Levels of quality management of blood transfusion services in Europe

The European blood legislation has defined several key quality elements to achieve Good Manufacturing Practice (GMP) in the field of blood transfusion. During the recent years, the blood legislation is in the process of implementation throughout its member states. Following the Directive 2002/98/EC, Directive 2005/62/EC has given further requirements for quality-management systems to be fulfilled by blood establishments. In addition, GMP/Good Laboratory Practice (GLP) and ISO standards are used inter alia by blood establishments. In order to support the implementation of the blood legislation, the European Public Health Work Plan (2005/2007) has cofunded two projects, led by the German Red Cross and supported by the European Blood Alliance, delivering a common European Standard Operating Procedure (SOP) methodology (EU-Q-Blood-SOP) and criteria and standards for the inspection of blood establishments (EUBIS). The EU-SOP manual will assist blood establishments in preparing for the inspection of their services related to the implementation of quality relevant elements required by the EU Directive 2002/98/EC and its technical annexes. The standards and criteria for inspection of blood establishments will cross-reference existing quality standards to the directive requirements and define requirements for the structure of quality-management systems based on the directive 2002/98/EC and its technical annexes. Based on these requirements, inspection standards and criteria are developed to assist in the independent assessment of quality systems established by individual blood establishments. These assessments are done in relation to the requirements defined by the European Union legislation on blood, in order to safeguard the quality of blood and to achieve continuous improvement of its quality throughout Europe.     

European best practice in blood transfusion: improvement of quality‐related processes in blood establishments

Transfusion medicine is an expanding field comprising the interaction between several medical disciplines. Looking at the ‘vein to vein process’ covering the donation of blood by the voluntary donor up to the application of blood components to patients, modern blood transfusion services comprise a large variety of sociomedical functions. The production of standard cellular blood components, such as erythrocyte and thrombocyte concentrates, plasmatic blood components as well as special cellular components such as blood stem cells, mesenchymal cells or granulocytes will require an extensive laboratory testing repertoire to monitor product quality and safety. The European blood legislation has defined several key quality elements to achieve good manufacturing practice in the field of blood transfusion. In addition, GMP/GLP and ISO standards are used inter alia by blood establishments. Following the call for proposal in the field of public health by the European Commission, a consortium of blood establishments from 16 European member, acceding and EFTA states has been established in order to survey the individual quality management systems used by the participants and to developed guidelines for quality systems. These guidelines are aimed at assisting blood establishments in preparing for government inspections as required by Directive 2002/98/EC. They could also be used to adapt existing procedures to comply with current EU requirements and/or to prepare for accreditation and certification of these institutions. Major benefits from those quality management systems are (1) the definition of an overall quality policy, (2) improved personnel responsibility, qualification and training, (3) error and risk assessment system, (4) continuous improvement, (5) improved resource management, (6) performance improvement. The definition of cost–benefit relation between certification and accreditation of blood establishments will depend on the individual institution itself and the amount of processes covered. With the release of the new EU Directive 2005/62/EC, there are currently EU requirements available that describe in detail relevant processes to be covered by quality system following good practice used in blood establishments. A future challenge for transfusion medicine would be optimizing the synergetic effects expressed by the EU directive, GMP and ISO standards.     

Transposition of the Blood Directive into national law--the perspective of Portugal.

European union has published a directive 2002/98/CE in January 2003. The goal of the directive is to standardize the requirements of safety and quality throughout the blood transfusion chain in the countries of the European union. Member states have to implement the principles of this directive in their own regulation. Portugal has already identified what will be the consequences of the new regulation in the health system.     

Annual Report 2004 - French National Reference Centre for Rare Blood Groups and Immunohaematology (CNRGS)]

In 2004, the French Reference Centre for Rare Blood Groups and Immunohaematology (CNRGS) developed 7 types of activities: 1) Studies of complex Immunohaematology issues (IH), 2) Studies of rare blood phenotypes, 3) the transfusion of patients showing complex issues, 4) IH reactive control in consistency with the 98/79/CE European Directive, 5) European studies and expertise on reactives and techniques, 6) Biotechnologies applied to blood groups, in particular RH, KEL, FY, JK, DO and CO, 7) Implementation of allo-immunization research programs (cellular immunology and grafting issues). The CNRGS efficiency is based on the 'reference-research' link thanks to the Inserm partnership and direct applications to patients allowing to a better risk management and control.     

