Root Cause Analysis Fema Paper
Task 2 Template
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.
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.
A & A1 responses provide general information, and do not relate to the scenario. Describe in your own words. A numbered list can be used for A1.
For A2 apply Steps 1-4 of the RCA process to the scenario being sure to conclude with the causative and contributing factors.
Step 1: Identify what happened. The team must try to describe what happened accurately and completely. To organize and further clarify information about the event, some teams create a flowchart, a simple tool that allows you to draw a picture of what happened in the order it occurred.
Step 2: Determine what should have happened. The team has to determine what would have happened in ideal conditions. It can be useful to create a flow chart based on this information and compare it to the chart from Step 1.
Step 3: Determine causes (“Ask why five times”). This is where the team determines the factors that contributed to the event. Teams look at direct causes (most apparent) and contributory factors (indirect in nature) during this process. Some experts recommend that RCA teams “ask why five times” to get at an underlying or root cause. The IHI Open School provides online courses in quality improvement, patient safety, leadership, patient- and family-centered care, managing health care operations, and population health. These courses are free for students, residents, and professors of all health professions, and available by subscription to health professionals. One useful tool for identifying factors and grouping them is a fishbone diagram (also known as an “Ishikawa” or “cause and effect” diagram), a graphic tool used to explore and display the possible causes of a certain effect. Seven different factors influence clinical practice and medical error: patient characteristics, task factors, individual staff member, team factors, work environment, organizational and management factors, institutional context.
Step 4: Develop causal statements. A causal statement links the cause (identified in Step 3) to its effects and then back to the main event that prompted the RCA in the first place. By creating causal statements, we explain how the contributory factors – which are basically a set of facts about current conditions – contribute to bad outcomes for patients and staff. A causal statement has three parts: the cause (“This happened …”), the effect (“ … which led to something else happening …”), and the event (“ … which caused this undesirable outcome”).
Step 5: Generate a list of recommended actions to prevent the recurrence of the event. Recommended actions are changes that the RCA team thinks will help prevent the error under review from occurring in the future. Recommendations often fall into one of these categories: i. Standardizing equipment ii. Ensuring redundancy, such as using double checks or backup systems iii. Using forcing functions that physically prevent users from making common mistakes iv. Changing the physical plant v. Updating or improving software vi. Using cognitive aids, such as checklists, labels, or mnemonic devices vii. Simplifying a process viii. Educating staff ix. Developing new policies Some actions are more effective than others at dealing with the root causes of error. The National Center for Patient Safety defines strong, intermediate, and weak actions: i. A strong action is likely to eliminate or greatly reduce the likelihood of an event. ii. An intermediate action is likely to control the root cause or vulnerability. iii. A weak action by itself is less likely to be effective.
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. To organize and further clarify information about the event, some teams create a flowchart, simple tool that allows you to draw a picture of what happened in the order it occurred.
Model for improvement:
1. Set an aim. A general statement — something like, “We will improve our infection rate” — isn’t good enough. The aim statement should be time-specific and measurable, stating exactly: “How good?” “By when?” and “For whom?”
2. Establish measures. You need feedback to know if a specific change actually leads to an improvement, and quantitative measures can often provide the best feedback.
3. Identify changes. So, how are you going to achieve your aim? Where do new ideas come from? You can spark creative thinking in various ways, and there are tools that can help.
4. Test changes. This is where the PDSA cycle portion of the Model for Improvement comes in. By planning a test of change, trying the plan, observing the results, and acting on what you learn, you will progressively move toward your aim. Measurement is an essential part of testing changes with PDSA (Plan-Do-Study-Act): It tells you if the changes you are testing are leading to improvement.
5. Implement changes. After you have a change that results in improvement under many conditions, the logical next step is to implement it — meaning, make the change the new standard process in one defined setting
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.
The improvement Plan (IP) needs to address the factors you identified in A2. IHI refers to this as an “action plan”. Describe the changes you would implement in the ED to prevent recurrence.
Describe the 3 stages of the theory, and show how you would apply Lewin’s strategies to the implementation of your IP from B. Provide at least one strategy specific to your plan for each stage to help staff accept new IP.
3 Stages to Lewin’s change theory:
From Lewin’s perspective, the first stage in helping people adapt to change involves unfreezing or loosening their attachment to their current attitude or practice. That means helping them understand why change is necessary and clarifying how the change will be accomplished. When implementing a change in health care, this stage might include communicating with staff and sharing external research or internal data about the change. It may also focus on training or the distribution of resources that will help people understand the need for the change.
In the second stage, the process of change actually occurs. This may be a difficult time for individuals affected by the change. These people will need lots of support as questions and frustrations arise. 3. Freezing
Once the changes occur or something has transitioned to a new way of being, Lewin identifies a need to actively “re-freeze” the process in its new state, so that it can continue to operate as designed. This ensures that people will not naturally return to the old way of doing things. This re-freezing may involve new protocols and procedures, periodic process checks to learn how the new process is working in relation to its design, and reinforcement through internal communications and other formats that remind people of the new process.
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.
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. FMEA includes review of the following:
· Steps in the process
· Failure modes (What could go wrong?)
· Failure causes (Why would the failure happen?)
· Failure effects (What would be the consequences of each failure?)
