QUALITY ASSURANCE HOSPITAL AND LAW

MBA (HOSPITAL MANAGEMENT – II Year)

Dr.K.Dhamodharan. M.A., B.L.,
M.B.A (H.R) M.M.M., M.Sc (Psy) M.B.A (Fin) M.Phil., Ph.D

DEPARTMENT OF MANAGEMENT STUDIES DIRECTORATE OF DISTANCE EDUCATION NEYVELI STUDY CENTRE TN 093 VINAYAKA MISSIONS UNIVERSITY SALEM – 636 308

UNIT - 01 QUALITY ASSESSMENT AND IMPROVEMENT - QUALITY ASSURANCE – QUALITY ASSESSMENT - ORIGIN OF QUALITY IMPROVEMENT - DEFINING QI – QUALITY IMPROVEMENT TOOLS. UNIT - 02 APPLYING QI TO MEDICAL RECORDS - PERFORMANCE MONITORING – CLINICAL PERTINENCE - COMPLIANCE PROGRAMES - FRAUD AND ABUSE. UNIT - 03 THE HOSPITAL LAWS: THE BASIC STATUTES; ORGANISATION AND

PROCEDURES ACT; BOMBAY NURSING HOMES REGISTRATION ACT(1949); THE DRUGS (1940); BOMBAY DRUGS (CONTROL) ACT 1960; DEATH CERTIFICATE; ORGAN TRANSPLANTATION ACT 1994; INDIAN PENAL CODE AND OTHER ACTS; PROSECUTION; LAW OF TORTS; NATURAL JUSTICE. UNIT - 04 MEDICO - LEGAL PROBLEMS IN RELATION TO HEALTH ADMINISTRATION LAW OF CONTRACTS, SPECIFIC PERFORMANCE - LAW APPLI ABLE TO HOSPITAL EMPLOYEES MEDICAL JURISPRUDENCE AND FUNCTIONING OF HOSPITALS – CONSUMER PROTECTION ACT AND HOSPITALS - I.D.ACT, W.C.ACT. UNIT - 05 MEDICAL ETHICS: ETHICAL PROBLEMS IN THE MEDICAL PROFESSION; RIGHTS OF PATIENTS; DUTIES OF PATIENTS; PROFESSIONAL CONDUCT OF THE DOCTORS; DOCTORS OBLIGATIONS; DOCTORS RIGHTS; GOAL OF MEDICAL CARE; CODES OF CONDUCT; DUTIES OF A PHYSICIAN TO THE SICK; DUTIES OF PHYSICIANS TOWARDS EACH OTHER; MEDICAL NEGLIGENCE.

Unit-01
1. What is quality Assurance?
In developing products and services, quality assurance is any systematic process of checking to see whether a product or service being developed is meeting specified requirements. Many companies have a separate department devoted to quality assurance. A quality assurance system is said to increase customer confidence and a company's credibility, to improve work processes and efficiency, and to enable a company to better compete with others. Quality assurance was initially introduced in World War II when munitions were inspected and tested for defects after they were made. Today's quality assurance systems emphasize catching defects before they get into the final product. So, Quality assurance is the process of verifying or determining whether products or services meet or exceed customer expectations. Quality assurance is a process-driven approach with specific steps to help define and attain goals. This process considers design, development, production, and service. The most popular tool used to determine quality assurance is the Shewhart Cycle, developed by Dr. W. Edwards Deming. This cycle for quality assurance consists of four steps: Plan, Do, Check, and Act. These steps are commonly abbreviated as PDCA.

2.

What is quality improvement?
Many industries commonly use quality improvement (QI) techniques to improve service delivery and process performance. Yet, there has been scarce application of these proven methods to public health settings and the public health field has not developed a set of shared principles or a common definition for quality improvement. Quality improvement is a distinct management process and set of tools and techniques that are coordinated to ensure that departments consistently meet the health needs of their communities. Quality improvement in public health is the use of a deliberate and defined improvement process, such as Plan-Do-Check-Act, which is focused on

