A. The sentinel event was related to respiratory arrest secondary to conscious sedation procedure. There were several factors that played a role which included high patient census, poor staffing, alarms dismissed by staff members, patient was left unmonitored, and no supplemental oxygen initated prior to the procedure. When the patient was pulseless no CPR was initiated until the code team arrived and critical interventions were delayed by the emergency room staff. The patients medication reconciliation or history weren’t reviewed by the emergency room physician. Tripple doses of intravenous valium and dilaudid were given without a lapse in time. The patient was elderly and on chronic oral opioid medications.
“Normally these types of medications are administered with low doses and titrated per patient’s sedation level. Patient, monitoring or sedation level weren’t assessed between doses. This event is known as a sentinel event. In any situation that causes injury, or death a root cause analysis must be completed and reported to the Joint Commission.
B. To implement a change in the conscious sedation procedure a team or committee needs to be established. All staff in the emergency room can become active participants by joining a committee or subcommittee. These main categories may include patient characteristics, task factors, individual staff members, team factors, work environment, and organizational management (IHI, 2014). A cause and effect, or wishbone graph can be constructed to clarify the error and process for the team, leading up to the event. The committee then needs to develop causal statements. These statements link the cause to its effects and then back to the main event that promoted the root cause analysis. These statements link the cause to its effects and then back to the main event that promoted the root cause analysis (Huber & Ogrinc, 2014). Guidelines for writing causal statements include the need for clarity in the relationship, statements should use neutral language and not imply blame, cause should be given for any human error, and any violation of procedure should also have a preceding cause (Huber & Ogrinc, 2014).
Recommendations should meet the following criteria; they should be clearly linked to the identified root causes, address all of the root causes, designed to reduce the likelihood of reoccurrence, severity, be clear and concise (Huber & Ogrinc, 2014). A report is an important part of the process that should be forwarded to management. The report should include the committee’s progress, encourage each committe member to take an active role in the process and may point areas in the plan are weak. The areas that are weak can be improved upon and when a goal is reached (Huber & Ogrinc, 2014). Once the committee has come up with a solution to a issue that is noted the report is forwarded to the chief executive officer. For the process of change to be effective, it’s important for the committee to have staff and patient advocates that represent each unit that might be affected by the change. When looking at making changes the direct and contributory changes will help with process. In regards to Mr. B the direct causes were alarms being ignored, pt not monitored appropriately which should have included blood pressure, oxygen saturation, cardiac monitoring and patients level of sedation. No oxygen or
Etco2 monitoring either. High doses of intravenous dilaudid and valium without a lapse in time according to standard aministration dosages per pharmacy. Side effects related to valium and dilaudid intravenously include respiratory depression, cardiac arrythmia’s and hypotension.
Delay of life saving interventions by the emergency room staff. Contributory factors included high patient census, poor staffiing, poor communication between staff and physician, patient on chronic opioid medications, patient elderly and the emergency room conscious sedation protocol wasn’t followed. To implement change there are several steps in the improvement process. One of the first steps in the process of change a committee is formed. The emergency room physician, nurse, emergency room nurse manager, pharmacist and other ancillary staff could form the committee. The committee would review documentation, incident reports, discuss this information and create an outline. Some of the tools that can be utilized to help them with this process is the Model for Improvement, PDSA or Plan Do Study Act, workflow mapping, assessments, audits, feedback, benchmarking and best practice research Root Cause Anlysis.
