RFQ 75N91024Q00002.pdf

REQUEST FOR QUOTATION

(THIS IS NOT AN ORDER)

THIS RFQ □ IS IS NOT A SMALL BUSINESS SET-ASIDE

PAGE OF PAGES

1. REQUEST NUMBER

75N91024Q00002

2. DATE ISSUED

07/19/2024

3. REQUISITION/PURCHASE REQUEST NUMBER 4. CERT. FOR NAT. DEF.

UNDER BOSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY NIH/NCI OFFICE OF ACQUISITIONS; 9609 Medical Center Drive, Bethesda, MD 20892

6. DELIVER BY (Date) 09/02/2024

5b. FOR INFORMATION CALL (NO COLLECT CALLS) 7. DELIVERY

FOB DESTINATION OTHER

(See Schedule)

NAME

Catherine Muir, Contracting Officer

TELEPHONE NUMBER

AREA CODE

NUMBER

276-5434

9. DESTINATION

a. NAME OF CONSIGNEE

Kathleen Stine 8. TO:

a. NAME b. COMPANY b. STREET ADDRESS

9609 Medical Center Dr.

c. STREET ADDRESS c. CITY

Rockville

d. CITY e. STATE f. ZIP CODE d. STATE

MD

e. ZIP CODE 20850

10. PLEASE FURNISH QUOTATIONS TO THE

ISSUING OFFICE IN BLOCK 5a ON OR BEFORE CLOSE OF BUSINESS (Date)

09/02/2024 3:00 PM ET

IMPORTANT: This is a request for information and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it to the address in Block 5a. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or service. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotation must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

ITEM NUMBER

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

Provide a Firm Fixed Price Quote to perform the attached Statement of Work (SOW) July 19, 2024 entitled "Medical record abstraction services for Pediatric Proton and Photon Therapy Comparison Cohort" for non-severable services.

Contract Type: Firm Fixed Price (FFP)

Contract Term: Fourteen (14) months beginning on date of award, with no option periods.

Questions related to this acquisition shall be submitted to muirca@mail.nih.gov before Aug. 2, 2024 at 3:00PM ET. All email inquiries shall have "Question - RFQ 75N91024O00002" included in the subject line.

Simplified Acquisition Terms & Conditions apply.

In order to receive an award, the Contractor must be successfully registered, and have a valid, current Entity Record, including current Representations and Certifications, in SAM.gov.

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS(%) b. 20 CALENDAR DAYS(%) c. 30 CALENDAR DAYS(%) d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations are are not attached.

13. NAME AND ADDRESS OF QUOTER 14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

15. DATE OF QUOTATION

a. NAME OF QUOTER

b. STREET ADDRESS 16. SIGNER

a. NAME (Type or print) b. TELEPHONE

c. COUNTY AREA CODE

d. CITY e. STATE f. ZIP CODE c. TITLE (Type or print) NUMBER

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition not usable

STANDARD FORM 18 (REV. 6/1995)

Prescribed by GSA-FAR (48 CFR) 53.215-1(a) mailto:muirca@mail.nih.gov

SOLICITATION RFQ No. 75N91024Q00002

I. General Information:

Document Type: Combined Synopsis / Solicitation Title: “Medical record abstraction services for Pediatric Proton and Photon Therapy Comparison

Cohort” Solicitation Number: 75N91024Q00002 Posted Date: July 19, 2024 Response Time & Date: 3:00p.m. ET; Sept. 2, 2024 Classification Code: R702 – Support-Management: Data Collection Set-Aside: N/A NAICS Code: 541990-All Other Professional, Scientific, and Technical Services

II. Contracting Office Address National Cancer Institute 9609 Medical Center Drive Rockville, Maryland 20892

III. Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items”, pursuant to Simplified Acquisition procedures Federal Acquisition Regulation (FAR) subpart 13.106, "Soliciting competition, evaluation of quotations or offers, award and documentation," as supplemented with additional information included in this notice. A point of clarification, an item is considered to be commercial because of the supply or service itself, not because of who provides the item (Office of the Secretary of Defense Acquisition, Technology, and Logistics (Acquisition Initiatives), 2001, CID Handbook, v.1, page 10). This announcement constitutes the only solicitation where quotations are being requested, and any other written solicitation document will not be issued.

