Is Your Laboratory Director Meeting CLIA Compliance?

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Do You Meet CLIA Requirements?

The CLIA regulations define the responsibilities and qualifications of the laboratory director.  As defined in CLIA, the laboratory director is responsible for the overall operation and administration of the laboratory.  This responsibility includes assuring compliance with all the applicable regulations. 



According to the CLIA regulations, a Laboratory Director can direct no more than five non-waived laboratories.  Some states have further restrictions on the number of laboratories an individual may direct.  Increasingly, COLA has identified several Laboratory Directors who are at their maximum number of directorships, and occasionally there will be an application for a sixth laboratory which we cannot honor.


Factors Causing Confusion

While the Accreditation Organizations can identify the number of laboratories an individual is directing under their purview, they do not have access to enable them to identify if a given individual is directing a laboratory under the oversight of another Accreditation Organization.  Likewise, an Accreditation Organization cannot determine if a Laboratory Director is the director of a laboratory with a certificate of compliance, under state oversight.


How CMS Is Addressing The Matter

Recently, CMS has notified us of several Laboratory Directors who were directing the maximum of five COLA inspected laboratories, but in addition were director of laboratories under another Accreditation Organization or a laboratory with a certificate of compliance.  In these instances, both we and CMS are notifying the involved director of the need to divest directorship so that they direct only a maximum of five laboratories.
We ask all our Laboratory Directors to please keep this CLIA regulation in mind when they agree to become director of an additional laboratory.  Below are two sites you might find helpful.


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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.