S02 Hamilton G5 Ventilators Service Maintenance.pdf

PAGE 1 OF 1. REQUISITION NO.

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

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

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

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

SEE ADDENDUM

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

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

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

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

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

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

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

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

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

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C25724Q0655 05-22-2024

Angela Kyte 210-694-6200 05-28-2024

10:00 CDT

36C671 Department Of Veterans Affairs Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

X 100

X

339112

1000 Employees

N/A

X

Department of Veterans Affairs Dallas VA Medical Center 4500 S. Lancaster Road

Dallas TX 75216

36C671

Department Of Veterans Affairs Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

This requirement is being procured as an 100% SDVOSB set-aside.

Please see Section B for Statement of Work and Price / Cost Schedule.

Please submit all questions to angela.kyte@va.gov by

05/24/2024 @10:00AM CST.

Please review 52.212-2 for evaluation criteria.

Please submit all documentation via email to angela.kyte@va.gov

See CONTINUATION Page

X X

X 1

Rafael Rodriguez Contracting Officer

36C25724Q0655

Table of Contents

SECTION A

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

COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2023)

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

C.3 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (FEB 2024)

C.4 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.5 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.6 52.222-55 MINIMUM WAGES FOR CONTRACTOR WORKERS UNDER EXECUTIVE

ORDER 14026 (DEVIATION) (OCT 2023) (JAN 2022)

C.7 VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED SERVICE-

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

C.8 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.9 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018) . 42

C.10 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) ......... Error!

Bookmark not defined.

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

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

COMMERCIAL SERVICES (SEP 2023)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND

VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

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

REPRESENTATION AND DISCLOSURES (DEC 2023)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)53

E.6 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

(NOV 2021)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (FEB 2024)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C257 Rafael Rodriguez

Department Of Veterans Affairs

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

Transaction # 549-25-2-096-0003

General: The contractor shall provide service support for our Hamilton G5/MR-1 Ventilators and corresponding components located at the VA Medical Center located in Dallas, TX, which is part of the VA North Texas Healthcare System (VANTHCS). The Hamilton G5 Ventilators is a ventilator for adult patients, offering ventilation with responsive flow triggering and volume monitoring. It is utilized for complex, critically ill patients in all ICU settings.

Description of Work: The contractor shall provide all required service, repair, PM, ES inspection, reporting, and parts for the Hamilton G5/MR-1 Ventilator’s software and equipment in accordance with the original equipment manufacturer (OEM) specifications. Field service engineers must be licensed or contracted with the original manufacturer in order to work on the equipment. All parts must be certified new from the original manufacturer. The C&A requirements do not apply, and that a Security Accreditation Package is not required. Reference below for equipment type and the required service:

Equipment Description: Hamilton G5/MR-1 Ventilators

EE# SN# Manufacturer Model Equipment category Location

176246 21948 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176247 22011 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE

5A109P-2J- D

176248 22000 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5B250-2J-D

176249 21996 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE

5A109K-2J- D

176250 21979 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE

5A124G-2J- D

176251 21937 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176252 21970 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176253 22003 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A124L-2J-D

176254 21990 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE

5A109S-2J- D

176255 21983 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE

5A109P-2J- D

176256 21809 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE

5A109N-2J- D

176257 21958 HAMILTON HAMILTON- VENTILATORS: INTENSIVE 5A293-2J-D

CO G5 CARE

176258 21998 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5B230-2J-D

176259 21945 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE

5A124M-2J- D

176260 21976 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE BC100B-2-D

176261 21993 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176262 22008 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5B251-2J-D

176263 22013 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176264 21849 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A109L-2J-D

176265 21946 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176266 22006 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176267 21775 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE

5B500Q-2J- D

176268 21637 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176269 21999 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5B251-2J-D

176270 22009 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176271 21977 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176295 22014 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176296 21965 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE

5B500Q-2J- D

176297 21943 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5B251-2J-D

176298 22007 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE

5A109V-2J- D

176299 22004 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176300 21806 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A124F-2J-D