This RFQ contains contractual information pertinent to this solicitation. It is not an exact representation of the contract document that will be awarded as a result of this solicitation. The contract price and other contractual provisions pertinent to your organization, for example, those relating to the organizational structure, e.g. Entity Structure is “Corporate Entity (Tax Exempt)” and the Profit Structure is “Non-Profit Organization”; may be discussed, as needed, during the quotation review process, and will be included in the resultant contract. The enclosed information is intended to provide the Vendor with the necessary information to understand the terms and conditions of the resultant contract. Therefore, it is the responsibility of each Quoter to identify in their quotation any terms and conditions in this RFQ that are not applicable to their Entity type, as represented in its SAM.gov Entity record. Otherwise, it will be understood that the Quoter does not take exception to the terms and conditions in this RFQ.

This solicitation is a Request for Quotation (RFQ). It includes all applicable provisions and clauses in effect through Federal Acquisition Circular 2024-03.

The associated North American Industry Classification System (NAICS) code for this procurement is 541990, with a small business size standard of $19.5 million.

Multiple awards are anticipated to be made as a result of this solicitation. The anticipated total award value of all the awards is to exceed the current Simplified Acquisition Threshold amount, thus why FAR 12 pursuant to FAR 13.5 “Simplified Procedures for Certain Commercial Products and Commercial Services” is applicable to this requirement. Awards will be awarded as firm fixed-price type purchase orders. THIS IS A COMPETITIVE ACQUISITION conducted using simplified acquisition procedures under FAR 13.106-1 for a purchase order under FAR 13.302-1 procedures.

The National Cancer Institute is seeking to obtain data on a group of pediatric cancer patients treated with proton or photon radiotherapy to contribute to an existing cohort of proton- or photon-treated pediatric patients. The Contractor(s) shall retrieve existing data from medical records for pediatric cancer patients treated at their institution with proton or 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. All interested companies shall provide a quotation for the requirement defined in Attachment 1 – Statement of Work.

Place of Performance

Service shall be performed remotely from the Contractor’s facility.

Non-severable Services The services acquired under this purchase order are non-severable services, or work that results in a final product or end-item and for which benefit is received only when the entire project is complete.

Period of Performance The planned Period of Performance shall consist of one (1) 14-month non-severable base period; anticipated start date on or about Nov. 1, 2024.

Basis for Award and Evaluation Award shall be made using a tradeoff process to the quoter(s) who represent the best value. All evaluation factors other than Price, when combined, are significantly more important than Price. A technically acceptable quotation is one in which the quoter(s) complies with the Statement of Work (SOW), and with each of the Factors and sub-Factors listed below . Each Quoter is responsible for identifying in their quotation any terms and conditions in this RFQ that are not applicable to their Entity type, as represented in its SAM.gov Entity record, and are to submit in their quote, alternative, more appropriate, reasonable terms and conditions applicable to their Entity type. Otherwise, it will be understood that the Quoter does not take exception to the terms and conditions in this RFQ. Quotations that are not technically acceptable will not be considered for award.

The Government intends to evaluate the quotation and award Firm-Fixed-Price Purchase Order(s) without discussions with the quoter. Therefore, the quoter's initial quotation should contain the quoter's best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. Additionally, the Government reserves the right to request revisions to the quotation that seek additional price discounts, request revisions to the technical quotation, or clarify aspects of the quotation. In the event quotation revisions are requested, the Government will not necessarily be seeking revisions from all quoters. The Government may reject the quotation if such action is in the Government's interest and waive informalities and minor irregularities in the received quotation.

The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations.

Unless otherwise provided in the Schedule, offers may not be submitted for quantities less than those specified. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, unless the offeror specifies otherwise in the offer.

