Root Cause Analysis and Failure Mode and Effect Analysis

Root Cause Analysis and Failure Mode and Effect Analysis


Despite the notable advancements in healthcare delivery, there exist flaws in care, which impede the achievement of patient care goals. Patient safety events occur, which are harmful and sometimes result in death.

Root Cause Analysis and Failure Mode and Effect Analysis
There is a need by the healthcare providers involved in patient care together with the organizational leaderships to emphasize patient safety and minimize errors during care. To address the problem, healthcare organizations carry out root cause analysis to identify the causes and strategies to preclude future occurrences. (Kellogg et al., 2017). According to Kellogg et al. (2017), root cause analysis is a process of retrospectively studying the causes of a problem in an organization and identifying its solutions. Click here to see general purpose of conducting a root cause analysis (RCA).

  1. Purpose of conducting root cause analysis

In healthcare organizations, root cause analysis is used to study the causes of errors that result in undesired care outcomes. The safety events must not be related to the nature of the condition affecting the patient. The process focusses on all causes rather than the main cause only. All disciplines that provide care in collaboration with organizational leadership provide solutions to the problem and lay a plan to prevent future occurrences of the problem. Effective use of root cause analysis improves the quality care provided and improves the patient’s hospital experience. (Kellogg et al., 2017).

  1. Root cause analysis template steps

Institute for Healthcare Improvement identified six steps, followed by the healthcare team when identifying the cause of an error in care. The first step is to identify what happened in an organized, complete, and accurate manner. The investigators describe how the event occurred in the simplest form possible. In the second step, the investigating identifies what should have happened. Identifying what is expected enables the team to understand the problem better. The third step is determining the causes of the problem, both the direct and indirect causes. Problem-solving is only achieved when the causes of the problem are known. “Ask why five times” can be used to identify the causes of the problem. Fishbone diagram can also be used to identify and group the causes. (Cherry & Jacob, 2019).

The fourth step is developing the causal statements that provide a connection between the identified causes and their effects and a final to the reason for conducting the root cause analysis. The fifth step is providing recommendations that preclude the future occurrence of the problem. The recommendations can be grouped into strong, intermediate, and weak. The recommendations can focus on staff education, equipment standardization, the introduction of new policies, and even the use of forceful activities that hinder the errors from occurring. The sixth step involves writing a summary of the findings and the recommendations and communicating it to the relevant stakeholders. The relevant individuals are used to affect the anticipated change to steer improvement. (Cherry & Jacob, 2019). In the healthcare system, it involves the immediate patient caregivers, the healthcare team and organization leaders.

  1. Application of Root Cause Analysis process (See example here).

Step 1- Mr B arrived at the emergency department with complaints of severe pain in the left leg and hip area related to a fall. His leg got stabilized and to manually manipulate and relocated the hip; he needs to be sedated. In the process, the patients are over-sedated, and inadequate monitoring of the patient is done. 10mg of diazepam and 4mg hydro morphine was administered in 15 minutes. The doctor identified the use of oxycodone and the patient’s weight as the reasons behind the slow response to sedation. Over-sedation depressed the respiratory system resulting in decreased breathing, which was believed to be the cause of the fibrillation. Heart fibrillation causes cardiac arrest and eventually brain death caused by brain tissue anoxia. (Craig & Boyle, 2019). The patient died when he was removed from the life support machines since his brain had already died.

Step 2- The patient needed to be professionally put on conscious sedation by experienced and knowledgeable healthcare providers as per the hospital policy. Sedated patients are supposed to be on continuous monitoring of the blood pressure, oxygen saturation and the cardiac cycles. A nurse should have been assigned to monitor the progress of the patient until full recovery and discharge from hospital.
Root Cause Analysis and Failure Mode and Effect Analysis

Step 3- Subsequent undesired care outcomes followed double administration of diazepam and hydro morphine. The hospital had a policy guiding conscious sedation, and all healthcare workers involved in sedation were required to complete the moderate sedation training module before practice. Both the doctor and Nurse J never followed the hospital guidelines. Failure to allocate a nurse to monitor Mr B’s ECG, B/P and oxygen saturation throughout sedation was another error that contributed to the undesired outcome. ECG remained unmonitored. Nurse J was an experienced critical care nurse who had completed the moderate sedation module, but she contributed to the harmful event. The LPN disregarded the first oxygen saturation warning and reset the readings assuming it to be the machine’s error even though the equipment is in good condition. The patient was not put on oxygen therapy immediately when the oxygen saturation levels started decreasing, and the respirations remained unmonitored. Another error occurred with the delay in calling the rapid response team with the first alarm.