176301 21997 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176302 21856 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176303 22012 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176304 22001 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5A293-2J-D

176305 21995 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE

5A124A-2J- D

176417 21866 HAMILTON HAMILTON- VENTILATORS: INTENSIVE BC100B-2-D

CO G5 CARE

189200 23618 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5B201-2J-D

189203 23619 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5B201-2J-D

189204 23621 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5B201-2J-D

189192 22532 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5B201-2J-D

189193 22533 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5B201-2J-D

189194 22661 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5B201-2J-D

189195 23473 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5B201-2J-D

189196 23598 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5B201-2J-D

189197 23604 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5B201-2J-D

189205 23622 HAMILTON

CO

HAMILTON-

G5

VENTILATORS: INTENSIVE

CARE 5B201-2J-D

176286 3532 HAMILTON

CO

HAMILTON-

MR1

VENTILATORS:

TRANSPORT 5A109J-2J-D

176287 3503 HAMILTON

CO

HAMILTON-

MR1

VENTILATORS:

TRANSPORT 5A212-2J-D

Components of the Hamilton G5/MR-1 Ventilators requiring maintenance service coverage include;

• Ventilators

• Cables, Parts

The coverage of the full-service consists of:

• Repairs

• Parts

• Preventative maintenance

• Inspection

• Equipment tracking

• Reporting of issues.

Field service engineers, project managers, or other support staff must be licensed or contracted with the original manufacturer in order to work on the equipment. All parts must be certified new from the original manufacturer. We have had an initial inspection by Outset Medical and they have determined the part numbers above. The vendor shall commence work within 24 hours of receiving award PO.

Vendor shall not commence work without receiving written authorization by the COR.

Hours spent towards the project will be sent to the COR each Friday for tracking purposes.

Hours of Performance: Work shall occur Monday – Friday during normal duty hours. After hours work is authorized upon approval of Biomedical Engineering department. Service shall start upon contract award. Delivery for all issues requiring corrective and periodic maintenance shall be available during standard business hours. Telephone and remote diagnostics shall be available during standard business hours.

Holiday Date New Year’s January 1st Martin Luther King’s Birthday 3rd Monday in January President’s Day 3rd Monday in February Memorial Last Monday in May Juneteenth June 19th Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veteran’s Day November 11th Thanksgiving Day 4th Thursdays in November Christmas Day December 25th

Check in Requirements: The Field Service Engineer must report to the Biomedical Engineering Department to obtain a badge and sign in with the Biomedical Engineering Service before work begins. Submit any mobile media devices that would be used on the system to a virus scan. Upon completion of work, the Field Service Engineer must report to the Biomedical Engineering Service to sign out and brief Biomedical Staff or Supervisor if Biomedical Staff is unavailable concerning completion of service. At the end of briefing Field Service Engineer will return the badge and sign out in the Biomedical Engineering Department.

Unscheduled Maintenance (Repair Service):

A. Contractor shall maintain the equipment in accordance with the manufacturer's specifications. The Contractor will provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. All required parts shall be furnished.

B. The Contracting Officer, Contracting Officer’s Representative or designated alternate has the authority to approve/request a service call from the Contractor.

C. Response Time: - Contractor's FSE must respond with a phone call to the COR or his/her designee within two (2) hours after receipt of telephoned notification from 8 a.m.

to 9 p.m. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within two (2) hours after receipt of this second notification and will proceed progressively to completion without undue delay.

