compliance with
standards

• Surveyors might choose to interview a patient about his or her level of satisfaction with
the care provided by the organization, as well as ask the patient for feedback on how the
organization could improve its care or services.

• Leaders, including the members of the governing body and administration of the
organization, may be interviewed regarding the organization’s processes and how they
are designed to meet standards related to planning, budgeting, quality assurance
activities, and human resource management.

• Clinicians may be interviewed about patient care processes (e.g. patient assessment,
medication usage, or diagnostic testing).

Touring the Facility


• Accreditation surveyors usually tour the health care organization’s buildings and patient
care areas in order to evaluate standards related to:

– Overall building safety,

– waste management,

– overall upkeep and cleanliness,

– equipment and supply management,

– infection control,

– fire safety, and

– Emergency preparedness.

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• Diagnostic services such as the radiology department and the laboratory are also assessed
with respect to:

– Safety,

– Effectiveness,

– Quality control, and

– Equipment management

• Support services such as dietary, pharmacy, and rehabilitation therapy are also areas
included in the accreditation survey of a hospital or health center.

Survey Findings
• The surveyors’ evaluation findings are then analyzed to determine whether the hospital or
health center meets an acceptable threshold of compliance in order to be awarded
accreditation.

• One advantage of the accreditation approach is that it combines the evaluation and
findings of multiple surveyors into a single impression about the organization’s
compliance with standards and overall quality of care.

• Since the focus is on continuous improvement of organizational systems and processes,


the on-site survey is often consultative and educational, as well as evaluative in nature.

• Surveyors are often able to offer recommendations regarding “best practices” at other
similar organizations or make suggestions on quality approaches that the organization
might want to adopt in the future.

• The threshold for determining whether or not the health care organization is accredited
must be based on pre-determined rules that are consistently applied in order for an
accreditation program to maintain its credibility and enjoy the public’s and health care
professionals’ confidence.

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• Processes to protect the accreditation decision from political and professional influences
are essential to establish

• One mechanism to accomplish this is the publication and distribution of the explanation
of the standards’ intent, as well as the decision rules, so that any interested individual or
organization knows exactly what level of compliance to the standards is needed to
achieve accreditation.

Outcomes of Accreditation Surveys


An organization can receive one of the following two accreditation decisions:

– Accredited: An accreditation decision that results when an organization


demonstrates acceptable compliance with ]CI core and non-core standards in all
areas.

– Accreditation Denied: An accreditation decision that results when an organization


is consistently not in compliance with ]CI standards, when JCI withdraws its
accreditation for other reasons, or when the organization voluntarily withdraws
from the accreditation process.

– To gain accreditation, organizations must demonstrate acceptable compliance


with all core and non-core standards and achieve a minimal numerical score on
these standards.

– This basic level of standards compliance, the organization's numerical score will
indicate the overall standards achievement level.

– Accredited organizations receive a final accreditation report and award certificate.

– The report indicates the level of compliance with ]CI standards achieved by the
organization.

– The decision of the JCI Accreditation Committee is transmitted to the Chief Executive
Officer of the applicant organization as identified on the application for survey.

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Length of Accreditation Awards
• An accreditation award is valid for three years unless revoked by JCI.

• The award is retroactively effective on the first day after JCI completes the organization's
surveyor, when follow-up is required, completes any required focused surveys.

• At the end of the organization's three-year accreditation cycle, the organization must be
reevaluated to be eligible for renewal of its accreditation award.

Change in Organization Status


• If, during the period of accreditation, the organization undergoes changes in its structure,
ownership, or' services, it must notify JCI.

• ]CI will then determine the need to resurvey the organization and render a new
accreditation decision.

• If, during the period of accreditation, JCI receives information that the organization is
substantially out of compliance with the current accreditation standards, JCI will
determine the need to resurvey the organization

Communication

Why Communication?
• Organization leaders, including quality professionals, need good communication skills to
achieve results in the process of managing QM/Pl systems and in facilitating the growth
and development of QI Teams.
• Leaders spend a tremendous amount of time educating, inspiring, persuading, and
facilitating others.

• Communication is the act and art of giving and/or receiving information; a message.
• Information is that which is necessary to reduce uncertainty, i.e., to gain knowledge or
know something not known before.
• The purpose of good communication is to be able to reflect upon and exchange ideas.
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BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
ELEMENTS

Communication Components

• The Sender/Source (originator);

• The Transmitter (verbal or nonverbal mode);

• The Message (perceptions, ideas, facts, etc.);

• The Receiver (decodes message and attaches meaning);

• Feedback (clarification regarding intended Vs. perceived meaning) .

Understanding
• information depends upon both the source's and the receiver's:

- Communication skills

- Attitudes

- Experience

- Knowledge

Modes of Communication
• Symbolic (passive: clothing, hair, jewelry, cars)

• Verbal

• Nonverbal (body language and behavior ambulation, touching, eye contact, distancing,
gesturing, or word emphasis);

• Written

• Actions (a combination of the above).

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Barriers to Effective Communication

• Semantics (different understanding of terminology) or language

• Too many words used -- inarticulateness

• Personal, cultural, or experiential differences

• Physical or emotional distance

• Lack of interest or preoccupation

• Hostility, hidden agendas, or defensiveness;

• Tendency to make false judgments, interpretations, or assumptions.

Common Communication Problems


• Use words whose meanings are unclear or ambiguous;

• Generalize to such an extent that any meaning in the particular case is lost

• Presume that others are thinking what the speaker is thinking

• Miss the context in which a statement is made;

• Stampede and take the last statement as the final statement.

Organizational Communication
Communication Networks in Organizations
• Functions

– Becoming informed or informing others;

– Evaluating one's own inputs or others' performances; Directing others or being


directed or instructed; Influencing others or being influenced.

• Types:

– Formal organizational channels;

– Informal channels, involving members who are at the same level in an


organization.

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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
Effective communication

The most important thing in communication is to hear what isn't being said."
Peter F. Drucker

JCAHO, Press Release, February 10, 2005]


• "Ineffective communication and lack of disclosure are the most prominent complaints of
patients, and their families, who are victims of medical error or negligence," [Medical
Liability System Hinders Improvements,

According to Steven Covey, author of The Seven Habits of Highly Effective People,

• Communication cannot be both effective and efficient. With people, he says "slow is fast,
and fast is slow. “
• Effective communication may require more upfront time, but ultimately results in fewer
misunderstandings.
• Ineffective communication, often resulting from attempts to be efficient, is hurried, but
unclear, and can lead to poor understanding, confusion, delays, mistakes, and anger in
emotionally charged situations.

Six factors determining communication effectiveness and comprehension:

• Time/urgency
• Culture/Ethnic
• Socioeconomic
• Literacy
• Gender
• Personality/Behavioral

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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
Characteristics Of Effective Communication

It is two-way, with ideas, values, attitudes, beliefs and feelings flowing freely (a sharing
process):

- Adequate self-concept (picture of self and the situation);


- Coping with angry feelings and other emotions;
- Self-disclosure (ability to talk truthfully and fully about oneself);
- Mutual trust.

There is active listening (taking responsibility for what is heard; attending):


Have a purpose;

- Stand or face the speaker;

- Suspend initial judgment; try to determine your own biases, if any;

- Resist distractions and temptation to interrupt;

- Seek the important themes and real meaning;

- Watch for the speaker's nonverbal, as well as verbal, messages;

- Reflect before answering.

Listening

• Steps in Listening:

- Sensation

- Hearing of words and sounds

- Interpretation

- Evaluation

- Response

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Developing listening skills:
Clear distracting paperwork from your desk or move away from it when meeting face-to-face;

- Train yourself to notice eye color at the beginning of every conversation to ensure significant
eye contact;

- Train yourself to ask questions to learn information (e.g., "What about…?"), rather than
making statements (e.g., "I need to know….");

- Learn to "lubricate" conversations with appropriate phrases (e.g., "Yes, I see") to keep the
other person talking and keep your attention focused;

- Use appropriate facial expressions, but do not smile continuously, as people may think you
either are not really listening or are not taking them seriously.

There is effective feedback:


Repeat what is said, rephrasing in your own words primary content and feelings;

- Be ready to respond when appropriate.

It is not stressful.
• If you are concerned that you are not communicating, you probably are not.

There is clear and direct meaning


 Both for the content message and the relationship message (every communication always
carries both messages):

- Clarity of expression of thoughts and ideas;

- Unencumbered by mixed/contradictory messages (verbal, nonverbal, or symbolic).

Written Communication

Incorporating Basic Language Techniques


• Achieve the "You" Attitude:

– Make the reader your focus, except in formal writing or if expressing negatives or
correcting mistakes, e.g., "The process revisions you requested are being
implemented," rather than "We are implementing the process revisions."

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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
Maintain a positive, unbiased tone,

• When communicating negative information, avoiding negative words and emphasizing


what the reader can do, rather than what the reader cannot do,

– Example

"Always wash your hands before touching the patient," rather than "Never touch the
patient before washing your hands."

• Use language that is free from bias related to culture, gender, race or ethnicity, age, and
disability.

• Be clear, direct, and concise: Consider average sentence length of 14-20 words; eliminate
"waste" words that don't impact meaning.

• Avoid slang and jargon, particularly technical terminology, unless all readers understand.

• Maintain good will: Positive, professional tone, a courteous close; send congratulatory
and appreciation messages whenever possible and appropriate.

Four Steps for Efficient Composition


• Generating material

• Organizing material

• Drafting and editing

• Avoiding writer's block

Generating Material
• Intuitive methods

– Brainstorming

– Free writing

– Journal or note writing

• Analytical methods:

– Focusing on one aspect of a defined topic;

– Journalists’ questions: Who? What? Where? When? How? Why?

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– Rhetorical questioning, e.g., Meaning? Description? Component parts?

– How made or done? Causes? Consequences? Comparisons? -

• Synthesizing methods:

– Reading

– Interviewing

Organizing Material
• Divide ideas into groups and differentiate among those groups:

– First-level idea: Most important idea, placed prominently at either beginning or


end

– Second-level points: The main divisions (limit to 5-7 main points)

– Lower-level points: Support each main division.

• Put ideas in order:

– By time

– By components

– By importance

– Likelihood of agreement

– Likelihood of disagreement

For leaders:
Make it brief—one page if possible;

-- Use bullet points;

-- Present the idea or issue first:

--- Support with data if possible;

--- Provide your rationale for presenting the idea or the basis for your concern.

-- Make a recommendation (leaders appreciate problem solvers):

--- Propose an action or solution with rationale;

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--- Support with data if possible.

-- Suggest a timeframe for response and/or your follow-up.

Drafting and Editing


• Drafting:
– Be creative;
– Don't force beginning-to-end composition;
– Schedule time between drafting and editing.
• Editing ..Consider
– Communication objective; Audience;
– Organization - ordered ideas;
– Good writing; Grammar and punctuation.

Avoiding Writer's Block


• Expect complexity;

• Schedule enough time;

• Differentiate thinking from organizing;

• Organize before you write;

• Separate drafting from editing;

• Try creative editing techniques:

• Pretend talking to the reader;

• Free-writing;

• Talking into a tape recorder.

• Edit from a word-processed hard copy;

• Move sections around as necessary (word processor);

• Expect to rethink.

Effective Verbal Presentations


• Use an effective opening:

• Refer to the unusual/unique: Rhetorical question;

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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
• Anticipatory promise of what will be discussed;

– Vivid image;

– Startling example or story;

– Important statistic.

• Refer to the familiar:

– The relationship between the audience and the subject;

– Something familiar to the audience.

• Include a preview (agenda/outline):

– State the main points;

– State the problem or need to be remedied;

– State the major objectives, areas of discussion, and approximate time to be spent
on each.

• Make your points clear:

– Limit to 3-5 main points;

– Use explicit transitions from point to point;

– Summarize between main points or between sub- points.

• Use an effective closing:

– Reiterate the main points (REPEAT!)

– Refer back to the opening;

– Call for action or identify benefits;

– Reach a consensus.

Quality Communication

• Quality of communication

• Promote organizational values/ commitment

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• Patient management issues

Compile/Write Performance Improvement Reports

• Design systematic approach


• Design standardized reporting format
• Establish a template of process, outcome, & structure measures for each report
• Establish frequency of each report
• Inform support personnel/staff regarding timely submission of data for the report

Role of QM Professional
• Integrate PI concepts within organization

• Educate all staff on their role

• Continuously remind personnel how their activities are simply a form of performance
improvement

• Communicate PI concepts through newsletter and other communication venues

• Serve as a role model & facilitator

Coordinate Dissemination of PI Information


• Assure that the appropriate personnel are aware of the information & the big picture

• Assure that the appropriate reports and minutes are disseminated as required

• Assure that all PI information, discussion & decisions appropriate for a meeting are
addressed

• Become creative in how you disseminate the information

REPORTING TECHNIQUES

Reporting quality management findings may include:

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Presentation of aggregate data, summary tables, and/or graphs to teams, committees,
departments, services, QI Council, governing body, other settings or network organizations, etc.

Oral and written progress reports of ongoing data collection and measurement activities;

Written summaries of specific performance measures/studies, including findings, analyses,


conclusions, and actions to all appropriate groups;

Written summaries of all QM activities for specific time periods, e.g., quarterly, semi-annually,
or annually:

- Important function, quality initiative, or process monitored;

- Indicator/performance measure used;

- Time period for data collection/measurement;

- Data sources;

- Actual performance level compared to the anticipated level (norm, historical level, or
benchmark) or trigger for intensive analysis;

- Problems or best practices identified;

- Actions taken or planned;

- Follow-up on effectiveness of previous actions, if appropriate;

- Planned ongoing activities to sustain improvement.

• Periodic aggregated data reports of specified performance measures to reference


databases (HEDIS®, IMSystem, Quality Indicator Project, etc.);

• Report cards of performance on key standardized comparative measures to purchasers


and consumers of healthcare

Reporting must be:

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Complete

- Accurate

- Timely

- Appropriate

QI PROJECT REPORTING

• Summary Reporting of QI Projects, including the use of storyboards, to improve


processes may include:

– Name of Project Team;

– Name of organization;

– Brief description of opportunity to improve;

– Names of team members, indicating leader and facilitator;

– Statement clarifying the problem, with baseline data;

– Description of the cause of variation, with process tools used;

– Description of action/intervention;

– Benefits realized (including financial impact if present);

– Relevant process and outcome data.

TECHNICAL REPORT PREPARATION


• Content includes:

– Cover letter accompanying report

– Summary or abstract (one concise paragraph at beginning or end)

– Title page

– Introduction: Statement of the problem, background of the problem, and scope

– Methods: Sources and procedures for data collection

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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
– Results: Findings and data summaries, including tables, charts, and graphs

– Discussion: Conclusions and recommendations

Preparation of the periodic summary reports related to the quality of patient care and the
improvement of organization performance:

- All key performance improvement activities, including [See also Chapter IV, Performance
Improvement Processes]:

-- Status of strategic quality initiatives;

-- Status of quality planning and quality improvement projects for key processes;

-- Significant patient care issues identified, actions taken, and results, including sentinel/adverse
events, root cause analyses, actions, and outcomes;

Summary performance measure and trend data (prioritized by the governing body), as
applicable to the organization, including, but not limited to:

• Evaluation of contract services


balanced scorecard or dashboard data

• Clinical outcome data for key functions or services

• Pertinent cost data for key services

• Mortality rates and trends

• Nosocomial infection rates and infection control activities

• Patient satisfaction/complaint data

• Staff satisfaction/complaint data Staff turnover/absenteeism

• Occurrence data and risk management activity summaries

• Patient wait times

• Claims and other financial data

• External reviews/studies/reports

• Payment denials

• Performance appraisals

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Education, Training and Communication

Performance Improvement Education &Training


8 Top down process

8 Senior management

8 Governing body

8 Physicians

8 Comprehensive training at all levels

Curriculum Elements

8 Explain need for improvement

8 Common quality language

8 Goals

8 Structure

8 Processes of quality

8 Responsibilities

8 How to’s--tools and techniques

8 Change

Organization wide Presentation of PI Concepts

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Quality Improvement Content

8 Leadership

8 Management

8 Staff

8 Educate everyone

Staff QM/PI Orientation, Training, And Education

In the age of quality/performance improvement, education is the name of the game for the entire
organization, and the quality professional must assume the role of educator and consultant, more
than the role of doer.

The quality professional must understand both performance improvement and educational
concepts and their implications within the organization and be able to teach them to others.

Organizationwide
Quality Management Understanding Staff orientation, training, and education should include:

8 The organization's commitment to quality -- all pertinent statements, including quality


management philosophy, continuous quality improvement concepts, and the mission,
vision, and values;

8 QM structure, system, processes, and improvement 'approach.

Quality management /Performance Improvement Orientation And Training

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Who should receive it?

 QM/PI staff, including all reviewers;

 Department managers and medical directors;

 Ql Team participants;

 Organization staff, clinical and non-clinical; - Administration;

 Medical staff/practitioner panel or group;

 Governing body.

Orientation should include, at least, information about: -

 Organizational mission, vision, and values

 Governance, policies, and procedures

 Department/service policies and procedures

 The individual's job description

 Performance standards/expectations

 The organization's plant, technology, and safety management programs and the
individual's safety responsibilities

 The organization's quality management/ performance improvement activities and the


individual's role in these activities.

 The organization's infection control program and the individual's role in preventing
infection, if applicable.

QM/PI Training should include, at least, information about: -

 QI/PI philosophy, management, and methods;

 Organizational culture, mission, vision, and values;

 Patient- and other customer-centered performance improvement;

 Important functions; - Teams;

 Shared expertise, information, and ownership;

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 Change process;

 Confidentiality and conflict of interest;

 The organization's QMIPI approach and methodologies;

 Team process tools;

 Statistical process control, data collection and analysis.

 Learn in relationship to perceived need...

Address “What’s In It For Me” (WIIFM)

Are impatient...

Make the best use of your time and respect theirs

Want organized and relevant information...

Provide a clear structure and sequence.

Use life experiences to learn…

Make interactive and draw on their experiences

Want to apply what they learn…

Stress application and build in “how-to” exercises

 Adults are motivated to learn when THEY identify they have a need to learn;

 Adults are motivated by societal or professional pressures which require a particular


learning need;

 Adults can be motivated to learn when the benefits of a learning experience outweigh
the desire to resist;

 Adults hate to have their time wasted;

 Adults use their knowledge from years of experience as a filter for new information
and do not change readily;

 Adults learn best from their own experiences;

 Adults prefer to determine their own learning experiences;

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 Some adults like some lectures. All lectures won't be liked by all adults; Adults like
small group discussion;

 Adults want practical answers for today's problems;

 Adults enjoy practical problem solving;

 Adults like physical comfort;

 Adults like tangible rewards and benefits from training;

 Refreshments and breaks establish a relaxed atmosphere and convey respect to the
learner.

Dimensions of Effective Teaching

Instructor "knowledge":

 Being accurate, factual, and up-to-date in QM/UM/RM;

 Directing managers, physicians, nurses, administration to useful research and


references;

 Having the ability to objectively identify and analyze concepts, principles, and
problems.

Interaction skills:

 Establishing and maintaining rapport;

 Controlling interaction to meet the objectives;

 Creating a climate of mutual respect;

 Stimulating active participation;

 Eliciting lively exchange/discussion;

 Reading body language to determine if minds are being turned off or on.

Organization and Clarity:

 Getting the message across;

 Making oneself understood;

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 Systematically and effectively:

o Stating learning objectives

o Presenting ideas in a logical progression

o Placing emphasis where appropriate

o Summarizing succinctly and timely

Enthusiasm and stimulation:

 Awakening interest and stimulating response;

 Using movement, humor, voice inflection to prevent boredom;

 Conveying charisma, self-confidence, and an enjoyment of teaching

TEACHING TACTICS

'The art of teaching is to create a nurturing environment in which the student can escape
only by thinking.'

Involve learners in the lesson:

o Identify their needs;

o Ask questions;

o Role play; discussion; writing.

 Provide reinforcement/feedback to the learners:

o Smiling; gestures;

o Knowledgeable answers to questions.

 Utilize effective questioning techniques;

 Exhibit enthusiasm:

o Focus on the audience;

o Act enthusiastic, even if not feeling like it at the moment.

Be a Professional Role Model:

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 Practicing skills, standards, and values to be developed by others;

 Being accessible;

 Providing opportunities to discuss practical applications of knowledge and skills and


apply problem solving approaches;

 Being self-confident and self-critical; -

 Assuming responsibility;

 Recognizing one's own limitations; -

 Showing respect for others.

Utilize Appropriate Teaching Methods/ Learning Activities

Lecture;

Discussion;

Discovery or inquiry-oriented discussion/case study;

Socratic (asking questions);

Independent study units/

Small groups

Case study;

Demonstration;

Practice;

Role playing (scenario);

Simulation (script);

Testing.

Educational Program Development

Perform needs assessment:

o "Can't do" versus "won't do" queries;

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o Current level of knowledge, skills, and attitudes; Conditions affecting leaning;

o How to best measure progress/success;

o Availability of resources.

 Specify goals and objectives;

 Develop measuring tool for behavioral objectives;

 Obtain administrative support for program based on goals;

 Analyze goals and objectives to determine type and sequencing of skills;

 Analyze learner characteristics:

o Learners have different expectations;

o Different professions have specific past experiences;

o Individuals tend to respond to different stimuli:

 Auditory (remember what they hear);

 Visual (remember what they see);

 Tactile (remember what they can touch).

 Specify appropriate instructional strategies; Select media to support strategies;

 Develop courseware;

 Do formative evaluation and make appropriate revisions;

 Implement program.

Physician Learning

Adult learning model and…

Use data, data, data

Use respected peers

Use social influence and norms

Be results oriented

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Use clinical examples

Avoid jargon

Evaluating Effectiveness of PI Training

 What went well?

 Why?

 List things done well

 List things that caused problems

 Why did problems occur?

 What better solutions are available?

Change

Everything has changed but our ways of thinking, and if these do not change we drift toward
unparalleled catastrophe.

Albert Einstein

Paradigm Shifts & Change

 Change--movement from current state

 Models of Change

 Wheatley Model Stages

o Awareness, Curiosity, Visualization, Learning, Use

 Kubler-Ross Model Stages

o Equilibrium, Denial, Anger, Bargaining, Chaos, Depression, Resignation,


Openness, Readiness, Acceptance

 Things are the way they are because they got that way

 Unless things change, they are likely to remain the same

 Change would be easy if it weren’t for all the people

 People don’t resist change; they resist being changed

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Economics. CPHQ Exam Trainer, JCI & NBH Consultant
Survey Preparation

 12-18 months before

 Consultant role, not owner

 Manage the survey process

o Survey preparation timelines

o Building and maintaining multi-disciplinary team

o Application/attestation

o Response to standards, roadmaps

 Coach interviewees

 Coordinate “mock” review

 Educate all on standards and intent

 Ongoing evaluation and coaching

 Liaison with accrediting agency

Medical Staff Credentialing


The process of assessing and validating the qualifications of a licensed independent practitioner
to provide patient services and to participate on the medical staff.”

 Credentialing (in both provider and managed care organizations) and privileging (in
provider organizations) are processes of confirming and controlling the clinical
competence and professional performance of, at a minimum, all licensed independent
practitioners.

 A licensed independent practitioner (LIP) is any individual who is professionally


licensed by the state (U.S.) and permitted by the organization to provide patient care
services without direction or supervision, within the scope of that license.

