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Frequently Asked Lab Personnel Questions

Some states have additional requirements for personnel above and beyond the CLIA requirements.

Additionally, below are answers to a few frequently asked questions related to CLIA Lab Directors, in general.

State Differences in Personnel Requirements

What qualifications do I need in order to serve as CLIA Lab Director?

a.  A doctoral degree and board certification are the minimum requirements to qualify as a high complexity Medical Laboratory Director as per the CLIA regulations, but some states have additional requirements for licensure, experience, and/or credentials.
b.  Moderate Complexity qualified Medical Lab Directors must possess at least a bachelor’s degree coupled with experience to be approved by CLIA.
c.  Most states do not have specific requirements for the qualifications of Lab Directors overseeing Waived testing, but CA, HI, IL, MD, MA, NV, NJ, NY, PA, and TN do.

What are the states that have overarching requirements above the CLIA guidelines for Technical Supervisor/Consultant?

AL, CA, FL, GA, IL, KS, KY, LA, MD, MA, NJ, NY, ND, PA, TN, and WV.

What are the states that have overarching requirements above the CLIA guidelines for General Supervisor/Testing Personnel?

CA, FL, NV, NY, TN, HI, LA, MT, ND, RI, and WV.

CLIA Lab Director FAQs

What does a CLIA Lab Director do?

The main focus of the CLIA Laboratory Director is compliance of the lab; if the Director is only involved on a part-time basis, many activities can and will be delegated to full-time, on-site staff members. A part-time CLIA Lab Director does not typically write SOPs, perform the validation, or write the validation summary, for example, but it is the job of the Director to review and sign off on all of these things.

Can I bill insurance under my Lab Director’s NPI number or existing provider contracts?

Laboratories should apply for their own NPI number and credential directly with insurance for reimbursement. The Medical Laboratory Director’s NPI number and existing contracts with insurance companies, if they are in possession of these, is not the appropriate way to bill for reimbursement, particularly if the Director is involved with the lab on only a part-time basis.

Do CLIA Lab Directors fulfill other roles in the lab required by CLIA?

Medical Laboratory Directors oftentimes fulfill the Clinical Consultant role for independent reference labs they are serving. Directors will also occasionally qualify and be willing to serve as Technical Supervisor, depending upon the lab’s situation, other staff’s qualifications, sample volume, etc. However, most CLIA Lab Directors are not willing to fulfill the roles of General Supervisor or Testing Personnel.

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