Clinical and Laboratory Standards Institute, Wayne, PA 2015.Ĥ) | Clinical and Laboratory Standards Institute. A Framework for Using CLSI documents to Evaluate Clinical Laboratory Measurement Procedures. Clinical and Laboratory Standards Institute, Wayne, PA 2014.ģ) | Clinical and Laboratory Standards Institute. Preliminary Evaluation of Quantitative Clinical Laboratory Methods Approved Guideline. 2003(Jan 24) Ģ) | Clinical and Laboratory Standards Institute. Clinical laboratory improvement amendments of 1988 final rule. Evidence of Compliance: Written procedure for verifying test method performance specifications AND Records of verification and written assessment of each component of the test method performance specifications for each test REFERENCES 1) | Department of Health and Human Services, Centers for Medicare and Medicaid Services. If data include discordant results, there must be a record of the discordance and investigation of any impact on the approval of the test for clinical use. The written assessment must include an evaluation of each component of the verification study, including the acceptability of the data. NOTE 6: The requirement for a written assessment applies to all tests implemented after Jhowever, all nonwaived tests must have records of completed analytical verification, regardless of the implementation date. NOTE 5: If a method is verified by someone other than the laboratory's personnel (eg, manufacturer's representative), the laboratory must have records to show that the verification correlates with its in-house test performance by showing confirmation of performance specifications by the laboratory personnel testing known specimens. NOTE 4: If multiple identical instruments or devices are in use, there must be records (data and written assessment) showing that the method performance specifications have been separately verified for each test and instrument or device. NOTE 3: The reportable range of an assay is the range of values that the laboratory reports for that assay. NOTE 2: Precision is verified by repeat measurement of samples at varying concentrations/activities within run and between run over a period of time. The use of routine quality control materials or calibrators used to calibrate the method is not appropriate. Use of matrix-appropriate reference materials, patient specimens (altered or unaltered), or other commutable materials with known concentrations or activities may be used to verify accuracy. | Prior to clinical use of each unmodified FDA-cleared or approved test, the laboratory has performed a verification study and prepared a written assessment of each of the following test method performance specifications, as applicable, using a sufficient number of characterized samples: Analytical accuracy Analytical precision Reportable range NOTE 1: Accuracy is verified by comparing results to a definitive or reference method, or an established comparative method. COM.40300 | Verification of Test Performance Specifications - FDA-cleared/approved Tests | Phase II
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