CS OVER 950K.docx

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Part 12 and as supplemented with additional information included in this notice. This solicitation is issued as a Request for Quotation (RFQ), solicitation number 36C25026Q0638, in accordance with FAR Part 12. This announcement constitutes the only solicitation; QUOTES ARE BEING REQUESTED and a written solicitation will not be issued. Awards resulting from the (RFQ) will be based on Best Value to the Department of Veterans Affairs giving consideration to: Technical Capability, Past Performance, Price. This acquisition is Unrestricted, the North American Industry Classification System (NAICS) code is 621991 and has a size standard of $40 million dollars. The solicitation incorporates provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2025-007, effective March 13, 2026. The Government will issue a Firm Fixed Price, Indefinite Delivery/Indefinite Quantity Contract.

STATEMENT OF WORK (SOW)

1. Background:

The Department of Veterans Affairs Network Contracting Office (NCO) 10, Louis Stokes Cleveland Veterans Affairs Medical Center (CLE VAMC), Pathology and Laboratory Medicine Service (PLMS) requires a reliable, continuous, and regulatory-compliant supply of blood and blood components to support inpatient and outpatient clinical services.

Blood and blood components are mission-critical biological products required to sustain hospital operations and direct patient care, including but not limited to:

· Emergency trauma resuscitation.

· Surgical and perioperative services.

· Oncology and chemotherapy support.

· Hematology and transfusion therapy.

· Intensive care and critical care management.

· Cardiovascular and gastrointestinal procedures.

· Management of anemia, coagulopathies, and massive transfusion protocols.

There is no substitute for human blood and blood components in transfusion medicine. These biological products cannot be synthetically manufactured and must be collected, tested, processed, and distributed under strict federal regulatory oversight. Any interruption in supply would immediately jeopardize patient safety, halt surgical services, compromise trauma response capability, delay oncology treatments, and place transfusion-dependent patients at significant clinical risk.

Failure to maintain a continuous and compliant blood supply would also place CLE VAMC at risk of regulatory noncompliance under Food and Drug Administration (FDA), American Association of Blood Banks (AABB), Joint Commission, and Veterans Health Administration (VHA) standards.

Due to stringent federal qualification criteria, FDA licensure requirements, donor screening standards, interstate shipment authorizations, and biologics regulatory oversight associated with blood collection and distribution, this requirement necessitates procurement from a qualified and properly licensed blood supplier.

The Government intends to award an Indefinite Delivery, Indefinite Quantity (IDIQ) contract consisting of a Base Year plus four (4) Option Years to ensure uninterrupted patient care, regulatory compliance, and operational readiness.

This requirement is mission essential and cannot be accomplished without an awarded contract to a qualified blood supplier.

2. Scope:

The Contractor shall furnish all labor, materials, testing, processing, packaging, transportation, regulatory compliance, and associated services necessary to supply blood and blood components to CLE VAMC, PLMS.

The Contractor shall maintain the operational capability necessary to support routine, urgent, and emergency transfusion requirements, including access to specialty blood products and immunohematology reference services necessary to support patient care operations. The Contractor shall also maintain the capability to support continuity of blood product availability during periods of increased demand, regional shortages, severe weather events, disasters, public health emergencies, or other circumstances that may disrupt normal supply operations.

Products shall be supplied in quantities and at times required to support ongoing clinical operations in accordance with all Federal laws, FDA regulations, and contract terms.

3. Specific Tasks:

BLOOD PRODUCT SUITABILITY REQUIREMENTS:

Testing Requirements:

All blood shall:

· Be tested for ABO and Rh typing.

· Be screened for unexpected antibodies.

· Be tested for infectious disease markers in accordance with FDA requirements.

· Meet all FDA transfusion suitability standards.

Collection and Processing:

· Blood shall be collected using a closed aseptic system.

· Containers shall be FDA-approved, sterile, and pyrogen-free.

· Units shall be free of hemolysis, gross chyle, icterus, or clots.

· Labeling shall comply with FDA and ISBT standards.

Red Blood Cells:

· Low-volume red cells will not be accepted.

· Each unit shall include:

· At least one peel-off ISBT number

· At least two heat-sealed segments

· Minimum seven (7) days remaining shelf life unless approved by VA Blood Bank personnel.

Platelets:

· Apheresis platelets shall have at least one (1) day remaining shelf life.

· Same-day expiration units require prior approval.

· Platelets shall undergo pathogen reduction technology when available.

Cold Stored Platelets:

Cold stored platelets are platelet blood products stored at refrigerated temperatures, typically between 1–6°C, rather than at standard room temperature conditions used for conventional platelets. These products are specifically utilized in transfusion medicine for patients experiencing active bleeding, trauma, massive transfusion events, emergency surgery, and other critical situations where rapid hemostatic support is required.

