1 ALPHA programme

In September 2003, the ALPHA Council began to extend its standards and certification services to include the standards and organisation of programs which provide external assessment but do not award accreditation - such as voluntary professional peer review, and statutory regulatory and licensing systems.

Council also agreed to develop standards and criteria for the assessment - and potentially the accreditation - of training programmes for accreditation surveyors.

Although supportive of smaller accreditation programmes in principle, ALPHA would be especially willing to work with programmes which are institutional members of ISQua to develop a formal progression towards full international accreditation. Several members of the UK and European Accreditation Forums are included in this development.

The ALPHA principles and standards, revised to meet these changes towards a more inclusive programme, will be available for comment on the ISQua website early in the new year. www.isqua.org

2 Specialty accreditation

The survey, begun in January 2003, was designed to produce a list of active assessment organisations across Europe but many known programmes did not respond.

Table 1 Specialty accreditation Europe - programmes responding to 2003 survey
Led by = 1 run by government; 2 partially independent; 3 totally autonomous NGO
Specialty Programme Country Led Start Website


Autism Autism Services Accreditation UK 3 1993 w02-0211.web.dircon.net/nas/accreditation/
Clinical pathology, EQA Clinical Pathology Accreditation UK 3 1992 www.cpa-uk.co.uk/
Child health informatics CHIC Accreditation Scheme UK 3 1998 www.chiconsortium.org.uk
Clinical conditions (27) Quality Improvement Scotland Scotland 2 1999 www.healthquality.org
General Practice Quality Team Development EnglandWales 3 1999 www.rcgp.org.uk/qtd
General practice RCGP Membership by Assessment UK 3 1999 www.rcgp.org.uk
Health librarianship Accreditation Library & Information Services UK 3 1997 Documents available www.nelh.nhs.uk
Health promotion Health promoting hospitals UK 3 None
Health Records ADR Programme UK 3 1995 www.caspe.co.uk
Human Resources Improving Working Lives England 1 2000 www.doh.gov.uk/iwl
Mental health, primary care, palliative care. Health Quality Service Accreditation Programme UK 3 1989 www.hqs.org.uk
Nephrology Accreditamento professionale di Nefrologia Italy 3 1996 www.sin-italia.org/qaccred
Nuclear Medicine Peer review Programme in Nuclear Medicine UK 3 1980 www.bnms.org.uk
Primary care research Primary Care Research Team Assessment EnglandWales 3 1998 www.rcgp.org.uk/rcgp/research/
Radiology, laboratory, emergency wards QUOS - Quality in Sicilian Hospitals Italy 1 2000 www.cefpas.it/Html/Mcq.htm
Regulation of Care Services Commission for the Regulation of Care Scotland 3 2001 www.carecommission.com
Small hospitals, community services Healthcare Accreditation Programme UK 3 1989 www.caspe.co.uk
Specialist palliative care Quality by Peer Review England 3 1990 www.qualitypeerreview.org

Table 2 Other known specialty accreditation programmes in Europe
Cardiology British Cardiac Society, UK
Diabetology Diabetes UK
Elderly Ministry of health,Poland
Family medicine Ministry of health,Poland; IQS MoniQuor, Portugal; Visitatie, Netherlands
Hospital data NHS accreditation of data reporting, UK
Laboratory Netherlands
Nursing Centre for Development of Nursing Policy and Practice; Royal College of Nursing Institute, UK
PHC computing NHS accreditation of primary care computer systems, UK
Physiotherapy Private Practitioners, UK
Pulmonology British Thoracic Society, UK
Radiology Qualisan , Finland; Visitatie, Netherlands
Rehabilitation Switzerland
Speech therapy Royal College Speech and Language Therapy, UK
Sports medicine National Sports Medicine Institute, UK
Tissue banking NHS accreditation of human tissue banks, UK

Radiology - EC directive
The EC sponsored an international symposium in Tampere, Finland in May on "clinical audit" as now required under article 6.4 of Medical Exposure Directive 97/43/Euratom. One interpretation of this directive is to establish external assessment of the performance of diagnostic and treatment centres with respect to optimum diagnostic effectiveness and reduced dosage to patients. EU Member States should have introduced national regulations and procedures by May 2000. I suggest that, if they do not already, accreditation programmes should ensure that standards and surveys address this issue. See www.europa.eu.int/comm/environment/radprot . The same website includes the EC guidelines on referral criteria for diagnostic radiology (…/118/rp-118-en.pdf) which also offer some evidence-based criteria for assessment.

