Att1-SOW_75N91024Q00100.pdf

STATEMENT OF WORK

1.0 TITLE

Preventive Maintenance Service for LAP Laser Green DORADO Patient Positioning System

2.0 BACKGROUND

The Radiation Oncology Branch (ROB) at the National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), designs and conducts pre-clinical and clinical research on the biologic and therapeutic effect of radiation therapy. The research clinical trials that the ROB develops and conducts involve novel technology and/or imaging based approaches to radiation therapy treatment.

Since 2020, the ROB uses a laser-based radiotherapy positioning system, LAP Laser Green DORADO/DORADOnova, in conjunction with a Philips Big Bore CT scanner for the imaging of patients prior to treatment. This system assists in reproducible patient positioning during radiation therapy planning and is utilized during treatment planning workflow. This non-invasive medical device projects visual laser beams which can be positioned at specified coordinates via a control system. This ensures the accurate alignment of patients which is critical as it provides the reference positioning of the patient as they receive radiotherapy. Furthermore, the LAP Laser Green DORADO allows for the initial registration of the patients physical setup during each radiation therapy session.

The DORADO system must be kept in good working order, as well as re-calibrated periodically, to ensure that patients receive the correct radiation dosage to the targeted tissues. Any drift in calibration or accuracy will have significant adverse effects for patients. Therefore, the ROB requires a service contract to keep the LAP Laser Green DORADO system in good working order and ensure quick repair in the event of a problem to minimize any delays to a patient’s radiotherapy.

3.0 SCOPE

The Contractor shall provide all labor, material and equipment necessary to maintain and provide preventive maintenance for the existing laser system:

LAP Green DORADO/DORADOnova, Serial Number 0072769.

All maintenance services shall be performed on-site in accordance with the Original Equipment Manufacturers (OEM) most current standard commercial maintenance practices. 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 – 9:00pm EST, Monday through Friday) for any issues not able to be resolved remotely, or during normal business hours.

Software updates/services may be provided remotely as applicable. 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 perform the following tasks:

4.1 PREVENTIVE MAINTENANCE

The Contractor shall perform one (1) planned preventive maintenance visit during the contract period. Technically qualified factory-trained personnel shall perform this service. The 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.

This shall include diagnostics, visual inspection, system check, cleaning of all system components, retightening of the fixing and installation points for ceiling and side lasers, measurement of the laser currents and the laser power for all laser sources, quality control by means of the Wilke Phantom and laser adjustment to the virtual isocenter, and performance test of the DORADO control elements, according to manufacturer’s latest established maintenance protocol.

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.

A report indicating the work performed shall be provided to NCI’s Technical Point of Contact (TPOC) within three (3) business days of completion. The report shall be provided in electronic format (Word or PDF file).

4.2 EMERGENCY SERVICE

On-site, emergency repair service visit shall be provided during the term of this contract at no additional cost to the Government. Emergency service shall be provided during normal working hours, Monday through Friday excluding Federal Holidays (see Section 3.0). Upon receipt of notice that any part of the equipment is not functioning properly, the Contractor shall provide an initial response within one (1) hour, and a target on-site response within twenty-four (24) business hours 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, travel, and OEM parts shall be included.

Within three (3) business days of the completion of any emergency repair services performed, the Contractor shall provide a brief emergency service report to the TPOC stating the equipment malfunction that occurred, the repair efforts, and the duration that was required to restore the equipment to operation. The emergency service report shall be provided in electronic format (Word or PDF file).

4.3 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 original equipment manufacturer (OEM) specifications. Upon identification of required parts, they shall be delivered within 24 hours, or the following business day should the request fall on a Friday, or preceding 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.

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.

4.4 SOFTWARE UPDATES/SERVICE

The Contractor shall provide Software Service and updates in accordance with the manufacturer’s latest established service procedures, to include telephone access to technical support for use of program software and troubleshooting of the operating systems, at no additional cost to the Government. The Contractor shall receive advance approval for the installation of all software updates and revisions from the Government. Software service shall include software check during annual maintenance visits, all major software versions, upgrades, updates and Mandatory Safety Releases, installing the most recent version of the covered software. Software service shall include all maintenance release/service pack updates. Defective software shall be replaced at no additional cost to the Government.

4.5 TECHNICAL PHONE SUPPORT

The Contractor shall provide at no additional cost to the Government unlimited clinical technical telephone support during standard business hours for troubleshooting for the instrument and clinical application support (8am – 9pm Monday through Friday), excluding Federal holidays.

4.6 SERVICE EXCLUSIONS

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

4.7 PERSONNEL QUALIFICATIONS

Only technically qualified factory-trained personnel shall perform service on the LAP Green DORADO/DORADOnova at NIH, as covered by this purchase order. All primary service personnel shall have at least one backup support person with at least the same level of expertise on the equipment covered under this purchase order.

5.0 TYPE OF ORDER

This shall be a firm fixed-price purchase order.

5.1 SEVERABLE SERVICES

The services acquired under this purchase order are severable services. Funds are only available for use for the line item to which they are obligated. Unused funds from one period (line item) may not roll over for use in other periods.

6.0 PERIOD OF PERFORMANCE

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

Base Period July 17, 2024 – July 16, 2025 Option Period 1 July 17, 2025 – July 16, 2026 Option Period 2 July 17, 2026 – July 16, 2027 Option Period 3 July 17, 2027 – July 16, 2028 Option Period 4 July 17, 2028 – July 16, 2029

7.0 PLACE OF PERFORMANCE

Onsite services shall be performed at the following location:

NIH/NCI

Building 10, Rm. B2-3631 9000 Rockville Pike Bethesda, MD 20892

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

Also, due to the current COVI-19 Pandemic there maybe additional access restrictions. Please refer to the NIH Security and Access site for more details: (www.nih.gov/about-nih/visitor-information/campus-access-security).

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 Technical Point of Contact (POC) 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/making-files-accessible/create-accessiblepdfs/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.

9.0 TECHNICAL POINT OF CONTACT

The Technical Point of Contact (TPOC) is responsible for inspection and acceptance of all work in relation to this requirement, and will serve as the Governments primary point of contact throughout the duration of the requirement. All efforts must be coordinated with this individual.

The TPOC for this requirement is:

Name:

Email:

Phone:

Note: The TPOC has limited authority as defined within this Statement of Work. They do not have the authority to commit or obligate Government funds, or make changes to the terms and conditions of the purchase order. As such, any changes to the purchase order must be performed by a warranted Government Contracting Officer with appropriate delegated authority to do so.

10.0 DELIVERABLES AND DELIVERY SCHEDULE

DELIVERABLE REQUIRED FORMAT DUE DATE

Preventive Maintenance Service Report (Section 4.1)

Electronic, Word or PDF format

3 business days after completion of service

Emergency Maintenance Service Report (Section 4.2)

Electronic, Word or PDF format

3 business days after completion of service

Delayed Delivery Notification (Section 4.3)

Electronic, Word or PDF format

Immediately upon identification of delayed deliveries

Software Updates/Revisions (Section 4.4)

Electronic, Word or PDF format

1 business days after completion of service