Typically, CMS will issue one CLIA certificate per fixed location. There are, however, situations in which a laboratory may oversee testing for several locations or where more than one certificate per location is necessary. The following is a list of these situations and the necessary qualifications to obtain a CLIA certificate.
A laboratory may request multiple site laboratory status if it meets any one of the following three exceptions:
Laboratories that are not at a fixed location, i.e., laboratories that move from testing site to testing site, such as mobile units providing laboratory testing, health screening fairs, or other temporary testing locations may be covered under the CLIA certificate and address of the designated primary site or home base, using its address.
Not-for-profit or Federal, State, or local government laboratories that engage in limited (not more than a combination of 15 types of moderately complex or waived tests per certificate) public health testing may file a single application. Laboratories that perform high complexity testing are not eligible for this exception.
Laboratories within a hospital that are located at contiguous buildings or on the same campus or same physical location or street address and under common direction may file a single application or multiple applications for CLIA certificate(s) for the laboratory sites within that hospital.
Facilities who believe they qualify for ‘Multiple Site’ status must submit their request using the CLIA Application for Certification, Form CMS-116. On page 2 of the application, the laboratory should check “Yes” for the multiple site exception and indicate which exception applies to their situation (Exception 1, 2, or 3). The laboratory should fill out the bottom section of page 2 indicating the name, address, and telephone number of each location and the tests performed. If additional space is needed, a separate sheet can be attached.
Two Certificates at One Location
Two labs may operate at the same location with separate CLIA certificates as long as both labs comply with the following conditions:
The times for laboratory testing must be shown for each laboratory’s operation and must not overlap;
Each lab must have a unique name;
The testing personnel must not perform testing for both labs at the same time;
Each laboratory must maintain entirely separate records and demonstrate independent operation; and
It is recommended that each lab enroll in separate PT programs to prevent PT Referral.
The laboratories can share the same Laboratory Director as long as the director does not violate the 5 non-waived laboratory rule. Facilities who believe they meet these conditions must submit their request in writing to the Tennessee CLIA State Agency (SA) for final approval by CMS.
CLIA no longer addresses issues regarding shared labs. Billing issues regarding multiple providers at a single location sharing one CLIA certificate must be addressed directly to the reimbursement entities, such as Medicare or insurance carriers. CLIA will only address issues regarding the laboratory’s certification.
Out-of-State Labs Performing Temporary Testing in Tennessee
Facilities outside of Tennessee wishing to perform temporary diagnostic testing, such as health screens, within the state may do so as long as they hold a valid CLIA certificate in the state where their home base resides. The following written notification is required for each testing event that will be conducted in Tennessee:
- A completed CLIA Application for Certification, Form CMS-116. The application must include the facility’s CLIA number and be flagged as ‘For Information Only’ at the top of the application.
- A coversheet giving details of the temporary testing event, such as the location(s) of the testing, the date(s) the testing will occur, and a list of tests that will be performed.
- The facility should notify the Tennessee Medical Laboratory Board Administrative Office to ensure that they are in compliance with all state licensure requirements for the State of Tennessee.