CDC-Public Health Surveillance for the Prevention of Complications of Bleeding and Clotting Disorders 2014

Subrecipient of the Cooperative Agreement with CDC and American Thrombosis and Hemostasis Network (ATHN) shall perform public health surveillance of patients with bleeding and clotting disorders in compliance with HHS Grants Policy Statement (Rev. January 1, 2007), as amended from time to time. This includes without limitation all administrative services specified in the notice of award and as may be reasonably required for the continued funding of that award. Subrecipient will provide qualified personnel to support this project. The specific individual, time allocation and rate are specified in the approved Budget, included as Attachment 5 of the Project Agreement. Role includes the following. " Surveillance Data Officer - Responsible for data collection, data integrity and reporting of public health surveillance data as specified for this project. " Scientific Spokesperson - Represents the scientific viewpoint of the HTC for the surveillance project and ensures validity of the surveillance data from the HTC. Scientific spokesperson is encouraged to provide input to the Regional Scientific Spokesperson who serves as a member of the Science Committee. This Committee will assist in developing the science of the project and evaluating results. It will review data to be collected to assure appropriateness of questions being asked and will assist with the review, analysis and publication of project findings. " Other support as needed to address administrative issues such as budget, contracts, IRB and HIPAA compliance as necessary, to collect specific data elements, process blood samples and participate on working groups. Subrecipient will use best efforts to ensure quality and timely performance of requirements related to the cooperative agreement within the approved budget. This includes but may not be limited to the following: " Ensure that surveillance data officer and others involved in the project are appropriately trained to perform the public health surveillance and remain informed about the project (e.g., through attendance at national/regional meetings, webinars, periodic conference calls related to this project or through written correspondence); " Adhere to human subjects protections through timely IRB submission and/or patients authorizations/consents as appropriate; " Actively recruit and enroll patients, and track authorization/consent as needed, in ATHN clinical infrastructure; " Collect demographic, diagnosis and mortality information for all eligible patients served by your HTC in order to increase knowledge about the demographics of the population receiving care. (such as for the HTC Population Profile, and the Mortality Reporting form.) " Collect longitudinal patient-level registry data on certain characteristics of patients with eligible bleeding diagnoses. (Such as for the Registry for Bleeding Disorders); Collect and submit accurate and complete surveillance data through ATHN clinical infrastructure or other approved transmission process for ALL eligible patients for the HTC Population Profile prior to calendar year deadline of February 1, " Collect and submit accurate and complete surveillance data through ATHN clinical infrastructure or other approved transmission process for a proportionate number of eligible patients based on percentage of national HDS in the region for the Registry for Bleeding Disorders by September 29, 2014; " Collect and submit laboratory specimens for testing for inhibitors and infectious diseases as part of the Registry for Bleeding Disorders following the algorithm and process developed and within timeframes required ; " Self-audit and review data, and respond to data quality assurance queries as needed; " Collaborate to disseminate findings. Subrecipient will collaborate with Region Recipient, ATHN and CDC in fulfilling and reporting on project activity: " Authorizing changes to budget and staff if it exceeds 25% of the subrecipient's total awardSubmitting itemized invoices to Region Recipient preferably 45 days following the close of the quarter, but no less than semi-annually, (i.e., Close of the quarters are December 31, March 31, June 30 and September 30, preferred invoice dates are February 15, May 15, August 15 and November 15); " Submitting final itemized invoice to Region Recipient no later than 45 days following the close of the end of budget period, therefore due November 15 " Reporting progress to support ATHN's timely submission of the Final Progress Report (due within 90 days following the end of year 3) to CDC. This report from ATHN will include at least progress made toward project goals, description of results and a list of publications resulting from the project.