SOLICITATION NOTICE
R -- Cancer and Other Disease Risks in U.S. Radiologic Technologists: Virtual Pooled Cancer Registry Follow-up
- Notice Date
- 5/27/2016
- Notice Type
- Presolicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CP62592-76
- Archive Date
- 6/11/2016
- Point of Contact
- Catherine Muir, Phone: (240) 276-5434
- E-Mail Address
-
muirca@mail.nih.gov
(muirca@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E144, Bethesda, MD 20892, UNITED STATES Description: National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Radiation Epidemiology Branch (REB), plans to procure on a sole source basis support services to link the USRT cohort with the virtual pooled cancer registry database, from the University of Minnesota (UMN), Department of Environmental Health Sciences, School of Public Health, 420 Delaware Street S.E., 807 Mayo, Minneapolis, MN 55455 This acquisition will be processed in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1) and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541990 and the business size standard is $15.0M. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. The period of performance is estimated as follows: Base Period (non-severable discrete work segment): June 24, 2016 through June 23, 2017 Option I (non-severable discrete work segment): November 24, 2016 through May 23, 2018 Option II (non-severable discrete work segment): November 24, 2017 through May 23, 2018 It has been determined there are no opportunities to acquire green products or services for this procurement. The Division of Cancer Epidemiology and Genetics (DCEG) is a research program of the National Cancer Institute (NCI), one of the National Institutes of Health (NIH). The Division is the world's most comprehensive cancer epidemiology research group. Its renowned epidemiologists, geneticists, and biostatisticians conduct population and multidisciplinary research to discover the genetic and environmental determinants of cancer and new approaches to cancer prevention. The Division's research impacts public health policy in the United States and around the world. The research mission of the Radiation Epidemiology Branch (REB) is to identify, understand, and quantify the risk of cancer in populations exposed to medical, occupational, or environmental radiation, and to advance understanding of radiation carcinogenesis. The purpose of this acquisition is to procure support services for an ongoing radiation epidemiology cohort study of U.S. Radiologic Technologists (USRT). The objectives of this contract are to link the USRT cohort with the virtual pooled cancer registry database to: (a) identify new cancers in study participants that were not reported by questionnaire responders; (b) identify new cancers in subjects who did not complete one or more questionnaires; (c) assess the accuracy of self-reported cancers; (d) obtain detailed medical information on incident cancers regardless of source; and (e) evaluate the completeness of the virtual pooled cancer registry. Since 1982, the REB and the University of Minnesota (UMN) have conducted a cohort study of cancer incidence and mortality among 146,022, primarily female (73%), U.S. radiologic technologists (USRT) to quantify radiogenic risks from protracted low dose exposures and to determine the applicability of current radiation risk estimates. Other studies of medical radiation workers have examined substantially smaller, mostly male, populations of radiologists and radiologic technologists. A fourth survey of the cohort was conducted during 2012-2013 to obtain updated information on cancer incidence, cancer and other disease risk factors, work history, and personal medical radiation exposures. About 58,000 of 94,000 (62%) known living cohort members completed the fourth survey. The National Association of American Central Cancer Registries (NAACCR), with funding support from the Division of Cancer Control and Population Studies, NCI, is currently constructing a virtual pooled cancer registry for use in conducting national cancer surveillance and cancer incidence follow-up in epidemiologic cohort studies. The USRT study and another ongoing cohort study have been selected to participate in a test of the completeness and utility of the pooled virtual cancer registry for such studies. A major benefit of participating in this test will be the opportunity to identify new cancers in USRT study participants. NAACCR will initially provide a summary of the total number of cancers identified by state. After obtaining necessary state IRB approvals, NAACCR will provide a file containing individual-specific information on incident cancers (i.e. date of diagnosis, ICDO code, cell type, stage, grade, receptor status, genetic markers, other) and demographic characteristics (i.e. year of birth, gender, race, state of residence). To assess the completeness of cancer ascertainment in USRT cohort members, observed total cancer and cancer-specific incidence in study participants will be compared with expected incidence based on general U.S. population rates. Additionally, self-reported cancers will be compared with registry-derived cancers overall, by time period, and by geographic area. Accuracy of self-reported diagnoses will also be evaluated. Contractor shall perform the following: Base Period (non-severable discrete work segment): • Assist