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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 42 - Public Health |
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Chapter IV - Centers for Medicare & Medicaid Services, Department of Health and Human Services |
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SubChapter G - Standards and Certification |
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Part 493 - Laboratory Requirements |
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Subpart P - Quality Assurance for Moderate Complexity (Including the Subcategory) or High Complexity Testing, or Any Combination of These Tests |
§ 493.1709 - Standard; Comparison of test results.
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(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) If a laboratory performs tests that are not included under subpart I of this part, Proficiency Testing Programs, the laboratory must have a system for verifying the accuracy of its test results at least twice a year.