donoraction

Following document is based on documents accompanying a recent EU initiative ‘to establish common standards of quality and safety of human organs for transplantation’ and its Action Plan in particular on one hand ⁽¹⁾, and the way Donor Action^® wants to offer Member States an answer to fulfill a majority of the requirements as defined by the Commission’s 10 Action Priorities on the other hand ⁽²⁾.

The number of organ donations and transplantations has grown steadily across the EU and thousands of lives are saved every year through this medical procedure. Organ transplantation is now the most cost-effective treatment for end-stage renal failure. For end-stage failure of organs such as the liver, lung and heart it is the only available treatment.

Currently, there are wide variations in quality and safety requirements between Member States. A national approach could not ensure a minimum standard of quality and safety for the organs that are exchanged between EU countries each year. A Directive was approved by the European Parliament in June 2010 (Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation) ⁽³⁾ to ensure a high level of health protection throughout the EU by establishing common standards of quality and safety of human organs intended for transplantation.

The Directive will ensure that the necessary quality and safety structures are put in place across the EU for the donation and transplantation of organs. This will also facilitate the exchange of organs and expand the pool of organs available, ensuring a better match between donor and recipient. It will do so via several means:

· A competent authority will be appointed in each Member State, where one does not already exist, to make sure that the quality and safety standards of the Directive are complied with;

· A system for the authorization of organ procurement and transplantation will be established, based on common quality and safety criteria;

· National quality programs will be introduced to ensure continuous monitoring of performance, leading to learning and improvement;

· Member States will put in place organ traceability systems and systems for the reporting of serious adverse events and reactions;

· Transplant teams in all Member States will be reassured that they will receive the appropriate and complete information required regardless of the country of origin of the organ;

These standards will help to reassure the public that human organs procured all over the EU will carry the same basic quality and safety guarantees, regardless of the country. Moreover, measures introduced by the Directive such as the establishment of competent authorities and systems of traceability should help to fight "organ trafficking".

Now that this Directive has received a positive vote in the European Parliament, what happens next?

After adoption by the Council and publication in the Official Journal in June 2010, the Member States now have 24 months to transpose the Directive into national law. The Directive leaves enough flexibility to Member States to accommodate the existing systems where in place, so red tape and administrative burdens should be minimal. Member States shall report to the Commission every 3 years on the implementation of the Directive.

What is the Action Plan on organ donation and transplantation and how does it tie in with the Directive?

The Directive and the Action Plan on organ donation and transplantation are mutually reinforcing. While the Directive lays down binding measures to be adopted by the Members States for the quality and safety of organs, the Action Plan, adopted in 2009, has a broader scope, covering also the availability of organs and efficiency of transplantation systems. The Action Plan runs for the period 2009 to 2015 and sets out 10 priority actions. The Action Plan will help increase the number of organs for transplantation. The approach is collaborative between Member States and based on the identification and development of common objectives, agreed quantitative and qualitative indicators and benchmarks, regular reporting and identification of best practices. The Action Plan will promote a number of initiatives aimed at increasing organ donation through organization changes that have proven effective in some Member States. It will also help Member States to evaluate the performance of their transplant systems and exchange best practices to improve them.

How does the Donor Action^® Program match with the Priority Actions of the Action Plan?

To assist Member States in achieving the EU Action Plan Priorities with already existing support packages, following paragraphs describe how Donor Action^® (DA) (www.donoraction.org) can make the difference in answering to the relevant Priorities as announced:

1. Increasing organ availability from deceased donors to their full potential

1.1 Commission Priority Action 1: Appointing Donor Transplant Coordinators in all hospitals with a potential for organ donation

Improvements in the complex process from donor identification to the transplantation of an organ have shown to have a large impact on organ donation rates ^(4,5) . The presence of a key donation person at hospital level (donor coordinator) in particular, whose main responsibility is to pro-actively identify potential donors, is one of the first steps in improving donor identification rates ⁽⁶⁾. Member States should therefore aim to incorporate in their Sets of National Priority Actions the objective of gradually appointing Donor Transplant Coordinators in all hospitals where there is potential for organ donation. The Commission could have a coordinating and monitoring role in this respect; for that purpose Member States should be encouraged to report to the Commission the number of hospitals that have appointed a transplant donor coordinator. Building on this principal objective, the Action plan must help to establish internationally recognized standards for donor coordinator programs in the forthcoming years of the Action Plan and promote the implementation of effective training programs for donor coordinators.

Donor Action^® expertise in the field:

One of the cornerstones of DA’s methodology since its development in the mid-90ies has been the establishment in each hospital with a potential for donation of a multidisciplinary Donation Committee, with a key role for the Transplant Coordinator (TC). DA has gone even a step further, with its recommendation to appoint in each Critical Care Unit (CCU) a DA Link. This is a well-respected member of the CCU staff who serves as the unit’s focal point for donor identification, referral, family care and communication and donor clinical management. Such an appointment can focus responsibility for the donation process proactively and independently of the transplant team and establish an in-hospital partner for the TC.

