Trudi Navigation System Service 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 Integra Lifesciences Corp. 1100 Campus Road, Princeton, NJ 08540 for a base year with two (2) options years.

The Philadelphia VA Medical Center requires preventative maintenance and repair services for the Integra TruDi Navigation System. These systems provide a 3D image guided navigation for the Ear, Nose, and Throat (ENT) procedures. It uses patient-specific CT scan data, tracking hardware, microsensor technology, and proprietary software to show a surgeon the precise location of surgical instruments in real-time relative to the patient's anatomy, helping to ensure a safe and complete procedure.

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 13, 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 13, 2025.

Statement of Work

A. GENERAL GUIDANCE

1. Title: Full Service and Maintenance for Government owned Integra TruDi Navigation System, at VAMC Philadelphia.

2. Scope of Work: The contractor shall provide full service and maintenance for the government owned Integra TruDi Navigation System, obligatory by the requirements stated herein. The facility is located at:

Philadelphia VA Medical Center (VAMC) 3900 Woodland Ave Philadelphia, PA 19104

3. Background: This contract is issued to ensure the continuous reliability of the Integra TruDi Navigation System identified in this SOW. This equipment requires repair and preventative maintenance by trained personnel using manufacturer approved parts and specifications. Safe and reliable operation of the equipment at all times is considered critical to the health of patients.

4. Performance period: Base year plus two option years.

5. Type of Contract: Firm-fixed-price.

B. GENERAL REQUIREMENTS

1. This agreement includes all preventative maintenance and corrective maintenance to the Integra TruDi Navigation System for continuous reliability.

a. Equipment to be serviced:

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

b. Corrective and Preventative Maintenance:

i. The Contractor and Biomedical Engineering shall maintain the equipment in accordance with Section D Conformance Standards. Service for corrective and preventative maintenance will be provided per hours of coverage defined in Section B.1.f. 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 CO or Biomedical Engineering Staff Member.

iii. Outside of the contract’s hours of coverage, emergency on-site services require authorization by the POC. 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. The VA Administrative Officer of the Day is an authorized caller and can also be contacted for verification.

iv. In the event the contractor is unable to correct deficiencies on the device, a system replacement will be provided within 2 business days.

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. Software Updates/Upgrades:

i. Software patches and quality updates/upgrades are included at no additional cost under the terms of this contract and shall be applied in accordance with manufacturer specifications.

ii. The contractor shall gain permission from VA prior to installing any software updates, to ensure any interoperability issues are addressed prior to installation.

d. Parts:

i. All parts supplied shall be OEM and fully compatible with existing equipment. No refurbished parts 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 and specialty components. Used parts, those removed from another system, shall not be installed without approval by Biomedical Engineering Staff. 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 Biomedical Engineering Staff. All defective parts replaced become the property of the Contractor, unless otherwise specified by the CO or Biomedical Engineering Staff.

e. Service:

i. The contractor must be able to provide telephone support as needed for the equipment owned by VA Philadelphia.

ii. Personnel with OEM equipment training will respond directly by phone or on-site as deemed appropriate for the situation, within 2 hours of the call for service. If situations are responded to by phone and do not resolve the service issue, OEM trained personnel will be required for an on-site visit within 2 business days after receipt of initial notification unless otherwise agreed upon, in writing, by the CO. Full resolution is expected within 48 hours of initial call. If the contractor cannot remediate the issues within this timeframe, the POC or alternate POC shall be notified immediately and provided an estimated time for resolution.

f. Hours of Coverage:

i. The contractor will provide on-site Technician Support Monday-Friday 7AM-5PM Local Time, including holidays.

ii. The contractor will provide Phone Support Monday-Friday 7AM-8PM Local Time, including holidays.

g. New Equipment:

i. Equipment may be added or deleted from the service contract as needed upon notification by the Contracting Officer (to be documented in writing via contract amendment). Deleted equipment will be credited in full amount if deleted before any scheduled maintenance has been performed on it.

h. Equipment Relocation/Reinstallation

i. The contractor shall provide up to 2 relocations and reinstallations within 100-mile radius by a Certified Technician.

