Organizational Systems and Quality Leadership

A. Complete a root cause analysis that takes into consideration causative factors that led to the sentinel event. (This patient’s outcome) The terms failure analysis, incident investigation, and root cause analysis are used by organizations when referring to their problem solving approach. Regardless of what it’s called there are three basic questions to every investigation:

1. What’s the problem(s)?
2. Why did it happen? (the causes)
3. What specifically should be done to prevent it? (Galley, n.d., ∂ 1)

In the case of Mr.

J, these were multiple issues that led to and contributed to his unexpected demise after what is usually considered a routinely performed procedure in an emergency department setting. The JCHAO (Joint Commission on Accreditation of Healthcare) defines a sentinel event as “an unexpected occurrence involving death or serious physical or psychological injury”, (Frain, Murphy, Dash, & Kassai, ∂ 1) and in the case of Mr. B, his death would be considered a sentinel event which would warrant a review by a team of interdisciplinary members of the hospital.

In this particular case members of the team would include one or more ED physicians, the RN in the scenario and the LPN, a respiratory therapist, a nursing supervisor, a hospital administrator, the ED nurse manager, a hospital pharmacist, and a risk manager. More staff nurses from the ER could also be involved. A credible and successful root cause analysis will identify all of the elements that contributed to the event, an action plan will be developed to prevent the event from reoccurring and ensure that those actions are completed.

Action plans should be based on best practices and appropriate standards. (Frain et al., ∂ 10) The scenario presented starts out as what appears to be an average afternoon shift in a small 6 bed emergency department in a rural hospital. Staffing consisted of one emergency room physician, one registered nurse (RN), on licensed practical nurse (LPN) and a secretary. Due to the size of this particular ER, there appears to be limited staffing and therefore limited resources to handle large volumes of patients and or critical patients. There are two patients already being worked up in the department at the time of Mr. B’s arrival and they are stable, have already been evaluated and they are awaiting further treatment or orders. Mr. B is brought to the ED by private vehicle complaining of left leg and hip pain after losing his balance and falling over his dog. The triage nurse noted that other than the patient displaying tachypnea, his vital signs were otherwise within normal limits.

The patient states his pain level is severe, a “ten out of ten”, and physical examination finds a shortened left lower extremity with calf swelling and ecchymosis. In triage it is noted that the patients leg is stabilized and he is subsequently moved into a patient room where the admitting RN, Nurse J, takes over and gets a more thorough history of this patient, noting impaired glucose tolerance, prostate cancer and chronic back pain. Mr. B regular medications include Atorvastatin and also Oxycodone for his chronic back pain. The doses and how often he takes these mediations is not provided. Although there is no mention of any radiology studies being performed on Mr. B after his arrival, it is assumed that this was performed before the ER physician completed his evaluation and ordered 5 mg intravenous diazepam to sedate the patient to perform a manual reduction of a dislocated hip. After waiting for 5 minutes, the physician then instructed the RN to administer 2mg of hydromorphone, a powerful narcotic analgesic.

The staff waits five more minutes, after which the physician then instructs the RN to repeat both doses of diazepam and hydromorphone because he is not satisfied with the patient’s level of sedation. It is after these medications are administered that the physician notes patient’s weight and history of opiate use. Five minutes after the last dose of medication is administered a successful reduction of the left hip takes place and the patient remains sedated. The reduction procedure, which initially began at approximately 16:05, ended at 16:30. Although Nurse J is monitoring this patient, she is alerted that EMS (Emergency Medical Services) is bringing in an elderly patient with reported acute respiratory distress. Nurse J, an experienced critical care nurse, elects to place Mr. J on an automatic blood pressure machine with a pulse oximeter.

Although not stated, it is likely that this is a portable machine and is not hooked up to any wall monitors. It does not have continuous EKG monitoring. It does not have end tidal CO2 monitoring. Nurse J then elects to leave the patient in the company of his son with a blood pressure of 110/62 and an oxygen saturation of 92% on the portable machine. The patient is breathing room air and does not have any other monitoring. The ambulance patient has arrived to the department and both the RN and LPN are involved in stabilizing this new arrival and discharging the previous patients as the lobby is now becoming congested with more patients seeking care. There is no mention of anyone suggesting that additional staff should be brought in to help with the load. During this time the pulse oximeter alarm fires off in Mr. B’s room showing at saturation of 85%.

