Title 42 Part 493 → Subpart K → §493.1281

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart K → §493.1281

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart K → §493.1281

e-CFR data is current as of January 16, 2020

Title 42Chapter IVSubchapter GPart 493Subpart K → §493.1281

Title 42: Public Health
Subpart K—Quality System for Nonwaived Testing

§493.1281   Standard: Comparison of test results.

(a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites.

(b) The laboratory must have a system to identify and assess patient test results that appear inconsistent with the following relevant criteria, when available:

(1) Patient age.

(2) Sex.

(3) Diagnosis or pertinent clinical data.

(4) Distribution of patient test results.

(5) Relationship with other test parameters.

(c) The laboratory must document all test result comparison activities.