P11. Intent to Sole Source - 36C25627Q0062.docx

Special Notice Special Notice

GENERAL INFORMATION

Network Contracting Office 16 5075 Westheimer Road, Suite 750

Houston TX 77056-5643

DESCRIPTION

NOTICE OF INTENT TO AWARD A NON-COMPETITIVE CONTRACT

Operational Lease of Flexible Endoscopy and Bronchoscopy Equipment The Department of Veterans Affairs (VA), Network Contracting Office 16 (NCO 16), intends to pursue an acquisition for the operational lease of flexible endoscopy and bronchoscopy equipment and associated accessories for the Veterans Health Care System of the Ozarks (VHSO), VA Medical Center, Fayetteville, Arkansas. The required period of performance is January 1, 2027, through December 31, 2029.

The proposed contractor is Olympus America Inc., UEI: FLWQVLFLMEL3, located at 3500 Corporate Parkway, Center Valley, PA 18034.

The VHSO requires replacement of its existing leased endoscopy and bronchoscopy equipment to support clinical operations and the Veterans Health Administration's objectives for equipment standardization, patient safety, consistency of clinical practices, and reliable equipment reprocessing.

The requirement includes an operational lease for flexible endoscopy and bronchoscopy equipment and associated components, including video system components, medical monitors, flexible endoscopes, colonoscopes, diagnostic and therapeutic bronchoscopes, ultrasound bronchoscopy equipment, workstations, monitor stands, cables, hoses, and associated accessories. The equipment must meet the Government's clinical, functional, compatibility, and operational requirements described in the Statement of Work.

The acquisition is anticipated to be structured as an operational lease in accordance with the applicable Federal Supply Schedule (FSS) contract terms and the resulting order.

The Government is considering an acquisition strategy involving Olympus equipment to support the required clinical configuration and equipment standardization objectives. Any restriction to Olympus America Inc. as the sole source, or to Olympus products on a brand-name basis, must be supported by the applicable acquisition rationale, market research, and required approvals before award.

Anticipated NAICS Code: 532490 – Other Commercial and Industrial Machinery and Equipment Rental and Leasing.

Anticipated Product Service Code (PSC): W065 – Lease or Rental of Equipment—Medical, Dental, and Veterinary Equipment and Supplies.

Interested parties that believe they can meet the Government's requirement are invited to submit information demonstrating their capability to provide equipment and associated services meeting the requirements of the Statement of Work. Responses should address equipment configuration, compliance with the Government's stated salient characteristics, component compatibility, delivery and installation, initial user orientation, and applicable operational lease terms.

Responses shall be submitted electronically to:

Point of Contact: Caleb Parker Email: Caleb.Parker@va.gov Response Deadline: 10-21-2026, 12:00 PM CDT Responses should identify the submitting company and provide sufficient technical and commercial information for the Government to assess the company's ability to meet the requirement.

This notice is intended to support the Government's acquisition planning and determination of the appropriate procurement strategy. It is not a solicitation, request for quotation, or request for proposal, and it does not obligate the Government to make an award to Olympus America Inc. or any other contractor.

The Government will consider responses solely for acquisition-planning purposes. The Government is under no obligation to acknowledge receipt of submissions or provide feedback to respondents. The Government will not reimburse respondents for costs associated with preparing or submitting information in response to this notice.

The Government reserves the right to determine the appropriate acquisition strategy in accordance with applicable laws, regulations, and acquisition procedures. Submission of a response does not guarantee inclusion in any subsequent solicitation or receipt of an award.

STATEMENT OF WORK

Operational Lease of Flexible Endoscopy and Bronchoscopy Equipment Veterans Health Care System of the Ozarks (VHSO) VA Medical Center – Fayetteville, Arkansas

1. Background The Veterans Health Care System of the Ozarks (VHSO), Department of Veterans Affairs (VA), requires the continuation of an operational lease for flexible endoscopy and bronchoscopy equipment to support clinical services at the VA Medical Center in Fayetteville, Arkansas.

The requirement supports the Veterans Health Administration’s (VHA) objective of standardizing medical equipment where clinically appropriate to promote patient safety, consistency of clinical practices, efficient equipment utilization, and reliable reprocessing workflows. Standardization is intended to reduce unnecessary variation in equipment operation and associated procedures while supporting continuity of patient care.

The existing leased equipment is scheduled for replacement with new equipment. The Government requires an operational lease that provides the equipment, associated accessories, installation, initial user orientation, and other services expressly identified in this Statement of Work (SOW).

2. Scope of Work The Contractor shall provide, deliver, install, configure, test, and place into operational service the flexible endoscopy and bronchoscopy equipment and associated accessories identified in Section 3.

