36C10G26Q0004.docx

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6515--Clitoral Therapy Device (CTD) (VA-24-00037945)
Solicitation number
36C10G26Q0004
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This document is a Request for Quote (RFQ) for a Clitoral Therapy Device (CTD) issued by the U.S. Department of Veterans Affairs Strategic Acquisition Center. The solicitation is a small business set-aside for a single award Indefinite Delivery/Indefinite Quantity (IDIQ) contract with a base year and four one-year option periods. The government seeks to procure CTD devices and accessories that meet specific minimum technical requirements, including a hand-held battery-operated device with removable cups, extension tubing, batteries, a carrying accessory, instructional materials, and customer service support.

Key procurement details include a quote submission deadline of January 6, 2026, at 2:00 PM ET, with a three-phase evaluation process encompassing technical literature review, physical product evaluation, and past performance assessment. Offerors must provide product literature, demonstrate corporate capability, submit a letter of supply, and potentially provide an authorized distributor letter. The solicitation requires FDA-approved devices, with contractors capable of handling 100-500 orders per day. Pricing must include a 3% Service Level Agreement (SLA) fee, and the minimum guaranteed contract amount is $1,000, with the maximum aggregate value to be determined. Contractors must comply with various federal contracting requirements and certifications.

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36C10G26Q0004_2.docx DOCX document
36C10G26Q0004 0001.docx DOCX document
Attachment CTD Q and A.xlsx XLSX spreadsheet
Attachment 8 - Authorized Gov Distributor Letter.docx DOCX document
Attachment 3 - Quarterly Reporting Tool.xlsx XLSX spreadsheet
Attachment 1 - Schedule of Supplies.xlsx XLSX spreadsheet
Attachment 7 - Sample Letter of Supply.docx DOCX document
Attachment 6 - Past Performance Questionnaire -CTD.docx DOCX document
Attachment 5 - CTD Questions - Clitoral Therapy Device.xlsx XLSX spreadsheet
Attachment 4 - Contract Discrepancy Report.pdf PDF
Attachment 2 - Pay.gov Vendor Submittal Instructions.docx DOCX document
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36C10G26Q0004 Clitoral Therapy Device (CTD)

PAGE

2 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

36C10G26Q0004 Jessica Abrams Jessica.Abrams@va.gov 01-06-2026 14:00

EST

36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697 X X 339113 800 Employees N/A X U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697 36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

VAFSC

U.S. Department of Veterans Affairs Financial Services Center

PO BOX 149971

(see Section B.3 invoicing/payment) Austin TX 78714-8917 1 (877) 489-6135 See CONTINUATION Page Title: Clitoral Therapy Device Period of Performance: Base with four, one (1) year options See Performance Work Statement, Price/Cost, Schedule, Supplemental Instructions, and attachments for solicitation Requirements.

RFQ Due Date: January 6, 2026 See CONTINUATION Page Brian Shepard Table of Contents

