Blood Bank and Biologics
The LFS Biologics Section is responsible for surveys & investigations of:
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Blood Banks and collection centers
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Hematopoietic progenitor cell banks and collection centers
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Cord blood banks and collection centers
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Transfusion -related Investigations
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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 - 26th Edition – Effective date - November 1, 2009
AABB Standards for Cellular Therapy Product Services - 4th Edition – Effective date - March 1, 2010
Other References:
AABB Standards Source, current and past editions.
Clinical Laboratory Improvement Amendments (CLIA) Regulations http://www.cms.hhs.gov/CLIA
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
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)