European Union and blood transfusion]

Blood transfusion is progressing, Europe is growing, European blood transfusion organisations are developing rapidly. The first step was the publication of a new directive (2002/98/CE). The directive is the result of a compromise between technocracy, lobbying and blood transfusion professionals. European blood transfusion must be based on medical, scientific and social criteria. Two imperatives must be considered: the respect of ethics and; independence from the commercial system.The primary objective is to give satisfaction to patients while respecting blood donors.     

Perspectives and organisation of haemovigilance in compliance with the European Directive 2002/98/EC]

Haemovigilance has been a new concept in transfusion medicine since 1994. After 10 years, the situation can be assessed to evaluate the efficiency of the national organisation in each European country. Now, the new European Directive states the main orientations in the field of haemovigilance. Now, this inventory of the haemovigilance network shows a very heterogeneous and diverse situation. The frequency of transfusion reactions/incidents in recipients is more than 325 per 10(5) blood components in France, whereas in the United Kingdom it is 8.5 for 10(5) blood products! The systems and the organisation are different but the essential aim is to increase public health safety. In this article, we propose seven principles to organise the future of European haemovigilance.     

Work of the European Haemovigilance Network (EHN).

Haemovigilance has become a crucial part of the blood safety concept. In the Member States of the European Union, national haemovigilance systems are already in place or are developing. With the coming into force of the European Blood Directive 2002/98/EC, Community haemovigilance has become a priority: cooperation between the national haemovigilance systems will be of vital interest. The process of collaboration has already been initiated some years ago by the European Haemovigilance Network (EHN) with the following objectives: to favour the exchange of valid information between its members, to increase rapid alert/early warning between the members, to encourage joint activities between the members and to undertake educational activities relating to haemovigilance. This has been achieved by the EHN by developing and maintaining a website [http://www.ehn-org.net], by establishing a system for rapid alert and early warning (RAS), by discussing on all kinds of definitions relevant to haemovigilance, initiating standardisation of processes and forms (developing a common "mother matrix"), by starting with the compilation and analysis of European data (generated by the national haemovigilance systems in Europe) and by organising annual European Haemovigilance Seminars, where all these items are discussed. As in the past, the EHN will continue in the future to play a major role in promoting European haemovigilance.     

A comparative analysis across the globe: blood transfusion therapy in thalassaemia major

The major arms of the clinical management of thalassaemia major include life-long regular blood transfusion and iron chelation therapy – essential to address the consequences of the genetic defect, mainly the severe anaemia and the bone marrow hyperactivity. Effective blood transfusion therapy requires adequate and safe blood. However, the standards for both blood screening and blood transfusion practices vary depending on the geographical area, from country to country and even within the same country, between different regions and medical centres. The Thalassaemia International Federation (TIF), a patients’ parents-driven organization with 98 member thalassaemia or thalassaemia-related associations from 60 countries around the world, was established in 1987 with the mission to promote the quality of medical care and its access to every patient with thalassaemia across the world. An important activity contributing towards the fulfilment of its goals has been the establishment of an educational programme, in collaboration with the World Health Organization, with which in official relations since 1996. The educational programme that now enjoys international recognition focuses on providing awareness to the community at large and information and training to patients/parents and health professionals, and includes (i) preparation, publication, translation and distribution of educational books, leaflets and other material, (ii) the organization of local, national, regional and international conferences, workshops, seminars and field trips. In the context of TIF's educational programme, a survey has been conducted covering a period of 2 years, the aim of which was to evaluate the effectiveness of blood transfusion therapy in patients with thalassaemia major, in a number of affected countries around the world.     

Eighty years of the Slovenian Institute of Public Health: challenges for the future

Eighty years after the first national public health institution was founded in Slovenia, the Institute of Public Health of the Republic of Slovenia (IPHRS) endeavors to meet ever-growing national demands. With the independence of Slovenia in 1991, new tasks had to be tackled, many of which were initially coupled with typical difficulties of a postcommunist country in transition. Also, increasing demands of the European Union (EU) and other international partners had to be met. The IPHRS monitors the health of the Slovenian population and its determinants and contributes to planning and implementation of population-based interventions for the better health of the whole nation. The diversity of the IPHRS activities is mirrored by the organization's internal complexity, multi-disciplinary approach, and links to various sectors. Currently, activities are organized within five centers: Center for Population Health Research; Center for Health Care Organization, Economics and Informatics; Center for Environmental Health; Center for Communicable Diseases; and Center for Health Promotion. The IPHRS is the key national institution in public health research, which is an integral part of all the areas covered by the Institute. The IPHRS also provides education programs in the field of public health. In the near future, it will be important to sustain current activities while integrating into the new program of Community action in the field of public health as well as contributing to the response to challenging public health issues in the wider context of the whole European region. Our aim is to integrate the Institute's activities in the programs relevant to public health issues of outstanding importance in this European sub-region. The IPHRS, given the geographic position and recent history, can act as an intermediate between the public health networks in EU and other countries in the sub-region.     

