Root Cause and Failure Modes & Effects Analyses in Nursing

Root Cause Analysis (RCA)

The basic definition of root cause analysis is a systemic process of identifying the foundational causes of specific problem and determining an approach to respond to them. In the context of management and leadership, it is not just reactively responding to issues, but identifying the causes so that problems can be prevented in the future (ASQ, n.d.). For healthcare, the systemic methodology aims to study detrimental incidents within the health provision process and distinguish the key factors that contribute to errors rather than focusing on the immediate cause.

Steps

1. Identify what happened – the RCA team seeks to describe the event accurately and completely, in order to organize and identify the problem.
2. Determine what should have happened – a description of what should have occurred in ideal conditions or according to procedure/policy.
3. Determine causes (five ‘whys’) – identifying factors that contributed to the event, looking at direct causes as well as contributing factors to find an underlying root cause.
4. Develop causal statements – causal statements links the causes identified previously to the event which triggered the RCA, which helps to explain the chain of events about contributing factors and conditions leading to negative outcomes.
5. Generate recommended actions to prevent recurrence of event – actions that the RCA team believes will prevent errors in the future, with some actions being more effective or stronger than others. It can range from standardizing equipment to double checks to simplifying a process and educating staff.
6. Summary report and communication/sharing – results of the RCA should be shared with staff involved to lead to improvement (Institute for Healthcare Improvement, n.d.a).

Causative and Contributing Factors

A range of factors contributed to the adverse event which eventually led to Mr. B’s death. The first error was that protocol for conscious sedation was not followed. The patient was not placed on continuous B/P, ECG, and pulse oximeter despite being sedated and meeting the criteria. Another potential factor was the medication dosage prescribed by Dr. T. Intravenous diazepam acts within several minutes of administration and can have lasting effects for more than 12 hours. Meanwhile, hydromorphone is a powerful pain reliever with a reaction time of 5 minutes and a peak effect time within 20 minutes. While this combination is rarely used, it is a powerful sedative with longer duration of effect. If re-dosage is necessary it is recommended to decrease the dosage of the medication (Schow et al., 2015).

Meanwhile, Dr. T asked to administer the same dose shortly after the original dose did not have the intended effect, but the double dosage may have put Mr. B in deep sedation which should have at the very least been closely monitored. Finally, there was the error of not placing Mr. B on supplemental oxygen. He arrived in triage with an RR of 32 which is indicative of tachypnea, thus low oxygen levels, with supplemental oxygen being potentially helpful. However, the major error occurred when the son reported a dropping O2 levels to as low as 85% but Mr. B was still not placed on supplemental oxygen by the LPN despite the availability of respiratory as necessary. This was likely due to a combination of a lack of training as well as understaffing in the hospital and ED.

Improvement Plan

The improvement plan consists of applying RCA to the event. A team should be formed from management and leadership, including nursing manager or director, emergency room director, respiratory therapy representative, and general hospital management. The event should be described in detail starting from when Mr. B was admitted and how conditions changed. The next step is to detail how care for the patient should have occurred given ideal effects and conditions. The team will investigatee gathering data from both objective sources such as documentation and subjective ones such as staff interviews. Then, causal statements are formed for each involved causes from an impartial perspective and detailed. In the next step, proposals are taken to prevent the issue, including better staff training, emphasizing adherence to policies, and wider availability of staff. Finally, the team creates an RCA report and distributes to staff in the hospital which include recommendations for improvements, key elements to recognize, and potential for improvement.

Lewin’s Change Theory

Lewin’s change model suggests that individuals are influenced by restraining forces that seek to maintain the status quo or positive forces that influence change. He proposed a three-step process which is meant to accomplish change consisting of the following steps:

1. Unfreeze – essentially kickstarting the transformation by shifting the status quo and preparing staff for the necessity of change. This step provides the window to prepare for change, make employees understand the need, and educate on the upcoming modifications – all so that the change is not sudden, and people can prepare;
2. Executing the transition – the stage of implementation of the changes, either practically or policies coming into effect. Essentially, staff now must introduce the changes into daily routines and adapt to them;
3. Refreeze – allows to solidify the change, making it the new status quo for work and organization. It allows to establish new equilibrium so the change becomes a habit and there is lesser resistance to it (Wojciechowski et al., 2016).

Applying the Lewin’s Model of Change to the scenario can begin after the intervention plan has been developed with all previous errors identified and new policies are decided upon. The unfreeze stage would occur after the RCA is shared with the involved and wider staff, and there is an indication that new stronger policies would come into place. It would require communication and information from management to the staff regarding the importance of these changes. The execution stage is the point when the new policies come into effect, which would also impact elements such as shift scheduling, work rotations, and duties for staff. At this point management and leaders work with the staff to smooth out any complexities and potential confusion. Finally, there is the refreeze stage, with the staff being more aware of the new changes, the hospital embeds these into policy. There is much more precaution in patient safety, better communication and collaboration among interdisciplinary teams.

