Blood transfusion in a global context - Practice in Blood Centres and Hospitals

Practical Transfusion Medicine 4th Ed.

24. Blood transfusion in a global context

David J. Roberts¹, Alan D. Kitchen², Stephen Field³, Imelda Bates⁴ & Jean Pierre Allain⁵

¹ University of Oxford and NHS Blood and Transplant and Department of Haematology, John Radcliffe Hospital, Oxford, UK

² National Transfusion Microbiology Laboratory and NHS Blood and Transplant, Colindale, London, UK

³ Welsh Blood Service, Cardiff, Wales, UK

⁴ Liverpool School of Tropical Medicine, Liverpool, UK

⁵ NHS Blood and Transplant and Division of Transfusion Medicine, Department of Haematology, University of Cambridge, Cambridge, UK

Introduction

‘17% of the world's population has access to 60% of the global blood supply’

Inequality in the provision of ‘safe blood’ round the world mirrors the unequal distribution of almost all other resources crucial for effective health services or indeed for health itself. Unfortunately, in many countries, providing safe blood is made more difficult by lack of donors and the high frequency of transfusion-transmissible infections. At the same time, the problems posed by the poor supply of blood are compounded by the frequent need for urgent life-saving transfusions in childbirth, in children with malaria and the increased demand for HIV/AIDS patients.

The purpose of this chapter is not to guide those developing transfusion services in less affluent countries but to inform a wider audience of the problems faced in the development of effective transfusion services in these countries. A secondary aim is to stimulate some debate and analysis of the problems faced by transfusion services globally. Finally, a short chapter must be selective and our choice of topics and examples, and their solutions, reflect our own experience in Southeast Asia and sub-Saharan Africa.

Blood safety or blood supply?

A safe and rapid supply of blood is an essential part of medical services. An unsafe blood supply is costly in both human and economic terms. Transfusion of infected blood not only causes direct morbidity and mortality in the recipients but also has an economic and emotional impact on their families and communities and undermines confidence in modern healthcare. Those who become infected through blood transfusion are often infectious to others and contribute a significant secondary wave of iatrogenic infections. Investment in safe supplies of blood is cost-effective for every country, even those with few resources. At the same time, an insufficient supply costs lives; in developing countries, transfusion does save lives because, unless transfused, severely anaemic patients do not survive. This has been shown in 26% of haemorrhages in pregnant women when not transfused and in infants with acute malaria [1,2]. Where should the priority be? The shockwave of the HIV epidemics put overwhelming emphasis on blood safety but now that >80% of HIV infected patients survive >10 years, the supply of blood should take back its legitimate place as a priority.

The World Health Organization (WHO) has identified four key objectives for blood services to ensure that blood is safe for transfusion.

· Establish a coordinated national blood transfusion service that can provide adequate and timely supplies of safe blood for all patients in need.

· Collect blood only from voluntary nonremunerated blood donors from low risk populations and use stringent donor selection procedures.

· Screen all blood for transfusion-transmissible infections and have standardized procedures in place for grouping and compatibility testing.

· Reduce unnecessary transfusions through the appropriate clinical use of blood, including the use of intravenous replacement fluids and other simple alternatives to transfusion, wherever possible.

The WHO also emphasizes that effective quality assurance should be in place for all aspects of the transfusion process, from donor recruitment and selection, through infection screening, blood grouping and blood storage, to administration to patients and clinical monitoring for adverse events.

It is axiomatic that transfusion medicine is a distinct and multidisciplinary sector of the health service and should be incorporated into national health plans. It is the responsibility of governments to develop policies and legislation that will facilitate the development of a national transfusion service and ensure that the blood transfusion process and its associated quality assurance programmes are of a high standard. However, it must be realized that in some areas such as sub-Saharan Africa, transfusion is almost exclusively an emergency measure to treat patients with extreme, life-threatening anaemia. This situation has two important consequences.

· Blood is considered a therapeutic commodity with little more regard from the medical community and government than drugs delivered by the pharmacy.

· Whole blood is an appropriate choice, helping to reduce the cost of transfusion (sparing component preparation expenses).

