Historical
MM14-A
Proficiency Testing (External Quality Assessment) for Molecular Methods; Approved Guideline
The purpose of this guideline is to complement currently available regulatory and guidance documents regarding the management and operations of proficiency testing programs. Presently, these documents guide the administration of such programs, but consideration of panel selection, analysis of data for evolving technologies, and reporting to responsible parties (i.e., other than government agencies) are not addressed. For molecular methods, these issues are important for all stakeholders, including regulatory agencies, accrediting agencies, proficiency test providers/organizations, proficiency test materials manufacturers, clinical laboratories, and test/reagent manufacturers. This document addresses the people who produce, distribute, and administer proficiency testing materials. It should enable clinical laboratories, manufacturers, and other organizations to develop and implement proficiency testing programs for nucleic acid testing.
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Clinical And Laboratory Standards Institute [clsi]
