Apply for a Massachusetts Clinical Laboratory License

Instructions for clinical laboratories applying for licensure to operate in Massachusetts

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.

Required documents

The following documents must be completed in full as part of the clinical laboratory licensure application packet.

You must also include a list of corporate officers and/or the Board of Trustees, whichever is applicable.

         *The CORI Form and Instructions were updated June 22, 2018.

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.

Name Fee Unit
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
99 Chauncy St.
11th Floor
Boston, MA 02111

Next steps for Apply for a Massachusetts Clinical Laboratory License

Processing

After DPH receives all completed application materials:

  • The CORI form is processed, which may take up to 14 days.
  • Following the successful completion of the suitability review, 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 about 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.

Contact for Apply for a Massachusetts Clinical Laboratory License

Address
99 Chauncy St., Boston, MA 02111

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