The LPN enters the room and resets the alarm and repeats a blood pressure, but there is no mention of the LPN assessing the patient’s respiratory and or mental status. At 16:43, almost forty minutes after Mr. B’s procedure had begun, the son who is at the bedside with him states the monitor is alarming. Nurse J finds a Mr. B in respiratory arrest and a stat code is called. A code team arrives and the patient is connected to a cardiac monitor for the first time.

The patient is in ventricular fibrillation, CPR is begun, and according to this scenario he is intubated before he is defibrillated. After thirty minutes of interventions, this patient is resuscitated to a normal sinus rhythm with pulses, but is unable to breathe without a ventilator. He has fixed and dilated pupils and no spontaneous movements. Most likely due to the facility being a small rural hospital, they must transport this patient to a higher level of care, and he is flown out to another facility where the patient was ultimately determined to have brain death and was taken off of life support.

A-1 Discuss the errors or hazards in the care in this scenario Causative factors in this scenario appear to include poor staffing to patient ratios, inadequate adherence to hospital policy for moderate sedation, and an obvious lack of communication between peers /coworkers. The human factors point to failure of staff to follow an established protocol, possible fatigue, possible inability to focus on the task, and a lack of utilizing critical thinking skills. There did not appear to be any equipment problems other than the fact that the appropriate equipment that was available was not accessed. The environmental nature of emergency medicine lends itself to hazards in the fact that a department can go from being quiet and mellow in one moment, to being volatile and hectic the next moment. It is an environment of unpredictability and bestows care to a wider population of patients than any other department in the hospital.

Common environmental issues to all emergency rooms can include poor location and accessibility of equipment, overhead paging systems that no one hears, security risks, lighting and space issues, lack of privacy due to patients being placed in hallways and other open areas not designated as patient care areas. Organizational factors may include budgeting limitations, staffing to patient ratios and contingency problems. Dealing with unexpected sick calls, inability to fill those calls, power outages and electronic documentation systems that fail, external environmental disasters, rapid influxes of unexpected patients and the media are all common factors that can disrupt hospital care. Well written policies are a must to guide staff in continuing to provide quality care while minimizing errors and hopefully avoiding sentinel events.

Potential hazards and errors can be avoided by learning from the literature and past experiences of other emergency departments. Specific protocols for procedures performed in the ER are developed for this very reason. In the given scenario there is the issue of proper staffing which posed a hazard to the patient who eventually expired. Nurse to patient ratios in this scenario were inappropriate due to the fact that a patient who had received moderate sedation was not closely monitored and ideally should have received one on one nursing care for the duration of his procedure and until he met discharge criteria. This would have been possible had the RN asked for back up which was apparently available. Looking back on the scenario, it was noted that immediately after the joint reduction of Mr. B had been performed, a critically ill ambulance patient had arrived and the RN was responsible for that patient as well.

In the emergency department, or any department for that matter, nurses are continually subject to frequent interruptions, the need to multi-task, and reliance on “work-arounds” because of inadequate systems support. (Cherry & Jacob, 2011, p. 473) In the case of nurse J, she may have been fixated on completing other tasks, such as stabilizing the ambulance patient, thus distracting her from the ongoing developments with Mr. B. who appeared to be resting comfortably with his son at the bedside. Assuming the patient was safe with a family member, the RN missed the opportunity to reverse the downslide of events that unfolded. Not anticipating the need for additional help is a hazard when staff become overwhelmed but continue to proceed as if help is not needed, because they may be accustomed to being understaffed and working only with what they have. Therefore, this presents the issue of the culture of safety, or lack thereof. It did not appear that there was any organized culture of safety and the communication between staff members appeared to be minimal.

Possibly there was an environment of distrust between coworkers, or an intimidating environment in which the RN was afraid to speak up to the ERMD regarding the management of the patient’s pain and sedation. Perhaps the LPN was intimidated by the RN and did not chose to inform the RN of the abnormal vital signs. It appears that inconsistent or absent communication skills among the staff present that day contributed overall to a hazardous situation. And lastly, possible poor training and education of staff creates a hazardous environment and the lack of critical thinking skills demonstrated in this scenario suggests that this is an area that needs to be examined closely at this hospital. There is no mention of what the LPN’s responsibility is in assessing the patient but it is difficult to comprehend how an experienced health care worker in an ER would not investigate a poor pulse oximetry reading further than simply resetting the monitor.