SECTION A2
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES2
SECTION B - CONTINUATION OF SF 1449 BLOCKS5
B.1 CONTRACT ADMINISTRATION5
1.1 CONTRACT ADMINISTRATION5
1. 2 CONTRACTOR REMITTANCE ADDRESS5
1.3 INVOICES:5
1.4 GOVERNMENT INVOICE ADDRESS5
1.5 ACKNOWLEDGMENT OF AMENDMENTS:6
1.6 CONTRACT MINIMUM AND MAXIMUM DOLLAR VALUES6
1.7 CONTRACTOR PERFOMANCE6
B.1 SCOPE OF WORK7
2.1 INTRODUCTION7
2.2 GENERAL INFORMATION7
2.3 MINIMUM TECHNICAL REQUIREMENTS7
2.4 CONTRACT TYPE AND PERIOD OF PERFORMANCE9
2.5 IDIQ TERMS AND CONDITIONS10
2.5.1 ORDERING10
2.6 PRODUCT REFRESH11
2.7 NOTIFICATION OF SUBSTITUTED AND BACK-ORDERED ITEMS/REPLACEMENT WITH ALTERNATE SUPPLY12
2.8 PRODUCT REMOVAL OR RECALL12
2.9 INFORMATION SECURITY CONSIDERATIONS13
2.10 DELIVERY REQUIREMENT14
2.11 INSPECTION AND ACCEPTANCE15
2.12 REPORTS15
2.13 PERFORMANCE METRICS16
B.2 PRICE/COST SCHEDULE17
ITEM INFORMATION17
SECTION C - CONTRACT CLAUSES18
C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)18
C.2 52.204-13 System for Award Management—Maintenance18
C.3 52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters20
C.4 52.212-4 Terms and Conditions—Commercial Products and Commercial Services22
C.5 52.216-18 ORDERING (AUG 2020)28
C.6 52.216-19 ORDER LIMITATIONS (OCT 1995)29
C.7 52.216-22 Indefinite Quantity29
C.8 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)30
C.9 52.219-8 Utilization of Small Business Concerns30
C.10 52.233-3 Protest after Award33
C.11 VAAR 852.219-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (JAN 2023) (DEVIATION)34
C.12 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)36
C.13 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)38
C.14 SAC 18-01 – SAC Service Level Agreement Fee and Submission of Quarterly Sales Reports; (January, 2016)38
C.15 MANDATORY WRITTEN DISCLOSURES40
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS41
See attached document: Attachment 1 - Schedule of Supplies.41
See attached document: Attachment 2 - Pay.gov Vendor Submittal Instructions.41
See attached document: Attachment 3 - Quarterly Reporting Tool.41
See attached document: Attachment 4 - Contract Discrepancy Report.41
See attached document: Attachment 5 - CTD Questions - Clitoral Therapy Device.41
See attached document: Attachment 6 - Past Performance Questionnaire -CTD.41
See attached document: Attachment 7 - Sample Letter of Supply.41
See attached document: Attachment 8 - Authorized Gov Distributor Letter.41
SECTION E - SOLICITATION PROVISIONS42
E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)42
E.2 52.204-7 System for Award Management—Registration42
E.3 52.204-90 Offeror Identification46
E.4 52.209-7 Information Regarding Responsibility Matters50
E.5 52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law51
E.6 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services52
PHASE 155
PHASE 256
PHASE 357
E.7 52.212-2 Evaluation—Commercial Products and Commercial Services59
E.8 52.225-2 BUY AMERICAN CERTIFICATE (OCT 2022)61
E.9 52.233-2 SERVICE OF PROTEST (SEP 2006)62
E.10 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)63

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION

1.1 CONTRACT ADMINISTRATION

1.1.1 The Strategic Acquisition Center (SAC) Contracting Officer (CO) is responsible for providing overall scope oversight, maintaining communication between contractors and the United States Department of Veterans Affairs (VA), ensuring contract compliance, administering the national Indefinite Delivery Indefinite Quantity (IDIQ) contract and modifications, and ensuring that annual performance evaluations are completed at the national contract level. Nevertheless, any CO assigned to the SAC and acting within his/her warrant authority may take formal action on this contract when contract action needs to be taken, and the primary CO is unavailable. The CO reserves the right to designate a Contracting Officer’s Representative (COR) at the IDIQ contract level. The CO shall issue a designation letter to the COR and the contractor to ensure that all parties understand the limited authority of the COR.

1.1.2 The IDIQ contract may only be modified by written modification, executed by a SAC warranted CO. The Contractor shall not provide products that are not expressly stated in the contract or order. A COR does not have the authority or means to obligate the Government or change the terms and conditions of the IDIQ contract.

1.1.3 All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: TBD

b. GOVERNMENT: Contracting Officer 36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center 10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

1. 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
[X]
52.232-36, Payment by Third Party

1.3 INVOICES: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]
c. Other[X]

1.4 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.

1.4.1 Submission of a proper invoice – The following data must be included in invoice for it constitutes a proper invoice:

a. Name and address of the contractor

b. Invoice date and number

c. VA Facility Name & Address

d. Purchase Order No.

e. Contract No.

f. Item number, description, quantity, unit of measure, price, extended price and a total of supplies delivered, or services performed.

g. Patient Unique Identifier

h. Cumulative billing (per line item and total)

i. Proof of supplies delivered, or services performed MUST also be provided.

j. Signature, printed name and title of Government receiving official and date of delivery or performance period must be included or accompany with invoice.

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

AMENDMENT NO
DATE

1.6 CONTRACT MINIMUM AND MAXIMUM DOLLAR VALUES

The minimum guaranteed amount for contracts awarded under this solicitation is $1,000.00 for a single award which shall be obligated at the time of IDIQ award. Orders beyond the minimum shall be determined by department needs. The Government has no obligation to award orders beyond the minimum guaranteed amount. In accordance with FAR 16.504(a)(4)(ii), the maximum aggregate value for all orders awarded under the contracts award under this solicitation shall not exceed TBD. The Government’s obligation for the minimum guaranteed amount applies only to the base period of the contract.

1.7 CONTRACTOR PERFOMANCE

Attachment A Contractor Discrepancy Report (CDR), may be issued by a CO or COR to document less than acceptable performance by the Contractor at any point during the period of performance. It shall be noted that issuance of a CDR shall not be the first form of communication or plan of resolution unless the seriousness of the situation warrants such formal documentation from onset. The CO, COR and Contractor shall maintain open and effective communications to avoid the issuance of CDRs to the maximum extent practicable. All parties acknowledge that a finalized CDR shall become part of the official file and will be used to report on annual performance under the IDIQ.

