College of American Pathologists




October 4, 2013
© 2013 College of American Pathologists
Special Report
CMS Proposes Changes to Proficiency Testing (PT) Referral Sanctions

October 4, 2013—The Centers for Medicare and Medicaid Services (CMS) has released proposed rule CMS–1443–P, which would guide CMS on increasing the flexibility of its penalties for a laboratory that refers PT material for testing to another laboratory.

In the rule, which modifies enforcement of the Clinical Laboratory Improvement Amendments (CLIA), regulations that govern all non-research laboratory testing in the U.S., CMS is proposing three categories of sanctions based on the severity and extent of the referral:

  • Category 1: Revocation of CLIA Certificate – The most severe sanctions, applied to laboratories in which a serious violation, such as repeat PT referral, is determined to have occurred.
  • Category 2: Suspension or Limitation of CLIA Certification – An intermediate category, which would be applied to laboratories that are determined to have referred PT samples unintentionally.
  • Category 3: General Sanctions – The least severe level of sanctions, applied to laboratories that refer PT specimens which are not tested by another laboratory. In these cases, the laboratory in violation would be required to pay a civil penalty and complete a correction plan, including staff training on proper procedures.

Over the past several years, the CAP has lobbied CMS and Congress to address the draconian sanctions that laboratories faced for inadvertent PT referrals. In December 2012, the College backed the Taking Essential Steps for Testing Act of 2012 (TEST Act), which was signed into law and will be implemented by the proposed rule. The TEST Act gives CMS greater discretion in determining sanctions for PT referrals.

“The old rule triggered automatic and severe sanctions that could effectively shut down labs for even minor or inadvertent PT referral problems,” said Dr. Richard Friedberg, MD, PhD, FCAP, chairman of the Department of Pathology at Baystate Health and chair of the CAP Council on Government and Professional Affairs. “The bipartisan support for the TEST Act demonstrates how flawed the original rule was.”

The proposed rule appears to reflect many of the CAP’s recommendations on increasing the flexibility of PT referral sanctions based on the severity of the violations.

“Overall, the CMS rule is largely aligned with the guidance that the CAP provided,” Friedberg said. “The civil penalties for minor infractions, however, are out of sync and should be re-visited.” CAP staff will continue to analyze the proposed rule and will submit comments to CMS by November 18.


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