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StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

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Root cause analysis and medical error prevention.

Gunjan Singh ; Raj H. Patel ; Sarosh Vaqar ; Joshua Boster .

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Last Update: February 12, 2024 .

Continuing Education Activity

The term "medical error" encompasses diverse events that vary in magnitude and can potentially harm the patient. According to the 2019 World Health Organization (WHO) Patient Safety Factsheet, adverse events due to unsafe patient care are among the top 10 causes of death and disability worldwide. However, understanding that healthcare delivery involves multiple variables in a dynamic environment with many critical decisions made quickly is essential to finding the underlying causes of adverse events. Reducing medical errors requires a multifaceted approach at various levels of healthcare. In the event of a sentinel occurrence or adverse patient outcomes, a thorough evaluation is warranted to prevent such events. Root cause analysis provides a method of assessment for these situations so that a system-based intervention can be implemented rather than blaming individual clinicians. Upon completing this activity, healthcare professionals will gain a comprehensive understanding that root cause analysis (RCA) is a mandated process for healthcare institutions to mitigate future errors and promote patient safety. By acquiring proficiency in RCA application and methodology, healthcare professionals can effectively drive changes and improvements within the healthcare setting, resulting in enhanced patient care and a reduction in medical errors. The course also highlights the interprofessional team's role in performing this analysis to prevent medical errors and improve clinical outcomes.

Implement effective root cause analysis of a sentinel event and strategies for prevention.
Apply root cause analysis reporting standards in accordance with the Joint Commission requirements.
Identify the indications for reporting sentinel events to the Joint Commission and the steps that should be taken following the occurrence of such incidents.
Collaborate within an interprofessional team to prevent the most common types of clinical errors and improve clinical outcomes.
Introduction

Medical error is an unfortunate reality of the healthcare industry and a continuously discussed topic due to its grave impact on patient care and outcomes. In a 1999 publication by the Institute of Medicine (IOM), it was highlighted that deaths resulting from medical error exceeded those attributed to motor vehicle accidents, breast cancer, or AIDS. [1] One study reported that approximately 400,000 hospitalized patients experience some preventable harm each year, while another estimated that >200,000 patient deaths annually were due to preventable medical errors. [2] [3] [4] Moreover, the reported cost of medical errors is wide-ranging, with some experts estimating healthcare costs of $20 billion each year, while others approximate costs of $35.7 to $45 billion annually from hospital-acquired infections alone. [2] [3] Subsequent reports that discuss potential etiologies of medical errors have blamed systemic issues. Others have focused attention on certain groups of patients that may be more vulnerable to medical error than others. [5] [6] Recently, the impact of medical errors on a patient's family members and healthcare professionals has been emphasized due to its effects on exacerbating burnout, poor work performance, mental health decline, and even suicidal ideation. [7] [8]

Though pinpointing the definitive cause of medical error in certain situations may be challenging, evaluating strategies that can be used to mitigate and prevent these adverse events from occurring in the first place is essential. One such method is root cause analysis, which has been shown to reduce clinical and surgical errors in various specialties by establishing a quality improvement framework. [9] This article will discuss the application of root cause analysis in medical error prevention and strategies for maintaining continuous quality improvement in the healthcare setting.

Sentinel Events and Root Cause Analysis

The Institute of Medicine defines a medical 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] Recognizing the differences between medical malpractice and medical error is essential. An adverse event in a healthcare setting may be attributed to medical error and not meet the threshold of malpractice or negligence. Medical errors generally result from the improper execution of a plan or improper procedural planning. Thus, the complexity of the occurrence of a medical error can range widely and manifest in any aspect of patient care, from hospital admission to discharge, as well as the outpatient setting. Medical errors may occur without directly harming the patient; however, even in these instances, evaluating the cause of any medical error, whether or not the patient is harmed, and developing guidelines and strategies to prevent future occurrences is critical. [10] [11]

The Joint Commission defines a sentinel event as any unexpected adverse event "involving death, serious physical or psychological injury, or the risk thereof. The phrase 'or the risk thereof' includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome." Sentinel events indicate the need for an immediate investigation to discover the cause and develop corrective measures. Moreover, the Joint Commission reviews all sentinel events that have resulted in unexpected mortality, significant permanent harm, or severe, temporary harm requiring intervention to sustain life, which they require all member healthcare agencies to report. [12] [13] These events are not only debilitating to patients but can also impact the livelihood of healthcare providers. Sentinel events are unrelated to the patient's underlying medical condition but are attributable to improper medical intervention or improper technique. For instance, if a patient receives medication and experiences an anaphylactic reaction, clinicians must determine whether the reaction was due to the medication or failure to review the patient's allergies before administration. Thus, these cases must be critically reviewed to delineate whether or not the etiology of the error was preventable, which is often a challenging task.

Root cause analysis (RCA) is a process for identifying the causal factors of a medical error that may result in a sentinel event. A standardized RCA process is mandated by the Joint Commission to determine the cause of medical errors and thus allow healthcare institutions to develop strategies to mitigate future errors. [13] Despite broad adoption in the business, engineering, and industrial sectors, RCA use in the medical field has been limited. The RCA process aims not to assign individual blame but to identify lapses in system-level processes that can be restructured to prevent patient harm and reduce the likelihood of future sentinel events. Thus, identifying the root cause of a medical error can better direct the need for additional training and resources.

Applying Root Cause Analysis

For accreditation purposes, the Joint Commission requires that healthcare institutions have a comprehensive process for systematically analyzing sentinel events. The RCA process is one of the most commonly utilized tools for this purpose. Through the RCA process, healthcare institutions attempt to identify all the contributing factors that led to an adverse event. Essentially, RCA investigations continually question why a medical error occurred until all underlying deficiencies in a system are found. RCA emphasizes lapses in system-level processes rather than individual actions. Following a sentinel event, a designated RCA team must be assembled to review and identify necessary changes at the systematic level that can improve performance and reduce the likelihood of a repeat sentinel event. [14] Failure to perform an RCA within 45 days of a sentinel event may result in the healthcare institution being placed on an accreditation watch, which is public information. Repeat violations may result in an onsite review by the Joint Commission that may jeopardize accreditation. [15]

An RCA's initial step is forming an interprofessional team to investigate and define the problem. Typically, a designated process is implemented to communicate with senior leadership throughout the investigation, establish internal target dates, and meet Joint Commission deadlines. After identifying the problem, the team should evaluate systematic factors contributing to the error. Throughout the process, collecting data regarding the potential underlying causes is essential. The team should propose and implement immediate changes so that a repeat sentinel event does not occur during the RCA process. While developing these interventions, the team should evaluate the list of root causes, consider their interrelationships, and explore risk-reduction and process improvement strategies to prevent future errors at the systematic level. Furthermore, the team should discuss the proposed process modification with senior leadership and key stakeholders and determine if they are acceptable. There are various models used to guide RCA inquiries. One model is referred to as "The Swiss Cheese Model." According to this framework, errors occur due to failures on 4 primary levels, classified as unsafe acts, preconditions for unsafe acts, supervisory factors, and organizational influences that can allow patient injury when lined up. Therefore, RCA teams work to identify breakdowns on each of these levels that led to an adverse event. [16]

The Joint Commission has also created a framework with a series of 24 questions to organize an RCA and as a general template to prepare the report submitted to the Joint Commission. The 24-question guide considers various situational factors that may have contributed to a sentinel event. This includes examining the systematic process, human factors, equipment malfunctions, environmental factors, uncontrollable external factors, organizational factors, staffing and qualifications, contingency plans, performance expectations, communication issues, and technology. [13] With detailed consideration of each of these topics, an in-depth analysis of the cause of the sentinel event can occur. Communication is one factor examined in several of the 24 questions, including communication within organizational structure, conveying messages effectively and efficiently, and ensuring a proper communication system. Environmental factors should also be examined to determine if any situational issues were ongoing during the sentinel event that may have impacted the outcome. Moreover, staffing is another issue that should be examined during an RCA review to determine if the staff were appropriately qualified, competent, and portioned for their assigned duties. [17]

