Quality

Our commitment to the quality and safety of our blood products is evident in the complex operational and quality systems we have in place across our donor screening, testing, manufacturing and distribution processes.

In all that we do, we comply with and often exceed regulatory requirements from AABB, the FDA and other regulatory agencies. We consistently achieve favorable outcomes from external inspections and are considered a thought leader in quality management systems for the blood banking industry.

Quality is more than just compliance with regulations. In addition to a rigorous regulatory focus, Blood Systems’ Quality focus extends from the customer to business and performance excellence. This focus includes listening to and understanding the voice of the customer, performance improvement in productivity and efficiency, elimination of waste, reduction in variation, reduction in cost, robust process design, and importantly providing value to the customer.

Across United Blood Services and throughout its Blood Systems parent organization, we apply the concepts of Operational Excellence, including Lean and Six Sigma-based process improvement. These methodologies work to attain operational efficiencies that ensure high customer satisfaction.

Quality Initiatives:

  • Comprehensive Quality Manual
  • Performance improvement initiatives using our own cadre of Yellow, Green and Black Belt staff
  • Comprehensive metrics to include key performance and key quality and operational metrics
  • Focused business performance management reviews
  • Defined processes for ongoing data and process analysis for improvement
  • Internal Quality Audits
  • 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 and Good Tissue Practices
  • Task-based training, competency and proficiency testing
  • Validated processes and equipment
  • 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

LICENSING AND ACCREDITATION

Blood centers are licensed by US FDA and accredited by AABB. Additionally, Blood Systems Laboratories holds current certifications for the Clinical Laboratory Improvement Act (CLIA), the Foundation for Accreditation for Hematopoietic Cell Therapy (FAHCT) and the American Society for Histocompatibility and Immunogenetics (ASHI), and licensure with the New York State Department of Health and California Department of Health Services.