P01_SOW_TVHS Blood and Blood Products 2025 ACY.docx

DESCRIPTION/SPECS/WORK STATEMENT

1. Delivery Requirements

a. Contractor shall provide blood and blood components to the VA Tennessee Valley Healthcare System, Alvin C. York Campus in Murfreesboro in accordance with the estimated quantities noted below. The contractor shall provide two (2) deliveries per week with up to one additional delivery per week. All deliveries are to be made directly to the Alvin C. York Campus Blood Bank (specific location to be designated after award of contract).

b. Contractor shall provide blood and blood components to the VA Tennessee Valley Healthcare System, Nashville Campus in accordance with the estimated quantities noted below. The contractor shall provide five scheduled deliveries per week to the Nashville Campus. All deliveries are to be made directly to the Nashville Campus Blood Bank (specific location to be designated after award of contract).

c. The below schedule of supplies/service represents estimated requirements for the TVHS VA Medical Centers. The amounts indicated are estimates of the quantities of blood and blood components, which will be furnished annually. These items may be provided within fifteen percent (higher or lower) of the estimated amount without a formal amendment to this contract based on the actual needs of the VA Medical Center and available supplies of blood and blood components in the contractor blood center. On occasion, a VA Medical Center may order items that are not listed above, in which case, charges will be based on your published price list.

d. The VA Medical Centers will periodically issue orders orally, by facsimile, in writing, or by electronic commerce for red blood cells and other blood components as needed. The VA Medical Center will specify group and type wherever applicable and indicate tentative delivery schedule. Emergency orders will be placed by telephone at the expense of the VA Medical Center. Delivery is subject to the availability of products at the time orders are received by the contractor.

2. TECHNICAL REQUIREMENTS:

a. The Contractor will provide human blood and blood components upon request of the VA Medical Center. The following must be provided:

i. Contractor agrees that its blood center(s) will furnish all personnel, supplies and facilities necessary to collect, process, store and deliver Human blood components and derivatives.

ii. Contractor will provide Human blood components only from volunteer donors.

iii. All blood components and derivatives that are provided under this contract will be collected, processed and stored in accordance with Food and Drug Administration (FDA) Regulations (21 CFR) and applicable contractor standard operating procedures under contractor’s U.S. License. Specifically, contractor agrees that all components shipped will have been tested and found to be non-reactive for HBsAg, RPR, HBc antibody, antibodies to HIV-1, HIV-2, HCV, HTLV-1 and HIV-Ag. Additional tests may be implemented as the need arises.

iv. Human blood components provided by contractor will include those items listed in the Schedule.

v. Human blood components upon shipment must comply with the following regulations:

1. Code of Federal Regulations (21) Section 606.120 and 606.121 Subpart G

2. Code of Federal Regulations (21) Section 606.165 Subpart I.

3. Code of Federal Regulations (21) Section 210 and 211.

4. The American Association of Blood Banks 17th Standards for Blood Bank and Transfusion services: Standard Number G1.000 and G2.000.

vi. Contractor agrees to deliver supplies as requested by each VA Medical Center on a twenty-four (24) hour per day, seven days per week availability, including all Holidays. Charges for deliveries beyond those noted in this solicitation will be borne by that VAMC. HOWEVER, the contractor must utilize the prearranged transportation services established by the VAMC. If the contractor utilizes other transportation sources, the contractor will bear all costs associated for transportation.

vii. Specimen and blood components must be transported in such a way as to ensure the integrity of specimens and blood components and comply with accreditation standards as defined by the FDA and American Association of Blood Banks (AABB).

viii. Contractor will provide routine test results as soon as possible. STAT (emergency) test results shall be reported as soon as possible.

ix. IX: The contractor is responsible for supplying pathogen-reduced apheresis (PR) Platelets that are treated with a Platelet Additive Solution.

