Per the Institute of Medicine, a medical error is defined as "the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim." It is important to recognize the differences between medical malpractice and medical error. An adverse event in a healthcare setting may be attributed to medical error while not meeting the threshold of malpractice or negligence. Medical errors generally result from the improper execution of a plan or improper planning of a method of execution. Medical errors can also occur during preventative care measures, for example, if a provider overlooks a patient's allergy when administering medication. Thus, the complexity of the occurrence of a medical error can range widely and manifest at any aspect of patient care, from admission to discharge and in the outpatient setting. It is also essential to recognize that medical error may occur without causing direct harm to the patient. Regardless, it is critical to evaluate the cause of all medical errors, whether or not the patient is harmed, and develop guidelines and strategies to prevent future occurrences.
If medical errors harm the patient, they are classified as preventable adverse events or sentinel events. Sentinel events are preventable adverse outcomes that warrant urgent investigation to determine the cause of the error. These events are not only debilitating to patients but can also impact the livelihood of healthcare providers. It is important to note that sentinel events are unrelated to the patient's underlying medical condition but result from improper medical intervention or improper technique. If a patient receives medication and experiences an anaphylactic reaction, it must be determined whether the reaction was due to the medication itself or the provider's 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 oftentimes a challenging task.
Root cause analysis (RCA) is a process for identifying the causal factors underlying variations in performance. In the case of medical error, this variation in performance may result in a sentinel event. A standardized RCA process is mandated by the Joint Commission to identify the cause of medical errors and thus allow healthcare institutions to develop strategies to mitigate future errors. Despite its wide adoption in the business, engineering, and industrial sectors, its use in the medical field has been limited. It is important to note that 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 the systematic analysis of sentinel events. The RCA process is one of the most commonly utilized tools for this purpose. Through the RCA process, healthcare institutions can optimize patient care and enact measures to mitigate adverse events that compromise patient safety. In addition to improving patient safety and quality metrics, an RCA's purpose includes optimizing process flow and outcomes.
The emphasis of an RCA is placed heavily on system-level processes, not particular individuals' actions. A designated RCA team is assembled, which reviews and identifies necessary changes at the systematic level, improving performance and reducing the likelihood of a repeat sentinel event. Failure to perform an RCA within 45 days of the occurrence 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.
The first step of an RCA is to form a multidisciplinary team to analyze and define the problem. There should be a designated process to communicate with senior leadership throughout the journey while also meeting deadlines internally and with the Joint Commission. After identifying the problem, the team should evaluate systematic factors that may have contributed to the error. Throughout the process, it is important to collect data regarding the potential underlying causes. The team should propose and implement immediate changes so that a repeat sentinel event does not occur during the RCA process itself. Next, the team should evaluate the list of root causes and consider their interrelationships. During the RCA process, the team will explore risk-reduction and process improvement strategies to prevent future errors at the systematic level. After identifying process improvement strategies, the team will need to communicate with senior leadership and key stakeholders to evaluate whether the proposed process modifications are acceptable.
The Joint Commission has created a framework and series of 24 questions to aid in organizing an RCA. This framework is recommended to be utilized as a general template when preparing the RCA report that will eventually be submitted to the Joint Commission after thorough evaluation. The 24 question framework recommended by the Joint Commission considers a variety of 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, informational disruptions, communication, environmental risks, training, and technology.
With detailed consideration of each of these topics, in-depth analysis into the cause of the sentinel event can occur. One factor that makes an appearance in several questions is communication. Communication within the team and with leadership is critical to maintaining organizational structure. Without proper communication systems in place, it can be difficult to convey messages effectively and efficiently. Environmental factors should also be examined to determine if there were any situational issues ongoing at the time of the sentinel event that may have impacted the outcome. Staffing is another important topic that should be examined to determine if the staff were appropriately qualified and competent for their assigned duties.
Through thorough discussion, evaluation, and analysis, a set of corrective actions can be developed, identifying areas for targeted improvement. While utilizing the 24 question framework, it is important always to consider causative etiologies because it will help determine the specific area 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 that are 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. Alternatively, a sentinel event can also be considered as one of the following, even if the event did not cause death or severe harm:
- Patient suicide: any patient receiving care (including emergency department care), treatment, or services within the healthcare setting or 72 hours following their discharge.
