Breast Cancer Survivors Cohort – Late Effects of Breast Cancer Treatments
1.0 DESCRIPTION The Division of Cancer Epidemiology and Genetics (DCEG), plans to procure services, on a sole source basis, from the Kaiser Foundation Research Institute, 1800 Harrison St, 16th floor, Oakland, CA 94612-3466. The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(1)(i); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541715 and the small business size standard is 1,000 employees. It has been determined there are no opportunities to acquire green products or services for this procurement. 2.0 BACKGROUND Although breast cancer survivors live longer, they have a substantially increased risk of developing second cancer and cardiovascular disease compared with the general population. Prior studies have found racial and ethnic differences in the risk of second cancer and mortality due to cancer and cardiovascular disease among breast cancer survivors. However, it remains unclear whether these racial and ethnic differences might be explained, in part, by factors such as patient characteristics (e.g., age at diagnosis, co-morbidities), tumor characteristics, or treatment-related factors. The Radiation Epidemiology Branch (REB) and the Integrative Tumor Epidemiology Branch (ITEB), National Cancer Institute (NCI), previously developed the Kaiser Permanente (KP) Breast Cancer Survivors Cohort study, a retrospective cohort of female breast cancer survivors (1-year survivors, diagnosed 1990-2019, followed-up tough 2020) from four KP study sites (Northwest, Colorado, Washington, and Georgia) to evaluate relationships between treatment and other risk factors with the development of second malignancies and cardiovascular disease. The current study population has a low proportion of Asian American or Pacific Islander women (<1,000 women). The state of Hawaii has a diverse population with Japanese and Caucasians accounting for an estimated 25% of the population, Native Hawaiians and other Pacific Islanders ~ 20%, Filipinos ~12%, and Chinese ~8%. The KP-Hawaii databases containing information on health plan members constitute ~18-20% of the state's population and are similar to the state in diversity. Thus, gaining access to the databases including KP-Hawaii breast cancer survivor patients provides a distinctive opportunity to investigate racial and ethnic disparities in the risk of second cancers, cardiovascular disease, and mortality among these cancer survivors. This proposed effort will support cohort expansion to the KP Hawaii patient database including Kaiser Hawaii electronic health records, and electronic prescription files and linkage of this patient cohort to data from the Hawaii SEER cancer registry cohort of breast cancer survivors. 2.1 OBJECTIVE This procurement provides for the Contractor to access the Kaiser Hawaii electronic data files (including tumor registry files, pharmacy files, files of procedures codes) to assemble a cohort of female breast cancer survivors enrolled in KP Hawaii health plan to add to the NCI KP Breast Cancer Survivors Cohort. 3.0 SCOPE The procurement aims are to develop a base cohort of breast cancer patients from the KP Hawaii databases to be added to the NCI KP Breast Cancer Survivors Cohort. The Contractor is required to gain access to the Kaiser Hawaii databases of female patients diagnosed between 1995-2021 with a first primary unilateral in situ or invasive breast cancer from the tumor registry or electronic health records, who were aged 18+ years at breast cancer diagnosis and remained enrolled in the KP Hawaii health plan at one year after diagnosis. The cohort database includes demographic and clinicopathological characteristics, initial and subsequent treatment information, and data on subsequent cancer diagnoses (including second, third and later primary cancers). Additional data will include vital status, date of last follow-up for vital status, date of death and cause of death, KP Hawaii enrollment start and end dates, breast cancer recurrence when available, mammography screening data, cardiovascular disease incidence and risk factors, hysterectomies/oophorectomies and other risk factor data. Cancer treatment information includes radiotherapy and detailed chemotherapy, biological response modifiers, immunotherapy, and hormonal and SSRIs prescription data from the electronic pharmacy database. Information obtained under the procurement will be used to evaluate racial and ethnic differences in the risk of second cancers and mortality due to cancer and cardiovascular disease, and the effects of breast cancer treatments including endocrine therapy, radiotherapy, and chemotherapy on these outcomes. 