RFP 36C10G25R0046_GE MUSE ECG Data Management System.pdf

PAGE 1 OF 65 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

36C10G25R0046 08-18-2025

Anthony Zibolski 202-664-6820 09-15-2025

10:00 AM EDT

36C10G U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

X 100

X

339112

1000 Employees

N/A

X

In accordance with section B.7

36C10G

U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

VAFSC

Financial Services Center

PO BOX 149971

(see Section B invoicing/payment) Austin TX 78714-8917

1 (877) 489-6135

See CONTINUATION Page

Department of Veterans Affairs Veterans Health Administration Equipment Life Cycle Management Program

TITLE: NX EQ GE MUSE ECG Data Management System

An individual SBA Nonmanufacturer Rule Waiver has been granted for this requirement.

$0.00 See CONTINUATION Page

X X

X 1

Anthony Zibolski Contracting Officer

36C10G25R0046

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B – CONTRACT ADMINISTRATION / INVOICE INSTRUCTIONS

B.1 CONTRACT ADMINISTRATION:

B.2 CONTRACTOR REMITTANCE ADDRESS:

B.3 INVOICES:

B.4 GOVERNMENT INVOICE ADDRESS:

B.5 FSC MANDATORY ELECTRONIC INVOICE SUBMISSION:

B.6 REPORTS:

B.7 TERMS AND CONDITIONS

B.8 ACKNOWLEDGMENT OF AMENDMENTS

B.9 PRICE/COST SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 MANDATORY WRITTEN DISCLOSURES

C.2 SAC 18-01 SAC SERVICE LEVEL AGREEMENT FEE AND SUBMISSION OF

QUARTERLY SALES REPORTS: OPEN MARKET (JAN 2016)

C.3 FAR 52.211-11 LIQUIDATED DAMAGES-SUPPLIES, SERVICES, OR RESEARCH

AND DEVELOPMENT (SEPT 2000)

C.4 FAR 52.216-18 ORDERING (AUG 2020)

C.5 FAR 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.6 FAR 52.216-21 REQUIREMENTS (OCT 1995)

C.7 FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.8 FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.9 VAAR 852.204-71 INFORMATION AND INFORMATION SYSTEM SECURITY (FEB

2023)

C.10 VAAR 852.211-70 EQUIPMENT OPERATION AND MAINTENANCE MANUALS

(NOV 2018)

C.11 VAAR 852.211-76 LIQUIDATED DAMAGES – REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023) ALTERNATE I (FEB 2023)

C.12 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023)

(DEVIATION)

C.13 VAAR 852.219-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (JAN 2023)

(DEVIATION)

C.14 FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 ATTACHMENT A: QUARTERLY SALES REPORTING TOOL

D.2 ATTACHMENT B: PRODUCT DESCRIPTION

D.3 ATTACHMENT C: CONTRACT SECURITY HANDBOOK 6500_6_APPENDIX C ..37

D.4 ATTACHMENT D: PRICE COST SCHEDULE

D.5 ATTACHMENT E: JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL

AND OPEN COMPETITION

D.6 ATTACHMENT F: CERTIFICATION OF RECALL OR SAFETY ISSUES

D.7 ATTACHMENT G: PAST PERFORMANCE REFERENCES

D.8 ATTACHMENT H: PAST PERFORMANCE QUESTIONNAIRE

D.9 ATTACHMENT I: DRAFT BUSINESS ASSOCIATE AGREEMENT

SECTION E - SOLICITATION PROVISIONS

E.1 FAR 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.2 FAR 52.204-24 REPRESENTATION REGARDING CERTAIN

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT

(NOV 2021)

E.3 FAR 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.4 FAR 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT

2018)

E.5 FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (SEP 2023)

E.6 FAR 52.216-1 TYPE OF CONTRACT (APR 1984)

E.7 FAR 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.8 FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEB 1998)

E.9 FAR 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.10 FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION

FEB 2025)

SECTION B – CONTRACT ADMINISTRATION / INVOICE INSTRUCTIONS

B.1 CONTRACT ADMINISTRATION:

