Organizational Systems and Quality Leadership Root cause Analysis (RCA),and failure mode and effects analysis (FMEA)

Organizational Systems and Quality Leadership Root cause Analysis (RCA),and failure mode and effects analysis (FMEA)

  1. Root Cause Analysis

Errors and adverse events significantly contribute to mortality and morbidity in healthcare today. When these adverse outcomes occur in healthcare organizations, it is necessary to conduct an investigation to determine the causes and plan for the prevention of the errors in the future. A root cause analysis (RCA) is a systematic approach used to understand the causes of adverse events and to prevent the errors from occurring again. The RCA process looks back at the error that occurred to identify flaws in the system that can be corrected to prevent the error from happening. The general purpose of conducting an RCA is to identify what happened, why it happened, and the changes necessary to prevent future errors. While using this approach, the healthcare provider ought to understand that a good RCA allows the designing of an implementation plan that addresses the failure at its source.

A1. RCA Steps

Conducting a root cause analysis requires laying of events in chronological order to help understand what happened and the points that require correction. Chronology in performing an RCA is based on the fact that accidents in healthcare always result from multiple stems rather than a single linear cause. The Institute for Healthcare Improvement (IHI) designed six steps that guide the process of analyzing a healthcare problem as follows:

Step 1: Identify what happened

Step 2: Determine what should have happened

Step 3: Determine causes

Step 4: Develop causal statements

Step 5: Generate a list of actions to prevent recurrence of the event

Step 6: Share the findings

Step 1: Identify what happened

Identification of the scenario is often the first step when conducting a root cause analysis. The RCA team must identify the problem accurately and completely through observation, asking questions, and investigation. The preliminary information about the scenario can be collected from healthcare workers, the patient’s or healthcare worker’s environment, and the systems involved. While collecting the information about the healthcare problem, objectivity and honesty is required to accurately state the actual errors leading to the problem ( Institute for Healthcare Improvement, n.d.-a). Sometimes the RCA team can draw flow charts to create a physical picture of what happened.

Step 2: Determine what should have happened

Identification of the healthcare problem is preceded by what should have happened in an ideal healthcare environment. Hospital policies, procedures, and practice guidelines are used to determine the most appropriate approach that would have prevented the adverse outcome. The RCA team should take time to examine the situation, draw a flow chart for the most probable course of action and compare it with the faulty approach that led to adverse outcomes. The RCA team selected should therefore have adequate knowledge, skills, and expertise to effectively solve the problem.

Step 3: Determine causes

Various factors can contribute to healthcare problems. During this stage, the RCA team determines the events leading to the problem and identifies specific causes that contributed to the adverse event. It is recommended that the RCA team should look for the most apparent causes and also identify contributory or indirect causes to the problem. A fishbone diagram is a graphic tool identified to display various causes of certain effects in healthcare. For example, factors contributing to healthcare problems can be related to patient characteristics, task factors, individual staff members, team factors, work environment, organizational and management factors, and institutional context (Institute for Healthcare Improvement, n.d.-a). It is recommended that the causes should be assessed five times to elicit different responses to the root causes of the healthcare problem.

Step 4: Develop causal statements

Causal statements are used to provide links between the causes and their effects and then back to the main event that prompted the RCA process. The causal statements help demonstrate how the contributory factors led to an adverse outcome. Additionally, the causal statements are used to demonstrate the connection between different teams or events that were involved during the adverse event. Flow charts and diagrams from the previous steps can be helpful during the creation of causal statements. The importance of this step is that it allows healthcare workers to see how their actions led to a series of other actions that caused adverse events.

Step 5: Generate a list of actions to prevent recurrence of the event

The RCA team should actively generate a list of actions that can help prevent a similar adverse event from occurring in the future at this stage. While planning for the actions to use, the team should consider if the actions selected are strong, weak, or intermediate. For instance, strong action is likely to greatly reduce the incidence of an event while a weak action is less likely to solve the problem. The RCA team should involve other stakeholders when necessary to design changes that are long term and likely to avoid the problem in the future. For example, the changes can include changing backup systems, educating staff, developing new policies, standardizing equipment, or simplifying processes.