The WHO has provided a recommended structure of national blood transfusion services. They suggest that at the national level the transfusion service should have a medical director, an advisory committee and clear national transfusion policies and strategies with the appropriate statutory instruments to ensure the national coordination and standardization of blood testing, processing and distribution. Notwithstanding these recommendations, transfusion activities must be integrated with other services at local and national levels.

There has been some progress to realize WHO's recommendations for a national blood programme. In Africa, in 2002 the WHO estimated that among the 46 member states in the African continent, only 14 had a national blood policy and just six had a policy to specifically encourage and develop a system of voluntary nonremunerated donation. In the most recent survey, in 2007, 40/41 of African states surveyed had a national blood policy, but only 56% (23/41) countries were able to implement their policies.

It is worthwhile reflecting on why the development of national transfusion services has not been achieved. A key reason is that it is logistically complex. Management skills to run such services are lacking. There has been an understandable emphasis on primary healthcare over the last 25 years and this may have diffused interest in hospital-based curative medicine. A second reason may be the high cost of blood transfusion in relation to disposable income and healthcare budgets. The average annual income in sub-Saharan Africa is in the range of $400–1000, and a unit of blood costs $10–20 in a hospital service and $60–100 in a centralized service. Blood is therefore an expensive commodity in relation to the annual per capita budget for healthcare in these countries and it remains to be seen if blood costing more than $50 per unit when produced in centralized, externally funded units is sustainable. Precise cost–benefit analyses for the use of blood have not been done. Nevertheless, blood transfusion for severe malarial anaemia and severe haemorrhage can be life saving, and it seems plausible that the cost of transfusion probably approaches the generally accepted cost–benefit range of $1 per year of life saved for health interventions in the poorest countries.

Box 24.1 Case studies: examples of blood transfusion systems in sub-Saharan Africa

Integrated National Blood Service – Ivory Coast

The Côte d'Ivoire blood service was created in 1992 with substantial subsidies from the European Union. A National Blood Transfusion Centre is located in Abidjan, the capital, with three smaller provincial centres. In addition, blood depots are located in hospitals of five other main cities. For a population of 18 million, approximately 80 000 units of blood were collected in 2002, mostly from volunteer blood donors recruited amongst secondary school students (>60%), although 24% of them were first-time donors.

Any hospital in the country can access the blood supply free of charge to the hospital and the patients. The government allocates funding. Less than 20% of the blood is processed into blood components that are mostly used in the capital. Antibodies to HIV, HCV as well as HBsAg are tested by EIA in the capital. The recurrent cost per unit produced is estimated at $40.

Regional hospital – Ghana

In a 1200-bed hospital, the current demand for blood components is, in adults, whole blood for acute anaemia or massive haemorrhage and in children 200 ml plasma-depleted red cells for anaemia related to malaria, sickle cell disease or thalassaemia. Approximately 10 000 candidate donors are screened per year and 7000 blood units are available for clinical use. Patients' families are asked to pay $14 for a unit of blood and $7 if the blood is replaced. Volunteer blood is primarily collected in secondary schools (80% of total volunteer donations). Anti-HIV, HBsAg and anti-HCV are screened pre-donation with high performance rapid tests so that blood bags (representing one-third of the total consumable budget) are not wasted. Furthermore, deferred donors can be identified, informed and counselled, and contribute to a decreasing prevalence of viral markers in volunteer donors.

Rural community hospital – Zimbabwe

This 40-bed hospital is too isolated to conveniently order and receive blood from the regional hospital centre and has to rely on its own resources to produce the 100–200 blood units per year they need. They have procured the blood bags and the anti-HIV and HBsAg rapid tests from the regional blood centre. Because of the small demand, collecting and keeping a refrigerated blood stock is neither feasible nor economical. The staff have designed an alternative strategy called ‘blood club’. The local population was informed about transfusion through village meetings and sketches presented by the local drama group, which illustrated situations involving the need for blood and blood donors. Volunteers who agreed to join the club were registered and tested for blood group and HBsAg. HBsAg negative volunteers (80%) are called upon if blood is needed in the hospital. When a patient needs blood, the blood group is determined and two blood group-matched volunteers are brought to the hospital and tested for anti-HIV. Blood is then collected from an HIV-negative donor. The patient's family are charged $9 for each unit of blood.