Educational requirements and experience of the staff needs to be reviewed and revised by the interdisciplinary team as part of the improvement plan. Errors made in this scenario that contributed to this sentinel event include the fact that there was a specific protocol for conscious sedation and it was ignored. Although Nurse J was ACLS (advanced cardiac life support) certified, and she had completed the hospital’s training module, she did not follow the guidelines in the written protocol which more than likely would have prevented any of this event from happening. Perhaps she did not understand the protocol, perhaps she was accustomed to taking short cuts, or perhaps she was drug or alcohol impaired. Another possibility is that the nurse was not able to find the online protocol on the hospital portal. Perhaps the portal was difficult to navigate and the policy was difficult to locate. Being under time constraint, a nurse might decide to forgo looking up the policy because it is too time consuming to look for it. Only Nurse J. would be able to provide us with this critical information.

It is not clear as to why an experienced critical care nurse with no history of negligence did not follow proper procedure. Other errors include the fact that sufficient monitoring equipment was available and not utilized, including use of supplemental oxygen and possible end tidal CO2 monitoring. Furthermore, no one in the department called for any back up, such as a nursing supervisor or a respiratory therapist to help manage the patient. The ER physician who ordered the medications did not communicate with the nurse before the procedure about the risks associated with this patient, including the patient’s home use of opiates for his chronic pain. Polypharmacy, possible use of supplements, adherence issues, and the potential for adverse drug events all posed potential hazards that needed to be addressed. (Williams, 2002, ∂ 1)

The RN did not question the physician about the orders and the physician in turn, did not question the nurse if she had any concerns. There was no “time-out” procedure performed by the staff, which would have given staff members the opportunity to voice concerns. The doctor also failed to notice that the patient was not being appropriately monitored, and along with the rest of the staff he did not appear to display a teamwork mentality.

The key to a successful root cause analysis is to search for answers as to what system errors and failures need to be corrected, and not to pursue blame on any one individual. Individual blame centers around forgetfulness, inattention, or moral weakness. It is punitive. A systems approach examines the conditions under which health care workers work and sets up defenses to avert errors or mitigate their effects. (Cherry & Jacob, 2011, p. 473) The goal is to bring staff together to design and implement processes that provide uniform standards of treatment and care and provide safety to all involved and minimize the likelihood of harm or a sentinel event.

B. Improvement Plan

By requiring the staff of the emergency department to reexamine its actions on that day, a dialogue is created that hopefully will create a strong motivation to seek out better and newer ways to handle patients that require sedation and monitoring. If the participation is not there, then the motivation will not be created and change will not occur. One way of developing an improvement plan would be to apply the theories of change developed by physicist and social scientist Kurt Lewin in the 1950s.

His change management model, known as Unfreeze-Change-Refreeze, refers to a three stage process of transitioning through change. Lewin believed that to begin any successful change process, one must first understand why the change must take place, and this is where the motivation for change begins. He stated that one must be helped to re-examine many cherished assumptions about oneself and one’s relations to others. This is the stage known as “unfreezing”. (Thompson, n.d., p. 1)

In the case of the emergency department, the entire team needs to be compelled to change the way sedation procedures are performed, as well as how patients are handled before and after the procedure. In addition to reviewing the procedural sedation protocol, the team needs to look at overall hospital care of those receiving any medications that cause respiratory depression. This should not be too difficult to promote since the procedure performed that fateful day resulted in harm and subsequent death of a patient. Not only was the patient and his family harmed, the entire organization was harmed and is liable for this incident. The hospital and its emergency department’s community reputation is going to suffer. Knowing that the staff that day is probably emotionally traumatized and possibly fearful of the consequences, the environment is ripe for change and the unfreezing stage can begin with a review of the sedation policy and why it was not followed.

