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Laboratory Field Services

Notification of Changes — Clinical Laboratory License

Major and Minor Changes to Clinical Laboratory License

California Business and Professions Code (BPC) section 1265 (e) and (g) require clinical laboratories to notify Laboratory Field Services within five days of the appointment of an interim director and within 30 days of any change of ownership, name, location, or permanent laboratory director.

Pursuant to BPC 1265 (e), a clinical laboratory license will be automatically revoked 30 days after a major change of directorship or ownership.

These license change instructions apply to clinical laboratories and facilities performing non-waived moderate and/or high complexity testing with state LAB IDs beginning with CLF, CLA, CLM, CDF, CDA, CDM. For registration change instructions visit the Notification of Changes - Clinical Laboratory Registration webpage. 

Definitions:

A major change in laboratory directorship” means a change in laboratory director or directors resulting in a situation where less than 50 percent of the laboratory directors to whom the current laboratory license is issued remain after the change (see BPC 1211 (j)). The laboratory must submit a completed application for a new clinical laboratory license within 30 days of a major change of directorship or cease engaging in clinical laboratory practice.
 

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.

 

Submitting a Notification of Laboratory Change

IMPORTANT: Failure to complete and submit all the required items (forms, fees, supporting documents or information) for the submitted change(s) may prevent or delay the processing of the submitted change(s).

Basic Information Changes:

To submit a basic information change limited to change of physical and/or mailing address, telephone number, fax number, email address, contact person—complete and mail form LAB 193: Notification of Laboratory Change (PDF) to:

CDPH – Laboratory Field Services
Laboratory Facility Registration
850 Marina Bay Parkway, Bldg P, 1st Floor
Richmond, CA 94804-6403

Major and Minor Directorship or Ownership Changes:

To submit a major or minor change of directorship or ownership, refer to the Directorship Changes and Ownership Changes sections. Failure to complete and submit all the required items (forms, fees, supporting documents or information) for the submitted change(s) may prevent or delay the processing of the submitted change(s).

 

 

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