After discussion, evaluation, and analysis, corrective actions should be developed, identifying areas for targeted improvement. While utilizing the 24-question framework, causative etiologies should be considered to help determine areas that can be restructured to reduce risk. The root cause analysis should be clear and precise while providing appropriate depth and scope. The Joint Commission has identified a series of adverse events subject to their purview. Primarily, this would be a sentinel event that has resulted in death or permanent loss of function unrelated to any underlying medical conditions, including: [17]

Patient suicide involving any patient who received care from a healthcare system, including the emergency department, within 72 hours following their discharge
The unanticipated health issue of a full-term infant
An infant discharged to the wrong family
Abduction of any patient receiving care, treatment, or services
Elopement of a patient within a healthcare setting, leading to harm
Hemolytic transfusion reaction requiring administration of blood products
Rape, assault, or homicide of anyone on healthcare premises
Wrong patient, site, or procedure for any surgical procedures
Unintended retention of a foreign body in a patient following surgery
Severe neonatal hyperbilirubinemia
Prolonged fluoroscopy with cumulative dose to the wrong body region
Fire, flame, or unanticipated smoke, heat, or flashes during patient care
Intrapartum maternal death
Severe maternal morbidity

The finalized RCA report must follow a set standard to meet the Joint Commission's requirements, including:

Participation of the organization's leadership and key stakeholders
Thorough explanation of all findings
Consideration of any relevant or applicable studies
Internal accuracy and consistency, without contradictions or unanswered questions

Case Illustrations with Root Cause Analysis Interventions

The following cases illustrate various types of medical errors, the process of root cause analysis through which failures were identified, and how interventions were implemented in each situation to prevent similar errors in the future.

Case example 1

A 42-year-old primigravida woman at 34 weeks gestation was brought to the obstetric emergency department at midnight with complaints of severe headache, blurry vision, and right upper quadrant pain for the last 5 to 6 hours. She noted lower extremity edema and facial swelling that was gradually increasing. She has gestational hypertension and, 1 week ago, was prescribed labetalol 200 mg twice a day. On initial presentation, her blood pressure was 190/110 mm Hg on 2 separate occasions, 5 minutes apart. She had gained 2 kilograms since her last antenatal checkup in the clinic a week ago. The patient was diagnosed with severe preeclampsia. The senior obstetric resident ordered a loading dose of magnesium sulfate to prevent imminent seizure. The hospital protocol used an intravenous (IV) and intramuscular (IM) regimen where the patient received a 4 g IV bolus and a 10 g IM dose administered as 5 g in each buttock. The senior resident gave verbal orders for magnesium sulfate administration to the junior resident, who verbally communicated the order to the nurse.

The magnesium sulfate dosing regimen was complex, with multiple doses in different locations, and was incorrectly prepared by the nurse who felt rushed in an urgent situation. Because the chart displaying magnesium sulfate's preparation in the drug preparation room had faded, the nurse relied on her memory. As part of the protocol, the nurse recited the dosage to another nurse, who cross-checked it from a printed chart and noted the error in time. The senior resident also identified the error as the dose was communicated aloud, and the drug administration was stopped.

Root cause analysis with corrective measures : A root cause analysis was performed, and measures were taken to avoid this problem. As the Institute of Safe Medication Practices recommended, magnesium sulfate was marked as a high-alert medication. Furthermore, premixed solutions prepared by the pharmacy for the bolus dosing were instituted instead of requiring nurses to mix this high-risk medication on the unit. The second nurse verification measure was retained, with the second nurse instructed to double-check all doses, pump settings, drug names, and concentrations before administration of any drugs. Moreover, the RCA recommended that all medication orders be provided in writing and entered in the electronic medical record using computerized provider order entry (CPOE) systems, regardless of the situation's urgency, to avoid dosing errors. The RCA team emphasized that verbal communication for medication administration should always be avoided. If verbal communication is necessary or unavoidable, the RCA recommended that the nurse taking the order read back the order given to the prescribing physician to minimize any prescribing errors.

Case example 2 (The name and date of birth used in this example are for illustrative purposes and do not represent an actual patient. Any similarities if noted, are purely coincidental.)

Anna Joy, date of birth October 30, 1991, was a primigravida at 30 weeks gestation admitted to a busy obstetric ward with complaints of intermittent cramping abdominal pain. She had come from Spain to visit her sister, who was living in Boston. The patient's ability to communicate in English was limited, preferring to speak Spanish. However, her husband and sister were fluent in English and assisted with translation throughout the history, exam, and admission. The patient was seen by an obstetrician who advised routine threatened preterm labor evaluation and observation.

Another patient, Ann Jay, date of birth September 30, 1991, was 34 weeks gestation and admitted to the same ward for gestational diabetes mellitus with hyperglycemia. A consulting endocrinologist advised glucose monitoring and insulin administration. The nurse taking care of the patient was given orders, performed a finger-stick blood glucose check, and informed the endocrinologist about the results over the phone. The endocrinologist advised 6 units of regular insulin before lunch. After being told by the nurse that the patient was feeling decreased fetal movement, the admitting obstetrician recommended ongoing observation and fetal kick counts.

The family members of the first patient, Anna Joy, informed the nurse that they were going to lunch. The morning shift nurse later required a half-day leave because of personal issues and quickly handed her patients to another nurse. The ward was busy and running at full capacity. The new nurse decided to give the insulin injection first as the patient was about to receive her lunch. She did not know that Anna Joy preferred communication in Spanish. The nurse asked a few questions and rushed through patient identification with the help of 2 unique patient identifiers. She administered the insulin injection to the first patient, only realizing later that the insulin was supposed to be given to the second patient, Ann Jay. The attending obstetrician and the endocrinologist were informed. They took the necessary measures and closely monitored the patient for the next few hours; however, no adverse effects were noted.

Root cause analysis with corrective measures : A root cause analysis was performed, and measures were taken to avoid this problem. The RCA team noted that the nurse caring for both patients had worked in the hospital for 5 years and was recently transitioned to the obstetric ward. This had never happened to her before. The team recognized that the modern patient care delivery process relies on an interprofessional care team's efficient and effective integration. A clear, consistent, and standardized communication method between the team members contributes to safe patient care and minimizes the risk of adverse outcomes. The RCA team did not lay blame on the nurse involved. They instead instituted a standardized handoff platform and required all patient handoffs to occur using this format in the future. During shift change, the handoff between clinicians and nurses is pivotal in providing high-quality care. The aim should be to provide the oncoming team with up-to-date, accurate, and complete information. The RCA team outlined clinical education programs for nurses and clinicians to ensure high-quality and effective handoff occurs at every shift change and patient handoff. They also instituted mandatory use of hospital-based interpreters when communicating with patients who are not fluent in English. The hospital procedure for verifying patient identification using two unique patient identifiers, the name and the date of birth, was retained. However, an additional mandatory step of verifying the patient's identity using an arm-band barcode was instituted before every medication administration. They also highlighted patient charts and rooms when patients had similar names and dates of birth.

Case example 3

A 26-year-old primigravida at 39 weeks gestation with no associated high-risk factors was admitted to a busy labor and delivery floor with labor pains. The patient was managed according to routine labor protocol. When the patient had reached a cervical dilatation of 4 cm, the cardiotocograph showed prolonged fetal bradycardia lasting for 3.5 minutes, which did not resolve with conservative interventions. The patient was transferred to the operating room for an emergent cesarean section. The baby was delivered in good condition, with no intraoperative complications. Before closure, the operating obstetrician asked the scrub nurse to perform a surgical count. The scrub nurse reported a missing gauze piece from the surgical trolley. Therefore, the scrub and the floor nurses performed additional counts several times. A second on-call obstetrician was summoned to assist the primary surgeon in checking the surgical field for the missing gauze piece. The surgical gauze had a heat-bonded barium sulfate marker embedded in the fabric to help with x-ray identification. An intraoperative x-ray was obtained to evaluate for a retained sponge, and the results were negative. After discussing the case with the department chief, the abdomen was closed. Due to the associated delays, the operative time was significantly lengthened, totaling 2 hours and 30 minutes.

