36C24426Q0054.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 4 2901 Pleasant Valley Blvd Altoona, PA 16602

POINT OF CONTACT*

Victoria Droz Contracting Officer Victoria.Droz@va.gov 814-515-4454

PLACE OF PERFORMANCE

VAPHS

University Drive

Pittsburgh, PA 15240

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION:

The following is a Sources Sought/Request for Information notice. This posted notice is not a Pre- Solicitation or Solicitation document. The government is not currently soliciting bids, quotes or proposals at this time; however, reserves the right to do so at a later date.

The Pittsburgh VA Healthcare System (VAPHS) located at University Drive, Pittsburgh, PA 15240, has a future requirement for blood products.

Please see attached Performance Work Statement (PWS) for all information, supplies, and requirements.

ALL INTERESTED PARTIES MUST ALSO HAVE AN ACTIVE REGISTRATION IN THE SYSTEM FOR AWARD MANAGEMENT (SAM) DATABASE. TO REGISTER, PLEASE VISIT WWW.SAM.GOV.

Responses to this notice shall include:

Company Name Address Point of Contact Phone Number Email Address DUNS Number CAGE Code Tax ID Number

** Note: In accordance with the U.S. Supreme Court decision regarding Kingdomware, service disabled veteran owned (SDVOSB) and veteran owned (VOSB), who are interested in this procurement and consider themselves to have the resources and capabilities necessary to provide these services shall be verified in VetBiz Registry as follows to be considered:

http://www.vip.vetbiz.gov/.

Process in 38 U.S.C. 8127(d) whereby a contracting officer of the “Department ” shall award contracts on the basis of competition restricted to small business concerns owned and controlled by veterans, if the contracting officer has a reasonable expectation that two or more small business concerns owned and controlled by veterans will submit offers, and that the award can be made at a fair and reasonable price that offers the best value to the United States.” For purposes of this VA specific rule, a service-disabled veteran-owned small business (SDVOSB) or a veteran-owned small business (VOSB), must meet the eligibility requirements in 38 U.S.C. 8127(e), (f) and VAAR subpart 819.7003 and be listed as verified in the Vendor Information Pages (VIP) database.

Please provide answers to all questions below regarding your firm’s Socio-Economic status pursuant to North American Industrial Classification Code (NAICS) 621991:

1. Is your business a small business under NAICS 621991? YES ______ NO ______

2. Is your firm a Veteran-Owned Small Business? YES ______ NO ______

3. Is your firm a Service-Disabled Veteran-Owned Small Business? YES ______ NO ______

4. Is you firm a certified HUB Zone firm? YES ______ NO ______

5. Is your firm a Woman Owned business? YES ______ NO ______

6. Is your firm a Large Business? YES ______ NO ______

7. Do you have a GSA/FSS schedule for these items? YES______ NO______

Schedule Number: ___________________

Expiration Date: _____________________

Please provide a capability statement as well as any relevant literature addressing your organization’s ability to supply the required services/items. Also, please include a point of contact name, phone number and email address.

Note: Questions regarding this notice should be addressed to Victoria Droz via email only. NO PHONE CALLS WILL BE ACCEPTED REGARDING THIS REQUIREMENT.

Please submit all responses to this notice via e-mail to:

Victoria Droz Contracting Officer Victoria.Droz@va.gov

Responses to this Sources Sought Notice are required by no later than 12:00 PM EST on Monday, November 3, 2025.

Performance Work Statement Contract Title: Blood products for VA Pittsburgh Health System Background: The VA Pittsburgh Health System seeks a vendor to supply blood and blood products and reference testing on blood bank samples to the blood bank for transfusion purposes.

Scope of Procurement: The Contractor shall provide Blood and Blood Products and reference testing on blood bank samples to the VA Pittsburgh Health System in accordance with the pricing, terms and conditions contained herein.

Performance Period: TBD.

Contractor Requirements:

1. The Contractor will furnish all personnel, supplies, and facilities necessary to collect, process, store and deliver human blood components and derivatives. The contractor must submit proof that he holds an unrevoked U.S. License which is issued by the Director of Biologics, Food and Drug Administration (FDA) as a source of supply for while blood.

a. All whole blood and blood components provided to patients in VA medical centers must meet the requirements of the American Association of Blood Banks (AABB) and/or the FDA, and Department of Health and Human Services.

b. Specimen and blood components must be transported/ shipped in such a way to ensure the integrity of specimens and blood components and comply with accreditation standards and requirements as defined by FDA and AABB. If interstate shipment of blood and blood components are involved, the Contractor must submit with the offer a statement that such FDA approval has been authorized.

c. If the Contractor fails to meet FDA requirements at their facility, the Contractor will continue to be responsible for supplying VA Pittsburgh with blood products obtained and tested at another FDA accredited facility as stated herein at the agreed upon pricing. No additional charges shall be imposed on VA Pittsburgh if the Contractor must import products.

d. If the Contractor is unable to recruit enough donors to meet the community needs and the needs of VA Pittsburgh, it shall be the Contractor’s responsibility to import blood components in order to meet VA Pittsburgh requirements at no additional cost.

