5. Towards an European harmonization of external auditing

5.1 Contrasts in European approaches to external audit

The table here below shows the stage of accomplishment of the accreditation programs in the EC countries (to be completed by the information gathered under WP 2 and by the inclusion of other other families of auditing methods used in European countries).

Accreditation	Program (Shaw, 2004, Accreditation toolkit)	Total
Active program	COMPULSORY: France, Germany, Italy (regional), VOLUNTARY: Ireland, Bulgaria, Netherlands, Poland, Portugal, Spain, Switzerland (two), UK (three)	11
In development	Bosnia (RS, FBiH), Croatia, Czech Republic, Denmark (two), Finland, Hungary, Kyrgyzstan, Latvia, Lithuania, Malta, Slovakia	11
No national program	Albania, Armenia, Austria, Belgium, Cyprus, Estonia, Kazakhstan,Luxembourg, Sweden, Turkey, Yugoslavia	>11

5.2 A tentative classification of European attitudes in managing external auditing

Some global characteristics are related to countries' policies. It is roughly possible to divide the European attitudes in three tiers from North to South of Europe.

• The countries of Northern Europe, which tend to have a small number of citizens with a high income, encourage a very wide distribution of facilities to monitor their medical systems. (i) Certification methods (ISO) are commonly used. (ii) These countries are much more interested than countries in Southern Europe in assessing the general primary care sector (particularly in Finland). (iii) Monitoring is based much more on voluntary external continuous audit (accreditation, certification, peer review) supervised by the State. They are pushing for the voluntary adoption of high standards. Paradoxically, these countries have few rules (based on minimum standards), but they assess relatively severely, with full transparency for the public, and with fairly strong professional obligations and sanctions. Public satisfaction for the medical system is generally high because of the global quality of care, the commitment of the politicians, and of the extent of the social coverage (little or no out-of-pocket financing of the healthcare systems).



• The countries of Southern Europe have more rules (accreditation is compulsory in France and Italy), are more directive and more focused on public HCOs and hospitals. Their desire to promote excellent practice leads them to be more demanding in terms of rules (an approach which is differs significantly from the intention of accreditation), but there is a certain tolerance and numerous derogations in terms of practical implementation (Roman legal tradition). These countries make a lot of rules, but audit less. If audit results are negative, there are fewer places for sanctions (compared to Northern countries) unless a crisis occurs, but, in such a case, a special additional mechanism will be required (general inspection). The public satisfaction is generally high, first because of the good financial coverage, and because of the trust in the government to make decisions on healthcare management that are beneficial for citizens.



• The central tiers of Western EC countries (UK, Germany, Austria, Netherlands...) often fall between these two approaches. They adopt almost all the tools and strategies (peer review, accreditation, quality, certain ISO standards). For example in UK, initiatives are based on the many recommendations and guides provided by the National Patient Safety Agency (with a distinctly higher level of inducement than in France), with an objective of minimum standards to be adopted by all. Performance assessment is currently stronger than in France, with an emphasis on cost effectiveness and safety management at top management level. However, the public satisfaction tends to be less than in Northern and Southern countries, especially in UK. Note that the public satisfaction is likely to be based on a social perception and not necessarily relate to an objective reality.



• The Eastern countries are increasingly visible but are still dealing with economic problems and trying to reconcile ambition Western European model) and social realism. In summary, politically-driven systems induce a more hierarchical culture and the adoption of very strict but frequently unrealistic rules ; the aim is to encourage excellent practice, while accepting that the current situation falls short of the desired quality level. Conversely, the less hierarchical states pragmatically adopt guaranteed minimum standards and delegate the supervision and monitoring of the system to private bodies. There are many methods, all of them leading to apparently positive results according to a large consensus of opinions from both the auditors and the health care professionals. It is then difficult to recommend a specific method of external assessment for HCOs. While there is evidence that individuals practices have a strong impact on patient safety, there are few studies of the impact of hospital wide assessment programs. The MARQuIS program (Method of Assessing Response to Quality Improvement Strategies) running in parallel to the SIMPATie program, has an objective to assess and compare the different National quality strategies, and may provide comparative data.

5.3 Feasibility of harmonization: from the easiest to the most demanding

In view of the above, a European external audit platform will necessarily be either very minimalist (lowest common denominator), or will consist of a number of alternative paths, depending on the political models. It may be based on goals or methods. It is easier to harmonise goals than methods.

The following table suggests the different available solutions from the easiest and minimalist, to the most sophisticated, but potentially difficult to harmonize. The total of the port folio of solutions could also be interpreted as a tentative map road for implementation of harmonization within EC countries during the next decades.

	Objectives	External audit methods
Minimum tool platform (lowest common denominator)	Encouragement to use the tool Improve patient safety by imposing minimum standards : on facility safety on product safety (foodstuffs and healthcare products) on the adoption of good care practices in relation to safety (prophylaxis, etc.)	Feasible: Identify common indicators Develop and apply a culture of quality assurance Publish common European standards for good basic practice More difficult: Impose the choice of an audit tool
Minimum performance platform	Monitor performance Improve patient safety by imposing a minimum performance level work on transparency work on the care circuit work on the system’s actual performance (errors, adverse events)	Feasible: Encourage the use of common performance indicators, and list these indicators More difficult: Determine a minimum performance standard by medical sector Come to an agreement on a standardised strategy in the event of conformity / non-conformity (European, national, regional?)
Common minimum system platform Common systemic approach, align healthcare systems	Align safety cultures Improve patient safety by standardising healthcare systems Develop safety and organisational governance standards	Already difficult Cross audits between countries, reinforced benchmark strategy List the differences, be aware of these differences, and make public information on the advantages and drawbacks of each model Very difficult Strong political voices Financial constraints Leads to the idea of an Agency