6505--Blood Components and Specialized Testing

STATEMENT OF WORK BLOOD/BLOOD COMPONENTS SUPPLIER & IMMUNOHEMATOLOGY REFERENCE LABORATORY A. Specifications: 1. An FDA-licensed blood supplier will supply the Altoona Veterans Affairs Medical Center, 2907 Pleasant Valley Blvd, Altoona, PA 16602 with blood/blood components for transfusion services as well as specialized reference laboratory support such as consultation service, assistance in resolving complex antibody problems, and assistance in locating rare or unusual blood units to meet the transfusion needs of the patient. All whole blood and blood components provided to patients in VA medical centers must meet the requirements of the Food and Drug Administration (FDA). 2. Autologous blood/blood components must be typed for ABO and Rho(D) in accordance with licensed methodologies and must be tested for all transfusion transmitted disease markers currently required by the FDA. 3. All blood/blood components must be collected from donors in accordance with the requirements of the FDA. 4. All blood/blood components must be labeled, stored, and shipped in accordance with the current regulations of the FDA. In the event that these regulations change during the course of the contract, the contractor shall implement the necessary changes as directed/recommended by the regulatory and accrediting agencies. 5. In the event of a recall, Contractor shall promptly send copies of the recall request to the Laboratory Medical Director at the VA medical center where the blood product was issued. RECALL is defined as: A request from the supplier of blood component to return a specific unit(s) which was inadvertently issued to the VA medical center, regardless of the reason, or was issued to the VA medical center prior to the receipt of information about a donor which would have prevented such release. 6. The contractor must be capable of providing the blood components and specialized testing on a 24-hour per day, seven days per week basis. 7. The Contractor shall modify products as requested and as necessary for the protection of the patient, to include, but not limited to leukocyte reduction and irradiation. 9. In order to maintain efficacy in transfusion, blood and blood components will be maintained during storage and transport to the VA Medical Center according to guidelines published by the American Association of Blood Banks (AABB.) 10. The supplier will work cooperatively with the VA Medical Center in order to provide effective management of blood inventory. This includes release and transfer of blood and blood products to reduce waste related to product expiration. 11. If the possibility of potentially infectious blood or blood components being supplied to the VA Medical Center exists, the supplier will agree to notify the VA Medical Center in writing with related information to include donor unit number, date supplied, and date confirmed. This notification will occur within seven (7) business days of confirmation. 12. The Contractor shall provide a quantity and/or type specific or type compatible products to include but not limited to the following products in-order to meet the needs of the Altoona VAMC: Minimal Altoona VAMC Inventory: Leukoreduced Plateletpheresis/ Red Blood Cells FFP Random Platelets O Pos 2 As needed As Needed O Neg 2 A Pos 2 As needed As Needed A Neg As Needed B Pos As Needed As needed As Needed B Neg As Needed AB Pos As Needed As needed As Needed AB Neg As Needed *Altoona VAMC shall have the capability to adjust quantity of units and blood type of inventory needed based on adjusting needs of the facility. 13. If the Contractor fails to meet FDA requirements, the contractor will continue to be responsible for supplying the Altoona VAMC with blood products obtained and tested at another FDA accredited facility as stated herein at the agreed upon pricing. No additional charges shall be imposed on the Altoona VAMC if the Contractor must import products. 14. The supplier must include the assigned purchase order number (which is provided by the Altoona VAMC) on all invoices for payment. C. Orders/Deliveries 1. Orders will be categorized into two types: routine and STAT. All product pricing will be the same for routine and STAT deliveries. These categories are defined as follows: a. Routine-Shipments of blood products to maintain minimum inventory levels b. STAT A need for blood products so acute that a patients life could be jeopardized if the request for blood products is unfulfilled. STAT orders must be delivered within 1 hour. 2. Contractor shall make delivery services for blood and blood components available to the VA laboratory 24 hours per day, seven days a week, 365 days a year, subject to blood product availability. Should the contractor be unable to provide delivery at a specific time (ex. Holiday), Altoona VAMC will be notified in advance. 3. Altoona VAMC will order blood products on an as needed basis. No standing order will be established.