Breast Cancer Survivors Cohort – Late Effects of Breast Cancer Treatments
General Information Short Title: Breast Cancer Survivors Cohort – Late Effects of Breast Cancer Treatments Document Type: Notice of Intent Solicitation Number: 75N91020R00008 Posted Date: 2/21/2020 Re... General Information Short Title: Breast Cancer Survivors Cohort – Late Effects of Breast Cancer Treatments Document Type: Notice of Intent Solicitation Number: 75N91020R00008 Posted Date: 2/21/2020 Response Date: 2/28/2020 Classification Code: B599 – Special Studies/ Analysis - Other NAICS Code: 541690 – Other Scientific and Technical Consulting Services Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E232 Bethesda, MD 20892, UNITED STATES Background The Breast Cancer Survivors’ Cohort Study is a large-scale retrospective cohort study of breast cancer survivors with the National Cancer Institute (NCI) to address questions about the late-effects of modern breast cancer treatments using with detailed treatment information. To address these issues, NCI previously contracted to obtain additional data to expand a cohort at Kaiser Permanente Washington (KP-WA) of women diagnosed with stage I-II breast cancer between 1990-2008. The cohort expansion included extending stages to include 0 and III and expanded the years of diagnosis and follow-up from 1990-2016 (followed through 2017). The expansion involves using electronic medical records and radiotherapy records to study the late effects of radiotherapy, chemotherapy and hormonal treatment on risk of second cancers, cardiovascular disease and other late effects, while accounting for confounding by lifestyle factors such as obesity, hormonal (estrogen) use, and smoking use. The study goals include ascertaining detailed radiotherapy records from which NCI will employ state-of-the-art dose reconstruction to evaluate the relationship between radiation dose to various organs and outcomes such as second cancer risks and cardiovascular outcomes. The aim of the current procurement by the Radiation Epidemiology Branch (REB), Division of Cancer Epidemiology (DCEG), NCI, is to expand the scope of Kaiser Permanente Washington KP-WA breast cancer survivors’ study to abstract physical radiotherapy reports for an estimated 2020 women treated with radiation from 1990 to 2016, and obtain electronic medical data on cardiovascular disease prevalence and cardiovascular risk factors prior to breast cancer diagnosis and cardiovascular disease incidence and risk factors during follow-up for the entire cohort. In addition, the procurement will obtain needed data on smoking-related conditions, and height/weight data from KP-WA electronic medical files. Objective The information obtained under the procurement will be used to evaluate the effects of breast cancer treatments including hormonal therapies, radiotherapy and chemotherapy on outcomes which include contralateral breast cancer (CBC), other second cancers, cardiovascular disease and death. The objectives of the procurement are: a) To retrieve radiation summaries and treatment plans for an estimated 2020 women in the KP-WA cohort (treated with radiotherapy, diagnosis years 1990-2016, stage I, II and III, for whom radiation summaries have not previously been obtained (list provided by NCI). b) To retrieve from KP-WA electronic files data on cardiovascular outcomes and risk factors, smoking-related conditions and height/weight data. Scope Specifically, the procurement aims are: Radiotherapy study: The procurement will require KP-WA to retrieve and scan radiotherapy summaries from the medical charts for up to 2020 KP-WA breast cancer patients treated with radiotherapy who were diagnosed with stage I, II or III breast cancer diagnosed during 1990-2016, for whom radiation summaries have not previously been obtained (list to be provided by NCI). Cardiovascular study: The procurement will require KP-WA to ascertain prevalence and incidence of cardiovascular disease (CVD), and other cardiac outcomes, and cardiac risk factors, as defined by NCI, for the entire cohort of women with invasive breast cancer (stages I, II, III) who were diagnosed 1990-2016 with follow-up through 2017. Smoking-related data and height/weight data: The procurement will require KP-WA to ascertain smoking-related data, as defined by NCI, and height/weight data from electronic medical files for the entire cohort of women with invasive breast cancer (stages I, II, III) who were diagnosed 1990-2016 with follow-up through 2017. Contract Requirements / Personnel Qualifications The contractor shall be required to have access to the KP-WA files, and KP-WA electronic data