General Information Relating to Clinical Laboratory Licensure

Massachusetts General Law 111D defines a laboratory and states which testing facilities require clinical laboratory licensure and/or approval. The regulations relating to clinical laboratory licensure can be found at 105 CMR 180.000 Rules and Regulations Relating to the Operation, Approval, and Licensing of Laboratories.

Clinical laboratories performing testing and requiring licensure MUST obtain a license prior to starting testing. Laboratories that are already licensed and wish to add a specialty or subspecialty MUST notify and obtain approval from the Department prior to starting testing.

Clinical laboratories for which a license application is made, must participate successfully in an approved proficiency-testing program covering all laboratory analytes for which proficiency testing is available. The laboratory must be enrolled under the same name which appears on the license and must authorize the proficiency testing service to release all test results to the Clinical Laboratory Program.

Please refer to the below Required Documents sheet for a list of forms that must be returned as part of the licensure packet. Failure to complete and return forms in a timely manner will result in a delay of the licensure process as incomplete packets can NOT be processed.

Return the application, required forms, and licensure fee to:

Clinical Laboratory Program
99 Chauncy Street
Boston, MA 02111

If you have any questions while completing the application feel free to call this office at the number noted above.

This information is provided by the Clinical Laboratory Program within the Department of Public Health.