Our commitment to quality test results and the safety of our blood products is evident in the thorough operational and quality systems we have in place across our screening, testing, manufacturing and distribution processes.
We are considered a thought leader in quality management systems for our industry. Our laboratories hold current certifications for the Clinical Laboratory Improvement Act (CLIA), the Foundation for Accreditation of Cellular Therapy (FACT), College of American Pathologists (CAP), and the American Society for Histocompatibility and Immunogenetics (ASHI), and licensure with the states of New York, Maryland, Rhode Island, Pennsylvania and California. Our blood centers are licensed by the U.S. Food and Drug Administration (FDA) and accredited by the Association for the Advancement of Blood & Biotherapies (AABB) and COLA, Inc. In all that we do, we comply with and often exceed regulatory requirements. See a full list of our accreditations.
A Process for Operational Excellence
We believe quality is more than just compliance with regulations. In addition to a rigorous regulatory focus, Vitalant’s quality focus extends from the customer to business and performance excellence. This 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 Vitalant, we apply the concepts of operational excellence, including Lean and Six Sigma-based process improvement. These methodologies ensure operational efficiencies that deliver high customer satisfaction.
Our Quality Initiatives
Vitalant’s quality initiatives include:
- 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 products traceable and trackable by 510K-approved computer system (cleared by the U.S. 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.
- Detailed quality manual.