Each individual there and staff that were not there that day need to be made aware and can meet one on one with the department manager to voice their concerns and questions. Barriers hopefully will be identified as to why the sedation protocol was not followed that day. The hospital already provides an electronic educational module on conscious sedation procedures which would have a required date for staff to complete. This module should be reviewed for any inconsistencies and updated and it should be made easily accessible on the computer portal. The actual written policy should also be easily accessible on the portal as well as in print form in a binder at the nurses station, should staff not have access to the computer. An analgesic protocol could be developed in which there would be a minimum time lapse between opioid doses (for instance 10 minutes versus 5) and the use of a hospital approved sedation scoring system should be in place.

Patients in addition to requiring continuous pulse-oximetry monitoring should also be on continuous end tidal CO2 monitoring as well, long considered a more effective way of measuring effective ventilatory status. A new electronic training module on the use of end tidal CO2 monitoring would be mandatory for nursing staff to complete and equipment in the ED would be upgraded to provide for this type of monitoring. A representative could come and demonstrate the use of this type of monitoring and sign off employees for a mini-education module.

Although many emergency departments have upgraded their documentation to all electronic, it might be helpful for staff nurses who are continuously monitoring patients at the bedside to use paper forms to document the pre procedure requirements including consents, time-outs, intra procedure medications and response to those meds and vital signs as well as post procedure Aldrete scores and recovery notes. This would be advantageous for simply the reason that not every bed has access to a computer.

Health care providers certified in Advanced Cardiac Life Support (ACLS) must be in direct attendance with the patient throughout the entire course of the sedation and until the patient is fully recovered. Their primary responsibility is to monitor the vital signs including heart rate and rhythm, blood pressures, respiratory rate and oxygen saturation, as well as the patency of the patient’s airway. The RN managing the patient should never leave the patient unattended or engage in tasks that would compromise this continuous monitoring. The RN is responsible for taking the leading role in assuring that the care provided is safe. Proper airway equipment and drug reversal agents should be at the bedside and this must be documented. In order to unfreeze the staff and help them to change their behaviors, the ED could hold mock sedation procedures to practice their skills in managing a sedated patient.

Annual skills days should be held with review of the policy and equipment used. Staff would be signed off annually on this module. Certifications for BLS(basic life support), ACLS, PALS(pediatric advanced life support) and possibly TNCC (trauma nurse core curriculum), should be up to date and the hospital should offer these courses on campus to make it easier for their employees to maintain their certifications.

Staff members whose scope of practice do not require them to practice ACLS or PALS should be reeducated on what normal vital signs are, how to set parameters on the cardiac monitors, how to take vital signs on the cardiac monitor and they need to review basic BLS skills by attending their own skills day. Teaching should include basics on what normal vital signs are for different age groups, and how medications can alter these vital signs. If the hospital has the funds to open a simulation lab, all nurses and allied health personal could practice simulated scenarios on mannequins and even videotape them. This would be a huge asset for the staff of all the patient care departments.

Another part of the improvement plan would include classes for staff on communication and critical conversations. Learning how to communicate as a team and voice concerns about patient safety is a skill that requires practice, confidence and no fear of retribution or intimidation. Staff members who deal in stressful and hectic environments may at times be uncertain when they see behaviors that are unsafe and therefore may elect to say nothing when they believe the care of a patient may be compromised. In the case of the LPN who turned off the SPO2 alarm, I would wonder if perhaps there was a communication barrier between her and the RN and or the MD, or was it simply a knowledge deficit.

An action plan needs to be in place for a saturated emergency department in which additional staff can be called in with a less than 30 minute wait time, or perhaps float other available qualified staff from other departments, such as the critical care unit or the telemetry floor. Because critical care nurses are accustomed to working in a 1:1 environment with their patients, it would have been ideal to float a CCU nurse to the department when Nurse J realized she could not take care of the rest of the department without leaving Mr. B unattended. Of course this may not have been feasible since we do not know the census in the CCU. Chart reviews are also an invaluable tool for improvement.

The manager will assign nurse in the ED to perform a monthly audit of all sedation charts with checklists of what was done correctly and what was not. These audits are important for providing data on how the ED needs to improve its performance and safety measures. This data will be provided not only at ED staff meetings but at quality improvement meetings involving the nursing director and hospital administration. If there is a problem convincing the hospital to provide safe staffing levels, the ED must provide strong data in order to show administration that there is a need to provide additional nursing.