Step 4- The main error causing the event was the negligence of the hospital’s policy on conscious sedation. All the factors that contributed to the event followed the main error. Double administration of benzodiazepine and opioids in 15 minutes suppressed the patient’s respiratory system resulting in decreased breathing and eventually raising the need for mechanical ventilation. Suppression of the respiratory system is among the proverbial side effects of the medication. Lack of immediate interventions to reverse the failing respiratory system negatively impacts on the cardiac system. Cardiac failure develops due to heart muscle fibrillation, thus decreased cardiac output. Decreased cardiac output means vital organs of the body, such as the brain are not receiving enough oxygen, a situation worsened by a failed respiratory system. Brain hypoxia develops, which in turn results in brain death when there are no immediate interventions. (Craig & Boyle, 2019).

Step 5- The errors resulting in the event happened due to ignorance and unnecessary errors by the healthcare team. Diazepam is not a priority medication for use when sedating the elderly because of the high risks of the development of adverse events. Mr B is 67 years old, meaning diazepam was not the drug of choice for his sedation; thus through their pharmacological knowledge, a different drug should have been used. Furthermore, administration of double doses of benzodiazepines and opioids within a short period is not recommended because of the risk of overdose. (Craig & Boyle, 2019). The healthcare providers should have reviewed the hospital policy on moderate sedation to have a guide on the proper process of sedation.

Nurse J is an experienced critical care nurse with knowledge of the hospital’s moderate sedation procedures ought to have questioned the use of the drugs together with the ordered doses. Sarcastically, Nurse J is the one who administered all the doses as instructed by the doctor. Nurses are trained to be critical thinkers who should understand the rationale of every intervention of patient care.

Sedated patients need to be on continuous monitoring by the healthcare team and not by the patients’ relatives. Continuous monitoring of the vital signs, oxygen saturation, and cardiac cycles are done and recorded. Any slight deviations from the normal should be a cause of worry to the healthcare team and the cause unidentified and intervened. Mr B was left with his son while the healthcare team was busy with other patients. The gap justifies the need for adequate staffing of all departments in the healthcare organizations. Receiving new patients does not mean that the already existing should be left unattended.

Respiratory failure could have been prevented if the LPN had taken the first alarm serious instead of resetting the readings. The decrease in oxygen saturation is a justification for further respiratory assessments and monitoring. The nurse briefly stayed in the room. The patient was left with his son, who had no knowledge of what was happening but managed to call the nurse upon the second alarm when the patient had no palpable pulse and signs of breathing. Patients under sedation should be on oxygen therapy. Despite the patient being on blood pressure and oxygen levels monitoring, no recordings were being made to determine the progress of the patient.

  1. Improvement plan

To prevent future occurrences of the event, it is critical for the healthcare organization to continuously educate its staff on conscious sedation and need of monitoring patients under sedation. The guidelines should be written and posted on the walls of the sedation rooms to act as reminders. In case of such events, there needs to be a strict discipline of the involved individuals. The healthcare team will become more alert, thus reducing negligence in care. The LPN could have failed to take early interventions due to lack of knowledge of why monitoring should be done. The doctor could have been keen on the medication to use to sedate the patient and the recommended doses adhered to.

  1. Lawin’s change theory

Lawin identified three phases effective when implementing a change in an organization. The phases include unfreezing, change, and refreezing. Effective application of the change theory in implementing the change plan would minimize undesired events in the future, thus provision of quality care. (Gilissen et al., 2018). In the unfreezing stage, the organizational leaders will raise awareness about the undesired event and organize regular educational sessions for all healthcare providers in the organization. The education will focus on conscious sedation and all the necessary updates communicated. The staff is encouraged to follow current trends on conscious sedation. The organization should also budget for necessary research on the issue. The sedation guidelines need to be communicated to new employees upon recruitment.

In the change phase, all employees are subjected to a new way of doing things. Educational materials are distributed to all departments in the organization, and some messages communicated in the hospital walls. The information is continuously updated. The healthcare providers involved in patient sedation are subjected to supervision in the pilot phase. Upon full implementation, the staff should be reminded of disciplinary actions on workers who fail to follow the guidelines while good deeds will be rewarded. In the refreezing phase, the staff will be expected to and embrace the change. New policies will be developed and incorporated into the recruitment process of new employees.

  1. Failure Mode and Effects Analysis (FMEA)

Failure Modes and Effects Analysis is an organized method of evaluation of a specific process to identify potential failures and their causes. (Cherry & Jacob, 2019). In the healthcare system, FMEA is used to determine and mitigate failures in care that negatively affect patient safety. The healthcare providers, together with the organizational leadership, identifies risks and why the risks might occur, their effects, and ways of preventing their occurrence. FMEA is applied before the implementation of a new service or to introduce change to an already existing service to prevent future sentinel events. (Jain, 2017).

