CLSI MM19

Establishing Molecular Testing in Clinical Laboratory Environments, 1st Edition

This guideline provides comprehensive guidance for planning and implementation of molecular diagnostic testing, including strategic planning, regulatory requirements, implementation, quality management, and special considerations for the subspecialties of molecular genetics, infectious diseases, oncology, and pharmacogenetics.

This document is available in electronic format only.

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Chairholder: Leslie Hall, MMSc, M(ASCP) and Jean Amos Wilson, PhD, FACMG, CGMB

Date of Publication: November 30, 2011

Order Code PDF: CLSI MM19AE
ISBN Number: 1-56238-774-X

Order Code Print: print not available

Edition: First

Pages: 252

CLSI MM19 Additional Details

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This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of March 2017. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI MM19 Abstract

Clinical and Laboratory Standards Institute document MM19-A—Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline provides a framework for decision making and implementation of clinical molecular diagnostics, and is intended for those in established clinical laboratories that are implementing a molecular program for the first time. When implementing any diagnostic test for patient care, many elements should be addressed before the test is brought “online.” This document focuses on the path of workflow, including laboratory safety and the quality management system, with emphasis on considerations for molecular diagnostics. An organized approach to strategic planning with SWOT (strengths, weaknesses, opportunities, and threats) is presented. Relevant regulatory requirements and the implementation plan are discussed in detail.