The WHO ‘volunteer only’ policy has had considerable negative side effects in sub-Saharan African countries that implemented it on the basis that it increased blood safety. This was based on the assumption that volunteer nonremunerated donors (VNRD) were safer than the traditional family-replacement donors (FRD). Recent data from multiple sources showed clearly that there was no difference in prevalence of confirmed viral markers between first time VNRD (60–90% of VNRD) and genuine FRD [3]. Blood shortage was maintained if not worsened by excluding a perfectly acceptable source of blood and costs were kept unnecessarily high.

To prepare enough safe blood in a sustainable fashion, African countries need to develop their own ways to produce it. Uncritical adoption of external advice and models may lead to unsustainable and inappropriate solutions. What then are the models of transfusion services in Africa and what are the consequences for the timely supply of safe blood?

Organization of transfusion services in sub-Saharan Africa

African countries have developed a variety of systems to try to achieve a sustainable safe blood supply. These vary from large, modern, national blood centres to locally organized donor programmes for individual district healthcare facilities [4].

A minority of countries have invested significant resources in transfusion services, often with financial support and advisers from European governments, the United States Agency for International Development (USAID) or nongovernmental organizations (NGOs), including Red Cross, Red Crescent, Family Health International and the Safe Blood for Africa Foundation. In these countries, there has been a commitment to establishing centralized systems based on the example of wealthy nations (Box 24.1). These centres typically collect over 10 000 units a year, use automated equipment and produce some blood components. Blood donor recruitment, screening and processing of donated blood are carried out in specifically designed premises away from the hospitals where blood is transfused. However, the majority of countries in sub-Saharan Africa do not operate a centralized transfusion service. Each hospital recruits blood donors and processes blood for transfusion. These hospitals often handle less than 1000 units a year and experience difficulties in standardization, quality assurance and in maintaining supplies of high quality reagents [5].

Recruiting voluntary donors from the community is complex and expensive and depends on regular education programmes, collection teams, vehicles and cold storage. It is proving very difficult to expand the number of volunteer donors [5]. Indeed, over the last 15 years, there has been increasing difficulty in persuading donors to donate, as fear of knowing one's HIV test result has become more widespread. There are also cultural beliefs surrounding blood donation that inhibit donors coming forward. Some of these appear to be misinformation about donating blood (e.g. ‘men will become impotent if they donate blood’; ‘HIV can be caught from the blood bag needle’). It is worth noting that similar problems faced widespread acceptance of blood donation when Percy Oliver and Geoffrey Keynes began to establish the first blood banks of volunteer donors in London over 70 years ago.

There are, however, other cultural beliefs that are much more complex and related donors' to deep-seated and ethnographically diverse understanding of the value of blood to the individual and to society, e.g. blood is related to kinship or personal health. Understanding local beliefs surrounding blood and blood donation is likely to be important in developing effective services.

As volunteer donors are in short supply, family members are frequently used to provide blood for their relatives in hospital. In 2002, in Africa as a whole, WHO estimated that over 60% of blood originated from replacement/family donors. In sub-Saharan Africa the proportion of blood derived from replacement donors is certainly higher. These replacement donors should be family members, but relatives may not only be reluctant to donate for the reasons discussed above but are also open to exploitation by ‘professional donors’ who charge relatives a fee to donate in their place. Most viral infections such as HIV, HBV and HCV have similar prevalence in replacement and volunteer donors. There are therefore no objective reasons to reduce replacement donors in sub-Saharan Africa (and elsewhere); being both volunteer and nonremunerated, they share with volunteer nonremunerated donors in Sub-Saharan Africa the difficulties of becoming regular donors. Local transfusion systems allow many patients to survive serious illness and are often maintained by dedicated staff in difficult circumstances. However, even with the best input from local staff, these district services experience problems of supply and safety.

The supply of blood

Patients in poorer countries usually present late in the course of their disease, and the delays and lack of stored blood inherent in the replacement donor system mean that patients may die before a blood transfusion can be organized. By the time a donor has been found, screened and venesected, and the blood is transfused into the patient, several hours or even days can elapse. A survey of the blood supplied by a dedicated district service in East Africa showed that the average delay in sourcing blood for children with severe malaria anaemia was 6 hours. Anecdotal evidence suggests that in some areas and at some times in many areas blood may not be available at all. Finally, locally based services at regional or national centres have difficulty in separating blood, even into simple fractions such as red cells, platelets and plasma, to provide specific components if needed.

