36C26326Q0861 Intent to Sole Source.pdf

INTENT TO SOLE SOURCE - 36C26326Q0861

This is a notice of intent to solicit and negotiate with a single source pursuant to Revolutionary FAR

Overhaul (RFO) 12.102 Restricting Competition. The statutory authorities for restricting competition under RFO 12.102 are 41 U.S.C 1901 and 1903.

The Department of Veterans Affairs, Network Contracting Office 23 intends to enter into single source negotiations, and subsequently award a firm fixed-price contract for one year with four option years to

The American National Red Cross, 431 18th St. NW, Washington, DC 2006 (SAM UEI: G69LHXJ3ABL5) for

Blood and Blood Products in support of the Nebraska Western-Iowa Health Care System.

This notice of intent is not a request for competitive quotations. However, all responsible sources may submit a capability statement along with the information requested below, which shall be considered by the Government. The Government will consider responses received by the closing date of this notice.

Information received will be considered solely for the purpose of determining whether or not to conduct a full and open competitive procurement or a small business set-aside competitive procurement. The

Government will not pay for any information received in response to this announcement.

If the Government decides to compete this requirement, a synopsis shall be issued utilizing the combined synopsis/solicitation procedure identified in RFO 12.

A determination not to compete this requirement based upon responses to this notice is solely within the discretion of the Government.

THE NAICS CODE IS: 621991. Business size standard is $40 Million.

POTENTIAL SOURCES SHALL PROVIDE THE FOLLOWING INFORMATION IN THEIR RESPONSE:

1. Company name, address, zip code. primary contact(s), e-mail address & phone number.

2. Name of primary contact, e-mail address & phone number.

3. Your firm’s SAM UEI number.

4. State if your firm is a large business, small business, service-disabled-veteran-owned small business, veteran-owned small business, HUB zone 8(a), women-owned small business or a small-disadvantaged business under the NAICS code.

5. State if your firm has the required items on Schedule (FSS, GSA, other…).

6. Your firm’s Capability Statement and in your response, you must explain how your product meets the product characteristics specified below.

HOW TO RESPOND:

All responses shall be emailed to: Joseph.Bennett@va.gov All responses shall be received no later than: 05:00 PM CT, Wednesday July 8, 2026.

The Subject Line of all emails shall include: 36C26326Q0861

STATEMENT OF WORK

Blood Products, Reference Laboratory Testing, Apheresis Services

A. GENERAL INFORMATION

B. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables, reference laboratory testing, apheresis services as described in this statement of work (SOW) and attached itemized list, except as otherwise specified.

C. Background:

The Omaha VA Medical Center (VAMC) has a requirement for a reliable FDA registered source of blood products and services for the treatment of patients. All products will be used for human administration, blood and blood products are considered domestic end times as they are drawn and processed in the United States of America. All referred patient testing results will be included in treatment of the patient based on clinical presentation. Apheresis services will be provided in accordance with written orders issued by the patient’s ordering physician.

D. Performance Period: 10/01/2026 – 09/30/2027, with four Option Years.

E. Type of Contract: Firm-Fixed Price, five-year Indefinite Delivery Indefinite Quantity (IDIQ)

F. GENERAL REQUIREMENTS

G. Blood Products: Contractor shall furnish all personnel, supplies, and facilities necessary to collect, process, store, and deliver human blood components and derivatives. The contractor shall supply the following blood products which are listed on the attached Price/Cost Schedule, Attachment A.

H. Services: Contractor shall provide all the following services to the Omaha VAMC.

I. Vendor shall stock and maintain homologous leukoreduced red blood cell units, blood components, plasma derivatives and/or services. Said units shall be procured from volunteer donors only and shall be tested and processed in a manner commensurate with standards consistent with those promulgated by the American Association of Blood Banks (AABB) and regulations of Title 21, Code of Federal Regulations as administered by the U.S. Food and Drug Administration (FDA). Inventory levels will be mutually agreed upon and may be changed from time to time, subject to review by the Director of the Omaha VAMC Hospital Transfusion Service and the Contractor. Changes or modifications to the contract require the authorization of the Contract Officer.

mailto:Joseph.Bennett@va.gov

J. Normal hours of operations are Monday through Friday, between the hours of 8:00am and 4:00pm, excluding holidays. Federal holidays observed are as follows:

New Year’s Day (January 1st) Birthday of Martin Luther King, Jr. (third Monday in January) Washington’s Birthday (third Monday in February) Memorial Day (last Monday in May) Juneteenth (June 19th) Independence Day (July 4th) Labor Day (first Monday in September) Columbus Day (second Monday in October) Veterans Day (November 11th) Thanksgiving Day (fourth Thursday in November) Christmas Day (December 25th)

*Note: If the federal holiday falls on a Saturday it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday.

