Paper presented at a seminar on Quality Assurance held at the Ministry of Health Headquarters in Kuala Lumpur on 14th June 1997 by Prof Dr Omar Hasan Kasule, Sr. MB ChB, MPH, DrPH (Harvard),  Deputy Dean for Research and Post-Graduate Affairs, Kulliyah of Medicine, International Islamic University PO Box 70 Jalan Sultan PJ 46700 Telephone 03 755 3433 Fax 03 757 7970


The paper describes the author’s practical experience as a quality assurance consultant at BCJ Infirmary Baltimore MD 1990-91, DCDC Infirmary Washington DC 1990-91, and SCIP Hospital Pittsburgh PA 1992-1995. The terms quality control (QC), quality assurance(QA), and quality improvement (QI) are defined. The nature and purposes of quality assurance are described. Methods of QA used by the author are summarised. The paper also draws from the author’s experience to describe the presentation and follow-up of QA reports, their proper use, and their possible misuse. 




1.1 Quality Control (QC)

The concept of quality control (QC) started in industry where the aim was to detect defective parts and products and not allow them to be sold to the consumer. Quality inspectors were trained and inspection methods were developed to be able to certify that products were good before release into the market. Statisticians working for manufacturing companies have developed very sophisticated approaches of error analysis.


1.2 Quality Assurance (QA)

The concept of quality assurance (QA) is more advanced than that of quality control. It assumes that there is a definable quality level that is acceptable and efforts are made to make sure that performance does not fall below that. It has a disadvantage of being static in nature in a rapidly changing and improving field.


1.3 Quality Improvement (QI)

The concept of quality improvement (QI) assumes that whatever is done could be done better and that the criteria or levels of performance have to improve on a continuous basis. It is a more dynamic concept than the two described above. QI is the trend of the future because the increasingly competitive health care industry will insist on quality. Health care providers as well as managers will be interested in methods of  not only assuring but of improving that quality.


1.4 Health Care Providers (HCP)

This term refers to the professionals who take care of patients. It includes physicians, nurses, and other professional support personnel. The basic interest of all of these is to provide professionally competent care. They have a professional and moral responsibility to do the best for their patients. In the traditional mode of health care they were not supposed to consider resources in their clinical decisions. They would aim at quality care whatever the price. However in these days of managed care, they are finding it increasingly difficult not to consider resources and health economics. They are also becoming resentful of cost and profit-conscious business managers who want to control their consumption of health care resources and remind them that these resources are limited.



1.5 Health care consumers (HCC)

Healthy and ill persons who seek preventive or curative health services are generally referred to as health care consumers. Their aim is to get quality care in a respectful atmosphere. Today’s consumer is more demanding because of higher education and more general knowledge about medicine. The increasing trends of private care are making consumers demand quality for the price they pay. The definition of quality used to be left to the professional health care providers. This situation is changing with consumers being interested as well.


1.6 Health care Managers (HCM)

This is a new breed in the health care industry whose basic interests may be more related to business efficiency and perhaps profits. Without being health care professionals, they exert a powerful impact on the way health care is delivered by controlling the health care resources. This control often goes out of bounds when business managers in a hospital seem to be dictating what types of treatment modalities a physician must use or what types of medication he should prescribe. These managers can not be dismissed as an unwelcome interference. They play a vital role because in the long run, economics cannot be divorced from medicine.




2.1 Betterment of Care

The quest for quality is an integral part of good medical practice. QA should not be looked at as looking over the shoulders of health care providers to discover their mistakes and thus condemn or penalise them. Successful quality programs should be welcomed by the care providers and they should look at them as a means of improving their work. QA is team-work. It is a misconception to look at QA consultants as policemen prowling around the hospital to catch culprits who are violating standards of good practice. All care providers are members of the QA team and all share the same purpose of improving care. All will share the credit of improved care as a result of QA efforts. The quality process can not be generic. Each institution or even each department has its own approach to quality. There can not be one prescription that fits all situations. The quality process must be simple, practical, and relevant to the local situation. All people involved in the process must be able to understand it. As soon it becomes too complex or too technical it loses its major impact.


