36C24923Q0366.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 400 Murfreesboro TN 37129

POINT OF CONTACT*

Doug Huddy Contracting Officer douglas.huddy@va.gov 615-225-3418

PLACE OF PERFORMANCE

ADDRESS

1639 Medical Center Parkway

Murfreesboro TN

COUNTRY

ADDITIONAL INFORMATION

DESCRIPTION

This not a request for quotes; the Government is seeking information for market research purposes only. VA Network Contracting Office (NCO) 9 is seeking sources interested and capable of providing the items as described in the attached Statement of Work.

The North American Industry Classification System (NAICS) is 621991

The Service Code (PSC) is Q999

Responses to this notice shall include:

1. A positive statement of your firm’s interest and capability to meet the requirements of the attached description of the required items.

2. Company/individual name, size status for the above reference NAICS code, a service capability statement, SAM Entity Unique Identifier (EUI), address, point of contact and examples of similar facilities to which similar items have been provided.

3. Contractors should provide information on whether they are certified SDVOSB, VOSB, Hub zone, 8(a), women-owned concern. If standard company brochures will be provided as a response to this Source Sought Notice, ensure that additional information tailored to this notice is included.

4. This is not a solicitation for quotes. If a solicitation is issued, it will be announced on the Contract Opportunities website https://sam.gov at a later date, and all interested parties must respond to that solicitation announcement separately from the response to this announcement. Contractors must be registered in System for Award Management (SAM), see internet site: https://www.sam.gov for information about registration.

5. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each.

6. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner?

7. If you are in GSA, please provide schedule and contract number.

8. Responses to this notice must be submitted via email to douglas.huddy@va.gov. No telephone inquiries will be accepted.

DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

Requirement: Delivery of blood and blood products to Veterans Affairs Tennessee Valley Healthcare Systems at Murfreesboro and Nashville campuses.

Requirements are in accordance with the attached statement of work.

The contemplated action is a “base-plus-four ordering periods” project.

DESCRIPTION/SPECS/WORK STATEMENT

1.

A. Contractor shall provide the following 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). The contemplated action is a base + four ordering periods ordering vehicle.

Below are the estimated quantities for the Alvin C. York Campus, 3400 Lebanon Pike, Murfreesboro, Tennessee, for the period October 1, 2023, through September 30, 2024, with 4 option years through September 30, 2028

B. Contractor shall provide the following 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 four (4) deliveries per day (5 days per week) with up to five (5) additional deliveries per week, if necessary 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).

Below are the estimated quantities for the Nashville Campus, 1310 24th Avenue South, Nashville, Tennessee, for the period October 1, 2023, through September 30, 2024, with 4 option years through September 30, 2028.

Item No.

Description

c. The above 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 during the contract period. 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

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.

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. Blood Warranty

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. Any proposed subcontractor changes from what is proposed under this contract must have prior approval by the VA Tennessee Valley Healthcare System Contracting Officer. 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. To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Service – Office of Inspector General, List of excluded individuals/entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract. Further the contractor is required to certify in its proposal that all persons listed in the contractor’s proposal have been compared against the OIG list and are not listed. During the performance of this contract the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities.

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.

Sources Sought Notice