---
kind: "section"
citation: "21 C.F.R. § 606.151"
title: "21"
number: "606.151"
heading: "Compatibility testing."
url: "https://uscodex.org/cfr/21/606.151"
---

# §606.151. Compatibility testing.


Standard 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.

## Notes

### Amendments

[40 FR 53532, Nov. 18, 1975, as amended at 64 FR 45371, Aug. 19, 1999; 66 FR 1835, Jan. 10, 2001; 66 FR 40889, Aug. 6, 2001]

### Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360j, 371, 374; 42 U.S.C. 216, 262, 263a, 264.

### Source

Source: 40 FR 53532, Nov. 18, 1975, unless otherwise noted.

### Amendments

[40 FR 53532, Nov. 18, 1975, as amended at 64 FR 45371, Aug. 19, 1999; 66 FR 1835, Jan. 10, 2001; 66 FR 40889, Aug. 6, 2001]