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C489 TASK
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Jan 9, 2024
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1 Revised 09/2022 SAT1 — SAT TASK 2: RCA AND FMEA C489: Organizational Systems & Quality Leadership
2 Revised 09/2022 SAT1 — SAT TASK 2: RCA AND FMEA A. Root Cause Analysis The IHI has established a Root Cause Analysis which is a multistep process that allows the discovery of underlying causes of adverse outcomes. By identifying the root cause of an event an opportunity to prevent future occurrences is presented. A1. RCA Steps 1.
To identify what happened completely and accurately. It is suggested to utilize a flowchart so that information can be organized and clarified regarding the event. 2.
Determine what should have happened, in ideal situations. Again, developing a flowchart is recommended so that a comparison can be made. 3.
Determine causes, ask “Why?” five times. A suggested tool is a fishbone diagram, it is a graphic tool used to show possible causes, also known as “Ishikawa” or “cause and effect” diagram. Allows team to determine factors, direct and indirect, that contributed to the event. 4.
Develop causal statements. This helps link the cause(s) directly to the effect(s) and then back to the main event. A causal statement contains three parts, the cause, the effect, and the event. 5.
Create a list of recommended steps to prevent the recurrence of the event. The recommendations fall into a variety of categories such as, standardizing equipment, ensuring redundancy to account for double checks, software improvements, cognitive aids such as checklists, simply processes, educations or develop new policies.
3 Revised 09/2022 6.
Develop a summary to share. A2. Causative and Contributing Factors Leadership should designate team members to help establish an RCA team to investigate. The team should consist of staff with personal knowledge of processes and systems involved in the event (CMS.gov). The team members may or may not have been involved in the incident. Mr. B arrived to the hospital after a fall and was reporting severe pain. He presented with overall normal vital signs, except for respirations, which were significantly elevated. A physical exam revealed a shortened left leg, edema, ecchymosis, and limited range of motion. Relevant medical history revealed chronic back pain, which is managed by long-term use of oxycodone, as well as impaired glucose tolerance and high cholesterol. 1. Staffing within the ER consisted of 2 nurses (an LPN and an RN), one ER physician, a secretary, and a respiratory therapist. At the time of Mr. B’s arrival at the ER, he was the third patient, of the other patients one was stable and pending discharge and the other was pending laboratory results for further treatment. A review of medical records indicates a high dosage of narcotics within a very short time frame; Diazepam 5mg IVP at 16:05, hydromorphone 2mg IVP at 16:15, an additional dose of diazepam 5mg IVP and hydromorphone 2mg IVP were given at approximately 16:20 with satisfactory sedation achieved by 16:25. After successful reduction hip reduction around 16:30 Mr. B was placed on BP monitoring every 5 minutes and continuous pulse oximetry and left in the room to rest with his son at the bedside. It was at this time that the ER received an emergency dispatch of a patient in acute respiratory distress. Mr. B’s vitals at the time were BP 110/62, O2 sat 92%, he remains without supplemental oxygen, no respiratory or cardiac monitoring was initiated. Nurse J and LPN have received the new emergency transport
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4 Revised 09/2022 and working on discharging patients from the ER, with the lobby becoming crowded with new patients waiting to be seen. Mr. B’s O2 alarm is heard and shows “low O2 saturation” with a reading of 85%, the LPN briefly enters the room resets the alarm, and obtains a repeat BP reading. Mr. B remains off supplemental oxygen and any respiratory and cardiac monitoring. Less than 15 minutes after Mr. B’s hip reduction was complete the son emerged from the patient room to inform the nurse that the “monitor is alarming.” As Nurse J enters the room the vitals on display show BP 58/30 O2 sat 79%, Nurse J is unable to detect a palpable pulse or respirations. A STAT CODE is called, and resuscitative efforts begin, cardiac monitor initiation demonstrated ventricular fibrillation. CPR is initiated and continues for 30 minutes with defibrillation, reversal agents, IV fluids, and vasopressors administered. The ECG demonstrated normal sinus rhythm and BP of 110/70. After the code event, Mr. B was fully dependent on mechanical ventilation with a very poor neuro status. Upon the family’s request, Mr. B was transported to a facility capable of more advanced care. Seven days later, it was relayed that an EEG had determined brain death in Mr. B and the family requested that life-support be removed. 2. The physician should’ve followed the conscious sedation policy that the hospital had in place. Despite the patient's history of narcotic use for prolonged pain, an excessive amount of narcotics was provided over a very short period of time. Inadequate monitoring was established for the patient. All systems should have been monitored until the patient returned to baseline vitals. The LPN should’ve escalated care by notifying the RN immediately of the initial low O2 alarm. The ER should’ve had more adequate staffing. 3. Not properly following conscious sedation protocol with proper drug administration and adequate monitoring and supervision post-administration. Failure to follow policy resulted in a rapid decompensation resulting in the death of Mr. B. Following the “why’s” helps determine
5 Revised 09/2022 the root cause: 1. Why did this occur? Failure to follow hospital-established protocol regarding conscious sedation; 2. Why did staff fail to follow protocol? LPN failed to report low O2 saturation to Nurse J upon initial alarm; 3. Why did LPN not notify Nurse J? Staffing had reached a critical point with new admissions and crowded lobby; 4. Why was the ED short-
staffed? Staff failed to call for additional assistance; 5. Why did a call for assistance not occur? Weak communication between all the ED staff members. 4. Development of a causal statement should include the following elements, the cause, the effect, and the event: The failure of communication between staff members (cause) increased the risk of staff not adhering to hospital policy (effect), leading to the patient decompensating without intervention resulting in brain death and the untimely passing of an otherwise healthy patient (event). 5. Recommending practice changes are listed to help prevent the recurrence of the event. The list could include: 1. A revision of the conscious sedation protocol to include closer supervision while waiting for the patient to return to baseline. 2. A review of the staffing practices within the ED and adjust as needed to ensure proper coverage. 3. Ensure compliance with mandatory staff education with annual refreshers. 6. Write a summary and share it with the staff, offer an in-service, or incorporate it into a staff meeting and review necessary changes to be implemented. This allows the communication of the events that occurred and encourages the staff to make practice changes that support safe practice and promote patient safety. B. Improvement Plan
Daily rounds to ensure that adequate staffing is in place and a plan in place should back-
up (float pool) be needed in an unpredictable setting such as the ED.
