This document 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.
CLSI Publishes New Guideline on Establishing Molecular Testing in Clinical Laboratory Environments (MM19-A)
Wayne, Pennsylvania, USA—November 2011—The Clinical and Laboratory Standards Institute (CLSI) recently published Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline (MM19-A). This document 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.
“Molecular diagnostics is the center of a wave that is transforming laboratory medicine, and the health care industry is a key enabler of personalized medicine. Removal of technical obstacles is driving some molecular technologies into routine clinical environments,” says Jean Amos Wilson, PhD, FACMG, CGMB, Berkeley HeartLab, Inc., Alameda, California, USA, and Co-Chairholder of the committee that developed the document. “MM19 provides a framework for a routine clinical laboratory that does not have the expertise to create its own assays to incorporate certain molecular testing into its menu by providing tools for strategic planning, safety and facility requirements, and workflows for verification/validation and test launch.”
The target audience of this guideline is the stakeholders who play a role in the strategic decision to implement a molecular diagnostic program, including the medical and technical directors who may not have previous experience with molecular testing; the supervisory technical staff who implement molecular assays for the first time; quality management systems (QMS) groups who will adapt the quality plan to incorporate the unique aspects of the new program; and the production staff who will perform and maintain all aspects of the assays.
Leslie Hall, MMSc, M(ASCP), Mayo Clinic, Rochester, Minnesota, USA, and Co-Chairholder of the committee that developed the document, describes the practicality of this document for medical, technical, and supervisory technical staff. “The section of the document that covers the reporting of genetic diseases will be useful to medical staff, and the technical staff will appreciate the appendix of different platforms for infectious diseases.”
The applicability of MM19 persists throughout the laboratory. “QMS professionals will find the appendix of international regulatory bodies useful, and the section on safety will interest the production staff. There is also a good section on strategic planning for the laboratory that includes things to think about before setting up a test,” Hall adds. “This document will give novice molecular laboratory professionals the confidence they need to bring a molecular test into an environment that may not have had molecular testing before—making MM19 an especially important resource for improving patient care.”
CLSI is a volunteer-driven, membership-supported, nonprofit organization dedicated to developing standards and guidelines for the health care and medical testing community through a consensus process that balances the perspectives of industry, government, and the health care professions. For additional information, visit the CLSI website at www.clsi.org or call 610.688.0100.
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