Joint Statement before the BPAC
04 December 2012
Labeling of Red Blood Cell Units with Historical Antigen Typing Results
M. Allene Carr-Greer, Director, Regulatory Affairs, AABB
Today we have heard presentations related to many aspects involved in the practice of testing donors for minor RBC antigens, and various ways in which these results are provided along with the unit of blood to transfusion services. While there are many transfusion services that perform minor RBC antigen testing, many blood centers have assumed this responsibility. The movement toward having the testing performed by reference laboratories at blood centers has occurred for a variety of reasons (i.e., rarity of test materials, cost of test materials, and availability of experienced and trained staff to perform the testing). Because of the current discussions we also have become aware of the variability in practices and join the FDA in seeking a rational approach for the distribution of current donations with historical RBC antigen screening results.
The use of historically screened RBCs represents a long-established practice that should not be curtailed without compelling reasons. The prohibition of integral labeling of units with historical antigen screening results is contrary to current good manufacturing practices and should be remedied without undue delay. FDA recognizes that integral labeling provides the best level of safety for recipients. For example, 21 CFR 606.121(e)(2)(ii) requires that the name of an antibody that has been identified during donor testing be included on the label. According to 21 CFR 606.121(j) the name of the antibody can be provided on an attached tie tag. Requiring that the historical antigen test results be provided on a detached report requires multiple steps to ensure the same level of safety that integral labeling provides.
FDA inspections and AABB assessments of licensed and accredited blood establishments have shown that current manufacturing processes include the appropriate steps for ensuring test samples and donated products are accurately linked to the donor, and that this linkage carries throughout the manufacturing process. Furthermore, FDA has acknowledged the robustness of this process to encompass labeling with historical test results by accepting the following language developed for the Circular of Information.
“All blood has been collected from donors who have tested negative by a licensed test for antibodies to
T. cruzi either on the current donation or at least one previous donation.”
We believe all of this supports the fact that there is no need for further validation of processes currently in use for linkage of donor identification and test results (current and/or historical).
We encourage the FDA to allow and assist the AABB workgroup in completion of their work – that is focused on assuring the quality of the antigen typing results – and to carefully consider the draft protocol that is developed. We also request that the agency provide a route for all blood establishments to use whereby historical results can be properly attached to the current donation.
AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.
Founded in 1962, America's Blood Centers is North America's largest network of community-based blood programs. Seventy-five blood centers operate more than 600 collection sites in 45 U.S. states and Canada, providing half of the United States, and 20% of Canada's volunteer donor blood supply. These blood centers serve more than 160 million people and provide blood products and services to more than 4,200 hospitals and health care facilities across North America. ABC's U.S. members are licensed and regulated by the U.S. Food & Drug Administration. Canadian members are regulated by Health Canada.
The American Red Cross shelters, feeds and provides emotional support to victims of disasters; supplies more than 40 percent of the nation's blood; teaches skills that save lives; provides international humanitarian aid; and supports military members and their families. The Red Cross is a not-for-profit organization that depends on volunteers and the generosity of the American public to perform its mission. Over six million units of whole blood are collected from nearly four million Red Cross volunteer donors, separated into 9.5 million components, and supplied to approximately 3,000 hospitals and transfusion centers to meet the needs of patients each year.