THE NEED FOR A STANDARDIZED REPORT FORMAT

At present, there is no agreement on a common set of data elements for representing patient safety information, much less specification of allowable values for those elements. Each entity self-determines the content of its reports; some even develop their own terminology to represent the information. At the state level, for example, New York and Florida are 2 of 21 states with mandatory requirements for reporting adverse events. The data elements they collect for the most serious adverse events have some areas of commonality:

  • Similar patient information is collected.

  • Similar information is collected on the time/location of the incident.

  • Each requires a description of the occurrence and analysis of its root causes.

  • Each requires a description of the corrective actions taken.

  • Only one health care data standard, the International Classification of Diseases, Ninth Edition (ICD-9), Clinical Modification (CM), is used by each to identify the diagnosis and procedures associated with the event (Rosenthal et al., 2000).

However, each state has developed its own taxonomy for classifying actual events. The New York Patient Occurrence Reporting and Tracking System (NYPORTS) works within the broad categories of statutorily defined reportable incidents. The system makes use of a detailed list of 54 reportable codes with “includes” and “excludes,” organized by type of event, to promote greater consistency among state hospitals (Rosenthal et al., 2001). Florida, on the other hand, divides the events into two categories—those that must be reported within 15 days and on an annual basis (Rosenthal et al., 2001). Each category includes four or five broad types of events to be reported. Another important difference is that the New York system has a set of questions designed specifically for medication errors, a known major adverse event category; the Florida system does not. The differences among the 15 state patient safety systems are even more pronounced.

The following “real world” example further illustrates the problem with numerous disparate data elements for documenting an adverse event. If an individual suffered a serious adverse drug event (ADE) while in a New York hospital, the clinician would first file a report internally for review by the designated hospital representative. A second report would be filed with the New York State Department of Health through NYPORTS. Another third



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