VISN SOW - BLOOD AND BLOOD PRODUCTS.pdf

STATEMENT OF WORK

BLOOD AND BLOOD PRODUCTS

VA INTEGRATED SERVICE NETWORK (VISN) 7

1. INTRODUCTION

1.1 The intent of this requirement is to provide a primary Blood and Blood Related Products source for VISN 7 (Georgia, Alabama, and South Carolina) VA Medical Centers and affiliated clinics.

1.2 The Contractor will deliver the following items, in suitable containers, to VISN 7 in such quantities and at such times as may be required in accordance with all terms, conditions, provisions and the schedule herein. Requirement is not limited to items listed on schedule – additional miscellaneous items may be required.

Description

1. Fresh Frozen Plasma

2. Red Blood Cells, Leukoreduced

3. Platelet Pheresis

Leukoreduced

4. Cryoprecipitate

5. Pooled Cryoprecipitate

6. Autologous Red Cells

7. Directed Red Cells

8. Red Blood Cells, Irradiated, Leukoreduced

9. Antigen Typing

10. Antibody Identification

11. Plasmapheresis

12. Pathogen Reduced

Platelets

13. Miscellaneous Items, as needed

1.3 The VISN 7 Transfusion Service will not receive, or store units found reactive for HIV Antibody, VHIV(p24) Antigen or HB Surface Antigen.

1.4 Authorized personnel in the Blood Bank, Pathology & Laboratory Medicine Service, VISN 7 will order supplies furnished under this contract. A system of establishing a “Standing Order” shall be available.

1.5 The Contractor shall provide blood/blood products as available when ordered, and VAMC shall purchase blood/blood products according to the appropriate fee schedule.

1.6 The Contractor shall provide the applicable fee schedule with their proposal.

2. SPECIFICATIONS

2.1 All blood shall be tested as required by the Food and Drug Administration (FDA), the American Association of Blood Banks (AABB), all applicable state regulatory agencies, laws, rules, and regulations. The Contractor and VAMC shall maintain standards in accordance with FDA, AABB, all applicable state regulatory agencies, laws, rules, and regulations, including OSHA Blood borne Pathogen Exposure Final Rule 29 CFR Part 1910.1030, effective March 2, 1996, and any subsequent revisions thereof.

2.1. All blood shall be collected by the close system under aseptic conditions and shall be stored in currently approved, appropriate solutions and the container shall be correctly labeled. The label shall also bear the expiration date of the contents which shall not exceed 42 days from date of collection of source blood when collected and stored with anti-coagulant citrate phosphate, dextrose adenine solution (AS) or 35 days from date of collection of source blood, when collected and stored with anti-coagulant citrate phosphate dextrose adenine solution (CPDA1).

2.1.b All blood supplies shall be free of hemolysis, and clots, based on the contractor’s visual inspection of such blood prior to delivery.

2.2 Offers shall be considered only from offerors whose blood bank is currently registered and/or licensed with the FDA, Department of Health and Human Services pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, as amended, 21 USC Section 260.

2.3. Prior to award the offeror must submit proof that he holds an unrevoked US license which is issued by the Director, Bureau of Biologics, FDA under Section 351 of the Public Health Service Act, as amended, 42 USC Section 262, as a source of supply for whole blood.

Contractor shall maintain licensure and accreditation throughout contract period.

2.4 If interstate shipment of blood or blood component is involved, the offeror must submit with the offer a statement that such approval has been authorized under Section 251 of the Public Health Service Act, as amended, 42 USC Section 262.

2.5 The offeror shall certify that he will comply with the requirements outlined below with respect to donors, containers, delivery, etc.

2.6 Offers will be considered only from blood banks that are able to provide the VA with 100% “volunteer donors” blood in accordance with the latest FDA rules and regulations.

Definition of a “volunteer donor”: “A volunteer donor is a person who does not receive monetary payment for blood donation. Benefits, such as monetary time off from work, membership in blood assurance programs and cancellations on non-replacement fees that are not readily convertible to cash, do not constitute monetary payment.”

2.7 For non-local delivery, unless directed otherwise by VAMC, the Contractor shall ship products to VAMC by overnight courier. Products ordered by 2:00 p.m., Monday through Friday shall be shipped by air for delivery by the following day. On weekends, the products shall be shipped on Monday for delivery on Tuesday. Packing will ensure the products arrive within the correct temperature range and condition required by FDA/AABB. For local delivery, as applicable, products shall be delivered to the VAMC Blood Bank within 1 hour for STAT orders and 4 hours for ROUTINE orders from the time the order is placed with the contractor.

2.8. Any platelet products received that have a shelf life of less than three (3) days shall be credited if not used before expiration.

2.9. All Fresh Frozen Plasma shall have expiration dates at least nine (9) months in advance when shipped.

2.10. VAMC has in place the suitable temperature-monitored freezer and refrigerator for appropriate storage of the products.

2.11 Donor Requirements:

a. The offeror shall maintain blood donor listing which include names, addresses and social security numbers of the donors; along with the date the donor(s) blood or blood components is furnished to the medical center under this contract. All donor information, including without limitation, information in the donor database, is confidential and proprietary to the Contractor.

b. Donor selection shall be in accordance with criteria established by FDA and/or the

AABB.

2.12. The contractor’s reference laboratory is staffed and operational during normal business hours from 8:30 a.m. until 5:00 p.m. on non-holiday weekdays (“Normal Business Hours”). The contractor shall provide emergency reference laboratory services outside of normal business hours with advanced notice during business hours in order to plan appropriately. The VA understands and agrees that depending on the complexity of the patient’s blood sample, the time involved for testing resolution may range from several hours to several days.

2.13. Subject to availability, voluntary blood donations and absence of force majeure events, the contractor will endeavor without guarantee to deliver emergency shipments within two (2) hours after contractor staff member receives and reviews an order, subject to geographical distance and driving time.

2.14. The contractor will provide all labor, equipment, technique, qualified personnel, and expertise necessary to provide therapeutic apheresis (plasmapheresis) services at VAMC, as needed, under the direction and control of the VA attending physician. The replacement fluids will be provided by the VA.

2.15.

2.16. Original VA sensitive information will remain at VAMC. Any copies provided to the contractor become the property of the contractor.