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Section 16: Quality Assurance, Quality Control, Laboratory Records, and Water Quality
16.3 Verification and Validation of Test System Performance Specifications
Authors:Last Updated:2023
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I. Introduction
Clinical laboratory testing in the United States is regulated by the Centers for Medicare and Medicaid Services (CMS) through the Clinical Laboratory Improvement Amendments (CLIA) (1). CLIA provides…
II. Definitions
510(k): Also known as a premarket notification. 510(k) submissions to the FDA are used for medical devices being introduced into the market for the first time that are substantially equivalent…
III. Specimen Collection, Transport, and Handling
Patient samples must be residual samples that are no longer needed for testing. Prospective collection of specimens for the purpose of test verification or validation may require informed consent and approval…
IV. Materials
Required materials will vary depending on the systems being assessed. Refer to sections below for selective examples.
V. Quality Control (QC)
It is suggested that QC be performed prior to verification or validation of a new test system. Following verification/validation of a test system, routine QC should be performed as part of quality assurance…
VI. Procedure
A new system is the new method being introduced to the laboratory for the first time. Examples of a new system may include: A method or instrument being brought into or developed…
VII. Procedures for Special Systems and Scenarios
Precision and accuracy must be verified for a new MIS being introduced into a laboratory. Reportable range is not applicable for these systems. However, for commercial systems the manufacturer…
VIII. Data Analysis
Basic statistics lessons at www.westgard.com provide in‐depth explanations of these topics. SD measures imprecision by determining dispersion of values around the mean…
IX. Reporting
All reports from a validated laboratory‐developed test should include a disclaimer stating, “This test was developed and its performance characteristics determined by…
X. Additional Considerations
CLIA requires the establishment or verification of performance specifications prior to the release of any patient test results. An acceptable study must be signed off by the laboratory director or qualified designee before the evaluation…
Section Editor: Linoj Samuel
Editors in Chief: Amy L. Leber and Carey-Ann D. Burnham
Citation Information
Copyright © 2023 by ASM Press. ASM Press is a registered trademark of the American Society for Microbiology. All rights reserved. No part of this publication may be reproduced or transmitted in whole or in part or reutilized in any form or by any means, electronic or mechanical, including photocopying and recording, or by any information storage and retrieval system, without permission in writing from the publisher.