Ministers' Deputies
    CM Documents

    CM(2004)152 20 August 2004
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    898 Meeting, 30 September 2004
    6 Social cohesion


    6.1 European Health Committee (CDSP) –

    Abridged report of the 55th meeting (Strasbourg, 15-16 June 2004)

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    1. The European Health Committee (CDSP) held its 55th meeting on 15-16 June 2004 in Strasbourg. The agenda is set out in Appendix 1. The list of participants is included in the full report, which can be obtained directly from the Health Division.

    Ms Taru Koivisto (Finland) whose term of office lapsed at this meeting, was re-elected Chair for one year.

    The CDSP elected the following experts as new members to its Bureau: Ms Barnes (Ireland), Mr Urban Koçak (Czech Republic), Ms Alonso Cuesta (Spain), Ms Sordat (Switzerland), Ms Čičevalieva (The Former Yugoslav Republic of Macedonia).

    The CDSP celebrated its 50th anniversary and welcomed the publication of a special edition of the Social Cohesion Newsletter on Health as a social right. The Newsletter highlights the human rights dimension of health care and puts forward the CDSP's work into future prospectives.

    2. The CDSP held an in-depth discussion on the implementation of the document called “Council of Europe's public health and related activities: towards a strategic approach”. It agreed on working mechanisms and timelines with a view to finalising the implementation document at its November 2004 meeting for submission to the Committee of Ministers.

    3. The new Director General ad interim of Social Cohesion held an in-depth exchange of views with the CDSP on the developments made since the 54th CDSP meeting as regards the “Integration of the activities of the Partial Agreement in the Social and Public Health Field into the regular programme of activities”. The initiative as proposed by the Secretary General was described in document CM(2004)63 and the Committee of Ministers agreed to consult the European Health Committee (CDSP).

    The interim reply will be transmitted to the Committee of Ministers at one of its forthcoming meetings.

    4. The CDSP reviewed the state of implementation of its work programme for 2004.

    4.1 The CDSP adopted:

    ¬ The draft Recommendation on the impact of information technologies on health care – The patient and Internet. It is transmitted to the Committee of Ministers for adoption (Appendix 2).

    This draft Recommendation emphasizes the role of the internet as new information source for the patient. Provided that this information is of good quality the use of the internet would lead to a new partnership between health professionals and the better informed patients.

    ¬ The draft Recommendation on teaching transfusion medicine to nurses. It is transmitted to the Committee of Ministers for adoption (Appendix 3).

    The draft Recommendation recommends to member states that all nurses receive education in blood transfusion. More specifically, only nurses who have been trained and assessed as competent in blood transfusion medicine should be allowed to practice blood transfusion.

    ¬ The draft Recommendation on criteria for the authorisation of organ transplantation facilities. It is transmitted to the Committee of Ministers for adoption (Appendix 4).

    This draft Recommendation recommends to member states that certain criteria should be met before authorising facilities eligible for organ transplantation. The criteria to be met are defined in the draft Recommendation.

    ¬ The 2nd edition of the Guide on safety and quality assurance for organs, tissues and cells with a view to its publication.

    4.2 The CDSP took note with satisfaction that the draft Recommendation on health and media had been completed and would be reconsidered with a view to adoption at its next meeting. This draft Recommendation emphasizes the responsibility of health authorities to provide the general public with health information thus broadening the public's general knowledge about health.

    4.3 The CDSP agreed on a number of principles on how health issues should be addressed in a possible revision of the relevant articles in the Social Charter and agreed to transmit the conclusions of the Committee of Experts to the Governmental Committee of the Social Charter Committee. The conclusions should be accompanied by a letter signed by the Chair of the CDSP explaining the rationale behind the proposals.

    4.4 The CDSP took note of the progress in the implementation of the work carried out by the Committee of Experts on “Health services in a multicultural society”, “Management of safety and quality in health care – prevention of adverse events in health care, a system approach”, “Hospitals in transition: new balance between institutional and community care” and “Transborder mobility of health professionals and its implications for functioning of health care systems”.

    The CDSP adopted specific terms of reference for the Committee of Experts on Blood Transfusion (SP-HM) (Appendix 5) and for the Committee of Experts on Quality Assurance in blood transfusion services (SP-GS) (Appendix 6). The specific terms of reference are transmitted to the Committee of Ministers for approval.

    5. With reference to the European Union Directive on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (2004/23/EC), adopted on 31 March 2004, the CDSP noted with satisfaction the co-operation between the Council of Europe and the European Commission in this field; it welcomed in particular that the standards of the technical requirements to be elaborated under Article 28 of the said Directive will be compatible with the Council of Europe's 2nd edition of the Guide to the safety and quality assurance for organs, tissues and cells.

    This co-operation will ensure that the same technical requirements for tissues and cells will apply pan-European wide.

    6. The CDSP examined and approved its work programme for 2005. In this context the CDSP took note with satisfaction that its second meeting was formally re-instated in the budgetary provisions (two meetings each lasting two days).

    The CDSP agreed to include the following new activities in its work programme for 2005:

    · A Committee of Experts on the impact of genetics on the organisation of health care services and the training of health professionals;
    · A Committee of Experts on health inequalities from a gender perspective;
    · A European Conference on the organisation of palliative care.

    7. The CDSP agreed to hold its next plenary meeting on 16 and 17 November 2004 in Strasbourg.

    Appendix 1

    DRAFT AGENDA

    1. OPENING OF THE MEETING

    2. ADOPTION OF THE AGENDA

    3. REPORT OF THE BUREAU

    4. ELECTION OF A NEW CHAIRPERSON AND OF NEW MEMBERS OF THE BUREAU

    5. DECISIONS OF THE COMMITTEE OF MINISTERS

    5.1 Report of the 54th meeting

    6. ACTIVITIES OF AND CO-OPERATION WITH OTHER INTERNATIONAL ORGANISATIONS

    6.1 European Commission, WHO (Europe) and the Federation of Red Cross and Red Crescent Societies

    6.2 Meeting of the Chief Medical Officers of the member states of the European Union

    6.3 6th Tripartite meeting (European Commission, WHO, Council of Europe)

    7. INTEGRATION OF THE ACTIVITIES OF THE PARTIAL AGREEMENT IN THE SOCIAL AND PUBLIC HEALTH FIELD INTO THE REGULAR PROGRAMME OF ACTIVITIES

