Attachment 1 - Statement of Work.pdf

Statement of Work

1.0 TITLE

US Pediatric Photon Therapy Comparison Cohort Study

2.0 BACKGROUND

The Radiation Epidemiology Branch (REB), Division of Cancer Epidemiology and Genetics (DCEG), National Cancer Institute (NCI) carries out studies to quantify second cancer risks associated with ionizing radiation exposures in pediatric cancer patients. REB has a specific interest in the risk of second tumors following proton therapy in children, because concerns have been raised about whole-body scatter doses from neutrons, brain necrosis and other late effects including second tumors.

Pediatric radiation oncology is undergoing rapid changes due to the widespread introduction of proton therapy. By reducing high-dose exposure to nearby normal tissue, protons should reduce a wide-range of serious adverse-effects, such as second cancers. To date, no studies have directly evaluated the potential benefits or risks of protons for children, and some case series have raised concerns about serious unanticipated side-effects, such as brain necrosis. There is widespread agreement amongst the clinical and scientific community that large-scale collaborative efforts are urgently required to address these questions. We propose to establish the US Pediatric Proton Therapy study, the first prospective cohort study including pediatric cancer patients treated with proton therapy and a comparison group of similar patients treated with photon therapy. This new cohort will build upon a foundation created by the US Pediatric Proton Consortium Registry (PPCR), which currently includes 17 US proton therapy centers and has recruited 3000 pediatric proton patients who have actively enrolled in the registry since 2012. To examine whether proton therapy results in improved outcomes compared to photon therapy, there is a critical need to obtain data from a control group of patients treated with photon therapy. NCI’s primary aim is to add a comparison group of photon patients in order to quantify the subsequent cancer risks after proton compared to photon therapy. Subsequent cancers are one of the most common and serious adverse-effects of pediatric radiotherapy. The 2018 REB site visit strongly supported the proposed cohort study and the suitability of the intramural research environment for this complex and long-term effort. They also agreed with the motivation and justification for urgent development due to the impending transition from photons to protons despite the absence of direct evidence regarding long term outcomes. Due to this transition it may be impossible to identify a suitable comparison group of photon patients in the future.

Pediatric cancer is rare and therefore in order to assemble a comparison cohort of photon treated pediatric patients of adequate size, multiple pediatric treatment centers need to be included. No single center will likely have enough patients to obtain data for the desired comparison cohort of 10,000 patients meeting eligibility criteria and treated with photon therapy.

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2.1 OBJECTIVE

The goal of this acquisition is to obtain data on a group of photon-treated pediatric cancer patients to serve as a comparison group to an existing cohort of proton-treated pediatric patients.

The contractor(s) shall retrieve existing data from medical records for pediatric cancer patients treated at their institution with photon therapy. De-identified clinical and treatment data obtained from this procurement will be used to evaluate the risks and benefits of proton therapy versus photon therapy for children with cancer.

3.0 SCOPE

The contractors shall function in a commercial capacity to identify all photon treated pediatric cancer patients meeting inclusion criteria for the comparison cohort, retrieve required data elements from existing medical records, and enter data elements (not to include personal identifiers) into a secure data collection tool developed by the Pediatric Proton Consortium Registry (PPCR) team at Massachusetts General Hospital (MGH). The contractors shall locate radiotherapy and imaging data from eligible photon-treated pediatric patients, de-identify as necessary, and upload the de-identified data to an online imaging file repository maintained by the PPCR team at MGH.

4.0 CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS

The Contractor shall perform the following tasks from the Contractor’s existing medical records:

4.1 Study Patient Identification

4.1.1 Based on existing medical records, identify all photon-treated pediatric cancer patients who were less than 22 years of age at diagnosis and treated with photons since January 1, 2007.

4.1.2 Compile a list of eligible patient records, overall and by cancer diagnosis, treated with photon therapy at the study center. Patient records shall be eligible to have data abstracted and included in the study after the patient has completed photon therapy.

4.1.3 Obtain any regulatory approvals required by the treating institution for retrieval and release of de-identified clinical and treatment details from existing medical records for photon-treated pediatric cancer patients.