NCI in contacting NAACCR representatives to obtain information about needed approvals, transfer agreements, submission file formats, and other requirements. • Assist NCI in obtaining IRB approvals to conduct the initial linkage with NAACCR to obtain total cancer information by state. • Develop data transfer agreement packages and assist NCI in obtaining data transfer approvals. • Develop file formats and documentation, prepare and submit to NAACCR a file of USRT study participants for linkage with the pooled virtual cancer registry. • Assist in reviewing returned summaries from NAACCR on numbers of cancers identified by state, and determining from which states to pursue IRB approvals. • Submit interim progress reports as tasks are completed and a final summary of findings that includes a recommended list of states from which detailed cancer information for individual cohort members should be pursued upon completion of all Base Period tasks. Option I (non-severable discrete work segment): • Assist NCI/NAACCR in obtaining IRB approvals from individual states to conduct the second linkage with NAACCR to obtain individual-specific cancer information by state. • Pending receipt of IRB and other required clearances, prepare and submit a second cohort file to NAACCR to obtain individual-specific cancer information from selected states. • Receive NCI-recoded cancer validation database, and prepare a new cancer validation database "Master USRT cancer validation database" that will incorporate original and recoded cancer outcome information from self-report and medical record review, cancer information from the individual registries, and new cancer outcome variables that will be developed based on the most valid information available from each of the sources. • From the return file provided by NAACCR, evaluate results to ensure correct matches for individual cohort members. • Enter NAACCR-reported breast, thyroid, brain, and hematopoietic cancers into the Master USRT cancer validation database, compare against existing reports to identify new and previously-reported cancers, identify cancers that were previously reported but misclassified, rule out duplicates, identify cancers that were previously reported and/or medically validated but not identified from the virtual cancer registry, and, after determining decision criteria with NCI investigators, create new cancer outcome variables for the entire cohort of questionnaire responders and non-responders based on the best available information from self-report, medical record review, and cancer registries. • Submit preliminary cancer incidence files to NCI for review. • Submit a final cancer incidence file with detailed documentation. • Submit interim progress reports as tasks are completed and a final Option I progress report upon completion of all tasks. Option II (non-severable discrete work segment): • Assist NCI in evaluating the accuracy of cancers that were self-reported by individual technologists. • Assist NCI in evaluating the completeness of the virtual cancer registry by determining which of the self-reported and/or medically validated cancers were not identified through the virtual registry linkage. • Work with NCI to prepare a publication-quality summary of the completeness and accuracy of self-reported cancer information before and after medical record review, and the completeness of the virtual cancer registry. • Submit a final progress report for Option II upon completion of all tasks. CONTRACTOR QUALIFICATIONS: • The Contractor shall have access to the U.S. Radiologic Technologists Study cohort database, including personal identifiers and historical cancer incidence data. • The Contractor shall have access to the certification records of the American Registry of Radiologic Technologists, including updated certification and address information. • The Contractor shall have experience in developing and maintaining large databases for cohort follow-up studies, tracing large numbers of individuals, performing record linkage with large databases, confirming matches, evaluating cancers identified from multiple sources and ruling out duplicates, capturing and editing data, and developing and documenting data sets for analysis. REPORTING REQUIREMENTS AND DELIVERABLES: Unless otherwise noted, the Contractor shall submit the following deliverables to the Contracting Officer Representative (COR): The contractor shall submit one-page progress reports for each task and a detailed final progress report for each option period upon completion of all tasks. The final reports shall include all task reports and a summary of final results for the phase. The due dates are subject to change and will be adjusted in consultation with the COR. DELIVERABLES: Base Period (non-severable discrete work segment): Task 1 - Establish contact with NAACCR and obtain information. Due within 1 month after contract award. Task 2 - Assist in obtaining IRB approvals for the initial linkage with NAACCR. Due within 2 months after contract award. Task 3 - Data transfer agreements. Due within 3 months after contract award. Task 4 - File submitted to NAACCR for linkage. Due within 4 months after contract award. Task 5 - Assist in reviewing cancer summaries by state and determining which states to pursue. Due within 10 months after contract award. Task 6 - Final summar