What are the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88)?
• CLIA ’88 establishes quality standards for laboratory testing and an accreditation program for clinical laboratories. • CLIA ’88 requirements vary according to the technical complexity in the testing process and risk of harm in reporting erroneous results. The regulations established three categories of testing on the basis of the complexity of the testing methodology: a) waived tests, b) tests of moderate complexity, and c) tests of high complexity. • Manufacturers apply for CLIA ’88 categorization during the premarket process. • Under CLIA, laboratories performing only waived tests are subject to minimal regulation. Laboratories performing moderate or high complexity tests are subject to specific laboratory standards governing certification, personnel, proficiency testing, patient test management, quality assurance, quality control, and inspections.
Related Questions
- Since I perform only a few simple tests in my office, do Clinical Laboratory Improvement Amendments (CLIA) regulations apply to my practice?
- What is proficiency testing under Clinical Laboratory Improvement Amendments of 1988 (CLIA) and why is it important?
- What are the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88)?
