75N91023Q00067_DRAFT SOW.pdf

STATEMENT OF WORK

Reference# 75N91023Q00067 Page 1 of 10

1.0 TITLE

Maintenance Service for Elekta Brachytherapy System

2.0 BACKGROUND

The Radiation Oncology Branch (ROB) within the Center for Cancer Research (CCR) at the National Cancer Institute (NCI) of the National Institutes of Health (NIH) requires preventative maintenance and software updates for its government-owned Elekta Brachytherapy equipment and software. The equipment works together along with associated software and computer hardware as a single, integrated, multi-component system to care for patients receiving brachytherapy as part of their cancer treatment. Brachytherapy involves the use of radioactive materials that are regulated by the Nuclear Regulatory Commission (NRC) due to the inherent public health implications of the possession and transportation of these materials. The ROB’s Elekta Brachytherapy System is crucial for patient treatment and cannot be out of service for any length of time.

3.0 SCOPE

The Contractor shall provide all labor, material and equipment necessary to maintain and provide preventive maintenance, including testing the parts, accessories, and software for the following government-owned Elekta Brachytherapy System equipment and software:

1. Elekta Flexitron Afterloader Brachytherapy Delivery System Serial Number: FT00280 Service Level: Gold

Inclusive of the following hardware components:

Part Number Description SBFL-40CH-IR-Y Flexitron 40Chennels Iridium SBFL-3POSCHCK-Y 3 CH Source Position Check Ruler SBFL-REM-CAM-Y Remote Controlled Camera

To receive quarterly replacement of radioactive source material (192Ir, model 136.147, nominal activity 12 Ci), which includes the following:

Part Number Description OBFL-SRC-10CI Flexitron Source HDR 10Ci OBFL-IR-CHCKCBL Flexitron Iridium Check Cable OB-SHIP-HNDLNG Shipping and Handling Costs

And the following Terminal Control Console workstation, that shall be refreshed once during the total 5-year contract period:

Part Number Description Ref #136960 Serial# FT08537

HP Small Form Factor desktop

2. Elekta Oncentra Brachy - Brachytherapy Planning System and Software Suite

Serial Number: 85512 Service Level: Gold

Inclusive of the following operational software licenses:

SBOB-APPL-MOD-Y Oncetra Brachy, Applicator Modeling

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SBOB-EXP-FLT-Y Oncetra Brachy, Export float SBOB-IPSA-FLT-Y Oncetra Brachy, IPSA float SBOB-IR-FLT-Y Oncetra Brachy, Image Registration float SBOB-IMP-FLT-Y Oncetra Brachy, Import float SBOB-PA-FLT-Y Oncetra Brachy, Plan Analysis float SBOB-BP-FLT-Y Oncetra Brachy, float

And the following computer workstation, that shall be refreshed once during the total 5 year contract period:

Part Number Description

SBOB-HW-PLFM-Y

Ref #170009-00 Serial #851841

Oncetra Brachy, Hardware Platform - HP Z8 workstation

3. Elekta Oncentra Prostate - Brachytherapy Planning System and Software Suite

Serial Number: 70209 Service Level: Gold

Inclusive of the following operational software licenses:

SBOP-ECRM-Y ECRM (EndoCavity Rotational Mover) SBOP-SEEDS-Y Oncentra Seeds SBOP-STPENCDR-Y Oncentra Prostate OncoSelect Step+Enc SBOP-SLCT-BK8-Y Adapter OncoSelect Step B-K Med8848 (OCP)

And the following hardware component:

SBOP-ENC-SLCT-Y Stepper encoder – OncoSelect Stepper

And the following computer workstation, that shall be refreshed once during the total 5-year contract period:

Part Number Description Product# 131055A02-06 Serial # 70209

Oncetra Prostate – HP ZBook 15 laptop

All maintenance services shall be performed on-site in accordance with the Original Equipment Manufacturer’s (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 Elekta observed holidays and 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. 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:

http://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays

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4.1 PREVENTIVE MAINTENANCE

The Contractor shall perform four (4) quarterly preventive maintenance inspections (PMIs) during each 12-month performance period on the Elekta Brachytherapy System. During each quarterly PMI, the Contractor shall replace the radioactive source material for the Flexitron Afterloader and conduct a comprehensive inspection of the system. The Elekta Oncentra Brachy and Elekta Oncentra Prostate systems shall receive one (1) preventive maintenance inspection during each 12-month performance period.

Technically qualified, OEM-trained personnel shall perform this service. PMI Service for all equipment 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.