Essential Data in the Credentialing Process:

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 Current licensure

 Relevant training and experience

 Current competence

 Peer recommendations

 Clinical privilege delineation*

 Ability to perform

 Challenges to licensure/registration

 Voluntary/involuntary terminations or restrictions

 Professional liability

 Data Bank queries/reporting

 Temporary Privileges

 Fair Hearing/Appeals Process

 Frequency

 Documentation and approval

 Role of the healthcare quality professional

Granting Clinical Privileges

 Delineation of clinical privileges

 Delineation of admitting privileges

 Categories of privileges

 Limitations of privileges

 Practicing within scope

The Medical Executive Committee

 The executive committee receives and acts on reports and recommendations from
medical staff committees, clinical departments, and assigned activity groups

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 Makes “..medical staff recommendations directly to the governing body

 Medical staff structure;

 Mechanisms for Credentialing, delineation of clinical privileges, membership,


termination, and fair-hearing procedures

 Individuals for membership and delineation of clinical privileges;

 Participation in organization performance improvement activities.

Medical Staff Role in Performance Improvement

 Medical Staff are Required to participate in organization performance improvement


activities

 Medical staff leadership role when the performance of a process is dependent primarily
on the activities of one or more individuals with clinical privileges.

 Process measurement, assessment, and improvement including:

 Medical assessment and treatment of patients Use of medications;

 Use of blood and blood components;

 Use of operative and other procedures;

 Efficiency of clinical practice patterns;

 Significant departures from established patterns of clinical practice.

 Other patient care processes including but not limited to:

 Education of patients and families.

 Coordination of care with other practitioners and hospital personnel, as relevant to


the care of an individual patient.

 Accurate, timely, and legible completion of patients’ medical records. [MS.


8.2.1-MS. 8.2.3];

Medical Staff Role in Performance improvement

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 When assessment findings are relevant to individual performance, determine appropriate
use in peer review and/or ongoing competency evaluation and clinical privilege renewal
or revision.

 Communication to appropriate members the findings, conclusions, recommendations, and


actions taken to improve organization performance

 Development and use of criteria identifying deaths in which autopsy should be performed

 When there are no medical staff clinical departments, all individuals with clinical
privileges have their privileges recommended and the quality of their care reviewed
through designated medical staff mechanisms described in the medical staff or governing
body bylaws and rules and regulations

 The leaders establish a planned, systematic, organizationwide approach to

 process design and performance measurement, analysis, and improvement.

 The activities are planned in a collaborative and interdisciplinary manner

 Focusing on process improvements, but with the implementation of appropriate


action, when a determination is made that there are issues related to an
individual's performance.

Same Level of Quality of Patient Care

 There is a mechanism designed to ensure that the same level of quality of patient care is
provided by all individuals with delineated clinical privileges, within medical staff
departments, across departments, and between members and nonmembers of the medical
staff who have delineated clinical privileges [MS.6.8].

Hospital Medical Staff Characteristics

 It includes fully licensed physicians and may include other licensed individuals permitted
by law and by the hospital to provide patient care services independently in the hospital.

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 All medical staff members have delineated clinical privileges that define the scope of
patient care services they may provide independently in the hospital.

 All medical staff members and all others with delineated clinical privileges are subject to
medical staff and departmental bylaws, rules and regulations, and policies and are subject
to review as part of the organization's performance improvement activities.

 Definition: The verification of the practitioners night and competency to provide patient
care in the appropriate setting.

 Frequency: Credentialing, as well as Recredentialing at least every two years, usually


linked to license renewal, is performed for all licensed independent practitioners
regardless of medical professional staff membership.

 Definition: Permission to provide specific medical or other patient care services in the
granting organization, within well-defined limits, based on the individual's professional
license and his or her experience, competence, ability, and judgment and on the
organization's ability to provide and support the service.

 Clinical privileging and reprivileging cannot be centralized. This process must always be
setting-specific, based on services available, so has to be accomplished at each provider
site.

Clinical Privileging/Reprivileging Process

 The granting/renewing of clinical privileges (and basic Credentialing) is performed


regardless of medical/professional staff membership status, if applicable.

 For independent practitioners in hospitals who are not medical staff members, renewal of
clinical privileges must be tied to the institution's provisions for periodic performance
appraisal.

 Frequency: Privileges are granted for the time period specified in the bylaws or policies
and procedures, but for no more than two (2) years.

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 During the periodic reappraisal process set by the organization, the privileges must be re-
requested and be renewed, revised, added, or deleted based on the outcome of the
evaluation.

 The 2-year requirement is the same in all JCAHO program standards.

Mechanisms for Granting and Renewing Clinical Privileges

 The organization establishes specific mechanisms for hospital-specific appointment and


reappointment of medical staff members and for granting and renewing or revising
hospital-specific clinical privileges.

 The governing body appoints and re-appoints to the medical staff and grants initial,
renewed, or revised clinical privileges, based on medical staff recommendations, in
accordance with the bylaws, rules and regulations, and policies of the medical staff and of
the hospital.

 Individuals in administrative positions who desire medical staff membership or clinical


privileges are subject to the same procedures as all other applicants for membership or
privileges.

 All individuals who are permitted by law and by the hospital to provide patient care
services independently in the hospital have delineated clinical privileges, whether or not
they are medical staff members.

 The mechanisms provide for professional criteria that are specified in the medical staff
bylaws and uniformly applied to all applicants for medical staff membership, medical
staff members, or applicants for delineated clinical privileges. These criteria constitute
the basis for granting initial or continuing medical staff membership and for granting
initial, renewed, or revised clinical privileges.

 The professional criteria are designed to assure the medical staff and governing body that
patients will receive quality care.

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 Appraisal for reappointment to the medical staff or renewal or revision of clinical
privileges is based on ongoing monitoring of information concerning the individual's
professional performance, judgment, and clinical or technical skills.

 Departmental or major clinical service recommendations are part of the basis for
developing recommendations for continued membership on the medical staff or for
delineating individual clinical privileges.

 Individuals provide treatment and perform operative and other procedure(s) within those
areas of competence indicated by the scope of their delineated clinical privileges.”

Privilege Status

 Temporary: Temporary privilege to practice until Credentialing and individual privilege


delineation has been processed and approved by the governing body. The length of time
that a practitioner can provide patient care under temporary privileges should be
restricted and be closely monitored.

 Approved: Delineated privileges approved for the time period specified by the
institution, but never longer than two years.

 Emergency: Any practitioner is permitted to do everything possible to save a life or


protect a patient from further or serious harm within the scope of his/her license,
regardless of membership status, Credentialing status, or approval of specific privileges.

APPOINTMENT/REAPPOINTMENT

Eligibility:

 The medical/professional staff includes fully licensed physicians (doctors of medicine


and osteopathy) and may include other licensed individuals permitted by law and the
organization to provide independent patient care services (e.g., psychologists, podiatrists,
dentists).

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 Any independent practitioner is potentially eligible for medical/professional staff
membership.

 At the option of the institution, the medical/ professional staff may include licensed non-
physicians in its membership

 Appointment or reappointment to the medical staff and the granting, renewal,or revision
of clinical privileges are made for a period of no more than two years.

 Appointment or reappointment to the medical staff and the initial granting and renewal or
revision of clinical privileges are also based on information regarding the applicant's
competence.

 A separate record is maintained for each individual requesting medical staff membership
or clinical privileges"

 The medical/professional staff uniformly applies specific professional criteria to all


practitioners, physicians and non-physicians, during both the initial application process
and each reappraisal.

 Applicants supply requested information, consent to the inspection of pertinent records


and documents, agree to be bound by the bylaws, rules and regulations, and request
specific privileges;

 Both appointment and reappointment require approval of the governing body.

Information Management
• The goal of the information management function is to support decision making to
improve patient outcomes, improve health care documentation, improve patient safety,
and improve performance in patient care, treatment, and services, governance,
management, and support processes.
• While efficiency, effectiveness, patient safety, and the quality of patient care can be
improved by computerization and other technologies, the principles of good information
management apply to paper-based or electronic methods.
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• A hospital’s provision of care, treatment, and services is a complex endeavor that is
highly dependent on information.
• When many individuals and areas throughout the hospital are involved in the provision of
care, treatment, and services, their work is coordinated and integrated.
• As a result, hospitals treat information as an important resource to be managed effectively
and efficiently.
• Managing information is an active, planned activity.
• The hospital’s leaders have overall responsibility for managing information, just as they
do for managing the hospital’s human, material, and financial resources.
• The quality of care, treatment, and services is affected by the many transitions in
information management that are currently in progress in health care, such as the
transition from handwriting and traditional paper-based documentation to electronic
information management, as well as the transition from free text* to structured† and
interactive text.

The Information Management Function:


• Coordinates collection of data and information;
• Makes clinical/organizational information from one system available to another;
• Organizes, analyses, interprets, and clarifies data;
• Generates and provides access to longitudinal data; and
• Provides the capability to link patient care and non-patient care data over time; internal
and external information sources; data and information from literature
• Assure timely, easy access to data/information, balanced with security requirements;
• Assure data accuracy and data comparability by following available standards and
guidelines;
• Produce and use aggregate, comparative, and external knowledge-based information to
improve patient safety and quality of patient care, treatment, and services;
• Increase collaboration and information sharing;
• Redesign information-related processes for efficiency and effectiveness.

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Information Uses in Healthcare

• Standards, July 2006 CAMH]

• Clinical/service decision making

• Organization decision-making

• Performance Improvement

• Education

• Research

DECISION MAKING PROCESSES


• If we are to make appropriate decisions to truly improve the care and services provided to
our patients over time, we must collect quality data that converts into understandable,
useful information:

• DATA  leads to  INFORMATION  leads to  KNOWLEDGE 


leads to  DECISION MAKING

Traditional Clinical Model [See Diagram]:


• In the past and near present—without good data—we relied upon our opinion, logic,
intuition, rationalization, rumor, and/or hearsay to lead us to recommendations and
hopefully appropriate action to improve the quality of care and service. In essence, we
had no defined process for decision making.

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Quality Management Model


In a data-based model of decision making, the information management function closely
resembles scientific method

- Design is based on proposal/hypothesis;

- Design enables data collection;

- Data, through statistical analysis, leads to information;

- Information must be interpreted and understood to lead to knowledge;

- Knowledge leads to wisdom and appropriate decision making;

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- Decisions in quality management fall into three categories of activity (the "Quality
Management Cycle"):

-- Quality Planning

-- Quality Control/Measurement

-- Quality Improvement

Key Processes must be effective to achieve the information management goal:

• Identify information needs (assessment);

• Plan and design the information management structure;

• Capture, organize, and report data/information;

• Process and analyze data/information;

• Store and retrieve data/information;

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• Transmit, display, disseminate, integrate, and use data/information;

• Safeguard data/information.

Steps in the Information Management Process

• Identify critical information needs;

• Define data elements;

• Determine data collection plan;

• Acquire/collect data;

• Aggregate and display data;

• Analyze data; Present data/information;

• Report information;

• Act on information;

• Collect more data to assess the decision.

MANAGEMENT
OF
THE LEGAL ASPECTS

CONFIDENTIALITY OF PATIENT INFORMATION

• Confidentiality in healthcare deals both with the patient's personal right to privacy and
the need for the organization to maintain the confidentiality of all information pertaining
to peer review and the measurement and analysis of patient care provided by licensed
independent practitioners.

• Confidential information is information that one keeps or entrusts to another with the
understanding that it will be kept private and not shared.

• Protected information is information that cannot be obtained by others or used in a


court of law.

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• The patient's physical medical record is the property of the healthcare provider facility.

• The provider is responsible for safeguarding both the record and the informational
content against loss, defacement, tampering, and unauthorized use.

• Written policy must stipulate just how the provider complies with state statutes and
accreditation standards.

• The patient is considered the “owner” of the information in the U.S. and can access and
copy that information by signing a release form.

• Well-defined policies on the use and disclosure of medical information, encompassing all
patient-identifiable record systems maintained within the organization, must be in place.

• These systems generally include the medical record, as well as abstracts, studies,
registers, etc., in any form, e.g., paper, electronic, audio, or Internet.

• For psychiatric cases, psychotherapy information is maintained separately and made


available as necessary {A HIPAA requirement}.

Consent

• Patients in most acute care healthcare settings give advance written consent (assent;
agreement), even though such consent is optional under HIPAA, for:

- Medical and surgical treatment: The provision, coordination, or management of healthcare


services by one or more providers, including consultation between providers and referrals from
one provider to another; and

- Release of sufficient medical information to the payer to assure payment, e.g., confirm
benefits entitlement, determine necessity for treatment, validate orders and charges.

• Written consent may or may not be obtained in primary and specialist care office
practices.

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• Two types of consent forms should be obtained:

- A general admission or treatment consent, as applicable (information provided by the


organization, but not necessarily by the practitioner);

- A special consent form for highly technical testing, medical, or surgical treatment (information
provided by the practitioner). Patients give separate informed consent prior to performance of
specific surgical, radiological, and other invasive and high-risk procedures

Generally, written authorization by patients is not required for use of their personal health
information by the provider organization in healthcare operations, those internal activities
encompassing:

- Quality, utilization, and risk management, including case management and care coordination;

- Competency assurance activities, e.g., staff performance evaluation, LIP credentialing and
reappraisal, and peer review;

- Infection surveillance and control;

- Patient safety;

- Education of patients' families;

- Other auditing, legal, insurance, business, and general administrative activities.

However, it is now standard practice in the U.S., because of HIPAA in a “Notice of Privacy
Practices,” to:

- Inform patients of possible intended uses of identifiable health information and their right to
restrict use or disclosure;

- Make a good faith effort to obtain written acknowledgement of receipt of the Notice; and

- Post the Notice in a prominent location in the facility.

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Those in provider organizations permitted access to medical record information for organization
operations without written authorization of the patient include:

- Governing body, and designees, to ensure quality of patient care;

- Chief Executive Officer (CEO);

- Physicians and healthcare personnel involved in the care;

- Chiefs of clinical services and clinical department directors, along with designated committees,
for performance measurement and/or individual performance evaluation, including peer review);

- Duly appointed committees/QI teams of the organization, in determining the quality of care
and requisites for accreditation, and all support staff;

- Health information management/medical record personnel;

- Designees of the CEO as needed regarding legal and risk management concerns or health
services planning.

INFORMED CONSENT

Definition:

• Adequate information is provided to the patient or legal representative in order for the
patient or legal representative to make a rational, informed decision to permit medical-
surgical treatment.

• The patient is free to reject recommended treatment

• Information for special procedures must be provided by the practitioner performing the
procedure and must include:

- The full extent of the treatment plan;

- The extent of the side effects and risks involved;

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- Alternative treatments available;

- The risks of non-treatment.

- A valid written consent must contain the following elements:

 The exact name of the procedure under consent;

 The consenter's understanding of:

• --- The nature of the procedure

• --- Alternatives

• --- Risks and benefits involved

• --- Probable consequences of non-treatment

 Date of consent;

 Witness.

- Informed consent forms requiring the patient's signature prior to treatment


become a permanent part of the medical record.

- Oral consent, though just as legally binding, is difficult to prove in court.

• An organizationwide policy concerning case or peer review "conflict of interest"


should be incorporated into Quality Management and Utilization Management Plans, as
well as into medical staff bylaws, if applicable, or other peer review committee
documents, depending on the entity’s structure.

• A typical statement might read:

In order to minimize the potential for conflict of interest, no committee member or


reviewer shall participate in the review of clinical cases in which he or she is primary care giver,

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is a participant in a specific situation under review, or has any economic interest either in the
case or with the practitioner under review.

• If at any time potential for conflict of interest is identified, the medical or department
director, committee chairperson, or the chief of staff shall seek the objective expertise of
other qualified practitioners, either from other departments or committees, from other like
organizations, or from the community as deemed appropriate.

• In managed care, a statement might read:

Any and all providers who have a personal, professional, and/or financial involvement
with a medical case being reviewed will be excused from participating in the review of said case.

Release of Information

• Based on government regulations

• Written consent for outside release

• Release without written consent

• A written consent is required for an organization to release patient information to anyone


outside the organization.

• A typical release-of-information form should have the following elements:

• Patient's name

• Name of individual/ organization requesting information

• Reason for release of information

• Anticipated use of information released

• Exact material to be released

• Time that the release of information is valid

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• Documentation that information is released only to the individual/organization
above

• Signature and date of the patient or legal representative (as defined by policy/state
law)

Confidentiality Policy/procedure

• Identification of individuals with access to information

• Delineation of specific information to which individuals have access

• Requirements for individuals with access to information to keep that information


confidential

• Requirements for release of health information

• Requirements for removal of medical records

• The patient's medical record is the property of the healthcare facility

• Medical records should be removed from the organization's jurisdiction and safekeeping
only in accordance with a court order.

• Mechanisms for securing information against unauthorized intrusion, corruption, and


damage

• Portions of medical records may be stored separately,

• Organizations can restrict access to computer files or portions of computer files by the
use of security codes or by restricting certain computer operations to specific terminals
and/or individuals

• An organization that relies on computerized information should have an adequate backup


plan for each computer application

Patient Safety

MEDICAL ERRORS
Magnitude of the Problem

In the U.S., death from medical errors is now considered to be a national epidemic, based on the
report To Err is Human: Building a Safer Health System (Kohn, Corrigan, and Donaldson,
editors) released by the Institute of Medicine (lOM) in November 1999.

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The report synthesizes the results of numerous studies on medical errors and, based on
data collected from two hospitals in New York that were extrapolated nationally, estimates that
medical errors result in 44,000 to 98,000 deaths annually.

The lOM also estimated that medical errors account for as much as $29 billion annually
in lost income, disability, and healthcare costs.

First do no harm

 The assumption of safety in the provision of healthcare is as fundamental as care itself.

 "Safety is the most basic dimension of performance necessary for the improvement of
healthcare quality.

 Safety is the underlying reason for risk management, infection control, and
environmental management programs.

 It is the reason we insist on qualified clinical practitioners and support staff, validating
education, expertise, and other credentials; providing appropriate orientation and
continuing education; and performing periodic appraisal.

The Healthcare Environment

The healthcare environment that is most effective in identifying and reducing those errors and
risk factors contributing to unintended adverse patient outcomes:.

 Has leaders who foster commitment to safety through personal example, communication,
and strategic planning;.

 Establishes a vision of the desired patient safety culture that is communicated throughout
the organization on a focused, ongoing basis;.

 Provides a strategy for change and improvement and allocates financial, personnel,
educational, and time resources;

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 Encourages patients, families, organization staff, and leaders to identify and manage
actual and potential risks to patients, staff, and visitors;

 Encourages error management and intervention:-

 Recognition and acknowledgment of risks and errors;

 Initiation of actions to reduce risks and errors;-

 Safe communication and/ centralized internal reporting of findings,


actions, successes, failures;-

 A focus on processes and systems and minimization of individual blame


for errors;.-

 Organizational learning and sharing knowledge to effect behavioral

What is a culture of safety?

Components of a safety culture include:

 Commitment to safety as the primary priority

 Availability of the necessary resources

 Incentives, and rewards for safety

 Openness about errors and problems

 Commitment to organizational learning

 Unity, loyalty, and teamwork among staff

 Non Punitive Environment

Challenges of Creating a Culture of Safety

Internal Factors:

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 Over Self-confidence of Healthcare providers

 Routine work/Work Load

 Lack of resources

 Lack of Information about the magnitude of the problem

 Lack of commitment from Hospital leaders

 Lack of effective supervision

 Competency of Staff

External Factors:

 External Environment

 Lack of supportive Infrastructure

 Community Awareness

 Individual behavior

 Culture of Fear

Medico-Legal Practice

 Leadership: Hospital leaders must establish safety as a priority.

 A learning and improvement cycle: Analysis focuses on systems rather than individuals
and is non-punitive. Analysis should include trend and aggregate data.

 Accountability: Improvement team members must be held accountable for identifying


effective solutions.

 Timely feedback: The system must feed back useful information to front-line workers,
especially those who report the problem, and must do so in a timely manner.

erumluC ynefaIrgniporpmI

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 Incentives and rewards for pursuing safety: A simple, but powerful reward
implemented by one hospital was a formal letter of thanks from the Chief Executive.

 Reporting For Learning

 Use education and communication strategies to broaden the “circle of believers”

 new employee orientation,

 mandatory patient safety training,

 just-in-time root cause analysis participant training, as well as informal


interactions.

 Employee newsletters and email “safety-grams” can be used to discuss lessons


learned and to share improvements and recommended practices.

2006 National Patient Safety Goals

#1) Improve the Accuracy of Patient Identification

Use at least two patient identifiers (neither to be the patient's room number) whenever
administering medications or blood products; taking blood samples and other specimens for
clinical testing, or providing any other treatments or procedures.

#2) Improve the effectiveness of Communication among Caregivers

For verbal or telephone orders or for telephonic reporting of critical test results, verify the
complete order or test result by having the person receiving the order or test result "read-back"
the complete order or test result.

Standardize a list of abbreviations, acronyms and symbols that are not to be used
throughout the organization.

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Measure, assess and, if appropriate, take action to improve the timeliness of reporting,
and the timeliness of receipt by the responsible licensed caregiver, of critical test results and
values.

Implement a standardized approach to “hand off” communications, including an


opportunity to ask and respond to questions

#3) Improve the safety of using medications

Standardize and limit the number of drug concentrations available in the organization.

Identify and, at a minimum, annually review a list of look-alike/sound-alike drugs used in


the organization, and take action to prevent errors involving the interchange of these drugs.

Label all medications, medication containers (e.g., syringes, medicine cups, basins), or
other solutions on and off the sterile field in perioperative and other procedural settings.

# 4) Eliminate wrong-site, wrong-patient, wrong-procedure surgery: (1) preoperative


verification process/checklist for available documents/studies; (2) surgical site marking process
involving the patient [now in a Universal Protocol

#5) Improve the safety of using infusion pumps

Improve the safety of using infusion pumps: Ensure free-flow protection of all
intravenous infusion pumps

#6) Improve the effectiveness of clinical alarm systems

 Specific recommendations:

 Implement regular preventive maintenance and testing of alarm systems.

 Assure that alarms are activated with appropriate setting and are sufficiently
audible with respect to distances and competing noise within the unit.

#7) Reduce the risk of healthcare-acquired infections

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Comply with current Centers for Disease Control and Prevention (CDC) hand hygiene
guidelines.

Manage as sentinel events all identified cases of unanticipated death or major permanent
loss of function associated with a health care-associated infection.

#8) Accurately and completely reconcile medications across the continuum of care

Implement a process for obtaining and documenting a complete list of the patient’s
current medications upon the patient’s admission to the organization and with the involvement of
the patient. This process includes a comparison of the medications the organization provides to
those on the list.

A complete list of the patient’s medications is communicated to the next provider of


service when a patient is referred or transferred to another setting, service, practitioner or level of
care within or outside the organization.

#9) Reduce the risk of patient harm resulting from falls

Implement a fall reduction program and evaluate the effectiveness of the program.

The Patient Safety Program

All healthcare organizations are expected to implement specific patient safety programs that
include at least the following components:.

 A designated, qualified individual or interdisciplinary group to manage the


program (typically individuals may include directors of quality/performance
improvement, risk managers, safety officers, or clinical leaders);.

 A defined scope of program activities, including ongoing proactive efforts to both


identify and reduce risk, as well as to respond to errors (from patterns of "no
harm" errors to "near misses" to sentinel events);

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 Mechanisms to ensure that all applicable functions of the organization are
integrated into and participate in the program;

 Procedures for immediate response to medical errors, including care of affected


patients, containment of risk to others, and preservation of facts for analysis;

 Internal and external medical error reporting processes;

 Defined intervention mechanisms, e.g., proactive risk reduction activities,


systematic tracking of identified risks, root cause analysis for sentinel events;

 Defined mechanisms for support of staff involved in a sentinel event;

 Reporting to the governing body.

