Type of Notice: This is a Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. Background: The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) focuses on research to discover genetic and environmental determinants of cancer and identifying new approaches to cancer prevention. Purpose and Objectives: DCEG plans to build a prospective multi-center adult cohort study of 150,000-200,000 adult participants enrolled through U.S. integrated health care systems to study the causes of cancer and the means of its prevention. The core objectives of the cohort are for participants to complete an online consent followed by an online questionnaire, and provide blood and urine donation as well as possibly discard samples (e.g. discard Fecal Immunochemical Test (FIT) cards). The cohort will additionally have all of the desirable attributes of a contemporary study as part of its core research objectives including serial biospecimens, tumor tissue, comprehensive data from Electronic Medical Records (EMR) on elements such as drug prescription, medical conditions and procedures, and repeated questionnaires combined with reliable passive and long-term follow-up strategies for cancer ascertainment. In addition to providing a rich source of information for a wide variety of hypotheses about the etiology of cancer, the cohort infrastructure will also be designed to allow investigation of non-cancer outcomes (e.g. cardiovascular events, diabetes). It would also allow for enhancements to be added at any phase to allow more detailed assessment of certain exposures (e.g. environmental exposures, lifestyle factors), collection of additional specimens (e.g. oral wash, stool), and to facilitate patient-centered and health delivery research to improve patient care through evidence-based decisions. Project Requirements: Three separate acquisitions are anticipated to create the proposed successful large-scale cohort, including a support service contractor for field activities (see Sources Sought Notice HHS-NIH-NCI-SS-ETSB-1007-58); software solutions for IT systems infrastructure (See Sources Sought Notice HHS-NIH-NCI-ETSB-1008-58); and integrated health care system(s) to serve as recruitment sites. As part of market research, a Pre-Solicitation Conference for this project was held on June 2, 2016 (See Special Notice HHS-NIH-NCI-SN-Pre-SolicitationConference-ETSB-0000-58). This notice pertains to the integrated health care systems to serve as recruitment sites. Potential awards to recruitment sites will be to integrated health care systems to recruit and retain participants, collect and process biospecimens, link to electronic medical records, and serve on the governance committee. The recruitment sites will identify eligible health plan members. All eligible health plan members will be invited to participate in the cohort electronically. The following are the key tasks for the recruitment sites to meet the core objectives: The project will require integrated health care systems to recruit, enroll, follow-up and retain study participants identified in their own integrated health care system. Specific tasks to be performed by the Contractor include the following: Work cooperatively with the NCI, third party contractors (e.g. contractors for support service and software solution for IT systems infrastructure) and other field centers in all relevant aspects of study development and execution to produce the best science and maximize cost-effectiveness and efficiency of the study. 1. Collaborate with NCI and NCI support service contractor to develop and/or modify study protocols and materials customized to meet site-specific requirements. 2. Work cooperatively with all study investigators and staff, the NCI, and any consultants in all relevant aspects of the study. Perform administrative, operational, and technical duties to support productive collaboration among the study personnel at all sites, NCI, and the NCI support service contractor. 3. Participate collaboratively in study committees to provide a transparent committee process, open access to study documents, clear policies for access to data and materials, and an approval process for proposed studies, manuscripts, and ancillary studies that is fair and balanced. 4. Host one site visit per year at each field site. Prepare for participant recruitment and follow-up. 1. Obtain IRB approval. 2. Generate or modify algorithms as appropriate to identify eligible participants and pull selected demographic data used to determine eligibility (e.g. age, race, gender) from the electronic medical records as specified by NCI. 3. In collaboration with the NCI support service contractor, coordinate training and certification for study staff as required. 4. Implement appropriate quality assurance and quality control programs. 5. Work collaboratively with NCI, the NCI support service and software solutions contractor to facilitate integration of databases/systems with the IT systems infrastructure for coordination and management of field activities. Implement study protocol. Perform a run-in phase to recruitment and specimen collection to identify and resolve any barriers to successful implementation of the full study. Upon successful implementation of the protocol during the run-in phase, conduct full-scale recruitment and follow-up of participants. Develop and/or modify and validate algorithms to abstract exposure and disease outcomes data from electronic medical records. Collect specimens (e.g. blood, urine, and other specimens) within existing clinical infrastructure. 1. Collect biological specimens from participants according to standardized operating protocols (SOPs). 2. Process biological specimens according to standardized operating protocols (SOPs). 3. Develop and/or modify and validate algorithms to abstract selected data from EMR. Deliver abstracted data in a format specified by NCI to the cohort data repository. Perform regular routine updates of data to data stored in a central data repository as well as creating/modifying algorithms for new data abstraction to be included in the central data repository. Engage participants. Serve as the point of contact for interested individuals and enrolled participants. 1. While consent will be obtained electronically and questionnaires will be administered online by third party servicer, the recruitment site will serve as the point of contact for individuals and participants who would like additional information or have questions. 2. Host a toll-free study telephone line to answer questions from individuals and participants for all stages of the study (e.g. general study information, pre-enrolling questions, questionnaire issues, blood donation issues and engage with study participants throughout the follow-up phases. Anticipated Period of Performance: The anticipated period of performance for this requirement is a five-year base period, with five one-year option periods. Capability Statement/Information Sought: We encourage all responsible sources, particularly small businesses, to submit a capability statement which will be considered by the agency. Organizations that submit capability statements in response to this notice shall clearly document and demonstrate the capability to accomplish the following: 1. That the health care system has coordinated and integrated care provision, which ensures that all health care services received by members are captured through electronic medical records. If any services are not covered/captured through electronic medical records, details of these should be documented. 2. Provide an estimate on the number of potentially eligible study participants (members who have been cancer free for at least 1 year) by age (30-39,40-49,50-59,60-69,70+), race (American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander, White), and gender (Male, Female). 3. Ability to recruit study participants among eligible health plan members by email. If not, document ability to recruit study participants through alternative invitation method(s). 4. Ability to, or future ability to, build a system within existing infrastructure to perform automated data abstraction from Electronic Medical Records (EMR). 5. Ability and willingness to build a system within existing infrastructure to share abstracted EMR data with researchers outside of respondent's institutions. 6. Ability to or future ability to build a system within existing infrastructure to place individual orders for specimen collections (e.g. blood, urine). 7. Ability or future ability to process samples following study-specific protocols. 8. Ability or future ability to build a system within existing infrastructure to collect tissue from consented participants. 9. Ability and willingness to work with collaborators on multi-center research projects. Interested qualified organizations should submit a tailored capability statement for this requirement, not to exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above. Capability statements should also include an outline of previous or similar projects performed. All statements must include an indication of current certified small business status; this indication should be clearly marked on the first page of your capability statement, as well as the eligible small business concern's name, point of contact, address and DUNS number. Information Submission Instructions: All capability statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Rosa Lopez, Contract Specialist, at
[email protected] and Jill Johnson, Contracting Officer at
[email protected] in MS Word or Adobe Portable Document Format (PDF), by July 11, 2016 3:00PM, EST. All responses must be received by the specified due date and time in order to be considered. No collect calls or facsimile transmissions will be accepted. 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 the information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised the Government is under no obligation to acknowledge receipt of the information received or provide feedbacks 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 Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. 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).