Blood Banks 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

To contact the Blood Banks and Biologics section please email rhunter@cdph.ca.gov or LFSBiologics@cdph.ca.gov

Staff Contacts:

Bob Hunter - Examiner II - Program Manager, Biologics

Guidelines for Initial Application & Routine Inspection

• Blood Bank and Donor Centers – Guidelines for Initial Application and Routine Inspection of California Biologics Facilities

• Cord Blood – Guidelines for Initial Application and Routine Inspection of California Biologics Facilities

• Plasma Centers – Guidelines for Initial Application and Routine Inspection of California Biologics Facilities

• FAQ's - Frequently Asked Questions - Biologics (PDF)

• Lab 118 Blood Bank Personnel Form (PDF)

Guidelines for Renewal Application

• Biologics License Renewal Instructions

Letters of Interest

• Zika, Dengue, and Chikungunya Viruses Information Supplement
  A supplement to AABB Association Bulletin #16-04 providing additional information on Zika virus.

• Communications Regarding Zika Virus Positive Blood Donors
  Guidance for communication by the California Department of Public Health to California blood collection centers regarding local Zika virus transmission, reporting Zika virus-positive blood donors, and blood center notification for local Zika virus transmission.

• CDPH Information on Zika

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

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

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

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

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

• "Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis" draft guidance, July 27, 2018

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 - 31st Edition – Effective date April 1, 2018

• AABB Standards for Cellular Therapy Product Services - 8th Edition – Effective date July 1, 2017

• Other References:

• AABB Standards Portal, current and past editions

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