REGULATORY UPDATE: FDA Updates Biological Product and HCT/P Deviation Reporting Codes, HCT/P Product Codes

October 06, 2021

The Food and Drug Administration recently updated the Biological Product Deviation (BPD) Reporting and HCT/P Deviation Reporting Codes for fiscal year (FY) 2022. Modifications to the blood reporting codes include the deletion of all codes related to Zika virus (ZIKV). In May, FDA determined that ZIKV is no longer a relevant transfusion-transmitted infection and withdrew the July 2018 guidance that recommended ZIKV testing.

FDA added additional language to the blood component labeling code LA-82-20 to clarify that reporting “is not required if tag/transfusion record was switched between two units intended for the same patient.” The agency also clarified that quality control and distribution code QC-97-07, used to report product release prior to obtaining a current sample for ABO, Rh, antibody screen and/or compatibility testing, now includes “antibody screen/crossmatch expired.” FDA also changed two BPD codes, one under “Process Control” and one under “Quality Control and Distribution,” for reporting deviations or unexpected events that occurred in a licensed, non-blood establishment for FY 2022.

In addition, the agency updated the list of Biological Product Deviation Reporting and HCT/P Deviation Reporting-Non-Blood Product Codes. No changes were made to the Biological Product Deviation Reporting Blood Product Codes.

Contact regulatory@aabb.org with questions.