After the uncertainty of the unfreeze stage has occurred, change then begins to take place. Staff will start to believe and act in ways that support the new growth of the department. The transition will not happen rapidly as people take time to learn and embrace new ways of doing things and for each individual the rate of change is personal. In order to accept the new change and contribute to its success, staff will need to understand how the changes will benefit them and not every person will feel this way. Most healthcare workers probably feel that if healthcare delivery is made safer and better for their patients, then they will buy in to the need for changes and produce those changes.

Unfortunately some of these people may feel harmed by change, and it is possible to notice some folks not participating in meetings, outside events, or educational updates. They may voice discontent with the whole process and complain that the changes are unnecessary. They may feel the status quo is being challenged and are threatened if they are unable to adapt to the changes. They may eventually leave the department or even the hospital environment as a whole. These are the people who may require the most encouragement and handholding to get them through the transition. Time and communication are of utmost importance and as staff gains understanding of the changes, they also need to feel connectedness to the organization throughout the transition period. (Thompson, n.d., p. 3)

Lewin’s third stage of change, or Refreezing, takes place when the organization has identified the barriers to sustain the changes made, and when it has identified what makes the changes work. Employees feel confident and comfortable using new communication techniques, they participated in learning the new procedures and feel supported by their peers and leadership. There is an established feedback system for employees to participate in regarding their education and training, in which they can voice what works and what doesn’t. Changes are now used all of the time and are incorporated into the normal day to day operations in the ED. If the changes are not used regularly and not anchored in to the culture of the ED, the refreezing state cannot occur and employees may get caught in a “transition state” where each person is not sure how things should be done and there is no consistency for policies and procedures being followed.

For the refreezing states to be successful, the department should celebrate its success with the change. Employees will need to have a sense of closure and management needs to help them feel appreciated for enduring an uncertain and uncomfortable time. It is important to encourage staff to believe that the contributions they have made have made the changes a success. (Thompson, n.d., p. 4) Continuing to provide support and transparency keeps employees informed and motivated to preserve the new changes in place. Allowing staff to voice their opinions and participate in how changes are rolled out is part of this process. Overall, a team approach to care is of utmost importance in the ED and each individual should be encouraged and reminded regularly how important their contributions are to the whole.

Reward systems to encourage pride and enthusiasm for work well done can be included at monthly staff meetings. One or two employees might receive a gift or a trophy for hard work, these recipients would be nominated by their peers who anonymously write a nice note about someone who did something nice for a patient or a staff member or just did a particularly great job that day. Team building activities can also include an organized activity outside of the ED where employees and their family members can socialize together and relax. Nursing leaders and managers should strive to build environments that are conducive to friendships, facilitating and promoting good communication and respectful communication between nurses, physicians and administrators. (Blosky & Spegman, 2015, p. 34) Trust is the cornerstone of good communication, which was sorely lacking in the ED that day.

C. Use a failure mode and effects analysis to project the likelihood that the process improvement plan you suggest would not fail. (Identify the members of the interdisciplinary team who will be included in the RCAS and the FMEA)

FMEA is a step by step process used to identify all possible failures in a design , a manufacturing or assembly process or a product or a service. FMEA was started by the US military in the 1940s, and was further developed by the aerospace and automotive industries. (American Society for Quality [ASQ], n.d., p. 1) It has been adopted by the healthcare industry successfully as a tool to identify areas of healthcare processes tat may fail, in order to prevent harm or sentinel events before they occur.

“Failure modes” are the ways, or modes in which something may fail. Failures are errors or hazards, which affect the customer and in healthcare the customer is usually the patient. These errors or hazards can be actual, or potential. Effects analysis is the study of consequences of those failures. Failures are prioritized in order of how severe the consequences are, their frequency of occurrence, and their ease of detection. The purpose of the FMEA is to eliminate or reduce the percentage of failures, starting with the highest priority areas. (ASQ, n.d., p. 1)

In the scenario of Mr. B, unfortunately the FMEA cannot change the outcome, but it will be a proactive method of developing a new policy and procedure for how sedation cases are handled in the emergency room setting. The FMEA will be used to evaluate the new protocol for sedation procedures as well as staffing protocols related to monitoring 1:1 patients. This evaluation will occur before the actual implementation and will be used to assess its impact on the existing protocols.(IHI, 2015, p. 1) The process that needs to be evaluated and improved specifically to the case of Mr. B, would be the moderate sedation policy and its specifics to requirements of staff during the procedure and the recovery period.

