Instructions for licensed Massachusetts clinical laboratories applying to renew their state licensure.
- This page, Renew a Clinical Laboratory License, is offered by
- Division of Health Care Facility Licensure and Certification
- Bureau of Health Care Safety and Quality
- Department of Public Health
Renew a Clinical Laboratory License
Contacts
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:
- Clinical Laboratory License Information Form
- Clinical Laboratory Disclosure of Ownership Interest Statement
- Laboratory Personnel Report [CMS 209]
- List of Laboratory Tests Performed Onsite
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
Open DOC file, 2.82 MB,
Clinical Laboratory License Information Form
(English, DOC 2.82 MB)
Open DOCX file, 42.95 KB,
Clinical Laboratory Disclosure of Ownership Interest Statement
(English, DOCX 42.95 KB)
Contact for Renew a Clinical Laboratory License
Address
67 Forest Street, Marlborough, MA 01752