REQUEST FOR INFORMATION (RFI) ONLY Data Center services to the WTC Health Program Sources Sought This notice shall not be construed as an RFP or as any commitment or obligation on the part of the Government to issue a solicitation. The Government does not intend to award a contract on the basis of this request, so proposals will not be considered. No reimbursement will be made for any costs associated with providing information in response to this synopsis or any follow-up information requests. As permitted by FAR Part 10, this is a market research tool being utilized for informational and planning purposes. Your responses will assist the Government in the development of its acquisition strategy for a possible Request for Proposal (RFP), to be issued at a later date, and in determining whether any type of small business set-aside is possible for this procurement or whether full and open competitive procedures should be utilized. This is strictly market research and the Government will not entertain any questions. Background On January 2, 2011, the President signed Public Law No. 111-347, the James Zadroga 9/11 Health and Compensation Act (“Zadroga Act”). Title I of the Zadroga Act amended the Public Health Service Act to add Title XXXIII establishing a new federal health care program called the “World Trade Center Health Program within the Department of Health and Human Services. See “James Zadroga 9/11 Health and Compensation Act of 2010,” Public Law 111-347 (codified at 42 U.S.C. §§ 300mm – 300mm-61). On December 18, 2015, the Zadroga Act was amended to provide authority and funding for the WTC Health Program to continue through 2090. See Pub. L. 114-113 (Dec. 18, 2015), “Consolidated Appropriations Act, 2016,” Div. O, Title III (“James Zadroga 9/11 Health and Compensation Reauthorization Act”). Further information regarding the WTC Health Program Laws can be found at: http://www.cdc.gov/wtc/laws.html and http://www.cdc.gov/wtc/ppm.html. The WTC Health Program was established to provide care for previously enrolled responders (Fire Department - New York City -FDNY and general responders) and affected community members (now called “WTC survivors”), and for newly enrolled responders and survivors. The Program has been structured through a series of contracts for Clinical Centers of Excellence (CCEs), a Nationwide Provider Network (NPN), and Data Centers (DCs). The CCEs/NPN are authorized to provide health screening or medical monitoring evaluation, diagnostic and treatment services for a limited number of qualifying conditions, social benefits counseling, and limited outreach activities. The DCs ensure standardization of medical and screening protocols, create medical diagnostic and treatment guidelines, collect, maintain and analyze data from standardized assessments in a uniform and quality manner, receive and analyze health care claims data, provide annual health surveillance reports, conduct analyses for program operational support and improvement, and supply approved datasets for peer-reviewed scientific research efforts. Additional, secondary efforts include coordination activities in a manner to help facilitate transparency and collaboration of outreach and retention activities of the CCEs, in accordance with the WTC Health Program’s overarching strategic plan for outreach and retention. Coordination activities shall be conducted in a manner to meet the needs of all CCEs and using a framework and point of contact established by NIOSH. In the spring of 2011, CDC awarded a contract to provide operational support services to assist NIOSH with implementation of the WTC Health Program as defined by the Zadroga Act. A major function of this support contract was to process health care claims for services rendered by Program providers, route them for federal payment and communicate the specific payment details back to the rendering provider. A periodic extract of claims paid was then sent to the Data Centers (DC) to represent the treatment data for assigned member cohorts. The WTC Health Program and its Contractors (CCEs, DCs, Nationwide Provider Network [NPN], and Support contractors) are engaged with stakeholders through formalized Steering Committees established under the Zadroga Act. Objective and Scope Objective The purpose of this contract is to provide Data Center services to the WTC Health Program in a manner that is consistent with the requirements of the Zadroga Act. The Zadroga Act defines a Data Center as “a Center that the WTC Program Administrator determines has the capacity to carry out the responsibilities for a Data Center under Section 3305(a)(2).” Section 3305(b)(2). These responsibilities are set out in this Performance Work Statement. The Zadroga Act defines Corresponding Centers by specifying “a Clinical Center of Excellence and a Data Center shall be treated as ‘corresponding’ to the extent that such Clinical Center and Data Center serve the same population group.” Section 3305(b)(3). Scope The Scope of Work for a Data Center is based on requirements in Sections 3304 and 3305(a)(2)(A) of the Zadroga Act. Summary of Tasks: Receive, analyze, and report to the WTC Program Administrator on data, in accordance with section 3304, that has been collected and reported to such DCs by the corresponding CCE/NPN under section 3305(b)(1)(B)(iii) of the Zadroga Act; Collect and maintain research quality database from standardized initial health evaluations and annual medical monitoring exams, including responses to questionnaires and medical testing results (i.e., labs, imaging, spirometry, EKG); Share the database described in #2 with NIOSH at least annually, including a comprehensive data dictionary; Track and report numbers of members consented for aggregation of data by disease/illness categories on a semi-annual basis to inform the NIOSH research award process; Track and report numbers of members consented for contact by outside researchers for study recruitment, by disease/illness categories on a semi-annual basis to inform the NIOSH research award process; Prepare, discuss and submit an annual health surveillance report from the aggregated data from monitoring and cancer screening, in accordance with the report template, definitions, and methodology previoulsy developed by the DCs and approved by the WTC Health Program Administrator; Conduct active surveillance for selected health conditions identified by analysis of monitoring or other aggregated data and