Quality programmes, accreditation and certification in Switzerland

Texte intégral

(1)International Journal for Quality in Health Care 2001; Volume 13, Number 2: 157–161. Country Report. Quality programmes, accreditation and certification in Switzerland J. SCHILLING1, R. CRANOVSKY2 AND R. STRAUB3 1. Institute of Social and Preventive Medicine (ISPMZ), University of Zurich, 2Swiss Medical Association (FMH), Berne and Swiss Accreditation Service (SAS), Berne-Wabern, Switzerland. 3. Abstract Purpose. To report on current quality initiatives in health care in the context of accreditation and certification in Switzerland. Source of information. A review from the Swiss Accreditation Service, the Swiss Medical Association and the University of Zurich. Setting. In Switzerland, health care providers and health insurers are obliged by law to sign contracts on quality of care. The law texts and related ordinances do not state explicitly the content and format of quality contracts between providers and costs payers. Finding adequate practical solutions is the responsibility of the partners involved. Six different possibilities of quality initiatives are studied and discussed in this report. These include initiatives to create independent certification or inspection bodies for health care organizations accredited by the national accreditation body. Findings. So far, there is only one established standardized system with clear requirements. This accreditation and certification model is an adaptation of the International Standards Organization but so far it has not been used often in the public domain. Each of the other five approaches are more frequently applied but none of them lead to full external peer review certification including medical outcome yet. Conclusions. A lot of harmonization work still has to be done and clear branch specific requirements need to be agreed upon. Practicability and validity of external peer review schemes may also need further evaluation and improvement to reach the goals of health care systems in the future. Keywords: accreditation, certification, conformity, health care, quality. Quality systems in the domain of health care have one primary aim. This aim is to improve quality and to build up the confidence of patients, professionals and cost payers in the quality of the indications, the processes, the outcomes and in the efficiency of co-operation between the different partners involved. Swiss law includes definitions of the terms ‘accreditation’ and ‘certification’ [1,2]. The requirements to attest the competence of organizations seeking federal recognition are defined concisely. Ordinances [2,3] regulate the duties of the Swiss Accreditation Service (SAS), the Swiss Federal Office of Metrology and the Federal Accreditation Commission in this context. There are also regulations for the accreditation of conformity assessment bodies, e.g. certification bodies in the field of quality systems.. The SAS maintains a quality system, complying with the criteria of the European standard series EN 45000 [4]. It conforms to this criteria when choosing technical/scientific experts as well as when defining processes for the accreditation of conformity assessment bodies. The SAS has multilateral agreements with national accreditation bodies all over Europe [5] and is a full member of the European co-operation for Accreditation [6]. Accreditation in this context confirms that certification bodies can issue internationally accepted certificates in a specific domain. Therefore, certified health care providers, (e.g. hospitals, rehabilitation centres, outpatient care organizations or private doctors) can obtain internationally acceptable certificates, e.g. for quality management systems. This confirms its compatibility with the requirements of specific normative documents, e.g. the ISO 9001 standard [7].. Address reprint requests to J. Schilling, Institute of Social and Preventive Medicine, University of Zurich, Sumatrastrasse 30, CH-8006 Zurich, Switzerland. E-mail: juli@ifspm.unizh.ch or R. Straub, Swiss Accreditation Service, c/o Swiss Federal Office of Metrology, Lindenweg 50, CH-3003 Berne-Wabern, Switzerland. E-mail: rolf.straub@eam.admin.ch.  2001 International Society for Quality in Health Care and Oxford University Press. 157.

