Transfusion Medicine - Jeffrey McCullough

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that sometimes occurs in developing and least developed countries (Table 2.2). In many countries, blood donations are not tested routinely for the combination of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus, and syphilis [1]. This is because of a shortage of trained staff, unavailability of or poor quality of test kits, or infrastructure breakdowns. Sometimes transmissible disease testing is not done because the need is so urgent that the blood must be transfused immediately after it is collected. Rapid tests may be useful [19]. The cost of transmissible disease testing is also problematic because it may approach the annual per capita expenditure for all of health care in some countries [20, 21]. This, combined with the use of replacement or paid donors and the low rates of repeat blood donors with their lower rate of positive tests for transfusion‐transmissible diseases, leads to a major concern about blood safety in developing and least developed countries [21, 22]. Impressive progress has been made in establishing testing systems, increasing blood collections, standardizing operations, and increasing the availability of safe blood [3, 5, 7–12]. “Many factors influence the global implementation of self‐sufficiency” [23, 24], and a consensus statement from WHO experts is available defining the rationale [24].

      In much of the world, components are not used routinely. The whole blood is converted into components ranging from <25% in low‐resource countries to 97% in high‐income countries, and use of whole blood ranges from 0% to 100% [1].

      US blood supply

      In contrast with the worldwide supply, the US blood supply is provided by many different organizations with different organizational structures and philosophies. These organizations function rather effectively to meet the nation’s blood needs, and thus are referred to in this chapter as the US blood supply system, although they are not really a unified system.

      Source: Data are summarized from Gibbs WN, Corcoran P. Blood safety in developing countries. Vox Sang 1994; 67:377–381.

Donor testing for
HIV HBV Syphilis All volunteer donors Some replacement donors Some paid donors % Repeat donors
Developed 100 100 94 85 20 5 88
Developing 66 72 71 15 80 25 47
Least developed 46 35 48 7 93 25 20

      HBC, hepatitis B virus; HIV, human immunodeficiency virus.

      Traditionally, blood centers were freestanding organizations, almost all of which were nonprofit. These centers were governed by a board of local volunteers; their sole or major function is to provide the community’s blood supply. Each blood center collects blood in a reasonably contiguous area. The blood center may supply hospitals in its area but may supply hospitals in other areas as well. The area covered by each center was determined by historical factors and was not developed according to any overall plan. Rather, local interests dictated whether, how, and what kind of community blood program was developed. There is a total of approximately 66 accredited blood centers in the United States [25, 26], although these are combining and it appears that soon there may be only a few blood collection organizations in the United States. As a result of the HIV epidemic [27], the regulatory environment changed [28], and the blood collection system in the United States underwent substantial revisions [26–28]. The organizations have adopted philosophies and organizational structures resembling those found in the pharmaceutical industry rather than the previous hospital laboratory and medical model. Modern quality assurance systems and good manufacturing practices [28, 29] like those used in the pharmaceutical industry have been introduced. New computer systems now provide greater control over the manufacturing process [29], and changed management structures deal with the new kinds of activities and philosophy. Blood centers and supply organizations are now operated using a very structured business and manufacturing philosophy, organization, and culture (see Chapter 21). This structure is now undergoing extensive change. Blood centers are merging, forming large national organizations that have less local focus. These organizations collect blood in the most efficient manner and sell that blood where it is more advantageous.

      Most hospitals in the United States do not collect any blood but rather acquire all of the blood they use from a community center. Blood banks that are part of hospitals usually collect blood only for use in that hospital and do not supply other hospitals. However, few, if any, hospitals collect enough blood to meet all of their needs. They purchase some blood from a local or distant community blood center. Of those that do collect blood, there are no good data available to define the proportion of their needs that they collect. This can be presumed to be quite variable and involve primarily plateletpheresis.

      Periodically the CDC surveys blood collection organizations and hospitals to determine the blood supply and utilization [26]. The most recent report is from 2017, when data were obtained from 88% of blood suppliers and 80% of hospitals. In 2017, 10,397,000 units of allogeneic whole blood and 10,000 units of autologous blood were collected [26]. An additional 1,794,000 units of red cells (15%) was collected by apheresis, giving a total of 12,201,000 units. Laboratory testing led to discard of 78,000 (0.6%), and an additional 590,000 units was not suitable for use, leaving a total of 11,533,000 units available for transfusion [26].

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