Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance
other · Centers for Medicare and Medicaid Services · Rule · Published 2022-07-11 · Effective 2022-08-10 · 87 FR 41194
Document
Document number
2022-14513
Federal Register citation
87 FR 41194
CFR reference
42 CFR 493
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Centers for Medicare and Medicaid Services
Publication date
2022-07-11
Effective date
2022-08-10
HHS docket
CMS-3355-F
Abstract
This final rule updates proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address current analytes (that is, substances or constituents for which the laboratory conducts testing) and newer technologies. This final rule also makes technical changes to PT referral regulations to better align them with the CLIA statute.