Root Cause Analysis (RCA) and Effects Analysis (FMEA) Essay
Sentinel events are unanticipated occurrences that compromise patient safety and medical outcomes by resulting in injuries, deaths, and lengthy hospitalization. Though unexpected, healthcare professionals can embrace evidence-based strategies to prevent events such as medication errors and patient falls. One of the most profound approaches for safeguarding patient safety and averting future sentinel events is root cause analysis (RCA). The Institute of Healthcare Improvement (IHI) (2018) defines RCA as “a systematic approach to understanding the cause of an adverse event and identifying system flaws that can be corrected to prevent the error from happening again.” Further, it provides a retrospective approach for reflecting on past errors and implementing preventive measures by embracing a chronological order of inquiry to promote comprehensive analysis. While root cause analysis contributes to patient safety and improved medical outcomes, this paper elaborates its inputs in solving the case study of Mr. B’s premature deaths and emphasizes the role of nursing leadership in preventing sentinel events.
Steps for Conducting a Root Cause Analysis (RCA)
As noted earlier, the RCA enables healthcare professionals to reflect on past mistakes and incidences of sentinel events to enhance a culture of learning and avert their future occurrences. In this sense, it allows caregivers to identify structural, human, and organizational loopholes that facilitate adverse events such as medication errors and patient falls. Therefore, it effectively promotes adequate preparedness, skill enhancement, and bolstering knowledge regarding viable interventions for safeguarding patient safety. Despite these considerations, healthcare professionals may oppose RCA due to the underlying fear of blame games and punishments by health organizations. As a result, the Institute of Healthcare Improvement (IHI) proposes six steps for conducting RCA to realize comprehensive identification and understanding of causative and contributing factors leading to the sentinel event outcomes. These steps are identifying what happened, determining what should have happened, identifying causes, developing a causal statement, generating a list of recommendations, and writing and sharing the summary.
Step 1: Identifying the Incidence and Describing the Event
The Institute of Healthcare Improvement (IHI) (2018) requires healthcare professionals to clarify a sentinel event by organizing data and findings into simple tools such as diagrams and flowcharts. Such steps enable comprehensive analysis and easy identification of causative and contributing factors for an adverse event. It is possible to apply this step to Mr. B’s case study by describing a series of events from his arrival at the six-room emergency department (ED) of a sixty-bed rural hospital on Thursday 3:30 p.m. to his airlifting to a tertiary facility for advanced care and his subsequent death seven days later. Mr. B is a 67-year-old patient who arrives at the hospital’s emergency department accompanied by his son and a neighbor. He is complaining and moaning of severe pain in his (L) leg and hip area following a fall after tripping over his dog. Healthcare professionals admitted him to the triage room, where they recorded his vital signs, including blood pressure (BP), heart rate (HR), temperature (T), and respiratory rate (RR).
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After recording his vital signs, Dr. T recommended diazepam medication for skeletal relaxation, pain control, and sedation (hydromorphone IVP). The goal for administering these medications is to allow healthcare professionals to manually manipulate, relocate, and align Mr. B’s hip- a process they effectively complete after sedating the patient. After the procedure, caregivers placed the patient on continuous blood pressure and oxygen monitoring. The attending staff became preoccupied with attending to the large numbers of patients crowded in the waiting room. An automatic blood pressure machine and a pulse oximeter alerted healthcare professionals on Mr. B’s deteriorating oxygen saturation levels and fluctuating blood pressure. However, the Licensed Practice Nurse (LPN) rushed to the room to reset the alarm and repeat the B/P reading.
At 4.43 p.m.4.43 p.m., Mr. B’s son alerted the attending nurse, nurse J, about the “alarming monitoring.” By that time, the nurse provided emergency care to a patient with respiratory distress by conducting assessments, evaluations, ordering treatments, and interpreting lab reports. While Mr. B’s B/P and oxygen saturation deteriorated to 58/30 and 79%, respectively, the RN conducted CBR and intubated the patient. Further, the nurse defibrillated him and administered reversal agents, IV fluids, and vasopressors until he regained a normal sinus rhythm with a pulse and a B/P of 110/70. After that, they airlifted him to a tertiary facility for advanced care, where he died after seven days following a family request to remove life support systems.
