Jeffrey McCullough - Transfusion Medicine

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33 33. To L, Dunnington T, Thomas C, et al. The United States’ potential blood donor pool: updating the prevalence of donor‐exclusion factors on the pool of potential donors. Transfusion 2020; 60:206–215.

34 34. Zalpuri S, Schotten N, Baart AM, et al. Iron deficiency–related symptoms in whole blood donors: a systematic review. Transfusion 2019; 59:3275–3287.

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Gary Bachowski MD, PhD

The blood supply system in the United States has developed along two main tracks (see Chapter 2). One involves nonprofit community, regional, and national blood centers that obtain cellular elements and plasma from whole blood or apheresis donations provided almost exclusively by unpaid volunteers. Most of these products are used directly for transfusion.

The other blood collection system involves large‐scale collection of plasma by plasmapheresis. This system consists of for‐profit organizations and almost all of this plasma comes from paid donors. This plasma is manufactured into plasma derivatives, such as albumin, coagulation factor concentrates, or intravenous immunoglobulin, and these are sold on the national and international market.

Whole blood is collected by venipuncture from healthy adults into plastic bags containing a liquid anticoagulant preservative solution. The whole blood is separated into red blood cells, plasma, and occasionally platelet concentrate (see Chapter 5). The plasma can be: (a) frozen and used for transfusion, (b) further processed into cryoprecipitate (to be used for transfusion) and cryoprecipitate‐poor plasma (which can serve as a raw material for further manufacture of plasma derivatives), or (c) provided as a direct source of raw material for subsequent manufacture of plasma derivatives. Modifications can be made to these components to obtain blood products that will be effective for specific purposes. A complete list of components that can be produced from whole blood and are licensed by the US Food and Drug Administration (FDA) is provided in Chapter 5. Although blood banks may distribute some plasma derivatives, most are distributed through manufacturers by hospital pharmacies. Blood centers also produce platelets, red cells, plasma, and granulocytes by apheresis (see Chapter 6) in which the component(s) of interest is (are) removed in a blood cell separator and the remaining blood is returned to the donor.

Because blood is considered to be a drug and is regulated under FDA law, most aspects of potential donor selection and the collection of blood are carried out under requirements established by the FDA. This chapter attempts to provide concepts and rationale for blood donor assessment and blood collection but does not refer to every specific FDA requirement. However, it should be understood that all of these activities must conform to FDA requirements, which can be found in the Code of Federal Regulations and various FDA guidelines. For blood banks that desire accreditation by the AABB (American Association of Blood Banks), the standards of that organization must also be followed. The Technical Manual of the AABB [1] is an excellent reference that provides details for much of the content of this chapter.

The selection process for blood donors is designed to ensure the safety of the donor and to obtain a high‐quality blood component that is as safe as possible for the recipient ( Table 4.1). In general, 10–15% of presenting donors are either deferred or provide an unsatisfactory unit of blood due to short‐term deferrals (e.g., hemoglobin), long‐term deferral (e.g., malaria), permanent deferral (e.g., hepatitis B/C), disease marker reactive donations, or an unsatisfactory collection process [2–4]. The loss of these potential donors and donations has a huge impact on the blood supply [5].