If use of a CDR is warranted, the CO/COR shall complete the CDR, citing the IDIQ and/or order number and the specific IDIQ and/or order section or clause related to the performance issue. The CO/COR shall provide a detailed and descriptive narrative of the background and issue. Upon receipt of the CDR, the Contractor shall provide a timely and detailed response to the CO/COR. The Contractor’s response shall include any important or relevant information or justification for the performance issue and a proposed resolution. The CO/COR will review the response from the Contractor and the CO shall issue a final recommendation or plan of action. The CO, COR, and Contractor shall maintain communication to ensure that the recommendation or plan of action is carried out. The CO may issue a cure notice without issuing a CDR.

The Contractor’s performance on the IDIQ shall be reported to the Contractor Performance Assessment Reporting System (CPARS) on an annual basis. The CO and COR shall make use of information from CDRs, as well as any additional knowledge and information available to them with respect to the Contractor’s performance, to complete the CPARS. Contractors shall familiarize themselves with the CPARS process and be prepared to respond to reports entered by the CO and COR.

B.1 SCOPE OF WORK

2.1 INTRODUCTION

The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Prosthetic and Sensory Aids Service (PSAS), has a need for Clitoral Therapy Device (CTD) and accessories. VHA has specifically identified CTD’s as a candidate for standardization. The Government desires to continue the practice of reducing costs by standardizing products and sources of supply while, simultaneously, balancing clinician considerations for obtaining quality products.

2.2 GENERAL INFORMATION

The contractor shall guarantee their ability to provide an uninterrupted source of supply for the CTD devices as specified in the minimum technical requirements for the effective period of performance of the contract to include providing a commercial warranty. Purchases by the Government of products established under the resulting IDIQ will be de-centralized. The orders will indicate the specific items ordered, item quantities, and all necessary delivery and payment procedures.

The devices shall be Food and Drug administration (FDA) approved.

2.3 MINIMUM TECHNICAL REQUIREMENTS

The following are the Minimum Technical Requirements (MTRs) as identified by the Integrated Product Team (IPT) for CTD’s. The MTRs are based on the clinical needs of impaired patient population receiving care in VA medical facilities.

Product Identification and Minimum Technical Requirements

Clitoral Therapy Device (CTD)

MTR 1
1 Therapy Hand -Held Battery-Operated Clitoral Therapy Device
MTR 2
Shall include 2 removable Cups
MTR 3
Shall include 1 Extension Tubing
MTR 4
Shall include (2) AAA batteries
MTR 5
Shall provide a carrying/storage accessory
MTR 6
Shall include access to visual video instruction for use
MTR 7
Shall come with written Instructions for Use (pamphlet) in both English and Spanish
MTR 8
Shall provide toll free customer service number
MTR 9
Shall provide a manufacture warranty (1 -year)

Replacement Parts. The below components must be available for replacement as medically necessary for appropriate functioning.

MTR 10
Removeable Cup (15-pack)
MTR 11
Removable Cup (5-pack)
MTR 12
Extender (2-pack)

a. Corporate Capability:

· The Contractor shall provide sufficient inventory and warehousing.

· The Contractor shall be able to handle 100 to 500 orders per day and meet the required delivery requirements.

· The Contractor shall have control over its supply chain management to avoid any gray market products. The Contractor shall AVOID gray market products

· Device shall be Food and Drug Administration (FDA) approved.

· Contractors shall have in place business practices that safeguard PHI and PII Veteran Patient Information.

· The Contractor shall have a process in place for safety recalls and a mechanism to track trends or failure for safety recalls.

b. Letter of Supply (Authorized Distributor)

· The Contractor shall state if they are a distributor or manufacturer.

· If the Contractor is an authorized distributor, the contractor shall provide a letter from the manufacturer for each product proposed authorizing them to be a distributor for the life of the contract. The offeror shall be authorized to distribute to any VA medical facility in any of the fifty (50) states, and also included the District of Columbia, Philippines and Puerto Rico.

· If the Contractor is an authorized distributor, the Contractor shall provide a letter of supply from the manufacturer which assures the offeror has sufficient uninterrupted sources of supplies for the life of the contract.

· Unauthorized, 3rd Party reseller will not be eligible for an award.

c. Litigation:

· For the past five years, Offerors shall state if the company has any legal proceedings and claims that have arisen in the ordinary course of business and that have not been fully adjudicated. If there are claims and legal proceedings, the Offerors shall state what they are and the current status. If the Offeror has no pending litigations, an affirmative statement shall be provided with the proposal.

