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Lab Background

Blood Systems Laboratories Donor Testing Services (BSL/DTS) was created to centralize all United Blood Services (UBS) donor testing operations into one large state-of-the-art laboratory. BSL/DTS has two laboratories, one located in Tempe, Arizona and one in Bedford, Texas, which were designed and constructed to house the centralized operations in an environment that supports compliance with Good Manufacturing Practices.

The Special Testing laboratory is located in the Tempe, Arizona facility.

Experience With Diverse Customer Needs
BSL/DTS began centralization of testing in 1991 and has gradually increased volume and number of customers since then. We currently perform testing for 20 UBS centers located throughout the country and over 40 additional external blood center and hospital customers. The Special Testing laboratory performs confirmatory and supplemental testing for these customers as well as approximately 20 customers using special testing services only.

External Agencies
BSL is regulated by the FDA, the American Association of Blood Banks (AABB)/CLIA, Centers for Medicare & Medicaid Services (CMS),the State of New York, the State of California and the State of Arizona.

Medical Oversight
Thomas Wiltbank, MD is the Medical Director for Blood Systems Laboratories, Tempe, Arizona. Kevin Land, MD is the Medical Director for Blood Systems Laboratories, Bedford, Texas. The Medical Directors are responsible for general medical oversight of the laboratory consistent with the duties described for the Laboratory Director in CLIA '88. Included in these duties are review and approval of standard operating procedures, validation protocols, Quality Control records and clinical reports. Medical Directors also serve on the BSL Quality Assurance Committee to review error management and audit reports, as well as the Quality Control Committee that reviews quality indicators and process control monitors.

 

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Blood Systems, Inc. has two Donor Testing Service (DTS) laboratories. Our second laboratory, in Bedford, Texas was opened in 1999. Both DTS laboratories are Food and Drug Administration (FDA) licensed facilities. Both DTS laboratories also hold current certifications for the Clinical Laboratory Improvement Act (CLIA) as well as accreditation with the American Association of Blood Banks and the New York State Department of Health.

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