RFQ Combined Synopsis 36C24425Q0724.docx

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J&J Ethicon NeuWave Ablation System PM&R
Solicitation number
36C24425Q0724
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This is a Request for Quote (RFQ) issued by the Department of Veterans Affairs Network Contracting Office 4 for full-service maintenance of a J&J Ethicon NeuWave Microwave Ablation system located at the VA Pittsburgh Healthcare System. The solicitation (36C24425Q0724) seeks a five-year contract from July 31, 2025 to July 30, 2030, with a base year and four one-year option periods. The procurement is classified under NAICS code 811210 for Electronic and Precision Equipment Repair and Maintenance, with a business size standard of $34.0 million, and will be competed on a full and open competitive basis.

Vendors must submit comprehensive quotes by June 20, 2025, at 10:00 AM Eastern Time, with specific requirements including technical, administrative, pricing, and past performance sections. The contract will be firm-fixed-price, and offerors must be registered in the System for Award Management (SAM). Quotes will be evaluated using a comparative evaluation methodology considering technical acceptability, price, past performance, and socioeconomic factors. The solicitation emphasizes the critical nature of the medical equipment, requiring unlimited telephone support, on-site service, and a guaranteed 98% system uptime. Vendors must comply with various federal regulations, including VA security guidelines, privacy requirements, and accessibility standards.

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36C24425Q0724

SUBJECT*
J&J Ethicon NeuWave PM&R | NCO 4 Services 3

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*
15215
SOLICITATION NUMBER*
36C24425Q0724
RESPONSE DATE/TIME/ZONE
06-20-2025 10:00 EASTERN TIME, NEW YORK, USA
ARCHIVE
7 DAYS AFTER THE RESPONSE DATE
RECOVERY ACT FUNDS
N

SET-ASIDE

PRODUCT SERVICE CODE*
J065
NAICS CODE*
811210
CONTRACTING OFFICE ADDRESS
Department of Veterans Affairs

Network Contracting Office 4

1010 Delafield Road Pittsburgh PA 15215

POINT OF CONTACT*

Contract Specialist Haley Snyder haley.snyder@va.gov

PLACE OF PERFORMANCE

ADDRESS
VA Pittsburgh Healthcare System

University Drive Campus

4100 Allequippa St

Pittsburgh PA

POSTAL CODE
15240
COUNTRY
USA

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 in conjunction with Part 13 of Federal Acquisition Regulation (FAR), as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. This Solicitation is issued as a Request for Quote (RFQ), and the solicitation number is 36C24425Q0724.

This notice incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2025-03 effective 17 January 2025, and the Veterans Affairs Acquisition Regulations (VAAR). The complete text of any of the clauses and provisions may be accessed in full text at FAR | Acquisition.GOV.

This Solicitation is being competed on a full and open competitive basis. The Government reserves the right to make split awards as a result of this solicitation. The NAICS Code is 811210 – Electronic and Precision Equipment Repair and Maintenance and the Product Service Code (PSC) is J065 Maintenance, Repair, and Rebuilding of Equipment – Medical, Dental, and Veterinary Equipment and Supplies and the business size standard is $34.0 million.

The Network Contracting Office 04 is seeking Full-Service Maintenance of the VA Pittsburgh Medical Center owned J&J Ethicon NeuWave Microwave Ablation system. The Statement of Work (SOW) is provided.

Complete instructions for submitting a response to this solicitation and applicable provisions and clauses are found in “36C24425Q0724.” All offerors are advised to pay careful attention to the quote submission instructions as there are very specific instructions as what is required to be provided.

The period of performance (POP) is estimated to be 7/31/2025 – 07/30/2030.

Any award resulting from this solicitation will be issued on a Standard Form 1449.

NOTE: To receive an award resulting from this solicitation, offerors MUST be registered in the System for Award Management (SAM) database. Registration may be done online at: www.acquisition.gov or www.sam.gov.

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the contract specialist, Haley Snyder at haley.snyder@va.gov. No questions will be answered after 17 June 2025, 10:00 AM EST.

