Countries with low and medium human development index (least developed and developing countries) represent 82% of the human population but use only 39% of the global blood supply. Additional funding for blood services is needed in these countries, but that alone does not level out this unfair balance. Political will of the decision makers to acknowledge the existence blood transfusions and blood banks and to create an organization for them is a prerequisite for development. Acceptance of blood transfusion as a specialty in medicine and national coordination of the blood services provide better service even with the already existing financial input given to blood transfusion. Different models for blood service operations exist; a centralized national blood service is not the only alternative and may not be feasible in large countries, but national coordination is beneficial even for them. Education of the public for voluntary, non-remunerated blood donation and training of the personnel can be achieved even with limited resources, and guidance as well as training material is available, e.g. from the World Health Organization. Regulation of blood services helps in improving the safety of blood transfusion, but lack of laws and regulations must not be accepted as an excuse for not organizing the blood services. International assistance may be necessary after decisions of a nationally organized or coordinated blood service system have been reached, and implementation is planned. However, without local commitment at all levels – national, regional and local – sustainability cannot be expected.
The World Health Organization Global Database for Blood Safety (GDBS)1 shows that countries with a low human development index (HDI) use only 3% of the global blood supply although they account for 11% of the global population. Countries with a medium HDI use 36% of the global blood supply and have 71% of the global population. Low- and medium-HDI countries are either developing countries or countries with limited resources. Countries with a high HDI (the industrialized world) represent only 18% of the global population, but use 61% of the global blood supply (Figure 1). This and other data presented in the GDBS demonstrate that there is a definite need to build sustainable blood transfusion services in developing countries.
ALTERNATIVE MODELS FOR SUSTAINABLE BLOOD SERVICES
Individual doctors as well as surgical and obstetric wards find their own solutions to treat bleeding patients with blood transfusions even if no nationally organized or other official blood service system exists. Blood transfusion may sometimes be the only available treatment in countries with limited resources for hospital care, partly because alternatives to blood such as physiological saline solutions, colloids or other plasma expanders are not available.2 This in turn may lead to ineffective and unnecessary use of blood. It is conceivable that having an organized blood service in the hospital gives a better result with the same financial resources and saves time and energy of the clinical wards. These arguments, in addition to improved safety of transfusion, should be sufficient to justify building a blood service in the hospital.
This reasoning can be extended to the national level, justifying the creation of national blood service organizations. The size of the country and/or its infrastructure may require regionalization of the national blood service system. Many countries, even in the industrialized world (United Kingdom, France, the Netherlands, Denmark), which can well bear the costs of hospital-based or independent individual blood services, have in recent years reorganized their blood services into national or regional systems. This has resulted not only in financial savings but also in a better and more uniform level of quality assurance and improved safety of blood transfusion on the national scale.
A national blood service organization in its ideal form sets many requirements to the infrastructure of the country. Conceivably, a district medical officer working in a village with 100 km of dirt road connection to the nearest hospital and no decent transportation, and with a profusely bleeding patient, cannot understand how a national blood service could help him/her in that particular situation. However, the options of national versus local blood services do not need to be mutually exclusive. While understanding the doubts,3 one should recognize that some kind of national coordination, guidance and regulation, as recommended by the World Health Organization, would be beneficial even for the local and independent blood services and also for the lonely district medical officer. Uniform standard operational procedures, quality requirements and standards for the operations and blood component production are advantages of nationally coordinated or national blood service systems.
The obstacles of creating sustainable blood services in developing countries (Table 1) are difficult to overcome. It is important to realize that the budget given for the blood services must be proportionate to the total healthcare budget of the country or, in the case of an independent hospital blood bank, proportionate to the hospital budget. It is difficult to define what this proportion should be. In many industrialized countries, some 2–3% of the hospital budget for medicines goes for blood and blood products. This may not be a right yardstick for developing countries. In any case, upon making the decisions on the resources given to blood services, the decision makers should be made aware of all associated risks if the allocated funds are inadequate and compromise tests for transmissible diseases or other functions, which are necessary for sufficient safe blood donation and transfusion.
Table 1. Important requirements, and obstacles to overcome, for building and sustainability of blood services in developing countries
Responsibility for decision
Responsibility for implementation
Sustainability is improved if the political commitment and provision of funding for the blood service activities are defined by national legislation.
