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VIEWPOINT

How can healthcare standards be standardised? Charles D Shaw

Correspondence to Dr Charles Shaw, Quality in healthcare, Independent adviser, Houghton, Arundel, West Sussex BN18 9LW, UK; [email protected] Received 12 January 2015 Revised 5 June 2015 Accepted 12 June 2015 Published Online First 30 June 2015

To cite: Shaw CD. BMJ Qual Saf 2015;24:615–619.

ABSTRACT International travel, medical tourism and trade have created a demand for reliable assessment of healthcare provision across borders, and for information which is accessible to patients, insurers and referring institutions. External assessment schemes for healthcare providers may be clustered into three types: statutory regulation and institutional licensing, International Standardization Organisation certification, and voluntary systems such as peer review and healthcare accreditation. Increasing complexity of healthcare provision, pressures for public accountability and expectations of professional self-governance place a burden on the inspectors and the inspected. If only to contain costs of external assessment and to increase access to reliable information for patients and insurers, the three approaches must work together rather than compete. This paper summarises the origins, aims, authority and methods of the three general models, describing current pressures and opportunities for convergence (between systems and across borders) in the UK and in Europe.

INTRODUCTION Forty years ago, expectations of ‘good’ healthcare were rarely defined in the UK —in terms of either clinical practice or organisation and management of services.1 National Health Service (NHS) planning guidelines (such as targets for the number of hospital beds per population) and Royal College wish lists (such as for staffing and equipment) were limited to resource inputs. Almost no one defined how resources should be used, or what outcomes should be expected. Now clinicians, managers and regulators are enthusiastic to define their expectations, to focus on performance (in terms of good practice and achieving results) and to harmonise assessment between services. Comparable assessment of health services requires comparable statements of requirements. These may be expressed as

standards (agreed levels of service), guidelines (recommendations to guide decisions) or mandatory guidance with which health services must comply. This paper describes the origins and development in the UK of three approaches to standard setting, which are also common globally. They are based on biomedical and health service research (such as for peer review and voluntary accreditation), healthcare regulation (for registration and institutional licensing) or accreditation to standards of the International Standardization Organisation (ISO). Each approach has its own history and adherents and has developed according to the needs and authority of a variety of interested parties. To reduce duplication and increase effectiveness of external assessments, these parties are looking to overcome barriers to collaboration. For example, in Europe, one major challenge is to reconcile the ISO system of standards and compliance (or conformity) assessment with evidence-based healthcare and professional peer review systems. THE CLINICAL APPROACH TO STANDARDS Historically, clinical practice was an amalgam of medical school example, published opinion, local consensus and personal preference. Wide variation in practice drew little attention until it was highlighted by the publication of Archie Cochrane’s monograph on Effectiveness and Efficiency in 1972.2 In the 1980s, there was more open discussion, for example, in consensus development conferences. Cochrane argued for clinical practice to be based on controlled trials and biomedical research, rather than tradition. The expansion of reliable research evidence, and the amalgamation of results from small-sample trials, began to define ‘good’ medical practice and

Shaw CD. BMJ Qual Saf 2015;24:615–619. doi:10.1136/bmjqs-2015-003955

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Viewpoint services and shed light on remaining areas of uncertainty. Systematic analysis by professional associations and Royal Colleges began to illustrate unacceptable variations in process and outcome (such as in anaesthetics3 and electroconvulsive therapy4) and laid the groundwork for clinical service accreditation. The introduction to the NHS of mandatory medical audit (one element of the Thatcher reforms of 1989)5 6 fuelled the demand for robust standards against which clinical practice could be evaluated. In Scotland, the Royal Colleges collaborated to establish the Intercollegial Guidelines Network (SIGN) in 1993 to support the development of clinical standards and tools for their measurement. In England, the National Institute for Health and Care Excellence (NICE) was established as a statutory body in 1999. Both SIGN7 and NICE8 developed systems for turning evidence into reliable standards and practical guidance for clinicians. Both systems generate standards which are consistent with international principles such as the Appraisal of Guidelines, Research and Evaluation project (AGREE)9 and with the published criteria for selecting clinical guidelines for inclusion in the USA National Guidelines Clearing House.10 REGULATORY APPROACHES TO STANDARDS Regulatory standards for the NHS developed less systematically and were driven by policy, embarrassment and legislation. Prompted by a succession of public scandals in the 1970s, largely over what were then called geriatric and mental hospitals, health advisory services were established for England and Wales and for Scotland. They designed criteria and procedures for the independent assessment of long-term care by multidisciplinary teams, but there was no equivalent assessment of acute hospitals or primary care until the Commission for Health Improvement (CHI) was established for England and Wales in 2001. In Scotland, the Carter report on acute services11 recommended a single mandatory system of accreditation for hospitals and primary care to deliver a national programme of quality assurance and accreditation of clinical services based on standards developed by SIGN. Thus, the Clinical Standards Board for Scotland was set up in 1999 2 years before CHI and with a different remit. Both regulators have since been reorganised and relabelled a few times. Now the Care Quality Commission (CQC), Healthcare Improvement Scotland, the Healthcare Inspectorate Wales and the Regulation and Quality Improvement Authority in Northern Ireland are responsible for the regulatory supervision of health and social care services in their respective countries. The original ‘Standards for Better Health’, used by the Healthcare Commission (which replaced CHI) for assessment of healthcare providers in England from 2006, combined guidance from the Department of Health functions of controls assurance and of risk

