Welcome to the State of California 

Blood Bank and Biologics  
 

The LFS Biologics Section is responsible for surveys & investigations of:

  • Blood banks and collection centers
  • Hematopoietic progenitor cell banks and collection centers
  • Cord blood banks and collection centers
  • Transfusion-related Investigations
  • Plasma collection facilities 

 

Contact information

Bob Hunter (213) 620-6574 - Examiner II - Program Manager, Biologics

Ron Harkey (510) 620-3808 - Examiner III - Chief, Blood Bank, Tissue Bank and Cytology

 

Applicable CA Laws and Regulations 

California Health and Safety Code:  Sections 1279, 1600-1630, 1645

California Code of Regulations - Title 17:  Sections 950-1028 Production and Distributions 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 Bank and Transfusion Services - 28th Edition – Effective date November 1, 2012  

AABB Standards for Cellular Therapy Product Services - 6th Edition Effective date July 1, 2013

Other References:

AABB Standards Source, current and past editions

Clinical Laboratory Improvement Amendments (CLIA) Regulations http://www.cms.hhs.gov/CLIA 

 

FAQs:  LINK to FAQs

 

Guidelines for Initial Application and Routine Inspection

         Guidelines for Initial Application and Routine Inspection of California Biologics Facilities – Blood Bank and Donor Centers(PDF- New Window)

         Guidelines for Initial Application and Routine Inspection of California Biologics Facilities – Cord Blood (PDF- New Window)

Guidelines for Initial Application and Routine Inspection of California Biologics Facilities – Plasma Centers (PDF- New Window)

Letters of Interest

CDPH Information on Zika (opens in New Window)

Reporting West Nile Virus-Positive Blood Donors to the California Department of Health Services (updated) (PDF-New Window)

Recommendations for facilities to implement for the 2008 West Nile virus (WNV) mosquito season (PDF- New Window)

Information Regarding 15 and 16 Year- old Donors (PDF- New Window)

Biologics Renewal Cover Letter (PDF- New Window)

"A Patient's Guide to Blood Transfusion" (English-PDF- New Window)

"A Patient's Guide to Blood Transfusion" (Spanish-PDF- New Window)

Lab 118 Blood Bank Personnel Form - Fill in (Word- New Window)

Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus (New Window)

 
 
Last modified on: 6/6/2016 4:07 PM