Primary Blood Contract

STATEMENT OF WORK: BLOOD AND BLOOD PRODUCTS - One (1) base year and four (4) one-year option periods

1. INTRODUCTION

1.1 The intent of this requirement is to provide a primary source for procurement of blood and blood products by Blood Bank, Pathology & Laboratory Medicine Service, VA Medical Center, Birmingham, AL. The Awardee of the Primary Blood Contract may not also be awarded the Alternate Blood Contract. This is an indefinite delivery, indefinite quantity contract with firm-fixed price task/delivery orders placed against it.

1.2 The Contractor will deliver the following items, in suitable containers, to Department of Veterans Affairs (VA) Medical Center, Blood Bank, 700 South 19th Street, Room 3429, Birmingham, AL, 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 (see Item #12 below) and will be billed based on current price list.



Description Estimated Quantities

1. Fresh Frozen Plasma 210

2. Red Blood Cells, Leukoreduced 1200

3. Platelet Pheresis Leukoreduced 190

4. Cryoprecipitate 70

5. Pooled Cryoprecipitate 10

6. Autologous Red Cells 4

7. Directed Red Cells 4

8. Red Blood Cells, Irradiated, Leukoreduced 4

9. Antigen Typing 10

10. Antibody Identification 10

11. Plasmapheresis 16

12. Miscellaneous Items as needed 45



1.3 The VA Medical Center 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, VA Medical Center, Birmingham, AL 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 BVAMC 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 BVAMC 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.a 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.

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.

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.

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

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."

For non-local delivery, unless directed otherwise by BVAMC, the Contractor shall ship products to BVAMC 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 BVAMC Blood Bank within 1 hour for STAT orders and 4 hours for ROUTINE orders from the time the order is placed with the contractor.

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

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

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

Donor Requirements:

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.

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

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.

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 and order, subject to geographical distance and driving time.

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

Original VA sensitive information will remain at BVAMC.

3. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE

Packaging and Marking

Blood components shall be labeled in accordance with all FDA requirements, including kind of component, blood group and type (ABO/Rh), expiration date, unique donor unit identification, and storage and handling.

Blood components shall be packaged for shipping and transport to ensure the FDA required temperature ranges are maintained: red cell components (1-10 degrees Celsius), frozen plasma components (below minus 20 degrees Celsius), and platelet components (20-24 degrees Celsius).



Test and Evaluation:

a. Upon receipt of the units of blood/blood components, the BVAMC lab employee will inspect/evaluate each unit to ensure appropriate labeling, shipping temperature, appearance, expiration date, bag integrity, hemolysis, and clots. Documentation of inspection is maintained in the laboratory and the vendor is notified of any deficiency.

4. INVOICES - Payment: Payment will be monthly in arrears, upon receipt of a properly prepared invoice. The contractor shall submit all invoices via electronic invoice submission to the VA Financial Services Center through OB10 Electronic Invoicing Services, or alternate service as declared by VA.

RETURN POLICY: Return of blood products will be in accordance with the contractor's return policy.

REPORTING AND DOCUMENTAITON OF TRANSFERS - Transfer of blood products will be in accordance with the contractor's transfer policy.

ADVERSE EVENT REPORTING - VA will notify the Contractor of any possible infectious disease or other serious complication associated with transfusion that may have resulted from any of the blood, including suspected post-transfusion hepatitis, transfusion-associated HIV or HTLV infection, and any other transfusion-associated infections (malaria, babesiosis, bacterial contamination or infection) and death. VA will make available to the Contractor information concerning transfusions to include product names, lot identifications and quantities, any therapeutic adverse effects, complaints or other pertinent information relating to the blood.

REJECTED GOODS - The contractor shall remove rejected supplies within 48 hours after notice of rejection. Supplies determined to be unfit for human consumption will not be removed without permission of the local health authorities. Supplies not removed within the allowed time may be destroyed. VA will not be responsible for nor pay for products rejected. The contractor will be liable for costs incident to examination of rejected products.



QUALITY ASSURANCE SURVEILLANCE PLAN (QASP) - BLOOD CONTRACT

Tasks ID Indicator Standard Acceptable Quality Level (AQL) Method of Surveillance Remedies/Deductions/Incentives

Meeting Turnaround Times 1 Provide timely non-local product delivery. Product shall be shipped to BVAMC by overnight courier. Products ordered by 02:00 pm, Mon-Fri shall be shipped by air for delivery by the following day. 90%

Observation and Audit Exercise of option years for satisfactory performance.

2 Provide timely local product delivery. Products shall be delivered to the BVAMC Blood Bank within 1 hour for STAT orders and within 4 hours for Routine orders from the time the order is placed. 90%

Delivery and Inspection 1 Packaging and Marking/Labeling Blood components shall be labeled IAW all FDA requirements. 100% Observation and Audit Exercise of option years for satisfactory performance.

2 Shipping and Transport FDA required temperature ranges are maintained: red cell components (1-10 C); frozen plasma components (below minus 20 C); platelet components (20-24 C) 95%

3 Component Inspection All blood products shall be free of hemolysis and clots. 90% Observation and Audit Exercise of option years for satisfactory performance.

Certifications 1 Provide licensing As requested by using service line 100%

2 Provide accreditation Before contract award