4. About decisions and after audit follow-up actions

This section deals with the key step in auditing which is the less harmonized across different countries and programs. Most Western countries recognize the need for delivering three types of conclusion after an external auditing process, according to the result of the audit:

• Type 1: The auditing process is satisfactory and the HCO is fully accredited with or recommendations and with an agreement on priorities to be pursued and on actions to maintain quality and safety initiatives



• Type 2: The auditing process concludes that the medical establishment is not at major risk for patients, although, in some critical areas, it does not comply with standards and additional specific efforts are required. The medical establishment must comply with these critical points within a defined period of time (to be mutually agreed according to the changes to be made). The compliance is re-evaluated by auditors at the end of the agreed period. The auditing process is recognized as fully successful when the corrections have been made.



• Type 3: The auditing process concludes that the establishment is at major risk for patients. In that case, the logic should ask for immediate closing. A mutually agreed plan for improvement can be also defined with the selective closing of some activities and wards.

There is little evidence in the literature on the uniformity of application of these three types of conclusion. There is a potential for a wide variation in the applications of follow up actions among European countries, because of the variable cultural, economic and political contexts and because of the variable practice of the auditors who propose the inclusion of a partially non compliant establishment into conclusions of type 2 or type 3. It appears that type 3 decisions are extremely rare, both to avoid social consequences associated with closing, and as a consequence of a strategy to keep the HCO enlisted into the auditing program and to promote a positive attitude fostering improvement. Conversely, type 2 decisions are very frequent.

It is essential that the corrective actions be perceived as credible in regards to the risk detected in the organisation in order to build trust into the auditing program (Australian Council for safety and Quality, 2003).

This section needs much further work for a potential standardisation among EC countries, including debates on cultures.