NCI_Statement of Work_ (Draft).pdf

STATEMENT OF WORK

National Institutes of Health / National Cancer Institute / Office of Acquisitions

1.0 TITLE

Maintenance and Service Agreement for Varian TrueBeam/ARIA/Eclipse Radiation Therapy Systems

2.0 BACKGROUND

The Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Radiation Oncology Branch (ROB), designs and conducts pre-clinical and clinical research on the biologic and therapeutic effects of radiation therapy.

ROB treats patients via radiosurgery, intensity-modulated 3-D conformal radiotherapy (IMRT), real-time dose measurement, brachytherapy, and magnetic resonance (MR)-guided procedures in accordance with approved clinical protocols. These treatments are enabled by two Varian TrueBeam STX linear accelerator radiation therapy systems which deliver a precise, highly localized radiation dose in order to treat the prescribed cancerous target volume while sparing adjacent, healthy tissues to the maximum extent possible. ROB’s Varian TrueBeam STX radiation therapy systems have extreme spatial precision (< 1mm) and are capable of generating x-ray beams of multiple energies, as well as multi-energy electron beams using sophisticated techniques such as intensity modulation, dynamic arc, and respiratory gating that are dynamic in nature.

The TrueBeam STX radiation therapy systems are remotely monitored through a secure proprietary internet connection, Varian SmartConnect. This connection performs automatic remote diagnostic and maintenance services, predicts and detects fault conditions, and send alerts in real time. The two TrueBeam linear accelerator platforms have identical peripheral devices, allowing patients to easily be treated on one or the other linear accelerator. The platforms are controlled by Varian software applications, ARIA and Eclipse, on separate IT devices. The software component ARIA functions as radiation oncology information system whereas the hardware (dedicated workstations and servers) and software components of Eclipse and Eclipse Proton are used for radiation treatment planning. The Varian TrueBeam system also includes the data analysis application InSightive. The mature software system ARIA-Eclipse works in concert with the linear accelerators, and ARIA securely interfaces with NIH’s Hospital Information System (HIS) for seamless data exchange (patient demographics, document, laboratory values).

All components, including IT hardware and software, of the Varian TrueBeam radiation therapy systems are FDA-approved medical treatment Regulatory Class II Medical Charged-Particle Radiation Therapy Systems (21 CFR 892.5050) which must follow radiation safety regulations for manufacturers of radiation-emitting electronic products (21 CFR 1000-1050). The systems are further governed by 42 CFR 482.26(b)(2) and 42 CFR 485.623(b)(1). In addition, the ROB must follow processes and documentation defined by The Centers for Medicare & Medicaid Services (CMS, Ref:S&C:14-07-Hospital: Hospital Equipment Maintenance Requirements). A failure or latent flaw in the radiation treatment system could result in serious injury or death to a patient or the operator. The CMS and The Joint Commission thus define imaging/radiologic systems, whether used for diagnostic or therapeutic purposes, as “critical” equipment, which must be maintained per manufacturer’s recommendations. The Varian radiation therapy system is continually improved by its manufacturer in accordance with ISO 9001:2000 (quality management system) and ISO 13485:2016 (quality management system of medical devices). Therefore, Varian software updates are being released at a high frequency.

Due to the precise tolerances required for treatment and the critical nature of multiple session treatment delivery, it is essential that the TrueBeam radiation therapy systems be maintained to the highest standards and comply with all applicable regulations, and that, should a malfunction occur, it can be diagnosed and remedied rapidly so as to not compromise patient treatment or safety of the patient or operator. Any issue must be quickly mitigated to ensure patient safety and continuity of services. For these reasons, each TrueBeam platform is 24/7 automatically monitored via HL7 approved secure connection for proactive identification of possible faults and alerts.

ROB intends to upgrade both TrueBeam linear accelerator platforms with Varian’s HyperSight imaging solution in the foreseeable future. The upgrade will allow NIH clinicians to capture images during the course of treatment of individual patients at higher accuracy and to use image-based treatment delivery gating rather than gating based on external surrogates. Furthermore, the upgrade will enable NIH clinicians to adjust radiation for anatomical changes to the tumor and surrounding organs over the course of treatment. The upgrade will also significantly shorten image acquisition time, thereby reducing patient motion-related artifacts and to minimize patient discomfort.

2.1 OBJECTIVE

The ROB requires (i) secure remote monitoring services for the TrueBeam STX radiation therapy systems, (ii) a minimum 97% overall uptime rate of the TrueBeam radiation and RGSC systems; (iii) preventive maintenance, emergency services and technical support services for the Varian TrueBeam linear accelerator hardware components, including all associated peripheral devices and firmware components; (iv) preventive maintenance, emergency services, and technical support services for the Varian Respiratory Gating System component (RGSC); (v) software services and hardware refreshers for Varian ARIA, Eclipse, and Insightive; (vi) interoperability upgrades; and (vii) annual training events on the use of the TrueBeam STX radiation therapy systems.

