SOW_75N91024Q00135.pdf

National Institutes of Health / National Cancer Institute / Office of Acquisitions Solicitation No.: 75N91022Q00050

1.0 TITLE

Maintenance and Service Agreement for two (2) Varian TrueBeam 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) treats patients using radiotherapy in accordance with approved clinical protocols. The ROB also performs research to better understand the roll of radiation in the treatment of disease. These treatments are delivered by linear accelerators which are able to deliver a precise dose distribution that is highly localized in order to treat the prescribed target volume while sparing adjacent, uninvolved tissues to the maximum extent possible. These machines are capable of extreme (< 1mm) spatial precision 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.

To meet these needs, ROB utilizes two Varian TrueBeam STX linear accelerators (H192104 & H193045). These devices have identical equipment between them, allowing patients to easily be treated on one or the other linear accelerator. Due to the precise tolerances required for treatment and the critical nature of multiple session treatment delivery, it is essential that these units be maintained to the highest standards and that, should a malfunction occur, it can be diagnosed and remedied quickly so as to not compromise patient treatment. Also, because of the unique construction of these machines, only service personnel that have been specifically trained to service this particular equipment are capable of providing the level of service required.

3.0 SCOPE

The Contractor shall provide all labor, material, and equipment necessary to maintain and provide preventive and emergency maintenance services for the NCI ROB’s TrueBeam Platforms, their supporting subsystems, and components. Currently, the TrueBeam platforms consist of the following:

Serial or Version Number

Varian Component 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) 3.0 3.0

STATEMENT OF WORK

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

HCL1171 HCL1281

SRS (stereotactic radiosurgery) Intracranial Package HOM0084 HOM0557

Visual Coaching Device (VCD) HCD02BC HCF02B8

All maintenance services shall be performed on-site in accordance with the Original Equipment Manufacturers (OEM) most current standard commercial maintenance practices. Software 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 – 5:00pm 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 – 9:00pm EST, Monday through Friday) for any issues not able to be resolved remotely, or during normal business hours. Software updates/services maybe provided remotely as applicable. Contactor shall communicate with the Government’s COR 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 PREVENTIVE MAINTENANCE

For TrueBeam units, the Contractor shall perform three (3) planned preventive maintenance inspections (PMI) during the contract period per factory guidelines for each machine. Technically qualified factory-trained personnel shall perform the service. 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.

4.2 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 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 as well as the existing approved proprietary firewall (MICAP) in order to isolate Varian equipment from the network in general and provide secure communications via SSL-VPN-TLS using a secure remote connection for each TrueBeam that meets 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.

4.3 EMERGENCY SERVICE

On-site, emergency repair service visit shall be provided during the term of this contract at no additional cost to the government. The Contractor Call Center shall be available at 8:00 AM – 5:00 PM EST for placing emergency calls. The Call Center shall contact the on-call service engineer for help in diagnosing problems. Emergency services shall be provided during “Standard Hours,” defined as Monday through

Friday 8am - 5pm EST, excluding Federal Holidays. In addition, onsite service shall be provided during “Extended Hours” (5pm-9pm EST) for issues that cannot be resolved remotely. Upon receipt of notice that any part of equipment/software not functioning properly the Contractor shall provide a one (1) hour initial response, and a four (4) 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. Emergency service calls shall not replace the necessity for planned preventative maintenance. All labor and travel shall be included in the price.

The TrueBeam systems: (S/N:H192104 and H193045) require 24/7 automatic remote monitoring via HL7 approved secure remote connection for each TrueBeam 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.

4.4 UPTIME REQUIREMENT

The Contractor shall maintain an overall uptime rate of 97% or better for all equipment covered under this requirement. The uptime rate shall be calculated utilizing the following formula:

UPTIME = NORMAL WORKING HOURS – DOWNTIME x 100

NORMAL WORKING HOURS

Normal working hours for this equipment 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 equipment inoperable for patient care. Normal pre-scheduled services such as preventive maintenance will not be included in the calculation of this rate.

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 parts shall meet OEM specifications. 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 SOFTWARE UPDATES/UPGRADES

4.6.1 Software Updates: 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. Contractor shall also provide any associated training required. Given the complex nature of the system, the contractor must also work in 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.

4.6.2 Upgrades: Software services shall include software upgrades required to maintain all software at the current, commercially released software versions required to remain FDA compliant at no additional cost to the Government. In addition, the Government’s objective is that Contractor will provide an approach to ensure all hardware remain operable with all implementations of future software upgrades.

4.6.3 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.

4.7 TECHNICAL SUPPORT

The Contractor shall provide unlimited clinical technical telephone support during standard business hours for trouble-shooting instrument issues and support for clinical applications, as well as software troubleshooting support (MON-FRI 7:00AM – 5:00PM EST), excluding Federal holidays. Technical support shall be provided over the phone, email, and via remote access internet portal.

4.8 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 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.

4.9 FIELD SERVICE REPORTS

Field Service Reports (FSR): Contractor shall provide an electronic FSR to NCI’s COR/TPOC within seventy-two (72) of hours 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. Contractors 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

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.

4.10 PERSONNEL QUALIFICATIONS

Personnel shall have a minimum of two (2) years factory training and experience in the servicing of the TrueBeam radiation therapy systems, and associated software 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.

5.0 PERIOD OF PERFORMANCE

The anticipated period of performance shall be for ten (10) months as follows:

Aug 2, 2024 – June 1, 2025

6.0 PLACE OF PERFORMACNE

Onsite services shall be performed at the following location:

NIH, NCI,

10 Center Dr

10 CRC, B2-3661

Bethesda, MD 20892

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).

7.0 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:

COR Name:

COR Email:

COR Phone No.:

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."

8.0 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.