Step 2: Determining What Should Have Happened
The Institute of Healthcare Improvement (IHI) (2018) requires healthcare professionals to state what would happen in ideal conditions by creating a flow chart based on the event description. In Mr. B’s case study, it is possible to identify loopholes and issues that compromise the set standards for emergency care delivery. Firstly, Dr. T instructed nurse J to administer additional dosage for diazepam IVP and hydromorphone IVP without analyzing potential impacts of the patient’s medical history and body weight. Secondly, the LPN did not communicate with nurse J to voluntarily report on deteriorating vital signs-a step that would prompt immediate interventions. Thirdly, the attending healthcare professionals did not call the backup staff members to alleviate workload and facilitate care coordination. Finally, the standards for moderate sedation procedures require caregivers to monitor patients until they achieve discharge thresholds (Jo & Kwako, 2019). The staff members in the case study did not control or effectively monitor the patient’s electrocardiogram (ECG) and respiration.
Step 3: Determining the Causes
At this point, it is essential to identify and categorize associated factors into two categories: direct causes (causative factors) and contributing aspects (Institute of Healthcare Improvement, 2018). The case study shows that failure to adhere to clinical guidelines for delivering emergency care was the primary cause of the error. The physician (Dr. T) did not conduct a thorough background analysis of the patient’s medication history and body weight-a factor that led to mistakes in medication administration. Also, unfamiliarity with communication and reporting mechanisms exacerbated the situation when the LPN failed to notify nurse J about the patient’s deteriorating vital signs. Finally, lack of coordination between the attending team and the backup staff increased the workload for nurse J, resulting in burnout and failure to deliver quality care.
Similarly, various contributing factors exacerbated the situation by compromising caregivers’ ability to identify and prevent the incident. For instance, overcrowding at the emergency department’s waiting room overwhelmed healthcare workers, limiting their ability to provide patient-centered care. Secondly, the lack of patient monitoring guidelines and clinical protocols for delivering emergency care contributed to the situation.
Step 4: Developing a Causal Statement
A causal statement explains how contributory factors adversely affect the patient and healthcare professionals. Therefore, it provides an interplay between three considerations: the cause, the effect, and the event (Institute of Healthcare Improvement, 2018). In the case study, factors like non-adherence to clinical protocols, the influx of patients in the emergency department, LPN’s unfamiliarity with communication and reporting patterns, and ineffective coordination between the attending healthcare workers and the backup staff compromised patient safety by limiting aspects of quality care, including proper assessment of vital signs, timely monitoring of patient’s progress, and team performance.
Step 5: Generating a List of Recommendations
Undoubtedly, listing recommendations based on the first four steps is a profound approach for inspiring quality improvement initiatives and preventing future sentinel events. According to Cramer et al. (2020), reporting and investigating sentinel events are necessary to prevent harm and safeguard patient safety. Healthcare professionals should embrace flexible and straightforward communication processes to enhance delegation and process efficiency in the case study. Also, it is essential to conduct extensive training to enhance LPNs’ knowledge of clinical guidelines. Finally, the healthcare facility should consider creating checklists in the emergency department that will enable RNs and LPNs to adhere to operational standards and avoid procedural errors.
Step 6: Summarizing and sharing information
The primary objective of conducting RCA is to identify causative and contributing factors for sentinel events to allow healthcare professionals to learn from past events. In this sense, the RCA’s usefulness relies massively upon the organizational safety culture, decision-making procedures, and management styles (Martin-Delgado et al., 2020). Eventually, health organizations should embrace interdisciplinary collaboration and team performance when conducting root cause analysis to inspire quality improvement initiatives and prevent future sentinel events. Based on Mr. B’s case study, effectively sharing findings is a profound strategy for enhancing knowledge, equipping caregivers, and motivating the hospital to implement evidence-based practices and proven interventions for averting harm.
