36C24923Q0366_1.docx

Special Notice Special Notice

GENERAL INFORMATION

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

ADDITIONAL INFORMATION

DESCRIPTION

NOTICE OF INTENT TO SOLE SOURCE

The Department of Veteran’s Affairs Tennessee Valley Healthcare System intends to award a sole source firm-fixed price contract to the American Red Cross for the delivery of blood and blood products in accordance with the statement of work attached to this notice. The contemplated contract action is for supplies and services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302-1 and 10 U.S.C. 3204(a)(1).

This notice of intent is not a request for competitive quotations; however, all quotations/responses received by the deadline specified in this notice, in accordance with FAR 5.203, will be considered by the Government. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

DESCRIPTION/SPECS/WORK STATEMENT

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). Requesting a follow-on contract for a base + four option years.

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

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.

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

• 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.

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

• 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.

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

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

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

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

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

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

• 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.

• 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).

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

Credit for Transferred Blood:

· Credit at the rate charged per item will be allowed for blood transferred prior to expiration date. Customer may return certain Blood products to ARC for full or partial credit so long as, in ARC's discretion, such Blood products meet ARC's reissue criteria. The reissue criteria include, without limitation, positive answers to all of the following questions ("Reissue Criteria"): a. Is the Blood product indated? b. Does the Blood product have two or more segments? c. Has the Blood product been maintained continuously within the required temperatures? d. Is the Blood product normal in appearance? e. Is the Blood unit container intact? f. Is the Blood product unmodified? g. Does the Blood product meet all Customer quality requirements? Customer may not return any of the following Blood products: a. Autologous and Directed Blood products. b. Outdated Blood products. c. Frozen Blood products. d. Non-ARC Blood products. e. Nonleukoreduced Red Cells f. Platelet products

Blood Warranty

· 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. It therefore follows that the American Red Cross cannot guarantee or warrant the blood in any way. The American Red Cross is not responsible for any loss or damage arising out of the blood unless and to the extent caused by the negligence or misconduct of the American Red Cross. This language supersedes and replaces 52.212-4(O).

Licensing and Accreditation

• 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.

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

Subcontractor Changes

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.

HIPPA COMPLIANCE ARC is not a covered entity under HIPPA.

PRIVACY ACT ARC is not performing patient treatment.

INSPECTION OF BLOOD/ADVERSE EVENTS

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.

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.

LOOKBACK

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.

FEE ESCALATION CLAUSES

Notwithstanding Section 52.216-1, this contract is subject to compliance by the Contractor and the Government with: (a) all recommendations from, or requirements mandated by, any state or federal agency, and (b) requirements of applicable accreditation agencies. The Government is responsible for the incremental costs of such recommendations and requirements, so long as the Contractor provides the Government with sixty (60) days' prior, written notice of such incremental costs

EXCLUDED PARTIES HHS/OIG 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.

Responsibilities of the VA Medical Center

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

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

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

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.

CONTRACTING OFFICER (CO):

The contracting officer (CO) named below is responsible for the overall administration of the contract. Lori Ellis, VA Tennessee Valley Healthcare System 1639 Medical Center Parkway Suite 400 Murfreesboro, TN 37129.

The awarded Contractor is advised that only the Contracting Officer, acting within the scope of the contract and his/her duties and responsibilities and, after advice and consultation with the Contracting Officer’s Technical Representative, has the authority to make changes which effect contract prices, quality, quantity, delivery terms and conditions, term of contract.

In no event shall any understanding or agreement, contract modification, change order, or other matters in deviation from the terms of this contract between the Contractor and a person other than the Contracting Officer, be effective or binding upon the Government. All such actions must be formalized by the proper contractual document executed by the Contracting Officer.

CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE:

Prior to contract award, the Contracting Officer will designate a VA Medical Center employee as COTR. All work coordination shall be made through the COTR. Upon award, the Contractor shall be provided a copy of the letter of delegation identifying the authorized COTR and their roles and responsibilities during the term of the contract. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer.

Special Notice