activities that are responsive to community needs and improving population health. It refers to a continuous and ongoing effort to achieve measurable improvements in the efficiency, effectiveness, performance, accountability, outcomes, and other indicators of quality in services or processes which achieve equity and improve the health of the community. Department of Health and Human Services led an effort to develop what is now known as the Consensus Statement of Quality in the Public Health System. This statement defines quality in public health as “the degree to which policies, programs, services, and research for the population increase desired health outcomes and conditions in which the population can be healthy.”5 It also identifies a set of goals that will foster quality-improvement activities and help achieve quality in public health. Quality improvement, as defined above, encompasses activities that focus on specific processes or projects—such as improving customer satisfaction or increasing immunization rates—as well as a public health department's adoption of an organization-wide commitment to quality improvement. This distinction between project-level QI and organization-wide QI is referred to as “Small qi” and “Big QI,” respectively.

3. What are the quality improvement tools?
Quality Quality is a key component of customer (or patient) satisfaction with any service or product. In medical care, measuring quality is even more difficult than in other fields. There are three types of quality: Perceived Quality: This is the customer’s (patient’s) personal belief as to the quality they receive. Actual Quality: This is often measured by some quantitative metric (e.g.: defects per 100, number of breakdowns, ease of use). In the medical world, finding relevant metrics to measure performance is difficult. Often we can measure the amount of medical errors per 100 patients a physician makes, but this will not measure superior physician quality. Peer review is one way to measure actual quality, but since this is often done in a non-quantitative way, even most medical professionals are uncertain of quality of care they give.

Expected Quality: This is the quality level a customer expects. This is often influenced by marketing and word-of-mouth information. An example of differences in expected quality would be that someone with top notch health insurance coverage would likely expect a professional, sleek, expensive office setting in the San Diego area. If the same person had no health insurance and decided to go to Tijuana for medical care, their expected quality of care would likely be lower. Taguchi Methods Dr. Genichi Taguchi is a Japanese statistician and Deming Prize winner who has introduced a novel quality control system. Below I point out some of the highlights. Quality is measure by the total loss to society. What is the total loss to society? It contains 2 parts. First there is the cost to manufacture or provide the good to the consumer. Second, there is the cost of inferior quality. In the healthcare setting, simply reducing financial costs will be unsatisfying under the Taguchi methodology if quality of care is not at the same time maintained or improved. Continuous Quality Improvement and Cost Reduction are necessary. Did you hear that economists? Most economists analyze a problem in a fairly static setting. Technology parameters are taken as given and economists are able to derive an optimal solution for a given problem. This answer is less satisfying if you know that your parameter assumptions are relevant only in the very short run. Economists such as Schumpter and his notion of creative destruction are able to incorporate a ‘continuous improvement’ framework in their economic analysis. Quality improvement involves reducing variation. It is important to have a quality product all the time. This is done by reducing variation (e.g.: 6σ methodologies). This precept is very difficult to apply to medical care because of patient heterogeneity.

Product and Process Design have a strong impact on quality. In service sectors, often product and process design are one and the same

Improving quality involves applying appropriate methods to close the gap between current and expected levels of quality as defined by standards. This core QA activity

uses quality management tools and principles to understand and address system deficiencies, enhance strengths, and improve healthcare processes. A range of quality improvement approaches exist, from individual problem solving, rapid team problem solving, and systematic team problem solving to process improvement and redesign and organizational restructuring/reengineering. QA topics that are part of Improving Quality include:

The Four-Step Approach to Quality Improvement The Spectrum of Quality Improvement Approaches Performance Improvement Benchmarking The Four-Step Approach to Quality Improvement. Quality improvement (QI) methodology has evolved over the years. Early QI efforts assumed that improvements could be readily attained by adding new or more things, such as new machines, procedures, training, or supplies. It was believed that simply adding more resources or inputs would improve quality. People working to improve quality learned that increasing resources does not always ensure their efficient use and, consequently, may not lead to improvements in quality. In fact, a key lesson is that in many cases quality can be improved by making changes to healthcare systems without necessarily increasing resources. Interestingly, improving the processes of healthcare not only creates better outcomes, but also reduces the cost of delivering services by eliminating waste, unnecessary work, and rework.Inspecting main activities or processes is another approach that managers have used to identify and solve problems. This method tried to increase control over staff and often blamed people for mistakes. This philosophy of improving quality showed limited success because it did not necessarily identify barriers to improvement or generate the support of workers, who felt resistant to being evaluated. In contrast, current QI approaches examine how activities can be changed so employees can do their work better. For example, poor employee performance may stem from a lack of supplies, inefficient processes, or the lack of training or coaching rather than worker performance. The philosophy behind the QA Project’s approach to QI recognizes that both the resources (inputs) and activities

