Transfusion safety and haemovigilance committees]

Transfusion safety and haemovigilance committees (TSHC) were initially created in the public health care sector. Nowadays, they are also a mandatory committee of private health care institutions. The members of the TSHC, as well as the way the committee is driven and organized, are defined by law. The aim of the committee is focused on the management of transfusion safety and haemovigilance. The TSHC takes part in the improvement of the safety of transfused patients, and monitors the applying of haemovigilance rules. It also handles the training of all staff members involved in the blood transfusion process.     

XMRV,Q fever and other emerging infections: impact on management of blood safety

As a result of continuous improvement efforts, the blood supply is now extremely safe. However, emerging infections offer a real or potential challenge to such safety. Since 2003, two new tests have been implemented in the United States in order to reduce the risk of transfusion transmission of West Nile virus and Trypanosoma cruzi. In addition, Babesia microti and dengue viruses are considered to be high-priority threats. Q fever outbreaks in the Netherlands illustrate a localized threat that has been assessed and managed through human and agricultural public health measures and by selective testing of blood donors. The recently recognized gammaretrovirus XMRV has generated scientific and social controversy and illustrates a number of problems in managing blood safety policy.     

The impact of training in transfusion medicine

Background Basic training skills and program for all health care providers working in the blood transfusion services is important and essential. All blood transfusion staff should have active participation in a training program that includes teaching all national and international regulations related to blood transfusion administration and guidelines of safe blood and blood products. The blood bank staff (physicians, medical technologists and nurses) should pass proper assessment procedures in order to work in this vita health related services. All staff working in blood transfusion services should receive a proper education and learning skills in this field of medicine. Awareness of blood safety and Good Manufacturing Practice (GMP) in blood transfusion should be greatly increased among them. Methods and Results Sustainable national and international education and training in blood transfusion services are needed and should be considered as a priority. Methods of teaching and training may include courses or workshops consist of a series of lectures, practical sessions, problem based learning and computer based distance learning programs. A proper training and continuous medical education in blood transfusion services have played an important role in minimizing the risk of transfusion related complications in many countries. Conclusions Creating an effective learning and training environment is a real challenge for most developing countries. Transfusion medicine is a branch of medicine which has a great link with almost all medical and surgical specialties. Blood transfusion safety plays an important and significant role in the patient's management. Proper qualified training personnel are the key of delivering safe blood components and the Good Manufacturing Practice (GMP) in blood transfusion services.     

Emerging pathogens and possible threats to blood services

New pathogens emerge regularly. These new agents include both bacterial and viral pathogens. Many viral agents have a viremic phase during the course of infection and are transmitted by blood transfusion. New infectious agents provide a major challenge for blood services. The extend and mode of transmission through blood is initially unclear. Serological tests and molecular tools are used to detect infectious donors. A residual risk remains due to the diagnostic window period and sensitivity limits of the tests systems. Some detection systems proved to be extremely helpful, e.g. for HIV, HCV or WNV, but sometimes provide in certain periods of the infection false-negative results due to sensitivity problems or to escape mutants (e.g. Hepatitis B). WNV provides an excellent example, how rapid and efficient blood donation services coped with this new threat for blood safety. Not all emerging infectious agents transmissible by blood represent a threat for the health. A number of putative pathogens turned out later not to be associated with pathogenesis. Prion diseases represent a particular challenge for detection in blood donors. Since the ‘normal’ cellular form the host protein is widely distributed, the usual nucleic acid amplification systems or serological tests are not feasible. Extremely sensitive tests (picogram range) are required for detection of the pathological protein in the asymptomatic period. Variants of existing viruses e.g. newly emerging Influenza A subtypes with the potential for pandemic spread represent an enormous threat for public health and for the safety of blood. Blood services should take precautions for an influenza pandemic. The mosquito borne Chikungunya virus turned out to be transmitted by blood transfusion and caused many infections in the islands of the Indian Ocean and in India. Newly emerging infectious agents require attention and rapid actions in order to guarantee a safe and reliable blood supply.     

