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Europe faces an incredible diversity of national healthcare systems. The extent of this problem is intensified by the fact that the European Community’s competence in this field is marginal. Article 152 of the Treaty establishing the European Community states that the EU must fully respect members’ responsibilities for the “organisation and delivery of health service and medical care”. In this case, the limits of this subsidiarity principle should be emphasised. It only applies once the member states fulfil their basic obligation, namely ensuring the delivery of high quality healthcare service. Judgments of the European Court of Justice have shown that member states do not fully comply with this requirement. The Watts-case (Case C- 372/04) points out that a state can refuse authorization for treatment abroad, if it is not assured that the patient in question receives "high quality treatment".
This creates important challenges for European hospitals in terms of quality requirements and progress measurement. Problems, such as reducing the number of errors in healthcare, still represent a major hurdle for hospital management.
Quality management in healthcare may be defined as a system that defines the quality policy, objectives and responsibilities and puts into place the structures (quality planning, quality control, quality assurance and quality improvement) to ensure it. The organisation of such systems differs from country to country due to the absence of comprehensive and common standards. The most effective and internationally accepted methods for external quality assurance are those resulting from assessment and audits.
There are four basic external peer review models (approaches) intended to measure the quality of service management:
1. Industrial certification- International Organisation for Standards (ISO 9000 series) (Switzerland, the Kings Fund Institute)
2. European Foundation for Quality Management – EFQM (Scandinavia)
3. Speciality driven visitation such as Visitatie (Dutch version of scheme based on the peer review)
4. Accreditation in healthcare (UK, Mediterranean countries)
International Organisation for Standards
This model has its roots in standards designed for defence engineering and manufacturing industries in the United Kingdom in 1947. Currently there are 11,000 international standards in use. In the field of healthcare, there were 230,000 ISO 9000 certificates awarded. The process consists of certifying organisations, which mostly operate on a for-profit basis and are recognized by national accreditation bodies, which carry out audits.
These organisations focus on quality systems and process control. This approach is not peer-reviewed since experts using ISO norms, not a sectorspecific organisation, perform it. The specific norms/standards may be applied in all types of organisations. Thus, this method stresses system quality and not actual work content. When this model is used in quality management, it may contribute to a description of the process itself but not the appropriateness of a specific treatment. The ISO method is mostly applied in technical departments (such as laboratories, transport) and describes the management and decision making process in hospitals. This frequently updated model is often seen as one that can easily merge with others.
Foundation for Quality Management
14 large European companies with the support of the European Commission originally introduced this model. At present, it comprises some 600- member organisations. This model is the only one to originate exclusively in Europe. It serves as a base for some national quality awards. EFQM focuses on the quality management development perspective.
This model may be used as a self-assessment tool or by organisations applying for external review in order to achieve the European Quality Award (or national awards). The basic idea behind this project is to motivate and support development and improvement in activities leading to quality in areas such as customer satisfaction as well as business results. This model supports the implementation of so-called Total Quality Management. There is a noticeable difference with ISO, as the EFQM does not standardise systems, but promotes quality management. This is achieved through award schemes and self-assessment, wherein a special published model is used. The EFQM appears to be the most complete model, as it focuses on Total Quality Management and defines the necessary quality areas that require management.
Medical associations originally implemented this model as a peer review for re-registration of members in the Netherlands in 1992. Currently, this method is commonly used in the Netherlands, but also serves as reference in other countries. The method was developed by professionals and is carried out by them.
It focuses on clinical performance, with a special emphasis on knowledge and skills. In the visitatie scheme, the emphasis is placed on the functioning of specific groups of specialists more than on the whole organisation, and it provides no award or certification at the end of the process.
Origins of this model go back to 1917, when the American College of Surgeons set up a Hospital Standardization Program. It was later introduced in Australia in 1926, then in Canada in 1953 and only in the 1980s in Europe (in the Catalan region of Spain). It is now used internationally (for example, more then 80% of nations participating in the ExPeRT project used this model). Professionals created it with a focus on the organisational process. This model puts emphasis on specific departments, only recently extending it to the whole organisation. It seeks to grasp all the activities in healthcare organisation, not only the management process, but also important issues such as infection contamination in hospitals.
In some countries, such as Greece, Portugal, Ireland and the United Kingdom, little governmental action is taken in the field of health service standards. Outcomes vary according to the use of quality assessment systems or the lack thereof. In Portugal, there is an ongoing debate going on about issues concerning quality in healthcare, no implementation planned. In contrast, the United Kingdom has a series of successful programmes (such as the Hospital Accreditation Programme) without national regulation.
According to the ExPeRT project, ISO is the most commonly used method, followed by accreditation, then EFQM and visitatie. The popularity of the ISO 9000 may be explained by the fact that it is internationally recognised and may be applied only to particular departments. Accreditation, on the other hand, is designed to be applied to the whole organisation. All methods have interesting and valuable elements, but accreditation and visitatie seem to be the most adequate to healthcare professionals. Both EFQM and ISO deal primarily with the organisational side of the process.
Although there is no unique European system for external quality assessment in hospitals, some convergence may be observed between national situations. Responsible bodies in different European countries recognise positive elements in all models and try to implement them into their national systems. In some countries, such as Sweden and the United Kingdom, all of the models are used simultaneously. A trend towards creating international standards is also developing (for example ALPHA standards of the International Society for Quality in Healthcare). Seminars, such the one organised by the European Association of Hospital Managers, create great opportunities for discussion in this field. Hopefully, in the near future, a single European model for external quality assessment will emerge in all hospitals.
With contributions from Hans-Konrad Selbmann (Institut für Medizinische Informationsverarbeitung, Germany), Marja Pokka-Vuento (SHQuality Ltd, Finland), P.M. Doets and Drs. M.L. Bosman, MSM (NIAZ, The Netherlands), Juozas Galdikas (State Health Care Accreditation Agency, Lithuania), Barbara Kutryba (National Centre for Quality Assessment in Healthcare, Poland).