4.0 CONTRACT REQUIREMENTS AND PERSONNEL QUALIFICATIONS The contractor shall be required to have access to the KP Hawaii electronic data files, including tumor registry files, pharmacy files, files of procedures performed while enrolled in the KP Hawaii plan, and other medical and data files as described in this procurement, as needed to meet the requirements of this Statement of Work. TASKS Base Period 4.1 Secure Institutional Review Board (IRB) clearance for this project, obtain all necessary Health Insurance Portability and Accountability Act (HIPAA) clearances, and obtain a Data Use Agreement (DUA) between KP Hawaii and NCI. 4.2 Work with NCI investigators to develop the study collection tools and algorithms to successfully identify all data eligible for inclusion in this study. 4.3 Form the KP Hawaii cohort of female enrollees from the Hawaii tumor registry and electronic medical records. Eligibility requirements: Women diagnosed at ages ≥18 years with a first primary invasive breast cancer at KP Hawaii (as identified by the Hawaii tumor/SEER registry) with unilateral early stage (0-IV) breast cancer diagnosed during 1995-2021. Women were required to be enrolled in KP Hawaii at their diagnosis of initial in situ/invasive primary breast cancer, and to have survived and remained at risk without a second or later subsequent primary cancer for one year after initial breast cancer diagnosis. 4.4 Initiate linkage to the Hawaii SEER databases to identify all women diagnosed with a first primary unilateral breast cancer at ages 18+ years between 1995-2021, including establishing contract with SEER and completing necessary documents or approvals (e.g., IRB, DUA). 4.5 For each woman in the breast cancer cohort identified in Task 4, collect the following data: Data requirements: 4.5.1 Breast cancer data: Data on the incident breast cancer diagnosis will include: Date of diagnosis (mo, day, yr); ICD-O-3 breast cancer tumor site, morphology and behavior code; sex, laterality; behavior code; grade; AJCC stage; revision of AJCC stage; other stage data if available (summary stage, SEER historic staging, clinical and TNM pathologic staging), ER status; PR status; HER-2-neu status; oncotype DX breast cancer recurrence score (if available), tumor size; and lymph node status (number of regional nodes positive, number regional nodes examined). First and subsequent course of breast cancer treatment (yes, no, unknown) and dates of treatment for surgery and type of surgery (including surgery for contralateral breast and breast surgery codes), radiotherapy, chemotherapy, immunotherapy, and endocrine therapy will be obtained from KP Hawaii Tumor Registry, electronic medical records, prescription files, (Primary), and SEER Hawaii tumor registry files (Secondary). 4.5.2 Follow-up status: Vital status and date of last vital status (date of last contact), date of death, cause of death (ICD-9 or 10 code), from KP Hawaii or SEER Hawaii files. Start and end date of KP Hawaii enrollment. 4.5.3 Other variables: Date of birth, race and detailed race description, and ethnicity from KP Hawaii or SEER files with race and ethnicity supplemented from KP Hawaii electronic files. 4.5.4 Other cancer outcomes: Data on other cancer outcomes will include second, third and all subsequent cancers developing in the cohort are to be obtained from KP Hawaii or SEER Hawaii files: tumor sequence (order); date of diagnosis; ICD-O-3 primary cancer site; ICD-O-3 morphology; behavior code; grade; laterality (if applicable) method of diagnostic confirmation; tumor size, and stage (AJCC stage/other staging if available). For subsequent breast cancers: laterality, stage, and hormone receptor status (ER, PR, HER-2-neu status), and oncotype DX breast cancer recurrence score (if available). If available, recurrence of breast cancer, type of recurrence and date of first recurrence. 4.5.5 Oral and infused chemotherapy: Dates of all prescriptions for chemotherapy, including brand and generic name of drug, generic product identifier, days supplied, route of chemotherapy/immunotherapy/biologic response modifiers/ G-CSF drugs (granulocyte colony stimulating factors- filgrastim, pegfilgrastim), strength/dose of drug, and procedure code of drug. These data on prescriptions will include all prescriptions for chemotherapy after breast cancer diagnosis including chemotherapy for recurrent/metastatic breast cancer during the study period. List of specific drugs to be obtained will be provided by NCI investigators. 4.5.6 Endocrine therapy: Dates of all prescriptions of endocrine therapy dispensed to treat breast cancer (including tamoxifen, any aromatase inhibitors, selective estrogen receptor modulators), including formulation, product name, generic name, duration/number of days, quantity dispensed, strength/dose of drug, and pharmacy codes during the study period, including therapy given after a recurrence or for metastasis. List of specific drugs to be obtained will be provided by NCI investigators. 4.5.7 SSRIs: Dates of all prescriptions of SSRIs dispensed, including product name, generic name, duration/number of days and pharmacy codes during the study period. List of specific drugs will be provided by NCI investigators. 4.5.8 Other potential tamoxifen inhibitors: Dates of all prescriptions of other tamoxifen inhibitors dispensed, including product name, generic name, duration/number of days and pharmacy codes during the study period. List of specific drugs will be provided by NCI investigators. 