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management. Whereas the Clinical Standards Board for Scotland followed the more evidence-based approach of SIGN to developing standards for service delivery in Scotland, Standards for Better Health had less scientific credentials.12 Fundamental standards for safety and quality, based in part on the finding and conclusions of a number of recent reviews and public inquiries, became binding on health services in England in April 2015.13 CQC registers all health service providers on the basis of compliance with these statutorily defined standards. THE ISO SYSTEM OF STANDARDS The British standard for quality management systems (BS 5750) was published by the British Standards Institution (BSI) in 1979. Since it was originally developed in response to challenges in British high-tech industries to develop a quality assurance system for design, manufacture and installation, it had little early impact on UK health services. However, BS 5750 was the basis for the widely adopted international family of standards for quality management systems (ISO 9000) and became also a European norm. The framework for ISO accreditation within the European Union (including the UK) is defined by Regulation 765/200814 and refers to the marketing of goods and products. However, the ‘strategic vision for European standards’ proposes extension of this EU regulation to include services.15 Organisations which assess compliance with recognised ISO standards (certification or inspection bodies) may be accredited by the sole national accreditation body, in this case the UK Accreditation Service (UKAS), which is authorised by UK, European and international legislation. Thus, national accreditation bodies may both accredit certification bodies that award ISO9001 and accredit other types of conformity assessment bodies such as medical laboratories. In healthcare, accreditation was applied directly to provider institutions (initially hospitals) and to medical training long before ISO was invented. The two uses of the term accreditation must be explicitly differentiated, especially in efforts to harmonise external assessment in healthcare. The 2014 joint statement of the Department for Business, Innovation and Skills (BIS) and the Department of Health on accreditation in health and social care16 advises ‘Where new quality assurance schemes are planned in the NHS or social care, particularly where there is interest in schemes awarding certification or accreditation, their initiators should work with UKAS from an early stage to ensure that the schemes are sufficiently rigorous to meet EU and UK accreditation requirements’. The statement does not acknowledge the potential confusion between accreditation awarded to service providers (as in healthcare accreditation) and to compliance assessment organisations which evaluate service providers (as in ISO accreditation). Shaw CD. BMJ Qual Saf 2015;24:615–619. doi:10.1136/bmjqs-2015-003955

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Viewpoint PEER REVIEW AND HEALTH SERVICE ACCREDITATION The concept of voluntary accreditation of health services, as a vehicle for improvement rather than regulation, came to the UK from Canada in the 1980s and was incubated at the King’s Fund until organisational audit was launched in 1989, the same year in which the Thatcher reforms introduced the purchaser-provider split in the NHS. Numerous regional and specialtybased accreditation and similar peer review programmes grew in the 1990s. This happened alongside the competitive internal market which was expected to create a demand from purchasers for third party assessment of providers. These voluntary programmes developed their own organisational standards based on similar healthcare accreditation programmes, national guidance, specialty training requirements and, in some cases, on guidance from regional health authorities. There was no framework to harmonise the standards or assessment procedures of voluntary accreditation schemes between specialties, or within and between countries, until standards for external assessment programmes were first published by the International Society for Quality in Health Care in 2001. Of the 15 voluntary programmes documented in the UK in 2002,17 3 (including clinical pathology and psychiatric units) survived to 2015. Without powerful incentives (financial or regulatory) for participation, or demonstrated consistency within and between them, voluntary programmes struggle to pay their way as a development tool or to meet the needs of commissioners or regulators. Despite promising growth during the 1990s, the original King’s Fund programme had not achieved enough impact on the UK health system to compete or collaborate with the new regulator, the CHI. NEW PARTNERSHIPS In England and Wales, the tide may now be turning as the CQC faces the inherent problems of combining a regulatory function (of public protection) with a developmental function (of organisational excellence). Both functions require assessment against reliable standards but the assessment of excellence in clinical services demands the expertise of clinical specialists. Now CQC is seeking to work with independent accreditation and peer review programmes as ‘information sources’ if they meet specified criteria.18 These criteria include elements of the Concordat of audit, review, inspection and regulation in 2006,19 the Health Quality Improvement Partnership (HQIP) proposals for professionally led clinical service accreditation in 200920 and the International Society for Quality in Healthcare standards for healthcare assessment organisations.21 The 2014 policy statement from the UK Department for BIS and the Department of Health expects new quality assurance schemes in the NHS to comply with quite different requirements for Shaw CD. BMJ Qual Saf 2015;24:615–619. doi:10.1136/bmjqs-2015-003955

