1. Context and definition of external auditing

1.1 Context: A growing need for mandatory auditing systems

There is a growing public demand on European countries' governments for a better medical service. This demand combines with a global demand for additional transparency and pay-for-performance medical systems. Many studies also point to the public dependency on the closest neighbouring medical establishment. The public has often few or no opportunity to select the best establishment, and the demand is clearly to have a standardised level of good and safe care in each establishment wherever it is located 1 . This standard of safe care is expected to cross borders as the mobility of patients increases. Politicians may well loose elections if this national standard of care is not attained. The consequence is clearly a move towards more tandardised and mandatory auditing processes, to the detriment of optional and voluntary programs.

Another consequence is that such a progressive shift towards mandatory systems and greater accountability, if generalized, could result in an alignment of external auditing to minimum standards. In this context, one of the challenges is to structure external evaluation models that will foster improvement as well as accountability and will mobilise all organisations whatever their level of quality towards objectives of excellence.

The growing need for European harmonization, which is the very reason of the SIMPATIE project, is particularly sensitive to this aspect, and will probably accelerate the move to a minimum mandatory common platform for auditing; conversely, the development of new advanced and costly patient safety initiatives could be considered in the next decade of much lower priority compared to this need of a common basic platform within and among EC countries.

1.2 Definition of external auditing

• covers all auditing actions related to delivery of care;


• is carried out by staff who do not belong to the health care organisation being audited (although the process is necessarily connected to internal evaluation, both processes ideally converge on a similar set of safety goals and indicators and feed one another);


• strives to provide an objective assessment of the quality of services delivered by the HCO against the most up to date standards;


• identifies weak points to be improved by a specific deadline;


• contributes to transparency and quality in the health care system through information and external recognition; and, by this


• ensures user confidence in the health system and in the care delivered.


Beyond local improvement, it is expected that the external auditing process will induce system-wide changes involving multiple HCOs, and on a national scale in case of national programs 2 .

1.3 The three key steps of external auditing

A comprehensive approach of external auditing is based on a thorough description of three milestones:

• The first point is to make the objectives of the auditing process as pertinent and as clear as possible.


• The second point concerns methods to evaluate the achievement of objectives. The port-folio of methods should be described at various levels of granularity from general principles to detailed tools.


• The third point focuses on how to deal with the results and how to make decisions, and on the follow-up by corrective and maintenance actions.


These three points organize the sections of this report.