A Process Improvement Plan for Decreasing the Likelihood of Scenario Reoccurrence
While reflecting on Mr. B’s case study, it is valid that the organization should implement evidence-based interventions to prevent a reoccurrence of the scenario outcome. Therefore, the improvement plan would include three major components: extensive staff training and education, setting checklists for emergency care delivery, and bolstering effective communication and reporting by embracing a culture of safety. Staff training and education programs correlate with improved patient safety. According to Audet et al. (2018), education programs enhance nurses’ knowledge, enabling them to identify and address issues that may result in adverse health effects. On the other hand, procedural checklists for emergency care delivery mechanisms reduce serious patient safety events (Cramer et al., 2020). Finally, embracing a culture of safety emails various aspects, including promoting effective communication between healthcare professionals, promoting timely incident reporting, and enhancing interdisciplinary collaboration to address patient safety concerns.
Incorporating Lewin’s Change Theory into the Proposed Improvement Plan
Kurt Lewin’s change theory presents three steps for initiating, implementing, and sustaining change: unfreezing, the change process, and refreezing. Hussain et al. (2018) argue that the unfreezing stage entails renewing the organization’s direction, structure, and capabilities to accommodate change. This phase is consistent with the proposed improvement plan because it emphasizes addressing status quos and resistance to change. For instance, the organization should create a culture of change, introduce clinical checklists, and train employees regarding appropriate ways of delivering emergency care. These interventions can face challenges due to the underlying leadership and resource impediments. Therefore, unfreezing the institutional culture is a profound strategy for initiating change.
Secondly, the change process entails multiple approaches for implementing improvement initiatives, including employee involvement, effective communication, emotional support, and incentives to employees to enhance their participation in the change process (Hussain et al., 2018, p. 124). When implementing the proposed plan for preventing future sentinel events, it is essential to enhance stakeholders’ engagement, share knowledge, incorporate new technologies, and ensure leadership commitment to improving healthcare quality and safety.
Finally, the refreezing phase consolidates individual and collective efforts for sustaining change after successful implementation. This stage entails various processes, including changing behavior, attitudes, and norms to accommodate a safety culture, transforming the existing organizational structures, systems, and processes, and enhancing interpersonal relationships to promote stakeholder collaboration. It is essential to refreeze components of the improvement plan by monitoring the progress, embracing a transformative leadership style, and evaluating conformity to new cultural attributes.
The Failure Mode and Effects Analysis (FMEA) Process
The Failure modes and effects analysis (FMEA) tool enable healthcare professionals to evaluate organizational processes to identify areas of susceptibility to failures and the relative impact of different failures. According to the Institute of Healthcare Improvement (IHI) (2017), FMEA includes reviews of the following sub-themes; steps in the process, failure modes (what could go wrong), and failure effects (what would be the possible consequences of each failure). Therefore, this framework provides a systematic way of evaluating possible loopholes and preventing them by correcting processes rather than reacting to the adverse effects of a sentinel event or past failures. Therefore, it emphasizes the essence of preventing harm rather than responding to adverse effects.
How to Test Interventions from the Process Improvement Plan
While the organization needs to implement staff education and training programs alongside other improvement initiatives, such as introducing procedural checklists, it is essential to test these interventions by choosing appropriate tracking measures. The Agency for Healthcare Research and Quality (AHRQ) (2017) underscores the importance of testing the acceptance and adherence to revised practices to assess their impacts on process improvement. Other effective measures for evaluating quality improvement interventions are examining how new practices affect the delivery of patient-centered care and leveraging feedback from staff members, patients, and family members to determine their satisfaction with new approaches. Finally, the frequent evaluation would provide information regarding areas of improvement and assist in investigating the plan’s feasibility.
Nursing Leadership Qualities
Nurses are responsible for portraying leadership skills considering their education and expertise levels. In this sense, they should guide other healthcare professionals, including nurse assistants and licensed practice nurses (LPNs), on appropriate interventions for promoting patient safety and enhancing care quality. According to Oldland et al. (2020), nurses play a critical role in providing and coordinating care, preventing adverse effects, and optimizing health productivity and quality. Therefore, nursing leadership skills are among the domain of healthcare quality that touches on various components, including promoting quality care, improving patient outcomes, and influencing quality improvement initiatives. For instance, Liu et al. (2019) contend that registered and licensed nurses should influence change and quality improvement programs by participating in interdisciplinary teams and collective efforts to improve structures and processes. As a result, they bear the mantle of communicating, advancing, and implementing change.