Some of the failure modes that may occur or have the potential to occur would be staff resistance to change, inexperienced nurses or practitioners with lack of education, inadequate ability to staff the ED appropriately during influx of patients, sick calls, or inadequate equipment or equipment failure. (Study Mode, 2014, p. 12) The key to a successful FMEA will be the involvement of a interdisciplinary team, which would most likely consist of the some of the same members of the RCA.

An emergency room physician, preferably the director, director of respiratory therapy, the hospital pharmacist, the ED nursing director, a risk manager, a head administrator who can lead the group in decision making, one or two ACLS certified staff nurses from the ED that perform sedation procedures, head of anesthesiology, and possibly even members from other departments where moderate sedation is performed. The team will need to meet regularly and be committed to providing continuing support during the course of implementation.

C1: Interventions

With the unfortunate scenario of Mr.B, it is now up the the interdisciplinary team to begin testing interventions that will or may be integrated in to the new plan for management of moderate sedation patients, with the goal of improving safety and eliminating adverse events. Once the established team has focused their aim, their next step would be to test a change or a few changes in the ED. This would be done with subsequent procedural sedation procedures which are commonplace in the ED. A small but major change to test would be the mandatory presence of an ACLS certified RN in 1:1 care of the patient from the beginning of the procedure and throughout it to discharge.

The goal of this change is to prevent adverse events from respiratory depression in 100% of all patients receiving sedation in the following 6 month period. Performing this test several times will enable the team to see if the staff is actually complying with the new protocol and what barriers there are to prevent it from being successful. Staff will give feedback later as to what is working and what is not, and what they think needs to be done to make the changes work. An effective way to implement testing would be to utilize a PDSA cycle.

The Plan-Do-Study-Act (PDSA) cycle is known as shorthand for testing a change by planning it, trying it, observing the results, and acting on what is learned. (Institute for Healthcare Improvement [IHI], 2015, p. 1) According to the Institute for Healthcare Improvement, the reasons to teats changes are as follows: To increase ones belief that the changes will result in improvement To decide which of several proposed changes will lead to the desired improvement To evaluate how much improvement can be expected from the change To decide whether the proposed change will work in the actual environment To decide which combinations of changes will have the desired effects on the important measures of quality To evaluate costs, social impact, and side effects from a proposed change To minimize resistance upon implementation

The Institute for Health Improvement lists these steps in the PDSA cycle to include:

Step 1: Plan

Plan the test or observation, including a plan to collect the data State the objective of the test: “Minimize or eliminate adverse events from respiratory depression while being monitored in the ED under conscious sedation” Make predictions about what will happen and why

Develop a plan to test the change (Who, what, when where? What data needs to be collected?)

Step 2: Do
Try out the test on a small scale: maybe only perform the test in a 3 week period, on sedation procedures performed between the busiest times of the ED, for example between noon to 6pm. In a 6 bed rural ED, this might actually be the busiest time period. Carry out the test

Document problems and observations, unexpected and expected
Begin analysis of the data

Step 3: Study
Set aside time to analyze the data and study the results, for example: a biweekly or monthly meeting of the FMEA team. Complete the analysis of the data
Summarize and reflect on what was learned

Step 4: Act
Refine the change, based on what was learned from the test. Determine what modifications should be made. Prepare a plan for next test, probably on a larger scale. For example, test all sedations over a month , for actual 24 hour periods in the ED.

In addition to performing the PDSA cycles, the ED could appoint a volunteer or volunteers from the department to form a safety committee with a leader being the liaison who would have the authority to come up with quick solutions to certain problems that are encountered in the department on a daily basis. The liaison would take care of fixing broken equipment or replacing it, ordering new equipment and providing user training, communicating with staff about safety concerns and bringing these concerns to management and the FMEA team.

