Quality Assurance
Our commitment to the quality and safety of our blood products is evident in the complex system of quality processes and controls we have in place across our donor screening, testing, manufacturing and distribution procedures.
In all that we do, we comply with and often exceed regulatory requirements from AABB, the FDA and other regulatory agencies. We consistently achieve superb regulatory audit ratings and are considered a thought leader in quality management systems for blood banking.
Across United Blood Services and throughout its Blood Systems parent organization, we apply Six Sigma-based process improvement methodologies to attain operational efficiencies that ensure high customer satisfaction.
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
LICENSING AND ACCREDITATION
Blood centers and our Blood Systems Laboratories 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.