accreditation to ISO standards. This principle has been successfully applied to accreditation of diagnostic services in the UK but how it applies to healthcare accreditation of clinical services remains unclear. The challenge is being addressed in England by the Clinical Service Accreditation Alliance (CSAA).22 The CSAA was established in 2014 to harmonise clinical service accreditation between the specialties in order to integrate with each other and to support the regulatory function of the CQC. It comprises royal colleges and professional bodies across healthcare, including the Royal College of Physicians and Royal College of Surgeons, HQIP, the British Standards Institute and the UKAS. PARALLELS IN EUROPE The search in the UK for coherent standards between regulators, ISO and non-government organisations extends to the rest of Europe. The vision of crossborder mobility of staff23 and patients24 (as well as goods and products) demands some definition of what is good healthcare. Nearly all member states would welcome common European standards for patient safety25 but the European Commission does not yet have a strategy for health service standards. An invitation in 2014 to tender for a system to assess European reference networks26 seeks expertise from existing healthcare accreditation schemes; but a project to set-up, develop and pilot a European quality assurance scheme for breast cancer services is to be underpinned by accreditation to ISO standards.27 The European counterpart of the British Standards Institute is the Comité Européenne des Normes which has already developed standards for healthcare (including chiropractic and aesthetic surgery) which are required to be transposed into the legislation of member states. These standards do not meet the appraisal criteria of the AGREE principles or of clinically orientated systems such as those developed in the UK by SIGN and NICE. The European Commission’s strategic vision15 does recommend that ‘A systematic approach to research, innovation and standardisation should be adopted at European and national level’. The Joint Research Centre of the European Commission, together with the European Standards Organisations, launched an initiative in 2013 to bring the scientific and standardisation communities closer together, ‘Putting Science into Standards’.28 The Comité Européenne des Normes is now aiming to extend the discussion to standards in healthcare. CONCLUSIONS Whatever the legal status of ISO in the UK or the European Union, the system cannot work effectively in healthcare without more explicit consultation and ultimately agreement that the principles of evidence based on biomedical and health service research must be incorporated. Specialty bodies and professional associations

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Viewpoint cannot share the burden of supervision with healthcare regulators without agreed definitions of terms, responsibilities, requirements and assessments. Current debate on resolving this quandary in England already involves many of the primary stakeholders, including royal colleges, the national accreditation body (UKAS), the national standards body (BSI) and one healthcare regulator (CQC). The principal agenda is to achieve an effective cooperation between clinical service accreditation and healthcare regulation in England but, for the UK to comply with the EU directive on quality systems, all four countries of the UK (which have devolved responsibilities for health services) must be involved. A major advance, for the UK and for the European Union, would be to identify the general requirements for researching, developing and evaluating standards for health services. Here is an opportunity for a consortium of UK stakeholders, working with BSI, to develop a ‘standard for healthcare standards’ to enable compatibility and exchange of requirements between systems, settings and specialties. A nationally developed standard could offer a model for the European Union—and for the international community—but it would require support from the UK Department of Health and the Department for BIS. Contributors Paul Stennett, Chief Executive, UK Accreditation Service; Stephen Mitchell, External Affairs Advisor–Health, UK Accreditation Service; Robert Turpin, Sector Content Manager– Healthcare, BSI Standards and Dr Roland Valori, Clinical Director of Accreditation, Royal College of Physicians, London, contributed to this paper. Competing interests None declared.

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Provenance and peer review Not commissioned; externally peer reviewed.

