Like surveillance systems, reporting can be used to monitor trends. The two CDC-managed systems and the CMS MPSMS are considered surveillance systems; the other five are for event reporting. Most of these systems are essentially voluntary, with the exception of VAERS and MedWatch, which mandate reporting by certain parties (health professionals, manufacturers, and/or user facilities). In the cases where reporting is mandatory, specific time frames are established within which reports must be received; these time frames vary according to the seriousness of the event.

Reportable Events

In terms of the events reported and monitored by the federal systems, they vary a great deal from one to the next (see “Reportable events/events monitored” and “Classification system and/or severity index” rows of the tables). Some systems include reporting for close calls (i.e., near misses), while others focus solely on adverse events.1 However, a few general statements can be made about them. The CDC- and FDA-managed systems tend to focus on specific types of adverse events, based on patient outcome or what caused the event—nosocomial infections; infections resulting from hemodialysis; vaccine events; and medical device, biologic and blood product, drug product, and special nutritionals events. Although these systems are quite specific in terms of events reported/monitored, they can be used across numerous health systems. The focus of the other four systems—MPSMS, MHS PSP, NCPS, and PSRS—is essentially the opposite of the first four. They are designed for use within the health systems that serve their members: Medicare, the MHS, and the Veterans Health Administration (VHA). The types of events reported to and monitored by these systems are more general and, in some cases, are not categorized at all. Adverse/serious events are included in all of these systems; however, four of them—MHS PSP, NCPS, PSRS, and MedWatch (for device problems only via MedSun)—also include close calls and/or near misses. Additionally, the MHS PSP includes nonpatient specific events such as a fire or system failure in the facility. Often, an organization will classify an event or determine whether an RCA is needed based on a risk assessment scale. For example, the NCPS reporting system classifies events and close calls using the Safety Assessment Code (SAC) matrix and requires an RCA if a close call or adverse event has a high SAC score or at the discretion of the patient safety manager.

1  

Adverse/serious events and close calls/near misses are defined differently by each system (see tables).



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