Root cause analysis with corrective measures : An RCA of the event revealed inconsistent practices regarding the surgical count before initiating the procedure. Moreover, only the scrub nurse was responsible for performing this count. The RCA team determined that the surgical count is critical and must be performed in a standardized fashion to eliminate variation and minimize human error. They highlighted international standards that recommend standardizing the counting process and systematically tracking the instruments, gauze, and sponges in the sterile field. Subsequently, they instituted the World Health Organization's Surgical Safety Checklist as a mandatory step for all procedures, regardless of the urgency of the procedure. The team also recommended that the counting process be concurrently audible and visual, performed by the scrub nurse and the circulating nurse independently, and done before and after every procedure. They emphasized that the best practices for surgical count be followed regardless of the clinical situation.

Case example 4

A 25-year-old man presented for bilateral LASIK surgery at a same-day surgery center. The operating surgeon, a community-based surgeon not routinely operating at this facility, examined the patient, and informed consent was obtained preoperatively. The refractive error was -4 D for the right eye and – 5 D for the left eye. The plan was to remove the refractive error altogether. There was a timeout to ensure the correct patient and procedure. The LASIK procedure commenced by creating corneal flaps on both eyes, which was completed uneventfully. Then, the patient was adjusted on the operating microscope so that the first eye was directly under the excimer laser, and iris recognition was attempted before the laser-guided corneal power correction was performed. Though the machine did not recognize the iris pattern after 3 attempts, the surgeon decided to proceed. The technician thought this was rare as they had good iris recognition rates of >98% this month. However, he did not want to contradict the surgeon. Before the procedure, the circulating nurse noted that the patient's table was adjusted to the wrong side with the left eye under the laser instead of the right. She pressed the emergency stop button, and the treatment was terminated. After identifying the mistake, the surgeon and technician restarted the machine to treat the correct eyes in the correct sequence.

Root cause analysis with corrective measures : Unlike unilateral procedures, bilateral procedures are especially challenging, particularly if the treatment varies between the 2 sides. An example is LASIK, where both eyes are typically corrected simultaneously, and there is no obvious pathology on the eye except for the refractive error. The correction is determined preoperatively, and the result is not immediately titrated. Therefore, the risk for wrong-site procedures is significant, given these ambiguities. To avoid these adverse events, the RCA team implemented a verification procedure where the optometrist, technician, and surgeon must verify each eye's refractive error before the procedure and after programming the laser. Some advanced laser machines have a built-in layer of defense where the iris pattern of the eye is uniquely identified via iris recognition, helping to determine the correct eye and enhance treatment protocol. Some treatments, however, do not include iris recognition, and therefore, the onus lies on the technicians, nurses, and surgeons to identify the appropriate eye correctly.

Case example 5

A community clinic treats approximately 110 patients daily. The clinic is run by 2 primary care physicians, with the assistance of 2 nurses and scribes. A 10-year-old boy was brought to the clinic by his parents due to a runny nose for the last 10 days. On examination, the primary care physician diagnosed allergic rhinitis and advised them to use over-the-counter cetirizine. One of the scribes had called in sick that day, so a secretary was assisting the physician. The physician advised the parents that cetirizine is an over-the-counter medication that could be obtained at their pharmacy of choice. After 2 days, the patient's mother returned to the clinic and reported that the child was lethargic. The clinic front desk staff told the mother they would convey this to the physician, who was very busy that day. The physician instructed the staff to inform the parents that somnolence was typical for children taking cetirizine and to keep the child at home for the next few days. The message was conveyed to the mother, who decided to take the child to another specialist as she was concerned by the sedation. The specialist noted that the child was taking a 10-mg cetirizine tablet twice a day, which is double the recommended amount.

Root cause analysis with corrective measures : An RCA review at the primary clinic identified a typographical error in the patient instruction handout. Instead of 5 mg twice daily, the instructions had a dosage of 10 mg twice daily. Subsequently, the RCA recommended a verbal and written verification procedure be instituted with the prescribing physicians of all drugs and dosages transcribed by the scribes or office personnel. Moreover, the physician and staff were to read prescription and over-the-counter drug recommendations and doses to the patient or caregiver from the visit summary instructions to verify a match with the clinician's notes. The RCA also mandated a document review for all patient callbacks or return visits before communicating with a patient to avoid future errors.

Case example 6

All-Eyes Laser Center is a busy same-day ophthalmic laser center that performs multiple laser procedures daily but specializes in retinal and anterior segment lasers. A 60-year-old man, JM, suffered from chronic angle-closure glaucoma and had been advised to undergo a Yttrium-Aluminum-Garnett (YAG) laser iridotomy, which involves creating a small hole in the peripheral part of the iris to increase the aqueous flow between the anterior and the posterior chamber. This treatment is frequently performed to prevent an angle-closure attack and further glaucoma progression. This laser surgeon also does another laser procedure called a YAG capsulotomy in which the posterior capsule in a pseudophakic eye is lasered to create an opening to improve vision impaired by after-cataract posterior capsular opacity. The YAG laser device platform allows both procedures to be performed with one machine.

The day JM was scheduled for the YAG procedure was unusually busy at the laser center, and the surgeon was running behind schedule. There were 5 patients ahead of JM, and an approximately 2-hour delay was anticipated. With each patient, the typical practice before a YAG iridotomy procedure consisted of the nurse practitioner checking the patient history, confirming examination findings, and instilling 2% pilocarpine eye drops to cause constriction and ensure good exposure of the peripheral iris crypts. The laser surgeon would then perform the procedure, directing the laser to create a small iridotomy.

After JM was taken to the procedure room, a proper timeout was confirmed, including the correct eye and procedure. However, when the patient was positioned at the laser machine, the surgeon noticed that the pupil was dilated rather than constricted. The surgeon again verified the patient's tag and name and the correct procedure. Though the patient and the procedure were both determined to be correct, the surgeon believed attempting an iridotomy on a dilated pupil would be dangerous. Therefore, the procedure was not performed, and the patient was transferred out of the laser suite. The patient was informed of the error and instructed that he would be rescheduled for the correct procedure in a few days. The error was attributed to the nurse administering the wrong eye drop, secondary to high patient volume and practice inconsistencies.

Root cause analysis with corrective measures : An RCA was performed, and measures were taken to avoid this problem in the future. Though this error did not harm the patient, the risk of the wrong procedure being performed was high. Therefore, the RCA team recommended segregating patients for YAG capsulotomy and YAG iridotomy to different seating areas that were clearly labeled. The 2 eye drops, tropicamide and pilocarpine, were kept in their respective areas, and the staff was not allowed to take them out from their designated area. A barcode-based verification was also instituted and used each time the drop was instilled. Many clinics utilize precautions for similar-sounding medications and patient names. However, in a clinic where multiple procedures with a relatively quick turnover are being performed, pre-procedure medications without designated patient areas have a significant risk of being mixed. Using the precautions such as those mentioned above can help reduce medication errors.
Issues of Concern

The IOM identifies medical errors as a leading cause of death and injury. [1] According to the 2019 World Health Organization (WHO) Patient Safety Factsheet, adverse events due to unsafe patient care are among the top ten causes of death and disability worldwide. Preventable adverse events in the US cause an estimated 44,000 to 98,000 hospital deaths annually, which exceeds motor vehicle collision deaths. [1] Furthermore, in terms of health care, disability, and loss of productivity, medical errors are estimated to cost the community an additional 37.6 to 50 billion dollars. [1] The most severe consequences of medical errors are the adverse events patients and their families suffer. Therefore, utilizing RCA is critical to identify systemic flaws that led to a medical error so that corrective measures can be promptly implemented.