The safety liaison would be trained in Human Factors Engineering, the science of why people make mistakes. The staff will need to be reassured that this person is their ally and not an informant or disciplinarian. (Institute for Healthcare Improvement [IHI], 2015, ∂ 1) This is a person they should feel comfortable reporting their concerns to. This person could take an active role in the PDSA testing and collect data as which could be added to the monthly chart audits of all the conscious sedation procedures performed since that fateful day with Mr. B.

C2: Presteps: Discuss the pre-steps for preparing for the FMEA. Step one in preparing for the FMEA in regards to revising the sedation protocol involves selecting a specific process to evaluate. While there were many factors that contributed overall to the sentinel event that occurred , the FMEA should be focused on a sub process. Conducting an FMEA on a combination of the sedation protocol, the staffing ratio issues, the communication problems between staff members, knowledge deficits of staff and equipment issues would be an overwhelming task, so instead we will consider individual analysis of each variant. In this case, we are going to focus on creating a better defined policy on how to safely perform conscious sedation in the emergency room setting in order to prevent further sentinel events.

We want to define in the policy what licensed and certified personnel is to be present and performing the procedure, and step by step spell out what is required of those team members from the time of informed consent to the time the patient is discharged from the ED. The policy needs to be easily accessible and there needs to be a standard way of making sure staff has read the policy and understands how to follow it. The goal is to make sure that the patient has 1:1 care at all times with qualified personnel and leaves the ED in stable, improved condition. The second pre-step is to recruit the multidisciplinary team, including everyone who is involved at any point in the process. Be clear that not all people need to be included on the team throughout the entire process, but should be part of the discussions in which they are or did participate in the process. For example, In the case o f Mr. B, radiology was probably at the bedside performing pre and post reduction films, in which the RN clearly would not have remained at the bedside unless he or she was wearing a lead apron.

Pharmacy may have become involved if they had to mix any post resuscitation drips for the patient after he returned to a sinus rhythm from ventricular fibrillation. The secretary was involved in calling a rapid response team, and members of that team may be able to provide valuable insight as well. The third pre-step is to have the team meet together to create a list of all of the steps in the process. Every step should be numbered and be as detailed as possible. Note that this may take numerous meetings to complete this portion, due to all of the variables and complexities.

Using flowcharts helps team members to visualize the processes more clearly and create a more understandable outline of the steps. There needs to be a group consensus that the outlined steps of the FMEA correctly show the process. By creating a step by step flow sheet the team will be able to visualize the scenario in detail and begin the process of elimination of what does and does not work and move on to pre-step 4. The team will now begin to list all of the possible failure modes. Possible failure modes include absolutely anything that could go wrong, such as the following: Staff not trained in protocol

Staff not knowing how to properly use equipment
Monitor not connected to patient
Equipment not plugged in
Medications not reconciled
Communication problems between peers
Assessments not completed
Ancillary staff not educated
IV fluids not running
Patient experienced respiratory arrest

These are just of the few of the possible failure modes that could be listed. For each of these failure modes, the team must list a cause. For example, in the case of Mr. B, he was never connected to a cardiac monitor until he went unresponsive, so the team must try and explain the cause of this. Prestep #5 , for each failure mode, the team will need to assign a numeric value which is called the Risk Priority Number or RPN. The RPN is a measurementof three variables: the likelihood of the failure occurring, of it being detected, and its severity. This is a scoring method that assists the team in determining what areas need the most most focus on improvement.

C3 Three Steps:

Once again, assigning numeric values to three separate variables assists the team in determining the issues which should be prioritized in order of importance, or the need for improvement. The three topics are as follows:( IHI, 2015, p. 4) the likelihood of occurrence: In other words, how likely is it that this failure mode will happen” A score between 1 and 10, with 1 meaning “very unlikely to occur” and 10 being “very likely to occur”. In the case of Mr. B, had a FMEA already been in place prior to his visit to the ED, the likelihood of his demise would have been much more unlikely to occur. But the system had failed him and due to all of the multiple mistakes that did occur that day, the likelihood of what happened was higher up on the numeric scale. the likelihood of detection: If this failure mode does happen, how likely is it that it will be detected? ”

