IVDs waived under CLIA should use direct unprocessed specimens -- proposed rule.
This article was originally published in The Gray Sheet
Executive Summary
IVDs WAIVED UNDER CLIA SHOULD USE DIRECT UNPROCESSED SPECIMENS, the Health Care Financing Administration says in a proposed rule published in the Sept. 13 Federal Register. Use of "direct unprocessed specimens" is one of several "clarified criteria" being proposed by HCFA for in vitro diagnostics that are placed in the waived category under the Clinical Laboratory Improvement Amendments of 1988. Waived tests are exempt from many CLIA requirements such as proficiency testing and personnel standards.