Types of Medical Errors

Healthcare professionals should be familiar with the different types of medical errors to understand better the adverse events that may be caused. Errors are not always due to human miscalculation or miscommunication, as outlined by the cases above. Some errors are inherent to clinical situations, such as patient falls in hospital settings and healthcare-associated infections. Common types of medical errors include surgical errors, diagnostic errors, medication errors, equipment failures, patient falls, hospital-acquired infections, and communication failures. [3] [18]

Surgical errors : Errors in surgery have the highest risk of severe patient injury and death. Intraoperative errors are estimated to be the primary issue in 75% of malpractice cases involving surgeons. Surgical errors involving the wrong site, patient, or procedure should never occur. Investigations into the factors that led to these types of surgical errors have demonstrated that common causes include clinician factors (eg, feeling rushed, distractions, and fatigue), miscommunication, changing or inadequate staffing, organizational factors (eg, discarding specimens as waste and not labeling specimens), medical record issues, and cognitive errors. [19]
Diagnostic errors : The National Academy of Medicine defines a diagnostic error as "the failure to establish an accurate and timely explanation of a patient's health problems or to communicate that explanation to the patient," therefore, delayed or missed diagnoses are considered errors as well. [20] According to the Joint Commission, diagnostic errors result in the death or injury of 40,000 to 80,000 patients annually. Diagnostic errors are most common in primary care solo practices due to workload, time constraints, and the inability to confer easily with colleagues. [21] Malignancies, surgical complications, and neurological, cardiac, and urological issues are the 5 conditions most frequently misdiagnosed. [22] [23] [24] According to studies, these conditions are frequently misdiagnosed secondary to knowledge gaps, resulting in deficient bedside assessment and clinical reasoning. Identifying these commonly misdiagnosed conditions is beneficial, as diagnostic errors are primarily cognitive rather than organization-based errors; therefore, clinicians can be forewarned of the potential challenges when caring for these patients. [25] In addition to a clinical knowledge deficiency, common contributing factors to diagnostic error include a clinician's fatigue, distraction, failure to consider differential diagnoses, neglect of diagnostic testing follow-up, and inadequate patient follow-up care. [11] [21]
Medication errors : These errors are widely accepted as the most common and preventable cause of patient injury. [26] Because there are several components involved with patient medications (eg, prescribing, dispensing, dosing, and administering), errors can occur in any of those areas. The reported incidence of medication error-associated adverse events in acute hospitals is approximately 6.5 events per 100 admissions. [26] Medication errors before or after discharge from an acute care facility are the most easily overlooked or missed errors. [26]
Equipment errors : Medical equipment design flaws, mishandling, user error, and malfunction are common causes of medical errors. Additionally, a significant number of medical devices have been implanted in patients (eg, pacemakers, defibrillators, and nerve and brain stimulators), which may malfunction and result in life-threatening complications. Equipment errors can be due to device differences between manufacturers, inadequate testing and maintenance, poor design, and poor maintenance. Errors involving tube and catheter connections (eg, using catheters for unintended purposes, running the wrong line through a pump, and misplacing feeding tubes into the lung) are also common. These adverse events can have life-threatening effects if a misconnection is not corrected early. [27] [28] To complicate the situation further, medications and food supplements are often delivered via these routes, and placement errors can result in administration or omission mistakes.
Hospital-acquired infections : Healthcare-related infections are considered a failure of the system. As many as 1 in 20 hospitalized patients may acquire a healthcare-related infection, increasing complications and the length and cost of the hospital stay. Healthcare-related infections add close to $35 billion to the annual cost of healthcare in the United States. [29] Common causes of hospital-acquired infections include failure to practice basic hand hygiene and poor technique in placing indwelling urinary and vascular catheters. Subsequently, the most prevalent infections are catheter-associated urinary tract infections, surgical site infections, hospital-acquired pneumonia, central line-associated sepsis, and care-related skin and soft tissue infections. [29]
Patient falls : Each year, over one-third of people older than 65 suffer a fall, with one-third of these causing injury. [30] In a healthcare setting, several factors may further increase the risk of falls, including blood loss medication side effects, post-anesthesia effects, decreased blood sugar, altered mental status, advanced age, mobility impairment, and inadequate staffing. [31]
Communication errors : Optimal interprofessional communication, as well as with patients, is essential for patient care. Therefore, communication errors commonly result in adverse events. [32] Reasons for impaired communication include disruptive patient behavior, environmental distractions (eg, cell phones and pagers), cultural differences, hierarchy issues, personality differences, language barriers, and socioeconomic variables, such as education and literacy. [11] Additionally, errors in written communication, such as using nonstandard abbreviations, illegible handwriting, failure to question inappropriately written orders, and failure to complete correct specimen labeling, frequently occur. [11]
Clinical Significance

RCA helps healthcare organizations study events that resulted in patient harm or undesired clinical outcomes and identify strategies to reduce further medical errors and improve patient safety. Clinician participation in root cause analysis is vital as these initiatives recognize and address essential patient care aspects. Through a review of data gathered by the Joint Commission, the most common categories of clinical error resulting in patient death, which can be prevented through root cause analysis, have been identified. These sentinel events, which account for a significant proportion of morbidity and mortality within the hospital setting, include: [13]

Surgical errors
Diagnostic errors
Patient suicide
Medication errors
Equipment errors
Hospital-acquired infections
Patient falls
Communication errors

Medical Error Prevention Measures

By identifying the deficiencies, failures, and risk factors that lead to an adverse event, corrective measures can be developed to prevent similar errors. Subsequently, individuals involved in every aspect of healthcare can help implement appropriate preventative strategies to reduce future medical errors and improve patient safety. [17] The following interventions are some strategies institutions have implemented to address these common systemic flaws.

Surgical Errors

Preventative measures for surgical errors have frequently consisted of adopting checklists, counting instruments, initiating antibiotic prophylaxis for deep vein thrombosis, and utilizing radio-frequency marked sponges. [3] Additionally, the performance of a surgical time-out has become a widespread strategy to reduce surgical errors. A time-out is a pause before a surgical procedure begins. The surgical team pauses and reviews the patient's identity, the consent form, the procedure being performed, and the correct anatomical structures and side involved, which should be marked on the patient's skin. If multiple procedures by separate surgical teams are planned, separate time-outs must be done. Surgeons and every surgical team member involved in the procedure must be present during the time-out, and any disagreement during the time-out should trigger an investigation by the surgical team until the discrepancy is resolved. [33]

Wrong-site surgery is a major cause of medical errors that can be mitigated through various preoperative safety checkpoints and has been the subject of a sentinel event alert by the Joint Commission. [13] [34] These errors have most commonly been noted in orthopedic surgeries. [35] Risk factors include several surgeons involved in surgical care or transfers to another surgeon for patient care, multiple procedures on a single patient, time constraint pressures, and unique circumstances requiring unusual or special positioning during a surgical procedure. [34] Wrong-site surgeries can easily be mitigated by ensuring proper preoperative measures, such as labeling the correct surgical site with an indelible pen or distinctively marking the nonsurgical site before the surgery. Intraoperative radiography can also assist in aiding the correct surgical site during the procedure.

