United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2022_register executive 2022-07-09 article Part II Rules and Regulations D09002ee1c7a33a8c D09002ee1c7a33ba3 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Centers for Medicare & Medicaid Services originator org United States Government Agency or Subagency 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. 87 FR 41194 https://www.govinfo.gov/app/details/FR-2022-07-11/2022-14513 2022-14513 fr11jy22-17 RIN 0938-AT55 4120-01-P CMS-3355-F https://www.govinfo.gov/app/details/FR-2022-07-11/2022-14513 https://www.govinfo.gov/content/pkg/FR-2022-07-11/html/2022-14513.htm https://www.govinfo.gov/content/pkg/FR-2022-07-11/pdf/2022-14513.pdf Administrative Practice and Procedure Grant Programs-Health Health Facilities Laboratories Medicaid Medicare Penalties Reporting and Recordkeeping Requirements 49 p. 41194 41242 87 FR 41194 Title 42 Part 493 42 CFR Part 493 RIN 0938-AT55 Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance; Federal Register Vol. 87, Issue RULE 2022-14513 II DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 2022-08-10 CMS-3355-F 4120-01-P 2022-14513 Final rule.

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.

Effective August 10, 2022, except for the amendments to Sec. Sec. 493.2 and 493.801 through 493.959 (amendatory instructions 2 and 5 through 21), which are effective July 11, 2024. Sarah Bennett, CMS, (410) 786-3531; or Nancy Anderson, CDC, (404) 498-2741. Administrative Practice and Procedure Grant Programs-Health Health Facilities Laboratories Medicaid Medicare Penalties Reporting and Recordkeeping Requirements Clinical Laboratory Improvement Amendments Proficiency Testing Regulations Related to Analytes and Acceptable Performance, http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/Search.cfm https://truvenhealth.com/your-healthcare-focus/life-sciences/data_databases_and_online_toolsMarkets/Life-Sciences/Products/Data-Tools/MarketScan-Databases https://www.aacc.org/science-and-practice/annual-meeting-abstracts-archive https://www.aha.org/statistics/fast-facts-us-hospitals https://www.ahrq.gov/research/findings/nhqrdr/index.html https://www.bls.gov/oes/current/oes_nat.htm https://www.bls.gov/oes/tables.htm https://www.cdc.gov/labstandards/hs.html https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Clinical-Laboratory-Fee-Schedule-Files https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493#493.2 https://www.guideline.gov/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4698806/ https://www.thecommunityguide.org https://www.uspreventiveservicestaskforce.org/Page/Name/recommendations Vol. 87, no. 131 Office of the Federal Register, National Archives and Records Administration 2022-07-11 continuing daily deposited born digital 227 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2022-07-11 P0b002ee1b66ae240 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr11jy22 https://www.govinfo.gov/app/details/FR-2022-07-11 https://www.govinfo.gov/content/pkg/FR-2022-07-11/pdf/FR-2022-07-11.pdf https://www.govinfo.gov/content/pkg/FR-2022-07-11/xml/FR-2022-07-11.xml fdlp 41025 41242 DGPO 2022-07-09 2024-05-29 FR-2022-07-11 machine generated eng FR FR-2022-07-11 87 131