2. Allogeneic blood/blood components must be typed for ABO and Rho(D) in accordance with licensed methodologies and must be tested for all transfusion transmitted disease markers currently required by both the FDA and AABB.

a. All blood must be collected by the closed system under aseptic conditions, processed in appropriate solutions and the container so labeled. The label must also bear the expiration date of the contents, which must not exceed the Food and Drug Administration (FDA) allowable limit for the type of anticoagulant in which the blood component is drawn.

b. All blood supplied must be free of hemolysis, clots, and excessive chyle.

3. Autologous blood/blood components must be typed for ABO and Rho(D) in accordance with licensed methodologies and must be tested for all transfusion transmitted disease markers currently required by the FDA.

4. All written deliveries shall be phrased in the layperson’s language. Statistical and other technical terminology shall not be used without providing a glossary of terms.

5. The offeror must be capable of providing the blood components and specialized testing detailed in the SOW attachments on a 24-hour per day, seven days per week basis. 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.

6. Government reserves the right to inspect Contractor’s facilities to monitor contract compliance, but the Contractor shall still remain fully liable for contract compliance absent any government inspections. The Contracting Officer’s Representative (COR) shall inspect the blood components and has the authority to inspect quality, quantity, and verify adherence to the technical and delivery requirements of the contract. The government reserves the right to reject any blood or blood components that do not meet FDA regulations.

7. The Contractor will supply the VA with assurance of the follow:

a. Traceability of all products from collection to delivery.

b. Quality Control (QC) procedures and QC data made available for review.

c. Quality management systems are in place.

d. Current good manufacturing practices are followed.

8. The Contractor’s records pertaining to potency, safety, compatibility testing, and quality of units transfused to VA Pittsburgh patients will be available to VA Pittsburgh upon request except for the identity of the donor.

9. VA Pittsburgh shall not be required to provide confidential patient information unrelated to patient care unless it relates to the transfusion. All confidential patient information must be requested by the Contractor through “Release of Information.”

10. Reporting ICN: For test results being returned to the VA laboratories running VISTA lab, referral labs are to include a VA ICN or VA EDIPI number with patient reports as an identifier.

VA referring VISTA labs are to supply the patients VA ICN or VA EDIPI with each lab order to enable the referral lab to include it with results returned to the VA.

11. According to VHA Directive 1220, blood bank services, including blood and blood components must be available 24/7 within 60 minutes.

Changes in Testing Requirements for Transfusion Transmitted Diseases If additional testing for transfusion transmitted diseases is nationally mandated by the FDA during the contract period, specific price adjustments may be requested by the supplier to address the cost for the additional testing. If this should occur, a letter detailing the rationale for the price increase must be submitted to the Contracting Officer at least 30 days before the intended implementation date.

Donor Requirements

1. The contractor shall maintain readily available blood donor lists, including names, addresses, and social security numbers. Such lists must indicate whether, and on what date, blood of a particular donor was furnished to the VA under this contract.

Offeror’s donor identification numbers must be unique to the donor unit and must have an FDA approved numbering schematic.

2. Donor selection must be in accordance with criteria established by the FDA and/or the AABB.

3. Contractor prior to delivery will complete the following tests:

· ABO Grouping

· Rho(D) Testing

· Irregular Red Blood Cell Antibody detection

· hepatitis B surface antigen (HBsAg)

· antibodies to hepatitis B core (anti-HBc)

· antibodies to hepatitis C (anti-HCV)

· antibodies to human immunodeficiency virus, type 1 and type 2 (anti-HIV1 and anti-

· HIV2)

· antibodies to human T-lymphotropic virus, type 1 and type 2 (anti-HTLV-I and anti-

· HTLV-II)

· genetic viral material to detect HIV type 1 and HCV by nucleic acid amplification

· syphilis

· Other FDA required testing of blood products

4. Each platelet component must be tested for bacterial contamination in accordance with AABB standards.

5. Whole blood, red blood cells and components will be supplied in standard FDA licensed collection containers.

6. The above work will be completed on all blood and its components prior to shipment.

Types of Orders/Deliveries/Invoices

1. 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. This should be a daily delivery.

