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HHS/CMS RIN: 0938-AR83 Publication ID: Spring 2013 
Title: ●Adverse Action for Proficiency Testing Referral Violations (CMS-3282-P) 
Abstract: This proposed rule would establish adverse actions for proficiency testing referral violations and align enforcement actions with statutory changes that provide greater discretion. Enactment of the Taking Essential Steps for Testing Act of 2012 on December 4, 2012, amends the Public Health Services Act and provides greater discretion for the Secretary to substitute intermediate sanctions in lieu of the mandatory 2-year prohibition on the laboratory owner and operator when a CLIA certificate is revoked due to intentional PT referral, or to rely only on such intermediate sanctions and consider alternatives to mandatory revocation in such cases. This change has resulted in a conflict between the CLIA regulations and the statute. As currently written, the regulations offer no discretion and require CMS to revoke the laboratory's CLIA certification for at least 1 year and ban the owner and operator for 2 years when proficiency testing referral is confirmed. 
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: No  Unfunded Mandates: No 
CFR Citation: 42 CFR 493   
Legal Authority: 42 USC 263a   
Legal Deadline:  None
Action Date FR Cite
NPRM  03/00/2014 
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:
Melissa Singer
Medical Technologist
Department of Health and Human Services
Centers for Medicare & Medicaid Services
7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-0365

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