Scheduled Maintenance:

A. The Contractor shall perform preventative maintenance (PM) to ensure that equipment listed in the schedule performs in accordance with TJC, NFPA-99, UL, OSHA, VA, and CDRH Standards. (An outline of the PM procedures and schedule shall be provided to the Biomedical Engineering Department). The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (if applicable). This documentation shall be provided to Biomedical Engineering at the completion of the PM. The contractor shall provide written description of Preventive Maintenance Inspections (PMI). This description shall include an itemized list of the procedures performed, including electrical safety. PM services shall include, but need not be limited to, the following:

a. Reviewing operating system software diagnostics to ensure that the system is operating in accordance with Section 3, Conformance Standards or the manufacturer's specifications.

b. Calibrating and lubricating the equipment.

c. Performing remedial maintenance of non-emergent nature.

d. Testing and replacing faulty and worn parts and/or parts likely to become faulty, fail or become worn.

e. Inspecting and replacing where indicated, electrical wiring and cables for wear and fraying.

f. Inspecting, and replacing where indicated, all mechanical components which may include, but is not limited to: X-ray tube mounting hardware, patient restraints and support devices, cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, keyboards, and patient couches for mechanical integrity, safety, and performance.

g. Returning the equipment to the operating condition defined in Section 3, Conformance Standards.

h. Providing documentation of services performed.

i. Inspecting and calibrating the hard copy image device.

B. PM services shall be performed in accordance with, and during the hours defined in, the preventive maintenance schedule established herein. All exceptions to the PM schedule shall be arranged and approved in advance with the COR.

C. Any charges for parts, services, manuals, tools, or software required to successfully complete scheduled PM are included within this contract, and its agreed upon price, unless specifically stated in writing otherwise.

Documentation: Contractor shall furnish a detailed field service report upon completion of work to Biomedical Staff in the Biomed Department. Payment will not be processed until a properly completed service report is received. The service report shall contain, at a minimum, the following information:

• Type, model, System ID, and serial number (s) of all equipment on which maintenance was performed.

• Total time spent performing maintenance.

• Detailed narrative description of the services required

• Copies of all test reports

• Complete list of parts replaced

• Date and time the repair was completed

The service report shall itemize every item in the specification. Each item shall state the "as found" condition or values, the "calibrated to" or "adjusted to" values, the factory design tolerances, and a complete description of all work performed concerning the items. Included will be a list of new parts used and recommended future repairs.

Period of Performance:

Base Year: 6/3/2024 – 6/2/2025 Option Year 1: 6/3/2025 – 6/2/2026

Place of Performance:

Department of Veterans Affairs Dallas VA Medical Center 4500 S. Lancaster Road Dallas, Texas 75216

Contracting Officer Representatives: Prior to contract award, the Contracting Officer shall designate a VA Medical Center employee as the COR. All work coordination shall be made through the COR. The Contractor shall be provided a copy of the letter of delegation authorizing the COR at the commencement of the term of the contract. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer.

Information Technology Security Requirements: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. The contractor shall comply with all Federal laws and regulations the VA has developed when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor. The information made available to the contractor by VA for the performance of this contract will be used only for the purposes of performance under this contract. The certification and accreditation requirements do not apply to this requirement and a security accreditation package is not required.

Security Statement: Sensitive VA information is contained within the systems covered by this contract.

Biomedical Engineering shall perform virus scans on all removable media prior to use on VA medical equipment. This includes all types of removable media, including media (e.g., USB devices, CDs, dongles, etc.) that has been issued by VA, media not issued by VA, and media brought in by vendors or independent service organizations. Within accordance of VA Directive 6500, Information Security Program, September 2007

The Vendor will not transfer any VA information to a location outside the VA and only to VA locations determined by the VA System Administrator. The information in these systems may be covered by the Privacy Act 1974 which contains criminal penalties of abuse of information.

During onsite service, the Vendor shall be chaperoned by VA Personnel. However, the vendor shall not be issued a User ID/Password.

Non-volatile memory devices, working or non-working, shall NOT be removed from the VA Medical Center Dallas until the ISO has certified that the data has been destroyed. For magnetic devices and media, the data destruction will be by degaussing. Other forms of cleansing will be used for non-magnetic media.

The vendor will not have remote access to complete the repair(s) and preventive maintenance.

