Quality management in blood establishments

Transfusion medicine has a specific position relative to other fields of medical science. A series of laboratory and clinical medicine activities and pharmaceutical-like manufacture, with tight interaction of various professionals are involved in the complex chain of transfusion medicine, from the promotion of blood donation through the utilization of blood products. Maintaining constant high quality and safety of the products and services required by blood donors, patients and public at large are the prime and foremost goals to be pursued in transfusion medicine. These supreme goals can only be achieved through efficient quality management in all segments and with due support from all those involved in this complex system. Recognizing quality as a necessity, transfusion services all over the world have introduced or are just being introducing quality management systems according to particular standards and regulations. In EU countries, quality management in blood establishments is legal obligation defined by the 2005/62/EC Directive. Only a comprehensive and integrated quality management system can guarantee quality in a continuous way. Standard requirements and specifications of such an integrated system based on GMP and ISO 9000 series standards are elaborated in this paper.     

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.     

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.     

The European network of transfusion medicine societies (EuroNet-TMS): The White Book 2005]

Europe is building up. It develops in a quite complex environment, in which health care represents an important field of activities. As for blood transfusion, it plays a major role especially in the development of medical activities as well as for the patients treatments. Today, blood components are still of human origin and there are no substitutes for them. As a medical discipline, Blood Transfusion represents a broad field in medicine which requests the involvement of numerous actors. It is up to professional medical/scientific societies to promote the discipline. This is why it has been considered necessary and relevant to build up a federation of transfusion medicine societies throughout the European Union (EU) ; it is called EuroNet-TMS, the European Network of Transfusion Medicine Societies. This network groups more than 7500 professionals of involved in blood transfusion activities. It has six major objectives: 1) To find coherent responses to issues at stake in transfusion; 2) To promote medical and scientific developments of blood transfusion in Europe; 3) To ensure the highest and most up-to-date scientific level to meet safety and quality standards; 4) To offer similar services to all EU citizens in the field of blood transfusion; 5) To share knowledge and date within Europe; 6) To develop interfaces with decision-makers among the diverse European countries. The first step is the writing of the "White Book 2005" which reports the state of the art of blood transfusion in Europe; a prospective plan is proposed to be discussed.     

Where will pathogen inactivation have the greatest impact?

Blood safety has always been a major task in transfusion medicine. A strategy to obtain this aim should include donor education, donor selection, and testing of blood donations. Pathogen inactivation adds another level of safety. In the fractionation industry, pathogen inactivation methods are mandatory. Several countries also use pathogen‐inactivated plasma – from pools or single donors. Concerning the cellular blood components, there is still no method available for red cell concentrates, whereas methods for platelet concentrates are available in some countries and others are in the pipeline for commercialization. The efficiency of the ‘old’ methods to increase blood safety and the costs of the methods seem to be major obstacles for the introduction of the systems. There are also concerns on product quality and loss of volume during the inactivation process. As the importance of pathogen inactivation is largest in countries with blood donors who carry infections it is impossible to protect against, either due to high incidence of the infection or due to shortage of tests, cost will be a major question when pathogen inactivation is considered. Pathogen inactivation of red cell concentrates will also be a necessity. When pathogen inactivation methods are available for all blood components, they will have great impact to protect the patients in countries where a high percentage of the population is infected by agents transmissible through blood transfusion, and in all situations to protect against new pathogens and ‘old’ pathogens that become more virulent. The total risk of contracting infectious diseases through blood transfusion will probably be important when implementation of new methods for pathogen inactivation is considered.     

Transfusion medicine: Overtime paradigm changes and emerging paradoxes

This essay aims to discuss some aspects of blood transfusion in the perspective of the changes that occurred over time as well as modifications of the paradigms that transformed the activities and the organization of blood transfusion services. Without specific knowledge, pioneers envisioned precision and personalized medicine, rendering transfusion medicine operational. Transfusion medicine is like The Picture of Dorian Grey: always young despite being old and sometimes appearing old-fashioned. Over the years, the transfusion medicine discipline has evolved, and major progress has been achieved, despite some troublesome periods (for example, the tainted blood scandal, and—at the time being—the offending plasma market and the selling of human parts). Transfusion medicine has at all times implemented the rapidly developing biomedical technologies to secure blood components. The safety of blood components has now reached an exceptional level in economically wealthy countries, especially compared to other health care disciplines. Strengthening of the safety has mandated that blood donors and recipients are unrelated, an issue which has eased preservation and fractionation practices; blood is no longer arm-to-arm transfused and neither is whole blood, the commonest component. However, it is interesting to note that a revival is occurring as whole blood is back on stage for certain specific indications, which is one among the many paradoxes encountered while studying this discipline.     