Step 6: Share the findings

Sharing the findings is the last step of the RCA process that involves writing a summary and sharing the findings with other stakeholders. The summary should identify the causes of the adverse outcome, parties involved, and ways to rectify the problem. This step is an opportunity to engage key players to help drive the next steps in quality improvement.

A2. Causative and Contributing Factor

Step 1: Identify what happened

The sentinel case scenario provided explains how errors in care delivery led to the death of Mr. B, a 67-year-old patient. The patient was brought to the ER by his son after sustaining a fall and later diagnosed with left hip dislocation. On arrival to the ER, the patient’s history was taken and he was scheduled for a small procedure requiring manual manipulation, relocation, and alignment of the hip. Nurse J and Doctor T were both available to provide care to the patient alongside other patients in the ER at that particular time. To prepare the patient for the procedure, sedation using diazepam and hydromorphone was given. After a successful manipulation, relocation, and alignment of the patient’s hip, there were challenges with the patient’s recovery. Failure to monitor the patient’s vitals during recovery led to the deterioration of the patient’s condition prompting resuscitation. Unfortunately, the patient ended up dying in another healthcare facility after referral as a result of brain death.

Step 2: Determine what should have happened

There are many gaps that can be observed in the care for Mr.B leading to his demise. First, the patient came to the health facility at 3:30 pm with a lot of pain rated at 10 after sustaining a fall. The respiratory rate of the patient was 32b/m with normal blood pressure. The first action that should have been taken was pain control for the patient which could have also made the patient relax. It was until 4: 05 pm that the doctor and the nurse fully turned their attention to the patient. At this point, I noticed that more patients required attention in the ER but there were a few staff available that afternoon. A backup protocol should have been activated to ensure that enough staff was available to settle the busy ER.

Doctor T and Nurse J worked together to prepare the patient for the small procedure requiring hip realignment. A complete drug history should have been taken before subjecting Mr.B to high doses of sedatives which prompted respiratory distress in the later stages of care. Upon completion of the procedure, the patient was only placed in a blood pressure monitoring machine and assigned his son to monitor the recovery process. The nurse should have ensured an ECG machine was connected and also the patient put on oxygen while continuously monitoring his vitals until full recovery. Another gap observed is that the LPN silenced the alarm when the patient’s oxygen saturation was 85% instead of putting supplemental oxygen. I am also convinced that if Nurse J started resuscitation immediately he realized the patient was not breathing the patient’s life could have been saved. Instead, the nurse called for the STAT CODE team who came to start resuscitative efforts.

Step 3: Determine causes

The adverse patient outcome in the sentinel event was caused by different factors attributed to healthcare worker inefficiency. The first cause of the whole problem was a failure to take a complete patient history to determine the current medications and their effect on current treatment. Complete medication history should have enabled the nurse and the doctor to use the correct dose of sedatives for the patient’s procedure. The second cause of the adverse effect is the negligence of healthcare workers in the ER especially taking precautions after oversedation of the patient. The doctor should have instructed the nurse to closely monitor the patient after realizing that the patient’s use of oxycodone for home pain management impaired the sedation process.

Lack of enough healthcare workers was the other problem leading to adverse patient outcomes. There were too many patients requiring attention that day and only a few staff were available to provide comprehensive care to patients. I believe the lack of enough personnel led to poor monitoring of the patient. Another cause of the adverse outcome was poor judgment by healthcare providers especially the LPN who only silenced the patient’s alarm instead of putting the patient on oxygen. Ineffective collaboration between healthcare teams is another cause of the adverse outcome. For instance, the respiratory team was available but they were not called upon when the patient’s oxygen saturation went down.

Step 4: Develop causal statements

The patient came to the ER with a respiratory rate of 32 b/m and it was necessary to control the patient’s pain. If the physician could have thought of pain management, he could have realized that the patient uses oxycodone back at home. The nurse and the doctor failed to take a complete medication history for the patient which led to excessive use of diazepam and hydromorphone. From another perspective, the busy nature of the ER made it difficult for the nurse and the doctor to patiently wait before adding sedative doses to the patient. If enough staff were available, it could have been easy to monitor the effects of diazepam and hydromorphone instead of increasing the dosages.