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

a. CONTRACTOR: TBD

POC

TITLE

EMAIL

PHONE

UNIQUE ENTITY ID

b. GOVERNMENT: Contracting Officer 36C10G

Anthony Zibolski U.S. Department of Veterans Affairs Strategic Acquisition Center 10300 Spotsylvania Ave., Suite 400 Fredericksburg, VA 22408 Anthony.Zibolski@va.gov

Deputy Program Manager, ELCM

TBD

VHA Office of Procurement & Logistics Operations

TBD@va.gov

Contracting Officer Representative (COR), ELCM

TBD

VHA Office of Procurement & Logistics Operations

TBD@va.gov

B.2 CONTRACTOR REMITTANCE ADDRESS:

All payments by the Government to the Contractor will be made in accordance with 52.232-33, Payment by Electronic Funds Transfer—System for Award Management.

B.3 INVOICES:

Payment shall be submitted monthly in arrears based upon delivery, acceptance, and receipt of a properly prepared invoice.

In order to comply with the Improper Payment Elimination and Recovery Act of 2010 (IPERA), the VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (VAFSC).

The Contractor shall submit invoice within 30 days of delivery.

mailto:Anthony.Zibolski@va.gov

B.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 Request.

B.5 FSC MANDATORY ELECTRONIC INVOICE SUBMISSION:

Contractors are required to submit payment requests in electronic form in accordance with the submission instructions below.

TUNGSTEN ELECTRONIC INVOICE SUBMISSION

FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

Contracting POC: Anthony Zibolski, Contracting Officer COR (Contracting Officers Representative): TBD Contract/Task Order Number: TBD

a. Vendor Electronic Invoice Submission Methods:

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below.

1. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party Contractor, Tungsten, to transition vendors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

2. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org)

b. Vendor e-invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below.

1. Tungsten e-Invoice Setup Information: 1-877-489-6135

2. Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

3. FSC e-Invoice Contact Information: 1-877-353-9791

4. FSC e-invoice email: vafsccshd@va.gov

See https://www.fsc.va.gov/einvoice.asp for more information.

http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.tungsten-network.com/US/en/veterans-affairs/ http://www.x12.org/ mailto:VA.Registration@Tungsten-Network.com mailto:vafsccshd@va.gov https://www.fsc.va.gov/einvoice.asp

B.6 REPORTS:

Monthly Report: In order for the contracting office to submit the required financial reporting to FPDS-NG the Contractor shall submit ATTACHMENT A QUARTERLY SALES REPORTING TOOL on a monthly basis to the Contracting Officer, Contract Specialist and Contracting Officer Representative. The report is due by the 5th of each month.

Quarterly Report: In addition to the monthly submission, the same ATTACHMENT A QUARTERLY SALES REPORTING TOOL, shall be submitted quarterly as outlined below.

In order to track compliance, VA requires the Contractor to submit the quarterly report of sales in the approved format listed in ATTACHMENT A QUARTERLY SALES REPORTING TOOL based on the Government’s 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 agrees that they shall adhere to this requirement. The Contractor shall provide a quarterly report, no later than 60 calendar days after the end of each fiscal quarter ending December, March, June, and September. Reports shall be sent electronically to the Government points of contact until the Contractor is notified, in writing, of a different point of contact.

a. Contracting Officer: Anthony Zibolski

b. COR: TBD

B.7 TERMS AND CONDITIONS

THE FOLLOWING TERMS AND CONDITIONS ARE MANDATORY

1. By establishing a contract, the Contractor agrees to supply established items(s) to satisfy the Government’s requirement when an order is place under the contract during the effective period of performance. If, however, the Contractor determines to terminate production of the selected item and contemplates replacement with an 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) or the entire contract may be canceled.

2. EXTENT OF OBLIGATION:

The Government is obligated only to the extent of authorized purchases made under the resultant contract. This contract does not obligate any funds, nor is the

Government obligated to make any purchases under this contract. The Government does not guarantee any volume of purchases through a contract. The terms and conditions included in this contract apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this contract and the contract holder’s invoice, the provisions of this contract will take precedence.

a. Uninterrupted Source of Supply –By establishing a contract, the awardee agrees to supply established item(s) to satisfy the Government’s requirement when an order is placed under the contract during the effective period of the established contract. If the awardee decides to terminate production of the selected item and contemplates replacement with an 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) is unacceptable, the individual item(s) or the entire contract may be cancelled.

b. Inspection and Acceptance –The acceptance paragraph in FAR 52.212-4 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 contract requirements. The Government inspection of commercial items will not prejudice its other rights under the acceptance paragraph. The provisions of FAR 52.212-4 are incorporated by reference.

