The implementation of quality management systems in hospitals: a comparison between three countries

Since the 1990s, there is a general trend for stakeholders to put more pressure on hospitals for accountability, transparency and equity of access to health. The governments of various European countries have, therefore, stimulated the use of Quality Mangement systems (QMS) and external evaluation in healthcare. Former research has identified four principal models and national variants of external evaluation, e.g. medical speciality-driven visitation, traditional accreditation against explicit standards, European Quality Awards based on the model of the European Foundation of Quality Management (EFQM), and certification using ISO standards (ISO 9000 series)[1]. Although the evaluation models have common roots, their standards have been developed in response to national legislation, economics, culture and demand. The models share common principles and values, but have a different focus and are differently detailed. The perceived appropriateness of every model for hospitals is only one element influencing the prevalence of one approach over another [2, 3]. Legislation also affects the use and development of external evaluation of hospitals. Some countries (e.g. Greece, Portugal and the UK) have no legal requirement for hospitals to meet specific organizational standards, whereas in other countries (e.g. Germany, France and Austria) governments have legislated some form of internal and/or external assessment of hospital services [4, 5].

The objective of the study was to investigate agreement and disparities in the implementation of QMS between The Netherlands, Hungary and Finland with respect to the evaluation model used and the national policy strategy of the three countries.

In this article, QMS is broadly defined as 'all the procedures explicitly designed to monitor, assess and improve the quality of care'. Examples are for example peer review, patient satisfaction surveys, complaints handling, audits, compiling a quality manual. The QM-activities that constitute a QMS were listed in a questionnaire. Disparities between the Netherlands, Hungary and Finland were expected due to the stimulating effects of the national quality policy and the Quality Acts and recommendations implemented. The most common evaluation model, the national policies and the country-specific quality legislation are explained below. Figure 1 shows the differences between the three countries.

National quality requirements for Dutch hospitals are laid down in the 1996 Care Institutions Quality Act. This Act obliges all care organizations to set up a QMS to improve the quality of care. The QMS should reflect a cyclic process for monitoring, evaluating and, if necessary, improving the quality of care. The Act only provides a framework, no standards. It is up to hospitals to develop their own QMS and choose their own QM-activities and procedures; for example using protocols and guidelines, peer review, audits, benchmarking, satisfaction surveys. The Quality Act, however, requires that all care institutions provide clarity on the QM-activites and the quality of care by publishing an annual quality report which must be sent to the Ministry of Health, the Health Inspectorate and the regional patient/consumer organizations.

More and more hospitals are implementing the quality assurance standards of NIAZ (The Netherlands Institute for Accreditation of Hospitals). These standards contain requirements for the organization of a hospital. They describe what has to be regulated in a hospital in order to warrant that the quality of care delivered is not depending on individuals or left to chance. 35 Department-specific standards have been developed and one standard for the whole organization. Accreditation is a form of self-evaluation and peer review, and is aimed to enhance quality improvement. In addition, some hospital departments, such as laboratories, have an ISO certificate. There are no hospitals that have received an ISO certification for the whole organization. Hospitals are not no financially compensated for the implementation of QMS by health insurance funds or the Ministry of Health.

Since 1993, the Individual Health Care Professions Act governs the quality of professional practitioners. A statutory title protection and registration has been introduced for a number of professional practitioners, such as physicians, nurses, dentists and physical therapists. Continuous quality improvement by practitioners is required. The Act also contains a number of provisions to protect patients against incompetent treatment. Various procedures, such as administering injections, are restricted to a limited group of professionals. The medical specialists emphasise visitation, an external evaluation of peers, focusing on organisational aspects of the care process, and evidence-based guidelines [6, 7].

In Hungary, the "Act CLIV of 1997 on Health" has a chapter entitled "Professional requirements for health care services" [8]. This chapter makes the operation of a QMS obligatory for every hospital. In addition, the implementation of ISO:9002 was financially stimulated.

The Act does not identify what kind of QM-activities should be performed in the daily practice, what kind of processes should be created, what kind of indicators should be set related to the structure, process or outcome [10].

In Finland, the municipalities (local authorities) are responsible for organizing and funding both primary and specialised care. Therefore, the responsibility is highly decentralised. There are approximately 450 municipalities, some of these are small with less than 2000 inhabitants. The municipalities have so far provided primary care in their own health centres, alone or together with neighbouring municipalities.

