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

HTC-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. HTC-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. 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 participate in the Regional Scientific 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 such as range of motion measurements, process blood samples and participate on working groups. HTC- 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 tracking in WebTracker™ or using tracking reports provided by ATHN; • Collect demographic, diagnosis and mortality information for patients served by your HTC in order to increase knowledge about the demographics of the population receiving care. (Similar to Hemophilia Data Set, known as HDS) • Collect longitudinal patient-level registry data on certain characteristics of patients with eligible bleeding diagnoses. (To be defined in the future)