Maryland Laboratory License
General Info - Statewide License
The Clinical Laboratories Unit at The Office of Health Care Quality, is responsible for State licensure of all clinical laboratories that perform tests on specimens obtained from Maryland citizens and for federal certification of all clinical laboratories located in Maryland.
Obtaining the License
Ready to get your license? - Steps, Requirements, and Documents
For laboratories located in the state of Maryland:
The lab should be prepared to apply for both Maryland licensure and CLIA before they are ready to test as they must hold both before they begin testing to be in compliance. Both applications are to be filled out and signed by the chosen lab director and mailed with original signatures to the office address listed on the state application along with additional documentation outlined on the last page of the state application checklist.
Once an application is approved, there is about a 3-4 week period for processing, after which the lab will be invoiced by CMS for CLIA. Once invoice for CLIA is paid, the lab will receive a state license and a CLIA certificate. Once received, the laboratory is in compliance to test. Every two years thereafter the director will be billed by CMS and receive a renewal packet from the state of Maryland.
Link to CLIA application: https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms116.pdf
For laboratories located outside of Maryland that wish to test specimens from Maryland:
The state application is to be filled out and signed by the CLIA laboratory director and mailed with original signature to the office address listed on the state application along with additional documentation outlined on the last page of the state application checklist. Once an application is approved, there is about a 3-4 week period for processing, after which the lab will issued a license. Once received, the lab can test specimens from Maryland.
Why the License is required?
The OHCQ shall license a person to operate a laboratory by issuing a letter of exception or permit when the laboratory is in compliance with the applicable standards.
What laws and regulations give Department of Health the legal authority to issue this approval?
10.10.03.00 Title 10 Maryland Department of Health Subtitle 10 Laboratories Chapter 03 Medical Laboratories - Licenses