House Public Health Interim Hearing April 11, 2012 Interim Charge #2 Adolfo M. Valadez, M.D., M.P.H. Assistant Commissioner for Prevention and Preparedness Services Division

Definition of health or disease registry A database that contains information about people diagnosed with specific types of diseases Describes health of a population as opposed to any single individual In public health practice, the term “registries” is usually reserved for chronic or non-infectious disease

Definition of health or disease registry Summary data from a state health registry is used to: describe the disease burden in the state monitor trends evaluate progress on a population or state- level facilitate health care resource planning conduct research on the causes of disease

Definition of health or disease registry DSHS has registries that capture disease- specific information on all diagnosed Texans: Birth Defects Registry Cancer Registry Trauma Registry ImmTrac, the immunizations registry, collects immunization records of Texas children and adults with consent.

Public Health Disease Reporting Systems Identify persons with transmissible or communicable diseases to assist in limiting transmission of infectious or communicable diseases. examples are tuberculosis and HIV. Data is used to intervene with patients and physicians: treatment medication referrals to other public social service entities, and other public health interventions

Birth Defects Registry Contains information on the occurrence of birth defects: type of defect when and where diagnosed, including patient information on the child and mother Birth Defects Registry staff are allowed access, by law and rule, to facility medical records relating to birth defects; no individual consent is required. Data is used to: describe patterns of birth defects in the state investigate clusters support public health research on causes of birth defects

Cancer Registry Health care facilities are required to report all new cases of cancer to the Registry; no individual consent is required. The Registry collects, manages, analyzes, and disseminates data on the occurrence of cancer; the type, extent, location of the cancer, and the type of initial treatment. Data is used to: describe the burden of cancer in the state respond to community requests for the local incidence of cancer (“cancer clusters”) support cancer control efforts measure progress in prevention, diagnosis, treatment and survival support research on the causes of cancer

Trauma Registry Providers and hospitals are required to report EMS runs, trauma cases and injuries to the registry; no individual consent is required Collects, analyzes, and disseminates information on EMS runs and trauma, including spinal cord, traumatic brain, and submersion injuries Data is used to: investigate the causes of injuries describe the distribution across the state determine health outcomes and associated costs reduce trauma and injury in the state

Immunization Registry (ImmTrac) Providers and payors report all immunizations administered to an individual younger than 18 years of age. Collects information from multiple reporting sources with the goal of serving as a repository of individuals’ complete immunization histories. The 81 st Legislature made ImmTrac a voluntary lifetime registry. Data is used to: assess the immunization status of clients assess community coverage levels generate client immunization history records

Security of Registries Data systems are maintained on secure DSHS servers within firewalls Security and access controls follow statutory requirements and rules in addition to DIR and national standards Registries have designated security coordinators and security plans that are continually updated and maintained. Agreements are in place with registered users, user logins and passwords are maintained according to policy Data is released only to entities authorized by statute Authorized registered entities such as providers, payors, schools Program staff who must access the data to perform their job duties Those who receive authorization for access through the DSHS Institutional Review Board and Executive Steering Committee

Health Registries Improvement Initiative Rider 78, 81st Legislature, provided funds to assess, improve, and upgrade health registries. Replace sub-standard technology with modern, more secure technology solutions Cancer Registry with 2.6 million cancer reports is housed in a 1994 FoxPro software system Costs of maintaining outdated system is over $500,000 per year.

Health Registries Improvement Initiative Identifies technology solutions that: “can talk to each other” reduce or eliminate paper reporting, such as faxes reduce the reporting burden of hospitals and other entities by integrating common registry functions (e.g., electronic lab reporting)

Health Registries Improvement Initiative Birth Defects, Cancer, and Trauma registry systems are currently being replaced On target for completion by the end of August 2012 In May 2012, DSHS will identify a solution for replacing the ImmTrac Registry Replacements were made possible by leveraging general revenue and federal funds

Achievements of DSHS Health Registries Cancer Registry met national Gold Certification in 2006, made possible by increased funding from the legislature. Data has been used to support over $50 million in cancer research including the Cancer Prevention and Research Institute ($31.8 million).

Achievements of DSHS Health Registries ImmTrac is assisting immunization providers to test their certified electronic health records technology by submitting electronic immunization records to DSHS. This collaboration with providers supports their ability to meet Stage 1 Meaningful Use criteria established by the federal Centers for Medicare and Medicaid Services.

Achievements of DSHS Health Registries Texas Birth Defects Registry is the largest in the United States. Has supported 210 published studies of birth defects (36 national studies and 174 Texas studies). In collaboration with Texas universities, over $13 million federal funds has been received to study the causes of birth defects.

HB 411 Implementation Status Update Outlines approval requirements for Newborn Screening Specimens and Data: Restricts research to those with public health purposes (relating to cancer, birth defect, infectious disease, chronic disease, environmental exposure, or newborn screening) Approvals must be posted on DSHS website

HB 411 Implementation Status Update Implementation Status: DSHS policy regarding newborn screening specimen and data management has been revised to reflect statutory changes and is in approval process. Specimen uses are posted on Newborn Screening Laboratory website

HB 411 Implementation Status Update DSHS Institutional Review Board must contain at least three members not affiliated with a health agency, and that at least one in this group be a member of the public. Implementation Status: DSHS IRB policy was revised. Additional non affiliated public member was added.

HB 411 Implementation Status Update Change from opt-out for storage and external research to opt-in: Any specimen for which consent is not obtained, must be destroyed within two years of receipt Eliminates 60-day deadline for destruction except in some cases of revocation of consent

HB 411 Implementation Status Update Implementation Status: New disclosure statement and consent form developed with input from stakeholders Available as part of 2012 Newborn Screening Specimen Collection Kit Available online as stand-alone document Distribution in May 2012

Increasing awareness of provider requirements Developing and scheduling training for 2,000 providers to aid with implementation on June 1, Updating rules in Texas Administrative Code to add provider requirements. HB 411 Implementation Status Update

SB 7, First Called Session Texas Health Care Information Collection (THCIC) Hospitals and ambulatory surgical centers submit administrative claims data to THCIC Article 7 authorizes confidential sharing of data within DSHS and with HHSC Modifies SB 156 Authorizes sharing only with DSHS and HHSC programs after approval by DSHS Institutional Review Board Implementation of Article 7 will: Enhance disease and health condition surveillance; Improve research data in the health registries; Decrease the burden on disease/health condition reporting from external stakeholders; Improve data quality and allow additional research; Reduce duplication of effort and costs of analysis at the agencies.