Blood type compatibility dating
Refer to CBER's memorandum to registered blood establishments, dated March 20, 1991, titled "Responsibilities of Blood Establishments Related to Errors and Accidents in the Manufacture of Blood and Blood Components".Currently, there is no regulation that requires unlicensed, registered blood establishments or transfusion facilities to submit error and accident reports to the FDA.This reference provides the most updated interpretation of certain regulations and guidelines.This reference is not intended to be a "How to..." it is a technical reference and is intended to be used in conjunction with the Inspection Operations Manual (IOM), the Code of Federal Regulations, Title 21 (21 CFR), the Compliance Program for the Inspection of Licensed and Unlicensed Blood Banks (CP 7342.001) and the Compliance Policy Guides for biologics (CPG 7134).Unsuitable donors include, but are not limited to, those who test repeatedly reactive for anti-HIV or HBs Ag and have not been properly reentered or have a medical history which would preclude donation.The regulations do not prohibit firms from collecting blood from deferred donors.In several instances the manual refers to memoranda published by CBER and sent to registered blood establishments.
Consequently, field investigators are no longer required to fill out the checklist during establishment inspections nor submit it with inspectional reports.The "Guide to Inspections of Blood Banks" is a consolidation of information previously provided in the Blood Bank Inspection Checklist and Report, and the Instruction Booklet for Blood Bank Inspection Checklist and Report, FDA-2609.This guide, which provides the most updated interpretation of certain regulations and guidelines, was prepared by the FDA, Office of Regulatory Affairs and the Center for Biologics Evaluation and Research.The establishment should have a validated pink copy of Form FDA-2830, Blood Establishment Registration and Product Listing, for the current calendar year or evidence of having submitted same.If the data on the registration form is not correct, list corrections to be made in comments, and instruct the establishment to submit in writing the updated information to the Division of Blood Applications, (HFM-370), 1401 Rockville Pike, Rockville, MD 20852- 1448.
Questions concerning practices which may be hazardous should be addressed to the Division of Inspections and Surveillance (HFM-650) at (301) 594-1194. This will serve to identify establishments in correspondence, applications and other forms of communications.