6 Revised 09/2022 Implementation of a pre-sedation checklist for conscious sedation protocol, ensuring proper equipment is readily available. This is to include full cardiac monitoring, continuous pulse oximetry, BP monitoring every 5 minutes, and a crash cart nearby. 1:1 post sedation monitoring until the patient has recovered to baseline vital signs and is patient is awake with the ability to talk and drink. To ensure proper training of all staff members, implementation of training with mandatory annual educational refreshers on conscious sedation protocol. Offer testing at the end of each training session to ensure understanding of educational content. B1. Change Theory
Lewin’s Change Theory, developed by physicist and social scientist Kurt Lewin, is comprised of three stages: 1.
Unfreezing – this stage is associated with convincing someone to stop using an older method. 2.
Change – this is the productive stage of Lewin’s theory and is the acceptance of change. 3.
Refreezing – at this stage, the change is now established and has become the standard procedure. Awareness of the situation and the events that helped contribute to the sentinel event helps a person be less resistant to change. It shows the ineffectiveness of current policies in place and the detrimental risk to patient care. The second stage is often challenging because habits are formed and change itself can cause stress to some. The third stage is achieved once all the changes have been put into place and staff have acclimated to the new steps and or procedures. C. General Purpose of FMEA
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7 Revised 09/2022 Failure Mode and Effects Analysis (FEMA), allows action plans to be created to decrease or eliminate failures. In the medical field, failures can lead to patient harm or even death. FEMA is designed to identify, prioritize, limit, or stop the failure modes. C1. Steps of FMEA Process
1.
Select a process to evaluate. 2.
Recruit a multidisciplinary team, the Interdisciplinary team starts the analysis of the process. 3.
Describe the process, each step of a new process is clearly described and explained. 4.
List possible failures, members express opinions and potential problems. 5.
From previously gathered information in step 4, use Risk Profile Numbers to plan improvement efforts. a.
Design and implement changes that are agreed upon by the Interdisciplinary team, to identify weaknesses and improve patient care. b.
Measure the success of changes made. C2. FMEA Table
See attached document name “FMEA Table” D. Intervention Testing
To test the performance of the interventions from the process improvement plan a Plan-
Do-Study-Act (PDSA) cycle can be useful. It allows the planning and trying of interventions as well as observing results and acting on the information gained. Based on information gathered during the cycle, adjustments or changes can be made to the interventions to improve the overall outcome. These PDSA cycles can be repeated until the desired buy-in is achieved with optimal outcomes. Follow-up with the implementation of performance improvement meetings scheduled
8 Revised 09/2022 monthly for review of charts for patients that receive conscious sedation to ensure adequate documentation of vitals pre- and post-sedation. Review of checklists in patient charts will also assist in ensuring that the staff is following the new intervention. Also, audits performed by supervisors can identify issues with compliance among staff members and will ensure long-term compliance with the newly implemented interventions. E. Demonstrate Leadership
Being a patient’s advocate is a nurse’s way to demonstrate leadership in promoting quality of care. By demonstrating competence in the most up-to-date evidence-based practices available to ensure the best outcome for the patients that they serve. Implementation of the most up-to-date evidence-based practices will assist in improving patient outcomes. Great nursing leaders will strive to continue educating themselves to improve their practice by utilizing the newest EBP and reviewing policies in place to ensure positive patient outcomes. Nurses must continuously improve themselves to impact the quality of care for their patients. Their responsibilities include identifying at-risk patients, addressing their problems, learning about best nursing practices, and monitoring patient progress. E1. Involving Professional Nurse in RCA and FMEA Processes Nurses are the frontline workers who should have a vital role within the RCA and FMEA process and all other quality improvement processes within a hospital. Nurses are the face of the hospital and are the most knowledgeable when it comes to the patients that they see. Nurses are also the most aware of a process's efficiency so their opinions and suggestions should be highly valued when considering a quality improvement change.
9 Revised 09/2022 F. References Institute of Healthcare Improvement (n.d.). Patient safety 104: root cause and systems analysis summary sheet. Retrieved from https://srm--
c.na60.content.force.com/servlet/fileField?id=0BE0c000000LYai Institute for Healthcare Improvement (2017). QI Essentials Toolkit: Failure Modes and Effects Analysis (FMEA) Tool. https://srm.file.force.com/servlet/fileField?id=0BE0c0000009CfC CMS (n.d.) Guidance for Performing Root Cause Analysis with Performance Improvement Projects. Retrieved from https://www.cms.gov/medicare/provider-enrollment-and-
certification/qapi/downloads/guidanceforrca.pdf Cherry, B. (n.d.). Contemporary Nursing: Chapter 17 Nursing Leadership and Management. Retrieved from https://wgu.vitalsource.com/reader/books/9780323554206/epubcfi/6/62[%3Bvnd.vst.idre
f%3DCHP0017]!/4/2/4/2[CN]/5:9[r%201%2C7
] Schneider, A. (Producer). (2017, October 31). Failure modes and effects analysis [video file]. Retrieved from https://wgu.hosted.panopto.com/Panopto/Pages/Viewer.aspx?id=675fb8c8-60db-49bd-
a1e0-d2201cc45c05
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