- Full-term infant having an unanticipated death.
- An infant was discharged to the wrong family.
- Abduction of any patient receiving care, treatment, or services.
- Elopement of a patient within a healthcare setting, leading to their harm.
- Hemolytic transfusion reaction requiring administration of blood products.
- Rape, assault, or homicide of anyone on scene at the healthcare premises.
- Wrong patient, site, or procedure for all invasive procedures, including surgery.
- 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 occurring during patient care.
- Intrapartum maternal death.
- Severe maternal morbidity.
Further, to be considered a credible RCA, the final report must follow a series of standards, including:
- Participation of the organization's leadership and key stakeholders involved in the process/system under review.
- Thorough explanation of all findings.
- Consideration of any relevant or applicable literature.
- Internal accuracy and consistency, without contradictions or unanswered questions.
Case Example 1
A 42-year-old primigravida female at 34 weeks gestation was brought to the obstetric emergency at midnight with complaints of severe headache, blurry vision, and right upper quadrant pain for the last five to six hours. The patient noted gradually increasing lower extremity edema and facial swelling. She has a history of gestational hypertension and was prescribed labetalol 200 mg twice a day, one week previously. At the time of presentation, the blood pressure was 190/110 mm Hg on two separate occasions, five minutes apart. She had gained two kilograms since her last antenatal checkup in the clinic one week previously.
The patient was diagnosed with severe pre-eclampsia. The senior obstetric resident ordered a loading dose of magnesium sulfate to prevent imminent seizure. The hospital protocol used the IV and IM regimen where the patient receives a four-gram (20% concentration) intravenous solution bolus and 10-gram intramuscular dose (50% concentration), five gram in each buttock. The senior resident provided the order for magnesium sulfate administration to the junior resident verbally, who subsequently verbally communicated the order to the nurse.
This magnesium sulfate dosing regimen is complex with multiple doses in different locations and was incorrectly prepared by the nurse who felt rushed in an urgent situation. A chart displaying magnesium sulfate's preparation in the drug preparation room had become faded and was supposed to be replaced but was delayed. Therefore the nurse prepared the medication relying on her memory. Before administering the medicine to the patient, as a part of the protocol, she repeated the dose strength aloud to another nurse who cross-checked it from a printed chart and picked up the error in time. The senior resident also identified the error as the dose was communicated aloud and stopped administering the drug.
Magnesium sulfate is on the list of high alert medications by the Institute of Safe Medication Practices. The drug has a serious risk of causing significant patient harm when used in incorrect dosages and concentrations. Accidents and adverse outcomes continue to occur with magnesium sulfate in obstetrics because of the complex dosing regimen and preparation. It is worthwhile to review important safety procedures that can minimize risk. It is advisable to use premixed solutions prepared by the pharmacy for the bolus rather than requiring nurses to mix high-risk medications on the unit.
Learning lesson: Variation is an inherent part of each process and contributes to the errors in medicine. By standardizing the activities in each process, variation can be minimized, and errors can be reduced. Before administering high-risk medications, a second nurse should double-check all doses, pump settings, the drug name, and concentration should be read out loud in front of the care delivery team.
Case Example 2
The name and date of birth used in this example are imaginative, used for illustrative purposes, and do not represent an actual patient. Any similarities, if noted, are purely coincidental, considering that there are more than 7 billion people in the world!
Anna Joy (date of birth October 30, 1991) was admitted to a busy obstetric ward. She was a primigravida at 30 weeks of gestation with complaints of intermittent cramping abdominal pain. She had come to visit her sister living in Boston from Spain. The patient's ability to communicate in English was limited, and she preferred communicating in 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 investigations for threatened preterm labor and observation.
Another patient Ann Jay, (date of birth September 30, 1991), was also admitted to the same day's obstetric ward. She was 34 weeks gestation and was admitted because of gestational diabetes mellitus with hyperglycemia. Her obstetrician advised an endocrinology referral, and the endocrinologist advised glucose monitoring and insulin administration. The nurse taking care of the patient was provided with the instructions, performed a finger-stick blood glucose check, and informed the endocrinologist about the results over the phone. The endocrinologist advised six units of regular insulin pre-lunch. The nurse also informed the obstetrician that the patient felt a decrease in fetal movements. The obstetrician advised 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 took a half-day leave because of personal issues and quickly handed over the patient 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 waiting for lunch. She did not know that Anna Joy preferred communication in Spanish, and family members were absent during that time. The nurse asked a few questions and rushed through patient identification with the help of two unique patient identifiers. She administered the insulin injection to the first patient and later realized that it was supposed to be given to the second patient, Ann Jay.
