Application of the Department of Health and Human Services Proposed Waived Status Requirements for in Vitro Diagnostic Testing Devices: Case Study (Laboratory Management‪)‬

US Public Law 100-578 of 1988 [1] (CLIA'88) resulted in regulations that categorized all test procedures on the basis of their complexity [2]. The legislation exempted from extensive regulation certain simple procedures, often performed by nonlaboratory professionals and (or) patients in a home healthcare setting. Because most of the regulations were waived for these procedures, the term "waived tests" became part of laboratory jargon. Through the early drafts of the CLIA regulations, the concept of waived testing underwent several iterations. The final version of CLIA'88, published in the February 28, 1992, Federal Register, placed eight general types of test devices or analytes, including some glucose and hemoglobin methodologies, into the waived category. Before implementing CLIA'88, the CDC used a point-scoring system to classify each in vitro diagnostic test procedure or device into one of three categories. Approximately 2500 procedures were classified as high complexity, 7500 as moderate complexity, and 8 as waived. The eight tests classified initially as waived included those available over-the-counter (home use), suitable for use by non-laboratory-trained individuals, and those in which erroneous results posed no risk of serious harm to the patient. These tests essentially met the initial definition of waived, meaning free from regulation under CLIA'88. The waived category, both for the inclusions and exclusions, created immediate controversy and occupied the discussions of the Clinical Laboratory Improvement Advisory Committee almost from its initial meeting [3]. Much concern centered on these tests being used in some point-of-care situations where the exemption from regulation could be perceived as a substantial benefit. The Clinical Laboratory Improvement Advisory Committee was concerned with the subjective nature of the test classification criteria and the possibility that some tests on the list that were not error-free and that incorrect results would be truly harmful.