carried out (processes) must be addressed together to ensure or improve the quality of care.In response to the wide variety of settings and circumstances it has encountered in over 30 developing countries, the QA Project defines quality improvement as consisting of four key steps. Step one: Identify > Determine what to improve Step two: Analyze > Understand the problem Step three: Develop > Hypothesize about what changes will improve the problem and develop solution strategy based on these changes Step four: Test and implement > Test the hypothesized solution QI is not limited to carrying out these four steps, but rather emphasizes continuously looking for ways to further improve quality. When improvements in quality are achieved, teams can continue to strive for further improvements with the same problem and/or address other opportunities for improvement that have been identified. Step one: Identify. The goal of the first step, identify, is to determine what to improve. This may involve a problem that needs a solution, an opportunity for improvement that requires definition, or a process or system that needs to be improved. Examples of problems or processes that are commonly identified include low coverage, inadequate counseling, lack of drugs, lost lab reports, and excessive waiting time.This first step involves recognizing an opportunity for improvement and then setting a goal to improve it. Quality improvement starts by asking these questions: What is the problem? How do you know that it is a problem? How frequently does it occur, or how long has it existed? What are the effects of this problem? How will we know when it is resolved?

Step two: Analyze. Once areas for quality improvement have been identified, the second step is to analyze what we need to know or understand about this opportunity

for improvement before considering changes. The objectives of the analysis stage can be any combination of the following:

Clarifying why the process or system produces the effect that we aim to change Measuring the performance of the process or system that produces the effect Formulating research questions, such as the following: Who is involved or affected? Where does the problem occur? When does the problem occur? What happens when the problem occurs? Why does the problem occur? To reach these objectives, this step requires the use of existing data or data collection. The extent to which data are needed depends on the quality improvement approach chosen. Techniques to analyze problems include clarifying processes through flowcharts or cause-effect analyses, reviewing existing data, and, when needed, collecting additional data.

Step three: Develop. The third step, develop, uses the information accumulated from the previous steps to explore what changes would yield improvement. A hypothesis is formulated about which changes, interventions, or solutions would reduce the problem and thus improve the quality of care. A solution strategy is then developed based on this hypothesis. It is important to remember that at this point the hypothesis remains a theory, as it has not yet been tested. A hypothesis is a tentative assumption made in order to test its consequences. It is based on people’s knowledge and beliefs about the likely causes and solutions of the problem.

Step four: Test and implement. This step, test and implement, builds on the first three. A hypothesis is tested to see if the proposed intervention or solution yields the expected improvement. Because interventions that prove to be effective may not yield immediate results, allowing time for change to occur is important in the testing process. The results of this test determine the next step.

The Spectrum of Quality Improvement Approaches

Rapid Team Problem Solving. Rapid team problem solving is an approach in which a series of small incremental changes in a system is tested—and possibly implemented—to improve quality. This approach entails many small to medium size tests of individual changes in similar systems. Like individual problem solving, this approach could be used in any setting, although it generally requires that teams have some experience in problem solving and/or seek a mentor to help implement this approach quickly. This approach to quality improvement is less rigorous in the time and resources required than the next two approaches because it largely relies on existing data and group intuition, thereby minimizing lengthy data collection procedures. Rapid team problem solving may involve cause analysis, but implemented in a less rigorous fashion than in systematic problem solving. Teams are ad hoc (temporary) and disband once the desired level of improvement has been achieved.

Systematic Team Problem Solving. Systematic team problem solving is often used for complex or recurring problems that require a detailed analysis; it frequently results in significant changes to a system or process. The mainstay of this approach is a detailed study of the causes of problems and then developing solutions accordingly. This detailed analysis usually involves data collection and therefore often requires considerable time and resources. While systematic team problem solving can be used in any setting, due to its indepth nature, it is most appropriate when the ad hoc team can work together over a period of time. Typically, such teams disband once sufficient improvement objectives are reached.

