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laboratory field services

Major & Minor Changes of Ownership 

Definition:

A major change in ownership” means a change in ownership where 50 percent or more of the ownership interest is owned by persons other than the owners to whom the current clinical laboratory license is issued. See BPC 1211 (f). The laboratory must submit a completed application for a new clinical laboratory license within 30 days of a major change of ownership or cease engaging in clinical laboratory practice. 

 

Major Change of Ownership

Required State Forms:

Original signatures and dates must be on all forms. Copies are not acceptable.

State forms below and more can be accessed on the Laboratory Field Services (LFS) forms page.

Required Federal Form:

For major changes in your site since the last renewal, please complete and mail the required federal form, CMS 116 to the address below.

  • CMS 116 (PDF)- CLIA application form for new or for changes in your site such as change in laboratory director, ownership, change in certificate type, address, etc.

Required Fee:

Submit license fee payable in the form of a check or money order to the State of California Department of Public Health. Credit card payments are not accepted. The fee is non-refundable and subject to change with each fiscal year.

For a full list of clinical laboratory license fees please refer to the Laboratory Field Services (LFS) fee schedule (PDF).
 

Mail the required state and federal forms, documents  and fee to:

California Department of Public Health
Laboratory Field Services
850 Marina Bay Parkway, Bldg. P, 1st Floor
Richmond, CA 94804-6403

​Minor Change of Ownership

Original signatures and dates must be on all forms. Copies are not acceptable.

Required Documents:

  • Cover letter explaining the change of ownership

  • Official documents of ownership transaction: Copy of Bill of Sale, Sales Agreement, Merger Agreement, Partnership Agreement or Articles of incorporation which include all owners’ name(s) and list of the Board of Directors and home addresses

  • LAB 1513 (PDF) — Disclosure of Ownership and Control Interest Statement including home addresses of all owners and corporate officers

  • LAB 193 (PDF) — Notification of Laboratory Change

  • CMS 116 (PDF) - CLIA application form for new or for changes in your site such as change in laboratory director, ownership, change in certificate type, address, etc.

Mail the required state and federal forms, documents, and fee to:

California Department of Public Health
Laboratory Field Services
850 Marina Bay Parkway, Bldg. P, 1st Floor
Richmond, CA 94804-6403

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