The attending obstetrician of the patient and the endocrinologist were informed. They took the necessary measures and closely monitored the patient for the next few hours. No inadvertent effects were noted. The nurse taking care of both the patients worked in the hospital for the last five years and was recently transitioned to the obstetric ward. This had never happened to her before, and she realized that she should have checked the instructions more carefully when setting up the patient's medication. She thought she performed the patient identification information, but not carefully enough. She did not check the patient's armband and could not communicate effectively with the patient because of the language barriers. Also, the system relied on using the patient's family members and not hospital interpreters for communication.
The hospital procedure for verifying patient identification information was using two unique patient identifiers, the name and the date of birth. During the handover process between the two nurses, there was no highlighting that the patients had similar names and dates of birth.
Learning lesson: The modern patient care delivery process relies not on an autonomous physician but efficient and effective integration of a multidisciplinary care provider team. The team comprises clinicians from different sub-specialties, nursing staff, and other allied healthcare professionals. A clear, consistent, and standardized communication method between the team members contributes to the strong foundation of patient care. During shift change, the hand-off between clinicians and nurses is pivotal in providing high-quality care. The aim should be to provide up-to-date, accurate, and complete information to the oncoming team. The care providers need education about the importance of effective hand-offs. Similar sounding patient names can result in significant medical errors. Two unique identifiers should always be used with each interaction with a patient.
Case Example 3
A 26-year-old primigravida female was admitted to a busy hospital's labor and delivery suite at 39 weeks gestation with labor pains. There were no associated high-risk factors. The patient was admitted to the labor ward and managed as per the routine protocol. She progressed in spontaneous labor, but the cardiotocograph showed prolonged fetal bradycardia lasting for three and a half minutes at 4 centimeters (cm) cervical dilatation. The fetal bradycardia did not resolve with initial conservative measures.
The patient was transferred to the operating room for a category one emergent cesarean section. A category one cesarean section means that the baby should be delivered within 30 minutes of the procedure's decision. It is done when there is an immediate threat to the life of the mother or the baby. The baby was delivered in good condition, and there were no intraoperative complications. However, before closure, the operating obstetrician asked the scrub nurse to perform a surgical count. The scrub nurse reported that there is a missing gauze piece from the surgical trolley. The count was performed several times by the scrub and the floor nurse. The second on-call obstetrician was called to assist the primary surgeon in checking for the surgical field's missing gauze piece.
The surgical gauze had a heat bonded barium sulfate marker embedded in the fabric to assist with x-ray identification. An intra-operative x-ray was obtained to evaluate for intra-peritoneal gauze and was negative. The case was discussed with the department chief, and abdominal closure was performed. Due to the associated delays, the operative time was increased significantly (two hours and thirty minutes).
Learning lesson: The surgical count is of extreme importance and must be performed in a standardized fashion that eliminates variation and error. Per international standards, there should be standardization of the counting process and systematic tracking of the instruments, gauze, and sponges in the sterile field. To eliminate errors, the counting process should be concurrently audible and visual. The process should be performed between the scrub nurse and the circulating nurse. The best practices for surgical count should always be followed.
Case Example 4
A 25-year-old male presented for bilateral LASIK surgery at a same-day surgery center. The patient was examined by the operating surgeon, a community-based surgeon who does not routinely operate at this facility. Informed consent was obtained by the operating surgery pre-operatively. The refractive error was -4 D for the right eye and – 5D for the left eye. The plan was to remove the refractive error completely. There was a timeout to ensure the correct patient and procedure. The LASIK was started by making corneal flaps on both eyes, which was completed uneventfully. The second step was the excimer laser-guided corneal power correction.