The specific patient safety program includes at least:

 Policies, procedures, and education mechanisms to reduce and control risk to


patients (and staff);

 An occurrence/event reporting system;

 Proactive activities to identify high-risk processes and implement actions to


reduce avoidable risk;

 A process for immediate response to medical errors and sentinel events;

 Mechanisms to incorporate all related functions and safety programs;

 Performance measurement;

 Documentation and reporting

All health care organizations have inherent environmental hazards and safety risks. Therefore
the organization needs to identify those risks and implement processes to minimize them:-

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 A written environmental management plan and designated leader to coordinate
activities and respond to immediate threats; components include management!
coordination of:-

 Safety-- Security–

 Staff education

 Hazardous materials and waste—

 Emergency power: maintenance, testing, and inspection—

 Fire safety: drills, equipment, building features—

 Medical equipment: maintenance, testing, and inspection–

 Utilities: maintenance, testing, and inspection–

 Standards and process to measure organization and staff performance

 Proactive risk assessments of buildings, grounds, equipment, and physical


systems, with procedures implemented to reduce risk potential;-

 Establish safety policies and procedures, including smoking prohibition;-

 Maintain grounds and equipment and respond to product recalls;-

 Reporting; measuring, assessing, and improving; and annually evaluating the


environment of care.

Related Safety Programs


B. Employees

 Staff, licensed independent practitioners, students, and volunteers should be able to


describe their roles and responsibilities relative to safety, based on their specific job
responsibilities and education received.

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 They should be able to participate in safety drills, should know and comply with all
applicable safety policies and procedures, and should report adverse occurrences/events
upon first observation or first knowledge.

Participates and respond to safety rounds

Specific ways in which physicians and other practitioners can facilitate patient safety/clinical risk
management efforts:.

 Identify general areas of potential risk in the clinical aspects of patient care and
safety;.

 Help design programs to reduce risk in clinical aspects of patient care;.

 Develop criteria for identifying specific cases with potential clinical and safety
risk; .

 Evaluate specific cases identified as having potential or real clinical risk;.

 Participate on teams to correct problems in the clinical aspects of patient care and
safety identified through performance improvement and risk management
activities;

 Patient safety must be #1 priority

 Facilitate appropriate integration of the appropriate organization functions, including


infection surveillance, control, and prevention, and all safety processes;.

 Minimize duplication of effort in policy/procedure development, education of staff and


patients, data collection and aggregation, and communications;.

 Prioritize and coordinate performance measurement and the data and information
available for analysis, reporting, and decision making;

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 Ensure that reactive activities such as root cause analysis (RCA) and proactive activities
such as failure modes and effects analysis (FM EA) are conducted timely, efficiently, and
effectively..

 Coordinate the flow of information to all who need to know and respond, including
results of occurrence/event reporting, performance measurement, reactive and proactive
activities, educational content, and safety policies and procedures.

Science of Safety

Accident Causation

“In place were not just one, but a series of safeguards— some human, some procedural, some
technical—that were supposed to ensure an accident of this nature could never happen. Yet, quite
clearly, these safeguards failed.

“In place were not just one, but a series of safeguards— some human, some procedural, some
technical—that were supposed to ensure an accident of this nature could never happen. Yet, quite
clearly, these safeguards failed.” — Gen. John Shalikashvili Chairman, Joint Chiefs of Staff

Individual Approach to Causation:

Errors arise primarily from aberrant mental processes, e.g., forgetfulness, inattention, poor
motivation, carelessness, negligence, and recklessness.

Systems Approach to Causation:

 Basic premise: humans are fallible, errors are expected even in the best organizations „
 Causes include traps in the workplace and organizational processes „
 Countermeasures are based on the assumption that working conditions can be changed

How Do Accidents Happen?

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All complex systems are intrinsically hazardous— − Road, rail, and air traffic − Space missions
− Nuclear reactors „ Generally heavily defended against failure „ Contain latent errors „
Routinely run in degraded modes „ Catastrophe requires multiple failures.

Ideal: Each Defensive Layer Impenetrable:

In reality, defenses are like slices of Swiss cheese „ Holes continually opening, shutting, shifting
„ Presence of holes in any one “slice” does not normally cause a bad outcome „ Accidents
happen when the holes in many layers momentarily line up to allow an accident.

Human Performance

Paradox

„ Health care workers generally − Highly trained − Conscientious − Well-meaning − Use


sophisticated treatment „

Errors and harm are common

Human Performance:

Skills „ Rules „ Knowledge

Individuals and System Design:

Role of individuals in error causation „

Not to point blame „

But to help us design systems that take this into account.

Skill-Based Errors:

You know what you are doing, but your actions don’t go as planned (slips, lapses, fumbles).

Slips (Attention), Lapses (Memory), Fumbles (Execution)

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You have a dentist’s appointment but drive to work anyway “Have a good flight.” “You too.”
You forget your colleague’s name Coffee misses mouth

Rule-Based Errors: „ You think you know what you are doing, but fail to notice
contraindications, apply a bad rule, or fail to apply a good rule (rule-based mistakes and/or
violations)

Rule-Based Errors (If A,Then Do B) „ Crossing over the double-yellow line „ Ignoring the rule
“Any female of child-bearing age is pregnant”

Knowledge-Based Errors „ You’re not really sure what you are doing (knowledge-based
mistakes in novel situations)

Knowledge-Based Errors „ Driving on an unfamiliar road „ Is it nerve, artery, vein?

Cognitive Biases in Decision Making „ Availability (recency)—things are more frequent if they
come readily to mind „ Visibility bias

Cognitive Biases in Clinical Decision Making „ Overconfidence

Cognitive Biases in Clinical Decision Making „ Representativeness—if it looks like a duck . . .

Search satisficing—call off the search once something is found.

Human error inevitable

Adverse Events and Safety in Health Care: Concepts and Definitions:

Case „ Patient underwent wound debridement „ Surgeon ordered stat antibiotic „ The patient had
a penicillin allergy „ Difficulty communicating with pharmacy for stat medications „ Nurse
borrowed antibiotic from another patient to shorten time to first dose „ Antibiotic was
administered „ Anaphylactic reaction

Two Viewpoints on Human Error 1. The person (active failure) approach: Focus on acts and
omissions by individuals 2. The system (latent failure) approach: Traces causal factors back to
the system as a whole

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Reason—Complex Systems

Definition Diagrams:

Error „ The failure of a planned action to be completed as intended (i.e., error of execution) and
the use of a wrong plan to achieve an aim (i.e., error of planning) „ Also includes failure of an
unplanned action that should have been completed (omission) „ Refer to processes of care

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Iatrogenic injury „ Injury originating from or caused by a physician (iatros, Greek for
“physician”), including unintended or unnecessary harm or suffering arising from any aspect of
health care management, including problems arising from acts of commission or omission „
“Harm” generally refers to outcomes or results

Adverse Event „ An event that results in unintended harm to the patient by an act of commission
or omission rather than by the underlying disease or condition of the patient „ “Preventable
harm” „ Both “preventable” and “unpreventable” are evolving concepts

Near Miss „ An error of commission or omission that could have harmed the patient, but serious
harm did not occur as a result of chance (e.g., the patient received a contraindicated drug but did
not experience an adverse drug reaction); prevention (e.g., a potentially lethal overdose was
prescribed, but a nurse identified the error before administering the medication); or mitigation
(e.g., a lethal drug overdose was administered but discovered early and countered with an
antidote)

Patient Safety „ The prevention of harm caused by errors of commission and omission

The IOM Report(s) (Wu)

 Synthesize the key points found in seminal reports


The IOM Report(s):

To Err Is Human

Prior to “The” IOM Report „ National Halothane Study „ Anesthesia Patient Safety Foundation
„ Celebrated cases − Libby Zion − Betsy Lehman „ Harvard Medical Practice Study

Institute of Medicine Report (1999) „ The problem is large „ Health care workers are not to
blame „ Errors and safety are caused by systems

A Systems Approach Is Necessary „ Errors are a leading cause of death and injury „ Blaming an
individual does not change the factors and conditions that contribute to errors, and the same error

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is likely to recur „ Preventing errors and improving patient safety requires a systems approach „
Leadership, knowledge, and tools are needed

Lesson 1: The Problem Is Large „ 44,000–98,000 deaths annually „ 7,000 death from medication
errors „ Total cost of preventable adverse events is between $17 and $29 billion Relative silence
surrounds the issue

More than from motor vehicle accidents, breast cancer, or AIDS

Accidental Deaths in the U.S. An estimated one million people are injured by errors during
hospital treatment each year and 120,000 people die as a result of those injuries, according to a
study led by Lucian Leape of the Harvard School of Public Health. Here’s how that number
compares with other causes of accidental death in the United States.

The Workers Are Not to Blame

Lesson 3: Errors and Safety Result from System Factors

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A Comprehensive Approach „ Needed to achieve a 50% reduction in errors over 5 years „


Leadership at level of government and health care organizations „ Enhance knowledge and tools
„ Break down legal and cultural barriers that impede safety improvement.

Errors Can Be Prevented „ To err is human, but errors can be prevented „ Safety is a critical first
step in improving quality of care

December 7, 1999 „ December 7, 1999: President Clinton directed the Quality Interagency
Coordination Task Force to respond with a strategy to identify prevalent threats to patient safety
and reduce medical errors − Goal: Reduction in medical errors by 50% in next 5 years

QuIC Report to the President „ Report of the Quality Interagency Coordination Task Force
(QuIC) to the President, February 2000 − Doing What Counts for Patient Safety: Federal Actions
to Reduce Medical Errors and Their Impact

Steps Toward Increasing Safety „ Center for Patient Safety formed within the Agency of
Healthcare Research and Quality „ Funding provided for reporting systems „ Greater attention on

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patient safety paid by regulators and accreditors „ Greater emphasis paid to patient safety within
health care organizations

Crossing the Quality Chasm

“Americans should be able to count on receiving care that uses the best scientific knowledge to
meet their needs, but there is strong evidence that this frequently is not the case. The system is
failing because it is poorly designed. . . . For too many patients, the health care system is a maze,
and many do not receive the services from which they would likely benefit.”

Optimal Patient Outcome System

High Quality of Care „ Safe „ Effective „ Patient-centered „ Timely „ Efficient „ Equitable

Simple Rules for the 21st-Century Health Care System

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Crossing the Quality Chasm „ Redesigning the health care delivery system will require changing
the structures and processes of the environment in which health professionals and organizations
function in four main areas

Four Changes in Structure and Process „ Applying evidence to health care delivery „ Using
information technology „ Aligning payment policies with quality improvement „ Preparing the
workforce

Evidence-Based Practice „ Move from practice based on tradition to practice based on evidence

Information Technology „ Electronic health records „ Reporting systems „ Automated treatment


delivery systems

Payment Policy „ Public and private purchasers should develop payment policies that reward
quality „ Current methods provide little financial reward for improvements „ Compensation
methods should be more closely aligned with quality-improvement goals

Preparing the Workforce „ Change the way health professionals are trained „ Modify regulation
and accreditation „ Use the liability system to support changes in care delivery

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Essential Reading „ To Err Is Human: Building A Safer Health System. National Academies
Press, 2000 „ Crossing the Quality Chasm: A New Health System for the 21st Century. National
Academies Press, 2001

» Safety and Medicine (Pronovost)

Evaluate the evidence that medical errors are a leading cause of death and injury
RAND Study Confirms Continued Quality Gap

Preventable Deaths „ 172,263 preventable deaths in the ICU from failing to use five
interventions

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How can this happen? Need to view the delivery of health care as a science

How can we improve? The system is a set of parts interacting to achieve a goal.

Every system is perfectly designed to achieve the results it gets Caregivers are not to blame.

System Failure Leading to Error

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Medication Error Waiting to Happen „ Esmolol HCl (Brevibloc) distributed in dilute form and
concentrated form „ Similar packaging for both, resulting in easy confusion and dosing errors
(http://www.fda.gov/medbull/mederror.html )

Impact of ICU Organization on Performance „ Physicians „ Nurses „ Pharmacists

Reliability Contingent upon Culture of Safety „ To improve reliability from 10-1 to 10-3 is
contingent upon culture of safety − Standardize what is done, when it is done X Reduce
complexity − Create independent checks for key processes X How often do we do what we
should − Learn from defects X How often do we learn from defects

Reliability Contingent upon Culture of Safety „ To improve reliability from 10-1 to 10-3 is
contingent upon culture of safety − Standardize what is done, when it is done X Reduce
complexity − Create independent checks for key processes X How often do we do what we
should − Learn from defects X How often do we learn from defects.

Improving Reliability:

„ Accept that we will make mistakes „ Focus on systems rather than blame „ Speak up if you
have concerns, listen when others do „ Create clear goals, ask questions early „ Standardize,
create independent checks, and learn from mistakes

» Systems of Influence (Morlock)


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 four systems of organizational influence affect patient safety
Systems of Influence in Organizations* „ Four systems of influence operate simultaneously in
organizations to affect our behavior:

1. The system of formal authority

2. The system of expertise

3. Organizational politics

4. Organizational culture *Mintzberg, Henri. (1983). Power in and around organizations.


Englewood Cliffs, New Jersey: Prentice-Hall.

System of Authority „ Formal control structure of the organization „ Coordination of activities


is achieved through a formal hierarchy of positions „ Individuals participate as superiors and
subordinates „ Influence is exerted through both personal and bureaucratic controls

System of Authority: Personal Controls „ − Giving direct orders − Setting decision


premises/boundaries − Reviewing decisions of subordinates − Allocating resources.

System of Authority: Bureaucratic Controls „ Establishment of impersonal standards that


guide decisions and activities X May be for the content of work performed (e.g., formalizing job
descriptions, rules and regulations, standardizing work procedures) X May be set with respect to
the goals to be achieved

System of Authority: Rewards and Sanctions „ At least in theory, controls are reinforced by the
organization’s formal system of rewards and sanctions

System of Expertise „ Develops in organizations where work to be performed is complex


enough that key participants must include technical experts or professionals who have received
considerable training outside the work setting „ At least in theory, work standards are
internalized through a long period of training

Coordination is achieved through standardization of skills, interpersonal consultation, and mutual


adjustment „ Often results in “status hierarchies” based on complexity of the skills and the
degree to which they are critical to the organization

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Organizational Culture „ System of shared beliefs about the organization that make it unique or
at least distinctive to its members „ Individuals participate as “members” „ A strong culture has a
unifying and “leveling” effect on individuals who participate as members

Organizational Politics „ Arena in which participants try to exert influence over decisions and
activities in ways that are informal and illegitimate in the sense that they are not sanctioned by
formal authority, certified expertise, or the organizational culture „ Arises when there are gaps in
the other influence systems

Influence is exerted through one or more “games,” each with its own structure and rules „
Individuals participate as players and observers

Organizational Politics:

Arena in which participants try to exert influence over decisions and activities in ways that are
informal and illegitimate in the sense that they are not sanctioned by formal authority, certified
expertise, or the organizational culture „ Arises when there are gaps in the other influence
systems „ Influence is exerted through one or more “games,” each with its own structure and
rules (not everybody plays) „ Individuals participate as players and observers „ Most visible
games are various kinds of budgeting games „ Political games also arise because of patient
safety.

The Patient Safety Games: Reporting System „ Reporting system games − “Not on my watch” −
“Not on my turf” − DVT example—errors of omission

The Patient Safety Games: Performance Data „ Games surrounding performance data − Shoot
the messenger − Criticize the methods − Change the case mix − Filter the data − Examples:
CABG mortality − Drive out fear, or fear will drive the data − Filter: Exclude from denominator.

Games Involving the Reporting of Performance Data:

Games surrounding performance data − Shoot the messenger − Criticize the methods − Change
the case mix − Filter the data − Examples: CABG mortality − Drive out fear, or fear will drive
the data − Filter: Exclude from denominator

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Lessons for Patient Safety „ These four systems of influence operate simultaneously in all
organizations, including health care settings „ Leaders with authority and leaders with expertise
(physicians, nurses, pharmacists, and others) need to be visibly committed to patient safety goals
− One good example: Executive “walk-arounds” − Another: Involving clinical experts who are
“thought leaders” in the development of guidelines

Lessons for Patient Safety (cont.) „ We need to be aware that “bad news,” such as the experience
of adverse events, does not travel easily up hierarchies of authority or status

Lessons for Patient Safety (cont.) „ Strengthening the system of culture has an equalizing effect
on the members of an organization, makes it easier to focus on the patient’s safety, and facilitates
adverse event reporting „ Strengthening the roles of formal authority, expertise, and culture in
efforts to improve patient safety will weaken the system of politics and gamesmanship

Safety Culture at Work: Addressing Safety Culture Provides the Lubrication That Makes
System Change Possible (Sexton & Wu)

 Recognize the value of caregiver culture assessments in quality improvement efforts

 Learn that safety culture is valid, related to outcomes, and responsive to interventions
 Learn the methodological rigor of collecting, interpreting, feeding back, and using safety
culture data

» Lecture 7: Playing in the Sandbox: Teamwork Climate, Situational Awareness, and


Communication (Sexton, Wu) –

 Review the dynamics of teamwork, communication, and measurement

 Explore the usefulness of measuring these variables to assess and improve safety

» Measuring Patient Safety (Pronovost, Wu)

 Recognize some of the challenges to measuring patient safety

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 Explain an approach to measuring aspects of safety in clinical practice

Measuring Patient Safety: How Do We Know We Are Safer?

Measuring Safety: Theory and Practice

How Would We Know? Have we made progress in improving safety now, six years after “To
Err Is Human”? How would we know?

Outline „ Where does safety fit into quality? „ Understand challenges to measuring safety „
Understand an approach to measuring safety

Domains of Quality „ Efficiency „ Timeliness „ Equity “Measures are lenses to evaluate these
domains” — IOM. Crossing the Quality Chasm.

Conceptual Model for Measuring Safety?

Example „ Structure − Presence of a smoking cessation program or materials „ Process −


Percentage of smoking patients given smoking cessation materials, total time spent in smoking
cessation counseling „ Outcome − Percentage of patients who quit smoking, cardiovascular
event rates

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Attributes of System-Level Measure for an Organization „ Scientifically sound, feasible,
important, usable „ Apply to all patients „ Aligned with value; encourage desired behaviors „
Meaningful to front-line staff who do the work

Balancing Theory and Practice:

What Can Be Measured As a Valid Rate? „ Rate requires − Numerator—event − Denominator—


those at risk for event − Time „ Minimal error − Random error − Systematic error X Bias X
Confounding

Bias: Systematic Departure from Truth „ Selection bias − Do not capture all events or those at
risk for event „ Information bias − Errors in measuring event or those at risk for event − Missing
data/loss to follow-up „ Analytic bias

Safety Measures „ Measures valid as rates − How often do we harm patients? − How often do
we do what we should? „ Non-rate measures − How do we know we learned from defects? −
Have we created a culture of safety? X Safety Attitudes Questionnaire (SAQ)

Examples of Process Measurement and Outcomes

Keystone ICU Safety Dashboard:

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Summary Sheet

Understanding Medical Error and Patient Safety  How can health care practitioners
prevent inadvertent harm to their patients? The first step is to acknowledge that such
harm occurs and may be the result of medical error.  According to the World Health
Organization, patient safety means offering "freedom … from unnecessary harm or
potential harm associated with healthcare."
 According to Institute of Medicine’s 1999 report To Err is Human, between 44,000 and
98,000 Americans die in hospitals each year due to mistakes in their care.
 Why is health care so dangerous? o Diagnosing and treating patients is incredibly
complex. o Practitioners are often inadequately trained or prepared to deliver care as a
wellintegrated team. o Errors often occur as a result of flawed processes or systems of
care — not because of negligent or irresponsible individuals. o The culture of safety —
"the attitudes, beliefs, perceptions, and values that employees share in relation to safety"
— that exists in most health care organizations is weak compared to many other high-
risk, complex businesses such as the airline, petroleum, and nuclear power industries.
 Making dramatic improvements in patient safety will require the following
commitments from both individuals working in health care and the organizations in
which they work:

o Acknowledge the scope of the problem of medical errors and make a clear commitment
to redesign systems to achieve unprecedented levels of safety.

o Recognize that most patient harm is caused by bad systems and not bad people, and
therefore we must end our historic response to medical error, which has been saddled
with finger-pointing and shame.
o Acknowledge that individuals alone cannot improve safety; it requires everyone on the
care team to work in partnership with one another and with patients and families.

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Understanding Unsafe Acts  Unsafe acts are categorized as either errors or violations. o
The first type of error is called either a slip or a lapse.

 An example of a slip is accidentally pushing the wrong button on a piece of equipment


— you and others can see that you pushed the wrong button.

 An example of a lapse is some form of memory failure, such as failing to administer a


medication — no one can see your memory fail, so the error is not observable.

o The second type of error, in which an action goes as intended but is the wrong one, is a
mistake.
 A violation is a deliberate deviation from an operating procedure, standard, or rules.
The IHI Open School provides online courses in improvement capability, patient safety,
leadership, person- and family-centered care, triple aim for populations, and quality, cost,
and value. These courses are free for students, residents, and professors of all health
professions, and available by subscription to health professionals.

A Call to Action – What YOU Can Do

 Here are five behaviors that any practitioner can do to improve safety for patients in his
or her direct care:
1. Follow written safety protocols.
o For example: Sanitize and wash your hands to reduce the spread of infection.
2. Speak up when you have concerns.
o For example: Report unsafe working conditions, close calls, and adverse events.

3. Communicate clearly.

o For example: Use SBAR – Situation, Background, Assessment, Recommendation.

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4. Don’t let yourself or others get careless.

o For example: Confront “drift,” when colleagues make slow, incremental moves away
from safe actions.

5. Take care of yourself.


o For example: Get an appropriate amount of sleep and control your stress.

Understanding Medical Error and Patient Safety

Introduction

“First, do no harm."

This phrase is one of the most familiar tenets of the health care profession. If you poll a group of
health care professionals, it is likely all would say they strive to embrace this motto in their
practice. And yet, patients are inadvertently harmed every day in the health care system,
sometimes with severe consequences.

Consider this example:

Image courtesy of CDC/Amanda Mills

Your energetic 70-year-old grandmother is enjoying a beautiful day in her garden, when she slips
and falls. She says she’ll be fine, but because she has some lingering pain in her right shoulder,
you urge her to see her primary care physician anyway, just to be sure.

Her primary care physician is leaving for vacation the next day, but kindly squeezes her in
between two scheduled appointments before he goes. He diagnoses her with a hematoma (upper
arm bruise), orders a shoulder x-ray, and asks her to return for a follow-up visit in one week.

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You’re relieved the injury appears to be no big deal.

Before the week is over, however, your grandmother is increasingly uncomfortable. She calls her
primary care physician’s office to request some pain medication, which her physician hadn’t
offered, and her physician’s colleague writes her a prescription.

At her one-week follow-up appointment, a physician’s assistant diagnoses your grandmother


with a shoulder sprain. He assures you and your grandmother that her pain level is normal, given
her age and the extent of the fall.

Three days later, the pain keeps getting worse. With growing concern, you take her to an after-
hours care office, where she sees a provider who now diagnoses her with shoulder impingement
and refers her to physical therapy (PT). You ask the provider diagnosing your grandmother to
review her x-ray from 10 days earlier, but he doesn’t have access to her medical record.

As a result of her visit to the after-hours clinic, your grandmother attends PT on three
consecutive Tuesdays. Her physical therapist becomes concerned with her lack of progress, and,
upon investigation, finds the x-ray from her initial visit to her primary care physician was never
reviewed or reported.

The following day, the primary care office reviews the x-ray and calls your grandmother right
away, instructing her to see an orthopedic surgeon — she has a shoulder dislocation and needs
surgery immediately.

Before starting the procedure, the surgeon talks with you and your grandmother and explains that
your grandmother may suffer some permanent loss of function, due to the delay in diagnosis.
Distressed, your grandmother turns to you and asks, “But who will water my flowers?”

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As upsetting as this story is, these types of situations (and worse) can happen to anyone — and
they happen more frequently than we care to believe.

In fact, studies show 1 in 3 Americans have experienced a medical error in their own or a family
member’s care at some point in their life.1

So, how can health care providers prevent inadvertent harm to their patients?

