How To Obtain a Maryland Lab License and CLIA Certification
To apply for a license for a new laboratory license, please mail with original signatures both the Maryland State Compliance Application and CLIA application with supporting documents outlined on the state application checklist page, to the address on the state application.
There is no fee to apply for a Maryland laboratory license. CMS will bill you for CLIA fees. After a completed application and all requested information is received by OHCQ, it takes 2 - 3 weeks to receive a Maryland laboratory license and CLIA certificate.
To report any changes to your license, please use the Laboratory Licensing Change Form.
Performing CLIA Waived Tests in Maryland
To conduct CLIA-waived tests in Maryland, a laboratory must have a CMS CLIA Certificate of Waiver and either a Maryland Laboratory Permit or a Letter of Exception. All laboratories must follow the same CLIA-waived test requirements, including the requirement to follow the manufacturer's instructions for performing the test.
To add a new CLIA waived test to a Maryland Laboratory Permit or a Letter of Exception, the laboratory must complete a Change Form.
CLIA waived tests on the Excepted list are on Schedule B of the Change Form. If a CLIA-waived test is not on the Excepted Test list, the applicant selects the test discipline under Schedule A. If help is needed with test selection please call (410) 402-8025. OHCQ processes the request in 1 - 2 days.
The procedure to recommend the addition of new tests to the Excepted Test list, by review of the Laboratory Advisory Committee is in COMAR 10.10.02.01(E).
File a Clinical Laboratories Complaint
Phone (410) 402-8025 | (877) 402-8202 | TTY (800) 735-2258
Fax (410) 402-8213
Cheryl Sloan and Dana Roberts, Administrators
Paul Celli, Program Manager