Regulation of blood services in Africa

Blood and blood products save lives and are a part of the WHO Essential Medicines List. Access to safe and quality-assured blood and blood products are essential for health systems strengthening and it is a global concern. Their use is associated with infectious and immunologic risks. At global level, many resolutions have been adopted by the World Health Assembly that urged Member States to ensure regulatory control of access to quality-assured blood and blood products along the entire transfusion chain. The WHO has also developed an action framework to advance universal access to blood. As part of the implementation of these resolutions and guidelines, the WHO Regional Office for Africa and some partners provided support to countries in the region to strengthen their capacity to establish an effective blood regulatory system through organization of regional training workshops on blood regulation, benchmarking of blood regulatory systems, internship at Paul Ehrlich Institut and establishment of the African Blood Regulators Forum. The current status of blood regulation reveals that there are weak transfusion legislation and blood regulatory systems in most African countries, since many national blood transfusion services still rely on self-regulation. However, the national regulatory authorities have reached the maturity level 3 in two countries (Ghana and Tanzania), but only the experience from Ghana has been described in this paper. Like in other low- and middle-income countries, the regulatory systems for associated substances and medical devices including IVDs are not well established in the African region. Misunderstanding by different stakeholders, lack of legislation that provides legal basis, weak capacity and insufficiency of resources are main challenges facing countries to establish an effective national blood regulatory system. To address these challenges, strong advocacy with governments and collaboration with partners are needed to strengthen national blood regulatory systems.     

Mise en place de l’hémovigilance en Afrique subsaharienne

Purpose of the studyHemovigilance being an essential part of blood transfusion safety, many countries have set legislation for its organization and its establishment. In Sub-Saharan Africa, where transfusion practice is facing many challenges, hemovigilance does not always appear as a priority. Nevertheless, in 2000, Burkina Faso decided to reorganize its blood transfusion system according to the World Health Organisation recommendations and other international standards. A national blood transfusion center and regional blood transfusion centers were created. From 2005 to 2009, a hemovigilance pilot project was conducted by the regional blood transfusion center of Bobo-Dioulasso.MethodsThe implementation of this hemovigilance project included the following steps: training of medical and paramedical personnel of the health facilities provided with blood and blood products by the regional blood transfusion center, distribution of post transfusion and hemovigilance forms, and the creation of a hemovigilance and transfusion committee.ResultsDuring the period 2005–2009, 34,729 blood products were distributed for 23,478 patients. The return rate of the post-transfusion and hemovigilance forms (number of files completed partially or completely and returned to the regional blood transfusion center compared to the number of units distributed) raised from 83.1 to 94.8%, the rate of traceability (rate of forms returned to the regional blood transfusion center and totally completed) raised from 71.6 to 91.6%, and the concordance between the patient for which the blood was delivered and the patient transfused moved from 92.9 to 98.0%. The notification rate of transfusion incidents raised from 1.1 to 16.1 per 1000 units transfused during that period.ConclusionThe implementation of a hemovigilance system is possible in the Sub-Sahara African countries. This constitutes a major element in the improvement of different steps of transfusion safety. The implementation of a hemovigilance system requires negotiations between transfusion centers and the hospital personnel, and should be facilitated by the official regulation on blood transfusion practices.     

Towards a safe and sufficient blood supply in Sub‐Saharan Africa

Most countries in Sub‐Saharan Africa (SSA) are either low‐income or low‐middle income countries, that is countries whose gross national income per capita is $995 (USD) or less or $996–3895, respectively. Added to this, they have very few health care professionals specifically trained in transfusion medicine and are the countries whose populations have a high prevalence of transfusion‐transmissible agents (especially HIV, hepatitis B and malaria) and whose patients (women haemorrhaging at birth, men in motor vehicle or motorcycle accidents, children with malaria or sickle cell anaemia) are often in urgent need of blood transfusion. This combination of few resources, both financial and human, combined with many potential donors at risk of transmitting infection and patients with urgent transfusion requirements renders the provision of a safe and adequate blood supply in SSA extremely challenging. In this review, we will discuss the current literature addressing how these challenges are being met and present one example of a SSA national blood transfusion service, the Uganda Blood Transfusion Service.     

