36C24425Q0355.docx

SUBJECT*

646-25-3-068-0043 | PM&R Imaging Equip Ethicon NeuWave | NCO 4 Services 3 (VA-25-00046600)

GENERAL INFORMATION

Network Contracting Office 4

1010 Delafield Road Pittsburgh, PA 15215

POINT OF CONTACT*

Contract Specialist Haley Snyder haley.snyder@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Special Notice

DESCRIPTION

Special Notice

NOTICE OF INTENT TO AWARD SOLE SOURCE: Department of Veterans Affairs (VA) Regional Procurement Office East (RPOE), Network Contracting Office 4 (NCO 4) intends to award a sole source contract pursuant to FAR 13.106-1(b) Ethicon US LLC. is located at 1000 US Highway Suite 202, Raritan, NJ 08869, for a one-year base period and four one-year option periods from 01 April 2025 through 31 March 2030.

The Pittsburgh VA Health Care System has a requirement for Full-Service Maintenance to Ethicon NeuWave Microwave Ablation System.

THIS NOTICE IS NOT A REQUEST FOR COMPETITIVE QUOTES; however, any responsible firm that believes it can meet the requirements may give written notification and capability statements prior to the response due date and time. Vendors shall indicate if they are the direct supplier of the items. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to perform the requirements and must include relevant corporate experience along with the applicable contract number, total contract dollar amount, contract period of performance, details of the relevant services and customer point of contact with corresponding telephone number and email address.

Responses must include following information:

1. Company Name

1. SAM number

1. Company’s address

1. Point of Contact information (title, phone number and email address)

1. Business size.

Response received will be evaluated; however, a determination by the Government not to compete the proposed procurement based on responses to this notice is solely within the discretion of the Government. Information provided will not be returned.

Responses are due by Thursday, 27 February 2025 at 10:00 AM (EST). No submissions will be accepted after this date and time. Responses shall be submitted via email to haley.snyder@va.gov.

The NAICS code for this acquisition is 811210 and the standard size is $34.0 Million.

Page 1 of

Special Notice

Statement of Work

A. GENERAL GUIDANCE

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

2. Scope of Work: The contractor shall provide full-service maintenance of government owned 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 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 and four one-year option periods.

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. 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

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. 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.

N. 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.

O. 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 following language from VA Handbook 6500.6 is required in this contract:

1. Appendix C: Paragraphs #3a, #5h, #6a, #7a, #7d, #9(all)

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.

End of Document