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Posted: November 6th, 2023

Organizational Systems and Quality Leadership – Mr. B, a 67-year-old patient

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:

1. Unfreezing

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.

2. 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:

RCA Process:
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

FMEA and Table:
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

_____________________________________________
A. General Purpose of Root Cause Analysis (RCA)
The general purpose of conducting a Root Cause Analysis (RCA) is to systematically investigate and identify the underlying causes of adverse events, near misses, or sentinel events in healthcare settings. The RCA process is designed to help organizations learn from errors, improve patient safety, and prevent the recurrence of similar incidents. RCA is a critical tool in healthcare quality improvement that focuses on understanding the root causes rather than assigning blame to individuals.

A1. Six Steps of RCA by IHI

Identify what happened: The first step involves accurately and completely describing the event. Creating a flowchart may help organize the information.

Determine what should have happened: The team must establish what would have been the ideal outcome under perfect conditions and compare it to the actual events.

Determine causes (“Ask why five times”): In this step, the team identifies both direct and contributory factors, delving deep into the causes of the event. The “5 Whys” technique is often employed to get to the root cause.

Develop causal statements: Create causal statements that link the identified causes to their effects and, ultimately, to the main event. This step explains how contributory factors led to the undesirable outcome.

Generate a list of recommended actions: The team formulates recommendations to prevent similar events from occurring in the future. These recommendations may involve standardizing equipment, changing policies, educating staff, and more.

Write a summary and share it: The summary is used to engage key stakeholders in the process and drive further improvements based on the findings.

A2. Applying RCA to the Scenario
In the scenario described, we can apply Steps 1-4 of the RCA process as follows:

Step 1: Identify what happened: Mr. B, a 67-year-old patient, experienced a sentinel event where he suffered cardiac arrest following a procedure.

Step 2: Determine what should have happened: Ideally, in this situation, Mr. B’s procedure should have been completed without adverse events, ensuring his safety and well-being.

Step 3: Determine causes (“Ask why five times”):

The cause of Mr. B’s cardiac arrest was inadequate monitoring after sedation.
This was because the ED staff was overwhelmed with other patients and resources were diverted.
This was due to the hospital’s staffing limitations and high patient load.
This, in turn, was because of inefficient patient flow management.
Ultimately, the root cause was a lack of effective resource allocation and planning.
Step 4: Develop causal statements: Causal statements link the identified causes to their effects. For example, “Inadequate monitoring of Mr. B after sedation led to a delayed response to his deteriorating condition, causing cardiac arrest.”

B. Process Improvement Plan to Prevent Recurrence
The improvement plan (IP) for the ED scenario aims to prevent recurrence by addressing the identified root causes. Applying Lewin’s Change Theory, we can divide the plan into three stages:

Unfreezing: The staff and management need to understand the urgency and importance of change. In this stage, we will communicate the root causes and consequences of Mr. B’s case, emphasizing the need for better patient safety.

Change: Implement changes in the ED, including:

Increasing staffing levels during peak hours to ensure better patient-to-staff ratios.
Introducing a real-time monitoring system that tracks patient vital signs and alerts staff to any deviations.
Conducting mandatory training for staff on the use of monitoring equipment and the importance of continuous patient surveillance.
Freezing: After implementing the changes, ensure that the new processes become the standard. This may involve regular audits, performance evaluations, and reinforcing the importance of the changes through internal communications.

C. Failure Mode and Effects Analysis (FMEA) Process
C1. Steps of FMEA by IHI
The Failure Mode and Effects Analysis (FMEA) process, according to IHI, involves the following steps:

Select a process to evaluate: Choose the process to be evaluated, ensuring it is specific and manageable.
Recruit a multidisciplinary team: Form a team that includes all relevant stakeholders involved in the process.
List all the steps in the process: Create a comprehensive and agreed-upon list of all the process steps.
Fill out the FMEA table: In this step, the team identifies potential failure modes, causes, effects, likelihood of occurrence, likelihood of detection, and severity for each step in the process.
Use RPNs to plan improvement efforts: Calculate Risk Profile Numbers (RPNs) for each failure mode to prioritize and focus improvement efforts on the most critical issues.
D. Testing the Interventions
To test the interventions from the process improvement plan, a pilot evaluation plan can be implemented. This plan may include:

Collecting data on staffing levels, patient-to-staff ratios, and the number of critical events before and after implementing changes.
Monitoring the utilization and response times of the real-time monitoring system.
Conducting surveys and feedback sessions with staff to assess their perception of the changes and any challenges faced.
E. Professional Nurse Leadership in RCA and FMEA
E1. Promoting Quality Care:
Professional nurses can lead by actively participating in RCA and FMEA teams, advocating for patient safety, and ensuring that the lessons learned are applied to improve care processes.

E2. Improving Patient Outcomes:
Nurses can take the lead in identifying areas for improvement through their frontline experience, suggesting changes, and ensuring that these changes are effectively tested and implemented.

E3. Influencing Quality Improvement Activities:
Nurses can serve as champions for quality improvement initiatives, drive change, and ensure that RCA and FMEA processes are routinely integrated into the organizational culture to enhance patient safety.

In the context of the scenario, professional nurses play a crucial role by providing clinical insights and contributing to the identification of root causes, participating in the development of improvement plans, and actively implementing and monitoring changes to improve patient outcomes. Their leadership qualities in these processes can drive positive change and enhance the overall quality of care.
Organizational Systems and Quality Leadership
Task 2: RCA AND FMEA

Western Governors University

Explain the general purpose of conducting a root cause analysis (RCA).
A root cause analysis (RCA) is a process for classifying the cause of a problem, and then a good way to approach and respond to the problem. The goal is to examine what happened, how the issue happened, and why it happened so that actions can be put into place to prevent a reoccurrence from happening (Institute for Healthcare Improvement).
Explain each of the six steps used to conduct an RCA, as defined by IHI.
Most often and RCA team involves four to six individuals from a mix of different professions. Each person should have fundamental knowledge of the problems and procedure involved in the accident. There is a total of six steps. The first step is to identify what happened. The team needs to explain what happened by organizing the information to clarify exactly what took place. The second step is to determine what should have happened. The team can create a chart to better understand what should have happened in an ideal situation. Number three is to determine causes (“Ask why five times”). This is how the team determines the factors that lead to the event. They look at the direct causes and the contributory factors as to why the incident happened. The fourth step is to develop causal statements. This is how they explain how the contributory factors lead to the bad outcomes. Step number five is to generate a list of recommended steps to prevent the recurrence of the event, which are changes that the team thinks will aid in preventing the error from happening again. The final sixth step is, write a summary and share it. This can help to engage people to aid in the steps of improvement (Institute for Healthcare Improvement).
Apply the RCA process to the scenario to describe the causative and contributing factors that led to the sentinel event outcome.
The first step is to identify what happened: Mr. B is a 67-year-old male who is 175lbs with a past medical history of, chronic back pain which he was taking oxycodone for, impaired glucose tolerance, prostate cancer, high cholesterol, and high triglycerides. He was brought to the Emergency department (ED) by his son and neighbor complaining of pain in the left leg and left hip. He states he lost balance and tripped over the dog causing him to fall. When he had arrived at the ED, his blood pressure, heart rate and temp were all within normal limits, and his respirations were noted to be elevated at 32 which could be from the severe pain he was experiencing, which he rated 10/10. He was noted to have shortening of the left leg, edema, ecchymosis, and limited range of motion. There were two nurses (an LPN and an RN), an ER doctor, one secretary, and hospital respiratory therapist on staff at this rural hospital. Mr. B was the third patient in the ER at the time of arrival. The doctor evaluated Mr. B and ordered the RN to give 5mg of diazepam IV push, when that did not have an effect after 5 minutes the doctor then ordered the RN to give Hydromorphone 2mg IV push which was given 10 minutes later. The doctor was still not happy with the results after 5 minutes so, he then ordered to give another 2mg of Hydromorphone and an additional 5mg of diazepam both IV push. The sedation goal of the doctor was finally achieved, and he performed a reduction of the left hip. The patient had tolerated the procedure and he was still sedated, without any supplemental oxygen placed. The ED was then notified of a patient on the way in for acute respiratory distress, so the nurse put the patient on an automatic blood pressure and pulse oximeter reading every 5 minutes and she left the room leaving the son to sit with the patient. Five minutes after the procedure had ended the patients blood pressure had decreased to 110/62 and his oxygen saturation decreased to 92%, remaining without