Human tissue banking - EC directive
The EC published a proposal in June 2002 for a Directive to ensure the quality and safety of human tissues and cells http://register.consilium.eu.int/pdf/en/03/st10/st10133-re03en03.pdf The Directive is currently under negotiation and is likely to be adopted in spring 2004. Its scope is broad, covering the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human applications and of manufactured products derived from human tissues and cells intended for human applications.

The UK National Health Service has established an accreditation programme which will be voluntary until 31 March 2004 www.doh.gov.uk/humantissuebanking/. Accreditation will become a legal requirement in the future following adoption of the EU Tissues and Cells Directive which requires compliance with a 33-page code of practice (or accreditation standards) which cover:
· Blood and blood products subject to other national requirements
· Human tissues used for research purposes other than for clinical trials
· Cells and cell lines used for gene therapy
· Commercially manufactured therapeutic products utilising human tissues (including cells and cell lines)
· Embryos produced in vitro and mature gametes
· Vascularised organs.
3 Publications
Global growth of accreditation
The results of an international survey by ISQua of accreditation programmes (2001) are included in "Quality and accreditation in health care services", published by WHO (Geneva) and ISQua in November 2003. A limited number of copies are available (free of charge but postage is payable). This study led to a focus on Europe which was published by EURO a year ago as Background for national quality policy in health systems see http://www.euro.who.int/document/e77983.pdf.
Accreditation toolkit
In 2003 ISQua also set up a working group, together with the World Bank and WHO, and chaired by Elma Heidemann (Canada) to identify the key success factors in setting up a health care accreditation programme. The resulting toolkit is designed to inform governments, funding agencies and new programmes about the critical stages of planning, organising and operating external assessment processes. This will be published on the World Bank and/or ISQua website early in 2004.
Does accreditation work?
Recent contributions to this growing debate include a book by Kieran Walshe Regulating Healthcare http://mcgraw-hill.co.uk/html/0335210228.html. This explores the development and use of healthcare regulation in the UK and the USA which both face a growing tide of regulation, accreditation, inspection and external review, aimed at improving their performance.

In August last year, nine chief executives of national accreditation programmes met with WHO in Geneva to discuss the role of accreditation in health systems and on the evidence for its effects. The report Preparatory meeting on the impact of accreditation of health services on a national health system includes a bibliography of evaluation in accreditation and is due to be published by WHO soon.

In November, the Quality Assurance Program, based in Bethesda Maryland, published the first report of a controlled trial of the effect of the Cohsasa programme in one province. The Impact of Accreditation on the Quality of Hospital Care: KwaZulu-Natal Province, Republic of South Africa can be downloaded free from http://www.qaproject.org/pubs/pubsor.html

The British Cabinet Office has acknowledged that government inspectorates are poorly coordinated, time consuming and do not learn from each other - or from independent sector assessors - at least in the UK. The Office of Public Services Reform's July report Inspecting for Improvement includes a proposal for national accreditation of a wide range of inspectors (and independent assessors) against explicit criteria. See http://www.pm.gov.uk/files/pdf/inspecting.pdf

