Using Root Cause Analysis and Failure Mode and Effect Analysis To Prevent Sentinel Events in Healthcare
Competencies: 734.3.1: Principles of Leadership – The graduate applies principles of leadership to promote high-quality healthcare in a variety of settings through the application of sound leadership principles.
734.3.2: Interdisciplinary Collaboration – The graduate applies theoretical principles necessary for effective participation in an interdisciplinary team.
734.3.3: Quality and Patient Safety – The graduate applies quality improvement processes intended to achieve optimal healthcare outcomes, contributing to and supporting a culture of safety.
734.3.4: Healthcare Utilization and Finance – The graduate analyzes financial implications related to healthcare delivery, reimbursement, access, and national initiatives
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 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, 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 ten out of ten 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 he is further evaluated and discharged from triage to the emergency department (ED) patient room. He is admitted by Nurse J. The admitting nurse 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 the nurse completes Mr. B’s assessment, Nurse J informs the ED physician of admission findings and the ED physician 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 four out of ten 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 the ED physician and are awaiting further treatment or orders.
After evaluation of Mr. B, Dr. T, the ED physician, 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, 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 en route 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 his 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, Mr. B’s B/P is 110/62 and his O2 sat 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 sat of 85%). The LPN enters Mr. B’s room briefly and 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 respiratory treatments, CXR, labs, etc.
At 4:43, 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 sat 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. Complete a root cause analysis (RCA) that takes into consideration causative factors, errors, and/or hazards that led to the sentinel event (this patient’s outcome).
B. Discuss a process improvement plan that would decrease the likelihood of a reoccurrence of the outcome of the scenario.
1. Discuss a change theory that could be used to implement the process improvement plan developed in B.
C. Use a failure mode and effects analysis (FMEA) to project the likelihood that the process improvement plan you suggest would not fail.
1. Identify the members of the interdisciplinary team who will be included in the FMEA.
2. Discuss steps for preparing for the FMEA.
3. Apply the three steps of the FMEA (severity, occurrence, and detection) to the process improvement plan created in part B.
4. Explain how you would test the interventions from the process improvement plan from part B to improve care in a similar situation.
Note:You are not expected to carry out the full FMEA, but you should explain each step, and how you would apply it to your process improvement plan.
D. Discuss how the professional nurse may function as a leader in promoting quality care and influencing quality improvement activities.
E. When you use sources to support ideas and elements in a paper or project, provide acknowledgement of source information for any content that is quoted, paraphrased or summarized. Acknowledgement of source information includes in-text citation noting specifically where in the submission the source is used and a corresponding reference, which includes:
• Location of information (e.g., publisher, journal, or website URL)