3. PURCHASE/ORDERING LIMITATIONS:

Orders placed against this contract are limited to FAR Clause 52.216-19 Order Limitations, as noted in the contract. The estimated total quantities are listed on ATTACHMENT D PRICE COST SCHEDULE. The quantities provided are estimates only, and VA makes no guarantee regarding the actual quantities that may be purchased.

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the GE MUSE ECG Data Management System product line as a candidate for a VA-wide (otherwise referred to as “national”) single Requirements contract award.

The Government's intent for this Requirements contract is to include all ancillary items to ensure the equipment can function as designed by the OEM and as clinically required.

The Government may through bilateral modification, add or remove items to this contract that are determined to be within scope of the solicited product line, not limited to the original items awarded. Additionally, any discontinued items may be replaced via future contract modification by the replacement part identified by the OEM, so long as the replacement part serves the same clinical purpose and function as the originally awarded item.

Furthermore, any new technology that is presented during performance of this contract may be evaluated by the Government for inclusion into the contract, via bilateral modification. This new technology must be determined to be within scope of the original contract.

4. INDIVIDUALS AUTHORZIED TO PURCHSE UNDER THE CONTRACT:

This is a Strategic Acquisition Center (SAC) decentralized contract. Orders are placed by VA Government Ordering Officer (OO) in accordance with the terms and conditions of the specific contract identified in the OO appointment memorandum approved by a SAC Contracting Officer. OOs may only place orders for those contracts that they are specifically appointed. Ordering Officers are responsible for issuing and administering orders placed under this contract. Ordering Officers may revise or modify their orders, but only within the scope of this contract. Ordering Officers have no authority to modify any term of this basic contract. Any deviation from the terms of the basic contract must be approved in writing by the SAC Contracting Officer responsible for this contract. Orders placed only by designated VHA ELCM Ordering Officers shall be submitted on a fully funded and completed Delivery Order. No orders shall be placed without first obtaining approved funding from a VA facility. Requesting Facility submits order requests through the NEC Order Portal ELCM NEC Ordering Portal - Power Apps for verification. Questions may be submitted to the VHAELCM OO Team via email at vaelcmnxeqorderingofficer@va.gov.

The Contractor shall accept orders against this contract only from the designated VHA ELCM OO when the Delivery Order has been reviewed by the OO for this contract. Fulfilling orders from persons other than the approved Ordering Officer may result in loss or delay in payment for supplies/services provided under such orders.

When a Contracting Officer appoints an Ordering Officer in writing after award, the Contracting Officer will furnish the Contractor with an updated list of individual Ordering Officers authorized to place orders against the contract. Contractor will acknowledge receipt of any order submitted by an individual Ordering Officer specified by appointment against the contract.

5. DELIVERY TICKETS:

The following provisions apply to all shipments:

Inspection: Destination Acceptance: Destination Shipping: Free on Board (FOB) Destination Ship To and Mark For: Deliveries shall be marked and shipped to various VHA locations identified in each order placed against the contract.

All shipments, either single or multiple container deliveries, shall bear and contain on the delivery tickets or sales slips (external shipping labels and associated manifests or packing lists) the following at a minimum:

(i) Name of supplier

(ii) Contract/Delivery Order/Task Order number

(iii) Date of purchase

(iv) Contract number https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fapps.gov.powerapps.us%2Fplay%2Fe%2Fdefault-e95f1b23-abaf-45ee-821d-b7ab251ab3bf%2Fa%2Ff5a4b923-8e9a-4db8-85d0-d00eb0ca1d07%3FtenantId%3De95f1b23-abaf-45ee-821d-b7ab251ab3bf%26hint%3D4065f86d-3290-468a-93da-5e182e642f3e%26sourcetime%3D1707251534292&data=05%7C02%7C%7C99f912a006124f21351308dc58a3cca1%7Ce95f1b23abaf45ee821db7ab251ab3bf%7C0%7C0%7C638482707742636597%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=PIgCdabLBHhw9mDSlAWIbA06V9opReZU4rMUVyIHB4Y%3D&reserved=0

(v) Itemized list of supplies or services furnished

(vi) Quantity, unit price, and extension of each item, less applicable discounts (unit prices and extensions need not be shown when incompatible with the use of automated systems, provided the invoice is itemized to show this information).