files, including tumor registry files, prescription drug files, files of procedures performed while enrolled in the KP-WA plan, radiation summaries, and other medical and data files as described in this procurement, as needed to meet the requirements of this Statement of Work. A specific outline of all the data to be included in this procurement is listed in detail below. For the base period, the Contractor shall perform the following tasks: Time Frame: 3/1/2020-2/28/2021: Task 1: Radiotherapy summaries for invasive breast cancer cohort diagnosis 1990-2016, followed through 2017: The Contractor shall retrieve radiotherapy summaries for up to 1500 women treated with radiotherapy, among the cohort of invasive first primary breast cancer survivors with stage I, II, or III cancers diagnosed 1990-2016 and followed through 2017, for whom radiation summaries have not been previously been obtained. NCI will provide a list of breast cancer survivors treated with radiotherapy whose radiation summaries are needed under this contract. The summaries typically include radiation details such as treatment fields used, the radiation dose/ number of fractions/ machine type for each field, wedge description, radiation boost, etc. from the medical charts. Deliverables: The Contractor shall send scanned copies of the reports to NCI with stamped ID and hospital number. A radiotherapy summary tracking log (i.e. an Excel spreadsheet including IDs, breast cancer diagnosis date, hospital number) shall be prepared by the contractor to be included with each deliverable of scanned radiotherapy summary reports. The Excel file will include patients for whom summaries were not available shall be included with study IDs, breast cancer diagnosis date and reason for unavailable radiotherapy report. These deliverables shall be made on a routine basis (at least quarterly or at the direction of the Principal Investigator). Task 2: Data Queries from NCI Regarding Conflicting, Inconsistent, Or Missing Information. The Contractor shall respond to data queries from NCI regarding conflicting, inconsistent, or missing information on the radiation summaries obtained and any new data queries that may arise on the radiation summaries obtained for the breast cancer cohort referred to above of diagnoses 1990-2016. The total estimated number of data queries is 300-400. Approximately 100-200 queries will be answered for the base period. Some data queries may require medical record review to respond to NCI questions. The Contractor shall obtain additional information, when available, to supplement the radiation summaries on the most common treatment fields and prescriptions that are typical for early versus advanced stage breast cancer, use of different wedge angles, physical wedges or dynamic wedges, use of IMRT or partial breast irradiation, and type of linear accelerator (i.e., Varian 600, Varian 2100, Elekta, Varian 21EX), including years of use. Deliverables: The contractor will respond to data queries in a timely manner when requested by the Principal Investigator. All queries must be answered by the end of the Base Period. For the option period one, the Contractor shall perform the following tasks: Time Frame March 1, 2021-Feb. 28, 2022 Task 1: Completion of radiotherapy summaries for invasive breast cancer cohort diagnosis 1990-2016, followed through 2017: The Contractor shall finish retrieving radiotherapy summaries for up to 520 women treated with radiotherapy (to reach 2020 across option years 1 and 2), among the cohort of invasive first primary breast cancer survivors with stage I, II, or III cancers diagnosed 1990-2016 and followed through 2017, for whom radiation summaries have not been previously been obtained. NCI will provide a list of breast cancer survivors treated with radiotherapy, whose radiation summaries are needed under this contract. The summaries typically include radiation details such as treatment fields used, the radiation dose/ number of fractions/ machine type for each field, wedge description, radiation boost, etc. from the medical charts. The Contractor shall send scanned copies of the reports to NCI with stamped ID and hospital number. A radiotherapy summary tracking log (i.e. an Excel spreadsheet including IDs, breast cancer diagnosis date, hospital number) shall be prepared by the contractor to be included with each deliverable of scanned radiotherapy summary reports. The Excel file will include patients for whom summaries were not available shall be included with study IDs, breast cancer diagnosis date and reason for unavailable radiotherapy report. Deliverable: The Contractor shall send scanned copies