Medical Error Prevention and Root Cause Analysis

Course #51332 - $12 • 2 Hours/Credits


Study Points

  1. Describe how the Institute of Medicine defines "medical error."
  2. Describe the types of sentinel events the Joint Commission has identified.
  3. Discuss what factors must be included in a root cause analysis in order for the Joint Commission to consider it "thorough" and "credible."
  4. Identify what types of adverse incidents must be reported to the Florida Agency for Healthcare Administration.
  5. Identify the most common sentinel events reported to the Joint Commission.
  6. Evaluate the most common misdiagnoses, as recognized by the Florida Board of Medicine, and outline the safety needs of special populations, including non-English-proficient patients.

    1 . The Institute of Medicine's (IOM) Committee on Quality of Healthcare in America defines error as
    A) a preventable sentinel or adverse event.
    B) a situation where the original intended action is not correct.
    C) a process where the correct action does not proceed as intended.
    D) 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 . Which of the following is NOT an example of a sentinel event subject to review by the Joint Commission?
    A) Patient rape
    B) Patient suicide
    C) Discharge of an infant to the wrong family
    D) Discharge of an elderly patient to the wrong assisted living facility

    ROOT CAUSE ANALYSIS PROCESS

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

    • 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

      • 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)

      • Prolonged fluoroscopy with cumulative dose >1,500 rads to a single field or any delivery of radiotherapy to the wrong body region or >25% above the planned radiotherapy dose

      • 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

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    3 . A "thorough" root cause analysis is one in which the participants
    A) identify the one person who is at fault.
    B) include consideration of all of the relevant literature.
    C) identify risk points and their potential contributions to this type of event.
    D) identify only one factor that may have been involved in contributing to the 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 . All of the following reflect a "credible" root cause analysis, EXCEPT:
    A) The analysis must be internally consistent.
    B) The analysis must include consideration of any relevant literature.
    C) The analysis must provide an explanation for all findings of "not applicable."
    D) The 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 . According to Florida law, which of the following adverse incidents must be reported to the AHCA within 15 calendar days?
    A) A surgical procedure that resulted in spinal damage to the patient
    B) A wrong-site surgical procedure that did not result in the death of the patient
    C) The death of a patient during a surgical procedure to remove an unplanned foreign object that remained from a previous surgical procedure
    D) All of the above

    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 and, as part of that program, develop and implement an incident reporting system, which 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.

    Florida Statute 395.0197 specifically defines an adverse incident as [8]:

    An event over which healthcare personnel could exercise control and which is associated in whole or in part with medical intervention rather than the condition for which such intervention occurred, and:

    1. Results in one of the following injuries:

      1. Death;

      2. Brain or spinal damage;

      3. Permanent disfigurement;

      4. Fracture or dislocation of bones or joints;

      5. A resulting limitation of neurological, physical, or sensory function which continues after discharge from the facility;

      6. Any condition that required specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent; or

      7. Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient's condition prior to the adverse incident

    2. Was the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient's diagnosis or medical condition;

    3. Required the surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage was not a recognized specific risk, as disclosed to the patient and documented through informed-consent process; or

    4. Was a procedure to remove unplanned foreign objects remaining from a surgical procedure.

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    6 . The Joint Commission prepares and distributes Sentinel Event Alerts to accomplish all of the following goals, EXCEPT:
    A) To identify reported trends
    B) To highlight areas of potential concern
    C) To maximize error reduction and prevention
    D) 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 . Which one of the following is NOT included among the most common sentinel events reported to the Joint Commission?
    A) Patient falls
    B) Infant abduction
    C) Medication errors
    D) Wrong-site surgeries

    ERROR REDUCTION AND PREVENTION

    Between 2005 and 2015, the Joint Commission reviewed 9,193 sentinel events [11]. Some events, such as fire, impacted multiple patients. Sentinel event reviews during this time period were frequently conducted for unintended retention of a foreign body; wrong-patient, wrong-site, wrong-procedure surgery; delay in treatment; operative and postoperative complications; patient suicide; patient fall; and medication error [11].

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    8 . A medication error may occur at what point during the process?
    A) When ordered by a physician
    B) When administered by a nurse
    C) When dispensed by a pharmacist
    D) All of the above

    ERROR REDUCTION AND PREVENTION

    Unquestionably, medication errors are one of the most common causes of avoidable harm to patients. These errors may occur at three critical points: when ordered by a physician, dispensed by a pharmacist, or administered by a nurse.

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    9 . Which of the following is NOT one of the five "rights" for medication administration?
    A) Right time
    B) Right route
    C) Right patient
    D) Right person administering

    ERROR REDUCTION AND PREVENTION

    The healthcare provider who has the responsibility to administer a medication has the final opportunity to avoid a mistake. In most cases, particularly in inpatient settings, this responsibility falls to the nurse. Nurses are often taught in nursing school to review the five "rights" prior to administering any medication: the right patient is given the right drug in the right dose by the right route at the right time [26]. Medication errors generally fall into four categories, which mimic these five "rights." The first is the failure to follow procedural safeguards, such as ensuring that essential patient information, including allergies, age, weight, and current medication regimen, is available. The second is unfamiliarity with a drug. In one case, a jury determined that a nurse was negligent for giving a drug without having reviewed the literature, which stated that the necessary precautions for the administration of the drug required the specialized skill of an anesthesiologist. The third category of drug administration is failure to use the correct mode of administration. A nurse in Delaware was held liable for administering a medication by injection after an order had been written to change the route to oral. The final category involves failure to obtain clarification if an order is incomplete, illegible, or otherwise questionable. In a case tried in Louisiana, a nurse was held liable for administering a medication that a physician ordered, notwithstanding that the dose was excessive. The nurse's administration of the drug led to the patient's death [27].

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    10 . What percentage of cancer patients are initially misdiagnosed?
    A) 12%
    B) 20%
    C) 32%
    D) 50%

    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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