scope:

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.

This guideline does not address clinical laboratory inspection, accreditation, or other regulatory processes.

It is recognized that the term "molecular" encompasses a variety of molecules; however, this guideline focuses particularly on nucleic acid testing methods. Though written specifically to address needs in this area, the principles stated may be determined to be applicable to programs outside of nucleic acid testing.

Organizations and programs that send blinded samples to laboratories and analyze the submitted results carry several different names. Some of these are: proficiency testing, performance testing, quality assessment or assurance programs, quality control programs, and external quality assessment/assurance. Countries or regions may place regulatory distinctions on these names. To facilitate the readability of this document, the terms proficiency testing, proficiency testing provider/organization, proficiency test program, and PT have been chosen to describe such activities, and regulatory categorization is not implied unless specifically noted.