Apply for a Massachusetts Clinical Laboratory License
Contact for Apply for a Massachusetts Clinical Laboratory License
Clinical Laboratory Program
The Details of Apply for a Massachusetts Clinical Laboratory License
What you need for Apply for a Massachusetts Clinical Laboratory License
A clinical laboratory that performs testing and requires licensure must obtain a license from the Department of Public Health (DPH) before starting testing.
Before applying for Massachusetts state licensure, a clinical laboratory must participate in an approved proficiency-testing program that covers all laboratory analytes for which proficiency testing is available. The laboratory must be enrolled under the same name that will appear on the license and must authorize the proficiency testing service to release all test results to the Clinical Laboratory Program.
A laboratory that is already licensed and wishes to add a specialty or subspecialty must notify and obtain approval from DPH before starting testing.
For more information about clinical laboratory licensure in Massachusetts, please see the frequently asked questions about clinical laboratory state licensure page.
The following documents must be completed in full as part of the clinical laboratory licensure application packet.
- Licensure Common Form
- Clinical Laboratory License Information Form
*The Clinical Laboratory License Information Form was updated February 1, 2019.
- Clinical Laboratory Disclosure of Ownership Interest Statement
*The Clinical Laboratory Disclosure of Ownership Interest Statement was updated February 1, 2019.
- This must be accompanied by either:
- Articles of Incorporation or Partnership approved by the Massachusetts Secretary of State; or
- Foreign Certificate of Approval signed by the Massachusetts Secretary of State, if the organization is not registered in Massachusetts
You must also include a list of corporate officers and/or the Board of Trustees, whichever is applicable.
- Suitability Disclosure Form
*only needed if prompted by certain questions responses on the Licensure Common Form
- Find out more information about the acceptable forms of documentation for qualifications of moderate and high complexity laboratory personnel
- Laboratory Personnel Report [CMS 209]
- List of Laboratory Tests Performed Onsite (DOC)
- CORI Form
Please use the CORI Directions to Complete for full instructions on completing CORI forms.
*The CORI Form and Instructions were updated June 22, 2018.
Information for Out-of-State Laboratories
Massachusetts clinical laboratory regulations 105 CMR 180.00: The operation, approval and licensing of clinical laboratories do not require that out-of-state laboratories be licensed in Massachusetts when testing specimens from Massachusetts residents.
If the out-of-state laboratory has a physical presence in Massachusetts, such as a collection station, we would require the laboratory to go through our state approval process for that collection station.
When testing specimens from Massachusetts residents, out-of-state laboratories may be subject to infectious disease reporting requirements under 105 CMR 300.000: REPORTABLE DISEASES, SURVEILLANCE, AND ISOLATION AND QUARANTINE REQUIREMENTS.
Fees for Apply for a Massachusetts Clinical Laboratory License
Calculate your application fee
Check the category of license applying for, or which the laboratory currently holds, as indicated on page 1 of the application:
- Full license (High complexity testing)
- Limited license (Moderate complexity testing)
Please pay in the form of a check or money order, payable to the Commonwealth of Massachusetts.
|Full license application fee||$300||for each Specialty area|
|Limited license application fee||$300||per applicant|
How to apply Apply for a Massachusetts Clinical Laboratory License
Please complete and return all forms and supplementary documents before applying. We are unable to process incomplete application packets.
Please send the application, all required forms and documentation, and the licensure fee to:
Clinical Laboratory Program
Department of Public Health
67 Forest Street
Marlborough, MA 01752
Next steps for Apply for a Massachusetts Clinical Laboratory License
After DPH Clinical Laboratory Program receives all completed application materials:
- Following the successful completion of the suitability review, including CORI processing, the Department must conduct an onsite survey to ensure that the laboratory is in compliance with all state regulations.
- Once the laboratory is found to be in complete compliance with all of the regulations, the Department will issue a license.
More info for Apply for a Massachusetts Clinical Laboratory License
Clinical laboratory licenses are valid for 2 years. However, if there is a change in ownership, the new owner of the laboratory is required to apply for a new clinical laboratory license.
- List of Approved Proficiency Testing Programs – Available on the CMS CLIA website