FMEA Improvement Plan


Patient safety events may lead to threats such as harm or death of the individual. For these threats to be addressed or prevented, organizations must dig deep so as to identify root causes and thereafter develop solutions. Although remarkable advances have been noted in most healthcare fields, errors are still persistent. Most of the errors which cause death, permanent harm, or even a severe temporary harm are as a result of system and process flaws. Often, they are not immediately identifiable, which is why an investigation is required. After identification, an action plan to prevent a recurrence of the same is put in place. Finally, FMEA is used to determine whether the plan will work or not.

Root Cause Analysis

To conduct a root cause analysis of the events that led to the brain death of Mr. B, several steps will be followed.

Step 1: Identify Possible Causal Factors

A sequence of events must have led to the problem (Davis, 2016). During the shift that Mr.B reported to the hospital, there were not enough medical personnel. When sedation is done, a patient needs to be closely monitored by a qualified professional.

Another event that may have caused the patients outcome was when the oxygen saturation alarm was heard and the reading indicated “low O2 saturation”. At this point, it would have been essential to offer Mr. B supplemental oxygen as it was clear the sedation recovery process was being challenged by respiratory complications (Cronrath et al., 2011).

Lastly, another causative factor is the choice of sedation drugs. Hydromorphine tends to cause depressed, shallow respirations, which may lead to respiratory complications in patients (Cronrath et al., 2011).

Step 2: Identify the Root Cause

The inadequate number of medical and nursing personnel in an emergency department may be caused by the fact that there is a high turnover. This is usually as a result of job dissatisfaction and unclear roles. If the LPN was knowledgeable in critical care and moderate sedation, she would not have ignored the firm oxygen saturation warning. Lastly, the patient succumbed as he stayed for long without sufficient oxygen due to respiratory distress that was not handled on time (Cronrath et al., 2011).

Step 3: Identify Communication Challenges

To ensure that shortage of medical staff is effectively dealt with, hospitals need to fully address their staffing needs. A professional should never be expected to handle tasks that are beyond their job description. In addition, hospitals need to ensure that it employs enough staff to cover the big gap that is causing work overload in employees. Similarly, it is important to offer employees more learning opportunities so that they can constantly improve their skills. This will ensure that errors such what the LNP did, is avoided.

Step 4: Prioritize Communication Challenges

The challenge that will be given a priority is the constant education and training of healthcare professionals. This is because it will yield far more benefits compared to adding more staff. There is no sense in hiring undertrained professionals in large numbers as they will put the health of patients at risk. As such, it is important to start with the additional training so that the progress can be gradual.

A Process Improvement Plan

To improve the process, training that is fully catered for should be offered to nurses after every three months. This is meant to improve their knowledge and skill which reflect on the quality of care offered to patients.

In addition, a code team should always be present in an emergency room. The team should be fully equipped with functional equipment, and all members must have the skill and knowledge to operate them (Cronrath et al., 2011). Staffing issues also need to be addressed immediately. This is because the quality of care depreciates when medical staff is heavily overloaded. This places patient care and safety in jeopardy. The hospital will hire two more RNs so that there will always be 3 RNs available.

Hospital policies and procedures will introduce protocols in relation to conscious sedation. For instance, only a qualified nurse will sedate and monitor a patient undergoing and recovering from sedation.

Change Theory

The change theory that will be used to implement the process improvement plan will feature Kurt Lewins Change theory. The model features three stages; unfreeze, change, and refreeze.

In the unfreeze stage, the hospital staff will be introduced to the changes that are about to take place. They will be given a chance to react to it and even offer their own suggestions. Awareness is important as it is what will encourage acceptance of the change (Burnes, 2004). Once the employees are willing to try out the change, the next stage is carried out.

The change stage features the transition where employees will be expected to adhere to the new rules. They now have to adopt to the new behaviors and ways of thinking. Constant reassurance is important in this stage, whereby they will constantly be reminded of the benefits of the change (Burnes, 2004).

Lastly, the refreeze stage is meant to solidify the newly implemented change so as to prevent employees from going back to what they were already used to (Burnes, 2004). Encouragement is very important in this stage.

Failure, Modes and Effect Analysis

Having an interdisciplinary team in the FMEA is very important. In this case, they will include nurses working in the ER, doctors working in the ER, hospital supervisors, pharmacist, nursing and medical directors, and a staffing coordinator. It features a wide range of professionals as it is important to have a broad range of knowledge when dealing with a specific problem. Administrators are needed to ensure the process of change can be enacted smoothly.

Specific steps are needed for preparing for the FMEA. First, all internal and external data relating to the process improvement will be collected and analyzed. Second, the scope of practice and practice guidelines as listed by the board of RN will be reviewed. Third, all current hospital policies and procedures relating to sedation will be identified and analyzed.

There are three steps of FMEA including; severity, occurrence and detection (Cronrath et al., 2011). Severity refers to how bad the outcome may be. Occurrence refers to the likeliness that this will occur. Lastly, looks at the ease of visualization. A risk priority number, ranging from 1 to 10 will be assigned for each failure mode. The results will grade the likelihood that failure will occur, that it is likely to be detected, and the amount of harm to be expected. Members of the team will each be expected to grade these three steps.

Test the Interventions from the Process Improvement Plan

To test whether or not the interventions are effective, the overall performance will be considered. The prevalence of medical errors prior to the implementation will be compared to what is presently being experienced. If the errors have reduced, then the interventions will be considered effective. However, if the errors have increased, or are still constant, then a different intervention will be required.

Another way to test the intervention is by interviewing the employees anonymously so as to gauge their satisfaction level. If they are more satisfied with their jobs, it means that the intervention was successful. However, if they are still contemplating on quitting their jobs, it means that there is still a problem as the intervention failed.

The Professional Nurse as a Leader in Promoting Quality Care and Influencing Quality Improvement Activities

A nurse is supposed to provide patients with holistic care. They are the professionals who are closer to the patient, and hence can identify crisis in a situation before any other professional (Lúanaigh & Hughes, 2016). They should, therefore, be constantly educated on the use of best evidence in their day to day activities. They should always be the first to follow protocol and even encourage the rest to follow suit so as to maintain a safer patient care. They should always communicate to the rest of the organization the factors which patients feel will improve their comfort in the hospital.


To ensure the best outcome for patients, it is clear that so much is required. Patients should be monitored frequently with a qualified professional so as to avoid factors that may lead to the worst possible outcomes. In the case study Nurse J should have been given the responsibility as she is qualified both in moderate sedation as well as in critical care. Unfortunately, due to the work overload as more patients kept coming in to the emergency department, the patient had to be left alone unattended.




Burnes, B. (2004). Kurt Lewin and the Planned Approach to Change: A Re-appraisal. Journal Of Management Studies41(6), 977-1002. doi:10.1111/j.1467-6486.2004.00463.x

Cronrath, P., Lynch, T. W., Gilson, L. J., Nishida, C., Sembar, M. C., Spencer, P. J., & West, D. F. (2011). PCA Oversedation: Application Of Healthcare Failure Mode Effect Analysis (HFMEA™). Nursing Economic$29(2), 79-87.

Davis, P. T. (2016). Root Cause Analysis. COBIT Focus, 1-2.

Lúanaigh, P. Ó., & Hughes, F. (2016). The nurse executive role in quality and high performing health services. Journal Of Nursing Management24(1), 132-136. doi:10.1111/jonm.12290