Biomedical Information Management and Analytic Support Services
THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE. I. Title: Biomedical Information Management and Analytic Support Services II. Background: The Div... THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE. I. Title: Biomedical Information Management and Analytic Support Services II. Background: The Division of Cancer Epidemiology and Genetics (DCEG), NCI conducts broad-based, high quality, high impact research to uncover the causes of cancer and the means of its prevention. DCEG maintains a national and international perspective, giving priority to emergent issues identified through epidemiologic, clinical, and laboratory observations, as well as to public health concerns identified by the NCI, Congress, regulatory agencies, and other appropriate bodies. The Division develops research resources and strategic partnerships in cancer epidemiology and genetics across NCI, NIH, and the global research community. III. Purpose and Objectives: The goal of this acquisition is to identify biomedical computing in support of, but not limited to, the ongoing epidemiology and genetic research programs, conducted in the Branches and Laboratories in DCEG which include domestic and international studies with diverse study designs in epidemiology and genetics research including prospective cohort studies, case-control studies, family studies, and randomized clinical trials. These studies span several geographic areas (potentially in any continent), are of varying size and complexity, and include dense, high-dimensional data on exposures, endpoints, clinical information, and biomarkers from molecular technologies. IV. Task Areas: Task Area A: Contract Initiation/Kick-Off The goal of this Task Area is to establish the necessary integrated infrastructure and procedures for effective communication for the period of the contract. Activities performed by the Contractor shall include, but are not limited to: 1. Establish a consistent method of invoicing and reporting that tracks labor hours to a study/project identifier and to the requestor and provides detailed reports of the work completed within the period of performance. The minimum level of information that shall be required is defined in the Additional Business Proposal Instructions. This method shall be flexible to accommodate for any changes to NIH, NCI, DCEG business needs that may occur in the future; including, but not limited to, changes to the process of submitting invoices using web-based systems. 2. Establish a method for data and knowledge transfer from incumbent contract, as required. 3. Establish a method to allow DCEG investigators and staff access to status reports and invoices for contract-related charges as real-time as technically feasible, as discussed with the COR. This method shall be flexible to accommodate for any changes to NIH, NCI, DCEG accounting systems or processes that may occur in the future. 4. Provide a summary of capabilities to the Contracting Officer’s Representative (COR), including a menu of services offered. Summary shall include the labor categories required and corresponding rates for each service for the purpose of informing all Division staff of the expertise and expected cost of the Contractor 5. Attend meetings and/or seminars to present capabilities, as required by the COR. Task Area B: Data Modeling, Acquisition and Management Under Task Area B the Contractor shall perform all activities necessary to provide biomedical data management support including manual and automated secure and standardized processes to enter, store and retrieve data and documents for DCEG research studies. This support is for DCEG studies which: a) vary by size and study design; b) include diverse data variables from diverse sources; and c) involve data exchange with multiple collaborators/repositories. Activities performed by the Contractor shall include, but are not limited to: 1. Transition all activities and services from the incumbent contractor. 2. Provide data modeling, acquisition and management services for studies with diverse variables, clinical and laboratory data, including environmental exposure (radiation, nutrition, microbial, hormonal, and others), occupational exposure/industrial hygiene parameters, demographics, medical history (i.e. clinical signs, imaging), and high-dimensional molecular data from biospecimens. It is expected that data will increase in size and complexity due to ongoing data collection efforts and additional data generated from molecular technologies (e.g. sequencing, tissue imaging). This shall correspond with scalable computational infrastructure, when possible, leveraging Cloud Computing made available by NIH programs such as STRIDES). 3. Provide services to store and manage data from diverse sources including data collection instruments such as questionnaire surveys, hospital/clinic medical record databases, pathology reports, laboratory results, death certificates, public records of environmental exposures, biospecimen inventory systems, or other databases including cancer registries and the National Death Index, which require standardized processes for data collection. Data storage services shall be configured, whenever possible, with interoperability with DCEG infrastructure to enable subsequent aggregation of data. 4. Provide support to collect and maintain field-data with appropriate work-flows and built-in mechanisms to help monitor the progress and accuracy of project-specific work. 5. As defined by the COR, store and annotate study data variables, including molecular data, to facilitate interpretation of such data in the context of biological information. This includes, but is not limited to, coding services for categorizing information based on demographic, reproductive, medical, radiation, occupational, or lifestyle factors as well as complex laboratory or genetic data. The Contractor shall provide instruction manuals to ensure consistent coding and to minimize errors in transcription and to enable automated entry where possible. 