As health care organizations increasingly focus on the monitoring of medical errors and adverse events, the use of voluntary reporting systems to detect, evaluate, and track such events has increased. This study describes types and rates of voluntarily reported events in 26 acute care hospitals using an electronic reporting system. Nonmedication-related clinical and medication-related events each represented about a third of all reports. Events that reached a patient made up the majority of reports, of which two thirds caused no harm to the patient and slightly over 1% resulted in permanent or life-threatening harm or death. Thirteen percent of reports were near misses that did not reach a patient and a similar percentage were environmental safety events. In this sample, a patient event occurred in approximately 10% of admissions, an adverse event in 3%, and life-threatening or permanent injury or death in 0.1%.
Our study represents “real-life” reporting by medical personnel of medical errors, adverse events, and near misses. No study personnel were employed to prompt reporting or observe actions by hospital staff, thus minimizing a “Hawthorne” effect because of study participation. We are not aware of a study to date that has described the types and frequency of adverse events and errors voluntarily reported as part of routine hospital operations.
Our study presents several important aspects of using an e-ERS in acute care hospitals. First, the rate of reports per 1,000 inpatient days varied substantially among institutions and did not correlate with hospital size or duration of e-ERS use, although there was a trend toward less variation among hospitals that had used the e-ERS for 2 or more years. Thus, a steady state may be reached once acceptance and adoption of the e-ERS spreads throughout an institution. Importantly, high reporting rates in an institution may not necessarily represent poor patient care, but rather an institutional culture that encourages reporting of errors and adverse events, integrates reporting into quality improvement processes, and focuses on system-level changes instead of individual blame and punitive actions.1
Second, the proportion of very serious adverse events, although small, was not negligible: slightly more than 1 per 1,000 admissions. If this rate is applied to the entire population of 33.7 million inpatients in nonfederal acute care hospitals in the U.S.,12
an estimated 34,000 patients per year could be seriously or permanently injured or die during hospitalization because of an adverse event.
Third, the e-ERS allowed for the reporting of a wide variety of different types and severities of adverse events and errors, and did not merely capture the most serious events. Nearly 70% of events that reached the patient produced no harm, and one quarter of all reports were either environmental safety issues or near misses. Thus, an e-ERS may be particularly helpful in capturing system defects (latent errors) and near misses that may not be detected by reviews of patient charts or medication records. Importantly, analyses of such near misses may help identify “root causes” of errors and adverse events.1, 3, 6
Finally, reporting rates reflect the reporters. Although the e-ERS was available and accessible to any hospital employee and staff member, physicians contributed less than 2% of all reports. The variation in reporting rates between nurses and physicians may be attributed to different definitions or perceptions of what constitutes an error or adverse event, and, importantly, different training about and attitudes toward reporting them. Nurses, but not physicians, receive training in and are encouraged to report adverse events and complications arising from medical treatment.13
Physicians do not receive education in the systematic evaluation of errors and adverse events, and thus operate within a belief system of self-blame and personal responsibility, rather than viewing such events as the end process of a series of systematic deficiencies. Additionally, physicians may not report because of “professional courtesy,” concern for implicating colleagues, or fear of repercussions.1, 14
It is difficult to compare the rates of events in our study to previously published ones primarily because of differences in data collection methods. Most published studies have relied on retrospective chart reviews, or have been research-based observational studies.4–6, 15–17
Interestingly, the adverse event rate of 3% of admissions in our study is similar to the 3% to 4% rates reported in 2 large medical record reviews of hospital discharges, the Harvard Medical Practice Study18
and a similar study in Colorado and Utah.19
Additionally, most studies have not relied on event reporting presumably because of low reporting rates. Studies of prompted reports of adverse events by house staff have shown rates of 0.5% to 4% of admissions,10, 20, 21, 22
and overall “quality problems,” including near misses, in 10% of admissions.10, 22
In 1 study, 2 hospitalists observed medical errors during routine patient care, finding an adverse event rate of 4% of admissions,22
again similar to the 3% rate in our study. In comparison, 1 study found a reported adverse event rate of 0.04% using a traditional paper-based method.23
There are several limitations of our study. Despite the widespread availability of the e-ERS in each institution and accessibility to all hospital employees, it is likely that not all errors, adverse events, or near misses were reported, and we did not rely on alternative methods to identify such events. Additionally, reporting bias is likely, exemplified by the exceedingly low rate of reporting by physicians; bias in the types of events reported may also exist.
Medical error and adverse event reporting rates are additionally influenced by institutional factors. The hospitals varied in size, geographic location, setting, academic affiliation, and number of months the e-ERS was in use, and these factors may have contributed to the large differences in reporting rates across hospitals. Additionally, as the e-ERS was implemented in each institution at different times, secular trends may also have affected reporting of events. Furthermore, institutions likely differed regarding implementation and adoption of an e-ERS, and overall culture regarding the reporting and management of adverse events and errors. Additionally, the understanding of processes that lead to medical errors and their systematic evaluation likely vary across hospital administrators and executive personnel. Thus, implementing any ERS requires training beyond the operational aspects to include education in the processes that lead to errors and adverse events. We did not have data on each institution's efforts in adopting and training in the e-ERS, acceptance of the e-ERS among hospital personnel, or hospital culture toward the reporting of errors and adverse events.
Despite these limitations, to our knowledge, this is the largest multihospital review of types of medical errors and adverse events reported using a commercial e-ERS as part of routine hospital operations. More research is needed to determine whether an e-ERS increases the reporting of adverse events and errors and reduces their occurrences. In one large hospital in the current study, use of the e-ERS increased the overall reporting rate of adverse events and errors by nearly fourfold. Additionally, occurrences of repeated events were easily and expediently detected and a common cause then identified (e.g., extravasation of parental nutrition associated with a procedure). Subsequent occurrences were tracked after changes in policy were instituted to determine their effects.
Thus, an e-ERS may help overcome 2 of the roadblocks to improving safety of medical care identified by Berwick.24
First, by making errors and adverse events reporting accessible to all hospital employees, as well as easy to review and track, they become more visible
to clinicians, hospital administrators, government officials, and the public. Second, a reporting system that allows for reporting of near misses and problems in the safety of the hospital environment may help uncover “root causes,” such as some system errors, that may not be identified by retrospective review. Additionally, a web-based e-ERS allows for real-time event notification and oversight, and for concurrent tracking of rates over time, tasks not easily performed with a paper-based system. Over the past 2 years, the National Patient Safety Agency in England has introduced a national system for identifying and reporting adverse events in health care; in the absence of such a national system in the U.S., hospital-wide e-ER systems may be important in the reporting, measuring, and tracking of adverse events and medical errors.
Physicians should take a leading role in quality efforts to reduce medical errors and adverse events. The factors associated with the low reporting rates by physicians and in some hospitals require further evaluation.