Study Points

Medical Error Prevention and Root Cause Analysis

Course #91334 - $15 -

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  • Participation Instructions
    • Review the course material online or in print.
    • Complete the course evaluation.
    • Review your Transcript to view and print your Certificate of Completion. Your date of completion will be the date (Pacific Time) the course was electronically submitted for credit, with no exceptions. Partial credit is not available.
  1. The Institute of Medicine's (IOM) Committee on Quality of Healthcare in America defines error as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim.

    DEFINING "MEDICAL ERROR"

    The IOM Committee on Quality of Healthcare in America defines error as "the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim" [1]. It is important to note that medical errors are not defined as intentional acts of wrongdoing and that not all medical errors rise to the level of medical malpractice or negligence. Errors depend on two kinds of failures: either the correct action does not proceed as intended, which is described as an "error of execution," or the original intended action is not correct, which is described as an "error of planning" [1]. A medical error can occur at any stage in the process of providing patient care, from diagnosis to treatment, and even while providing preventative care. Not all errors will result in harm to the patient. Medical errors that do result in injury are sometimes called preventable adverse events or sentinel events—sentinel because they signal the need for immediate investigation and response [6].

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  2. Patient rape is an example of a sentinel event subject to review by the Joint Commission.

    ROOT CAUSE ANALYSIS PROCESS

    The following subsets of sentinel events are subject to review by the Joint Commission [6,11]:

    • The event has resulted in an unanticipated death or major permanent loss of function, not related to the natural course of the patient's illness or underlying condition

    or

    • The event is one of the following (even if the outcome was not death or major permanent loss of function unrelated to the natural course of the patient's illness or underlying condition):

      • Suicide of any patient receiving care, treatment, and services in a staffed around-the-clock care setting or within 72 hours of discharge

      • Unanticipated death of a full-term infant

      • Abduction of any patient receiving care, treatment, and services

      • Any elopement (i.e., unauthorized departure) of a patient from a staffed around the-clock care setting (including the emergency department), leading to death, permanent harm, or severe temporary harm to the patient

      • Discharge of an infant to the wrong family

      • Rape, assault (leading to death or permanent loss of function), or homicide of any patient receiving care, treatment, and services

      • Rape, assault (leading to death or permanent loss of function), or homicide of a staff member, licensed independent practitioner, visitor, or vendor while on site at the healthcare organization

      • Hemolytic transfusion reaction involving administration of blood or blood products having major blood group incompatibilities (e.g., ABO, Rh, other blood groups)

      • Invasive procedure, including surgery, on the wrong patient or wrong site

      • Unintended retention of a foreign object in a patient after surgery or other invasive procedures

      • Severe neonatal hyperbilirubinemia (bilirubin >30 mg/dL)

      • Fluoroscopy resulting in permanent tissue injury when clinical and technical optimization were not implemented and/or recognized practice parameters were not followed

      • Fire, flame, or unanticipated smoke, heat, or flashes occurring during an episode of patient care

      • Any intrapartum (related to the birth process) maternal death

      • Severe maternal morbidity

      • Fall resulting in: any fracture; surgery, casting, or traction; required consult/management or comfort care for a neurological or internal injury; a patient with coagulopathy who receives blood products as a result of the fall; or death or permanent harm as a result of injuries sustained from the fall (not from physiologic events causing the fall)

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  3. A "thorough" root cause analysis is one in which the participants identify risk points and their potential contributions to this type of event.

    ROOT CAUSE ANALYSIS PROCESS

    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

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  4. A credible root cause analysis must be based upon a survey of everyone employed at the healthcare institution.

    ROOT CAUSE ANALYSIS PROCESS

    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.

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  5. A wrong-site surgical procedure that did not result in the death of the patient must be reported to the risk manager within three business days according to Florida law.

    ROOT CAUSE ANALYSIS PROCESS

    Healthcare professionals have an obligation to report adverse events to leadership and ensure that organizations have processes 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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  6. The Joint Commission prepares and distributes Sentinel Event Alerts in order to recommend ways in which the healthcare facility can terminate employees whose actions result in a sentinel event.

    ROOT CAUSE ANALYSIS PROCESS

    Unlike Florida's mandatory reporting of serious adverse incidents, the Joint Commission recommends that healthcare organizations voluntarily report sentinel events, and it encourages the facilities to communicate the results of their root cause analyses and their corrective action plans. As a result of the sentinel events that have been reported, the Joint Commission has compiled Sentinel Event Alerts. These alerts are intended to provide healthcare organizations with important information regarding reported trends and, by doing so, highlight areas of potential concern so an organization may review its own internal processes to maximize error reduction and prevention with regard to a particular issue [7].

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  7. Infant abduction is among the most common sentinel events reported to the Joint Commission.

    ERROR REDUCTION AND PREVENTION

    Between 2005 and 2021, the Joint Commission reviewed 14,731 sentinel events [11]. Some events, such as fire, impacted multiple patients. Sentinel event reviews during this time period were frequently conducted for patient fall; delay in treatment; unintended retention of a foreign body; wrong-patient, wrong-site, wrong-procedure surgery; patient suicide; operative and postoperative complications; and medication error [11].

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  8. The most common root cause documented for patient suicide was shortcomings in assessment, most commonly psychiatric assessment.

    ERROR REDUCTION AND PREVENTION

    The most common root cause documented for patient suicide reported between 2010 and 2014 was shortcomings in assessment, most commonly psychiatric assessment [18]. In addition, nearly 25% of behavioral health facilities accredited by the Joint Commission were found noncompliant with the requirement to conduct an adequate suicide risk assessment in 2014.

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  9. A medication error may occur when ordered by a physician, administered by a nurse, or dispensed by a pharmacist.

    ERROR REDUCTION AND PREVENTION

    Unquestionably, medication errors are one of the most common causes of avoidable harm to patients. These errors may occur at any of these critical points: when ordered or prescribed by a physician; during documentation; while transcribing; when dispensed by a pharmacist; when administered by a nurse; or during monitoring.

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  10. Approximately 32% of patients with cancer are initially misdiagnosed.

    ERROR REDUCTION AND PREVENTION

    The early detection and diagnosis of cancers is crucial for selecting the appropriate treatment approach and to ensure an optimum outcome. However, an estimated 12% of cancer patients are initially misdiagnosed, and the missed or delayed diagnosis of cancers remains a significant cause of medical malpractice claims [30,31]. The causes of missed diagnoses vary widely among cancers in different parts of the body. In many cases, patients who do not fit the typical profile for a specific cancer (e.g., young age) may be underdiagnosed, and it is important that cancer is considered as part of the differential diagnosis in ambiguous cases [31,32,33]. In order to prevent missed or delayed cancer diagnosis, practitioners may take steps to ensure adherence to clinical guidelines for screening and diagnosis, use tools to facilitate communication, and engage strategies to ensure appropriate follow-up [55].

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  • Back to Course Home
  • Participation Instructions
    • Review the course material online or in print.
    • Complete the course evaluation.
    • Review your Transcript to view and print your Certificate of Completion. Your date of completion will be the date (Pacific Time) the course was electronically submitted for credit, with no exceptions. Partial credit is not available.