One year ago, an ABC member blood center applied for a variance from Food and Drug Administration labeling regulations requiring results on red blood cell (RBC) labels to be from samples collected “at the time of filling the … blood container” and “on a specimen taken … at the time of collection.” The center requested permission for inclusion of historical RBC phenotyping and genotyping on the integral labels of RBCs (i.e., the base label or attached tie tags).
The rationale was that placing the label elsewhere would invite mistakes; also hospitals felt it wrong to pay for centers to repeat testing on well characterized donors. However, FDA interpreted the regulations as prohibiting the practice; so, historical results continue to be printed on packing slips and tie tags, unattached to phenotyped units, perverting the intent of current Good Manufacturing Practices (cGMPs).
In spring 2012, the issue was brought to the FDA Liaison Committee, consisting of AABB staff, officers, and committee chairs, with representatives from ABC, the American Red Cross, FDA, and College of American Pathologists. A working group was appointed to meet and return with a proposal, ably led by Becky See at AABB. The group included Ruth Sylvester and me, but more importantly, ABC subject-matter experts, Connie Westhoff (New York Blood Center) and Megan Delany (Puget Sound Blood Center). ABC centers were surveyed to describe current practices regarding historical results (serology and genotyping, licensed and unlicensed), especially their variability. The survey was reviewed with participation from FDA representatives, Jennifer Jones and Judy Ciaraldi, and in December, the issue was brought to FDA’s Blood Products Advisory Committee (BPAC).
There was consensus that integral labeling with historical results was an appropriate, important contribution
both to patient safety and cost effectiveness. BPAC endorsed a definition of “historical” as tests on two or
more distinct donations; maintenance of the linkage between the donor and results must be validated; and
hospital transfusion services should not be required to repeat screenings. As the working group also recommended, BPAC agreed there is no reason to treat serological and molecular testing differently, and while licensed reagents are preferred, use of unlicensed, validated reagents should not prevent integral labeling.
After the BPAC meeting, the group finalized definitions and draft AABB standards regarding historical antigen labeling included in the proposed 29thStandards for Blood Banks and Transfusion Services(5.8.4 and 184.108.40.206), now published for comment. While FDA approval is not guaranteed, the agency’s participation provides grounds for optimism. Throughout the process, FDA recognized the importance of integral labeling as a quality issue, and contributed to what appears to be an excellent resolution of the issue – in only one year.
Congrats and thanks to everyone involved.
Louis Katz, MD, Executive Vice President SMT/Medical; email@example.com