36C24427Q0010 SSN.docx

SUBJECT*

Custom Surgical Procedure Packs

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 4

1010 Delafield Road Pittsburgh, PA 15215

POINT OF CONTACT*

Contract Specialist Jeff Mann jefferson.mann@va.gov 717-202-5456

PLACE OF PERFORMANCE

Pittsburgh VA Medical Center

University Drive C

Pittsburgh PA

ADDITIONAL INFORMATION

EMAIL DESCRIPTION

DESCRIPTION

In accordance with FAR 10, Market Research, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to the Sources Sought Notice. The purpose of this announcement is to gain market research knowledge of potential qualified sources and their size classification.

The Department of Veterans Affairs, Pittsburgh VA Medical Center, University Drive C, Pittsburgh, PA 15240, is seeking potential sources capable of providing the Custom Surgical Packs in accordance with the Draft Statement of Need (SON) below.

This Sources Sought notice seeks market research information on vendor capabilities to supply equipment meeting or exceeding the performance specifications in SON and Appendix A. The Government intends to evaluate functionally equivalent alternatives from multiple manufacturers rather than restrict procurement to specific brand names. This market research effort aims to identify qualified suppliers and alternative equipment that can meet Pittsburgh VA Medical Center's clinical requirements while expanding competition and reducing costs.

Contractor questions in response to this Sources Sought Notice shall be emailed directly to Jefferson Mann at jefferson.mann@va.gov. Please include the Sources Sought #36C24427Q0010 in the subject line.

Please include the following information in your response:

1. Company name

2. Address

3. Contact person name, phone number, and email address

4. UEI #

5. Business size/classification/type (i.e. 8a, Hubzone, SDVOSB, VOSB, etc.)

6. FSS/eCAT/SAC/NAC/NASA SEWP or any other Government held contract, if applicable provide the number.

7. NAICS: 339112

8. Size Standard: 1300 Employees

9. Provide equipment lists, brochures, pamphlets, hyperlinks, or any other materials necessary to determine material capabilities including special features and any express or implied warranties.

Please answer the following questions:

1. Provide the brand name, country of origin, and all manufacturer part #’s for any listed equipment.

2. Are you the manufacturer, distributor, or equivalent solution to the above items? If not, can you provide additional information, as shown below? This confirms compliance with the nonmanufacturer rule IAW 13 CFR 121.406(b) Nonmanufacturers.

3. If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, Point of Contact, and size status (if available).

4. If you’re a small business, are you an authorized distributor/reseller for the items identified above? If so, please include your letter of authorization on the OEM’s letterhead.

5. If you’re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter, assemble, or modify the items requested in any way? If you do, state how and what is changed, assembled, or modified.

Responses to this Sources Sought Notice shall be submitted directly via email to jefferson.mann@va.gov. Responses that only include generic marketing material and do not provide for capability to meet requirements listed in the SON may not be considered. Responses must be received no later than 6:00 am ET, 10/19/2026. No solicitation document is available at this time. This notice is simply for Market Research Purposes Only. All information received in response to this RFI that is marked as proprietary will be handled accordingly. The VA will not reimburse any potential contractors for any costs associated with this Sources Sought Notice.

Page 1 of

STATEMENT OF NEED (SON)

IDIQ Contract for Custom Surgical /Procedure Packs VA Pittsburgh Health Care System University Drive C.

Pittsburgh, PA 15240

1. Background:

Pittsburgh currently utilizes twenty-eight (28) distinct custom surgical packs, which streamline surgical workflows by providing staff with pre-assembled, procedure-specific supplies. This approach enhances organization and efficiency, allowing for faster and more effective case setup.

2. Products Requested:

· Quantities

· The required quantities for each custom surgical procedure pack were calculated using historical usage data from the previous year (July 2025 – July 2026). For each pack type, total annual usage was reviewed, the average was calculated, and an additional 10 percent was added to account for anticipated increases in procedure volume. This final figure was used to determine the baseline procurement quantity.

3. Scope of Work Related / Requirements:

The Contractor shall provide for each custom surgical procedure packs (CSP) a lot number to allow for clear tracking of all packs and products. The Contractor shall ensure that the manufacturer and lot number of each component item is traceable.

· Sterilization Requirements:

· FDA Registered Organization.

· The Contractor shall be both responsible and liable for the sterility and quality of the product when properly used and handled by the Government.

