Federal Register - July 11, 2022
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Source: Federal Register
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Federal Register / Vol. 87, No. 131 / Monday, July 11, 2022 / Rules and Regulations TABLE 2 TO PARAGRAPH c2CRITERIA FOR ACCEPTABLE PERFORMANCEContinued
The criteria for acceptable performance are:
Analyte or test
Criteria for acceptable performance
Prothrombin time seconds or INR
21. Amend 493.959 by revising paragraphs b, d1 and 2 to read as follows:
493.959
Immunohematology.
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
Target 15%.
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.
d
1 To determine the accuracy of a laboratorys response, a program must compare the laboratorys response for each analyte with the response that reflects agreement of either 100 percent of 10 or more referee laboratories or 95
percent or more of all participating laboratories except for antibody identification. To determine the
accuracy of a laboratorys response for antibody identification, a program must compare the laboratorys response for each analyte with the response that reflects agreement of either 95 percent or more of 10 or more referee laboratories or 95 percent or more of all participating laboratories. Both 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 d2CRITERIA FOR ACCEPTABLE PERFORMANCE
Analyte or test
Criteria for acceptable performance
ABO group
D Rho typing
Unexpected antibody detection
Compatibility testing
Antibody identification
100%
100%
100%
100%
80%+
accuracy.
accuracy.
accuracy.
accuracy.
accuracy.
Dated: June 24, 2022.
Xavier Becerra, Secretary, Department of Health and Human Services.
FR Doc. 202214513 Filed 7722; 4:15 pm
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