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Renew a Clinical Laboratory License

Instructions for licensed Massachusetts clinical laboratories applying to renew their state licensure.

Clinical Laboratory Program

The Details of Renew a Clinical Laboratory License

What you need for Renew a Clinical Laboratory License

A clinical laboratory licensed by the Department of Public Health (DPH) must apply to renew licensure every 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.

Please note that a laboratory that is already licensed and wishes to add a specialty or subspecialty must notify and obtain approval from DPH before starting testing.

Required documents

The following documents must be completed in full as part of the clinical laboratory licensure renewal packet and submitted 60-90 days prior to the expiration of your current license:

 

Fees for Renew a Clinical Laboratory License

Calculate the application fee based on the license type currently held or if applying to change license type, the new license type, as indicated on page 1 of the License Information Form.

Please submit payment by check or money order, payable to the Commonwealth of Massachusetts.

Name Fee Unit
Full license (includes high complexity testing) $300 for each Specialty area
Limited license (moderate complexity and/or CLIA-waived testing only) $300 per applicant

How to renew Renew a Clinical Laboratory License

Please send the completed License Information Form, Disclosure of Ownership Interest Statement, all required documentation, and the licensure fee to:

Clinical Laboratory Program
MA Department of Public Health
67 Forest Street
Marlborough, MA 01752

Please ensure that all forms are complete and all supplementary documentation is included before submitting the licensure renewal application. Incomplete renewal applications cannot be processed.

Next steps for Renew a Clinical Laboratory License

Compliance

After DPH receives all completed renewal application materials and the clinical laboratory is found to be in complete compliance with all regulations, DPH will renew the license.

Downloads for Renew a Clinical Laboratory License

Contact for Renew a Clinical Laboratory License

Address
67 Forest Street, Marlborough, MA 01752
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