2.2 Identifying and Defining Problems

Mistakes and errors are part of life and are not completely avoidable. Errors of omission or commission will occur in any system managed by humans. A biological system will also develop errors inevitably. Some of the errors may be no-differential, occur purely by chance. Others may be differential reflecting a consistent bias or trend. QA is more meaningful for non-random errors because a causal pathway can be established and something can be done about them. QA does not set itself the purpose of establishing an error-free system because that is not possible. The important issue is detecting errors early and resolving them. The purpose of QA detects trends and factors that are pre-cursors of major problems. Random errors can not be predicted accurately but there are conditions that are conducive to their occurrence. Non-random events are easier to detect and study because they are consistent and associated causal or aggravating factors can be discovered.


2.3 Anticipating, Preventing, and Resolving Problems

QA does not confine itself to detecting problems, it aims at looking for solutions and preventing future recurrence.  A QA report is incomplete without a series of recommendations on how to improve. In the same  vein a QA report about a problem that is un-resolvable given the existing and real constraints in manpower, knowledge, technology, and resources is not of much benefit. The QA consultant does not confine himself to identifying or describing problems and recommending solutions, he must go a step further to persuade, convince, and cajole the care providers to change their ways and adopt his recommendations. He must also follow up on the implementation of the recommendations. New problems may appear as a result of that implementation. Sometimes the implementation may fail and the reasons for that must be found.


2.4 Education and reassurance of care providers

The QA process identifies problems and bottle-necks that the care provider can not see easily in the daily heavy routines of hospital work. It provides a new and different perspective to the health care delivery process such that the health care delivery personnel can undertake corrective or ameliorative measures. They thus become educated and definitely better at whatever they are doing. QA could be looked at as a process of learning from mistakes. To achieve this purpose the QA process must be continuous and comprehensive. When the QA process finds that the providers are doing a good job and they are told so, they are reassured. This reassurance is needed a lot in the situation of continuous stress experienced by health-care givers.


2.5 Protection of Consumers

Consumers need to be protected from dangerous, wasteful, or ineffective treatment modalities. The QA process could play the role of overseeing and detecting problems, pointing them out, and suggesting solutions. In the era of rapidly-evolving technologies and treatment modalities, serious problems appear frequently and require urgent and effective solutions. QA is likely to become a major pre-occupation of the health-care profession because of the privatisation of health care. Since the profit motive is always suspected to compromise care, both the consumers and the government want to make sure that quality care is provided.


2.6 Legal and Business Factors:

The health-care providers, including hospital and HMO managers as well as health insurance companies, are also interested in setting up a good QA program to be able to detect and correct problems. Two purposes would be achieved by this: (a) reassure clients and thus gain their loyalty in a very competitive field and (b) Decrease mistakes that could result in litigation and heavy court fines and penalties. Today’s consumers are more educated and more aware of medical matters and will not hesitate to go to court if they feel that they were given sub-standard or poor care.



3.1 Policy

QA should have strong institutional backing. The head of the hospital or institution should lend his personal backing. A QA policy and procedures should be approved by the governing board of the institution concerned. Care should be taken in formulating the QA policy and procedures to make sure that all providers of care are involved and that the policy has grass-roots support. They should ‘own’ the policy and not look at it as an imposition from above. The QA policy should not be rigid. It should be flexible and easy to adapt to changing circumstances without going through a major restructuring process.



3.2 External QA

It is always an advantage to have an QA reviewer from outside the institution. His reports are easier to accept because he has no personal connections or interests within the institution. He may also bring a new insight to the problems that people within the institution can not have. Recommendations for change from him are easier to accept. A favourable QA report by an outsider gives the institution more credibility. The best way to carry out external QA review is to have an independent consultant do it. He should not be a permanent employee of the institution but is paid a consultancy fee based on a clear consultancy contract.