The management of nonconformities in blood establishments

With the introduction of quality management system as either a voluntary activity or based on legal regulation, a transfusion establishment is committed to consistent use of nonconformity management in all its activities. Nonconformities are mostly detected in blood products, in all steps of the manufacturing process. A product in broad sense also refers to the services offered. Nonconformities may be found in input materials, devices and equipment as well. Efficient management of these nonconformities is one of the key elements of the materiovigilance system. A special category are the nonconformities that need not be identified directly in the products, materials or equipment, but their occurrence may have adverse effects on the product and service quality, safety of those involved in the transfusion chain, user confidence, or transfusion establishment economy. Nonconformities may be detected in regular work process, or during internal and external quality assessment, inspections, evaluation of the quality system by the managing board, management of complaints, etc. Each blood establishment should have written procedure describing nonconformity management, while the personnel should undergo continuous education on all aspects of this segment of quality management. Along with making proper decision on the nonconforming product/nonconformity, in the procedure of nonconformity management it is of great importance to assess the potential impact of this nonconformity on other products or processes, and to prevent the possible additional damage on time. As the management of nonconformities has a critical role for the quality and safety of transfusion treatment and is involved in all transfusion service activities, it is no surprise that an array of quality indicators that serve as a basis for corrective measures and continuous quality improvement derive from this segment of quality management.     

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.     

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.     

The impact of COVID-19 pandemic on blood supplies and transfusion services in Eastern Mediterranean Region

BackgroundSevere Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has spurred a global health crisis. The safety and supply of blood during this pandemic has been a concern of blood banks and transfusion services as it is expected to adversely affect blood system activities. We aim to assess the situation in the Eastern Mediterranean Region (EMR) during the first months of the pandemic.Materials and methodsA survey was designed to address blood supply, transfusion demand, and donor management during the coronavirus disease-19 (COVID-19) pandemic. Medical directors of different blood banks were invited to participate.ResultsA total of 16 centers participated with representation from 15/19 countries in the region. In total, 75% were from national blood banks. Most centres had a decrease in the blood supply, ranging from 26–50%. Representatives from 14 countries (93.3%) believed that public fear has contributed to a decrease in donations. Most centres (n = 12, 75%) had a reduction in transfusion demand, while those who did not, reported heavy involvement in treating patients with underlying haemoglobinopathies and haematological malignancies. Half of the centres activated their contingency plans. Four centres had to alter the blood donor eligibility criteria to meet demands. All centres implemented donor deferral criteria in relation to SARS-CoV-2, but were variable in measures to mitigate the risk of donor and staff exposure.ConclusionBlood services in the region faced variable degrees of blood shortages. We summarize lessons learnt during this pandemic for the blood banks to consider to plan, assess, and respond proportionately to future similar pandemics.     

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.     

Developing haemovigilance in Latin American countries

Haemovigilance is seen nowadays as a potent tool to improve quality and safety in blood transfusion. It needs to be integrated into the quality systems of the institutions active along the blood chain (blood establishments - producers of blood and blood components, hospitals - users of blood transfusions). Not many details are known about haemovigilance systems and activities in countries of Central and South America. A short survey has been undertaken in order to gain a general synoptic overview of haemovigilance in Latin American countries. The results obtained are encouraging, but show at the same time that gaps and weaknesses in the national systems need to overcome. It is obvious that a more detailed and structured study is necessary to assess the actual situation and differences and to consider measures to strengthen haemovigilance in the different national systems.     

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.     

Don ou marchandise ?

The European Union and many transfusion international organizations and societies held the unpaid blood donation as an imperative for enrolling donors, not always providing the means for implementing this regulation, in particular induced by the (pharmaceutical) industry's hesitations. In spite of this, all available data, whatever former or recent, prove that the unpaid blood donation has a higher transfusion safety level than the remunerated donation's. The author also stresses that blood industrialization, while considerably improving the transfusion safety, has also destroyed the past vicinity between donor and receiver within the hospital environment, detrimental to enrolling donors. He also evokes challenges to be coming up soon in transfusion centres as well as changing the role of Red Cross and Red Crescent societies to refocusing their activities on the promotion of blood donation and donor enrollment.     