Fees for labor, travel, and the radioactive source material shall be included at no additional cost to the Government. 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 TECHNICAL SUPPORT & EMERGENCY REPAIR

4.2.1 REMOTE SUPPORT

The Contractor shall provide unlimited remote technical support to the end-user. Technical support shall include diagnosis of the issue encountered by the end-user. If the issue can be corrected remotely, the Contractor shall perform remote corrective maintenance or walk the end-user through any simple adjustments and corrections necessary to resolve the issue. Technical support shall be provided by a certified service engineer or technically qualified OEM-trained personnel.

The Contractor shall provide a toll-free telephone number for real-time remote technical support requests. The Contractor shall use its best efforts to respond to all technical support requests submitted via telephone immediately. If the Contractor is unable to respond immediately, the Contractor shall provide support within one (1) hour after the technical support request call is made by the end-user.

Real-time remote technical support via telephone shall be available during normal business hours, Monday – Friday, 8:00 a.m. – 5:00 p.m. Eastern Standard Time, excluding Elekta observed holidays and Federal public holidays as defined by 5 U.S.C. 6103. Information on observed Federal holidays may be located at the OPM website:

https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/

In addition to the telephone number, the Contractor shall also provide an e-mail address and/or an online platform for technical support requests.

If the Contractor cannot resolve a remote technical support request within three (3) business days, the Contractor shall provide on-site emergency repair services within one (1) business day from the last attempt at remote support, in accordance with this Statement of Work.

https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/

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4.2.2 ON-SITE EMERGENCY REPAIRS

The Contractor shall perform unlimited on-site, emergency repair service visits related to instrument failure as needed during the term of this contract. All labor and travel for these services shall be included in the fixed price of this order, and no additional costs shall be accepted under this order.

Emergency service calls shall not replace the necessity for planned preventative maintenance.

Emergency services shall be provided during normal business hours, Monday – Friday, 8:00 a.m. – 5:00 p.m. Eastern Standard Time, excluding Elekta observed holidays and Federal public holidays as defined by 5 U.S.C. 6103. Information on observed holidays may be located at the OPM website:

https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/

Upon receipt of a complaint that any part of the equipment is not functioning properly, the Contractor shall provide a response within one (1) hour acknowledging receipt of the complaint. If a complaint is made outside of the business hours established in this section, the Contractor shall provide a response within one (1) hour of the start of the next business day.

The Contractor shall provide an on-site response within one (1) business day after receipt of the complaint. A qualified OEM-trained service representative shall be dispatched to inspect the malfunctioning instrument and perform all repairs and adjustments necessary to restore the instrument to normal operating condition. If a complaint is made outside of business hours, the Contractor shall provide an on-site response within one (1) business day from the start of the next business day.

Within three (3) days of the completion of any emergency repair services performed, the contractor shall provide a brief 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 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. Parts, shall be genuine Elekta OEM parts which meet original equipment 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 holiday observed by Elekta or 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.

Each computer workstation for the Felxitron, the Oncentra Brachy, and the Oncentra Prostate systems shall be replaced once during the five (5) year term of this Purchase Order. This computer hardware refresh shall be included at no additional cost to the Government. The purpose of this computer hardware refresh is to replace obsolete computer components. The new computer hardware provided by the Contractor shall meet or exceed the system software requirements in order to ensure optimal performance for each component of this important brachytherapy system. The computer hardware refresh shall happen at the direction of the Technical Point of Contact.

4.4 SOFTWARE UPDATES/SERVICE

The Contractor shall provide software service, including but not limited to all critical/non-critical firmware upgrade/updates/maintenance releases, in accordance with the manufacturer’s latest established service procedures, to include telephone access to technical support for use of program https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/

Reference# 75N91023Q00067 Page 5 of 10 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. Updates/Upgrades shall be applied remotely if possible. Defective software shall be replaced at no additional cost to the government. Installation of any software/updates shall be performed by a OEM trained technician. All software updates and services shall be provided remotely, as applicable. The Contractor shall provide an electronic report to the TPOC per the within one (1) day after successful performance of software updates. This report must also include the reason for the updates, and any effect it may have on equipment operation.

4.5 SERVICE EXCLUSIONS

The Contractor shall not be responsible for any repairs necessitated by abuse, neglect, vandalism, Acts of God, fire or water. The Contractor shall not be responsible for repair or replacement of consumables items.

4.6 PERSONNEL QUALIFICATIONS

Due to the public health implications of the radioactive source material used in the Elekta Brachytherapy System, the Contractor must possess a broad scope license from the Nuclear Regulatory Commission (NRC) to possess and transfer radioactive materials, and must be approved by the NRC for the maintenance of high dose-rate afterloading devices.