The above-mentioned district medical officer decides himself about the blood transfusion requirements for his patients. He may collect the blood himself as he may not have any blood service to turn to. Likewise, a hospital can decide upon the establishment of its own independent blood transfusion service. Such a decision may be easy to reach in some cases, but can be defended in general only if there is no national blood service system or none such is to be expected. The hospital clinicians who use the blood may see this option as a rapid solution for satisfying their immediate needs. There may also be other factors such as geographical and/or logistical as well as political problems which favor independent hospital blood services.
Political decision on establishment of a national blood service is often difficult to reach because not only national decision making but also agreement and cooperation of the hospitals are needed. Obtaining acceptance from the hospitals is more difficult if there are already existing hospital blood services. In large countries (e.g. with a population over 20 million), it may be politically and technically wise to allow regional independence for blood services, but a national coordination in some form can be feasible and politically acceptable, and should be preferred.
All different types of blood service systems have their advantages and disadvantages. Some of the strengths, weaknesses, opportunities and threats of the national government operated, Red Cross and Red Crescent as well as hospital-based (but nationally coordinated) blood services are presented in Tables 2, 3 and 4.
Table 2. Strengths, weaknesses, opportunities and threats of the government-operated national blood service system
Strengths Good coordination with national health policy and national quality standards Health authorities have direct control Sustainable funding, blood service costs are covered by health care National consolidated blood service with regionally centralized processing, testing and inventories: central management and local delivery Product liability covered by health care Supply chain management: close cooperation with hospitals Efficient use of resources and central purchasing of equipment, supplies and reagents
Weaknesses Difference between legislative actions, regulatory oversight and daily operations may not be clear Complexity of decision making and slow response to rapidly emerging challenge National needs may override local demand Donors may not be willing to donate blood for the government
Opportunities National blood service with consolidated structure and organization with regionally centralized processing, testing and inventories Potential for efficient use of human and economical resources uniformity of quality management, products and product quality Development of efficient supply chain management in cooperation with hospital blood banks National database of donors and blood components
Threats Political aspects may become too dominant Organization and operations may become bureaucratic and rigid Loss of independence Insufficient funding may retard development In shortage of blood donors: no responsibility to the community If components are free of charge this may lead to inappropriate clinical use
Table 3. Strengths, weaknesses, opportunities and threats of a Red Cross/Red Crescent operated national blood service system
Strengths In general trustworthy organization Flexible organization and fast decision making International traditions and networks Good public image and well-known brand Donors may favor donating to Red Cross Red Cross volunteers assist in recruitment and organizing donation sessions Red Cross/Red Crescent societies have experience in donor recruitment
Weaknesses National health authorities do not have direct control Cooperation with health authorities and regulatory bodies required Inappropriate governance including structure and organization and risk management Complex and highly technical healthcare activities may not fit in the organizational structure of a humanitarian, voluntary organization Separated from hospital blood banks and clinical transfusion practice
Opportunities Good coordination with national health policy Well-defined roles and responsibilities between Red Cross/Red Crescent Blood Service and national health authorities National consolidated structure and organization with centralized processing, testing and inventories: central management and local delivery A sustainable funding model, e.g. based on cost recovery Cooperation in inventory management with hospitals Assistance from partner Red Cross/Red Crescent societies
Threats Image and financial threats owing to product liability and litigation Insufficient funding may retard development Loss of independence Understanding of the expertise required by the blood service
Table 4. Strengths, weaknesses, opportunities and threats of the hospital-based blood services coordinated by national health authorities
Strengths When connected with university: research oriented Donors may favor donating to local hospital and patients No distribution costs Immediate access to fresh blood components Production may be tailored according to patient needs Close cooperation with wards and clinicians: appropriate clinical use of blood
Weaknesses National policy and standards difficult to create National health authorities do not have direct control No possibility for centralization of processing, testing and inventories Lack and inefficient use of resources Costly operation owing to small volumes No exchange of blood components: greater outdating Focus on delivery, not on donors, quality management, regulatory requirements
Opportunities Well-defined roles and responsibilities between hospital blood banks and health authorities Streamlined national coordination Exchange of blood components among hospitals Joint purchasing of materials and reagents Joint development of processes and blood components
Threats Hospital management may not understand the economics of running a blood service Insufficient funding may prevent investments and retard development Lack of awareness concerning all operational aspects Risk of low-quality blood components Understanding of importance of donor recruitment and public education by the hospital management Risk that there is no hospital blood transfusion committee to ensure consistent standards and appropriate use
Appropriate and stable funding for the blood service is necessary for sustainability. A hospital may be able to carry the financial burden of its own blood service, but it may be unreasonable to expect the blood service to reach a very high level of priority in funding because the funds are usually limited and the most urgent needs of the hospital are probably elsewhere. Gaining understanding from the hospital leadership for adequate funding for some of the special aspects of the blood service operation, like donor recruitment, can be difficult because these aspects are unfamiliar to the hospital leadership. The sustainability of a hospital blood service may be threatened by sudden changes in the budget or changes in the priority settings of the hospital.