    A. IMPLEMENTATION OF THE CURRENT WORK PROGRAMME

    8. EQUITY IN ACCESS TO HEALTH CARE AND HEALTH PROMOTION – PATIENT'S RIGHTS AND CITIZEN PARTICIPATION

    8.1 Revision of Article 11 of the Social Charter

    8.2 The impact of technologies on health care – the patient and internet

    8.3 The media and health

    8.4 Health services in a multicultural society

    8.5 Management of safety and quality in health care – prevention of adverse events in health care, a system approach

    8.6 Hospitals in transition: new balance between institutional and community care

    8.7 Transborder mobility of health professionals and its implications for functioning of health care systems

    8.8 Health Promotion and health education – the ENHPS

    8.9 Assistance activities

    9. AVAILABILITY OF AND ACCESS TO SAFE AND GOOD QUALITY IN HEALTH CARE SERVICES

    9.1 Blood Transfusion and Immunohaematology

    9.2 Preparation, use and quality assurance of blood components

    9.3 Cellular immune therapies – ways to provide safe products meeting high quality standards

    9.4 Organ transplantation

    9.5 Safety and quality assurance for organs, tissues and cells

    9.6 Assistance activities

    B. FUTURE PROGRAMME AND METHODS OF WORK

    10. INTERGOVERNMENTAL PROGRAMME OF ACTIVITIES FOR 2004 AND FOR 2005/2006

    11. ASSISTANCE PROGRAMME OF ACTIVITIES FOR 2004
    CO-OPERATION WITH THE COUNCIL OF EUROPE DEVELOPMENT BANK

    12. WORKING METHODS

    C. INFORMATION

    13. THE NETHERLANDS CHAIRMANSHIP OF THE COMMITTEE OF MINISTERS OF THE COUNCIL OF EUROPE – HEALTH RELATED INITIATIVES

    D. MISCELLANEOUS

    14. OTHER BUSINESS

    15. DATE AND PLACE OF THE NEXT MEETING

    Appendix 2

    Recommendation Rec(2004)…
    of the Committee of Ministers to member states on the impact of information technologies on
    health care – The patient and Internet

    (Adopted by the Committee of Ministers on …… 2004
    at the… 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 inter alia by the adoption of common rules in the health field;

    Recalling the commitment of member states to the fundamental right to freedom of expression and information as guaranteed by Article 10 of the Convention for the Protection of Human Rights and Fundamental Freedoms;

    Recalling that Article 2 of the Convention on Human Rights and Biomedicine establishes the primacy of the human being: "The interests and welfare of the human being shall prevail over the sole interest of society or science";

    Recalling that Article 3 of the Convention on Human Rights and Biomedicine requires that contracting parties provide equitable access to health care of appropriate quality; Article 4 requests that any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards; and Article 10 establishes the right of everyone to know any information collected about his or her health;

    Recalling the Convention on Information and Legal Co-operation concerning "Information Society Services", setting up a legal information and co-operation system in the area of new communication services and extending the application of Directive 98/48/EC beyond the borders of the European Union;

    Referring to the Declaration and Action Plan of the 2nd Summit of Heads of State and Government of the Council of Europe of 11 October 1997, where the heads of state and government resolved to develop a European policy for the application of the new information technologies;

    Convinced that new communication and information technologies will offer new opportunities for access to health information, education, communication and health-related services;

    Convinced that the use of new communication and information services will enable the participation of citizens in health matters, communication between individuals and health professionals, as well as the provision of health-related services;

    Recalling in this context Recommendation No. R (99) 14 of the Committee of Ministers to member states on universal community service concerning new communication and information services;

    Recognising the possible negative effects of the information society and aware that the technology should be used to lessen its own ill-effects;

    Recalling in this respect the Convention on Cyber crime and Recommendation Rec(2001)8 on self-regulation concerning cyber content;

    Considering that the collection of medical data often raises special concerns with regard to data protection, with a need to especially monitor situations where data are to be collected or used for purposes other than immediate health benefits for the individual;

    Recalling in this respect Recommendation No. R (97) 5 of the Committee of Ministers to member states, on the protection of medical data;

    Recalling Recommendation No. R (99) 5 of the Committee of Ministers to member states for the protection of privacy on the Internet, which provides a model for codes of conduct for protection of personal medical data;

    Aware of the fact that many people in Europe do not have sufficient opportunities to access new communication and information services, and that the development of access at community level can be achieved more easily than at individual level;

    Aware of the social, economic and technical differences which exist at national, regional and local levels for the development of new communication and information services;

    Aware of the possible synergetic effects of co-operation between public authorities and the private sector for the benefit of users of new communication and information services;

    Aware of the vital importance of "design for all" of the new technologies, that are accessible to all, to cater not only for people with various disabilities, but for anyone of a generation that has not grown up with the Internet;

    Recalling in this respect the Resolution ResAP(2001)3 of the Partial Agreement in the Social and Public health Field "towards full citizenship of persons with disabilities through inclusive new technologies", aiming at preventing the new type of "digital social exclusion";

    Recognising the right of patients and citizens to be provided with and to have easy access to relevant information about their health and health care in a format and language they can understand;

    Having regard to Recommendation No. R (2000) 5 of the Committee of Ministers to member states, on the development of structures for citizen and patient participation in the decision-making process affecting health care;

    Considering that it is necessary for each member state to help to promote health knowledge and Internet competence across society and broaden the public's general knowledge about the potential and limitations of information technologies in health care;

    Recognising that empowering citizens through the Internet can revitalise representative democracy, enhance social cohesion, lead to the better functioning of the health care system, and establish a better balance of interests and a partnership between the various players in the system;

    Aware that there are currently no agreed standards of practice with respect to the use of the Internet by patients or for the provision of health care, and that therefore the quality of health information on the Internet and the use of the Internet in health care should be seen as areas of high priority for such development;

    Recognising that the Internet has created a global health information community which transcends national borders and raises issues for states that go beyond their jurisdiction for Internet matters, making them profoundly difficult to regulate;

    Aware that national circumstances differ and that individual member states are at different levels of development with respect to the implementation of the Internet, in health or other areas, and that member states will need to adopt appropriate measures adapted to their situation;

    Aware that creating supportive environments for the application of information technologies in health matters requires investment for all countries, regardless of their economic situation and differences regarding the development of the Internet,

    Recommends that the governments of member states:

    1. adopt, where necessary, policies, legislative and other measures necessary for developing a model framework for best practices regarding information technologies in health related matters; in particular:

    – by acknowledging the fundamental right of citizens to have access to information on health issues, and therefore ensuring that existing legislation and policies are conducive to this end;

    – by reviewing existing policies, legislation and practices that fundamentally restrict, control or hamper patient access to information and services via the Internet and other communications media;

    – by encouraging international organisations to develop a register of current legislation in all member states concerning national regulations with an impact on the Internet and patients or citizens;

    – by creating an accessible database with a view to identifying all such legislation and policies which might conflict with the accepted fundamental values and principles;

    – by ensuring that appropriate access to evidence-based practice on the use of the Internet for purposes of accessing information, enabling communication between patients and clinicians and delivery of health services, be reflected in the training of all health professionals.

    2. support and participate in preparing guidance tools for better practice of Internet users;

    – by ensuring that appropriate evidence-based guidance is developed on new information communication technologies, such as the Internet, and that such guidance is integrally linked with the existing body of knowledge on educational practice guidance;

    – by making educational tools available to developers of educational materials, courses and other learning opportunities, for patients, citizens, as well as health professionals;

    3. promote international co-operation between organisations, research institutions and other agencies that are active in the health and Internet field in order to:

    – develop international and collaborative arrangements to define and develop appropriate ways to exploit the Internet for optimal use by patients and citizens, including, but not limited to:

    - quality of information provision;
    - accreditation of health information services and providers;
    - promoting the use of high quality legal standards in the cross-border exchange of health information between clinicians and patients;
    - confidentiality, legal jurisdiction, fraud and misrepresentation by providers of information and services, and redress;

    – allow the relevant organisations to review existing regulations, to ensure their compatibility with the Internet environment in respect of cross-border matters;

    – avoid and solve potential conflicts between existing data protection laws and the freedom for patients to access health information and services in a cross-border environment;

    – ensure better protection of human rights and ethical principles of the Council of Europe;

    4. foresee a periodical reassessment of this recommendation in light of the technological advances of the Internet and other existing and emergent information and communication technologies. Issues of the quality of health information and services, legal jurisdiction; and compatibility with existing Council of Europe documents and those of other bodies should be addressed.