(vii) Date of delivery or shipment In the case of multiple container deliveries, a statement readable near the VA 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.

The Contractor shall provide an order confirmation within four (4) working days of receipt of the delivery order.

The Contractor will provide tracking information or use of a website to obtain delivery status and proof of delivery.

The After Receipt of Order (ARO) is defined as the established number of days from Contractor’s receipt of order date to the line-item delivery date. The Contractor ARO is # days.

Packing Slips/Labels and Lists shall include the following:

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

6. PRODUCT REFRESH

Product refresh is when a current CLIN is no longer being manufactured due to obsolescence and the product item is being replaced with a newer, and more often, superior version of the same item. The current CLIN product will be revised to reflect the refreshed product information, manufacturer’s part number, IDIQ price (including Service Level Agreement (SLA) fee), etc.

The Government reserves the right to not accept the products offered under product refresh. The Contractor will be notified in writing if a product refresh is not accepted. All products offered shall be provided with the warranty that is agreed upon for this contract.

The contractor agrees to ensure that all upgraded improved/replaced products meet American with Disabilities Act (ADA) and Health Information Portability and Accountability Act (HIPAA) Federal requirements, see SECTION C - CONTRACT

CLAUSES.

The Contractor shall provide the COR and CO the following information for product refresh:

(1) A list of specific awarded item(s) being refreshed in the Price/Cost Schedule (to include commercial pricing, discount offered, and IDC price (inclusive of SLA fee));

(2) Product literature for the item(s) refreshed.

(3) A detailed description of the differences or benefits of refreshed as compared to the item(s) being discontinued or added.

(4) Proper identification of any product requirements and/or procedures related to those product(s) proposed to be refreshed or upgraded.

(5) FDA approval, if applicable

(6) Provide historical sales to VA by item(s), if applicable

(7) Copy of Commercial Warranty.

The request shall be submitted to the COR, copy to the Contract Specialist and Contracting Officer, for review and recommendation of approval to be submitted to the CO. The CO shall prepare a bilateral modification for execution.

7. PRODUCT REMOVAL OR RECALL

For any product awarded under this contract removed or recalled by the 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 manufacturer agrees to take the following steps immediately:

Notify the Contracting Officer (CO) at the Strategic Acquisition Center in writing, by the most expeditious manner possible.

Provide copies of the notification to CO, Contracting Specialist, Contracting Officer Representative, and 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 issuance on the 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 will 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

B.8 ACKNOWLEDGMENT OF AMENDMENTS

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

AMENDMENT NO DATE

B.9 PRICE/COST SCHEDULE

This is a nationwide Department of Veterans Affairs Requirements Contract for the procurement of GE MUSE ECG Data Management System, to include accessories, consumables, and warranty, in accordance with ATTACHMENT B PRODUCT DESCRIPTION. The quantity delivered will be dependent on the numbers ordered by the VA Medical Centers.

[The price/cost schedule will be incorporated into the fully executed contract]

SECTION C - CONTRACT CLAUSES

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:

C.1 MANDATORY WRITTEN DISCLOSURES

Mandatory written disclosures required by FAR clause 52.203-13 to the Department of Veterans Affairs, Office of Inspector General (OIG) must be made electronically through the VA OIG Hotline at https://www.va.gov/oig/hotline/ and clicking on "FAR clause 52.203-13 Reporting." If you experience difficulty accessing the website, call the Hotline at 1-800-488-8244 for further instructions.

(End of Clause)

C.2 SAC 18-01 SAC SERVICE LEVEL AGREEMENT FEE AND SUBMISSION OF

QUARTERLY SALES REPORTS: OPEN MARKET (JAN 2016)

a. Service Level Agreement Fee The Service Level Agreement (SLA) fee is established by the Supply Fund Board and is provided as a means of reimbursement for customary acquisition-related services necessary to obtain contractor services and/or supplies as required. The SLA is reimbursed to the SAC based on rates established by the supply fund board and are recouped based on a percentage of total quarterly sales. The Supply Fund Board may change the percentage at any time, but typically not more than once per year. Upon a change in the SLA, the Contracting Officer (CO) shall issue a unilateral modification to apply the change to CLIN prices based upon the SLA rate change. The SAC will provide reasonable notice prior to the effective date of the change.