Evaluation and award will be conducted in accordance with the requirements of FAR 13.106 and the following information provided. The technical evaluation will be a determination based on information furnished by the quoter.

The Government is not responsible for locating or securing any information which is not identified in the quotation. The Government intends to evaluate the quotations and make multiple awards.

FAR 52.212-2 Evaluation—Commercial Products and Commercial Services (Nov 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers in descending order of importance: Factor #1 Technical Capability, Factor #2 Personnel, Factor #3 Price, Factor #4 Past Performance. All evaluation factors other than price, when combined, are more important than price.

(b) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party.

Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

The following factors and sub-factors will be used to determine whether a quote is acceptable:

1. Factor #1-Technical Capability (See Attachment 2 – Technical Evaluation Criteria)

2. Factor #2 – Past Performance

a. Subfactor #1 – Recency and relevancy of present/past performance in relation to this effort

– In order to receive a rating of “acceptable” for this subfactor, quoter must, at a minimum provide past experience on similar type contract(s). The past experience should indicate successes of the contractor in completing / meeting delivery dates and customer satisfaction. The Government considers “recent” present/past performance to be within the past 3 years. The Government considers “relevant” present/past performance to be present/past performance effort involved in similar scope and magnitude of effort and complexities this solicitation requires.

The Government may also use past performance information obtained from other than the sources identified by the quoter. Information obtained from the Past Performance Information Retrieval System (PPIRS) database located at http//www.ppirs.gov is one of the sources that will be utilized. PPIRS functions as the central warehouse for performance assessment reports received from several Federal performance information collection systems and is sponsored by the DOD E-Business Office and administered by the Naval Sea Logistics Center Detachment Portsmouth.

NOTE: In accordance with FAR 15.305 (a)(2)(iv)), in the case of an offeror without a record of relevant past performance or for whom information on past performance is not available or so sparse that no meaningful past performance rating can be reasonably assigned, the offeror shall be determined to have unknown past performance. In the context of acceptability / unacceptability, “unknown” will be considered “acceptable.”

3. Factor #3 - Price

Invoice Submission/Payment Payment shall be made upon receipt and approval of each deliverable stated in the Deliverable Section in the attached Statement of Work, with the first payment equaling 10% of the total price and the three subsequent payments each equaling 30% of the total price. Payment authorization requires submission and approval of invoices in accordance with the attached payment provisions. A copy of each submitted invoice for payment shall also be e-mailed to the NCI COR’s contact information on the first page of the contract award.

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 are attached (See ATTACHMENT - INVOICE INSTRUCTION AND PAYMENT

PROVISIONS).

PROVISIONS AND CLAUSES

A. The provision at FAR Clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition and is hereby incorporated by reference. All Federal Acquisition Regulation (FAR) clauses may be viewed at https://www.acquisition.gov/browse/index/far.

B. The provision at FAR Clause 52.212-2, Evaluation – Commercial Items, is applicable and hereby incorporated by reference. The Evaluation Factors stated in this RFQ will be used to evaluate the acceptability of the quote.

C. In accordance with FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items, offerors must complete annual representations and certifications on-line at https://www.sam.gov/portal/public/SAM/.

D. FAR clause 52.212-4, Contract Terms and Conditions - Commercial Items applies to this acquisition and is hereby incorporated by reference.

PLEASE NOTE: The acceptance paragraph in 52.212-4 is based upon the assumption that the Government will rely on the quoter’s assurances that the commercial service tendered for acceptance conforms to the contract requirements. The government inspection of commercial services will not prejudice its other rights under the acceptance paragraph. Additionally, although the paragraph does not address the issue of rejection, the Government always has the right to refuse acceptance of nonconforming items. Other acceptance language +/or procedures may be proposed that is more usual and customary to the quoter’s organization business practices, e.g. modify the inspection/acceptance and warranty sections with alternate language, specifying that deliverables will conform to contract requirements and be subject to Government inspection and acceptance, removing the language requiring the repair or replacement of nonconforming supplies, and reperformance of nonconforming services, at no increase in contract price. In such cases, the quoter is requested to submit alternative language with their quote for the Contracting Officer to review. Mutually agreed upon language will be inserted into the Purchase Order’s terms and conditions as an addendum. Below is sample language that has been deemed acceptable:

http://www.ppirs.gov/ https://www.acquisition.gov/browse/index/far https://www.sam.gov/portal/public/SAM/ https://www.sam.gov/portal/public/SAM/ https://www.acquisition.gov/far/part-52#FAR_52_212_4

Inspection/Acceptance. The Contractor shall tender for acceptance only those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance.

Any dispute regarding the acceptability of the supplies or services will be resolved pursuant to FAR 52.233-1.

Warranty. The Contractor shall tender for acceptance only those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. Any dispute regarding the acceptability of the supplies or services will be resolved pursuant to FAR 52.233-1.

E. FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Products and Commercial Services (MAY 2024)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (DEC 2023) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232)

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015)

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (MAR 2023)

(6) 52.233-3, Protest After Award (AUG 1996) ( 31 U.S.C. 3553).

(7) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78

( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

52.203-17, Contractor Employee Whistleblower Rights (NOV. 2023) 52.204-27 Prohibition on a ByteDance Covered Application (JUN. 2023) 52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or

Proposed for Debarment (NOV. 2017) 52.222-3 Convict Labor (JUN. 2003) 52.222-19 Child Labor-Cooperation with Authorities and Remedies (FEB 2024) 52.222-21 Prohibition of Segregated Facilities (APR. 2015) 52.222-26 Equal Opportunity (SEP. 2016) (E.O. 11246).

52.222-35 Equal Opportunity for Veterans (JUN 2020) 52.222-36 Equal Opportunity for Workers with Disabilities (JUN. 2020) 52.222-37 Employment Reports on Veterans (JUN 2020) 52.222-40 Notification of Employee Rights Under the National Labor Relations Act (DEC. 2010) 52.222-50 Combating Trafficking in Persons (NOV. 2021) 52.222-54 Employment Eligibility Verification (MAY 2022) 52.225-13 Restrictions on Certain Foreign Purchases (FEB. 2021) 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving (MAY 2024) 52.232-29 Terms for Financing of Purchases of Commercial Products and Commercial Services (NOV. 2021) 52.232-33 Payment by Electronic Funds Transfer-System for Award Management (OCT. 2018)

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

https://www.acquisition.gov/far/part-52#FAR_52_203_19 https://www.acquisition.gov/far/part-52#FAR_52_204_23 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.209-10#FAR_52_209_10 https://www.acquisition.gov/far/52.232-40#FAR_52_232_40 https://www.acquisition.gov/far/part-52#FAR_52_233_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/part-52#FAR_52_233_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3

52.222-55 Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN. 2022) 52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN. 2022)

FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions 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. The quoter is cautioned that the listed provisions may include blocks that must be completed by the quoter and submitted with its quotation. In lieu of submitting the full text of those provisions, the quoter may identify the provision by paragraph identifier and provide the appropriate information with its quotation. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): https://www.acquisition.gov/Far/ and/or http://www.hhs.gov/policies/hhsar/.

52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (SEP. 2007) 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or

Statements-Representation (JAN. 20217) 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN. 2017) 52.204-7 System for Award Management 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (JUN. 2020) 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services.

52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Service or Equipment 52.204-26 Covered Telecommunications Equipment or Services-Representation

52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law.

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/.

52.203-12 Limitation on Payments to Influence Certain Federal Transactions (JUN. 2020) 52.226-8 Encouraging Contractor Policies to Ban Text Messaging While Driving.