4.5.9 Smoking history: Data on smoking will include tobacco use from electronic files. If available, date when tobacco use was measured will be included, both prior to initial diagnosis and after breast cancer diagnosis, and during the study follow-up period. List of diagnoses codes for smoking will be provided by NCI investigators. 4.5.10 Height and weight data: Data on height and weight will include date of measure from electronic files and if available, serial measurements including both the time periods before first breast cancer diagnosis and during follow-up. 4.5.11 Co-morbidity indices: Co-morbidity indices and date (e.g., Charlson comorbidity score), if available, from electronic files, both prior to initial diagnosis and after breast cancer diagnosis, and during the study period. 4.5.12 Cardiovascular disease: Cardiovascular disease incidence identified from 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), or relevant lab values or prescription files, 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. Clinical cardiovascular risk factors will be identified from the entire cohort of women with invasive breast cancer 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 or relevant lab values or prescription files). 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. Cardiovascular disease medications and laboratory measures will be identified from electronic or prescription files, including both the time periods before first breast cancer diagnosis and during follow-up (NCI to provide list of specific cardiac medications). 4.5.13 Mammography Screening: Date and type (screening or diagnostic) of all mammograms received, both prior to initial breast cancer diagnosis (up to 12 months before diagnosis) and during the study period. 4.5.14 Hysterectomy codes: Data on hysterectomies will include (information from different sources, when possible and data are available): a) Abstract hysterectomies/oophorectomies procedure and ICD codes with dates of all procedures performed, type of procedures and procedure codes for each patient from start of enrollment (or start of data availability) until end of study (NCI to provide list of specific hysterectomy/oophorectomy procedure codes); b) Abstract list of patients from the OUTREACH_EXCLUSION table, if available to contractor, used to exclude people from receiving cervical cancer screening reminders with the dates that the exclusion happened, and c) Explore any other source available to the contractor that could be used to abstract the required information. NCI will provide a list of procedures codes and program code used by other KP centers for this task). 4.5.15 Radiation procedures codes: When available in electronic files, abstract dates of all radiation procedures performed, type of procedure, and procedure codes for each patient from breast cancer diagnosis until the end of the study period. NCI to provide list of specific radiotherapy procedures codes program code used by other KP centers for this task. 4.5.16 Other variables as agreed to by KP Hawaii and NCI investigators. 4.6 Conduct quality control/quality assurance to confirm the completeness and accuracy of the data. This may include chart reviews and data quality checks by year, but any such review would be limited in size and scope and would include only a small percentage of all KP Hawaii breast cancer patients who are eligible to be included in the cohort. 4.7 Assemble study datasets that include data listed above, with all data identified only by unique study identification number. All data shall be delivered to Information Management Services (IMS) (Rockville, MD) using a secure, password-protected file transfer service. 4.8 Provide specific analytic coding schema, programs, and supporting information. 4.9 Contractor travel to NCI: Up to 3 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. Option Period One 4.10 Collect data on population-level socioeconomic and rurality attributes (either census-tract or county-level) using census and American Community Survey data, which will be obtained from KP Hawaii or SEER Hawaii files linked to residence at breast cancer diagnosis. List of specific attributes will be provided by NCI investigators. 4.11 Complete linkage the KP Hawaii cohort of female enrollees to the Hawaii Surveillance, Epidemiology, and End Results (SEER) registry. Combined SEER and KP Hawaii data could improve data completeness, account for missingness in KP Hawaii electronic health records data, provide cancer history for KP Hawaii members that may have been diagnosed prior to enrolling in KP Hawaii, and provide enhanced longitudinal follow-up on second cancer diagnoses, cancer treatment, and vital status for KP Hawaii members diagnosed with cancer and who may have disenrolled. 4.11.1 Develop code to conduct data linkage between SEER and KP Hawaii electronic health records data. Develop code to account for missing data in KP Hawaii electronic health records. 