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QUALITY

Physician and Quality Source consultant.

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.

QUALITY & EFFICIENCY CONSULTING SERVICES

United Blood Services Quality Source professional services team delivers results-oriented consulting services that enable hospital transfusion services and blood centers nationwide to attain compliance, enhance quality systems and save money, time and resources by adopting operational best practices.

Drawing upon their accomplished careers in blood centers, laboratories and transfusion services, United Blood Services Quality Source consultants offer clients their deep knowledge of blood banking best practices and their unique expertise in quality management and regulatory affairs, which are grounded in the Blood Systems parent organization's own corporate practices.

For hospital transfusion services, United Blood Services Quality Source offers a number of pre-packaged programs. Custom consulting and training services are available to blood centers as well as to hospitals, laboratories and blood banks. The programs for hospital laboratories and transfusion services are listed below. Click the program title for more information

CPT Coding & Reimbursement

To help you earn correct reimbursements for blood products you might otherwise miss, United Blood Services Quality Source consultants can perform a CPT Coding and Reimbursement Review to thoroughly examine your hospital’s blood product order entry processes. They will evaluate the code descriptors, which are critical to assigning charges that accurately reflect the actual blood products delivered to the patient. Our consultants also look line by line through your hospital chargemaster to assess and identify missing, outdated or non-assigned codes for blood and blood derivatives.

Lean Manufacturing

Long-term cost savings in the healthcare industry will come from increased efficiency. In a Lean Manufacturing program, United Blood Services Quality Source consultants train your staff through hands-on experience to eliminate extraneous activities that do not contribute value to the patient or end user. Applying lean manufacturing process improvement techniques can result in increased efficiency in workflows and elimination of unnecessary costs.

Operational Assessment

Identify opportunities for cost savings and operational efficiencies by getting an objective, third-party review and benchmarking of your transfusion service practices. The findings from this United Blood Services Quality Source program document for you both short- and long-term opportunities that can help you meet your facility’s business targets as well as assist with improving services and patient care long after the review is complete.

Gap Assessment

Be confident that your transfusion service or laboratory is prepared for your next regulatory inspection. A gap assessment performed by United Blood Services Quality Source serves as a pre-audit to identify areas for improvement and give you an early opportunity to take corrective action. Assessments can be performed in preparation for FDA, AABB, CAP, Joint Commission, COLA, ISO or DNV inspections.

On Q Workshops

Take 1-2 days to get current on regulatory agency requirements. United Blood Services Quality Source hosts short training programs called On Q for Transfusion Services. The On Q workshops are for new and veteran transfusion services professionals alike who want a deeper understanding of regulatory requirements and more insight into potential quality management system improvements.

Regulatory Crisis Management

Get back to your regular work faster by working with United Blood Services Quality Source to resolve any regulatory nonconformance. The consultant helps you quickly create a complete remediation plan, craft an appropriate response to the regulatory agency and implement corrective actions to prevent recurrence.

Jump Start to CAP 15189 Accreditation

If your laboratory is considering the CAP 15189 program, United Blood Services Quality Source can conduct an in-depth briefing about the requirements and help you plan your path to accreditation. To help you get started, this Jump Start to CAP 15189 Accreditation program includes training, a readiness assessment and project planning assistance.

Email & Telephone Support

For quality, compliance or procedural questions, the hospitals that depend on us for their blood supply have access seven days a week to responsive email and telephone support from United Blood Services Quality Source. We can answer your questions—typically at the first point of contact—on a wide range of quality and regulatory topics including equipment validation, FDA error reporting, change management and SOP approval. United Blood Services customers can access support by calling (877) 899-7772 or by sending email to qualitysource@bloodsystems.org.

 

Blood Systems and its divisions and affiliates provide comprehensive transfusion medicine services. These include: BioCARE • Blood Services (Blood Centers of the Pacific, BloodSource, Bonfils Blood Center, Community Blood Services, Inland Northwest Blood Center, The Institute for Transfusion Medicine, Lifeblood, LifeShare, LifeStream, United Blood Services) • Blood Systems Laboratories • Blood Systems Research Institute • Creative Testing Solutions