Close monitoring of patients recovering from sedation is recommended because the sedatives can sometimes cause respiratory distress. After completion of the procedure, the nurse failed to connect the patient to the EEG for monitoring of heart activity and supplemental oxygen until full recovery. Eventually, the patient went into distress, and it became difficult to breathe prompting resuscitation. The LPN noticed that the patient’s oxygen saturation was 85%, but failure to put the patient on oxygen led to breathing difficulties and consequently brain death a few days later. Lastly, Nurse J failed to commence resuscitation immediately he realized the patient was not breathing. Delayed resuscitation probably contributed to the lack of enough oxygen supply to the brain leading to brain death.

Step 5: Generate a list of actions to prevent recurrence of the event

The sentinel event can be prevented in future if the following actions will be taken.

  1. Any patient undergoing sedation should first have a full medical history taken including current medications.
  2. The backup plan should be activated in the ER when the patients needs exceed the available staff.
  • Mandatory education and training for nurses in the ER should be done to equip the staff with knowledge and skills on the care for patients under sedation.
  1. Strategies should be put to ensure interprofessional communication and collaboration during patient care.
  2. Improvement Plan

The plan to improve quality in the organization will involve interventions such as education for nurses, reviewing policies, and encouraging interprofessional collaboration. It will be important to review certifications for both nurses and doctors in the ER to ensure every individual has completed training on emergency care and moderate sedation for patients. It will be necessary to review these documents so that training and education can be organized depending on the gaps identified. Upon review of the individual certificate, a plan to educate and train ER staff on moderate sedation will be necessary to improve skills and knowledge on patient care. The education modules should stress patient care before, during, and after sedation. The training should also discuss how to use sedatives, their indications, and choices for patients with different conditions.

The adverse event observed can be improved in the future by setting clear guidelines and policies governing staffing in the ER. Emphasis on the patient to staff ratio should be put to promote effective care for patients seeking emergency care. For example, a backup plan will have greatly helped the nurse and the doctor involved in the sentinel event. The new policy will guide the staff on the most appropriate time to call for backup. Another plan for improvement of quality in the ER will involve the use of a checklist to ensure pertinent patient history is taken before sedation. Incorporation of the checklist into the EHR system can be an important step to ensure both the doctors and the nurses get to follow the right steps.

The other approach to improve care delivery to patients will be working on interprofessional collaboration. Interprofessional collaboration means different healthcare teams working together towards a common goal. For example, the respiratory team available during the sentinel event should have been contacted to ensure the patient was put on oxygen. Additionally, the LPN, Nurse J, and Doctor T did not have a clear communication pathway which prompted errors in patient care leading to the adverse event.

B1. Change Theory

Change is a common thread that runs through all organizations regardless of the size or type of industry. One of the cornerstone models for change management that still holds today was developed by Kurt Lewin. Lewin’s model contains three; unfreezing, change, and refreezing. The unfreezing stage involves the preparation of the organization to accept new change by breaking down the existing status quo. It involves challenging the beliefs, attitudes, and behaviors of employees to build a strong change that will improve quality and safety (Batrus et al., 2016). The primary goal during this stage is to create awareness on how the current level of doing things hinders the organization in some way.

The second phase is called moving or changing and it involves transitioning into the new state of being. The moving stage is characterized by the implementation of new change and letting the organization struggle with the new reality. The moving stage requires constant communication, education, and reinforcement to prevent the employees from going back to the old ways (Batrus et al., 2016). Holding meetings and other educational sessions during the moving stage should help to remind the employee’s reasons for change and how it will benefit them once fully implemented.

The third stage is the refreezing stage symbolizing stabilization of the new change. The stage is characterized by the formulation of organizational charts, clear job descriptions, and policies guiding the new process. Efforts must be made to ensure that the change is not lost but rather reinforced into the organization’s culture. Sometimes using rewards and providing feedback can help in the sustainability of new change into an organization.

