§ 493.959 - Immunohematology.

§ 493.959 Immunohematology.

Cross Reference

Link to an amendment published at 87 FR 41242, July 11, 2022.

(a) Types of services offered by laboratories. In immunohematology, there are four types of laboratories for proficiency testing purposes—

(1) Those that perform ABO group and/or D (Rho) typing;

(2) Those that perform ABO group and/or D (Rho) typing, and unexpected antibody detection;

(3) Those that in addition to paragraph (a)(2) of this section perform compatibility testing; and

(4) Those that perform in addition to paragraph (a)(3) of this section antibody identification.

(b) Program content and frequency of challenge. To be approved for proficiency testing for immunohematology, a program must provide a minimum of five samples per testing event. There must be at least three testing events at approximately equal intervals per year. The annual program must provide samples that cover the full range of interpretation that would be expected in patient specimens. The samples may be provided through mailed shipments or, at HHS' option, may be provided to HHS or its designee for on-site testing.

(c) Challenges per testing event. The minimum number of challenges per testing event a program must provide for each analyte or test procedure is five.

Analyte or Test Procedure

ABO group (excluding subgroups)

D (Rho) typing

Unexpected antibody detection

Compatibility testing

Antibody identification

(d) Evaluation of a laboratory's analyte or test performance. HHS approves only those programs that assess the accuracy of a laboratory's response in accordance with paragraphs (d)(1) through (5) of this section.

(1) To determine the accuracy of a laboratory's response, a program must compare the laboratory's response for each analyte with the response that reflects agreement of either 100 percent of ten 10 or more referee laboratories or 95 percent or more of all participating laboratories except for unexpected antibody detection and antibody identification. To determine the accuracy of a laboratory's response for unexpected antibody detection and antibody identification, a program must compare the laboratory's response for each analyte with the response that reflects agreement of either 95 percent or more of ten 10 or more referee laboratories or 95 percent or more of all participating laboratories. The score for a sample in immunohematology is either the score determined under paragraph (d)(2) or (3) of this sectionBoth methods must be attempted before the program can choose to not grade a PT sample.

(2) Criteria for acceptable performance. The criteria for acceptable performance are—

Table 2 to Paragraph (d)(2)—Criteria for Acceptable Performance

Analyte or test	Criteria for acceptable performance
ABO group	100% accuracy.
D (Rho) typing	100% accuracy.
Unexpected antibody detection	80% 100% accuracy.
Compatibility testing	100% accuracy.
Antibody identification	80%+ accuracy.

(3) The criterion for acceptable performance for qualitative immunohematology tests is positive or negative.

(4) To determine the analyte testing event score, the number of acceptable analyte responses must be averaged using the following formula:

(5) To determine the overall testing event score, the number of correct responses for all analytes must be averaged using the following formula:

[57 FR 7151, Feb. 28, 1992, as amended at 87 FR 41242, July 11, 2022]