CLIA PT Enforcement Ensnares Top Labs

Ohio State University Wexner Medical Center faces loss of its laboratory’s Medicare license

CEO SUMMARY: Think it can’t happen to you? Think again. Following self-disclosure of inadvertent referrals of proficiency testing (PT) specimens, the laboratory at Ohio State University Wexner Medical Center (OSUWMC) was visited by officials from the Ohio Department of Health and the Centers for Medicare & Medicaid Services (CMS). Following that survey, CMS sent notice to the OSUWMC laboratory that its CLIA license would be revoked, on August 10, 2012, in the absence of an appeal.

IN JUNE, NEWSPAPERS IN COLUMBUS, OHIO, reported that the clinical laboratory of the Ohio State University Wexner Medical Center (OSUWMC) faced loss of its CLIA (Clinical Laboratory Improvement Amendments) license as a result of unintentional errors in the handling of proficiency testing (PT) samples.

The Centers for Medicare & Medicaid Services (CMS) delivered the news to OSUWMC in a letter dated June 11, 2011. It was signed by Marilyn Hirsch, Manager, Division of Survey and Certification.

The letter informed OSUWMC that, in the absence of an appeal, its CLIA license would be revoked as of August 10, 2012. That action would cancel the laboratory’s “approval to receive Medicare payments for its services” as of that date.

CMS stated that the sanctions were in response to how OSUWMC was out of compliance in “enrollment of testing of samples” and “laboratories performing high complexity testing; laboratory director.” Earlier in the year, OSUWMC had self-reported the inadvertent referral of proficiency testing specimens.

The decision by CMS to take this action against one of the nation’s first-rank clinical laboratory organizations is highly unusual. But several lab industry attorneys say this type of sanction is happening elsewhere.

THE DARK REPORT is aware of another sizeable and highly-respected clinical laboratory organization that also had its CLIA license revoked within the past 12 months as a result of inadvertent handling of proficiency testing specimens. This laboratory has not publicly acknowledged that it switched its ownership and laboratory directorship in response to the sanctions levied against it by CMS.

The manner in which CMS interprets the CLIA language that governs proficiency testing is at the core of these enforcement actions. Further, since the inception of CLIA, clinical laboratory professionals have regularly pointed out to CMS that its interpretation of the proficiency testing guidelines is overly severe.

Interpretation Is An Issue

It is because of how CMS interprets the CLIA language pertaining to proficiency testing that the OSUWMC lab finds itself facing possible revocation of its CLIA license. This is a laboratory that says it performs more than 9 million tests annually and handles about 9,000 PT specimens per year.

Yet, because of the inadvertent referral of six PT samples since 2009, OSUWMC is facing loss of its CLIA license and its ability to receive Medicare payments. Another interesting twist to this case is that the OSUWMC laboratory self-reported the mishandling of PT specimens to CMS. Thus, it is facing loss of its CLIA license after having done the right thing.

It may not be a coincidence that bills were recently filed in both houses of Congress that would address how CMS interprets and enforces CLIA statutes that govern proficiency testing. Apparently, several Senators and a number of Representatives have heard directly from constituents about the problems resulting from how CMS responds to situations where a laboratory has inadvertently mishandled a proficiency testing specimen by referring it out.

Collectively, the harsh enforcement of CLIA as it pertains to the handling of proficiency testing specimens and the heightened interest of several Senators and Representatives in submitting bills to address this situation are important developments. It may be that a “pain point” has been reached across the clinical laboratory testing profession and support for a legislative fix to the proficiency testing issue has reached critical mass.

For that reason, this entire issue of THE DARK REPORT is devoted to the most recent developments in enforcement of CLIA proficiency testing requirements. It is an issue that directly touches every laboratory in the United States that holds a CLIA license.

First, you will read about the letter sent by CMS to OSUWMC and the response sent back to CMS by OSUWMC. Important details about how OSUWMC came to self-report its PT errors are provided for the first time.

Next, an experienced laboratory director who has participated in national policy activities for the clinical laboratory profession provides insights on how clinical labs typically handle PT specimens. There are also informed observations about certain aspects of the OSUWMC case.

This is followed by information from CMS on their policies relating to the CLIA law and proficiency testing. After that comes the commentary of an attorney who has decades of experience handling important clinical laboratory and pathology cases. He analyzes the OSUWMC case within the context of the ongoing criticism that the lab profession has directed to CMS for its interpretation of the CLIA statute. 

CMS Provides Statement

Our coverage is rounded out with a story that provides details about the bills recently submitted in both houses of Congress. These are intended to correct the current problems associated with CLIA regulations that pertain to proficiency testing.

In many ways, every CLIA-licensed lab in the United States has “skin in this game.” That’s because just one unintended mishandling of PT specimens can result in revocation of the lab’s Medicare license.


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