4.11.2 Complete quality control/quality assurance on subset of linked SEER and KP Hawaii records to ensure accuracy of data linkage, reconciliation of SEER and KP Hawaii data elements, and longitudinal follow-up. 4.12 Conduct quality control/quality assurance to confirm the completeness and accuracy of the data. This may include chart reviews and data quality checks by year, but any such review would be limited in size and scope and would include only a small percentage of all KP Hawaii breast cancer patients who are eligible to be included in the cohort. 4.13 Assemble study datasets that include data listed above, with all data identified only by unique study identification number. All data shall be delivered to Information Management Services (IMS) (Rockville, MD) using a secure, password-protected file transfer service. 4.14 Provide specific analytic coding schema, programs, and supporting information. 4.15 Contractor Travel to NCI: Up to 3 persons from the contractor (including the Principal Investigator) shall travel to other collaborators meeting in 2024 to discuss study progress and procedures, at a time and location to be mutually agreed upon. 5.0 TYPE OF ORDER This is a firm fixed-price purchase order. 6.0 NON-SEVERABLE SERVICES The services specified in each contract line item (CLIN) have been determined to be non-severable services - a specific undertaking or entire job with a defined end product of value to the Government. 7.0 PERIOD OF PERFORMANCE Base Period: September 15, 2023- September 14, 2024 Option Period 1: September 15, 2024- September 14, 2025 8.0 PLACE OF PERFORMANCE Name: Center for Integrated Health Care Research, Kaiser Permanente Hawaii Point of Contact: Stacey A. Honda, MD, PhD Address: 3288 Moanalua Road, Honolulu, HI 96819 Telephone Number: (808) 432-8801 Fax Number: (808) 432-8867 Email: Stacey.Honda@kp.org 9.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE The Contractor shall provide quarterly progress reports with a detailed description of the work done during the previous months and a final report that summarizes the results obtained from the contract. By (date TBD), the Contractor shall provide study datasets that include data listed in section 4.0 above, with data identified only by unique study identification number (ID). This will provide NCI with one month to inspect deliverables. All data shall be delivered to Information Management Services, NCI’s programming support group, via the Breast Cancer Survivors secure web site - https://portals.dceg.cancer.gov/kaiserbcsc/ and to NCI using the study secure, password-protected file transfer service listed above. All resultant reports shall be based on aggregate data that contain no personal identifiers. Technical Progress Reports: Quarterly Progress Reports shall describe the general progress of the work, as well as any problems encountered. The first quarterly report shall cover the first full tee months of the contract, in addition to any fractional part of the initial month. Thereafter, reports shall be submitted on a quarterly basis. Reports shall be due thirty (30) calendar days after the end of the reporting period. A fourth quarterly report will not be required for the period when an annual report or final report is due. All written deliverables shall be sent electronically to the NCI Technical Point of Contact (TPOC), TBD at award, in a Microsoft-compatible format, such as Microsoft Excel or text file unless approved by the TPOC in accordance with the deliverable schedule below. The TPOC shall review the contents of all draft deliverables. If no comments or requests for revisions are provided to the Contractor within 30 business days, the deliverables shall be considered acceptable. If revisions are required, NCI shall respond to the Contractor within five (5) business days of receiving the deliverable, specifying the required changes/revisions. Final copies of approved drafts shall be delivered to the NCI TPOC within five (5) business days after receipt of the Government’s comments. BASE PERIOD: Deliverables Due Date 1. Report on local IRB approval for KP Hawaii breast cancer survivors’ study and DUA (allowing access to NCI for data from Kaiser Hawaii breast cancer cohort as defined above). Within 1 month of execution of the contract 2. Report on identifying KP Hawaii breast cancer patient variables Within 3 months of execution of the contract 3. Report on initial efforts to be begin linkage to Hawaii SEER registry Within 7 months of execution of the contract 4. Summary of search of KP Hawaii and/or Hawaii SEER databases to identify all primary breast cancer patients who meet eligibility criteria and collect enumerated data on each case, when available, in the KP Hawaii electronic databases. Within 10 months of execution of contract. 5. Reports (to NCI/IMS) and completed/available assembled datasets of breast cancer cohort variables as defined in above tasks with patients identified by unique study identification number.. Within tee months after collecting the requested data and performing quality control/quality assurance. 