3.0 SCOPE

The Contractor shall provide all labor, material, and equipment necessary to maintain and provide preventive and emergency maintenance services required under this purchase order, for the NCI ROB’s Varian TrueBeam radiation therapy systems, including all supporting subsystems, components, and associated software solutions. Currently, the TrueBeam radiation therapy platforms at ROB consist of the following:

Varian Component

Serial or Version Number Varian

TrueBeam H192104

Varian TrueBeam H193045

STX Option HST2104 H193045 High-Definition Multi-Leaf Collimator (hMLC) HHM0460 HHM0734 Megavoltage Imaging System (MV Imager) HXMB060 HXMC776 Kilovoltage Imaging System (KV Imager) HXKB060 HXKC776 RapidArc Delivery HRD3000 HRD4462 Optical Imaging HOIB060 HOIC776 Integrated Collimator Verification and Interlock System (ICVI) HEC0077 HEC0362 PerfectPitch 6 Degree of Freedom Couch HPR0153 HPR0773

TrueBeam platform system software (on Windows 10 or higher)

3.0 3.0

SABR (stereotactic ablative radiotherapy) Extracranial Package (Calypso Essentials)

HCL1171 HCL1281

SRS (stereotactic radiosurgery) Intracranial Package HOM0084 HOM0557 Visual Coaching Device (VCD) HCD02BC HCF02B8 Visual Coaching Device for Philips CT scanner HDC052U Respiratory Gating System for TrueBeam (incl. interface to Government-owned Computed Tomography (CT) scanner)

HGS1921

Hypersight KV Imaging System TBD TBD

Note: ROB anticipates replacement of the MV and KV Imager components (S/N HXMB060, S/N HXMC776) during optional future upgrades of both linear accelerators with the Varian HyperSight imaging solution; see Sections 5.3 and 5.4 below.

Software components:

1. ARIA v. 16.1: This electronic health record radiation oncology information system is supported by several agent servers for the integration of all radiation planning, treatment, and CT imaging data in one central database, including archiving and restoration.

2. Eclipse: This radiation treatment planning system integrates with ARIA and incorporates information about the size, shape, and location of the tumor to be treated with radiation. It is used to design, simulate, and optimize radiotherapy treatment based on a physician’s dose instructions.

ROB uses the following three Eclipse versions:

a. Eclipse Calculation v.16.1, Product Code Serial Numbers (PCSNs) H489559, H487708, H480732, H480748, and H48J463

b. Eclipse Non-Calculation v.16.1, PCSN H48DG00

c. ECLIPSE FAS Servers v.16.1, PCSNs H480598 and H480599

d. Eclipse Proton v.13.6, PCSN H48A941.

3. InSightive v. 1.9, PSCN HIN0043: The stand-alone, cloud-based data platform application (virtual server) supports oncology data analytics with data pulled from ARIA through a dynamic dashboard.

Note: ROB anticipates upgrade of InSightive to InSightive Gen2; see Section 4.6.4 below.

All services shall be performed in accordance with the Original Equipment Manufacturers (OEM) most current standard commercial maintenance practices. Software updates/services and applications service may be performed remotely as applicable. Onsite and emergency services shall be provided during standard business hours (defined as 8:00 AM – 5:00 PM EST, Monday through Friday, excluding Federal Holidays, found at www.opm.gov/policy-data-oversight/pay-leave/federal-holidays), and extended hours (5:00 PM – 9:00 PM EST, Monday through Friday, excluding Federal Holidays) for any issues not not able to be resolved remotely. The Contactor shall communicate with the Government’s COR in order to coordinate efforts with other Contractors as needed. All travel, labor, materials, and related charges shall be included in the Purchase Order price.

4.0 SPECIAL ORDER REQUIREMENTS

The Contractor shall provide all labor, materials, and equipment required to complete the following:

4.1 REMOTE MONITORING AND DIAGNOSTIC SERVICES

The Contractor shall provide 24/7 automatic remote monitoring, diagnostic and maintenance services for the TrueBeam accelerator systems using software that monitors specific critical functions autonomously through a secure internet connection to automatically predict and detect fault conditions, and to automatically send alerts in real time. The Contractor shall then evaluate the alerts and initiate appropriate actions to correct system issues. The Contractor shall provide a secure mechanism for performing remote diagnostics and service. This system shall exclusively utilize the NIH Active Directory structure for login purposes. The monitoring system shall utilize the NIH Active Directory structure for login purposes as well as the existing approved proprietary firewall (MICAP) in order to isolate the Varian radiotherapy systems from the network in general and provide secure communications via SSL-VPN-TLS using a secure remote connection for each TrueBeam linear accelerator that meets all cybersecurity and PHI requirements. The monitoring system must meet all cybersecurity and PHI requirements and provide for proactive identification of possible faults and alerts so that the Contractor and the Government can quickly mitigate any issues with equipment and ensure patient safety and continuity of services.

