INTRODUCTION

Quality management (QM) and quality improvement (QI) are the basic concepts derived from
the philosophy of total quality management (TQM). Now it is preferred to use the term
Continuous Quality Improvement (CQI) since TQM can never be achieved. And the method
of monitoring of healthcare for CQI is done with Quality Assurance (QA). Unlike quality
assurance, QI follows client care rather than organizational structure, focuses on process
rather than individuals, and uses a systematic approach with the intention of improving the
quality of care rather than ensuring the quality of care. Of studies often focus on identifying
and correcting a system's problems, such as duplication of services in a hospital or improving
services.

Continuous quality improvement is the ongoing process of monitoring structure, process, and
outcome indicators in order to identify signal events, significant trends, and opportunities for
change that will guide health care professionals in preventing patient care problems and
improving already satisfactory patient services.

Quality Improvement is a systematic approach in analyzing the current performance of the

company in order to take necessary actions for the quality improvements.

DEFINITION
According to Donabedian 1982 ,

“Quality assurance is a judgment concerning the process of care based on the extent to which
that care contributes to valued outcomes.”

According to Shaw,

“Quality assurance is the measurement of provision against expectations with declared

intention and ability to correct any demonstrated weakness.”

According to British Standards Institute,

“Quality assurance is a management system designed to give maximum guarantee and ensure
confidence that the service provided is up to the given accepted level of quality, the standards
prescribed for that service which is being achieved with a minimum of total expenditure.”

“CQI is an ongoing quality improvement measure using management and scientific methods
of quality assurance involving data collection, its analysis, and formulating ways to improve
performance outcome according to proposed standard.”

Quality assurance vs. Continuous quality improvement (Koch, 1993)

Quality improvement is not necessarily a replacement for existing quality assurance

activities, but rather an approach that broadens the perspectives on quality.

QUALITY ASSURANCE (QA) QUALITY IMPROVEMENT (QI)

Inspection oriented (detection) Planning oriented (prevention)
Reaction Proactive
Correction of special causes Correction of common causes
Responsibility of few people Responsibility of all people involved with the
 work
Narrow focus Cross- functional
Leadership may not be vested Leadership actively leading
Problem solving by authority Problem solving by employees at all levels

OBJECTIVES

 To successfully achieve sustained improvement in health care, clinics need to design

processes to meet the needs of patients.
 To design processes well and systematically monitor, analyze, and improve their
performance to improve patient outcomes.
 A designed system should include standardized, predictable processes based on best
practices.
 Set Incremental goals as needed.

Quality assurance whether in health or education had two main objectives:

 To provide technical assistance in designing and implementing effective strategies for

monitoring quality and correcting systemic deficiencies and
 To refine existing methods for ensuring optimal quality health care through an applied
research programme

PURPOSES/ NEED
 Rising expectations of consumer of services.
 Increasing pressure from national, international, government and other professional bodies to
demonstrate that the allocation of funds produces satisfactory results in terms of patient care.
 The increasing complexity of health care organizations.
 Improvement of job satisfaction.
 Highly informed consumer
 To prevent rising medical errors
 Rise in health insurance industry
 Accreditation bodies
 Reducing global boundaries.

PRINCIPLES
 QM operates most effectively within a flat, democratic and organizational structure.
 Managers and workers must be committed to quality improvement.
 The goal of QM is to improve systems and processes and not to assign blame.
 Customers define quality.
 Quality improvement focuses on outcome.
 Decisions must be based on data.

According to W Edward Deming; (Deming‘s 14 points)

 Crete consistency of purpose for improvement of product and service.
 Adopt the new philosophy
 Cease dependence on inspection to achieve quality.
 End the practice of awarding business on the basis of price tag.
 Improve constantly and forever the systems of production and service.
 Institute training on the job.
 Institute leadership.
 Drive out fear.
 Break down barriers between departments.
 Eliminate slogans, exhortations, and target for the workforce.
 Eliminate numerous quotas for the workforce and numerical goals of management.
 Remove barriers that rob people of pride and workmanship.
 Institute a vigorous programme of education and self-improvement for everyone.
 Put everyone in the company to work to accomplish the transformation.