Testing and storage of donor blood

Local blood transfusion services encounter many problems, including lack of funding, insufficient training, poor management, frequent failure to supply reagents and consumables, and breakdown of the cold chain mostly related to frequent power cuts. Blood frequently has to be collected in small hospital-based units often with no dedicated staff and no specifically allocated budget. In the year 2000, the WHO review estimated that 25% of the blood in sub-Saharan Africa was not tested for anti-HIV and that blood transfusion was the origin of 5–10% of new HIV infections. Since then, a lot of investment has gone into providing HIV, HBsAg and to some extent HCV tests. The latest survey shows that >98% of blood is tested for HIV. The residual risk of HBV infection remains substantial because of donations containing undetected low levels of HBsAg or occult HBV DNA. Recent estimates of the residual risk of HIV transmission are 1:2600–6000, hepatitis C 1:400–1500 and hepatitis B 1:300–500, when using enzyme immunoassay (EIA) screening [6,7].

The cost of local blood supply

When a transfusion service is provided by individual hospitals, it places an enormous burden on laboratory resources. There has been almost no research into the cost of setting up and running transfusion services in resource-poor countries. One survey showed that in a typical district hospital in southern Africa, the overall cost of the transfusion service, including consumables, proportional amounts for capital equipment, staff time and overheads, was 36% of total laboratory costs. Each unit of whole blood cost the laboratory approximately $20 to collect and process.

The cost of a national service is even greater because of the additional costs of quality assurance, local education programmes, dedicated collection team(s), vehicles and cold storage. In addition, a national service has to solve the very real practical problems of maintaining regular distributions of sufficient quantities of blood to remote facilities. It is also frequently observed that the creation of a national service creates internal migration of technical staff from hospitals to national or regional centres. One solution to this would be to train staff specifically for the processing, testing and issue of blood and so release the time of valuable, skilled hospital staff.

Clinical use of blood

In contrast to Europe, most transfusions in sub-Saharan Africa are given for life-threatening emergencies, most often anaemia in children or pregnant women and haemorrhage following childbirth or trauma. Transfusions are administered to children predominantly for malaria-related anaemia and can undoubtedly reduce the mortality of children with severe anaemia. In these clinical circumstances, whole blood is indicated and should remain the main and cheapest blood component while packed red cells are indicated for nonhaemorrhagic indications, particularly in paediatrics and medicine. Many clinical guidelines, albeit based on consensus opinion rather than well-defined evidence, suggest transfusions are indicated if Hb < 4 or 5 g/dL with symptoms of decompensation [1, 8]. Even in areas of high HIV prevalence, young children generally have a relatively low risk of becoming naturally infected with HIV and potentially have a long life expectancy. Pregnant women are the second most common recipients of blood, particularly for haemorrhagic emergencies. Significant quantities of blood are also used in trauma, surgery and general medicine. There are neither systematic reviews nor international guidelines covering the use of blood in these specific contexts, and few audits of blood use. The scope for improving clinical practice and reducing unnecessary transfusion through education and the use of guidelines is probably substantial.

The problems surrounding the rapid supply of a safe supply of blood have led to the use of autologous blood transfusion. There are logistical and training problems to be overcome. However, small programmes have been established for autologous transfusion of elective surgery patients at district hospitals.

Putting the WHO objectives into practice: improving the supply, safety and use of blood in sub-Saharan Africa

Some countries have used external funds to establish an integrated national service, but few have been able to make the transition to a sustainable, national transfusion service in the absence of external funding and even fewer have been able to reach an adequate blood supply. Moreover, in several countries, external funding for ten or more years has failed to develop a functioning national transfusion service, and these failures have led some funders to withdraw grants to national transfusion services. However, some recent success has been achieved in developing a transfusion service in several centres in Nigeria (see Box 24.2). The alternative is that, in many areas, transfusion services have to be optimized within the existing general hospital budget. Whatever sums are available the specific, often interconnected problems, surrounding the supply, safety, cost and use of blood must be addressed. There has to be a balance between providing an ideal integrated national service and the more pragmatic solutions afforded by local services.