K. Contractor shall provide blood (leukoreduced red blood cell units) and blood products as needed during off-hours, weekends, and holidays. Deliveries shall be billed according to the after-hour courier fee as per the Price/Cost Schedule.

L. Contractor shall supply trained staff, supplies, and equipment for conducting donor mobile operations at/or within the Omaha VAMC.

M. Contractor shall provide reference testing and apheresis services in a manner commensurate with standards consistent with those promulgated by the American Association of Blood Banks (AABB) and regulations of Title 21, Code of Federal Regulations as administered by the U.S. Food and Drug Administration (FDA) and must maintain Clinical Laboratory Improvement Amendments (CLIA) certification.

N. THERAPEUTIC APHERESIS:

a. Responsibilities of the contractor:

i. The contractor will use reasonable efforts to provide apheresis services at the

Customer’s location. Such apheresis services will include the separation and removal of a blood component, reinfusion of the unused portion and the infusion of a suitable replacement fluid, if required, as well as other duties associated with therapeutic apheresis. Apheresis and Associated Duties are collectively referred to as Apheresis Services. For the avoidance of a doubt, Apheresis Services are included within the definition of Services as set forth in the Agreement. The contractor will perform the Apheresis Services in accordance with the written orders issued by the patient’s ordering physician as documented in the patient’s chart. Such written orders may include, without limitation, the treatment schedule, the patient’s weight, the amount of blood to be processed, the amount and type of replacement fluid, if required, and instructions for the care of the lines after the procedure, including without limitation, heparinization. The contracting physicians will not write the orders for the Apheresis.

ii. Before the performance of the Apheresis Services when necessary, consult with the ordering physician to determine the medical necessity, type, and frequency of the required procedure and to schedule a time of times, and a place to perform the Apheresis Services. Obtain a written informed consent for the performance of the Apheresis Services form the patient (or responsible guardian of parent).

iii. Monitor the patient during the provision of the Apheresis Services and report any progress and/or complications to the ordering physician or the physician responsible for the patient during the procedure.

iv. Perform the Apheresis Services at the customer’s location between the hours of 0700 and 1700 on non-holiday weekdays. The contractor will endeavor without guarantee to perform unscheduled emergency apheresis services (less than twenty-four (24) hours’ notice time) on a twenty-four (24) hour-a-day basis, subject to staffing availability.

v. Provide qualified personnel, equipment, supplies and disposables for the performance of the apheresis services. The contractor is responsible for proper equipment maintenance and documentation of contractor equipment, supplies and disposables. If the contractor is required to use the customer’s equipment or disposables for the performance of the apheresis services.

vi. Upon completion of the Apheresis Services, document on the patient’s chart a record of the Apheresis Services including replacement solutions administered, if any, fluid balance, medications given, and adverse reactions, if any, which occurred during the Apheresis Services.

b. Responsibilities of the Customer:

i. Ordering physician will contact the contractor by telephone in order to request

Apheresis Services for patient. The ordering physician will be knowledgeable of the patient’s condition, as well as the appropriate application of and risks and benefits associated with therapeutic apheresis.

ii. During consultation, ensure that the ordering physician provides the contractor with the patient’s name, diagnosis, physical size and location, pertinent laboratory values, and the ordering physician’s name and contact information.

iii. Maintain responsibility for making the final decision for the contractor to perform the apheresis service following the consultation and the patient’s care at all times, including the period of time the apheresis services are provided by the contractor.

iv. Provide the orders for the apheresis services with which the contractor must comply. In addition, the customer is responsible for obtaining the informed consent for the apheresis services as a treatment

v. Supply and prepare replacement fluids prior to the performance of the apheresis services.

vi. Make available at no additional cost a suitable site adequate for the performance of the apheresis services, support personnel, laboratory service accessibility, and emergency care, equipment and medical personnel. Customer will also provide security badges, parking and twenty-four (24) hour per day access to the building(s), the apheresis room(s), and record storage room(s) at no additional cost to the contractor.

vii. Ensure that the ordering physician, or at least on designated physician from the primary care team familiar with the patient, is readily available throughout the apheresis services.

viii. Arrange for the insertion of a central line or other venous access if venous access other than peripheral veins is required for the apheresis service.

ix. Dispose of any waste or biohazardous materials resulting from the apheresis service.

x. Provide the contractor with emergency evacuation procedures and the customer’s code system.

