36C24E27Q0005.pdf

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6515--Reprocessed Non-Critical Single Use Devices
Solicitation number
36C24E27Q0005
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This is a Request for Quote (RFQ) issued by the Department of Veterans Affairs (VA) Veterans Health Administration (VHA) for the establishment and modification of Blanket Purchase Agreements (BPAs) to supply reprocessed non-critical single-use devices for the Medical/Surgical Prime Vendor (MSPV) program.

The solicitation seeks pricing for reprocessed Class I and Class II single-use devices that meet FDA requirements under section 510(o) of the Federal Food, Drug, and Cosmetic Act. All reprocessed items must bear required labeling indicating reprocessor identity and comply with Trade Agreements Act requirements. Quoters must provide Authorized Distributor Letters from manufacturers, proof of EDI capability, and business certifications as applicable. Quotes remain valid for 180 calendar days post-solicitation and must be submitted electronically via email to the Contracting Officer (Brett Cook, 727-366-0517, brett.cook@va.gov) by November 18, 2026, at 12:00 PM EST. Awards will cover nationwide distribution through Prime Vendors to VHA facilities across 23 Veterans Integrated Services Networks. The evaluation uses tiered procedures prioritizing Service-Disabled Veteran-Owned Small Businesses (SDVOSB), Veteran-Owned Small Businesses (VOSB), and other small business concerns, with technical acceptability and fair/reasonable pricing as primary factors. All BPAs are FAR Part 12 commercial items agreements with no minimum orders guaranteed; delivery is FOB Destination with standard delivery not exceeding 14 business days from Prime Vendor order receipt. The solicitation incorporates multiple FAR and VAAR clauses addressing commercial advertising, gray market/counterfeit items, electronic payment requests, Trade Agreements, Buy American requirements, and security prohibitions.

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PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

240E

36C24E27Q0005 11-04-2026

Brett Cook 727-366-0517 11-18-2026

12:00 PM EST

Veterans Health Administration Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh PA 15215-1802

X 100

X

339113

N/A

X

Department of Veterans Affairs Veterans Health Administration (VHA) Other Government Agencies as Assigned

Department of Veterans Affairs Regional Procurement Office (RPO) East Contracting Officer (90C) MSPV - Supplies

00240E

US Department of Veterans Affairs Financial Services Center (FSC)

P.O. Box 149971 Austin TX 78714-8971

See CONTINUATION Page

Establish Blanket Purchase Agreements (BPA) or modify active BPAs in support of the Medical Surgical Prime Vendor Product Catalog for Reprocessed Non-Critical Single Use Devices

This Request for Quote (RFQ) is being issued pursuant to FAR 12. Evaluations of quotes will be conducted using tiered evaluation procedures.

All required documents to include the completed quote sheet must be emailed to the Contracting Officer listed in Block 7a on or before the closing due date & time listed in Block 8 of this document or as amended.

The attached Quote Sheet is the ONLY method for submitting quotes. Please read instructions carefully to ensure the quote sheet is complete, accurate and has zero errors (per the instructions included in the quote sheet).

Please submit questions in writing to the Contracting Officer listed in Block 7a.

See CONTINUATION Page

X X

X one

36C24E27Q0005

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (OCT

2026) (DEVIATION)

C.3 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.4 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (OCT 2026)

(DEVIATION)

C.5 52.219-27 NOTICE OF SET-ASIDE FOR, OR SOLE-SOURCE AWARD TO,

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS (SDVOSB) CONCERNS

ELIGIBLE UNDER THE SDVOSB PROGRAM. (FEB 2024) ……………………………..21

C.6 VAAR 852.219-74 VA NOTICE OF TOTAL SET-ASIDE FOR

VETERAN-OWNED SMALL BUSINESSES (OCT 2026) (DEVIATION)

C.7 VAAR 852.219-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (OCT 2026)

(DEVIATION)

C.8 LOCAL CLAUSE – MADE IN AMERICA – PERSONAL PROTECTIVE EQUIPMENT

(PPP)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (DEVIATION AUG 2025) (Tailored)

E.2 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (DEVIATION AUG 2025) (Tailored)

E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.4 52.240-90 SECURITY PROHIBITIONS AND EXCLUSIONS REPRESENTATIONS

AND CERTIFICATIONS (NOV 2025) (DEVIATION)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

Point of Contact:

Phone:

Email:

b. GOVERNMENT:

Brett Cook, Contracting Officer (36C24E) Phone: 727-366-0517 Email. brett.cook@va.gov Department of Veterans Affairs Veterans Health Administration (VHA) Regional Procurement Office East (RPOE)

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] In accordance with CLINs/SOW.