Changes in transfusion practice for surgery]

The context of transfusion has changed in recent years. Some data could lead to an increased demand: the risk of viral transmission has significantly decreased; a national survey has revealed that the mortality related to an insufficient or delayed transfusion was higher to the side effects of the transfusion itself. Some other data could decrease the demand: the preoperative use of EPO is now easier; the intraoperative use of antifibrinolytic has been shown to be efficient. The number of allogenic red blood cells units (RBCs) transfused each year in France regularly increases, while the transfusion of predeposited autologous blood is in sharp decline. However, in hospitals still using but reducing this technique, the consumption of allogenic RBCs does not increase and the transfusion of any blood (allogenic and/or autologous) decreases. The strategy is based on preoperative evaluation of usual blood loss and tolerable blood loss by accepting a reasonable risk of allogenic blood transfusion. Advances in public health seem to be found above all in the analysis of system failures.     

Évolution des pratiques transfusionnelles pour la chirurgie

The context of transfusion has changed in recent years. Some data could lead to an increased demand: the risk of viral transmission has significantly decreased; a national survey has revealed that the mortality related to an insufficient or delayed transfusion was higher to the side effects of the transfusion itself. Some other data could decrease the demand: the preoperative use of EPO is now easier; the intraoperative use of antifibrinolytic has been shown to be efficient. The number of allogenic red blood cells units (RBCs) transfused each year in France regularly increases, while the transfusion of predeposited autologous blood is in sharp decline. However, in hospitals still using but reducing this technique, the consumption of allogenic RBCs does not increase and the transfusion of any blood (allogenic and/or autologous) decreases. The strategy is based on preoperative evaluation of usual blood loss and tolerable blood loss by accepting a reasonable risk of allogenic blood transfusion. Advances in public health seem to be found above all in the analysis of system failures.     

Safety of blood transfusion at the international level. The role of WHO]

Blood safety is an international public health challenge, particularly since the emergence of HIV AIDS. Recognizing the gross disparities between countries in the adequacy of national blood supplies and the risks arising from poorly organized services, particularly in developing countries, the World Health Organization has developed a global strategy for blood safety and availability. Dr N. Dhingra, coordinator, blood transfusion safety, WHO Headquarters, and Dr V. Hafner, focal point for blood safety in the WHO regional office for Europe, present the main features of this strategy: well-organized, nationally coordinated blood transfusion services with quality systems in all areas; the collection of blood only from voluntary non-remunerated blood donors from low-risk populations; the quality-assured testing of all donated blood; the safe and appropriate use of blood and blood products; and global collaboration for blood safety. WHO's programs, some difficulties encountered and outcomes are also described in this article.     

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.     

Transfusional record and blood grouping methods: essential factors of transfusion safety]

The clinical and biological control of the whole transfusion process is a major preoccupation for everyone dealing with blood transfusion. Specially when the patient is a female recipient or belongs to a group with a high prevalence of alloimmunisation. This case report points out the outstanding importance of the immune compatibility, which must be strongly maintained to prevent any harmful consequences. The transfusional record transmission and a simple and sensitive blood grouping test are essential to increase transfusion safety.     

Les biothèques de transfusion sanguine en France : un outil de santé publique

Donor and recipient sample biobanks are a precious tool in hemovigilance studies as well as in epidemiological and biological research, in particular with regards to safety against blood-borne agents. This paper describes the main transfusion biobanks existing in France and gives their advantages and limits. The National blood donation biobank, organized for medicolegal reasons, preserves samples of each blood donation for a 5-year period. The biobank of the Blood and Organ Transmissible Infectious Agents (BOTIA) project stocks paired donor–recipient samples with a research objective. Preserved over a long period of time, such transfusion biobanks will be useful in terms of public health, as a reflection of the biological state of a population at a given moment.     

Dispositif pneumatique pour le transport des produits sanguins labiles

Blood product transport from blood bank to the patient care areas of hospitals is a key step in the transfusion process. The pneumatic tube system is now widely used in hospitals. Strict performance specifications must be respected to guarantee blood safety: robustness, easy to use and respect the constraints imposed to blood products. To secure the disposal of blood products ordered to a carrier (delivery step), a security device must be deployed (video camera, barcode reading, fax, chip), allowing in particular to limit the risk of addressing error when sending (in the case of device with several arrival stations) or picked up by the wrong carrier.     

Risk management: an important tool for improving quality.