and recommendations. Due upon completion of Base Period tasks. Option I (non-severable discrete work segment): Task 7 - Assist in obtaining state IRB approvals for the secondary linkage with NAACCR. Due within 3 months after Option I award. Task 8 - File submitted to NAACCR for linkage Within 5 months after Option I award Task 9 - Prepare Master USRT cancer validation database. Due within 7 months after Option I award. Task 10 - Evaluate NAACCR matches for correctness. Due within 8 months after Option 1 award. Task 11 - Review NAACCR-identified cancers and input into cancer validation database, incorporate detailed medical data, and summarize findings. Due within 14 months after Option award. Task 12 - Submit preliminary final data analysis files to NCI. Due pon request by the COR. Task 13 - Submit final cancer incidence file with detailed documentation. Due within 20 months after Option I award. Task 14 - Submit final progress report. Due upon completion of Option I tasks. Option II (non-severable discrete work segment): Task 15 - Assist in evaluating the completeness and accuracy of self-reported cancer information before and after medical record review. Due within 2 months after Option II award. Task 16 - Assist in evaluating the completeness of the virtual cancer registry. Due within 4 months after Option II award. Task 17 - Work with NCI to prepare publication-quality summary of the completeness and accuracy of self-reported cancers and the completed of the pooled registry. Due within 7 months after Option II award. Task 18 - Final progress report for Option II. Due upon completion of Option II tasks GOVERNMENT RESPONSIBILITIES: • The Contracting Officer's Representative (COR), with input from the study Principle Investigator, will be responsible for reviewing and approving all deliverables. • The DCCPS, NCI will be responsible for any costs associated with the NAACCR virtual pooled cancer registry linkage. CLEARANCES: • Clearances required before performing tasks under Base Period: NCI Special Studies IRB; University of Minnesota IRB • Clearances required before performing tasks under Option I: North American Association of Central Cancer Registries IRB(s) • Clearances required before performing tasks under Option II: None INSPECTION AND ACCEPTANCE CRITERIA: Deliverables described above willl be reviewed by the COR within 30 days of receipt. The work will be evaluated based on satisfactory performance of the tasks required in the Statement of Work. Acceptance will be based on tasks performed (as described in task reports) and suitability of related charges. The Contractor shall be notified as to the acceptability of the deliverables. PAYMENT: Payment shall be made upon receipt and acceptance of each deliverable. Payment authorization requires submission and approval of a progress report and an invoice per the attached Invoice & Payment Provision. This support services are provided by the University of Minnesota. The University of Minnesota has been under contract to the NCI since 1982 (NO1-CP-21015, N01-CP-15673, N01-CP-51016, HHSN261200900583P, N01-CP-31018, HHSN261201000139C) to conduct USRT cohort follow-up, including administering four questionnaire surveys to collect information on work history, cancer and other disease risk factors, and medical outcomes for assessing radiation-related and other risks.. Because of their direct involvement in the conduct of all aspects of the USRT study for more than 30 years, staff from the University of Minnesota (UMN) have access to and intimate knowledge of all information contained within the comprehensive USRT study database. The UMN maintains personal identifying information and protected health information for all USRT study participants and is charged by the UMN and NCI Institutional Review Boards that review and approve this study to maintain the privacy and confidentiality of these data. The UMN has an established relationship with the American Registry of Radiologic Technologists (ARRT), which certifies individuals in radiography, radiotherapy, nuclear medicine and other medical radiation specialties. The USRT cohort was initially identified and has been subsequently followed through certification and annual recertification records from the ARRT. ARRT has granted UMN sole access to their historical certification and annual recertification records. As the only organization with access to both the USRT and ARRT databases, UMN is uniquely qualified to perform the tasks described in the Statement of Work for this procurement. Because of the continuing nature of this cohort, maintaining the integrity and quality of this on-going study depends on the unique performance qualifications of the current Contractor. A change in Contractors would be disruptive to the ability of the REB to analyze the study's cumulative results. 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 the NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 3:00PM EDT, on June 10, 2016. All responses and questions must be in writing and faxed (240) 276-5401 or emailed to Catherine Muir, Contracting Officer via electronic mail at muirca@mail.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, current Entity Record, including current Representations and Certifications, in the System for Award Management (SA
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