supplemental oxygen, and without ECG and respiration monitoring. While the RN and LPN were occupied with the new arrival, Mr. B’s oxygen monitor was alarming to indicate his oxygen had dropped to 85%. Then Mr. B’s son came out to alarm the nurse that the monitor was ringing again, she finally entered the room to find his blood pressure at 58/30 and oxygen level at 79%, Mr. B had no signs of breathing and there was no palpable pulse. The nurse called a STAT code and resuscitative efforts were started, he was intubated, defibrillated, given reversal agents, given IV fluids, and given vasopressors. This lasted 30 minutes, the ECG returned to normal sinus rhythm, blood pressure was 110/70. Mr. B was fully dependent on the ventilator, his pupils were fixed and dilated, and he was not responding to stimuli. Mr. B was then transferred to a different hospital for care upon the families wishes. Seven days after this ER visit, Mr. B was given a “brain dead” diagnosis, the family decided to remove life support and Mr. B had passed away.
The second step is to identify what should have happened. The doctor and nurse needed to be trained on the conscious sedation protocols in place, as well as known the proper dose and proper drugs to be used in this situation. If the nurse knew the drug dosing, she should have questioned the medication that was ordered to give to this patient. The nurse should of abided by the hospital protocol and placed the patient on continuous blood pressure, ECG, and pulse oximeter reading throughout the procedure and until the patient meets the criteria for discharge which was, being fully awake, vital signs being stable, no nausea or vomiting, and able to void. When Mr. B’s oxygen saturation was dropping the LPN should have notified the RN, instead she just silenced the alarm from going off which defeats the purpose of the alarm. Finally, the ER should have called for additional nurses and staff to assist with the current patients to prevent any accidents from happening.
The third step is to determine the causes of the event. The direct cause of death would be the irreversible brain damage due to lack of oxygen for a prolonged period of time. The the contributory factors to the patient’s death would be the lack of staffing, the doctor over sedating the patient for the procedure, not adhering to the protocol for proper conscious sedation monitoring, and ignoring the patients alarm for low oxygen saturation.
Propose a process improvement plan that would decrease the likelihood of a reoccurrence of the scenario outcome.
The first thing that I would propose as an improvement plan to prevent a reoccurrence of this scenario is to conduct a mandatory training for the physicians, RNs, LPNs, and Respiratory Therapist regarding the conscious sedation protocol, that way everyone has the information needed including how to monitor, and what vitals to be monitoring. Then the only ones available to care for a patient that requires conscious sedation would be the ones who have successfully completed the training. I would propose to upper management that patients who have undergone conscious sedation require mandatory one on one monitoring until the criteria is met.
Discuss how each phase of Lewin’s change theory on the human side of change could be applied to the proposed improvement plan.
The Lewin’s change theory has three steps; including unfreeze=change=refreeze. Individuals are not open to change, they get comfortable with their routine and tend to resist any change. However, revealing that there is a problem in the system requires the proper steps to change and make things more effective. In this scenario the staff need to be aware of the issues that have taken place, and then convinced of the benefits of change to them as well as the patient. Hosting a meeting to discuss the event and what took place and what needs to take place to improve care and prevent this from reoccurring. Change is not easy for anyone but taking the proper approach to initiate the change, provide support for the change, and then monitor to make sure the change is being used will make it easy for everyone in this process (Mind Tools, 2019).
Explain the general purpose of the failure mode and effects analysis (FMEA) process.
The Failure Mode and Effects Analysis (FMEA) is a step by step approach to identify possible problems before they occur. It is used to take action in reducing and eliminating failures. They also document the current knowledge about the risk of failures to continue improvements (Institute for Healthcare Improvement, 2020).
Describe the steps of the FMEA process as defined by IHI.
The first step of the FMEA process identified by the IHI is, define the scope and topic of the FMEA. The second step is to assemble a multi-disciplinary team of involved professionals. The third step is charting the steps of the process. The fourth step is hazard analysis which the team analysis completes the chart showing all the possible ways the process could fail, which includes the likelihood and severity. The fifth and final step is uses risk profile numbers (RPNs) to plan improvement, which identifies ways to keep the high-risk plans from failing (Institute for Healthcare Improvement, 2020).
Complete the attached FMEA table by appropriately applying the scales of severity, occurrence, and detection to the process improvement plan proposed in part B.