HHSAR 352.222–70, Contractor Cooperation in Equal Employment Opportunity Investigations HHSAR 352.232–71, Electronic Submission of Payment Requests HHSAR 352.239–73, Electronic and Information Technology Accessibility Notice HHSAR 352.239–74, Electronic and Information Technology Accessibility

QUOTATION SUBMISSION/ GENERAL INSTRUCTIONS/ FORMAT

Please submit via email to the Contracting Officer as an attachment to the SF 18.

Your quotation shall contain the following:

• Completed and signed and dated SF18.

• Technical portion of the quotation clearly and fully demonstrating the quoter’s capabilities, knowledge and experience regarding the technical requirements in the attached Statement of Work. Failure to respond explicitly to all of the Statement of Work will result in the quoter’s quotation being deemed technically unacceptable. A quotation that merely restates the requirements of the Statement of Work will be deemed technically unacceptable.

The technical portion of the quotation shall be limited to no more than TWENTY (20) pages total. Any submitted Appendices and/or Attachments do not count against the page limitations.

The quoter shall provide their price quotation suitable to a Firm Fixed Price award to include a budget to accomplish the work in the attached Statement of Work.

This Request for Quotation (RFQ) does not commit the Government to pay any cost for preparation and submission of a quotation. In addition, the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this proposed acquisition. By submitting a quotation in response to this solicitation, it is understood that your firm's quotation shall become a part of the official contract file.

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

Quotation must stipulate that it is predicated upon all the applicable terms and conditions of this RFQ and be signed by an official authorized to bind the organization. In addition, the quotation must contain a statement to the effect that it is firm for a period of at least 90 days from the date of receipt thereof by the Government.

Quotations must provide clear responses, specifically addressing the requirements within this solicitation. Quotations which merely offer to conduct a project in accordance with the requirements of the Government's scope of work will not be eligible for award.

In order to receive an award, quoters must have an active registration in www.sam.gov and have complete Representations and Certifications. Quotes must be submitted with one (1) of the following:

o provide a copy of valid Representations and Certifications from the System for Award Management (SAM) at www.sam.gov.

OR

o a completed FAR 52.212-3 Quoter Representations and Certifications Commercial Products and

Commercial Services, signed by an authorized representative of the quoter

Quoters shall submit a signed SF-18 in addition to their prepared price quotation that contains all information necessary to allow for a comprehensive evaluation of the prices quoted. Specifically, quotations must include the following:

• Federal Tax Identification Number (TIN);

• Unique Entity Identifier (UEI) Number (see SAM.gov); and

• Business Size (e.g., small or large)

Questions must be submitted electronically (via email) to Contracting Officer, Catherine Muir at muirca@mail.nih.gov in Adobe Portable Document Format (PDF), no later than 3:00 PM ET Aug. 2, 2024.

Quotations must be submitted electronically (via email) to the Contracting Officer, Catherine Muir at muirca@mail.nih.gov in Adobe Portable Document Format (PDF), no later than 3:00 PM ET on Sept 2, 2024.

QUOTATIONS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED, UNLESS

ACCEPTANCE WOULD BE IN THE BEST INTEREST OF THE GOVERNMENT.

Please refer to Solicitation Number: 75N91024Q00002 on all correspondence.

Attachments:

Attachment 1 - Statement of Work Attachment 2 - Technical Evaluation Criteria Attachment 3 - Invoicing Instructions with IPP 4-21-22 Attachment 4 - Invoicing Instructions without IPP 4-21-22 http://www.sam.gov/

Attachment 1 Statement of Work Page 1 of 6

RFQ 75N91024Q00002

STATEMENT OF WORK

For

Dated July 19, 2024

1.0 TITLE

Medical record abstraction services for Pediatric Proton and Photon Therapy Comparison Cohort

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, few 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. Therefore, the NCI established the Pediatric Proton and Photon Therapy Comparison Cohort, a retrospective cohort study with prospective follow-up including pediatric cancer patients treated with proton therapy and a comparison group of similar patients treated with photon therapy. To examine whether proton therapy results in improved outcomes compared to photon therapy, there is a critical need to obtain data from a large, representative sample of pediatric proton patients and a control group of similar patients treated with photon therapy. NCI’s primary aim is to obtain data on patient characteristics, cancer diagnosis and treatment details for proton patients and to add similar data for 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.

