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.

Required documents

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.

Temporary Laboratory License for CLIA-waived COVID-19 Testing

For facilities wanting to conduct only CLIA-waived COVID-19 testing and no other clinical laboratory testing, please see Temporary Laboratory License for CLIA-waived COVID-19 Testing and Clinical Laboratory Alternate Sites guidance, as well as corresponding Application Form for Temporary Laboratory License for CLIA-waived COVID-19 Testing.

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.

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