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appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Qual Saf Health Care 2003;12:18–23. U.S. Department of Health & Human Services. Agency for Healthcare Research and Quality. (Revised) Criteria for Inclusion of Clinical Practice Guidelines in the National Guidelines Clearinghouse. 2013. 6/5/2015. http://www. guideline.gov/about/inclusion-criteria.aspx Scottish Office. Acute services review report. Quality assurance and accreditation. Edinburgh: Scottish Office Publications, 1998. Shaw CD. Standards for better health: fit for purpose? BMJ 2004;329:1250–1. National Health Service, England. Statutory instrument 2014 No. 2936. The Health and Social Care Act 2008 (Regulated Activities) Regulations. 2014. 6/5/2015. http://www.legislation. gov.uk/uksi/2014/2936/pdfs/uksi_20142936_en.pdf Regulation (EC) 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products. 6/5/2015. http://europa.eu/legislation_summaries/ internal_market/single_market_for_goods/free_movement_ goods_general_framework/l33248_en.htm European Commission. A strategic vision for European standards: moving forward to enhance and accelerate the sustainable growth of the European economy by 2020 COM (2011) 311. Brussels. 2011. 6/5/2015. http://eur-lex.europa. eu/LexUriServ/LexUriServ.do?uri=COM:2011:0311:FIN:EN: PDF Department for Business, Innovation and Skills and the Department of Health UK. Policy on accreditation in health and social care. 2014. 6/5/2015. http://www.ukas.com/ media-centre/news/news-archive/2014/UKAS_Recognition_ within_Health_and_Social_Care.asp Shaw CD. Accreditation in the UK. Hospitals 2002;4:57–9. Healthcare Quality Improvement Partnership. Application for accreditation and peer review schemes to be a CQC information source. 2014. 6/5/2015. http://www.hqip.org.uk/ assets/Core-Team/CQC-accreditation-information-sourcecriteria-and-application-form.doc Commission for Healthcare Audit and Inspection. Getting the best from inspection, audit, review and regulation of health and social care. 2006. 6/5/2015. http://www.nhsbsa.nhs.uk/ SecurityManagement/Documents/HC_Concordat_May06.pdf Health Quality Improvement Partnership. A core model for professionally led, clinical service accreditation version 2: 26. 2009. 6/5/2015. http://www.hqip.org.uk/assets/Core-Team/Coremodel-for-clinical-service-accreditation-Version-2-26-November2009.pdf International Society for Quality in Healthcare. Guidelines and Standards for External Evaluation Organisations, 4th Edition V1.0. 6/5/2015. http://www.isqua.org/accreditation/referencematerials Health Quality Improvement Partnership. Accreditation of clinical services. 6/5/2015. http://www.hqip.org.uk/ accreditation-of-clinical-services European Parliament and the Council of the European Union, Directive 2005/36/EC on the recognition of professional qualifications. 6/5/2015. http://eur-lex.europa.eu/LexUriServ/ LexUriServ.do?uri=OJ:L:2005:255:0022:0142:EN:PDF European Parliament and the Council of the European Union, Directive 2011/24/EU on the application of patients’ rights in cross-border healthcare. 6/5/2015. http://eur-lex.europa.eu/

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Viewpoint LexUriServ/LexUriServ.do?uri=OJ:L:2011:088:0045:0065: EN:PDF 25 European Commission. Report from the commission to the council on the basis of Member States’ reports on the implementation of the Council Recommendation (2009/C 151/ 01) on patient safety, including the prevention and control of healthcare associated infections Brussels, 13.11.2012 COM (2012) 658 final. 6/6/2015. http://ec.europa.eu/health/patient_ safety/docs/council_2009_report_en.pdf 26 European Commission Consumers, Health and Food Executive Agency. Call for tender Chafea/2014/Health/05 concerning the development of a manual and toolbox for the assessment of

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European Reference Networks. 6/5/2015. http://ec.europa.eu/ chafea/health/tender-05-2014_en.html 27 European Commission Joint Research Centre. European Commission Initiative on Breast Cancer. 6/5/2015. http://ihcp. jrc.ec.europa.eu/our_activities/public-health/cancer_policy_ support/priority_activities/ECIBC/ 28 European Commission Joint Research Centre. Round table European Forum for Science and Industry “Putting Science into Standards: the example of Eco-Innovation”. 6/5/2015. https://ec.europa.eu/jrc/en/event/round-tableeuropean-forum-science-and-industry-putting-science-standardsexample-eco

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How can healthcare standards be standardised? Charles D Shaw BMJ Qual Saf 2015 24: 615-619 originally published online June 30, 2015

doi: 10.1136/bmjqs-2015-003955 Updated information and services can be found at: http://qualitysafety.bmj.com/content/24/10/615

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How can healthcare standards be standardised?

International travel, medical tourism and trade have created a demand for reliable assessment of healthcare provision across borders, and for informat...
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