(2) J. Schilling et al.. Accreditation in Swiss federal terms [2] is an independent confirmation of professional competence. It proves the ability to perform specific tasks based on European standard requirements. In Switzerland, accreditation is granted by the Swiss Federal Office of Metrology. It is based on SAS assessments and comments from the Federal Accreditation Commission. Nevertheless, private consultants operating within the domain of health care in Switzerland also use the term ‘accreditation’ thus giving it different meanings. However, national and international acceptance is only attained through the SAS. The SAS procedure is based on ongoing economic treaties with the European Community and authorities overseas (e.g. Canada) in several sectors of industry, business and service, as well as in health care. By definition certification in terms of health care gives an independent confirmation of the ability of a health care organization to implement and follow specific quality requirements stated in normative documents. In accordance with international and European policy, certification and accreditation have a legal base in all European countries including Switzerland. In this country report, firstly, a brief overview of the complexity of the Swiss Health Care System is given. Secondly, six variations to achieve the goals of top quality are presented and discussed.. The complexity of the Swiss health care system Switzerland is a federal state composed of 26 cantons. Federal authorities have political power only in the areas explicitly delegated by the cantons. Decisive political power remains in the hands of citizens. Any change in the Swiss Constitution must be accepted by the Swiss population and the majority of the cantons through a mandatory referendum. By rights of optional referenda and initiatives, almost any issue may be submitted to popular vote. The smallest political entities, the communities and the cantons, are solely responsible for the health and social welfare of people living within their boundaries. Uniform federal examinations for medical doctors, pharmacists, veterinarians and dentists were introduced in the late 19th century. This was the first building block of responsibility by federal powers in matters of health. Laws relating to epidemics were passed in 1886 and the implementation of health and accident insurance at a federal level followed in 1912. The legal basis for health services led to the current mixed public and private system. Basic health insurance (social insurance) is mandatory for everyone and accident insurance is mandatory for all employees. In addition, disability insurance and insurance for persons in active military service exist. Accident and disability insurance are linked to the social security system along with retirement funds for the elderly. These insurance plans are more comprehensive than the current US Medicare or Medicaid programmes.. 158. The last important development in the Swiss health care system was the introduction of the revised Swiss federal law on health insurance on January 1 1996 [8]. This law regulates compulsory basic health insurance for primary and selected specialized services. It also allows people the choice of various ‘classic’ health funds and managed care plans. A clear distinction is made between ‘social insurance’ offering a range of primary care (ambulatory and hospital services) and ‘supplementary insurance’. With ‘private insurance’ patients may choose between hospitalization in private wards or single-bed rooms. They may also use certain services not included in the basic package, e.g. payment of certain drug prescriptions or special treatment procedures. The number of people with private insurance is diminishing due to the rise in monthly premiums over the last few years but is still estimated to be 30% of the population. The federal government is empowered to act on important health issues. It can authorize sanctions against illegal activities, e.g. in the production, prescription and application of pharmaceuticals. The federal government is obligated to act on important issues such as transmissible diseases, (e.g. AIDS, hepatitis), immunization programmes, contagious diseases and epidemics. Last but not least, the federal government can act on the issue of quality if providers of care and insurers do not outline contracts on quality containing basic requirements [9]. The federal government acts through the department of internal affairs and through its specialized offices, e.g. public health, social insurance and statistics. The 26 cantons have their own laws on health care, hygiene, hospitals and social welfare. These laws are not harmonized among cantons. Consequently, the cantons have prime responsibility for health care and social welfare. Nevertheless their duties include the implementation of federal laws. Cantons are also responsible for hospital planning and financing, licensing of health professionals in private ambulatory care and the supervision of tariffs.. Initiatives In Switzerland there are currently six different but relevant initiatives aiming to convince the interested partners that the processes and outcomes of health care may fulfil the requirements of the Swiss population. Accreditation/certification according to the standard EN 45001 [7] is well established in medical laboratories in Switzerland. This type of accreditation confirms the quality of test results based on accepted values, requirements and validated procedures – and thus the technical competence of the provider. Health care is quite different from other systems of service and industry. An attempt was therefore made to adapt the International Standards Organization (ISO) 9001 standard. This is in accordance with the system of accreditation and certification of European and international.