Pediatric cancer is rare and therefore multiple pediatric treatment centers need to be included to assemble both proton therapy and comparison photon therapy cohorts of adequate size. No single center will have enough patients to obtain data for the target size of 10,000 proton and 10,000 photon patients meeting eligibility criteria. To date, the NCI has established contracts for similar data collection with thirteen pediatric radiation centers; data from additional institutions are needed to meet the required number of 20,000 patient records.

2.1 OBJECTIVE

The goal of this acquisition is to obtain data on a group of proton-treated pediatric cancer patients and a group of photon-treated pediatric cancer patients to serve as a comparison group. The Contractor shall retrieve data from existing medical records for pediatric cancer patients treated at their institution with proton or 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.

Attachment 1 Statement of Work Page 2 of 6

STATEMENT OF WORK

For

3.0 SCOPE

The Contractor shall identify all proton treated pediatric patients and all photon treated pediatric cancer patients at their institution. For all patients meeting inclusion criteria, they shall retrieve required data elements from existing medical records and enter data elements (not to include personal identifiers) into a secure data collection tool maintained by the Coordinating Center for data collection. The Contractor shall locate radiotherapy and imaging data from eligible proton or photon-treated pediatric patients, de-identify as necessary, and upload the de-identified data to an online imaging file repository maintained by the Coordinating Center.

4.0 CONTRACT REQUIREMENTS AND REQUISITE 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 a) all proton-treated pediatric cancer patients who were less than 22 years of age at diagnosis, diagnosed with Hodgkin lymphoma, a central nervous system tumor, neuroblastoma or sarcoma, and treated with protons since January 1, 2007, and b) all photon-treated pediatric cancer patients who were less than 22 years of age at diagnosis, diagnosed with Hodgkin lymphoma, a central nervous system tumor, neuroblastoma or sarcoma, and treated with photon therapy since January 1, 2007.

4.1.2 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 proton or photon-treated pediatric cancer patients.

4.1.3 Develop a data sharing agreement to allow sharing of de-identified data from patient medical records to be transferred to the Coordinating Center.

4.2 Data Collection

The Contractor shall:

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.

Required data elements will 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, and details of any subsequent cancer diagnoses or treatments if applicable.

4.2.3 Enter or upload de-identified abstracted data for eligible patient records into the study-specific database maintained by the Coordinating Center. A data collection tool, including automated workflows to specify the extent of data and

Attachment 1 Statement of Work Page 3 of 6

STATEMENT OF WORK

For specific data elements required for each patient based on the cancer diagnosis entered, can be made available by the Coordinating Center. The Contractor shall be able to use a data collection platform of their choice but shall be responsible for providing the required data elements in a format that allows for automated transfer into the primary database maintained by the Coordinating Center. The Contractor shall be responsible for providing data in a format that is acceptable to the NCI.

4.2.4 Maintain a list of study ID and patient identifiers to include name, date of birth 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).

4.2.5 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), and treatment plans (RT Plan). 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 shall be required to unarchive original treatment plans as needed. De-identified imaging and treatment-related files, including DICOM files, shall be renamed using a standard naming convention provided by the Coordinating Center and uploaded to a secure file repository. The MIMcloud system (MIM Software, Inc.) shall be available as the primary file repository because it is already in use by the Coordinating Center, but alternative secure solutions can be used if necessary, at the discretion of the Contractor and with approval of the NCI. The file repository shall not include patient identifiers or linkages that would allow re- identification.

4.2.6 Provide NCI and the study Coordinating Center with an initial progress report detailing progress and timeline for obtaining required regulatory approvals after the first two months after award, followed by progress reports every four months thereafter summarizing work performed in the previous four months and 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.