Risk management implies that one has identified and analysed the root cause of the risk. In blood transfusion public and political opinion on the perceived risks are mainly related to product stigmatisation, to cognitive aspects of risk. Therefore this perception is affective, and has a negative connotation. In order to manage risk in an optimal manner, we need to understand how people think about it, and recognise that thoughts, feelings and behaviour are determined not only by psychological factors, but also by social, cultural and political influences. Perception of risk is always situated within a context, which may differ. Therefore people (i.e., public and political opinion) seem to act inconsistently from one risk context to another. Crucial for understanding the logic behind different risk perceptions is how people think about a hazard and organise information about it. The blood supply system has aspects that make it very vulnerable to crises of confidence, as the subject of blood can easily become stigmatised. The impact of the latter on the perception of blood transfusions and their recipients as well as the willingness of the public to accepttransfusions can be dramatic. Risk perception needs to be monitored in order to anticipate and adequately deal with public and political acceptance. We know that risk and stigmatisation are closely interconnected, and that the costs are likely to be high both for human health and for the maintenance of the healthcare system. Thus there is a global need to carefully monitor the safety of the blood supply systems and communicate risk information in a way that both informs people and builds up public and political confidence. It is therefore not sufficient to simply state that the blood supply is safe; it must also be made safe. So risk management becomes an integral part of quality management, as it deals with the public perception of the blood supply system and its respective elements: procurement and use.     

The role of the transfusion practitioner in the management of anaemia

Anaemia is a major public health issue, affecting 25% of the population worldwide, according to the World Health Organization. Iron deficiency is responsible for approximately half of all cases globally, with other causes including anaemia of chronic disease, other nutritional deficiencies, haemoglobinopathies, renal impairment, malignancy and bone marrow disease. In the elderly, where anaemia is even more common, the cause is frequently multifactorial. Patient blood management (PBM) is an evidenced‐based, integrated, multidisciplinary approach aimed to improve clinical outcomes by effectively managing anaemia and conserving the patient's own blood, thus reducing unnecessary exposure to transfusion. PBM has the patient as the central focus, with the aim being to improve their outcomes while including them in the process. The term transfusion practitioner (TP) includes those known as transfusion nurses, transfusion safety officers, haemovigilance officers or patient blood management (PBM) co‐ordinators. A key aspect of the role is driving and influencing clinical blood management activities such as PBM to help align practice to internationally recognized guidelines and standards. TP skills are a valuable asset to support patient groups and clinical settings to be targeted to achieve best outcomes. TPs know the organization and are well placed to help develop anaemia assessment and management concepts and processes, and provide education and support to promote and embed these practices. In this review, we outline the impacts of anaemia in the healthcare setting, along with different approaches to anaemia management (focussing on perioperative care), highlighting where the TP can support or lead activities.     

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.     

Is it possible to organize into a hierarchy blood donation contraindications?]

Because it symbolizes henceforth the sanitary risk and fears which are linked to it, the blood transfusion must master the potential or real risks associated to its practice. The analysis of these risks leads to confirm the initial selection phase of candidates for blood donation as an always original stage of the blood transfusion safety towards the identified infectious risks, but also mainly towards the emergent or modelled risks. The evaluation of the current system of prevention leads to consider two potential dangers: the ineffectiveness of the selection because of the lack of meaning given to this stage, and the donors' disaffection caused by badly accepted or badly justified deferrals. The deficit of meaning can be due to an insufficient information of the population as for the policy of collective prevention of transfusion-transmitted infectious diseases. It can be worsened by the construction of the pre-donation interview which can appear as a succession of questions without visible links. This paper suggests risk analysis to blood transfusion, and a reflection to improve this important stage of blood product safety approach represent by the selection of candidates to a blood donation.     

Use of whole blood as the routine transfusion product in Africa

In many countries in sub‐Saharan Africa (sSA) whole blood is more commonly available from blood transfusion services than red cell concentrates. Although in recent years, many countries have made significant progress in the implementing component preparation, this has largely been facilitated by external funding support. The large majority of rather than none of the sSA countries are leucocyte‐reducing or irradiating blood for transfusion. Systems for the routine detection of adverse consequences of blood transfusions (haemovigilance) only exist where transfusion safety has been identified as a health priority by the government. As a resource, the availability of blood transfusion in these countries is limited since less than 5 units of blood were donated per 1000 population far below the recommended requirement of 20 units/1000 per year. Young children are the main users of blood for transfusion in these sSA regions, largely due severe anaemia secondary to infection and sickle cell anaemia. Outcomes for children with severe anaemia are poor, even in those receiving a transfusion. Although it has been speculated that this may be due to transfusion‐related cardiac or pulmonary events, available data from observational studies and clinical trials indicate that these are rare complications of transfusion. Evidence from clinical physiology studies including those examining myocardial functions before and after the receipt of whole blood provide reassuring evidence that volume overload is rare and clinical trials reporting outcomes in children receiving whole blood transfusion, including a Phase II trial examining higher volumes, indicate that there is no evidence of cardiac or pulmonary overload events.     

