Recommendation Rec(2006)16
of the Committee of Ministers to member states
on quality improvement programmes for organ donation

(Adopted by the Committee of Ministers on 8 November 2006
at the 979th meeting of the Ministers’ Deputies)

The Committee of Ministers, under the terms of Article 15.b of the Statute of the Council of Europe,

Considering that the aim of the Council of Europe is to achieve greater unity between its members and that this aim may be pursued in particular by the adoption of common rules in the public health field;

Taking into account Resolution (78) 29 on harmonisation of legislations of member states relating to removal, grafting and transplantation of human substances, the final text of the 3rd Conference of European Health Ministers (Paris, 16 and 17 November 1987), Articles 19 and 20 of the Convention of Human Rights and Biomedicine (ETS No. 164), and Articles 3 and 4 of the Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin (ETS No. 186);

Considering that:

– organ transplantation is a well-established, life saving, and effective treatment. It may be the only treatment available for some forms of end stage organ failure and is the most clinically effective and cost effective treatment for chronic renal failure;

– member states should provide high quality transplant services for the benefit of their citizens. Considering the organ shortage, all necessary steps should be taken to ensure that all available organs are properly safeguarded and used so as to maximise the benefit of patients;

– the process of organ donation and transplantation is a complex process which involves a long series of stages which should be followed rigorously in order to be effective. Each of these stages should be analysed whenever a problem arises in order to detect weaknesses in the process and take the necessary corrective measures;

– the document “Meeting the organ shortage” approved by the Council of Europe, states the need to develop a protocol to identify potential donors, including the registration of donors, and to clarify the roles and responsibilities of hospital professionals in donor identification,

Recommends that the governments of member states take all necessary measures to ensure that:

i. a quality improvement programme for organ donation is put in place in every hospital where there is a potential for organ donation;

ii. the quality improvement programme is primarily a self-evaluation of the whole process of organ donation, jointly performed by the specialists in intensive care and the transplant co-ordinator of every hospital. Whatever the nature of the programme, it should represent an appropriate mechanism for monitoring the whole process of organ donation in intensive care units;

iii. the hospital programme is harmonised at regional and national level in order to compare adequately the results obtained and to adopt the most appropriate measures to improve organ donation;

iv. external audits performed by experts from other hospitals, regions or countries are performed regularly after the implementation of the self evaluation programme, in order to further improve the process and provide greater transparency;

v. the objectives of these programmes include:

– definition of the theoretical capacity of organ procurement, depending on the characteristics of the hospital;
– detection of obstacles to the process of organ donation and procurement and analysis of the causes of potential donor losses, as a tool to identify areas for improvement;
– a description of factors with regard to hospitals which can influence the donation and transplantation process;

vi. a systematic review of all medical records of patients who have died in intensive care units (ICU) and possibly in other similar units is performed on a regular basis in order to analyse any undetected potential donor and establish means for improvement;

vii. in every hospital, region and country the following data must be periodically monitored:

General data:

– number of available hospital beds;
– number of available ICU beds;
– number of neurosurgery procedures;
– number of patients admitted to the ICU and emergency rooms;

Specific data:

– hospital deaths;
– brain deaths;
– number of potential organ donors;
– number of organ donors;

viii. appropriate standards must be defined in every country according to the characteristics of the hospital and the health system in order to compare the results with those of other regions or countries, so as to better define the areas for improvement.



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