(n.d.). The committee needs to identify the goals for improvement with conscious sedation protocols and procedures. It’s important for the goal to be clear, concise and provide guidance to staff that are participating. The guidelines need to explain the roles of staff members, how often the committee meets, and explain the objectives. By including staff it creates a culture of change and willingness to improve patient care. Some of the changes that can be implemented in the emergency room during conscious sedation is increased staffing, creating flex nurses that would assume care of the conscious sedation patient. The flex nurse would be responsible for assessing, monitoring and making appropriate interventions as required. The extra emergency room nurse would be responsible for administering medications as ordered by the emergency room physician. A check off list would be required to be completed prior to the initiation of the procedure and signed off by the flex nurse as well as the emergency room physician. All patient’s who’s ASA score is three or greater the physician would be required to notify anesthesia. Anesthesiologist would be required to clear the patient for the procedure and sign off on it. The nurses would be required to do a medication reconciliation, emergency physician would review and pharmacy would calculate dosing depending on patients history, and medications. If there was inadequate staff the procedure would be delayed until the appropriate staff were available and the patient would be kept comfortable. When making a change the committee and staff need to feel supported. Additionally, any transition or change is a slow process and can require upper management to encourage and support the committee over a long period of time. When the committee has made clear what changes need to be made, how the process is going to take place and how is the change going to be achieved. It’s important for the committee to create a list of objectives and outcomes that are measurable. The SMART acronym is very useful and commonly used. Specific – objectives should refer to specific, detailed outcomes rather than vague or broad statement. Measurable – it should be possible to monitor whether or not something has changed. Appropriate – the objectives set should be achievable and realistic. Relevant – the objectives should make sense in terms of the overall purpose of the project. Time bound – the objectives should set clear time frames. A good guide to look at when evaluating the success look at the outcomes that were listed at the beginning of this process.
Objectives: To report on a three-year follow-up evaluation of nursing care indicators following the implementation of the conscious sedation guidelines and decreasing episodes of adverse events. Intervention/methods: Site observations and interviews were conducted with key informants in the emergency Conclusions: Long-term follow-up of both clinical indicators and contextual factors are important to monitor to promote sustained implementation of guidelines. B1. Theory is a system of ideas or statements held as an explanation or account of a group of facts or phenomena” (The Process of Change. (n.d.). Because theories differ widely in their focus, perspective, and underlying paradigms, divided them into impact theories and process theories (The Process of Change. (n.d.). Impact theories describe hypotheses and assumptions about how a specific intervention will facilitate a desired change, as well as the causes, effects, and factors determining success (or the lack of it) in improving health care (The Process of
Change. (n.d.). Process theories refer to the preferred implementation how they should be planned, organized, and scheduled in order to be effective and how the target group will utilize and be influenced by the change (Spetz, Burgess & Phibbs, 2012). To complete the improvement process there needs to be appropriate suggestions to improve clinical practice, patient safety and quality of care. According to the IHI change theory is a general notion or approach to change that has been found to be useful in developing specific ideas for changes that lead to improvement (The Change Theory. (n.d.). Lewin’s Model of Change consist of three steps to initiate change. The first stage is motivation which is also known as unfreeze. It promotes effective communication and empowers staff members to be open to different ways of working.
Once the emergency room has a sense of organization and stability is known as refreeze, this is required to create confidence so that the committee can move onto the next step (Spetz, Burgess
& Phibbs, 2012). Change and transitions of a new process or procedure can be a challenge for staff. Some staff are resistant due to the unkown or the thought that they have to add one more task to care for patients. Some staff members may become overwhelmed and feel that there isn’t enough time in the day to complete tasks. Lack of cooperation from staff members, anxiety about utilizing new protocols can be roadblocks to the progression towards change. . (Spetz,
Burgess & Phibbs, 2012). Once the change has occurred it’s important to evaluate and assess for issues related to the change. One process that the committee could utilize to evaluate the progress is utilizing a PDSA cycle to evaluate the success rate. PDSA has four steps which are plan, implement, study the outcome and evaluate the sucess of the change and figure out if changes are needed to the plan.(Root Cause Anlysis. (n.d.).