Teams use FMEA to evaluate processes for possible failures and to prevent them by correcting the processes proactively rather than reacting to adverse events after failures have occurred. This emphasis on prevention may reduce risk of harm to both patients and staff. FMEA is particularly useful in evaluating a new process prior to implementation and in assessing the impact of a proposed change to an existing process.
Steps in FMEA process:
1) Select a process to evaluate with FMEA. Evaluation using FMEA works best on processes that do not have too many sub-processes. If you’re hoping to evaluate a large and complex process, such as medication management in a hospital, divide it up. For example, do separate FMEAs on medication ordering, dispensing, and administration processes.
2) Recruit a multidisciplinary team. Be sure to include everyone who is involved at any point in the process. Some people may not need to be part of the team throughout the entire analysis, but they should certainly be included in discussions of those steps in the process in which they are involved. For example, a hospital may utilize couriers to transport medications from the pharmacy to nursing units. It would be important to include the couriers in the FMEA of the steps that occur during the transport itself, which may not be known to personnel in the pharmacy or on the nursing unit.
3) Have the team list all of the steps in the process. Working with a team that represents every point in the process you’re evaluating, establish a mutually agreed upon, ordered list of all the steps in the process.
4) Fill out the table with your team
5) Use RPNs to plan improvement efforts. Failure modes with high RPNs are probably the most important parts of the process on which to focus improvement efforts. Failure modes with low RPNs are not likely to affect the overall process much, even if eliminated completely, and they should therefore be at the bottom of the list of priorities. Identify the failure modes with the top 10 highest RPNs. These are the ones the team should consider first as improvement opportunities.
For the Table:
In the left-most column, input the numbered list of the steps in the process. Then, working with the members of the team who are involved in specific steps, fill out the remaining columns as follows:
o Failure Mode [What could go wrong?]: List anything that could go wrong during that step in the process.
o Failure Causes [Why would the failure happen?]: List all possible causes for each of the failure modes you’ve identified.
o Failure Effects [What would be the consequences of the failure?]: List all possible adverse consequences for each of the failure modes identified.
o Likelihood of Occurrence (1–10): On a scale of 1-10, with 10 being the most likely, what is the likelihood the failure mode will occur? o Likelihood of Detection (1-10): On a scale of 1-10, with 10 being the most likely NOT to be detected, what is the likelihood the failure will NOT be detected if it does occur?
o Severity (1-10): On a scale of 1-10, with 10 being the most likely, what is the likelihood that the failure mode, if it does occur, will cause severe harm?
o Risk Profile Number (RPN): For each failure mode, multiply together the three scores the team identified (i.e., likelihood of occurrence x likelihood of detection x severity). The lowest possible score will be 1 and the highest 1,000. To calculate the RPN for the entire process, simply add up all of the individual RPNs for each failure mode.
o Actions to Reduce Occurrence of Failure: List possible actions to improve safety systems, especially for failure modes with the highest RPNs. a) Tip: Teams can use FMEA to analyze each action under consideration. Calculate how the RPN would change if you introduced different changes to the system.
C – Describe in your own words C1 – There are 5 steps in the FMEA process according to IHI; completing the FMEA table is Step 4. A numbered list can be used. Describe in your own words.
The content to apply to the FMEA table is your Improvement Plan from B, and NOT the original Scenario errors. Your objective is to describe your plan in 4 steps in Column 1; next hypothesize a fail for each step in Column 2. You apply the scales/scoring to each fail. Then calculate the RPN for each row.
See Steps 3 & 4 of FMEA process.
D. Explain how you would test the interventions from the process improvement plan from part B to improve care.
Propose a specific initial evaluation plan, or pilot to evaluate/monitor whether your plan would work as you expect before full implementation. What data could you collect; what activities will you monitor during the pilot.
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.
E – The focus is on leadership activities here. Provide an activity or way the BSN RN can demonstrate leadership for each bullet-point. You can share from your professional experience or organizational opportunities.
For E1 – what leadership qualities does the BSN RN bring to the RCA/FMEA team as compared to the MD or LPN for example.
Citations for IHI:
Institute for Healthcare Improvement. (2019). Patient Safety 104: Root Cause and Systems Analysis Summary Sheet. Retrieved from http://www.ihi.org/education/ihiopenschool/Courses/Documents/SummaryDocuments/PS%20104%20SummaryFINAL.pdf
Model for Improvement:
Institute for Healthcare Improvement. (2019). Quality Improvement 102: The Model for Improvement: Your Engine for Change Summary Sheet. Retrieved from http://www.ihi.org/education/ihiopenschool/Courses/Documents/QI102-FinalOnePager.pdf
Lewin’s Change Theory:
Williams, D. (2019). QI 201: Planning for Spread: From Local Improvements to System-Wide Change. Retrieved from http://app.ihi.org/lmsspa/#/6cb1c614-884b-43ef-9abd-d90849f183d4/ea07c796-a771-4713-8bd8-520188b6c793/lessonDetail/2adf747a-862f-4862-ab0c-561318f05b67/page/1
Institute for Healthcare Improvement. (2017). QI Essentials Toolkit: Failure Modes and Effects Analysis (FMEA). Retrieved from http://www.ihi.org/resources/pages/tools/FailureModesandEffectsAnalysisTool.aspx