Healthcare facilities that are accredited by Joint Commission are required after a sentinel event to conduct a root cause analysis (RCA). A root cause analysis is conducted to determine the cause or factors that contributed to the sentinel event. A few things must be asked in the RCA such as who, what, where, why and how in order to identify the cause. After the cause of the sentinel event is determined and a corrective action plan has been put in place a failure mode and effects analysis (FMEA) could be conducted to reduce the likelihood that it should happen again.
A 67 year old male (Mr. B) was brought into the emergency room for pain to left leg and left hip. The injury occurred when the patient had a fall due to him losing his balance after tripping over his dog. The hospital is a 60 bed rural hospital located in Mr. B’s hometown. Mr. B was brought in by his son and neighbor. Upon triage Mr. B was complaining of pain 10/10 on the numerical pain scale and his vitals were found to be stable. Mr. B has a history of impaired glucose tolerance, prostate cancer, and chronic pain which he is on oxycodone. The Patient states he had no known allergies or previous falls. Upon the nursing assessment Nurse J. has noticed that the patient has limited range in motion, his left leg has swelling and appears shortened in comparison to the right.
Nurse J. has informed the ED physician which he came to his bedside for evaluation. Upon evaluation the physician decided that Mr. B needed to have a reduction of his left hip, due to the dislocation and will require a conscious sedation. Mr. B requires multiple doses of medication to achieve the desired sedation affect for the reduction. Once the reduction was successful Mr. B is left with son in the room where a full set of vitals were not continuously monitored and goes into respiratory failure which lead to the death of Mr. B. Staffing on this day is the day of the event consisted of a secretary, emergency department physician (Dr. T), and two nurses (one RN and one LPN). A respiratory therapist is in house and available as needed in this six bed ED and sixty
At 3:30pm- Mr. B was taken to ED for left leg and left hip pain from a fall. Pain is a 10/10 vitals include 120/80 blood pressure (BP), 88 heart rate (HR) and regular, 98.6 temperature, (T), 32 respirations (R), 175 lbs.. At 4:05pm- Mr. B was given Diazepam 5mg IVP which had no affect after 5min. At 4:10pm- Dr. T orders 2mg of hydromorphone to be given to Mr. B. At 4:15pm- Mr. B was given 2mg of hydromorphone IVP.
At 4:20pm- Dr. T is not satisfied with level of sedation and orders Mr. B to be given 2mg of hydromorphone, and diazepam 5mg IVP. At 4:25pm- Mr. B appears to be sedated and reduction of his (L) hip takes place. The patient remains sedated and appears to have tolerated the procedure. The procedures concludes at 4:30pm. No distress is noted, patient is placed on monitor for blood pressure to be taken every 5 minutes along with pulse oximeter but no supplemental oxygen or ECG leads (monitors cardiac rhythm and respirations) was placed on patient at this time. At 4:30pm- Nurse J allows Mr. B’s son to remain in the room with him as he is being monitor by blood pressure machine only. Nurse J leaves the room. At 4:35pm- Mr. B vitals are BP 110/62, O2 sat is 92% still no oxygen or ECG leads are on patient at this time. EMS is transporting a patient in respiratory distress, lobby is beginning to get congested.
LPN and Nurse J. in the process of discharging 2 patients and are checking in the patient that EMS has transported in. LPN enters Mr. B’s room and resets his alarming monitor that was showing a sat of 85% and restarts the B/P to recycle. LPN does not supply oxygen and does not alert Nurse J at this time. Management is not notified that patient acuity and patient load is increasing. Nurse J is now fully engaged with the emergency care of the respiratory distress patient. At 4:43pm- Mr. B’s son comes out of room and informs the nurse that the monitor is alarming with vitas of B/P 58/80 O2 of 79%. The patient has no palpable pulse and is not breathing. A STAT code is called and the son is taken to the waiting room.
The code teams arrives places Mr. B on cardiac monitor where he is in ventricular fibrillation and the team begins resuscitative efforts. CPR is started and the patient is intubated. Mr. B is defibrillated and reversal agents, vasopressors and IV were started. At 5:13pm- After 30 min of interventions the ECG returns to a normal sinus rhythm with Mr. B’s B/P being 110/70. The patient is completely dependent on the ventilator, his pupils are fixed and dilated and there is no spontaneous movements. The family as asked for the patient to be transferred out to a tertiary facility for further advanced care.
Seven Days later Mr. B has died. The family had requested that life-support be removed after brain death had been determined by EEG’s. This is a sentinel event.
