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The importance of patient safety in healthcare and the use of root cause analysis (RCA) and failure modes and effects analysis (FMEA) to prevent medical errors. It outlines the steps involved in conducting an RCA and FMEA, and provides an improvement plan for a hospital to prevent adverse events from occurring. The document also discusses Lewin's Change Theory and the Plan-Do-Study-Act approach for testing interventions.
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Task 2 Western Governors University Organizational Systems and Quality Leadership Task 2 A. Root Cause Analysis When the Institute of Medicine (IOM) published findings on medical errors that caused patient harm, it brought forth a focus on the identification and recommended improvements in six dimensions of healthcare in the U.S. One of these dimensions for improvement is patient safety. Patient safety is paramount in healthcare. The IOM reported that medical errors, near misses and adverse events continue to occur at an astonishing rate. The Institute for Healthcare Improvement (IHI, 2019c) defines a root cause as a “latent vulnerability in a system that allows an incident to occur.” A root cause analysis (RCA) is a process that looks to understand and respond to root causes, to prevent harm. It is a systematic approach to understanding multiple contributing causes that lead to an adverse event to occur and taking actionable measures that will yield effective, sustainable results. A1. RCA Steps According to the IHI, an RCA team is composed of four to six people to utilize a six-step process to conduct a root cause analysis. The members of the team should not include those involved in the event. Individuals involved in the event should be interviewed for information. Step one is identifying what happened. The collecting of information to accurately and completely describe the adverse event that occurred. Step two is to determine what should have
happened. During this step, the team determines that given ideal conditions, what should have happened. Step three is to determine the causes. Determining the factors that contributed to the adverse event. Often times, it is not just one root cause but multiple factors that contribute to an error occurring. Step four is to develop causal statements. A causal statement links the cause that was identified in step 3 to its effects and then back to the main event that prompted the root cause analysis. Step five is to generate recommended actions. These actions are changes that the root cause analysis team reasons will help prevent the adverse event from happening in the future. Finally, step six is to write a summation and communicate it. A2. Causative and Contributing Factors The hospital will need to put together a team in order to conduct a root cause analysis. Members of the team will involve four to six individuals of various disciplines. Once the team is assembled, they will embark on the six steps of the RCA. The first step is to identify what happened with Mr. B. Mr. B. sustained a ground level fall causing him to be brought to the hospital emergency department by his son and neighbor with complaints of severe pain in his left hip and leg. After admission to the emergency department, it was determined that he needed a conscious sedation procedure for the physician to perform a closed hip reduction. Due to not adhering to the moderate sedation protocol, lack of staffing, lack of monitoring of Mr. B. during and post procedure, and not addressing his past medical history, Mr. B. went into cardiac arrest. The hospital transferred him to a different facility for advanced care and unfortunately, Mr. B. passed away after being removed from life support. The second step of the process is to determine what should have happened under ideal circumstances. Upon completion of Nurse J’s assessment of the patient, the information would
multiple administrations of opioid medications given over a short period of time? Why was the patient left unmonitored post procedure? Why did the LPN not communicate to the RN about the oxygen saturation alarm? Why was the RN pulled away from the patient post procedure? Step four is developing a causal statement. Because of staffing shortages in the unit and no formalized checklist of recommended conscious sedation requirements, the nursing staff in the department lacked the support and resources to appropriately monitor a patient undergoing conscious sedation. These contributing factors set up a situation where they had to rely on their memory and limited staff to ensure they completed critical tasks. This increased the likelihood that appropriate measures for a patient undergoing a conscious sedation procedure would not be met, leading to inadequate monitoring of Mr. B’s conscious sedation procedure and contributing to his death. Step five is generating a list of recommended actions to prevent the recurrence of the event. Several recommendations could be made for occurrences where moderate sedation procedures would be encountered. First recommendation, before a conscious sedation procedure is to be performed staffing levels need to be appropriate to patient ratio in the department; therefore, the charge nurse should be communicating to the department manager or nursing care supervisor for the need of additional staff and support. Educating staff and reviewing competencies for performing conscious sedation procedures should be completed annually. Utilizing checklists and performing a timeout protocol to ensure all pertinent safety points when conscious sedation procedures are to be performed. The final step of the RCA is summarizing and sharing it with others. A simplified flowchart can create a narrative of what happened in the order it occurred and engage key
