DynaCAD SOW.docx

Statement of Work Southeast Louisiana Veterans Health Care System New Orleans, LA 9/28/2026

3.1.1 The proposed contract shall include a service plan to furnish all parts and labor to support and maintain in good working condition the DynaCAD and UroNav systems at SLVHCS for a period of 12 months during the hours of operation from 6:00am – 7:00pm (CST), Monday-Friday excluding federal holidays. The systems covered are as follows:

All materials and services provided shall be in accordance with the OEM specifications and guidelines. During schedule service intervals, all parts including batteries and accessories shall be replaced at no additional cost to the Government. Unscheduled and scheduled travel are included as part of the service contract. The Scope of Work includes the following items:

Coverage shall include:

· UroNav Fusion Biopsy System-Invivo Solutions Service: Gold

· parts and factory repair labor cost for defective systems

· transport cost for receiving systems back after repair (one leg of freight cost)

· next day delivery for smart set of field replaceable parts, including related transport cost

· immediate access to remote applications & tech support (standard office hours)

· on-site technical support (time, material and travel cost)

· 1 time period of 2 days per year on-site application training (not valid for Esys/SensaVue)

· System tune-up service up to 2 times / year, on customer request

· free updates for Invivo Software, which comprises enhancement of existing feature packages

· 25% discount on upgrades for Invivo Software with new feature packages

· UroNav Transperineal Stepper Biopsy-Invivo Solutions Service: Silver

· parts and factory repair labor cost for defective systems

· transport cost for receiving systems back after repair (one leg of freight cost)

· next day delivery for smart set of field replaceable parts, including related transport cost

· immediate access to remote applications & tech support (6AM to 7PM Central)

· 1 time period of 1 day per year on-site application training (not valid for SensaVue)

· free updates for DMS Software, which includes enhancement of existing feature packages

· DynaCAD Prostate Server SW- Invivo Solutions Service: Custom

· immediate access to remote applications & tech support (standard office hours)

· 1 time period of 2 days per year on-site application training (not valid for Esys/SensaVue)

· System SW tune-up service up to 2 times / year, on customer request

· free updates for Invivo Software, which comprises enhancement of existing feature packages

· Software Upgrades available for commercial purchase or via FCO if warranted for bug fixes

· 25% discount on upgrades for Invivo Software with new feature packages

· Software Re-Installation Fee Coverage.

3.2 Place of performance: Diagnostic Imaging Service, Southeast Louisiana Veterans Health Care System (SLVHCS), 2400 Canal Street, New Orleans, LA, 70119

3.3 Requests for services shall be made via telephone or email by authorized VA Clinical Engineering personnel, the Contracting Officer, or other authorized VA designee only.

3.4 All work shall be approved prior to commencement.

3.5 Work shall not be considered complete until accepted by an authorized VA designee. Contractor shall only be paid for work that has been completed during the performance period of the contract. Contractor cannot be paid (and should not invoice for work/services that have not been scheduled or completed).

3.6 All work shall be coordinated through an authorized VA designee. Access to VA space must be coordinated and approved by VA Clinical Engineering personnel (or designee) prior to the beginning any work that is to be performed.

4. DELIVERABLES

4.1. Contractor shall furnish all parts, maintenance kits, consumable and expendable items, and supplies necessary to perform scheduled and unscheduled maintenance on the equipment. All materials and services provided shall be according to the OEM specifications and guidelines. During scheduled service intervals, all parts including new batteries and accessories shall be replaced at no additional cost.

4.2 “Punch List” of Required Deliverables (see below):

DELIVERABLE #1:

SOFTWARE UPDATES:

Software updates and patches as necessary to maintain full functionality of the installed system. All software updates shall be installed by the contractor to current OEM specifications during the performance period of the contract at no additional cost to the government. Before installation/configuration, applicable software must be validated by the Clinical Engineering Department (or other appropriate departments/individuals) to ensure that such software conforms to the agency’s architecture and accessibility standards. Installation processes must comply with security, privacy, and safety requirements per VA standards, policies, and directives set forth. OEM software updates must meet all requirements of VA Handbook 6500 and Directive 6550. Before initiating OEM updates the contractor shall coordinate with one or more of the following parties if necessary: Clinical Engineering Department, COR, Information Security Officer (ISO).