APPROACHES
 General approach
 Specific approach
General approach: - It involves large governing or official bodies evaluating a person or
agencies‘ability to meet established criteria or standard during a given time.

a) Credentialing- It is the formal recognition of professional or technical competence and

attainment of minimum standards by a person and agency. Credentialing process has 4
functional components
 To produce a quality product
 To confirm a unique identity
 To protect the provider and public
 To control the profession
b) Licensure- It is a contract between the profession and the state in which the profession is
granted control over entry into an exit from the profession and over quality of professional
practice.
c) Accreditation- It is a process in which certification of competency, authority, or credibility
is presented to an organization with necessary standards.
d) Certification
e) Charter- It is a mechanism by which a state government agency under state law grants
corporate state to institutions with or without right to award degrees.
f) Recognition- It is defined as a process whereby one agency accepts the credentialing states
of and the credential confined by another.
g) Academic degree

Specific approach: - These are methods used to evaluate identified instances of provider and
client interactions.

a) Audit- It is an independent review conducted to compare some aspect of quality

performance, with a standard for that performance.
b) Direct observation- Structured or unstructured based on presence of set criteria.
c) Appropriateness evaluation- The extent to which the managed care organization provides
timely, necessary care at right levels of service.
d) Peer review- Comparison of individual provider‘s practice either with practice by the
provider‘s peer or with an acceptable standard of care.
e) Bench marking- A process used in performance improvement to compare oneself with best
practice.
f) Supervisory evaluation
g) Self-evaluation
h) Client satisfaction
i) Control committees
j) Services- Evaluates care delivered by an institution rather than by an individual provider.
k) Trajectory- It begins with the cohort of a person who shares distinguishing characteristics
and then follows the group going through the healthcare system noting what outcomes are
achieved by the end of a particular period
l) Staging- It is the measurement of adverse outcomes and the investigation of its
antecedence.

m) Sentinel- It involves maintaining of factors that may result in disease, disability or

complications such as;
 Review of accident reports
 Risk management
 Utilization review

ELEMENTS/ COMPONENTS

According to Donabedian;
 Structure Element- The physical, financial and organizational resources provided for
health care.
 Process Element- The activities of a health system or healthcare personnel in the
provision of care.
 Outcome Element- A change in the patient‘s current or future health that results from
nursing interventions.

According to Manwell, Shaw, and Beurri, there are 3A‘s and 3E‘s;
 Access to healthcare
 Acceptability
 Appropriateness and relevance to need
 Effectiveness
 Efficiency
 Equity

STANDARDS
Standards are written formal statements to describe how an organization or professional
should deliver health service and are guidelines against which services can be assessed.
Standard is an established rules or basis of comparison in measuring or judging capacity,
quantity context and value of objects in the same category. Kirk and Hoesing (1991) stated
that standards are needed to;
 Provide direction
 Reach agreement on expectations
 Monitor and evaluate results
 Guide organizations, people and patients to obtain optimal results.

Standards are directed at structure, process, and outcome issues and guide the review of
systems function, staff performance, and client care. The organizations providing quality
indexes are;
 AHRQ –Agency for Healthcare Research and Quality
IHI –Institute for Healthcare Improvement
JCAHO –Joint Commission on Accreditation of Healthcare Organizations
NAHQ –National Association for Healthcare Quality
IOM –Institute of Medicine
NCQA –National Committee for Quality Assurance

CHARACTERISTICS OF STANDARD

The characteristics of standards which undo that standard:

Statement must be broad enough to apply to a wide variety of settings.
Must be realistic, acceptable, attainable.
Nursing care must be developed by members of the nursing profession; preferable nurses
practising at the direct care level with consultation of experts in the domain.
Should be phrased in positive terms and indicate acceptable performance, ie. good,
excellence etc.
Nursing care must express what is desirable optional level.
Must be understandable and stated in unambiguous terms.
Must be based on current knowledge and scientific practice.
Must be reviewed and revised periodically.
May be directed towards an ideal, ie. optional standards or may only specify the minimal
care that must be attained, i.e. minimum standard.
And one must remember that standards that work are objective, acceptable, achievable and
flexible.

CLASSIFICATION OF STANDARDS

There are different types of standards used to direct and control nursing actions. Standards
can be normative or empirical. Normative standards describe practices considered 'good' or
'ideal' by some authoritative group. Empirical standards describe practices actually observed
in a large number of patient care settings. Here the normative standards describe a higher
quality of performance than empirical standards. Generally, professional organizations
(ANA/TNAI) promulgate normative standards where as low enforcement and regulatory
bodies (INC/MCI) promulgate empirical standards.

Nursing care standards can be divided into ends and means standards. The ends standards are
patient-oriented; they describe the change as desired in a patient's physical status or behavior.
The means standards are nursing oriented, they describe the activities and behavior designed
to achieve the ends standards.