2.4 CONTRACT TYPE AND PERIOD OF PERFORMANCE

Type of Contract: The contract shall be a single award IDIQ contract. Delivery orders (DO) shall be issued on a firm-fixed price basis against the IDIQ contract.

The IDIQ contract period of performance is a one year base period and a 4-year option period as follows:

Base Year: One year from contract award Option Year 1: One year from end of Base Year Option Year 2: One year from end of Option Year 1 Option Year 3: One year from end of Option Year 2 Option Year 4: One year from end of Option Year 3

FEDERAL HOLIDAYS

Unless specifically authorized in writing by the Contracting Officer, no services will be provided, and no charges will be incurred and/or billed to any order against this contract on any of the federal holidays listed. There are eleven Federal holidays set by law (5 U.S.C 6103) that VA follows:

Under current definitions, five are set by date:

New Year's DayJanuary 1
Juneteenth National Independence DayJune 19
Independence DayJuly 4
Veterans DayNovember 11
Christmas DayDecember 25

If any of the above falls on a Saturday, then Friday shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

The other six are set by a day of the week and month:

Martin Luther King, Jr. BirthdayThird Monday in January Washington's BirthdayThird Monday in February
Memorial DayLast Monday in May
Labor DayFirst Monday in September
Columbus DaySecond Monday in October
ThanksgivingFourth Thursday in November

2.5 IDIQ TERMS AND CONDITIONS

2.5.1 ORDERING

The resultant IDIQ will be decentralized. Orders $15,000.00 and below will be placed by Prosthetics. Orders over $15,000.00 shall be placed by warranted CO. Orders exceeding the micro-purchase threshold may be placed against the IDIQ contract via Electronic Data Interchange (EDI), via facsimile or email in writing. No verbal/oral orders can be placed or accepted on this IDIQ.

“Government wide commercial purchase card” means a uniquely numbered credit card issued by a contractor under GSA’s Government wide Contract for Fleet, Travel, and Purchase Card Services to named individual Government employees or entities to pay for official Government purchases. The use of Government Purchase Card must comply with Agency, Office of Management and Budget, and Financial Management Regulations and Procedures.

The contractor may accept payments for written orders made using the Government wide commercial purchase card. Invoicing instructions will be identified in delivery orders.

The contractor shall not process a transaction for payment through the purchase card clearinghouse until the purchased supplies have been accepted. Purchase card transactions shall be included in the quarterly sales reporting.

The contractor shall acknowledge receipt of a Government order and confirm via fax, email, etc. within 24 hours of receipt.

At a minimum, orders shall contain the following information.

a. Date of order.

b. Contract number and order number.

c. For supplies and services, line-item number, subline item number (if applicable), description, quantity, and unit price or estimated cost and fee (as applicable). The corresponding line-item number and subline item number from the base contract shall also be included.

d. Delivery or performance schedule.

e. Place of delivery or performance (including consignee).

f. Any packaging, packing, and shipping instructions.

g. Accounting and appropriation data.

h. Method of payment and payment office, if not specified in the contract

2.6 PRODUCT REFRESH

The contractor shall provide improved items within the awarded product line as appropriate new industry technologies emerge and/or products become obsolete. The revised product listing shall be submitted in writing to the CO and COR.

Further, the contractor shall ensure that all CTD devices and accessories offered are state-of-the-art. "State-of-the-art" is defined as the most recently designed components approved by the United States Food and Drug Administration (FDA) and are announced for marketing purposes. All improved or enhanced products shall be provided with the contractor’s commercial warranty.

The contractor shall ensure that all new products are approved in accordance with the pre-market notification under the U.S. Food and Drug Administration (FDA) 510K process and labeled appropriately.

The contractor shall provide the COR and CS/CO the following information:

(1) A list of specific awarded items to be updated or/and added in the Price/Cost Schedule.

(2) Product literature for the new items and a detailed description of the differences or benefits of the new items and/or awarded items

(3) Specific analysis of the comparative advantages/disadvantages of the items involved to be updated; and

(4) Proper identification of any new product requirements and/or procedures related to those new products.

(5) FDA approval, if required.

Approved FDA new items may be added to the contract via modification for negotiation of pricing so long as the terms are within scope.