! C. We are human and unfortunately errors and sentinel events happen. Failure modes and effects analysis (FEMA) is a technique that evaluates and indentifies and eliminates possible failures,issues and errors related to a system, design, process even befor they start FMEA was developed for use by the United States military and utilized in Aeronautics. FMEA looks at the process of patient care and takes a multidisciplinary team to look at a the process from a Quality improvements. FMEA looks at the system of care and utilizes a multidisciplinary approach to evaluate the process from a quality improvement point of view. This process can be utilized to look at different processes which are measurable. Measures that are in place must be clear and information that is objective related to how effective the process. According to the Joint
Commision it requires all practitioners must be accredited and take an active role in risk management to identify and predetermine weaknesses within their practice and to initiate change to decrease patient injuries or death. The health failure modes and effects analysis have five different stages. Defining the topic is the first step in the process, and then the team has to be created which should consist of about six to ten members. The team consists of team leader, facilitator, recorder, process experts and all staff including nurses and physicians that were involved in the sentinel event. The facilitator is in charge of the process and helps to navigate all team members through the process. The team members create a outline or map about the issue, each step must be numbered. Next, a hazard analysis needs to be done, which identifies causes of failure modes, each failure mode is given a number using the scoring matrix. Each factor that is noted goes through the process utilizing the tree analysis. Once the tree analysis is complete the team decides if there needs to be addressed further. If the decision is made to take it to the next step then a list of causes for every failure mode is listed in order. Once the hazard analysis is complete its important to put together an action plan with desired outcomes. When looking at the plan and the outcomes it’s important to define what needs to be eliminated or looked at and which person will be in charge of the interventions that will take place. Failure Modes and
Effects Analysis is a approach that evaluates processes to point out which interventions might fail, and takes a proactive approach to evaluate and make revisions as needed. Failure Modes and Effects Analysis are almost the same as a root cause analysis. The process is a a group effort from nurses, doctors, pharmacists and other ancillary staff including management and usually from each unit where the sentinel event or safety issue happened. Each issue is broken down into sections. The committee list failure modes and causes which points out areas where there are issues with the process, and other issues that resulted in a sentinel event. As soon as the committee is able to form and agree on the issues they give a number, known as the Risk Priority
Number. The Risk Priority Number has three different degrees and are made up of patient incidents . A number is assigned from 1 to 10, and 1 is the low number with 10 being the highest. The Risk Priority Numbers with the highest scores are concentrated on. Once the committee is formed and the roles are designated each team member takes on a active role as
Teamleader, recorder, advisor, and team members. The panel of collaborative practitioners look at the issues that led up to the event. Discussions between practitioners, analyze different documents that are related to the incident, protocols and other information that is available. The panel may consult and discuss with staff members that were invovled in the incident to shed light on the staffs perspective of the sentinel event. It’s imperative for the panel to receive a great deal of details as possible related to the situation to complete the Root Cause Analysis and make it successful. Flow charts with detailed information showing the progression of events that took place to help transition to the next phases of the process. After reviewing the information the panel needs to figure out what occurred. The panel can look at policies and procedures, explore best practice models and converse with the directors of each department. A flow chart can also be created with the information that was discussed with the director of each department and put the flow charts side by side for a understanding where the process’s flaws are at. The next stage in the process is to figure out the direct causes and contributory causes of the process failure. The most noticeable causes for the mistakes, related to the circumstances in the event that was reviewed the emergency room nurse, LPN and the emergency room physician failed to monitor and recover the patient according to the current policy for moderate sedation procedures in the emergency room. Due to the lack of appropriate staff the patient was left unmonitored during pre, during and post procedure which lacked key interventions and assessments for patient safety.
