HOW DOES CLIA OVERSEE LABORATORY DEVELOPED TESTS?
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1 Institute of Medicine National Cancer Policy Forum Workshop on Policy Issues in the Development of Personalized Medicine in Oncology HOW DOES OVERSEE LABORATORY DEVELOPED TESTS? Penelope Meyers, M.A., MT(ASCP)SBB Centers for Medicare & Medicaid Services Division of Laboratory Services June 8, 2009
2 What is? Clinical Laboratory Improvement Amendments of 1988 Regulates all testing on humans for health purposes using minimum quality standards Accurate, reliable testing regardless of location
3 Regulations Comprehensive set of requirements for laboratories Apply to laboratories regardless of location Requirements based on test complexity: high complexity, moderate complexity, or waived
4 Requirements Registration, certification, accreditation Proficiency testing Facilities Quality Systems Personnel Inspections Enforcement
5 Quality Systems: Analytic Procedure manual Requirements for reagents, equipment, instruments, etc. Establishment and verification of performance specifications Maintenance and function checks Calibration procedures Control procedures Test records
6 Establishment and Verification of Performance Specifications Laboratories must VERIFY performance specifications for FDAapproved test systems. Laboratories must ESTABLISH performance specifications for laboratory-developed tests.
7 Establishment and Verification of Performance Specifications Unmodified, FDA-cleared or approved test system: lab must verify Accuracy Precision Reportable range of test results Normal values
8 Establishment and Verification of Performance Specifications Test system not subject to FDA clearance or approval: lab must establish Accuracy Precision Reportable range of test results Normal values
9 Establishment and Verification of Performance Specifications Test system not subject to FDA clearance or approval: lab must establish Analytical sensitivity Analytical specificity to include interfering substances Any other performance characteristic required for test performance
10 Establishment and Verification of Performance Specifications Laboratory must determine calibration and control procedures based on performance specifications established or verified.
11 Laboratory Developed Tests: Performance Specifications requires laboratories to establish analytic validity. is not authorized to regulate clinical validity or clinical utility.
12 Laboratory Developed Tests: Performance Specifications Reviewed by surveyor at time of inspection No pre-market review Surveyor resources CMS genetics subject matter expert Consult CDC or FDA
13 Quality Systems: Preanalytic and Postanalytic Test Request Specimen submission, handling, referral Test Report
14 Quality Systems: General Confidentiality Specimen identification and integrity Communications and complaints
15 Proficiency Testing CMS-approved PT for 84 listed analytes All other analytes, including laboratory-developed tests, are required to undergo an evaluation of accuracy twice annually. Evaluate results and take corrective action Project to update proficiency testing
16 Personnel Personnel requirements are based on level of test complexity. Laboratory-developed tests are categorized as high complexity tests. Laboratories performing high complexity tests are subject to the most stringent personnel requirements
17 Inspections Laboratories are inspected every two years. Many laboratories choose to be inspected by accreditation organizations, whose standards are often more stringent than regulations. Some states have additional laboratory requirements.
18 Summary contains comprehensive requirements for clinical laboratory testing. Laboratory-developed tests are subject to the highest level of oversight. Establishment of analytic validity is required. Establishment of clinical validity and clinical utility is not required. does not require pre-market review of laboratory-developed tests. standards = quality laboratory testing
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