The Contractor shall remove the existing leased equipment identified by the Government, replace it with new equipment meeting the requirements of this SOW, and provide initial orientation for applicable clinical personnel.

The equipment shall be provided under an operational lease in accordance with the Statement of Work.

The Contractor shall furnish all labor, transportation, handling, equipment, accessories, documentation, and other resources necessary to perform the work specified in this SOW, except for resources expressly identified as Government-furnished.

No additional equipment, services, or charges outside the awarded order are authorized without prior written approval from the Contracting Officer (CO).

3. Equipment Requirements and Salient Characteristics

3.1 General Requirements

All equipment shall:

a. Be new, unused, and commercially available at the time of delivery.

b. Be suitable for its intended clinical application and meet applicable manufacturer specifications, medical-device regulatory requirements, and recognized safety standards.

c. Be compatible with the other proposed components of the offered system, including processors, displays, scopes, ultrasound components, workstations, stands, and cables, as applicable.

d. Include all accessories, interconnecting cables, power cords, adapters, and other components necessary for the equipment to operate as proposed.

e. Be delivered with applicable operator manuals, technical documentation, cleaning and reprocessing instructions, and warranty or service documentation applicable to the operational lease.

f. Be capable of operating with the facility's existing infrastructure to the extent required by the Government and confirmed during pre-installation coordination.

g. Meet the clinical and functional requirements specified in this SOW. An alternative product may be proposed if the solicitation permits alternatives and the offered product demonstrably satisfies all applicable requirements.

3.2 Required Equipment Inventory

The following equipment and accessories constitute the Government's preliminary equipment inventory. The requiring activity shall confirm the quantity of each item before solicitation issuance.

The reference identifiers above are included to identify the equipment contemplated by the requiring activity. They shall not, by themselves, establish an exclusive brand or manufacturer restriction unless the solicitation expressly identifies the requirement as brand name only and the required acquisition justification and approvals have been completed.

Where brand-name-or-equal competition is authorized, an offered equivalent must meet the Government's stated salient physical, functional, and performance characteristics. The Government will evaluate proposed equivalents against the same documented requirements.

3.3 Clinical and Functional Requirements

The complete equipment configuration shall support the clinical procedures for which the equipment is intended, including applicable gastrointestinal endoscopy, colonoscopy, diagnostic bronchoscopy, therapeutic bronchoscopy, and endobronchial ultrasound procedures.

The proposed system shall meet the following requirements, as applicable to each offered component:

a. Provide endoscopic imaging and visualization appropriate to the intended clinical procedure.

b. Support the intended scope types and functions, including diagnostic, therapeutic, and ultrasound-enabled procedures where required.

c. Provide the required image display capability, including UHD 4K display capability where specified by the Government.

d. Support the required image processing and visualization functions, including narrow-band imaging and dual-focus functionality where required for the specified clinical applications.

e. Include ultrasound processing and compatible ultrasound bronchoscopes where required for the Government's intended EBUS applications.

f. Provide compatible system interconnections and video signal transmission using the required cable lengths and signal specifications.

g. Include a suitable mobile workstation and monitor support stand where listed in the required inventory.

h. Provide the necessary hoses, cables, connectors, power cords, and accessories to deliver a complete, functional configuration.

i. Operate in accordance with applicable manufacturer instructions and the facility's approved clinical and reprocessing procedures.

The Government shall validate the detailed technical requirements before issuing the solicitation. Where a particular feature, interface, accessory, or configuration is mandatory, the solicitation shall identify it as a required salient characteristic and explain the functional need it supports.

4. Period of Performance and Delivery

4.1 Period of Performance

The required lease period is January 1, 2027, through December 31, 2029, subject to the terms of the resulting award and the applicable FSS contract.

The Contractor shall coordinate delivery and installation sufficiently in advance to support operational readiness by January 1, 2027.

4.2 Delivery Location

All equipment shall be delivered to:

Veterans Health Care System of the Ozarks Attn: Warehouse, Building 8 1100 N. College Avenue Fayetteville, AR 72703

The Contractor shall include the Government purchase order number on shipping documentation and in the attention line of the shipping address.

4.3 Delivery and Installation Coordination

The Contractor shall coordinate delivery, removal, installation, and commissioning with the designated Government technical representative and applicable clinical personnel.

Before shipment, the Contractor shall confirm the proposed delivery date, shipping arrangements, equipment inventory, installation requirements, and any facility prerequisites.

The Contractor shall provide written delivery confirmation and a packing list identifying each item by description, manufacturer, model or reference number, serial number where applicable, and quantity.

