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Solicita on No. 75N91023Q00142 A achment 9 – Data Sharing Plan for Pa erns of Care FY24 Study

A achment 9 – Data Sharing Plan for Pa erns of Care FY 2024 Study

Data Sharing Plan/Informa on

NIH implemented a new Data Management and Sharing Policy in 2023 (h ps://sharing.nih.gov/data-management-and-sharing-policy/about-data-management-and-sharing-policies/data-management-and-sharing-policy-overview). The goal of this policy is to promote the sharing of scien fic data, including providing accessibility to high-value datasets and promo ng data reuse for future research studies.

The new Data Management and Sharing Policy will apply to data collected for NCI Pa erns of Care (POC) studies. Specific regarding data sharing with extramural research for POC data include:

1. POC data will be released only as a “national” data set. That is, the registry that supplied data for a case will not be identified in these data sets.

2. Similar to SEER-Medicare data, POC data will not be public use data files. Investigators will be required to obtain approval for specific research questions to obtain POC data to ensure the confidentiality of patients and providers. There will be limits on the amount of data that will be approved for any one research request.

3. The process for obtaining approval for POC data will be similar to the process employed for SEER-Medicare data. This will include submission of:

o An application form specifying the research question(s) and analysis plans; the study cohort(s); the POC and SEER data elements requested; the personnel to be involved in data analyses; and a timeline for completion;

o A POC data use agreement (DUA);

o Documentation of Institutional Review Board (IRB) approval;

o Information on how the data will be stored to maintain confidentiality and access restricted to approved personnel; and o Details of funding for research using POC data.

Applica ons will then be reviewed by NCI-led content experts.

4. As with the currently-used POC DUA, all manuscripts or book chapters including analyses of POC data will require review by NCI personnel prior to submission for review and publication.

Ques ons on the data sharing policy for Pa erns of Care data can be directed to Dr. Michael Halpern at michael.halpern@nih.gov.

U.S. Department of Health & Human Services | National Institutes of Health

COMBINED SYNOPOSIS/SOLICITATION FOR COMMERCIAL SERVICES

I. General Information Title: NCI Patterns of Care Study: Diagnosis Year 2021 (Prostate

Cancer and Ovarian Cancer)

Solicitation Number: 75N91023Q00142

Posted Date: 02/02/2024

Response Time & Date: 3:00PM ET on 02/20/2024

Product or Service Code: R702 – Support – Management: Data Collection

Set Aside: N/A

NAICS Code: 541990 – All Other Professional, Scientific, and Technical Services

Contracting Office Address: National Cancer Institute, 9609 Medical Center Drive, Bethesda, Maryland 20892

Contracting Officer: Angela Moore, angela.moore2@nih.gov

II. Description

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued.

This Solicitation Number 75N91023Q00142 is a Request for Quote (RFQ) and includes all applicable provisions and clauses specified herein in effect through FAR Federal Acquisition Circular (FAC)2023-06 (October 5, 2023) This will be awarded as firm fixed-price type purchase order(s) using simplified acquisition procedures for commercial services.

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

The purpose of this acquisition is to collect data for the National Cancer Institute (NCI) Patterns of Care (POC) Study, relevant to the Congressional Mandate to NCI (Public Law 100-607, Sec. 413 (a)(2)(C) adopted on November 4, 1988).

The primary objectives of this POC Study are to: 1) describe the use of recommended biomarker tests which shall be verified with the treating physician/physician office staff or with a unified medical record (record with all inpatient and outpatient records in a single file) or complete medical records (all inpatient and outpatient cancer treatment records obtained from more than one hospital/healthcare system/medical practice); and 2) describe the use of targeted therapy which shall

RFQ 75N91023Q00142 Page 3 of 10 be verified with the treating physician/physician office staff or with a unified or complete medical record.