The first step is to acknowledge that such harm occurs and may be the result of medical error.
This lesson provides an introduction to the topic of medical error, describing its scope and
impact on patients, families, and the providers who serve them. Lesson 2 of this course will get
into how we define and classify error.

The Need to Keep Patients Safe

Whenever you enter a health care organization to receive medical attention, you become a
patient of that organization. And as a patient, you’re dependent on the people providing care and
treatment to adequately diagnose your problem, provide effective and appropriate treatment, and
ensure your safety.

Ensuring your safety. What does that mean, exactly?

According to the World Health Organization (WHO), “Patient safety is the absence of
preventable harm to a patient during the process of health care.”A focus on safety can also
reduce the severity of harm, should it occur.

Fundamentally, the concept of patient safety focuses on preventing medical error. Before we can
prevent such error, we need to understand it and understand why it occurs.

The Problem of Medical Error Gains Recognition

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In 1999, the Institute of Medicine (IOM) released its landmark report, To Err Is Human, which
called for a swift reduction of medical errors in the United States.

The report revealed that between 44,000 and 98,000 people died each year in US hospitals due to
medical errors. That was more than the number of people who died in a given year from motor
vehicle accidents, breast cancer, or AIDS.3

As you can imagine, media outlets from across the US and abroad quickly turned these statistics
into startling headlines:4

“Medical Errors Blamed for Many Deaths; As Many as 98,000 a Year In U.S. Linked To
Mistakes”
-- The Washington Post, 11/30/99

“Medical Mistakes in U.S. Kill Thousands”


-- The Toronto Star, 11/30/99

“Medical Mistakes 8th Top Killer”


--USA Today, 11/30/99

“Congress Urged To Create Federal Agency To Protect Patients: Medical Malpractice


Kills Thousands
Of People Annually In The U.S., A Science Panel Concludes”
--New York Times News Service, 11/30/99

In articles and newscasts that reached more than 100 million readers and viewers in the US
alone, a simple analogy in particular stood out: Medical errors were the equivalent of three fully
loaded jumbo jets crashing and killing everyone onboard every other day.4,5

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Thanks to the widespread media attention, patient safety was suddenly a matter of national
priority. Within days, President Clinton signed the Healthcare Research and Quality Act of 1999,
tasking the Agency for Healthcare Research and Quality (AHRQ) to study and produce annual
reports on health care quality in the US.6 During the next five years, the pace of English-
language articles published on patient safety almost tripled.7

But even as awareness spread rapidly, in a 2005 article Five Years After “To Err Is Human”:
What Have We Learned? co-authors of to the original IOM Report called the country’s overall
progress “frustratingly slow.”8

The Problem of Medical Error Today

Now that almost 15 years have passed, where do we stand? Simply put, the number of errors
remains way too high.

Although To Err Is Human was optimistic in its vision for improvement, AHRQ’s annual
National Healthcare Quality Report continues to identify safer care as a top priority, reporting
health care quality and access remain suboptimal, particularly for minority and low-income
groups, with overall improvement rates of only 2.5 percent per year.

This is even more concerning in the context of a 2011 study: Flawed reporting systems – such as
those used by AHRQ – likely miss more than 90 percent of adverse events occurring in US
hospitals.

And to look beyond the US, here are some current international health care statistics from WHO:

 In developed countries, as many as 1 in 10 hospital patients is harmed while receiving


care.

 Each year, unsafe injections cause 1.3 million deaths.

 At any given time, 1.4 million people worldwide suffer from hospital-acquired infections.

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 In some countries, as many as 70 percent of injections are done with unsterilized syringes
or needles.

 Studies show improving patient safety could save some countries between $6 and $29
billion a year.

These statistics are staggering. However, examining the impact of medical error on a single
patient can be even more powerful. Take a moment to watch the following video about one
family’s experience, and see if you can identify the health system failures as they occur.

We have one final statistic to put this all into perspective once again, especially if you’re ever
nervous about flying: A 2013 New York Times articlereported commercial air travel has become
so reliable that even if you flew every day, it would take an average of 123,000 years to die in a
plane crash

Why Are Errors Occurring?

Most health care professionals — physicians, nurses, pharmacists, and so forth — are drawn to
health care out of a desire to help others. They go through intense training and are carefully
screened for their positions. Some take further instruction — such as this online course — to
enhance their education and better prepare for patient care duties.

So, given the conscientious nature of the typical health care provider and the comprehensive
training he or she receives, why is it that so many errors occur?

There are many answers to that question. Here are some of them:

 The practice of modern medicine involves numerous drugs and highly technical
equipment. Since 2001, the FDA’s Center for Drug Evaluation and Research has averaged 23
new drug approvals per year.

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 Providers may not be prepared to work as a well-integrated team, so multiple caregivers
and patient handovers leave room for miscommunication at every turn. One teaching hospital
reported 4,000 handoffs daily, for a total of 1.6 million per year.

 The “culture of safety” (meaning the attitudes, perceptions, and values that employees
share in relation to safety) may be weak in health care compared to other high-risk
industries. According to WHO, industries with a perceived higher risk such as aviation and
nuclear plants have a much better safety record than health care.

 Diagnosing and treating patients is incredibly complex, and often performed under time
pressure and/or with insufficient information.According to the Society to Improve Diagnosis
in Medicine, diagnostic error (wrong, missed, or delayed medical diagnosis) occurs in up to 15
percent of cases.

 The science of medicine is filled with nuance and gray areas, and what one health care
organization feels is good practice, another may not. A 2002 AHRQ review identified more
than 120 different systems being used to rate the strength of scientific evidence.

 Providers are often caring for a great number of patients, all of whom are unique. A 2012
study of over 13,000 US physicians found more than 40 percent saw over 20 patients each day.

 For a front-line provider, there are always new medications, new technologies, new
procedures, and new research findings to assimilate.There are more than 10,000 types of
medical devices available today.

Consider the following scenario.

Early one evening, at the beginning of a new shift, Janet needs to obtain blood samples for four
of her patients. She collects one sample and, before she gets a chance to label it, is called to help
with another patient who is having an emergency. One of her colleagues called in sick and the
unit is understaffed, so she cannot give her blood sampling duties to someone else; she must put
them on hold. Janet places the unlabeled specimen on the nurse’s station with a sticky note
nearby indicating the patient’s name. She then goes to help with the other patient.

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After completing her work with the emergent patient, Janet returns to the nurse’s station and
discovers four unlabeled vials of blood and no sticky note. She realizes that another nurse on the
unit is obtaining blood samples from his patients and was also called away. Now, both nurses
have no idea which vials belong to which patients.

QWhat about this scenario makes a medical error likely to occur?

a) Competing priorities
b) Multiple patients
c) Staffing issues
d) Time-sensitive care
e) All of the above

Let’s take a look at another example.

A patient is scheduled for surgery on his right forearm. When preparing the patient, an intern
marks and initials the correct surgical site on the dressing; however, the dressing is removed
prior to the surgery, so the mark is also removed. A resident corrects the intern's mistake by
marking the surgical site on the skin, using a water-soluble marker. Unfortunately, neither the
marking nor the resident’s initials are legible because the alcohol-based preparation of the
surgical site smears the ink. The attending surgeon is new and not familiar with the hospital’s
marking procedures, so he does not realize the site has been marked. In addition, the nurses
helping with the surgery are busy preparing the patient and the operating room, so they are not
focused on verifying the surgical site. The operating room schedule is tight, and everyone is in a
hurry to move the surgery forward.

QWhat type of error is more likely to occur because of the systems failures in this scenario?

a) Improper anesthesia dosing


b) Retained foreign body after surgery

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c) Wrong-site surgery
d) None of the above

Although many providers believe an error as significant as wrong-site surgery will never happen
under their watch, such errors continue to occur, involving even the most careful providers. In
the US, these types of errors (including wrong-patient, wrong-procedure, wrong-site, and wrong-
side surgeries) happen up to 40 times per week. A December 2012 report in Surgery looked at
malpractice payments for these types of surgical “never events” from 1990-2010: They totaled
1.3 billion dollars.

A Changing Perspective on Medical Error

Historically, the medical profession has viewed medical errors as either an inevitable byproduct
of complex care or the result of provider incompetence, often seeking to blame the providers
involved in the error rather than examining the systems that may have failed. This “blame and
shame” approach generally did little to further the cause of patient safety and, in fact, was more
often a step backward.

The truth is, patients and family members are not the only people affected by medical error. The
providers who experience those errors — directly or indirectly — are also affected.

Here’s a video about one provider’s experience with a medical error.

[Excerpt from Beyond Blame, a film produced by Bridge Medical, Inc., and distributed by
the Institute for Safe Medication Practices.]

The good news is, during the past 15 years, health care organizations have begun to realize and
accept that most errors cannot be linked to the performance of the individual and are
instead the result of a series of system errors that work together to yield unsafe situations.

Even better news is that these system errors are often preventable and do not have to occur.
It’s Not Just About Harm
So far, we have focused in this lesson on errors that cause harm. But from a patient and family
perspective, any error — even those that don’t cause any harm — can be problematic. So-called

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“close calls” or “near misses” as well as provider behaviors, breakdowns in communication, loss
of information, and a variety of system conditions that appear to be unsafe can lead to a lack of
trust between providers and patients and represent areas of high risk.

If we look at these near misses as “accidents waiting to happen,” they represent opportunities to
prevent error and ensure safety.

Watch the following clip from Donald M. Berwick, MD, MPP, President Emeritus and Senior
Fellow at the Institute for Healthcare Improvement and Former Administrator for the Centers for
Medicare and Medicaid Services, one of the international authorities on health care quality and
patient safety. In 1999, Berwick’s wife, Ann, started developing symptoms of a serious
autoimmune spinal disease. An avid athlete, she suddenly found it difficult to walk across her
bedroom. She was hospitalized six times in six months — and Ann and her husband quickly
found themselves experiencing a very different side of health care.

Going Forward

Organizational theorists such as Karl Weick and James Reason have described safety as a
“dynamic non-event.”

According to Reason, safety is dynamic because it requires “timely human adjustments” and
a non-event because “successful outcomes rarely call attention to themselves.”

In other words, to make “nothing bad happen” requires a lot of good things to be done right. We
can’t solve medicine’s patient safety problems by using the same kind of thinking that created
them in the first place.

To make dramatic improvements in patient safety will require the following commitments from
both individuals working in health care and the organizations in which they work:

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 Acknowledge the scope of the problem of medical errors and make a clear commitment
to redesign systems to achieve unprecedented levels of safety.

 Recognize that most patient harm is caused by bad systems and not bad people, and
therefore we must end our historic response to medical error, which has been saddled with
finger-pointing and shame.

 Acknowledge that individuals alone cannot improve safety; it requires everyone on the
care team to work in partnership with one another and with patients and families.

To deliver the right care — for every patient, every time — requires a new way of thinking about
error in medicine, and a new approach to preventing errors and harm. To thoroughly understand
and accept this approach.

1) According to WHO, in developed countries worldwide, what is the approximate likelihood


that a hospitalized patient will be harmed while receiving care?

10%
According to WHO, in developed countries up to 10 percent of hospital patients may be
harmed while receiving care.

2) Since the publication of To Err Is Human in 1999, the health care industry overall has seen
which of the following improvements?
A) Wider awareness that preventable errors are a problem.
More than a decade after the publication of To Err Is Human, there is now wide recognition
throughout health care that the number of errors is way too high. Although this awareness has
not yet led to consistently lower rates of preventable medical error, progress is being made.
Health care organizations have begun to realize and accept that most errors cannot be linked to
the performance of individuals, but rather to the systems in which they function.

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3) Safety has been called a “dynamic non-event” because when humans are in a
potentially hazardous environment:
It takes significant work to ensure nothing bad happens
The best answer is it takes significant work to ensure nothing bad happens. When things go
right in a potentially hazardous environment, nothing bad happens. But in order for this “non-
event” of nothing going wrong to occur, a lot of things must be done right. Thus, safety has
been described as a “dynamic non-event.”

4) To prevent this type of error from recurring in this unit, which of the following is
MOST important?
An improved culture of safety and teamwork
Had there been a culture of safety fostering better teamwork, this error may well have been
prevented. In this case, when James asked Maria for help, she made him feel bad instead of
being a team player. In this type of environment, James may be reluctant to ask for help, even if
he is more closely supervised. We can generally assume that health care providers do not want
to harm their patients, so the threat of punishment is not the best way to prevent mistakes.
Although errors may occur when there is no recognized best practice, in the case of IV fluid
replacement, clear recommendations do exist.

5) Who is likely to be negatively affected by this medical error?


The best answer is all of the above. Patients and families are not the only ones affected when a
medical error occurs. In this case, James is likely to be devastated, and Maria may be affected
as well. Some providers even leave their profession after committing errors leading to a death.

Understanding Unsafe Acts


Most people commit unsafe acts all the time while they’re driving. They fail to stop completely
at a stop sign, they forget to signal when turning, or perhaps they chat on their cell phones. These

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kinds of unsafe acts happen in health care, too — and sometimes they have serious consequences
for patients. In this lesson, you’ll learn how the human brain is wired to make certain kinds of
mistakes. You’ll also learn to identify four varieties of unsafe act, as defined by psychologist
James Reason: slips, lapses, mistakes, and violations.
Introduction

What if we told you that every day you do something unsafe?

“Now, wait a minute,” you might say. “I am a very careful person, and I don’t do things that are
unsafe!” You may not realize you’re doing them, but you are.

How many of us have:

 Driven a car and failed to check the rearview mirror before changing lanes
 Sprinted across a slippery pool deck as the lifeguard blows her whistle
 Dodged traffic as we crossed the street in between crosswalks
 Removed perfectly cooked brownies from the oven but failed to turn the oven off
 Illegally parked “for just a second”
 Used a lawnmower or any piece of machinery without proper footwear

Although most of us don’t do these things intentionally — we are distracted, in a hurry, or just
plain forgetful — these behaviors are nevertheless unsafe.

Now, what if we told you these types of unsafe acts are the very same as those that lead to the
worst medical errors? You might ask “What does lawn care have to do with health care, and how
can you compare double-parking to harming a patient?”

You’ll soon see how the term “medical error” is slightly misleading, because the patterns of
errors that occur in health care are no different from those that occur in any other setting —
including the highway, swimming pool, city street, home kitchen, backyard, or anywhere else

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with a potential hazard. The reasons why we might operate machinery without proper footwear
are essentially the same as why we might fail to practice proper hand hygiene in the patient
setting. By understanding the concept of unsafe acts, you can begin to understand why and how
medical errors occur.
What Is Considered an Unsafe Act?

So what exactly do we mean when we say “unsafe act”?


In his groundbreaking book Human Error, British psychologist James T. Reason defines
an unsafe act as “an error or a violation committed in the presence of a potential hazard.”1
According to Reason, unsafe acts may be categorized as either errors or violations. Errors may
be further categorized as slips, lapses, and mistakes.
Picture it like this:

In a second, we’ll explain the rest of these terms.

But first, in case you’re already asking yourself “Why would I ever need to know the differences
between various types of unsafe acts and errors?” keep the following in mind: We’re not just
teaching you terms. Rather, we are providing you with a framework in which to understand
medical errors and how they happen.

Only with a solid understanding of these concepts can we address the complex issue of medical
errors and improve patient safety.

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Taking a Closer Look at Human Error
In Human Error, Reason said that errors can be divided into two types of failures:

1. An action does not go as intended.


2. An action goes as intended, but it’s the wrong one.

The first type of failure, in which an action does not go as intended, is a so-called error of
execution and may be further described as being either a slip— if the action is observable — or
a lapse, if it is not.

An example of a slip is accidentally pushing the wrong button on a piece of equipment — you
and others can see that you pushed the wrong button.

An example of a lapse is some form of memory failure, such as failing to administer a


medication — no one can see your memory fail, so the error is not observable.

The second type of failure, in which an action goes as intended but is the wrong one, involves a
failure in planning. This category of error, in Reason’s terminology, is known as a mistake.

Here’s one example of a mistake:

During a physical exam, a physician detects a lump in the right breast of a young, female patient.
He’s convinced, based on the patient’s age and family history, that the lump could not be
cancerous. He tells the patient that she probably has fibrocystic breasts — a common, non-
cancerous condition — and fails to pursue a more definitive diagnosis. Later, it’s discovered that
the lump is in fact cancerous.

In this situation, the physician’s plan is clear, and his actions go exactly as he planned — but the
plan is incorrect.

Let’s look at an example that could happen to anyone and shows all three types of error: slips,
lapses, and mistakes.

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A nurse, Jessica, oversleeps and is running late to work. As she rushes through her morning
routine, she experiences a lapse, forgetting she’d promised to call her mother to confirm plans
for later in the day.

She makes it out the door in record time and decides to drive toward the highway, thinking it will
be faster than her usual route to the hospital. She quickly realizes her mistake, however —
traffic is backed up for miles!

At last, Jessica makes it to work. As she hurries inside, she finally remembers to call her mom.
But in her hurry, she experiences a slip, and accidently calls her boyfriend instead.

While she has him on the phone, she briefly tells him about her frustrating morning —
“three errors and I haven’t even seen a patient yet!”

Taking a Closer Look at Violations

Now that we have introduced the concept of error, let's take a minute to introduce violations.

According to the World Health Organization (WHO), a violation is “a deliberate deviation


from an operating procedure, standard, or rules.”2Although deliberate, violations are not
necessarily the result of deviant behavior or intended to cause harm.

Let's look at an example.

At the end of the day, a respiratory therapist is rushing home to cook dinner for his wife. Because
he is in a hurry, he speeds up (instead of slowing down) at two yellow lights. Without realizing

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it, he exceeds the speed limit both times, and the second time the light turns red before he makes
it through. When he quickly stops at the store to grab one more ingredient for the meal, he parks
a little closer to a fire hydrant than he knows he really should.

These are all examples of violations, where the respiratory therapist either didn’t recognize the
risk he was taking or felt the risk was justified. He is not a bad person, and he is not acting with
conscious disregard for safety, but his actions are unsafe.

Making Sense of Unsafe Acts

To help you understand all these definitions, here’s a recap of how “unsafe acts” can be broken
down and defined according to their root cause:

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Let’s take a moment to see whether you can distinguish among different types of errors and
violations in a few scenarios. (Some of these may be all too familiar!)

QYou reach your car after a long work shift and realize you left your car keys inside
(oops!). This is a:

a) Slip
b) Lapse
c) Mistake
d) Violation

You forgot something — this was a lapse!

QBy the time you get your keys and finally get moving, you are so frustrated you decide to take
an illegal left-hand turn out of the parking lot, to make up for lost time. This is a:

a) Slip
b) Lapse
c) Mistake
d) Violation

You deliberately deviated from the rules, so you committed a violation.

QYou get home and take out your keys to unlock the door — you put the wrong key in the lock
and the door knob won’t turn. This is a:

a) Slip
b) Lapse
c) Mistake
d) Violation

You knew which key you needed, but you slipped and grabbed the wrong key.

QOnce inside, your roommate says “Sorry dinner is so cold. I thought you’d be home sooner! I
made a

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a) Slip
b) Lapse
c) Mistake
d) Violation

Your roommate made a mistake in cooking dinner too early, based on an incorrect assumption.
Errors and Violations in the Workplace and Health Care Setting

Now that you’ve seen some examples and identified a few of your own mistakes or poorly
justified decisions, you should better understand the inevitability of error and violation as a
fundamental facet of the human condition.

The challenging reality is that the same mental processes that lead us to make silly mistakes and
risky decisions when the stakes are relatively low don’t just go away as stakes increase. They’re
still at play when we go to work in a potentially hazardous setting.

Consider a few examples from several high-risk industries:

 Slip: An electrician knows he needs Class 4 rubber insulating gloves to protect himself
but slips and grabs a pair that offers less protection.

 Lapse: A worker in a power plant lapses and forgets to double-check a critical reading.

 Mistake: A truck driver makes a mistake and decides to speed up as he merges into
oncoming traffic when he should have slowed down.

 Violation: A pilot commits a violation, skipping part of a pre-flight checklist in the


interest of getting the flight off on time.

The list goes on, and you can imagine the potential consequences.

What has historically been different about health care compared to other high-risk industries is “a
culture of infallibility” — the idea that if we are good at our jobs, we cannot make mistakes. But

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the truth is, most preventable harm to patients is caused by unsafe acts of the very providers who
are trying to help them.

With the human condition in mind, it’s easy to see how a well-meaning pharmacist could:

 Slip: Experience a slip and grab a medication that is different than one she intended to
grab.

 Lapse: Have a lapse in memory and forget about her patient’s known drug allergy.

 Mistake: Make a mistake by misjudging the likelihood that a harmful interaction could
occur.

 Violation: Commit a violation by skipping the use of a historically malfunctioning bar-


coding system, even though it’s protocol, because you think “It’s probably broken anyway.”

As you can see, just trying to be perfect is not a rational or effective approach to prevent patient
harm.

Recognizing the Different Types of Unsafe Acts

To further emphasize the inevitability of unsafe acts, here are some real-life case examples. As
you read each example, think about which types of unsafe acts — slips, lapses, mistakes, or
violations — contributed to the adverse outcome.

Case Example #1:

A 28-year-old, significantly obese woman goes to a clinic, complaining of calf pain that keeps
getting worse. She tells her primary care physician that she thinks the pain is due to the new
shoes she bought and her new commitment to walking and exercising more. She describes her
pain to the doctor as a 10 on a scale of 1 to 10. She has no history of leg trauma, and her only
medication is a birth control pill. After examining her, the physician does not see anything
unusual. The physician prescribes ibuprofen and muscle relaxants and instructs the woman to

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return to the clinic if her symptoms do not get better. A week later, the woman returns to the
clinic complaining of chest pain and shortness of breath. The clinic transfers her to the
emergency department, where she soon has a cardiac arrest and is unable to be resuscitated. A
post-mortem examination reveals a massive blockage in the artery that passes through her lung.

QWhat type of unsafe act, if any, does this case demonstrate?

a) Slip
b) Lapse
c) Mistake
d) Violation
e) There is no unsafe act in this case

In this example, the physician who assessed the patient made a mistake. When the patient
attributed her pain to new shoes and a new exercise routine, the physician took that available
information and almost immediately concluded the patient had strained her calf muscle. Her
symptoms were representative of many other patients he had seen who try to do too much
exercise with too little preparation, too quickly. Anchored on his diagnosis, he thought more
about the treatment than he did about what other factors might be causing her condition.
Although her obesity and use of birth control medication were both factors predisposing her to
deep venous thrombosis (DVT) — blood clots — he became narrowly focused on next steps, not
appreciating something he already knew: his physical exam was an unreliable strategy to
determine the presence or absence of DVT.

This example involves the concept of heuristics — cognitive shortcuts that allow for rapid, often
unconscious decision making. Unfortunately, heuristics are also associated with cognitive biases
that can be strong, but incorrect

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Case Example #2:

A 35-year-old man named John goes to a new primary care physician for an initial visit and to
get a referral for an ophthalmologist. After John’s visit, the physician still has John’s medical
record open on his computer screen while he is reviewing lab results for a different patient, Bill.
Bill’s results indicate that he is anemic and has blood in his stool, suggesting he needs a
colonoscopy to check for an ulcer or cancer.

The physician tries to order a colonoscopy for Bill but accidentally enters a referral to the
Gastrointestinal (GI) lab for a colonoscopy for John instead. The referral states John has blood in
his stool and mild anemia. John takes off work and goes through the uncomfortable procedure.
The day after his colonoscopy, John calls the physician’s office and asks when he was tested for
blood in his stool and if he really needed the procedure. It is at this time the physician realizes
John has undergone an unnecessary procedure and Bill has not received the colonoscopy he
needs.