Only technically qualified OEM-trained personnel shall perform service to the equipment covered by this contract. All primary service personnel shall have at least one backup support person with at least the same level of expertise on the equipment covered by this contract. All relevant service personnel must be approved by the NRC for maintenance of high dose-rate afterloading devices.

4.7 SECTION 508 COMPLIANCE

Regardless of format, all digital content or communications materials produced as a deliverable under this contract, 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.

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.

5.0 TYPE OF ORDER

This shall be a firm-fixed-priced 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:

https://www.section508.gov/

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Base Period July 15, 2023 – July 14, 2024 Option Period 1 July 15, 2024 – July 14, 2025 Option Period 2 July 15, 2025 – July 14, 2026 Option Period 3 July 15, 2026 – July 14, 2027 Option Period 4 July 15, 2027 – July 14, 2028

7.0 PLACE OF PERFORMANCE

Remote support services shall be provided at the Contractor’s facilities or facilities offered by the Contractor.

Onsite services shall be performed at the following location:

NIH

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 Federal Acquisition Regulation (FAR) clause 52.212-4, all work described in the statement of work (SOW) and delivered under this purchase order is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative for this order is the NCI technical point-of-contact (TPOC).

The Technical Point of Contact (TPOC) are 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 these individuals.

The technical-point-of-contact shall be established at award.

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.

8.1 REPORTS/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 4.2.2)

Electronic, Word or PDF format

3 business days after completion of service

Software Updates/Revisions (Section 4.4)

Electronic, Word or PDF format

1 business days after completion of service

Delayed Delivery Notification (Section 4.3)

Electronic, Word or PDF format

Immediately upon identification of delayed deliveries https://www.nih.gov/about-nih/visitor-information/campus-access-security https://www.nih.gov/about-nih/visitor-information/campus-access-security

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9.0 PAYMENT

Payment shall be made in quarterly in arrears. Payment authorization requires submission and approval of invoices to the Technical Point of Contact and NIH OFM, in accordance with the payment provisions listed below:

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-25.

Highlights of this clause and NIH implementation requirements follow:

I. Invoice Requirements

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats, or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be considered in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the

Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the NBS:

Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Unique Entity Identifier (UEI) which is in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

8. Federal Taxpayer Identification Number (TIN). In those rare cases where a contractor does not have a UEI number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

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NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

B. The Contractor shall submit invoices to the Department of Treasury’s Invoice

Processing Platform (IPP) at https://www.ipp.gov with a copy to the approving official, as directed below.

The Contractor shall submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer’s Representative:

Approving Official: Contracting Officer Name- Email Address-

Contracting Officer’s Representative Name- Email Address-

II. Invoice Payment

A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. Interest Penalties

A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with https://www.ipp.gov/

Reference# 75N91023Q00067 Page 9 of 10 the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (November 2021)

(a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of Clause)

V. HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 2022)

(a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ‘‘Content of Invoices’’ and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer’s written authorization with each payment request.

(End of Clause)

FAR 52.217-8 – OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

http://www.ipp.gov/

Reference# 75N91023Q00067 Page 10 of 10

FAR 52.217-9 – OPTION TO EXTEND THE TERMS OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 15 days of purchase order expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 66 months.

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/ and/or http://www.hhs.gov/policies/hhsar/.

CLAUSE NO. TITLE DATE

FAR 52.204-13 SYSTEM FOR AWARD MANAGEMENT

MAINTENANCE

OCT 2018

FAR 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

FAR 52.204-19 INCORPORATION BY REFERENCE OF

REPRESENTATIONS AND CERTIFICATIONS

DEC 2014

FAR 52.212-4 CONTRACT TERMS AND CONDITIONS –

COMMERCIAL ITEMS

NOV 2021

FAR 52.232-39 UNENFORCEABILITY OF UNAUTHORIZED

OBLIGATIONS

JUN 2013

FAR 52.233-4 APPLICABLE LAW FOR BREACH OF CONTRACT

CLAIM

OCT 2004

HHSAR 352.203-70 ANTI-LOBBYING DEC 2015

HHSAR 352.222–70 CONTRACTOR COOPERATION IN EQUAL

EMPLOYMENT OPPORTUNITY INVESTIGATIONS

DEC 2015

HHSAR 352.224–71 CONFIDENTIAL INFORMATION DEC 2015

HHSAR 352.227-70 PUBLICATIONS AND PUBLICITY DEC 2015

HHSAR 352.237-74 NON-DISCRIMINATION IN SERVICE DELIVERY DEC 2015

http://www.acquisition.gov/far/ http://www.hhs.gov/policies/hhsar/