Design of Molecular Proficiency Testing/ External Quality Assessment; Approved Guideline
|Publication Date:||1 May 2013|
The purpose of this guideline is to complement currently available regulatory and guidance documents regarding the management and operations of proficiency testing/external quality assessment (PT/EQA) programs. Presently, these documents guide the administration of such programs, but consideration of panel selection, analysis of data for evolving technologies and tests with many possible measurands, method-based PT/EQA, and reporting to participants are not addressed. For molecular methods, these issues are important for all stakeholders, including regulatory agencies, accrediting agencies, PT/EQA providers/organizati
This guideline does not address the process of testing and reporting PT/EQA in the medical laboratory, medical laboratory inspection, accreditation, or other regulatory processes.
This guideline focuses on nucleic acid (DNA and RNA) PT in the areas of human genetics, infectious disease, molecular oncology, and pharmacogenetics. Though written specifically to address needs in this area, the principles stated may 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. These challenge programs may be called PT/EQA, quality assessment or assurance programs, QC programs, ring trials, sample exchange, and EQA/assurance. Countries or regions may place regulatory distinctions on these names. To facilitate the readability of this document, the terms PT/EQA, PT/EQA provider/organizatio