Spurred by patient safety concerns, the Clinical Laboratory Improvement Advisory Committee will strive to publish CMS' lab survey results in CDC's Morbidity & Mortality Weekly Report.

Despite improvements in lab compliance over the course of CMS' multi-year study, preliminary data from the 2003 survey of clinical labs sparked calls for action from CLIAC during the HHS advisory committee's meeting, held Feb. 11-12 in Atlanta.

In addition to forming a workgroup to translate the CMS data into a publishable form, CLIAC will draft a letter to the HHS secretary expressing concerns about the results.

The committee hopes publication of the data will help communicate problematic laboratory practices associated with CLIA-waived testing to physicians and other healthcare professionals who may be unaware of the widespread quality and training deficiencies identified by the survey.

The issue was brought to the forefront several years ago when CMS presented results from a 1999 pilot study of two states that found quality deficiencies in a large number of CLIA-waived labs. Subsequently, CMS expanded the survey to include additional states.

In spring 2002, as a follow-up to the expanded pilot, CMS initiated a three-year project to conduct nation-wide site visits to 2% of waived facilities (¹ Also see "CLIA Expanded Lab Survey To Address Manufacturer Instructions" - Medtech Insight, 28 January, 2002., p. 5).

The survey samples from CLIA-waived labs and facilities subject to more stringent oversight under the Clinical Laboratory Improvement Amendments of 1988. Under the law, lab oversight is linked to three categories of test complexity - waived, moderately complex and highly complex.

CLIAC has been closely following CMS survey results as it considers criteria manufacturers should meet to gain waived categorization for a test (see ² Also see "CLIAC Waiver Criteria Input Readied As FDA Gears Up To Draft Guidance" - Medtech Insight, 23 February, 2004.). At the meeting, the HHS committee associated worries about lab practices with misgivings about current statutory definitions for what should qualify as a CLIA-waived test.

Preliminary results from the 1,756 sites included in the 2003 CMS survey reveal that 20% of labs did not perform required quality controls, 12% did not have manufacturer instructions and 16% had training deficiencies. In 2002, a survey of 897 labs showed nearly a quarter of labs (24%) did not perform QC as required, 13% did not have manufacturer instructions and 21% had training deficiencies.

Also of particular concern to CLIAC was the impact of staff turnover on testing proficiency - in both years, 44% of labs experienced changes in testing personnel - and a small but significant percentage (2%-3%) of labs where "imminent and serious risks to human heath" were found.

"This is a critical crisis of major proportions and is a wake-up call and a message to everybody who has anything to do with laboratory testing and the laboratory community," physician and CLIAC member Kim Hetsko, MD, declared. "These types of numbers are far too high. Even one death is too many."

Other CLIAC members stressed the importance of linking the data to adverse events. "I think it is important to identify not only is there risk, but [also] how often does that risk actually translate into a real problem," AdvaMed liaison Luann Ochs, Roche Diagnostics, remarked.

There is a need to find out whether, on balance, CLIA-waived tests help or hurt health outcomes, other committee members agreed.

CLIAC members also urged CMS to continue to survey and educate labs on appropriate testing practices and recommended that a best-practice document be created for CLIA-waived labs.

"Data...demonstrate that if you have a program of surveillance and review, that over time laboratories improve. It is as simple as that," CLIAC member Jared Schwartz, MD/PhD, Presbyterian Healthcare, commented.

Schwartz added that manufacturers are not to blame for the survey results, but nevertheless could be impacted if testing practices do not improve.

"It is not the technical component here that is the problem," he acknowledged. However, "if we don't deal with pre- and post-analytical issues...we are going to be hurting the American public, because the technology that is coming out is unbelievable technology that is going to radically change the way healthcare is delivered. We don't want to do anything to impede that new technology."

CLIAC Taking Steps To Publish CMS Survey Data On Lab Compliance

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