4.2 UPTIME REQUIREMENT

The Contractor shall maintain overall uptime rates of 97% or better for the TrueBeam radiation platforms and the RGSC covered under this requirement. The uptime rates are calculated during daily quality assurance tests for each system, utilizing the following formula:

𝑈𝑝𝑡𝑖𝑚𝑒 % 𝑁𝑜𝑟𝑚𝑎𝑙 𝑤𝑜𝑟𝑘𝑖𝑛𝑔 ℎ𝑜𝑢𝑟𝑠 𝐷𝑜𝑤𝑛𝑡𝑖𝑚𝑒

𝑁𝑜𝑟𝑚𝑎𝑙 𝑤𝑜𝑟𝑘𝑖𝑛𝑔 ℎ𝑜𝑢𝑟𝑠 ∗ 100

Normal working hours for these radiotherapy systems are anticipated to be 2,080 hours annually. For the purposes of this requirement, downtime will be calculated based on any event that renders the radiation systems inoperable for patient care. Normal pre-scheduled services such as preventive maintenance will not be included in the calculation of these rates.

The uptime rates for the TrueBeam radiation platforms and the RGSC shall be included in the Field Service Reports; see Section 4.7 below.

4.3 PREVENTIVE MAINTENANCE SERVICES FOR VARIAN TRUEBEAM EQUIPMENT

COMPONENTS AND THEIR INTERFACES

Only technically qualified, OEM factory-trained personnel shall perform the services on the TrueBeam radiation therapy systems including RGSC and ARIA/Eclipse at ROB. Service shall consist of a thorough cleaning, calibration, adjusting, inspection, and testing of all equipment in accordance with the manufacturer’s latest established service procedures. All equipment shall be operationally tested through at least one (1) complete operating cycle at the end of the preventive maintenance inspection to assure optimum and efficient performance.

The Contractor shall perform the following preventive maintenance inspections (PMI) during each 12-month contract period of performance:

1. For both Varian TrueBeam STX linear accelerator platforms, including all subcomponents: three

(3) annual planned PMIs. Each PMI shall include a review of the current firmware versions and installation of updates; as well as verification of the operability of proprietary interfaces between the Hospital Information System (HIS) and the ARIA. The Contractor shall maintain and update these proprietary interfaces as necessary in order to maintain the CRIS-ARIA network path. See Sections 4.6.5 and 4.6.6 below for upgrades concerning hardware and interoperability.

2. For Varian Visual Coaching Devices: one (1) annual planned PMI.

3. For Varian Respiratory Gating System component (RGSC): one (1) annual planned PMI. The PMI shall include a review of the current software version and installation of updates; as well as verification of the operability of the proprietary interface between the CT scanner and the RGSC in accordance with the manufacturer’s most current standard commercial service procedures to assure optimum and efficient performance.

4.4 EMERGENCY SERVICE

On-site, emergency repair service visit shall be provided during the term of this contract at no additional cost to the Government for any issues that cannot be resolved by telephone or via remote service. The Contractor Call Center shall be available at 8:00 AM – 5:00 PM EST for placing emergency calls and contact the on-call service engineer for help in diagnosing problems. Emergency services shall be provided during “Standard Hours”, defined as Monday through Friday 8 AM – 5 PM EST, excluding Federal Holidays. In addition, onsite service shall be provided during “Extended Hours” (5:00 PM – 9 PM EST) for issues that cannot be resolved remotely. Emergency service calls shall not replace the necessity for planned preventive maintenance.

The Contractor shall provide an electronic service report within five (5) business days detailing work completed and any recommendations for additional work.

4.4.1 EMERGENCY SERVICE FOR TRUEBEAM LINEAR ACCELERATORS PLATFORMS AND

SUBCOMPONENTS

Upon receipt of notice that any part of the TrueBeam Platforms is not functioning properly the Contractor shall provide a one (1) hour initial response, and a four (4) hour on-site/remote response of a qualified factory-trained service representative to inspect the equipment and perform all repairs and adjustments necessary to restore the equipment to normal and efficient operating condition.