As to the suggested effective training of Transplant Coordinators, DA has a long history of over a hundred of training courses for related health professionals, Transplant Coordinators included, and organized in Europe, the America’s, North Africa, the Middle and Far East, and Australia. Since 1996, Critical Care and transplant professionals from over 25 countries have attended specifically designed international, national and regional DA training courses. These courses not only familiarize participants with the program’s aims, objectives and materials but also include teaching the multiple skills required for the introduction of change to CCUs on the difficult subject of organ donation.

Of equal importance is to promote Quality Improvement Programs for organ donation (Priority Action 2) in every hospital where there is potential for organ donation. These programs are primarily a self-evaluation of the whole process of organ donation ⁽⁷⁾ according to the characteristics of the hospital and the health system. These will make it possible to compare results and thus to pinpoint areas for improvement. Consequently, it will also be beneficial to promote accessibility to and training for a specific methodology in relation to these Quality Improvement Programs.

Donor Action^® expertise in the field:

Since its introduction, more than 15 years ago, DA has taken a systematic approach towards achieving quality assurance in the whole donation process and is designed to give hospitals participation and ownership of improved practices that can be tailored to meet identified needs in CCUs (Accident & Emergency and Intensive Care Units).

A comprehensive package of tools, resources and guidelines are provided to help a CCU diagnose its potential for donation, develop appropriate protocols and establish a team with clearly defined roles and responsibilities in donation activities. It allows targeted and consistent education and performance monitoring systems.

DA’s quality assurance approach, named ‘DA Diagnostic Review’, is based primarily on a Medical Record Review (MRR) process, which is a validated web-based analytical tool that has been developed to measure gaps between potential and actual donors and indicate when and where in the process potential donors are missed. While its software provides simple push button reporting systems, it also provides for detailed and sophisticated analysis of the data both aggregated and by individual ICU, hospital, region, or country.

To date, DA has collected over 60,000 records from patients who died in over 500 hospitals around the globe and that have been entered into its DA System Database.

2. Living donation as complementary to deceased donation: not applicable, since DA is involved only in all aspects of deceased donations.

It has been proven that there is an important positive correlation between having discussed the issue of donation within the family and the willingness to actually donate organs. Since public awareness and opinion play a very important role in increasing organ donation rates, continuing education should form an essential part of all Member States' communication strategies on the issue. People should be encouraged to speak about organ donation and to communicate their wishes to their relatives. The Commission, therefore, felt the need of improving the knowledge and communication skills of health professionals and patient support groups on organ donation and transplantation.

Donor Action^® expertise in the field:

The European Donor Hospital Education Program (EDHEP), Eurotransplant’s predecessor of Donor Action^®, has been integrated since the mid-nineties as the Family Care and Communication improvement measure module of the DA Program. EDHEP was designed to meet the training needs of critical care staff in breaking bad news, caring for the bereaved, and requesting donation. EDHEP is a two-part educational package consisting of a presentation about the donor shortage followed by a one-day workshop^(8,9). The implementation of EDHEP throughout the world has been facilitated through effective national working groups and standardised "train the trainer" courses. Today, EDHEP continues to be the gold standard in improving knowledge and communication skills of health professionals in several Member States and beyond.

In addition, DA’s Hospital Attitude Survey (HAS) is another DA tool to monitor health professionals’ knowledge and communication skills improvements. DA’s HAS is a simple, anonymous web-based questionnaire administered to critical care staff in units undergoing MRR, to assess self-reported attitudes and knowledge about donation and transplantation, involvement, skills/self confidence in donation related activities and support provided in the donation process. In addition, CCU staff are asked how much education they have received on donation related matters, and how much more education they feel they need. By offering their staff this requested educational support, hospitals will optimize their donation processes.

EDHEP and DA’s HAS, therefore, are direct answers to the Commission’s expressed need to improve health professionals’ knowledge and communication skills with regard to organ donation related tasks.

The Commission will help Member States to develop mechanisms facilitating the identification of organ donors across Europe …

Donor Action^® expertise in the field:

Since more than 15 years already, DA has been assisting ICU’s, hospitals, regions and countries throughout Europe and beyond with identifying potential organ and tissue donors by offering its MRR methodology and software (see 1.2), which is a validated web-based analytical tool, developed to measure gaps between potential and actual donors and indicate when and where in the process potential donors are missed. Over 80 publications in peer-reviewed journals are witnessing DA’s methodology’s to have significantly increased donation rates in hospitals adhering to its principles (www.donoraction.org) .

4. Priority Actions for enhancing the efficiency and accessibility of transplantation systems

Even among EU countries with well-developed health and organ transplant services, there are still considerable differences in organ donation and transplantation activity. It is clear that some organizational systems are performing better than others. Hence, initiatives focused on identifying the most efficient systems, sharing experience and promoting best practices in accordance with local characteristics are promoted by the Action Plan.