Non-volatile memory devices, working or non-working, shall NOT be removed from the VA facility until the ISO has certified that the data has been destroyed. For magnetic devices and media, the data destruction will be by degaussing. Other forms of cleansing will be used for non-magnetic media.

The vendor will have remote access to complete the repair(s) and preventive maintenance.

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and 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 must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. 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).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA.

Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the

COTR.

GENERAL RULES OF BEHAVIOR

a. Rules of Behavior are part of a comprehensive program to provide complete information security. These rules establish standards of behavior in recognition of the fact that knowledgeable users are the foundation of a successful security program. Users must understand that taking personal responsibility for the security of their computer and the information it contains is an essential part of their job.

b. The following rules apply to all VA contractors. I agree to:

(1) Follow established procedures for requesting, accessing, and closing user accounts and access. I will not request or obtain access beyond what is normally granted to users or by what is outlined in the contract. (2) Use only systems, software, databases, and data which I am authorized to use, including any copyright restrictions. (3) I will not use other equipment (OE) (non-contractor owned) for the storage, transfer, or processing of VA sensitive information without a VA CIO approved waiver, unless it has been reviewed and approved by local management and is included in the language of the contract. If authorized to use OE IT equipment, I must ensure that the system meets all applicable 6500 Handbook requirements for OE. (4) Not use my position of trust and access rights to exploit system controls or access information for any reason other than in the performance of the contract. (5) Not attempt to override or disable security, technical, or management controls unless expressly permitted to do so as an explicit requirement under the contract or at the direction of the COTR or ISO. If I am allowed or required to have a local administrator account on a government-owned computer, that local administrative account does not confer me unrestricted access or use, nor the authority to bypass security or other controls except as expressly permitted by the VA CIO or CIO's designee. (6) Contractors’ use of systems, information, or sites is strictly limited to fulfill the terms of the contract. I understand no personal use is authorized. I will only use other Federal government information systems as expressly authorized by the terms of those systems. I accept that the restrictions under ethics regulations and criminal law still apply. (7) Grant access to systems and information only to those who have an official need to know. (8) Protect passwords from access by other individuals. (9) Create and change passwords in accordance with VA Handbook 6500 on systems and any devices protecting VA information as well as the rules of behavior and security settings for the particular system in question. (10) Protect information and systems from unauthorized disclosure, use, modification, or destruction. I will only use encryption that is FIPS 140-2 validated to safeguard VA sensitive information, both safeguarding VA sensitive information in storage and in transit regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA. (11) Follow VA Handbook 6500.1, Electronic Media Sanitization to protect VA information. I will contact the COTR for policies and guidance on complying with this requirement and will follow the COTR's orders. (12) Ensure that the COTR has previously approved VA information for public dissemination, including e-mail communications outside of the VA as appropriate. I will not make any unauthorized disclosure of any VA sensitive information through the use of any means of communication including but not limited to e-mail, instant messaging, online chat, and web bulletin boards or logs. (13) Not host, set up, administer, or run an Internet server related to my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA unless explicitly authorized under the contract or in writing by the COTR. (14) Protect government property from theft, destruction, or misuse. I will follow VA directives and handbooks on handling Federal government IT equipment, information, and systems. I will not take VA sensitive information from the workplace without authorization from the COTR. (15) Only use anti-virus software, antispyware, and firewall/intrusion detection software authorized by VA. I will contact the COTR for policies and guidance on complying with this requirement and will follow the COTR's orders regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with VA. (16) Not disable or degrade the standard anti-virus software, antispyware, and/or firewall/intrusion detection software on the computer I use to access and use information assets or resources associated with my performance of services under the contract terms with VA. I will report anti-virus, antispyware, firewall or intrusion detection software errors, or significant alert messages to the COTR. (17) Understand that restoration of service of any VA system is a concern of all users of the system. (18) Complete required information security and privacy training, and complete required training for the particular systems to which I require access.