Diagnostic Errors

Diagnostic errors such as misdiagnoses, delayed diagnostic test results, lack of staffing or physician availability, delays in order fulfillment, inadequate treatment, and delays within the emergency department can cause delays in medical treatment that may result in patient death and permanent injuries. Reducing diagnostic errors requires a comprehensive approach that implements various strategies due to the many factors that can lead to these errors. System-based safety checks and cognitive aids are often recommended as interventions to help prevent diagnostic errors. Cognitive aids include algorithms to help guide decision-making based on accepted guidelines, "trigger tools" within electronic health records that remind clinicians to consider differential diagnoses for commonly misdiagnosed conditions, and checklists to prevent the omission of critical steps. [11] [36] According to a 2015 New England Journal of Medicine article, trigger tools are essential in reducing this type of medical error. [36] Trigger tools are electronic algorithms that identify potential adverse events. This is accomplished by searching electronic health records and flagging specific occurrences. [36] The use of cognitive aids and trigger tools has been shown to decrease the rate of misdiagnoses in recent studies. [36] Addressing deficiencies through various other strategies (eg, device-based decision support, simulation-based training, and increased specialist utilization) may also help reduce diagnostic errors. [24] Though ingrained practice methods and physician overconfidence can attenuate the success of these interventions, fostering critical thinking and promoting "pause and reflect" methods have been found to help avert diagnostic errors, especially in cases with obscure clinical findings or unexpected clinical trajectories. [37] [25] Aside from encouraging critical thinking, opportunities for case discussions and second opinions should be made available for the treating providers. Healthcare facilities should also provide avenues for second opinions or interdisciplinary teams where cases can be discussed. [37] Other interventions to reduce diagnostic errors of commonly misdiagnosed conditions include simulation-based training, performance feedback, and encouraging the contributions of nurses, pharmacists, and other health professionals during patient care. [24]

Patient Suicide

Patient suicide is an unfortunate cause of death commonly seen in psychiatric care settings. [13] Several risk-reduction methods can be implemented for this adverse event, including ensuring a controlled environment free of hazardous materials, frequent patient observation, effective communication, adequate staffing in the facility, suicide assessment upon admission, regular psychiatric evaluation, and assessment for the presence of contraband.

Medication Errors

Medication administration errors are a common and avoidable adverse event that can occur at various patient care levels, involving many individuals in a multidisciplinary patient care team. [38] Barcode administration and handheld personal digital assistants increase medication administration safety by providing real-time patient information, medication profiles, laboratory values, drug information, and documentation. Moreover, electronic medication administration helps identify incorrect medications and orders that have been canceled or modified. However, circumventing barcode procedures decreases safety at the point of care. Automatic dispensing systems that quickly make drugs available to patients allow pharmacy clinicians to engage in other safety activities, such as medication reconciliation. Additionally, look-alike medications should be stored away from more dangerous medications. Hospitals can also standardize storage areas and avoid medication containers that have a similar appearance. Pharmacy clinicians should remove dangerous medications from floor stock and discard out-of-date drugs as a preventative measure. Other strategies include using color-coded intravenous lines, utilizing standard concentrations of vasoactive agents, labeling syringes immediately after preparation, and capitalizing the differences on the labels of medications with similar names. [11] [3]

Equipment Errors

Health professionals should be involved in setting and evaluating institutional, organizational, and public technology-related policies. Safety primarily can be improved by developing protocols for equipment maintenance, training, monitoring, and reporting adverse events related to technology. Additionally, clinicians should be educated in remaining vigilant despite clinical assistance by devices and able to manage equipment failure situations. [39] Unique connectors for anesthesia catheters and feeding tubes can be used to reduce the chances of tubing misconnections. [40] Furthermore, clinicians and support staff should always trace lines back to the origin before connecting or disconnecting devices or starting infusions and labeling high-risk catheters. [27] [28]

Hospital-acquired Infections

Changing the behaviors of healthcare team members is effective in reducing iatrogenic infections. Hand hygiene campaigns have been shown to decrease the number of nosocomial infection rates for various infections and should be universally endorsed. [41] Most healthcare facilities now employ specific protocols for minimizing central venous and urinary catheter use and using protective measures such as chlorhexidine for vascular catheter site care to reduce the incidence of healthcare-associated bloodstream infections, ventilator-associated pneumonia, and catheter-associated urinary tract infections. [3] Minimizing the duration of use of indwelling catheters has also effectively reduced the incidence of associated infections. [41] [3]

To decrease the risk of nosocomial infections, pharmacy-driven antibiotic stewardship programs should be regularly employed in all patients admitted to a healthcare facility. [42] Frequent skin assessment and evaluation by wound care teams with regular and focused nursing education and evidence-based treatments should be routinely employed to lower healthcare-associated pressure injuries. [43] The care of surgical sites should follow similar protocols, with some studies proposing chlorhexidine-impregnated dressings to decrease the incidence of surgical site infections. [3]

Patient Falls

Similarly, patient falls are a constant source of injury within healthcare facilities. Patients at high risk for falls should be identified, and appropriate safety precautions should be taken. Elderly patients tend to be prone to falls due to their age-related changes in vision or cardiovascular problems. Elderly patients also frequently have increased balance issues and muscle weakness over time, leading to ambulatory dysfunction. Having fall-prevention protocols in place, identifying potential high-risk areas within the home, and mitigating them through safety measures can improve patient safety and outcomes. [13]

Standardized protocols can reduce fall rates by ensuring a safe environment for risk-prone patients. Patient factors contributing to falls include advanced age, mobility impairment, and postsurgical effects. [31] Inadequate nurse staffing, an increased portion of staff made of new nurses, and increased shift hours are organizational factors that can lead to patient falls. [31] Implementing fall prevention protocols in hospitals and long-term care facilities has significantly reduced these errors. Furthermore, standardized fall risk assessments such as the Morse Fall Scale can decrease patient falls. [3] Institutional interventions such as staff education, patient mobility training with rehabilitation professionals, and nutritionist support have also been shown to reduce patient falls. [3] Other strategies include identifying patients at high risk for falls, providing patient safety companions, educating caregivers about fall prevention, and setting bed alarms and frequent safety rounds for all high-risk patients. [3]

Communication Errors

A courteous and respectful workplace where the interprofessional team collaborates promotes a safe work environment for all healthcare team members, families, and patients. Risk management committees and interprofessional task forces should work collaboratively on risk assessment and reduction. Joint education programs help providers and support staff learn roles and develop relationships to improve safety. The Joint Commission's Safety Goals require that for critical test results and verbal or telephone orders, a "read-back" verbatim to the practitioner by the person receiving and recording the result or order. The practitioner should then verbally acknowledge the accuracy of the order. [11]

Additionally, healthcare staff should avoid common errors in written communication, such as using nonstandard abbreviations, illegible handwriting, failure to question inappropriately written orders, and failure to complete correct specimen labeling. Therefore, staff should be encouraged to ask questions when uncertain and trained to double-check that the patient's name is spelled correctly and their correct date of birth is present. The Joint Commission requires healthcare professionals to use 2 or more patient identifiers when labeling, delivering, and maintaining specimens. Since this is a National Patient Safety Goal, The Joint Commission closely monitors healthcare institutions' adherence to this requirement as they prepare medications and transfusions and transfer patients from unit to unit. [11]

Clinicians should also follow well-communicated protocols that guide care and communication with patients. Age-associated hearing and cognitive decline increase the likelihood of communication errors regarding medications. Ensuring appropriate communication skills tailored to distinct patient groups is crucial in preventing such errors. Young children and infants are similarly prone to common medical errors due to the lack of direct participation in decision-making and patient care. Thus, specialized communication is needed to convey medical instructions to elderly and younger patients and their caregivers to ensure no lapses in communication. Providers should listen to patients' questions concerning how care is delivered. Concerns must be respected and accepted if care plans contradict established evidence-based medicine. Moreover, the Joint Commission has supported "speak up" initiatives, which encourage hospitals to inform patients about the importance of their contributions to the care they receive in preventing medical errors. To make patients active participants in avoiding medical errors, encourage patients to ask about unfamiliar tests, unplanned diagnostic tests, and medications and to verify the correct surgical site. [11] Additionally, skilled medical interpreters can be crucial in effectively communicating instructions and information to patients instead of family members, who may often be biased. Implementing standardized clinician-family communication at the patient bedside with family engagement and bidirectional communication also decreased the frequency of harmful medical errors and positively impacted the family experience. [44]

Communication errors during patient hand-offs can occur when incorrect information is passed to the receiving clinician, or pertinent information is omitted. [45] Several techniques developed to minimize errors when handing off patients include using electronic records and mnemonics (eg, situation, background, assessment, and recommendation [SBAR]) to address all pertinent information. [46] [47] The SBAR tool is considered a best-practice communication technique to deliver information in an organized and logical fashion during hand-off and critical patient care situations. [47] The US's National Academies of Sciences, Engineering, and Medicine also recommend that these hand-offs occur in real-time and allow the opportunity to ask and respond to questions regarding pertinent facts about patient care. [48] This principle should be used when discharging patients from the hospital as well. Clinicians should remember to perform a final bedside evaluation and review discharge instructions before sending any patient home, including giving the patient a thorough written follow-up plan, counseling on new medications, and instruction to return to the hospital or office for new or worsening symptoms.