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.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO. DATE

The U.S. Department of Veterans Affairs (VA), Veterans Health Administration (VHA) manages the United States’ largest integrated healthcare system, providing care at 1,380 healthcare facilities, including 172 medical centers and 1,193 outpatient sites of care of varying complexity (VHA outpatient clinics), serving approximately 9 million enrolled Veterans each year. The healthcare system receives the majority of medical and surgical supply support through the Medical/Surgical Prime Vendor (MSPV) program.

The objective of this procurement is to establish new and/or modify existing Blanket Purchase Agreements (BPAs) for Open Market medical/surgical supplies for nationwide usage.

The MSPV Program aims to ensure availability and consistency of medical/surgical supplies and to obtain volume-based, standardized ‘best’ pricing. MSPV desires to continue the practice of achieving cost avoidance while simultaneously balancing clinician considerations for obtaining quality medical/surgical supplies.

Please carefully review this Request for Quote (RFQ) in its entirety for complete description.

B.2 STATEMENT OF WORK

Section I. Background

A. Background

1. The U.S. Department of Veterans Affairs (VA), Veterans Health Administration (VHA) manages the United States’ largest integrated healthcare system, providing care at 1,380 healthcare facilities, including 170 medical centers and 1,193 outpatient sites of care of varying complexity (VHA outpatient clinics), serving approximately 9.1 million enrolled Veterans each year. The healthcare system receives the majority of medical and surgical supply support through the Medical/Surgical Prime Vendor (MSPV) program.

2. MSPV Program will utilize Prime Vendor (PV) contracts for distribution and supply management services. Facilities will order from the MSPV Product List, which will be formed by awarding Blanket Purchase Agreements (BPA) to Original Equipment Manufacturers (OEM) and authorized suppliers of medical/surgical supplies (referred to as “Authorized Suppliers” herein). AbilityOne nonprofit agencies (NPA) will be awarded BPAs for items on the AbilityOne Procurement List (AB1 PL) and are considered the OEM or Authorized Supplier as applicable.

All suppliers and resellers who participate in MSPV must be authorized to provide the supplies by the OEM. An Authorized Distributor Letter from the manufacturer shall be included with the response. See Section III.A4. Supply Requirements for specific requirements pertaining to the Authorized Distributor Letters.

3. This procurement may establish new Agreements and/or modify existing Agreements in direct support of the MSPV Program. This procurement is a key element in the success of the program as the Agreements will provide the mechanism that will supply medical/surgical supplies for distribution to VHA facilities located in the United States (US) and US Territories and Other Government Agencies (OGAs) as identified by VA (referred to as “facilities” herein). The MSPV Product List, current Prime Vendors, and current list of delivery locations can be found here:

https://www.va.gov/opal/sac/mspv.asp

B. Scope

1. The objective of this procurement is to establish Agreements and/or modify existing

Agreements for MSPV Open Market and AbilityOne Procurement List medical/surgical supplies for nationwide usage. VHA aims to ensure availability and consistency of medical/surgical supplies and to obtain volume-based, standardized pricing. VHA desires to continue the practice of achieving cost avoidance while simultaneously balancing clinically driven strategic sourcing considerations for obtaining quality medical/surgical supplies.

2. The response to this solicitation will include proposed pricing for medical/surgical supplies the Offeror wishes to provide to the government from the list of items on the attached quote sheet.

3. An open market FAR Part 12 BPA will be established between the Authorized Supplier or

AbilityOne NPA and the government under the terms and conditions incorporated in this BPA. This BPA does not obligate any funds and there is no obligation for the Government to place orders against this BPA.

http://www.va.gov/opal/sac/mspv.asp

4. Covered medical/surgical supplies eligible for order under MSPV are defined as medical, surgical, dental, and laboratory supplies. Supplies for covered products on the AbilityOne Procurement List on or before December 22, 2006, or a product or service that (1) is a replacement for a product or service on the commission's procurement list; (2) is essentially the same and meets the same requirements as the product or service being replaced, and

(3) meets the VA's quality standards and delivery schedule shall be awarded to AbilityOne NPAs.

a. Items identified as “essentially the same” as a covered product on the

AbilityOne Procurement List that have been solicited and/or identified on the MSPV PL shall be removed from the Open Market BPA holder’s agreement.

5. New BPAs awarded as a result of this solicitation may be modified as additional supplies move through the evaluation process. BPAs will be administered by the VHA Office of Acquisitions and its assigned Contracting Officer (CO).

C. Federal Acquisition Regulation (FAR) Requirements under FAR 12.201-1

1. Extent of Obligation: Purchases for items on the MSPV Product list will be placed by the

VHA healthcare facilities or authorized OGAs through the MSPV PVs.

2. Purchase Limitation: Purchases for items on the MSPV Product List will be placed with the PVs. Although there are currently no plans for the government to order directly against this BPA, if that occurs, the limit of that order may not exceed the threshold for use of simplified procedures at 12.201-1(a) (including the increased threshold at 12.001(c).