b. Credit for Transferred Blood:

i. Credit at the rate charged per item will be allowed for blood transferred prior to expiration date. VA may return certain Blood products for full or partial credit so long as such Blood products meet pre-defined reissue criteria.

c. Risk Management

i. There are risks, side effects and hazards associated with human blood products that cannot be prevented, even through careful blood donor screening and testing. These risks, side effects and hazards are set forth in the CIRCULAR OF INFORMATION FOR THE USE OF HUMAN BLOOD AND BLOOD COMPONENTS as prepared by the American Association of Blood Banks, America’s Blood centers and the American Red Cross and recognized as acceptable by the US Food and Drug Administration.

d. Licensing and Accreditation

i. Contractor shall have all licenses, permits, accreditation and certificates required by local, state and federal laws. To include requirements, regulations, recommendations, standards, specifications, guidelines, and directives of the Food & Drug Administration, the U.S. Public Health Service, American Association of Blood Banks, Foundation for the Accreditation of Hematopoietic Cell Therapy, National Marrow Donor Program, Joint Commission on Accreditation of Healthcare Organizations, and American Red Cross regulations. In the event of any conflict between the Regulations, U.S. law shall be given priority.

ii. Contractor shall be accredited by the U.S. Food and Drug Administration (FDA), and the American Association of Blood Banks (AABB).

e. Subcontractor Changes

i. All subcontractors must meet prime contractor vendor requirements. Contractor shall be responsible for finding an outside laboratory with appropriate licensure and accreditation to perform tests that the contractor cannot perform. Contractor shall notify the VA Campus Laboratory and Contracting Officer of any change of subcontract. Any changes shall be submitted to the Contracting Officer in writing for review and approval.

f. Inspection of Blood / Adverse Events

i. The Government will promptly inspect the blood upon receipt and report any actual or suspected damage, irregularity, testing or labeling error. The Government will also promptly report blood lost due to shipping error. The Government will keep complete and accurate records, as required by the law, of patients supplied with blood (product names, lot identifications and quantities), any therapeutic adverse effects and complaints and other Blood-related information.

ii. Upon discovery, the Government will report possible transfusion-transmitted infections or other serious complications associated with transfusion which may have resulted from blood ("Adverse Event"). The Government will cooperate with the Contractor's investigation of any Adverse Event and supply information concerning the recipient of the blood to the Contractor, upon forms provided by the Contractor.

g. Lookback

i. With respect to blood manufactured by the contractor, contractor will provide the following notifications to the Government: (a) within three calendar days if blood collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection; (b) within forty-five (45) days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by the FDA; and (c) as set forth in 21 C.F.R 610.48(b)(3). Under no circumstances will the contractor ever reveal the identity of the blood donor.

h. Excluded Parties HHS/OIG

i. At time of award, contractor represents to TVHS that as of the Effective Date: (i) it has not been excluded, debarred or otherwise deemed ineligible to participate in Medicare, Medicaid or any other federal or state healthcare programs or in any federal or state procurement or non-procurement programs; and (ii) it has not been convicted of a criminal offense related to the provision of federal health care items or services, that could lead to debarment or exclusion.

i. Responsibilities of the VA Medical Center

i. Maintain proper refrigeration or other proper storage facilities for the storage of the blood and blood components.

ii. Inspect each shipment upon receipt, in accordance with 52.212-4, Inspection/Acceptance. The VA Campus will report by phone any discrepancies immediately.

iii. Keep complete and accurate records of patients supplied with the supplies under this contract.

iv. The contractor shall provide the Contracting Officer's Technical Representative (COTR) a Blood Product Return Policy for each VA Medical Center prior to start-up of contract.

3. Pricing Schedule

i. Analysis of historical requirements along with coordination with American Red Cross has found estimated annual usage and corresponding pricing in accordance with the schedule below:

ii. Average cost per year for Murfreesboro - $80,000.00

iii. Average cost per year for Nashville - $1,665,000.00

$39,730.00

Pooled Cryoprecipitate (5 units per pool)