In order to facilitate SLA reimbursement, offerors must include (imbed) the SLA fee into their prices; therefore, the fee will be reflected in the total amount charged and transparent to ordering activities.

The current SLA which applies to this contract action is 3.0%. This SLA Fee shall be imbedded in the awarded contract/agreement price(s) and offers submitted in response to this solicitation shall include this SLA Fee in the price of every line item offered.

b. Quarterly Sales Reports.

The Contractor shall report all contract sales under this contract and submit collected SLAs as follows:

(1) The Contractor shall accurately report the dollar value, in U.S. dollars and rounded to the nearest whole dollar, of all sales made under this contract by calendar quarter (January 1–March 31, April 1–June 30, July 1–September 30, and October 1– December 31). Reported sales must include all sales made to all authorized contract or agreement users, whether shipped directly to the users or through Prime Vendor https://www.va.gov/oig/hotline/ contractors. The report shall reflect sales by contract line item and shall segment sales by the Department of Veterans Affairs (VA) and Other Government Agencies (OGA).

The reported contract sales shall include the SLA Fee and each quarterly report shall show the total SLA Fee amount collected on the reported sales. The Contractor shall maintain a consistent accounting method of sales reporting, based on the Contractor’s established commercial accounting practice. The Contractor shall consistently use only one of the following acceptable points at which sales may be reported—

i. Receipt of order;

ii. Shipment or delivery, as applicable;

iii. Issuance of an invoice; or

iv. Payment.

(2) Sales under this contract/agreement shall be reported to the SAC within 60 calendar days following the completion of each reporting quarter. The Contractor shall continue to furnish quarterly reports, including “zero” sales, through physical completion of the last outstanding order of the contract/agreement.

(3) The sales report signed by an authorized representative of the contractor shall be emailed to the appropriate individual(s) listed in the terms and conditions of the contract or agreement.

c. SLA Remittance The Contractor shall remit the SLA fee to the SAC in U.S. dollars within 60 calendar days after the end of the reporting quarter and final payment shall be remitted within 60 days after physical completion of the last outstanding task order or delivery order of the contract.

The SLA Fee collected and due shall be paid electronically. To ensure that the payment is credited properly, the contractor shall electronically transmit the SLA fee along with the coinciding quarterly sales report at www.pay.gov (VA Strategic Acquisition Center (SAC)); specific instructions shall be provided when the contract action resulting from this solicitation is awarded (i.e. post-award/BPA issuance conference and/or post-award letter when used in lieu of a conference).

The Government reserves the right to inspect, without further notice, such records of the Contractor as pertinent to sales under any contract or agreements resulting from this solicitation. Failure to remit the full amount of the SLA within 60 calendar days after the end of the applicable reporting period constitutes a contract debt to the United States Government under the terms of Federal Acquisition Regulation (FAR) Subpart 32.6. The Government may exercise all rights under the Debt Collection Improvement Act of 1996, including withholding or setting off payments and interest on the debt (see FAR clause 52.232-17, Interest). Should the Contractor fail to submit the required sales reports, falsify them, or fail to timely pay the SLA, the Government shall have, in addition to the rights and remedies described in this clause, all other rights and remedies permitted by Federal law and statutes.

C.3 FAR 52.211-11 LIQUIDATED DAMAGES-SUPPLIES, SERVICES, OR

RESEARCH AND DEVELOPMENT (SEPT 2000)

(a) If the Contractor fails to deliver the supplies or perform the services within the time specified in this contract, the Contractor shall, in place of actual damages, pay to the Government liquidated damages of $37.50 per calendar day of delay.

(b) If the Government terminates this contract in whole or in part under the Default- Fixed-Price Supply and Service clause, the Contractor is liable for liquidated damages accruing until the Government reasonably obtains delivery or performance of similar supplies or services. These liquidated damages are in addition to excess costs of repurchase under the Termination clause.