participants to help drive the next steps in improvement. This can be accomplished in multiple ways, which include staff meetings, emails, continuing education modules, and skills day. B. Improvement Plan The improvement plan should address the factors that contributed to the events occurrence. First utilizing a standardized checklist for a patient undergoing a moderate sedation procedure should be used. The first area the checklist would address is a thorough review of the patient’s past medical history and current medications, especially the use of narcotics and opioids. Reviewing the use of narcotics and opioids can compound the effect medications have on the patient’s respiratory drive and to cause hypotension. The second area of the checklist would include appropriate doses of sedation medication given the patient’s age and condition. The checklist would also ensure all the appropriate equipment to perform the procedure and to monitor the patient during and post procedure. This would also cue the staff to ensure the proper staff to patient ratio is available. The checklist would also contain a flowsheet to record necessary information regarding conscious sedation. Documentation would include noting medications administered, amount given, route, and documenting the patient’s vital signs at specified increments. Each aspect of this checklist would ensure patient safety and decrease the likelihood for any error to occur. B1. Change Theory Change is an inevitable part of healthcare. In Lewin’s Change Theory, there are three stages: unfreezing, moving, and freezing. Effective change occurs in these three stages. The unfreezing stage “promotes problem identification and encourages the awareness of the need for change. People must believe that improvement is possible before they are willing to consider change (Cherry & Jacob, 2017).” A department staff meeting should be conducted to
process of looking at potential issues that arise and developing a plan to prevent the error from occurring. The FMEA process is an approach made by a multi-disciplinary team with each of the team members having knowledge of how things work with the process (IHI, 2019a). C1. Steps of FMEA Process The FMEA process involves five steps. The first step is to select a process that will be evaluated with FMEA. It is stated that the FMEA process works best with processes that do not have too many sub-processes. The second step is assembling a multidisciplinary team. Involvement of a team member who is involved at any point of the process being evaluated is highly recommended. The third step is for the team to list all the steps of the process. An ordered list of the steps involved in the process can be utilized. The fourth step is for the team to list failure modes and causes. This step involves listing anything that could potentially go wrong, including minor and rare problems and identifying possible causes. The fifth step is using risk profile numbers to plan improvement efforts. For each failure mode, a numeric value is assigned, also called the risk profile number, for the likelihood of occurrence, likelihood of detection and severity. A higher risk profile number guides the team to prioritize their efforts. C2. FMEA Table See attached document. D. Intervention Testing To test the interventions from the process improvement plan, using the approach known as Plan-Do-Study-Act (PDSA) allows the improvement plan to be tested on a small scale prior to deploying the improvement plan on a larger scale. First, the improvement plan would recruit the aid of one RN and one physician to test the standardized conscious moderate sedation checklist within the emergency department. The checklist would initially address a thorough assessment
of the patient’s past medical history, updated medication list, especially the use of narcotics and opioids which may affect the administration of the conscious sedation medications. The checklist would include appropriate dosages for the patient based on age and pre-existing conditions. The checklist would address the appropriate monitoring equipment to perform the procedure, during and post-procedure, and would also include the proper staff to patient ratio to allow the RN to remain with the patient post-procedure. The next item on the checklist would include a flowsheet to allow proper documentation of all indicated vital signs, ECG, blood pressure, oxygen saturation level, respiratory rate, and heart rate. Furthermore, the flowsheet allows documentation of the administration of medications specifically the amount, time, and route of administration. The standardized checklist would also note the specific criteria that the RN must assess prior to discharge of the patient. The use of the standardized checklist would ensure the conscious sedation procedure is to ensure consistency and completeness in carrying out a critical task, and to reduce error by compensating for potential limits of memory and attention. E. Demonstrate Leadership A professional nurse can demonstrate leadership in three areas: promoting quality care, improving patient outcomes, and influencing quality improvement activities. The professional nurse promotes quality care by utilizing evidenced based research to influence current practice. Advancing technology in health information technology has transformed the way nurses deliver high quality care. Utilizing clinical decision-making tools within electronic health record (EHR) system to support evidence-based practice and individualized care. An example is reducing hospital acquired pressure injuries, utilizing the EHR reminds the professional nurse to bundle care, provides reminders to reposition the patient, and thus preventing adverse events.
Institute for Healthcare Improvement. (2019a). QI essential toolkit: Failure modes and effects analysis. [PDF Handout]. Institute for Healthcare Improvement. (2019b). QI essential toolkit: PDSA Worksheet. [PDF Handout]. Institute for Healthcare Improvement. (2019c). Patient Safety 104: Root Cause and Systems Analysis. Retrieved from https://srm--c.na60.content.force.com/servlet/fileField? id=0BE0c000000LYai. Institute of Medicine. (2004). Keeping patients safe: Transforming the work environment of nurses. Washington D.C.: National Academies Press.