3. Individuals Authorized to Purchase Under the BPA: Purchases for items on the MSPV

Product List will be placed through the PVs. Should it be necessary for the government to order directly against this BPA, a list of authorized individuals must be approved by VHA- Office of Acquisitions and MSPO.

D. Type of Contract

1. FAR Part 12.104 - Blanket Purchase Agreement (BPA) or FAR Part 8.103 - Ability One BPA.

2. A BPA or modification to an existing BPA does not obligate the Government to purchase any products awarded to any suppliers nor does it obligate funds.

3. An annual review of all BPAs will be conducted by the government to include a review of terms, conditions, and pricing.

4. The Government reserves the right to cancel or terminate a BPA with 30 days’ written notice or upon bilateral agreement, whichever is sooner. Any cancellation or termination will be communicated to the BPA holder by the CO who administers the BPA.

Section II. MSPV Business Processes

A. Commercial Agreements

1. The Authorized Supplier awardee is required to enter into a commercial agreement with all awarded PVs, who will provide national distribution and supply management services to facilities, in order to participate in MSPV. The commercial agreement will govern the terms and conditions of the PV and Authorized Supplier relationship and will not contradict the underlying terms and conditions established by this BPA or the underlying PV contracts.

Failure to comply with the terms of this BPA, including provisions related to commercial agreements, will be considered cause for cancellation of the BPA.

2. After award of the BPA, the supplies offered by the respective Authorized Supplier will be released on an updated MSPV Product List on the 15th of the following month. An updated MSPV Product List will be released every 30-calendar days. PVs and Authorized Suppliers are required to establish commercial agreements within 60-calendar days of the respective MSPV Product List release.

3. If Authorized Suppliers are awarded BPAs prior to the award of the PV contracts for MSPV, the government will notify Authorized Suppliers of the names of PVs as soon as possible to enable formation of commercial agreements.

4. Authorized Suppliers are responsible for establishing commercial agreements. Either PVs or

Authorized Suppliers may initiate a commercial agreement. The terms and conditions outlined in the commercial agreement must be mutually agreed upon by both parties. Once a commercial agreement is established between an Authorized Supplier and a PV, the Authorized Supplier will notify the respective Contracting Officer and include the name of the Authorized Supplier and the PV. One email may contain details on multiple commercial agreements.

5. The commercial agreements prescribed in this section are solely between the PV and VHA Authorized Suppliers and do not involve the Government as a responsible party. However, standard delivery times that are established in the commercial agreement shall not exceed 14 business days from receipt of the order from the PV.

6. The contractor shall provide the CO with the date Commercial Agreements are established between each prime vendor. The date shall be within 60 days of award. If there are issues establishing Commercial Agreements, the contractor shall notify their respective Contracting Officer within 7 days and provide a detailed report as to why the Commercial Agreement cannot be established. This report is due every 30 days until compliant.

B. Pricing

1. Supply pricing established in BPAs between the Authorized Supplier and the government will be made available to PVs.

2. The Authorized Supplier BPA-holder shall not charge the PV awardees more than the prices set forth in the BPA.

3. All quotes provided by the Authorized Supplier as part of the solicitation response shall remain valid for 180 calendar days after close of the solicitation.

4. The BPA unit of measure data field for each individual line item approved for inclusion in MSPV (case, box, each, vial, etc.) represents the shipper quantity that the BPA holder agrees to sell to any PV for the purpose of distribution to facilities. All prices are Free on Board (FOB) Destination. Therefore, the BPA price shall include all order processing, materiel handling, and transportation costs incurred by the BPA holder. BPA holders are not authorized to unilaterally assess added handling and freight charges against the servicing PV unless there is an emergency request and the customer agrees to incur and pay separately the additional delivery charges.

C. BPA Modification

BPAs can be modified for OEM Changes, Vendor Changes, Price Changes, Supply Additions/Removals and Direct Replacements. All modifications will be based on Government needs and will be made on a quarterly basis. All modifications will be reflected on the MSPV Product List the month following the approved and signed BPA Modification.

1. OEM Information Change Request

OEM information change requests include OEM Name, OEM DUNS Number, and OEM Part Number. To make a changes request related to product OEM information, please contact the assigned VHA Office of Acquisitions Contracting Officer for your BPA. The CO will provide the correct form for these changes. Please do not provide discontinued item replacements using this request form. Contact your Contracting Officer directly should you have products requiring direct replacement.

2. BPA Supplier Information Change Request

The Authorized Supplier may request supplier information changes by contacting the respective Contracting Officer for their BPA.