Other objectives are to: 3) describe the use of adjuvant therapy, which shall be verified with the treating physician/physician office staff or with a unified or complete medical records; 4) characterize the practice patterns in different communities; 5) compare the patterns of treatment (surgery, radiation therapy, systemic therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, and other adjuvant therapy) over time and by age, sex, race/ethnicity, and insurance status; 6) describe comorbidities and the effect of co-morbid conditions on treatment; 7) describe treatment by hospital characteristics (i.e., for profit vs. not for profit, teaching vs. non-teaching, bed size, etc.); 8) describe the use of diagnostic tests and compare their use by demographic variables; 9) abstract information documented in the medical record on delays or changes in diagnosis, treatment, and supportive/palliative care among individuals diagnosed with cancer specifically due to the COVID-19 pandemic; 10) assess the incidence of cancer recurrence and metastasis following initial diagnosis; and 11) describe medical record documentation of patient financial impacts due to the COVID-19 pandemic potentially affecting cancer care. It is anticipated that while abstracting data from medical records, individuals at participating registries will encounter Personally Identifiable Information (PII) as permitted by their IRB approval for this study (if needed) and state regulations. However, only de-identified data will be shared with NCI and NCI DCCPS’ Biomedical Computing Contractor for this study.

The Quoter shall provide a quote by the due date and time for the requirement defined in Attachment 1 – Statement of Work.

III. Place of Performance

Service shall be performed remotely from the Contractor’s facility as noted in Attachment 1 - Statement of Work.

IV. Non-Severable Services

The services to be acquired under this purchase order will be considered non-severable services.

V. Period of Performance

The anticipated period of performance shall consist of one (1) 12-month base period.

VI. Basis for Award and Evaluation

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

Evaluation and award will be conducted in accordance with the requirements of FAR 13.106. 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 quote. The Government may evaluate the quotes received and make multiple awards.

RFQ 75N91023Q00142 Page 4 of 10

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)

Award shall be made using a tradeoff process to the quoter(s) who represent the best value. A technically acceptable quote is one in which all the Mandatory Criteria are met and the quoter(s) complies with the Statement of Work (SOW) and does not take exception, nor object to any of the terms of the RFQ. Quotes that are not technically acceptable will not be considered for award.

MANDATORY CRITERIA

The following minimum criteria must be met, or a quoter will not be deemed to be Technically Acceptable:

1. Population-based data on prostate and ovarian cancer cases diagnosed in 2021 (i.e., all cases diagnosed in 2021 within a given state or region, regardless of their insurance, where they were treated, or other characteristics);

2. Data on patient characteristics (including age, sex, stage, race/ethnicity and tumor grade and histology) at the start of the study in order to identify cases for the sampling plan; and

3. The ability to access medical records for these patients and contact physicians to collect additional treatment information.

If all three of the mandatory criteria are not met, then the quoter will be deemed Technically Unacceptable and no further review of the quote will be done and the quoter will not be eligible for award.

In addition, the following factors and sub-factors will be used to evaluate the prospective quoter to determine acceptability.

Technical Capability is the evaluation factor of the greatest importance followed by Personnel as the second most important factor, both of which are used to determine technical acceptability. Price is also a factor of significant importance. And the factor of Past Performance is of the least importance. All evaluation factors other than price, when combined, are more important than price. See below for a description of each Evaluation Factor.

RFQ 75N91023Q00142 Page 5 of 10

Factor #1 Technical Capability:

The quoter shall provide sufficient detail for Technical Capability by describing your organization’s relevant experience, methods and approach to accomplish each technical requirement in the attached Statement of Work in achieving the project deliverables.

The Government will evaluate the quoter’s demonstrated Technical Capability in particular regarding:

a. Population-based cancer registry: that is, a cancer registry that includes information for all individuals who are diagnosed with cancer while residing within a defined geographic region, regardless of where they receive treatment, what type of cancer they have, what type of insurance they have, or any other individual characteristics. This is critical to ensure the population sampled in the Patterns of Care study is representative of the overall population of individuals diagnosed with cancer.

b. Able to select a stratified random sample of patients with one or more specified types of cancer based on instructions provided by NCI.

c. Able to identify additional patients for the study sample if patients in the initial sample are determined to be ineligible.

d. For the selected study sample of patients, ability to:

1. Possess or are able to collect detailed clinical and sociodemographic information, including sex and race/ethnicity; tumor stage, histology, grade, and metastases; regional lymph nodes examined and number positive; type of cancer surgery performed and reason if no surgery was performed; radiation therapy and systemic therapies received; and comorbid medical conditions.

