CLSI MM14

Design of Molecular Proficiency Testing/External Quality Assessment, 2nd Edition

This document provides guidelines for a quality proficiency testing/external quality assessment program, including reliable databases; design control in the choice of materials and measurands; good manufacturing processes; documentation procedures; complaint handling; corrective and preventive action plans; and responsive timing of reports.

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Chairholder: Lisa Kalman, PhD

Date of Publication: May 23, 2013

Order Code PDF: CLSI MM14A2E
ISBN Number: 1-56238-874-6

Order Code Print: print not available

Edition: Second

Pages: 84

CLSI MM14 Additional Details

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This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of September 2018. The document’s next scheduled review is generally five years after the reaffirmation date.

CLSI MM14 Abstract

As medical laboratory tests involving detection of nucleic acids become more common, well-designed and executed proficiency schemes are needed to assure quality and to further the development of this complex and rapidly growing area of laboratory medicine. MM14-A2—Design of Molecular Proficiency Testing/External Quality Assessment; Approved Guideline—Second Edition has been developed to guide the individuals and organizations responsible for providing proficiency testing (PT). It will also serve medical laboratories with a benchmark for evaluation of new programs or to facilitate development of laboratory-based PT or alternative assessment schemes when appropriate schemes are not available from formal programs. Specific sections discuss the design of PT programs; sources of materials; production, manufacture, and QA of samples; sample distribution; receipt and evaluation of data; and reporting responsibilities. Also discussed are examples of method-based PT programs and alternative assessment strategies and how they can be used to evaluate laboratory test performance. This document also lists and describes relevant regulatory and guidance documents related to PT.