For the provision of specialised care Finland is divided into 21 hospital districts. Every municipality still has to belong to a hospital district for the provision of specialised care. The municipalities are the owners of the hospital districts through membership in the federations of the hospital districts.

The regulatory and monitoring role of the state has decreased along with the dismantling of norms and relative decrease in health care funding. The basic nature and operating framework for the health care services is laid down in law, but detailed questions of the scope, content, organization or quality of services are not included. Differences in health service provision from one municipality to another may occur.

No quality legislation has been passed in Finland, but national recommendations have been issued. The quality policy at national level is based on 'steering by information'. In stead of quality acts, four national recommendations have been issued in the years 1994–1999. In the most recent recommendation (1999) the recommendations are organized according to eight topics:

1 customer participation in QM;

2 leadership for the steering of quality;

3 personnel as a prerequisite for high quality;

4 QM for preventive as well other activities;

5 management of processes as a basis for QM;

6 information as a basis for the continuous enhancement of quality;

7 systematisation of QM;

8 detailed recommendations and quality criteria support quality management.

In addition to the quality management recommendations, there are several acts that can be considered as quality related acts, for example the Act Concerning Health Care Professionals (title protection, registration and disciplinary rules). For the legal protection of patients, Finland has issued the Status and Rights of the Patient Act in 1993. This Act includes a mandatory patient ombudsman and complaint handling, as well as use of care/treatment plans. The Patient Injury Act safeguards patients' interest in the event of malpractice. Handling of adverse incidents caused by medical devices is mandatory (Medical Devices Act).

Hospitals use several QM models and criteria for the development of their QMS. The Finnish Quality Award based on the EFQM-model is used in about 50 % of the hospitals as are ISO 9000 standards. But, only one hospital has an ISO-certificate for the whole hospital. The Finnish health care accreditation model is based on the King's Fund model (UK). It is used in about 20% of central, regional and private hospitals (15).

Most of the hospital clinical laboratories have received laboratory accreditation by FINAS and the majority of pathology departments a Pathology Quality Mark [15]. External audits became mandatory in radiology units in 2000, based on the Radiation Act.

The main underlying assumption in this article is that, in general, the three countries develop the same QM-activities, but, (expected) governmental legislation or financial stimulation can stimulate the use of QM-activities better than recommendations alone. Therefore, it was hypothesized that hospitals in a country with governmental legislation have a more developed QMS and develop more QM-activities. The second expectation is that financial stimulation is more effective than legislation only.

The data for this study were collected in the winter of 1999/2000. A questionnaire was sent to all hospitals in the Netherlands, Hungary and Finland (a population survey). The addressees of the questionnaires were the managing directors of the hospitals, but, has been filled in most of the hospitals together with the quality manager. The questionnaire measured the extent of the implementation of QM-activities.

The questionnaire was developed in the Netherlands in 1995 and further improved in 1999. The reliability and validity of the questionnaire were tested in 1995 and are described elsewhere (16). The questionnaire had a closed, Likert-type format with two to four ordinally scaled response options per item.

A non-response analysis was conducted by telephone in 2000. The non-respondents were asked three questions: does the hospital have a quality manager, a quality policy and a guideline for patient information. It appeared that the non-respondents reported fewer QM-activities compared to the respondents. Therefore, a slightly positive bias in the results cannot be excluded.

Data collection

The data collected concerned firstly the extent of QM-activities. The questionnaire listed various QM-activities (see figure 2). These items were empirically clustered into five focal areas, with the reliability coefficients given below.

For the items in the first four focal areas, we used the affirmative answers (yes, this QM-activity is present in the organization). In the fifth focal areas, the items had three response options as follows: The quality improvement procedure: 1) is not present 2) is present, but not entirely operational 3) is present and operational. Operational was defined as meaning that the information obtained from peer review, audits or satisfaction surveys for example, is systematically used to make improvements. For the purposes of this article we combined the responses options 2 (present) and 3 (present and operational).

All missing values were recorded as zero, assuming that missing implied that the QM-activity was 'not present' in the organization. Hospitals with more than 5 missing activities were left out. Differences between countries were described if the differences were greater than 10%.