Delivery alone shall not constitute acceptance of the equipment.

5. Contractor Personnel and Facility Access

5.1 Identification and Access

Upon arrival at VHSO, Contractor personnel shall report to VA Police Dispatch and comply with facility procedures for obtaining contractor identification or a visitor badge.

Contractor personnel shall visibly display the issued identification while on VHSO premises and return the badge as directed before leaving the facility.

The Contractor shall comply with applicable VA facility security, safety, infection prevention, access-control, and conduct requirements communicated by the Government.

5.2 Scope Limitations

The Contractor shall not perform work, provide additional equipment, substitute items, or incur additional charges outside the awarded scope without prior written authorization from the CO.

Only the CO may authorize changes to the contractual scope, price, or terms. Technical personnel may provide technical direction within their delegated authority but may not modify the contract.

6. Contractor Responsibilities

6.1 Removal and Replacement

The Contractor shall remove the existing leased equipment designated by the Government and replace it with the equipment provided under the resulting order.

Removal and replacement shall be coordinated with the Government to minimize disruption to clinical operations.

The Contractor shall:

a. Coordinate the removal date and replacement schedule with the Government.

b. Maintain an inventory of removed and replacement equipment.

c. Identify removed equipment by description, model, and serial number, where available.

d. Protect Government property and facility infrastructure during removal and installation.

e. Ensure that all replacement equipment is complete, undamaged, and operational.

f. Remove packaging and debris generated by the Contractor.

g. Arrange return shipment or disposition of existing leased equipment in accordance with the existing lease terms and the written direction of the CO.

The Contractor shall not dispose of, transfer, or remove Government-owned property without written authorization.

6.2 Installation and Commissioning

The Contractor shall install and configure the leased equipment in the locations designated by the Government.

Installation shall include, as applicable:

a. Assembly and placement of system components, workstations, and stands.

b. Connection of compatible equipment, video cables, power cords, hoses, and accessories.

c. Configuration of system components necessary for intended operation.

d. Verification of component compatibility and proper connections.

e. Performance of manufacturer-recommended installation checks and operational tests.

f. Identification and correction of installation deficiencies before requesting acceptance.

g. Provision of installation records and applicable technical documentation.

The Contractor shall coordinate any required electrical, network, information technology, or facility modifications with the Government. Such modifications shall not be performed without prior written approval from the CO.

6.3 Initial User Orientation

The Contractor shall provide initial orientation for applicable clinical practitioners and other designated users.

Orientation shall be coordinated through the VHSO Nursing Education Section and the Government's designated clinical representative.

Training shall include, as applicable:

a. Equipment startup, shutdown, and basic operation.

b. Operation of the supplied processors, displays, scopes, and associated components.

c. Use of relevant imaging and visualization functions.

d. Basic troubleshooting and identification of equipment faults.

e. Safe handling, storage, and transport of equipment.

f. Manufacturer-approved cleaning, disinfection, and reprocessing requirements applicable to the supplied devices.

g. Procedures for obtaining technical assistance and reporting equipment failures.

The Contractor shall provide training materials and a record of the training delivered, including the date, subject matter, and personnel or groups trained.

The Government shall identify the number of training sessions and anticipated attendees before delivery. Additional training beyond the agreed initial orientation shall require approval by the CO unless included in the awarded lease terms.

Contractor orientation does not replace any clinical credentialing, competency validation, or mandatory facility training required by the Government.

6.4 Equipment Documentation

At or before acceptance, the Contractor shall provide the applicable:

a. Equipment inventory and serial-number list.

b. Operator and technical manuals.

c. Manufacturer instructions for use and reprocessing.

d. Installation and operational test records.

e. Warranty and service contact information applicable to the lease.

f. Training records.

g. Documentation necessary to support equipment management, maintenance, and safe clinical use.

Documentation may be provided electronically unless the Government specifies another format.

6.5 Maintenance and Equipment Support

The Contractor shall provide maintenance, repair, replacement, and technical support to the extent included in the applicable FSS operational lease terms and the awarded order.

Before award, the solicitation shall identify the applicable support obligations, response times, preventive maintenance requirements, loaner or replacement equipment provisions, and any service exclusions.

The Contractor shall not represent that a service is included in the lease unless it is included in the applicable contract or expressly incorporated into the resulting order.

Any equipment malfunction affecting safe or intended operation shall be reported promptly to the designated Government representative. The Contractor shall coordinate corrective action with the Government and comply with applicable manufacturer instructions and facility requirements.

