Quality Source | Licensing and Accreditation

Blood Systems' innovative Quality Source offers a diverse portfolio of quality-focused programs and services designed to help others. Our program includes highly skilled quality professionals with experience in blood center operations, blood banks and transfusion medicine, and regulatory affairs (FDA, GMPs, GTPs, AABB, JCAHO).

Targeted expertise, extensive resources, proven quality programs, problem-solving skills and process improvement methods enable Quality Source to deliver a broad range of flexible, customizable solutions to improve quality.

We are able to offer quality-focused programs at a variety of levels of service that include:

• quality awareness and in-service education and training
• quality assessments (audits, gap assessments)
• procedure development
• quality support services

Our clients have benefited from programs such as tailored cGMP training, deviation management/problem solving training, audits and gap assessments (preparation for external inspections), procedure development, regulatory support and quality leadership.

For more information, contact Quality Source at 1-800-288-2199, extension 5804 or by e-mail at qualitysource@bloodsystems.org.

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Blood Centers of the Pacific 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), and licensure with the New York State Department of Health and California Department of Health Services.

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

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