Cold stored platelets provide enhanced immediate clot-forming capability and are commonly utilized in emergency and surgical settings due to their effectiveness in controlling active hemorrhage. These products are particularly valuable in trauma response, operating room procedures, critical care environments, and massive transfusion protocols where rapid stabilization of bleeding patients is essential.

Due to the specialized handling, storage, inventory management, and clinical coordination requirements associated with cold stored platelet products, the contractor must possess the operational capability and transfusion support infrastructure necessary to provide uninterrupted access to these products in support of patient care operations at CLE VAMC.

Special Processing:

The Contractor shall provide upon request:

· Irradiated blood products within 4 hours

· Washed packed red blood cells within 8 hours

· Antigen-negative and phenotypically matched units

· Molecular typing capabilities

DONOR REQUIREMENTS:

The Contractor shall:

· Provide volunteer donor blood compliant with FDA regulations

· Follow FDA donor eligibility criteria

· Maintain look-back, quarantine, recall, and notification procedures

· Notify CLE VAMC within required regulatory timelines of infectious disease findings

· Never disclose donor identity

REGISTRATION, LICENSURE, AND AUTHORIZATION:

The Contractor shall:

· Maintain FDA registration under 21 USC 360

· Hold a valid U.S. Biologics License under 42 USC 262

· Meet interstate shipment requirements where applicable

· Maintain AABB accreditation

Proof of licensure shall be maintained throughout contract performance.

REGULATORY COMPLIANCE AND NOTIFICATION:

The Contractor shall:

· Handle emergency release products in accordance with Federal and State regulations

· Notify CLE VAMC:

· Within three (3) calendar days of discovery of donor infectious disease risk

· Within forty-five (45) days following supplemental testing results

· In accordance with 21 CFR 610.48(b)

PACKAGING AND MARKING:

· Products shall be labeled per FDA guidelines.

· Processing shall occur immediately after collection.

· Shipping shall comply with all FDA and 21 CFR transportation requirements.

HOURS OF SERVICE:

The Contractor shall provide support twenty-four (24) hours per day, seven (7) days per week, three hundred sixty-five (365) days per year. Routine scheduled deliveries are not required on the National holidays identified in Section 10.1 of this Statement of Work. However, Emergency (STAT) and Critical Emergency deliveries shall remain available and mandatory at all times, including nights, weekends, and National holidays, to ensure uninterrupted support of patient care operations.

DELIVERY REQUIREMENTS:

Routine Delivery:

· Within 24 hours of order placement

· Orders placed electronically

· Pre-scheduled deliveries may be coordinated

Emergency (STAT) Delivery:

· Within two (2) hours

· Available 24 hours/day, 7 days/week, 365 days/year

Critical Emergency (<2 Hours):

· Contractor response within 10 minutes

· If unable to supply, VA may utilize secondary source

· Emergency products available within one hour for pickup

RETURNS AND CREDITS:

Credit may be issued:

· Damaged products

· Regulatory recalls

· Shipping discrepancies

Returned products must include completed vendor credit documentation certifying custody and temperature compliance. Vendor shall pay return shipping when applicable.

Credits shall not exceed the original purchase price.

REFERENCE LABORATORY REQUIREMENTS:

The Contractor shall provide access to an AABB-accredited reference laboratory that:

· Operates 24 hours per day

· Provides electronic preliminary results

· Issues final reports within seven (7) calendar days

· Provides antigen-negative and rare donor units

· Performs molecular RBC phenotype testing

· Maintains accessible Medical Director consultation

All patient data shall comply with HIPAA requirements.

JOINT COMMISSION AND REGULATORY STANDARDS:

The Contractor shall ensure personnel are fully trained and compliant with:

· FDA regulations

· AABB standards

· Joint Commission transfusion requirements

· Applicable Federal healthcare regulations

4. Period of Performance:

Base Year: July 1, 2026 – June 30, 2027 Option Year One: July 1, 2027 – June 30, 2028 Option Year Two: July 1, 2028 – June 30, 2029 Option Year Three: July 1, 2029 – June 30, 2030 Option Year Four: July 1, 2030 – June 30, 2031

5. Performance Monitoring:

The Contracting Officer Representative (COR) will:

· Monitor delivery timeliness and responsiveness

· Verify product quality and regulatory compliance

· Validate invoice accuracy

· Document contractor performance

Final inspection and acceptance shall occur at the VA Northeast Ohio Healthcare System, Louis Stokes Cleveland VA Medical Center.