of the reports to NCI with stamped ID and hospital number. A radiotherapy summary tracking log (i.e. an Excel spreadsheet including IDs, breast cancer diagnosis date, hospital number) shall be prepared by the contractor to be included with each deliverable of scanned radiotherapy summary reports. The Excel file will include patients for whom summaries were not available shall be included with study IDs, breast cancer diagnosis date and reason for unavailable radiotherapy report. These deliverables shall be made on a routine basis (at least quarterly or at the direction of the Principal Investigator). Task 2: Data Queries from NCI Regarding Conflicting, Inconsistent, Or Missing Information The Contractor shall complete their responses to data queries from NCI regarding conflicting, inconsistent, or missing information on the radiation summaries obtained and any new data queries that may arise on the radiation summaries obtained for the breast cancer cohort referred to above of diagnoses 1990-2016. The estimated number of remaining data queries in option period one will be approximately 200-300. Some data queries may require medical record review to respond to NCI questions. The Contractor shall obtain additional information, when available, to supplement the radiation summaries on the most common treatment fields and prescriptions that are typical for early versus advanced stage breast cancer, use of different wedge angles, physical wedges or dynamic wedges, use of IMRT or partial breast irradiation, and type of linear accelerator (i.e., Varian 600, Varian 2100, Elekta, Varian 21EX), including years of use. Deliverables: The contractor will respond to data queries in a timely manner when requested by the Principal Investigator. All queries must be answered by the end of the Option Period. Task 3: Ascertainment of cardiovascular disease events and clinical cardiovascular risk factors from electronic medical records: Prevalence and incidence of cardiovascular disease (CVD), and other cardiac outcomes: For the entire cohort of women with invasive breast cancer (stages I, II, III) who were diagnosed 1990-2016 with follow-up through 2017, the Contractor shall identify from their electronic files, using inpatient and outpatient procedure and diagnosis codes, occurrences of selected cardiac outcomes (NCI to provide list of cardiac and other related outcomes of interest and corresponding ICD-10 codes), from the any time prior to the initial first primary invasive breast cancer to the end of follow-up. An Excel spreadsheet including IDs, cardiac outcome(s), cardiac risk factors, diagnosis codes, date(s) of event, shall be prepared by the Contractor and provided to NCI. Deliverables: An Excel spreadsheet including IDs, cardiac outcome(s), cardiac risk factors, diagnosis codes, date(s) of event, shall be prepared by the Contractor and provided to NCI as when the task is completed but at least one month prior to the end of the Option Period. Clinical cardiovascular risk factors: For the entire cohort of women with invasive breast cancer (stages I, II, III) who were diagnosed 1990-2016 with follow-up through 2017, the Contractor shall capture data on clinical cardiovascular risk factors (including diabetes, hypertension, dyslipidemia, and other related risk factors) from electronic files, from the years prior to the breast cancer diagnosis to the end of follow-up. (NCI to provide list of cardiac and other related outcomes of interest and corresponding ICD-10 codes and other required codes). Deliverables: An Excel spreadsheet including IDs, cardiac risk factors, diagnosis codes, date(s) of ascertainment of risk factors, shall be prepared by the Contractor and provided to NCI when the task is completed but at least one month prior to the end of the Option Period. Task 4: Retrieval of Smoking related data and height/weight data from electronic medical records: Smoking history from electronic medical records: Include available data on tobacco use, tobacco related conditions, and smoking cessation consultations from electronic files on cohort of women with invasive breast cancer (stages I, II, III) who were diagnosed 1990-2016 with follow-up through 2017. The contractor will include tobacco use/tobacco related conditions/ other smoking related citations for all instances in the electronic files, both prior to initial diagnosis and after breast cancer diagnosis, and during the study period. An Excel spreadsheet including IDs, tobacco related condition/consultation, diagnosis codes, date(s) of ascertainment shall be prepared by the Contractor and provided to NCI. NCI will provide list of and corresponding