3.3 Internal QA

In addition to external QA review, the institution should appoint internal QA reviewers. A QA review nurse normally suffices to collect the data needed. A QA physician could then work with her to analyse the data and reach conclusions. The nurse could do the follow-up on the recommendations. The physicians should however always be personally involved in discussions with other care providers.


3.4 Departmental or divisional responsibility

The QA process could be organised by department or section. Each department could set up its own QA committee and appoint QA reviewers. It could also decide on its own procedures.



4.1 All care providers

QA succeeds most when it is part of the institution’s organisational culture. Thus all care providers should be educated to think of themselves as stake-holders in the QA process. This can be achieved by holding special seminars and workshops on QA. 


4.2 QA nurse

A QA nurse usually suffices for data collection both on routine and more sophisticated cases. She should be specially trained for this job. She should be given opportunities to visit other institutions and also attend seminars and conferences to stay up to date in this rapidly-evolving field. She should be given due recognition and status in the institution so that other care providers do not look at her as a person interfering in their work. Working as a QA nurse should not be career. Every 2-3 years there should be a rotation so that another person becomes a QA nurse and the former QA nurse returns to the ward where she will be more quality-minded.


4.3 QA Physician

A QA physician can be selected on a part-time basis to cover a department or section of the hospital. It is not good practice to have a full-time QA physician; he will soon lose effectiveness by being out of touch with the realities of the ward. He may also start being looked at as a ‘policeman’ which will jeopardise his role. It is best for the QA physician to be from the junior ranks again to emphasise that QA in not control or supervision from above. The role of the QA physician should be to supervise the QA nurse and also analyse the data she collects. He is the one to present the QA report to his peers because they may not easily accept it from the nurses. The position of QA physician should also be held in rotation every 1-2 years.


4.4 QA Manager

For very large institutions with many QA nurses and physicians scattered in many departments, there is need for administrative co-ordination. This can be achieved by appointing a hospital QA Manager. His functions are: (a) make sure that QA procedures of each department are co-ordinated and that everybody knows what everybody else is doing (b) convey QA recommendations to top hospital management in situations that require high-level decisions involving material and human resources to resolve the outstanding problems ensure inter-departmental co-ordination in resolving common problems.


4.5 QA committee

QA committees at the institutional and departmental levels should be set up chaired by the most senior physician available. They should meet on a monthly basis to listen to summary reports of problems identified, how they were resolved, and measures to prevent recurrence in the future. They should set themselves the task of giving general guidelines and not working on the details.




5.1 Setting criteria

The first step in any quality process is to define the criteria to be used. The criteria should not be too rigid because each health care delivery situation has its own peculiarities. The criteria used in an emergency room should be different from those of a cardiac clinic. The criteria should also change with time. As some problems are resolved, new ones appear or take up a higher profile and should be given priority. Simply stated a criterion is a simple statement of the expected standard or quality care. The criterion should be simple and defined in such a way that it is possible to quantify it. The process of setting criteria should involve all those concerned and everybody should know by which criteria they are being judged. The criteria may be simple routine issues like proper documentation of the patient record (identification numbers, dates & times, signatures of providers, vital signs). They may involve more specialised issues of proper case management (diagnosis, treatment, and follow-up). Some criteria are related to drug prescriptions (indication, dose, route, interactions, contra-indications, and side-effects). There are other criteria that focus on consumer satisfaction both in a physical or psychological sense. The concept of criteria in practice requires agreeing on common protocols or approaches for managing various conditions such that each physician does things in pretty much the same way. Some physicians may find this an interference in their professional independence but experience has shown that it can result in better, more efficient, and predictable care that can be evaluated easily.


