External Assessment of Health Service Standards

• Summary
• Introduction
• European Models of External Standards Assessment
• Accreditation in the European Union
• Application Outside Europe
  • USA
  • Australia
• Common Concerns
• References
  
  
  
  

Summary

Clinicians and managers of health care are expected to receive and to act according to increasingly explicit and diverse guidance on clinical practice and service organisation.

Even when sound, this guidance often does not reach or affect the people or practices which they were intended to change. Current proposals for statutory bodies in the UK National Health Service (NHS) focus on clinical practice rather than the clinical environment and management systems that need equally robust and complementary improvement mechanisms. A European Union-funded research project, External Peer Review Techniques (ExPeRT), has identified four basic approaches to external improvement of health care organisations,  ¹   which could help to embed evidence-based medicine and promote effective health service environments, if they were themselves more integrated and consistent within and between countries. These principles are consistent with the findings of recent national reviews in Australia, Scotland and USA and support arguments in favour of an internationally agreed framework for defining and assessing standards for the organisation of health services, as is being developed by the International Society for Quality in Health Care.

Introduction

Medicine is moving from traditionally implicit codes of practice towards more explicit regulation and guidelines. The acceleration of technology, the reduced half-life of medical knowledge and increasing evidence of wide variations in clinical performance have eroded a resistance to regulation that was once based on the preservation of clinical freedom. We are now more ready to accept the principle (attributed to Lenin) that, "Freedom is precious; so precious it must be rationed".

National guidance now abounds in key areas of clinical standards – particularly individual competence, technology and service delivery – but often fails to be effective for lack of effective means to ensure that it is implemented locally. "Clinical governance", a term new to the NHS, has yet to take root, and clinical guidelines have a disappointing impact.  ²   Barriers to improvement seem to lie more with organisations and systems than with individuals; the great majority of medical errors are due to failures of systems rather than of clinicians.  ³  

In the United Kingdom, the clinical audit programme was set up in response to a 1989 White Paper in 1989 and then driven by the NHS through targeted funding, prescribed organisation and reporting.  ^{4  ,   5}   The programme achieved a cultural change and much activity but also demonstrated the behavioural and organisational challenge of implementing change in actual practice.  ⁶   Clinical governance, proposed in the recent White Paper  ⁷  , and enlarged upon in the subsequent discussion documents for England,  ⁸   Scotland,  ⁹   Wales  ¹⁰   and Northern Ireland,  ¹¹   is the current solution to the same problem. In England and Wales, a National Institute for Clinical Excellence (NICE) is to be set up to collect, develop and validate clinical guidelines and to provide practical methods for local and national audit; but it will have no extra resources to ensure the recommended methods are implemented. A Commission for Health Improvement (CHI) will be set up to inspect and supervise failing organisations (as proposed by the Royal Commission on the NHS in 1979  ¹²  ); but it will have no extra resources for regular inspections throughout the NHS.

The functions of these statutory innovations have yet to be defined in relation to the many other legitimate and established sources of standards and guidelines which are based on research or real life. These sources include the specialty colleges, associations and societies, the General Medical Council, the Ombudsman, training organisations, the Clinical Negligence Scheme, independent enquiries, the National Audit Office, the Audit Commission and patients’ and voluntary organisations. They share an ambition – as an ethical or legal responsibility – to define and improve standards; but they have few or no mechanisms to see that these are implemented locally.

European Models of External Standards Assessment

ExPeRT  ¹³   has identified four systematic approaches to linking national (or international) standards to local practice. Each, to varying degrees, is voluntary and independent and uses explicit standards to combine internal self-assessment with external review by visits, surveys, assessments or audits. Certification of compliance with norms of the International Standards Organisation (commonly the ISO 9000 series), and business excellence assessment and awards using the model of the European Foundation for Quality Management (EFQM) were developed for manufacturing, commerce and service industries but have been applied widely in health care; both EFQM and ISO 9000 have recently been revised. "Visitation" (Dutch visitatie) or reciprocal visiting, either informally or in relation to the assessment of clinical training, is driven by professional and often uni-disciplinary organisations and has a long tradition in health care as a form of peer review. Beyond training, it has also been applied to service development (such as the hospital specialties programme in the Netherlands  ¹⁴  ) but the basis of assessment is primarily clinical and confidential and less explicit than the standards and processes of ISO or EFQM.

Each of the four European models has features which could improve the others in their application to health services, and their proponents are beginning to discuss convergence, such as with the Dutch "harmonisation" of industrial and health care models including EFQM, visitatie and accreditation,  ¹⁵   and with the publication of health service interpretations of ISO 9000. There is also potential to integrate user-orientated care service frameworks together with the more provider-orientated traditional standards of accreditation. Many accreditation programmes are already focussing more on care pathways, patients’ experience and clinical performance. Since they already have a cadre of trained surveyors, a regular cycle of site visits and assessment procedures, they could readily provide a vehicle to integrate, disseminate and monitor national standards that are derived from a wide range of sources.

