Who can be a director of a CLIA lab?
3. Who can direct a clinical laboratory in California? Only a licensed physician and surgeon, a licensed osteopath, or a licensed doctoral scientist can direct a laboratory in California.
What are the principal responsibilities of the laboratory director CLIA?
The laboratory Director is responsible for the overall operation and administration of the laboratory, including the employment of competent personnel, equipment, safety, laboratory policies, quality assurance, all testing (including proficiency testing) and test reports.
How do I become a CLIA certified lab?
You can enroll your laboratory in the CLIA program by completing an application (Form CMS-116) available on the CMS CLIA website or from your local State Agency. Send your completed application to the address of the local State Agency for the State in which your laboratory is located.
Who is considered as the director of the laboratory?
The director of a clinical laboratory is usually a board-certified medical doctor, PhD scientist, or in some cases, a medical laboratory scientist.
What is CLIA certified lab?
The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Each agency has a unique role in assuring quality laboratory testing.
Do you need a CLIA certificate for a lab in PA?
If testing materials are maintained at the testing site, or tests are performed by staff not employed by the CLIA-certified laboratory, that facility or building is a permanent laboratory location and both a PA Laboratory Permit and CLIA Certificate would be required to perform testing.
How to become a director of a laboratory in Pennsylvania?
The qualifications for a director of a laboratory can be found in Pennsylvania’s regulations governing Clinical Laboratories . Please note, CLIA has additional, more stringent requirements for an individual serving as the director of a laboratory performing moderate and/or high complexity testing.
How to become a high complexity laboratory director?
The qualification for a laboratory director of high complexity testing at 42 CFR 493.1443 (b) (3) (i) is that the laboratory director must hold an earned doctoral degree in a chemical, physical, biological or clinical laboratory science from an accredited institution and be certified and continue to be certified by a board approved by HHS.
What kind of degree do you need for CLIA?
April 10-11, 2019 Personnel Requirements CLIAC recommends that HHS consider modifying CLIA personnel requirements as follows: Recommendation 1:Biological science degrees such as biology, chemistry, medical technology, and clinical/medical laboratory science are acceptable degrees for laboratory personnel.