4.4.2 EMERGENCY SERVICE FOR ARIA/ECLIPSE

Upon receipt of notice that any part of the ARIA/Eclipse software is not functioning properly, the Contractor shall provide an initial response within 30 minutes when the issue either prevents or significantly impairs performance of critical system functions (“Severity Level 1” and “Severity Level 2”); and provide an initial response until the end of the following business day when the issue can be circumvented or avoided on a temporary basis by the end user or is a low impact issue (“Severity Level 3” and “Severity Level 4”). The Contractor shall continue working on the issue until a solution or acceptable workaround is provided. The Contractor shall notify the Government promptly if an issue cannot be resolved and contact the on-call service engineer for help in diagnosing problems.

4.4.3 EMERGENCY SERVICE FOR RESPIRATORY GATING FOR SCANNERS (RGSC)

Upon receipt of notice that any part of the RGSC is not functioning properly, the Contractor shall access the system via secure remote access within 2 business hours to diagnose the problem. If defective parts are detected, the Contractor shall dispatch within twelve (12) business hours a qualified factory-trained service representative to inspect the equipment and perform all repairs and adjustments necessary to restore the equipment to normal and efficient operating condition.

4.4.4 EMERGENCY SERVICE FOR RESPIRATORY GATING FOR SCANNERS (RGSC)

Upon receipt of notice that any part of radiation system not functioning properly the Contractor shall provide a one (1) hour initial response, and a four (4) hour on-site/remote response of a qualified factory-trained service representative to inspect the equipment system and perform all repairs and adjustments necessary to restore the equipment system to normal and efficient operating condition.

4.5 REPLACEMENT PARTS

The Contractor shall furnish all required replacement parts at no additional cost to the Government, with the exception of consumables. All replacement parts shall be functionally equivalent to or superior to the OEM parts that were included in the original FDA 510(k) clearance. Parts that were repaired or replaced must also demonstrate compatibility with the device’s processes and modalities that were validated in the medical device’s Instructions For Use (IFU). The Contractor shall have any replacement parts validated by the original equipment manufacturer (Varian Medical Systems) to ensure that the FDA approved configuration has been maintained.

Upon identification of required parts, they shall be delivered within 24 hours, or the following business day should the delivery fall on a Friday or proceeding a Federal Holiday. If parts will take longer than 24 hours to be delivered for any reason, the Contractor must provide the TPOC with a notification stating the reason and estimated delivery timeframe immediately upon identification of delivery delay and the estimated arrival date for replacement parts.

4.6 IT SOFTWARE AND HARDWARE SERVICES

4.6.1 SOFTWARE SERVICES - GENERAL

Given the complex nature of the TrueBeam system, the Contractor must work in close coordination with the COR and other contractors as needed to mitigate issues between system software and all other associated hardware and software which may communicate with equipment to ensure interoperability is maintained, and issues with TrueBeam are addressed. The Contractor shall provide and ensure that the systems’ software is maintained in accordance with the manufacturers latest established service procedures. Software updates shall include all major software update releases, firmware updates, all maintenance release/service pack updates, FDA mandated updates, reliability fixes to existing software, and all other similar updates required for equipment. For any updates that render computer hardware, Operating System, monitors, and other devices attached to the covered equipment inoperable, the relevant hardware shall be upgraded or replaced in order to meet required specifications. The Contractor shall also provide any associated training required (see Section 4.9 below for details).

The Contractor shall receive advance approval for the installation of all software updates and upgrades from the Government. Defective software shall be replaced at no additional cost to the Government.

Installation of any software/updates shall be performed by a factory trained and certified technician. The Contractor shall provide diagnostic and remedial support services for the software products remotely through secure remote service tools to the greatest extent possible. For this purpose, the Contractor shall provide a remote service connection (see Section 4.2 above), and an automated software deployment tool to the Government.

The Contractor shall provide an electronic report to the COR within three (3) business days after successful performance of software or hardware update services. This report shall also include the reason for the update, and any effect it may have on OEM radiation system operation

4.6.2 SOFTWARE SERVICES - ARIA, ECLIPSE, INSIGHTIVE

The Contractor shall include a System Protection Plan which provides the most recent software product versions for ARIA, Eclipse, and Insightive, to include service packs, maintenance releases, upgrade releases, and newly released versions, at no additional cost to the Government. All software update services shall be conducted in accordance with the OEM’s latest established service procedures, at no additional cost to the Government. Defective software shall be replaced at no additional cost to the Government.

Software update services shall include:

1. Mandatory safety releases: updates, error corrections, or modifications to OEM software issued by OEM for safety reasons.

