Transfusion Medicine - Jeffrey McCullough

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of whole blood collected by blood supply organizations or hospitals, is sold to commercial companies in the plasma fractionation industry, who in turn manufacture the plasma derivatives and sell them in the pharmaceutical market. The blood banks’ sale of their plasma to the commercial fractionator (manufacturer) may, but usually does not, involve an agreement to provide some of the manufactured derivatives back to the blood bank.

      Federally licensed plasma collection and manufacturing organizations

      Organizations and facilities need FDA licenses for either plasma collection or the manufacture of derivatives from plasma, or both, depending on the activities they conduct. In the past decade, this system has undergone considerable consolidation.

      Countries other than the United States have nonremunerated plasma donor programs; however, few, if any, of these provide all of the plasma needs. The US system of paid plasma donors produces about 80% of the US and 60% of the world’s plasma supply [35]. Thus, the United States is a major exporter of plasma or finished product derivatives.

      Plasma collection activity

      Data regarding the plasma derivative industry is proprietary and thus is not readily available. It is estimated that the US plasma and plasma products industry employs more than 10,000 people nationwide and may produce 44 million liters or more of plasma annually in the United States. Individuals who donate plasma to support the plasma derivative industry receive $20 or more per donation, and it is estimated that donors receive compensation of millions from plasma collection facilities annually. This is in contrast with whole blood donors, who donate voluntarily and do not receive compensation. Much of the plasma obtained from whole blood collected by blood banks is also used for derivative production. The volume of this plasma can be very roughly estimated as follows: approximately 12 million units of whole blood, suitable for use, is collected annually. If approximately 5 million units is used for frozen plasma and cryoprecipitate, the remaining 7 million units could produce about 1.5 million liters of plasma, which is not nearly enough to meet the need for the manufacture of derivatives.

      Some organizations such as the American Medical Association, the College of American Pathologists (CAP), the American College of Surgeons, or the American Society of Anesthesiologists, may from time to time take positions on blood bank– and transfusion medicine–related issues, and maintain blood bank or transfusion medicine committees. The American Society of Hematology includes transfusion medicine in its scientific programs and a section of its journal Blood. Several nongovernmental or professional organizations are devoted exclusively to blood banking and transfusion medicine.

      AABB, formerly the American Association of Blood Bank

      Institutional members of the AABB are classified either as a blood center, a hospital blood bank, or a hospital transfusion service. The blood center collects blood and distributes it to several hospitals but does not transfuse blood. A hospital blood bank both collects and transfuses blood, and a hospital transfusion service transfuses but does not collect blood.

      America’s Blood Centers

      America’s Blood Centers (ABC) is an association of independent (that is, not American Red Cross) not‐for‐profit community blood centers established in 1962. Efforts to meet the goals of safety, quality, and efficiency in blood services are met through programs such as group purchasing of supplies, services, and liability insurance; efforts to increase volunteer blood donation; effective sharing of blood resources; strengthening of blood center management skills; training programs to ensure compliance with federal regulations; and efforts to ensure fair and balanced resolution of disputes between blood centers and the public they serve. ABC works nationally by helping to shape and influence federal and state regulations, policies, and standards of care that its membership believes are in the best interest of the donors and patients they serve. The association also works to identify and promote needed research and development in blood services; promotes information exchange between members of operational practices; and promotes new programs, policies, and ideas by conducting surveys and meetings of small working groups and by developing workable models. ABC has approximately 70 institutional members with about 600 donor centers throughout the United States that collect about 60% of the nation’s volunteer donor blood supply.

      Plasma Protein Therapeutics Association

      The PPTA is a trade association that advocates for the world’s source plasma collectors and producers of plasma‐based therapeutics [35]. Members of PPTA represent nearly every company in the world that collects source plasma for further manufacture. These members operate about 650 plasma collection facilities worldwide and carried about 38 million donations in the United States in 2018 [37]. The role of PPTA is to develop standards and training programs, represent the industry to the public and governments, and provide forums for discussion of new issues or technology.

      The WHO operates a program in Blood Safety and Clinical Technology [1–3]. The program involves developing guidelines for nationally coordinated blood programs, national blood policies, technical support, a Global Collaboration for Blood Safety program, country‐level activities to improve access to safe blood, a Quality Management Project, Guidelines on the Clinical Use of Blood, maintaining the chain of reagents and materials needed for blood operation, laboratory personnel safety, and the safe use of injectables and injection materials. It also sponsors a wide variety of educational symposia worldwide.

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