Blood management in disaster situations in Pakistan

Background Pakistan has a fragmented blood transfusion system which is demand driven and predominantly relies on family replacement donors. In order to provide adequate and nationwide access to safe, efficacious and affordable blood supply, the Government of Pakistan, in 2008, initiated a blood safety systems reform programme in the country. Institutional framework Until recently, Pakistan had followed the conventional relief and response-oriented model for managing disasters. But following the 2005 Earthquake, appropriate policy and institutional arrangements have been put in place to reduce losses from disasters, and a more proactive approach based on Disaster Risk Reduction has been adopted. The National Disaster Management Authority (NDMA) has been created with the mandate to coordinate and monitor implementation of the National Policies and Strategies on disaster management. The health sector response arm of NDMA is the National Health Emergency Preparedness and Response Network (NHEPRN) which serves as the nerve centre to assess and analyse responses, prioritize interventions, develop action plans and implement emergency responses including transfusion support. Blood management response In the absence of an integrated healthcare system and the presence of a fragmented blood transfusion system, the national response to blood management in disasters is patchy, insufficient and lacks proper coordination. In addition to the few national service providers like the Armed Forces and the Pakistan Red Crescent Society, a large number of NGOs also provide transfusion support essentially by mobilizing huge numbers of voluntary blood donors. But there is limited evidence or documentation of these efforts. Coordination is limited between various partners causing overestimation of transfusion requirements, duplication of efforts, and at times wastage of collected blood. In contrast to normal times, the response of the public towards voluntary blood donation is overwhelming when calamities strike. But in the absence of a proper donor management system the true potential of the enthusiastic public response during crisis has not been harnessed to make the system safer and better prepared for disasters. Challenges In the recent past, Pakistan has faced a spate of natural and man-made disasters including earthquake, floods, internal and externally displaced populations, terrorism, dengue, etc. These disasters are not of an unmanageable dimension. However, due to the lack of a proper system, the real challenge is timely and coordinated response. Recent experiences have identified the impediments of an effective response in disaster situations as damage to health physical infrastructure, breakdown in logistic and communications support, lack of information on available blood stocks, inaccurate determination of the magnitude of the calamity, inability to reasonably estimate the transfusion requirements, lack of coordination and duplication of efforts, lack of priority to transfusion therapy within emergency medical care, absence of documentation and analysis of the transfusion support provided, lack of appointment/identification of national focal points, and absence of platform for experience sharing for stakeholders involved in blood transfusion disaster management.     

Situation actuelle et perspectives de la transfusion sanguine au Togo

We report the successive stages of the reorganization of the blood transfusion sector in Togo. The starting point was the elaboration of the national policy of blood transfusion, then the adoption of a decree organizing the sector as well the various decree of application, particularly that related to transfusion good practices. The current policy recommends two poles of qualification of the blood ant its components and the creation of six stations of collection and distribution attached to these poles. The reorganization started with the rehabilitation of the National Blood Transfusion Centre (CNTS) in Lomé. If the problem of human resources is alarming, especially the availability of hemobiologists, the rehabilitation allowed the increase of the blood collection passing from 5272 donations in December 2003 to 18 164 in December 2008. However, the requirement of blood products is satisfied in 50% in all the country. In 2003, 24% of the blood products were rejected for positive viral markers against 8.37% in 2008 in relation with the improvement of blood safety. Efforts must be continued to reinforce it in the CNTS and to make a better selection of the donors at the Regional Blood Transfusion Centre (CRTS) de Sokodé. The analysis of the weak points of the sector (human resource insufficiency, shortage of the blood products, blood safety) made it possible to indicate solutions to improve the sector of blood transfusion sector. Future outcome is funded in the blood transfusion safety development project in Togo financed by the Agence française de développement (AFD, French development agency).