CMS Proposes Sanctions Against OSU Laboratory

Procedural PT errors cause CMS to send notice of revocation of lab’s CLIA license

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CEO SUMMARY: As its reward for self-reporting the referral of six proficiency testing (PT) specimens in three years, the laboratory at Ohio State University Wexner Medical Center (OSUWMC) has been told by the Centers for Medicare & Medicaid Services (CMS) that its CLIA license could be revoked, subject to appeal by the laboratory. Here are the details of this story, as presented in a letter prepared by OSUWMC’s laboratory director and sent to CMS officials.

THIS IS A NEWS STORY that deserves the full attention of pathologists and clinical laboratory administrators across the nation. CMS has served notice to the Ohio State University Wexner Medical Center (OSUWMC) that its CLIA license could be revoked.

That’s the headline. The story behind this headline is that the threatened license revocation came after the OSUWMC laboratory self-reported to CLIA (Clinical Laboratory Improvement Amendments) regulators that it had inadvertently referred six proficiency test samples.

Self-Disclosure

CLIA regulators responded to this self-disclosure with an on-site inspection in March 2012. Next, the laboratory director at OSUWMC was sent a letter from the Centers for Medicare & Medicaid Services (CMS) informing her that, on August 10, 2012, the OSUWMC laboratory CLIA certificate would be revoked, in the absence of an appeal.

Further, once the revocation becomes effective, both the owner and the laboratory director of the OSUMWMC lab would be prohibited from owning or operating a laboratory for a minimum of two years.

In its letter, CMS justified its decision to levy the most severe CLIA sanctions in its power because of “improper proficiency testing referral.” The letter further stated:

Your Condition-level noncompliance constitutes immediate jeopardy and is likely to cause serious harm to the individuals served by your laboratory and to the health of the general public.

The deficiencies found at your laboratory have been determined to be of such a serious nature that they substantially limit your laboratory’s capability to render accurate and reliable services and to protect the health and safety of your laboratory clients.

In fact, the inadvertent PT referrals did not cause harm and were not likely to cause any harm to patients at any time, OSUWMC said in a response to the charges in the letter from CMS.

Officials from CMS and OSUWMC did not return phone calls from THE DARK REPORT requesting comment for this article. However, THE DARK REPORT reviewed the letter and the accompanying list of deficiencies sent by CMS on June 11 to OSUWMC.

It also reviewed the appeal letter prepared by the hospital in response. This letter was sent to CMS on June 25 and signed by Laboratory Director Amy S. Gewirtz, M.D.

As of press time, it was unclear if CMS had made a final decision or when it would make a decision. If CMS rules against the lab, OSUWMC could further appeal to an administrative law judge within CMS.

Interpreting PT Rules

Each year, the OSUWMC lab network performs about 9.2 million patient tests. It also handles about 9,200 proficiency tests annually.

According to the letter Gewirtz wrote to CMS, this case began on February 15, 2012, when a PT sample (labeled TTD-02) was mistakenly sent to an outside lab (Mayo Medical Laboratories). After tests were run on the PT sample that day, some OSUWMC lab staff members discussed the need to send it out. But others identified it as a PT sample that should stay in house. Despite these conversations, it was sent out, Gewirtz wrote.

The next day, February 16, Mayo called OSUWMC to say it received TTD-02, identified it as a PT sample, and did not perform testing on the sample. Mayo also said that it would report the incident as an improper PT referral to the College of American Pathology (CAP) and to the Ohio Department of Health (ODH), as CLIA requires, according to the OSUWMC letter.

“No inter-laboratory communications regarding the laboratory’s PT results occurred,” Gewirtz wrote. This statement is important because Gewirtz explained unequivocally that Mayo did not test the sample and that the lab staff at OSUWMC did not discuss its test results with any staff at Mayo. Inter-lab communication about PT sample testing results could be an indication that the lab is cheating.

Gewirtz also instructed the lab compliance manager to notify CAP, ODH, and officials within OSUWMC that it referred the specimen incorrectly. This self-reporting is important because it is one indication that the lab recognized the mistake and was being completely transparent about the error.

Two weeks later, the staff at the OSUWMC lab were implementing corrective action related to the mishandling of PT sample TTD-02, Gewirtz wrote. On February 29, the lab compliance manager discovered that a PT blood culture specimen was accidentally referred to the laboratory at OSU East Hospital, Gewirtz wrote.