Box 24.2 Towards development of a National Transfusion Service in Nigeria

Nigeria, the most populous country in Africa, had in 2004 a highly fragmented hospital-based transfusion system. There was little coordination from the central government and most of the blood came from replacement and paid donors. Testing for transmissible disease markers was inconsistent and poorly controlled. The current practice of family replacement donors in a hospital-based blood service is the most economical option, but in the face of high child and maternal mortality rates the blood supply has proved to be insufficient. There was therefore the need to change practice.

The Safe Blood for Africa Foundation with a grant from USAID established a demonstration blood service in capital Abuja. This service collected its blood from voluntary unremunerated donors in the local community. The blood was tested for HIV, hepatitis B and C, labelled with ISBT 128 compliant labels and distributed to the local hospitals. A simple but effective quality management system was established with standard operating procedures written and followed. A validated transfusion computer system was installed which only allowed release of validated units of blood to hospitals. The objective of this project was to be the model for other centres throughout the country. The Federal Ministry of Health soon established regional centres in Kaduna, Owerri, Port Harcourt, Ibadan, Maiduguri and Jos, and has a long-term plan to roll out further centres in future. The Minister of Health also established an expert committee which drafted a national blood policy and national guidelines for the standards for the practice of transfusion in Nigeria. The Safe Blood for Africa Foundation provided technical assistance for the establishment of these centres and provided training to the staff in all elements of transfusion.

The major problem was to recruit blood donors. The youth were encouraged to donate with the establishment of a Club 25 programme. There was active promotion through the media and was highlighted by a televised donation by the President on the occasion of the official opening of the Abuja centre. A problem encountered was the high number of donors presenting with haemoglobin levels below the required standard of 12.5 g/dL. This is probably a reflection of the poor health status within the community.

Improving the blood supply and the safety of the donor pool

Careful donor selection is crucial not only to improve the supply of blood but also to reduce transfusion-transmitted infection risk (see Box 24.3 and Table 24.1). The selection of volunteer donors from lower risk populations is considered the most effective approach and considerable effort has been devoted to promoting voluntary, repeat donations. However, in most parts of Africa, replacement donors are the main resource. They are typically males 25–35 years old. As the availability of replacement donors is limited, the most effective way to improve the availability and safety of blood is to recruit volunteer donors. In practice these are often secondary school students with median age ranging between 16 and 20 years. They are younger and have a greater proportion of females than replacement donors. Experience has shown that while recruiting volunteer donors in schools can be relatively inexpensive, making them into repeat donors is difficult and expensive. Since only repeat donation has been proven to increase blood safety, encouraging both volunteer nonremunerated and family-replacement donors to donate blood repeatedly is the challenge for sub-Saharan African blood services in order to provide safer blood [3, 9].

Table 24.1 Prevalence of transfusion-transmissible agents in sub-Saharan African blood donors.

Table024-1

Box 24.3 Epidemiology of bloodborne infections in sub-Saharan Africa

HIV

The overall prevalence of HIV antibody in sub-Saharan Africa ranges between 0.5 and 16%. In donors, it tends to remain below 5% in West Africa, below 10% in East and Central Africa and above 10% in southern Africa [4, 10, 11, 18].

Hepatitis B

Chronic hepatitis B prevalence, indicated by the presence of circulating HBsAg, ranges between 5 and 25% of the population including blood donors. This high prevalence is due to (vertical) transmission at birth or (horizontal) infection in infancy and the virtual absence of national vaccination programmes. Infection after the age of 10 is uncommon. HBsAg is more prevalent in West Africa (10–25%) than in East or Central Africa (5–10%); the lowest prevalence is found in southern Africa (5% or less).

Hepatitis C

Antibody to HCV is not routinely screened for in many parts of Africa, but the prevalence of this infection ranges between 0.5 and 3% and reaches 10–15% in Egypt. The prevalence may be high locally, suggesting the importance of specific factors such as various types of injections and past diagnostic or vaccination campaigns contributing to spread the infection.

Other infections

Most countries in sub-Saharan Africa do not screen for HTLV since the prevalence is low (<2%).

Although the risk of acquiring syphilis from infected blood is low, most blood banks in sub-Saharan Africa do screen for Treponema pallidum. Fresh blood is potentially infectious for syphilis, but storage at 4°C can inactivate the bacterium.

