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laboratory field services

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 LFSBiologics@cdph.ca.gov

Guidelines for Initial Application & Routine Inspection

 

Guidelines for Renewal Application

 

Letters of Interest

  

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

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