4.2 Data Collection

4.2.1 Participate in training on the study protocol and data collection procedures.

4.2.2 Abstract specified diagnosis and treatment data elements from medical records

(not to include identifiers) for all eligible patients as identified in 4.1.1 above.

Data elements to be abstracted will differ depending upon the cancer diagnosis of each patient. Basic demographic and diagnosis data will be abstracted for all

Attachment 1 - Page 2 of 8 eligible patient records (sex, race, ethnicity, cancer diagnosis, type of radiation therapy). Only for patient records in specific diagnosis groups (CNS tumors, sarcomas, Hodgkin lymphoma, neuroblastoma, bone tumors), a more extensive list of data elements including treatment variables will be required. The specific required data elements are to include sex, race, ethnicity, insurance status, state of residence, state of diagnosis and treatment, all cancer diagnoses and associated cancer details, all courses of radiotherapy received, chemotherapy agents received, surgeries performed for treatment of the primary cancer.

4.2.3 Enter de-identified abstracted data for eligible patient records into the study-specific data collection tool maintained by the PPCR. The data collection tool will include automated workflows to specify the extent of data and specific data elements required for each patient based on the cancer diagnosis entered.

4.2.4 Verify a sample of 5% of abstracts by independent re-abstraction in order to provide quality control of the data abstraction. Provide documentation of the outcome of the re-abstraction to NCI.

4.2.5 Maintain a list of study ID and date of cancer diagnosis for each patient on a secure institutional server, separate from the study data collection platform and not accessible by study staff outside the institution (i.e. coordinating center or

NCI).

4.2.6 Retrieve and obtain copies of de-identified electronic radiation treatment records including Digital Imaging and Communications in Medicine (DICOM)-RT Image, organ-at-risk contours (RT Structure Set), final treatment plans (RT Plan), dose distribution (RT Dose), treatment plans (RT Plan), and any follow-up radiologic imaging studies as available. Include review by a radiation physicist/dosimetrist to ensure collection of the correct file types and inclusion of final treatment plans as necessary. In the event diagnostic imaging and/or radiation treatment-related files are archived, center staff will be required to unarchive original treatment plans as needed. De-identified imaging and treatment-related files, including DICOM files, will be uploaded to a secure file repository. The MIMcloud system (MIM Software, Inc.) will be available as the primary file repository because it is already in use for the Pediatric Proton Consortium Registry, but alternative secure solutions can be used if necessary at the discretion of the Contractor. The file repository will not include patient identifiers or linkages that would allow re-identification.

4.2.7 Provide NCI and the study coordinating center with a monthly progress report summarizing the number of eligible patient records identified, number of eligible records with data abstracted and number of patient records with imaging and treatment files uploaded to the study file repository.

4.2.8 Take required steps to ameliorate issues with data quality or completeness, as identified by NCI.

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Contractor Qualifications: The Contractor shall have at least 500 pediatric cancer patients treated with photons since January 1, 2007. The contractor shall have the capacity to identify all eligible patients treated at the institution and to perform required data abstraction on all eligible patients within the specified period of performance.

5.0 TYPE OF ORDER

This is a firm fixed price purchase order.

6.0 PERIOD OF PERFORMANCE

The period of performance shall be for 12 months from date of award (approximately August 16, 2020 to August 15, 2021).

7.0 PLACE OF PERFORMANCE

Work shall be performed at the Contractor’s facility.

8.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

The NCI Principal Investigator (PI), technical point of contact and Contract Officer’s Representative (COR) shall review the deliverables submitted by the Contractor for acceptance within 14 days of receipt, to ensure consistency with the contract terms and approve the submitted reports. At the completion of the review, the NCI technical point of contact or COR shall notify the Contractor as to the acceptability of the deliverable. If any changes or revisions are required of the Contractor, the revised deliverables shall be submitted to the PI, technical point of contact and COR within 14 days of the date of notification. If no comments or request for revisions are provided within 14 business days, the deliverables shall be considered acceptable. In general, the NCI PI and technical point of contact shall provide technical scientific review and approval of all deliverables submitted by the Contractor.