2. Provide the county, zip code, and census tract of residence at time of diagnosis.

3. Access their inpatient and outpatient medical records and have onsite (i.e., employed by the registry) personnel and infrastructure to perform abstraction of specified data from these medical records.

4. Perform quality assessment of this data abstract process by having separate onsite personnel perform duplicate medical record data abstraction and compare results to the original data abstraction.

5. Contact the treating physician practices for patients for whom outpatient medical records are not accessible and request completion of a physician verification form to collect information on outpatient cancer treatment.

Factor #2 Personnel

The quoter shall name and describe the Key Personnel who will be assigned to manage performance and supervise the work in the attached Statement of Work. Information is required which will demonstrate their general qualifications and recent experience with similar technical requirements. If the proposed Key Personnel will not be assigned full time to this contract, show the approximate percentage of time they will be available for this contract.

The Government will evaluate the quoter’s Personnel in particular regarding:

a. Demonstrated experience relevant to the Statement of Work;

RFQ 75N91023Q00142 Page 6 of 10

b. Substantial knowledge regarding cancer staging; medical terminology; and patient medical records;

c. Time availability to perform the activities specified in the quote; and

d. Sufficient personnel to perform quality assessment independent of the personnel involved in the initial medical chart review and abstraction.

Factor #3 Price

The quoter shall provide their price quote with the total fixed price to accomplish the work in the attached Statement of Work. Based on the number of cases provided and total fixed price quoted, the Government will calculate each quoter’s price per case. (i.e. the price per case is the total fixed price divided by the number of cases that the quoter is quoting to abstract.)

Price will be evaluated for reasonableness in accordance with FAR 13.106-3. For a price to be reasonable, it must represent a price to the Government that a prudent person would pay when consideration is given to prices in the market. Normally price reasonableness is established through adequate price competition.

Factor #4 Past Performance

The quoter shall provide recent and relevant past experience on at least two (2) contracts for similar work to the tasks described in Attachment 1 - Statement of Work.

The Government will evaluate the recency and relevancy of present/past performance in relation to this requirement. In order to receive a rating of “acceptable” for this evaluation factor, the quoter must, at a minimum, provide past performance on at least two (2) recent and relevant contracts with similar tasks. The past performance should indicate successes of the quoter in completing /meeting delivery dates and customer satisfaction. The Government considers “recent” present/past performance to be within the past three (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 Contractor Performance Assessment Reporting System (CPARS) is one of the sources that will be utilized.

NOTE: In accordance with FAR 15.305 (a)(2)(iv)), in the case of when a quoter is 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 quoter shall be determined to have “unknown” past performance. In the context of acceptability/unacceptability, “unknown” will be considered “acceptable.”

VII. PRIVACY ACT

It has been determined that this acquisition is subject to the Privacy Act of 1974. The System of Record’s Notice (SORN) that is applicable to this acquisition and resultant contract is 09-25-0200.

RFQ 75N91023Q00142 Page 7 of 10

VIII. INVOICE AND PAYMENT INFORMATION

Payment shall be made not more frequently than quarterly upon acceptance and approval of deliverables.

Payment authorization requires submission and approval of invoices to the NCI Branch B mailbox, Purchasing Agent, Contracting Officer, COR, and NIH OFM, in accordance with the attached payment provisions listed below in this section.

See the Invoice Instructions Attachment 6.

IX. PURCHASE ORDER PROVISIONS AND CLAUSES

A. The provision at FAR Clause 52.212-1, Instructions to Offerors – Commercial Products and

Commercial Services (SEP 2023), 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. In accordance with FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Product and Commercial Services (NOV 2023), quoters must complete annual representations and certifications on-line at https://www.sam.gov.

C. FAR 52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services (NOV 2023) 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.

D. FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Products and Commercial Services (DEC 2023) applies to this acquisition. (See Attachment 4)

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 offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror 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 https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/index.html

FAR 52.204-7 System for Award Management (Oct 2018)

FAR 52.204-8 Annual Representations and Certifications (Mar 2023)

FAR 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020)

FAR 52.204-22 Alternative Line Item Proposal (Jan 2017)

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

RFQ 75N91023Q00142 Page 8 of 10 text of a clause may be accessed electronically at these addresses: http://www.acquisition.gov/far/ and https://www.hhs.gov/grants-contracts/contracts/contract-policies-regulations/hhsar/index.html

Additional Clauses which apply to this acquisition are:

FAR 52.202-1 Definitions. (Jun 2020)

FAR 52.203-5 Covenant Against Contingent Fees. (May 2014)

FAR 52.203-7 Anti-Kickback Procedures. (Jun 2020)

FAR 52.203-17 Contractor Employee Whistleblower Rights (Nov 2023)

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 52.204-21 Basic Safeguarding of covered Contractor Information Systems (Nov 2021)

FAR 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving. (Jun 2020)

HHSAR 352.239-73 Electronic and Information Technology Accessibility Notice (Dec 2015)

HHSAR 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

X. INSPECTION AND ACCEPTANCE CRITERIA

Pursuant to FAR Clause 52.212-4, all work described in the SOW to be delivered under this purchase order is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI Contracting Officer’s Representative, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

Regardless of format, all digital content or communications materials produced as a deliverable under this purchase order, shall conform to applicable Section 508 Standards to allow Federal employees and members of the public with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by Federal employees or by members of the public who are not individuals with disabilities. Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor.

HHS guidance regarding accessibility of documents can be found at:

https://www.hhs.gov/web/section-508/index.html

Federal Government-wide guidance regarding accessibility of documents can be found at:

https://www.section508.gov/manage/program-roadmap/ 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.

RFQ 75N91023Q00142 Page 9 of 10

XI. QUOTE SUBMISSION / GENERAL INSTRUCTIONS

Please submit the Quote via email to the Contracting Officer as an attachment to the SF 18 along with all the Representations listed below in this Section XI. (See Attachment 7 “Additional Quote Instructions” for important instructions).

This Request for Quote does not commit the Government to pay any cost for preparation and submission of a quote. 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 acquisition. By submitting a quote in response to this Solicitation, it is understood that your firm’s quote shall become a part of the official contract file.

Quotes must stipulate that it is predicated upon all the terms and conditions of this RFQ and be signed by an official authorized to bind the organization. In addition, the quote 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.

Quotes must provide clear responses, specifically addressing the requirements listed above. Quotes which merely offer to conduct a project in accordance with the requirements of the Government's scope of work may not be eligible for award.

Quoters shall submit a signed SF 18 and prepare a price quote and narrative that contains all information necessary to allow for a comprehensive evaluation of the prices quoted. See Attachment 7 “Additional Quote Instructions” for further information.

The Quote must include a cover page with the following:

Legal Name Federal Tax Identification Number (TIN);

Unique Entity Identifier (UEI) Number (see SAM.gov); and Business Size (e.g., small or large) in regard to the selected NAICS code Date of Submission Name and Contact Information for the quoter’s authorized representative

The following documents SHALL also be submitted as part of the Quote (in addition to everything required per Attachment 7 “Additional Quote Instructions”:

1. Completed SF-18 signed by an Authorized Representative which includes the Total Quoted

Price in 11(f). Ensure that the following fields are filled in: Items 8 a-f, 11(f), and Items 13-15.

2. A valid Representations and Certifications from the System for Award Management (SAM) at www.sam.gov must be submitted.

3. A completed copy of Attachment 3 - FAR 52.212-3, Offeror Representations and Certifications – Commercial Products and Commercial Services

4. A completed copy of Attachment 5 - FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment

5. Complete Payment Schedule provided in Attachment 7 - Additional Quote Instructions

6. Completed copy of Attachment 8 – Summary of Related Activities

RFQ 75N91023Q00142 Page 10 of 10

Questions must be submitted electronically (via email) to the Contracting Officer Angela Moore at angela.moore2@nih.gov in MS Word, no later than 3:00 PM ET on February 13, 2024.

Quotes must be submitted electronically (via email) to Contracting Officer Angela Moore at angela.moore2@nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 3:00 PM ET on February 20, 2024.

Please refer to Solicitation Number 75N91023Q00142 on all correspondence.