Point of Contact Haley Snyder Contract Specialist Services 3 (Medical Equipment Maintenance Services) Department of Veterans Affairs/Regional Procurement Office - East/Network Contracting Office 4 Haley.snyder@va.gov

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

*= Required Field
Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS6
B.1 CONTRACT ADMINISTRATION DATA6
B.2 PRICE/COST SCHEDULE7
ITEM INFORMATION7
B.3 DELIVERY SCHEDULE8
B.4 STATEMENT OF WORK9
SECTION C - CONTRACT CLAUSES19
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2023)19
C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025)25
C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)33
C.4 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)33
C.5 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)33
C.6 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)34
C.7 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (JAN 2023) (DEVIATION)34
C.8 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)35
C.9 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)35
C.10 VAAR 852.239-76 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY (FEB 2023)36
C.11 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)37
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS38
SECTION E - SOLICITATION PROVISIONS38
E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)38
E.2 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)41
E.3 52.2122 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)47
E.4 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION FEB 2025)48
E.5 52.216-1 TYPE OF CONTRACT (APR 1984)66
E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)66
E.7 VAAR 852.239-75 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY NOTICE (FEB 2023)66

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: TBD

b. GOVERNMENT: Contracting Officer 36C244 Department of Veterans Affairs Network Contracting Office 4

1010 Delafield Road Pittsburgh PA 15215

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] Upon receipt, inspection and acceptance by the Government

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:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
12.00
MO
___________
_____________

NEUWAVE SERVICE PREMIER - EQUIPMENT: EE# 432891, SN# NM23NEA01129 IAW Statement of Work.

Contract Period: Base POP Begin: 07-31-2025 POP End: 07-30-2026 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, and Rebuilding of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

12.00
MO
___________
_____________

NEUWAVE SERVICE PREMIER - EQUIPMENT: EE# 432891, SN# NM23NEA01129 IAW Statement of Work.

Contract Period: Option 1 POP Begin: 07-31-2026 POP End: 07-30-2027

PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, and Rebuilding of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

12.00
MO
___________
_____________

NEUWAVE SERVICE PREMIER - EQUIPMENT: EE# 432891, SN# NM23NEA01129 IAW Statement of Work.

Contract Period: Option 2 POP Begin: 07-31-2027 POP End: 07-30-2028

PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, and Rebuilding of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

12.00
MO
___________
______________

NEUWAVE SERVICE PREMIER - EQUIPMENT: EE# 432891, SN# NM23NEA01129 IAW Statement of Work.

Contract Period: Option 3 POP Begin: 07-31-2028 POP End: 07-30-2029

PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, and Rebuilding of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

12.00
MO
__________
_____________

NEUWAVE SERVICE PREMIER - EQUIPMENT: EE# 432891, SN# NM23NEA01129 IAW Statement of Work.

Contract Period: Option 4 POP Begin: 07-31-2029 POP End: 07-30-2030

PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, and Rebuilding of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

GRAND TOTAL
______________

B.3 DELIVERY SCHEDULE

ITEM NUMBER
SHIPPING INFORMATION
QUANTITY
DELIVERY DATE
0001
SHIP TO:
Department of Veteran Affairs

VA Pittsburgh Healthcare System - University Drive 4100 Allequippa St Pittsburgh, PA 15240

USA

12.00
07/31/2025-07/30/2026
MARK FOR:
Kiersten Elliott

412-360-3012 Kiersten.Elliott@va.gov

1001
SHIP TO:
Department of Veteran Affairs

VA Pittsburgh Healthcare System - University Drive 4100 Allequippa St Pittsburgh, PA 15240

USA

12.00
07/31/2026-07/30/2027
MARK FOR:
Kiersten Elliott
2001
SHIP TO:
Department of Veteran Affairs

VA Pittsburgh Healthcare System - University Drive 4100 Allequippa St Pittsburgh, PA 15240

USA

12.00
07/31/2027-07/30/2028
MARK FOR:
Kiersten Elliott
3001
SHIP TO:
Department of Veteran Affairs

VA Pittsburgh Healthcare System - University Drive 4100 Allequippa St Pittsburgh, PA 15240