Malaria can be transmitted by transfusion. In areas of low or no malaria transmission, screening for the parasite is important, as recipients are likely to have no immunity. In countries where malaria is highly endemic, the prevalence of Plasmodium in donor blood is often very high (16–55%) [19] and excluding donors with low-grade parasitaemia is often impracticable and pre-emptive treatment of patients receiving transfusion with antimalarial drugs often an unfortunate necessity [20].

Bacterial contamination of blood components is underrecognized and may reach 10% of products at the time of issue [15,16].

Residual risk of transfusion transmission of bloodborne viruses

Improving the size and reliability of the donor pool affects not only the supply but also the safety of blood. In particular, a previously screened donor pool would reduce the substantial residual risks of transfusion-transmitted infection due to the window period for HIV and HCV and occult chronic carriage for HBV (HBsAg negative/DNA positive).

The present residual risk of viral transmission by transfusion has been assessed for HIV. In studies conducted in Kenya, Zambia and the Democratic Republic of the Congo, the risk of HIV transmission by transfusion was estimated to be between 1 and 3%, related in part to prevalence, but also to test performance, storage conditions and staff training. The residual risk of HBV infection remains substantial because of donations containing undetected low levels of HBsAg or occult HBV DNA. This risk remains high for children below the age of 10 but the problem is at least in part mitigated by the very high prevalence of adult recipients carrying HBV markers (60–90%). Precise estimates of the residual risk of HIV transmission in Ivory Coast in 2002–2004 were 1:2600–6000, HCV 1:400–1500 and HBV 1:300–500, when using EIA screening.

These figures represent the risk of the respective infection even when using the best EIAs. This residual risk emphasizes the pressing need to improve the safety of the donor pool, to develop cheap and reliable nucleic acid testing and to optimize the use of blood.

Several strategies have been devised to encourage repeat donors and thus reduce the risk of virus carriage. In Zimbabwe, Pledge 25 Club, a programme using education and incentives to attract school students to give blood 25 times, has been successful. Similar, less ambitious schemes, for example a ‘Club 5’, could also be effective. The WHO slogan of ‘Safe blood starts with me’ has also resulted in educational programmes around the world. These schemes can be complemented by strategies to recruit donors from faith-based organizations or collaborating with radio stations to organize and promote blood donations. The success of well-organized requests for blood donors has been proven in some campaigns but remains to be tested in many countries where national calls for donors have not been made in the absence of centralized blood transfusion services. Specific strategies intending to encourage family-replacement donors to become repeat donors are being developed, shifting from donating blood for someone they know to someone they do not know.

The best use of fluid replacement regimes for severe haemorrhage requires further study. At the same time, other novel solutions are being sought to alleviate the shortage of blood. It may be feasible to use placental blood as an accessory source of blood to transfuse small children in malarious areas. The placenta containing this blood is normally discarded after delivery. However, the high haematocrit and easy availability may make it suitable for small-volume emergency transfusions if blood can be collected free of bacterial contamination, which appears to be a major obstacle to implementation of such programmes.

Improving screening for blood-transmitted infections

Test sensitivity is critical in the face of high prevalence rates for HIV, HBV and HCV (Box 24.3 and Table 24.1) [4, 10, 11]. These high prevalence rates pose a very substantial danger and a major logistic and technical challenge to those trying to provide safe blood. Even with the best available testing procedures using antigen or antibody detection there remains a substantial residual risk of HIV transmission in the order of 1 in 3000 though the failure to detect seronegative early HIV infection in the pre-seroconversion window period (see above). In these situations, the prevalence rate may be reduced by 90% in repeat donors, reinforcing the value of a stable donor pool.

The techniques used for screening must be considered carefully to ensure effective screening of the particular donor population and the skills of the staff involved. Nucleic acid testing is highly effective and has been introduced in South Africa and a few centres elsewhere [12]. However, widespread use of NAT remains neither affordable nor practical for most centres and countries. Cheaper and/or simplified methods to perform NAT testing would be useful.

