Blood Banks and Biologics

The LFS Biologics Program is responsible for license application review, approval, renewal, survey and investigation of:

• Community Blood Banks and Collection Centers
• Hospital Blood Banks
• Blood and Blood Components Collection Centers
• Cord Blood Banks and Collection Entities
• Plasma Collection Centers
• Biologics Processing and/or Storage Facilities

Contents:

New License Application

Mail requirements with original signatures to the mailing address found below.

Requirements:

 LAB 114 - Biologics License Application (PDF)
 LAB 118 - Personnel Report (PDF)
 Application fee (See Fee Schedule PDF​). Make check payable to CDPH/LFS.
 Supporting Documents: List of document varies depending on operation type. You may contact LFSBiologics@cdph.ca.gov​ for futher instructions.

Mail requirements with original signatures to the mailing address found below.

Requirements:

 LAB 175 - Application for Renewal (PDF)
 LAB 118 - Personnel Report (PDF)
 Application fee (See Fee Schedule PDF​). Make check payable to CDPH/LFS.

Change Application​

• Change of Medical Directors
• Change of Ownership
• Change of Address

Mail requirements with original signatures to the mailing address found below.

Requirements:

 LAB 114 - Biologics License Application (PDF)
 LAB 118 - Personnel Report (PDF)
 Application fee (See Fee Schedule PDF​). Make check payable to CDPH/LFS.
 Supporting Documents: Required document varies depending on type of change, please contact LFSBiologics@cdph.ca.gov​ for futher instructions.

A Patient's Guide to Blood Transfusion

Click the desired button to download the PDF brochure:

Donor Adverse Events (DAE)

Amendment of California Health and Safety Code (HSC)§ 1607​ took effect on January 1, 2023. A blood bank shall annually report to the department any adverse donor event requiring emergency medical intervention.

• Notice of Reporting Donor Adverse Events (DAE)(PDF)
• Download DAE Excel file reporting tool​​

Information for Reportable Disease

• CDPH Center for Infectious Diseases
• California Reportable Disease Information Exchange (CalREDIE)

Applicable California Laws and Regulations

• California Health and Safety Code:​
  Sections 1279, 1600-1630, 1645
• California Code of Regulations - Title 17:
  Sections 950-1028 Production and Distribution of Biologics, Licensure
• California Business and Professions Code:
  Sections 1200-1327 (Also see Sections 650-657 for billing issues and Sections 119 & 125 for license offenses)
• Applicable Standards adopted into California’s Biologics Law:
• AABB Standards for Blood Banks and Transfusion Services - Current Edition 
• AABB Standards for Cellular Therapy Services - Current Edition 
• Other References:
• Clinical Laboratory Improvement Amendments (CLIA) Regulations
• CMS.gov website​​​​​
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