QWhat type of unsafe act, if any, does this case demonstrate?

a) Slip
b) Lapse
c) Mistake
d) Violation
e) There is no unsafe act in this case

In this example, the physician made a slip. The action he intended to make – to refer Bill to GI –
was correct, but did not go as planned due to an observable error of execution, which was
inputting the recommendation for John, the wrong patient, instead.

Case Example #3:

A 70-year-old woman is having issues with her bladder and rectum that require surgery. During
her surgery, a gauze sponge is placed in her vagina to control bleeding. After the surgery, the

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surgeon writes an order for the recovery care team to remove the vaginal sponge prior to her
discharge. The surgeon means to tell them this in person, too, as well as the patient and her
daughter, but forgets to mention it to any of them directly. The nurse assigned to the patient in
the recovery area is working with a second nurse who offers to remove the patient’s Foley
catheter — a tube inserted into the bladder to drain urine — and vaginal sponge. This
nurse removes the catheter but gets interrupted and does not remove the sponge. The first nurse
means to double-check that the sponge was removed but is extremely busy and forgets. The
patient follows up with her primary care provider seven days later because of vaginal pain and
the sponge protruding from her vagina.

QWhat type of unsafe act, if any, does this case demonstrate?

a) Slip
b) Lapse
c) Mistake
d) Violation
e) There is no unsafe act in this case

In this example, there were several lapses in intended execution that contributed to the patient’s
medical error. Although the surgeon wrote an order to remove the sponge prior to discharge, the
surgeon forgot to communicate that order directly to the care team or patient, as intended. It turns
out the surgeon had been up for 24 hours performing surgeries and forgot due to lack of sleep.
That was the first lapse. The nurse who offered to help the first nurse by removing the patient’s
Foley catheter and vaginal sponge got interrupted in the process and remembered to remove the
Foley catheter but forgot to remove the sponge, which was the second lapse. Then the first nurse
forgot to double-check that the sponge was, in fact, removed. This was the third lapse.

Case Example #4:

A 52-year-old woman with a history of ulcers and bleeding in her gastrointestinal tract as a result
of taking ibuprofen is seen by a doctor at the primary care office. After examining her, the
physician tries to prescribe ibuprofen to treat her condition. The medication order entry system
issues an alert — the 25th one that day — and the physician ignores the alert without reviewing

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the patient’s medical record, thinking the alert is likely to be another “false alarm.” Behind on his
schedule, he chooses to override the alert and prescribe the ibuprofen. After taking the
medication, the patient develops bleeding in her gastrointestinal tract and has to be admitted to
the hospital.

QWhat type of unsafe act, if any, is represented throughout this case example?

a) Slip
b) Lapse
c) Mistake
d) Violation
e) There is no unsafe act in this case

Answer: D.

An analysis of this incident indicates that the unsafe act was not human error per se, but
a violation.The physician who ignored the medication order entry system alert without
reviewing the patient’s medical record made a conscious decision not to follow standard safe
practice, convincing himself that it was another false alarm and succumbing to the time pressures
of his busy schedule. Although it’s easy to see why the violation occurred, it is not a “mistake”
because he deliberately deviated from the rules.

Now That We Know About Unsafe Acts, What Can We Do About Them?

If we can now agree that expecting providers to be perfect is not a rational or effective approach
to preventing human error and patient harm, what is? In other words, how can we prevent and/or
mitigate the effects of unsafe acts in health care?

we already discussed how “naming, blaming, and shaming” individuals has done little to help. It
does not just because providers are not tryingto harm their patients. It’s also because by focusing
on the individual as the cause of error, organizations fail to identify and remove the error-
provoking properties within the larger systems of care. Systems consist of a multitude of
complex processes, all of which need to be considered as important context when an error
occurs. Until you fix the system, the same error is just as likely to occur.

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Implementing a “systems approach” to addressing medical error means:

 Focusing largely on the conditions under which individual providers and care teams work
 Designing in workflow and defenses to avert errors
 Minimizing the conditions that lend themselves to violations
 Putting mechanisms in place to mitigate unsafe acts that may inevitably occur

As opposed to other failed approaches we've discussed, this approach can be quite successful in
preventing medical error and making patients safe. To look at some

examples:

 After identifying a number of communications and teamwork failures that were


contributing to the preventable error of wrong-site surgeries, WHO took a systems-level
approach to the problem by developing the World Health Organization Surgical Safety
Checklist.3 A prospective study found the checklist reduced deaths from wrong-site surgery by
almost 50 percent. (To learn more about how you can use the checklist in your facility, visit
IHI’s Surgical Checklist Progress page.)

 OSF St. Joseph’s Medical Center in Bloomington, Illinois, virtually eliminated surgical
site infections in a test group of patients by implementing a combination of solutions,
including administering antibiotics prior to surgery, eliminating the use of razors to shave the
operative site, controlling patient blood sugar during and after surgery, providing supplemental
oxygen during and after surgery, and keeping patients warm during surgery.4

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 Brigham and Women’s Hospital in Boston, Massachusetts has been using structured
interactions between hospital leadership and front-line staff — called Executive
WalkRounds™ — to improve communication across the organization, capture information
about high-risk situations that could lead to patient harm, and respond proactively to these
situations. These WalkRounds have been directly linked with improvements in organizational
attitudes about teamwork and safety.

As you can see, when we view unsafe acts as consequences rather than causes of problems, we
can both accommodate the human condition and change the conditions under which
humans work.

1) According to James Reason, by definition an “unsafe act” always includes:


a) A potential hazard
b) Harm to one or more patients
c) One or more mistakes
d) All of the above
Correct Answer:a) A potential hazard

James Reason calls unsafe acts errors or violations committed in the presence of a
potential hazard. Errors can be further divided into slips, lapses, and mistakes. They may or
may not actually result in harm, but the potential for harm is present.

Anita, a nurse practitioner, is seeing Mr. Drummond in clinic. Mr. Drummond is a 57-year-old
man with diabetes and chronic kidney disease. Having kept up on the literature, Anita is aware
that tightly controlling his diabetes can slow the progression of his renal disease. She discusses
her plan to increase his dose of glargine (long-acting insulin) by 12 units per day with one of the
family physicians in the clinic, who agrees. At the end of the day, as she is working on her
documentation, she realizes she never told Mr. Drummond to increase his insulin dose.

2) This is an example of what type of error?

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a) Lapse
b) Mistake
c) Slip
d) Error of planning
e) Violation
Correct Answer:a) Lapse
Anita had a memory failure, which is a classic lapse. She understood what should be done and
created a good plan. She even discussed it with a co-worker. However, in the midst of a busy
clinic schedule she likely got distracted and forgot to implement the plan.

Roger, a pharmacist in a hospital, is working in the discharge pharmacy filling medications for
patients who are going home. He sees a prescription for ciprofloxacin, an antibiotic, and he asks
his pharmacy technician Mike to fill it quickly, as the patient is waiting and anxious to leave.
Mike checks the shelves and sees they are out of ciprofloxacin, but they do have levofloxacin (an
antibiotic in the same class that covers most, but not all, of the same types of infections). Mike
knows he should usually check with the prescribing physician before making a substitution.
However, in the interest of efficiency in this particular case, Mike deems it OK to go ahead. He
substitutes the medications.

3) This is an example of what type of unsafe act?


a) Mistake
b) Slip
c) Lapse
d) Error of planning
e) Violation
Correct Answer:e) Violation
This is a violation because Mike made a deliberate decision to disregard standard procedure
when he changed antibiotics for this patient without the prescriber’s authorization. This change
may result in harm if the levofloxacin does not treat the organism and site of infection.

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4) Which of the following is the most significant advantage of shifting to a systems view of
safety within health care?
a) It is easier to identify and remove people who are unsafe
b) It allows us to change the conditions under which humans work
c) It prevents human mistakes
d) It allows us to view unsafe acts as violations
e) All of the above
Correct Answer:b) It allows us to change the conditions under which humans work
Having a systems view of health care allows us to change the conditions under which humans
work by recognizing that humans are not perfect and systems have a significant role to play in
safety. This view is applicable in all patient care settings, as all care settings these days are
complex.

At University Hospital, the rate of Clostridium Difficile colitis has doubled during the past year.
After reviewing the data, the hospital’s senior leaders conclude that this is due to poor hand
hygiene on the part of the staff, even though they have a clear hand washing policy in place and
don’t believe most staff are intentionally disregarding the policy. They decide to start a hand
washing campaign and post signs all over the hospital reminding providers to wash their hands.

5) What type of error is this intervention best designed to address?


a) Mistake
b) Slip
c) Lapse
d) Error of Planning
e) Violation

Correct Answer:c) Lapse


Signs and other reminders are good strategies for addressing lapses, specifically memory failure,
which is what the leadership believes is generally happening in this hospital. While these types
of campaigns may also address violations or mistakes, they are generally less successful in these
areas.

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A Call to Action — What YOU Can Do
When it comes to improving patient safety, it helps to have your whole organization on board.
However, it doesn’t necessarily take a complex, multifaceted improvement effort to make
progress in reducing medical errors – progress can start with a commitment from individuals like
you.

Introduction

“Huh?”

Don’t worry; we’ll explain how this relates to health care improvement in a moment. But first,
pretend you are going about your grocery shopping, and consider what you would do if you saw
this puddle of spilled milk.

It may not be your responsibility to clean up the spill, and you may not have the tools to do it on
your own. But that doesn’t mean you are powerless to act!

For now, the overarching point is it doesn’t necessarily take a hugely complex, multifaceted
improvement effort to make some progress. If everyone who takes this course commits to
improving safety in his or her own practice, the health care system becomes that much safer.

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Four Critical Behaviors to Improve Safety

Here are four behaviors — under your control — that you or any provider can adopt to improve
patient safety.

Behavior One: Follow Safety Protocols


“To err is human” — but so is to violate.

Most, if not all, health care organizations have protocols in place that help preserve patient
safety. Some of these are standardized throughout the industry — for example, administering
antibiotics before surgery — and some have been developed specifically for a particular
organization — for example, using different color-coded stickers on the medical record to
indicate a patient’s risk for falls. Protocols are often developed through the analysis of trended
data or as a result of a single adverse outcome.

But regardless of how a protocol is developed, how carefully it is considered, or how well it is
written, it only works if people follow it.

With this in mind, every provider must be responsible for:

Knowing and following proper protocols to the best of his or her ability

Helping other providers remember and follow proper protocols, especially confronting “drift”
(the gradual movement away from established protocol)

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most people who commit violations — whether they’re a driver speeding down the highway or a
physician skipping through a checklist — are not intending to cause harm, but rather intending to
get something done, often without a thorough understanding of the potential consequences.

As you can see, by insisting the surgical team follow the hospital’s protocol for completing the
pre-surgery checklist, Dr. Benton prevented a costly delay and ensured the safety of Dr. Carter.
Again, the protocol itself could be the best protocol ever created by the hospital, but if the
surgical team doesn’t follow it, Dr. Carter’s life is in danger.

Other examples of protocols that may be relevant to your work include the following:

 Two patient identifiers: Protocols that require two separate patient identifiers can help
make sure you accurately identify a patient prior to the administration of a medication or the
drawing of blood, for example.

 Alarm monitoring: These protocols ensure that physiologic monitoring systems intended
to protect patients are not ignored or inappropriately inactivated.

 Specimen labeling and handling: These policies and procedures ensure specimens are not
lost or incorrectly labeled, resulting in a repeat draw, a delay in diagnosis or treatment, or a
“wrong-patient, -site, or -procedure” event.

 Equipment disinfection/sterilization: These procedures minimize the risk of infection


caused by improperly disinfected or sterilized medical equipment and reusable devices.

 Hand washing and sanitizing: These procedures outline when, where, and how providers
should wash their hands and help reduce the spread of infection, targeting one of the most
significant areas of patient harm.

Of course, the reality is not all protocols and procedures are equally effective. They may take too
much time to follow or they may be unclear. Or perhaps there is a better way to reduce the risk
they are trying to address. What then?

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Simply not following the protocols and procedures is not the answer!

As a provider of safe patient care, you need to speak up if your organization’s safety protocols
are not working for you and your patients. Although we are well aware the act of speaking up is
not always easy, it’s a critical way for you to improve safety in your practice — so critical, in
fact, it’s our next behavior.

Behavior Two: Speak Up When You Have Concerns


Have you ever been in a situation where you see something not working or something unsafe?

Let’s go back to our scenario of the spilled milk in the grocery store. You probably know a
slippery floor is potentially dangerous, and you should report the issue. But maybe you’re in a
hurry or simply don’t want to be bothered. You may assume someone else will make the effort to
report the problem. Or, if you saw an employee inadvertently spill the milk, you may assume he
or she will clean it up, and not want to get him or her into trouble.

In health care, situations such as this can occur frequently:


 Something spills on the floor of a hallway
 A coworker fails to wash his or her hands before touching a patient
 A surgeon skips the pre-surgery checklist

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Deep down, you know you should speak up, but will you?

Watch this video in which a surgeon, Lucian Leape, who now teaches at the Harvard School of
Public Health, wishes someone had spoken up to prevent his mistake.
Here are several ways you can “speak up,” which can enhance the safety of the organization in
which you work.

 Identify and report issues with policies and procedures. If a policy or procedure is not
available, workable, intelligible, or correct, you should report it. As previously mentioned,
working around issues with policies and procedures does nothing to help you protect your
patients.

 Report unsafe working conditions, close calls, and adverse events. We know from
studying “high reliability organizations” — organizations that consistently perform complex
procedures safely and without error — that within these organizations staff members report
errors, elaborate experiences regarding near misses to learn from them, and treat any gap in
performance as a symptom that something might be wrong with their system. They recognize
that small errors can quickly lead to big ones, and when people’s lives are at stake, waiting for
“big ones” can be too late.

 Verbalize concerns. Perhaps the most difficult part of “speaking up” is doing it when it
matters most. If you see another member of the health care team do something that puts the
patient’s safety at risk, you should speak up. In most cases, patients do not feel like they have
a voice, or are not able to detect an impending catastrophe. Without you, a patient may have
no voice. Think about what you would want if you were in his or her shoes, and then do the
right thing.

While it is easy for us to say “you must speak up,” we know acting on this intention is not
always easy. Here’s what Dr. Berwick had to say about this.

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Behavior Three: Communicate Clearly

“If there were one aspect of health care delivery an organization could work on that would have
the greatest impact on patient safety, it would be improving the effectiveness of communication
on all levels — written, oral, electronic.”
-- Richard K. Croteau, MD

This quote comes from the former Executive Director for Strategic Initiatives for The Joint
Commission. In the 15 years since To Err Is Human, which we discussed in Lesson 1, The Joint
Commission has been studying trends of errors in health care to identify the most common root
causes and help focus improvement efforts. The findings show a clear place to start: An
estimated 80 percent of serious medical errors can be linked to miscommunication between
caregivers when patients are transferred or handed-off.

Can you imagine an air traffic controller or military scout not having an effective strategy to
ensure critical information is received and registered? As a provider, you should have a strategy,
too.

Just as a pilot would read back the correct runway to the air traffic controller before landing the
plane, you can write down and read back verbal orders before treating a patient. Even restaurants
practice read back with take-out orders, and read back should be used more prominently in
health care.

You also need a structured technique for delivering that information. One such technique –
developed by the author of this course, Doug Bonacum, inspired by his service in the US
Navy — is SBAR.

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SBAR, which stands for “situation, background, assessment, recommendation,” is especially


useful when you’re trying to communicate a complex set of facts so that the listener can make a
decision. Consider the following interchange between a doctor and nurse using SBAR:

Nurse Smith: Good morning, Doctor Singh. This is Amy Smith.

Doctor Singh: Good morning, Ms. Smith. What can I do for you?

Nurse Smith:

 Situation: I am calling about Mr. Gutierrez in Room 303. His breathing has become
increasingly labored over the last four hours, and he is now quite short of breath.

 Background: Mr. Gutierrez is post-operative Day 3 from a hip replacement. He has a


history of hypertension and congestive heart failure. He was doing well — both in his eating
and physical therapy program — until today. Now his respiratory rate is 26 (high), and his
oxygen saturation is 93 percent (low). I am concerned, of course, about both of these. His
lungs are crackly and he has taken in about a liter-and-a-half more fluid than he’s discharged.

 Assessment: My assessment is that he is fluid overloaded.

 Recommendation: I’d like to heparin lock his IV (to keep the IV catheter open and
flowing freely) and have you evaluate him as soon as possible. When can you come?

Doctor Singh: I am on my way. You should expect me in Room 303 to evaluate Mr. Gutierrez
in 15 minutes.

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As you can see from the previous exchange, when you give a well-crafted SBAR
communication, you give your colleagues the information they need to act quickly and the
assurance that you are taking control of the situation.

The Joint Commission recognizes effective communication with patients is also imperative. As
of July 2012, it’s added standards for patient-centered communication to its accreditation criteria
for hospitals.2

Listen to and honor patient and family perspectives and choices.

 Identify a patient and family’s knowledge, values, beliefs, and cultural background.

 Share complete and unbiased information with patients and families in affirming and
useful ways.

 Encourage patients and families to participate in care and decision-making at the level
they choose.

An Example of Inadequate Communication

Now that we have seen some concrete ways that you as an individual can improve
communication, read through the following example, which highlights the importance of
effective communication.

It is 3 AM. You are a senior anesthesia resident (physician-in-training) on call at a large hospital,
and you have been working non-stop since 6:30 AM the day before. You have just finished a
long surgery, and your beeper alerts you to a very sick patient from the Cardiac ICU (let's call
him Mr. H). You phone the surgery resident, and she gives you a detailed patient history, which
includes the fact that a surgical exploration of the patient is necessary to determine whether
blood has been cut off to his bowel.

You call the anesthesia attending (consultant) and assemble the team who will be caring for Mr.

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H. Several of the anesthesia residents get the operating room ready while another resident runs to
the Cardiac ICU to evaluate Mr. H and obtain an informed consent from his family.

You are keenly aware of the high-risk nature of this procedure. In your head, you quickly run
through some possible “worst case” scenarios in order to better anticipate complications. You
discuss these with your attending and your colleagues.

The patient arrives to the operating room and the surgery begins. Soon after the incision is made,
the diagnosis of ischemic bowel — where blood is cut off to the bowel — is confirmed. The
patient loses some blood and the decision is made to transfuse a unit of packed red cells. At the
same time, labs are drawn and, soon after, your team is alerted to a dangerously abnormal result.
Mr. H’s potassium is high and his creatinine (an indicator for kidney function) continues to
increase, showing signs of kidney deterioration.

The high potassium is a cause for concern. In a setting of worsening kidney failure and an
ongoing blood transfusion, Mr. H’s body is ill-equipped to eliminate the excess potassium. With
this in mind, your attending tells you to administer 10 units of insulin (in addition to the other
concurrently utilized potassium-lowering treatments). You reach for the insulin vial and draw 10
ccs. You then attach your 10cc syringe to the IV line and inject all of the insulin.

You are stricken with panic as you register what you have just done. You remember that each cc
contains 100 units of insulin. You just delivered1,000 units of insulin to an already compromised
patient.

You immediately inform your attending, and while one of you starts administering IV dextrose
— to counteract the insulin overdose — the other gets ready to draw the blood sugar level. You
inform the surgeon of the adverse event. After the surgery is completed, you transfer Mr. H back
to the Cardiac ICU and accompany the surgeon to speak to the family.

Mr. H’s glucose levels fluctuate over the course of the next few hours, but due to the continued

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vigilant blood glucose monitoring, Mr. H’s blood sugar levels never get dangerously low.
Nevertheless, his overall condition continues to deteriorate and Mr. H dies later that day.

You leave the hospital after a quick and awkward conversation with your attending and you feel
awful. You blame yourself for the drug error — after all, if you had just been more careful, this
would not have happened (and getting the strange looks from some of the residents and faculty
certainly does not make you feel better). You wonder why you went into medicine anyway and if
you will ever make a decent doctor.

Behavior Four: Take Care of Yourself

Have you ever gone to work when you were exhausted, feeling ill, or anxious about something?

Seems like a stupid question, doesn’t it?

Of course, we all have done that, and perhaps make a regular habit of it.

However, going to work when you are not feeling your best can lead to patient harm. For
example, a study of fatigue in operational settings found cognitive performance after 24 hours
without sleep is equivalent to performing with a blood alcohol level of 0.10.4

Think of it this way: It’s like being allowed to care for patients when you’re not functioning well
enough to offer them a ride home!

Unhealthy levels of stress can also degrade performance, and often go hand-in-hand with the
health care profession. Depending on specialty, the prevalence of physician burnout —
characterized by mild to severe exhaustion, cynicism, and inefficacy due to overwork or stress —
ranges from 25–60 percent among practicing physicians.

Fortunately, no matter who you are, small steps can go a long way toward reducing stress and the

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risk of burnout. For example, here are a few tips from the American Psychiatric Association
(APA) and other sources:

 Use self-restraint and try not to overextend yourself.


 Take daily time-outs for exercise, yoga, or meditation.
 Make time to connect with friends and family in a meaningful way.

We know it’s easy to put yourself last if you’re extremely busy caring for others, but keep in
mind that you owe it to yourself and your patients to show up “fit for duty” every day. It’s hard
to do your best when you’re not at your best, and keeping patients safe requires nothing less.

An Insulin Overdose

At the end of this activity, you will be able to:

 Discuss how errors in communication can lead to adverse events.

 Identify two systemic factors that can lead to medication errors.

 List at least two ways to change systems to prevent such errors.

Description: You are a senior anesthesia resident on call at a large hospital and suddenly find
yourself at the center of an avoidable medication error. You’re devastated and left wondering —
is it all your fault? In this case, we’ll consider a number of factors that might have contributed to
the drug error that occurred, as well as some possible ways in which the error might have been
prevented.

The Case

It is 3 a.m. on your call night. You are a senior anesthesia resident on call at a large hospital and
you have been working non-stop since 6:30 a.m. the day before. You have just finished a long
surgery and your beeper alerts you to a very sick patient from the Cardiac ICU. You phone the
surgery resident and she gives you the following patient history:

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Mr. H is a 78-year-old gentleman who was admitted to the cardiac ICU last night for an active
MI (myocardial infarction). On admission exam, his abdomen was found to be extended and
rigid and the surgical team is suspecting ischemic bowel for which an immediate surgical
exploration is warranted. Mr. H is intubated, his vital signs are currently stable on several
inotropes (IV drips supporting the heart function), and his kidney function has been getting
progressively worse.

You call your attending on call and assemble the team who will be caring for Mr. H. Several of
the anesthesia residents work on getting the operating room ready while another resident runs to
the Cardiac ICU to evaluate Mr. H and to obtain an informed consent from his family.

You are keenly aware of the high-risk nature of this procedure. In your head, you quickly run
through some possible “worst case” scenarios in order to better anticipate complications. You
discuss these with your attending and your colleagues.

The patient arrives to the operating room and the surgery begins. Soon after the incision is
made, the diagnosis of ischemic bowel is confirmed. The patient loses some blood and the
decision is made to transfuse a unit of packed red cells. At the same time, labs are drawn and,
soon after, your team is alerted to a dangerously abnormal result. Mr. H’s potassium is high and
his creatinine (an indicator for kidney function) continues to increase, showing signs of further
kidney deterioration.

The high potassium is a cause for concern. In a setting of worsening kidney failure and an
ongoing blood transfusion, Mr. H’s body is ill equipped to eliminate the excess potassium. With
this in mind, your attending tells you to administer 10 units of insulin (in addition to the other
concurrently utilized potassium-lowering treatments). You reach for the insulin vial and draw 10
ccs. You then attach your 10-cc syringe to the IV line and inject all of the insulin. You are
stricken with panic as you register what you have just done. You remember that each cc contains

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100 units of insulin. You just delivered 1000 units of insulin to an already compromised
patient.