3. Recalls/Discontinued Items with Replacement Request

a. If items on the authorized supplier’s price schedule are discontinued the contractor shall notify VA within 7 days.

b. A BPA modification shall be made for any supply recall that applies to a supply on the MSPV Product List. Such instances may include, but are not limited to, a supply that is removed or recalled by the Authorized Supplier due to defects in the supply or potential dangers to patients, or if any required modification, removal or recall is suggested or mandated by a regulatory or official agency (e.g., FDA).

c. The contractor shall notify the VA within 1 day for Class I recall, 3 business days for Class II recall and 7 days for Class III. The notification shall include, but not be limited to the following:

i. Complete supply description and/or identification, recall numbers and the

BPA line-item number assigned.

ii. Reasons for modification(s), removal, or recall.

iii. Necessary instructions for return for credit, replacement, or corrective action.

d. BPA modifications for recall or policy change will happen on an infrequent, as needed basis. Any items discontinued for any reason and/or recalled that have a Direct Replacement shall be initiated by contacting the Contracting Officer who administers your BPA.

e. A copy of the recall with lot numbers included in the notification described above shall additionally be provided to:

Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106

4. Removal Requests

Agreements may also be modified to remove supplies from the MSPV Product List.

a. If a supply is no longer available and no direct replacement is available or suggested, the Government will remove it from the MSPV Product List through modification. Please coordinate the removal action by contacting your respective Contracting Officer.

5. The VA will update the MSPV Product List to reflect changes after BPA modifications are complete. BPA modifications must be completed by the end of the month to be posted on the MSPV Product List on the 15th of the following month.

6. All regulatory requirements applicable to the original BPA will apply to any revision approved and awarded by modification.

7. The Authorized Supplier may request modifications by contacting the respective Contracting Officer of their BPA.

8. The Authorized Suppliers shall additionally provide the information above to all Prime

Vendors (PV) participating in MSPV.

9. Either party reserves the right to cancel or terminate a BPA with 30 days’ written notice or upon bilateral agreement, whichever is sooner.

D. Data Transmission

1. All orders shall be processed using an Electronic Data Interchange (EDI). The Authorized Supplier must ensure that data transmission method and format to PVs are through any system that conforms to the current X12 (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).

The X12 EDI website http://www.x12.org) includes additional information on EDI formats.

a. At a minimum the Authorized Supplier must be able to process the following EDI transactions:

i. EDI 214- Transportation Carrier Shipping Status Message

ii. EDI 850 – Electronic Purchase Order

iii. EDI 855 – Purchase Order Acknowledgement

iv. EDI 856 – Advance Shipment Notice

v. EDI 810 – Electronic Invoice

vi. EDI 860 – Purchase Order Change Request

vii. EDI 865 – Purchase Order Change Request Acknowledgement

b. EDI 997 – Functional AcknowledgementEDI is the computer-to-computer exchange of business documents in a standard electronic format between business partners. By moving from a paper-based exchange of business documents to one that is electronic, VHA receives benefits such as reduced cost, increased processing speed, reduced errors and improved relationships with business partners. Electronic format means an automated system transmitting information electronically according to accepted data transmissions using a system that conforms to the X12 EDI formats established by the ASC chartered by ANSI. For more information see the X12 EDI Web site (http://www.x12.org).

2. The Contractor shall report date EDI compliance is established between each prime vendor.

The date shall be within 60 days of award. If prime vendor is backlogged for establishing http://www.x12.org/ http://www.x12.org/

EDI, the contractor shall notify the VA and provide monthly updates until compliant.

Section III. Work Requirements

A. Supply Requirements

1. Supply and Delivery. The Authorized Supplier shall provide an uninterrupted supply and delivery of supplies to all PVs participating in MSPV at an enterprise/nationwide level (reference Appendix C: Veterans Integrated Services Networks (VISNs)).

a. Suppliers shall review VHA enterprise usage data annually to confirm their capacity to support.

b. Suppliers shall provide proof that they have sufficient credit limit with OEM(s) to support

VHA enterprise

2. Medical/Surgical Supplies. Medical/surgical supplies are those that are involved in the diagnosis and treatment of disease and the maintenance of health (usually through nonsurgical means). They are characterized as one or more of the following:

a. Primarily and customarily used to serve a medical purpose

b. Generally, not useful to a person in the absence of illness or injury

c. Usually ordered and/or prescribed by a physician and/or a health care professional

d. Medical supplies utilized in conjunction with durable medical equipment are included if the supplies are necessary for the function of the equipment

3. Surgical Supplies. Surgical supplies are those involved with the branch of medicine which generally treats disease or injury by operative intervention (physical means rather than drugs); i.e., operations requiring access to the inside of the body as well as manipulation from outside the body.

4. Shelf Life. Supplies delivered shall have at least six months shelf life remaining upon delivery to the ordering facility. For those supplies which have an initial expiration date/shelf life of six months or less from the manufacturer, at least 75% of the original shelf life shall remain at time of delivery to the ordering facility.

