36C26025Q0580.docx

Request for Information (RFI) 36C26025Q0580

Title: Blood and Blood Products Supporting the Western States Network Consortium (WSNC) NAICS Code: 621991 - Blood and Organ Banks Synopsis: This is a Request for Information (RFI) issued solely for informational and planning purposes. This is not a solicitation for proposals and no contract shall be awarded from this announcement. The Department of Veterans Affairs (VA) is seeking information from contractors who can provide blood and blood products to support the needs of the Western States Network Consortium (WSNC) under NAICS Code 621991.

Objective: The VA is looking at consolidation of blood and blood product contracts at a VISN, Regional, or National level depending on the commercial marketplace and industry availability. The intent is to award at least one Indefinite Delivery/Indefinite Quantity (IDIQ) contract to qualified contractors who can provide blood and blood products at a VISN, regional or national level. This RFI seeks information from all potential contractors regarding their capabilities to meet the requirements stated below and as outlined in Attachment A.

Requirements: Contractors will need to demonstrate their ability to:

1. Support Areas: Specify the geographical areas they can support within the WSNC.

A. The WSNC is comprised of Veterans Integrated Service Networks (VISN’s) 17, 19, 20, 21, and 22. This link will direct you to a map of all facilities in the VHA (select Veterans Health Administration from the dropdown box): Interactive US Map - Locations (va.gov) I. VISN 17: Texas, Eastern New Mexico.

II. VISN 19: Montana, Wyoming, Eastern Idaho, Eastern Nevada, Utah, Oklahoma and Colorado.

III. VISN 20: Oregon, Washington, Idaho, and Alaska.

IV. VISN 21: Northern California, Nevada, Hawaii Islands, Philippines Islands, Guam, and American Samoa.

V. VISN 22: Southern California, Arizona, New Mexico, and Southern Colorado

2. Products Provided: Provide detailed information on the types of blood and blood products that can supply (See Attachment A for product description and draft schedule, please list any additional items or products that can be supplied)

3. Business Size: Indicate their business size under NAICS Code 621991 ($40M) (e.g., small business, SDVOSB, VOSB, large business, etc.).

Submission Requirements: Interested parties must provide the following information:

1. Company Information: Name, address, point of contact, phone number, email address, and SAM UEI number.

2. Capabilities Statement: A statement detailing the company's capabilities in providing blood and blood products.

3. Geographical Coverage: A list of the areas supported within the WSNC (additionally, indicate areas of service coverage outside of the WSNC).

4. Product List: A comprehensive list of blood and blood products available.

5. Business Size: Confirmation of business size under NAICS Code 621991.

6. Existing Contracts: Identify any existing contracts or ordering vehicles under FSS, VA, or other Federal Agencies.

7. Curtesy Pricing: Market Research pricing (base and 4 ordering periods under attachment A) based on a general VAMC location.

Response Deadline: All responses must be submitted electronically via email to michael.allred1@va.gov no later than 06/11/2025 by 4 PM PDT.

Disclaimer: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. The purpose of this notice is to obtain information regarding the availability and capability of verified sources, to include qualified SDVOSB/VOSB, to perform this potential requirement. All information received in response to this RFI marked as proprietary will be handled accordingly. The responses to this RFI will not be returned. Responses to this notice are not considered 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. Responses received will assist the Government in determining the appropriate acquisition strategy. The Government may or may not issue a solicitation as a result of this notice. There is no solicitation available at this time, and this is not a request for quotes.

Contact Information:

Michael Allred NCO 20 Contracting Officer Department of Veterans Affairs Veterans Health Administration michael.allred1@va.gov

Attachment A Blood and Blood Products Product Description and Schedule

Stock. VAMCs will designate number of blood product units and types required to maintain operations. At defined intervals or “rotation”, contractor will supply stock levels of blood products with expirations dates that extend beyond the next rotation. VAMCs will rotate previous stock levels to contractor for reissue.

Routine. Contractor will fill routine orders for blood products to maintain stock levels at appropriate VAMC. Routine orders shall be delivered within 24 hours.

STAT. Emergency orders of blood products are to be delivered within 2 hours of ordering during business hours and as soon as possible during off service hours. STAT orders will be always filled, 24 hours a day no matter the day of the week including holidays.

