"Regulatory Update"

Current Review of CLIA Standards Intended to Address Laboratory PT

EFFORTS ARE UNDER WAY TO REVIEW existing requirements for laboratory certification under the federal Clinical Laboratory Improvement Act (CLIA). CLIA legislation was a response by Congress to widely-publicized failings in the quality and performance of certain cytology and office laboratories during the 1980s. It has been 16 years since the existing requirements took effect.

It was 1992 when these CLIA laboratory certification standards were published by the Centers for Medicare & Medicaid Services (CMS) and became effective. Since that time, laboratory medicine has seen new technologies, new assays, and new laboratory practices become accepted into clinical practice. The objective of this unfolding review and revision to CLIA laboratory certification requirements is to reflect these changes in laboratory practices in the CLIA laboratory standards.

In a recent intelligence briefing on the subject of quality management systems (QMS), THE DARK REPORT commented that it was likely that the “impending reform and updating of CLIA standards will include a requirement that, to maintain status as a CLIA-licensed laboratory, the candidate laboratory must demonstrate its effective use of quality management systems in its daily operations.” (See TDR, August 18, 2008.)

No Plans For QMS Standards

“That is simply not the case,” stated CMS Director of Laboratory Services, Judy Yost, in a recent telephone interview with THE DARK REPORT. “There is no plan to review and incorporate the principles of quality management systems into current CLIA standards any more than what currently exists.”

Yost further noted that the ongoing review is neither a reform nor a major overhaul to existing CLIA requirements. “What is intended is to update the proficiency testing (PT) standards for laboratories, PT programs and the list of analytes for which PT is required to better align with the current practice of laboratory medicine,” she stated. “At its core, CLIA is a program to ensure quality testing in laboratories covered under these regulations.”

CLIA Licensure Standards

One factor that increases the complexity of developing appropriate CLIA laboratory licensure standards is that the requirements must be appropriate to sup- port accurate testing in a variety of laboratory types and settings. More than 206,000 CLIA certified laboratories operate in this country. These labs can be small and located in physicians’ offices, clinics and a multitude of other sites. They include the various laboratory testing sites in hospitals, integrated healthcare systems and reference laboratories.

Since introduction of the CLIA laboratory certification program in 1992, CMS’ inspection and proficiency testing (PT) data indicate improved performance over time. As well, there have only been isolated examples where a laboratory has systematically failed in ways that put patients at risk because of inaccurate or false test results.

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