    5. take to this end, whenever feasible, the measures presented in the appendix to this recommendation. taking account of their respective national circumstances;

    6. disseminate widely this recommendation and its appendix, where necessary accompanied by a translation;

    7. bring these texts in particular to the attention of health authorities, the new communication and information industries and medical end-users, targeting the patient groups.

    Appendix to Recommendation Rec(2004)…

    I. GENERAL CONSIDERATIONS

    1. The use of information technology in health care is of enormous potential to all citizens in improving information, communication and services supplied via Internet. However, the advantages and disadvantages of the Internet should be made clear to the patients-users and/or their carers. Governments should promote information about the fact that the Internet itself does not produce any new medical evidence or guarantee quality. The expectations of the benefits of new technologies should be mitigated by the latency period between the development and actual availability of new measures.

    2. Governments and medical authorities should be aware of the limitations of the Internet as a source of information. Failure to make known these limitations is unethical and infringes the autonomy of the individual.

    3. The responsibility is becoming increasingly shared, with health professionals maintaining their responsibility, but patients taking on more responsibility for the choice of means, and of personal responsibility through self-care and self-management.

    4. The focus of this recommendation is not only on patients, but also on all possible users, called "end-users" to avoid the more limiting connotation of the word "patient".

    5. Taking a patient-oriented perspective, the three areas of end-user needs have been identified: 1. information, 2. communication and 3. services.

    6. The field of information technology develops so quickly that the periodical reassessment and revision of this recommendation should be foreseen.

    II. GUIDING PRINCIPLES

    1. Government policy should be based on values propounded by the Council of Europe: human rights and patients' rights, human dignity, social cohesion, democracy, equity, solidarity, equal gender opportunity, participation, freedom of choice – balanced by the obligation to help strengthen one's own health.

    2. The state cannot be solely responsible for the Internet, since the Internet is unique in its forms of global governance, and operation, yet often falls within the jurisdiction of countries in virtue of the breadth of its applications. A shared approach to its development by all areas of society is necessary. This ensures that fundamental tenets of democratic society extend to the Internet and its applications

    3. Governments should recognise that utilisation of the Internet is part of the fundamental freedom of choice people have in seeking information, communications and services in health.

    4. Governments should promote public awareness of tools promoting quality, including systems for accrediting health information providers.

    5. Governments should not apply an "Internet exceptionalism" approach; treating Internet as something fundamentally different, requiring new rules. It would just create barriers to the integration of the Internet into society.

    6. Governments should ensure that regulations and laws are technology-neutral, to ensure that the legislative purpose is not invalidated by future technological innovations.

    7. Health information should be in principle neither restricted nor censored. Some restrictions may be justified, for example when regulating Web advertising. However, concern about the quality of health information should be made a priority.

    8. Correspondence between patients and health professionals should in all instances remain private and protected.

    9. Individual member states should choose how and in what way to organise their health services to make use of the Internet.

    10. Health policies are founded on the principle of universal access to health services and generally embrace active efforts to bridge social divides. The adoption of the Internet as a tool for health policy implementation is compatible with this approach.

    III. ACCESS TO THE INTERNET

    1. Member states should ensure low cost access to the Internet for all citizens, as part of the programme e-Europe 2005: An Information Society For All. It would serve also the health purposes and should improve the availability of modern information technology.

    2. Governments should identify critical gaps and barriers in access to the Internet for all, particularly to health-related Internet services: legal, social, economic, cultural, administrative and/or physical barriers. Measures and programmes should be implemented in order to reduce these obstacles, which often increase inequalities.

    3. Member states should take into account the needs of particular groups of citizens and patients.

    4. Member states should study the feasibility of developing ways to monitor the health impact of access to health information through Internet, in particular on emancipating patients, reinforcing their own responsibility and improving interaction with care providers.

    5. Governments should base their Internet access policy on the following principles: universality, recognition of borderless health services, technological neutrality and security.

    IV. IMPACT OF THE INTERNET ON CONFIDENTIALITY AND RESPONSIBILITY IN THE MEDICAL SETTINGS

    1. The services provided on the Internet could complement and enhance the traditional relationship between carers and the patient as well as the traditional model of consultation. In specific situations, they may replace traditional relationships only if potential shortcomings of online services could be neutralised by additional measures.

    2. The measures to protect confidentiality and privacy should guarantee the right of citizens to self-determination and therefore provide a legal basis for data processing on the grounds of consent, contract or law. The influence of the free access of patients to electronic health records should be considered.

    3. Individuals should not have to identify themselves except when it is important that their identity be known, e.g. to receive a health service or for medico-legal or reimbursement purposes. However, there are cases where anonymity might not be advisable, for example when communicating personal health data.

    4. Providers of information, communication and health services should under all circumstances be identifiable, including the final owner or provider.

    5. Internet care providers should be traceable and identifiable, so that security techniques, privacy policy and the identity of the individual in contact are known.

    6. National governments and industry should establish nationally acceptable systems to enable the individual's personal privacy and security, in particular by encouraging the widespread availability of digital signatures and digital identities, with suitably secure communications.

    7. Member states should promote the establishment of an authority or a committee, when not yet established or where necessary, which will be responsible for the development and updating of privacy and security standards.

    V. IMPACT ON HUMAN RIGHTS AND DEMOCRACY

    1. Member states should study the best ways of using the potential of the Internet to improve the health of the population by facilitating access to education and information on health related issues.

    2. Governments should take advantage of the important capacity of the Internet to facilitate and strengthen the position of citizens and patient in the shaping of health care policies.

    3. They should also encourage informed public debate between patients and citizens or services that use health information, in order to reach a consensus.

    VI. IMPACT ON HEALTH PROMOTION

    Internet should be used to improve the health of the population by facilitating access to education and information on health related issues and achieving effective participation on the empowerment of people and communities.

    VII. IMPACT ON QUALITY OF INFORMATION

    1. A key challenge for governments is finding ways to enable consumers and health professionals to tell the difference between good and bad quality information. For that purpose, efforts are needed to create a trustworthy Internet environment for all users.

    2. Properly regulated health information Internet sites, with suitable rules regarding identity of provider of information and provenance, should enable citizens, consumers, patients, and individuals generally to make up their own minds.

    3. Self-regulation and the use of ethical codes should be promoted by governments and the relevant authorities. In this respect the accepted criteria of transparency and honesty, authority, privacy and data protection, updating of information, accountability and accessibility should be taken into account.

    4. At a minimum, all Internet sites, whether providing information, communications or services should make explicit the following information:

    – authorship of the content and who owns the site content;

    – attribution of the content with specific information on who did the work;

    – disclosure of what information is gathered and for what purposes the personal data are used, as well as whether they share that information and if so, with whom;

    – disclosure of conflicts of interest, including any statements on the impartiality of the information. that includes sponsoring and hosting by third parties;

    – the date of the content is provided or the date of latest revision, including references to sources providing additional authenticity.