Stable funding for a national blood service is best achieved by an annual budget allocation from the government. The blood service may also have a permission to charge the hospitals for products and services (cost recovery principle), but this is less common in developing countries owing to weak social security system, non-existing sick insurance and inability of the patients to pay for blood transfusions. It is important to realize that the funding of the blood services always originates from the tax payers (government) even if the responsibility of running the blood service system has been given to some other organization than the government or the hospitals (e.g. Red Cross or Red Crescent Society). In such a case, the allocation- or cost-recovery-based funding should be earmarked or should otherwise come directly to the blood service and not just to the eventual parent organization. This allows good monitoring of the use of allocated funds and transparency to prove that the funds have been used for the approved purpose. This in turn should improve sustainability in the long run.
In costing the blood services, the cost of material, supply and equipment purchases as well as personnel salaries are usually appropriately calculated. The maintenance and depreciation of the equipment, vehicles and buildings should also be taken into consideration in drafting the annual budgets. The guidance on costing of blood transfusion services published by the World Health Organization gives attention also to this aspect.4
At the planning stage of a blood service, it is important to acknowledge that appropriately collected, tested and processed blood components are not cheap. In a study on African countries,2 it was reported that the cost of producing one unit of whole blood went up to US$60 on average, with a range of 10–200US$. According to the same report, general supplies for blood services were continuously available in only 37% of the participating countries. Also, the financial aspects favor national or nationally coordinated blood service systems, because they bring savings for instance in purchases of equipment, material and supplies, maintenance, personnel training, operational development and building the quality systems.
Although a law or regulation is not necessary to start running a blood service, it would be beneficial for the sustainability of the blood service if there were a law that would clearly indicate who has the practical responsibility of the blood services and how and by whom they are funded. Then neither the government nor the social security organization or any other organization to which the responsibility has been given would be legally able to withdraw from it without breaking a law.
Finding competent and dedicated leadership is essential for appropriate building up of the blood service system as well as for its sustainability. Competency of the director includes not only leadership competency but also authority in the society, good political sense, and abilities in networking and marketing. The director must be able to guarantee also good medical expertise in the blood service to be able to create and maintain a high level of quality of the operation and blood products. Good technical and medical expertise is also needed to gain the trust and appreciation of the medical community. This helps to prohibit the unnecessary establishment of small hospital blood services.
In developing countries, the expertise of the blood service logistics, financing and medical and technical aspects often depends on the knowledge and skills of only one or a few persons. Such skills are also much demanded elsewhere. This makes the blood service extremely vulnerable to personnel changes because, for instance, private business and industry can often offer better financial as well as career opportunities to these rare experts.
A sufficient blood donor base is a prerequisite for the sustainability of the blood service. Blood donation should be based on voluntary and non-remunerated donors. They are the safest and in the long run more reliable as regular blood donors than family and replacement donors. Payment for blood donation, especially in a developing country, may result in a temptation for the donor to hide his/her lifestyle, illnesses or other factors which would cause rejection from blood donation. In addition, payment for blood donation creates a risk of exploitation of the poor.
Recruitment of blood donors requires basic education of the population – starting from schools – and continuous marketing and public information about bleeding and need of blood, blood transfusion and donation. There is ample evidence that willingness to donate blood depends more on appropriate information than on standard of living, religion or other social characteristics. If people are well informed, they express universally their willingness to help by donating blood. This is demonstrated for instance by data from African countries, as reported by Tapko etal.2 The same report indicates that a donor basis consisting mainly of voluntary and non-remunerated blood donors can best be achieved in countries where there is a governmentally endorsed and implemented national blood policy. The example of Malaysia5 shows that it is possible to change from predominantly replacement donors (from 30% to some 1% of all donors) to voluntary non-remunerated donors, although in that case it took some 20 years. During the implementation of the strategy for the change of donor base, the number of blood collections in Malaysia increased almost tenfold. However, donor retention remains a problem as about 50% of all donors are first-time donors.