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

4.3 Contractor Qualifications: The Contractor shall provide an estimate of the total number of eligible patient records treated with a) protons and b) photons since January 1, 2007 and meeting the eligibility criteria outlined in 4.1.1 for which data will be provided to the Coordinating Center. The Contractor shall have the capacity to obtain required regulatory approvals at their institution, to identify all eligible patients treated at the institution, to

Attachment 1 Statement of Work Page 4 of 6

STATEMENT OF WORK

For perform required data abstraction on all eligible patients, and to locate and upload de-identified electronic radiation treatment records for all eligible patients within the specified period of performance.

5.0 GOVERNMENT RESPONSIBILITIES

The NCI COR and NCI Technical Point of Contact to provide the necessary information to the Contractor in order for them to complete Sections 4.0 and 9.0 of this Statement of Work.

6.0 TYPE OF ORDER

The award(s) will be firm-fixed-price.

7.0 PERIOD OF PERFORMANCE

The period of performance shall be for fourteen (14) months from date of award. The initial two (2) months shall be dedicated to obtaining required regulatory approvals and the remaining twelve (12) months shall be dedicated to data collection activities.

8.0 PLACE OF PERFORMANCE

Work shall be performed at the Contractor’s facility.

9.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

The NCI technical point of contact and Contracting Officer’s Representative (COR) shall review the deliverables submitted by the Contractor for acceptance within fourteen (14) calendar days of receipt, to ensure consistency with the contract terms and approve the submitted reports. At the completion of the review, the NCI 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 technical point of contact and COR within (five) 5 calendar days of the date of notification. If no comments or request for revisions are provided within fourteen (14) calendar days, the deliverables shall be considered acceptable. In general, the NCI COR shall provide technical scientific review and approval of all deliverables submitted by the Contractor.

The Contractor shall deliver the following items within the Period of Performance stated in the order and as coordinated with the NCI Contracting Officer’s Representative (COR) in a Microsoft compatible format.

All electronic reports and other digital files submitted shall be conformant with Section 508 of the Rehabilitation Act of 1973. Additional information about formatting and testing documents for Section 508 conformance, including guidance and specific checklists, by application can be found at:

1. Accessibility @ HHS | HHS.gov

a. Accessibility Conformance Checklists | HHS.gov https://www.hhs.gov/web/section-508/index.html https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

Attachment 1 Statement of Work Page 5 of 6

STATEMENT OF WORK

For

b. Accessibility Training Resources | Section508.gov

2. Create Accessible Digital Products | Section508.gov

a. Create Accessible Documents | Section508.gov

All deliverables shall be sent electronically per the following schedule:

Table of deliverables

Deliverable Description Due Date Amount to Invoice

#1 Progress Report

Description of progress on the first 2 months of performance, to include the following:

- Date of submission and current status of process to obtain Institutional Review Board approval of a study protocol.

- Date of submission and current status of process to obtain executed Data Use Agreement between the Contractor institution and Coordinating Center.

- Current status and anticipated timeline for any hiring of new staff required for initiation of data collection.

No later than 15 calendar days after the first 2 months after award

10% of total award amount

#2 Progress Report

Description of progress on months 3-6 of performance and a table with the number of eligible proton and 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 identified and uploaded to the study file repository.

Suggested progress report template shall be provided upon request, but alternate formats shall be allowed.

No later than 15 calendar days after the first 6 months after award

30% of total award amount

#3 Progress Report

Description of progress on months 7-10 of performance and a table with the number of eligible proton and 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 identified and uploaded to the study file repository.

Suggested progress report template shall be provided upon request, but alternate formats shall be allowed.

No later than 15 calendar days after the first 10 months after award

30% of total award amount https://www.section508.gov/develop/universal-design-video-series/ https://www.section508.gov/develop/ https://www.section508.gov/create/documents/authoring-guides/

Attachment 1 Statement of Work Page 6 of 6

STATEMENT OF WORK

For

#4 Final Progress Report

Total number of eligible proton and 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.

Due no later than seven days prior to the expiration of the period of performance.