Changing educational paradigms in transfusion medicine

Over the past decades, the fields of activity and knowledge in transfusion medicine have evolved into an array of diverse areas and sub-specialities including immunohaematology, blood component production, haemapheresis, pathogen detection, methods of cell and tissue collection and manipulation, cell conservation and banking, transplant immunology and haemostaseology. Physicians in most clinical disciplines require basic or more advanced knowledge in these fields to meet the requirements of modern medicine. Specialist physicians in transfusion medicine are valuable and competent partners for these related disciplines when it comes to safe, effective and tailored haemotherapy. Transfusion medicine is thus an important qualification at the interfaces of analytical laboratory medicine, pharmaceutical production and clinical disciplines such as internal medicine, anaesthesiology or surgery. In the past, blood transmittable diseases like HIV and hepatitis and adverse reactions to blood and cellular products have led to a complex system of regulatory and technical requirements. Good laboratory practice (GLP), good manufacturing practice (GMP), quality management systems and quality control on the pharmaceutical manufacturer’s level are only a few examples of the standards in today’s blood banking. European directives in the field of blood products, stem cell preparations and tissue have harmonized national regulation and led to higher uniform quality standards for biological preparations in a unified Europe, which is the desired outcome, but which also increases the complexity of this field. By contrast, directives 93/16/EEC, 2001/19/ EC, and 2005/36/EC, the directives of the European Parliament and of the Council on the mutual recognition of professional qualifications of European doctors currently in force, do not include transfusion medicine, blood transfusion or immune haematology at all. Other medical specialities, which like our field, are not common to all member states of the European Union, are listed in the above mentioned directives with the minimum length of training and minimal requirements for the qualifications. Bearing in mind the regional particularities of the medical speciality of transfusion medicine – caused by historical developments, rigidified by national legislations and the urgent need for quality standards also on the educatory level – we support a levelled approach in transfusion medicine education. Irrespective of the required day-to-day responsibilities in the blood field, which may range from basic level experience in haemotherapy, over specific knowledge of immunohaematology and clinical haemopathology, as needed for local blood bank management, up to the highest skill level required to direct a complex transfusion service and/or blood bank at an academic medical centre, transparent service quality requires defined minimum educational standards, which could then be adapted to fit specific national requirements. A long-term objective might be to introduce the transfusion medicine specialisation into the above-mentioned EC directives in order to guarantee quality and facilitate mutual recognition of transfusion medicine qualifications throughout Europe.     

The New Zealand national haemovigilance programme: the first step is the hardest

Blood transfusion is an important component of modern day medicine. As doctors our first consideration must always be the interests and safety of our patients. Haemovigilance programmes collect and analyse data on untoward events associated with transfusion. The information collated should be shared with health professionals who prescribe and administer blood products so that they can continue to deliver the good without unintended negative consequences. The European Directorate for the Quality of Medicines and Healthcare (EQDM) defines the standards for haemovigilance and acknowledges that it is a shared responsibility of the professionals in the field and the competent national authorities for blood safety. It includes the surveillance of donor-related events, epidemiological assessment of infections in donors, full traceability of blood components, device defects and reporting of post-transfusion infections. Implementation of a national haemovigilance system is a complex task and usually takes months of planning. Apart from the multiple resources it requires, a number of issues need to be considered: what is to be reported, how will it be reported and who will do the reporting. In addition, information and training needs to be provided to the key stakeholders. In order for a haemovigilance programme to be effective the data need to be collated, analysed and relayed back to the hospitals. Comprehensive annual haemovigilance reports that are readily accessible can include recommendations to promote strategies to reduce transfusion-related risks. In New Zealand the National Haemovigilance Programme was established in 2005. The population of New Zealand is 4·1 million. Reporting is voluntary and usually mediated via the hospital blood banks. The larger hospitals have Transfusion Nurse Specialists (TNSs) who provide education and assist with reporting adverse events. New Zealand is a country member of the Internal Haemovigilance Network (IHN) and utilizes the definitions of reporting categories agreed upon by the IHN. The majority of reports involve reactions that are mild. The overall rate of an adverse event is approximately 1 in 300 units transfused. Platelet concentrates are more frequently associated with reactions compared with other blood components and reactions are predominantly of the allergic type. The Haemovigilance Programme has demonstrated a reduction in the reported rate of transfusion-related acute lung injury (TRALI) since the introduction of male donor fresh frozen plasma (FFP) 3 years ago. The programme has also identified that bacterial contamination of blood components, incorrect blood component transfused (IBCT), wrong blood in tube (WBIT) and acute haemolytic transfusion reactions due to transfusion of passive haemolysin are risks that require further attention. Complications associated with blood donation are also included in the annual haemovigilance reports. Vasovagal reactions are the most frequently occurring donation-associated event and are higher in donors under the age of 20 years. Ongoing surveillance and review of untoward events associated with transfusion is vital so that we can continue to minimize risks related to blood products.     

