Cholesterol operational process specifications for assuring the quality required by CLIA proficiency testing

Abstract

Current U.S. governmental regulations and requirements for the quality of laboratory tests do not provide a consistent form, comparable numbers, or practical specifications for the routine operation of laboratory testing processes. For cholesterol, as an example, the Health Care Financing Administration provides an analytical performance criterion for proficiency testing to enforce the Clinical Laboratory Improvement Act (CLIA), whereas the U.S. National Cholesterol Education Program (NCEP) provides clinical guidelines for test interpretation, as well as analytical goals for imprecision and inaccuracy. Routine operating process specifications for imprecision, inaccuracy, and quality control can be derived from the analytical and clinical requirements for quality. Use of an analytical "total error" model and a clinical "decision interval" model provides logically consistent and numerically comparable specifications. Studies with these coherent models indicate that a cholesterol testing process properly planned to satisfy the CLIA analytical requirement will also satisfy the NCEP clinical requirement. To provide 90% assurance of detecting systematic shifts of a magnitude that would cause the CLIA analytical requirement to be exceeded, the operational specifications for a cholesterol testing process are an allowable CV of ≤2%, an allowable bias of ≤1%, and a control procedure with two measurements per run interpreted by 13s, 12.5s, or 13s/22s/R4s control rules.