clinical observations from the CCEs, other DCs and the NPN where the level of effort and methodology is pre-approved by the WTC Health Program Administrator – first for concept (and priority), timeline and level-of-efforts, and secondarily for methodology; Conduct special analytical projects where substantial resources are required where level of effort and methodology is pre-approved by the WTC Health Program Administrator and coordinated with the WTC Health Program Associate Director for Science; Maintain IRB approval and information technology support for participating entities performing the standardized protocols involving initial health evaluation and medical monitoring; Collaborate with NIOSH, CCEs/NPN, HPS, HPE contractors and NIOSH’s subject matter experts (SMEs) to maintain and update medical quality assurance guidelines, and rectification plans when needed; Record member transfers into and out of the corresponding cohort Assign a data analyst as the principal contact for each corresponding CCE/NPN to routinely address operational inquiries that include key retention metrics, medically fragile patients (based on claims), exposure and other variables (e.g. smoking history, cancer screening history) that impact treatment eligibility for certain conditions or risk factors meeting criteria for screening tests, and other issues that may impact CCE/NPN scheduling, capacity and clinical quality assurance; Perform and Organize routine collaboration with designated WTC Health Program scientists regarding intensive scientific analysis and active surveillance efforts - with advance notification to align expectations regarding publication intent in advance of stakeholder meetings; Manage NIOSH-approved requests by CCEs/NPN for ad hoc quality improvement and assurance efforts that go beyond the approved core medical quality indicators and operational metrics that assist with clinic scheduling and processing; Coordinate and administer the activities of the WTC Health Program Steering Committees established under section 3302(b), including analytical support when needed for program evaluation work as pre-approved by the WTC Health Program Administrator; Meet routinely with the corresponding CCE(s) and the NPN to obtain input on the analysis and reporting of data collected under clause (i) and on the development of monitoring and initial health evaluation protocols, cancer screening, diagnostic and treatment guidelines under clause (ii) (See 3305(a)(2)(A)(i) through (vi).); Engage in discussion across the WTC Health Program to guide cancer screening and diagnostic and treatment approaches for individuals with WTC-related health conditions with respect to section 3305(a)(2)(ii); Make any data collected and reported to a DC under Section 3305(b)(1)(B)(iii) available to health researchers and others as provided in the CDC/ATSDR Policy on Public Health Research and Non-Research Data Management dated January 26, 2016 (attached); Collaborate with the WTC Health Registry to evaluate needs for analysis across cohorts for issues suggestive of a condition that may be linked to 9/11 exposure, for significant assessment of comorbidities, to identify Registry members eligible for Program enrollment, and to explore possibilities for study recruitment to meet researcher needs; Provide analytic support to the WTC Program Administrator when information is required for program evaluation or by governmental accountability entities; Facilitate the coordination of outreach and retention activities of the corresponding CCEs/NPN; (OPTIONAL TASK) Obtain informed consent for research from NPN members; (OPTIONAL TASK) Obtain informed consent for research from Survivor CCE members Submission Instructions: Responses via electronic mail (email) are due on or before April 15, 2022 at 2pm Eastern Time to Marie Bartkevicius , email address:
[email protected] and must include the information requested below. Only emailed responses will be accepted. Responses greater than 15 pages double-sided pages (including all attachments) will not be considered. Late responses will not be accepted. The North American Industry Classification System (NAICS) Code for this Sources Sought Notice is 923120 – Administration of Public Health Programs Qualified firms shall submit a statement of interest on company letterhead demonstrating the firm’s qualifications to perform the defined work. Responses must be complete and sufficiently detailed to address the specific information. The documentation shall address, at a minimum, the following: Company Profile to include: Company name and address; Two points of contact (names, titles, phone numbers and email addresses); DUNS number and CAGE Code, as registered in the System for Award Management (SAM) at http://www.betaSam.gov/: Business designation/status (must correlate with SAM registration): _____ Small business _____ HUBZone _____ WOSB _____ 8(a) _____ VOSB _____ SDVOSB _____ Small Disadvantaged Business ______Large business Documentation, in detail, of the company’s capability: Staff expertise, including availability, experience, and formal and other training; Completed projects in the last 5 years of similar size and scope; Corporate experience and management capability; Examples of prior completed Government contracts, reference, and other related information; Staff expertise, including availability, experience, and training; Comments or opinions pertaining to the difficulty and/or feasibility of the potential requirement or proposed acquisition, possible solutions and/or approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts; Proposed NAICS code: Recommendations for a different NAICS code. If so, please explain? The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications and capabilities to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback 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 the response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Response is strictly voluntary - it is not mandatory to submit a response to this notice to participate in any formal RFP process that may take place in the future. However, it should be noted that information gathered through this notice may significantly influence our acquisition strategy. All interested parties will be required to respond separately to any solicitations posted as a result of this sources sought notice. We appreciate your interest and thank you in advance for responding to the Sources Sought.