The chapter describes the professional and regulatory landmarks which have influenced the development of the quality movement in health care in the UK and the USA. They reflect the similarities and differences in the approach to quality which have evolved within the National Health Service in Britain when compared with a free market system of health care such as that in North America.

A conceptual framework is used to approach the definition and assessment of quality of health care, noting in particular Donabedian's seminal triad of structure, process and outcome as well as the outcomes movement and other theoretical approaches to defining quality.

The characteristics of criteria, standards, guidelines and protocols are described and the terminological problems in this field are discussed. The use of standards for improving quality includes their application in clinical audit, for accreditation and re-accreditation, in contracting for health services and in regulation and inspection.

There is a new and unfolding relationship between clinical standard setting and management. Concepts such as continuous quality improvement and total quality management are challenging traditional assumptions about the need for a separation between professional, consumer and managerial approaches to improving quality. The National Health Service, following implementation of an internal market for public health care provision in Britain, is well placed to absorb and synthesise the many differing philosophies in the health care quality movement to the benefit of both patients and the health professions alike.

Process of care is the most immediate, relevant and susceptible to improvement of Donabedian's three elements of quality assurance. To place the study of process in context, the history of quality assurance in English-speaking countries is reviewed, with particular emphasis on the U.S.A. A range of methods are examined in detail and examples are provided to illustrate their strengths and weaknesses. Particular attention is paid to the use of explicit and implicit criteria. The importance of information technology in monitoring the process of care cannot be over-stated. Limited audit is possible with manual records but all substantial projects require computer support. The value of capturing data from operational systems rather than from dedicated projects is emphasised. Attention is drawn to the key importance of structured records and minimum data sets; these allow information to be pooled and process studies to be generalised. Examples are given of quality assurance projects which have used information technology. Finally potential future developments are reviewed with particular reference to clinical guidelines and computer-based clinical decision support systems.

In this chapter, we describe the role of patient outcome measurement in quality assurance under six main section headings. In the first section: ‘Why measure outcomes?’, we attempt to state a clear and logical case for considering the inclusion of patient outcome measurement in all systematic assessments of the quality of health care. In, ‘Problems of measuring patient outcomes’, we acknowledge and elaborate upon some of the commonly encountered theoretical and practical difficulties of patient outcome measurement, and upon some of the ways in which such issues might be addressed within specific contexts. The third section: ‘Characteristics of a good measure’, considers some of the basic scientific and practical properties which should be considered when choosing a patient outcome measure for a particular context. ‘Types of measures’ considers some of the general features of the different types of measures currently available. ‘Quality of Life’, looks more closely some theoretical and practical aspects of that particular, and increasingly popular, area of patient outcome measurement. The final section offers a summary description of where we are now, and where we can go from here.

The framework for this chapter stems from the proposal that the basic steps of the quality cycle should be combined with the practical stages of the scientific method to form an extended quality cycle comprising nine steps. The scientific and methodological implications of each step are considered in turn. The discussion of the three steps relating to the development, dissemination and implementation of clinical standards is based on a recent review of rigorous evaluations of clinical guidelines. The discussion of the three steps relating to the comparison of clinical performance with agreed standards is based on the existing principles of medical research. The final step is concerned with the management of change. The chapter ends by applying the steps of the extended quality cycle to the topic of thrombolytic therapy after acute myocardial infarction. The resulting hypothetical quality assurance exercise appears simple and potentially very effective. We conclude that, if quality assurance is pursued with a combination of scientific rigour, imagination and persistence, it has the potential to bring substantial benefits to patients and health professionals.

There are two distinct views about the purpose of quality assurance by means of medical audit. The first is that it is a job requirement, to be backed by sanctions where necessary. The second is that it is a desirable attribute of professional practice, backed only by exhortation and opportunities for further training. This difference of view lies at the heart of much of the dispute as to how medical audit should be pursued in the UK at present. It explains why the medical profession insists that such audit should be conducted by peers, for peers, and accountable only to peers, whereas managers want some say in what is audited, how it is audited, and also want the reports of such audit made available to them, so that they can act upon the findings in their role as employers (e.g. in organising workloads, contracts, etc.). In this chapter the ‘job requirement’ view is supported, and its implications explored. It is argued that unless this route is chosen, it is unlikely that medical audit will deliver improvements in the health of the population that are commensurate with its costs.