Blood supply management: experience and recommendations from the Netherlands

Sanquin Blood Supply is the only organization mandated to supply and deliver allogeneic blood products to all hospitals as requested. In the Netherlands two main responsible organizations can be distinguished, the blood establishment (Sanquin) and the hospitals. Sanquin monitors yearly the hospital demand for next years budget, the basis for the yearly collection plan with weekly steering based on the actual inventory levels. Blood supply management was developed recently to understand how nationally organized blood supply organizations have blood available for patients in need. An update was done of an analysis as recommended by the Council of Europe working party of the strength and weaknesses, opportunities and threats of the blood supply organisation in the Netherlands as described previously [ http://dx.doi.org/10·1111/j.1423-0410·2009·1252.x ]. The strengths are first the long standing commitment of voluntary blood donors. Donor commitment is high and research to understand motivation and retention to predict trends and developments in availability is important. This research has contributed to the EU co-funded DOMAINE project (Donor MAnagement IN Europe). The second strength is inventory management on a National level. The cooperation between blood supply and hospital transfusion laboratories is a third strength. A fourth strength is the national consensus on Blood Transfusion from experts in the whole transfusion chain that serves as national guideline. The transfusion trigger in the consensus resulted in a low 2011 transfusion rate of 31/1000 inhabitants as quality marker. Weaknesses are limited business hours for collection as result of efficiency aggravated by an ongoing decrease in demand. Further, inventory management has focused on minimizing the discard and less excess collection asks for flexible steering. Especially for Fresh Frozen Plasma steering effects are delayed by the 6 months quarantine period with risk of shortages by sudden increased demand or decreased collection levels. Another weakness is the challenge to get detailed clinical demand information. Opportunities of one virtual national inventory are the development of mathematical tools to support optimal inventory management. The increasing donor selection criteria may lead to less donor availability as a threat to the system. In the Netherlands the blood supply was centralized and with a national inventory availability is maintained and discard minimized. A national blood collection plan with weekly inventory review for RBC per blood type drives the operations. Mathematical models are used to optimize inventory management of platelets and developed for RBC. The EU co-funded DOMAINE manual describes donor management, while strict transfusion triggers resulted in moderate demand. This integrated system of donor and inventory management with moderate clinical use resulted in a reliable supply. Challenges encountered are delayed steering effect on fresh frozen plasma inventory levels, while safety measures and demographic changes can become a threat.     

Transitioning from ‘blood’ safety to ‘transfusion’ safety: addressing the single biggest risk of transfusion

Transfusion errors occur at all points in the transfusion chain, often occurring at multiple points in the transfusion process for the same patient. Such events have been reported to national haemovigilance programs in almost all countries, over and over again. An incredible number of safety changes have been implemented to improve blood safety, including but not limited to: nucleic acid testing for HIV/HBV/HCV, bacterial culture for platelet concentrates, use of male-only plasma, and the introduction of pathogen reduction strategies. By contrast, very little momentum has developed behind transfusion safety, in hope of improving the safe delivery of blood to patients. This article will review the interventions that have been studied by transfusion medicine services in attempt to improve transfusion safety at every link in the transfusion chain. The most important and indispensable safety step is the introduction of an error tracking system. Such a system should capture all deviations from standard operating procedures, including near-misses that are captured before the blood product is issued. Near-misses are 300-fold more common and represent latent safety concerns requiring urgent attention. The system should be anonymous to ensure that there is no barrier to reporting and no-fault to recognize that the vast majority of errors are due to latent system errors. The errors should be coded by type and location to allow for the ability to query the error database for the purposes of benchmarking and tracking and trending after system changes. Such a system will allow hospital transfusion services to focus their initiatives at the steps in the transfusion chain most in need of repair at their institution. The system changes that have been studied include: confirmatory group testing, computerized physician order entry, prospective screening of transfusion orders before/after issue, controlled patient registration, regional blood bank information systems, positive patient identification at time of sample collection and the start of transfusion (using barcode or RFID technology), controlled release refrigeration devices, patient involvement in the transfusion process, and healthcare professional education. For each area, the specific technologies or examples will be detailed, the reports from the literature will be reviewed, and the obstacles to implementation will be discussed. Now that blood safety has been assured, we need to re-focus our attentions on the single biggest threat to patients: errors in the transfusion chain at the hospital level. We need to ensure that patients get blood only when required, that they get the correct product of the correct blood group, at the right dose, at the appropriate infusion rate, to the correct patient, at the right time. We need to take a rigorous scientific approach to solving transfusion safety to ensure that each process change is properly tested and validated to verify that each newly introduced process is safe and effective.     