Accreditation in the European Union

In France, the governmental Agence Nationale d’Accréditation et d’Evaluation en Santé (ANAES) was established in 1997 with a mandate  ¹⁶   to accredit all 3,250 public and private hospitals and clinics; this accreditation process could eventually include assessment of the local application of national clinical guidelines developed by ANAES and other recognised bodies. This statutory authority to define and assess compliance with clinical and organisational guidelines is unique in Europe. In Italy, legislation  ¹⁷   requires accreditation to be set up nationally; this also gives an opportunity to embed evidence-based medicine, except that the standards and assessment process will be run independently by each regional government. In the UK, the statutory CHI will have access to all NHS premises in England and Wales (including primary care, hospitals and health authorities) which it is required to review (but not "accredit") every four years. In Scotland the Clinical Standards Board will have a similar statutory function, accrediting patient-oriented clinical services and issuing public reports. In the Netherlands, the National Hospital Federation adopted in 1995 a series of organisational standards developed by the Netherlands Organisation for Applied Scientific Research; this has created a national, non-governmental hospital accreditation programme "NIAZ". Elsewhere in Western Europe, equivalent national programmes are under development or consideration in Ireland, Switzerland, Germany, Spain and Finland.

Application Outside Europe

Several recent national and international studies have endorsed simultaneously a variety of public and independent systems. They conclude that these systems should be co-ordinated by government in order to ensure valid standards, reliable assessments, consumer involvement, demonstrated quality improvement, transparency and public access to criteria, procedures and results.

USA
The 1998 report of the USA Commission on "Consumer protection and quality in the health care industry"  ¹⁸   recommended that specifications for quality measurement and reporting should be consistently defined incorporating the existing private, professional and public mechanisms. Together they would develop common core sets of quality measures, standardise assessment processes to allow reciprocal recognition, ensure consumer representation, and make standards and assessment criteria and decisions available to the public at little or no cost.

Australia
In the same year a report for the Australian Commonwealth Government  ¹⁹   from a national expert advisory group likewise recommended that, by agreement with the State Governments, independent accreditation, certification and award programmes should be encouraged (or even made mandatory) as long as they reflected consumer issues in standards and assessment processes.

The report noted that, although accreditation is well-established in hospitals and in community care there is a growing interest in quality systems that are more commonly used by other industries, such as manufacturing and services, which offer more generic but internationally recognised certification against standards. In the main these are the Australian Quality Awards criteria (similar to EFQM in Europe and Baldrige Awards in the USA) and the International Organisation for Standardization (ISO). The report acknowledged that AQA and ISO do not have strong standards for clinical quality, but argued that they have the capacity to establish the organisational and cultural infrastructure to support clinical activities.

Common Concerns

There are common concerns, at least in Europe, Australia and the USA, about how organisational standards are defined and measured, and how effectively the existing systems support internal quality improvement at the same time as providing public accountability and information. There are also common arguments for consistency within nations and within trading regions. But countries will have to adopt common core standards and assessment processes if there is to be consistency and compatibility at national or international level.

The International Society for Quality in Health Care has produced a template for valid standards and reliable assessment as part of its ALPHA programme (Agenda for Leadership in Programs for Healthcare Accreditation, http://www.isqua.org.au/). This provides practical pointers on the development of standards, and criteria by which an assessment programme could itself be assessed.

The ALPHA standards were originally intended as yardsticks against which national accreditation programmes could themselves be assessed internationally and are founded on the criteria used by the "Wellington Group", which was first gathered to assess the national accreditation programme in New Zealand and has since then visited programmes in Australia and Canada. The standards also offer a template on which complementary local, specialty-based or patient-based programmes may develop and by which they could assess themselves, or be assessed.

Most of the arguments for standards and the audit of clinical practice, as steps towards evidence-based medicine, apply equally to the organisation of services and evidence-based management. Despite its potential to inhibit or promote good clinical practice, relatively little attention has been given to the science of health care management and organisation by researchers, governments and professions. In countries that have taken stock of current mechanisms, there are growing demands for consistency of organisational standards and external assessment within and between national systems, just as there are for clinical guidelines. Similar self-examinations may prove valuable in other countries, and may endorse the case for more international collaboration. And reciprocal recognition.

References

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16. ANAES service documentation. Décret no 97-311 du 7 Avril. Paris, Journal Officiel 1997; (82)–8
17. Decree of 14 January 1997. Rome, Gazetta Ufficiale della Repubblica Italiana, February 1997
18. President’s Advisory Commission on Consumer Protection and Quality in the Health Care Industry. Quality first: better health care for all Americans. 1998; www.hcqualitycommission.gov/final/
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