5. Authorized Distributor Letter (ADL). If the potential Authorized Supplier is not the OEM, the Authorized Supplier must provide an Authorized Distributor Letter from the OEM signed within the last 90 days of the date of the published solicitation to which the supplier is responding. The Authorized Distributor Letter from the OEM shall include for each product(s) proposed authorizing the Offeror as a distributor for the proposed product(s).

The letter must either state specific product(s) proposed or that the Offeror is an authorized distributor for all the manufacturer’s products. This letter must be on the manufacturer’s letterhead andcontain the signature and contact information of an authorized official for the manufacturer and cover the duration of the BPA. The Authorized Supplier shall maintain its Authorized Distributor status for all manufacturers and distributors of supplies throughout the life of this agreement as set-forth in the Authorized Distributor Letter referenced above. Failure to do so will result in cancellation of the BPA.

During the annual BPA review suppliers will be required to provide an updated ADL within the last 90 days, or an email from the OEM stating that the previous ADL is in good standing.

a. If the authorized suppliers’ ADL is rescinded the contractor shall notify VA within 7 days.

6. Information Requests. The Government reserves the right to request information from

Authorized Suppliers related to supply descriptions, pricing, or other topics at any time and the Authorized Supplier is required to provide such information.

7. Other Strategic Contracts/Agreements. This language is not generated to inhibit the PV or facilities from ordering supplies already on any other designated Government contract instrument. VA’s Strategic Acquisition Center (SAC) and the VHA Office of Procurement will ensure that supplies are placed on appropriate catalogs/Product Lists from which facilities may order. It is, however, incumbent on the PV to honor the parameters of the contract scope of work. Where apparent conflicts arise, the MSPV distribution CO (SAC) will make the final determination as to whether a supply is or is not within scope. The PV must consult with the CO prior to shipping any supplies, which do not clearly fall within the parameters of the above-mentioned scope of work for PV.

8. Removals. The Government reserves the right to remove any supply from the MSPV Product List upon 30-calendar days’ notice, resulting in modification of the BPA.

B. Gray Market

1. The Authorized Supplier shall be an OEM authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system such that the OEM warranty and service are provided and maintained by the OEM. All warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The Authorized Supplier shall provide new supplies ONLY; no remanufactured or "gray market" supplies. All supplies must be covered by the manufacturer's warranty.

2. Exception: This prohibition on remanufactured supplies does not apply to Class I or Class II single-use devices (SUDs) that meet the requirements for reprocessed devices under section 510(o) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), provided such items are sourced by the Government from a manufacturer or reprocessor that meets all applicable FDA requirements for reprocessing single-use devices.

3. Labeling Requirement: All reprocessed items furnished under this exception shall be labeled in accordance with section 502(v) of the FD&C Act. At a minimum, the labeling shall prominently and conspicuously bear the statement:

a. "Reprocessed device for single use. Reprocessed by [name of the person or establishment responsible for reprocessing]."

b. Items that do not meet this labeling requirement shall be considered misbranded and are not acceptable for delivery or acceptance under this BPA.

c. (c) Definitions As used in this clause:

I. "Reprocessed device" means a single-use device that has been subjected to cleaning, disinfection or sterilization, and functional testing to render it suitable for further use, in accordance with FDA requirements applicable to reprocessors.

II. "Reprocessor" means an entity, including a third-party reprocessor or a health care facility, that reprocesses a single-use device and is treated by FDA as a manufacturer for purposes of applicable statutory and regulatory requirements, including registration, listing, quality systems, medical device reporting, and labeling.

III. "Single-use device (SUD)" means a device that is intended for one use, or on a single patient during a single procedure, and is labeled as such by the original equipment manufacturer.

C. Trade Agreement Act Requirements

1. Supplies offered by the Authorized Supplier should be compliant with the Trade Agreements

(TA) Certificate, found at 52.225-6. End-products offered shall be manufactured or substantially transformed either in the United States or in a designated country. The BPA holder at the supply level must certify as follows in accordance with the TA Certificate:

a. The Offeror certifies that each end product, except those specifically listed, is a U.S.-made or designated country end product, as defined in the clause of this solicitation entitled “Trade Agreements.”

b. The Government will consider for award only offers of U.S.-made or designated country end products unless the Contracting Officer determines that there are no offers for such products or that the offers for such products are insufficient to fulfill the requirements of the solicitation.

2. This section applies to all suppliers except for AbilityOne NPAs in accordance with FAR 25.401(a)(4).

3. Make PPE in America Restrictions on Foreign Acquisition: All PPE items on the MSPV PL shall be complaint with the Make PPE in America Act in accordance with Public Law 117-58, Subtitle C—Make PPE in America, Sections 70951-70953. Any revisions to this Act shall be applicable to Agreements on the effective date of the revision.