2. Maintenance releases/updates: bug fixes, patches, and other error corrections by OEM to a OEM software product designed to enable this software to conform to its documentation. (Updates may be indicated by the number to the right of the second decimal in a software version number.)

3. Upgrades/Upgrade releases: upgrades, enhancements, and improvements by OEM to the features or functionality of its software. (Upgrades may be indicated by the number to the right of the first decimal in a software version number.)

4. Newly released versions: applications, modules, or releases of the software that include new features or functionality and that are released and marketed by OEM as versions or purchase options. (Versions may be indicated by the number to the left of the first decimal in a software version number.)

Note: Potential at-cost upgrades to newly released versions shall be agreed upon and arranged in conjunction with the Contracting Officer (CO) and the Contracting Officer’s Representative

(COR).

4.6.3 ECLIPSE PROTON TREATMENT PLANNING SYSTEM (TPS)

The Contractor shall provide the most recent software product version for the non-clinical Eclipse Proton Treatment Planning System (TPS), to include service packs, maintenance releases, upgrade releases, and newly released versions, at no additional cost to the Government.

Note: See Section 5.2 below for associated optional hardware refresh.

4.6.4 INSIGHTIVE SOFTWARE SERVICES

The Contractor shall provide the most recent software product version for Varian InSightive analysis software, to include service packs, maintenance releases, upgrade releases, and newly released versions, at no additional cost to the Government.

Due to the importance of the InSightive analysis software in supporting patient care efforts in conjunction with the ARIA and ECLIPSE platforms, should a new version of InSightive software be released during the Period of Performance of this contract, the Government reserves the right to procure new versions of this software via a modification to this award, under a separate purchase order, or any other manner deemed appropriate in accordance with Federal Acquisition Procedures.

4.6.5 IT HARDWARE UPGRADES

The Contractor shall notify the CO and the COR in advance if the current specifications of the IT hardware do not meet the technical requirements of an upgrade or a new version and arrange the replacement of the affected hardware with the Government. The Government reserves the right to procure upgrades for affected hardware via a modification to this award, under a separate purchase order, or any other manner deemed appropriate in accordance with Federal Acquisition Procedures.

4.6.6 INTEROPERABILITY UPGRADES

The Contractor shall maintain the functionality of existing interfaces that were originally created by the OEM for the Government. The Contractor shall perform all modifications and changes to existing and working interfaces that are required due to an OEM software update or upgrade at no additional cost to the Government.

4.7 FIELD SERVICE REPORTS

The Contractor shall provide an electronic Field Service Report (FSR) to NCI’s COR/TPOC within three

(3) business days of completion of any services performed on equipment or software covered under this requirement. The Contractor shall complete FSR to include at a minimum, the following:

1. Contractor’s Name

2. Technician’s name, telephone number, and signature

3. Date and Time at which services were performed

4. Equipment Make, Model, and Serial Number

5. Summary of malfunction/issue

6. Summary of work performed

7. Duration equipment was inoperable

8. Certification that equipment is fully operational

9. Uptime rate as applicable

The FSR shall be delivered in Microsoft Office 2013 or newer Word formats or Adobe PDF, unless prior approval for another format has been obtained from the COR.

4.8 TECHNICAL SUPPORT

The Contractor shall provide unlimited technical help desk telephone support during standard business hours (see Section 3.0 above) for trouble-shooting instrument issues, support for clinical applications, and software troubleshooting support, at no additional cost to the Government. Technical support shall be provided over the phone, email, and via remote access internet portal.

4.9 TRAINING

The Contractor shall provide application training to NIH staff who is authorized to use the TrueBeam accelerators and/or ARIA/Eclipse (approximately 24 end users) during normal business days, excluding holidays (see Section 3.0 above). Software training shall be provided by fully trained service and applications personnel at no additional cost to the Government. For any newly released software version (see Section 4.3 above),

1. An initial one-day training shall be conducted as an instructor-led webinar at least 10 business days prior software version or major hardware upgrade.

2. A second one-day training shall be conducted on-site (NIH main campus) no more than 5 business days after software version or major hardware upgrade.

The Contractor shall provide the COR with training materials in pdf or similar electronic media form at least five (5) business days prior scheduled training event.

In a service year in which there is no major software/hardware version upgrade, a one-day training shall be conducted as an instructor-led webinar.

4.10 CONTRACTOR QUALIFICATIONS/CERTIFICATIONS

To demonstrate qualified services and to safeguard patient information, the Contractor shall be certified for ISO 9001 – for a quality management system, and additionally for at least one the following standard:

ISO 13485:2016 – for a quality management system of medical devices and related services.