(3) Health care quality in Switzerland. standards. An interpretational guide explaining the standard ISO 9001 in the context of its application in hospitals was created. The philosophy of a worldwide industrial quality system standard was to be brought into the field of medicine. Firstly, the terminology was adapted. In addition, outcome indicators were proposed so that certification could be related to quantitative assessment of process and outcome. Hence, elements of total quality management and a continuous quality improvement philosophy were integrated in the interpretation guide H9001/2. These elements were introduced to increase the guide’s usefulness for the interested parties. A first interpretation guide of ISO 9001 was presented for hospitals in German [10]. The interpretation document was subsequently published in German, French and English [11]. A study of certification activities in Switzerland carried out in summer 1997 showed that 20 certificates were issued by accredited certification bodies on the basis of ISO 9001, nine on the basis of ISO 9002 and one environmental management certificate on the basis of ISO 14001 [12]. The range of institutions receiving certification included nursing homes, private hospitals, rehabilitation clinics, suppliers of medical products, dentistry, and veterinary care. A slightly modified approach is the accredited certification by the ‘Agence pour la Promotion et l’E´valuation de la Qualite´ dans les Institutions Sanitaires’ (APEQ) located in canton Vaud. This organization specializes in external inspection in the domain of nursing homes and rehabilitation centres [13]. The system of inspections by APEQ adopts some of the principles and basic methodology of the American and Canadian system of accreditation (JCAHO) [14] without adhering strictly to the system. A set of criteria and standards has been established by providers of health care. The focus is primarily on selfassessment followed by structured external audits. The SAS and the national metrology office accredited APEQ as an inspection body, primarily for nursing homes and rehabilitation centres, in accordance with the standard EN 45004 [15]. The Swiss Association for Quality in Health Care (SwissQuaH) launched an initiative called ‘accreditation talks’. This initiative corresponds with consultancy and self-assessment in ISO system terminology and European co-operation for accreditation policies. These structured talks are considered as preparation for an external audit [16]. They are based on a set of specific requirements, i.e. similar to the former JCAHO approach. Emphasis is also put on additional views borrowed from total quality management philosophy. This initiative should eventually lead to the creation of an independent certification body for hospitals. Nevertheless, before this possible future certification body can be accredited, several changes should be made in terms of the organizational structure and in the method of external audit. The Swiss Hospital Association (H+) in collaboration with the National Association of Health Care Insurers in Switzerland initiated a self-evaluation scheme named ‘quality programme’ leading on to a ‘structured quality report’. Specific contents are to be defined and agreed upon each. year. This initiative is based on a global contract, with the two partners collaborating for quality in health care, in accordance with the health insurance law [17]. During the first year of application, a quality report based on analysis of structures was published [18]. This quality initiative does not yet require an established quality system in health care institutions [19]. Quality efforts do not have to be confirmed by an independent body. In a second step, the introduction of data based quality assurance using outcome indicators for tracer conditions is proposed. With this approach, the health care providers retain considerable flexibility in reporting quality of care to the controlling authority of the federal office and cost payers. There is no need yet to establish a systematic quality system. This may be a cost-effective approach, as long as no further requirements are made by the partners involved. Performance orientated resource allocation. Following the philosophy of new public management, a project called ‘performance orientated resource allocation’ was started in 1995 by the Ministry of Health of the canton of Zurich. Several instruments for the measurement of outcomes in acute hospitals were defined and tested [20]. From the pilot projects, 10 tracer diagnoses and 12 global indicators resulted. After a first pilot test a second extended test in nine hospitals was realized [21]. In addition, five instruments for patient satisfaction were evaluated and tested. To further implement these measurements – that included benchmarking – health care providers, health insurers and the Zurich cantonal health authorities signed a quality contract on the further proceedings including financial agreements. Based on this contract, a quality association was founded, a quality commission in the canton of Zurich was created and a quality office for the operational issues was established [22]. All hospitals in the cantonal area are now obliged to measure indicators during a defined period of time. Hospitals in other cantons also intend to participate. In contrast with the contract on quality between health insurers and providers described above, this is one of the first quality contracts made according to the requirements of the Swiss federal office of social security [19].. Discussion Peer review systems in the field of medicine are already well established in the USA, Canada and Australia. In Switzerland, in the past decade, several initiatives for internal or external peer review systems have been suggested. For a comprehensive overview of the variety of activities in Switzerland, different aspects need to be considered. At the beginning of the past decade, the medical professionals started to study several different quality initiatives for their suitability in the health care sector. The Swiss National Alliance for Quality in Health Care was founded in 1994. This committee includes members from all important health care partners. The various possibilities for accreditation and certification were discussed. Three basic alternatives were. 159.