6. Place of Performance:

The supplies shall be delivered to the CLE VAMC receiving/loading dock

Louis Stokes Cleveland VAMC Pathology and Laboratory Medicine Service 10701 East Boulevard Cleveland, OH 44106

All shipments shall be F.O.B. Destination and comply with applicable Title 21 CFR requirements for storage, packaging, handling, and transportation. Delivery coordination shall be managed by the Contracting Officer's Representative (COR).

7. Minimum and Maximum Quantities:

The Government guarantees a minimum ordering quantity equal to the estimated Base Year requirement of $450,000.00. The maximum cumulative value of all orders issued under this contract shall not exceed $7,000,000.00.

8. Payment and Invoicing:

Payment shall comply with FAR 52.212-4(i).

· No advance payments authorized

· Invoices submitted four (4) times monthly

· COR review within three (3) calendar days

· Invoices must include:

· Contractor information

· Contract and funding numbers

· Delivery dates

· Itemized supplies/services

· Quantity and unit pricing

9. Schedule of Items:

0054 Pre-Rx RBCs w/chemicals/drugs, per cell

Separation by density gradient, retics

Differential/Auto Ads, each adsorption

0001U xHEA licensed RBC panel

81403 RHD genotyping, medium resolution

Offerors shall provide unit pricing and extended pricing for all Contract Line Item Numbers (CLINs) identified in the Schedule. Pricing shall be provided for the Base Year and four (4) Option Years.

Failure to provide pricing for all CLINs may render the quote unacceptable.

The Government will evaluate the total aggregate price of all CLINs for the Base Year and all Option Years.

The Schedule consists of:

Base Year CLINs 0001-0058 Option Year One CLINs 1001-1058 Option Year Two CLINs 2001-2058 Option Year Three CLINs 3001-3058 Option Year Four CLINs 4001-4058

The descriptions, estimated quantities, and units of measure for Option Years shall be identical to the corresponding Base Year CLINs unless otherwise modified by amendment.

10. Government Holidays:

National holidays observed by the Federal Government are as follows:

If a holiday falls on Sunday, the following Monday will be observed as the National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by the U.S. Government agencies. Also, included would be any day specifically declared by the President.

11. Clauses and Provisions:

The following clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial Services (NOV 2023) (DEVIATION OCT 2025), with the following added as addenda to the clause. FAR 52.212-4(c) is revised as follows: Changes in the terms and conditions of this contract may be made only by written agreement of the parties, except for administrative changes, including changes in the paying office, appropriation data, and other changes authorized by the Federal Acquisition Regulation and its supplements that may be made unilaterally by the Contracting Officer pursuant to FAR 43.103(b). Addendum to FAR 52.212-4 includes: FAR 52.203-6 Alternate I; FAR 52.203-17; FAR 52.203-19; FAR 52.204-13; FAR 52.209-6; FAR 52.209-9; FAR 52.209-10; FAR 52.216-18, Ordering, with paragraph (a) completed as follows: Such orders may be issued from date of award through June 30, 2031; FAR 52.216-19, Order Limitations, with paragraph (a) $100.00, paragraph (b)(1) $7,000,000.00, paragraph (b)(2) $7,000,000.00, paragraph (b)(3) five (5) calendar days, and paragraph (d) five (5) calendar days; FAR 52.216-22, Indefinite Quantity, with paragraph (d) completed as follows: The Contractor shall not be required to make deliveries under this contract after June 30, 2031; FAR 52.217-8, Option to Extend Services, with paragraph completed as follows: 30 days; FAR 52.217-9, Option to Extend the Term of the Contract, with paragraph (a) 30 days, paragraph (b) 60 days, and paragraph (c) five (5) years; FAR 52.219-8; FAR 52.219-9; FAR 52.219-16; FAR 52.219-28; VAAR 852.219-9; FAR 52.222-3; FAR 52.222-19; FAR 52.222-35; FAR 52.222-36; FAR 52.222-37; FAR 52.222-40; FAR 52.222-90, Addressing DEI Discrimination by Federal Contractors (APR 2026); FAR 52.223-18; FAR 52.225-5; FAR 52.232-33; FAR 52.232-36; FAR 52.232-40; FAR 52.233-3; FAR 52.233-4; FAR 52.242-13; FAR 52.244-6; FAR 52.252-2, Clauses Incorporated by Reference, with paragraph (b) completed as follows: https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_252_2 and http://www.va.gov/oal/library/vaar/index.asp; FAR 52.252-6, Authorized Deviations in Clauses, with paragraph (b) completed as follows: VA Acquisition Regulation (VAAR) and 48 CFR Chapter 8; VAAR 852.201-70, Contracting Officer's Representative; VAAR 852.203-70; VAAR 852.203-71; VAAR 852.232-72; VAAR 852.246-70; and VAAR 852.246-71.