USA

12.00
07/31/2028-07/30/2029
MARK FOR:
Kiersten Elliott
4001
SHIP TO:
Department of Veteran Affairs

VA Pittsburgh Healthcare System - University Drive 4100 Allequippa St Pittsburgh, PA 15240

USA

12.00
07/31/2029-07/30/2030
MARK FOR:
Kiersten Elliott

Page 1 of Page 1 of Page 1 of Page 1 of

B.4 STATEMENT OF WORK

A. GENERAL GUIDANCE

1. Title: Full-Service Maintenance of the VA Pittsburgh Medical Center owned J&J Ethicon NeuWave Microwave Ablation system.

2. Scope of Work: The contractor shall provide full-service maintenance of government owned J&J Ethicon NeuWave Microwave Ablation system, telephone support and onsite support, in accordance with the requirements stated herein. The facility is located at:

VA Pittsburgh Healthcare System University Drive Campus 4100 Allequippa St Pittsburgh, PA 15240

3. Background: This contract is issued to ensure the continuous reliability of the J&J Ethicon NeuWave system identified in this SOW. This system is used in surgery for ablation of soft tissue, including liver tumors. The unit requires repair and maintenance by trained personnel using manufacturer approved parts and specifications. This unit is critical for continuous patient care throughout the VA Pittsburgh Medical Center and the reliable and accurate operation of the equipment at all times is considered critical to the health of patients.

4. Performance period: One-year base plus four one-year option periods.

Base Year:July 31, 2025 - July 30, 2026
Option Year 1:July 31, 2026 - July 30, 2027
Option Year 2:July 31, 2027 - July 30, 2028
Option Year 3:July 31, 2028 - July 30, 2029
Option Year 4:July 31, 2029 - July 30, 2030

5. Type of Contract: Firm-Fixed-Price.

B. GENERAL REQUIREMENTS

1. This agreement includes all preventative maintenance and corrective maintenance repairs to the ablation system for continuous reliability.

a. Equipment to be Serviced:

i. Each of the following items are to be serviced in accordance with the specifications, terms and conditions of this contract.

1. J&J Ethicon NeuWave System: EE# 432891, SN# NM23NEA01129

b. Corrective Maintenance:

i. The Contractor and Biomedical Engineering shall maintain the equipment in accordance with Section D Conformance Standards. Service for corrective maintenance will be provided per hours of coverage defined in Section B.1g. Contractor shall provide unlimited telephone technical support, labor, travel, and parts, unless specifically excluded.

ii. Service calls to the Contractor requesting service are only authorized when they are received from the point of contact (POC), or designated alternate and first approved by the Contracting Officer (CO).

iii. Unplanned repairs require remote troubleshooting session prior to Field Service Engineer (FSE) dispatch.

iv. Outside of the Contract’s hours of coverage, emergency on-site services require authorization by the CO. The POC or a Biomedical Engineering Staff Member shall initiate these calls. If VA staff other than the POC or a Biomedical Engineering Staff Member place calls requesting services, the Contractor shall contact Biomedical Engineering Services and verify the request. Service responses on calls from unauthorized personnel can result in nonpayment.

v. Uncorrected deficiencies or unfavorable histories of downtime can result in the termination of this contract under the Termination for Default clauses of the Federal Acquisition Regulations.

c. Preventative Maintenance:

i. The Contractor shall perform preventative maintenance (PM) service to ensure that equipment listed in Section B.1a performs in accordance with Section D Conformance Standards. Any exceptions to the PM schedule shall be arranged and approved in advance with the POC.

ii. The Contractor shall provide complete and original documentation indicating PM work performed, referencing the procedures followed, actual tests and/or evaluation results obtained to the POC at the completion of the PM service.

iii. Parts (including required consumable parts, gases, reference catheters and footswitches as well as shipment charges), travel, and labor necessary for PM are provided by awarded contractor at no additional customer cost.

iv. Any charges for materials such as lubricants, fluids, cleaning supplies, services, manuals, or tools required for the Contractor to successfully complete scheduled PM shall be provided by the Contractor and are included within this contract and the agreed upon price.

