Nanosonic Intent to Sole Source Notice.docx

NOTICE OF INTENT TO AWARD SOLE SOURCE: IAW FAR 5.101 this notice is to advise the public that the Department of Veterans Affairs (VA) Regional Procurement Office East (RPOE), Network Contracting Office 4 (NCO 4) intends to award a sole source firm fixed price contract pursuant to FAR 13.106-1(b) with Nanosonics Inc located at 7205 E 87th St. Indianapolis, Indiana 46256, for a base year with four (4) options years.

The Pittsburgh VA Medical Center requires preventative maintenance and repair services for nine (9) Nanosonics Trophon 2 Systems. These systems provide automated High-Level Disinfection (HLD) for ultrasound probes. To ensure continuous reliability, maintenance must be performed by qualified personnel utilizing manufacturer-approved parts and adhering to OEM specifications.

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

Responses must include the following information:

1. Company Name

2. SAM UEI Number

3. Company’s Address

4. Point of Contact Information (title, phone number and email address)

5. 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. The information provided will not be returned.

The North American Industry Classification System (NAICS) code for this procurement is 811210 Electronic and Precision Equipment Repair and Maintenance and the size standard is $34 Million.

Responses are due by 10:00 am (EST) on October 01, 2025. This will be the only notice regarding the Government's intent to solicit and award a contract to a single source to meet this requirement. Any responses received will only be considered to determine the marketplace for future procurements. The Government will not pay for information submitted. Inquiries will only be accepted via email to matthew.wright6@va.gov. Responses are due by 10:00 am (EST) on October 01, 2025.

Statement of Work

A. GENERAL GUIDANCE:

1. Title: Full Service and Maintenance of the VA Pittsburgh Medical Center owned Nanosonics Trophon2 Systems.

2. Scope of Work: The contractor shall provide full service and maintenance for government owned Nanosonics Trophon2 systems required by 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 Nanosonics Trophon2 Systems. The units require repair and maintenance by trained personnel using manufacturer approved parts and specifications. These units are critical for continuous patient care of the Radiology Department at the VA Pittsburgh Medical Center. The equipment is utilized to provide High-Level Disinfection (HLD) of validated ultrasound probes. The reliable and accurate operation of this equipment at all times is considered critical to the health of patients.

4. Performance period:

5. Type of Contract: Firm-fixed price.

B. GENERAL REQUIREMENTS:

1. This agreement includes all preventative maintenance and corrective maintenance repairs for nine (9) Nanosonics Trophon2 systems for continuous reliability.

a. 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 corrective and preventative maintenance as well as 24/7 technical telephone support.

ii. Service calls to the Contractor requesting service are only authorized when they are received from the POC, CO, or designated alternatives.

iii. Outside of the Contract’s hours of coverage, emergency on-site services require authorization by the POC. The CO or a Biomedical Engineering Staff Member shall initiate these calls. If VA staff other than the CO 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. The VA Administrative Officer of the Day is an authorized caller and can also be contacted for verification.

iv. 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.

b. Preventative Maintenance:

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

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, 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 it’s 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 on patient scheduling. All exceptions to the preventative maintenance schedule and procedure shall be addressed and approved in advance 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 with the approval of the POC or alternate POC if downtime is not considered significant.

vi. The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and 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 CO and POC with a written estimate of the cost to make necessary repairs.

c. Parts, Software and Additional Discounts

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. Used parts, those removed from another system, shall not be installed without approval by the POC. 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 CO, POC, or Alt POC.

ii. Any parts delivery must arrive by the next day, 10:30 AM.

iii. Software patches, software enhancements (without hardware changes), and quality updates are included under the terms of this contract and shall be applied in accordance with manufacturer specifications.

1. Upon release from the OEM, software updates must be provided within a month.

d. Hours of Coverage:

i. The contractor will provide all required services within the normal business hours (8:00 AM to 5:00 PM (ET) M-F), excluding 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, POC or Alt POC. 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 should 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 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.

e. Customer Notification:

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

ii. When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s) 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 will 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

2. CO - Contracting Officer.

3. POC – Point of Contact.

4. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such a condition that they 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 manufacturers 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. 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

D. CONFORMANCE STANDARDS:

The 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 current performance specifications as established in the OEM’s technical specifications. Upon equipment failure, the contractor is required to return the equipment to fully functional and operating status. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

E. DOCUMENTATION/REPORTS:

The documentation will include equipment downtime 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 / Identification of 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), including Labor and Travel, Parts (with part numbers) and 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.

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 at each visit. If a final copy can be provided at that time, then a draft copy is not necessary, final copies must be provided within 5 business days of the time of each deliverable.

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 other than the CO 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 the contract will not relieve the contractor from performance of the requirements of this contract.

J. CONTRACTOR EXPERIENCE REQUIREMENTS:

1. Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.

2. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) shall have successfully completed a formalized training program, for the equipment or similar equipment identified in Section B.1a. To be valid, the training shall be completed within the last 2 years, or a certificate of the original training program and a recent class completion (on equipment identified in Section B.1a) to certify FSE’s continual education must be provided. For field experience, the FSE(s) shall have a minimum of two years of experience, with respect to scheduled and unscheduled preventive and remedial maintenance on equipment. Additionally, FSE(s) must provide proof of service key dongle ownership upon request by VAPHS to confirm they can service and troubleshoot the equipment in its entire capacity; refusal or lack of ownership void all training and field experience requirements met.

3. The FSE(s) shall be authorized by the contractor to perform the maintenance services as required. All work shall be performed by "Fully Qualified" competent FSEs. The contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the contractor services at VAPHS. The CO may authenticate the training requirements, request copies of training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VAPHS equipment. The CO and/or the POC specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the VAPHS equipment.

4. Any Contractor personnel must provide a copy of 1) Tuberculosis (Tb) vaccination documentation, 2) flu vaccination documentation and 3) copy of HIPAA compliance training certificate.

5. If a sub-contractor is utilized to fulfill the requirements of this contract, the sub-contractor must be pre-approved by VAPHS and must be responsible for maintaining the requirements stated herein. VAPHS reserves the right to meet all associated sub-contractors to determine their qualifications and ability to provide service, prior to contract award. Failure of sub-contractor to comply, either in whole or in part, with this SOW’s requirements is grounds for dismission. Upon dismissal, the contractor has exactly 1 week (7 business days) to provide a replacement sub-contractor or contract will be terminated due to failure to meet the contract requirements.

K. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD:

1. The contractor shall comply with the Federal 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 the performance of the contract.

L. 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 are defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- 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 are 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 an annual certification to the Contracting Officer (CO) that all contract staff performing services at VA facilities are following the VHA Directive 1192.

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 CO at the conclusion of the task order.

2. The CO 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. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

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 building and on premises 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:

Contractors 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 be scanned by Biomed or OIT.

All Contractors must receive Privacy training annually 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. The POC must ensure that all contractors are validated in the PIH domain.

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.