How Nurses’ Involvement in RCA and FMEA Demonstrates Leadership Qualities
As noted earlier, root-cause analysis (RCA) is a retrospective approach for identifying causative and contributing factors for a sentinel event. On the other hand, the FMEA framework provides a systematic way of evaluating processes, identifying failures, and assessing their relative impacts. RCA and FMEA are essential aspects that allow caregivers to prevent harm and learn from sentinel events rather than responding to their adverse effects. Martin-Delgado et al. (2020) argue that the effectiveness of RCA depends upon leadership commitment and organizational culture. As a result, nurses’ participation in these preventive approaches demonstrates their commitment to safeguarding patient safety and improving care quality. Also, these tools inspire change and improvement initiatives that focus on eliminating harm and improving processes. Therefore, nurses can channel their leadership qualities by embracing RCA and FMEA and advocating for positive change and interventions.
Mr. B’s case study provides insightful contentions regarding the importance of understanding causative and contributing factors for various sentinel events, including patient falls and medication mistakes. Based on the information from the case scenario, it is possible to avert harm and safeguard patient safety by conducting root causes analysis (RCA) and effects analysis (FMEA). Nurses are responsible for inspiring organizational change and advocating for revised practices to prevent the reoccurrence of adverse events. The RCA and FMEA provide systematic ways for understanding casual factors and developing evidence-based practices solutions for averting future harm.
Agency for Healthcare Research and Quality. (2020). Section 4: Ways to approach the quality improvement process. https://www.ahrq.gov/cahps/quality-improvement/improvement-guide/4-approach-qi-process/index.html#4a.
Audet, L., Bourgault, P., & Rochefort, C. (2018). Associations between nurse education and experience and the risk of mortality and adverse events in acute care hospitals: A systematic review of observational studies. International Journal of Nursing Studies, 80, 128-146. https://doi.org/10.1016/j.ijnurstu.2018.01.007
Cramer, J., Balakrishnan, K., Roy, S., David Chang, C., Boss, E., & Brereton, J. et al. (2020). Intraoperative Sentinel Events in the Era of Surgical Safety Checklists: Results of a National Survey. OTO Open, 4(4), 1-13. https://doi.org/10.1177/2473974×20975731
Hussain, S., Lei, S., Akram, T., Haider, M., Hussain, S., & Ali, M. (2018). Kurt Lewin’s change model: A critical review of the role of leadership and employee involvement in organizational change. Journal of Innovation & Knowledge, 3(3), 123-127. https://doi.org/10.1016/j.jik.2016.07.002
Institute for Healthcare Improvement. (2017). Failure modes and effects analysis (FMEA) tool. http://www.ihi.org/resources/Pages/Tools/FailureModesandEffectsAnalysisTool.aspx.
Institute of healthcare improvement (2018). Patient safety 104: Root Cause and System Analysis Sheet. http://www.ihi.org/education/ihiopenschool/Courses/Documents/SummaryDocuments/PS%20104%20SummaryFINAL.pdf
Jo, Y., & Kwak, H. (2019). Sedation strategies for procedures outside the operating room. Yonsei Medical Journal, 60(6), 491-499. https://doi.org/10.3349/ymj.2019.60.6.491
Liu, H., Zhang, L., Peng, Y., & Wang, L. (2019). Failure mode and effects analysis for proactive healthcare risk evaluation: A systematic literature review. Journal Of Evaluation in Clinical Practice, 26(4), 1320-1337. https://doi.org/10.1111/jep.13317
Martin-Delgado, J., Martínez-García, A., Aranaz, J., Valencia-Martín, J., & Mira, J. (2020). How Much of Root Cause Analysis Translates into Improved Patient Safety: A Systematic Review. Medical Principles and Practice, 29(6), 524-531. https://doi.org/10.1159/000508677
Oldland, E., Botti, M., Hutchinson, A., & Redley, B. (2020). A framework of nurses’ responsibilities for quality healthcare — Exploration of content validity. Collegian, 27(2), 150-163. https://doi.org/10.1016/j.colegn.2019.07.007
It is 3:30 p.m. on a Thursday and Mr. B, a 67-year-old patient, arrives at the six-room emergency department (ED) of a sixty-bed rural hospital. He has been brought to the hospital by his son and neighbor. At this time, Mr. B is moaning and complaining of severe pain to his (L) leg and hip area. He states he lost his balance and fell after tripping over his dog.