ATTACHMENTS:

Attachment 1 - Statement of Work dated February 1, 2024

Attachment 2 - Deliverables

Attachment 3 - FAR 52.212-3, Offeror Representations and Certifications – Commercial Products and Commercial Services

Attachment 4 - FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (Dec 2023).

Attachment 5 - FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment

Attachment 6 - Invoice Instructions With IPP 7-22

Attachment 7 - Additional Quote Instructions

Attachment 8 - Summary of Related Activities

Attachment 9 – NCI Data Sharing Plan for Patterns of Care FY 2024 Study

Attachment 10 - POC 2024 Data Acquisition Manual (2021 Diagnosis Year - Prostate Cancer and Ovarian Cancer) DRAFT version

REQUEST FOR QUOTATION

(THIS IS NOT AN ORDER)

THIS RFQ IS IS NOT A SMALL BUSINESS SET-ASIDE

15. DATE OF QUOTATION

16. SIGNER

a. NAME (Type or print)

c. TITLE (Type or print)

b. TELEPHONE

AREA CODE

NUMBER

STANDARD FORM 18 (REV. 6/1995)

Prescribed by GSA-FAR (48 CFR) 53.215-1(a)

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition not usable

8. TO:

b. COMPANYa. NAME

c. STREET ADDRESS

d. CITY e. STATE f. ZIP CODE

9. DESTINATION

a. NAME OF CONSIGNEE

b. STREET ADDRESS

c. CITY

d. STATE e. ZIP CODE

7. DELIVERY

FOB DESTINATION

OTHER

(See Schedule)

10. PLEASE FURNISH QUOTATIONS TO THE

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

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)

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

a. NAME OF QUOTER

b. STREET ADDRESS

c. COUNTY

d. CITY e. STATE f. ZIP CODE

14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

PAGE OF PAGES

1. REQUEST NUMBER 2. DATE ISSUED 3. REQUISITION/PURCHASE REQUEST NUMBER 4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY 6. DELIVER BY (Date)

5b. FOR INFORMATION CALL (NO COLLECT CALLS)

NAME TELEPHONE NUMBER

AREA CODE NUMBER

1.2

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REQUEST FOR QUOTATION(THIS IS NOT AN ORDER)

THIS RFQ

IS

IS NOT A SMALL BUSINESS SET-ASIDE

15. DATE OF QUOTATION

16. SIGNER

a. NAME (Type or print)

c. TITLE (Type or print)

b. TELEPHONE

AREA CODE

NUMBER

STANDARD FORM 18 (REV. 6/1995)

Prescribed by GSA-FAR (48 CFR) 53.215-1(a)

AUTHORIZED FOR LOCAL REPRODUCTION Previous edition not usable

8. TO:

b. COMPANY

a. NAME

c. STREET ADDRESS

d. CITY

e. STATE

f. ZIP CODE

9. DESTINATION

a. NAME OF CONSIGNEE

b. STREET ADDRESS

c. CITY

d. STATE

e. ZIP CODE

7. DELIVERY

FOB DESTINATION

OTHER (See Schedule)

10. PLEASE FURNISH QUOTATIONS TO THE ISSUING OFFICE IN BLOCK 5a ON OR BEFORE CLOSE OF BUSINESS (Date)

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)

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

a. NAME OF QUOTER

b. STREET ADDRESS

c. COUNTY

d. CITY

e. STATE

f. ZIP CODE

14. SIGNATURE OF PERSON AUTHORIZED TO SIGN QUOTATION

PAGE

OF

PAGES

1. REQUEST NUMBER

2. DATE ISSUED

3. REQUISITION/PURCHASE REQUEST NUMBER

4. CERT. FOR NAT. DEF. UNDER BDSA REG. 2 AND/OR DMS REG. 1

RATING

5a. ISSUED BY

6. DELIVER BY (Date)

5b. FOR INFORMATION CALL (NO COLLECT CALLS)