As proof of adequate up-to-date OEM factory training of its field engineers and the use of parts that meet the original specifications, the Contractor shall be certified and/or be accredited by the FDA. Upon request by the COR, the Contractor shall provide the appropriate certificate to demonstrate qualification.

4.11 PERSONNEL QUALIFICATIONS

Only technically qualified, OEM certified personnel shall provide service and applications support to the Varian TrueBeam radiation therapy systems at NIH/NCI/ROB, as covered by this contract. Upon request by the COR, the Contractor shall provide the education or training certificate(s) of personnel providing services to ROB under this contract to demonstrate appropriate qualification.

Personnel shall have a minimum of two (2) years factory training and experience in the servicing of TrueBeam radiation therapy systems as covered by this requirement. All primary service personnel shall have at least one (1) backup support person with at least the same level of expertise.

4.12 SERVICE EXCLUSIONS

The Contractor shall not be responsible for any repairs necessitated by abuse, neglect, vandalism, Acts of God, fire, or water. Should equipment be damaged under circumstances not covered under this order, the Government reserves the right to obtain any and all necessary repairs needed as a result of such events via a modification to the purchase order, under a separate purchase order, or any other method deemed appropriate and in accordance with Federal Acquisition Regulations.

5.0 OPTIONS

5.1 ECLIPSE HARDWARE REFRESH

The Contractor shall conduct one (1) hardware refresh to replace all computer hardware for all Eclipse workstations and servers with the latest versions provided by Varian. This shall include the re-installation and the configuration of software (ARIA, Eclipse calculation, and Eclipse noncalculation) as appropriate, and system testing. The Government anticipated this upgrade to occur in fiscal year 2026.

Note: see Section 5.2 below for a separate hardware refresh associated with Eclipse Proton.

The following computer hardware components shall be covered under the hardware refresh:

1. Five (5) clinical Eclipse calculation workstations (Current Dell service tags: FZBMZB3, FZBRZB3, FZBPZB3, FZBLZB3 and FZBNZB3).

2. One (1) non-clinical Eclipse non-calculation workstation (Current Dell service tag: 2TMLZB3).

3. Two (2) Framework Agent Servers (FAS) (Current Dell service tags: 2WCC8B3 and 11KH8B3).

4. Two (2) Graphics Processing Unit (GPU) Enabled FAS kits for FAS Servers.

The Contractor shall provide an electronic report to the COR within three (3) business days after successful performance of IT hardware refresher services.

5.2 ECLIPSE PROTON HARDWARE REFRESH

The Contractor shall conduct one (1) hardware refresh to replace all computer hardware associated with the software Eclipse Proton with the latest versions provided by Varian. This shall include the re-installation and the configuration of the Eclipse Proton software as appropriate, and system testing.

The Contractor shall provide an electronic report to the COR within three (3) business days after successful performance of IT hardware refresher services.

5.3 UPGRADE OF TRUEBEAM STX LINEAR ACCELERATOR HST192104

The Contractor shall upgrade the TrueBeam STX linear accelerator system S/N HST192104 with the “Varian HyperSight” imaging solution. The Government anticipated this upgrade to occur in fiscal year 2026.

5.4 UPGRADE OF TRUEBEAM STX LINEAR ACCELERATOR HST193045

The Contractor shall upgrade the TrueBeam STX linear accelerator system S/N HST193045 with the “Varian HyperSight” imaging solution. The Government anticipates this upgrade to occur in fiscal year 2027.

6.0 TYPE OF ORDER

This shall be a firm-fixed price purchase order.

7.0 PERIOD OF PERFORMANCE

The estimated period of performance shall consist of one (1) 12-month base period and four (4) 12-month option periods as follows:

Base Period: June 2, 2025 – June 1, 2026 Option Period 1: June 2, 2026 – June 1, 2027 Option Period 2: June 2, 2027 – June 1, 2028 Option Period 3: June 2, 2028 – June 1, 2029 Option Period 4: June 2, 2029 – June 1. 2030

Note:

1. The estimated period of performance for the maintenance of the Respiratory Gating System component (RGSC) S/N HGS1915 shall begin on June 10, 2025.

2. The estimated period of performance for ARIA/Eclipse/Insightive software services shall begin on September 22, 2025.

8.0 PLACE OF PERFORMANCE

All services able to be provided remotely, or off-site may be performed from the Contractor’s facilities.

All other services requiring the Contractor to be on-site shall be performed at the following locations:

TrueBeam linear accelerators, workstations:

NIH, NCI

10 Center Dr

10 CRC, B2-3661

Bethesda, MD 20892

Servers:

NCI at Shady Grove CBIIT East Data Center 9609 Medical Center Dr.