French training program for medical students in transfusion medicine. Transfusion Medicine Teachers' College]

In France, transfusion medicine training program has been updated. A national committee of professors in transfusion medicine propose a series of 13 items which represent the minimum knowledge that general practitioners should possess. This overview of transfusion medicine is far below the level that specialists should reach and they will need an additional specialized training. Several French universities have set up their own training program which is quite similar to the work of the committee of professors. The following recommendations are not strict guidelines but is a common basis which will be improved in 2005 according to new evidence based transfusion medicine.     

New Croatian legislation on tissue banking

Human tissues and cells are increasingly used in transplantation, and have also a very promising potential as starting material for tissue engineering and cell therapy. Due to their biological origin, tissues and cells also carry the risks of disease transmission, which need to be reduced as far as possible. Safety and quality standards for tissues and cells have to be concurrent with EU standards in all member states. EU standards in this area have been regulated by the Directive 2004/23/EC, which determines safety and quality standards for human tissues and cells. Two other directives support its implementation regulating technical requirements regarding different process phases of handling tissues and cells. Directive 2006/17/EC regulate technical requirements for donation, procurement and testing of human tissues and cells, whereas technical requirements concerning coding, processing, preservation, storage and distribution of human tissues and cells are regulated by Directive 2006/86/EC. Legal implementations of these directives throughout the European Union take places at different dynamic levels. Countries like Spain, Ireland, Denmark and Bulgaria have successfully completed this process. However, some countries have not met this challenge yet (e.g., Italy, The Netherlands, Latvia, Belgium, Luxembourg, Austria, Slovenia and Sweden), and others are only half-way through (e.g. Slovakia, Rumania, Portugal, Norway, Great Britain, et aI.). Some Member States indicated problems in the implementation of the Directive due to the limited number of experts in the field. In Croatia, the field of tissue and cell transplants is regulated by the Act of Conditions for Removal and Transplantation of Human Body Parts for Therapeutic Purposes (Official Gazette 177/04) and other decrees, which help regulating quality and safety for human tissues and cells, defining authorization systems for tissue and cell banks as well as supervising their work and determining the compliance regarding quality and safety for procurement, testing, processing and distribution of human tissues and cells for therapeutic purposes according to the required standards; Ordinance on Storing Personal Data of Donors and Recipients of Human Body Parts (OG 141/05), Ordinance on Cooperation with Related Foreign and International Organisations for the Purpose of Exchanging Organs and Human Tissues for Transplantation (OG 141/05), Ordinance on Measures to Ensure Safety and Quality of Human Body Parts for Medical Use COG 143/05), Ordinance on Distribution Principles of Unrelated Allogeneic Hematopoietic Cells and the Register of Potential Bone Marrow Donors COG 151/05), Ordinance on Distribution Criteria of Human Body Parts and Compilation of a National Waiting List (OG 152/05), Ordinance on the Method of Storage and Transportation of Human Body Parts Intended for Transplantation COG 152/05), Ordinance on Keeping Medical Documentation on Performed Removals and Transplants of Human Body Parts COG 152/05), Ordinance on Notification Procedures of the Death of Eligible Human Body Part Donors for Therapeutic Purposes (OG 152/05), Ordinance on the Work of Tissue Banks with and Supervision over Health Care Institutes or Divisions of Health Care Institutes COG 1/06), Ordinance on Method, Procedure and Medical Criteria for Death Determination of Body Part Donors for Transplants COG 3/06), and Ordinance on the Work of Coordinators in the Procedure of Removal and Transplantation of Human Body Parts for Therapeutic Purposes COG 51/06). The Croatian legislation is greatly consistent with the legislation of the European Union regarding this field. In the above mentioned law and decrees, Croatia has a legal foundation for regulating this field in compliance with EU standards.