Enhancing Healthcare Team Outcomes

Medical errors are undeniably an essential cause of patient morbidity and mortality within the United States healthcare system. These errors are prevalent at rampant levels, and the consequences of such errors can severely impact the patient, family members, and clinicians. The interprofessional healthcare team plays an invaluable role in preventing medical errors; team effort is crucial in identifying strategies and solutions to reduce the burden of medical error on the healthcare system. Nurses, pharmacists, rehabilitation professionals, nutritionists, and physicians are integral to the patient care team and crucial in preventing medical errors. Practitioners who work in error-prone environments must recognize their roles as healthcare team members responsible for reducing unnecessary errors. [49] The interprofessional team members comprising the RCA team should include professionals from all disciplines to ensure an effective investigation and implementation of corrective measures.

Clinicians should not hesitate to provide their peers with assistance in recognizing particular sources of common medical errors to deliver better patient care. Equal accountability and responsibility of all healthcare team members are critical in preventing errors and providing superior patient safety. [1] Quality assurance teams should employ RCAs with every sentinal event, especially in situations when the identification of medical errors becomes difficult or complex due to many underlying factors. RCAs can help identify factors within the healthcare delivery process that may impede the ability to provide quality patient care. Given the preventable nature of most medical errors, a thorough RCA can improve patient safety and allow healthcare organizations to serve as a model for others.

Healthcare professionals should be aware of common medical error sources and work as a team to identify possible risks when they become apparent. Doing so will increase the quality and efficiency of the healthcare industry and patient trust in the healthcare system. When an RCA is performed, the cooperation of all healthcare team members and clinicians involved in patient care is critical to understanding the underlying source of a medical error and identifying future strategies to mitigate such errors and improve patient outcomes.

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Disclosure: Gunjan Singh declares no relevant financial relationships with ineligible companies.

Disclosure: Raj Patel declares no relevant financial relationships with ineligible companies.

Disclosure: Sarosh Vaqar declares no relevant financial relationships with ineligible companies.

Disclosure: Joshua Boster declares no relevant financial relationships with ineligible companies.

This book is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) ( http://creativecommons.org/licenses/by-nc-nd/4.0/ ), which permits others to distribute the work, provided that the article is not altered or used commercially. You are not required to obtain permission to distribute this article, provided that you credit the author and journal.

Cite this Page Singh G, Patel RH, Vaqar S, et al. Root Cause Analysis and Medical Error Prevention. [Updated 2024 Feb 12]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-.

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RCA2: Improving Root Cause Analyses and Actions to Prevent Harm

This tool describes best practices for conducting a comprehensive Root Cause Analyses and Actions (RCA2) to improve patient safety by reducing medical errors, adverse events, and near misses; the Action Hierarchy tool helps identify which specific actions will have the strongest effect for successful and sustained system improvement.

Root Cause Analyses and Actions (RCA2) event review process
Action Hierarchy tool instructions, example, and template

Root cause analysis (RCA) is a process widely used by health professionals to learn how and why errors occurred, but there have been inconsistencies in the success of these initiatives.

To identify best practices around RCAs and develop guidelines to help health professionals standardize the process and improve the way they investigate medical errors, adverse events, and near misses, we have concentrated on the ultimate objective: preventing future harm. Prevention requires actions to be taken, and so we have renamed the process Root Cause Analyses and Actions, or RCA 2 (RCA “squared”) to emphasize this point.

The purpose of RCA 2 is to identify and implement sustainable systems-based improvements that make patient care safer in settings across the continuum of care. The approach is two-pronged:

Identify methodologies and techniques that will lead to more effective and efficient RCA 2
Provide tools to evaluate individual RCA 2 reviews so that significant flaws can be identified and remediated to achieve the ultimate objective of improving patient safety

The intent of an RCA 2 review is to identify system vulnerabilities so that they can be eliminated or mitigated; the review is not to be used to focus on or address individual performance, since individual performance is a symptom of larger systems-based issues.

After completing the RCA 2 investigation and analysis process, RCA 2 teams work to identify corrective actions to mitigate root causes of the adverse event. A tool such as the Action Hierarchy will assist clinical teams in identifying which actions will have the strongest effect for successful and sustained system improvement.

*NOTES:

Before filling out the templates, first save the PDF files to your computer. Then open and use that version of the tool. Otherwise, your changes will not be saved.
IHI does not endorse any software or training for the RCA 2 process that is not directly provided by IHI.

How to Cite These Documents: RCA 2 : Improving Root Cause Analyses and Actions to Prevent Harm . Boston: National Patient Safety Foundation; 2015.

Patient Safety Essentials Toolkit: Action Hierarchy Tool . Boston: Institute for Healthcare Improvement; 2019. (Available at ihi.org)

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How Much of Root Cause Analysis Translates into Improved Patient Safety: A Systematic Review

Jimmy martin-delgado, alba martínez-garcía, jesús maría aranaz, josé l valencia-martín, josé joaquín mira.

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*Jimmy Martin-Delgado, Foundation for the Promotion of Health and Biomedical Research, Hospital Universitario de Sant Joan d'Alacant, Carretera Nacional 332, ES–03550 Alicante (Spain), [email protected]

Received 2019 Sep 17; Accepted 2020 May 12; Issue date 2020 Dec.

The aim of this systematic review was to consolidate studies to determine whether root cause analysis (RCA) is an adequate method to decrease recurrence of avoidable adverse events (AAEs).

A systematic search of databases from creation until December 2018 was performed using PubMed, Scopus and EMBASE. We included articles published in scientific journals describing the practical usefulness in and impact of RCA on the reduction of AAEs and whether professionals consider it feasible. The Mixed Methods Appraisal Tool was used to assess the quality of studies.

Twenty-one articles met the inclusion criteria. Samples included in these studies ranged from 20 to 1,707 analyses of RCAs, AAEs, recommendations, audits or interviews with professionals. The most common setting was hospitals (86%; n = 18), and the type of incident most analysed was AAEs, in 71% ( n = 15) of the cases; 47% ( n = 10) of the studies stated that the main weakness of RCA is its recommendations. The most common causes involved in the occurrence of AEs were communication problems among professionals, human error and faults in the organisation of the health care process. Despite the widespread implementation of RCA in the past decades, only 2 studies could to some extent establish an improvement in patient safety due to RCAs.

Conclusions

RCA is a useful tool for the identification of the remote and immediate causes of safety incidents, but not for implementing effective measures to prevent their recurrence.

Keywords: Root cause analysis, Patient safety, Quality assurance, Translational medicine

Significance of the Study

Root cause analysis is a widespread technique used in the last two decades to investigate latent causes of adverse events.