Rockville, MD 20850

Note: NIH campus is a restricted campus. As such all-contractor personnel will be required to access campus via designated entrances where they are subject to security screening. Please refer to the NIH

Security and Access site for more details: (www.nih.gov/about-nih/visitor-nformation/campus-access-security).

9.0 CONTRACTING OFFICERS REPRESENATIVE (COR)

All services delivered to the COR will be deemed to have been accepted upon written confirmation of acceptance by the COR. The COR’s approval or revision to the services delivered shall be within the general scope of work for the Purchase Order. The following individual shall be the COR for this purchase order:

Name: (T.B.D Upon Award) Email:

Phone:

Performance of work under this Purchase Order must be subject to the technical direction of the Contracting Officer's Representative identified above. The term "technical direction" includes direction to the Contractor that fills in details and otherwise serves to ensure that tasks outlined in the statement of work are accomplished satisfactorily. Technical direction must be within the scope of the statement of work.

The Contracting Officer's Representative does not have authority to issue technical direction that:

a. Constitutes a change of assignment or additional work outside the Statement of Work (SOW);

b. Constitutes a change as defined in the clause 52.212-4 (c) governing "Changes”.

c. In any manner causes an increase or decrease in the contract price, or the time required for contract performance;

d. Changes any of the terms, conditions, or requirements of the contract;

e. Interferes with the Contractor's right to perform under the terms and conditions of the contract; or

f. Directs, supervises, or otherwise controls the actions of the Contractor's employees.

Technical direction may be oral or in writing. The Contracting Officer's Representative shall confirm oral direction in writing within five business days, with a copy to the Contracting Officer. The Contractor shall proceed promptly with performance resulting from the technical direction issued by the Contracting Officers Representative. If, in the opinion of the Contractor, any direction of the Contracting Officer’s Representative, or his/her designee, falls within the limitations in (b), above, the Contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government business day.

Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause 52.212-4 (d) titled "Disputes."

10.0 INSPECTION AND ACCEPTANCE

Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this purchase order is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI Contracting Officers Representative (COR T.B.D upon award) who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

Regardless of format, all digital content or communications materials produced as a deliverable under this purchase order, shall conform to applicable Section 508 Standards to allow Federal employees and members of the public with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by Federal employees or by members of the public who are not individuals with disabilities. Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor.

HHS guidance regarding accessibility of documents can be found at:

https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

Federal Government-wide guidance regarding accessibility of documents can be found at https://www.section508.gov/, including the documents describing the preferred method of authoring and testing documents produced in Microsoft Word 2013 or later, Microsoft Excel, and files formatted as

PDF.

11.0 DELIVERABLES

SOW Section Description Due Date

4.1 Secure remote monitoring services Immediately upon award

4.4 Emergency Service Report

Within five (5) business days after successful performance

4.6.2 Electronic report or email to the COR after successful performance of software update services for ARIA and/or Eclipse

Within three (3) business days after successful performance

4.6.3 Electronic report or email to the COR after successful performance of software update services for Eclipse Proton

Within three (3) business days after successful performance

4.6.4 Electronic report or email to the COR after

successful performance of software services for InSightive

Within three (3) business days after successful performance

4.4 Electronic report to the COR after successful

performance of emergency services Within five (5) business days after successful performance

4.7 Electronic Field Service Report, as electronic report or email to the COR after successful performance of maintenance services

Within three (3) business days after successful performance

4.9 Training materials in pdf or similar electronic

media form to the COR Five (5) business days or more prior scheduled training event

4.10 Certificate or accreditation of the Contractor as

requested by the COR Within ten (10) business days after successful performance

4.11 Education or training certificate(s) of personnel providing services to ROB as requested by the

COR

Within ten (10) business days after successful performance

5.1 OPTION 1: Electronic report to the COR after

successful performance of IT hardware refresher services for ARIA/Eclipse

Within three (3) business days after successful performance

5.2 OPTION 2: Electronic report to the COR after

successful performance of IT hardware refresher services for Eclipse Proton

Within three (3) business days after successful performance

5.3 OPTION 3: Electronic report to the COR after

successful performance of TrueBeam HST192104 upgrade with HyperSight

Within three (3) business days after successful performance

5.4 OPTION 4: Electronic report to the COR after

successful performance of TrueBeam HST193045 upgrade with HyperSight

Within three (3) business days after successful performance

12.0 PRICE SCHEDULE

Item Description Amount

Base Period: Remote monitoring, uptime, and PM for Varian TrueBeam STX, S/N HST192104, incl. all subcomponents and firmware ("TrueBeam Essentials"). PoP: 6/2/2025 – 6/1/2026

Base Period: Remote monitoring, uptime, and PM for Varian TrueBeam STX, S/N HST192104, incl. all subcomponents and firmware ("TrueBeam Essentials"). PoP: 6/2/2025 – 6/1/2026

Base Period: Remote monitoring, uptime, and PM for Varian Respiratory Gating system (RGSC), S/N HGS1915 (“Essentials”). PoP: 6/10/2025 – 6/1/2026

Base Period: PM for Visual Coaching Device S/N HDC052U. PoP: TBD –

Base Period: PM for Visual Coaching Devices S/N HCD02BC and HCF02B8.