The patient was adjusted on the operating microscope so that the first eye was directly under the excimer laser, and iris recognition was attempted. The machine did not recognize the iris pattern after three attempts. The surgeon decided to proceed without iris recognition. The technician thought that this was rare and that they had good iris recognition rates for this month (> 98%). However, he did not want to contradict the surgeon, who is known for his temper!
Before the procedure, the circulating nurse noted that the patient's table was adjusted to the wrong side, and the left eye was 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 sequence's correct eyes.
Compared to unilateral procedures, bilateral procedures are especially challenging, particularly if the treatment varies between the two 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 there is no titration of the result immediately. There is a significant chance for wrong-site procedures given these ambiguities. To avoid this disaster, a Swiss cheese type pattern is implemented in LASIK centers where the optometrist, technician, and surgeon always verify each eye's refractive error before the procedure and after programming the laser.
Some advanced laser machines have an inbuilt layer of defense where the iris pattern of the eye is uniquely identified via iris recognition, which helps identify the correct eye and enhances the treatment fidelity. Some treatments, however, do not include iris recognition, and therefore the onus lies on the surgeon to correctly identify the appropriate eye.
Learning lesson: The Swiss cheese model works on the principle that if there are multiple layers of check between the planned event and its execution, the error is preventable. This draws on an analogy from layers of swiss cheese stacked together. Each slice of cheese represents a checkpoint to avoid the error. The holes in the cheese slices are random, which represents a random error in the process. However, if multiple layers are stacked together, the probability of missing the error decreases. As we noted in this example, rechecking the correct site for the correct treatment dose can avoid disasters in bilateral procedures, especially when there are no obvious differentiating pathologies on examination.
Case Example 5
A community clinic treats approximately 110 patients per day. It is run by two primary care physicians, with the assistance of two nurses and scribes. A ten years old boy was brought to the clinic by his parents. The child had a running nose for the last ten days. On examination, the primary care physician noted simple 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, and they can go to their pharmacy of choice to obtain the medication. After two days, the patient's mother returned to the clinic and reported that the child is lethargic. The clinic's front desk noted this and said that they would convey the information to the physician, who was very busy that day. The physician said that it is typical for children taking cetirizine to be slightly sleepy on getting this information. He said that they should inform the parents to ask the child to avoid going to school for the next few days. The message was conveyed to the mother.
She decided to take the child to another specialist as she was concerned regarding the sedation. On the second opinion, a review of current medications was done. It was noted that the child was taking a cetirizine tablet 10 mg two times a day which is higher than typically recommended.
A review of the error was performed at the primary clinic. It was noted that there was a typographical error in the instructions given to the patient, saying 10 mg twice a day, instead of 5 mg twice a day, which the physician intended. The secretary, who was filling in for the scribe, did not double-check the physician's correct dose. The physician did not verify the patient's instructions before discharging the patient from the clinic. Furthermore, they did not recheck the medication dose when the mother called back with sedation concerns.
Learning lesson: When writing over-the-counter medications, the physician and the team should be very careful with the correct dosage and read them out again to the patient/attendant in the clinic from the summary instructions and verify that it matches their notes. There is often another defense layer for prescription-only medications in terms of pharmacists verifying the dose, which often does not exist with OTC medications. A swiss cheese-like model, where at least few checks are done to avoid errors, is useful. Also, a document review should be mandated before patient communication to avoid errors.
Case Example 6
All-Eyes Laser center is a busy same-day Ophthalmic Laser center with multiple laser procedures being performed throughout the day. The center specializes in retinal and anterior segment lasers. A 60-year-old male, JM, suffers from chronic angle-closure glaucoma and has been advised to undergo a YAG(Yttrium-Aluminum-Garnett) laser iridotomy. This procedure involves creating a small hole in the peripheral part of the iris to increase the aqueous flow between the anterior chamber and the posterior chamber to prevent a possible angle-closure attack and/or to prevent further progression of glaucoma.