Lack of expertise and time and a weak legal framework are some of the difficulties in fulfilling action plans from root cause analysis.

It is not clear if root cause analysis is effective in preventing the recurrence of adverse events.

Introduction

Root cause analysis (RCA) emerged in the health care field almost 20 years ago. This technique is used worldwide to understand the remote and direct factors favouring the occurrence of an avoidable adverse event (AAE) [ 1 ], and improvement of patient safety [ 2 ].

Three studies have analysed the utility and limitations of this technique [ 3 , 4 , 5 ], all agreeing that barriers to implementing RCA correctly remain, and most of these were focused on active errors and not latent causes. The published results invite us to reflect on whether the impact of this technique in practice is proving to be all that is theoretically expected, first, because substantial resources and human talent are required [ 5 ], and, second, because many of the recommendations made in the framework of this technique are not applied failing to prevent the same incidents from recurring [ 6 ].

It is one thing to perform a multidisciplinary and multicausal analysis of why an incident occurred, and another, totally different thing to ensure that the proposals derived from this analysis to avoid the recurrence of safety incidents are implemented successfully. The usefulness of RCA may depend on the safety culture of health institutions, decision-making procedures and middle management leadership styles. The objective of this study was to assess the usefulness (i.e., its capacity to improve patient safety) of RCA in health care practice in order to avoid recurrence of AAEs.

We conducted a systematic review of studies published in scientific journals from database creation until December 2018 on the practical usefulness of RCA in the reduction of recurrent AAEs.

Eligibility Criteria

Only studies that analysed the efficacy of RCAs in the improvement of patient safety and studies that analysed the views of professionals on its feasibility were included. This study was designed to address whether the results of RCA improve patient safety, whether the RCA methodology has been fully carried out, and whether health professionals consider it feasible.

The MOOSE protocol was followed. Studies published in scientific journals were included to describe the AEs commonly analysed and the practical usefulness of RCA in the reduction of AAEs or its limitations in improving patient safety. No exclusions were made based on the year of publication, the design of the study, or language. Both quantitative and qualitative studies were included. Research taking a descriptive approach was also included.

Search Strategy

The review of published studies was carried out on MEDLINE, Scopus and EMBASE. The search strategies were defined based on the combination of keywords related to RCA ((“root cause analysis”[MeSH Terms] OR (“root”[All Fields] AND “cause”[All Fields] AND “analysis”[All Fields]) OR “root cause analysis”[All Fields]) AND (“delivery of health care”[MeSH Terms] OR (“delivery”[All Fields] AND “health”[All Fields] AND “care”[All Fields]) OR “delivery of health care”[All Fields])) AND (“patient safety”[MeSH Terms] OR (“patient”[All Fields] AND “safety”[All Fields]) OR “patient safety”[All Fields]), and using the Boolean operators “AND” and “OR.”

In a complementary manner, we conducted manual searches in Google Scholar for the identification of grey literature using the same search equation. We also carried out a manual search based on the bibliographic references of the selected publications.

Data Extraction

J.M.-D. and A.M.-G. independently reviewed all potentially relevant studies. When no consensus was achieved between them, a third researcher (J.J.M.) reviewed the study to reach a consensus. All reviewers were capable of understanding Spanish, English and French, and studies were included in local languages if they included an English abstract, which allowed the authors to decide whether they had to be included for full text reading. No unpublished studies were found, nor was there a need to contact any of the authors of the studies included. Data extracted from each study included country, review committee, inclusion of managers, inclusion of personnel involved, design, database used, employee review method, sample (RCA number, recommendations, audits or interviews conducted), the type of event analysed and the main findings. In addition, where possible, information was extracted on the applicability of the RCAs and the interest of health professionals in the RCA.

Data Synthesis

For each of the above variables, categories of possible options were generated and the presence or absence of information in each variable was coded. Heterogeneity in the methods and measures applied was described when possible. Numbers of participants and AEs were also included. AAEs were classified as sentinel where applicable.

Quality Evaluation

For the assessment of quality of the included studies, J.M.-D. and A.M.-G. used the Mixed Methods Appraisal Tool (MMAT) [ 7 ]. The results led to an overall score for methodological quality, varying from 40–60% (moderate quality) and 80% (considerable quality) to 100% (high quality). None of the studies were excluded based on the quality assessment.

A total of 169 studies were identified, of which 127 remained after exclusion of duplicates. Seventy-seven were excluded as these studies did not include results concerning the effectiveness of RCA in decreasing the number of AAEs. Finally, 21 papers meeting all inclusion criteria were included (Fig. 1 ).

Study selection flow diagram. RCA, root cause analysis.

The samples of the studies show a high variability, from 20 to 1,707 subjects with analysed data (RCA number, recommendations, audits or interviews conducted). The studies were mainly conducted in North America (52%; n = 11), Australia (19%; n = 4) and Europe (14%; n = 3); 57% were quantitative studies (6 longitudinal and 6 cross-sectional), 1 study was a randomised controlled trial, and the rest were qualitative analyses. The most common setting was hospitals (86%; n = 18). The type of incident most analysed was AAEs, in 71% ( n = 15) of the studies, where sentinel events represented 13% ( n = 2) of the AEs, and serious AEs classified as Severity Assessment Code 1 (for Queensland Health) or 3 (for the Department of Veterans Affairs) accounted for 20% ( n = 3), while for the remaining 10 studies, information about severity was not disclosed. Incidents related to safety made up 5% ( n = 1), and in the rest of the included studies, interviews or mock-ups were implemented.

In only 5 studies (24%) were managers or coordinators included, and in only 1 study were personnel from the service taken into consideration. Independent hospital databases and national or regional databases were mostly used, each accounting for 29% of the studies. Although the Veterans Affairs National Center for Patient Safety database was used in 5 of the studies (24%), they also examined individuals. For the rest of the cases, databases were not used.

Of the 21 articles, 9 were rated as having a moderate quality (MMAT 40–60%), 5 were rated as having a considerable quality (MMAT 80%), and 7 were rated as high quality (MMAT 100%). The key features of each study are presented in Table 1 [ 3 , 4 , 5 , 6 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 ].

Main findings and features of the studies reviewed

RCA, root cause analysis, MMAT, Mixed Methods Appraisal Tool; NCPS, National Center for Patient Safety.

Interventions to Reduce Acute Care Transfers Quality Improvement tools.

Number of incidents, RCA, professionals, surveys, centres, indicators and recommendations.

Utility of RCA

Only in 2 studies (9%) could it be established that RCAs contributed to the improvement of patient care to some extent. In these studies, only 54 RCAs were reviewed. In 3 other studies (15%), the authors did not conclude that their implementation contributed to the improvement of patient safety, and in 10 (50%) of them, the recommendations made were weak, which did not lead to a reduction of AEs.

Some studies warned that sometimes poorly designed action plans and measures may generate new risks and may be insufficient to prevent the occurrence of new events [ 5 , 6 , 10 , 16 ]. In the study carried out by Hibbert et al. [ 4 ], in which the effectiveness and sustainability of the proposals arising from 227 RCAs were analysed, it was found that 72% of the recommendations categorised as relevant were not formulated and that the most common recommendations did not refer to latent causes in clinical practices but to active errors. Likewise, other studies [ 3 , 6 ] stated that most of the proposed recommendations focused on active errors and neglected latent causes, which provides short-term solutions but only partially helps to avoid future incidents. However, 1 study (5%) did demonstrate the usefulness of RCA and its recommendations [ 20 ].

Three studies (15%) showed that the RCA method was not applied properly [ 3 , 5 , 25 ]. François et al. [ 5 ] stated that only 23% of the 98 events selected for in-depth analysis covered all the domains defined by the method. Singh [ 3 ] pointed out that 65% of the RCAs carried out were not properly completed. In 5 studies (25%), the involvement of the professionals in the realisation of the RCA was analysed. While these appear to suggest a consensus that the relevance of RCA to establishing improved procedures caused it to be perceived as a beneficial analytical instrument, the researchers concluded that professionals encounter difficulties in conducting RCAs [ 8 , 14 ].