O. REFERENCE LABORATORY TESTING SERVICES:

a. The reference laboratory services are made available twenty four (24) hours a day seven (7) days each week. Customers understand and agree 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.

b. The reference laboratory(s) must continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare and Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments (CLIA) or must demonstrate accreditation by regulatory agency(s) with deemed status from the Centers for Medicare and Medicaid Services, e.g., The College of American Pathologists, and/or other statute regulatory agencies, as appropriate, and as mandated by federal and state statutes. The reference laboratory must maintain valid certifications during the performance period of this contract.

P. Orders will be categorized into three types: routine, as soon as possible and STAT. These categories are defined as follows:

a. Routine-Shipments of blood products to maintain minimum inventory levels or blood products ordered to fulfill a standing request.

b. As Soon As Possible (ASAP) – Shipments of blood products to fill a request for a waiting outpatient, or a non-life-threatening need, or to replenish a depleted inventory of a blood product which has been used since the previous routine delivery. ASAP orders will be processed and ready to ship within 4 hours.

c. STAT – A need for blood products so acute that a patient’s life could be jeopardized if the request for blood products is unfulfilled. STAT orders will be processed and ready to ship within one (1) hour of the order being placed. In the event there is an issue with antibodies and/ or compatibility of the blood available, the delivery time may be longer than 2 hours at the Government’s discretion. The Contractor shall notify the VA immediately in the event of a delivery time delay, or if it be delayed due to antibodies present or compatibility issues or not on hand.

Q. Quality of Products: All blood products and specimens must be transported/shipped in such a way to ensure integrity and compliance of standards and requirements. The government has the right to inspect quality, quantity, and to verify adherence to the technical and delivery requirements of the contract and regulatory agencies.

R. Donor Requirements: Donor selection must be in accordance with criteria established by the FDA and AABB. All ABO group, Rh type, infectious disease testing and final labeling must be completed prior to distribution of blood and blood components.

S. Orders/Deliveries/Invoices:

a. The Contractor shall notify the Omaha VAMC Blood Bank and advise them of the estimated delivery time. Based on the estimate delivery time, Omaha VAMC will determine the effect on patient care and advise the Contractor accordingly. Delivery shall occur within two (2) hours after preparation for ASAP and within one (1) hour for STAT orders. Omaha VAMC reserves the right to contact another vendor if the estimated delivery time is not acceptable to patient care. It is the responsibility of the Contractor to arrange for pickup of specimens and delivery of blood products in an emergency.

b. Blood products shall be delivered to the Laboratory main hospital building Room 2291.

All blood and blood products shall be properly packaged and insulated in such a way as to ensure that a proper temperature appropriate for the product is maintained during transport between contractor’s place of business and the Omaha VA Medical Center. The contractor will meet all federal and state DOT requirements for the transportation of human blood and blood products.

c. Contractor shall make delivery services for blood products available 24 hours a day, 7 days a week, 365 days a year.

d. All blood products should be leuko-reduced unless otherwise unavailable. If leuko-reduced products are not available, the contractor shall contact the blood bank to verify acceptance of blood or blood product.

e. The specific volumes distributed in a routine order will be mutually agreed upon by Omaha VA Medical Center and the vendor based on current inventory levels. Platelet, Cryoprecipitate orders and other special requests will be placed as needed.

T. CREDIT FOR RETURNED BLOOD OR BLOOD PRODUCTS

a. Full Credit will be given for blood products that are returned to the contractor under the following conditions:

b. When blood is delivered to the VAMC with a shelf life of less than 7 days or fewer. The contractor can contact the VA if the only product available has a short shelf life, and it is the only blood available to meet the patients’ needs. The VA can determine whether to accept or reject the short, dated blood product. The ARC shall provide credit for products that are put into quarantine at their direction, which expire while in quarantine, of the VAMC is unable to use due to the extended time the products were out of circulation.

c. When blood products do not meet the “acceptance criteria” of the VAMC Blood Bank.

Acceptance criteria may be based on abnormalities in physical appearance, indications of contamination, product temperature on receipt, and other criteria regarding the quality or acceptability of blood products.

U. RECALLED AND DEFECTIVE PRODUCTS

a. The contractor will immediately notify the Contracting Officer of any recalls of product of other important safety issues. As appropriate, the Contractor will replace and/or reimburse recalled/defective products at no cost to the government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled/defective products.

V. SEE ATTACHMENT A FOR LIST OF BLOOD PRODUCTS.

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