Structural Standard-A structural standard involves the 'set-up' of the institution. The
philosophy, goals and objectives, structure of the organization, facilities and equipment, and
qualifications of employees are some of the components of the structure of the organization,
e.g. recommended relationship between the nursing department and other departments a
health agency are structural standards, and because they refer to the organizational structure
in which nursing is implemented. The use of standards based on structure implies that if the
structure is adequate, reliable and desirable, standard will be met or quality care will be
given.
Process Standard-Process standards describe the behaviors of the nurse at the desired level
of performance. A process standard involves the activities concerned with delivering patient
care. These standards measure nursing actions or lack of actions involving patient care.

Outcome Standards-Descriptive statements of desired patient care results are outcome

standards, because patient's results are outcomes of nursing interventions. Here outcome is a
frame of reference for setting of standards refers to description of the results of nursing
activity in terms of the change that occurs in the patient. An outcome standard measures
change in the patient health status.

AREAS OF QA
The assurances in various key areas are;
1. Outpatient department- The points to be remembered are;
Courteous behavior must be extended by all, trained or untrained personnel.
Reduction of waiting time in the OPD and for lab investigations by creating more service
outlets.
Provide basic amenities like toilets, telephone, and drinking water etc.
Provision of polyclinic concept to give all specialty services under one roof.
Providing ambulatory services or running day care centers.

2. Emergency medical services

Services must be provided by well trained and dedicated staff, and they should have access to
the most sophisticated life- saving equipment and materials, and also have the facility of
rendering pre- hospital emergency medical aid through a quick reaction trauma care team
provided with a trauma care emergency van.

3. In- patient services

Provide a pleasant hospital stay to the patient through provision of a safe, homely
atmosphere, a listening ear, humane approach and well behaved, courteous staff.

4. Specialty services
A high tech hospital with all types of specialty and super- specialty services will increase the
image of the hospital.

5. Training
A continuous training programme should be present consisting of ‗on the job training‘, skill
training workshops, seminars, conferences, and case presentations.

MODELS
1. Donabedian Model (1985): It is a model proposed for the structure, process and outcome
of quality. This linear model has been widely accepted as the fundamental structure to
develop many other models in QA.
2. ANA Model: This first proposed and accepted model of quality assurance was given by
Long & Black in 1975. This helps in the self- determination of patient and family, nursing
health orientation, patient‘s right to quality care and nursing contributions.

Evaluate outcome of standards and

Identify structure , standard and criteria
criteria
Apply the process, standards and criteria

3. Quality Health Outcome Model: The uniqueness of this model proposed by Mitchell &
Co is the point that there are dynamic relationships with indicators that not only act upon,
but also reciprocally affect the various components.

4. Plan, Do, Study, Act cycle: It is an improvement model advocated by Dr. Deming which
is still practiced widely that contains a distinct improvement phase.
Use of PDSA model assumes that a problem has been identified and analyzed for its most
likely causes and that changes have been recommended for eliminating the likely causes.
Once the initial problem analysis is completed, a Plan is developed to test one of the
improvement changes. During the Do phase, the change is made, and data are collected to
evaluate the results. Study involves analysis of the data collected in the previous step. Data
are evaluated for evidence that an improvement has been made. The Act step involves taking
actions that will ‗hardwire‘ the change so that the gains made by the improvement are
sustained over time.
5. Six Sigma: It refers to six standard deviations from the mean and is generally used in
quality improvement to define the number of acceptable defects or errors produced by a
process. It consists of 5 steps: define, measure, analyze, improve and control (DMAIC).
 Define: Questions are asked about key customer requirements and key processes to
support those requirements.
 Measure: Key processes are identified and data are collected.
 Analyze: Data are converted to information; Causes of process variation are identified.
 Improve: This stage generates solutions and make and measures process changes.
 Control: Processes that are performing in a predictable way at a desirable level are in
control.

QUALITY TOOLS

 Chart audits -It is the most common method of collecting quality data using charts as
quality assessment tool.
 Failure mode and effect analysis: prospective view
It is a tool that takes leaders through evaluation of design weaknesses within their process,
enable them to prioritize weaknesses that might be more likely to result in failure (errors)
and, based on priorities decide where to focus on process redesign aimed at improving patient
safety.
 Root- cause analysis: retrospective view
It is sometimes called a fishbone diagram, used to retrospectively analyze potential causes of
a problem or sources of variation of a process. Possible causes are generally grouped under 4
categories: people, materials, policies and procedures, and equipment.
 Flow charts -These are diagrams that represent the steps in a process.
 Pareto diagrams -It is used to illustrate 80/ 20 rule, which states that 80% of all process
variation is produced by 20% of items.
 Histograms -It uses a graph rather than a table of numbers to illustrate the frequency of
different categories of errors.
 Run charts -These are graphical displays of data over time. The vertical axis depicts the
key quality characteristic, or process variable. The horizontal axis represents time. Run
charts should also contain a center line called median.
 Control charts -These are graphical representations of all work as processes, knowing
that all work exhibit variation; and recognizing, appropriately responding to, and
taking steps to reduce unnecessary variation