The literature collected analysed the usefulness of RCA as a process that allows the determination of factors that contribute to the occurrence of AAEs. Most of these were caused by communication problems among professionals [ 3 , 13 , 14 , 19 ], human error [ 9 ] and, finally, faults in the organisation of the health care process [ 3 , 22 ].

Weaknesses in Using RCA

Despite the fact that for professionals, RCA is a tool that allows improvements to the safety culture through the prevention of future AAEs [ 3 , 5 ], studies have identified the main weaknesses diminishing the usefulness of RCA in the framework of patient safety [ 5 ]. RCA is an extensive process that requires proper qualifications and attitudes. Studies have shown that the RCA method is often not properly applied, which directly affects the rigor and depth of the analysis of this tool [ 3 , 5 , 25 ]. The most common difficulties are a lack of time and resources of the work teams. Although none of the studies reviewed refers to how much time is needed to perform an RCA, in the study conducted by McGraw and Drennan [ 26 ], the results of an RCA investigation of pressure ulcers showed that a nurse can take up to 20 h to complete it. These factors directly affect the RCA process, hindering its complete execution [ 5 ].

Lack of time does not seem to be the only element that hinders the performance of RCAs; describing the events from a perspective different from individual error is challenging to professionals, who are sometimes reluctant to participate because of the distrust generated by possible future consequences. The belief that there is a culture focused on searching “those responsible” − in addition to creating tension in the work environment that may cause interprofessional problems [ 5 , 18 ] − is one of the main reasons for professionals refusing to participate in incident reporting systems [ 27 ].

Impact on Reducing AAEs

None of the studies reviewed assessed the ability of this process to reduce future AAEs. Moreover, in the study by Lee et al. [ 23 ], difficulties were found in determining whether the improvement actions implemented after the RCA were able to reduce the occurrence of AAEs, as the action plans did not follow a pattern of controlled implantation. On the other hand, Morse and Pollack [ 24 ] and Sauer and Hepler [ 22 ] were the only ones that found sufficient follow-up time, which allowed the determination of whether the recommendations agreed on in the RCA reduced the occurrence of AAEs to some degree. In order to increase the commitment and interest of health professionals in carrying out RCA, some studies have evaluated the usefulness of a mock RCA as prior training to provide medical staff with basic knowledge about patient safety and the methodology of this tool. The results showed that its use raised their confidence in being able to perform RCA and decreased their anxiety in the face of a possible AE [ 10 , 18 ]. This is supported by Boussat et al. [ 28 ], who found that professionals who were involved in Experience Feedback Committees had better scores on the Hospital Survey on Patient Safety Culture, especially in non-punitive response to error, communication and organisational learning dimensions.

Improvements in Introducing Changes

The studies reviewed show that managers and the personnel involved in AAEs had a low participation in the committees in charge of carrying out RCA. Peerally et al. [ 25 ] pointed out the need to professionalise the investigation of incidents by involving experts, as well as patients and family members, who can provide a unique perspective on the care received. Including those professionals who have been directly involved in the event also seems to have positive consequences, as it can contribute to the recovery of second victims by making them part of the solution [ 29 ]. Despite the progress and improvement in quality of care, the involvement of report systems such as RCA, especially the implementation of measures adopted, does not seem to be successful. Most of the included countries have so-called apology laws (39 states of the USA have Medical Professional Apologies Statutes; e.g., the Maryland Courts and Judicial Proceedings Code Ann. §10-92041), which aim to improve the relationship with the patient and their families, allowing them to provide information that improves the quality of care [ 27 ]. However, the presence of the professionals involved in an AE in RCA committees was mentioned in only 1 study [ 6 ], and in none of the cases were relatives present.

Although AEs are sometimes inevitable and part of the uncertainty of medical practice, the ultimate goal of the RCA is to help to produce solutions and apply necessary measures to ensure they do not happen again, that there is a lower probability of their occurrence, or that if they occur the possible consequences are mitigated. Although some studies have demonstrated the usefulness of RCA and its recommendations [ 24 ], most published studies found that just over half of the recommendations that resulted from RCA were not useful enough to prevent the same incidents from recurring in the future [ 6 , 14 , 25 ]. For this reason, researchers have proposed RCA-based tools that seek greater involvement of frontline professionals in the implementation of proposals to prevent the recurrence of serious AEs [ 30 ]. The non-existence of a formalised system that allows these recommendations to be addressed in a specific period of time, as well as the limited power of RCA committees to ensure compliance with these improvement actions [ 17 ], hinders implementing the proposed actions. It must be borne in mind that, normally, the people who will have to assume the responsibility of approving the measures suggested by the RCAs and the professionals who must implement these measures are usually not those who participated directly in the RCA. This makes it difficult for the proposals to be carried out.

It seems, therefore, that RCA is a process with considerable validity through which much may be learned about incidents [ 12 , 15 ]. However, it does not seem to produce enough benefits to address and resolve the problem [ 23 , 25 ] and, thus, to avoid possible AAEs. As explained by Najafpour et al. [ 13 ], RCA is a reactive method for investigating an event and finding its underlying factors. This method could provide answers to questions related to what happened, and how and why it happened, and should be used to design preventive interventions. It should be performed using an outlined framework process of investigation and analysis of clinical incidents performed by professionals with experience in patient safety and should include at least one manager and one of the personnel involved in it.

Limitations

Some of the limitations encountered are that most of the published data related to RCAs pertain to analysing the method of determining whether RCA is being implemented. Only reported results and quotations were assessed. Finally, little of the scarce evidence available regarding the impact − which was our objective − of carrying out RCAs can actually contribute to reducing the recurrence of the same incident, which may be due to the limited decision-making power of committees or to the proposed plan of action not being followed up in time.

Although early studies suggested that RCAs are effective in promoting ideas for preventing recurrence, more recent studies do not confirm these findings. A common gap that limits the effectiveness of this tool lies in the fact that RCAs are not usually accompanied by subsequent control of whether the devised improvement plan is carried out. Further research should focus on how to translate the results of ACR recommendations into practice to prevent recurrence of AAEs.

Statement of Ethics

For this systematic review, the MOOSE protocol was followed.

Conflict of Interest Statement

The authors have no conflicts of interest to declare.

Funding Sources

This research was funded by the PROMETEO Research Program, Consellería de Educación, Investigación, Cultura y Deporte, Generalitat Valenciana (Prometeu173).

Author Contributions

The conception and design were made by J.J.M.; the data were collected by A.M.-G. and J.M.-D.; the article was supervised by J.J.M.; all the authors contributed to writing, revising and approving the final draft.

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Book/Report

Root Cause Analysis in Health Care: A Joint Commission Guide to Analysis and Corrective Action of Sentinel and Adverse Events.

Root Cause Analysis in Health Care: A Joint Commission Guide to Analysis and Corrective Action of Sentinel and Adverse Events. Oakbrook Terrace, IL: Joint Commission Resources; 2020. ISBN: 9781635851618.

Root cause analysis has been widely adopted as a strategy to investigate events, despite questions regarding its effectiveness in health care. This revised publication provides information about updated approaches to root cause analysis with an emphasis on identification of causal and contributing factors. It highlights the use of failure mode and effects analysis as a complementary sentinel event examination strategy that enables design of proactive and reactive improvements.

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Strategies for Addressing Health Care Worker Fatigue. December 17, 2008

Medication Use: A Systems Approach to Reducing Errors, Second Edition. March 28, 2012

Patients as Partners: Toolkit for Implementing National Patient Safety Goal 13. October 26, 2007

Patients as Partners: How to Involve Patients and Families in Their Own Care. November 23, 2016

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