2.7 NOTIFICATION OF SUBSTITUTED AND BACK-ORDERED ITEMS/REPLACEMENT WITH ALTERNATE SUPPLY

The contractor shall notify the authorized purchaser point of contact within one (1) business day for non-emergency orders and within four (4) hours of an emergency order if any parts/materials cannot be delivered in accordance with the individual delivery order requirements. To ensure that the correct items are shipped, the contractor shall not substitute items without prior approval by order point of contact. Instances where the contractor cannot meet the Government’s requirement(s), the contractor shall notify the order point of contact of the shortest delivery period available. If the contractor’s shortest delivery period is not acceptable to the Government, the Government reserves the right to procure the item(s) from other sources.

The contractor shall supply established item(s) to satisfy the Government’s requirement when an order is placed under the contract during the duration of the effective period of the contract. If, however, contractor determines to terminate production or supply of the selected item and contemplates replacement with alternative item, the Government reserves the right to evaluate the potential replacement item(s). There is no guarantee that the Government will evaluate any replacement item(s) favorably. If the Government determines the replacement item(s) as unacceptable, the individual item(s) may be cancelled.

2.8 PRODUCT REMOVAL OR RECALL

The Contractor shall have a process in place for safety recalls and a mechanism to tract trends or failures for safety recalls. For any product awarded under this contract removed or recalled by the contractor or manufacturer due to defects in the product or potential dangers to patients, or if any required removal or recall is suggested or mandated by a regulatory or official agency, the contractor shall take the following steps within 24 hours of knowledge of the recall:

Notify the CO/CS/COR at the Strategic Acquisition Center and Program Office in writing, In the most expeditious manner possible.

Provide copies of the notification to CO, CS, COR, Manager at Product Recall Office, all Agencies and VA Facilities who purchased the product, which include, but not be limited to the following:

(1) Complete item description and/or identification, order numbers from customers and the contract number assigned as a result of an award on this solicitation;

(2) Reasons for modifications, removal, or recall; and

(3) Necessary instructions for return for credit, replacement, or corrective action.

A copy of the notification shall 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

2.9 INFORMATION SECURITY CONSIDERATIONS

The Certification and Accreditation (C&A) requirements do not apply and a Security Accreditation Package is not required (See VA6500). A Business Associate Agreement is not required for this contract.

The contractor shall safeguard Protected Health Information (PHI) and Personally Identifiable Information (PII). The Department of Veteran Affairs defines personally identifiable information as: “information which can be used to distinguish or trace an individual's identity, such as their name, social security number, biometric records, etc. alone, or when combined with other personal or identifying information which is linked or linkable to a specific individual, such as date and place of birth, mother’s maiden name, etc."

Protected Health Information - Protected Health Information (PHI) is a subset of Health Information, including demographic information collected from an individual, that:

(1) is created or received by a health care provider, health plan, or health care clearinghouse (e.g., a HIPAA-covered entity, such as VHA); (2) relates to the past, present, or future physical or mental condition of an individual, or provision of or payment for health care to an individual; and, (3) identifies the individual or where a reasonable basis exists to believe the information can be used to identify the individual.

NOTE: VHA uses the term PHI to define information covered by the Privacy Act and the Title 38 confidentiality statutes in addition to HIPAA.

Personally Identifiable Information - Personally Identifiable Information (PII) is any information pertaining to an individual that is retrieved by the individual’s name or other unique identifier, as well as PHI regardless of how it is retrieved. PII is a subset of personally identifiable information and is protected by the Privacy Act.

The HIPAA Privacy Rule defines Protected Health Information as PII transmitted or maintained in any form or medium by a covered entity, such as VHA. NOTE: VHA uses the term protected health information to define information that is covered by HIPAA but, unlike PII, may or may not be covered by the Privacy Act or Title 38 confidentiality statutes. In addition, PHI excludes employment records held by VHA in its role as an employer.

Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data- General, FAR 52.227-14(d) (1).

2.10 DELIVERY REQUIREMENT

Standard Delivery: All deliveries shall be made Free-On-Board (FOB) destination to any Veterans Affairs Medical Centers (VAMC) facility (which may include outpatient facilities) within the Continental United States (CONUS) and Outside the Continental United States (OCONUS).

Alternate Delivery: To meet the needs of Veteran patients across the VA healthcare system, there may be times the local PSAS will require delivery to an alternate location.

Alternate delivery shall only be used when the need arises to ship prescribed item(s) to other than the local medical center or Community Based Outpatient Clinics (CBOC). The local PSAS office will create a delivery order, to include the address to where the item(s) are to be shipped. The order can be placed by the local VAMC in the most economical manner they deem fit (i.e. GPC or delivery order). Alternate delivery procedures shall safeguard PHI and PII.