Blood products include, but are not limited to, the following products.

Leukoreduced Red Blood Cells

Apheresis Platelets – LVDS

Apheresis Platelets – PAS Pathogen Reduced

Plasma

Cryoprecipitate

Cryoprecipitate Pools

The Contractor shall modify products as requested and as necessary for the protection of the patient, to include, but not limited to leukocyte reduction and irradiation.

1.4 Medical Director. The contractor shall maintain a Medical Director available for consultation purposed and resolving blood product availability concerns.

1.5 Licensure, Certification and Accreditation. Contractor shall be currently registered and licensed with the Food and Drug Administration (FDA), Health and Human Services pursuant to Section 510 of the Federal Food, Drug, and Cosmetic Act, as amended, 21 USC Section 260 and certified by the Association of Blood and Biotherapies (AABB). All products, if interstate shipment of blood products is involved, contractor must submit statement that such approval has been authorized under section 251 of the Public Service Act, as amended, 2 USC Section 262, as a source of supply for blood products. Contract shall submit proof of AABB accreditation and CLIA certification upon request.

1.6 Service Standards. In addition to the service standards described above, Blood Center shall, throughout the term of this Agreement: maintain a written quality assurance program which includes quality assurance, quality control and proficiency testing programs. Upon Hospital's reasonable request, Blood Center will provide Hospital with written documentation reflecting Blood Center’s compliance with its quality assurance program.

Technical staff performing tasks under this contract shall be certified by a national professional certification body appropriate for the specialty and complexity of the task being performed. The Supervisory personnel, including the Medical Director(s) shall maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the College of American Pathologist (CAP), and AABB accreditation standards. The Medical Director shall be a licensed physician with suitable qualifications and experience to direct a laboratory and blood bank facility. Copies of the professional certification and licensure of the Laboratory Director and Medical Director shall be provided upon request.

1.7 Delivery of Blood Products. Blood Center and Hospital will establish a mutually agreeable schedule for routine stock deliveries. Additional fees for deliveries in excess of routine deliveries are set forth on Attachment A delivery fees. Blood Center shall provide and retain ownership of transportation containers and equipment for use in providing the routine delivery service for Products. Deliveries may be made seven (7) days each week, twenty-four (24) hours per day.

Contractor provide and maintain ownership of transportation containers verifying and meeting transportation and storage standards established by AABB.

1.8 Blood Product Testing and Donor Selection. If and to the extent required by applicable Standards and Laws, Blood Center will (i) perform donor and Blood Product testing; and (ii) utilize aseptic methods to minimize the risk of Blood Products contamination. Blood Center will employ methods to detect, limit or inactivate potential contaminates that are either FDA-approved or validated to provide sensitivity equivalent to FDA-approved methods. Information regarding specific testing methods is available upon request. To ensure compliance with applicable Laws and Standards or for operational reasons, Blood Center may from time-to-time update or initiate new donor testing procedures. Blood Center shall use commercially reasonable efforts to provide Hospital with thirty (30) days prior written notice of any such updated or new testing procedures and will determine whether it is necessary for Hospital to return or exchange Blood Products not subject to the updated testing procedures.

Blood shall be typed for ABO & Rh antigens and labeled in accordance with the methods recommended in the current editions of “Standard for Blood Banks and Transfusion Services and Technical methods and Procedures,” published by the AABB.

All blood shall be collected by closed system under aseptic conditions and shall be processed in appropriate solutions and the container meet International Society of Blood Transfusion (ISBT) label standards. All blood supplied shall be grossly free of hemolysis, clots, and excessive lipemia. Blood products will be considered only from blood banks that are able to provide the VA with 100% “volunteer donors” blood in accordance with the latest FDA rules and regulations. Definition of a “volunteer donor”. A volunteer donor is a person who does not receive monetary payment for blood donation.

1.9 Notifications, Recalls, and Lookback. The contractor will promptly notify the VAMC when information indicates that Blood may deleteriously affect a transfusion recipient.

Contractor will provide the following notifications to the Customer: (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 610.47(a)(3).