PRACTICAL ASPECTS OF BUILDING BLOOD TRANSFUSION SERVICES
Often, the developing countries that have had no nationally structured blood service system do not have the needed expertise or funding to get started. In such a case, international consultation may be useful. However, it should be kept in mind that the creation of a sustainable blood transfusion service system can only succeed if done by the locals. The consultant should not become the director or decision maker in the building process.
Training of the personnel should preferably be done locally, which makes it easier to fit the equipment, material and supplies as well as methodology into the local budget and available infrastructure. Training abroad in sophisticated laboratories that do not have the same financial restrictions may lead the ambitious trainees to try and fit these same systems in their own surroundings. This may be impossible owing to the infrastructure and the limitations of available resources.
What if there is not enough funding for the same level of operation as in the industrialized countries? It cannot be officially recommended to leave some of infectious marker tests undone or to recommend the use of normal household refrigerators instead of the expensive laboratory ones, but the director of the blood service has to make decisions on how to use the available funds and may sometimes be forced to find compromises which might not be acceptable in countries with sufficient resources. When controversial decisions must be made – such as not to test for hepatitis C – owing to financial or other administrative reasons, and when they may lead to compromises in the safety of blood, it is important to document the whole decision-making process. This includes documented explanation of the eventual risks to the political decision makers. In that way, the ultimate responsibility is shared.
If there are no national laws and regulations on blood transfusion services, the blood service should make and write down its own instructions according to which the operation must be run. Official regulations and laws are helpful, but the lack thereof should not prohibit the establishment of functioning blood services on a local or even on a national basis. However, regulations and standards must be written later on. They serve as a basis for the quality of blood collection and transfusion and clarify the chains of responsibility, the existence of which becomes important if untoward effects of transfusion occur.
The World Health Organization has designed and published a number of simple Aide Memoires (Table 5) and other guidance documents which are helpful for both decision makers and blood service experts aiming at building sustainable blood services. In these Aide Memoires, differences in national approaches are acknowledged by emphasizing national coordination rather than national blood services proper. The International Federation of Red Cross and Red Crescent Societies has also published guidance on development of blood programs.6
Table 5. Useful WHO Aide Memoires for building sustainable blood services
Languages available: Arabic (A), Chinese (C), English (E), French (F), Portuguese (P), Russian (R), Spanish (S).
Blood safety (A,C,E,F,P,R,S)
National Blood Programs
Quality systems for blood safety (A,C,E,F,R)
National Blood Programs
Safe blood components (A,C,E,F,R)
National Health Authorities
The clinical use of blood (A,C,E,F,R)
National Health Programs
Establishing a National Blood Program
National Health Authorities
Sometimes, the organizations mobilizing external aid for developing countries tend to rush into a country bringing along good medical and technical expertise and funding for material and supplies, and even for local salaries. All this is fine as long as there is also a strong local commitment. At the start of an externally funded project, the local commitment should at least include decisions by the government to establish the blood services. If the government or some other local source guarantees some funding (e.g. for the salaries and buildings) at the beginning of the development project, and there is a plan for the withdrawal of the external agency and gradually increasing local financial responsibility of the operation, prospects for a sustainable and sufficiently functioning blood service are good.
Building sustainable blood services in a developing country that has limited financial resources for the whole healthcare system is difficult. The blood services should fit into the rest of the national healthcare system, in which they usually have no priority. Sustainability can only be achieved if there is both political and financial commitment from the government. National coordination of the blood services improves not only safety of blood but also sustainability by allowing savings in the operation. Unfortunately, political changes in the national or local government bring instability and may risk the sustainability of blood services through changes in the priorities of the health care. Competition of the trained personnel with private business may also risk the sustainability.
External aid for improving blood services in developing countries is often available, but local resources are necessary to guarantee the sustainability after the withdrawal of the external support.
Kind provision of Tables 2, 3 and 4 by Dr Tom Krusius from the Finnish Red Cross Blood Service is thankfully acknowledged.