6. Reports (to NCI/IMS) and datafiles containing completed/available analytic coding schema, programs, and supporting information. Within one month after assembling the study datasets. 7. Reports on results of quality control/quality assurance to confirm completeness and accuracy of the data. Consecutively with deliverable #5 and completed within 11 months of execution of contract. OPTION PERIOD: Deliverables Due Date 1. Report on search of KP Hawaii and/or Hawaii SEER databases of abstraction/linkage of data on population-level attributes and exposures. Within 3 months of execution of the option period. 2. Report and datafiles containing linkage to Hawaii SEER registry. Within 7 months of execution of the option period. 3. Report and study datasets by unique study identification number.. Within tee months after collecting the requested data and performing quality control/quality assurance. 4. Report and files detailing analytic coding schema, programs, and supporting information. Within one month after assembling the study datasets. 5. Reports on results of quality control/quality assurance to confirm completeness and accuracy of the data. Consecutively with deliverable #4 and completed within 11 months of executing option period. Reports are to be delivered to: (TBD) 10.0 INSPECTION AND ACCEPTANCE CRITERIA Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this contract is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI TPOC, TBD, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor. Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without 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. Products, platforms and services delivered as part of this work statement that are ICT, or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. § 1194.1 & Apps. A, C & D, and available at https://www.access-board.gov/guidelines-and- standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards- and- guidelines. Per Section 508 and as mandated under HHS Policy for Section 508 Compliance and Accessibility of Information and Communications Technology (ICT) (07/2020) all documents or electronic files provided to the NIH NCI under contract must be conformant with Section 508 standards and accessible to persons with disabilities. Conformance shall be confirmed by use of material provided at HHS OS Factsheets & Reference Guides and verified tough the use of the HHS Checklist Documents (WCAG 2.0 Refresh); in addition, contractors and vendors are encouraged to make use of the instructional materials and checklists at GSA Section 508.gov’s Create Accessible Digital Products. 11.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR The unique qualification of the contractor (Kaiser-Hawaii) to this procurement is that Kaiser-Hawaii has exclusive access to data from the cohort of breast cancer survivors that will provide a diverse population with Japanese and Caucasians accounting for an estimated 25% of the population, Native Hawaiians and other Pacific Islanders ~ 20%, Filipinos ~12%, and Chinese ~8%. No other vendor has access to this data. For these Kaiser Breast Cancer Survivor studies, the Contractor will be required to have access to all databases for the Kaiser Hawaii breast cancer cohort of patients. Because of restrictions on access to the Kaiser patient database containing personal identifiers, their IRB requires confidentiality and restricted access -therefore, only staff employed by the Kaiser Hawaii organization would be eligible to apply for this contract. Thus, KP-Hawaii provides a distinctive opportunity to investigate racial and ethnic disparities in the risk of second cancers, cardiovascular disease, and mortality among breast cancer survivors. The National Cancer Institute (NCI) previously developed the Kaiser Permanente (KP) Breast Cancer Survivors Cohort study, a retrospective cohort of female breast cancer survivors (1-year survivors, diagnosed 1990-2019, followed-up tough 2020) from four KP study sites (Northwest, Colorado, Washington, and Georgia) to evaluate relationships between treatment and other risk factors with the development of second malignancies and cardiovascular disease. 12.0 SUBMISSION INSTRUCTIONS This notice is not a request for competitive quotations. However, if any interested party believes it can meet the above requirements, it may submit a proposal or quote for the Government to consider. The response 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. All responses and questions must be sent via email to the Contract Specialist, Dana Summons, at dana.summons@nih.gov by no later than 3:00 PM EST on July 12, 2023, (7/12/2023). 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. In order to receive an award, Contractors must be registered and have valid certification tough SAM.gov. Reference: 75N91023Q00112 on all correspondence.
75N91023Q00112 Department of Health and Human Services National Institutes of Health
6/28/23, 4:07 PM