Transcription of Guidelines and Regulations - Audit MicroControls
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Guidelines and Regulations - Audit MicroControls
Calibration Verification - Guidelines and RegulationsPresentation Topics & Objectives Define difference between Calibration and Calibration Verification What are acceptable Calibration Verification materials How and when Calibration Verification is to be performed Troubleshooting for a failed Calibration VerificationLet s Start From the Beginning January 24th, 2003 Centers for Disease Controland Prevention (CDC) and the Centers forMedicare & Medicaid (CMS) publish laboratoryregulations (CLIA) to become effective April24th, 2003 Include requirements for Calibration andCalibration Verification for nonwaived tests Nonwaived tests include moderately and highcomplexity testsDiscussion of Terminology Definitions and applications of following: Calibration Calibration Verification Reportable Range Analytical Measurement Range (AMR)Definitions Calibration: is the process of testing andadjusting the instrument or test systemreadout to establish a correlation between theinstrument s measurement of the substancebeing tested and the actual concentration ofthe substance Basically Tells the instrument how to read acertain level of the analyte being testedDefinitions Continued Calibration Verification: means testingmaterials of known concentration in the samemanner as pa
Manual procedures in ... http://www.cap.org/apps/docs/laboratory_accreditation ... Systems Accreditation Manager for COLA: http://laboratory-manager.advanceweb.com ...
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