6. Implement effective and innovative data management techniques that are optimized to enable efficient data retrieval for downstream integrative analyses of data from studies with complex and evolving study-designs, complex variables, and high-dimensional data variables. This should include the ability for DCEG investigators and Contractor staff to directly access, retrieve and/or analyze multiple data sets for a study in a comprehensive way, using appropriate, best-in-class business intelligence (BI) tools. 7. Implement standardized processes for timely, accurate and efficient data exchange with DCEG investigators, collaborators, and third-party Contractors, as authorized by the NCI DCEG Principal Investigator and as directed by the COR. In some cases, collaborators include large cooperative groups or research consortia. The Contractor shall also facilitate routine exchange of data with data repositories. 8. Maintain data and associated documentation in an efficient way to foster transition of data from the Contractor’s infrastructure to an NCI DCEG Principal Investigator or third-party Contractor with minimal effort. Ensuring that data systems being used to employ fast read/write capabilities and possess storage/processing capabilities to enable efficient storage, retrieval and analysis of the data. 9. As agreed upon by the COR, implement robust, comprehensive, periodic, and coordinated quality control (QC)/quality assessment (QA) plans and an update/versioning strategy to accommodate the volume and diversity of data collected, ongoing updates, and to enable diverse types of data usage. 10. Provide reliable, scalable data storage and computing infrastructure with built-in redundancies, as well as automated, reliable and secure back-up and recovery procedures for all data, tools, and services the Contractor is hosting, analyzing and providing for DCEG. Support for cloud-based systems and services are expected, wherever possible; including programmatic interoperability mechanisms in line with the Findable Accessible Interoperable Reusable (FAIR) Guiding Principles of data management and stewardship. Data management tasks may include data that contains Personally Identifiable Information (PII) and thus should be handled in accordance with the Federal Information Security Management Act (FISMA) law and all DHHS, NIH and NCI standards, regulations, guidelines and policies. 11. Implement physical, network and user-level data security, as required, to ensure confidentiality/privacy requirements are met in accord with the Federal Information Security Management Act (FISMA) law and all DHHS, NIH and NCI standards, regulations, guidelines and policies. 12. Explore Government, commercial and/or open source solutions, including certified FedRAMP cloud-based services, that may be available and that could be adapted to meet the mission need prior to development of custom hardware and/or software solutions. 13. Comply with all DHHS, NIH and NCI policies, guidelines and regulations, in accordance with Section H of the contract. 14. Provide, as required, staff with appropriate expertise to address the requirements as defined in each Task Order and coordinate training and certification for all Contractor staff, as required. 15. Ensure quality assessment and quality control of the work performed, as required, fostering excellent internal/external communications, tracking projects, and monitoring the budget. 16. For planning purposes, the Contractor shall provide details of the work required to complete a requested task to the DCEG requestor, within timeframe discussed for each task order, as required. The documentation shall be provided in a summary and detailed format and must be clear, and easily available to the requestor. 17. Work cooperatively with the NCI and relevant NCI third-party Contractors, as defined by the COR, in all relevant aspects of project management and execution to maximize cost-effectiveness and efficiency. NCI will prioritize the order of tasks and activities. 18. Provide general program support in planning, managing and reporting for this contract. This includes, but not limited to, project and risk management for the task orders. Task Area C: Data Analytics, Statistical and Bioinformatic Analysis and Tool Development Under Task Area C the Contractor shall perform all activities necessary to provide statistical programming, analytic support and tool/software development for DCEG research studies. Activities performed by the Contractor shall include, but are not limited to: 1. Prepare analytic datasets for derived variables and associated documentation. 2. Provide knowledgeable and skilled staff for statistical programming and analysis support of data from studies similar to those described in the Background Section. 