Upon the receipt of an alternate delivery order (applicable to shipping directly to Veteran):

a. Delivery shall be FOB destination to the address indicated on the delivery order.

b. Deliveries will be shipped using a mail tracking system to identify location and proof of delivery. The contractor shall retain proof of delivery and shall provide the information upon request from the VA.

c. Standard deliveries shall be made within 7 business days after receipt of a delivery order and alternate delivery shall be made within 3 business days after receipt of a delivery order.

d. The Government acceptance of all delivery orders shall take place at the delivery point.

Schedule for Deliverables: The following conditions apply to all shipments:

Inspection: Destination Acceptance: Destination

Ship To and Mark For: Deliveries shall be marked and shipped to various VHA locations or alternate delivery address nationwide which will be identified under each order placed against the IDIQ.

Special Shipping Instructions: Prior to shipping, the contractor shall notify VHA site point of contact by telephone and/or email, of all incoming deliveries including line-by-line details for review of requirements. All shipments, either single or multiple container deliveries, will bear VA’s Order number on external shipping labels and associated manifests or packing lists. In the case of multiple container deliveries, a readable statement near the order number will indicate total number of containers for the complete shipment (ex. “Package 1 of 2”), clearly readable on manifests and external shipping labels.

Packing Slips/Labels and Lists shall include the following:

IFCAP PO # ____________ (e.g., 166-E11234) Total number of Containers: Package ___ of ___. (e.g., Package 1 of 3)

2.11 INSPECTION AND ACCEPTANCE

The acceptance paragraph in FAR 52.212-4 (a) is based upon the assumption that the Government will rely on the contractor’s assurances that the commercial item tendered for acceptance conforms to the IDIQ requirements. The Government’s inspection of commercial items will not prejudice its other rights under the acceptance paragraph.

2.12 REPORTS

In order to track compliance, the contractor shall submit a quarterly sales report (QSR). The QSR shall include part number, quantity sold, contract unit price, total price sold per part number, facility sold, total quarterly sales, and SLA fee. Format may be developed by the contractor. For a sample of what is required reference Attachment 3 of the Solicitation.

The QSR shall be submitted on Government fiscal calendar year. See below:

QUARTER
PERIOD OF SALES
SUBMISSION DUE DATE
1st
October – December
Due last day in February
2nd
January – March
May 31st
3rd
April – June
August 31st
4th
July – September
November 30th

The contractor shall provide a quarterly report of sales, by line item, no later than 60 calendar days after the end of each calendar quarter ending March, June, September, and December. Reports shall be sent electronically to the CO, CS identified in B.1.1 and VA Prosthetic and Sensory Aids Services (PSAS) at VA003B1DEmp@VA.GOV ; until the contractor is notified, in writing, of a different point of contact. All SLA fee payments shall be made in at www.pay.gov. The contractor shall submit the QSR to CO and CS for review prior to remitting SLA fee in pay.gov.

A closeout report shall cover all sales not shown in the QSR and reconcile all errors and credits. If the contractor reported all contract sales and reconciled all errors and credits on the QSR, then a closeout report is not required. All closeout reports shall be submitted by December 31st (if required).

The Government reserves the right to inspect without further notice such records of the contractor as they pertain to sales under this contract. Willful failure or refusal to furnish the required reports, or falsification thereof, may be cause for Government contractual remedies under FAR 52.212-4 Contract Terms and Conditions – Commercial Items.

SAC Quarterly SLA Payments Process In accordance with clause SAC 18-01 Service Level Agreement Fee and Submission of Quarterly Sales Reports the contractor shall remit the SLA fee to the SAC in dollars within 60 calendar days after the end of the reporting quarter.

The website listed below should be used to provide help/clarification about using the Pay.Gov website to send the required quarterly SAC SLA Fee payments. Should your team need assistance please feel free to reach out directly to Pay.gov as the contact information is listed below for their helpdesk in addition to a link to their help/FAQ page as well.

PAY.GOV CUSTOMER SERVICE: 800-624-1373 (Toll free, Option #2) Email: pay.gov.clev@clev.frb.org Pay.Gov Hours (ET): 8:00 AM - 7:00 PM Monday - Friday Website for Questions: https://www.pay.gov/public/help/faqs The current company ID for the SAC is listed below. Please share this information with your banking institution as payments may not be processed without it. SAC Company ID: 0360010477 A Pay.Gov Conformation Receipt Is required for all payments and must be included in the quarterly sales report notification to the SAC CO and CS which is 60 calendar days after the quarter has ended. These are firm dates and must be properly adhered to by the contractor.

2.13 PERFORMANCE METRICS

The performance requirement summary below defines the performance standards and acceptable performance levels associated with this IDIQ contract and resulting orders. The contractor’s performance shall be evaluated based on standards in table below.

The contractor shall monitor performance against the terms and conditions outlined in the contract. Contractor performance will be monitored and measured using a Quality Assurance Surveillance Plan (QASP).

