Organizational Systems and Quality Leadership C489 Task 2
Root Cause Analysis – Purpose for conducting an RCA
Root Cause Analysis (RCA) is a systematic retrospective approach of discovery by a team of four to six care professionals across the healthcare institution, which looks into the system flaws that led to an adverse event in care. The RCA process has six steps that are followed in an attempt to identify ways in which the identified flaws might be corrected by a process improvement plan to prevent a reoccurrence (Institute for Healthcare Improvement [IHI], n.d. – b).
A1. RCA Steps – The 6 steps of the Institute for Healthcare Improvement (IHI) RCA
There are six steps to an RCA as defined by the IHI; One, identify what happened. Two, determine what should have happened, Three, determine the factors that led to the event. Four, determine what effect each factor caused that contributed to the cascading string of events that ultimately resulted in the adverse event in the first place. Five, generate a recommended action list to prevent the event from occurring again. Six, write a summary and share it with all departments and care teams to assist knowledge and process to prevent the adverse event from re-occurring in the healthcare system as a whole (IHI, n.d. – b).
A2. Causative and Contributing Factors – Factors leading to the sentinel event
Step One: The 67-year-old male patient with a simple left hip fracture was over sedated, improperly monitored and stopped breathing. The over sedation led to a depressed respiratory response and cessation of breathing which resulted in ventricular fibrillation, leading to cardiac arrest and eventual brain death due to anoxic brain injury. The patient’s brain death and removal from artificial life-sustaining ventilation led to his subsequent death (Western Governors University [WGU], n.d.).
Step Two: Instead of death the patient should have received conscious sedation and reduction of his left hip while having continuous electrocardiography (ECG) monitoring, blood pressure (BP) monitoring, and pulse oximeter monitoring administered by available respiratory therapy staff until fully awake with stable vital signs (VSS), no nausea or vomiting (N/V), and able to void per hospital policy, then sent home for full recovery (WGU, n.d.).
Step Three: The multifactorial errors leading to this event include; Concomitant ordering and administration of benzodiazepine and opioids. The ordering and administering of a double or second dose of concomitant benzodiazepine and opioids in a short time frame from the first administration is a contributing error, essentially doubling down on the first error. Not adhering to the hospital’s standard protocol for conscious sedation monitoring is another significant factor that led to harm in this case. Not summoning the extra available nursing and respiratory staff when a new emergency was inbound, caused the existing staff to become distracted with other care duties and contributed to errors in this case. Not placing the at-risk patient on oxygen was another factor in the string of events. Simply resetting the oximetry alarm was another error. Not calling a rapid response immediately when the patient’s oximetry reading was 85% was yet another significant error (WGU, n.d.).
Step Four: The effects each error caused were significant. None was more significant than the first by not following hospital protocol for conscious sedation; however, each subsequent error compounded the first error. Concomitant ordering and administration of benzodiazepine and opioids are known respiratory depressive medications, double dose administrations of those concomitant medications within minutes of the first concomitant medication administration acted dramatically to quickly depress the 67-year-old patient’s respiratory system to such a degree that the patient experienced complete respiratory failure and cardiac arrest via atrial fibrillation within 8 minutes from the RN’s last assessment. The resulting respiratory failure likely resulted in cardiac arrest via atrial fibrillation which stopped blood flow to the brain resulting in brain anoxia and ultimately led to the brain death of the patient (WGU, n.d.).
According to Beers criteria, benzodiazepine muscle relaxants like diazepam are not recommended for use in older adults due to their sedative effects, thus the physician should have considered other alternatives (Arnstein, 2010). The physician additionally ordered the sedating medication oxycodone concomitantly, not just once, but two times within minutes of each other (WGU, n.d.). The physician and registered nurse both should have been aware of warnings by the Food and Drug Administration (FDA) and the manufacturers of diazepam against concomitant use of benzodiazepines and opioids and utilized a more conservative approach to this patient’s sedation needs but did not, leading to eventual respiratory failure (Chaverneff, 2019; WGU, n.d.).
The registered nurse should have questioned the physician on ordering concomitant double doses of oxycodone and diazepam (WGU, n.d.). In questioning the doctor’s initial order the RN could have averted disaster and prevented error. The RN had the opportunity to question his second such order and could have prevented the dangerously sedative combination of medications given to this older adult patient for the second time within minutes of the first concomitant administration (Arnstein, 2010).