b. As Soon As Possible (ASAP) – Shipments of blood products to fill a request for a waiting outpatient, or a nonlife threatening need, or to replenish a depleted inventory of a particular blood product which has been used since the previous routine delivery. ASAP orders must be delivered 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. 1 hour for STAT deliveries is optimal. The Contractor shall be responsible for the cost of delivery. 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 the requirement will not be delivered within 1 hour if the 1-hour delivery time will not be met due to antibodies present or compatibility issues. The Contractor shall notify VA Pittsburgh Blood Bank and advise them of the estimated delivery time. Based on the estimate delivery time, VA Pittsburgh Blood Bank will determine the effect on patient care and advise the Contractor accordingly. VA Pittsburgh Blood Bank 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.

2. Contractor shall make delivery services for blood and blood components available 24 hours per day, seven days a week, 365 days a year, subject to blood product availability and a lack of force majeure events as set forth in 48CFR52.212-4(f).

3. The specific volumes distributed in a routine order will be established by VA Pittsburgh medical center. See below for the current inventory minimums. Within ten days after contract award, the contractor shall submit a proposed delivery and route schedule, identifying specific times and room numbers for approval. Schedule may be adjusted periodically.

4. Either leuko-reduced or non-leuko-reduced blood will be ordered on a specific basis.

5. Once units are received by a VA medical center, those units become the property of the VA medical center, and payment will be made appropriately, based on contract terms and proper invoicing. They are not to be treated as though they are on consignment. However, for inventory control purposes, efforts will be made by each VA medical center to assist the contractor and other facilities in meeting patient transfusion needs.

6. The VA will comply with all requirements and regulations associated with the recall and withdrawal of blood or blood components from its inventory due to health and safety risks. The Contractor shall participate in look back procedures initiated by VA Pittsburgh so as not to impede the ability of the Medical Center to identify if a patient has contracted a transfusion associated disease as a result of a transfusion. The Contractor shall promptly send copies of the recall request to the Blood Bank Medical Director at the VA medical center where the blood product was issued.

7. Efforts will be made to assist the supplier in hosting two blood donor drives at the VA medical center in those cases where it can be reasonably accommodated by the hosting VA site.

8. The Contractor shall invoice VA Pittsburgh bi-monthly (monthly is acceptable) in arrears. The electronic invoicing is done using OB-10 format and sending to Department of Veterans Affairs, Financial Services Center, Austin, Texas.

A detailed invoice shall list the total quantities of each product or service provided during a particular month including date, description, amounts, and quantity. By the 10th of each month, the Contractor shall provide the COR with the detailed invoice in addition to the totals of items and services used during the preceding calendar month, using the item numbers and descriptions exactly as they are listed in the contract. Credits issued and used for each billing cycle will be listed on the invoice.

9. Orders are placed daily into the vendor supported website by the Blood Bank staff.

10. Products are delivered to University Drive C, Bldg. 1 Room 2NE105, Pittsburgh, PA 15240.

Shelf Life

1. All blood/blood components must be labeled, stored, and shipped in accordance with the current regulations of both the FDA and the AABB. In the event that these regulations change during the course of the contract, the contractor shall implement the necessary changes as directed/recommended by the regulatory and accrediting agencies.

2. For routine orders, allogeneic blood/blood components must be supplied with appropriate remaining shelf life, as detailed below.

Platelets (random)

Shelf life more than 48 hours

ordered/collected for a specific patient

Cryoprecipitate

Shelf life more than 60 days

3. For ASAP and STAT orders, the contractor shall provide units with the appropriate remaining shelf life whenever possible however, the VA understands that the urgency of the situation and the availability of the blood product may preclude this possibility.

4. When the VA returns units prior to expiration in accordance with the contractors’ return policy, the contractor shall credit the VA for units which are returned, as detailed in the Price Schedule.

Value Added Services

1. Contractor shall provide physician consultative services to the VA Pittsburgh Healthcare System that are consistent with the services offered to other non-VA contracted customers. A description of the services must be included with the offeror’s proposal.

2. Contractor shall provide educational programs to the VA Pittsburgh Healthcare System that are consistent with the programs offered to other non-VA contracted customers. A description of the educational programs must be included with the offeror’s proposal.

Security Requirements In accordance with VA policy, contractors’ storage, generation, transmission or exchanging of VA sensitive information is involved with this procurement. VA Pittsburgh will send a sample labeled with full name and social security number and results are faxed or sent back to the VA Pittsburgh through encrypted email, for reference testing.

End of Document

Sources Sought Notice