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2019-02-02
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Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance
Part II
Proposed Rules
D09002ee1c1726395
D09002ee1c1726473
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Centers for Medicare & Medicaid Services
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org
United States Government Agency or Subagency
This proposed rule would update 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 proposed rule would also make additional technical changes to PT referral regulations to more closely align them with the CLIA statute.
84 FR 1536
https://www.govinfo.gov/app/details/FR-2019-02-04/2018-28363
2018-28363
fr04fe19-16
RIN 0938-AT55
4120-01-P
CMS-3355-P
https://www.govinfo.gov/app/details/FR-2019-02-04/2018-28363
https://www.govinfo.gov/content/pkg/FR-2019-02-04/html/2018-28363.htm
https://www.govinfo.gov/content/pkg/FR-2019-02-04/pdf/2018-28363.pdf
Administrative Practice and Procedure
Grant Programs-Health
Health Facilities
Laboratories
Medicaid
Medicare
Penalties
Reporting and Recordkeeping Requirements
32 p.
1536
1567
84 FR 1536
Code of Federal Regulations
Title 42 Part 493
42 CFR Part 493
Regulation Identification Number 0938-AT55
RIN 0938-AT55
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance; Federal Register Vol. 84, Issue
PRORULE
2018-28363
II
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
2019-04-05
CMS-3355-P
4120-01-P
2018-28363
Proposed rule.
This proposed rule would update 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 proposed rule would also make additional technical changes to PT referral regulations to more closely align them with the CLIA statute.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on April 5, 2019.
Sarah Bennett, CMS, (410) 786-3531; Caecilia Blondiaux, CMS, (410) 786-2190; 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 of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance
,
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/Search.cfm
http://www.regulations.gov
http://wwwn.cdc.gov/cliac/pdf/cliac0910.pdf
https://ftp.cdc.gov/pub/CLIAC_meeting_presentations/pdf/CLIAC_Summary/cliac0908_summary.pdf
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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/system/files/2018-01/fast-facts-us-hospitals-2017_0.pdf
https://www.ahrq.gov/research/findings/nhqrdr/index.html
https://www.bls.gov/oes/current/oes_nat.htm
https://www.cdc.gov/labstandards/hs.html
https://www.guideline.gov/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4698806/
https://www.ncbi.nlm.nih.gov/pubmed/18081434
https://www.nice.org.uk/guidance/cg137
https://www.resdac.org/cms-data/request/cms-virtual-research-data-center
https://www.thecommunityguide.org
https://www.uspreventiveservicestaskforce.org/Page/Name/recommendations
https://www.westgard.com/biodatabase1.htm
www.mayomedicallaboratories.com/test-catalog/appendix/criticalvalues/index.html
Federal Register
Vol. 84, no. 23
Office of the Federal Register, National Archives and Records Administration
2019-02-04
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2019-02-04
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0042-1219
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https://www.govinfo.gov/app/details/FR-2019-02-04
https://www.govinfo.gov/content/pkg/FR-2019-02-04/pdf/FR-2019-02-04.pdf
https://www.govinfo.gov/content/pkg/FR-2019-02-04/xml/FR-2019-02-04.xml
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