Even after administering the concomitant double doses of oxycodone and diazepam, the registered nurse likely could have averted the remaining cascade of events if she had placed the patient on the hospital’s standard protocol for conscious sedation monitoring. Additionally, even if the RN did not follow the hospital’s standard protocol implementation, she likely could have averted disaster had she placed the patient on oxygen due to the known respiratory depressive nature of the drugs she administered.
Respiratory therapy and extra nursing staff should have been summoned when it became apparent that another emergency patient was inbound to insure the existing patients’ stability was being appropriately and safely monitored and disaster may have been averted.
The LPN should have fully assessed the patient and called for help when the oximetry alarm first went off rather than simply resetting it, which led to the patient’s ultimate respiratory failure and anoxic brain damage. Had the LPN fully assessed the patient and noted the depressed or absent respirations she could have called for a rapid response minutes before it was eventually called, and possibly averted anoxic brain damage in the patient.
The combination of oxycodone and diazepam may have been the trigger for eventual respiratory failure, however, the lack of respiratory and ECG heart rate monitoring to prevent respiratory failure is the most significant error in the cascade of events that led to this patient’s demise. The nursing staff was operating blind without a full picture of the patient’s condition due to a lack of following the hospital’s standard protocol for conscious sedation ECG monitoring or patient respirations (WGU, n.d.). Had the nursing staff had the appropriate respiratory therapy staff and ECG monitors in place, the rapid respiratory and cardiac failure could have been averted.
- Improvement Plan – Process Improvement Plan (IP) “Action Plan” to prevent reoccurrence
The most preventable error that occurred was the medical doctor and registered nurse not following hospital protocol for conscious sedation of the patient (WGU, n.d.). The simple act of ensuring the patient received the hospital’s protocol of continuous electrocardiography (ECG) monitoring, blood pressure (BP) monitoring, and pulse oximeter monitoring administered by available respiratory therapy staff until they are fully awake with stable vital signs (VSS), and no nausea or vomiting (N/V), is the needed IHI process improvement “action plan” (WGU, n.d.; IHI, n.d. – b).
The proposed action plan would involve one simple change; a software upgrade to the electronic health record (HER) medication administration record (MAR). The change would disallow the procedure from starting when conscious sedation is chosen as the means of sedation unless the respiratory therapy staff authenticates as a double witness, with the physician or registered nurse, that the hospital protocol is in place before the computer system will allow administration of any sedating medications. This one simple improvement action plan would ensure that the procedure could never start unless the respiratory therapy staff was on location and had authenticated the procedure for conscious sedation with appropriate monitoring.
B1. Change Theory – Phases of Lewin’s Change Theory and implementation within the IP
Kurt Lewin broke the idea of change into three (3) distinct phases: Unfreezing, Change, and Refreezing (Schein, 1999). The step of Unfreezing may cause resistance against the proposed change because individuals are frozen, or aligned to a specific and particular way of doing things, their current homeostasis. Change involves creating a new pattern towards a new equilibrium, a new homeostasis or new normal. Refreezing is achieved when the new pattern becomes the norm, homeostasis, and current reality of doing (Schein, 1999).
For the IP in this scenario, the following aspects of Lewin’s phases of change are described with strategies for utilizing his theory to implement a new action plan to ensure the hospital protocol is utilized every time a patient requires conscious sedation;
Stage 1- Unfreezing:
Hospital administration will implement mandatory attendance to an education forum on conscious sedation and review the sentinel event that resulted in the death of a patient. During education, the new EHR software module will be rolled out and individual computer stations will be available to each employee participant to walk through each step of the process with a conscious sedation practice patient. The steps will include the medical provider entering a standard order for conscious sedation. The standard order will notify the respiratory therapist and registered nurse that the procedure for their patient is due now.
Each participant, the physician, registered nurse, and respiratory therapist will arrive at the practice patient. The registered nurse will scan the patient armband then click on the conscious sedation order to administer the ordered medications. Up will pop a required authentication for the respiratory therapist to authenticate his/her presence and affirm that continuous electrocardiography (ECG), blood pressure (BP), pulse oximeter monitoring is in place and functioning for the procedure. Once the respiratory therapist has authenticated his/her presence and affirmed that protocol equipment is in place, then and only then will the registered nurse or physician be able to administer any medication for conscious sedation, ensuring that at no time does any patient risk unmonitored respiratory or cardiac failure without immediate notice by lifesaving professionals while sedating and respiratory depressing medications are being administered.