All deliverables shall be sent electronically per the following schedule:

Table of deliverables (see Attachment for Progress Report template)

Deliverable Description Due Date #1 Progress

Report Number of eligible photon patients identified, number of eligible patient records with data abstracted and entered into REDCap system, and number of eligible patient records with imaging and treatment plan files uploaded to the study file repository. Numbers to be reported overall and by type of cancer, age in years at cancer diagnosis, and calendar year of cancer diagnosis.

3 months after award

#2 Initial Quality Control Report

Provide documentation of re-abstraction of 5% of eligible patient records and evaluation of concordance between initial abstraction and re-abstraction.

3 months after award

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Deliverable Description Due Date #3 Progress

Report Number of eligible photon patients identified, number of eligible patient records with data abstracted and entered into REDCap system, and number of eligible patient records with imaging and treatment plan files uploaded to the study file repository. Numbers to be reported overall and by type of cancer, age in years at cancer diagnosis, and calendar year of cancer diagnosis.

6 months after award

#4 Progress Report

Number of eligible photon patients identified, number of eligible patient records with data abstracted and entered into REDCap system, and number of eligible patient records with imaging and treatment plan files uploaded to the study file repository. Numbers to be reported overall and by type of cancer, age in years at cancer diagnosis, and calendar year of cancer diagnosis.

9 months after award

#5 Final Progress Report

Total number of eligible photon patients identified, number of eligible patient records with data abstracted and entered into REDCap system, and number of eligible patient records with imaging and treatment plan files uploaded to the study file repository. Numbers to be reported overall and by type of cancer, age in years at cancer diagnosis, and calendar year of cancer diagnosis.

12 months after award

#6 Final Quality Control Report

Provide documentation of re-abstraction of 5% of eligible patient records and evaluation of concordance between initial abstraction and re-abstraction.

12 months after award

9.0 PAYMENT

Payment shall be made quarterly. Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with the attached 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 (JUL 2013) 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 shall 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.)

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Untimely notification shall be taken into account 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. Data Universal Numbering System (DUNS) or DUNS + 4 as registered in the Central Contractor Registration (CCR).

8. Federal Taxpayer Identification Number (TIN). In those exceptional cases where a contractor does not have a DUNS 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.*

* 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.

Contractor/Vendor Electronic Invoice Submission to the Office of Financial Management

(OFM):

The Contractor/Vendor shall:

• Send the invoice to the NIH centralized invoice email box: invoicing@nih.gov

• Follow the below format in the email subject line, which is a must (Note: The keywords and separating bars in bold must be present to identify the information.)

Vendor: name of the contractor/vendor|PO: Contract Number/Task Order Number|Invoice:9999999

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• Ensure that the body of the email and attached invoice must both include the contractor/vendor’s correspondence email address in the below format (bolded information must be present to identify information):

Correspondence email address: xyz@abc.com

• Follow the system size limits that apply to the email and each invoice: individual email attachments cannot exceed 5 megabytes each; and the email plus all attachments cannot exceed a total of 30 megabytes.

• Clearly identify a valid and complete contract number on each invoice

• Clearly identify a valid and complete order number on each invoice

• Clearly identify an accurate DUNS number on each invoice

• Not include confidential information such as Social Security Numbers (do not include

TIN if it is a Social Security Number)

• Send one (1) invoice per email

The date/time that a valid invoice is submitted electronically to the email box (invoicing@nih.gov) will be the same date/time logged as that the invoice is received by NIH.

Please do not hand-deliver invoices to any NIH office. Please follow the above electronic submission instructions until further notice. In addition, please note that your contract or order will not be modified to reflect the above changes to the invoicing instructions. Failure to follow the above electronic submission instructions may result in invoice processing delays.

For Questions? Inquiries regarding the status of invoices such as receipt of invoices, due date, or payment of invoices should be directed to the OFM Commercial Accounts Branch, Customer Service Office at 301-496-6088. The office is open Monday-Friday from 8:30 am to 4:30 pm (eastern prevailing time). The Customer Service Office is closed daily between 12:00 pm to 1:00 pm (eastern prevailing time).

Contractor Courtesy Copy Electronic Invoice Submission to the Contracting Officer (CO):

The Contractor shall send the OFM-submitted invoice to the NIH Contracting Officer.

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.

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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 shall be made in accordance with 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 (DEC 2013)

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.

Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

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