Clinical Laboratory Facilities

Laboratory Field Services (LFS) provides licensing and registration services for clinical laboratories as prescribed by law.

Registration is for waived and PPMP only laboratory testing.

Licensure is for moderate or high complexity laboratory testing.

To obtain specific information on these processes, please refer to the following list to contact the person who can help you with your questions or to the links below.

Specific Program Contacts

Laboratory Facility License - Jun Mallillin (510) 620-3796

Laboratory Facility Registration - Jun Mallillin (510) 620-3796

Out of State Laboratory Facility licensing - Kathy Williams (510) 620-3838
CLIA Certification - Donna McCallum (213) 620-6160
CLIA Laboratory Inspections - Donna McCallum (213) 620-6160

Public Health Laboratories - Kathy Williams (510) 620-3838

Initial License and Registration Applications

Laboratory License Application Instructions (PDF, New Window)

Instructions on applying for a Clinical Laboratory license for moderate or high comlexity testing.

Laboratory Registration Application Instructions (PDF, New Window)

Instructions for applying for a Clinical Laboratory Registration for waived and PPMP testing.

Existing License and Registration Changes

Major Change of Laboratory Director (PDF, New Window)

Instructions to assist laboratories when there has been a major change of the laboratory director.

Major Change of Laboratory Owner (PDF, New Window)

Instructions to assist laboratories when there has been a major change of the laboratory owner.

Major change of Laboratory Director and Owner (PDF, New Window)

Instructions to assist laboratories when there has been a major change of the laboratory director and owner.

Notices

HIV Regulation Change (PDF, New Window)

LFS written approval not required to perform HIV testing.

HIV Written Consent Notice (PDF, New Window)

Elimination of written consent requirement for medical care provider-ordered HIV tests.

Frequently Asked Questions

POL FAQs (PDF, New Window)

Physician Office Laboratory - FAQs

Proficiency Testing

Proficiency Testing (PDF, New Window)

Proficiency Testing information for state clinical laboratory licensure.