NCI Patterns of Care (POC) Study: Diagnosis Year 2020 (Breast Cancer and Colorectal Cancer)

Title: NCI Patterns of Care (POC) Study: Diagnosis Year 2020 (Breast Cancer and Colorectal Cancer) Type of Notice: This is a Small Business Sources Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your response to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The NAICS code for this project is 541990. The small business size standard is $17M (effective July 14, 2022). Background: The Division of Cancer Control and Population Sciences Branch (DCCPS), Healthcare Delivery Research Program (HDRP), National Cancer Institute (NCI) carries out the NCI Patterns of Care Studies. 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 (see https://seer.cancer.gov/registries/list.html for a list of SEER cancer registries and their corresponding geographic areas). POC Studies are conducted to satisfy a Congressional directive (under Public Law 100-607, Sec. 413 (a) (2) (C) adopted November 4, 1988) to the National Cancer Institute (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 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 breast and colorectal cancers, frequently diagnosed cancer sites where care may have been affected by COVID-19 pandemic. The Study will also collect data on documentation of palliative care and patient financial impacts of the COVID-19 pandemic in the medical record. Purpose and Objectives: The purpose of this acquisition is to collect data for the NCI Patterns of Care Study, relevant to the Congressional Mandate to NCI (Public Law 100-607, Sec. 413 (a)(2)(C) adopted 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 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. Project Requirements: The Contractor shall perform the following tasks: 1. Abstract from the medical record all items on the abstract form as specified in the Fiscal Year 2022 POC Data Acquisition Manual (document in development), which will be provided to all participating registries at study initiation. Verify with the treating physician/physician's office staff or by abstracting a unified medical record (record with all inpatient and outpatient records in a single file) 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 unified medical record (record with all inpatient and outpatient records in a single file). 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 medical record, reviewing the unified medical record 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. A stratified random sample of female breast cancer cases diagnosed between January 1, 2020 and December 31, 2020 shall be 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 breast and primary lung cancer simultaneously) or were diagnosed at autopsy or on death certificate only. For colorectal cancer, a stratified random sample of cases diagnosed between January 1, 2020 and December 31, 2020 shall be 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, stage, and sex 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 basal cell or squamous cell carcinoma of the skin), simultaneously diagnosed cancers of more than one site (e.g., a patient diagnosed with primary colorectal cancer and primary lung cancer simultaneously) or were diagnosed at autopsy or on death certificate only. 3. 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 Fiscal 2022 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, and 11) upload the electronic database to the NCI DCCPS Biomedical Computing Contractor. 4. 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 Fiscal Year 2022 POC Study. 5. The Contractor shall submit Electronic Data Files as follows: a. NCI Centralized Abstractor Training Report shall be due no later than 15 days after the Abstractor Training b. Quarterly Progress Reports shall be due quarterly. c. Electronic Data Files of Abstract submissions shall be due on or before the completion date of the contract. These two (2) electronic data files, for Breast Cancer and Colorectal Cancer, shall be due to the Biomedical Computing Support Services contractor no later than the completion date of the contract. d. Final Report shall be due on or before the completion date of the contract. Final Invention Statement or Invention Disclosure shall be submitted electronically, with the Final Report due on or before the completion date. e. Abstract Submission shall be submitted electronically, with the Final Report, on or before the completion date. 6. Quality Control (QC) A sample comprising 5% of randomly sampled POC cases shall 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. Anticipated Period of Performance (POP): The estimated POP is 12 months from the date of award (Award Estimated around November 2022.) Other Important Considerations: To be determined. Capability Statement/Information Sought: Small businesses who possess the experience and demonstrate the capability to accomplish the aforementioned requirements and level of effort are requested to submit a capabilities statement which shall be considered by the agency. The capabilities statement must supply pertinent information in sufficient detail to demonstrate their ability to perform the required services. Information Submission Instructions: Information furnished must not exceed 20 pages (12-point font minimum), including all attachments, resumes, charts; and should include an outline of previous or similar projects performed. All responses must include an indication of current certified small business status, and clearly marked on the first page of the capability statement, as well as the eligible small business concern's name, point of contact, address, and Unique Entity Identifier (UEI) number. (The UEI number replaced the DUNS number.) Responses must be received in the contracting office by 12PM Eastern Time, August 29, 2022. All responses and questions must be in writing and emailed to Angela Moore, Contracting Officer via electronic mail at Angela.Moore2@nih.gov. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference Notice ID# HHS-NIH-NCI-SBSS-PCPSB-0180-AM on all correspondence. 1. Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation. 2. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).