PRIVACY

a. Contractors and any subcontractors must adhere to the provisions of Public Law 104-

191, Health Insurance Portability and Accountability Act (HIPAA) of 1996. This includes both the Privacy and Security Rules published by the Department of Health and Human Services (HHS).

b. As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities, Veterans Health Administration (VHA).

In accordance with HIPAA, the contractor may be required to enter into a Business Associate Agreement (BAA) with VHA.

c. Business associates must follow VHA privacy policies and practices when applicable.

All contractors and business associates must receive privacy training annually.

d. For contractors and business associates who do not have access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training, other VHA approved privacy training or contractor furnished training that meets the requirements of the HHS Standards for Privacy of Individually Identifiable Health Information as determined by VHA.

e. For contractors and business associates who are granted access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training or other VHA approved privacy training. Proof of training is required upon request.

Records Management Statement:

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VA Medical Center Dallas and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of the VA Medical Center Dallas or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VA Medical Center Dallas. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VA Medical Center Dallas control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts.

The Contractor (and any sub-contractor) is required to abide by Government and VA Medical Center Dallas guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA Medical Center Dallas policy.

8. The Contractor shall not create or maintain any records containing any non-public VA Medical Center Dallas information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The VA Medical Center Dallas owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VA Medical Center Dallas shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

12.00 MO ____________ _______________

Full service coverage for Hamilton-MR1 ventialtor, including

PM

Ventialtors included:

176246 176247 176248 176249 176250 176251 176252 176253 176254 176255 176256 176257 176258 176259 176260 176261 176262 176263 176264 176265 176266 176267 176268 176269 176270 176271 176295 176296 176297 176298 176299 176300 176301 176302 176303 176304 176305 176417 189200 189203 189204 189192

189193 189194 189195 189196 189197 189205 Contract Period: Base POP Begin: 06-03-2024 POP End: 06-02-2025 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, and Rebuilding of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

Full service coverage (1-year) for Hamilton-GS ventialtors, including PMs.

Ventialtors included:

176246 176247 176248 176249 176250 176251 176252 176253 176254 176255 176256 176257 176258 176259 176260 176261 176262 176263 176264 176265 176266 176267 176268 176269 176270 176271 176295 176296 176297 176298 176299 176300 176301 176302 176303 176304 176305 176417 189200 189203 189204 189192 189193 189194 189195 189196 189197 189205 Contract Period: Option 1 POP Begin: 06-03-2024 POP End: 06-02-2025 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, Full service coverage for Hamilton-MR1 ventialtor, including

PM

Ventialtors included:

176246 176247 176248 176249 176250 176251 176252 176253 176254 176255 176256 176257 176258 176259 176260 176261 176262 176263 176264 176265 176266 176267 176268 176269 176270 176271 176295 176296 176297 176298 176299 176300 176301 176302 176303 176304 176305 176417 189200 189203 189204 189192 189193 189194 189195 189196 189197 189205 Contract Period: Option 1 POP Begin: 06-03-2025 POP End: 06-02-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, Full service coverage (1-year) for Hamilton-GS ventialtors, including PMs.

Ventialtors included:

176246 176247 176248 176249 176250 176251 176252 176253 176254 176255 176256 176257 176258 176259 176260 176261 176262 176263 176264 176265 176266 176267 176268 176269 176270 176271 176295 176296 176297 176298 176299 176300 176301 176302 176303 176304 176305 176417 189200 189203 189204 189192 189193 189194 189195 189196 189197 189205 Contract Period: Option 1 POP Begin: 06-03-2025 POP End: 06-02-2026 PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, GRAND

TOTAL

B.4 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001-

SHIP TO: Department of Veterans Affairs Dallas VA Health Care System 4500 South Lancaster Road Dallas, TX 75216 United States

12.00 06/03/2024 to 06/02/2026

MARK FOR: Daniel Clarke ntxbiomedicalengineers@va.gov

FOB: DESTINATION

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)

(a) 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.

(b) 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.

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

(d) 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 at Federal Acquisition Regulation (FAR) 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(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 such as, 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. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(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…