● Physical causes: Material items failed in some way (equipment fails). ● Human causes: Someone did not do something that was needed or did something incorrectly (individual improperly uses equipment). ● Organizational causes: A system, process, or policy is faulty (no single person is responsible for equipment maintenance). Analysis of the incident is generally divided into: ● Data collection: Establishment of what happened through structural interviews, document review, and/or field observation. This provides a time line of events before and following the event. ● Data analysis: Examination of the sequence of events generated to determine the common underlying factors. This includes examining both active and latent failures in the sequence (AHRQ, 2001). At the conclusion of the root cause analysis, the team summarizes the underlying causes and their relative contributions and develops an action plan to address the identified deficits. Sentinel event forms and tools to assist in conducting a root cause analysis and action plan are available on the Joint Commission’s website (http://www. jointcommission.org/topics/patient_safety.aspx). Reporting medical/dental errors A major recommendation of the landmark HMD report was that voluntary reporting systems be developed for adverse events that result in minimal or no harm, and that a mandatory reporting system be established for errors that result in permanent injury or death. Although mandatory reporting at the national level has not been realized, several excellent voluntary systems exist and are described below. Several states have enacted mandatory reporting programs. Florida’s program is discussed as an example of a state program. The Joint Commission The Joint Commission encourages, but does not require, the reporting of all sentinel events. The Joint Commission also encourages accredited healthcare facilities to report close calls to help prevent future errors. The Joint Commission collects and analyzes data from the review of sentinel events, root cause analyses, and risk reduction measures that healthcare organizations submit (TJC, 2013). Between January 1, 1995, and June 30, 2010, the Joint Commission reviewed 6,923 sentinel events (TJC, 2014). Most sentinel events occurred in hospitals. Sixty-seven percent (4,642) resulted in patient death. Wrong-site surgery was the most common sentinel error, accounting for about 13% of all reported events (TJC, 2014). All data submitted are confidential. This information makes up the Joint Commission’s sentinel event database, which is also a major component of the evidence base for the National Patient Safety Goals (TJC, 2014, 2017b). The Sentinel Event Alert is an online report that identifies sentinel events, describes their common causes, and suggests actions to prevent these occurrences. It is available at http://www.jointcommission.org/ topics/hai_sentinel_event.aspx Accredited healthcare organizations are expected to: ● Review each alert and consider any relevant information appropriate to the organization’s services. ● Consider information in the alert when designing and redesigning relevant processes. ● Evaluate systems in light of the information in the alert. ● Consider standard-specific concerns. This includes evaluating the Joint Commission standard and contemplating any concern that may stem from the standard wording or interpretation. For example, Sentinel Event – Retained Foreign Object after Surgery raises the question: When exactly is “after surgery”? “After surgery”
Table 1: Criteria for Root Cause Analysis To be thorough, a root cause analysis must include: ● Determination of human and other factors most directly associated with adverse events or close calls. ● Analysis of underlying cause and effect systems through a series of why questions to determine where redesigns might reduce risk. ● Identification of risks and their potential contributions to the adverse event or close call. ● Determination of potential improvement in processes or systems that would decrease the likelihood of such events in the future, or a determination, after analysis, that no such improvement opportunities exist. To be credible, a root cause analysis must: ● Include participation by the leadership of the organization and those most closely involved in the processes and systems under review. ● Be internally consistent. ● Include consideration of relevant literature. ● Include corrective outcome measures and top management approval. Note: Adapted from the U.S. Department of Veterans Affairs, VA National Center for Patient Safety. (2014b). Root cause analysis. Retrieved from http://www.patientsafety.va.gov/professionals/ onthejob/rca.asp is any time after completion of the skin closure, even if the patient is still in the operating room under anesthesia. ● Implement relevant suggestions or reasonable alternatives or provide a reasonable explanation for not implementing relevant changes (TJC, 2008). Institute for Safe Medication Practices The Institute for Safe Medication Practices (ISMP) is a nonprofit organization whose mission is to educate the healthcare community, including consumers, about safe medication practices (ISMP, 2010, 2014). The institute directs the Medication Error Reporting System (MERP), which receives thousands of reports of medication errors from healthcare providers and consumers annually. The MERP reporting system is voluntary and confidential. The reporting form is available on the ISMP website ( https://www.ismp.org/ orderforms/reporterrortoismp.asp ). U.S. Food and Drug Administration MedWatch reporting program The FDA’s MedWatch program has three goals: (1) to educate healthcare providers and their patients about the importance of reporting serious adverse events to the FDA, (2) to take the new safety information that results from analysis of these reports and disseminate it to clinicians and their patients in a timely fashion for use at the point of care, and (3) to maintain safety surveillance of medical products (FDA, 2014a). The MedWatch program reviews the results of laboratory, animal, and human testing pre-market. Once products are marketed, the MedWatch program also conducts careful reviews of adverse experiences reported to it. MedWatch monitors drugs (prescription and over-the-counter), medical devices, biologics (except vaccines), and special nutritional products such as dietary supplements, infant formulas, and medical foods, as well as cosmetics. The MedWatch reporting system is voluntary, available to healthcare professionals and consumers, and has an online reporting site ( http://www.fda.gov/Safety/MedWatch/
HowToReport/default.htm ). State reporting systems
The National Academy for State Health Policy (NASHP) is an independent academy of state health policy makers dedicated to helping states achieve excellence in health policy and practice. Their electronic Patient Safety Map & Toolkit provides
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