    5. Providers of information should be required to provide sufficient information to the public to permit identification of the sources of information, any intermediaries, and any other factors, which can offer evidence of the quality of the information. They must explicitly seek visitors' informed consent for specific data-gathering and data-sharing activities.

    6. Governments should assess what quality-control system for providers of information is most appropriate for their circumstances. Governments should not necessarily undertake this role, but only ensure that a quality-control system exists. They should use existing regulations to establish quality standards for health information on Internet.

    VIII. IMPACT ON THE CURRICULA FOR HEALTH PROFESSIONALS

    1. Governments should offer support to health professionals to embrace the potential opportunities of the Internet to improve their competence and to understand the nature of new roles and relationships with patients and citizens.

    2. Governments should facilitate the introduction of the use of information technologies to health care providers and teaching institutions, and to reform curricula appropriately.

    3. Health professionals need to learn more about confidentiality and privacy over the Internet and the impact that patient management of the clinical encounter will have on their practice patterns.

    IX. MEASURES TO DERIVE MAXIMAL BENEFIT FROM THE INTERNET

    1. The key areas of benefit for patients, for the public at large are:

    – supporting public education on media and individual health and for health promotion purposes;

    – creating a culture of high quality health information which could extend to other non-Internet media such as books, magazines, television and radio;

    – helping individuals and groups to organise themselves:

    into advocacy coalitions around health issues,
    to share experiences of care as well as information,
    to participate in civil society and health policy and planning,
    to allow third parties to offer intermediary services to individuals to support them, as "trusted third-parties" and ”trusted health intermediaries”.

    2. There are also benefits to health systems, which should also be exploited:

    – appropriate telecommunications tariffs to ensure universal access to health information, communications and services to bridge social exclusion and the digital divide;

    – wider exploitation of new and emerging technologies that are in the public interest in the area of health, and a more rapid progression from the pilot projects of tele-health to its full scale implementation, as to the basis of a national information society, health policy and commercial strategy;

    – the use of the Internet in helping health service providers realise productivity gains from new technologies.

    3. Governments should identify ways to monitor the development of the application of the Internet in health and the related experiences, attitudes and behaviour of citizens and patients (medical end-users).

    4. Member states should consider establishing a standing committee on cross-border health (an observatory on international health and new technologies), to develop advice and policy guidelines for member states, and the development of appropriate regulation. This committee/observatory should help all member states develop appropriate guidance to cover a wide range of cross-border issues, including, but not limited to:

    – cross-border trade in health goods and services, such as medicines, digital telemetry and remote monitoring, including cross-border flow of health data (health records);

    – cross-border access to health information and internationally recognised standards for quality;

    – cross-border health communities and patients' groups;

    – cross-border flow of health data (telemetry) and information (health records);

    – cross-border education;

    – cross-border monitoring of health outcomes and health service production indicators.

    X. BEST PRACTICES

    1. Each government should decide upon the extent of information linkages, which will be considered legal and should establish the corresponding legal framework. Subject to the available technology, this framework should be enforceable.

    2. Patients' organisations and NGOs should be encouraged to play an active role in the evaluation, the regulation and the accreditation of health information available through the Internet.

    3. Governments should take all precautionary measures so that the rights of the patients are protected and respected, as in the traditional medical setting.

    4. Member states should facilitate exchange of information regarding the types of fraud existing, the incidents reported and the policies, which has proved to be useful in similar cases.

    5. Governments and health providers should ensure that they use information technologies as a way of reaching out to the public for consultation on important issues, in an active and committed manner.

    6. Patients and consumers should be able to benefit from the use of the Internet when interacting with health providers, by being able to access health records, make payments, make appointments, or order medical products.

    7. Public education is necessary to ensure that people feel they understand and are capable of participating fully. It is up to educational institutions (from primary school to university and beyond) and patients' groups, to help them set up support and communications programmes. Encouragement could range from favourable tax breaks for innovative non-profit services, to grants to institutions to enable public education programmes.

    8. Third parties should be able to offer intermediary services to individuals to support them. The Internet has created the notion of “trusted third-parties” to ensure reliability in transactions between parties. The evolution of some into "trusted health intermediaries" may be appropriate and compatible with efforts to encourage individuals to use services, even if they do not do so directly themselves.

    XI. ROLE OF DIFFERENT ACTORS

    1. Government

    Governments need to learn how to participate in this environment in a manner which is compatible with the innovative and accessible characteristics of the Internet.

    Governments should promote specific development of the Internet and health by:

    – encouraging co-operation between institutions, whether public or private;

    – encouraging diversity in the provision of telecommunications services, including appropriately liberalised tariff structures to favour access and use to overcome potential social exclusion;

    – promoting policies and procedures which are conducive to the development of health services, improve access, and enable uptake of services;

    – promoting policies for good Internet use across the economy (public, private, voluntary sectors, individuals, patients) and which serve to enhance public knowledge through appropriate education in the use of the Internet;

    – promoting policies to encourage pro-active development of health innovations through the Internet to benefit patients and citizens in the three priority areas of information, communications and services;

    – protecting end-users from fraud, unethical or harmful practices, for example by:

    applying legislation on consumer rights to the Internet,
    applying legislation on patients' rights and data privacy to Internet transactions,
    applying legislation on professional misconduct, illicit practices and quackery to providers of services in Internet,
    applying legislation on drug sales to Internet.

    2. Patients and citizens as end-users

    Individuals using the Internet should:

    – exercise normal vigilance when accessing health information over the Internet to ensure that they are accessing information that is trustworthy;

    – ensure they are informed consumers of health information and services.

    3. Institutional health providers

    Institutional health providers should:

    – adopt models of service delivery over the Internet which are patient-centred;

    – offer meaningful services, access to reliable information, and enable effective communications, including bringing more telehealth services into mainstream service;

    – consider how the Internet can be a tool for rational service planning;

    – adopt policies and evidence-based practices which actively reward or encourage innovations in the use of the Internet for health service delivery.

    4. Health professionals

    Health professionals should:

    – be consumers informed of the Internet's potential to improve patient care, through access to reliable information, the offering of significant and substantial services and communications.

    – be encouraged to develop entrepreneurial solutions to telehealth opportunities and be given the freedoms necessary to establish responsible organisations for the delivery of evidence-based telehealth services.

    XII. RESEARCH AREAS

    Research programmes should address the following issues:

    – the needs of individual patients and citizens, through surveys and systematic study;

    – the role of patient advocacy groups, and that of non-governmental bodies generally in health;

    – the role of telecommunications companies and communications policies;

    – the responsiveness of health professionals and health service providers to innovation and change;

    – the role of the health economy more widely;

    – the impact of the explosive growth in mobile telecommunication and its use in health care, health and new media (Internet, digital television, mobile telephones in particular);

    – behaviour of patients and their use of new technologies;

    – the scientific evidence on the effects of telehealth services.