30% of total award amount

10.0 PAYMENT

Payment shall be made upon receipt and approval of each deliverable stated in the Deliverable Section above, with the first payment equaling 10% of the total price and the three subsequent payments each equaling 30% of the total price. Payment authorization requires submission and approval of invoices in accordance with the attached payment provisions. A copy of each invoice should be e-mailed to the NCI COR’s contact information on the first page of the order.

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 are attached (See ATTACHMENT - INVOICE

INSTRUCTION AND PAYMENT PROVISIONS).

RFQ Attachment 2: Technical Evaluation Criteria 1 RFQ 75N91024Q00002

Technical Evaluation Criteria for RFQ 75N91024Q00002 TITLE: "Medical record abstraction services for Pediatric Proton and Photon Therapy Comparison Cohort”

The quoter shall provide sufficient detail describing your organization’s methods and approach to accomplish each technical requirement in the attached Statement of Work in achieving the project deliverables. Contractor Qualifications:. The Contractor shall provide an estimate of the total number of eligible patient records treated with a) protons and b) photons since January 1, 2007 and meeting the eligibility criteria outlined in 4.1.1 of the Statement of Work for which data will be provided to the Coordinating Center.

The Contractor shall have the capacity to obtain required regulatory approvals at their institution, to identify all eligible patients treated at the institution, to perform required data abstraction on all eligible patients, and to locate and upload de- identified electronic radiation treatment records for all eligible patients within the specified period of performance.

The Government will evaluate the Quoter’s Technical Capability based on the following three (3) Technical Criteria: 1) Eligible population, 2) Technical Capability, and 3) Organizational Capability.

Eligible population is significantly more important than all other technical criteria, followed by Technical Capability as less important than Eligible Population. And organizational capability is the least important of the technical criteria.

Technical Criterion 1: Eligible population

1. Demonstrated ability and experience to identify the number of eligible a minimum of 500 pediatric cancer patients treated from 2007 to the present with protons (any diagnosis) or and the number of eligible pediatric cancer patients treated from 2007 to the present with photons (if feasible, potentially eligible patients should be restricted to those diagnosed with Hodgkin lymphoma, central nervous system tumors, neuroblastoma, or sarcoma) at your institution, and not previously reported to this study.

Note: Priority for awards will be given to institutions with demonstrated ability to identify and abstract data for a minimum of 500 eligible patients. Among institutions having demonstrated ability to meet the minimum requirement of 500 eligible patients, higher priority will be given to institutions based on:

a. Higher number of total eligible patients (proton and/or photon)of proton patients in excess of the 500 minimum.

b. Longest history of treating pediatric cancer patients with proton therapy (i.e. identification of eligible patients treated with proton therapy from the earliest calendar years within the eligibility period).Higher number of total eligible patients in excess of the 500 minimum

Technical Criterion 2: Technical capability

1. Demonstrated ability to obtain regulatory approvals required within your institution to allow abstraction of data from existing patient medical records and to share deidentified data elements.

2. Demonstrated ability and experience to collect data on pediatric cancer diagnosis and treatment from electronic medical records.

3. Demonstrated ability and experience locating, obtaining and deidentifying patient radiation treatment plans, including DICOM files for all eligible patients. This includes demonstrated ability to retrieve archived materials if required. For example, radiation treatment plans may not be part of a patient’s standard medical record and may be physically/electronically housed separately in radiation oncology departments, which may require manual work to retrieve from archived materials.

4. Demonstrated ability and experience to maintain quality control over the data collection.

RFQ Attachment 2: Technical Evaluation Criteria 2 RFQ 75N91024Q00002

Technical Criterion 3: Organizational Capability

1. Demonstrated organizational capability to support data abstraction from medical records and availability of RT-DICOM files for pediatric cancer patients.

Updated on March 21, 2023

Invoice and Payment Provisions (Vendor has Transitioned to IPP)

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.*

NOTE: If your invoice must differ from the line items on the award, please contact the Contracting…