The clinical laboratory improvement program: Not your ordinary regulatory program

Abstract

The Clinical Laboratory Improvement Amendments of 1988 (CLIA'88) established national standards of laboratory practice and test performance in the areas of registration and certification, inspection, proficiency testing, personnel qualifications, quality control, patient test management, and quality assurance. A memorandum of agreement between the Department of Health and Human Services and the Department of Defense (DOD) established the DOD Clinical Laboratory Improvement Program (CLIP) and authorized the Assistant Secretary of Defense for Health Affairs to develop CLIA'88-comparable regulations governing DOD laboratories. In implementing the DOD program, the CLIA'88 regulations were adopted to the maximum extent possible and modified only as required to meet those unique DOD missions that precluded compliance. This article provides an abbreviated historical background on CLIA'88/CLIP, defines the testing categories identified under the CLIP regulations, and briefly describes the process for application and requirements for compliance.