    Appendix 3

    Recommendation Rec(2004)…
    of the Committee of Ministers to member states on teaching transfusion medicine to nurses

    (Adopted by the Committee of Ministers on …… 2004
    at the… 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 inter alia by the adoption of common action in the health field;

    Taking into account Resolution (78) 29 on harmonisation of legislation of member states relating to removal, grafting and transplantation of human substances;

    Recalling also its Recommendations Nos. R (80) 5 concerning blood products for the treatment of haemophiliacs, R (81) 14 on preventing the transmission of infectious diseases in the international transfer of blood, its components and derivatives, R (84) 6 on the prevention of the transmission of malaria by blood transfusion, R (85) 12 on the screening of blood donors for the presence of AIDS markers, R (86) 6 on guidelines for the preparation, quality control and use of fresh frozen plasma (FFP), R (88) 4 on the responsibilities of health authorities in the field of blood transfusion, R (95) 14 on the protection of the health of donors and recipients in the area of blood transfusion, R (95) 15 on the preparation, use and quality assurance of blood components, R (96) 11 on documentation and record-keeping to guarantee the traceability of blood and blood products especially in hospital, and Rec(2002)11 on the hospital's and clinician's role in the optimal use of blood and blood products;

    Considering:

    – the importance of blood components in modern haemotherapy and the need to ensure their safety, efficacy and quality;
    – that such components are of human origin and that hence specific ethical and technical principles have to be taken into account;
    – that biotechnology does not provide substitutes for most blood products;
    – the need to provide health authorities, transfusion services, hospital blood banks and clinical users with a set of guidelines for the preparation, use and quality assurance of blood components;
    – that the safety of blood transfusions (which must be prescribed by doctors) depends largely on the nursing staff involved in transfusions in hospital or at home, or working in blood establishments or in other specialised fields such as autologous blood transfusion and bone marrow transplantation;
    – that the majority of serious adverse reactions and untoward events associated with blood transfusion which can result in serious morbidity or mortality are caused by human and system errors in the whole blood transfusion chain;
    – that such complications can be avoided or reduced by the application of safety measures before and during transfusion;
    – that adequate training of nurses is a key determinant for ensuring the safety, efficacy, and quality of blood transfusions,

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

    1. all nurses receive training in blood transfusion;

    2. only nurses who have been trained and have specific qualifications in blood transfusion medicine are allowed to practice it;

    3. nurse training curricula reflect the requirements of modern transfusion medicine and other specialised fields of medicine such as oncological and haematological disorders, surgical procedures, autologous donation of blood, as well as bone marrow and organ transplantation;

    4. implementation and evaluation of continuous training programmes is carried out in order to improve the quality and safety of blood transfusion;

    5. mechanisms are developed for the co-operation between nurses, physicians, and other health care workers employed in hospitals, blood establishments, and hospital blood banks;

    6. procedures are set up to monitor knowledge of key processes, such as clinical audit, with ongoing feedback and implementation of remedial action, to ensure continuous improvement in performance;

    7. guidelines and procedural protocols on blood transfusion medicine for the nursing staff and other professionals are developed in accordance with relevant Council of Europe recommendations.

    TEACHING TRANSFUSION MEDICINE TO NURSES

    Explanatory Memorandum

    Α. Introduction

    1. To improve quality and safety in blood transfusion medicine in European countries, harmonization of blood transfusion practices is required.

    2. Recent reports on risk assessment in blood transfusion demonstrate that more than 30% of serious adverse reactions and untoward events associated with blood transfusion are due to human errors and system errors in the blood transfusion chain (vein-to-vein). These can be fatal or cause major or minor morbidity to the transfused patient.

    3. Most errors occur in blood sampling from the patient, in prescriptions of blood components, in the laboratory of the blood establishment or blood services, during collection of donor blood and in the ward where the blood components are administered.

    4. Haemovigilance systems stress that complications of blood transfusion can be avoided or reduced by the application of safety measures before, during, and after transfusion.

    5. Blood transfusion safety depends largely on the nursing staff (while the doctors are responsible for prescribing) involved in the transfusion of patients in hospitals or at home, and also on nurses working in many areas: pre- and post-donation counseling procedures in the donor sessions, in blood collection, in the processing, testing, storage and distribution of blood components. Nurses are also actively involved in autologous blood transfusion, as well as in other specialized fields such as bone marrow transplantation, collection, processing, storage and distribution of stem cells, and in organ transplantation.

    6. Reports from Europe, the USA and elsewhere on evidence–based practice in the field of blood transfusion stress that inadequate training of nurses is a key determinant of poor transfusion-related knowledge and practice of transfusion safety procedures.

    7. Within Europe, there is a wide range of nurses' responsibilities with respect to clinical and laboratory blood transfusion and therefore in the duties and actions they are allowed to undertake.

    8. Similarly, the curriculum for nurses' education differs considerably between countries and between the various grades of the profession.

    9. Therefore, there is a need to determine common basic principles for pre- and postgraduate education of nurses in both the clinical setting and in the blood transfusion establishment and to define a common basis for good transfusion practice.

    10. All nurses should receive education in blood transfusion. Only nurses who have been specifically trained and assessed as competent in BT medicine should be allowed to practice it, in cooperation with physicians and other health professionals and within the context of a training programme on new developments of this field.

    11. Procedural guidelines for the nursing staff and other professionals working in the clinical and the laboratory setting of blood transfusion medicine should be developed in compliance with the “Guide to the preparation, use and quality assurance of blood and blood components” and other recommendations of the Council of Europe on blood transfusion, to meet national and local requirements and with the aim of ensuring safety in transfusion.

    B. Current situation

    Grades of the nursing profession and training in blood transfusion medicine

    Within Europe, most nurses receive pre-registration training in college or university level nursing schools. Two to four years' training in the various disciplines of nursing contains a variety of curricula in basic blood transfusion, clinical indications and optimal use of blood products in medical conditions and in surgery.

    Postgraduate training to promote quality and safety in blood transfusion is usually organized by scientific societies and locally by academic or national health system institutions. Selection criteria, location of training, selection procedure, and conditions of service of nurses undergoing training, and the structure of the training programme (hours, topics, diploma etc), all vary. The responsibilities and duties of nurses in blood transfusion establishments and in hospital blood banks vary both between countries and within a country. In several European countries with established quality systems in blood transfusion, nursing staff receive accreditation for competence in the areas of their responsibility in conjunction with participation in continuous training in the field. A six-month in-training course in a Regional Blood Transfusion Centre is mandatory in Greece for all nurses and technicians working in a hospital blood bank. In several central and eastern European countries, nurses are involved in compatibility testing and other laboratory activities, as well as in blood sessions, pre- and post-donation counselling procedures, and in the organization of programmes for the recruitment of voluntary blood donors.

    In the USA, major challenges for the nurse with regard to complications, treatment and resulting nursing care arise in working with immunocompromised and oncology patients, as well as in preparing patients for bone marrow transplantation. A survey of the procedures performed by critical care nurses showed that those performed by the greatest number related to blood component transfusion, and that critical care nurses frequently performed some of these procedures with little or no supervision by a physician.

    In Belgium, a national study assessing blood transfusion practice has concluded that transfusion should be improved by better education of all physicians and nurses involved with transfusion and by improving standardization by better documentation, better reporting and better information to all health care workers involved.

    Factors associated with nurses' poor knowledge and practice in blood transfusion in hospitalised care in France were analyzed in relation to reflecting potential danger and life threat to the patients.