DELIVERABLE #2:

PARTS:

Only new, standard parts shall be furnished by the contractor. All parts shall meet current manufacturer standards and have versatility with presently installed equipment. All replacement parts become the property of the Government once installed by the contractor. Replacement parts are to be disposed of by the Contractor after obtaining approval from the Contracting Officer’s Representative. Replaced parts are to be disposed by the Contractor after obtaining approval from the Contracting Officer's Representative (COR).

DELIVERABLE #3:

SCHEDULED SERVICES:

Contractor shall perform the Original Equipment Manufacturer (OEM)'s Scheduled Periodic Manufacturer's Certification, electrical safety checks, and software updates on the equipment. Scheduled travel is included as part of the service contract. The contractor shall account for all travel expenses associated with the completion of the requested tasks. Anticipated travel costs associated with the execution of the service plan(s) on the equipment shall be included in the total cost of the service plan(s). The Contractor’s technical service representative shall contact Clinical Engineering and the COR at least three (3) weeks prior to the recommended scheduled maintenance date to plan/coordinate the required work that is to be performed. All services shall be performed during normal business hours unless an alternate work schedule has been approved by Clinical Engineering and/or the COR. Required services contained within the service plan on the equipment shall be delivered on a continual basis during the performance period of the contract. Required maintenance services and 24-7 support services (24 hours a day, 7 days a week) shall be provided as needed or as requested by the government.

DELIVERABLE #4:

UNSCHEDULED SERVICES:

Contractor shall perform all unscheduled services, including emergencies when needed. This includes on-site visits during normal (SPS) business hours to include repair, labor and travel costs relating to the services to be performed. The contractor shall account for all travel expenses associated with the completion of the requested tasks. Anticipated travel costs associated with the execution of the service plan(s) on the equipment shall be included in the total cost of the service plan(s). In cases when technical support is required over the phone, the contractor shall provide 24/7 technical support to the government at no additional cost. All site visits must be scheduled, coordinated, and approved by Clinical Engineering and/or the COR (or other authorized representative/designee) before such site visits take place.

DELIVERABLE #5:

MANDATORY SAFETY CORRECTIONS:

Safety corrections on the equipment as required by OEM or FDA regulations is covered within the scope of this requirement (contract).

DELIVERABLE #7

MOBILE MEDIA SCANNING:

The Contractor will identify if removable media (i.e. USB or DVD/CD Device) is required to perform the tasks/deliverables during the performance period of the contract. The COR (or other authorized representative/designee) will ensure that the removable media (to be used) is scanned with anti-virus software (to include running current virus definitions) prior to connection to any medical device system located in the facility. The computer system for scanning removable media will be designated by the COR.

DELIVERABLE #8

REPORTS/DOCUMENTATION:

For any services performed on site, upon arrival at the Medical Center, the technical service representative shall check in with the Clinical Engineering Department before performing any warranty related services, repairs and/or other maintenance services. This check-in is mandatory. A legible, signed service report shall be provided directly to Clinical Engineering Department following completion of each service call/visit and shall include equipment identification (i.e. serial number), date and time of service call, list of parts replaced, results of inspections and/or calibrations, and a description of the work accomplished. This report shall be signed or initialed by the Clinical Engineering Department. Service reports shall be provided within five days after completion of the work performed. All service reports shall be emailed within five days of completion of the maintenance work to VHANOLClinicalEngineering@va.gov and the Biomedical Equipment Support Specialist coordinating the work. During the service, the contractor shall report any changes in delivery requirements/problems to the COR (Contracting Officer Representative).

DELIVERABLE #9:

PERSONNEL:

Contractor shall provide all necessary personnel to maintain the system. Labor required for both scheduled and unscheduled (emergencies) services are included as part of the cost of the service plan/contract for this requirement. Contractor employees (who will be performing work and executing tasks/deliverables) on the equipment shall be factory trained, qualified, certified, and licensed on the specific maintenance services that are required/needed. Work/tasks shall not be performed by individuals lacking the credentials/qualifications/certifications listed herein. The Contractor shall provide written assurance of the competency for their personnel and a list of credentials of approved Field Service Engineers for each system before these individuals begin work or perform services on the equipment/system. All technical service representatives provided by the contractor shall comply with VA security management program directives and shall obtain the appropriate clearances from the VA police, possess the appropriate identification (job title, position/employer), and only be allowed in areas where access has been granted/authorized. All key personnel shall be certified by the manufacturer to be able to perform maintenance, upgrades, or any other service covered under this contract.