Performance Standards

SOW
Acceptable Quality

Levels

(AQL)

Monitoring Method

Maintain uninterrupted supply and delivery of VEDs devices and accessories
Section B.2.2
No more than 3 instances of supply unavailability per period of performance
Random Inspection and Customer Feedback
Devices and accessories meet minimum specifications
Section B.2.4
No more than 3 reports of items NOT meeting minimum salient characteristics.
Random Inspection and Customer Feedback
Provide notification of delays and discrepancies within 1 business day (standard) / four hours (emergency)
Section B.2.8
No more than 2 instances of unreported known performance delays and discrepancies
Random Inspection and Customer Feedback
QSR submission no later than the submission due date identified
Section B.2.12
All QSRs are submitted as outlined in 2.12
100% Inspection

All standard delivery completed timely and properly labeled

Section B.2.11

No more than 5 missed deliveries or improperly labeled deliveries within a Quarter
Random Inspection and Customer Feedback
All alternate delivery completed timely
Section B.2.11
No more than 5 missed deliveries (more than 3 days) within a Quarter
Random Inspection and Customer Feedback

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT

See Attachment 1 – Schedule of Supplies

GRAND TOTAL
__________________

Page 1 of Page 1 of

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 this/these address(es):

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

(End of Clause)

FAR Number
Title
Date
52.203-6
RESTRICTIONS ON SUBCONTRACTOR SALES TO THE GOVERNMENT
JUN 2020
52.203-13
CONTRACTOR CODE OF BUSINESS ETHICS AND CONDUCT
NOV 2021
52.203-17
CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS
NOV 2023
52.219-33
NONMANUFACTURER RULE
SEP 2021
52.225-1
BUY AMERICAN—SUPPLIES
OCT 2022
52.226-8
ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT MESSAGING WHILE DRIVING
MAY 2024
52.227-14
RIGHTS IN DATA—GENERAL
MAY 2014
52.229-12
TAX ON CERTAIN FOREIGN PROCUREMENTS
FEB 2021
52.232-33
PAYMENT BY ELECTRONIC FUNDS TRANSFER—SYSTEM FOR AWARD MANAGEMENT
OCT 2018
52.232-36
PAYMENT BY THIRD PARTY
MAY 2014
852.201-70
CONTRACTING OFFICER'S REPRESENTATIVE
DEC 2022
852.203-70
COMMERCIAL ADVERTISING
MAY 2018
852.212-71
GRAY MARKET AND COUNTERFEIT ITEMS
FEB 2023
852.246-71
REJECTED GOODS
OCT 2018
852.247-72
MARKING DELIVERABLES
OCT 2018

C.2 52.204-13 System for Award Management—Maintenance

SYSTEM FOR AWARD MANAGEMENT—MAINTENANCE (NOV 2025)

(a) Definitions. As used in this clause— Commercial and Government Entity code means—

(1) An identifier assigned to entities located in the United States or its outlying areas by the Defense Logistics Agency (DLA) Commercial and Government Entity (CAGE) Branch to identify a commercial or government entity by unique location (referred to as “CAGE code”); or

(2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by the NATO Support and Procurement Agency to entities located outside the United States and its outlying areas that the DLA CAGE Branch records and maintains in the CAGE master file (referred to as “NCAGE code”).

Unique Entity Identifier (UEI) means an identifier used to identify a specific commercial, nonprofit, or Government entity.

(b) Active registration.

(1) The Contractor shall maintain an active Federal Government contracts registration in the System for Award Management (SAM) at https://www.sam.gov during contract performance and through final payment under this contract. To maintain an active registration in SAM, the Contractor shall review at least annually its registration in SAM and validate that the information is current, accurate, and complete.

(2) The Contractor is responsible for the currency, accuracy, and completeness of the information provided within SAM, and for any liability resulting from the Government’s reliance on inaccurate or incomplete information. Updating SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document.

(c) Novation and change-of-name agreements.

(1) If the Contractor has legally changed its business name or “doing business as” name (whichever is shown on the contract), or has transferred the assets used to perform the contract, but has not completed the necessary requirements regarding novation and change-of-name agreements in part 42 of the Federal Acquisition Regulation (FAR), the Contractor shall provide the responsible Contracting Officer a minimum of one business day’s written notification of its intention to —

(i) Change the legal business name in SAM;

(ii) Comply with the requirements of FAR part 42; and

(iii) Agree in writing to the timeline and procedures specified by the responsible Contracting Officer. The Contractor shall provide with its written notification sufficient documentation to support the legally changed name.