List 4 steps in your Improvement Plan Process List 1 Failure Mode per step Likelihood of Occurrence
(1–10) Likelihood of Detection
(1–10) Severity
(1–10) Risk Priority Number
(RPN)
1. All physicians, RNs, LPNs, and Respiratory therapist do mandatory conscious sedation training

The protocol will not be followed as directed 6 7 6 252
2. Utilizing continuous O2 monitoring during and after the conscious sedation procedure until criteria is met

staff may take off monitor prior to criteria being met 7 6 9 378
3. Monitoring Blood pressure, and pulse before, during and after procedure

The patient’s vitals will fall or rise into abnormal values 6 4 8 192
4. Nurses and Doctors need to have mandatory training on medication to give for conscious sedation procedures They will not abide by the medication administration rules in place causing patients to be at risk 8 6 10 480
Total RPN (sum of all RPN’s): 1,302

Explain how you would test the interventions from the process improvement plan from part B to improve care.
To test the interventions from the process improvement plan, there would need to be intense monitoring taking place to confirm that the staff are complying. There would need to be someone conducting a chart review of patients who underwent conscious sedation to show and prove that the staff is using the new policies and procedures. Analyzing these patients’ vital signs to measure improvement and compliance as well. Supervisors could do random checks to make sure staff are abiding by the protocols.
Explain how a professional nurse can competently demonstrate leadership in each of the following areas:
• promoting quality care – Professional nurses can demonstrate leadership in promoting quality of care by advocating for the patient. Some of the patients are in their most vulnerable state, and if the nurse is listening to their concerns and speaking up for them when needed if the patient is at a compromised state then this is giving quality care to that patient.
• improving patient outcomes- Professional nurses can demonstrate leadership in improving patient outcomes by adhering to the set protocols to ensure patient safety. The nurse should always have the patient’s best interest at heart so providing compassionate, caring, safe care should improve patient outcomes, so they feel they are taken care of in the best way possible.
• influencing quality improvement activities- Professional nurses can demonstrate leadership in influencing quality improvement activities by constantly educating yourself and evolving with the standards of care. As a nurse leader you will have the quality indicators examined regularly and be ready to change as needed.
Discuss how the involvement of the professional nurse in the RCA and FMEA processes demonstrates leadership qualities.
The professional nurse should be involved in the RCA and FEMA processes because they are a part of the team. Nurses should implement and evaluate plans and processes continuously. As a nurse you are constantly using your critical thinking skills to best assist the patient and you are an advocator for the patients. So, if you are involved in these two processes most likely patient outcomes will be improved because nurses are on the forefront of patient care.

References
Institute for Healthcare Improvement. (2020). Failure Modes and Effects Analysis( FMEA) Tool. Retrieved
from http://www.ihi.org/resources/Pages/Tools/FailureModesandEffectsAnalysisTool.aspx

Institute for Healthcare Improvement. Patient Safety 104: Root Cause and Systems Analysis. Retrieved
on February 4, 2020 from app.ihi.org/LMS/Content/f99b4ea2-aeea-432d-a3573ca88b6ae886/Upload/PS%20104%20SummaryFINAL.pdf
Mind Tools. Lewin’s Change Management Model – Understanding the Three Stages of Change
(October 5, 2019) Retrieved from https://www.mindtools.com/pages/article/newPPM_94.htm

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