APPLICATION OF THE DEPARTMENT-OF-HEALTH AND HUMAN-SERVICES PROPOSED WAIVED STATUS REQUIREMENTS FOR IN-VITRO DIAGNOSTIC TESTING DEVICES - CASE-STUDY

The CLIA'88 classified all clinical. laboratory testing as waived, mod erate, or high complexity. The eight original waived tests were charac terized as simple, accurate, error-free, risk-free, and suitable for h ome use by nonlaboratory professionals, The subjective nature of the c lassification process was challenged immediately. The Clinical Laborat ory improvement Advisory Committee asked the CDC and the Health Care F inancing Administration to develop objective criteria that included as sessment of performance by field-test and in-house data. We examined t he efficacy of the CDC protocol with empirical data from the HemaCue B -Hemoglobin Test System(R) submission, to assess operator competency, intra-/interoperator and between-site imprecision, and accuracy. Non-l aboratory-trained operators demonstrated 2-3% imprecision (40-200 g/L) . Accuracy studies yielded a slope of 1.01, an intercept of 3.53 g/L, and r of 1.00 (52-230 g/L). Results met the protocol's Tonks' criterio n for imprecision (less than one-fourth of the reference range).