DRAFT STATEMENT OF WORK.docx

STATEMENT OF WORK

Reno VA Blood Products

A. GENERAL INFORMATION

1. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables and reference laboratory testing described in this statement of work (SOW) and attached itemized list, except as otherwise specified.

2. Background: The Reno VA Medical Center (VAMC) has a requirement for a reliable FDA registered source of blood products and services for the treatment of patients. All products will be used for human administration. All referred patient testing results will be included in treatment of the patient based on clinical presentation.

3. Performance Period: See Delivery Schedule.

4. Type of Contract: Firm-Fixed Price, five-year Indefinite Delivery Indefinite Quantity (IDIQ).

B. GENERAL REQUIREMENTS

1. Blood Products: Contractor shall furnish all personnel, supplies, and facilities necessary to collect, process, store, and deliver human blood components and derivatives. The contractor shall supply following blood products which are listed on the attached Price/Cost Schedule.

2. Services: Contractor shall provide all the following services to the Reno VAMC which are listed on the attached Price/Cost Schedule.

a. Vendor shall stock and maintain homologous leukoreduced red blood cell units, blood components, plasma derivatives and/or services. Said units shall be procured from volunteer donors only and shall be tested and processed in a manner commensurate with standards consistent with those promulgated by the American Association of Blood Banks (AABB) and regulations of Title 21, Code of Federal Regulations as administered by the U.S. Food and Drug Administration (FDA). Inventory levels will be mutually agreed upon and may be changed from time to time, subject to review by the Director of the Reno VAMC Hospital Transfusion Service and the Contractor.

b. Normal hours of operations are Monday through Friday, between the hours of 8:00am and 4:00pm, excluding holidays. Federal holidays observed are as follows:

New Year’s Day (January 1st) Birthday of Martin Luther King, Jr. (third Monday in January) Washington’s Birthday (third Monday in February) Memorial Day (last Monday in May) Independence Day (July 4th) Labor Day (first Monday in September) Columbus Day (second Monday in October) Veterans Day (November 11th) Thanksgiving Day (fourth Thursday in November) Christmas Day (December 25th) *Note: If the federal holiday falls on a Saturday it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday.

c. Contractor shall provide blood (leukoreduced red blood cell units) and blood products as needed during off-hours, weekends, and holidays. Deliveries shall be billed according to the after-hour courier fee as per the Price/Cost Schedule.

d. Contractor shall supply trained staff, supplies, and equipment for conducting donor mobile operations at/or within the Reno VAMC.

e. Contractor shall provide reference testing services in a manner commensurate with standards consistent with those promulgated by the American Association of Blood Banks (AABB) and regulations of Title 21, Code of Federal Regulations as administered by the U.S. Food and Drug Administration (FDA) and must maintain Clinical Laboratory Improvement Amendments (CLIA) certification.

f. Orders will be categorized into three types: routine, as soon as possible and STAT. These categories are defined as follows:

i. Routine-Shipments of blood products to maintain minimum inventory levels or blood products ordered to fulfill a standing request.

ii. As Soon As Possible (ASAP) – Shipments of blood products to fill a request for a waiting outpatient, or a non-life-threatening need, or to replenish a depleted inventory of a blood product which has been used since the previous routine delivery. ASAP orders will be processed and ready to ship within 4 hours.

iii. STAT – A need for blood products so acute that a patient’s life could be jeopardized if the request for blood products is unfulfilled. STAT orders will be processed and ready to ship within one (1) hour of the order being placed. In the event there is an issue with antibodies and/ or compatibility of the blood available, the delivery time may be longer than 2 hours at the Government’s discretion. The Contractor shall notify the VA immediately in the event of a delivery time delay, or if it be delayed due to antibodies present or compatibility issues or not on hand.

3. Quality of Products: All blood products and specimens must be transported/shipped in such a way to ensure integrity and compliance of standards and requirements. The government has the right to inspect quality, quantity, and to verify adherence to the technical and delivery requirements of the contract and regulatory agencies.

4. Donor Requirements: Donor selection must be in accordance with criteria established by the FDA and AABB. All ABO group, Rh type, infectious disease testing and final labeling must be completed prior to distribution of blood and blood components.

5. Orders/Deliveries/Invoices:

The Contractor shall notify the Reno VAMC Blood Bank and advise them of the estimated delivery time. Based on the estimate delivery time, Reno VAMC will determine the effect on patient care and advise the Contractor accordingly. Delivery shall occur within two (2) hours after preparation for ASAP and STAT orders. Reno VAMC reserves the right to contact another vendor if the estimated delivery time is not acceptable to patient care. It is the responsibility of the Contractor to arrange for pickup of specimens and delivery of blood products in an emergency.

a. Blood products shall be delivered to the Laboratory (Building 1, Room 3). Upon receipt, the shipping form shall be reviewed, the blood product inspected, the product temperature recorded along with the date and time of receipt, and both the courier and the receiver shall sign the shipping form. Copies shall be kept on file by both parties.

b. Contractor shall make delivery services for blood products available 24 hours a day, 7 days a week, 365 days a year.

c. All blood products should be leuko-reduced unless otherwise unavailable. If leuko-reduced products are not available, the contractor shall contact the blood bank to verify acceptance of blood or blood product.

d. The specific volumes distributed in a routine order will be mutually agreed upon by Reno VA Medical Center and the vendor based on current inventory levels. Platelet, Cryoprecipitate orders and other special requests will be placed as needed.