1. What factors about this case made this error more likely to occur?

The circumstance described in the case was ripe for miscommunication and false assumptions.
For one, the anesthesia team was fatigued. For another, the patient was very sick and the surgery
would have posed a significant challenge to any team, even under the most optimal conditions.
The insulin was packaged in a way that was not useful to the OR team. An insulin vial contains
highly concentrated insulin (100 units/cc) since it is packaged for SUBCUTANEOUS use (where
much larger doses are required), rather than INTRAVENOUS administration. For intravenous
use, insulin needs to get diluted into a much lower concentration (usually 1 unit/cc). Thus, each
time anesthesiologists in the OR use IV insulin, they first need to physically dilute it. Doesn’t
this practice seem like a mistake waiting to happen, especially under the circumstances described
in this case?

2. Can you think of ways the same circumstances could have been prevented?

This is a good example of a systemic problem that requires a systemic solution to reliably
minimize a potential for future drug error. One possible approach might be to cease having the
concentrated insulin vials available in the OR pharmacy, and to have the pharmacists take over
the preparation of all diluted insulin solutions (for example, 100 units of insulin in 100 ccs of
fluid for a very user-friendly concentration of 1 unit/cc).
Let us consider a few other examples in which medication administration is made safer by
changing the system, rather than by solely relying on practitioners’ vigilance to ensure patient
safety. For instance, anesthesiologists utilize color-coded labels for medications so that each
commonly used drug family is printed on its specifically colored labels (red for paralytics, blue
for narcotics, gray for local anesthetics, etc.). Thus, even a quick glance at a syringe can be very
helpful in reducing the mix-up of the different drug categories (imagine administering a long
acting paralytic instead of a narcotic at the end of the surgery!).
Similarly, different concentrations of medications like Ketamine (a potent anesthetic) are

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packaged completely differently, by varying the vial size, color of the label, etc. None of these
strategies is meant to replace vigilance, but each can greatly augment the safety of our practice.
Safety means fully acknowledging that to err is human.

3. What communication challenges and failures contributed to this medical error?

The attending assumed that the senior resident was well aware of the insulin dosing and the way
insulin was packaged. The attending may have felt that reviewing the insulin dosing with this
seasoned resident would have been construed as an insult, or at the very least, as a statement of
the obvious.
Meanwhile, the resident might have felt uncomfortable confirming the appropriate dosing with
the attending. It is not uncommon for residents to fear being judged for asking “obvious”
questions. The working environment did not foster a level of safety where all questions were
welcome, as obvious as they may have seemed.

4. How could you improve communication on the unit to prevent a similar error from
occurring next time?

Although all U.S. residency programs now limit work hours, it is still likely that a clinician will
one day find herself tackling a complex situation when she is very fatigued. Given
circumstances like these, every member of the medical team must feel comfortable voicing his or
her concerns at any time.

In a hierarchical system like the medical residency training program, the person with higher
authority has a responsibility to establish a safe working environment. The attending, keenly
aware of everyone’s fatigue as well as the high stakes of this case, might have stated something
like this: “Insulin comes in 100 units/cc. We need to dilute it into 1 unit/cc before administering
it to the patient. How do you plan to do that?” Not only would this have clarified an important

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dosing point, but it would have also helped foster a safe environment in which all questions and
concerns were actively encouraged. Additionally, the team might have practiced closed loop
conversations so that everyone would have known when an important task was completed (“I
just gave 10 units of insulin”).

On the other hand, the resident might have somehow mustered the courage to ask how to
administer insulin. Although it may be difficult for a resident to ask what seems to be an
obvious question, it is even more difficult when a patient suffers as a consequence of not asking.

You immediately inform your attending and while one of you starts administering IV dextrose,
the other is getting ready to draw the blood sugar level. You inform the surgeon of the adverse
event. After the surgery is completed, you transfer Mr. H back to the Cardiac ICU and
accompany the surgeon to speak to the family.
Mr. H’s glucose levels fluctuate over the course of the next few hours, but due to the continued
vigilant blood glucose monitoring, Mr. H’s blood sugar levels never get dangerously low.
Nevertheless, his overall condition continues to deteriorate and Mr. H expires later that day.

You leave the hospital after a quick and awkward conversation with your attending and you feel
awful. You blame yourself for the drug error—after all, if you had just been more careful, this
would not have happened (and getting the strange looks from some of the residents and faculty
certainly did not make you feel better…). You wonder why you went into medicine anyway and
if you will ever make a decent doctor.

Discussion Questions

1. In this case, insulin was routinely distributed from the OR pharmacy in high
concentrations, thereby posing a great danger if administered incorrectly. Can you think
of an example in your own work environment where you thought to yourself, “This is a
disaster waiting to happen!”

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2. Now that you have identified examples from your work environment, take a
closer look at the suboptimal systems that may be at work. Why does this “disaster
waiting to happen” exist in your workplace? Is it because there is no reporting system for
such situations? Do the employees feel disempowered to change their workplace?
There are many possibilities.

3. Next, what are some ways in which those systems could be improved?

4. Let us assume that the resident caught her mistake before she injected the syringe
with insulin, so that no harm was done. We may think of such a scenario as a “near
miss” event. In many work environments “near misses” are greatly underreported, and
the opportunity to learn from them gets lost. If you are a clinician, can you think of a
“near miss” experience of your own? How did you change your practice as a result?

5. Mistakes and adverse events often trigger the “who” rather than the “how”
question, thereby fostering a blaming environment in which reporting mistakes and near
misses does not feel safe. Think of a mistake or near miss that you observed at work.
How was it handled? Did the organization’s response to the error make you more or less
likely to report your own mistakes?

6. If your answer to Question 5 was “less likely,” what could the organization have
done differently to make you more likely to report your mistakes

Making it Real
Now that we have taken a closer look at each of the four behaviors, consider the following real-
life example, which shows how an absence of those behaviors can lead to patient harm.

A certified scuba diving instructor was scheduled for elective ear surgery to address a problem
that had been causing him ear pain during dives. The surgery was expected to be routine. Per
hospital protocol, prior to the start of surgery, an OR nurse placed a plastic cup with topical
adrenaline and a metal cup with lidocaine onto the sterile field. This practice was not only a

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hospital policy but also a relatively common practice across the United States at the time. While
the nurse had recently read about the death of a seven-year-old boy in Florida as a result of
unlabeled medication containers on the surgical field, she had never seen it become a problem in
her experience.

The surgeon performing the procedure on the scuba instructor was highly regarded, but on this
day he was very tired. He had been on call the night before and gotten no sleep. He asked for an
injection of lidocaine to be drawn up so that he could numb the surgical area around the patient’s
ear, but his nurse was busy conducting a sponge count and did not hear him. He reached for the
container and began to draw up the medication himself. No one on the team observed him nor
could recall hearing that he was proceeding with the injection. As he was in the process of
getting the medication ready, the nurse distracted him with an issue concerning the sponge count.
This was resolved and the procedure continued.

Within seconds of the injection, the patient’s heart rate soared and he went into cardiac arrest. An
investigation showed that the syringe that was supposed to contain lidocaine actually contained
the topical adrenaline, a highly concentrated strength that was intended only for external use. The
patient was resuscitated, but he experienced some long-term neurological effects.

While this was obviously a flawed procedure — the unlabeled medication containers allowing
for the possibility of a mix-up — there were also “red flags” to the individuals in the operating
room that could have been observed and addressed, thus preventing a disaster.

Take a minute to write down two things you think might have been done differently by
individuals in the operating room to avert this situation, keeping in mind the four behaviors we
just discussed:

1. Follow safety protocols.


2. Speak up when you have concerns.

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3. Communicate effectively.
4. Take care of yourself.
Conclusion
Throughout this course, we have introduced the problem of medical errors, discussed how errors
can occur, and suggested a new way of responding to and preventing medical errors — by taking
a systems approach instead of an individual one. We have also encouraged you to incorporate
four critical behaviors into your practice. Although we learned you can’t always prevent errors
from occurring, these tactics can help reduce your chances of making an error and increase
patient safety. By taking this course, you have started on a journey toward improving the safety
of your patients.

Now, we ask that you continue this journey.

By taking additional courses in Patient Safety and in other IHI Open School topics, you will gain
a further understanding of medical errors, the causes of those errors, and system approaches to
preventing and/or mitigating the effects of errors. The more you learn, the more you will be a
resource to your patients and help ensure they remain safe while in your care.

As you continue learning about patient safety, please keep the voice of Susan Sheridan in mind.
Sheridan lost her husband due to a medical error and has a disabled son as a result of a medical
error. She recognizes it’s not all up to you — but there is a responsibility you bear in your
selected profession, and that is to “first, do no harm.”

1) Which of these is a behavior providers should adopt to improve patient safety?

a) Develop ways to work around broken systems

b) Ignore patients’ individual preferences when they disagree with “best practice”

c) Follow written safety protocols, even if they slow you down

d) Obey your superiors without question

e) All of the above

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c) Follow written safety protocols, even if they slow you down
Safety protocols are in place for a reason, and you should follow them, even if they slow
you down. Sometimes there will be a problem with a policy or procedure, in which case you
should report it, rather than inventing a “workaround” (a method to circumvent a problem
without fixing it). Likewise, you should speak up if you believe any colleague — supervisors
included — is threatening patient safety. Part of patient-centered care is respecting patient
autonomy, even if it means considering different treatment approaches than what you would
normally consider “best practice.”
After a team training system is implemented in an operating room (OR), a junior circulating
nurse notices that a particular anesthesiologist goes missing from the OR at odd times, often
seems sluggish, and occasionally slurs her words. Concerned that the physician might be
impaired due to medication abuse, the nurse ponders what to do next.

2) What would be the MOST appropriate way for the nurse to respond?

a) Call the physician at home and warn her to stop abusing prescription medication

b) Refuse to work with that physician in the future

c) Start logging the suspicious occurrences as he sees them, so that he can bring a list to the
medical director

d) Talk to the medical director now, in confidence

e) Warn colleagues about working with that physician

d) Talk to the medical director now, in confidence

The junior nurse should speak up now that he has a concern, and he should tell someone
who is in a position to improve the situation for the entire hospital, such as the medical
director. Warning friends or refusing to work with this physician does not protect the patients of
this doctor. Speaking with a person in authority is the best option in this difficult situation.

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Linda, a pharmacist at an outpatient pharmacy for a medium-sized medical group, receives a call
from John, a nurse practitioner in the cardiology clinic. John tells Linda he needs to call in a new
prescription for hydrochlorothiazide at 50 mg once a day for Ms. Krane. At the end of the
conversation Linda says to John, “Okay, so you want Ms. Joanne Krane to have a new
prescription for hydrochlorothiazide at 50 mg by mouth once a day. Thirty pills and six refills.”

3) What has Linda just done?

a) Increased the likelihood of error by repeating an order

b) Provided a read back

c) Used SBAR in communication

d) B and C

Correct Answer:b) Provided a read back


This is a read back, which is used to confirm receipt of information (SBAR is a system for
delivering information). The pharmacist went through the step of verbally verifying the order
from the nurse practitioner by repeating it back to him, which can catch mistakes. The additional
time that a read back requires is not a waste. In fact, it may make work more efficient by
decreasing the need for later calls for clarification.

4) “SBAR” stands for:

a) Situation-Background-Assessment-Recommendation

b) Situation-Behavior-Assessment-Recommendation

c) Situation-Behavior-Action-Report

d) Situation-Background-Answer-Report

Correct Answer:a) Situation-Background-Assessment-Recommendation


SBAR stands for Situation-Background-Assessment-Recommendation. It is an adaptation of
a U.S. Navy communication technique and can be a very effective means to communicate urgent
patient care issues.
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5) When it comes to self-care, which of the following statements is true?

a) If you’re especially stressed because of a divorce, it may adversely affect your


performance

b) Lack of sleep can be similar to being drunk

c) Spending quality time with friends can make you a safer health care provider

d) All of the above

Correct Answer:d) All of the above


The best answer is all of the above. One study found that cognitive performance after 24 hours
without sleep is equivalent to performing with a blood alcohol level of 0.10. In addition to
getting sleep, managing your stress, such as by spending time with friends and family, is
important to maintaining a high level of functioning when you’re on the job. If you’re going
through an especially difficult time, such as going through a divorce, acknowledging and telling
others about the stress you are under is part of being a good team member, and it will help
improve patient safety.

Janet is a new physical therapist on the orthopedic surgery unit. Although learning a new
position has been exhausting and somewhat stressful, she remains excited about the opportunity,
and two weeks into her new job she has already volunteered to take on extra patients while a
colleague is away. Today, she has 16 patients, one of whom is George Martinez. He is a 47-year-
old man who had a left knee replacement two days ago. She goes to see Mr. Martinez in Room
six. For privacy reasons, patients’ first names are not listed outside the doors on Janet’s unit, so
she does not realize she is walking into the wrong patient’s room, and she does not check the
patient’s name on his wristband as protocol indicates she should. She is now in the room of Rudy
Martinez, a 56-year-old man who had an emergent left knee repair yesterday for a torn meniscus.
Janet starts to bend his knee, causing him to yell in pain. Worried, Janet finds George Martinez’s

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nurse and tells her about the situation and background of the problem, as well as her assessment
that something must be wrong.

6) Which of the four critical behavior(s) did Janet violate?

a) Communicate effectively

b) Follow safety protocols

c) Speak up when you have concerns

d) Take care of yourself

e) A and B

f) B and D

Correct Answer:f) B and D


The best answer is B and D. Janet neglected to follow an important safety protocol, which
likely had to do with the fact that she was not taking great care of herself, by failing to
recognize her limitations and taking on too much, too soon. As a result, Rudy Martinez suffered
unnecessary pain. At the same time, however, Janet effectively spoke up and communicated her
concerns as soon as she perceived a potential problem. Hopefully this will prevent something
worse from happening to either George or Rudy Martinez.

Human Factors

At the end of this activity, you will be able to:

 Identify human factors in everyday settings.

 Discuss how such human factors contribute to errors.

 Develop strategies to minimize or prevent error in a variety of settings.

Description: Maybe the floor’s wet and slippery. Maybe the cash register is confusingly
labeled. Maybe medications are hard to tell part. Everywhere you look — both in health care and
in ordinary retail settings — you can spot circumstances that make it easy for regular people to
make istakes. In this exercise, you’ll go out and analyze everyday situations to determine what

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human factors issues are at play. You’ll also decide what nterventions should be introduced to
minimize the opportunities for mistakes.

Have you ever driven home when you were tired, and, upon arriving safely in the driveway,
realized you couldn’t remember making a specific turn? The human brain works in mysterious
ways at times. The brain has a protective mechanism, an “autopilot” function that protects you
from your own fatigue by ensuring you do something the way you usually do it. Of course, this
can work against us. Sometimes the autopilot kicks in when we don’t want it to, steering us in a
different direction than we intended to go.

When our actions are not carried out as intended, it may be related to human factors –how our
human brain processes information and functions when affected by external and internal
conditions. When we’re not functioning at our best physically or emotionally – and when we’re
in an environment that affects our thinking and decisionmaking processes – errors can result.
Human factors that contribute to an error can be addressed by using strategies to minimize or
prevent risk.

In this exercise, you are asked to complete an analysis of day‐to‐day situations to determine if
human factors issues exist. You should consider the interventions that have been or should be
introduced to minimize the opportunity for errors. Here are some examples of such interventions:

 Before dispensing your cash, an ATM machine beeps and spits out your card so you
won’t leave it behind.

 You can’t put your car in gear unless your foot is on the brake – a design feature that
prevents you from shooting forward accidentally.

Next, you should visit a health care setting looking for human factors issues and remedies. One
example:

 Many medications have similar names or look alike, and sometimes patients get the
wrong doses as a result. To remedy this problem, some hospitals bar‐code medications
and train pharmacists and nurses to scan them before they’re dispensed and administered.

Through this exercise, you will gain an awareness of human factors issues that many of us face
daily. Raising awareness of these issues and sharing what we learn with our peers will help us
develop safer systems.

Instructions and Report-Out

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Visit any of the following:

 Restaurant

 Coffee shop

 Transportation system

 Retail store

 Hotel

 Major intersection

 Library

 Health care setting

Take note – can you spot human factors issues that create opportunities for errors?

 What processes rely on memory?

 What tools can be used to eliminate the need to rely on memory?

 How well would the processes you observe work if the individual involved were tired?
Distracted?

 What types of errors might occur? How would someone know if these error(s) had
occurred?

 Are there steps that can be skipped or bypassed? Is this a good or bad design? Why?

 Would a new person be likely to make more, less or the same number of errors as an
experienced person? Why?

 Are there systems in place—or that should be in place—to minimize the opportunities for
error?

Group Discussion

Discuss the human factors issues identified and the types of processes and tools put in place to
decrease the risk of error (e.g., barcode scanning). Discuss the following:

 What human factors issues did you identify?

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 Are processes/tools in place to reduce the opportunities for error?

 How do these reduce the risk of error?

 What types of errors could occur with these processes and tools?

If you did not observe human factors in a health care setting, consider the following questions:

 What are some examples in health care where similar processes and tools might also be
helpful? Why?

 What are some examples in health care where these processes and tools would not be
helpful? Why?

Case Study: Reconciling Doses

Learning Objectives: At the end of this activity, you will be able to:

 List the steps involved in medication reconciliation.  Describe the role of each of the
stakeholders in medication reconciliation.  Discuss how medication reconciliation
decreases the opportunity for medication errors and harm. Description Faced with a
patient who’s too confused to remember his medication regimen, a care team administers
an overdose of the anticoagulant Warfarin.

Key Topics
Care coordination and transitions, engage patients and families in care, health
information technology, health information technology: electronic health record, hospital
operations: discharge planning, reliable processes, transitions in care, medication safety,
medication safety: medication reconciliation.

Case & Commentary: A 68-year-old man with a history of diabetes and atrial fibrillation
maintained on warfarin presented to the emergency department (ED) with fever and
mental status change. Lumbar puncture was attempted three times without success;
empiric treatment for meningitis was started. Further examination revealed an area of
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cellulitis, and intravenous antibiotic therapy was changed accordingly. At the time of
admission, the patient was unable to recite his medication history, and his wife was
unclear about the doses. However, the EMS run-sheet had a list of the patient’s
medications and doses. The patient was started on the medication regimen per the EMS
report. Medication reconciliation is defined as the process of collecting the best
medication history possible, verifying the list, and comparing it to orders written at
admission, transfer, and discharge. Although reconciliation is always useful, it is
particularly crucial when patients are unable to provide a complete and accurate
medication history or when the history is not available to those who must make treatment
decisions. Evidence supporting the need for and the value of medication reconciliation is
strong. More than half of all medication errors occur at the interfaces of care. A review of
22 studies by Canadian researchers found (in the absence of reconciliation) errors in up to
67% of patients’ prescription medication histories. Researchers at Johns Hopkins
reported that an average of ten prescriptions needed to be changed weekly in the ICU
after errors were identified through a reconciliation process. Implementation of a
successful medication reconciliation process ensures that each of the members of the
health care team has access to the list of medications that the patient was taking prior to
admission, what was ordered at transitions of care, and a method to communicate an
intentional medication change or discontinuation. Rather than hoping that a medication
was appropriately discontinued and not overlooked, this intervention provides a process
to facilitate and standardize communication. The value of medication reconciliation has
been demonstrated “on the ground” by a number of institutions, most prominently Luther
Midelfort Hospital, a Mayo affiliate. Based on this work and the data cited earlier,
medication reconciliation has been one of the recommended changes for teams
participating in Institute for Healthcare Improvement collaboratives to reduce adverse
drug events. Accordingly, when the IH launched its 100,000 Lives Campaign to promote
six changes proven to improve patient care and prevent avoidable deaths, medication
reconciliation was chosen as the focus of efforts to reduce adverse drug events.
Moreover, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)
also selected medication reconciliation as one of its 2005 National Patient Safety Goals.

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An important step in the process is to collect the best medication list possible. Many
patients can and do provide accurate medication histories. When, as in this case,
cognitive, cultural, or other barriers prevent them from being able to provide an accurate
medication history, it is important to identify effective ways to collect this history,
accepting that the list may initially be incomplete. Interviewing family members and
contacting primary care physician offices and local pharmacies may improve the
accuracy of the list. Some hospitals have worked with ambulance staff to remind them to
pick up prescription bottles or medication lists that may be attached to refrigerators or
medicine cabinets. Each organization should have a process to continually improve the
system for collecting this medication history.

Case & Commentary: After 2 days, the patient was transitioned to Augmentin. While in
hospital, the patient had been receiving 5 mg of warfarin at bedtime, which, according to
the EMS intake sheet, was his usual outpatient dose. The team did not confirm this dose
with the patient’s family, primary physician, or pharmacy. At the time of discharge, his
INR was noted to be 4. Realizing the warfarin dose was too high, the team instructed the
patient to decrease his dose to 3 mg at bedtime and to have his INR rechecked in 3 days.
After 3 days, his INR was 10. He was treated with vitamin K. Two days later, the patient
returned to the ED with back pain, lower extremity weakness, and incontinence. He was
found to have an epidural hematoma, which was emergently evacuated. One week post-
operatively, the patient still had neurologic deficit. Implementing a medication
reconciliation process may represent a change in work flow, requiring more time from
staff members. But organizations should be encouraged by those who have successfully
implemented a medication reconciliation process as part of a larger medication safety
program. To implement a successful medication reconciliation process, organizations
should first examine the system presently in place. Using a high-level flow diagram may
be helpful in determining the different entry points into the hospital. An example can be
found here. A similar diagram for transfers and discharges will help the team understand
what is in place and how to develop a system to support medication reconciliation at each
stage.

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It is necessary to have a champion and a multidisciplinary team to work on testing


different changes that will lead to the desired system. A useful instrument to record the
team members and their roles is available here. Senior leadership support is necessary to
align the process with other hospital initiatives, provide resources for the project during
its development, and remove barriers. Due to the many entry points for admission into a
hospital, each hospital’s different levels of care, and each hospital’s varied populations,
there is no one way to implement this process throughout the hospital. Accordingly,
organizations cannot expect to roll out a reconciliation process overnight. Using a proven
improvement methodology (eg, such as the “Model for Improvement”), hospitals can test
and implement changes in different settings, using the results of these experiences to
inform dissemination. Medication reconciliation is a multidisciplinary process. Selecting
who should be involved in each step along the way should be based on available
resources and who can best complete the task. For example, a physician, nurse,
pharmacist, or pharmacy technician can collect the medication history. Although
pharmacists have been identified as being more effective in taking such a history, there is
no reason that they cannot train others to do this well. An effective model may be one in
which nurses collect a medication history, pharmacists verify the information, and
physicians use the resulting list to aid in making decisions about drug therapy. Physicians
also complete the last step described: document reasons or intentions to discontinue,
change, or hold medications in a manner that is clear to all. Forms to collect medication
histories have been employed by many organizations. Some have adapted the forms to
serve as both a medication list and an order form. Adding columns indicating whether a
medication should be continued, discontinued, or placed on hold minimizes re-writing
and facilitates communication among disciplines. This model may not be effective in all
organizations. As with any new process, hospitals must determine if the changes
introduce new opportunities for errors. Forms have also been used in the transfer and
discharge process. Placing the list in a prominent place in the chart or using colored paper
facilitates access to this information. Several examples of useful forms can be found on
the Web sites of the Institute for Healthcare Improvement and the Massachusetts

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Coalition for the Prevention of Medical Errors. To complete the process of medication
reconciliation, at the time of discharge, the discharge prescriptions must be reconciled
with the most recent inpatient orders and the patient medication list prepared at
admission. This comparison is useful to screen for therapeutic duplication, possible drug
interactions, omissions, or medications not ordered during the inpatient stay. Technology,
if well designed and implemented, can be a useful adjunct to medication reconciliation.
Systems whose electronic medical records allow medication histories to be downloaded
from an electronic nursing documentation system onto a form reduce the time-consuming
and error-prone process of manually completing forms. At discharge, reformatting the
patient medication profile from the pharmacy system into a prescription form can
streamline the discharge prescription process. Patients can play a significant role in
helping to design a process as well as being active participants in medication
reconciliation. Organizations such as McLeod Health in South Carolina have engaged
patients in developing a state-wide universal medication form. Individually, patients
should be encouraged to carry their medication lists and present them at each health care
visit. An example of a patient medication card, which can facilitate this process, can be
found here. Getting Started Implementing a robust program of medication reconciliation
should not be viewed as necessary to meet the regulatory or accreditation requirements
but, rather, as a patient safety initiative. The patient should be at the center of this work.
A successful medication reconciliation process is one in which all stakeholders are
accountable for its implementation, spread, and sustainability. Here are some practical
tips for getting an effective program up and running:  Start with a small segment of the
population. The process of collecting the medication history and writing orders for
elective surgery patients will be different from that for patients admitted through the ED
or a nursing home.  Evaluate the current system.  Identify who should participate in
each step of the process and define the responsibility of each position. For example,
nurses or pharmacists may be used to collect a medication history based on available
resources.  Determine when reconciliation should be applied at transfer. Medication
reconciliation applies if medications are reordered or there is intent to change treatment. 