NAME

TELEPHONE NUMBER

AREA CODE

NUMBER

THIS RFQ IS A SMALL BUSINESS SET-ASIDE.: 0

7. DELIVERY. FOB DESTINATION: 1

NOTE: Additional provisions and representations are attached.: 1

NOTE: Additional provisions and representations are not attached.: 0

7. DELIVERY. OTHER (See Schedule): 0

THIS RFQ IS NOT A SMALL BUSINESS SET-ASIDE.: 1

PAGE OF: 1

4. CERT. FOR NAT. DEF. UNDER BDSA REG. 2 AND/OR DMS REG. 1. RATING:

3. REQUISITION/PURCHASE REQUEST NUMBER:

1. REQUEST NUMBER: 75N91023Q00142

5a. ISSUED BY: NIH/National Cancer Institute/Office of Acquisitions, 9609 Medical Center Dr., Bethesda, MD 20892

5b. FOR INFORMATION CALL (NO COLLECT CALLS). NAME: Angela Moore, Contracting Officer

8. TO. a. NAME:

13. NAME AND ADDRESS OF QUOTER. f. ZIP CODE:

16. SIGNER. a. NAME (Type or print):

16. SIGNER. b. TELEPHONE. AREA CODE:

16. SIGNER. b. TELEPHONE. NUMBER:

16. SIGNER. c. TITLE (Type or print):

13. NAME AND ADDRESS OF QUOTER. e. STATE:

13. NAME AND ADDRESS OF QUOTER. d. CITY:

13. NAME AND ADDRESS OF QUOTER. b. STREET ADDRESS:

13. NAME AND ADDRESS OF QUOTER. c. COUNTRY:

13. NAME AND ADDRESS OF QUOTER. a. NAME OF QUOTER:

8. TO. c. STREET ADDRESS:

8. TO. d. CITY:

11. SCHEDULE (Include applicable Federal, State and local taxes). ITEM NUMBER. COLUMN A. Line 18 of 18: 1

11. SCHEDULE (Include applicable Federal, State and local taxes). SUPPLIES/SERVICES. COLUMN B.: Services required under the Statement of Work for

11. SCHEDULE (Include applicable Federal, State and local taxes). SUPPLIES/SERVICES. COLUMN B.: NCI Patterns of Care Study - Diagnosis Year

11. SCHEDULE (Include applicable Federal, State and local taxes). SUPPLIES/SERVICES. COLUMN B.: 2021 Prostate Cancer and Ovarian Cancer

11. SCHEDULE (Include applicable Federal, State and local taxes). QUANTITY. COLUMN C.:

11. SCHEDULE (Include applicable Federal, State and local taxes). QUANTITY. COLUMN C.:

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9. DESTINATION. a. NAME OF CONSIGNEE: Dr. Michael Halpern

9. DESTINATION. b. STREET ADDRESS: 9609 Medical Center Dr.

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9. DESTINATION. e. ZIP CODE: 20850

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RFQ# 75N91023Q00142 | ATTACHMENT 1 - Statement of Work dated February 1, 2024

STATEMENT OF WORK

NCI Patterns of Care (POC) Study: Diagnosis Year 2021

(Prostate Cancer and Ovarian Cancer) dated February 1, 2024

Independently and not as an agent of the Government, the Contractor shall furnish all necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work.

A. Background

The National Cancer Institute (NCI) Patterns of Care (POC) studies describe, characterize, and compare practice patterns and treatments provided for cancer in different geographic areas of the United States. POC Studies are conducted to satisfy a Congressional directive (under Public Law 100-607, Sec. 413 (a)(2)(C) adopted on November 4, 1988) to the NCI to “assess the incorporation of state-of-the-art cancer treatments into clinical practice and the extent to which cancer patients receive such treatments and include the results of such assessment in the biennial reports…”. To satisfy the directive and to update and enhance the utility of the POC Studies, a working group including representatives from the NCI’s Divisions of Cancer Control and Population Sciences and Cancer Treatment and Diagnosis and a representative from the American Cancer Society was developed to review knowledge gaps in cancer therapy dissemination and to develop priority areas for study. The group reached a consensus that a gap remains regarding factors associated with guideline use of biomarker tests and targeted therapy. Furthermore, there is limited information about the effects of the COVID-19 pandemic on cancer screening, diagnosis, treatment, and receipt of supportive/palliative care among individuals diagnosed with cancer. Therefore, this POC Study shall investigate patterns of care for patients with prostate and ovarian cancers. The Study will also collect data on documentation of palliative care and patient financial impacts of the COVID-19 pandemic in the medical record.