7. Government Responsibilities The Government shall:

a. Identify the designated technical representative and applicable clinical points of contact.

b. Coordinate access to the delivery and installation locations.

c. Identify the existing leased equipment authorized for removal.

d. Provide available information regarding facility infrastructure and operational constraints.

e. Coordinate clinical availability for installation and orientation.

f. Review Contractor deliverables and determine whether the requirements of the SOW have been met.

g. Provide acceptance, rejection, or requests for corrective action through authorized Government personnel.

The Government's technical representative may coordinate day-to-day performance but may not change contractual requirements, authorize additional costs, or waive contractual obligations.

8. Deliverables and Performance Standards The Contractor shall meet the following minimum performance standards.

9. Inspection and Acceptance The Government will inspect the delivered equipment and review the associated documentation to determine whether the Contractor has met the requirements of the awarded order.

Inspection may include:

a. Verification of item descriptions, quantities, model or reference numbers, and serial numbers.

b. Inspection for damage, completeness, and apparent defects.

c. Verification of required accessories and system connections.

d. Review of installation and operational test records.

e. Functional testing of applicable equipment.

f. Verification that required documentation and initial orientation have been provided.

The Government will notify the Contractor of identified deficiencies. The Contractor shall correct deficiencies at no additional cost when they result from failure to meet the awarded requirements, within the corrective-action period established by the CO.

Equipment that fails to meet the applicable requirements may be rejected in accordance with the contract and applicable acquisition terms.

Acceptance shall be documented by the authorized Government representative in accordance with the resulting order. Delivery, installation, or use of an item for inspection purposes shall not automatically constitute final acceptance.

10. Regulatory and Safety Requirements The Contractor shall ensure that all supplied equipment is legally marketed for its intended use and complies with applicable federal, state, and local requirements.

The Contractor shall provide the manufacturer’s instructions for use, applicable safety information, and reprocessing instructions for each supplied device.

The Contractor shall comply with applicable VA facility policies governing contractor access, infection prevention, equipment installation, and clinical-area conduct.

All equipment shall be operated, maintained, cleaned, disinfected, and reprocessed in accordance with applicable manufacturer instructions and Government-approved procedures.

11. Changes and Substitutions The Contractor shall not substitute equipment, accessories, or services without prior written approval from the CO.

Any proposed substitution shall include sufficient technical documentation to demonstrate that the proposed item meets the applicable requirements of the awarded order.

A substitution shall not be considered approved solely because it is described as equivalent by the Contractor or manufacturer.

The CO will determine whether a proposed substitution is permissible under the contract, the solicitation, and applicable acquisition procedures.

12. Performance Management and Contract Administration The Contractor shall designate a primary point of contact responsible for delivery coordination, installation, training, documentation, and issue resolution.

The Contractor shall promptly notify the Government of any anticipated delay, equipment shortage, compatibility issue, or other condition that may affect performance.

The Contractor shall provide the CO with a proposed corrective-action plan when directed to do so.

The Government retains responsibility for contract administration, acceptance, and decisions affecting the scope, price, or terms of the order.

14. Order of Precedence In the event of an inconsistency, the applicable order-of-precedence provision in the resulting contract or order shall govern.

15. Required Government Review Before Solicitation Before issuing the solicitation, the requiring activity and CO shall finalize the equipment quantities, detailed salient characteristics, installation and service requirements, and evaluation methodology.

The Government shall also confirm that the acquisition strategy, lease structure, pricing arrangement, and any brand-specific restrictions are consistent with the applicable FSS contract and acquisition procedures.

The final solicitation shall identify all mandatory requirements and the information offerors must submit to demonstrate compliance. Evaluation and acceptance decisions shall be based on those stated requirements and the procedures established in the solicitation.

16. Records Management: 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.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA.The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

3. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. This section applies when any person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract.

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

b. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of a Security Clearance shall be processed through the Special Security Officer located in HRA/OSP. Contractors shall conform to all requirements stated in the National Industrial Security Program Operating Manual (NISPOM).

d. All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.

e. The contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following: (1) Contractor/subcontractor personnel no longer has a need for access to VA information or VA information systems.

(2) Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason.

(3) Contractor believes their own personnel or subcontractor personnel may pose a threat to their company’s working environment or to any company-owned property. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data.

(4) Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record.

(5) Contractor/subcontractor personnel have their authorization to work in the United States revoked.

(6) Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel.

f. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor/subcontractor personnel. These measures include (but are not limited to): removing and then securing Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens. Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal.

g. Contractors/subcontractors who no longer require VA accesses will return VA-issued property to VA. This property includes (but is not limited to): documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA COR/CO.

Special Notice