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CLIA '88: NEW TEST COMPLEXITY CATEGORY

This article was originally published in The Gray Sheet

Executive Summary

CLIA '88: NEW TEST COMPLEXITY CATEGORY with less stringent requirements than those for "moderately complex" tests is being proposed by the Centers for Disease Control and Prevention. CDC suggested the new category at a June 22 meeting of the Clinical Laboratory Improvement Advisory Committee's subcommittee on test categorization in Atlanta. Under the Clinical Laboratory Improvement Amendments of 1988 "complexity" rules, tests are placed into one of three complexity categories: "waived," "moderately complex," or "highly complex," with the most stringent regulatory requirements placed on clinical labs conducting the highly complex tests. The CLIAC subcommittee responded favorably to the CDC proposal to add a fourth complexity category and encouraged the agency to pursue development of the idea. Summarizing the panel's position, Edward Baker, MD, director of CDC's public health practice program office and executive secretary of the subcommittee, said that "there is a need...for a category like this." CDC, in proposing the new category, is seeking a middle ground for some tests that would ease the regulatory burden for laboratories without waiving the tests from CLIA requirements. The proposal responds to the "many comments" received by CDC "suggesting that CLIA regulations should be more limited for some kinds of testing," CDC says. Similar action already has been taken for physician-performed microscopy procedures, which have been placed in a separate category to exempt the tests from the federal lab inspections mandated by CLIA ("The Gray Sheet" Feb. 1, I&W-13). Under the CDC proposal, the new category of tests would be subject to reduced personnel and facility inspection requirements. "What we are really proposing here is that the" quality control, quality assurance and proficiency testing requirements "be the same" under the new category "as they would be for moderate complexity testing," Carlyn Collins, director of CDC's division of laboratory systems, stated. Collins added that CDC could "look more to the personnel standards to see if we need to revisit that" and would "feel comfortable with less inspection" of facilities using tests in the new category. Panel member Paul Bachner, University of Kentucky Medical Center, Lexington, noted that the personnel requirements for labs performing moderate complexity tests include "a director, a clinical consultant, a technical consultant and testing personnel." For the new category, he recommended that CDC consider "merely requiring a director and making that director responsible for all varieties of requirements." Panel secretary Baker summarized members' suggestions that, for the new test category, inspections could be conducted on a random basis or when prompted by either a lab failing its proficiency testing or the federal government receiving complaints about the lab. Under CLIA, labs must be inspected on a biennial basis. Although CDC has not identified the tests that would be included in the new category, one candidate raised at the subcommittee meeting was streptococcus tests. Baker suggested that CDC try to "develop a subset of methodologies that we think are applicable" for placement in the new category, "and then come back for further discussion with the committee." The tests "would undergo a rigorous review process, and would be required to meet specific performance criteria," the proposal notes. "Instructions for test performance would include quality control procedures required by CLIA, as well as information on required quality assurance and proficiency testing." At the June 22 meeting, the subcommittee also discussed a CDC proposal to make the criteria for waived tests more specific than the language used in the CLIA law. Under the law, laboratory tests are waived if determined to be "simple laboratory examinations and procedures which have an insignificant risk of erroneous result," CDC explains. The agency notes that it has developed specific criteria for the category because the criteria in the statute have "proven to be the source of much of the pressure to expand the waived test list." Under CDC's proposal, "simple and easy to use" tests would be defined as those where: "the test consists of a very limited number of steps"; the "testing process is self-contained, requiring no operator intervention other than inserting the specimen"; there is a direct readout of results, with no calculation or conversion required; and, "for multiple determination instruments, there is no operator intervention for specimen or analyte." Proving that a test poses little likelihood of erroneous results requires a "fail-safe mechanism which renders no result when [the] instrument malfunctions or [the] result is out of reference range," CDC says. Also, a test's "performance specifications (accuracy, sensitivity and specificity)" should vary only a specified amount "from the accepted reference method." The panel agreed generally with CDC's criteria for the two statutory requirements. However, it took issue with CDC's elucidation of "no reasonable risk of harm." To qualify as causing no harm, CDC proposes two criteria: "no medical action is taken solely on the results of the test -- other testing is required" and the "test is performed for screening or presumptive diagnostic purposes." Summarizing the panel views, Baker said that CDC should "just simply strike the two [criteria] under this area." At least, he added, the "no medical action taken" statement should be modified "to a situation where the test would have to be repeated before any medical action was taken."
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