Method Validation Lab

As laboratory professionals, our responsibility to patient safety is evaluating, validating, and verifying each test method as we add it to the laboratory test menu. Many regulations, accreditation standards, and industry guidance documents exist to ensure the laboratory performs method validation in a scientifically sound manner.

the components that can be used to verify a lab c an perform the method satisfactorily. When there is no validation data avai lable, the MU may be the only parameter that can be compared to the specification to ensure the method works. The comparison of a lab's performance bias and precision can be compared to those from the collaborative

Conduct the method validation studies required by regulatory entities and good laboratory practice. Understand what validation studies must be performed for different types of tests and how often they must be done. Create a good method validation program that is sustainable and yields good value for the resources required.

laboratory-developed methodstests require validation. Laboratory validations shall be a planned activity assigned to qualified and authorized personnel and shall be as extensive as is necessary to meet defined method performance specifications. Validation and verification plans shall include predefined acceptance criteria. Any change to the plan,

1.2 This guide may be applied to the validation of laboratory developed in-house methods, addition of analytes to an existing standard test method, variation or scope expansion of an existing standard method, or the use of new or different laboratory equipment.

5. Method Validation . 5.1. Non-standardized methods, which include all laboratory developed methods, standardized methods modified beyond their intended scope and amplifications and modifications of standardized methods, are validated by 5.1.1. Examination to ensure completeness and compliance with requirements for

Method Validation and Verification Lauren N. Pearson, DO, MPH Establishing the performance specifications of a new diagnostic tool such as a new test, laboratory developed test or modified method Verification A one-time process to determine performance characteristics of a test before use in patient testing 5.

A method validation provides proof that a method is suited for its intended use and that it fulfills the necessary quality requirements. The international standards for clinicalanalytical laboratories quotDIN EN ISO 15189Particular requirements for quality and competencequot 1 and quotDIN EN ISOIEC 17025General requirements for the competence of testing and calibration laboratories

example of a method comparison validation in this article and eight steps demonstrate the process, described below. 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.

COM.40000 Method Validation and Verification Approval - Nonwaived Tests Phase II For each nonwaived test, there is an evaluation of the test method validation or verification study accuracy, precision, etc. signed by the laboratory director, or designee meeting CAP director qualifications, prior to use in patient testing to confirm the