v. Preventative maintenance will be provided at a scheduled time and must be scheduled at least one week in advance to minimize the impact to patient scheduling. All exceptions to the preventative maintenance schedule and procedure shall be addressed and approved in advanced with the POC. A designated staff member will accompany the Contractor as an observer during the inspection. The inspection shall be thorough and shall conform to manufacturer and Industry Standards for the equipment. Sufficient time shall be allowed to permit a thorough inspection and test of each device comprising the overall system. Maintenance work and inspections may be combined at the approval of the POC or alternate POC if down time is not considered significant.

vi. The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the POC, (in writing), of the existence or the development of any defects in, or repairs required to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The contractor shall furnish the POC with a written estimate of the cost to make necessary repairs.

d. Parts, Software, and Glassware

i. All parts supplied shall be OEM and fully compatible with existing equipment. No refurbished part shall be used in the repairs of units covered in this contract. The contract shall include all parts with the exception of consumable or expendable items. The contractor is required to install VA supplied parts when said parts are determined to be fully compatible. The determination of compatibility is at the discretion of the POC. All defective parts replaced become the property of the Contractor, unless otherwise specified by the POC or Alt POC.

ii. Software patches and quality updates are included under the terms of this contract and shall be applied in accordance with manufacturer specifications.

iii. Coverage for glassware is provided based on an estimated annual rotation.

e. Remote Service

i. The contractor must be able to provide remote support as needed by phone and via remote login to the equipment owned by VA Pittsburgh.

ii. Personnel with OEM equipment training will respond either directly by phone or remotely as deemed appropriate for the situation, within 30 minutes of the call for service. If situations are responded to by phone or remote system login do not resolve the service issue, OEM trained personnel will be required for an on-site visit within 4 hours after receipt of initial notification unless otherwise agreed upon, in writing, by the POC or Biomedical Engineering personnel. Full resolution is expected within 48 hours of initial call. If the contractor cannot remediate the issues within this timeframe, the POC or Alt POC shall be notified immediately and provided an estimated time for resolution.

iii. The contractor shall provide remote service. To achieve this, the contractor must have a current nationally-approved memorandum of understanding/interconnection security agreement (MOU/ISA). Without this document, the contractor will not be granted access to the systems based on the national policy. If the contractor cannot provide remote access following the VA policy, the contractor will not be considered for award.

f. System Uptime:

i. The contractor must guarantee a 98% uptime of all equipment outlined in B.1a over each 12-month contract period.

ii. Downtime will be calculated from the time a call is placed to the contractor to the time of repair completion and the system can be fully used. Uptime between 8am-5pm, Monday-Friday will be considered towards the overall uptime percentage for the contract.

g. Hours of Coverage:

i. The contractor will provide all required services within the normal business hours of 8am to 5pm (EST), Monday-Friday, excluding Federal holidays.

ii. All services shall be performed during these normal hours of coverage unless one of the following conditions exists:

1. The contractor wishes to furnish services at a time that is outside of the normal hours of coverage, at no additional cost to the Government, the contractor submits a request to the POC prior to the proposed start of the work, and the request is approved in writing by the POC before work is begun.

2. The POC directs that the services be furnished at a time that is outside the normal hours of coverage and the additional cost is recommended by the POC and authorized by the CO.

iii. Customer service shall respond to service request calls 24 hours a day, 7 days a week and all holidays.

iv. Work performed outside the normal hours of coverage must be preapproved by the CO. The Contractor will provide a written estimate of the charges prior to approval of the work.

v. Work performed outside the normal hours of coverage at the request of FSE/contractor shall be considered service performed during normal hours of coverage.

vi. There will be no additional charge for time spent waiting at the site during or after the normal hours of coverage for delivery of parts.