FMEA

Failure Modes and Effects Analysis (FMEA) is a vital systemic tool to conduct a proactive analysis of processes under which a failure or error can occur. In healthcare, the methodology is used to review processes, proactively review all potential outcomes, especially when it comes to failure, and prevent them through appropriate changes. In turn, this enhances quality of care or the consequences if something does go wrong (Institute for Healthcare Improvement, n.d.b).

Steps

1. Select a process or subject to evaluate – FMEA works best on non-complex processes, if needed to evaluate sophisticated procedures, they best be divided.
2. Recruit multidisciplinary team – all stakeholders and participants in the process should be involved, only for part of the analysis if necessary.
3. Team lists steps in the process – carefully breaking down the process being evaluated, and mutually agreeing to avoid confusion.
4. Fill out the FMEA table with team – working with members of the team based on the specific steps in the chart.
5. Use RPNs to plan improvement efforts – the RPN indicators suggest which failure modes with high RPNs are the most important and which can be left for another time.
6. Use FMEA to make changes – actions to reduce harm, evaluate impact of changes, and monitoring improvement over time Institute for Healthcare Improvement, n.d.b).

FMEA Table

List 4 steps in your Improvement Plan Process *	List 1 Failure Mode per step	Likelihood of Occurrence (1–10)	Likelihood of Detection (1–10)	Severity (1–10)	Risk Priority Number (RPN)
Use continuous vitals monitoring on all patients sedated or demonstrating irregular vitals upon admission.	Nurse does not attach the full range of vitals monitoring to the patient believed to be in a stable condition	5	6	4	120
Medication dosage should be administered in accordance with guidelines and recommendations	The attending physician fails consult medication guides or pharmacy for dosing instructions, re-dosage protocols, and/or medication conflicts	3	2	5	30
Respiratory therapy should be used for patients whose oxygen saturation falls below 90%	Staff not utilizing proper resources and not including respiratory therapy or supplementary oxygen in the treatment process.	4	4	6	96
Staffing levels should remain adequate, at 1 RN to 2 urgent unstable patients and 1 RN to 5 non-urgent stable patients according to guidelines. Backup staff should be called in if ratios are not met.	Failure to request additional staff, resulting in overwhelming nurse-to-patient ratios	7	2	4	56
					Total RPN (sum of all RPN’s): 302

Testing Interventions

One method of intervention testing is the Plan-Do-Study- Act (PDSA) cycle. Planning consists of collecting data and developing the best techniques for the intervention to be put into place. At the do stage, the intervention is carried out and observed. Data, problems, and other factors are recorded, and the efficacy of the intervention is observed.

At the study stage, evaluation is conducted. Data is compared and analyzed, to determine if the needed effect of the intervention has been achieved, as well as compared to the pre-intervention variables. Finally, the act stage consists of making a decision on the intervention. It can be either implemented fully if its ready, adapted and run through the PDSA cycle until it is a workable solution, or scrapped all together. The PDSA cycles is a highly effective and methodological means of testing and improving interventions (Minnesota Department of Health, n.d.).

Demonstrating Leadership

Nurses are frontline workers that ultimately oversee multiple quality of care aspects in patient treatment. Demonstrating efficacy and advocacy for best quality of care measures is key to nursing leadership. In turn, patient satisfaction improves, leading to better outcomes and positive aspects for the healthcare provider.

Nurses are held to high expectations, following the values set forth in the ANA Code of Ethics which empower nurses to promote and advocate for the health, safety, rights, and wellbeing of the patient. By being competent leaders, working together as a team, nurses can improve patient outcomes by reducing errors and adhere to evidence-based practice which seeks to not only enhance treatment options but also eliminate negative factors in terms of safety or quality. Nurses can advocate and influence quality improvement activities since nurses are the ones which most often face them, noticing potential gaps in policy and procedures. A nursing leader can use their influence to drive improvements, even in the smallest changes to shift towards more enhanced quality of care.

The RCA and FMEA as evident are highly systemic processes which hold a significant influence over policy and procedure in a healthcare facility. Nurse involvement demonstrates leadership as it represents a drive towards making positive improvements to changes in the hospital. As a key part of an interdisciplinary team, nurses contribute with their knowledge and perspective on the RCA and FMEA, guiding towards change that not only eliminate errors, but aid in the betterment of nursing and general practice through safety, quality, and ethical aspects of patient care. Leadership is often characterized by difficult choices and changing the status quo, which nurses are inherently doing by meaningful participation in these evaluation and change processes.

References

ASQ. (n.d.). What is root cause analysis (RCA)? Web.

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

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

Minnesota Department of Health. (n.d.). PDSA: Plan-do-study-act. Web.

Schow, B., Swigert, R. S., & Ringgold, C. (2015). IV sedation for cases of extended length using either diazepam with hydromorphone or midazolam with fentanyl. Journal of Oral and Maxillofacial Surgery, 73(9), e48. Web.

Wojciechowski, E., Murphy, P., Pearsall, T., & French, E. (2016). A case review: Integrating Lewin’s theory with lean’s system approach for Change. OJIN: The Online Journal of Issues in Nursing, 21(2), 4. Web.