Medical Error Prevention and Root Cause Analysis ________________________________________________
• Medication errors that do not result in death or major permanent loss of function • Suicide other than in an around-the-clock care setting or following elopement from such a setting • A death or loss of function following a discharge against medical advice • Unsuccessful suicide attempts unless resulting in major permanent loss of function • Minor degrees of hemolysis not caused by a major blood group incompatibility and with no clinical sequelae For further definition of terms, please refer to the Joint Com- mission’s Sentinel Event Policy and Procedures at https:// www.jointcommission.org/resources/patient-safety-topics/ sentinel-event/sentinel-event-policy-and-procedures. As part of the accreditation requirement, the Joint Commis- sion requires that healthcare organizations have a process in place to recognize these sentinel events, conduct thorough and credible root cause analyses that focus on process and system factors, and document a risk-reduction strategy and internal corrective action plan that includes measurement of the effec- tiveness of process and system improvements to reduce risk [6]. This process must be completed within 45 business days of the organization having become aware of the sentinel event. The Joint Commission will consider a root cause analysis acceptable for accreditation purposes if it focuses primarily on systems and processes, not individual performance [6]. In other words, the healthcare organization should minimize the individual blame or retribution for involvement in a medical error. In addition, the root cause analysis should progress from special causes in clinical processes to common causes in organizational processes, and the analysis should repeatedly dig deeper by asking why, then, when answered, why again, and so on. The analysis should also identify changes that can be made in systems and processes, either through redesign or development of new systems or processes, which would reduce the risk of such events occurring in the future. The Joint Commission requires that the analysis be thorough and credible. To be considered thorough, the root cause analysis must include [6]: • A determination of the human and other factors most directly associated with the sentinel event and the process(es) and systems related to its occurrence • Analysis of the underlying systems and processes through a series of “why” questions to determine where redesign might reduce risk • Inquiry into all areas appropriate to the specific type of event • Identification of risk points and their potential contributions to this type of event
• A determination of potential improvement in processes or systems that would tend to decrease the likelihood of such events in the future, or a determination, after analysis, that no such improvement opportunities exist To be considered credible, the root cause analysis must meet the following standards [6]: • The organization’s leadership and the individuals most closely involved in the process and systems under review must participate in the analysis. • The analysis must be internally consistent; that is, it must not contradict itself or leave obvious questions unanswered. • The analysis must provide an explanation for all findings of “not applicable” or “no problem.” • The analysis must include consideration of any relevant literature. Finally, as previously discussed, after conducting this root cause analysis, the organization must prepare an internal corrective action plan. The Joint Commission will accept this action plan if it identifies changes that can be implemented to reduce risk or formulate a rationale for not undertaking such changes, and if, where improvement actions are planned, it identifies who is responsible for implementation, when the action will be implemented, and how the effectiveness of the actions will be evaluated [6]. FLORIDA LAW Healthcare professionals have an obligation to report adverse events to leadership and ensure that organizations have pro- cesses in place to satisfy the Joint Commission requirement. In Florida, certain serious adverse incidents must also be reported to Florida’s Agency for Health Care Administration (AHCA). Florida law requires that licensed facilities, such as hospitals, establish an internal risk management program. As part of that program, licensed facilities must develop and implement an incident reporting system, which requires the development of appropriate measures to minimize the risk of adverse incidents to patients, as well as imposes an affirmative duty on all healthcare providers and employees of the facility to report adverse incidents to the risk manager or to his or her designee. The risk manager must receive these incident reports within 3 business days of the incident, and depending on the type of incident, the risk manager may have to report the incident to AHCA within 15 days of receipt of the report.
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MDFL0626
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