(c) The Contractor will not be charged with liquidated damages when the delay in delivery or performance is beyond the control and without the fault or negligence of the Contractor as defined in the Default-Fixed-Price Supply and Service clause in this contract.

(End of clause)

C.4 FAR 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued during the 12-month period of performance or four 12-month option periods.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor’s fax number;

or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor’s email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

C.5 FAR 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than one each, the Government is not obligated to purchase, nor is the Contractor obligated to furnish those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of 10 each;

(2) Any order for a combination of items in excess of $750,000.00; or

(3) A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 10 working days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.6 FAR 52.216-21 REQUIREMENTS (OCT 1995)

(a) This is a requirement contract for the supplies or services specified and effective for the period stated in the Schedule. The quantities of supplies or services specified in the Schedule are estimates only and are not purchased by this contract. Except as this contract may otherwise provide, if the Government's requirements do not result in orders in the quantities described as "estimated" or "maximum" in the Schedule, that fact shall not constitute the basis for an equitable price adjustment.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. Subject to any limitations in the Order Limitations clause or elsewhere in this contract, the Contractor shall furnish to the Government all supplies or services specified in the Schedule and called for by orders issued in accordance with the Ordering clause. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(c) Except as this contract otherwise provides, the Government shall order from the Contractor all the supplies or services specified in the Schedule that are required to be purchased by the Government activity or activities specified in the Schedule.

(d) The Government is not required to purchase from the Contractor requirements in excess of any limit on total orders under this contract.

(e) If the Government urgently requires delivery of any quantity of an item before the earliest date that delivery may be specified under this contract, and if the Contractor will not accept an order providing for the accelerated delivery, the Government may acquire the urgently required goods or services from another source.

(f) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided that the Contractor shall not be required to make any deliveries under this contract after one (1) year from the expiration of the contract effective period.

C.7 FAR 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT

(MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days of contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 45 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

C.8 FAR 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/

FAR/VAAR

Number Title Date

52.203-3 GRATUITIES APR 1984

52.203-12 LIMITATION ON PAYMENTS TO INFLUENCE CERTAIN

FEDERAL TRANSACTIONS JUN 2020

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS NOV 2023

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE AUG 2020

52.204-19 INCORPORATION BY REFERENCE OF

REPRESENTATIONS AND CERTIFICATIONS DEC 2014

52.204-21 BASIC SAFEGUARDING OF COVERED CONTRACTOR

INFORMATION SYSTEMS NOV 2021

52.211-17 DELIVERY OF EXCESS QUANTITIES SEP 1989

52.224-1 PRIVACY ACT NOTIFICATION APR 1984

52.224-2 PRIVACY ACT APR 1984

52.227-14 RIGHTS IN DATA—GENERAL MAY 2014

52.227-19 COMMERCIAL COMPUTER SOFTWARE LICENSE DEC 2007

52.232-39 UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS JUN 2013

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS MAR 2023

852.201-70 CONTRACTING OFFICER’S REPRESENTATIVE DEC 2022

852.203-70 COMMERCIAL ADVERTISING MAY 2018

852.204-70 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR

PERSONNEL MAY 2020

852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS FEB 2023

852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS NOV 2018

852.239-70 SECURITY REQUIREMENTS FOR INFORMATION

TECHNOLOGY RESOURCES FEB 2023

852.239-71 INFORMATION SYSTEM SECURITY PLAN AND

ACCREDITATION FEB 2023

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

852.242-71 ADMINISTRATIVE CONTRACTING OFFICER OCT 2020

852.246-71 REJECTED GOODS OCT 2018

852.222-71 COMPLIANCE WITH EXECUTIVE ORDER 13899

(DEVIATION) (APR 2025) APR 2025

852.239-76 INFORMATION AND COMMUNICATION TECHNOLOGY

ACCESSIBILITY FEB 2023

C.9 VAAR 852.204-71 INFORMATION AND INFORMATION SYSTEM SECURITY

(FEB 2023)

(a) Definitions. As used in this clause—Business Associate means an entity, including an individual (other than a member of the workforce of a covered entity), company, organization or another covered entity, as defined by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule, that performs or assists in the performance of a function or activity on behalf of the Veterans Health Administration (VHA) that involves the creating, receiving, maintaining, transmitting of, or having access to, protected health information (PHI). The term also includes a subcontractor of a business associate that creates, receives, maintains, or transmits PHI on behalf of the business associate.