    Alarming data from SHOT in the United Kingdom put emphasis on the crucial steps in safe transfusion practice, i.e., patient and pre-transfusion checks, asepsis and apparatus, checking and clerical procedures, keeping vigilant and keeping accurate records. A set of guidelines for checking procedures and potentially adverse signs and symptoms have been drawn up in order to alert registered nurses to safe transfusion practice.

    The Council of Europe in the “Guide to the preparation, use and quality assurance of blood and blood components” recommends that before and during transfusion the following measures should be applied:

    Pre–Transfusion:*

    1. Compatibility of identification of patient at blood sampling. The identification system should link the patient identification, the operator, the blood sample through processing, the blood product and should confirm the original patient identification at the time of blood administration. Emphasis must be placed on error recognition;
    2. Blood group serological investigation including blood typing, antibody screening and compatibility testing before transfusion of red cell products. The normal procedure shall be to make the investigation in due time before expected transfusion.
    3. Preparation/ handling of frozen components

    During and after transfusion: (

    1. Safety measures including identification of patient and blood unit and verification of compatibility between patient and blood unit;
    2. Clinical surveillance during and after transfusion to include careful observation of the patient, especially in the early stages of the transfusion where significant transfusion reactions are more likely to occur and in the transfusion of any component prepared by an open system;
    3. Controlled warming of blood;
    4. Avoidance of addition of medical products or infusion solutions in blood components;
    5. Handling of frozen units;
    6. Vigilance for the risk of air embolism and transfusion complication either in direct relation to the transfusion or with a delay of hours or days.

    C. Elements of nurses' training curricula

    Restructuring the pre and post-registration nurses' education curricula, and evaluating and monitoring good transfusion practice of nurses both within the blood establishment and in the hospitals should be considered by the national authorities of the member states. For this purpose, cooperation between the health authorities, nursing schools and academic institutions is required. Information from international bodies and several European countries suggests the inclusion of the following elements in nurses' basic, pre and post-registration education curricula.

    Basic Education:

    1. Physiology of blood and its functions;
    2. The concepts of blood component therapy;
    3. The principles of blood transfusion;
    4. Documentation and record-keeping.

    Pre-registration education:

    General principles of:

    1. Physiology of blood and its functions;
    2. The concepts of blood component therapy;
    3. History of blood transfusion;
    4. Organization aspects of blood transfusion;
    5. Blood components (red cells, platelets, plasma);
    6. Plasma products (albumin, immunoglobulins, clotting factors, etc.);
    7. Blood group serology and basics of red cell compatibility;
    8. The principles of blood transfusion and alternatives to the use of donor blood;
    9. Pre-transfusion and transfusion procedures;
    10. Phlebotomy and blood sampling for cross-match. Detailed procedures for patient identification. Introducing systems that allow error detection. One identification system that links patient, sample and blood product and confirms patient ID at the time of blood administration;
    11. Basic knowledge of transfusion triggers;
    12. Administering blood components and blood products, including special precautions for patients with heart disease, elderly, newborns. Special considerations in massive transfusion;
    13. Shelf life of blood components;
    14. Blood administration sets and equipment;
    15. Patient care and observation during transfusion. Checking of relevant vital signs and their documentation;
    16. Infections transmissible by transfusion;
    17. Adverse effects of transfusion: recognize symptoms of adverse reactions and initiate standard immediate action if transfusion reaction is suspected;
    18. Haematological disorders;
    19. Management of haemophilia and coagulopathies;
    20. Acquired haemostatic disorders and Disseminated Intravascular Coagulation;
    21. Haemolytic disease of the newborn;
    22. Documentation and records.

    Two independent stages in post registration training are proposed: donor nursing and transfusion nursing.

    Post-registration education:

    This education can be divided into two stages:

    I. Certification in donor nursing: for nurses working in blood establishments

    1. Procedures to select donors;
    2. Detailed procedures for donor identification;
    3. Procedures to an aseptic blood collection;
    4. The importance of the labelling in transfusion chain;
    5. Shelf life of blood components;
    6. Sets and equipments utilised in blood establishments to collect, processing, and analyse blood;
    7. Blood components processing techniques;
    8. Haemapheresis techniques;
    9. Autologous transfusion techniques, with special relevance for pre deposit autologous transfusion;
    10. Storage conditions of blood components;
    11. Transportation conditions of blood components;
    12. Fundamentals of leukocytes reduction, irradiation, and cryopreservation;
    13. Cryopreservation techniques;
    14. Infections transmissible by transfusion, including bacterial contamination;
    15. Adverse reactions or events in blood donor;
    16. Accidents or incidents during blood collection, processing and storage;
    17. Blood inventory management concepts;

    18. General concepts of the optimal use of blood components;
    19. General concepts of major pathologies using blood transfusion (acute anaemia, chronic anaemia, hereditary haemolytic anaemia, coagulopathies, bone marrow and organ transplantation, etc);
    20. Haemovigilance concepts;
    22. Quality Systems concepts;
    23. Documentation and records.

    II. Certification in transfusion nursing: for nurses working in blood bank hospitals, wards, anaesthesiology and intensive care units:

    1. General concepts of the optimal use of blood components;
    2. General concepts of major pathologies using blood transfusion (acute anaemia, chronic anaemia, hereditary haemolytic anaemia, coagulopathies, haematological diseases, bone marrow and organ transplantation, etc);
    3. Blood utilization management concepts;
    4. Transfusion sets;
    5. Administration of blood components: measures and cares pre, during and posttransfusion;
    6. Procedures to identify a patient:
    a. to collect a blood sample to pre transfusion testing
    b. to transfuse a blood component;
    7. Procedures to detect errors in transfusion chain;
    8. Pre transfusion testing;
    9. Accidents or incidents pre or during transfusion;
    10. Blood components: types and clinical indications;
    11. Transfusion support in: obstetrics, paediatrics, surgery, and intensive care units;
    12. Transfusion in chronic anaemia (oncology patients, hereditary haemolytic anaemia, etc);
    13. Transfusion in acute anaemia (emergency, major bleeding);
    14. Transfusion in bone marrow and solid organ transplantation;
    15. Transfusion in special cases, like Disseminated Intravascular Coagulation, massive transfusion, etc;
    16. Precaution measures in patients with heart disease, immune haemolytic anaemia, newborn, elderly;
    17. Management of haemophiliac patients or others congenital coagulopathies;
    18. Emergencies and disasters;
    19. Adverse reaction or events in transfused patients;
    20. Near misses;
    21. Alternatives to blood transfusion;
    22. Autologous transfusion techniques;
    23. Storage and distribution of blood components;
    24. Infections transmissible by transfusion, including bacterial contamination;
    25. Ambulatory transfusion;
    26. General concepts of collection, processing, and analysis of blood components;
    27. Fundamentals of leukocytes reduction, irradiation, and cryopreservation;
    28. Haemovigilance concept;
    29. Recognition and participation in the management of abnormal reactions after transfusion including “near misses”;
    30. Quality System concept;
    31. Documentation and records;
    32. The role of the nurse in hospital blood transfusion committee.

    The following section applies if an investigation of training and responsibilities of nurses is intended:

    Working methods

    1. Determine the spectrum of duties of nurses during blood transfusion, in the clinical setting as well as in the blood collection establishment, in all member states.