5.2 Sampling

The quality process attempts to draw conclusions about the total health care process by observing in detail some cases or events. Thus some form of sampling is needed. The sampling is not primarily driven by the need to get a representative sample. It is driven first by problem identification. Then the records and other sources of information that have relevance to that problem and can give a valid picture are examined. The worst form of quality assurance is to take a representative sample and start fishing for problems. The sampling units could be charts, wards or departments, patients, diagnoses, or procedures. Usually 10-20 units are sufficient to provide a valid picture of what is going on. It is a mistake for the QA reviewer to single out cases or procedures by an individual physician or nurse for review. In some cases critical incidents happen. They reflect the strengths and weaknesses of the health care system. The QA reviewer must have a system of surveillance to make sure that such incidents are detected. A critical incident is normally a problem or a major mistake. It is very useful in that it is sometimes on the final causal pathway of several problems in the health care delivery system. Analysing it well can unravel many problems that would normally take a long time to identify using the normal sampling techniques.


5.3 Collecting Data:

The best source of data in hospital practice and perhaps in most health care situations is the patient chart. The patient chart is supposed to be a comprehensive record of physician, nursing, prescription, and other activities. The first aim of QA managers is to make sure that records are complete, accurate, and updated. Thus chart review is the bed-rock of most QA programs. Additional information can be obtained from attending ward rounds, discussions with patients and physicians, or special questionnaires and surveys undertaken on specific problems. Data could be collected over a given period of time to describe the incidence of particular problems and establish trends. Data collection should be continuous and regular. The best is to have weekly reviews if there is sufficient manpower. QA reviews once a fort-night are possible. Monthly reviews are too far apart to be of much use. Very useful data could be collected from critical incidents that occur.


5.4 Analysing data:

The analysis needed in QA is very simple. Use of sophisticated statistics could only serve to confuse the picture. The QA analyst must first establish the incidence of a particular event or problem over a given time frame. He then should next consider the trend; is it increasing, decreasing, or is it steady. The co-factors associated with a particular trend are then studied and correlations are established. More detailed investigations are then undertaken to find the mechanism involved, how exactly the co-factor(s) operate(s) to cause the identified problem. The co-factors could be related to the care provider (attitude, job satisfaction, knowledge, skills), to health care resources (physical facilities, manpower, time), to the patient (attitude, co-operation, compliance), or the general organisational culture (laissez-faire, fastidious, efficiency, effectiveness, customer service). The data analysis by the QA reviewer should not be considered final. He should sit with the care providers and managers and review the basic data with them without telling them his own conclusions and biases. He should listen carefully to their perspectives of the problems since they could come up with a different conclusion. The reviewer should be prepared to change his own conclusions in the light of the discussions with the care providers. In some cases the providers may not be forth-coming in terms of analysing the data in which case the QA reviewer could give them his own conclusions and ask for their reactions.



6.1 Documentation

The most common problem is that of documentation. Care providers in their rush to deal with a heavy work-load do not take the time to document fully. The date and time procedures carried out or when the patient is seen are vital to make sure that there is a correct time-frame for follow-up. Care providers forget to sign their names and indicate their title; notes and instructions can not be appreciated fully unless their author is identified. An observation by a consultant is not the same as that of an intern. In many records the daily recording of the vital signs (temperature, blood pressure, pulse, and respiratory rate) is forgotten. Documentation is sometimes incomplete for example a chart may have an instruction to take blood pressure without mentioning how often or whether it is supine or prone. Careful review of charts sometimes reveals problems like results of an investigation being found without any notes indicating who ordered the investigation and why.



6.2 Investigations

The availability of many radiological and laboratory tests has made physicians lazy; they do not exert the mental effort needed to be selective and order only those investigations that make sense in terms of the findings from history taking and physical examination. Review of some charts reveals that the physician does not even bother to take a history and examine the patient carefully, he just orders a plethora of tests in the hope that one will indicate what the diagnosis is. Ignorance of physicians of the costs of these tests or a non-caring attitude since someone else is responsible for the bill also encourages this behaviour. The matter becomes worse if the physician has financial incentives to order too many investigations. The other side of this story is failure to order investigations that are obviously necessary given the patient’s symptoms and signs. Sometimes the physician makes a note about making investigations but does not actually write the order. In many cases there is no follow-up to make sure that the results are obtained and are in the chart with the result that the physician orders the same test several times and it is done that many times, a wasteful situation.