Business Associate Agreement (BAA) means the agreement, as dictated by the Privacy Rule, between VHA and a business associate, which must be entered into in addition to the underlying contract for services and before any release of PHI can be made to the business associate, in order for the business associate to perform certain functions or activities on behalf of VHA.

Information system means a discrete set of information resources organized for the collection, processing, maintenance, use, sharing, dissemination, or disposition of information whether automated or manual.

Information technology (see FAR 2.101) also means Information and Communication Technology (ICT).

Information technology-related contracts means those contracts which include services (including support services), and related resources for information technology as defined in 802.101.

Privacy officer means the VA official with responsibility for implementing and oversight of privacy related policies and practices that impact a given VA acquisition.

Sensitive personal information means, with respect to an individual, any information about the individual maintained by VA, including but not limited to the following:

(1) Education, financial transactions, medical history, and criminal or employment history.

(2) Information that can be used to distinguish or trace the individual’s identity, including but not limited to name, social security number, date and place of birth, mother’s maiden name, or biometric records.

Security plan means a formal document that provides an overview of the security requirements for an information system or an information security program and describes the security controls in place or planned for meeting those requirements.

VA Information Security Rules of Behavior for Organizational Users (VA National Rules of Behavior) means a set of VA rules that describes the responsibilities and expected behavior of users of VA information or information systems.

VA sensitive information means all VA data, on any storage media or in any form or format, which requires protection due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the information and includes sensitive personal information. The term includes information where improper use or disclosure could adversely affect the ability of VA to accomplish its mission, proprietary information, records about individuals requiring protection under various confidentiality provisions such as the Privacy Act and the HIPAA Privacy Rule, and information that can be withheld under the Freedom of Information Act. Examples of VA sensitive information include the following:

individually-identifiable medical, benefits, and personnel information; financial, budgetary, research, quality assurance, confidential commercial, critical infrastructure, investigatory, and law enforcement information; information that is confidential and privileged in litigation such as information protected by the deliberative process privilege, attorney work-product privilege, and the attorney-client privilege; and other information which, if released, could result in violation of law or harm or unfairness to any individual or group, or could adversely affect the national interest or the conduct of Federal programs.

(b) General. Contractors, subcontractors, their employees, third-parties, and business associates with access to VA information, information systems, or information technology (IT) or providing and accessing IT-related goods and services, shall adhere to VA Directive 6500, VA Cybersecurity Program, and the directives and handbooks in the VA 6500 series related to VA information (including VA sensitive information and sensitive personal information and information systems security and privacy), as well as those set forth in the contract specifications, statement of work, or performance work statement. These include, but are not limited to, VA Handbook 6500.6, Contract Security; and VA Directive and Handbook 0710, Personnel Security and Suitability Program, which establishes VA’s procedures, responsibilities, and processes for complying with current Federal law, Executive Orders, policies, regulations, standards and guidance for protecting VA information, information systems (see 802.101, Definitions) security and privacy, and adhering to personnel security requirements when accessing VA information or information systems.

(c) Access to VA information and VA information systems.

(1) Contractors are limited in their request for logical or physical access to VA information or VA information systems for their employees, subcontractors, third parties and business associates to the extent necessary to perform the services or provide the goods as specified in the contracts, agreements, task, delivery or purchase orders.

(2) All Contractors, subcontractors, third parties, and business associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors to access VA information and VA information systems shall be in accordance with VA Directive and Handbook 0710, Personnel Security and Suitability Program.

(3) Contractors, subcontractors, third parties, and business associates who require access to national security programs must have a valid security clearance.

