Coverage of quality improvement in health systems/health care organizations

The following paragraphs summarize the findings of the Europe for Patients survey (Legido-Quigley et al., 2008). These concentrate on those strategies for promoting quality of care already in existence within the EU. (See Annexes 5.2, 5.3 and 5.4 for more detail on each of the strategies and Annex 5.1 for more information on the methodology adopted.)

5.3.2.1 Health systems quality assessment

• Legislation and policies on quality of care. There is considerable variation

between and within EU Member States in the extent to which legislative measures relating to health care quality have been implemented. To some extent, this variation reflects the prevailing view in each country regarding whether health care quality should be addressed through legislation or by other measures, such as voluntary agreements. This question will almost certainly be determined by specific national circumstances and the absence of legislation should not necessarily be seen as a weakness.

• Approval of pharmaceuticals and medical devices. Systems for approval of pharmaceuticals are universal within the EU and are subject to the provisions of EU directives. Pharmaceuticals can be approved either by the European Medicines Evaluation Agency (EMEA) or by a Member State.

Medical devices are regulated by three EU directives (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices) and through national legislation in each Member State.

• Registration and licensing. These approaches involve activities designed to ensure that professionals or provider organizations achieve minimum standards of competence (for example, training, registration, certification and revalidation); there are also function-specific inspectorates for public health and safety (for example, fire, radiation and infection) in many countries (Shaw, 2000b). Licensing of health care institutions is common within the EU, although safety and organizational standards vary between European Member States and within Member States (for example, Italy).

Systems for professional registration and licensing are requirements set out in EU directives on free movement of professions. There are, however, ongoing discussions in several Member States about the effectiveness of professional registration, as described below.

• Training of professionals. There are many differences in the details of how professionals are trained within the EU. Mobility of health professionals within the EU is based on the principle of mutual recognition. As long as a training programme meets minimum standards (expressed in years, and in some cases hours of study), its graduates are assumed to be competent to practise throughout the EU. This approach is set out in Directives 77/452/

EEC and 77/453/EEC for nurses responsible for general care, in Directives 78/686 and 78/687 for dental practitioners, in Directives 80/154/EEC and 80/155/EEC for midwives, in Directive 93/16/EEC for doctors, and in Directives 85/532/EEC and 85/533/EEC for pharmacists. These directives among others now all come under Directive 2005/36/EC, which entered into force on 20 October 2007. The system of Recognition of Directive 2005/36/EC for sectoral professions (for which the minimum training requirements have been harmonized) is based on the automatic recognition

of the professional qualification. Continued professional development exists in several Member States in different forms. Therefore, the conditions for continued professional development have not been harmonized by Directive 2005/36/EC and, according to Article 47 (2) of the TEC, this requires a unanimous vote in the Council. Of course, once a doctor or other health professional is established in another Member State, (s)he must fulfil the national requirements related to continued professional development. When a migrant applies for recognition of her/his professional qualification, the competent authorities of the host Member State cannot require in addition to the professional qualification that (s)he fulfils the national requirements related to continued professional development for recognition of her/his professional qualification. This would completely undermine the acquis (automatic recognition of professional qualifications).

• Training in quality of care. This is more the exception than the norm within EU Member States. Spencer and Walshe (2006) note that appropriate training in health care quality improvement is poorly provided, although they stress its importance as a means of developing strong professional leadership.

• HTA. This is the comprehensive evaluation and assessment of existing and emerging medical technologies (including pharmaceuticals, procedures, services, devices and equipment), looking at their medical, economic, social and ethical effects (WHO Regional Office for Europe, 1998). The extent to which HTA is carried out – and any results used – varies widely.

5.3.2.2 Organizational quality assessment

• The ISO. This organization provides standards against which organizations or bodies may be certificated by accredited auditors (ExPeRT RG, 1998a).

In Belgium, some establishments providing technical, administrative and management services to health care institutions have been certified. In France, the United Kingdom, Poland, Finland, Germany, Denmark and Sweden, some hospitals have undertaken the ISO 9000 process but it has not become popular and it is sometimes seen as inappropriate for health services, given its intended focus on management processes rather than clinical quality.

• Accreditation. This has its origins in 1917 in the American Association of Surgeons and was then adopted by the American Hospital Federation and the American Doctors Association in 1951. Some versions of this approach are being explored across the EU. In particular, in several countries some hospitals have been encouraged to seek accreditation in order to procure better contracts with insurance funds. Some countries have examined

forms of accreditation within the framework of wider health care reforms (Denmark, Portugal and France) while others have established programmes that are either voluntary or compulsory (Czech Republic, Italy, the Netherlands, the United Kingdom, Spain, Finland and Germany).

• The EFQM. This is a framework for self-assessment used by facilities seeking the European Quality Award or national awards. The model is not, however, widely used in the health sector. Member States that have introduced the EFQM model include Finland, Luxembourg, some regions of Spain and Italy, and approximately 20% of inpatient facilities in Hungary.

5.3.2.3 Clinical quality assessment

• Clinical guidelines. These are systematically developed statements to assist practitioner and patient choices of appropriate health care in specific clinical circumstances (Field & Lohr, 1992). Many countries within the EU are showing great interest in developing and implementing clinical guidelines.

This is an area in which cooperation and sharing of information is yielding considerable benefits, as demonstrated by projects such as the Council of Europe’s Guideline Recommendation (Council of Europe, 2001), the EU-funded AGREE guideline research project (Burgers et al., 2003) and the foundation of the Guidelines International Network (G-I-N), a Scottish Charity coordinating the activities of national guideline agencies worldwide (Ollenschläger, Marshall & Qureshi, 2004). However, there is considerable diversity in the progress made by individual countries.

• Quality indicators. These are gaining importance in many EU Member States. However, there are still many challenges facing those involved in indicator development. In France, the accreditation process involves the implementation of a system of quality indicators that is noteworthy in terms of its focus on what is important rather than what data have already been collected. In the United Kingdom, the Healthcare Commission produces performance ratings for NHS trusts in England, reflecting the priorities of ministers. In Germany, national benchmarking services are included nearly in all hospitals, in 5000 clinical departments and in 20% of cases. There are 160 quality indicators covering 26 areas of care. Experts are involved at regional and national levels in developing indicators, determining best practice, advising on results and determining acceptable standards.

• Peer review. This has been defined as “standards-based on-site survey conducted by medical professionals in order to assess the quality of professional performance of peers, aimed to improve the quality of patient care” (ExPeRT RG, 1998b). It has been developed most extensively by the Dutch medical associations (NIP, 2006).

• Surveys of health care users and the public. Such surveys are sporadic in many EU Member States. The Eurobarometer series and the EQLS have both conducted surveys relating to population satisfaction with health services. (These surveys and their outcomes are discussed in more detail in Chapter 3.)