The authenticated software will then allow the scanning of the required medications for conscious sedation and the registered nurse will then be able to administer them per orders. In this way, the team of medical professionals can practice care in a fail-safe way of providing conscious sedation within the hospital policy to prevent adverse events of unmonitored respiratory or cardiac failure during or throughout recovery from a procedure. This change will enable the hospital system and healthcare team to achieve the desired outcome of safe conscious sedation during the change process towards full adoption of the change, from test pilot to full implementation.
Stage 2 – Change:
Implementation of change involves a new way of doing things and eventual acceptance of this new way. In this stage, people are unfrozen from the way they previously did things and begin doing them differently. This is the stage in which people are unfrozen, and implement the change to a new and better way of doing things. Great care must be taken during this stage to have clear communication, to ally people’s fear regarding the change and to ensure that no consequences occur for mistakes during change adoption.
This is the stage in which hospital leadership must take great care to listen to the providers that are required to do actual work under the newly proposed action plan (Schein, 1999). The observational team will have to visually watch the steps of the process, listen to feedback from participants using the system and modify or revise steps to ensure the implemented action plan meet the needs of the providers caring for patients, all while meeting the purpose for the change; meeting the goal of successful conscious sedation protocol implementation for every patient that requires it.
In the change phase, the process moves from the piloting phase into full system-wide implementation. The change occurs over a short time, but change can cause resistance from participants as they move from the way they used to do things, to the new way of doing things (Schein, 1999). When participants begin to embrace the change and more fully understand its merits, then the action plan can move from change into the final phase of refreezing.
Stage 3 – Refreezing:
Refreezing occurs when the entire staff moves from the stage of transition (change) to a much more stable state of equilibrium in which people accept, embrace and or internalizes the new way of doing things. The stage of Refreezing is the ultimate stage in which people accept or internalize the new ways of working and have fully adopted the change. Refreezing becomes the new normal, the new homeostasis, the way to do things (Schein, 1999).
- General Purpose of FMEA – Purpose of FMEA
The Fail Modes and Effects Analysis (FMEA) is a systematic and proactive approach to evaluate a process by a team of individuals and invested stakeholders. The FMEA attempts to identify areas of a process that might fail and attempts to consider a deeper look into how and why a step or entire process might fail. Further, the FMEA also seeks to determine the effect a particular failure might have on the desired outcome. The FMEA is preventive in nature seeking to identify potential areas that may fail before they do. Lastly, the FMEA seeks discovery into the parts of the process needing to be re-worked for the entire process to be successful (Institute for Healthcare Improvement [IHI], n.d. – a; Schneider, 2017).
C1. Steps of FMEA Process
The first step of the FMEA is to select a process to be evaluated, either a new process before it is implemented, or an existing or modified process. The second step is to recruit a multidisciplinary team for the evaluation including those that will implement the process; those with specialized knowledge, and others that may be necessary for ultimate success. The third step is to list all the steps in the process that are to be evaluated. The fourth step is to list all the failure modes, their causes, and their effects. As part of the identification of potential failure modes, the team will assign ratings for likelihood the failures will occur, be detected, and how severe a particular failure will be. The team will then assign a risk priority number (RPN) and identify actions to reduce the occurrence of a failure mode from being realized. The fifth step would be for the team to use the RPNs to plan improvements to a particular step or steps in the process to increase the viability of the overall process by starting with the failure mode with the highest RPN. The team would then seek to address the areas within the highest RPN steps within the newly designed process and implement modifications or changes to those areas to mitigate the possibility of failure in the high-risk steps of the new process (IHI, n.d. – a).
The members of the team would typically involve key stakeholders for the process change with specific knowledge of the various areas that will be disrupted. For this scenario, physicians, nurses, respiratory therapists, nurse managers, physician managers, technology specialists, and hospital administrators would be involved in the action plan implementation.
C2. FMEA Table – Steps, failure modes, scales of severity, occurrence, and detection identified
|Steps in the Improvement Plan Process:
|Likelihood of Occurrence (1-10)
|Likelihood of Detection (1-10)
|Risk Priority Number (RPN)
|1 Mandatory attendance to new software double verification training
|Not all RN, RT and MD participants are trained
|2 RN & RT notified of sedation procedure and arrive together
|Either the RN or RT does not arrive together in a timely manner
|3 Conscious Sedation Protocol dual Authentication confirmed by RT
|RT brings all equipment, ECG, Pulse Oximeter and BP monitor
|4 Medication administered by RN with protocol monitoring by standby RT
|RN waits for RT to authenticate protocol before giving meds
|Total RPN (Sum of all RPN’s): 447
(IHI, n.d. – a)
- Intervention Testing – Steps of pilot testing on proposed interventions to improve care
To test-pilot the interventions, I would engage the Emergency Department (ED) first. The ED has one of the highest likely needs for conscious sedation of patients. Further, provider engagement would likely be higher in the ED due to the fact that the prior sentinel event occurred to one of their patients.