    2. Assess the pre- and postgraduate training of nurses in blood transfusion in all member states by questionnaire addressed to national representatives who should obtain the relevant information from the health authorities and nursing institutes in cooperation with hospital senior nurses and academic nurses.

    3. Determine the differences in training due to differences in responsibilities.

    4. Determine common basic principles for good transfusion practice for nurses.

    5. Determine common basic principles for training in pre-registration and during practice for nurses.

    6. Investigate information available on the curricula recommended by international organizations.

    Working materials

    Inquiry by questionnaire:

    1. To Ministry of Health: number of nurses in the clinical setting – number of hospitals where transfusion occurs – number of blood components transfused – number of patients transfused – organization of blood transfusion – number of nurses in the blood establishments.

    2. To Ministry of Education or Ministry of Health (as appropriate): official curriculum for basic transfusion medicine training for nurses – official curriculum for transfusion medicine training for nurses in blood establishments – number of nursing schools – number of nursing students.

    Assessment of national data and results from the inquiry.

    Conclusion

    To increase efficiency in blood transfusion medicine, physicians and nurses and other health workers who handle blood or blood components should collaborate on development, evaluation and implementation. Documentation regarding transfusions needs to be simplified and coordinated. Knowledgeable staff is an essential element of safe systems. Basic knowledge should never be assumed: mechanisms to monitor knowledge of key processes along with ongoing feedback and remedial action are necessary to maximize performance. Nurse training curricula and formats at all levels must reflect the requirements of modern transfusion medicine from novice to expert. Working together, nursing and transfusion specialists will improve quality and safety in blood transfusion services.

    The Council of Europe's Recommendation could contribute to the adoption and implementation of training programmes at a national level.

    Selected Bibliography

    1. Council of Europe Recommendation No. R (88) 4 On the responsibilities of health authorities in the field of blood transfusion.
    2. Council of Europe Recommendation No. R (95) 15, “Guide to the preparation, use and quality assurance of blood components” 10th Edition, 2004.
    3. Council Europe Recommendation No. R (99) 14, On the protection of the health of donors and recipients in the area of blood transfusion.
    4. Council Europe Recommendation No. R (11) 2002 On the role of the hospital and the clinician in the optimal use of blood and blood components.
    5. European Union Directive on Blood Safety, 2002/98/EC.
    6. European Union directives on education for nurses and midwives (e.g. Directives 89/48/EEC, 92/51/EEC, 85/384/EEC, 93/16/EEC, proposal COM_COM(2002)0119, etc.)
    7. Serious Hazards of Transfusion (SHOT). Summary of annual report 1998-99.

    8. Devine P., McClure PL. Quality assurance of hospital transfusion practices : the role of nursing staff. QRB Qual Rev Bull 1988 Aug; 14 (8): 250-3.
    9. Glover G., Powell F.(1996) Blood transfusion. Nurs Stand 10 (21): 49-54.
    10. Mancini ME. Performance improvement in transfusion medicine. What did nurses need and want! Arch Pathol Lab Med 1999 Jun; 123 (6): 496-502.
    11. Saillour-Glenisson F., Tricaud S., Mathoulin-Pelissier S., Bouchou B., Galperine I., Fialon P., Salmi LP. Factors associated with nurses' poor knowledge and practice of transfusion safety, procedures in Aquitaine, France. Int J Qual Health Care 2002 Feb; 14 (1): 25-32.
    12. Jamieson EM., McCall JM., Blythe R., Whyte LA. (1997) Clinical Nursing Practices. Churchill Livingstone, Edinburgh.
    13. Murphy NF (1998) Haematological disease. In: Parveen K., Clark M. eds. Clinical Medicine. 4th edn. WB Saunders, Edinburgh: 353-414.
    14. Martyn Bradbury, Jeremy P Cruickshank. Blood transfusion: crucial steps in maintaining safe practice. British Journal of Nursing, 2000, 9 (3).
    15. Bayraktar N., Erdil F. Blood transfusion knowledge and practice among nurses in Turkey. J Intraven Nurs 2000 Sep-Oct; 23(5): 310-7.
    16. Reger TB., Roditski D. Bloodless medicine and surgery for patients having cardiac surgery. Crit Care Nurse 2001 Aug; 21 (4): 35-44.
    17. Benson K., Popovsky MA., Hines D., Hume H., Oberman HA., Glassma AB., Pisciotto PT., Thurer RL., Stehling L., Anderson KC. Nationwide survey of home transfusion practices. Transfusion 1998 Jan; 38 (1): 90-6.
    18. Transport and storage of infusion supplies and blood products. Home Health Care Nurse 2001 Sep; 19 (9): 537-8.
    19. Clark P., Rennie I., Rawlinson S. Quality improvement report: Effect of a formal education programme on safety of transfusions. BMJ 2001 Nov 10; 323 (7321): 1118-20.
    20. Ingrand P., Surer-Pierres N., Houssay D., Salmi LR. Reliability of the pretransfusion bedside compatibility test: association with transfusion practice and training. Transfusion 1998 Nov-Dec; 38 (11-12): 1030-6.
    21. Follea G., Bigey F., Dreno J., Vives C., Cazenave JP. Staff certification for mobile blood collection units. Transfus Clin Biol 1998 Apr; 5(2): 112-22.
    22. Geier K. Perioperative blood management. Orthop Nurs 1998 Jan-Feb; 17 (1 Suppl):6-36.
    23. Murphy M.F., Wilkinson J., Lowe D., Pearson M. National audit of the blood transfusion process in the UK. Transfus Med 2001 Oct; 11(5):363-70.
    24. Walterova L. Overview of clinical indications and optimal use of blood components: role of the Hospital Transfusion Specialist and Transfusion Committee. ESTM course “The future of blood safety, a challenge for the whole Europe: how can international regulations be implemented all over”. Sarajevo, October 2001.

    Appendix 4

    Recommendation Rec(2004)…
    of the Committee of Ministers to member states on criteria for
    the authorisation of organ transplantation facilities

    (Adopted by the Committee of Ministers on …… 2004
    at the… 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 inter alia by the adoption of common action in the health field;

    Taking into account Resolution (78) 29 on harmonisation of legislation of member states relating to removal, grafting and transplantation of human substances, the final text of the 3rd Conference of European Health Ministers (Paris, 16-17 November 1987); Articles 19 and 20 of the Convention of Human Rights and Biomedicine, and Articles 3 and 4 of the Additional Protocol to the Convention on Human Rights and Biomedicine, on Transplantation of Organs and Tissues of Human Origin;

    Considering that:

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

    - organ exchange and circulation of recipients among member states is becoming a more frequent phenomenon, and that a minimum common standard should be guaranteed to the citizens;

    - member states should therefore provide high-quality transplant services for the benefit of their citizens. Considering the limited organ supply, all necessary steps should be taken to make sure all available organs are properly safeguarded and used so as to maximise the benefit to patients;

    - the highest professional standards are to be maintained in the area of organ transplantation,

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

    1. An appropriate mechanism for the authorisation1 of health care facilities carrying out organ transplantations2 should be set up. In order to obtain authorisation these facilities should meet the following criteria:

    – feasibility of programme, based on clinical need assessment and a documented estimate of organ supply, to ensure that projected activity levels are sufficient to maintain clinical expertise and programme quality;

    – standards of vocational training of team members, and infrastructural conditions relating to availability of beds, intensive care facilities, and diagnostic and therapeutic back-up services (radiology, microbiology, immunology services, etc.), and to care provided by nursing, physiotherapy, social services and related medical professionals.