Conversely, VAMC’s will report possible transfusion-transmitted infections or other serious complications associated with transfusion which may have resulted from Blood ("Adverse Event"). VAMC’s will cooperate with investigation of any Adverse Event and supply information concerning the recipient of the blood product.

1.10 Credit and Return of Blood Components.

Damaged Blood: If the Blood arrives to the Customer: (1) in a damaged condition, or (2) in a condition rendering the Blood unsuitable for transfusion, then Customer should notify ARC immediately in Connect for further instructions. If ARC requests the return of Blood, ARC will pay the shipping costs associated with such returns. Credit may not be issued if notification is not made within 24 hours of product receipt.

Regulatory Recall: If the FDA or another regulatory agency requires ARC to recall Blood, or if ARC voluntarily chooses to recall Blood for quality reasons, Customer will discard the Blood unless ARC instructs otherwise. If ARC requests the return of recalled Blood, ARC will pay the shipping costs associated with such returns.

1.11 The VAMC may return blood units for reissue with a credit for the products per an agreed upon schedule of “Stock Rotation”. A credit will be given per eligible return units and may include a restocking fee. Confidentiality. Neither Party will disclose to any third party any provision in this Agreement unless: (a) required by law, in which case, the disclosing Party will provide prompt advance notice of disclosure so the other Party may seek a protective order or other remedy; (b) required by an accreditation or regulatory agency during an inspection, in which case, the disclosing Party will protect the disclosures through the use of a comprehensive nondisclosure agreement, or (c) such disclosure is to the disclosing Party's legal advisor(s), in which case, the disclosing Party will protect the disclosures through the use of a comprehensive nondisclosure agreement.

1.12 Pursuant to this Agreement, either Party (the "Disclosing Party") may provide Confidential Information to the other Party (the "Recipient"). For purposes of this Agreement, "Confidential Information" includes. all documents, materials and information regarding or relating to the Disclosing Party's business, assets, personnel (including but not limited to volunteers), financial condition, results of operations, inventions, discoveries, methods, operations, ideas, concepts, plans, designs, products, processes, know-how, trade secrets, intended uses, technology, and/or prospects. Without limiting the scope of the foregoing, "Confidential Information" shall also include all documents, materials and other information that constitute, relate to, and/or identify (i) protected health information about an individual; (ii) any vendor or other third party that provides any goods or services to, or receives any goods or services from, either Party. Any such documents, materials or other information disclosed to Recipient shall constitute Confidential Information regardless of whether it is marked or designated as "confidential" by the Disclosing Party. The term "Confidential Information" shall also include any changes, modifications, derivations, or improvements (collectively, "Changes") made by Recipient to any of the Confidential Information (whether at the request of the Disclosing Party or otherwise). The Disclosing Party shall retain all rights of ownership in the Confidential Information and in any and all Changes that Recipient may affect.

1.13 Notwithstanding the foregoing, "Confidential Information" shall not include information that (i) was already part of the public domain at the time of the disclosure by the Disclosing Party; (ii) became part of the public domain after the disclosure by the Disclosing Party; or (iii) was lawfully in Recipient's possession prior to the disclosure by Disclosing Party and was not acquired from Disclosing Party or from a third party who was under a contractual, legal, fiduciary or other obligation restricting or prohibiting transmittal of such information to Recipient.

1.14 Recipient shall safeguard and maintain all Confidential Information as strictly confidential and shall use it solely for the purpose of fulfilling its obligations under this Agreement. Recipient will limit access to Confidential Information to its employees with a need to know the Confidential Information and will instruct its employees to keep the information confidential. Without the Disclosing Party's prior written consent, Recipient shall not disclose any Confidential Information to any third party.

1.15 In the event that Recipient is required by law or is requested, in the course of any judicial, administrative, or governmental proceeding, to disclose any Confidential Information, Recipient shall promptly notify the Disclosing Party and reasonably cooperate with the Disclosing Party's efforts (at Disclosing Party's expense) to seek an appropriate protective order, confidential treatment, or other remedy.

ATTACHMENT A

QUANTITIES, FEES AND DELIVERY TERMS

BLOOD PRODUCTS

Apheresis Platelets – PAS Pathogen Reduced

SPECIALTY BLOOD PRODUCTS

STAT FEES

DELIVERY FEES