Laboratory instrument validation verification and maintenance manual

•Maintenance and calibration records •Personnel training and competency assessments •Parallel testing of duplicate instruments •Correlation with clinical findings Validation becomes part of the overall laboratory QA program and should cover the entire analytical process. The Validation, Verification, and Testing Plan provides guidance for management and technical efforts throughout the test period. It establishes a comprehensive plan to communicate the nature and extent of testing necessary for a thorough evaluation of the system.  · Test method validation CBAHI standard LB The laboratory develops a process for test method validation. LB The laboratory implements policies and procedures on test method validation including: LB Verification of accuracy/precision. LB Verification of sensitivity (lower detection limit).

The Validation, Verification, and Testing Plan provides guidance for management and technical efforts throughout the test period. It establishes a comprehensive plan to communicate the nature and extent of testing necessary for a thorough evaluation of the system. 1. Statement of Primary Laboratory Test Objectives Method validation is performed when a lab acquires a new instrument and is testing a new procedure; it is used for assessing if a new instrument is reporting valid results. Using statistics to determine accuracy, a method validation can establish the instrument performance compared. is no exception for analytical validation or verification of tests introduced prior to a specific date. The laboratory must have data for the validation or verification of the applicable method performance specifications and retain the records as long as the method is in use and for at least two years after discontinuation.

CLIA and CAP require continuous calibration verification. performance characteristics that should be evaluated in the initial validation of a method. 1 ឧសភា Linearities are performed whenever a new analyzer, analyte or method is introduced into the laboratory, or an analyzer is replaced. 6 មេសា TEST METHOD VALIDATION AND VERIFICATION - NONWAIVED TESTS The laboratory must follow manufacturer's instructions for instrument set up.