Lewin’s change management approach will be used to improve future outcomes in the organization. During the unfreezing stage, it will be necessary to discuss with the employees the events leading to the adverse outcome and how the new change will improve patient outcomes. The employees will also be informed on the importance of education and training in improving their skills and knowledge on the care for patients requiring sedation. Other similar examples can be used to ensure the employees get to understand why the new change is required in the organization. The moving stage will involve the implementation of the new guidelines in the emergency department. The first approach will involve education of ER staff on sedation and how to collaborate effectively with other professionals. Policies guiding moderate sedation and the use of sedatives will be used to guide patient care.

The refreezing stage will involve making the new changes part of the organization’s culture. Scheduled training and education sessions in the ER will serve to remind the healthcare professionals about sedation. New policies about sedation and staffing will be reinforced through monitoring. Rewards can be used for healthcare professionals who demonstrate improved patient care in the ER to support the new change. Additionally, new employees will be informed about the new change and part f their training will involve taking a moderate sedation program in the organization.

  1. General Purpose of FMEA

The failure modes and effects analysis (FMEA) is a structured approach used to discover potential failures that exist within a design of a product or a process (Institute for Healthcare Improvement, n.d.-b). Processes in healthcare organizations are designed to bring about quality improvement but sometimes can fail to elicit the desired response. Different defects can be available in the system leading to waste or harm and the FMEA process helps in identifying, prioritizing, and limiting these failure modes.

C1. Steps of FMEA Process

The Institute for Healthcare Improvement (IHI) describes five steps for conducting an FMEA as follows

 Step 1: Select a process to evaluate with FMEA

Selection of a process to evaluate is important during failure modes analysis. The selected process should focus on a specific area to make work easier and to avoid wrong analysis. The IHI recommends the division of large and complex processes for the achievement of better results. For example, the sentinel event FMEA is on sedation for conscious patients. This area is narrow and it will allow the FMEA team to determine factors leading to ineffective use of sedatives for the patient.

Step 2: Recruit a multidisciplinary team

Problem-solving in healthcare today requires the use of a multidisciplinary approach. The FMEA process also utilizes this approach where healthcare professionals from different disciplines are involved during the investigation of an issue. The sentinel event multidisciplinary team will involve the nurses, physicians, administration, and clinical nurse educators. This team is well-equipped to analyze the cause of the errors leading to the adverse outcomes and recommend a practice change.

Step 3: Have the team list all the steps in the process

A clear path is required during the conduction of an FMEA to enable making the right choices. The multidisciplinary team is required to list all the steps that will guide the process. Sometimes a few members of the multidisciplinary team can help in designing the way forward instead of involving non-essential staff. The IHI recommends the use of flowcharting to help in visualizing the whole process.

Step 4: Filling the table with the multidisciplinary team

The fourth step involves the listing of failure modes and the possible causes of the failures. The multidisciplinary team should work collaboratively to identify both minor and rare occurrences that are likely to prompt a process failure (Institute for Healthcare Improvement, n.d.-b). The IHI table consists of nine columns that address various aspects of failure including failure mode, failure causes, failure effects, the likelihood of occurrence, severity, risk profile number, and actions to reduce the occurrence of failure.

Step 5: Use RPNs to plan improvement efforts

RPNs represent risk profile numbers assigned depending on the likelihood of occurrence, the likelihood of detection, and severity. Upon assigning the RPNs, the multidisciplinary team plans for process improvement based on the findings. If the failure mode is likely to occur, evaluation of the cause is done and other considerations are made to reinforce the changes made. Modification of the processes and the use of other resources are necessary to effectively improve the failure modes.

C2. FMEA Table

See attached table

  1. Intervention Testing

Intervention testing for this process will be done using the PDSA cycle. The plan-do-study-act cycle is a stepwise process used to test for change in an organization. The cycle contains four phases that guide the evaluation of an outcome and testing again. The ‘Plan’ phase involves setting the objective and planning to carry out the activities of the other phases. The ‘Do’ phase involves carrying out the plan, documenting the expected outcomes and observations that might lead to the success of the plan. The ‘Study’ phase involves the analysis of results and comparison with the expected outcome. The ‘Act’ phase involves examining any changes that can be made to the initial implementation plan. The changes can be either to rectify mistakes or facilitate the start of another cycle.