  1. FMEA process

The first step involves the identification of the process to be evaluated. Evaluation can be done before the initiation of a new process and to modify an already existing process. The second step involves the identification and recruitment of necessary individuals and stakeholders to be used in evaluating and implementing the process. In the healthcare system, the multidisciplinary team can involve nurses, doctors, pharmacists and other stakeholders involved inpatient care. The third step is determining the steps of the process that needs evaluation. (Jain, 2017). Listing the steps is critical in ensuring that no risk is left out.

The fourth step involves identifying all the failure modes, causes and their effects on the process. The severity of the failure modes is identified together with their probability of happening. Risk Priority Numbers are assigned to each failure mode. Plans of action are identified together with the outcome measures. (Cherry & Jacob, 2019). The fifth step involves planning to improve the various steps of the process, prioritizing the steps with the highest Risk Priority Numbers. The multidisciplinary team implements the identified strategies on the steps to preclude future the occurrence of the risks. The highest risks are addressed first. (Jain, 2017). Implementation of the changes requires total involvement of vital stakeholders that the change will affect.

  1. FMEA table and a root cause analysis template
Steps in the improvement plan process Failure modes Likelihood of occurrence Likelihood of detection Severity Risk priority number
All staff members must attend alternate training sessions, whether on duty or not. Not all staffs off duty attend the training 5 5 6 160
The staff read the materials provided concerning conscious sedation Staff do not read the materials provided 7 1 8 300
The staff involved in sedation refer to the short notes posted on walls before patient sedation Staff do not take time to remind themselves of the sedation guidelines on the wall. 3 1 4 30
Newly recruited employees sign acceptance to strictly follow conscious sedation guidelines provided during the recruitment Newly recruited employees do not sign for their acceptance to strictly adhere to the guidelines 1 5 3 20


  1. Testing the intervention plan, Root Cause Analysis and Failure Mode and Effect Analysis

The testing will be more focused on the emergence department, where the event occurred. Much of the sedation in the hospital occur in the department. A team of supervisor will be sent to the department to observe the response of the healthcare team to the proposed changes. Data from the administration of questionnaires before and after the interventions will be used to analyze the healthcare workers experience and effectiveness of the process. Necessary changes on the process will be effected before the changes are incorporated into the already existing hospital policy.

  1. Leadership demonstration, Root Cause Analysis and Failure Mode and Effect Analysis

The nursing education system must train competent nurses who incorporate their leadership qualities in practice. In practice, nurses are required to competently practice leadership to provide quality care, improve patient outcomes, and influence quality improvement activities. In promoting quality care, nurses continuously assess patient needs and identify gaps in care that need immediate intervention. Nurses are expected to be patient advocates since they spend most of their time with patients. (Jain, 2017).

Nurse leaders provide holistic care by placing patients and their families at the centre of care. In an effort of improving the patient outcomes, nurses develop effective relationships with their patients and involve patients in the care. Patient involvement in the whole process of care positively impacts on their hospital experience. Studies indicate that creating a healing environment around patients is itself a cure besides medical treatment. (Sorrentino, 2016). In practice, nurses act as advocates for change that is geared towards improving the quality of care provided. In the process of care delivery, areas that need change are identified and communicated in meetings with other stakeholders.

  1. Involvement of professional nurses in RCA and FMEA

RCA and FMEA focus on identifying the problems and providing solutions to the problems. The processes employ problem-solving skills which are critical for professional nurses practising leadership. The process provides an opportunity for nurses to practice their leadership skills such as problem-solving, change advocacy, and decision-making. (Sorrentino, 2016). In the process, undesired events in care are prevented, and the goals of patient care achieved.



Cherry, B., & Jacob, S. (2019). Contemporary nursing: Issues, trends, and management (8th ed.). St. Louis: Mosby Elsevier. ISBN: 978-0323554206

Craig, D., & Boyle, C. (2019). Practical conscious sedation (Vol. 15). Quintessence publishing.

Gilissen, J., Pivodic, L., Gastmans, C., Vander Stichele, R., Deliens, L., Breuer, E., & Van den Block, L. (2018). How to achieve the desired outcomes of advance care planning in nursing homes: a theory of change. BMC geriatrics18(1), 47.

Jain, K. (2017). Use of failure mode effect analysis (FMEA) to improve medication management process. International journal of health care quality assurance.

Kellogg, K. M., Hettinger, Z., Shah, M., Wears, R. L., Sellers, C. R., Squires, M., & Fairbanks, R. J. (2017). Our current approach to root cause analysis: is it contributing to our failure to improve patient safety?. BMJ quality & safety26(5), 381-387.

Sorrentino, P. (2016). Use of failure mode and effects analysis to improve emergency department handoff processes. Clinical Nurse Specialist30(1), 28-37.


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