I. FEDERAL REPORTING SYSTEMS

Overview

Within the federal government, eight major patient safety reporting and surveillance systems (see Tables C–1a, C–1b, and C–1c for details) were examined. Most of these systems were initiated by the federal agencies that manage them; however, one was mandated in legislation—the Vaccine Adverse Event Reporting System (VAERS). These federal agencies include the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the Centers for Medicare and Medicaid Services (CMS), which are all part of the Department of Health and Human Services (DHHS); the Department of Defense (DOD); and the Department of Veterans Affairs (VA).

The CDC manages two of the eight systems: the National Nosocomial Infections Surveillance (NNIS) System and the Dialysis Surveillance Network (DSN). The NNIS system has two components—nosocomial infections and antimicrobial use and resistance. The CDC also works jointly with the FDA to manage VAERS.

The FDA manages MedWatch, which handles reporting of medical device, biologic and blood product, drug product, and special nutritionals events. CMS is developing and will manage the Medicare Patient Safety Monitoring Program (MPSMS), and the DOD manages the Military Health System Patient Safety Program (MHS PSP).

The VA manages the National Center for Patient Safety (NCPS) and is working with the National Aeronautics and Space Administration (NASA) to develop a complementary system called the Patient Safety Reporting System (PSRS).

The longest operating of these systems is NNIS, which was initiated by CDC in 1970. The rest began operating after 1990, including several in the past few years. The newest systems are the MPSMS, MHS PSP, and PSRS.

Surveillance or Reporting Systems

Two types of systems are used: surveillance and reporting. In general, surveillance systems abstract data from patient and other records and/or health care personnel to determine if an adverse event has occurred and/or to analyze the data in order to monitor trends. Reporting systems are designed for individuals to report specific events and, in some cases, conduct root-cause analyses (RCAs) to determine the causal factors for these events.



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