When things go badly – Managing quality problems and complaints in transfusion medicine

Continuous and dynamic progress in all segments of transfusion medicine has significantly improved the quality, safety and efficacy of transfusion therapy. In addition to the scientific and technological innovations, implementation of the quality system and haemovigilance in blood establishments significantly contributed to this progress. Despite the fact that most of the activities in transfusion chain take place without problems, some risks are still present and even the best organized and managed systems are sometimes faced with quality problems and complaints. In transfusion medicine, their causes are mostly related to the biological origin of blood products, while the complexity of the process and a large number of participants in transfusion chain facilitates the occurrence of errors. Some quality problems are caused by materials and equipment used in product realization, inadequate education or skills of the staff, suboptimal planning and organization of work. The best approach to managing quality problems is preventative approach, including comprehensive risk management, education, defining critical control points, permanent quality monitoring and audits. Quality problems and complaints should be resolved in a timely manner, following the standardized protocol with clearly defined responsibilities. All procedures and decisions should be documented and traceable. The root cause analysis of the problem should be carried out and followed by appropriate corrective actions. The ultimate goal is to increase quality, safety, productivity, efficiency and customer satisfaction, while reducing defects and costs.     

Transposing the E. E. U. Blood Directive into national law. Perspective of Slovenia.

Transposing the Directive (2002/98/CE) into the national legislation of EU Member States represents the basis for an equal minimal safe blood transfusion and a demanding job for each of these countries. In order to do this Slovenia will need to somewhat change and supplement the legislation adopted in 2000. In Slovenia, the introduction of the quality assurance system brought on the need for changes in the field of transfusion medicine some years ago. The Directive (2002/98/CE) above all signifies obligatory supplements in the field of organization of the transfusion services and especially organization on a national level. In the field of blood donations the development of the profession itself dictates changes. If and when the Directive (2002/98/CE) refers to clinical work, it will be easier to assert the demands for a more rational use of blood, its traceability and follow-ups of adverse events of a blood transfusion. An obligation to take into account the demands and standards of the Directive (2002/98/CE) will accelerate the fulfillment of numerous tasks which we have set for ourselves in the past in order to increase the safety of blood transfusion.     

Haemovigilance: recent achievements and developments in the near future

Since the introduction of haemovigilance in the 1990s, the majority of the European countries has established a national haemovigilance system and communication between these systems was organized through the European Haemovigilance Network (EHN). The concept of haemovigilance has steadily expanded and the number of haemovigilance systems outside Europe is increasing. Several of these systems have also joined the EHN. Furthermore, initiated by the World Health Organization, a Global Steering Committee for Haemovigilance has been installed to promote haemovigilance particularly in developing countries. Both these haemovigilance systems and the network have documented the safety of blood transfusion and indicated where the main problems and opportunities for improvement are. Furthermore, they have suggested measures for improvement of the safety and, last but not least, documented the effect of these measures. Therefore, they have contributed considerably to the improvement of the quality and safety of the blood transfusion chain. In the near future, the EHN will become an official International Haemovigilance Network. Ongoing developments concerning the scope of vigilance include the vigilance of optimal use of blood products and safety of cells and tissues of human origin (biovigilance).     

Safety of the blood supply in Latin America

Appropriate selection of donors, use of sensitive screening tests, and the application of a mandatory quality assurance system are essential to maintain the safety of the blood supply. Laws, decrees, norms, and/or regulations covering most of these aspects of blood transfusion exist in 16 of the 17 countries in Latin America that are the subject of this review. In 17 countries, there is an information system that, although still incomplete (there are no official reports on adverse events and incidents), allows us to establish progress made on the status of the blood supply since 1993. Most advances originated in increased screening coverage for infectious diseases and better quality assurance. However, in 2001 to 2002, tainted blood may have caused infections in 12 of the 17 countries; no country reached the number of donors considered adequate, i.e., 5% of the population, to avoid blood shortages, or decreased significantly the number of blood banks, although larger blood banks are more efficient and take advantage of economies of scale. In those years, paid donors still existed in four countries and replacement donors made up >75% of the blood donors in another eight countries. In addition, countries did not report the number of voluntary donors who were repeat donors, i.e., the healthiest category. In spite of progress made, more improvements are needed.     

Inactivation des pathogènes des concentrés plaquettaires : expérience française

The transfusion of platelet concentrates is increasing in oncohematology patients due to chemotherapy and hematopoietic stem cell grafts. The transmission of pathogenic agents, viruses, parasites and especially bacteria with platelet concentrates stored at room temperature (20–24 °C) is associated with a septic risk, partly prevented by bacterial detection. Photochemical inactivation of platelet concentrates, using a technique associating amotosalen and UVA, has been used for five years in a French region for the whole population and a large spectrum of patients, with efficacy and safety. Universal implementation of pathogen inactivation in labile blood products is a major and key step to improve safety against infection in transfusion.     

The White Book

It is necessary for European countries to have references and guidelines to cope with the wide field of blood transfusion. It is the institutions and professionals' role to provide for technical specifications linked to the collection, qualification, preparation, storage and distribution of labile blood products. In this context, EuroNet-TMS publishes every five year (2005, 2010...) a White Book meant to issue statements on the current situation, activities in progress in Europe and future developments.