B. Objectives

The primary objectives of this POC Study are to: 1) describe the use of recommended biomarker tests which shall be verified with the treating physician/physician office staff or with a unified medical record (record with all inpatient and outpatient records in a single file) or complete medical records (all inpatient and outpatient cancer treatment records obtained from more than one hospital/healthcare system/medical practice); and 2) describe the use of targeted therapy which shall be verified with the treating physician/physician office staff or with a unified or complete medical records. Other objectives are to: 3) describe the use of adjuvant therapy, which shall be verified with the treating physician/physician office staff or with a unified or complete medical records; 4) characterize the practice patterns in different communities; 5) compare the patterns of treatment: surgery, radiation therapy, systemic therapy, (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, and other adjuvant therapy) over time and by age, sex, race/ethnicity, and insurance status; 6) describe comorbidities and the effect of co-morbid conditions on treatment; 7) describe treatment by hospital characteristics (i.e., for profit vs. not for profit, teaching vs. non-teaching, bed size, etc.); 8) describe the use of diagnostic tests and compare their use by demographic variables; 9) abstract information documented in the medical record on delays or changes in diagnosis, treatment, and supportive/palliative care among individuals diagnosed with cancer specifically due to the COVID-19 pandemic; 10) assess the incidence of cancer recurrence and metastasis following initial diagnosis; and 11) describe medical record documentation of patient financial impacts due to the COVID-19 pandemic potentially affecting cancer care. It is anticipated that while abstracting data from medical records, individuals at participating registries will encounter Personally Identifiable Information (PII) as permitted by their IRB approval for this study (if needed) and state regulations. However, only de-identified data will be shared with NCI and NCI DCCPS’ Biomedical Computing Contractor for this study.

C. Technical Requirements

The Contractor shall perform the following tasks:

1. Abstract from the medical record all items on the abstract form as specified in the Diagnosis Year 2021 POC Data Acquisition Manual. Verify with the treating physician/physician’s office staff or by abstracting a unified or complete medical records the biomarker tests completed, radiation therapy, systemic therapy (targeted therapy, chemotherapy, immunotherapy, hormonal therapy), and other adjuvant therapy given to each patient to treat their selected cancers. Participation in treatment protocols and therapy provided shall also be verified with the treating physician/ physician’s office staff or with unified or complete medical records. If additional physicians who provided therapy are identified, they shall be contacted by the Contractor as well. Multiple attempts shall be made, as needed, to obtain complete therapeutic information from the treating physicians. In the case of facilities with a unified or complete medical records, reviewing the unified or complete medical records shall be considered equivalent to reviewing the physician's office records.

Review of hospital records that do not contain all of the inpatient and outpatient records shall not be considered equivalent to reviewing the physician’s office records.

Additional information shall be collected on diagnostic tests, surgery, pathologic margins, tumor characteristics, tumor recurrence, and hospital and physician characteristics. Information on insurance status and discussions about palliative care and effects of the COVID-19 pandemic shall be abstracted from the medical record.

2. Identify a stratified random sample of prostate cancer cases diagnosed between

January 1, 2021 and December 31, 2021 selected for data abstraction. Non-Hispanic Blacks, Hispanics, Asian/Pacific Islanders and Native American/Alaskan Natives shall be oversampled to obtain more stable estimates. Sampling shall also be by age group, stage, and tumor biomarker status where appropriate. Eligible cancer patients shall be sampled from cases age 20 years or older. Patients shall be ineligible if they have previous malignancies (except prior basal cell or squamous cell carcinoma of the skin), simultaneously diagnosed cancers of more than one site (e.g., a patient diagnosed with primary prostate and primary lung cancer simultaneously) or were diagnosed at autopsy or on death certificate only.

3. Identify a stratified random sample of ovarian cancer cases diagnosed between

January 1, 2021 and December 31, 2021 selected for data abstraction. Non-Hispanic Blacks, Hispanics, Asian/Pacific Islanders and Native American/Alaskan Natives shall be oversampled to obtain more stable estimates. Sampling shall also be by age group, stage, and tumor biomarker status where appropriate. Eligible cancer patients shall be sampled from cases age 20 years or older. Patients shall be ineligible if they have previous malignancies (except prior basal cell or squamous cell carcinoma of the skin), simultaneously diagnosed cancers of more than one site (e.g., a patient diagnosed with primary ovarian and primary lung cancer simultaneously) or were diagnosed at autopsy or on death certificate only.