INDICATORS OF QUALITY ASSURANCE

a) Waiting time for different services in the hospital

b) Medical errors in judgment, diagnosis, laboratory reporting, medical treatment or surgical
procedures, etc.
c) Hospital infections including hospital- acquired infections, cross infections.
d) Quality of services in key areas like blood bank, laboratories, X- ray department, central
sterilization services, pharmacy and nursing.

QUALITY IMPROVEMENT PROCESS- STEPS

QI process steps include;

 Identify needs most important to the consumer of health care services.
 Assemble a multidisciplinary team to review the identified consumer needs and services.
 Collect data to measure the current status of these services.
 Establish measurable outcomes and quality indicators.
 Select and implement a plan to meet the outcomes.
 Collect data to evaluate the implementation of the plan and achievement of outcomes.

QUALITY ASSURANCE CYCLE:

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). The
ten steps in the QA process are discussed.

1. Planning for Quality Assurance This first step prepares an organization to carry out QA
activities. Planning begins with a review of the organizations scope of care to determine
which services should be addressed.

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.

3. 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.

4. 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.

5. Identifying Problems and Selecting Opportunities for Improvement

Program managers can identify quality improvement opportunities by monitoring and
evaluating activities. 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. 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.

6. 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.

7. 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.

8. 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. Such studies can be based on clinical record reviews, health
center register data, staff or patient interviews, service delivery observations.
9. 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.

9. Implementing and Evaluating Quality Improvement Efforts

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. 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.

JCAHO QUALITY ASSURANCE GUIDELINES/STEPS:

1. Assign responsibility: According to the Joint Commission, ― The nurse administrator

is ultimately responsible for the implementation of a quality assurance program. Completing
step one of the Joint Commission‘s ten step process require writing a statement that
described who is responsible for making certain that QA activities are carried out in the
facility. Assigning responsibility should not be confused with assuming responsibility.

2. Delineate scope of care and services: Scope of care refers to the range of services
provided to patients by a unit or department. To delineate the scope of care for a given
department personnel should ask themselves,‘ what is done in the department?‘

3. Identify important aspects of care and services: Important aspects of nursing care can
best be described as some of the fundamental contribution made by nurses while caring for
patients. They are the most significant or essential categories of care practiced in a given
setting. There is no prescribed list of important aspects of care that every organization must
monitor.

4. Identify indicators of outcome (no less than two; no more than four): A clinical
indicator is a quantitative measure that can be used as a guide to monitor and evaluate the
quality of important patient care and support service activities. Indicators are currently
considered as being of two general types i.e. sentinel events and rate-based. Indicators also
differ according to the type of event they usually measures (structure, process or outcome).
5. Establish thresholds for evaluation: Thresholds are accepted levels of compliance with
any indicators being measured. Thresholds for evaluation are the level of or point at which
intensive evaluation is triggered. A threshold can be viewed as a stimulus for action.

6. Collect data: Once indicators have been identified, a method of collecting data about the
indicators must be selected. Among the many methods of data collection is interviewing
patient/family, distributing questionnaires, reviewing charts, making direct observation etc.

7. Evaluate data: When data gathering is completed in the process of planning patients care,
nurses make assessments based on the findings. In the QA process as a whole, when data
collection has been completed and summarized, a group of nurses makes an assessment of the
quality of care.

8. Take action: Nurses are action-oriented professionals. For many nurses, the greater
portion of every day is spent on patient‘s intervention. These actions and interventions
conducted by nurses promote health and wellness for patients. Converting nursing energy
into the QA process requires formulating an action plan to address identified problems.

9. Assess action taken: Continuous and sustained improvement in care requires constant
surveillance by nurses of the intervention initiated to improve care.

10. Communicate: Written and verbal messages about the results of QA activities must be
shared with other disciplines throughout the facility.

CONCLUSION
Quality assurance (QA) measures compliance against certain necessary standards, typically
focusing on individuals, whereas quality improvement (QI) is a continuous improvement
process focused on processes and systems . Evaluation and documentation are two sides of
the same coin. We cannot neglect any one as both are equally important. Since both ensure
quality care, a nurse need to do the subjective and objective evaluation and also has to
undergo self-evaluation about the care given.
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