This was an unusually busy day at the laser center. The laser surgeon was running behind. There were five patients ahead of JM, and there was an anticipated delay of around 2 hours. As is the practice at the center, the nurse practitioner prepared the patients before the laser, and then the laser surgeon performs the procedure. The preparation involves checking the history, confirming the examination findings, and then instilling eye drops to prepare the procedure's eyes. This laser surgeon does two types of laser procedures. YAG iridotomy, which is explained above, needs the eyes constricted with pilocarpine 2% eye drops, which ensures a good exposure of the peripheral iris crypts where the laser is directed to create a small iridotomy. The second procedure is a YAG capsulotomy. The posterior capsule in a pseudophakic eye is lasered to create an opening to counter an after cataract posterior capsular opacity and improve vision. The YAG laser platform is a combined platform in which both procedures can be done with one machine.
The surgeon arrived at the laser suite and started the lasers. When JM's turn came, a proper time out, including the correct eye and correct procedure, was confirmed. However, when the patient was positioned at the laser machine, the surgeon noticed that the pupil is dilated rather than constricted. The surgeon verified the patient tag and patient name again and the correct procedure. It was confirmed that the patient was indeed the correct one and the procedure intended was YAG iridotomy. It would have been dangerous to attempt an iridotomy in a dilated pupil. The surgeon did not proceed with the procedure, and the patient was transferred out of the laser suite. The patient was counseled regarding the error and instructed that he would be rescheduled for the correct procedure in a few days. The error was misattributed to the nurse administering the wrong eye drop secondary to high patient volume and inconsistencies.
A root cause analysis was performed, and measures were taken to avoid this problem in the future. This error did not result in harm to the patient. However, there is a significant chance of the wrong type of procedure being performed. Considering this, the laser center started segregating patients for YAG capsulotomy and YAG iridotomy to different seating areas which were clearly labeled. The two eye drops, tropicamide, and pilocarpine were kept only in these areas, and the staff was not allowed to carry these drops out from the designated area. A barcode-based verification was used each time the drop was instilled.
Learning lesson: There are precautions in place for similar-sounding medications and similar-sounding patient names. However, in a mixed clinic where multiple procedures are being performed with a relatively quick turnover, the pre-procedure medications can be mixed especially if there is no designated 'bedside area' for the patient. Therefore using the precautions noted above can avoid incorrect medication administration.
Root cause analysis has important implications in helping healthcare organizations study events that resulted in patient harm or undesired clinical outcomes and identify strategies to reduce future error and improve patient care and safety. Most notably, root cause analysis can help identify medication errors such as illegible handwritten prescriptions, similar name packaging or misleading presentations of drug strength or dosage, ineffective control of prescription labels, and lapsed concentration due to interruptions. Clinician participation in root cause analysis is vital as these initiatives recognize and address important patient care aspects.
Through a review of data gathered by the Joint Commission, six common categories of clinical error resulting in patient death, which can be prevented through root cause analysis, have been identified. This includes wrong-site surgeries, patient suicide, surgical complications, medical treatment delays, medication errors, and patient falls. These sentinel events account for a significant proportion of morbidity and mortality within the hospital setting.
Wrong-site surgery is a major cause of medical errors that can be mitigated through various safety checkpoints preoperatively and has been the subject of a sentinel event alert by the Joint Commission. This type of error has most commonly been noted in orthopedic surgeries. 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. This type of error can easily be mitigated by ensuring proper pre-operative measures such as labeling the correct surgical site with an indelible pen or distinctively marking the non-surgical site in advance of the surgery. Intraoperative radiography can also assist in aiding the correct surgical site during the procedure.
Patient suicide is an unfortunate cause of death, commonly seen in psychiatric care settings. Several risk-reduction methods can be implemented to 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.
Delays in medical treatment are preventable adverse events that may result in patient death and permanent injuries. This may result from misdiagnoses, delayed diagnostic test results, lack of staffing or physician availability, delays in order fulfillment, inadequate treatment, and delays within the emergency department. It is important to recognize this root cause and implement steps to improve timeliness, completeness and check the accuracy of medical communication to prevent such 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. The primary tool of prevention for this type of error is communication. It is important to have a standardized protocol for communication between the physician, nurse, pharmacist, and other clinicians involved in patient care to ensure that patients receive the correct medication at the appropriate dosage, route, and frequency.
Lastly, as discussed previously, patient falls are a constant source of error within healthcare facilities that specifically affect the elderly most frequently. It is important to recognize patients at a higher risk for falls and take appropriate safety precautions. Standardized protocols can reduce fall rates by ensuring a safe environment for risk-prone patients.