The Wexner Medical Center at Ohio State University (OSU) in Columbus has avoided the worst that can happen to a clinical laboratory for violating proficiency testing (PT) referral rules under the Clinical Laboratory Improvement Amendments (CLIA): revocation of the certification required to legally perform any diagnostic testing on human specimens and cancellation of approval to receive Medicare and Medicaid payments. The Centers for Medicare and Medicaid Services (CMS) had imposed these sanctions last summer after PT samples were sent to the Mayo Clinic and to another OSU lab for testing. The sanctions, however, were put on hold when OSU appealed (NIR 12, 16/Sept. 6, pp. 4-5). In a settlement reported in the Jan. 16 Columbus Dispatch, the center has agreed to pay $268,000 to resolve allegations that it violated CLIA PT referral rules. The lab will remain open under OSU control, but the center also agreed to appoint a new lab director and provide additional training to the lab staff. “We are grateful to CMS for its willingness to work toward a resolution that best meets the needs of our patients and the community,” said Larry Anstine, CEO of the Ohio State University Hospital, in a prepared statement. In 2011, […]
The Wexner Medical Center at Ohio State University (OSU) in Columbus has avoided the worst that can happen to a clinical laboratory for violating proficiency testing (PT) referral rules under the Clinical Laboratory Improvement Amendments (CLIA): revocation of the certification required to legally perform any diagnostic testing on human specimens and cancellation of approval to receive Medicare and Medicaid payments.
The Centers for Medicare and Medicaid Services (CMS) had imposed these sanctions last summer after PT samples were sent to the Mayo Clinic and to another OSU lab for testing. The sanctions, however, were put on hold when OSU appealed (NIR 12, 16/Sept. 6, pp. 4-5).
In a settlement reported in the Jan. 16 Columbus Dispatch, the center has agreed to pay $268,000 to resolve allegations that it violated CLIA PT referral rules. The lab will remain open under OSU control, but the center also agreed to appoint a new lab director and provide additional training to the lab staff.
“We are grateful to CMS for its willingness to work toward a resolution that best meets the needs of our patients and the community,” said Larry Anstine, CEO of the Ohio State University Hospital, in a prepared statement. In 2011, Ohio State’s medical laboratory network performed 9.1 million patient tests, 7.24 million of which were performed at the lab previously under threat, central Ohio’s only fully automated hospital lab, noted the Columbus Dispatch.
Background of the Case
The lab threatened with CLIA certificate revocation performs more than 60 percent of tests ordered for the center’s patients, according to OSU. At issue were six PT referrals that the center self-reported as accidents, noting that corrective action had been taken.
In February 2012 the lab sent a PT sample of Lyme disease to the Mayo reference lab for Western Blot confirmation. A subsequent review found that five more blood-culture specimens had been improperly referred to another OSU lab with a different CLIA certificate number between November 2009 and November 2011.
Staff from the Ohio Department of Health and CMS conducted a complaint survey of the center’s lab on March 28, 2012. In a follow-up letter on June 11, CMS told the lab’s director that the lab was out of compliance with federal rules on PT referrals. The lab responded with more than 100 pages of documents addressing this conclusion, but in a July 12 reply, CMS said this was not enough to change its opinion.
Accordingly, it revoked the lab’s CLIA certificate and Medicare and Medicaid approval, effective Aug. 10, if the lab did not appeal. The lab did appeal, thus blocking the sanctions while the matter was pending.
Perspectives on the Settlement
In comments on the case to G2Intelligence, attorney Robert E. Mazer with Ober/Kaler in Baltimore, said, “The required payment is a significant amount. But all things considered, this would appear to be a very favorable resolution for the hospital because its lab can continue to provide testing and bill Medicare and Medicaid for its services.
“The settlement may indicate that, in appropriate cases, CMS will accept lesser sanctions than revocation. However, the settlement is not precedent on which another lab can legally rely. Additionally, it’s very difficult to determine what factors CMS will consider important in determining whether to accept a sanction other than revocation based on a single settlement.”
A recent legislative change gives the agency leeway to impose lesser sanctions for PT referral violations, Mazer noted, “but the agency continues to have authority to revoke a CLIA certificate based on findings that a lab intentionally referred PT samples to another lab for testing which it is certified to perform. A laboratory can challenge CMS’ findings but an administrative law judge cannot require that a less severe penalty be imposed for such conduct.”
The new enforcement discretion granted to CMS was enacted in the bipartisan Taking Essential Steps for Testing (TEST) Act (Pub. L. 112-202), signed into law last Dec. 4. It amends the CLIA statute to revise sanctions for labs that unintentionally refer PT samples to other labs. CMS has the discretion to make the one-year CLIA certificate revocation optional rather than mandatory and to impose intermediate sanctions instead of the two-year prohibition against common lab ownership or operation that would otherwise apply (NIR 12, 22/Dec. 13, p. 8).
Being able to consider PT referral sanctions on a case-by-case basis is a change that CLIA officials have welcomed. Under previous policy, CMS maintained that the law gave it no choice but to impose the most severe sanctions, even for violations that were accidental or inadvertent.