Note: Any hardware/software update/upgrade installations shall be scheduled and performed during normal hours of coverage at no additional charge to the government.

vii. Federal Holidays Observed by the VA Medical Center

New Year’s Day,
Martin Luther King, Jr. Day,

President’s Day (Washington’s birthday), Memorial Day, Juneteenth National Independence Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically designated by the President of the United States.

h. Customer Notification:

i. Contractor shall notify Biomedical Engineering and the Police service when they arrive on site. Contractor will schedule all preventative maintenance with Biomedical Engineering.

ii. When the service(s) is/are completed, the Field Service Engineer (FSE) shall document the services rendered on a legible Vendor Engineering Service Report (ESR) per Section E.

iii. The FSE shall be required to check out with the Biomedical Engineering Department and submit the ESR(s) to the POC. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to the POC for an "authorization signature." If the POC is unavailable, a signed “accepted copy” of the ESR shall be sent to the POC within five business days of work completion.

iv. FAILURE TO COMPLY, EITHER IN WHOLE OR IN PART, WITH EITHER THE NOTIFICATION OR ESR REQUIREMENTS WILL BE DEEMED SIGNIFICANT NON-COMPLIANCE WITH THE CONTRACT AND MAY BE JUSTIFICATION FOR TERMINATION OF THE CONTRACT.

C. DEFINITIONS/ACRONYMS:

1. Biomedical Engineering - Supervisor or designee, Phone Number (412) 360-3780

2. CO - Contracting Officer.

3. POC – Point of Contact. An assigned Biomedical Engineering Staff.

4. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or operative conditions. Service shall consist of calibration and testing in accordance with the manufacturer’s latest established service procedures to ensure operation of equipment within manufacturer’s or VA’s performance specifications, whichever is the most rigorous. PM includes cleaning, inspecting lubricating and testing all equipment. All equipment shall be operated at least one complete operating cycle at the end of each PM.

5. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VA Medical Center premises.

6. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

7. Acceptance Signature - VAPHS employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR.

8. Authorization Signature - POC's signature; indicates POC accepts work status as stated in ESR.

9. NFPA - National Fire Protection Association.

10. CDRH - Center for Devices and Radiological Health.

11. VAPHS - Department of Veterans Affairs Pittsburgh Healthcare System.

12. OEM - Original Equipment Manufacturer

13. Deliverables – Goods and services required for maintenance/repair.

D. CONFORMANCE STANDARDS:

Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, JC, NEC, OSHA, HIPAA, Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM’s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

E. DOCUMENTATION/REPORTS:

The documentation will include equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards. In addition, each ESR must at a minimum, document the following data legibly and in complete detail:

1. Name of Contractor

2. Name of FSE who performed services.

3. Contractor Service ESR Number/Log Number.

4. Date, Time (starting and ending), Hours-On-Site for service call.

5. VA Purchase Order Number(s) (if any) covering the call, if outside normal working hours.

6. Description of Problem Reported by POC/User.

7. Identification of Equipment to be serviced to include the following: Equipment ID # or EE# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers.

8. Itemized Description of Service(s) Performed: including Costs associated with after normal working hour services, Labor and Travel, Parts (with part numbers), Materials, and Circuit Location of problem/corrective action.

9. Total Cost to be billed.

10. Signatures from the following:

a. FSE performing services described.

b. VA Employee who witnessed service described.

c. POC signature.

11. Equipment downtime calculated in accordance with Conformance Standards.

Note: Any additional charges claimed must be approved by the POC before service is started.

F. SCHEDULE FOR DELIVERABLES

Draft copies of deliverables shall be provided to Biomedical Engineering staff at VAPHS before the contractor leaves the facility. If a final copy is provided, then a draft copy is not necessary. However, when a draft copy is provided, a final copy must be provided within 5 business days.

G. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties without CO authorization, shall be borne by the contractor.

H. SERVICE MANUALS/TOOLS/EQUIPMENT

1. VAPHS shall not provide service manuals or service diagnostic software to the contractor for use in providing services under this contract. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation, (such as: operational and service manuals, schematics, and parts list), which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the CO upon request.

2. Prior to commencement of work on this contract, the contractor shall make available, if requested, a copy of the current calibration certification of all test equipment that is to be used by the contractor in performing work under the contract. This certification shall also be provided on a periodic basis when requested by VAPHS. Test equipment calibration shall be traceable to a national standard.

I. CONDITION OF EQUIPMENT:

The contractor accepts responsibility for the equipment described in this scope of work, in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract.