New approaches adapted to local situations appear promising. In small blood banks, the expensive microtitre plate systems used post donation can be replaced by cheaper, more cost-effective, high-performance rapid tests performed pre- or post-donation. Pre-donation testing provides the advantages of reducing material waste and easy, on-site communication with deferred donors who, otherwise, could not be reached [13]. There are fears that pre-donation testing may reduce the willingness of donors to come forward, although published data did not find evidence of this. At present, WHO does not recommend pre-donation testing. There is a diversity of opinion and some consider that WHO and aid agencies need to show flexibility and consider the benefits of multiple strategies adapted to local needs rather than recommending rigid models designed for totally different populations, staff and resources.

Without good quality assurance in collection, processing and testing of blood, the risk of HIV transmission by blood transfusion in high prevalence areas is very substantial [14]. There are encouraging reports that the application of stringent blood donor selection and universal screening with fourth-generation p24 antigen and HIV antibody assays when well monitored and controlled may be able to reduce the risk of HIV transmission to <1 in 3000 [7].

Some new technology is on the horizon. Rapid immunochemical and nucleic acid dipsticks are being developed for bloodborne pathogens and may cut the cost of pre- and post-donation testing to a tenth of present costs. Clearly, these and other inexpensive and effective testing technologies, as well as pathogen inactivation techniques, directed towards the needs of developing countries should become a major target of external support.

The WHO has established systematic evaluations of both EIA and rapid tests to guide developing countries in their choice of tests. These evaluations include test costs. Many rapid tests for anti-HIV and HBsAg and fewer for anti-HCV are available, but sensitivity and specificity, ease of use and cost vary greatly. Some of these tests are performed in one single step with results obtained in 10–20 minutes using whole blood, plasma or serum samples. The best assays have sensitivity similar to EIA for anti-HIV, detect 0.2 ng/mL of HBsAg and have >99% sensitivity for anti-HCV and >99% specificity.

Blood safety has often focused on the risk of viral infection in donors but bacterial contamination of units is a substantial problem. Two recent studies have highlighted the considerable risk of bacterial infection in nearly 10% of whole blood units [15,16]. Contamination appears to be of environmental rather than of donor origin and clearly may pose a substantial risk to patient safety. Quantifying and reducing these hazards will be an important challenge in the future.

Reducing the cost of transfusion services

The challenge for Africa is that enough safe blood should be available for health services and individuals even when resources are extremely limited. The majority of a blood unit cost originates from imported goods such as equipment, blood bags, grouping and screening assays. Staff costs are a relatively small proportion of the overall costs because salaries are low and because negligible resources are put into staff training, supervision and auditing mechanisms. According to published studies, a unit of blood from a hospital-based service may cost between $10 and 40, but even $10 is not affordable by most families in sub-Saharan Africa. Staff and logistic support for collecting volunteer nonremunerated donor blood account for 100–300% of additional costs compared to family-replacement donor blood collection. In any event, the relative high cost of providing blood makes it impossible to recoup the cost of blood by user fees alone and blood services will require internal or external public funding for the foreseeable future [17].

Because transfusion is such an expensive service, the costs often have to be subsidized by aid packages, external agencies or governments. Resources for transfusion services are often vulnerable to fickle, political and nonsustainable fluctuations. Developing systems that rely more on local resources means that in the long term they may be more dynamic, productive and sustainable. Certainly, much more research is needed comparing the cost-effectiveness of various strategies to supply safe blood to patients in poor countries.

Improving the clinical use of blood: guidelines for transfusion practice

The use of simple guidelines can reduce unnecessary transfusions and many institutions in sub-Saharan Africa and Asia have developed guidelines to promote rational use of blood transfusions and blood components. The scope for improvement in clinical practice is great. For example, strict enforcement of a transfusion protocol in a Malawian hospital reduced the number of transfusions by 75% without any adverse effect on mortality.

The principles underlying most transfusion guidelines are similar and combine a clinical assessment of whether the patient is developing complications of inadequate oxygenation, with measurement of their haemoglobin (as a marker of intracellular oxygen concentration). In sub-Saharan countries, the recommended haemoglobin threshold for transfusions is often well below that which would be accepted in more wealthy countries. In the USA, anaesthetists suggest that transfusions are almost always indicated when the haemoglobin concentration is less than 6 g/dL whereas in many African countries transfusions are recommended for children at haemoglobin concentrations less than 4 g/dL, provided there are no other clinical complications.