codes for tobacco related conditions/ consultations which will include counseling on smoking cessation, nicotine dependence treatment/consultation, potential nicotine induced disorders, conditions related to tobacco use, such as COPD, chronic bronchitis, emphysema, and other related conditions. Deliverables: An excel spreadsheet including IDs, conditions related to tobacco use, diagnosis codes, and date(s) of ascertainment, shall be prepared by the Contractor and provided to NCI when the task is completed but at least one month prior to the end of the Option Period. Height and weight data from electronic medical records: Include date of measure of height/weight, from electronic databases for cohort of women with invasive breast cancer (stages I, II, III) who were diagnosed 1990-2016 with follow-up through 2017. This task will include serial measurements on height/weight including both the time periods before first invasive breast cancer diagnosis and during follow-up. An excel spreadsheet including IDs, height and weight data, and date(s) of ascertainment, shall be prepared by the Contractor and provided to NCI. Deliverables: An excel spreadsheet including IDs, height and weight data, and date(s) of ascertainment, shall be prepared by the Contractor and provided to NCI when the task is completed but at least one month prior to the end of the Option Period. Contractor Travel to NCI: Up to 2 persons from the contractor (including the Principal Investigator) shall travel to NCI (Shady Grove Offices) to discuss study progress and procedures, at a time to be mutually agreed upon. Period of Performance The period of performance for this contract includes a base plus one option year. Base Period: March 16, 2020 to March 15, 2021 Option Period 1: March 16, 2021 to March 15, 2022 This acquisition will be processed under FAR Part 12 – Acquisition for Commercial items and will be made pursuant to the authority in FAR 13.106-1(b)(1) using simplified acquisition procedures for commercial items. The North American Industry Classification System code is 541690 and the business size standard is 1,000 employees. Only one award will be made as a result of this solicitation. This will be awarded as a Severable firm fixed price type contract with one option periods. It has been determined there are no opportunities to acquire green products or services for this procurement. The unique qualification of the contractor (KP-WA) for this procurement is access to data from the existing cohort of breast cancers survivors, a population-based cohort from Kaiser Permanente, Seattle, WA, which has been linked with the Seattle SEER registry to identify second cancer incidence and mortality. With the expansion of this existing cohort to include ascertainment of radiotherapy summaries, cardiovascular disease outcomes and risk factors, and data on possible epidemiologic confounds (smoking history, height/weight), the KP-WA patients will provide NCI with increased potential to provide important insights into risk factors for second cancers and cardiovascular disease outcomes in the general community health setting in DCEG’s already established breast cancer survivors cohort and to provide new information on cardiovascular diseases mortality. This contractor, Kaiser Washington, is the only institute to have access to the existing Washington State cohort of breast cancer survivors from which NCI needs additional data. Because of confidentiality issues, only the staff at Kaiser Washington Group Health have access to their electronic databases including names, social security numbers, addresses, etc. These staff will access their databases to extend the cohort and will search their paper files for the radiation summaries for these patients in the breast cancer cohort. The data files will then be stripped of all identifiers, given a unique ID for NCI and then sent to NCI under a signed Data Transfer Agreement. The pdfs of the radiation summaries are also de-identified and sent to NCI to use in radiation dosimetry. So only the staff at the Kaiser Washington located in Seattle, has access to these data and can perform the tasks in the Statement of Work. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 12:00 PM EST, on February 28, 2020. All responses and questions must be emailed to David Romley, Contract Specialist via electronic mail at david.romley@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, contractors must be registered and have valid certification in the System for Award Management (SAM) through sam.gov. Reference: 75N91020R00008 on all correspondence.
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