Main conclusions and recommendations

Towards an European harmonization of external auditing

4.1 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

4.2 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.

4.3 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

Conclusions and proposed actions

This report attempts to identify the evolution, trends and basic principles of external evaluation models in terms of the promotion of patient safety. These conclusions do not necessarily apply to external evaluation models of health care organisations when they address issues and dimensions of quality that do not directly relate to patient safety.

1. Adopting a minimum set of requirements or adopting core standards, practices and performance indicators for patient safety

Adopting a minimum safety platform with a minimum set of mandatory requirements and a corresponding surveillance system is a true challenge. The medical community must make significant effort to elaborate mimimum thresholds for acceptable standards and not to continue designing high cost and ultra best practices.

There is now evidence in the literature that simple measures that are not costly can show significant benefits (e.g. education, adopting a safe organisation of care, reporting, hand washing, phlebitis preventive protocols). This is an opportunity to involve new member countries while mobilising more advanced countries where very up to date practices may be pursued at the expense of basic ones that have been shown to have a large impact on the safety of patients and that rely less on technology than on individual and group practices.

This is a strong argument for the definition of specific safety priorities and for the organisation of external evaluation models around more targeted objectives. This does not imply that sustained quality improvement becomes a secondary goal but that the quest for excellence must build on a minimum platform
accessible to all.

There is a strong trend towards the development of mandatory programs of external evaluation of health care organisations in response to the need for accountability to the public and to their representatives the politicians and in response to the need for equity of access to safe care. As programs become mandatory, the objectives tend to become minimal standards applicable to most organisations that should take into account the organisation's and the country economic and cultural situation to avoid a strong pressure to violation leading to a paper policy and virtual safety.

This same trend leads to the development of programs which aim increasingly at national coverage and at the improvement of patient safety throughout a health system. A national approach has the added advantage of representing an opportunity for coordination of external evaluation activities to increase efficiency and decrease work load.

This implies the integration of specific strategies to identify and embed safe and well-evidenced professional practices such as national patient safety goals, required organisational practices, patient safety solutions and evidence-based bundles of care applicable to high risk situations.

Recommendations:

• External evaluation programs should integrate specific strategies to identify and embed patient safety objectives and well evidenced professional practices



• Standards should take into account the HCO's or the country's economic and cultural situation to avoid a strong pressure to violation leading to a paper policy and virtual safety



• There are advantages to a national approach to external evaluation including an improvement strategy for patient safety applicable throughout the health care system and a response to a strong demand for coordination of external evaluation activities to increase efficiency and diminish workload

2. Assessment of dynamic interfaces, resiliency and patient safety culture

There has been a change in focus in terms of targets for external evaluation of safety. From the physical safety of goods and individuals, to a focus on clinical standards and clinical governance, to the assessment of dynamic interfaces at all steps of the care pathway within the hospital and within shared care networks involving professionals and patients and, finally, concentrating on a systemic global approach associating commitment by top management, a proactive approach to risk and an emphasis on the responsibility of actors, on resilience strategies, on an open patient safety culture and on effective competence maintenance and development activities.

There is mounting evidence that leadership and mobilisation are key to implementation of safe practices and to the creation of an open and proactive safety culture. The external evaluation of dynamic interfaces, patient participation, safety culture and commitment of management and leadership are new frontiers in terms of external evaluation models that should be further researched.

External evaluation programs should be considered learning systems at the health care organisation level. Self-assessment will contribute to this objective leading to a global diagnosis, and to the identification of opportunities for improvement. Furthermore, the implementation of corrective actions prior to the survey will demonstrate to the external evaluation organisation the capacity of the hospital to effectively improve.

Recommendations:

• Methods should be developed to better assess recent trends such as dynamic interfaces, patient involvement, resiliency, safety culture and leadership



• External evaluation programs should be considered learning systems at the health care organisation level. Self-assessment will contribute to this objective.



• These programs do not assess the competence of individual professionals directly but may ask hospitals to demonstrate that they have effective competence maintenance and development activities, notably in the field of patient safety

3. Measurements are essential to any improvement strategy

Indicators should focus on different aspects of safe care that are easy to compare and standardise. Indicators for outcomes, processes, structure and context are available and will help to create a composite image of patient safety.

See the report of Work Package 4 on safety indicators

4. The external assessment process must be credible

The credibility of the external evaluation will depend on the strength of the three essential steps of these models.

* Safety objectives must be clear and follow the current trends of evolution in the field of patient safety. They must integrate the expectations and opinions of all stakeholders. They must be recognised as essential by the health care professionals.

* Credibility will depend on the methods to assess the achievement of the objectives. This raises the issues of reproducibility and competence of surveyors, of the ways to validate the objectivity of data through varied concrete approaches such as the patient tracer methodology, of audit frequency and of unscheduled surveys.

* Credibility will also depend on the quality of the decision process and on follow-up actions such targeted surveys relative to specific deficiencies. The publication of the results will contribute to the credibility of the process in the eyes of the professionals and patients.

Recommendations:

• Safety objectives must be consensual and clearly defined and should follow the current trends of evolution in the field of patient safety



• Surveyors should function as teams representing a mix of competences insuring a multifaceted approach, credibility, independence and consensus.



• It is essential that corrective actions be perceived as credible in regards to the risk detected in the organisation in order to build trust into the auditing program.



• The extent of publication of the results is debated:


~ The right to information of patients is recognised
~ Publication is a strong motivation to change
~ The information must be understandable to all stakeholders, including patients, and allow for national or regional comparison
~ The "accepted wisdom" amongst health professionals and health providers is that a safety culture is built in a "blame-free" setting and that publication may lead to the non disclosure and non correction of faults. However, feedback from patients suggests that more work is needed on agreeing an understanding of what these terms mean in practice and balancing the desire to encourage reporting with the ethical and professional requirement that patients or their families be fully informed of incidents affecting them
~ There must be a clear understanding by all of what is confidential and what can be published.

5. Towards strategies of European harmonisation

Recommendations:

• Make existing information available to member states on:
  
  ~ programs of external evaluation applicable to HCOs
  ~ on hospital quality based on the results of these programs



• Adopt common general goals and principles for external evaluation (on the model of those of the International Accreditation Program of ISQua) as well as a portfolio of common methods



• Incorporate into those principles European requirements on patient safety as they are being adopted



• Further harmonisation will be harder to achieve:




~ Common standards:



Easy: Physical standards
Relatively Easy: Clinical governance
Hard: Organisation and system approach

~ Monitoring of performance
~ Common processes of evaluation
~ Common logics of decision