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CDC MOVING 13 HDL CHOLESTEROL ASSAYS TO MODERATE COMPLEXITY UNDER CLIA; RAPID STREP TESTS SHOULD REMAIN IN MODERATE CATEGORY, CLIAC RECOMMENDS

This article was originally published in The Gray Sheet

Executive Summary

CDC is moving 13 high density lipoprotein cholesterol tests to the "moderate complexity" category for the purposes of regulation under the Clinical Laboratory Improvement Amendments of 1988, according to a Centers for Disease Control and Prevention document released at a Feb. 16-17 meeting of the Clinical Laboratory Improvement Advisory Committee (CLIAC). CLIAC endorsed CDC's downclassification of the group of HDL tests from the high complexity category. CLIAC's subcommittee on test recategorization had suggested reclassification of several HDL tests at a January meeting ("The Gray Sheet" Feb. 8, p. 9). Following a subcommittee recommendation, CDC recalculated complexity scores for the 130 HDL tests initially placed in the high complexity category. Following the recalculation, CDC determined that 13 tests should be downclassified. CDC's decision will be announced in an upcoming Federal Register notice. Being placed in the moderate complexity category means that upon recalculation, the assays were reassigned lower scores for certain factors that comprise the complexity measure (e.g. level of training and experience required to perform the tests). A test's complexity category determines the level of CLIA regulation with which a lab must comply ("The Gray Sheet" Feb. 24, 1992, p. 11). Among the 13 assays moving to moderate complexity is one performed with the Kodak Ektachem DT 60; this test was cited by the subcommittee as a model of HDL tests that should be recategorized. Tests performed on six other Ektachem models -- the 250, 400, 500, 700, 700 P and 700 XR -- also were moved to moderate complexity. The remaining recategorized tests are: EM Diagnostic Systems' Easy Plus and Easy ST (both with automatic sample pretreatment); DuPont's Analyst; Bio-Chem Laboratory Systems' ATAC 6000; and Ames' Clinistat and Seralyzer III. At the Feb. 16-17 meeting, CLIAC also considered a recommendation by the subcommittee that rapid strep tests remain in the moderately complex category instead of being waived or placed in the new physician-performed microscopy category. CLIAC agreed that the rapid strep tests, as a group, should not be moved from the moderately complex category. However, the committee also advised CDC to consider regrouping them according to methodology rather than type of test. At the meeting in January, subcommittee Chairman Steven Kroger, MD, CEO of the Commission on Office Laboratory Accreditation, Longmont, Colorado, maintained that the tests should not be evaluated as a group because they make use of several different test methodologies. He said that if considered separately, some tests may fit the criteria for a waiver. At the Feb. 16-17 CLIAC meeting, Sunnyvale, California-based ChemTrak repeated an assertion made at the January subcommittee meeting that "a mechanism needs to be set in place to allow fair and equitable consideration of all appropriate technologies for waived status." In response, CLIAC recommended that CDC determine the feasibility of developing a method for evaluating tests for the waived category. CLIAC asked that a proposal for such a mechanism be prepared in time for its meeting in late May. CLIAC also endorsed the subcommittee's recommendation that cervical/urethral Gram stains and Tzank smears not be placed in the physician-performed microscopy category. CLIAC concurred that the tests do not meet criteria for the newly created category.
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