Licensing and Accreditation

Blood Centers of the Pacific and our Blood Systems Laboratories are licensed by the US Food & Drug Administration and accredited by AABB. Additionally, Blood Centers of the Pacific is licensed by the US Department of Public Health, the Centers for Medicare and Medicaid and the California Department of Public Health. 

Blood Systems Laboratories holds current certifications for the Clinical Laboratory Improvement Act (CLIA), and licensure with the New York State Department of Health and California Department of Health Services.

• Licenses
  

Quality Initiatives:

• Comprehensive Quality Manual
• Internal Quality Audits (approximately 30 per center and laboratory each year)
• All blood products traceable and trackable by 510k approved computer system (cleared by the US FDA)
• Formal Change Control Process
• Annual training in current Good Manufacturing Practices
• Task-based training and competency testing
• Equipment satisfies safety requirements
• Shipping containers manufactured and labeled in compliance with Department of Transportation regulations 49 CFR 178.609
• Quality control testing on all shipping containers including:
  temperature range of container, duration time temperature, water immersion testing and drop testing
• Customers informed of regulatory inspection status
• Annual customer satisfaction survey