Compliance, Legal & Malpractice

Hospital Labs Losing CLIA Certification Due to Increased CMS Enforcement

During the past year, a small, but growing number of hospital laboratories have lost CLIA certification as a result of increased enforcement by the Centers for Medicare & Medicaid Services (CMS). In at least two cases, hospitals facing revocation of their laboratory's CLIA certification have taken the federal government to court.

This disturbing development is being tracked by the College of American Pathologists (CAP). R. Bruce Williams, M.D., FCAP, reported that, "One lab in a moderate size city lost CLIA certification and was shut down. Only after a new owner was found was that lab facility able to come back online." Williams chairs CAP's Commission on Laboratory Accreditation  and is a pathologist with The Delta Pathology Group  in Shreveport, Louisiana.

Primary sources of trouble are inadvertent problems in proficiency testing (PT). The sanctions from the CMS are so severe that CAP and the American Clinical Laboratory Association (ACLA) have launched educational efforts to alert pathologists and lab directors about this problem nationwide. CMS is due to issue guidance on PT testing in the coming weeks.

Dark Daily readers interested in learning more about this developing trend should access the March 24, 2008 issue of The Dark Report. In that issue, one story assesses the case of the Victor Valley Community Medical Center, which is facing revocation of its lab's CLIA certification and has filed a lawsuit in federal court.

 The hospital has operated under the threat that its lab could lose its CLIA certificate since September. In September, the CMS said it would revoke the lab's CLIA certificate as a result of the lab's violation of CLIA proficiency testing (PT) standards. If the hospital laboratory loses its license, it is likely that the 115-bed non-profit hospital would close, said lawyer Patric Hooper of Hooper Lundy & Bookman in Los Angeles. Hooper represents the hospital in a federal court action filed against CMS.

In an interview in the same issue of The Dark Report,  Dr. Williams explained that CMS is being more vigilant in pursuing possible violations of rules regarding PT referral and intra-laboratory communication. "Frequently, the sanctions are disproportionate to the level of noncompliance, especially when instances were unintentional," Williams said. "CAP is tracking a rise in unintentional incidents, and has found some cases of misunderstandings that have developed in the laboratory community. We are trying to clear up that confusion."

In The Dark Report interview, Dr. Williams offers specific advice to laboratories to avoid PT violations that could threaten a lab's CLIA certification. This is an important development and compliance issue.  Officers at every CLIA-licensed laboratory should take immediate steps to evaluate their lab's compliance with CLIA regulations, particularly as it applies to proficiency testing.

For additional information: 

• The Dark Report Issue Summary
  
• American Clinical Laboratory Association: CLIA Steps Up Enforcement: What Does It Mean for You?