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This article was originally published in The Gray Sheet

Executive Summary

HDL CHOLESTEROL TEST CLIA COMPLEXITY CATEGORIZATION may be lowered for some tests as the result of a recommendation made by the test categorization subcommittee of the Clinical Laboratory Improvement Advisory Committee (CLIAC) at a Jan. 29 meeting in Atlanta. In three-to-one and four-to-zero votes, the subcommittee decided that scores for two of seven criteria used to categorize tests as moderately or highly complex should be decreased for HDL tests. According to the panel, the tests require moderate but not high levels of interpretation/judgement skills and training/experience to perform. The subcommittee was split on whether the tests' score for the knowledge criterion should also be lowered. The subcommittee had been asked by the larger CLIAC to provide recategorization recommendations on the 130 currently available HDL tests. Of the 130 assays, 124 are in the high complexity category and six are in the moderate category. The change in the scores of these tests would move some tests, including those performed on six Kodak Ektachem analyzers, to the moderate complexity category. In its deliberations, the subcommittee used Kodak's Ektachem DT 60 as representative of HDL tests in the high complexity category that may be subject to recategorization. The Kodak product was used as an example because its complexity score was on the border between medium and high. According to subcommittee chairman Steven Kroger, MD, chief executive officer of the Commission on Office Laboratory Accreditation in Longmont, Colorado, the panel focused on the DT 60 because "it has surfaced as kind of the index case for classification under HDL cholesterol. As such, what we decide about DT 60 and its characteristics should fall over into other instruments" where the categorization issues are similar. The Centers for Disease Control and Prevention has placed the DT 60 HDL test in the high complexity category, which indicates that the test scored too high in the seven complexity categories to be considered moderately complex. In recommending a change in the score of HDL cholesterol tests, the panel effectively recommended that DT 60 be placed in CLIA's moderate complexity category. The subcommittee's role is to comment on the criteria used by the CDC to classify tests and to advise the CLIAC on the use of the criteria to classify certain tests. Kroger noted that the subcommittee's recommendations are not binding on the full CLIAC. "It's simply an advisory committee to the advisory committee," he said. He likened the subcommittee's function to that of a task force and added that the panel's consensus as well as dissenting opinions will be detailed in a report to the CLIAC. Also considered by the categorization subcommittee at the Jan. 29 meeting was whether Tzanck smears, used to diagnose Herpes simplex virus, and cervical/urethral Gram stains should be moved from moderate complexity to the physician-performed microscopy category created on Jan. 19 ("The Gray Sheet" Feb. 1, I&W-12). Subcommittee Executive Secretary, Edward Baker, MD, director of the CDC's public health practice program office noted a "consensus from the members, definitely saying that Gram stains and Tzanck smears should not be moved to the physician-performed microscopy category," because they did not meet the criteria for classification under the new category. In order to be placed in the new microscopy category, tests must require only "limited specimen handling or processing," and there must not be any existing controls for the tests. In addition, only tests currently in moderate complexity can be moved to the new category. The panel noted that Gram stains and Tzanck smears require several preparation steps, and controls are available for both preparations. Finally, the subcommittee considered whether the 35 commercially available rapid strep tests be moved to either the physician-performed microscopy or waived categories from moderate complexity. The panel determined that the move is not warranted because the average sensitivity and specificity rates of the tests are too low. Panel member Morton Schwartz, PhD, of Memorial Sloan- Kettering Cancer Center in New York City, said he sees "a risk from false negative values," that occur in test results. "It seems to me that...14 or 15% [false negative rate cited by one presenter to the panel] is not negligible," he said. Asked by Baker whether the tests meet the criteria for waiver, the subcommittee decided that they do not meet the requirement that they "pose no reasonable risk of harm to the patient if the test is performed incorrectly." Kroger agreed with the panel's decision but stated his opinion that the tests should not be considered as a group. He maintained that some tests, if considered separately from the group of rapid strep assays, may have sensitivities and specificities high enough to fit the waiver category. "My concern is that we may be in fact categorizing a heterogeneous group of methodologies that penalize certain tests that may fall into this category, that are appropriate for use in the waivered category," he said. Kroger added that he "would support a different approach to classifying these tests into the waivered category. Instead of as a group, classify them by methodology." Baker noted that future meetings of the subcommittee may reconsider current CLIA methods for determining what tests should be waived. He said that he had a "clear sense that we need very shortly to have a much more explicit basis for making this call." He added that the full CLIAC has suggested "that this subcommittee needs to be looking into this issue further." During the Jan. 29 session, the subcommittee also heard a suggestion from Sunnyvale, California-based ChemTrak that an additional type of test be placed in the waived category. ChemTrak said that single analyte, self-contained tests that require no user interaction after the test sample is added and require no calculation or interpretation of results should be waived. These types of tests are similar to the self- contained hemoglobin test that received a waiver in the Jan. 19 Federal Register. ChemTrak manufactures the Accumeter total cholesterol test, which has the characteristics that the firm is recommending for waiver. The test currently is in the moderately complex category.

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