Blood Banking and Regulation Procedures, Problems, and Alternatives (1996) / Chapter Skim
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I Overview of Regulatory and Policy-Making Procedures in Blood Banking
I Overview of Regulatory and Policy-Making Procedures in Blood Banking
Pages 1-26
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I Overview of Regulatory and Policy-Making Procedures in Blood Banking
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THE REGULATORY MANDATE The Center for Biologics Evaluation and Research (CBER) is that part of FDA responsible for regulating blood, plasma, and other biological products such as banked human tissue, somatic cells, stem cells, vaccines, allergenic products, and various biological therapeutics.
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Recent technical workshops have been on topics of gene amplification technology, to close the window of human immunodeficiency virus infectivity; hemoglobin substitutes; computer validation of blood quality assurance; evaluation of the interim regulations for banked human tissue; and viral inactivation methods to reduce infectivity in plasma products. Additional workshops being planned cover blood licensing and methods of leukocyte reduction in blood components.
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By that time the first blood bank, the Philadelphia Blood Bank, had been licensed, and biologics authorities embarked on the licensing of whole blood and blood derivatives. In 1955 the responsibility for biologics regulation was transferred from the National Microbiologics Institute (now the National Institute of Allergy and Infectious Diseases)
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led by medical personnel whose primary mission was public health rather than law enforcement, a laboratory of blood and blood products of the Division of Biologic Standards carried out the administration of biologic law in the manner of communication among physicians." This environment changed dramatically with the first prosecution of an individual in a commercial blood bank in 1962. The responsible head of the blood bank was found guilty of falsification of records, mislabeling, and adulteration and was permanently barred from practicing blood banking in any licensed facility.
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If the observations are of sufficient magnitude or if they continue after substantial notice has been given, the agency may issue a warning letter specifying the violations and threatening additional legal action if the problems are not addressed within a short time, usually 30 days. Pre-approval inspections are conducted by Center personnel experienced in the review of applications for blood processing facilities.
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From a regulatory perspective, strategies must be developed by FDA and industry to provide quality assurance, to prevent errors and accidents, and to ensure conformance with legal requirements without losing the identity of blood banks as both a needed medical service and as manufacturers of biological products. This will require the development of more meaningful partnerships between the federal government and the private sector and between the public and members of the health professions.
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CDC also provides consultation and assistance to federal agencies, state and local health departments, other nations, and international agencies. This consultation and assistance Unction has been notable in the blood arena, where CDC has provided data and expert opinion to the Food and Drug Administration (FDA)
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In one such interview-based study funded by CDC, HIV-seropositive donors at 20 blood centers are interviewed for HIV risk factors, their motivations for donation, and other behavioral characteristics. CDC has also Funded a national database with information from 19 American Red Cross blood centers, including all infectious disease marker, demographic, and donation history data.
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Other recommendations have addressed HIV antibody testing of blood and plasma, including topics such as interpretive criteria for Western blots, recommendations for screening, and what to tell and what not to tell a person who has been tested. Other recommendations concerning phlebotomy and laboratory procedures have been issued, such as universal precautions.
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, the Council of Community Blood Centers (CCBC) , the American Red Cross, and, with a lesser role, the College of American Pathologists.
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The College of American Pathologists conducts both a laboratory accreditation program and a survey program. Although most blood centers are not accredited by the college, many do use these surveys for purposes of the Clinical Laboratory Improvement Act (CLIA)
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In addition, AABB inspections tend to be collegial, contrast to the more obvious police-like aspects of an FDA visit. AABB's first response was to try to use teams of inspectors for large, complex blood centers, with each member of a team having responsibility for one major area or department.
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CCBC's scientific/medical/technical committee frequently brings individuals from FDA to speak at its meetings, again, to ensure that there is effective dialogue. OTHER STANDARDS AND GUIDELINES In addition to AABB standards, the American Red Cross Blood Service Directives can be significant for other blood centers as well.
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The emphasis is on adherence to standards and a regulatory mind-set on the part of the people who work in this field. The volunteer organizations believe that they do a good job of self-regulating and would like to emphasize that role and its importance as much as possible.
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A recent American Red Cross press release reported severe shortages in 10 major cities, including Boston, Los Angeles, and Washington, D.C. The Red Cross reported that some 300,000 additional blood donations were required in the next month for the national inventory to be rendered safe.
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AABB organizes these teleconferences, linking as many as 80 or 90 blood banks around the country and discussing topics pertinent to blood banking. THE BLOOD PRODUCTS ADVISORY COMMITTEE FDA initiated advisory committee systems in the early 1970s to provide technical assistance related to the development and evaluation of drugs, biologics, and medical devices.
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It was claimed by some that advisory committees were excessively influenced by FDA. In fact, however, the Blood Products Advisory Committee (BPAC)
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The Institute of Medicine forums and the regional blood banking organizations may also be included as other venues for dialogue. Likewise, meetings of other national organizations like the Hemophilia Foundation, College of American Pathologists, the American Society for Apheresis, and the American Society of Hematology may also be opportunities for dialogue among scientists, blood bankers, and regulators.
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Patients needing clotting factor concentrate need to be heard, as do blood bankers and manufacturers. The individuals at the cornerstone of blood banking practice and patient transfusion care nationally, however, not heard.
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One is the consensus development conference, including some on plasma, platelet, and red blood cell transfusions that addressed the indications for transfusion in an attempt to reduce them to the needed number. NIH also conducted, again in concert with other organizations, the National Blood Resource Education Program.
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The literature describes the practice of the "just-in-time" consult, in which a physician expert in transfusion medicine is involved immediately on receiving an order. This could be very effective with house officers in particular.
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