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This article was originally published in The Gray Sheet

Executive Summary

SELF-CONTAINED HEMOGLOBIN TESTS MOVED TO WAIVED CLIA CATEGORY in a final rule published by the Health Care Financing Administration in the Jan. 19 Federal Register. The tests are being moved from the moderate complexity category to the waived category under the Clinical Laboratory Improvement Amendments of 1988 because "such test systems are simple and accurate with little or no likelihood of erroneous result and pose no reasonable risk of harm if performed incorrectly," HCFA says. HCFA specifically notes that users of the test are not required to decide "what analyte to use" and that the tests provide automatic interaction between the sample and reagent, eliminating the need for user interaction. In addition, the test "provides direct readout and measurement, precluding the need for any calculation, interpretation, or other action or decision to obtain a result." In changing the test's category, HCFA acted on the advice of the Clinical Laboratory Improvement Advisory Committee (CLIAC), which recommended at an Oct. 28-29 meeting that Mallinckrodt/HemoCue Interessenter's HemoCue hemoglobin measurement system be placed in the waived category ("The Gray Sheet" Nov. 9, I&W-6). The rule defines the waived hemoglobin tests as "hemoglobin by single analyte instruments with self- contained or component features to perform specimen/reagent interaction, providing direct measurement and readout." The Jan. 19 final rule also creates a new category of tests made up of physician-performed microscopy procedures. The tests, which were previously in the moderate complexity category, are not being moved to the waived category but are being exempted from routine inspections. Noting that it received "numerous comments" requesting that the tests be moved to the waived category, HCFA said that it "rejected recategorization of these tests as waived because they do not comply with the statutory requirements for waived tests given the skills and training required to perform these microscopy procedures." However, HCFA says that it recognizes that to apply some requirements of the moderate category to physician-performed microscopy, "specifically the inspection requirements," would be "impractical and unnecessarily intrusive." Offsetting the exemption from routine inspections is the requirement that only physicians perform the tests, which is more stringent than the rules for other moderately complex tests. HCFA explains that "because physicians have extensive medical training greater than that required by these regulations for personnel performing moderately complex tests, and because these tests are done in the context of a patient examination, we believe that there is assurance that accuracy of testing can be maintained despite the lack of routine inspections." Development of the new category was recommended by CLIAC at its October meeting. HCFA, however, did not accept CLIAC's recommendation that the tests be exempt from proficiency testing and quality control requirements. The notice also delays the application of CLIA requirements to workplace drug testing. According to HCFA, "many commentors said that coverage of such testing would have an unintended chilling effect on efforts to establish drug testing programs." As a result, the agency delayed implementation in this area "until we have investigated the matter in greater detail." Expecting the delay, Rep. John Dingell (D-Mich.) introduced HR 33 on Jan. 5. The bill "would amend the Public Health Service Act to establish standards for the certification of laboratories engaged in urine drug testing," Dingell says in remarks published in the Jan. 5 Congressional Record. He attributes the delay in implementation to "a small group of business interests" that "prevailed upon the Secretary of HHS to suspend the effectiveness of the regulation." The next full CLIAC meeting is scheduled for Feb. 17 at the Centers for Disease Control and Prevention headquarters in Atlanta. Issues relating to CLIA personnel standards will be discussed. In addition, the committee may address its lack of industry representation. The Health Industry Manufacturers Association raised the issue of industry representation on the committee in a Dec. 22 letter to CDC Director William Roper. The letter asks that CDC "reconsider this matter and take steps to secure adequate industry participation in the Committee activities."

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