The Action Plan calls on Member States to enhance the efficiency of transplant systems

(Priority Action 6). To this end, they will develop their own Sets of National Priority Actions

in 2009. These will provide the basis for an overall evaluation of the success Member States

have in achieving the aforementioned common objectives. Member States should then aim to establish, in close collaboration with the Commission, a common set of indicators to monitor organ policy and a methodology to evaluate the potential in each Member State.

Donor Action^® expertise in the field:

As mentioned already before, DA’s MRR methodology and software have been developed since the mid-90s to monitor the donation process in participating hospitals and CCUs by assessing their donation performance, identifying areas for improvement and putting in place the appropriately adapted Core Program Modules⁽¹⁰⁾.

Because of its unique standardized algorithm and format, the DA MRR and System Database are currently the only existing tools to allow individual Member States to evaluate their donor potential and compare their performance with other countries, as demonstrated in multiple publications ^(11-13). The DA System Database is a user-friendly web-based relational database system designed to enter, analyze and report on the HAS and MRR data. A built-in self-validation system guarantees data consistency by preventing input errors from users and guiding them to follow the correct pathway. An easy push button system lets the user retrieve reports and analyze data: the Report Module provides pre-defined HAS and MRR reports and charts and offers single count and cross-type reporting features. Data can also be exported for further analysis by other statistical tools, such as SAS and MS Excel. For ease of use, the application is available in a number of European languages and also offers an online Translation Module.

6.1 Improving follow-up procedures and registers (Priority Action 9): not applicable

The Action Plan also seeks to develop a methodology that could support the EU legal framework in order for Member States to accredit programs on organ donation, procurement and transplantation. This could help, in the long run, to build a common accreditation system for organ donation/procurement and transplantation programs (Priority Action 10) at EU level and provide support for centers of excellence.

Donor Action^® expertise in the field:

With its proven record of international and national training courses, its strong links with the international transplant community, its expertise in the field of organ donation and large scientific output in peer-reviewed journals, DA should be considered the ideal partner to develop, together with the Commission and other partners, a common accreditation system for organ donation/procurement and transplantation programs.

This Action Plan identified 10 priority actions in order to aid Member States addressing the challenges in the field of organ donation and transplantation. On the basis of these actions Member States should develop their own Sets of National Priority Actions. The Action plan will provide the basis for an overall evaluation of the success Member States have in achieving the aforementioned common objectives. A midterm review (mid-term review 2012) of the actions will be carried out to evaluate their efficacy.

DA’s international expertise in the field of organ donation should encourage Member States’ Health Authorities to contact DA Management, if not done already, and consider establishing a partnership with DA to help them developing their own sets of National Priority Actions, complying with the Action Priorities as defined in the Commission’s Action Plan.

3. Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation, Official Journal L 207 , 06/08/2010 P. 0014 – 0029

4. Donor Action: an international initiative to alleviate organ shortage L. Roels, C. Wight, Progress in Transplantation, Vol 11(2) 90-97, 2001

5. Joining Efforts in Tackling Organ Shortage: The Donor Action Experience. L. Roels, B. Cohen, C Gachet & B. Miranda, Clinical Transplants 2003, Eds. M.Cecka & P. Terasaki, UCLA

6. An in-house coordinator program to increase organ donation in public trauma hospitals. Shafer T, Wood RP, Van Buren C, et al. J Transpl Coord. 1998 Jun;8(2):82-7.

7. Council of Europe Recommendation (2006)16 of the Committee of Ministers to member states on quality improvement programmes for organ donation. https://wcd.coe.int/wcd/ViewDoc.jsp?id=1062721&Site=CM (accessed 01/04/2022)

8. The European Donor Hospital Education Programme (EDHEP): addressing the training needs of doctors and nurses who break bad news, care for the bereaved, and request donation. Blok GA, van Dalen J, Jager KJ, et al., Transpl Int. 1999;12(3):161-7.

9. The European Donor Hospital Education Programme (EDHEP): enhancing communication skills with bereaved relatives. Morton J, Blok GA, Reid C, van Dalen J, Morley M., Anaesth Intensive Care. 2000 Apr;28(2):184-90.

10. Donor Action: a quality assurance program for intensive care units that increases organ donation C. Wight, B. Cohen, L. Roels, B. Miranda, J Intensive Care Med 2000; 15:104-114

11. Donation patterns in 4 European countries: data from the Donor Action Database. Roels L, Spaight C, Smits J, Cohen B, Transplantation 2008, 86(12): 1738-1743

12. Sustained impact of the Donor Action methodology on donation practices: a 7 year follow-up in 4 European countries. Roels L, Spaight C, Smits J, Cohen B. Transplantation 2008, 86(2S):265

13. Global strategies to meet the organ need – the European experience. Roels L, Rahmel A. Transpl Int 2011, 24(4):350-367