(4) J. Schilling et al.. considered as promising: JCAHO; ISO certification; and modified total quality management approaches, e.g. from the European Foundation for Quality Management. Since 1996, the Swiss federal law on health insurance [8] requires providers of health care and cost payers to sign contracts on quality of care. To meet this objective, efforts were made to adopt and develop further a variety of systems. The aforementioned feasibility study H9001/2, an adaptation of the internationally accepted standard ISO 9000 family, was performed. This effort resulted in an interpretation guide but breakthrough applications have not occurred so far, possibly due to the complexity and costs of the introduction but also because providers are not yet forced to prove the quality of their work through external review. The various approaches focusing on total quality management and continuous quality improvement also failed to make a breakthrough [23]. There were several public presentations and seminars on quality systems in health care. Total quality management approaches with continuous quality improvement elements were discussed as a possibility. However, no practical implementation of fully functional systems were shown. Even this possibility seems to have more impact on public debate than on any effective implementation in the real existing health care environment in Switzerland. Other approaches within the domain of health care in Switzerland have non-standardized requirements. A considerable amount of non-harmonized self-declaration by the applicants are present as well. The suggested requirements are rather basic; they have been made after discussion either within scientific medical circles, by committees of individual health care providers or within closed groups of providers. The process and outcome measures initiative in the canton of Zurich may prove promising. Outcome indicators are included and databased improvement, including benchmarking, is realized. In addition, a contract has already been signed by hospitals, cost payers and the local cantonal government, according to the requirements of Swiss federal office of social security [19]. The last alternative may be not to implement any external peer review system on a national and/or cantonal level. However, this could potentially be expensive and time-consuming. Health care organizations would be dependent on various private and semi-private consulting firms and associations working in the health care business. Undoubtedly, such an approach would lead to a costly outcome for Swiss tax and health insurance payers. As already mentioned, the term ‘accreditation’ has various meanings in Switzerland. The term ‘accreditation’ is often used to state an acceptance of organizations, premises or individuals by a scientific or medical association, cost payers or the state. This contrasts with the Swiss federal ordinance definition based on European Community Legislation. It is largely harmonized for purposes of testing, inspection and certification all over Europe. In spring 2000, the Swiss population voted for bilateral contracts with the European community. Therefore, harmonization of a common terminology may be anticipated. This country report clearly demonstrates that there are a. 160. variety of different initiatives trying to gain the confidence of the public in the health care system. With the exception of the domain of laboratory testing, there has not been a nationwide breakthrough thus far. Switzerland has a population of only 7.2 million. The main reason for this lack of breakthrough may be the complexity of the Swiss health care system: it has its national laws with cantonal executive power. According to the Federal Constitution, amendments of or new bills are subject to plebiscite. Last, but not least, another important unproven fact needs to be taken into consideration: the Swiss health care system in its whole complexity is regarded by the public as qualitatively excellent. There are no waiting lists. Every inhabitant in Switzerland has access to nearly anything he or she desires, almost everywhere throughout the whole country, within a short period of time [24]. Nevertheless comparable data on indication and outcomes, and evaluative studies are still scarce.. Conclusions The need to evaluate further and improve the practicability and validity of the different initiatives for quality is obvious. Further research may be necessary to analyse why the success of the different efforts have been mostly doubtful so far. It may prove to be a long process before external review is accepted by the health care partners. This is probably due to the complex democratic environment, the freedom of health care providers and cost payers to decide what kind of quality policy should be agreed upon, and the splitting of the political power.. Acknowledgements The authors thank I. Casablanca of SAS, C. Mu¨ller, J. Wirz and J. Piket of ISPMZ for their kind preparation of the manuscript. Although this country report has been funded in part by the Swiss Federal Office of Education and Science (Grant No. BBW 98.0127), it has not been subjected to agency review. Therefore, it does not necessarily reflect the view of the agency. Mention of organizations or quality systems in this paper does not automatically and in all cases constitute endorsement or recommendation for use in health care. Systems or organizations not mentioned in this report are not necessarily excluded from the health care sectors. The scope of this country report is therefore limited in its comprehensiveness.. References 1. Federal law of 6th October 1995 on technical barriers to trade [THG], SR 946.51 (in German). SR 946.51. 1995. 2. Ordinance on the Swiss Accreditation System and the Notification of Testing, Conformity Assessment, Registration and.

