C489 Root Cause Analysis Example

Organizational Systems and Quality Leadership SAT Task 2

  1. Root Cause Analysis

A systematic tool used by healthcare professionals to study how and why a problem occurs and how to prevent the problem from happening again.

C489 Root Cause Analysis Example

A1. There are six steps to most RCAs:

 Step 1: Identify what happened. In this step the team gathers information and describes what happened. A flow chart is developed to draw a picture of the incident in the order that occurred.

Step 2: Determine what should have happened. The team identifies what

would have happened with the correct procedures were followed.

Step 3: Determine causes (“Ask why five times”). In this step, the team looks at the direct cause and contributing factors.

 Step 4: Develop causal statements. A causal statement links the cause to its effects and then back to the main event that prompted the RCA in the first place.

Step 5: Generate a list of actions or changes to prevent the recurrence of the event in the future.

Step 6: Write a summary and share it. This can be an opportunity to engage the key players to help drive the next steps in improvement.

A2. Causative and Contributing Factors

In this scenario, it appears the patient received too much sedation. In the 20 min documented, Mr. B received 10 mg of diazepam and 4mg of hydromorphone. Safe dosing practices were not implemented. After arriving to the room, Nurse J places Mr. B on an automatic blood pressure machine programmed for every five minutes and a pulse oximeter, then leaves the room.

Because the patient was sedated, the nurse should have stayed in the room for the first 15 min to assess and monitor.  At 4:35pm, it was stated that the O2 sat was 92%. The patient was not placed on supplemental oxygen and his ECG and respirations are not monitored. Another contributing factor appears to be staffing. Staffing consisted of two nurses and an ER physician for patient care with more critical patients arriving by EMS.

  1. Improvement Plan

The improvement plan would begin with developing a team of multiple disciplinary healthcare members (i.e. Medical director, ER nurse manager, director of nursing, respiratory therapy) as a committee to perform a root cause analysis of the incident. The team will conduct interviews with the staff and perform records review to gather information on the occurrence. Contributing and direct factors would be identified. The team would identify what went wrong and develop a plan of action to prevent future occurrences.

B1. Change Theory

Change is crucial to the growth of a profession. Kurt Lewins change theory consist of three stages which include unfreezing, change and freezing. Unfreezing stage attempts to help people adjust to change or loosen an attachment to a specific practice or task. During this stage, the hospital directors and educational department can implement mandatory patient education sessions on conscious sedation and review the sentinel event that resulted in the death of a patient.

A new EHR software module can be introduced with checkpoints and hard stop capability if too much medication is detected. Extensive training will be provided. During the second stage of change, the new change is implemented. Staff will need support with coping with the new change as frustration may occur. The new medication safety checklist software will be effective with super-users onsite to assist with training.

The third stage involves freezing which locks the change in place. Frequent checks are implemented to see how the new process is working. This prevents the change from being unsuccessful and returning to the old process. The committee will do performance evals and system review to ensure staffing is documenting correctly and no more sentinel events are reported. C489 Root Cause Analysis Example

  1. General Purpose of FMEA

According to the Institute for Healthcare Improvement, Failure Modes and Effects Analysis ( FMEA) is a systematic, proactive method for evaluating a process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change ( ihi.org).

C1. Steps of FMEA Process

The FMEA tool allows teams to review, evaluate and record:

Review the process

  1. Failure mode. This consist of identifying anything that can go wrong during that step in the process.
  2. failure causes. In this step, list all possible causes for each of the failure modes that have been identified.
  3. Failure effects. The team will address all possible adverse consequences for each listed failure mode.
  4. Likelihood of occurrence. You will rate what is the likelihood the failure mode will occur on a scale of 1-10. 10 will be the most likely.
  5. Likelihood of detection. The likelihood the failure will not be detected if it occurs will be rated on a scale of 1-10 with 10 being the most likely.
  6. If the failure mode occurs, what is the likelihood that the failure mode will cause severe harm on a scale of 1-10.
  7. Record the risk profile number
  8. Review the action to reduce the occurrence of failure. List possible actions to improve safety

C2. FMEA Table

Submitted as a separate document

  1. Intervention Testing

Intervention testing is a test pilot to improve care. The ED would be involved in the test pilot program. The test-pilot roll out would include a team made up of the ED Nurse Manager and Medical Director to observe 5-10 conscious sedation patients. Upon first notification by a physician that orders have been written for a conscious sedation procedure, the observation team would verify the time of response from order placement in the Electronic Health Record (EHR) by the prescribing provider to the acknowledgment by the RN.

The observation team would verify the time it takes the RN and RT to  arrive at the patient’s bedside with ECG, BP and Pulse Oximetry monitoring equipment.  Upon placement of the ECG, BP and Pulse Oximetry monitoring equipment, the team would then observe any challenges the RN or RT face in double verification before medication administration could occur.

Upon successful conscious sedation verification by the physician, the ordered procedure would begin and be completed by the physician and other providers, and monitoring would be continued by the RN and RT, to ensure continuous BP, ECG, and pulse oximetry monitoring is maintained until the patient is symptom free, fully awake, with VSS, no N/V, and able to void per hospital policy.

  1. Demonstrate Leadership

E1. Involving Professional Nurse in RCA and FMEA Processes

The discussion logically describes how the involvement of the professional nurse in both the RCA and FMEA processes demonstrates leadership qualities.


Lesson 2: How a root cause analysis works. Retrieved from http://app.ihi.org

QI Essentials Toolkit: Failure Modes and Effects Analysis (FMEA) Tool. Institute for Healthcare Improvement; 2017. (Available on ihi.org)

Organizational Systems and Quality Leadership SAT Task 2


Healthcare organizations accredited by the Joint Commission are required to conduct a root cause analysis (RCA) in response to any sentinel event, such as the one described in the scenario attached below. Once the cause is identified and a plan of action established, it is useful to conduct a failure mode and effects analysis (FMEA) to reduce the likelihood that a process would fail. As a member of the healthcare team in the hospital described in this scenario, you have been selected as a member of the team investigating the incident.


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 €œmonitor 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.


A. Explain the general purpose of conducting a root cause analysis (RCA).

1. Explain each of the six steps used to conduct an RCA, as defined by IHI.

2. Apply the RCA process to the scenario to describe the causative and contributing factors that led to the sentinel event outcome.

B. Propose a process improvement plan that would decrease the likelihood of a reoccurrence of the scenario outcome.

1. Discuss how each phase of Lewin’s change theory on the human side of change could be applied to the proposed improvement plan.

C. Explain the general purpose of the failure mode and effects analysis (FMEA) process.

1. Describe the steps of the FMEA process as defined by IHI.

2. 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.

D. Explain how you would test the interventions from the process improvement plan from part B to improve care.

E. Explain how a professional nurse can competently demonstrate leadership in each of the following areas:

promoting quality care

improving patient outcomes

influencing quality improvement activities

1. Discuss how the involvement of the professional nurse in the RCA and FMEA processes demonstrates leadership qualities.

F. Acknowledge sources, using in-text citations and references, for content that is quoted, paraphrased, or summarized.