Note: This Reducing Risk Resource article is directed to the physicians and management staff who have responsibility for risk management at office-based physician practices, ambulatory care centers and radiology centers. For the sake of brevity, whenever the term “physician practice” is used throughout this article, it is intended to apply as well to ambulatory care and radiology centers. In the article, it is assumed that the physician practice has established procedures for reporting an incident or adverse event, and “near-misses” (collectively, “events”). Decisions about content and format of event reporting forms, types of events required to be reported, and by whom, as well as policies for analysis and dissemination of information obtained are beyond the scope of this article and therefore not addressed.
Introduction
This article presents practical guidelines for investigating unexpected events that happen during, or as a result of, care provided in the physician office practice setting. It also discusses some of the reasons for undertaking internal investigation of these events.
Surveys have shown that approximately 80 percent of ambulatory care in the U.S. is provided in office-based physician practices. The number of annual patient visits to physicians has also been increasing. As the delivery of medical care and services has grown, so too has the need to introduce risk management and patient safety principles into the physician practice setting.
Event Reporting
Event reports have historically been, and continue to be, a basic risk management tool that can help to identify unexpected events, injuries and potential claims. Such reports help give early notice of not only negative outcomes but also “near-misses” that may happen in the complex course of a patient’s healthcare experience. (See downloadable PDF of sample Event Report Form for use in your office)
Healthcare practitioners use a variety of terms to describe events that are or should be reported. The list includes, but is not limited to, the following: events, incidents, variances, occurrences, adverse events, errors, near-misses and potentially compensable events (“PCEs”). In this article, we will use the term “event” to refer to instances/situations which typically warrant being reported for risk management purposes. However, many other definitions have been put forth, such as this broad description: “any circumstance that is unexpected within the normal operations of the institution or the anticipated disease/treatment process of a patient." Another approach states it as simply “injuries related to medical management.” A “near-miss” refers to an unplanned event that did not, but could have, resulted in personal injury or property damage. And finally, the Joint Commission uses yet another term - “sentinel event” - which it defines as “an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof.”
An effective event reporting education program should give staff an understanding of the situations when a report should be completed and by whom. Event report forms are most effective when completed by the person who first becomes aware of or witnesses the event. The clinical facts surrounding an event should always be documented in the medical record. However, the actual reports should never be placed in or alluded to in the medical record.
Some physician practices may have experience with event reporting in general, or as a means of communicating adverse events to their insurance carriers. Many, however, have not routinely done so. Moreover, staff assigned the responsibility of trying to manage risks and patient safety in a physician practice, in contrast to a hospital environment, will encounter challenges arising from differences in office cultures, types of risk exposures and level of safety knowledge and interest among personnel. A survey commissioned by the Accreditation Association of Ambulatory Health Care’s Institute for Quality Improvement revealed that only one-third of the respondents indicated that they report and collect information on adverse medical events, and most of these were not physician practices, but ambulatory surgery centers.
We also note that many states, including New Jersey, have enacted laws that mandate reporting of specific types of medically related adverse events that occur in licensed health care facilities in the state to the governing authority for healthcare oversight. In general, state reporting requirements will apply to large surgical centers or ambulatory care facilities that are licensed by the state, but not to physician practices.
Cherry DK, Wood well DA. National Ambulatory Medical Care Survey: 2000 Summary [online] 2002 June 5. Available from Internet: http://www.cdc.gov/nchs/data/ad/ad328.pdf. [Also from ECRI-HRC-Out-Patient Settings 2, July 2003]
Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med 1991; 324(6):370-6.
The Joint Commission: Sentinel event policy and procedures [Online] 2006 October. A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called “sentinel” because they signal the need for immediate investigation and response. The terms “sentinel event” and “medical error” are not synonymous; not all sentinel events occur because of an error and not all errors result in sentinel events. Available from internet: http://www.jointcommission.org/SentinelEvents/PolicyandProcedures
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American Health Consultants Ambulatory Care studies show room for concern and comfort. Healthcare Benchmarks 2001 Oct. 8(10): 109-11. [See FN 13 in ECRI-HRC Analysis; vol. 3, Out-Patient Settings 2 - “Overview: managing Risks in Physician Practices”; July 2003.]
Guide to Investigating Events, Page 2 