Application of the Department of Health and Human Services proposed waived status requirements for in vitro diagnostic testing devices: case study

Abstract

Abstract The CLIA’88 classified all clinical laboratory testing as waived, moderate, or high complexity. The eight original waived tests were characterized as simple, accurate, error-free, risk-free, and suitable for home use by nonlaboratory professionals. The subjective nature of the classification process was challenged immediately. The Clinical Laboratory Improvement Advisory Committee asked the CDC and the Health Care Financing Administration to develop objective criteria that included assessment of performance by field-test and in-house data. We examined the efficacy of the CDC protocol with empirical data from the HemoCue B-Hemoglobin Test System® submission, to assess operator competency, intra-/interoperator and between-site imprecision, and accuracy. Non-laboratory-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’ criterion for imprecision (less than one-fourth of the reference range).