Ensuring that the transfusion guidelines are implemented is extremely difficult for poorer countries without formal monitoring and auditing systems. This is particularly problematic if the quality of haemoglobin measurements is not assured. Studies have shown that if clinicians do not have confidence in haemoglobin results, they will rely entirely on clinical judgement to guide transfusion practice and this can lead to significant numbers of inappropriate transfusions. In a typical district hospital in Africa the cost of providing a unit of blood is approximately 40 times the cost of a quality-assured haemoglobin test. Investment in improving the haemoglobin testing therefore has the potential for significant cost-saving downstream in the much more expensive transfusion process, as well as reducing the risk of transfusion-related infections.

Conclusion: the future of blood transfusion in a global context

Fulfilling the first WHO objective of establishing ‘a coordinated national blood transfusion service that can provide adequate and timely supplies of safe blood for all patients in need’ has proved to be very difficult in many countries, even given substantial external funding. Nevertheless, some countries have made progress and have recently established national transfusion services. On the other hand, progress has been made by developing local services and there has to be a balance between providing an ideal integrated national service and the more pragmatic solutions afforded by local services. Such a system does not necessarily imply centralization but hybrid systems including both purpose-built off-site large blood centres as well as hospital-based smaller units implementing adequate methods and quality assurance might serve patients optimally. There remains considerable scope to optimize fluid management regimens and to reduce unnecessary transfusions through the appropriate clinical use of blood and products.

Increased blood supply depends on the recruitment of all types of nonremunerated donors, whether volunteer nonremunerated donors or family-replacement donors, and the development of innovative strategies to make both groups of donors to give blood regularly. The examples and discussions in this chapter have centred on Africa, but the same considerations apply to many of the poorer countries in Asia and Latin America. In Brazil, both volunteer nonremunerated donors and family-replacement donors are considered under the same term of ‘voluntary’ donors. Here, there are wide variations in resources available for healthcare, not only between but also within countries.

In all countries, increased blood supply depends on the recruitment of volunteer donors and this should become the priority for policy development and resource allocation. A reliable and expanded donor pool will not only provide a life-saving therapy but also improve safety. Resources must be made available by governments to ensure that the essential supplies are available, such as blood bags, grouping reagents and test kits, and laboratory and blood bank management systems also need to be improved to ensure effective testing and processing, and the maintenance of the cold chain. Hospitals and other health facilities could cooperate to directly purchase cheap, high quality tests adapted to their needs.

There is currently a feeling of guarded optimism about the future of blood supply and safety in developing countries. The recent increase in allocation of resources for the prevention of HIV across the world, including the investment by governments of wealthy countries and contributions from international and private agencies, have begun to recognize the importance of reducing HIV transmission through blood but run the risk of neglecting other basic laboratory services, e.g. blood grouping and haemoglobin measurements. Parallel to the price reduction for antiviral drugs, the cost of screening tests supplied to developing countries has also decreased. The high cost of anti-HCV testing should now be reduced as the patent has expired in Europe. Also possible methods of pathogen inactivation applicable to whole blood are being developed that could, in one step, reduce or eliminate the risks of viral, bacterial and parasitic infections. More effective and efficient methods for testing blood are to be welcomed and pathogen reduction methods applicable to whole blood would be an enormous relief if affordable. The real challenge will be to integrate improvements in the supply and safety of blood in sustainable, coordinated national transfusion services.

Key points

1. In the last 5 years, nearly all African states had a national blood policy, but just over half have been able to implement their policies.

2. The main obstacles to implementation are a lack of trained staff, the high cost of blood in relation to the healthcare budgets and recruitment of donors.

3. In the absence of centralized services, facilities rely on blood collected by hospitals from family or replacement donors.

4. The high rate of chronic viral infections in the populations implies that the residual risk of infection of HIV and hepatitis B infection remains substantial with EIA testing.

5. Several initiatives are being trialled to improve the supply and/or safety of blood by encouraging repeat voluntary donors, reviewing donor testing strategies, developing systems that rely more on local resources, using umbilical cord blood and researching methods for low cost NAT testing.

6. There are few guidelines covering the use of blood and few audits of blood use so the scope for improving clinical practice and reducing unnecessary transfusion is probably substantial.

References

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