View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
HHS/CMS RIN: 0938-AT55 Publication ID: Spring 2018 
Title: ●Proficiency Testing Regulations Related to Analytes and Acceptable Performance (CMS-3355-P) 
Abstract:

This proposed rule would update proficiency testing (PT) regulations to include current analytes (substances or constituents for which the laboratory conducts testing) and newer technologies that are not included in the current Clinical Laboratory Improvement Amendments (CLIA) regulations. The rule would also include additional technical changes to PT referral regulations to align with statute.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: No 
EO 13771 Designation: Fully or Partially Exempt 
CFR Citation: 42 CFR 493   
Legal Authority: 42 U.S.C. 263a   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/00/2018 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Caecilia Blondiaux
Health Insurance Specialist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Clinical Standards and Quality, MS: C2-21-16, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-2190
Email: caecilia.blondiaux@cms.hhs.gov