4. The contractor shall notify the government within 15 days if an item on their price schedule moves manufacturing to a non-compliant country. This includes items that may be sourced from multiple countries of origin and Make PPE in America Act compliance cannot be guaranteed.

Personal Protective Equipment: This section contains restrictions on the acquisition of certain personal protective equipment imposed by the Make PPE in America Act (Pub. L. 117-58) on contracts, exercising of an option, and orders.

Definitions.

(a) “Component” means an article, material, or supply incorporated directly into an item of personal protective equipment.

(b) “Domestic personal protective equipment” means personal protective equipment, including the materials and components thereof, that is grown, reprocessed, reused, or produced in the United States.

(c) “Foreign-made domestic personal protective equipment” personal protective equipment that is assembled outside the United States containing only materials and components that are grown, reprocessed, reused, or produced in the United States.

(d) “Foreign personal protective equipment” means personal protective equipment other than domestic personal protective equipment or foreign-made domestic personal protective equipment.

(e) “Personal protective equipment” means surgical masks, respirator masks and powered air purifying respirators and required filters, face shields and protective eyewear, gloves, disposable and reusable surgical and isolation gowns, head and foot coverings, and other gear or clothing used to protect an individual from the transmission of disease.

(f) “United States” means the 50 States, the District of Columbia, and the possessions of the United States.

Restrictions

The following restrictions implement section 70953 of the Make PPE in America Act, and they apply to all types of actions, orders, option exercises, and contracts.

(a) Contracting officers shall purchase domestic personal protective equipment.

(b) Any contract for personal protective equipment shall have a base period of performance of at least 2 years, plus all option periods.

Exceptions

(a) Acquisition of an item of personal protective equipment, or component thereof, otherwise covered includes:

(1) maximizes sources for foreign-made domestic personal protective equipment;

and;

(2) certifies every 120 days that it is necessary to procure personal protective equipment under alternative procedures to respond to the immediate needs of a public health emergency.

(b) Acquisitions of an item of personal protective equipment, or component thereof, including those described in paragraph (a) —

(1) that is, or that includes, material listed in section 25.104 of the Federal Acquisition Regulation as one for which a nonavailability determination has been made; or

(2) as to which the Senior Procurement Executive determines that a sufficient quantity of a satisfactory quality that is grown, reprocessed, reused, or produced in the United States cannot be procured as, and when, needed at United States market prices; and

(3) The Senior Procurement Executive certifies every 120 days that it is necessary to procure personal protective equipment to respond to the immediate needs of a public health emergency.

(c) When either of the exceptions in the paragraphs (a) or (b) are used:

(1) Only the VA Senior Procurement Executive is authorized to make the certification in paragraphs (a)(2) and (b)(3) or the nonavailability or unreasonable cost determination in paragraph (b).

(2) The supporting documentation for the VA Senior Procurement Executive shall be prepared by the VA Component(s) and:

(i) For the certification in paragraphs (a)(2) and (b)(3):

(A) include a written justification documenting the immediate public health emergency requiring use of alternative procedures; and

(B) be concurred on by the Head of the Contracting Activity before submission to the Senior Procurement Executive.

(ii) For the nonavailability or unreasonable cost determination in paragraph (b):

(A) include a written justification documenting why a nonavailability or unreasonable cost exception is required; and

(B) be concurred on by the Head of the Contracting Activity before submission to the Senior Procurement Executive.

Specific application of the Buy American Act and Trade Agreements Act.

In the event the VA Senior Procurement Executive determines neither domestic personal protective equipment nor foreign-made domestic personal protective equipment are available due to nonavailability or unreasonable cost, contracting officers shall apply either –

(a) The clause at Federal Acquisition Regulation (FAR) 52.225-1 Buy American – Supplies and the provision at FAR 52.225-2 Buy American Certificate;

(b) The clause at Federal Acquisition Regulation (FAR) 52.225-3 Buy American – Free Trade Agreements – Israeli Trade Act and the provision at FAR 52.225-4 Buy American – Free Trade Agreements – Israeli Trade Act Certificate; or

(c) The clause at FAR 52.225-5 Trade Agreements and the provision at FAR 52.225-6 Trade Agreements Certificate, as applicable.

D. Delivery

1. The Authorized Supplier shall deliver supplies in accordance with “Normal”, Expedited, “Just-In-Time (JIT)”, and drop shipment as outlined in commercial agreements between the PV and the Authorized Supplier.

2. All BPA holder deliveries shall be FOB Destination.

3. The Authorized Supplier shall deliver supplies to the PV consistent with established commercial agreements.

E. Orders

1. The primary purpose is for the PV to place orders directly to the Supplier. However, in the event a facility needs to place a direct order against the BPA, they must obtain agreement from the Supplier and MSPV Supplies Branch Chief or higher.