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Select/create the forms. This is best done on paper, at first, even if the ultimate intent is to
computerize the process.  Test changes in each area.

Organizations must use a measurement strategy to determine the effectiveness of the


process that has been implemented. For example, measuring the fraction of unreconciled
medications at different transfer points can help those involved understand how well the
process is working. Take-Home Points  Medication reconciliation is an effective process
to reduce errors and harm associated with the loss of medication information as patients
transfer through different levels of care.  In order for medication reconciliation to be
successful, all stakeholders must be involved.  Collect the best medication history
possible, verify that history, and ensure that the information is available at the point of
order writing.

Hospitals should develop different processes to support medication reconciliation based


on patient entry points into the hospital and available resources.  Patients can play a vital
role in medication reconciliation by carrying an up-to-date medication list and making it
available to each provider they encounter.  Medication reconciliation should be applied
any time medication orders are re-written or there is a change in treatment plan. 
Reconciliation at discharge is necessary to avoid therapeutic duplication, drug
interactions, and omissions of medications that may have been discontinued or placed on
hold during hospitalization.  Many hospitals have successfully implemented
reconciliation using low-technology solutions (eg, forms) rather than computers.

Medications like Warfarin require close monitoring to ensure the patient is taking the
correct dose. The Joint Commission issued a Sentinel Event Alert related to
anticoagulants in September 2008. In addition, Goal 3E of the 2008 National Patient
Safety Goals also addresses anticoagulation safety. What steps has your healthcare

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facility taken to avoid medication errors involving warfarin or other anticoagulation
drugs?

2. The article discusses several ways to obtain information to complete medication


reconciliation. Can you think of any other ways you could obtain information?

3. How long should a healthcare facility have to complete medication reconciliation at


admission, transfer, and discharge?
4. The case isn't very clear about what strength of tablets the patient had at home or was
prescribed. It appears he had 5mg tablets at home. He was instructed to take 3mg tablets
at home. Discuss the potential pitfalls of altering a patient’s dose and medications at
discharge.

5. Technology, if well designed and implemented, can be a useful adjunct to medication


reconciliation. At the same time, patients need to take more ownership of their
medication list. What should the medication list of the future look like? Should it be
paper and be kept in your purse or wallet, stored on a portable hard drive, credit card that
can be swiped, available online, etc.? Discuss the pros and cons of these various methods.
Activity Use the example of the workflow discussed in the case to document the existing
workflow from multiple entry points (i.e. ER, elective surgery, etc.) Medication
reconciliation is a multidisciplinary process. Identify and discuss who currently
completes the medication history and reconciliation process at your healthcare facility.
What are the pros and cons of each of these providers taking part in this process? Look at
aspects like time, cost, knowledge, etc

Disruptive Behavior: The Controlling Boss


 Describe how disruptive behavior can lead to patient harm.
 Discuss the importance of responding to disruptive behavior in health care.
 Determine the steps you would take if you experienced or witnessed disruptive
behavior in your local health care setting.
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Description Physician Kevin Stewart explains how he accidentally hurt a patient when he
was trying to avoid a confrontation with his foul-tempered supervisor. He then offers
advice for people who find themselves on the receiving end of disrespectful behavior
Discussion

Questions 1. Why do you think health care professionals may behave disrespectfully
toward their colleagues?
2. Come up with two ideas for how to eliminate disruptive behavior.
3. Have you ever had a controlling boss? How did you deal with it?
4. Pretend you are a resident in a local hospital and you witness a senior physician yelling
at a nurse. What steps would you take to address the situation?

Learning from Medical Errors (Part 1)


At the end of this activity, you will be able to:

 Give examples of errors that clinicians have made in their patients’ care.

 Discuss the range of feelings providers can have in the aftermath of a medical error.

 List factors that contribute to errors in the medical setting.

Description: A patient suffers horrible burns. An operation takes twice as long as it should. A
child dies from internal bleeding. Errors like these, unfortunately, still happen in health care.

What is one error that you’ve made? What did you learn from it? What can others learn from it?
In this video, prominent clinicians describe the errors that still haunt them today — and point out
ways those errors could have been prevented.

Discussion Questions:

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1. What is an error you (or someone you know) made in a health care setting? What
did you learn from it? How might it have been prevented? (If you can’t think of a medical
error you’ve experienced, talk about any significant error you’ve made in your life.)

2. Lucian Leape’s story centers around a decision that was based on unambiguous
findings in the medical literature. Was his error truly an error, then? Why or why not?
Kathy Duncan says competent care providers often get flustered during emergencies and
don’t take basic safety measures. Imagine you’re the CEO of the hospital where
Duncan’s error (burning a patient with an unpadded defibrillator) occurred. What might
you do to ensure no one in your hospital would ever make this mistake again?

3. In his story, Michael Leonard talked openly with his patient’s wife about the error
in her husband’s care. If you were a member of that patient’s family, how would you
have reacted to the information? Would you want your loved one to continue to receive
care at that facility? What would be your primary concerns in the aftermath of the error?

Learning from Medical Errors (Part 2)

At the end of this activity, you will be able to:

 Give examples of mistakes that clinicians have made in their patients’ care.

 Discuss the range of feelings providers can have in the aftermath of a medical error.

 List factors that contribute to errors in the medical setting.

Description: A baby falls gravely ill after a botched blood transfusion. A student nearly commits
a medication error. A patient dies after a clumsy surgery. Errors like these, unfortunately, still
happen in health care. In this video, current and former clinicians (including IHI’s Former CEO,
Don Berwick) describe the errors that still haunt them today — and point out ways those errors
could have been prevented.

Discussion Questions:

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1. At the end of his story, Allan Frankel lists “so many things that could [have been]
different,” including better communication, teamwork, planning, discussion, checklists,
and system reliability. Listen to his story again, and pinpoint all the places where each of
these improvements could have made a difference.

2. Imagine you’re in charge of the hospital where Kevin Knoblock works. What will
you do to ensure no one misreads medication instructions the way he did? How much
should you rely on your staff members’ personal efforts to try harder?

3. Don Berwick says he felt too guilty to discuss his mistake with his colleagues and
the hospital’s managers. If you made a serious mistake that affected a patient, what
circumstances would make it easier for you to admit it openly? What circumstances
would make it harder?

What Happened to Josie?

Learning Objectives: At the end of this activity, you will be able to:

 Discuss factors that contribute to avoidable patient harm, even at renowned facilities.

 Explain how patient-centered care can help prevent adverse events.

Description: In 2001, 18-month-old Josie King died of dehydration and a wrongly-administered


narcotic at Johns Hopkins Hospital. How did this happen? Her mother, Sorrel King, tells the
story and explains how Josie’s death spurred her to work on improving patient safety in hospitals
everywhere.

Discussion Questions

1. What factors contributed or may have contributed to Josie King’s death?

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2. With those contributing factors in mind, how could Josie’s death have been
prevented, and what process changes would you recommend to prevent a similar tragedy
from occurring?

3. How could the hospital and its providers have given Sorrel King more power over
how Josie was treated?

4. Put yourself in the shoes of one of the clinicians who cared for Josie. How would
you have reacted when Sorrel said, “You did this to her and now you must fix her”?

5. If you plan to be a clinician, what are specific things you can do to make patients
feel respected and included in decisions about their health care?

Don't Push

Learning Objectives: At the end of this activity, you will be able to:

 Describe the delicate balance of effectiveness and safety when it comes to powerful
drugs.

 Discuss the ways protocols can be helpful and whether they can at times be problematic.

Description: IV haloperidol to manage psychosis in an AIDS patient causes polymorphic


ventricular tachycardia (‘torsade de pointes’), necessitating a transvenous pacemaker. Was the
patient’s treatment appropriate? Read the Case Study and commentary, and form your own
opinion.

The Case

A 37-year-old HIV-positive woman was brought to the emergency room by her family because
she had exhibited altered mentation for 3 days. The patient had been diagnosed with HIV

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infection 3 years earlier. Her opportunistic infections included thrush and Pneumocystis
carinii pneumonia (PCP). She had never received highly active antiretroviral therapy (HAART).
Nevertheless, her lowest CD4 count was 560 and her viral load was low. The patient did not
have any significant past surgical or psychiatric history. Medications on admission included only
trimethoprim/sulfamethoxazole [Bactrim] for PCP prophylaxis.

The patient’s mental status deteriorated rapidly after admission: she tossed about on her bed and
had visual and auditory hallucinations. Per the hospital’s safety protocol, the planned lumbar
puncture was put on hold because of her agitation. Neurology and psychiatry consultations were
sought. The psychiatry team recommended haloperidol administered via intravenous (IV) push 5
mg every 20 minutes until sedation was achieved, so that the neurologist and psychiatrist could
evaluate the patient. However, after 3 doses of haloperidol, the patient’s face turned pale and she
started gasping for air. The patient was connected to a cardiac monitor on a crash cart, which
showed polymorphic ventricular tachycardia ("torsade de pointes") (See Below Figure).

The patient received IV magnesium sulfate immediately. In the cardiac intensive care unit, she
required placement of a transvenous pacemaker. She was able to return to a regular medical floor
1 day later, and her mental status improved without any intervention over the subsequent week.

The Commentary

The almost fatal outcome in this case directly resulted from treatment with high and frequent
doses of haloperidol, administered according to a commonly used critical care protocol that calls
for multiple, sometimes escalating doses of the drug, at 15-20 minute intervals.(1,2) The issue
here is whether such a protocol was appropriate and whether it provides the best balance of
effectiveness and safety, given the large number of new, "atypical" antipsychotic agents now
available.

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Because this patient had no significant psychiatric problems prior to developing an unspecified
change in mental status, hospitalization was indicated to rule out an opportunistic central nervous
system (CNS) infection, metabolic derangement, or other cause of delirium. It would be helpful
to know whether she was already experiencing psychotic symptoms prior to admission or
whether definite signs of an organic process, such as confusion and disorientation, were evident
during the evaluation. A recent onset of psychosis without organic symptoms would be much
less worrisome.

The prevalence of psychosis during the course of HIV infection ranges from 0.5%-15%.(3) It
may be independent of HIV encephalopathy or dementia, or may be the result of an underlying
vulnerability to becoming psychotic under stress. This woman is at the upper age of risk for
developing schizophrenia but well within the prime age range for a first episode of mania. The
stress of being HIV positive and attendant changes in social and work function can contribute to
the emergence of vulnerability to these disorders.

Had psychotic symptoms alone been present during the evaluation or right after admission, it
would have been appropriate to administer one of the atypical antipsychotic drugs (eg,
aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone) orally, instead of oral,
intramuscular (IM), or IV haloperidol or other older, "typical" antipsychotic drugs. Clozapine is
a second-line treatment, reserved for patients who fail to respond to one or two of the other
atypical antipsychotic drugs. The distinction between typical and atypical antipsychotic drugs
relates to their capacity to cause extrapyramidal symptoms (EPS); the atypical drugs are much
less likely to produce these adverse effects. Because patients with AIDS are more susceptible to
developing EPS (4) (possibly because AIDS compromises the dopaminergic and cholinergic
systems required for normal motor behavior [5]), atypical antipsychotic drugs are the treatment
of choice for HIV-related psychoses (6,7), with or without dementia. Clozapine produces the
least EPS of all of the agents, and has been used in HIV-positive patients, despite its ability to
cause agranulocytosis in about 0.7% of individuals.(8)

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Oral antipsychotic medications require days to weeks to take effect. Intramuscular medication
reaches the brain within 30 minutes (intravenous injection does so within minutes), but only
haloperidol and ziprasidone are currently available and FDA-approved for IM use. Three issues
must be considered in choosing between them: (i) the risk of torsade de pointes; (ii) the risk of
EPS; and (iii) cost. Given repeatedly, IM haloperidol, 5 mg-10 mg, and IM ziprasidone, 20 mg,
produce virtually the same increases in QTc interval (2.2 ms). Intramuscular ziprasidone
produced greater improvement in agitation and psychopathology with fewer EPS than IM
haloperidol (9), and is therefore the preferred choice when control of agitation within 20 minutes
to 2 hours is sufficient. Intramuscular olanzapine (Zyprexa®) is expected to receive FDA
approval in the near future; it represents an equally preferable choice to haloperidol in this
setting.(10) If sedation is required within minutes, IV lorazepam may be added.

No case of torsade de pointes from ziprasidone has been reported even though more than
450,000 people have received the oral formulation (A. Loebel, MD, oral communication, Pfizer
Inc., September 2003). This suggests the risk is low. Since IM ziprasidone costs approximately
20 times more than IM haloperidol, ziprasidone will likely prove cost effective only in subgroups
of patients at high risk for adverse effects from haloperidol, such as AIDS patients.

The limited mental status data provided in the case summary made the need for rapid and deep
sedation difficult to determine. The patient is described as "tossing in her bed" which, unless she
was restrained, suggests no more than moderate agitation, no intent to harm herself or others, and
enough cognitive intactness to avoid wandering. The severity of visual and auditory
hallucinations is not described, but, even when severe, these are not considered justification for
IV haloperidol push therapy. Consequently, an atypical antipsychotic (administered IM or
possibly orally) would likely have been adequate here, especially since limb restraints could be
added if necessary.

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In my opinion, IV haloperidol push treatment (1,2,11-14) to achieve rapid sedation of agitated


psychotic patients to facilitate medical work-up is generally problematic. The initial basis for
this practice was small, uncontrolled studies, which indicated that massive doses of IV
haloperidol were sometimes necessary and well tolerated.(11,12) This evolved into widely
adopted recommendations for giving IV haloperidol at doses of 2 mg IV (range 0.5-10 mg) and
doubling the dose every 20 minutes until adequate control is achieved.(1,2) Dissemination of this
practice has been accompanied by numerous case reports of torsade de pointes (14-16), with an
incidence of 3.6% in one series.(16) Given the clear risks, more evidence is needed before
recommending high-dose IV haloperidol rather than giving lower doses a chance to work.

If high-dose IV haloperidol is to be used, or might become a possibility, baseline QTc interval


and serum magnesium and potassium concentrations should be measured.(14) If the baseline
QTc interval is 440 ms or longer, and patients have electrolyte disturbance or are receiving other
drugs which might prolong QTc interval, IV haloperidol should be given cautiously. Continuous
cardiac monitoring during the course of IV haloperidol push therapy is warranted.(1,2,14) Of
note, another butyrophenone, droperidol, was withdrawn from clinical use because of the high
rate of torsade de pointes in critical care patients.

Was it correct to discharge this patient without any antipsychotic treatment after her mental
status improved? The rapid improvement suggests that the psychotic symptoms were not related
to underlying schizophrenia or mania. There is too little information to draw firm conclusions
about the basis for the mental changes that preceded hospitalization. Most likely, this was a case
of HIV psychosis, not the sign of an adventitious CNS infection. In such cases, with the
psychosis clearing so rapidly, prophylactic treatment with an antipsychotic drug is probably not
indicated. However, education of the patient and family to watch for early signs of psychosis or
other forms of psychopathology would be indicated to avoid another costly and potentially

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dangerous visit to an emergency room. Recurrent psychotic episodes would necessitate
continuous treatment with one of the newer antipsychotic drugs.

Take-Home Points

 Obtain a detailed history of the type and temporal course of mental status changes in
HIV-positive patients before initiating medical workup and treatment of the changes.

 Treat psychotic symptoms in HIV-positive patients with low oral doses of an atypical
antipsychotic drug, such as aripiprazole, olanzapine, quetiapine, risperidone, or
ziprasidone (or offer IM ziprasidone), depending on the clinical status of the patient and
need for rapid control.

 If sedation is truly urgent for medical or safety reasons, use IV push haloperidol but
attempt to keep the dose as low as necessary.

 Pretreatment ECG, measurement of QTc, and ongoing monitoring for development of


torsade de pointes throughout course of treatment with IV haloperidol and during
recovery is indicated.

 Efficacy and safety of IM ziprasidone vs. IV haloperidol need to be studied in


randomized clinical trials.

Figure

Electrocardiogram showing torsade de pointes. Torsade de pointes, which generally occurs in


patients with prolonged QT intervals, is characterized by QRS complexes that change amplitude
and direction, or "twist."

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Discussion Questions

1. Map the process that led to this patient being harmed, including the harm(s) itself.
Where does your process map begin? Where does it end? See IHI.org for resources on
process mapping.

2. This case involves communication between teams, namely the primary team and
the psychiatry and neurology consultation teams. Even though the details of the
communication are omitted, what aspects of teamwork impacted this patient's care? Was
the impact positive? Negative? What challenges do primary teams face when seeking and
deciding whether to follow management recommendations from consultant services?

3. What role does this hospital’s "safety protocol" play in this case? Was harm
avoided by its being in place? Discuss the ways protocols can be helpful to improving
patient care? In what ways might protocols be ineffective interventions or even obstacles
to improvement?

4. This patient was diagnosed as having delirium (a state of decreased level of


alertness and connectedness with one's immediate environment that often comes with
delusions and hallucinations). Often, delirium that arises on a general medical floor (as
opposed to a psychiatric unit) is managed with medications (as in this case) but also with
physical restraints (not employed in this case). While physical restraints restrict certain
rights of patients, they also serve to protect them from themselves by, among other
things, limiting the amount of medication needed to control agitated behavior. Should
physical restraints be considered "harm"? Are they safer or less safe than using

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medications first to manage delirium? How would you go about teaching non-mental
health care specialists how to use restraints safely and effectively?

5. Upon review of this case, an "interdisciplinary adverse event review committee"


was alarmed by the fact that this patient was administered IV haloperidol without
simultaneous cardiopulmonary monitoring (e.g., telemetry). The committee has asked
you to chair an "improvement team" to rectify this situation. What steps would you take
to ensure that the next patient administered IV haloperidol in your hospital would be
connected to appropriate cardiopulmonary monitoring?

6. If you were a member of the team caring for this patient, how would you explain
what happened to her? Is an apology warranted? Since polymorphic ventricular
tachycardia is a known complication of using IV haloperidol, when it occurs, does it
constitute an “error”?

Glucose Roller Coaster

Learning Objectives: At the end of this activity, you will be able to:

 Explain why good communication is critical to patient safety.

 Identify risks associated with “cross-coverage” and “signout.”

Description: A woman hospitalized for congestive heart failure (with no history of diabetes) is
given several rounds of insulin and D50, after repeated blood tests show her glucose to be
dangerously high, then dangerously low. Turns out, the blood samples were drawn incorrectly
and the signouts were incomplete.

The Case

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A 71-year-old woman with congestive heart failure was admitted to the hospital. Her medical
history was significant for dialysis-dependent, end-stage kidney disease and coronary artery
disease. She did not have a preadmission diagnosis of diabetes.

While in the step-down unit on the evening of admission, the patient had a routine phlebotomy
sample drawn, and the blood sugar level was 674 mg/dL. At 11:30 pm, the nurse notified the
covering intern, who telephone-ordered 10 Units of regular insulin to be given subcutaneously.
At 1:10 am, a finger-stick glucose level was 50 mg/dL, and the intern verbally ordered 1 amp of
D50 to be given intravenously (IV). At 3:00 am, a phlebotomized specimen revealed a glucose
level of 19 mg/dL, and the intern verbally ordered another amp of D50 IV, as well as a D10 drip.
At 5:27 am, a finger-stick glucose was 99 mg/dL. At 11:00 am, a phlebotomy sample revealed a
blood glucose level of 351 mg/dL. Another covering intern was notified, and 8 units of regular
insulin were ordered to be given subcutaneously. At 3:40 pm, the patient was unresponsive, and
a finger-stick glucose level was 13 mg/dL. Two amps of D50 were verbally ordered, and follow
up finger sticks were in the normal range.

Later, it was discovered that many of the phlebotomy specimens had been drawn above an IV
line infusing dextrose solution. The step-down nurse was re-educated regarding blood draws in
relation to lines. Despite multiple episodes of hypoglycemia, all subsequent glucose levels were
normal and this patient suffered no lasting harm.

The Commentary (Dr.Shoeb submitted to Dr.Diana Pascu @ University of Verona, Italy)

Although multiple factors contributed to this patient's roller coaster glycemia (Figure 1 Below),
her case highlights the challenges and perils of "cross-coverage," the management of patients by

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physicians other than those primarily responsible, and the limitations of "signout," the transfer of
patient data and care responsibility when the primary physician goes off-duty.

From a resident's perspective, cross-coverage is hard. The most challenging aspect is obvious
and inherent: residents must make clinical decisions about unfamiliar patients, often with
inadequate information. Without a complete history, a physical exam, and a full assessment of a
patient's problems, providing high-quality care is challenging. Published literature supports this
notion: discontinuity, and by definition, cross-coverage, in the care of hospitalized patients can
lead to increased lengths of stay, in-hospital complications, and preventable adverse events.(1-3)

Cross-coverage is not only inherently difficult, but it occurs when many other duties and tasks
are vying for residents' attention. Cross-coverage responsibility is often added to the need to care
for their patients. Alternatively, cross-coverage is sometimes organized as a stand-alone role
(such as in "nightfloat"), but in these circumstances the demands are often high. On the internal
medicine service at our institution, for example, the on-call interns provide some early evening
coverage during the busiest admitting time of the day. Moreover, our nightfloat intern may be
responsible for as many as 40-60 patients (including some in the ICU) and can expect to receive
5-20 pages per hour. Clearly, it is impossible to directly evaluate each patient or review each
chart when called. Therefore, inexperienced residents are often asked to prioritize and triage
patients with limited or inadequate information. We are not told in this case if the interns were
sleeping in their call rooms or busy admitting patients, but it is a safe bet that they had other
patient care responsibilities. In this setting, significant or potentially life-threatening problems,
like hypoglycemia, are often managed over the phone, which can lead to poor outcomes, as seen
here.

Cross-coverage is common in modern medical training programs. At our institution, residents


spend 2-4 weeks out of each year in a cross-cover or "float" capacity; we know of other

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programs in which residents spend even more time in these roles. Adding up all the "floating"
(particularly since the implementation of the ACGME duty hours limitations [4]), this type of
duty can consume as much as 20% of a resident's inpatient training.

However, despite potential implications for patient safety and medical errors, cross-coverage is
not viewed as a fundamental or core component of medical education. Residency is filled with
didactics on atrial fibrillation and preeclampsia, but no structured training in efficient triage and
quality care of unfamiliar patients. Nightfloat interns typically don't receive any structured
orientation, and are often told to "Just keep 'em alive until the morning." When called about
patients they are covering, residents and interns may view it as a nuisance or interruption in their
other duties, regardless of the clinical situation. In this culture, it is not surprising that a busy
intern with limited or inadequate knowledge of a 71-year-old with heart failure would be tempted
to manage her care with reflexive verbal orders without a more thorough evaluation.