The object of this study was to investigate agreement and disparities in the implementation of quality management systems (QMS) between the Netherlands, Hungary and Finland with respect to the quality model used and the national policy strategy of the three countries. The main assumption was that the three countries develop the same QM-activities, but that governmental legislation or financial stimulation are more effective in stimulating the use of QM-activities. Therefore, it was hypothesized that hospitals in a country with governmental legislation are further with the implementation of a QMS and the required QM-activities than hospitals in countries with recommendations. Another assumption was that financial stimulation will be even more effective.

The main strength of the study is the measurement instrument which was thoroughly tested in former research [16, 17]. The instrument provides detailed information about QM-activities, independent of specific characteristics of sub-sectors and independent of the quality model used by an organization (ISO, EFQM or other models).

The study's weakness is inherent in investigations conducted by questionnaires. We measured whether or not a QM-activity was present in an organization. The questionnaire approach did not permit us to assess the effectiveness of these activities in serving the purpose of quality assurance. The occurrence of social desirability in the responses could not be excluded. To diminish this effect, the hospital could report the activities anonymously to the researchers and it received individual feedback on the own results compared to the results of all the other hospitals (The Netherlands). Furthermore, social desirability seems unlikely because no sanctions were imposed on non-compliance with the Act in The Netherlands and in Hungary.

In general, the differences between the three countries in the implementation of QMS and QM-activities are not as great as one would expect because of the different history of the countries and health care systems. The average number of QM-activities that have been developed in the three countries is 22 in the Netherlands and Finland, and 20 in Hungary. One specific activity of the Netherlands, the client council, does not exist in Finland or Hungary. All other activities are to some extent present in all the three countries.

The assumption was that hospitals in countries with a legal requirement of QMS would be further with the implementation of QMS than hospitals in countries where the implementation of QMS is voluntary. Therefore, hospitals in the Netherlands and Hungary are expected to be further than hospitals in Finland. This is not the case for Hungary.

The results show that only a minority of hospitals (less than 5%) has developed a QMS (stage 3). There is no real difference between the Netherlands and Finland – most hospitals have implemented various QM-activities, but only 3% – 4% have implemented an integral QMS. On the other side, hospitals in Hungary are less far than hospitals in Finland. Despite the ISO-certification of 30% of the Hungarian hospitals, most Hungarian hospitals are still in the preparation stage, whereas most Finnish hospitals have started with the implementation of the QMS. This means that the hypothesis has to be rejected.

An explanation for the little influence of national quality policy and legislation could be the broad definition of QMS. In the Netherlands and in Hungary, the Quality Act is only a framework legislation that states that hospitals should have a QMS, but it does not give information on the QM-activities that are needed for an integral system. Furthermore, this means that any kind of control or inspection whether hospitals fulfil the requirements of the law, is difficult and no sanctions are taken in both countries.

In addition, the results show that only the QM-activities that are stated by name in the Dutch Quality Act are present in more than 90% of the hospitals, e.g. annual quality report, infection and incident committee, and complaint registration. It seems that only clearly stated QM-activities have been implemented by the majority of the hospitals.

In Hungary, the implementation of ISO:9002 was financially stimulated. In order to receive the money, the management of the hospital had to show which QM-activities the hospital had developed. Therefore, it can be expected that a majority of the Hungarian hospitals have developed the typical requirements and activities mentioned in the ISO:9002 standard (Figure 1). The results do not entirely confirm this expectation. Less than half of the hospitals have implemented the necessary quality policy documents.

Overall, the results show that there is a lack of patient participation in the Dutch, Hungarian and Finnish hospitals. The results indicate that a law or financial reimbursement have some influence on the implementation of QM-activities if they are specific enough. More general, notions about QMS or quality improvement depend on intrinsic motivation of health care providers and hospitals and a QMS will not be implemented by the majority of the hospitals. More pressure seems to be necessary. On the other hand, Finland has no legislation stating mandatory measures and despite this, hospitals have implemented QM-activities and developed QMS.

In line with the conclusions, the national quality policy in the Netherlands and in Hungary is changing and the pressure on hospitals is increasing. In the Netherlands, a new national quality programme has been launched to stimulate hospitals and the healthcare inspectorate is asking for performance indicators.

This guideline has a specific manual for implementation and was developed on the basis of ISO 9000:2000 standards, the EFQM model and the Hungarian Hospital Care Standards (12).

Table 1 Percentage hospitals with QM-activities in the Netherlands, Hungary and Finland

Table 2 Percentage hospitals in stage 2 and stage 3 of the five focal areas of a QMS

Table 3 Percentage hospitals in the various developmental stages of the implementation of a QMS