Process Improvement. The most complex of the four approaches, process improvement, involves a permanent team that continuously collects, monitors, and analyzes data to improve a key process over time. Process improvement generally occurs in organizations where permanent resources are allocated to quality improvement. The permanent team may use any of the other three QI approaches, for example, forming ad hoc teams to solve specific problems. Process improvement is often used to assure the quality of important services in a health facility or organization. Since this approach is often used to respond to core processes of a system, various stakeholders contribute to the analysis stage.The table below compares the four QI approaches.

In sum, experience with quality improvement has rendered it a simpler, more robust methodology, and the application of QI methodology to a wide range of settings has become clearer. The settings include both clinical and nonclinical environments, with the approaches ranging from individual problem solving to process improvement by permanent teams. In all of these approaches, the methodology and principles remain unchanged, though their specific methods may vary.

4. What is quality Assessment?
uality assessment is the measurement of the quality of healthcare services. A quality assessment measures the difference between expected and actual performance to identify opportunities for improvement. Performance standards can be established for most Dimensions of Quality, such as technical competence, effectiveness, efficiency, safety, and coverage. Where standards are explicit, a quality assessment measures the level of performance according to those standards. For dimensions of quality where standards are more difficult to identify, such as continuity of care or accessibility, a quality assessment describes the current level of performance with the objective of improving it.

A quality assessment frequently combines various data collection methods to overcome the intrinsic biases of each method alone. These methods typically involve either some form of direct observation of health worker performance or indirect assessment of performance, such as through testing of providers, patient interview, or record review. Examples of such methods include:

Observation of service delivery (by expert observers, peers, supervisors) Mystery client method Audit of individual patient records Review of data from automated information system Testing (written tests, simulation with standardized patients, computer-based testing) Health worker interview Patient exit interview Some methods are more intrusive than others. Quality assessment methods are subject, to varying degrees, to the "observation effect," wherein subjects are thought to perform better or possibly worse than they might in everyday practice or provide answers they perceive the interviewer wants to hear because they are aware that their performance is being assessed. The nature of the bias introduced by the observation effect is usually thought to be in the direction of overestimating performance, assuming that health workers might be performing at their very best when they think their performance is being observed. This is not always the case, however, since the presence of observers might also have the effect of making health workers nervous and undermine their performance. The mystery client method, wherein trained individuals pose as clients seeking health services unbeknownst to the providers and observe whether the providers perform certain predetermined tasks, has been cited as a promising method for reducing observation bias.

Another issue in quality assessment is the fact that health providers’ performance may vary from one patient to the next or from day to day, depending on patient characteristics (e.g., disease severity, cultural factors) and other situational factors

(e.g., total number of patients, presence of other providers, availability of drugs and supplies). Multiple measurements of provider-patient interaction or performance of the same task are needed to obtain a reliable indication of usual performance. The cost of applying the different performance assessment methods also varies widely in terms of the cost incurred to produce each unit of observation.

Quality assessment is often an initial step in a larger QA process which may include providing feedback to health workers on performance, training and motivating staff to undertake quality improvements, and designing solutions to bridge quality gaps

Unit 2 APPLYING QUALITY IMPROVEMENT TO MEDICAL RECORDS
Administrators at hospitals are increasingly accountable for both the cost-efficiency and the quality of care provided in their centers. Quality of care, in particular, can be difficult to monitor, especially in the management of chronic disorders such as those treated in community outpatient clinics. Many outcome measures suitable for acute treatments have less relevance in chronic care. It is not surprising; therefore, that few approaches have been described to monitor the quality of care in outpatient mental health settings. The longstanding issue of the quality of medical record documentation becomes more important in light of the increasing focus on measures of efficiency and outcome. Stakeholders turn to medical record documentation for the data required for measuring many outcomes. Better record keeping may provide more accurate data for quality measurement systems. The medical records review process uses a protocol in a format similar to the one presented by Rago and Gilbert (13). Although the review has both quantitative and qualitative components, the primary goal is to assess the overall quality of the documentation of services in the medical record. Copy of the notes can be had from the author on request

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