Audit within general medicine originated from a review of patient clinical records. The main effect of such activities was to lead to an improvement of documentation and a realisation that audit could be performed amicably. Once case note reviews had been established it was usually necessary to progress to specific topic review. Such audits required more input of doctors' time, and to be performed properly needed the support of committed audit staff and limited support from computer technology.

The primary aim of medical audit is to improve clinical care. Although an important component it is not the primary purpose of audit to save money.

This chapter traces the development of quality assurance in general practice over the last quarter of a century. The practical implementation of quality assurance in British general practice is set against experience in other countries. Examples illustrate how ideas for improving care have already been incorporated into normal practice. We describe some of the methods currently in use and speculate about how systems of professional accreditation might become acceptable. Finally we consider the future role of quality assurance in general practice.

It is with some pride that members of the nursing profession point to Florence Nightingale as one of the forerunners in developing quality evaluation in health care. Her interest and belief in the necessity of routine collection of hospital data for comparative purposes is well documented. Given the clarity of the vision and the force with which it was communicated it is interesting to speculate why nursing did not directly or immediately benefit from Nightingale's vision. It was almost a century before mechanisms were in place to allow some of Nightingale's recommendations to be realised.

This chapter focuses on application of quality assurance procedures to the management of patients with chronic diseases. The three principal themes developed are amongst the most central to effective and efficient long-term management, namely medical information systems, clinical guidelines and protocols, and patient and clinical outcomes.

The present state of play of the three themes is outlined, potential methodologies and technology to apply quality assurance techniques are described, and some implementation strategies for the management of chronic disease are described.

Consideration of these topics strongly suggests that quality assurance must have a high profile in the care of patients with chronic diseases. Purchasers of care now have to be confident that adequate quality assurance policies are in place. Providers of care also recognise that quality control has to be implicit in their daily practice and that quality assessment of the service that they provide is an acceptable and necessary exercise. The challenge is to involve the professions and the patient in the process of quality assurance and to prove that it is a cost-effective tool in achieving such benefits as may, or may not, be identified in the care of patients with chronic diseases.

Audit is the critical evaluation of medical practice to effect an improvement in quality of service. Quality has been described as ‘getting it right the first time’ and audit as asking ‘whether you are doing the right thing and you doing it right?’. Surgeons are acutely aware of the penalty paid by the patient when he ‘gets it wrong’. Immediate complications such as wound infection and anastomotic leakage may require additional therapy, delay discharge from hospital, necessitate further surgery or even lead to death. Late complications may result in recurrence of the presenting pathology or complications which cause more distress than the original disease. Surgery and audit seem to be closely linked and naturally associated. Surgical skills have developed immeasurably, no doubt accelerated by the realisation of the penalties of failure. Fortunately the cost of poor performance to the surgeon is no longer to have ones hand cut off as it was in 1750 BC under the rule of King Hammurabi of Babylonia.

The quality of care for pregnant women and their babies must be a high priority to ensure the health of future generations. Unique features are the need to deal with at least two ‘patients’, that the process of parturition is usually normal, and that there is a long history of incorporating women's views into definitions of good care. Methods of assessing structure, process and outcome of care are described, and the limited evidence of their efficacy in improving care. High-quality care in the future will require collaboration between women, midwives, family doctors and obstetricians.

Assuring the quality, safety and efficacy of the complex medicinal drugs known as ‘biologicals’ has many facets of importance to public health. This survey covers the historical basis of this area of medical science through current issues and practices to the anticipation of future challenges. The key role of the World Health Organization in promoting international biological standardisation and of biostatistics in the design and analysis of biological assays is emphasised. Examples of the importance of quality control and standardisation are drawn especially from the fields of bacterial and viral vaccines. Assurance of the quality of these is essential for the successful implementation of childhood vaccination programmes aimed at the reduction and eradication of communicable diseases worldwide.

