Proficiency Testing Providers for Regulated Analytes

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Proficiency testing is laboratory testing of unknown samples provided by a CMS approved proficiency testing provider.  The CLIA regulations require proficiency testing to be performed on all regulated analytes. 


Annually CMS provides information on those proficiency testing organizations that provide materials which can be used for the regulated analytes.  

For unregulated analytes, split sample analysis or proficiency testing materials must be used to assess laboratory performance. 

Some of the proficiency testing providers do provide materials which will fulfill some of the unregulated analyte proficiency testing requirements and many laboratories utilize this service.

At the start of the year, be certain you are registered appropriately for 2019 proficiency testing. 

There are no requirements that specific proficiency testing providers or accreditation organizations be used, only a requirement that proficiency testing be performed.     

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About the author

Dr. John Daly

John T. Daly, M.D. is Chief Medical Officer of COLA. Dr. Daly received his MD degree at Weill Cornell University Medical College, performed his internship and residency in Anatomic and Clinical pathology at Duke University Medical Center and a residency in Forensic Pathology at the Office of the Chief Medical Examiner in Chapel Hill, N.C. He is board certified in anatomic, clinical and forensic pathology. Through the course of his career, Dr. Daly has had extensive experience directing and advising laboratories of all sizes including physician office practices, Federal Health Clinics, surgical centers, Community Hospitals and the integrated academic health system clinical laboratories of Duke Medicine. He retired as Director of Laboratories of Duke Medicine, and continues his affiliation as a member of the emeritus staff. He then joined the accreditation organization, COLA, as the Chief Medical Officer. In this role he continues to provide guidance that helps labs improve safety in labs, standardize and streamline operations while achieving CLIA compliance.


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