“She informed me of this discovery right away, and in response I directed her to conduct a review of all PT blood culture specimens received during the previous two years,” continued Gewirtz. “As a result of this two-year look back, the compliance manager identified four additional PT blood culture specimens that were accidentally referred to the East Laboratory.”

Inspection Expected

Following these actions, the number of incorrect PT referrals identified at the OSUWMC lab totaled six since 2009.

“At my direction, the compliance manager notified CAP of the accidental PT referrals on March 1,” she continued. “CAP advised the lab to make a self-report to CMS and ODH during the inspection it anticipated would occur as a result of the accidental PT referral to Mayo.”

The five blood culture testing errors are examples of another source of confusion regarding CLIA PT requirements. Labs frequently send PT samples to other labs within their lab organization or network based on the mistaken belief that sending PT samples to a lab in the same network is allowed. This is what happened at OSUWMC with the five blood culture PT samples, she wrote, also emphasizing that no inter-laboratory communication occurred.

In the letter to CMS, Gewirtz also outlined the corrective steps the lab took, including computer edits to prevent accidental PT referrals, online and in-person training, and new and revised policies. The OSUWMC letter concluded with a list of four reasons that CMS should not revoke the lab’s CLIA certificate.

First, the lab did not intentionally refer PT samples to another laboratory for analysis. Second, the lab did not circumvent—nor did it intend to circumvent— CLIA’s PT requirements.

Third, the accidental PT referrals did not cause harm and were not likely to harm individuals the lab serves or the general public. “The conduct at issue did not constitute immediate jeopardy because… there is no reason to question the integrity of the PT survey results at issue,” she wrote. Also, when it discovered the first accidental PT referral, the lab reported it to ODH and CAP and implemented a correction plan.

“Fourth, and most importantly, revocation of the lab’s CLIA certificate and cancellation of the lab’s ability to receive Medicare payments would have dire consequences for patients and providers throughout central Ohio and beyond,” she wrote in the letter to CMS.

As this issue of THE DARK REPORT went to press, it was unknown how negotiations between OSUWMC and CMS were proceeding. One deadline mentioned in the CMS letter was its intent to revoke the CLIA license of the OSUWMC laboratory effective August 10, 2012, in the absence of an appeal. As of this date, neither party has made a public statement about whether the sanction is to be enforced on this date or, presumably, will be postponed as CMS weighs the response letter sent by OSUWMC.

Further, the information contained in this intelligence briefing was drawn primarily from the CMS letter to OSUWMC and from the response letter sent by OSUWMC to CMS.

 CMS Letter Sent to OSUWMC Summarizes Survey Findings

AFTER REPORTING THAT HER CLINICAL LABORATORY had made a small number of procedural mistakes in its proficiency testing (PT), Laboratory Director Amy Gewirtz, M.D., was expecting a visit from lab surveyors.

On March 28, staff from the Ohio Department of Health and the Centers for Medicare & Medicaid Services (CMS) conducted a CLIA-compliance survey of the lab at the Ohio State University Wexner Medical Center (OSUWMC). CMS officials detailed the results of their survey in a letter to Gewirtz on June 11.

CMS said OSUWMC lab staff failed to follow the proper PT procedures in November 2009, July 2010, July 2011, and November 2011, and twice on February 2012. It wrote that:

Due to the laboratory’s failure to comply with certificate requirements and performance standards as evidenced by the finding of improper referral of the laboratory’s proficiency testing samples to another laboratory for analysis, the laboratory’s failure to meet all condition-level requirements of CLIA, and our determination of serious and immediate jeopardy, the CMS proposed to take action to impose the following sanctions against the laboratory’s CLIA certificate:

—42 C.F.R. §493.1806(a)(b)– Principal Sanction: Revocation of your laboratory’s CLIA certificate.

—42 C.F.R. §493.1807(a)– Principal Sanction: Cancellation of your laboratory’s approval to receive Medicare payments for its services. This sanction will become effective on the date the revocation of the CLIA certificate becomes effective.

In the last 10 pages of the letter, CMS numbered and listed the deficiencies it cited during its compliance survey on March 28.

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