The following provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors—Commercial Products and Commercial Services (SEP 2023) (DEVIATION OCT 2025), with addenda. Paragraph (c) is revised by changing "30" calendar days to "60" calendar days. FAR 52.212-2, Evaluation—Commercial Products and Commercial Services (NOV 2021) (DEVIATION OCT 2025); FAR 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services; FAR 52.209-7, Information Regarding Responsibility Matters; FAR 52.216-1, Type of Contract, with the Contract Type identified as Firm-Fixed-Price Indefinite-Delivery/Indefinite-Quantity (IDIQ); FAR 52.225-18, Place of Manufacture; FAR 52.233-2, Service of Protest; FAR 52.252-1, Solicitation Provisions Incorporated by Reference, with paragraph (b) completed as follows: https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-52#FAR_52_252_1 and http://www.va.gov/oal/library/vaar/index.asp; VAAR 852.233-70, Protest Content/Alternative Dispute Resolution; VAAR 852.252-70, Solicitation Provisions or Clauses Incorporated by Reference; VAAR 852.270-1, Representatives of Contracting Officers; and FAR 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications.

12. Instructions to Offerors:

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT:

Rachelle J. Hamer Department of Veterans Affairs Network Contracting Office (NCO) 10 6150 Oak Tree Blvd., Suite 300 Independence OH 44131

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

5. PROCEDURE FOR SUBMITTING DOCUMENTS TO THE DEPARTMENT OF VETERANS AFFAIRS.

DOCUMENTS THAT ARE TO BE PROVIDED TO THE CONTRACTING OFFICER WILL BE SUBMITTED USING THE APPROPRIATE VEHICLE BELOW.

rachelle.hamer@va.gov

6. SUBMISSION OF OFFER: All information shall be submitted in the manner described below and offerors who do not submit all information may not be considered for award.

1. Offers are to be broken out to include line item pricing for each CLIN with the approximate yearly total for the base period, option years and a grand total.

1. This requirement will be awarded on all-or-none basis.

1. Offerors shall be registered and active in the System for Award Management (SAM) (www.sam.gov) at the time of quote submission and shall maintain an active SAM registration through contract award and performance.

This solicitation and resulting contract adheres to the format defined in FAR 12 for the acquisition of commercial items. This procurement will be conducted in accordance with FAR Part 12.

7. Offer Evaluation and Award.

This is a competitive Request for Quotes (RFQ) that will be evaluated under FAR Part 12. The Government will issue a Firm Fixed Price, Indefinite Delivery/Indefinite Quantity Contract with one (1) base year, plus (4) four option years, for a total of five years if applicable, resulting from this solicitation to the responsible offeror whose offer conforms to the requirements within this solicitation and will be the most advantageous to the Government, price and other factors considered. The following factors will be used to evaluate offers:

Technical Capability Past Performance Price

Subcontracting Commitments/Subcontracting Plan - Monitoring and Compliance:

In accordance with FAR 52.219-9, Small Business Subcontracting Plan, offerors that are other than small business concerns shall submit an acceptable Small Business Subcontracting Plan with their quote. The subcontracting plan shall be submitted in accordance with FAR 19.704 and FAR 52.219-9. Failure to submit an acceptable subcontracting plan may render the quote ineligible for award.

This solicitation includes FAR 52.219-9, Small Business Subcontracting Plan, and VAAR 852.219-9, VA Small Business Subcontracting Plan Minimum Requirement. Accordingly, any contract resulting from this solicitation will include these clauses.

The contractor is advised that, in performing contract administration functions, the Contracting Officer may utilize support contractor(s) to assist in assessing the contractor's compliance with subcontracting commitments incorporated into the contract. To the extent such support contractor(s) require access to the contractor's business records or proprietary information in order to perform these functions, the Government will ensure appropriate nondisclosure and conflict-of-interest protections are in place. The contractor shall cooperate with the Government and provide access to records necessary to permit assessment of compliance with subcontracting plan requirements and commitments.

8. Evaluation:

Award will be made to the responsible offeror whose proposal represents the best value to the Government considering Technical Capability, Past Performance, and Price.

The evaluation will be rated on capabilities information submitted and specifications of requirements from the Statement of Work (SOW).

Technical Capability and Past Performance, when combined, are significantly more important than Price.

Offerors shall submit:

Completed pricing schedule.

Technical proposal demonstrating capability to meet all requirements of the Statement of Work.

Past performance references for contracts of similar size and scope.

Completed representations and certifications as required by the solicitation.

An Offeror’s initial offer should contain the best terms from a price and technical standpoint. Offerors are reminded that representatives from your company SHALL NOT contact any Cleveland VAMC personnel to discuss this RFQ during the solicitation and evaluation process.

Quotes must be received no later than 5:00 p.m. (EST), June 18, 2026. Submit quotes via email to rachelle.hamer@va.gov.