(5) Health care quality in Switzerland. Approval Bodies (Accreditation and Notification Ordinance, AkkBV) 17th June 1996. SR 946.512. 1996. 3. Ordinance of 27th February 1992 on federal accreditation commission (in German). SR 941.291.4. 1992. 4. EN 45003: Calibration and testing laboratory accreditation system. General requirements for operations and recognition. Berne: Federal Office of Calibration; 1995. 5. European co-operation for accreditation, EA-1/01, policy and procedures for the multilateral agreement. November 1997. 6. European co-operation for accreditation, EA-1/03: EA Annual Report. 1998.. 14. Comprehensive Accreditation Manual for Hospitals. Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations; 1994. 15. EN 45004: General criteria for the operation of various types of bodies performing inspections. 1995. 16. Annual Report 1997 (in German). Berne: Swiss Association for Quality in Healthcare (SwissQuaH); 1997. 17. Rahmenvertrag betreffend Qualita¨tsmanagement (Skeletal contract on quality management). Aarau/Solothurn: H+ Die Spita¨ler der Schweiz/KSK Konkordat der Schweizerischen Krankenversicherer; 1997.. 7. EN ISO 9001: Quality systems, model for quality assurance in design, development, production, installation and servicing. 1994.. 18. Results of the first structurized quality report 1998 (in German). Aarau/Solothurn: H+ Die Spita¨ler der Schweiz/KSK Konkordat der Schweizerischen Krankenversicherer; 1998.. 8. Federal law of 18th March 1994 on the health insurance, SR 832.10 (in German). 1994.. 19. Piller O. What isn’t measured, can’t be improved (in German). Managed Care 2000; 4:1.. 9. Langenegger M. Quality management in the Public Health Service. General conditions of the Federal Office for Social Security for the realisation (in German). Soziale Sicherheit 1999; 3: 151–152.. 20. Hochreutener M. The hospital reform LORAS and the outcome measurements in the canton of Zurich. In Lauterbach S, ed. Health Economics and Quality Management. Stuttgart: Schattauer; 2000.. 10. Cranovsky R, Schilling J, Faisst K et al. H 9001/2: Quality management systems for health care institutions; interpreted in accordance with the international standards ISO 9001 and ISO 9002 (in German). Qualita¨tsmanagement in Klinik und Praxis 1997; 5 (suppl 6): 1–28.. 21. Hochreutener M, Sta¨ger L. LORAS-Publik ‘Outcome 98’ (Final Report). Zurich: Health Ministry of the Canton of Zurich; 1999.. 11. Cranovsky R, Schilling J, Straub R. Quality Management System for Health Care Institutions. Interpretation guide of ISO 9001/ 2. Frankfurt: pmi Verlag AG; 2000.. 23. The European Foundation for Quality Management. Official Journal of the European Organization for Quality, Berne 1994: 4–6.. 12. Straub R. Accreditation and Certification within the Health Care Sector (in German). Berne: Swiss Accreditation Service (SAS), Federal Office of Metrology; 1997. 13. Syste`me pour la Promotion et l’Evaluation de la Qualite´. Prilly/ Lausanne: Agence pour la Promotion et l’Evaluation de la Qualite´ dans les Institutions sanitaires. 2000.. 22. Hochreutener M, Sta¨ger L. Checks and Balances – The Zurich Solution for Seemingly Unfathomable Contradictions. Managed Care 2000; 4: 18–22.. 24. Schilling J. Quality Assurance in Medicine: Methodology for research on indications in interventional cardiology and gynaecology (in German). Frankfurt am Main: pmi Verlag AG; 1998.. Accepted for publication 4 August 2000. 161.

(6)