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This is a request for quote (RFQ) from the National Cancer Institute (NCI), a division of the National Institutes of Health within the Department of Health and Human Services, for data collection services to support the Patterns of Care Study for breast and colorectal cancer cases diagnosed in 2020. The contractor will collect population-based data on patient characteristics, treatment patterns, and effects of the COVID-19 pandemic from medical records. The anticipated period of performance is one base year with a start date in late November 2022. Quotes are due by 3:00PM ET on November 1, 2022 and will be evaluated based on technical capability, personnel, price, and past performance. Award will be made to the offeror representing the best value as determined by a tradeoff process.

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

COMBINED SYNOPOSIS/SOLICITATION FOR COMMERCIAL ITEMS

I. General Information Title: Patterns of Care Study: Diagnosis Year 2020 (Breast Cancer and

Colorectal Cancer)

Solicitation Number: 75N91022Q00180

Posted Date: 10/12/2022

Response Time & Date: 3:00PM ET on 11/01/2022

Classification 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 Items,” 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 75N91022Q00180 is a Request for Quote (RFQ) which includes all applicable provisions and clauses specified herein in effect through FAR Federal Acquisition Circular (FAC) 2022-06 (May 26, 2022). 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 $17 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); and 2) describe the use of targeted therapy 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). Other objectives are to: 3) describe

RFQ 75N91022Q00180 Page 3 of 9 the use of adjuvant therapy, 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); 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) describe the medical record documentation of the effects of the COVID-19 pandemic on cancer screening, diagnosis, treatment, and supportive/palliative care among individuals diagnosed with cancer; 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.

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. 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 and is estimated to be awarded late November 2022.

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 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

RFQ 75N91022Q00180 Page 4 of 9 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.

(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 quotation 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 breast and colorectal cancer cases diagnosed in 2020 (i.e., all cases diagnosed in 2020 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, HER-2 status for breast cancer patients, and tumor histology for colorectal cancer patients) at the start of the study in order to identify cases for the sampling plan; and

3. The ability to access medical records from 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 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. See below for a description of each Evaluation Factor.

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.

RFQ 75N91022Q00180 Page 5 of 9

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; 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;

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.

RFQ 75N91022Q00180 Page 6 of 9

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 and a price per case. (ie. the price per case is the total fixed price divided by the number of cases that the quoter is quoting it will 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) similar type contracts. 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.

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, Contracting Officer, COR, and NIH OFM, in accordance with the attached payment provisions listed below in this section.

See the Invoice Instructions Attachments 7a and 7b.

RFQ 75N91022Q00180 Page 7 of 9

IX. PURCHASE ORDER 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. In accordance with FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial

Items, quoters must complete annual representations and certifications on-line at https://www.sam.gov/SAM/pages/public/index.jsf

C. FAR 52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services (Nov 2021) 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 (May 2022) applies to this acquisition.

(See Attachment 3)

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/.

FAR 52.204-7 System for Award Management (Oct 2018) FAR 52.204-8 Annual Representations and Certifications (May 2022) 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 text of a clause may be accessed electronically at these addresses: http://www.acquisition.gov/far/ and http://www.hhs.gov/policies/hhsar/.

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 52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014) FAR 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

RFQ 75N91022Q00180 Page 8 of 9

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 HHSAR 352.222–70, Contractor Cooperation in Equal Employment Opportunity Investigations

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:

HHS Accessibility & Section 508 | HHS.gov

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.

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 Section XI. (See Attachment 8 “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 proposed 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 60 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.

RFQ 75N91022Q00180 Page 9 of 9

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 8 “Additional Quote Instructions” for further information.

The Quote must include 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)

The following documents must also be submitted as part of the Quote (in addition to everything required per Attachment 8 “Additional Quote Instructions”:

1. A valid Representations and Certifications from the System for Award Management (SAM) at www.sam.gov.

2. A completed copy of Attachment 4 - FAR 52.212-3, Offeror Representations and Certifications – Commercial Products and Commercial Services

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

4. A completed copy of Attachment 6 – FAR 52.204-26 Covered Telecommunications Equipment or Services

– Representation.

5. Completed copy of Attachment 9 – Summary of Related Activities

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 October 19, 2022.

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 Tuesday, November 1, 2022. QUOTES RECEIVED AFTER THIS DATE AND TIME

WILL NOT BE CONSIDERED.

Please refer to Solicitation Number 75N91022Q00180 on all correspondence.

Attachments:

Attachment 1 - Statement of Work dated October 12, 2022 Attachment 2 - Deliverables Attachment 3 - FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or

Executive Orders—Commercial Products and Commercial Services (May 2022).

Attachment 4 - FAR 52.212-3, Offeror Representations and Certifications – Commercial Products and

Commercial Services Attachment 5 - FAR 52.204-24 Representation Regarding Certain Telecommunications and Video

Surveillance Services or Equipment Attachment 6 - FAR 52.204-26 Covered Telecommunications Equipment or Services, Representation Attachment 7a - Invoice Instructions With IPP 7-22 Attachment 7b - Invoice Instructions Without IPP 7-22 Attachment 8 - Additional Quote Instructions Attachment 9 - Summary of Related Activities

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