The PDSA cycle can be used to test an intervention aimed at educating healthcare providers in the emergency department about sedation of conscious patients. The plan is to design a health education program for nurses and doctors in the ER on the importance of history taking for patients requiring sedation. Secondly, the clinical nurse educator with design an education and training course for all ED staff on the use of sedatives and the care for patients under moderate sedation. The areas of emphasis will include the choice of sedatives, dosage of the drugs, monitoring of the patient after sedation, and documentation.

The ‘Do’ phase will involve actual education of the ER staff on moderate sedation. Weekly meetings will be held to ensure all staff attends the training sessions and that every aspect of patient care is observed. At this phase, an observation will be made on the healthcare worker’s response to the new change and any modifications that might be required. The ‘Study’ phase will involve an observation of the new change and monitoring moderate sedation activities in the ER. Any adverse events resulting from the new change will be recorded to facilitate the formulation of other interventions. The ‘Act’ phase will depend on the conclusion from the whole cycle. Failure of the education approach to lead to better patient outcomes will prompt the use of other measures.

  1. Demonstrate Leadership

Promoting quality. Nurses are in a better position to promote quality in healthcare in various ways. For instance, professional nurses can engage in designing and implementing quality improvement programs in the ER to lower the risk of errors leading to adverse events. For example, the professional nurse can guide ER staff in taking courses that increase knowledge and skills on moderate sedation. Through organizing these activities, the nurse leader helps to improve the quality of services provided to patients.

Improving patient outcomes. Patient outcomes can be improved through the implementation of evidence-based practices to guide the delivery of safe patient care. For example, interprofessional collaboration is recognized to be important in promoting better patient outcomes. It is a practice that can reduce errors in medication and promote safe delivery of care to patients. The nurse leader plans on designing processes that can promote collaborative care which can help in improving patient outcomes.

Influencing quality improvement activities. Quality care is the extent to which health care services provided to individuals and patient populations improve the desired health outcome. Professional nurses have an opportunity to influence quality improvement through the formulation of policies in healthcare (Boamah, 2018). For example, the nurse leader can be part of the team forming policies dealing with staffing in the healthcare facility. The leader can also help in airing grievances of nurses to professional bodies regarding the issue of staffing and employment of nurses.

E1. Involving Professional Nurse in RCA and FMEA Processes

The RCA is a tool that helps healthcare organizations to retrospectively study events leading to patient harm or undesired outcomes and eventually address the root causes. This approach involves the selection of a multidisciplinary team that helps in identifying the problem, determining what should have happened, and proposing solutions to prevent future problems. The professional nurse can be part of the multidisciplinary team responsible for investigating problems and generating a list of actions to prevent the recurrence of the event. The nurse leader can also help in the selection of the members of the multidisciplinary team involved in process improvement.

The FMEA is a tool used by organizations to identify various modes of failure within a process. The nurse leader can play a key role in selecting the team for the analysis of processes and help in evaluating potential impacts of changes made in the organization. The nurse leader also collaborates with other stakeholders to plan action for failure modes that are likely to occur.


Batrus, D., Duff, C., & Smith, B. J. (2016). Organizational change theory: Implications for health promotion practice. Health Promotion International, 31(1), 231-241.

Boamah, S. (2018). Linking nurses’ clinical leadership to patient care quality: The role of transformational leadership and workplace empowerment. Canadian Journal of Nursing Research50(1), 9-19.

Friedman, A. L., Geoghegan, S. R., Sowers, N. M., Kulkarni, S., & Formica, R. N. (2017). Medication errors in the outpatient setting: Classification and root cause analysis. Archives of Surgery142(3), 278-283. DOI: 10.1001/archsurg.142.3.278

Institute for Healthcare Improvement. (n.d.-a). Patient safety 104: Root cause and systems analysis.Retrieved from

Institute for Healthcare Improvement (n.d.-b). QI essentials toolkit: Failure modes and effects analysis (FMEA). Retrieved from