LAC 48:V.8605. Responsibilities of the Department of Health

A. The Department of Health shall maintain a secure information system. This system will receive and manage electronic reporting of health information from multiple sources. The sources are described in this Rule to maintain a longitudinal de-duplicated registry of individuals with sickle cell disease in the state. B. The Department of Health shall maintain qualified personnel responsible for data linkage, analysis, and management of the registry and associated activities. C. The Department of Health shall routinely receive, process, link, and analyze demographic and diagnostic data from reporting entities. Such action should be taken to identify cases. In response, the department may request treatment, service, and health outcome data from reporting entities to link and analyze population-level monitoring and action. D. The Department of Health may, as it deems appropriate, conduct special analyses and studies using data from the registry. Such data should be used to inform policy and other actions needed to improve access and outcomes among individuals with sickle cell disease in the state. Also, the data will inform the quality of health care and related services in this state. E. The Department of Health shall maintain and publish guidelines and procedures for operations of the registry in a publicly available technical manual. At a minimum, the technical manual shall include: 1. comprehensive instructions for the registry staff; 2. technical specifications for the registry; 3. a list of the data elements included in the registry data submission and reporting timelines and procedures for reporting entities, mandatory and discretionary variables, and technical specifications for reporting; 4. guidelines for data management; 5. quality and performance measures for the system; 6. data quality requirements to ensure the quality and completeness of data in the system; and 7. data protections and authorized uses. F. The Department of Health shall routinely assess the completeness, timeliness, and accuracy of data reported to the registry. This should be done to ensure its rigor as a public health monitoring system. G. The Department of Health shall ensure that the registry and its activities comply with all applicable requirements of the Health Insurance Portability and Accountability Act of 1996, P.L. 104-191. The registry and its activities shall also comply with regulations adopted pursuant to that Act, including but not limited to the HIPAA Privacy Rule, 45 CFR Part 164, and other applicable laws and regulations governing disclosure of health information. H. The registry shall undergo regular audits by the Department of Health’s Internal Audit Unit. These audits will ensure compliance with this Rule, data security standards, and privacy laws. I. The Department of Health shall maintain a public-facing website with the registry’s technical manual, associated publications, and department contact information. J. The Department of Health shall publish an annual report. The report will include findings on the epidemiology of sickle cell disease and population-based information about the care and health outcomes of individuals with sickle cell disease in the state.