(4) HIPAA Business Associate Agreement requirement. Contractors shall enter into a Business Associate Agreement (BAA) with VHA, VA’s Covered Entity, when contract requirements and access to protected health information is required and when requested by the Contracting Officer, or the Contracting Officer’s Representative (COR) (see VAAR 824.103–70). Under the HIPAA Privacy and Security Rules, a Covered Entity (VHA) must have a satisfactory assurance that its PHI will be safeguarded from misuse. To do so, a Covered Entity enters into a BAA with a contractor (now the business associate), which obligates the business associate to only use the Covered

Entity’s PHI for the purposes for which it was engaged, provide the same protections and safeguards as is required from the Covered Entity, and agree to the same disclosure restrictions to PHI that is required of the Covered Entity in situations where a contractor—

(i) Creates, receives, maintains, or transmits VHA PHI or that will store, generate, access, exchange, process, or utilize such PHI in order to perform certain health care operations activities or functions on behalf of the Covered Entity; or

(ii) Provides one or more of the services specified in the Privacy Rule to or for the Covered Entity.

(A) Contractors or entities required to execute BAAs for contracts and other agreements become VHA business associates. BAAs are issued by VHA or may be issued by other VA programs in support of VHA. The HIPAA Privacy Rule requires VHA to execute compliant BAAs with persons or entities that create, receive, maintain, or transmit VHA PHI or that will store, generate, access, exchange, process, or utilize such PHI in order to perform certain activities, functions or services to, for, or on behalf of VHA. There may be other VA components or staff offices which also provide certain services and support to VHA and must receive PHI in order to do so. If these components award contracts or enter into other agreements, purchase/delivery orders, modifications and issue governmentwide purchase card transactions to help in the delivery of these services to VHA, they will also fall within the requirement to obtain a satisfactory assurance from these contractors by executing a BAA.

(B) BAA requirement flow down to subcontractors. A prime Contractor required to execute a BAA shall also obtain a satisfactory assurance, in the form of a BAA, that any of its subcontractors who will also create, receive, maintain, or transmit VHA PHI or that will store, generate, access, exchange, process, or utilize such PHI will comply with HIPAA requirements to the same degree as the Contractor. Contractors employing a subcontractor who creates, receives, maintains, or transmits VHA PHI or that will store, generate, access, exchange, process, or utilize such VHA PHI under a contract or agreement is required to execute a BAA with each of its subcontractors which also obligates the subcontractor (i.e., also a business associate) to provide the same protections and safeguards and agree to the same disclosure restrictions to VHA’s PHI that is required of the Covered Entity and the prime Contractor.

(d) Contractor operations required to be in United States. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practicable. If such services are proposed to be performed outside the continental United States, and are not otherwise disallowed by other Federal law, regulations or policy, or other VA policy or other mandates as stated in the contract, specifications, statement of work or performance work statement (including applicable Business Associate Agreements), the Contractor/subcontractor must state in its proposal where all non-U.S. services are provided. At a minimum, the Contractor/ subcontractor must include a detailed Information Technology Security Plan, for review and approval by the Contracting Officer, specifically to address mitigation of the resulting problems of communication, control, and data protection.

(e) Contractor/subcontractor employee reassignment and termination notification.

Contractors and subcontractors shall provide written notification to the Contracting Officer and Contracting Officer’s Representative (COR) immediately, and not later than four (4) hours, when an employee working on a VA information system or with access to VA information is reassigned or leaves the Contractor or subcontractor’s employment on the cognizant VA contract. The Contracting Officer and COR must also be notified immediately by the Contractor or subcontractor prior to an unfriendly termination.

(f) VA information custodial requirements.

(1) Release, publication, and use of data. Information made available to a Contractor or subcontractor by VA for the performance or administration of a contract or information developed by the Contractor/subcontractor in performance or administration of a contract shall be used only for the stated contract purpose and shall not be used in any other way without VA’s prior written approval. This clause expressly limits the Contractor’s/ subcontractor’s rights to use data as described in Rights in Data— General, FAR 52.227–14(d).

(2) Media sanitization. VA information shall not be co-mingled with any other data on the Contractors/subcontractor’s information systems or media storage systems in order to ensure federal and VA requirements related to data protection, information segregation, classification requirements, and media sanitization can be met (see VA Directive 6500, VA Cybersecurity Program). VA reserves the right to conduct scheduled or unscheduled on-site inspections, assessments, or audits of Contractor and subcontractor IT resources, information systems and assets to ensure data security and privacy controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with Federal and VA requirements. The Contractor and subcontractor will provide all necessary access and support to VA and/or GAO staff during periodic control assessments or audits.

(3) Data retention, destruction, and contractor self-certification.