The patients demise was due to respiratory failure, arrest and death secondary to sedation medications that were administered during the moderate sedation procedure. Failure Mode and
Effects Analysis is a process is comparable to Root Cause Analysis is a organized process that deals with issues after an event happens Failure Mode and Effects Analysis identifies and eliminates process failures before a situation happens. It is also an effective tool to evaluate new and existing procedures and methods. For new procedures, it points out possible snafues or unintentional outcomes before they are implemented. It also helps with reviewing current processes to recognize how projected changes will effect the structure. When issues are noted and need to be changed to the procedure or system, the stages that are followed are the same as
PIP. Select a procedure that has issues, create the positions of team leader, facilitator, recorder, team members. The facilitator is in charge of the process and helps to navigate all team members through the process. There needs to be a clear definition and understanding of the stages in the process. The team needs to identify and anticipate issues that may arise during the process. The staff that utilize the procedures and system are an important part to the process when deciding which deficit areas or issues to focus on. The goal is to eliminate those issues that happen more often and have a huge effect on patient safety. The team needs to focus on interventions that improve, decrease or prevent issues related to patient safety. It’s important when making changes the outcomes must be measurable and evaluated for success. 6 M’s / Fishbone list of potential causes from past FMEAs and Eight Disciplines of Problem Solving (8D). Path 1 Development
(Failure Modes) Path 1 consists of inserting the Functions, Failure Modes, Effects of Failure and
Severity Rankings. The Pre-Work documents assist in this task by simply taking information previously captured to populate the first 4 to 7 columns (depending on the worksheet selected) of the FMEA. Functions should be written in verb-noun context. Each function must have an associated measurable. Functions may include: Wants, Needs and Desires translated,
Specifications of a Design, Government Regulations, Program-specific Requirements,
Characteristics of Product to be analyzed, Desired Process Outputs. Failure Modes are Anti
Functions; Effects are the results of failure, where each individual Effect is given a Severity
Ranking. Actions are considered at this stage if the Severity is 9 or 10. Causes are selected from the Boundary Diagram, Parameter Diagram, or past failures and placed in the Cause column when applicable to a specific failure mode. The columns completed in Path 2 are: Causes from
ION or 6M’s, Preventions from Standard Work and previously successful designs, Occurrence
Rankings for each Cause, Classification of Special Characteristics, if indicated, Actions are developed to address high risk Severity and Occurrence combinations, defined in the Q-1
Criticality Matrix. Path 3 Development involves the addition of Detection Controls to prevent a design flaw (for Design FMEA) or Cause and/or a Failure Mode that may reach a customer (for
Process FMEA). The columns completed in Path 3 are: Detection Controls, Detection Ranking,
Actions are taken to improve the controls if they are insufficient to the risks determined in Paths
1 and 2. The Actions that were previously determined in Paths 1, 2 or 3 are assigned a Risk
Priority Number (RPN) for Action follow-up. RPN is calculated by multiplying the Severity,
Occurrence and Detection Rankings for each potential failure / effect, cause and control combination. Actions should not be determined based on an RPN threshold value. This is done commonly and is a practice that leads to poor team behavior. Columns in Action Priority include: Verification of Actions captured in Paths 1, 2 and 3, RPN Values, Responsibility and
Timing to clarify who is responsible for the Action and when the Action is expected to be completed. Actions indicated from the FMEA analysis are closed through the collection of data and observations after a counter measure has been taken. The purpose of an FMEA is to discover and mitigate risk. FMEAs which do not find risk are considered to be weak and non-value added.
Effort of the team did not produce improvement and therefore time was wasted in the analysis.
After successful confirmation of risk mitigation actions the core team or team leader will re-rank the appropriate ranking value (Severity, Occurrence or Detection). The new rankings will be multiplied to attain the new RPN. The Old RPN is compared to the new RPN and the relative improvement made to the design or process has been confirmed. Columns completed in step 7:
Re-ranked Severity, Re-ranked Occurrence, Re-ranked Detection, and Re-ranked RPNC1.
RCA’s investigate the issues of sentinel events and creates ways to prevent further issues. Before the process can start, a committee is formed as urgently as possible. The Institute for Healthcare
Improvement recommends a multi faceted approach with approximately five to seven members from each area of the hospital that is involved (Huber & Ogrinc, 2014). The comittee arranges into different roles from: team leader, secretary, consultant and ancillary members. After the committee and roles are identified the root cause analysis process is initiated and explores what happened for the sentinel event to occur.
C2. One of the first steps to take when completing an FMEA is to determine the participants.