J. CONTRACTOR EXPERIENCE REQUIREMENTS

Each respondent must be an authorized distributor and certified FSE of the original equipment manufacturer (OEM). This documentation shall be provided if requested by the POC or Biomedical Engineering.

K. SECURITY REQUIREMENTS

If working on-site, contractor will be required to comply with security guidelines. Contractor is required to:

1. Agree to follow VA Pittsburgh Policy LD-073 medical center policy (MCP) Vendor Access. Be registered on the vendor credentialing and visitor management system called Symplr - https://www.symplr.com/. Add VA PITTSBURGH HEALTHCARE SYSTEM UNIVERSITY DRIVE: PITTSBURGH, PA to their territory. Contractor must be “greenlighted” prior to working on site. Greenlight requires completed information and up to date documentation which includes an up-to-date flu vaccination, Tb test, Covid-19 vaccine, and HIPPA certification at a minimum.

2. The government shall not provide any additional compensation for cost to register staff in Symplr. Vendor shall follow most updated guidelines from the Occupational Safety & Health Administration (OSHA), Center for Disease Control (CDC), and Food & Drug Administration (FDA).

3. Check in with the VA Police and Biomedical Engineering (Ground floor, Room AN305C) each time they come on-site to perform contracted services or by obtaining a VA Contractor ID badge from the VA Police. VA ID badge must be worn at all times while on VA premises.

L. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD:

1. The contractor shall comply with the Federal/California OSHA Bloodborne Pathogens Standard. The contractor shall:

a. Have methods by which all employees are educated as to risks associated with bloodborne pathogens.

b. Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens.

c. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens.

d. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract.

M. INFLUENZA PREVENTION PROGRAM:

1. VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Healthcare personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full-time and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. Those HCP unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center.

2. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation:

a. Documentation of vaccination, e.g., signed record of immunization from a healthcare provider or pharmacy, or a copy of medical records documenting the vaccination.

b. Completed Healthcare Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine.

3. The contractor is required to submit annual certification to the POC that all contract staff performing services at VA facilities are in compliance with the VHA Directive 1192.

N. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the POC at the conclusion of the task order.

2. The POC will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized.

O. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS:

1. The contractor's FSE shall wear visible identification at all times while on the premises of VAPHS. Identification shall include, as a minimum, the employee’s name, position, and the contractor’s trade name.

2. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. VAPHS will not invalidate or make reimbursement for parking violations of the contractor under any conditions.

3. Smoking is prohibited inside any buildings and on premise at VAPHS. This covers all smoking and tobacco products, including but not limited to:

a. Cigarettes

b. Cigars

c. Pipes

d. Any other combustion of tobacco

e. Electronic nicotine delivery systems (ENDS), including but not limited to electronic or e-cigarettes, vape pens, or e-cigars.

f. Chewing tobacco

4. Cellular phones and two-way radios are not to be used within six feet of any medical equipment.

5. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

P. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Contractor may not have access to the VA network or any VA sensitive information under this contract.

Contractor owned computer equipment including laptops are not permitted to be connected to the VA network. Any removable storage device used in medical equipment must first be scanned by Biomed or OIT.

The language from VA Handbook 6500.6 is required in this contract.

All Contractors must receive Privacy training within 30 days of award and annually thereafter using one of the following methods:

1. Complete “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information” training by using VA’s TMS system (https://www.tms.va.gov/). Contractors may use the TMS Managed Self Enrollment method to complete the training in TMS. Proof of Privacy training shall be submitted to the POC upon initial completion and annually thereafter upon request.

2. Complete the hard copy version of “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information”. Signed training documents must be submitted to the POC.

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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 Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

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

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

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

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

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

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

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

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

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

(D) Contractor point of contact.

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

(6) Interest.

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

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

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

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

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

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

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

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

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in FAR 32.608-2 in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

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

(End of Addendum to 52.212-4)

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204–23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (DEC 2023) (Section 1634 of Pub. L. 115–91).

(3) 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115–232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.232–40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) (31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

[] (1) 52.203–6, Restrictions on Subcontractor Sales to the Government (JUN 2020),…

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