2. There is no guarantee of any orders resulting from this BPA.

3. There is no minimum order quantity (MOQ) requirement for the Government in the MSPV program. Suppliers are responsible for any MOQs established by their OEM partners.

F. Drop Shipments

1. The Authorized Supplier can provide supplies directly to facilities through drop shipments, rather than through PV distribution. Drop shipments are ordering facility-authorized shipments made on supplies that a manufacturer does not normally distribute through a PV but makes available for order and delivery directly to the facility. Authorized Suppliers shall identify and provide supporting documentation from the OEM if supplies are available only via drop shipment as part of the solicitation response.

2. Requirements for drop shipment supplies will be outlined in commercial agreements, including order accuracy, fill rate, shelf life, and others. Deliveries of drop shipments will be made directly to the ordering VA facility within 5 business days of receipt of order from the PV. Orders for drop-ship items must identify the VA PO number on the packing slips and package labeling.

3. The PV is responsible for invoicing VA for drop shipments; it is not the responsibility of the

Authorized Supplier.

4. Once shipped, the Authorized Supplier shall provide tracking information to the PV in the EDI 856 Advance Shipment Notice

G. Terms and Conditions

1. No purchases are planned to be made against this BPA. However, in the event that a facility needs to place a direct order against the BPA, they must obtain agreement from the Supplier and MSPV Supplies Branch Chief or higher.

2. The Non-Manufacturing Rule (NMR) does not apply to FAR Part 12 BPAs IAW FAR 19.505(a).

a. As applicable, the NMR will apply at the order level.

b. AbilityOne is exempt from the NMR in accordance with FAR 19.1404(a)(2).

3. All Offerors who wish to qualify as an SDVOSB and/or a VOSB must be certified by the Small Business Administration (SBA). Additional information and the certification process can be found on https://veterans.certify.sba.gov

4. The Authorized Supplier shall provide written notice to their respective BPA Contracting

Officer of any changes related to the company or the supplies offered under its BPA.

Changes include, but are not limited to, changes in company information, including contract administrator, company name, address and phone number.

5. Reports: The government may request reports to be provided by the Authorized Supplier.

Examples of reports that may be requested are confirmation of line-item details, back-order reports, deficiency reports, or other reports as requested by the government.

H. Authorized Representatives

1. The Contracting Officer for this solicitation is as follows:

Primary: Brett Cook

2. If required, a Contracting Officer's Representative (COR) for requirements under this Agreement will be delegated in writing by the CO.

Appendix A: Acronyms

ANSI American National Standards Institute ASC Accredited Standards Center BPA Blanket Purchase Agreement CO Contracting Officer COR Contracting Officer's Representative CVE Center for Verification and Evaluation DAPA Distribution and Pricing Agreement DLA Defense Logistics Agency EDI Electronic Data Interchange FAR Federal Acquisition Regulation FDA Federal Drug Administration FOB Free on Board FOIA Freedom of Information Act GS1 Global Standard 1 GSA General Services Administration HIBCC Health Industry Business Communications Council HUB Historically Under-utilized Business IFF Industrial Funding Fee IPT Integrated Product Team ISBT International Society for Blood Transfusion JIT Just-In-Time MedPDB Medical Product Data Bank MSPV Medical Surgical Prime Vendor NAC National Acquisition Center NAICS North American Industry Classification System NMR Non-Manufacturer Rule OEM Original Equipment Manufacturer OGA Other Government Agency POP Period of Performance PV Prime Vendor QSR Quarterly Sales Report RFQ Request for Quote SAC Strategic Acquisition Center SAM System for Award Management SD/VOSB Service-Disabled Veteran-Owned Small Business SOW Statement of Work SUD Single Use Devices TAA Trade Agreement Act VA U.S. Department of Veterans Affairs VHA Veterans Health Administration VISN Veterans Integrated Services Network VOSB Veteran-Owned Small Business

Appendix B: Veterans Integrated Services Networks (VISNs)

VISN 1 VA New England Healthcare System VISN 2 New York/New Jersey VA Health Care Network VISN 4 VA Healthcare VISN 5 VA Capitol Health Care Network VISN 6 VA Mid-Atlantic Health Care Network VISN 7 VA Southeast Network VISN 8 VA Sunshine Healthcare Network VISN 9 VA MidSouth Healthcare Network VISN 10 VA Healthcare System VISN 12 VA Great Lakes Health Care System VISN 15 VA Heartland Network VISN 16 South Central VA Health Care Network VISN 17 VA Heart of Texas Health Care Network VISN 19 Rocky Mountain Network VISN 20 Northwest Network VISN 21 Sierra Pacific Network VISN 22 Desert Pacific Healthcare Network VISN 23 VA Midwest Health Care Network

