The Centers for Medicare & Medicaid Services will follow up its expanded pilot survey of CLIA labs by initiating nationwide site visits to 2% of waived facilities beginning in March.

CMS expects to conduct the visits to certificate-of-waiver (COW) and provider-performed microscopy procedure (PPMP) labs through September when the fiscal year ends. The upcoming survey will continue to assess how waived tests are used in the field and will take an "overall approach," focusing broadly on those who perform the tests, according to CMS.

Initially, increases in tests granted waiver under CLIA prompted Colorado and Ohio to initiate on-site inspections of a random sample of CLIA-waived and PPMP labs in a 1999 pilot study. The visits uncovered significant quality problems in over 50% of labs in the two states.

CMS responded by expanding the two-state survey in October 2000, following up in eight additional states through January 2001. The agency inspected 2.5%, or 436, of waived and PPMP laboratories in the selected states.

In the expanded pilot, CMS found several widespread quality problems in waived labs: 32% failed to have manufacturer's instructions for current tests and did not perform quality control as required by the manufacturer or CDC. Half as many labs (16%) failed to follow manufacturer's instructions. In PPMP laboratories, 38% did not properly perform proficiency testing for test accuracy.

Among CMS' goals are addressing manufacturer instruction problems, staffers indicate. Rather than introducing punitive fines for labs with quality problems, primary focus will be placed on practitioner education in a consultative, "exchange of information mode," CMS says.

It remains unclear what impact results from the survey will have on the ongoing CLIA waiver criteria that are being drafting by CMS in collaboration with FDA and CDC. Findings from the initial surveys, however, have been cited to support promulgation of more stringent criteria for CLIA wavier. Representatives from CMS, FDA and CDC will attend the Clinical Laboratory Improvement Advisory Committee's Jan. 30-31 meeting in Atlanta to further discuss waiver criteria.

CLIA Expanded Lab Survey To Address Manufacturer Instructions

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