(2) If the Contractor fails to comply with the requirements of paragraph (c)(1) of this clause, or fails to perform the agreement at paragraph (c)(1)(iii) of this clause, and, in the absence of a properly executed novation or change-of-name agreement, the SAM information that shows the Contractor to be other than the Contractor indicated in the contract will be considered to be incorrect information within the meaning of the “Suspension of Payment” paragraph of the electronic funds transfer (EFT) clause of this contract.

(d) Assignees.

(1) The Contractor shall not change the legal business name or address for EFT payments or manual payments, as appropriate, in the SAM record to reflect an assignee for the purpose of assignment of claims (see FAR part 32). Assignees shall be separately registered in SAM.

(2) Information provided to the Contractor’s SAM record that indicates payments, including those made by EFT, to an ultimate recipient other than that Contractor will be incorrect information within the meaning of the “Suspension of Payment” paragraph of the EFT clause of this contract.

(e) Unique entity identifier (UEI). The Contractor shall ensure that its UEI is maintained throughout the life of the contract.

(f) Commercial and Government Entity (CAGE) code. The Contractor shall ensure that the CAGE code is maintained throughout the life of the contract. To update a CAGE code, the Contractor shall initiate the change by updating its SAM registration.

(g) Communicating changes. The Contractor shall communicate any change to its UEI or CAGE code to the Contracting Officer within 30 days after the change, so a modification can be issued to update the UEI or CAGE code on this contract. A change in the UEI does not necessarily require a novation.

(End of clause) C.3 52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters UPDATES OF PUBLICLY AVAILABLE INFORMATION REGARDING RESPONSIBILITY MATTERS (NOV 2025)

(a) The Contractor shall update the information in the Federal Awardee Performance and Integrity Information System (FAPIIS) on a semi-annual basis, throughout the life of the contract, by posting the required information in the System for Award Management via https://www.sam.gov.

(b) All information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available. FAPIIS consists of two segments—

(1) The non-public segment, into which Government officials and the Contractor post information, which can only be viewed by-

(i) Government personnel and authorized users performing business on behalf of the Government; or

(ii) The Contractor, when viewing data on itself; and

(2) The publicly-available segment, to which all data in the non-public segment of FAPIIS is automatically transferred after a waiting period of 14 calendar days, except for-

(i) Past performance reviews required by part 42.

(ii) Information that was entered prior to April 15, 2011; or

(iii) Information that is withdrawn during the 14-calendar-day waiting period by the Government official who posted it in accordance with paragraph (c)(1) of this clause.

(c) The Contractor will receive notification when the Government posts new information to the Contractor’s record.

(1) If the Contractor asserts in writing within 7 calendar days, to the Government official who posted the information, that some of the information posted to the non-public segment of FAPIIS is covered by a disclosure exemption under the Freedom of Information Act, the Government official who posted the information must within 7 calendar days remove the posting from FAPIIS and resolve the issue in accordance with agency Freedom of Information procedures, prior to reposting the releasable information. The contractor must cite 52.209-9 and request removal within 7 calendar days of the posting to FAPIIS.

(2) The Contractor will also have an opportunity to post comments regarding information that the Government has posted. FAPIIS will retain the comments as long as the associated information is retained, i.e., for a total period of 6 years. Contractor comments will remain a part of the record unless the Contractor revises them.

(3) All information posted in FAPIIS on or after April 15, 2011, except past performance reviews, will be publicly available (section 3010 of Pub. L. 111-212).

(d) The Government will handle public requests for system information posted prior to April 15, 2011, under Freedom of Information Act procedures, including, where appropriate, procedures promulgated under E.O. 12600.

(End of clause)

C.4 52.212-4 Terms and Conditions—Commercial Products and Commercial Services

TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2025)

(a) Definitions. The clause at Federal Acquisition Regulation (FAR) 52.202-1, Definitions, is incorporated by reference.

(b) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(c) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(d) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(e) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal, or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause FAR 52.233-1, Disputes, which is incorporated in this contract by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence. Examples of occurrences include acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. When an excusable delay occurs, the Contractor shall—

(1) Notify the Contracting Officer in writing as soon as possible;

(2) Remedy the delay as quickly as possible; and

(3) Notify the Contracting Officer when the occurrence is over.

(g) Invoice. The Government will handle invoices according to the Prompt Payment Act (31 U.S.C. 3903) and 5 CFR part 1315. The Contractor shall submit invoices to the address designated in the contract to receive invoices. An invoice must include the information required by 5 CFR part 1315.9(b).

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees, and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark, or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act ( 31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date that appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(4) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable;

(D) Contractor point of contact; and

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(5) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by FAR part 33 if–

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see FAR part 32).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(…

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