3. Provide support for preparation of routine and ad hoc reports that may draw on information from one or more systems managed by the Contractor or the NIH, as defined by the COR. 4. Provide support for manuscript preparation including independent verification of analysis performed by DCEG investigators, and production of tables, charts, figures and specialized graphics as requested. 5. Provide routine statistical programming and analysis of epidemiological data. 6. Provide statistical and bioinformatics analyses of data resulting from molecular technologies. 7. Develop new analytical approaches/models for data analysis and study design. Such development of new methods may require simulations to test theories underlying new algorithms and validate the proposed method, or to compare these with existing ones. 8. Maintain flexibility to accommodate analysis in a variety of packages, including but not limited to, newer molecular technologies and methods to perform analyses of the data from these technologies. 9. Maintain flexibility to be able to deliver data in many formats, as defined by the NCI COR. 10. Provide support, as required, in a manner that assigns expertise to the requested task and does not assign individuals to specific studies or the Branches. Underlying work documentation and resources shall be made available to increase efficiency in performing tasks and avoid duplication of effort. 11. Streamline communication and information sharing between the Contractor and NCI DCEG staff to harmonize similar analytic and programming efforts and remove duplication of work, to whatever extent possible. 12. Provide documentation of all software and tools to provide an understanding of how the product was developed and is to be used. 13. Provide all statistical programming and analytic coding to the NCI DCEG Principal Investigators (PIs) for future use. 14. Maintain and enhance software systems with version control, as well as web-sites and tools previously developed. Examples of such tools can be found at: https://dceg.cancer.gov/tools, git-based versioning services such as GitHub are generally recommended. 15. Develop all systems and websites in compliance with federal regulations and adhere to NCI templates wherever feasible. This includes, but is not limited to, Section 508 compliance, where applicable. 16. Comply with all DHHS, NIH and NCI policies, guidelines and regulations, in accordance with Section H of the contract. 17. Maintain interoperability and compatibility with any existing or planned IT systems. 18. If Government Property is provided by the contracting agency), the Contractor shall comply with all provisions incorporated into the contract related to government property. Ensure that no existing federal, HHS, or NIH system can be leveraged, reused and/or slightly modified where possible to meet the mission need [i.e. no Government Off-the-Shelf (GOTS) solution]. If no GOTS solution will meet the requirement, the Contractor shall explore the use of commercial and/or open source solutions, including cloud-based services, that may be available and that could be adapted to meet the mission need prior to development of custom hardware and/or software solutions. 19. Coordinate and integrate all Task Order activities including staffing decisions, prioritizing support for projects, and managing and monitoring any subcontracts. 20. Provide, as required, staff with appropriate expertise to address the requirements as defined in each Task Order and coordinate training and certification for all Contractor staff, as required. 21. Ensure quality assessment and quality control of the work performed, as required, fostering excellent internal/external communications, tracking projects, and monitoring the budget. 22. Provide an estimate of the time to complete the task and the accompanying documentation to the NCI COR, within the timeframe defined within the task order, as required. The documentation must be provided in a summary and detailed format and must be clear, and easily available to the requestor. Estimates of the budget to perform the task shall be provided by the Contractor at the discretion of the task requestor. 23. Work cooperatively with the NCI and relevant NCI third-party Contractors, as defined by the COR, in all relevant aspects of project management and execution to maximize cost-effectiveness and efficiency. NCI will prioritize the order of tasks and activities. V. Additional Information This potential acquisition will be competed through Full and Open Competition. The Government anticipates making multiple five-year, indefinite delivery indefinite quantity (IDIQ), task order contract awards. The Government anticipates that at least one task order will be awarded with each base contract. Any resultant task order awards may include option periods and option quantities per FAR clauses 52.-217-9 Option To Extend the Term of the Contract and 52.217-7 Option for Increased Quantity - Separately Priced Line Item. The RFP will be available electronically on or around February 18, 2020 and may be accessed through the Contract Opportunities at https://beta.sam.gov/. IT IS THE OFFERORS’ RESPONSIBILITY TO MONITOR THE AFOREMENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS. WE ENCOURAGE ALL RESPONSIBLE SOURCES, PARTICULARLY SMALL BUSINESSES, TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted.
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