Investigation of sentinel event should begin with a Team and method of investigation. Interdisciplinary team included in the RCA should include the Director of Nurses, Nursing Supervisor, Risk management, Nursing Coordinator, and Manager of the department. Once the team is put together the RCA should be started. The team should set up interviews with all staff that was involved and present in the department the day the sentinel event happened. A complete chart review should be conducted by team.
The policies on conscious sedation, staffing of department, and standardized work should be reviewed. When the cause is identified a corrective action plan should be conducted. The corrective action plan will allow a series of projects can be put in place to help create or change polices if needed. The new or changed polices should be put into education models to teach to current and new staff as needed.
The Root Cause Analysis
Causative factors- (why it happened) determined cause
Individual’s cause factors
Nurse J did not follow procedure for conscious sedation. The patient was not placed on continuous B/P, ECG, and pulse oximeter throughout the procedure. Respiratory Therapist was not informed of the conscious sedation. LPN did not address low o2 saturation of 85% between the 4:35pm-4:43pm. Dr. T did not take in account of the patient’s weight and chronic pain medication use. Nurse J did not question the medication that Dr. T ordered.
Team’s cause factors
Management was not called and informed of staffing needs and acuity of patients. Back up staff was not called in to help when acuity and patient load had increased. Commination between Nurses and Dr. T were not present when the patient began to decompensate.
Management /Organizational cause factors
Unsafe Staffing at ED. There was not enough staff present to safely manage emergencies in the ED. RCA Findings:
Errors and/or Hazards
1. Per protocol the patient was not hooked up to the proper monitoring equipment at the bedside. The facility procedure police called for continuous B/P ECG, and pulse oximetry during and after procedure until patient meet the discharge criteria. The nurse should have remained with patient during the recovery period. Crash cart with defibrillator was not present during the procedure nor was the proper reversal agents that could reverse the medication given for sedation. 2. Nursing staff communication was very poor. LPN did not notify Nurse J or ED physician when the patient’s o2 saturation dropped down to 85%. Oxygen was not placed on patient when O2 saturation dropped which led to respiratory failure causing the patient to code and eventually led to Mr. B’s death.
3. Communication between ED staff and management lacked when staffing needs increased. Patient safety was put at risk when the patient load and acuity increased in the ED and the staffing did not increase. Staffing shortage caused the nurse and nursing support staff to attend to other patients and leave Mr. B unmonitored which led to respiratory distress due to the patient being over medicated for sedation which led to respiratory failure and eventually led to Mr. B’s death. 4. The ED physician did not request the patient be transferred to the nearest trauma center due to lack of recourse’s in the emergency department.
Recommended Corrective Action Plan/Change Theory/Improvement Plan
1. Improved patient safety during conscious sedation: Effective immediately all conscious sedation procedures will be conducted per protocol. Within 10 days the conscious sedation procedure should be evaluated by a committee to ensure the best practices are being used. Within 30 days of this RCA all staff should be educated on conscious sedation protocol. All nursing staff should use review protocols for conscious sedation before a conscious sedation procedure is to take place. 2. Communication within the department should be evaluated immediately by a group of staff members to find out where the miscommunication failure lies. This could be that the nursing support staff is unaware of the parameters that should be reported to nurse or physician. With 10 days of this RCA a policy on documentation of communication should be put in place to ensure that all nursing staff are documenting the communication of a patients change in status has be reported to physician.
Effective immediately all nursing support staff should be educated on parameters that should be reported to nursing staff and physicians. This should be put into a policy along with documentation of communication. 3. Improved patient to nurse ratios: Management should put in place a safe nurse to patient ratio for the emergency room. Communication policy between department and management should be put in place effective immediately to ensure that no other patient should be placed in harm’s way due to staffing shortage. The emergency department should be put on diversion if the patient load and acuity places patients at risk for harm in any manner. A copy of the RCA should be given to management and leadership. Management should share the finding with all emergency department staff.
Feedback should be done 30 days after corrective action plan or change theory have been put in place to ensure that everything that has been put in place is effective for the department to improve patient safety. Constant reevaluation of patient safety should be conducted and feedback given to improve patient safety by all providers involved. Management will continue to ensure that all staff follow all protocols to ensure that patient care and safety are not compromised. At a 90 days bench mark after the corrective action plan has been put in place management should revisit the any changes made to protocols and polices to ensure compliance and effectiveness is still in place and reevaluate the process to ensure patient safety.