Visit https://www.va.gov/directory/guide/division.asp?dnum=1 http://www.va.gov/directory/guide/division.asp?dnum=1

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

FAR

Number

Title Date

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL NOV 2023

52.203-17

PRODUCTS AND COMMERCIAL SERVICES

CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS NOV 2023

52.203-19 PROHIBITION ON REQUIRING CERTAIN INTERNAL JAN 2017

52.204-13

CONFIDENTIALITY AGREEMENTS OR STATEMENTS

SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.209-10 PROHIBITION ON CONTRACTING WITH INVERTED NOV 2015

52.219-3

DOMESTIC CORPORATIONS

NOTICE OF HUBZONE SET-ASIDE OR SOLE-SOURCE OCT 2022

52.219-6

AWARD

NOTICE OF TOTAL SMALL BUSINESS SET-ASIDE NOV 2020

52.219-13

ALTERNATE I (MAR 2020)

NOTICE OF SET-ASIDE OF ORDERS ALTERNATE I (MAR MAR 2020

52.219-14 2020)

LIMITATIONS ON SUBCONTRACTING OCT 2022

52.219-30 NOTICE OF SET-ASIDE FOR, OR SOLE-SOURCE AWARD OCT 2022

TO, WOMEN-OWNED SMALL BUSINESS CONCERNS

ELIGIBLE UNDER THE WOMEN-OWNED SMALL

52.219-33

BUSINESS PROGRAM

NONMANUFACTURER RULE SEP 2021

52.225-1 BUY AMERICAN—SUPPLIES OCT 2022

52.225-5 TRADE AGREEMENTS NOV 2023

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

52.225-6 FEB 2021

852.246-71 852.247-71

TRADE AGREEMENTS CERTIFICATE

REJECTED GOODS

DELIVERY LOCATION

OCT 2018

OCT 2026

C.2 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(OCT 2026) (DEVIATION)

(a) Definitions. As used in this clause-

(1) Contract financing payment has the meaning given in FAR 32.001.

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, e-mail, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the Contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the Contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A Contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI)

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances below, the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of clause)

C.3 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.4 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (OCT 2026)

(DEVIATION)

(a) This procurement is restricted to new Original Equipment Manufacturer (OEM) items only.

The contractor must furnish only new, authentic OEM goods, such as supplies or equipment/parts, or software licenses. The contractor is prohibited from providing used, refurbished, remanufactured, or gray market goods. Gray market goods refer to OEM goods sold, intentionally or unintentionally, outside of an authorized sales territory or through unauthorized dealers within authorized sales territory.

(b)The contractor must furnish only new, authentic, and unmodified goods from OEMs or authorized suppliers. The contractor is prohibited from providing counterfeit goods, including any unauthorized reproductions, substitutions, or alterations. This prohibition also applies to used items/goods that are misrepresented as new, as well as materials with falsified or misleading information about grade, serial number, lot number, date code, or performance specifications.

(c) The contractor must be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranties and services associated with the equipment/system must be in accordance with the OEM terms and conditions.

(End of clause)

C.5 52.219-27 NOTICE OF SET-ASIDE FOR, OR SOLE-SOURCE AWARD TO,

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS (SDVOSB)

CONCERNS ELIGIBLE UNDER THE SDVOSB PROGRAM. (FEB 2024)

(a) Definition.

Service-disabled veteran-owned small business (SDVOSB) concern means a small business concern—

(1) (i) Not less than 51 percent of which is owned and controlled by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran; or

(2) A small business concern eligible under the SDVOSB Program in accordance with 13 CFR part 128 (see subpart 19.14).

(3) Service-disabled veteran, as used in this definition, means a veteran as defined in 38 U.S.C.

101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16) and who is registered in the Beneficiary Identification and Records Locator Subsystem, or successor system that is maintained by the Department of Veterans Affairs’ Veterans Benefits Administration, as a service-disabled veteran.

Service-disabled veteran-owned small business (SDVOSB) concern eligible under the SDVOSB Program means an SDVOSB concern that—

(1) Effective January 1, 2024, is designated in the System for Award Management (SAM) as certified by the Small Business Administration (SBA) in accordance with 13 CFR 128.300; or

(2) Has represented that it is an SDVOSB concern in SAM and submitted a complete application for certification to SBA on or before December 31, 2023.

Service-disabled veteran-owned small business (SDVOSB) Program means a program that authorizes contracting officers to limit competition, including award on a sole-source basis, to SDVOSB concerns eligible under the SDVOSB Program.

(b) Applicability. This clause applies only to—

(1) Contracts that have been set aside for, or awarded on a sole-source basis to, SDVOSB concerns eligible under the SDVOSB Program;

(2) Part or parts of a multiple-award contract that have been set aside for SDVOSB concerns eligible under the SDVOSB Program;

(3) Orders set aside for…

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