4 ISO
Interpretation of ISO 9000 series
The Comité Européenne des Normes (CEN) has set up a working group which is coordinated by the Swedish Standards Institute to develop an interpretation of ISO 9000:2000 which could be related to health care. A draft document was discussed in Madrid in October and will be considered again in March 2004.
ISO 15189:2003 - Medical laboratories
The European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) developed Essential Criteria for Quality Control Systems for Medical Laboratories in order to reconcile the limitations of EN45001 and ISO9001 as standards for medical laboratories. See www.ec-4.org/essential_criteria.html. This led to the document ISO 15189:2003 Medical laboratories -- Particular requirements for quality and competence which includes standards which are characteristic of health service accreditation, for example relating to clinical judgment and behaviour rather than mechanics. The development of quality and accreditation in medical laboratories is well documented in a special issue of Clinica Chimica Acta in July 2001; 309: 109-214
5 Programme News
Belgium
The national alliance of health insurers, Mutualité chrétienne based in Brussels, is piloting a programme for the accreditation of some aspects of risk management in 11 hospitals (out of 121 across Belgium), emphasising self-assessment, collaboration between the hospitals and a 'tailored' approach based on priorities identified with each hospital during a pre-visit.
Croatia
The law of 21 July 2003 introduced a mandatory accreditation programme from January 2004, using standards which are already drafted. This will be operated by the Ministry of Health and the Health Insurance Fund has agreed to give a 5% supplementary payment to accredited hospitals.
Denmark
The Danish Quality Model is built on the National strategy on quality improvement in health care www.sst.dk/publ/Publ2002/NATIONAL_STRATEGY/INDEX.HTML published in 2002. The model provides a framework for integrating a range of internal and external quality improvement strategies including clinical indicators, self-assessment and accreditation of care pathways (similar to Scotland). The Quality Programme originates from economic agreements between the Government, Danish Regions and the Copenhagen Hospital Cooperation. Detailed proposals, including the scope and function of a mandatory accreditation programme, are available at www.sst.dk/publ/publ2003/Programme_Proposal_version_1_22.pdf. This 28-page document would be of particular interest to anyone who is trying to draft proposals for a new accreditation programme. Tenders have been invited for external technical assistance in setting up a single Danish national accreditation programme with the aim of including all 76 hospitals by 2006.
Luxembourg
Since 1992 there has been discussion between the 14 hospitals of the Grand Duchy, the health Ministry and the health care insurers in order to provide incentives for improvement of quality and performance. A pilot project with the 14 hospitals focused on four defined aspects of performance (patient records, pain control, infection control and mammography) and awarded a budget increase of up to 2% according to the score given by external assessors. The scheme will now be broadened, using the EFQM model to assess overall performance of all hospitals by 2006.
Malta
A project Quality Assurance in Maltese Hospitals was launched in 2001 by the Ministry of Health to cover nursing homes, secondary hospitals and the 900-bed teaching hospital in Valetta. The Medical and Kindred Professions Ordinance stipulates that hospitals require a licence to operate which is renewed annually but accreditation not mentioned in law at this stage.
Scotland
The Clinical Standards Board for Scotland was amalgamated in January 2001 with the Clinical Resource and Audit Group (CRAG), Health Technology Board for Scotland, Nursing and Midwifery Practice Development Unit and the Scottish Health Advisory Service (elderly and mental health services). The new NHS Quality Improvement Scotland (NHS QIS) is independent of government but is accountable to the Scottish Executive for delivering its work programme and for the public money it spends website. Its new website is www.nhshealthquality.org but full text of over twenty sets of clinical pathway standards can still be downloaded from www.clinicalstandards.org/finalstand.html.
6 Conferences in Europe
ESQH, Udine
Representatives of European natonal societies for quality in health care devoted a session of the September meeting in Udine to external assessment methods. Comments on the current state of accreditation in Europe included:
- Problems with governmental programmes include:
o fragmentation between regions, cantons
o uneconomic processes, inconsistent standards
- Insurance funds and governments are increasingly interested in accrediting horizontal care pathways and disease management rather than vertical management units - both within hospitals and linking primary, secondary and tertiary care. There is much interest in the approach of Quality Improvement Scotland
ISQua, Amsterdam
The ISQua conference has included workshops and sessions on accreditation at every meeting since Venice in 1995. The next meeting is 20-22 October 2004. See www.isqua.org
9th European Forum, Copenhagen
12-14 May, 2004 See www.quality.bmjpg.com
European Association of Hospital Managers, Oslo
One of the major themes of the 2004 conference (9-11 September) will be hospital accreditation. See www.hospital.be or current issue of Hospital
NCQA conference, Krakow
This meeting will not take place in spring as usual. Probably later in the year instead.

CD Shaw 8 December 2003