Compliance with drug therapy is a much neglected part of the science of therapeutics. It is a particular problem with certain chronic diseases, for example, hypertension and diabetes; and certain classes of therapeutic agent, for example, anticoagulants and antiepileptics. Methods for the monitoring of compliance are discussed and it is concluded that the best available are either the electronic drug delivery system or chemical monitoring with a suitable long half-life compound. Until modern methods of measuring drug compliance are introduced, patients will surfer disability and even death. It should also be mandatory for controlled clinical trials of new therapeutic entities to include an acceptable mechanism (or method) for the assessment of adherence to the protocol. If not, the results will be vitiated.

Blood transfusion services, in almost all parts of the developed world, are subject to the same rigours of quality standards as those applied to the rest of the pharmaceutical industry. These standards are established and monitored by governments but are greatly enhanced by staff involvement and commitment. More recent developments, which in some respects are unique to blood transfusion services, have been the commitment of many blood transfusion services to engage in an audit process which seeks to define better the most appropriate uses of blood and blood products.

There are many steps in the process between the clinician requesting a clinical biochemistry test and receiving a numerical result. Each of these steps must be subject to quality assurance techniques. Clinical biochemistry laboratories now have mature, integrated systems of internal quality control, external quality assessment and quality assurance to ensure that the results issued do aid in the provision of optimum patient care. The recent advent of a professionally led laboratory accreditation scheme will stimulate further improvements in quality. Enthusiastic adoption of the techniques of quality management science, in the form of total quality management systems, will focus future attention on laboratories providing services to the standards dictated by consumers. Translation of these standards into objective operational specifications will then allow laboratories to adopt appropriate comprehensive quality assurance techniques which will guarantee the quality demanded.

There is widespread interest in development of approaches to monitoring the quality of the diagnostic service provided by pathology departments. Novel approaches are being developed for analysis of performance, while there is active interest in the selection of diagnostic categories that can be reliably applied in service laboratories. Initial progress has been slow but organisational problems and professional inertia have been largely overcome. The scene is now set for continuing critical appraisal which must lead to improvements in clinical care.

Quality assurance in laboratory haematology includes (a) constant checking of test reliability by internal quality control, (b) external quality assessment by an independent agency to check performance of a number of laboratories at intervals in order to obtain a retrospective indication of their ability and (c) proficiency control by supervision of the pre-test and post-test phases of laboratory work, from specimen collection to delivery of the report to the clinician.

The procedures which comprise quality control are described; these include use of control preparations with control charts, CUSUM analysis, constancy of daily means of the blood count indices of ‘absolute values’, duplicate testing, clinical correlation and the important role of the blood film to check the instrument-derived blood count measurements.

A description of the functions of an external quality assessment scheme is based on the UK National Scheme (UK NEQAS). The blood count and other tests of general haematology have been used as models to describe the procedures for qualitative and quantitative tests, low results are analysed and performance is assessed. The tribulations and triumphs of NEQAS are described and it is concluded that NEQAS has a vital role in ensuring good laboratory practice in general, and the reliability of the individual laboratories who participate in the scheme. NEQAS, in turn, must ensure its own ability to provide stable materials which are suitable for each test in the programme, and to analyse data correctly. There is also need to take account of the continued expansion of laboratory services as new techniques are introduced and to develop appropriate EQA procedures and materials in order to incorporate these in a comprehensive scheme.

National External Quality Assessment Schemes (NEQAS) in Microbiology have been established and operative in the United Kingdom for over 20 years. The essential components of such schemes with an account of the supporting expert advisory structures are described. Participation is voluntary and the primary aim is educational and designed to elevate standards of diagnostic practice generally through comparisons of performance within peer groups. The effect of such schemes on microbiological diagnostic performance is discussed.

The need for harmonisation within the European Community is addressed, together with an account of preliminary work relating to formulation of Directives in the field of medical devices.

The process of accreditation of diagnostic pathology laboratories through CPA (UK) Ltd. is briefly described.