Once participants are together it’s important to utilize flowcharts so all committee members are on the same page of the issue that needs to be evaluated (Failure Mode and Effect Analysis
(n.d.). The second step is brainstorming for possible concerns that are related to the issue and it’s important to analyze concerns from staff, and other issues related to the process and also the environment that the sentinel event happened. Step three looks at the issues noted in each failure mode (Failure Mode and Effect Analysis. (n.d.). The team should review each failure mode and identify potential effects of the failure, should it occur. There may be several effects for each failure mode. Step four is where the 1-10 scale is used. one equals low, where ten is high. The team needs to assign an estimation of the severity of the effects if a failure did occur. A severity rating should be given for each effect. In step a frequency rating needs to be assigned. The best way to determine the frequency rating is to use actual data, if available (Failure Mode and Effect
Analysis. (n.d.). Use incident reports or logs, etc. In the absence of data, the team ust estimate the likelihood of failure. Use the one to ten scale. In step six the committe places a number depending on the severity, occurrence and detection rating and looks at the possible failure or effects. Start by looking at current controls that may detect a failure the effect of failure. If there are no current controls in place, then the detection rate will be an effect of a failure. If there are no current controls in place, then the detection rate will be low and the item will receive a high rating (Failure Mode and Effect Analysis. (n.d.). The next step involves calculating the Risk
Priority Number for each failure mode. Multiply the severity rating times the occurrence rating times the detection rating for all items. The total risk priority number should be calculated by adding all of the RPNs. Step 8 is when the team needs to prioritize the failure modes for action.
Rank failure modes in order from the highest RPN number to the smallest (Failure Mode and
Effect Analysis. (n.d.). The team must now decide which items to work on. Step nine is where take action to eliminate or reduce the high-risk failure Modes. They need to identify and implement actions to eliminate or reduce the high-risk failure modes. Use an organized problem solving process such as Rapid Cycle Quality Improvement and the plan, do, study, act process.
Step 10 is where the team calculates the resulting RPN as the Failure Modes are reduced (Failure
Mode and Effect Analysis. (n.d.). Once action has been taken to improve a process, new severity, frequency and detection rating should be determined and the resulting PRN calculated.
A significant reduction in the RPN should be noted. If not, the actions taken to improve the process were not sufficient to reduce the severity, frequency and detection rating and additional actions should be taken.
C3. FMEA uses three criteria to assess a problem: The severity of the effect on the customer, how frequently the problem is likely to occur and how easily the problem can be detected.
Participants must set and agree on a ranking between 1 and 10 (1 = low, 10 = high) for the severity, occurrence and detection level for each of the failure modes (Failure Mode and Effect
Analysis. (n.d.). Although FMEA is a qualitative process, it is important to use data (if available) to qualify the decisions the team makes regarding these ratings. The three components that make up the RPN are occurrence, or how often the error is likely to happen, detection, if the error occurs how likely will it be identified and severity, how severe is the error if it were to occur
(Failure Mode and Effect Analysis. (n.d.).
C4. After reviewing the scenario there are alot of different ways to assess and test the conclusions that are reached. The method that I decided to focus on was the PDSA which is known as The Plan-Do-Study-Act (PDSA) cycle which is a short and concise way to test change
(PDSA. (n.d.). PDSA has four steps which include planning, trying it, observing the results, and acting on what is learned from the process ( PDSA. (n.d.). It’s important to test the changes to evaluate how much improvement can be expected, decide if the suggested change will present the desired outcome (PDSA. (n.d.).
D. The emergency room nurse in this scenario has the opportunity to change the outcome and safety of patients. The emergency room nurse has the opportunity to become involved in committees that focus on quality improvement process and to educate other nurses and ancillary staff in the emergency room. Although there was a moderate sedation policy in the emergency room it wasn’t utilized. She can also assist the management and house supervisors to create a flex plan for staffing and support staff to assist in increased patient census and critical situations in the emergency room from moderate sedation, codes, stroke codes and stemi’s. She might also attend committees that focus on positive change, evidenced pratices as well as additional opportunities to get involved in a committee and help shape the future of nursing. The committees could include Advanced Practice Council, Nursing Policy & Procedure, House Wide
Competency & Education, and Patient Education with a focus on staffing, moderate sedation and patient positive outcomes. The emergency nurse could meet with pharmacy to educate staff on dangerous and possible side effects of administering opioids and sedative medications. The emergency nurse could present educational opportunities for staff about changes made to moderate sedation policy and procedures. Nurses are the first to see the patient and have the oportunity to alert the physician about increased risk of respiratory failure related to sedation.
The emergency room nurse can implement a plan of care to assess and monitor the patient.
Making the appropriate interventions to decrease adverse situations related to moderate sedation.

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