Minimizing patient risk in this setting is challenging. The attending could invest time teaching
the interns involved about inpatient problem triage and proper signout, but reprimanding
individual housestaff cannot be the only solution. Raising individual awareness about the
inherent risks involved in information and patient care transfer is beneficial, but reliance on
individual provider vigilance and performance has been ineffective.(5) Instead, efforts should
focus on modifying the culture of cross-coverage at academic institutions. Clearly, more time
and energy could be dedicated to structured training in the management of acute conditions in
unfamiliar patients, as well as to patient signout.

The signout process itself can be improved. The transfer of information between two individuals,
whether between control tower and pilot or two physicians, creates an opportunity for
miscommunication and errors in judgment, even under the best circumstances. Adding to the
risk, resident signout is often performed in a haphazard, unstructured fashion—30 seconds in an

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elevator or two sentences on the phone while walking out the door—which can lead to
forgetfulness and error.(6) Standardization of communication, employed in the airline industry,
is one potential solution. Checklists (7) and signout cards (8) may decrease the risk of error and
improve the satisfaction of the housestaff. Information technology—including computerized
signouts (9), an easily accessible medical record, and computerized physician order entry—can
improve the quality of data transferred and allow for better informed cross-coverage.

However, improving signout at an institution does not require the installation of sophisticated,
complex, and expensive electronic medical records or technology. At UCSF Medical Center, for
example, our full-fledged, hospital-wide computerized physician order entry system is presently
being implemented. Nevertheless, we have accomplished two interventions at a reasonable cost
that have markedly improved signouts and allowed housestaff to learn key information about
cross-coverage patients without the ritual of rifling through stacks of index cards (assuming the
cards can be located at 3 am). The first is alphanumeric text paging. Nurses and others now can
easily look up residents' names on a web site, write a short message, and send it to their pagers.
We estimate that 75% of pages are informational only; freeing the resident from having to stop
what he or she is doing, find a phone, and return a page (which might be for anything from a
"just wanted you to know that I have drawn Mr. Smith's potassium" to "Mrs. Jones looks like she
might code in the next few minutes") allows the residents to prioritize their time, minimize their
distractions, and provide better cross-coverage.

The second important intervention at our institution has been the development of a computerized
signout program. Although some commercial programs are available, our residents wrote their
own program in a database format. Housestaff now create and update signout sheets on every
patient, and the system is available at computers around the institution. Residents can also
transmit requests to schedule tests or discharge appointments to ward clerks. Figures 2 and 3
(below) show screen shots from the system. We are in the process of migrating the system to the
web, creating a portal for nurses to access the records and input requests and concerns, and

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allowing the system to communicate with wireless devices. Although the ideal system will link
to a robust electronic medical record (and draw information like medication lists and lab results
from it), this standalone system is a practical, relatively inexpensive solution to the clear and
present danger of cross-coverage fumbles.

Fortunately, this patient did not suffer any long-term consequences. In this case, patient
unfamiliarity, inadequate signout, time limitations, and the institutional culture surrounding
cross-coverage likely influenced the interns' management. No solution is foolproof. Nonetheless,
improving training in cross-coverage, standardizing the signout process, and using information
technology may allow practitioners to bridge these gaps.

Take-Home Points

 New ACGME duty-hour requirements are increasing resident cross-coverage, signout,


and discontinuity of care for hospitalized patients.

 Errors during cross-coverage are often due to patient unfamiliarity, other work burden,
resident fatigue, and decreased supervision.

 Improving training in cross-coverage, standardizing the signout process, and using


information technology may decrease the error rates of signouts.

 Although robust, institution-wide informatics solutions are ideal, alphanumeric paging


and standalone signout database systems are two examples of relatively simple,
inexpensive interventions that can improve signouts and cross-coverage while more
expensive and complex systems are being implemented.

Figures:

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Figure 1. The Glucose Roller Coaster

Figure 2. Front Page of Computerized Signout Program

Figure 3. Blank Computerized Signout Sheet

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Discussion Questions

1. Time constraints are often issues during handoffs. How might you develop a
system designed to allow teams the opportunity to review handoff lists with each other
prior to signing over patients?

2. What other questions could have been asked or researched by the day-team that
might have revealed a potential problem with this patient's blood sugars (e.g., were there
any old laboratory values that could be referenced)?

3. If you were designing an orientation for new interns on the potential pitfalls of
being a "night float" or cross-covering intern, what would you advise to prevent errors
such as those that occurred in the "Glucose Roller Coaster" case study?

4. Dr. Sharpe mentioned that institutional culture surrounding cross-coverage can


influence interns' management of patients. Can you think of any examples of this? In
what ways could an institution's culture change?

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Misread Label

Learning Objectives: At the end of this activity, you will be able to:

 Explain how human error can result in adverse events.

 Identify the dangers associated with look-alike/s0und-alike drugs.

 Discuss the benefits of apologizing to a patient (or a patient’s family) after an adverse
event.

Description: An infant born with sluggish breathing is given Lanoxin® instead of naloxone, and
dies of digoxin toxicity.

The Case

An infant was born with sluggish respirations. During labor the infant’s mother had received
meperidine [Demerol, a pain medication], a narcotic with a half-life of 2.5-4.0 hours in adults
and 12-39 hours in neonates. The physician started resuscitation and ordered naloxone [an opiate
antagonist]. Shortly after administration of the medication, the infant’s condition began to
deteriorate further.

Prompted by the proximity of the deterioration to the administration of the naloxone the
physician checked the packaging of the drug. The syringe had inadvertently been filled with
Lanoxin® [digoxin, a cardiac medication] instead of naloxone. The packages of both drugs,
made by the same manufacturer, were almost identical. ECG revealed bi-directional ventricular
tachycardia, consistent with digoxin toxicity.

Approximately 1 hour later the infant died. A post-mortem digoxin level was 17 ng/ml
(therapeutic range 0.8 to 2 ng/ml).

The Commentary

What does this tragic case tell us, and more importantly, what can we learn from it? Following
symptoms of meperidine toxicity, a doctor prescribed naloxone, an appropriate antidote.

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However, digoxin, a cardiac glycoside, was administered instead, and the baby died of digoxin
toxicity.

On face value, it is almost impossible to imagine how this could have occurred. However, when
one realizes that the brand name of digoxin is Lanoxin®, and that in this case both drugs were
made by the same manufacturer and presented in similar packaging, it may be slightly easier to
understand how the error happened. Both are drugs that would be stocked on a typical neonatal
unit, and the doses used are similar. The intravenous dose of naloxone recommended for use in
newborn babies is 10 mcg/kg every 2-3 minutes, and a digoxin loading dose is 10 mcg/kg to 17.5
mcg/kg depending on the age of the baby and whether he was full term. If whoever administered
the drug confused naloxone with Lanoxin, either because she thought this was the brand name
for naloxone, or simply because the name on the packaging was misread, there would be few
cues to suggest that the wrong drug had been selected until after it had been administered.

Observational studies in hospitals have reported administration errors in 3%-8% of doses in the
United Kingdom (UK) (1,2), and in 0.6%-14.6% in the United States (US) (3), excluding wrong
time errors. Methods and definitions vary, so it is difficult to compare studies directly, but it is
clear that administration errors are not uncommon. Wrong drug errors are typically a smaller
proportion of these, occurring in about 0.2% of all doses given.(4) Fortunately, most
administration errors do not result in outcomes as tragic as in this case.

There are various approaches to investigation. For example, the Clinical Risk Unit in the UK has
developed a protocol for the investigation and analysis of adverse events in clinical practice (8)
based on a well-known model of human error.(9) This method requires training to be used
effectively, but involves interviewing staff involved to identify care management problems and
why each occurred. The investigation aims to identify contributing factors at the level of the
institution, organization and management, work environment, team, individuals, task, and the

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patient.(10) Such an approach would likely be useful in investigating this incident, and would
highlight more wide-reaching issues than the simple fact that someone gave the wrong drug.

Little is known about the true causes of administration errors like this one. However, studies
have examined the causes of prescribing errors (5) and other types of medical error (6) using
psychological models of human error. In addition to exploring why the error occurred at the level
of individuals at the "sharp end," such studies also aim to identify the organizational and
environmental factors that make errors possible. The objective of identifying these latter factors
is that actions here are likely to have the most impact in preventing future errors. While there
have been no in-depth studies of the causes of administration errors, similar packaging, and look-
alike or sound-alike names (7) are considered important contributing factors.

There are various approaches to investigation. For example, the Clinical Risk Unit in the UK has
developed a protocol for the investigation and analysis of adverse events in clinical practice (8)
based on a well-known model of human error. (9) This method requires training to be used
effectively, but involves interviewing staff involved to identify care management problems and
why each occurred. The investigation aims to identify contributing factors at the level of the
institution, organization and management, work environment, team, individuals, task, and the
patient. (10) Such an approach would likely be useful in investigating this incident, and would
highlight more wide-reaching issues than the simple fact that someone gave the wrong drug.

1. What systems do you think might prevent or minimize this type of error?
Consider:

o Do you think health care facilities should restrict the forms available or the
concentrations available in pediatric units?

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o Should practitioners be required to include indications for all medication orders?

o Do you think independent double-checks would have prevented this incident?

o Both of the medications involved may be used emergently in an acute situation.


What can be done in a high stress emergent setting to prevent incidents like this?

Defenses could be built in at many stages, depending on the outcome of the investigation. These
may include purchasing products from different manufacturers, reviewing how look-alike and
sound-alike products are stored, and highlighting drugs that could potentially be confused.
Another approach may involve improving systems of communication between prescribers and
nursing staff. It has been proposed that all medication orders should include the indication for
which the drug is being used, as this may prevent some errors (though probably not in an urgent
situation such as this one). In this case, had the physician indicated that the baby was being
treated for opiate toxicity, the nurse might have hesitated to draw up a cardiac glycoside.

More global changes are needed to increase the risk assessment carried out when naming
medicinal products, to minimize the risks of mix-ups occurring. The Institute for Safe
Medication Practices provides proprietary reviews of proposed names, trademarks, packaging,
and labeling for pharmaceutical industry clients (http://www.ismp.org/Pages/MedErrs.html) in
an attempt to prevent potentially confusing names. Unfortunately, such reviews are not yet
compulsory.

Little is known about the true causes of administration errors like this one. However, studies
have examined the causes of prescribing errors (5) and other types of medical error (6) using
psychological models of human error. In addition to exploring why the error occurred at the level
of individuals at the “sharp end,” such studies also aim to identify the organizational and
environmental factors that make errors possible. The objective of identifying these latter factors
is that actions here are likely to have the most impact in preventing future errors. While there
have been no in-depth studies of the causes of administration errors, similar packaging, and look-
alike or sound-alike names (7) are considered important contributing factors.
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2. In your opinion, should this error be disclosed to the parents? If so, what would that
look like?

Experts in medical ethics and professional organizations all endorse disclosure of errors. A
recently published exploration of both patients’ and physicians’ attitudes toward medical error
disclosure, which used scenarios with errors specifically involving medication, found that
patients wanted disclosure of all harmful errors and sought information about what happened,
why, and how similar errors will be prevented in the future.(11) There was less agreement over
whether near misses should be disclosed. Physicians agreed that harmful errors such as this one
should be disclosed, but the report found that they “chose their words carefully” when telling
patients about errors. Although physicians disclosed the adverse event, they often avoided stating
that an error had occurred, why it happened, and how it would be prevented. These findings back
up those of other studies (12) from the viewpoints of both doctors and patients.

Take-Home Points

 Errors in drug administration occur relatively often.

 Packaging and look-alike/sound-alike drugs are thought to be important contributing


factors.

 Risk assess look-alike and sound-alike products and consider how they are stored.

 Improving communication between medical and nursing staff may help to prevent errors.

 Patients and their families want disclosure of errors, along with information on how
similar errors will be prevented in the future.

462
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Dr. Shoeb Ahmed Ilyas
BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
Knowing Is Not Enough
A healthy 57 year old man underwent a liver donation procedure. He began to manifest some
tachycardia late on the second postoperative day. Early on the third post-operative day, he began
to hiccup, complained of being nauseated and was pronounced dead later that day.

Topic(s): Transitions in Care;Adverse Event;Patient Safety;Handoffs;Surgical


Safety;Communication;Surgical Infection Prevention;Reliable Processes;Infectious Diseases

Knowing Is Not Enough

Learning Objectives: At the end of this activity, you will be able to:

 Describe how staffing shortages and inappropriate supervision can lead to adverse events.

 Discuss how poor communication among hospital staff can lead to adverse events.

 Identify contributing elements to a case resulting in the death of a patient.

Description: A healthy 57-year-old man underwent a liver donation procedure. He began to


manifest some tachycardia late on the second postoperative day. Early on the third post-operative
day, he began to hiccup, and complained of being nauseated; later that day he was pronounced
dead.

The Case

On January 10, a healthy 57-year-old man underwent a liver donation procedure that successfully
resected approximately 60 percent of the right lobe of his liver in preparation for transplanting
that liver into his brother, a 54-year-old man who suffered from a degenerative liver disease.

After what was described as a technically uneventful transplant, the donor patient seemed to do

463
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Dr. Shoeb Ahmed Ilyas
BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
well on the first postoperative day. Late on the second postoperative day, he began to manifest
some tachycardia. Early on the third post-operative day, he began to hiccup and complained of
being nauseated. He was given symptomatic treatment. Later that day, he began to vomit
brownish material. He became oxygen-desaturated and was placed on 100% oxygen by mask. He
continued to vomit, aspirated, and suffered a cardiac arrest, from which he was not resuscitated;
he was pronounced dead on the third post-operative day.

At autopsy, he was found to have aspirated bloody vomit in his lungs and Clostridium
perfringens growing in several abdominal sites.

Three months later, the state health commissioner issued a 10-page report of an inquiry into the
circumstances surrounding the patient’s death, offering the following reconstruction of the
sequence of events:

 January 10—Patient undergoes surgery to remove the right lobe of his liver. No
complications occur during the procedure.

 January 11—Patient is recovering; his condition is stable.

 January 12—Patient is “examined” during rounds by first-year transplant fellow and


PGY 4 surgical resident. Transplant fellow neither looks at, nor asks for patient’s vital
signs. At 4 pm, patient develops tachycardia.

 January 13—

 Approximately 1am, patient develops hiccups and nausea. Patient is given


medication to control symptoms, which may have masked the underlying
problem.

464
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BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
 At 8:45am, patient is examined by PGY 4 surgical resident who is
unaware of the patient’s continuing tachycardia and nausea and previous
hiccups and writes a progress note indicating vital signs are stable.

 1:10 pm patient vomits brownish materials, tachycardia persists. PGY 1


surgical resident calls transplant fellow who is in a bookstore outside the
hospital. He advises against insertion of a nasogastric tube. Upon returning
to the hospital, and despite the patient’s distress, he does not examine him,
but instead prepares a pre-operative work-up on another patient scheduled
for surgery the next day.

 2:00pm patient’s oxygen saturation is unacceptably low; 100% oxygen is


administered by mask.

 3:00pm nurse calls PGY 1 resident to inform her that the patient is
continuing to vomit and has difficulty breathing.

 3:10pm patient becomes unconscious after vomiting more brownish


materials and frank blood. Code is called; resuscitation measures are
unsuccessful.

 3:40pm patient is pronounced dead.

Autopsy revealed large amounts of vomited blood in the patient’s lungs, the presence of
Clostridium perfringens infection in the patient’s portal vein, esophagus, stomach, small
intestine, and lung. A separate investigation into the infection is underway.

1. Pretend you are the state health commissioner. Would you conclude that the
patient received appropriate care? Why or why not?

The report concluded that the patient’s post-operative care was fragmented at best, and entrusted
to individuals who, although qualified, were unable to provide the level of attention necessary for
his total post-operative care. According to the commissioner, “The hospital allowed this patient

465
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Dr. Shoeb Ahmed Ilyas
BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
to undergo a major, high-risk procedure and then left his postoperative care in the hands of an
overburdened, mostly junior staff, without appropriate supervision. Supervision of medical
residents was far too lax, resulting in woefully inadequate post-surgical care.”

More detailed findings included:

 Patient was neither carefully monitored nor appropriately examined and evaluated post-
surgery. Caregivers, including nursing staff and a fourth-year surgical resident failed to
promptly identify abnormal vital signs that would have allowed them to respond
appropriately when the patient developed tachycardia and hiccups 48 hours post-op.

 Significant changes in the patient’s condition were not communicated to all those
responsible for his care.

 During the weekend in question, the hospital’s transplantation institute was inadequately
staffed with nurses and physicians in charge of providing the necessary care for 34
transplant recipients and donors.

 A first-year surgical resident (PGY-1) was left alone for three hours on January 13 (the
day of the patient’s death) to care for all 34 patients. She described herself as feeling
“overwhelmed” by the responsibility of caring for so many patients with only nurses to
help her. She had been a surgical resident for five months and had started on the
transplant service 12 days before January 13.

 A first-year transplant fellow on pager out of the hospital failed to respond immediately
when informed by the PGY-1 of a significant change in the patient’s condition.

 The operating surgeon never saw the patient post-operatively.


The hospital chief operating officer said that the state’s report was accurate.
As a result of the investigation, the health department cited a total of 18 deficiencies
against the medical center under the categories of Governing Body, Medical Staff,
Nursing Services, Patients’ Rights, Medical Records, Surgical Services and Critical Care

466
Ruby Med Plus
Dr. Shoeb Ahmed Ilyas
BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
and Special Care Services. Regulations require the hospital to propose a specific
corrective action for every deficiency cited, explaining in detail how each is to be
addressed.

2. Pretend you work for the hospital. How would plan to address each of the issues in
the bulleted list above?

The department suspended adult living liver transplantation procedures for at least six months
while they sought solutions to the problems identified in the report. This was the first death to
occur in a living donor in the program with 170 living liver transplantation /donation procedures
having been done in the last 9 years.

A national expert indicated that there was no registry of patients who receive live donor liver
transplants, so he was unable to comment about the frequency of this type of complication, but
thought it was rare. The death of a live donor represents the worst-case scenario envisioned by
ethics experts.

In what may be an unrelated event, the former health department chief for the same state took
great pride approximately 13 years earlier in the passage of a law which limited the amount of
time any given resident doctor could work on duty in any week to 80 hours.

This surgery residency has a total of 72 residents and enjoys full accreditation. Approximately 25
percent of their resident staff come from international medical schools.

In the lay press, this hospital has been described as one of the “nation’s best” for many services.
The hospital is in the “top 50” US hospitals for several conditions. In the months preceding this
incident, the hospital had been working on a general priority of “trimming costs” as part of their
efforts to meet operating targets.

Discussion Questions

467
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Dr. Shoeb Ahmed Ilyas
BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
1. What role, if any, do you think trimming costs and limiting resident duty hours
played in the outcome for this patient? Can you think of an example in your own
experience when “trimming costs” and/or staff shortages resulted in a minor or major
problem or adverse event?

2. What are your general reactions to the Case Study? For example, the narrative
says, “The death of a live donor represents the worst-case scenario envisioned by ethics
experts.” What does this mean to you, and do you agree?

3. Imagine you were the first-year resident left alone for three hours on the day of
the patient’s death. What thoughts would be going through your head? Is there anything
you would have done differently?

4. If you were the CEO of the hospital, what would you have said to the family of
the deceased man? Would you have apologized? What words would you have used?

An Extended Stay
A 64-year-old man with a number of health issues comes to the hospital because he is having
trouble breathing. The care team helps resolve the issue, but forgets a standard treatment that
causes unnecessary harm to the patient. A subsequent medication error makes the situation
worse, leading a stay that is much longer than anticipated.

Topic(s): Adverse Event;Engage Patients and Families in


Care;Handoffs;Leadership;Teamwork;Medication Safety;Care Coordination and
Transitions;Communication;Reliable Processes

Learning Objectives: At the end of this activity, you will be able to:

 Explain how system failures can lead to patient harm.


 Describe how lack of communication between providers and hospital departments can
lead to patient harm
468
Ruby Med Plus
Dr. Shoeb Ahmed Ilyas
BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant
 Discuss how to debrief with colleagues after an adverse event.

Description: A 64-year-old man with a number of health issues comes to the hospital because he
is having trouble breathing. The care team helps resolve the issue, but forgets a standard
treatment that causes unnecessary harm to the patient. A subsequent medication error makes the
situation worse, leading to a stay that is much longer than anticipated.

Mr. Stanley Londborg is a 64-year-old man with a long-standing history of a seizure disorder. He
also has hypertension (high blood pressure) and chronic obstructive pulmonary disease (COPD).
He is no stranger to the hospital because of his health issues. At home, he takes a number of
medications, including three for his COPD and three — levetiracetam, lamotrigine, and valproate
sodium — to help control his seizures.

Mr. Londborg came to the emergency department (ED) last week because he was wheezing and
having trouble breathing. The physician in the ED conducted a physical examination that yielded
signs of an acute worsening of his COPD, which is known as COPD exacerbation. (In many
cases, COPD exacerbation is the result of a relatively mild respiratory tract infection, but could
be due to something more serious, such as pneumonia.)

The physician in the ED ordered a chest x-ray, which did not show any signs of pneumonia. He
admitted Mr. Londborg to the hospital for treatment of acute COPD exacerbation, resulting from
a relatively mild respiratory tract infection. Before leaving the ED, Mr. Londborg also underwent
routine blood work, which showed an elevation in his creatinine, a sign that his kidneys were
being forced to work harder due to his infection.

On the medical floor, the care team treated Mr. Londborg with oral steroids and inhaled
bronchodilators (standard medical therapy for his condition), which resulted in a gradual
improvement in his respiratory symptoms. Nurses also gave him IV fluids for the issue with his
kidneys, which slowly resolved.

469
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BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant

Mr. Londborg was steadily improving, so it seemed this visit to the hospital would be one of his
shorter ones.

But on his third morning in the hospital, Mr. Londborg complained to the intern (a first-year
resident) on the care team about acute pain in his left leg. This symptom, potentially indicating
deep venous thrombosis (a blood clot in his leg commonly known as DVT), prompted the team
to order an ultrasound of Mr. Londborg’s lower extremities. (A primary concern with DVT is
that blood clots in the legs may dislodge and travel to the lungs, causing a pulmonary embolism,
which could be deadly.)

The resident on the care team (who oversees the intern) then checked Mr. Londborg’s
medication orders and was surprised to see that the admitting doctor had not ordered prophylaxis
for DVT (i.e., blood thinners, such as heparin or enoxaparin). The resident was surprised because
patients admitted to the hospital typically receive this treatment to prevent blood clots from
forming while they lie in their hospital beds. Further, nothing about Mr. Londborg’s medical
record suggested he shouldn’t have received this treatment as an important precautionary
measure.

Let’s pause to consider and discuss a couple questions about the case before we continue…

Discussion Questions:

1) The patient did not receive standard treatment to prevent the formation of a DVT. What are
some possible reasons why this error occurred?

2) Can you suggest system process improvements that might reduce the likelihood of similar
errors in the future?

1) The patient did not receive standard treatment to prevent the formation of a DVT. What
are some possible reasons why this error occurred?

470
Ruby Med Plus
Dr. Shoeb Ahmed Ilyas
BS, BDS, MPH, MHA, M.Phil (HHSM), MS (GH), MS (PSY), MHRM, PGDMLE, F.H.T.A, Cert. in Health
Economics. CPHQ Exam Trainer, JCI & NBH Consultant

The physician may simply have forgotten to do it. Or, perhaps it is a very cumbersome process to
enter this order. The main cause, most likely, is that the system relies on the admitting physician
to remember this step in addition to other decisions regarding acute medical management. In this
case, the physician was already distracted by thinking about what could be causing his patient's
COPD exacerbation and busy ordering an x-ray, medications, and blood work.

2) Can you