World Trade Center Health Program - Data Center

The Centers for Disease Control and Prevention (CDC), National Institute for Occupational Safety and Health (NIOSH) intends to issue a solicitation to continue support for healthcare of the responders who participated in the rescue, recovery, and cleanup in the aftermath of the attack on the World Trade Center (WTC) on September 11, 2001 and the survivors of that attack. 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. The WTC Health Program was established to provide care to previously enrolled responders (FDNY and general responders) and affected community members (now called "WTC survivors"), and for newly enrolled responders and survivors. The WTC Program has been structured through a series of contracts for Clinical Centers of Excellence (CCEs) and Data Centers (DCs). 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 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. 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, "Consolidated Appropriations Act, 2016," Div. O, Title III ("James Zadroga 9/11 Health and Compensation Reauthorization Act"). The Zadroga Act sets forth a number of statutory requirements for the WTC Health Program, including specific requirements for contracts with CCEs and DCs, as well as requires the establishment of a nationwide network of healthcare providers to ensure reasonable access to Program benefits for enrolled WTC responders and survivors residing outside the New York City metropolitan area. 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 subsection 3305(a)(2)." Section 3305(b)(2). The Scope of Work for a Data Center (DC) is based on requirements in Sections 3304 and 3305(a)(2)(A) of the Zadroga Act: 1. Receiving, analyzing, and reporting to the WTC Program Administrator on data, in accordance with section 3304, that have been collected and reported to such Data Centers by the corresponding Clinical Centers of Excellence under section 3305(b)(1)(B)(iii) of the Zadroga Act; 2. 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); 3. Tracking and reporting numbers of members consented for aggregation of data by disease/illness categories on a semi-annual basis to inform the NIOSH research award process; 4. Tracking and reporting 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; 5. Preparing, discussing and submitting an annual health surveillance report from the aggregated data from monitoring and cancer screening, in accordance with a proposed report template and methodology approved by the WTC Health Program Administrator; 6. Semi-annual routine analysis of aggregated health data and discussion with CCEs, other DCs, and the NPN to determine if active surveillance is advised for quality case ascertainment; 7. Conducting 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; 8. Conducting special analytical projects where substantial resources are required where level of effort and methodology is pre-approved by the WTC Health Program Administrator; 9. Maintaining IRB approval and information technology support for participating entities performing the standardized protocols involving initial health evaluation and medical monitoring; 10. Collaborating with NIOSH, CCEs/NPN, HPS, HPE contractors and NIOSH's subject matter experts (SMEs) to develop medical quality assurance guidelines, and rectification plans when needed; 11. Assigning a data analyst as the principal DC contact for each corresponding CCE to routinely address operational inquiries that include key retention metrics, medically fragile patients (based on claims), exposure and smoking variables that impact treatment eligibility for certain conditions or risk factors meeting criteria for screening tests, and other issues that may impact CCE scheduling, capacity and clinical quality assurance; 12. 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; 13. NIOSH-approved requests by CCEs for adhoc quality improvement and assurance efforts that go beyond the approved core medical quality indicators and operational metrics that assist with clinic scheduling and processing; 14. Coordinating and administering 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; and 15. Meeting 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, and diagnosis and treatment guidelines under clause (ii). See 3305(a)(2)(A)(i) through (vi). 16. Engaging in discussion across the WTC Health Program to guide cancer screening; and for diagnostic and treatment approaches for individuals with WTC-related health conditions with respect to section 3305(a)(2)(ii). 17. Making any data collected and reported to a Data Center 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); 18. Collaborating 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, and to explore possibilities for study recruitment to meet researcher needs. 19. Providing analytic support to the WTC Program Administrator when information is required by governmental accountability entities; and 20. Facilitating the coordination of outreach and retention activities of the corresponding CCEs. NIOSH is responsible for creating an outreach and retention strategy for the WTC Health Program that is applicable to all cohorts and at the national and local level. Program-wide outreach activities will be coordinated through a NIOSH point of contact, with assistance from the DCs in synchronizing activities within their cohort. The DCs' activities in outreach and retention coordination should be approved by NIOSH and should be limited to efforts to assist the CCEs in a manner to enhance communication, transparency, cooperation, and avoidance of duplication of efforts when engaging the relevant cohort. Coordination activities also include engaging all CCEs for planning cohort-wide events or fostering CCE participation in outreach and retention activities in the local NYC-area for the cohort. At the awarding of this contract, each CCE will be given an opportunity to provide input on how best to define the role of the DC in coordinating activities to meet the needs of all CCEs. Evaluation activities will be coordinated with NIOSH, with reports available on request. The purpose of the intended solicitation is to award multiple contracts to data centers to provide data services to the WTC Health Program in a manner that is consistent with the requirements of the Zadroga Act. The solicitation will be posted on or about September 14, 2016.