Mr. B was admitted to the triage room where his vital signs were B/P 120/80, HR-88 (regular), T-98.6, and R-32, and his weight was recorded at 175 pounds. Mr. B. states that he has no known allergies and no previous falls. He states, “My hip area and leg hurt really bad. I have never had anything like this before.” Patient rates pain at 10 out of 10 on the numerical verbal pain scale. He appears to be in moderate distress. His (L) leg appears shortened with swelling (edema in the calf), ecchymosis, and limited range of motion (ROM). Mr. B’s leg is stabilized and then is further evaluated and discharged from triage to the emergency department (ED) patient room. He is admitted by Nurse J. Nurse J finds that Mr. B has a history of impaired glucose tolerance and prostate cancer. At Mr. B’s last visit with his primary care physician, laboratory data revealed elevated cholesterol and lipids. Mr. B’s current medications are atorvastatin and oxycodone for chronic back pain. After Mr. B’s assessment is completed, Nurse J informs Dr. T, the ED physician, of admission findings, and Dr. T proceeds to examine Mr. B.
Staffing on this day consists of two nurses (one RN and one LPN), one secretary, and one emergency department physician. Respiratory therapy is in-house and available as needed. At the time of Mr. B’s arrival, the ED staff is caring for two other patients. One patient is a 43-year-old female complaining of a throbbing headache. The patient rates current pain at 4 out of 10 on numerical verbal pain scale. The patient states that she has a history of migraines. She received treatment, remains stable, and discharge is pending. The second patient is an eight-year-old boy being evaluated for possible appendicitis. Laboratory results are pending for this patient. Both of these patients were examined, evaluated, and cared for by Dr. T and are awaiting further treatment or orders.
After evaluation of Mr. B, Dr. T writes the order for Nurse J to administer diazepam 5 mg IVP to Mr. B. The medication diazepam is administered IVP at 4:05 p.m. After five minutes, the diazepam appears to have had no effect on Mr. B, and Dr. T instructs Nurse J to administer hydromorphone 2 mg IVP. The medication hydromorphone is administered IVP at 4:15 p.m. After five minutes, Dr. T is still not satisfied with the level of sedation Mr. B has achieved and instructs Nurse J to administer another 2 mg of hydromorphone IVP and an additional 5 mg of diazepam IVP. The physician’s goal is for the patient to achieve skeletal muscle relaxation from the diazepam, which will aid in the manual manipulation, relocation, and alignment of Mr. B’s hip. The hydromorphone IVP was administered to achieve pain control and sedation. After reviewing the patient’s medical history, Dr. T notes that the patient’s weight and current regular use of oxycodone appear to be making it more difficult to sedate Mr. B.
Finally, at 4:25 p.m., the patient appears to be sedated, and the successful reduction of his (L) hip takes place. The patient appears to have tolerated the procedure and remains sedated. He is not currently on any supplemental oxygen. The procedure concludes at 4:30 p.m.,and Mr. B is resting without indications of discomfort and distress. At this time, the ED receives an emergency dispatch call alerting the emergency department that the emergency rescue unit paramedics are enroute with a 75-year-old patient in acute respiratory distress. Nurse J places Mr. B on an automatic blood pressure machine programmed to monitor his B/P every five minutes and a pulse oximeter. At this time, Nurse J leaves Mr. B’s room. The nurse allows Mr. B’s son to sit with him as he is being monitored via the blood pressure monitor. At 4:35 p.m., Mr. B’s B/P is 110/62 and his O2 saturation is 92%. He remains without supplemental oxygen and his ECG and respirations are not monitored.
