October 06, 2022
The Food and Drug Administration recently updated the list of Biological Product Deviation Reporting and HCT/P Deviation Reporting – Deviation Codes for fiscal year 2023.
Modifications to the blood reporting codes include the deletion of biological product deviation (BPD) codes related to travel risk factors associated with Creutzfeldt-Jacob Disease (CJD). Additionally, FDA modified the reporting codes for CJD risk associated with having received a human cadaveric dura mater transplant or having a family history of CJD (blood relative diagnosed with familial prion disease).
In May, FDA removed the recommendations to indefinitely defer blood donors for geographic risk of possible exposure to bovine spongiform encephalopathy for time spent in the United Kingdom from 1980 to 1996 and for time spent in France or Ireland from 1980 to 2001, as well as for receipt of a blood transfusion in the U.K., France or Ireland since 1980.
FDA modified the “Quality Control” reporting code for products shipped at incorrect temperature to clarify reportable events, which include “shipment with incorrect or missing coolant, e.g., no ice in RBC shipment; number of units did not meet validated container.” In addition, the agency made 41 changes to the BPD Reporting - Blood Product Codes as of Oct 1.
Also included were new deviation reporting codes for human cells, tissues and cellular and tissue-based products (HCT/P) for West Nile virus testing (“Testing not performed or document when required” and “Testing incorrectly performed when required”).
The agency also updated the Licensed Non-Blood BPD Reporting Codes (page 14), and the list of BPD Reporting and HCT/P Deviation Reporting - Non-Blood Product Codes.
Contact regulatory@aabb.org with questions.
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