4. The Contractor shall:

1) obtain local Institutional Review Board (IRB) approval as appropriate for their institution;

2) select eligible cases with assistance from the NCI DCCPS’ Biomedical Computing Contractor;

3) provide the Contracting Officers Representative (COR) with documentation regarding the sampling procedure and all data necessary to determine the appropriate sample for their registry;

4) obtain requested data from medical record review and physician/physician office staff contact;

5) follow up with multiple attempts to obtain the treatment data from each patients’ physician(s)/physician office staff;

6) abstract data obtained from the medical record onto data collection forms following the specification in the Diagnosis Year 2021 POC Data Acquisition Manual;

7) edit and collate the collected data;

8) enter the data into the abstracting software provided by the NCI or abstract directly from the medical record into the abstracting software with the appropriate consolidation of data from multiple sources;

9) appropriately sample new cases registered after the initial sample was drawn;

10) track study progress, noting successes and failures;

11) upload the electronic databases to the NCI DCCPS’ Biomedical Computing Contractor.

5. The Contractor shall prepare and provide Quarterly Progress Reports that shall include the items described in the Deliverables Attachment (See Deliverables Attachment).

6. The Contractor shall designate one Abstractor/quality assurance individual to attend Abstractor Training to discuss uniform and standardization of procedures for sampling cases from each registry and for the coding of variables under the Diagnosis Year 2021 POC Study. The NCI Centralized Abstractor Training report will include the name and position of person(s) who attended training and plans to implement training to conduct the Statement of Work. (See Deliverables Attachment 2).

7. The Contractor shall prepare and provide a Final Report that shall include technical progress inclusive of the work performed for the entire contract period of performance as described in the Deliverables Attachment. (See Deliverables Attachment).

8. Quality Control (QC)

Identify a sample comprising 5% of randomly sampled POC cases to be re-abstracted for quality control purposes. This shall be done by a staff member other than the one who performed the initial medical record abstraction. Re-abstracting shall be conducted as the abstracts are completed, not at the conclusion of the study. The re-abstracted data shall be edited by the supervisor, marked “QC”, and uploaded with the other abstracts. Retraining of the abstracting staff shall occur as needed as the QC is performed.

9. Each Contractor shall complete the number of abstracts for its registry as proposed in its final quote. (The number of cases will be updated at the time of award to reflect the negotiated case counts).

10. The Contractor shall provide the Electronic Database Files of Abstract submissions of abstracted Prostate Cancer data and abstracted Ovarian Cancer data during the period of performance as described in the Deliverables Attachment.

Solicitation Instructions (Will delete upon award)- For solicitation purposes, the Quoter must propose a MINIMUM of 125 prostate cancer cases and 50 ovarian cancer cases. QUOTER

WILL INITIALLY PROPOSE THE NUMBER OF CASE ABSTRACTS ITS REGISTRY IS PROPOSING IT

CAN PERFORM AT THE PROPOSED PRICE. This number can include no more than 50% of the total number of prostate cancer cases that were diagnosed in 2021 and reported to the Quoter/registry.

Case counts may change upon negotiation AND will be based on the number of cases identified by your registry that it proposes it will perform in the final quote. Please ensure the number of cases quoted in the price quote is consistent with the number of cases proposed in the technical portions of the quote. (Case counts per registry are subject to change and may be negotiated after initial quote based on several factors to include the number of offers received and total number of cases proposed by Quoters overall.)

Version 2024.1 111/08/2023

POC 2024 DATA ACQUISITION MANUAL

2021 DIAGNOSIS YEAR

PROSTATE CANCER

OVARIAN CANCER

DRAFT 11/08/2023: SUBJECT TO REVISION

Attachment 10 - POC 2024 Data Acquisition Manual (Draft)

TABLE OF CONTENTS

SECTIONS Page

I. INTRODUCTION

1. Study overview ............................................................................................... I-5

2. Objectives ......................................................................................