PoP: TBD – 6/1/2026

6 Base Period: Software services for Varian ARIA. PoP: 9/22/2025 – 6/1/2026

7 Base Period: Software services for Varian Eclipse. PoP: 9/22/2025 – 6/1/2026

Base Period: Software services for Varian InSightive. PoP: 9/22/2025 –

Option Period 1: Remote monitoring, uptime, and PM for Varian TrueBeam STX, S/N HST192104, incl. all subcomponents and firmware ("TrueBeam Essentials"). PoP: 6/2/2026 – 6/1/2027

Option Period 1: Remote monitoring, uptime, and PM for Varian TrueBeam

Essentials"). PoP: 6/2/2026 – 6/1/2027

Option Period 1: Remote monitoring, uptime, and PM for Varian Respiratory Gating system (RGSC), S/N HGS1915 (“Essentials”). PoP: 6/10/2026 – 6/1/2027

Option Period 1: PM for Visual Coaching Devices S/N HDC052U, HCD02BC, and HCF02B8. PoP: 6/2/2026 – 6/1/2027

Option Period 1: Software services for Varian ARIA. PoP: 9/22/2026 –

Option Period 1: Software services for Varian Eclipse. PoP: 9/22/2026 –

Option Period 1: Software services for Varian InSightive. PoP: 9/22/2026 –

Option Period 2: Remote monitoring, uptime, and PM for Varian TrueBeam

Essentials"). PoP: 6/2/2027 – 6/1/2028

Option Period 2: Remote monitoring, uptime, and PM for Varian TrueBeam

Essentials"). PoP: 6/2/2027 – 6/1/2028

Option Period 2: Remote monitoring, uptime, and PM for Varian Respiratory Gating system (RGSC), S/N HGS1915 (“Essentials”). PoP: 6/10/2027 – 6/1/2028

Option Period 2: PM for Visual Coaching Devices S/N HDC052U, HCD02BC, and HCF02B8. PoP: 6/2/2027 – 6/1/2028

Option Period 2: Software services for Varian ARIA. PoP: 9/22/2027 –

Option Period 2: Software services for Varian Eclipse. PoP: 9/22/2027 –

Option Period 2: Software services for Varian InSightive. PoP: 9/22/2027 –

Option Period 3: Remote monitoring, uptime, and PM for Varian TrueBeam

Essentials"). PoP: 6/2/2028 – 6/1/2029

Option Period 3: Remote monitoring, uptime, and PM for Varian TrueBeam

Essentials"). PoP: 6/2/2028 – 6/1/2029

Option Period 3: Remote monitoring, uptime, and PM for Varian Respiratory Gating system (RGSC), S/N HGS1915 (“Essentials”). PoP: 6/10/2028 – 6/1/2029

Option Period 3: PM for Visual Coaching Devices S/N HDC052U, HCD02BC, and HCF02B8. PoP: 6/2/2028 – 6/1/2029

Option Period 3: Software services for Varian ARIA. PoP: 9/22/2028 –

Option Period 3: Software services for Varian Eclipse. PoP: 9/22/2028 –

Option Period 3: Software services for Varian InSightive. PoP: 9/22/2028 –

Option Period 4: Remote monitoring, uptime, and PM for Varian TrueBeam

Essentials"). PoP: 6/2/2029 – 6/1/2030

Option Period 4: Remote monitoring, uptime, and PM for Varian TrueBeam

Essentials"). PoP: 6/2/2029 – 6/1/2030

Option Period 4: Remote monitoring, uptime, and PM for Varian Respiratory Gating system (RGSC), S/N HGS1915 (“Essentials”). PoP: 6/10/2029 – 6/1/2030

Option Period 4: PM for Visual Coaching Devices S/N HDC052U, HCD02BC, and HCF02B8. PoP: 6/2/2029 – 6/1/2030

Option Period 4: Software services for Varian ARIA. PoP: 9/22/2029 –

Option Period 4: Software services for Varian Eclipse. PoP: 9/22/2029 –

Option Period 4: Software services for Varian InSightive. PoP: 9/22/2029 –