A score between 1 and 10, with 1 meaning “very likely to be detected” and 10 being “very unlikely to be detected.” On the day of Mr. B’s demise, there were multiple opportunities for the staff to detect that there was a potential problem, but they did not. No one noted the lack of staff, communication was poor, and proper equipment was not utilized. So, this question goes back to the Root Cause Analysis and in the FMEA the team will need to determine how the staff can detect these failures before harm occurs again to someone else. the severity: If the failure mode happens, what is the likelihood that the patient will be harmed? ” A score between 1 and 10, with 1 meaning “very unlikely that harm will occur” and 10 being “very likely that severe harm will occur”. According to the IHI, a score of 10 often means death. In Mr. B’s case, the consequence that resulted from the failures in the ED that day was his untimely death. So the severity rating for that particular day would be a 10.

D. Discuss how the professional nurse may function as a leader in promoting quality care and influencing quality improvement activities: The professional nurse plays a critical role in hospital quality improvement, since nurses are the primary caregivers in the system of healthcare. They are pivotal in improving the processes in which care is provided. According to Cynthia Barnard, MBA, the role of the professional nurse in quality improvement is two-fold: to carry out interdisciplinary processes to meet organizational QI goals, as well as measuring, improving and controlling nursing sensitive indicators affecting patient outcomes specific to nursing practices. She states that all levels of nurses, from the direct care at the bedside, to the chief nursing officer (CNO), play a part in promoting QI within the healthcare provider organization. (HCpro, 2010, p. 1)

Ms. Barnard lists the following levels of nursing and their professional responsibilities: The CNO: The CNO sets the tone for the nursing departments participation in QI. As an administrator, the CNO is responsible for integrating nursing practices in to the organizational goals for excellence in patient outcomes by communicating the strategic goals to all the levels of staff.

The nurse manager (NM) or nursing director: The NM or director is responsible for communicating and operationalizing the organization’s QI goals and processes to the bedside nurse. The NM identifies specific nursing sensitive indicators that need improvement according to the organization’s specific patient population and coordinates QI processes to improve these at the unit level. The direct care nurse: The bedside nurse is the key to quality patient outcomes, carrying out the protocols and standards of care shown by evidence to improve patient care.

Important to this provision of quality care is the fact that professional nursing leaders are the key factor in setting the tone and providing an environment in which all health care staff feel empowered to uphold these expectations. If nursing leadership and administration feel that they have less than adequate engagement of staff, it may be simply because the staff may not always understand the rationale and momentum behind particular quality improvement initiatives. For nurses to be involved in delivering high quality care, it is imperative that leadership allows the participation of staff nurses into the design and implementation of processes by continuously educating and informing them, instead of simply telling nurses what they are supposed to do.

A hospital culture that encourages quality as everyone’s responsibility is most likely to achieve sustained and noticeable improvement. Because nursing practice occurs in the context of a larger team, the impact of other departments and practitioners must be included in leadership’s efforts to improve quality. (Draper, Felland, Liebhaber, & Melichar, 2008, p. 4) By having every staff member engaged, including the other members of clinical staff, ie; physicans, respiratory therapy, even housekeeping and dietary management, accountability for patient safety and quality becomes a group effort and does not rest mainly on the shoulders of the nursing population.

American Society for Quality (n.d.). Failure Mode Effects Analysis (FMEA). Retrieved July 3, 2015, from Blosky, M. A., & Spegman, A. (2015). Communication and a healthy work environment. Nursing Management, 46(6), 32-38. Cherry, B., & Jacob, S. R. (2011). Contemporary nursing; issues, trends and management. Available from Draper, D. A., Felland, L. E., Liebhaber, A., & Melichar, L. (2008). The rrole of nurses in hospital quality improvement. Retrieved July 3, 2015, from Frain, J., Murphy, D., Dash, G., & Kassai, M. (n.d.). . Retrieved, from Galley, M. (n.d.). Basic elements of a comprehensive root cause investigation; three steps and three tools that organize and improve your problem solving capability. Retrieved June 29, 2015, from HCpro (2010). Ask the expert: Understanding nursing roles in quality improvement. Retrieved July 6, 2015, from Institute for Healthcare Improvement (2015). Failure modes and effects analysis. Retrieved July 3, 2015, from

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