Failure Mode and Effects Analysis (FMEA)
A Failure Mode and Effects Analysis is proactive versus the RCA which is reactive. A FMEA assesses a process for risks of failures or adverse effects of a process and prevents them by correcting what is wrong proactively (Institute for Heathcare Improvement, 2004). A Healthcare facility may use FMEA tools on the Institute for Healthcare Improvement website to evaluate a process in the facility. This tool will calculate a risk priority number (RNP) of a process, evaluate the impact of the process and the changes that are being considered, and tract the improvement over time (Institute for Heathcare Improvement, 2004).
1. Step one: Select a process to be evaluated with FMEA. The FMEA for this paper will focus on the conscious sedation protocol. 2. Step Two: Recruit a multidisciplinary team and include a member from every department that may be involved or affected. This team for the conscious sedation protocol should will include.
A member from Legal
Emergency Department Tech
3. Step Three: Information needs to be gathered by the team. A list of steps in the process being evaluated should be put together or even an outline of steps would be helpful to the team. All internal and external data, clinical practice guidelines, current policies and procedures, current literature and any other information that may pertain to the process that is being evaluated. For the purpose of this paper we would use data on outcomes of conscious sedation protocols, RCA’s on bad outcomes, clinical practice guidelines and any research documentation that would aid in best practices for conscious sedation.
Team meetings should be structured with an agenda. A leader or primary person with extensive knowledge of the FMEA knowledge (Department of Defense Patient Safety Center, 2004) 4. Step Four: The Team should list the failure modes and causes. In each process all failure modes should be listed, and then for each failure mode a list of possible causes should be listed as well. In this scenario we will use this as an example
Wrong medication prepared
Wrong dose prepared
5. Step Five: A Risk Priority Number (RPN) will be assigned to each failure mode for the likelihood of occurrence, for the likelihood of detection, and for the severity. This step is also known as the three steps FMEA. The RPN is a numerical rating. For this scenario here is an example Likelihood of Occurrence: This will measure the likelihood a failure mode is to occur. The score range will be 1-10 with 1 meaning it is very unlikely to occur and 10 meaning very likely to occur. Example- Wrong medication prepared = 5
Likelihood of Detection: This will measure the likelihood a failure mode is to be detected if it should occur. The score range will be 1-10 with 1 meaning it is very likely to be detected and 10 meaning very unlikely to be detected. Example- Wrong medication prepared = 6
Severity of occurrence: This will measure the severity of the failure mode should it occur. The score range will be 1-10 with 1 meaning no effect and 10 will be death should a failure mode occur. Example- Wrong medication prepared= 9
6. Step Six: The team will evaluate the results. For each failure mode the three scores are multiplied with each other. The failure mode with the highest RPN will be the one that will be evaluated by the team to ensure patient safety. The higher the RPN a failure mode has the higher the potential for harm it may cause. The RPN score can be as high as 1,000 and as low at 3. Example- Wrong Medication Prepared
5x6x9= overall score =270
7. Step Seven: An improvement plan will be made based on the RPN. Likely to Occur. Have a triple check put in place. Have team attempt to eliminate all possible causes. Example-Have medication scanned when pulled from Pyxis to check providers order. Have patient scanned before medication may be prepared to check providers order. Have patient and medication scanned to ensure correct patient with the correct medication and proper providers order.
Unlikely to be detected.
Look for warning signs that the error may not be detected.
Use data from any previous or prior errors.
Use any data available to determine severity of error.
Make available any and all resources to prevent further errors and severity of errors.
Final Step- The final step in the FMEA is to plan an observation or test. A plan should be clear of its objections and should have some sort of predictions or outcomes. During the test all data should be documented. In this data collection phase all observations including problems or unexpected issues should be documented and later evaluated. After the test is complete and all data collected the team should meet for analysis of the data. A summary of the analysis should be documented.
All changes or modifications to the process will be based on the test and analysis of data conducted. Any and all changes should be communicated to all staff members. These changes may or may not show improvement to the process, this is why constant reevaluation of all process should be conducted and any feedback should be given to leadership for the reevaluation of the process.
Nurses play a vital role in health care. Nurses have the most contact with a patient. Nurses carry out any orders and or processes. A nurse is the patient advocate, they are the ones who will advocate for patient safety. Nurses are the advocates who will be looking for evidence base practices to improve patient care and patient safety. Improving quality of care for each patient will improve the outcomes for each patient.
Department of Defense Patient Safety Center. (2004, 12 26). Failure Mode and Effects Analysis. Retrieved from FMEA Info Centre: http://www.fmeainfocentre.com/handbooks/FMEA_Guide_V1.pdf Institute for Heathcare Improvement. (2004). Failure Modes and Effects Analysis (FMEA). Retrieved from Institute for Heathcare Improvement: http://www.ihi.org/resources/Pages/Tools/FailureModesandEffectsAnalysisTool.aspx