FDA updates biological product and HCT/P deviation codes, blood and HCT/P product codes
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).
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 and the list of BPD Reporting and HCT/P Deviation Reporting - Non-Blood Product Codes.
