21 CFR 606.151
Compatibility testing.
- Inspections citing it: 61
- Of those classified, ended OAI: 0%
- Last cited: FY2026
Inspections Citing It by Fiscal Year
Sites in and outside the US, FY2017 to Oct 20, 2026.
Regulation Text
eCFR, as of Nov 6, 2026Standard operating procedures for compatibility testing shall include the following:
(a) A method of collecting and identifying the blood samples of recipients to ensure positive identification.
(b) The use of fresh recipient serum or plasma samples less than 3 days old for all pretransfusion testing if the recipient has been pregnant or transfused within the previous 3 months.
(c) Procedures to demonstrate incompatibility between the donor's cell type and the recipient's serum or plasma type.
(d) A provision that, if the unit of donor's blood has not been screened by a method that will demonstrate agglutinating, coating and hemolytic antibodies, the recipient's cells shall be tested with the donor's serum (minor crossmatch) by a method that will so demonstrate.
(e) Procedures to expedite transfusion in life-threatening emergencies. Records of all such incidents shall be maintained, including complete documentation justifying the emergency action, which shall be signed by a physician.
Recently Cited Sites
Newest inspections citing this section; each opens the site- The Stamford HospitalUnited States · Mar 2, 2026
- Collaborative Laboratory Services, LLC- Saint Francis CampusUnited States · Aug 20, 2025
- Wisconsin Diagnostic Laboratories, LLCUnited States · Jun 25, 2025
- Saint Joseph's Hospital of Atlanta, Inc.United States · Jun 6, 2025
Counts are inspections with posted citations that cite any paragraph of the section, once per inspection, from FDA's Data Dashboard. OAI share is over inspections FDA finally classified. Text from eCFR, the official online CFR. FDA Data Dashboard and eCFR