    2. Medical professionals forming part of an organ transplant team should be properly qualified and their previous training in the field of transplantation should be documented and personalised.

    3. A quality-management system should be put in place to evaluate performance against established national and/or international standards as applicable, and to ensure the quality of the process of organ procurement and transplantation, following the principles described in the Council of Europe's Guide to safety and quality assurance for organs, tissues and cells.

    4. Authorisations should be regularly reviewed against agreed quality criteria and standards, as well as against audit results.

    5. Outcome results for each type of transplant should be within the margins of international registers, at an equivalent degree of complexity of patients. In order to guarantee clinical results and cost-effective performance, minimal yearly activity standards shall be established in order to maintain an active programme.

    6. These minimal activity standards, required to keep active each kind of transplant programme, should be related to the mean number of cadaveric organs available to the transplant team in recent years.

    7. Any transplant centre which, after several warnings, continues to fail to meet activity or outcome criteria may have its authorisation withdrawn.

    8. No new transplant centre may be authorised if there are not enough organs available to enable a new centre to reach the required standards.

    9. Any new transplant centre should be authorised, accredited or licensed on the basis of agreed criteria and initially should be limited in time. If, within an agreed timescale, the new centre does not achieve the required standards, authorisation shall be withdrawn.

    Appendix 5

    Specific terms of reference of the Committee of Experts on Blood Transfusion (SP-HM)

    1. Name of the Committee:

    Committee of Experts on Blood Transfusion (SP-HM)

    2. Type of Committee:

    Committee of Experts

    3. Source of Terms of Reference:

    European Health Committee (CDSP)

    4. Terms of Reference:

    Policy Activities

    With a view to shaping European policies, based on democratic and ethical principles, the SP-HM shall:

    a. examine the factors affecting the availability of blood and blood components;

    b. study ways to ensure fair access to blood and blood components in periods of blood shortage;

    c. consider ethical and human rights issues involved in ensuring safety, quality and health policy aspects of blood transfusion;

    d. evaluate the possible impact of new therapeutic and regulatory developments;

    e. promote safety and efficacy of blood transfusion at all levels of the blood transfusion chain from the donor to the recipient,

    f. examine the emergence of new transmissible diseases;

    g. promote continuous education and training in transfusion medicine at all levels

    h. follow the developments in the field of European self-sufficiency, in co-operation with the European Commission and other organisations;

    i. assist member states in the restructuring and improvement of their blood transfusion services.

    To carry out the above, the SP-HM should define a programme of work by identifying a limited number of subjects for short-term study, either by the Bureau of the SP-HM or by consultants. For each subject of study, terms of reference should be drafted, a calendar prepared and an outcome suggested.

    Service Activities

    a. Promote quality assurance with the latest developments including the up-dating of the technical Appendix to Recommendation No (95) 15 on the preparation, use and quality assurance of blood components.

    b. Ensure availability of rare blood products by means of the European Bank of Frozen Blood of Rare Groups according to Agreement 26 on the Exchange of therapeutic substances of human origin.

    5. Membership of the Committee:

    a. The governments of all member states are entitled to appoint one or two delegates among the experts and the Health authorities responsible for blood transfusion related activities.

    b. The following states or organisations may send representatives, without the right to vote or defrayal of expenses, to meetings of the Committee:

    Australia, Canada, Holy See, Israel, Japan, Mexico, New Zealand, United States of America, European Commission, World Health Organisation (WHO), International Society of Blood Transfusion (ISBT), International Federation of Red Cross and Red Crescent Societies, and Order of Malta.

    6. Working Structures and methods:

    a. One plenary spring meeting of two days every two years in Strasbourg or outside, to be decided by the Bureau and approved by the CDSP. The Council of Europe's budget bears travel and subsistence expenses for one delegate per member state. A Bureau consisting of 10 SP-HM delegates will meet one day before the plenary meeting and separately (autumn) for two days.

    Every other year the Bureau will meet in spring for half a day followed by a meeting of one day and a half, to which all SP-HM delegates will be invited at their own expense. The Bureau will meet separately in the autumn for two days.

    b. The tasks of the Bureau are the following:

    - monitor progress in the implementation of the programme of work,
    - deal with urgent questions and take the necessary decisions,
    - carry out relevant research work when appropriate,
    - prepare the relevant agenda, identify the preparatory work needed and possible follow-up.

    c. The Chairperson and the members of the Bureau will be elected for 2 years by the SP-HM plenary.

    d. The Bureau will meet in Strasbourg unless the choice of another place can be duly justified.

    7. Duration:

    These terms of reference expire on 31 December 2006

    Appendix 6

    Specific terms of reference of the Committee of Experts on Quality Assurance in Blood Transfusion Services (SP-GS)

    1. Name of Committee:

    Committee of Experts on Quality Assurance in Blood Transfusion Services (SP-GS)

    2. Type of Committee:

    Committee of Experts

    3. Source of Terms of Reference:

    European Health Committee (CDSP)

    4. Terms of Reference:

    i. Quality Assurance

    - to promote quality assurance with the latest developments including the up-dating of the technical Appendix to Recommendation (95) 15 on the preparation, use and quality assurance of blood components.

    ii. Transfusion transmitted diseases

    - review of their incidence and preventive measures, including the selection of donors.

    iii. Microbiological safety

    - in blood and blood components,
    - in the laboratory,
    - new methods, in particular, molecular biology.

    iv. Exchange of sera

    - to improve proficiency testing.

    The Committee will submit its report to the Committee of experts on blood transfusion (SP-HM).

    5. Membership of the Committee:

    a. The Council of Europe's budget bears travelling and subsistence expenses for one expert per state from:

    Belgium, Denmark, France, Germany, Hungary, Italy, Poland, Spain, Sweden, and United Kingdom.

    All other member states are invited to send one expert each at their own expense.

    b. Qualifications desirable in members: specialists in the fields covered by the terms of reference, working within the framework of a national and/or regional transfusion centre. Terms in office should not exceed three years, unless otherwise decided by the National Health Authorities.

    c. The following states or organisations may send representatives, without the right to vote or defrayal of expenses, to the meeting of the Committee:

    Australia, Canada, Holy See, Israel, Japan, Mexico, New Zealand, United States of America, European Commission, World Health Organisation (WHO), International Federation of Red Cross and Red Crescent Societies, International Society of Blood Transfusion (ISBT).

    6. Working Structures and Methods:

    One meeting of 4 days every year.

    7. Duration:

    These terms of reference expire on 31 December 2006.

    ( It may be helpful if nurses responsible for transfusion are provided with a checklist for each stage of the transfusion process to ensure each step is undertaken appropriately.

Note 1 For the purpose of this Recommendation, the term authorisation refers to any appropriate mechanism for designating, authorising, accrediting or licensing health care facilities carrying out organ transplantations.
Note 2 This Recommendation refers to the facilities where organs are being implanted.


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