6.3 Prescriptions

Many mistakes are made in prescriptions. Fortunately few involve prescribing the wrong drug. In most cases mistakes are in the dosage or frequency. Mistakes about the route of administration are rare and if they occur are easily identified by the nursing or pharmacy staff. Poor history-taking is responsible for untowward drig interactions and allergic reactions. Review of many charts indicates that many physicians are not aware of the side-effects of the drugs they prescribe because there is often no notation in the chart that they enquire about symptoms of possible side-effects when they review the patients.


6.4 Follow-up

The concept that case management is a complete job involving follow-up even after cessation of treatment does not seem to be well appreciated by many physicians. Review of charts does not show planned follow-up of discharged patients.




7.1 Basic Philosophy

The basic philosophy involved in presenting QA findings is not to apportion blame but to identify problems and resolve them. The QA process should be a win-win for all involved. The patient gets good care. The providers are reassured if they are doing well or they are educated to improve their care so that they will shine next time around. The institution gains the loyalty of its patients and is saved from costly legal battles that could arise out of poor quality care and professional malpractice.


7.2 QA Caucus meeting

The QA findings in a department should be discussed in a small caucus of providers concerned in that department. Many issues that were seen as problems may actually not turn out to be so when additional information is obtained from people who are involved directly. The meeting could also suggest solutions to the problems and decisions are taken about what to do with clear tasks being assigned to individuals. The initial report should be modified to reflect new information from the caucus. The report should be up-dated after the next meeting of the caucus when the results of intervention decisions taken at the last meeting are available and can be incorporated in the report.

7.3 The departmental QA Report

A departmental QA report, based on QA caucus reports,  must be written on a regular basis. It is best done on a monthly basis. A more frequent one does not identify trends well. The QA reports should be sequential. The next report should discuss follow-up and solution of problems identified in the previous report. It should also comment on any trends seen earlier. It should mention whether they have increased or decreased during the reporting period. Preventive anticipatory measures taken must be also mentioned. The report should not in the normal circumstances mention any names of care providers or of patients. It should focus on the problem and not seek to apportion blame.


7.4 The Institutional QA report

The institution should issue a QA report either every 6 months or every year. The report should mainly mention problems encountered in the year, how they were resolved, and the results. It is a valuable document that stakeholders in the institution may want to read once in a while. The distribution of this report has to be thought about seriously. It is a very important document that if it falls in the hands of competitors or aggrieved parties could be misused either to generate bad publicity or institute some legal action. It should therefore always be treated as a confidential internal document.


7.5 Follow-up

It is not enough to write a report and distribute it. It may lie unattended on people’s desks or get filed away and is forgotten. The QA reviewer should take the initiative to discuss the draft report with the care providers concerned before it is officially published or is issued. He should also solicit their views and plans of action for dealing with them. A summary of these plans could be included in the final report.


7.7 Problems that arise out of the QA process

Personal clashes could arise if some care providers feel that the QA report was biased against them or was an attempt to show them in bad light. Patients or their lawyers could use the QA report as written admission by the institution of wrong-doing and they may sue in courts of law.




The tendency in health care in Malaysia is towards privatisation. Health Maintenance Organisations are being set up. Health insurance companies are starting. Many private hospitals are being built. The health care industry’s share of the National GDP is increasing. All these trends are bringing the normal market forces to operate within the hospital and with them will come increased attention to quality.


Government Responsibility

In the market place the aim is to maximise profits. This may lead to cutting corners and poor quality of care in some situations. The government will have to step in and exercise its social responsibility of protecting the consumers. Thus it can institute QA programs and may even go further and publish QA guidelines and criteria.

Professor Omar Hasan Kasule June 1997