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This article was originally published in The Gray Sheet

Executive Summary

CLIA '88: 16 HDL TESTS MOVED FROM HIGH TO MODERATE COMPLEXITY CATEGORY under a July 26 Federal Register notice which finalizes HHS' list of in vitro diagnostic test categorizations under the Clinical Laboratory Improvement Amendments of 1988. The Centers for Disease Control and Prevention, which is responsible for assigning existing tests to CLIA "complexity categories," in March provided a list of only 13 high density lipoprotein cholesterol tests that it planned to move down to the moderately complex category ("The Gray Sheet" March 1, p. 8). The final list adds four new HDL tests to that list and moves one back to the high complexity group for a total of 16 new HDL tests in the moderate category. Four devices manufactured by Pharmacia Diagnostics, the GemProfiler, Gemini, Gemstar, and Gemstar II, were downclassified to moderately complex. The notice lists the devices as Electronucleonics, Inc. tests; Electronucleonics was acquired by Pharmacia in February 1989. The final list also differs from the proposed changes in that it bumps Miles Diagnostics' Ames Clinistat up to high complexity. Including the newly added products, 22 HDL devices are now classified as moderately complex; 109 HDL tests fall into the high complexity group. Some of the HDL tests were reclassified by CDC after the Clinical Laboratory Improvement Advisory Committee (CLIAC) recommended a reassessment of the tests' complexity scores. Under CLIA '88 final regulations, tests are classified as either "waived," moderately complex or highly complex. A test's complexity category determines the level of CLIA requirements with which a laboratory must comply. The final list classifies roughly 12,000 existing tests, including approximately 2,000 tests that were not included in any of the four previous partial categorization lists published by HHS. Overall, CDC received 435 comments on the original 10,000 test categorizations and reclassified about 1%, or 100, of the products. "The relatively small number of comments that were received on the thousands of test categorizations is testimony to the merit and credibility of the test categorization process," HHS proclaims. "It also confirms that CDC was successful in completing the monumental task of accurately categorizing thousands of laboratory procedures." "Most of the recategorizations occurred as a result of the change in the approach to scoring tests within the area of microbiology," HHS says, leading to a number of microbiology tests being moved from moderate to highly complex. Microbiology tests "involving identification and/or susceptibility determinations of organisms transferred from culture media have scored in the high complexity category," HHS notes. The department originally published this change in a Sept. 2, 1992 Federal Register notice ("The Gray Sheet" Sept. 7, 1992, p. 6). The changes were subsequently put on hold, however, "to allow for additional input." CLIAC endorsed the proposal during a meeting in October 1992 ("The Gray Sheet" Nov. 9, 1992, I&W-6). In response to comments, HHS also "reevaluated approximately 280 antigen detection systems in the microbiology area and recategorized 16 systems" from moderate to high complexity "based on the amount of interpretation, judgment, knowledge, and training required for these procedures." The 16 products include systems manufactured by Analytab, Cambridge Biotech, Fairleigh Dickenson, Alexon, Sanofi, Abbott, Isolab, Baxter and Meridian. The final test list also addresses several specific manufacturer requests to move cholesterol tests, such as Cholestech's LDX and ChemTrak's Accumeter, from the moderate to the waived category. HHS says that "the manufacturer of the Cholestech LDX has recently submitted new information on this test system. The request for currently under review." Similarly, "the Chemtrak Accumeter is currently being reevaluated for possible inclusion on the list of waived tests." On March 2, FDA cleared Chemtrak's over-the-counter version of the Accumeter, the Cholestrac ("The Gray Sheet" March 8, p. 14). Under CLIA regs, tests cleared for home use may be placed in the waived category. HHS also says that scores for final complexity categorizations will be released by the department upon request. "Scores for specific test systems and analytes may be requested" by contacting the Public Health Service in Atlanta, Georgia, the department remarks, adding: "Many requests were received to release the final scores." The Health Industry Manufacturers Association sought public release of categorization scores in its April 1992 comments to HHS on final CLIA regs ("The Gray Sheet" May 4, 1992, p. 28).

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