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

iii. Federal Holidays Observed by the VA Medical Center:

a. New Year’s Day

b. Martin Luther King, Jr. Day

c. President’s Day (Washington’s birthday)

d. Memorial Day

e. Juneteenth National Independence Day

f. Independence Day

g. Labor Day

h. Columbus Day

i. Veterans Day

j. Thanksgiving Day

k. Christmas Day

l. Any other day specifically designated by the President of the United States.

2. Customer Notification:

i. The contractor shall notify Biomedical Engineering and the Police service when they arrive on site (Biomedical Shop Room 3A152, building 2). Contractor will schedule all services with Biomedical Engineering. All vendor mobile media devices (USB drives, CDs, DVDs, etc.) must be scanned by Biomed before use.

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). All ESRs shall be submitted to the equipment user for an "acceptance signature" and to Biomed for an "authorization signature." If a signature is not available, a signed accepted copy of the ESR will be sent to the point of contact in Biomed 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 - VAPHI 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. VAPHI - Department of Veterans Affairs Philadelphia Medical Center.

12. OEM - Original Equipment Manufacturer

13. CEU – Continuing Education Credit

D. CONFORMANCE STANDARDS:

1. Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, TJC, 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:

1. 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. ESR’s must also be emailed to vhaphibiomedicalservicereports@va.gov, with the Vendor Name and contract Obligation Number listed in the Subject Line. In addition, each ESR must at a minimum document the following data legibly and in complete detail:

a. Name of Contractor.

b. Name of FSE who performed services.

c. Contractor Service ESR Number/Log Number.

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

e. VA Purchase Obligation (PO) number covering the call, if outside normal working hours.

f. Description of Problem Reported by POC/User.

g. Identification of Equipment to be serviced to include the following: Equipment ID #

h. or EE# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers.

i. 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.

j. Total price to be billed.

k. Signatures from the following:

i. FSE performing services described.

ii. VA Employee who witnessed service described.

l. Equipment downtime calculated in accordance with Conformance Standards.

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

F. SCHEDULE FOR DELIVERABLES

1. Draft copies of deliverables shall be provided to Biomedical Engineering staff 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

1. 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. CONDITION OF EQUIPMENT:

1. 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 of performance of the requirements of this contract.

I. CONTRACTOR EXPERIENCE REQUIREMENTS

1. Each respondent must have an authorized distributor of the original equipment manufacturer.

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

J. 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.

K. 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 annual certification to the POC or designee that all contract staff performing services at VA facilities are in compliance with the VHA Directive 1192.

L. CORONAVIRUS DISEASE VACCINATION PROGRAM:

1. VHA Directive 1193 requires all health care personnel (HCP) to participate in the coronavirus disease vaccination 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. 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 1193. 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 VA Form 10-263 if unwilling or unable to receive the vaccine.

3. The contractor is required to submit annual certification to the Contracting Officer’s Representative (COR) or designee that all contract staff performing services at VA facilities are in compliance with the VHA Directive 1193.

M. CONFIDENTIALITY AND NONDISCLOSURE:

1. It is agreed that:

a. 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.

b. 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 in response.

c. 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 VAPHI. 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. VAPHI will not invalidate or make reimbursement for parking violations of the contractor under any conditions.

3. Smoking is prohibited inside any buildings and on premises at VAPHI. 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

1. Contractors may not have access to the VA network or any VA sensitive information under this contract. Contractor-owned computer equipment, including laptops, is not permitted to be connected to the VA network. Any removable storage device used in medical equipment must be scanned by Biomed or OIT.

2. All Contractors must receive Privacy training annually using one of the following methods:

a. 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 or designer must ensure that all contractors are validated in the PIH domain.

b. 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 or designee.

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

a. Appendix B: all

b. Appendix C: Sections 1, 2, 3, 4, 5, 6, 7, 8, 9

P. RECORDS MANAGEMENT OBLIGATIONS

1. Applicability

a. This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

2. Definitions

a. “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

b. The term Federal record:

i. includes [Agency] records.

ii. does not include personal materials.

iii. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

iv. may include deliverables and documentation associated with deliverables.

3. Requirements

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

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

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

d. [Agency] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Agency] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

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

f. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

g. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Agency] policy.

h. The Contractor shall not create or maintain any records containing any non-public [Agency] information that are not specifically tied to or authorized by the contract.

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

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

k. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.