Nurse J and the LPN on duty have received the emergency transport patient. They are also in the process of discharging the other two patients. Meanwhile, the ED lobby has become congested with new incoming patients. At this time, Mr. B’s O2 saturation alarm is heard and shows “low O2 saturation” (currently showing a saturation of 85%). The LPN enters Mr. B’s room briefly, resets the alarm, and repeats the B/P reading.
Nurse J is now fully engaged with the emergency care of the respiratory distress patient, which includes assessments, evaluation, and the ordering of respiratory treatments, CXR, labs, etc.
At 4:43 p.m., Mr. B’s son comes out of the room and informs the nurse that the “monitor is alarming.” When Nurse J enters the room, the blood pressure machine shows Mr. B’s B/P reading is 58/30 and the O2 saturation is 79%. The patient is not breathing and no palpable pulse can be detected.
A STAT CODE is called and the son is escorted to the waiting room. The code team arrives and begins resuscitative efforts. When connected to the cardiac monitor, Mr. B is found to be in ventricular fibrillation. CPR begins immediately by the RN, and Mr. B is intubated. He is defibrillated and reversal agents, IV fluids, and vasopressors are administered. After 30 minutes of interventions, the ECG returns to a normal sinus rhythm with a pulse and a B/P of 110/70. The patient is not breathing on his own and is fully dependent on the ventilator. The patient’s pupils are fixed and dilated. He has no spontaneous movements and does not respond to noxious stimuli. Air transport is called, and upon the family’s wishes, the patient is transferred to a tertiary facility for advanced care.
Seven days later, the receiving hospital informed the rural hospital that EEG’s had determined brain death in Mr. B. The family had requested life-support be removed, and Mr. B subsequently died.
Additional information: The hospital where Mr. B. was originally seen and treated had a moderate sedation/analgesia (“conscious sedation”) policy that requires that the patient remains on continuous B/P, ECG, and pulse oximeter throughout the procedure and until the patient meets specific discharge criteria (i.e., fully awake, VSS, no N/V, and able to void). All practitioners who perform moderate sedation must first successfully complete the hospital’s moderate sedation training module. The training module includes drug selection as well as acceptable dose ranges. Additional (backup) staff was available on the day of the incident. Nurse J had completed the moderate sedation module. Nurse J had current ACLS certification and was an experienced critical care nurse. Nurse J’s prior annual clinical evaluations by the manager demonstrated that the nurse was “meeting requirements.” Nurse J did not have a history of negligent patient care. Sufficient equipment was available and in working order in the ED on this day.
Your submission must be your original work. No more than a combined total of 30% of the submission and no more than a 10% match to any one individual source can be directly quoted or closely paraphrased from sources, even if cited correctly. An originality report is provided when you submit your task that can be used as a guide.
You must use the rubric to direct the creation of your submission because it provides detailed criteria that will be used to evaluate your work. Each requirement below may be evaluated by more than one rubric aspect. The rubric aspect titles may contain hyperlinks to relevant portions of the course.
- Explain the general purpose of conducting a root cause analysis (RCA).
- Explain each of the six steps used to conduct an RCA, as defined by IHI.
- Apply the RCA process to the scenario to describe the causative and contributing factors that led to the sentinel event outcome.
- Propose a process improvement plan that would decrease the likelihood of a reoccurrence of the scenario outcome.
- Discuss how each phase of Lewin’s change theory on the human side of change could be applied to the proposed improvement plan.
- Explain the general purpose of the failure mode and effects analysis (FMEA) process.
- Describe the steps of the FMEA process as defined by IHI.
- Complete the attached FMEA table by appropriately applying the scales of severity, occurrence, and detection to the process improvement plan proposed in part B.
Note: You are not expected to carry out the full FMEA.
- Explain how you would test the interventions from the process improvement plan from part B to improve care.
- Explain how a professional nurse can competently demonstrate leadership in eachof the following areas:
- promoting quality care
- improving patient outcomes
- influencing quality improvement activities
- Discuss how the involvement of the professional nurse in the RCA and FMEA processes demonstrates leadership qualities.
- Acknowledge sources, using in-text citations and references, for content that is quoted, paraphrased, or summarized.
- Demonstrate professional communication in the content and presentation of your submission.
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