· Re-sterilization of any product is prohibited.

· Quality assurance staff shall include personnel familiar with operating room procedures, infection control practices, aseptic techniques, and sterilization methods.

· Custom Surgical Procedure Pack Items:

This Statement of Work incorporates Appendix A – Custom Surgical Pack Component List. Appendix A is an Excel File that itemizes all components included in each surgical procedure pack. Appendix A is considered part of this Statement of Need.

The facilities will be notified of any substitutions and must give approval before any substitution is made. Substitution of an item marked with an asterisk (*) in the items referenced in Appendix A – Custom Surgical Pack Component List must follow specific criteria.

· When exercising the options of supplying an item considered to be “substitution”, the item shall be of equal size, dimensions, composition, and quality to the item specified.

· If no substitution of a product is specified or offered, the offeror will notify the COR and then may provide the pack as specified.

Any changes that cause terms of the contract to be modified are the authority of the Contracting Officer and shall only be made through modification.

· Recalls:

The Contractor shall have a documentation system for component product accountability and lot number recordings for product recalls.

· Changes to Composition / Components of CSP(s):

Only the Contracting Officer has the authority to make changes to the contract.

· The Contractor shall provide each facility with an electronic inventory report each week which details: the number of the current versions of packs in stock, the current forecast, the three-month average usage, the number of packs per case, and the cost of the pack. Trends must be communicated between the sales representative and the COR with a mutual determination to adjust inventory levels.

· The arrangement of the component parts in the pack shall be coordinated by both the Surgical Service Line staff and Contracting Officer’s Representative (COR). This coordination shall be prior to production by the Contractor.

· Packaging:

Items shall be packaged adequately to prevent deterioration and damage during shipping, handling, and storage.

· Each pack shall have a label specifying the manufactured date of the pack and the expiration date of any dated products.

· All outer packaging must contain the complete contract number and delivery order number in addition to the shipping address.

· A packing list/slip shall be enclosed with each shipment indicating the contract number, delivery order number, items/quantity ordered, and items/quantity shipped.

· Any pack determined to be defective (e.g., contains expired components, sterility has been compromised, etc.), through no fault of the Government, shall be returned to the Contractor at the Contractor’s expense. Full credit or replacement shall be made to the Government.

· Production and Supply:

The Government requires the Contractor to undertake production of such quantities of the product as are necessary to reasonably assure the Government of an uninterrupted supply of the product based upon an anticipated monthly usage. The Government may not obligate funds for product in inventory or production whenever the contract is terminated.

The Contractor shall complete component pack changes within thirty (30) days, after written notification by the Contracting Officer. Due to the possible need for changes, the Government shall be obligated to only a thirty (30) day supply of packs manufactured based on anticipated use/negotiated stock levels when modifications are completed.

· Quality Assurance:

The Custom Sterile manufacturing facilities shall be registered and in good standing with The Food and Drug Administration.

4. Ordering, Invoicing and Payment:

Deliveries will be made upon receipt of an individual delivery order issued by the designated Ordering Officers. Each delivery order will state the quantity of packs required, delivery date, and delivery and billing address. A delivery order number will be assigned to each request for delivery against this contract.

The Contractor shall submit properly completed individual itemized invoices to the addresses designated by the facilities to receive invoices. The invoice address payment office shall be provided to the Contractor at time of delivery order placement by the order-placing facility. Additional information can be found in the contract administration section of the contract. No advance payments shall be authorized.

Payment of invoices may be delayed if the appropriate invoices as specified in the contract are not completed and submitted as required.

5. Delivery and Place of Performance Requirements:

Deliveries shall be made within forty-eight (48) hours or as needed by receipt of order by the contractor from the ordering facility.

Pittsburgh, PA 15240

· Vendor Credentialing:

Vendor access to the VA Pittsburgh Healthcare System is by appointment only and requires credentialing through our vendor credentialing policies issued by the hospitals leadership and police services.

All vendors are required to check-in and obtain a day badge, which will include date, time, and location of approved appointment. Company badge with photo ID is also required to be worn while onsite at any of the Medical Center. Vendors are only permitted to visit the location identified as per pre-registered visit and must exit the facility promptly, checking out via Police Services.

See attached document: Appendix A - Custom Surgical Pack Component List.

End of Document Page 1 of