After mandatory in-person training and confirmation that all medical providers have completed the test-patient training and are familiar with the new software double verification authentication procedure, roll out of the new process could occur.
Part of the test-pilot roll out would include an observation team made up of the ED Nurse Manager and Medical Director for oversight on each of the first ten (10) conscious sedation patients. The oversight team will be utilized to verify that the new steps are working as planned and that staff has the needed support and supplies to implement the plan seamlessly for each patient.
Upon first notification by a physician that orders have been written for a conscious sedation procedure, the observation team would verify the time of response from order placement in the Electronic Health Record (EHR) by the prescribing provider to the acknowledgment by the RN. Secondarily the observation team would verify the time it takes the RN and RT to jointly arrive at the patient bedside with ECG, BP and Pulse Oximetry monitoring equipment. The upon placement of the ECG, BP and Pulse Oximetry monitoring equipment, the team would then observe any challenges the RN or RT face in double verification before medication administration could occur.
Upon successful conscious sedation verification by the physician, the ordered procedure would begin and be completed by the physician and other providers, and monitoring would be continued by the RN and RT, to ensure continuous BP, ECG, and pulse oximetry monitoring is maintained until the patient is symptom free, fully awake, with VSS, no N/V, and able to void per hospital policy.
If any hiccups are noted and changes are required after the first ten patients, the FMEA table would be redone and procedures modified until the FMEA team is confident the process has been successfully implemented. Based on a successful pilot or re-pilot of the proposed change and implementation system-wide, patients requiring conscious sedation before a procedure starts will receive better care because; no sedating medications can be administered without proper respiratory and cardiac monitoring equipment having been dually verified as onsite and are monitoring appropriately.
- Demonstrate Leadership – Professional nurse leadership competencies in an action plan
Any nurse can be an advocate for improvement in an action plan. It is a natural part of their role to show professional leadership competencies in the promotion of quality care for the patients they serve. The increase in quality care will result in improved patient outcomes. Improved patient outcomes will further fuel their keen eye in spotting areas where quality improvement initiatives can be implemented system-wide under their leadership and direction.
Promoting Quality Care:
During the course of change, any nurse can demonstrate professional leadership and actively lead in a myriad of ways relative to the process of and for change. As a natural part of their function, nurses are front line advocates for quality patient care. Nurses assess and field patient’s needs in an ongoing manner throughout their shifts. As such, nurses are often the first voice for change because they see firsthand the inefficiencies of the healthcare system and are ever seeking to improve the quality of care they deliver. They are often the first voice pressing forward their ideas to improve the quality of care being delivered by the entire team and healthcare system. Secondarily their licensure and jobs are at stake if care is subpar so they are ever pressing forward quality care ideas to ensure improvements are realized for nursing staff, and the patients they care for.
Improving Patient Outcomes:
Nurses see firsthand what poor care looks like, whether it is personal patient self-care or community-based deficits of care and are therefore seeking to improve patient outcomes in a full scope quality improvement manner, not just the care they deliver in-house. Patient outcomes cannot occur without proper nurse-led patient healthcare education and instruction for care by the nurse involved in care. Patient outcomes are improved by daily reinforcement by the nurse of the needed lifestyle changes a patient faces to make a lasting change in their lives. The continuous reinforcement changes the trajectory of a patient’s lifestyle activities from one that originally resulted in that patient’s hospitalization to a new and improved set of lifestyle choices. While the nurse is not always successful in establishing an ingrained acceptance by the patient for a new set of lifestyle choices, the nurse’s advocacy does improve overall outcomes.
Nurse-led Quality Improvement:
Nurses are frequently involved in nurse-led initiates because of these previously mentioned factors. Their initiatives frequently improve patient outcomes and their work is highly influential in shaping quality improvement activities that result naturally in improved fiscal saving to healthcare organizations according to the American Association of Critical Care Nurses (AM Nurse, 2014).
E1. Involving Professional Nurse in RCA and FMEA Processes
As a professional nurse, my utilization of the RCA and FMEA processes was further deepened by taking this course. I was recently involved in an RCA process at my hospital for a patient of mine that fell which resulted in an in-place fracture of her neck. It was very fulfilling to have been in this class and being asked to participate in both the RCA and FMEA processes at work but to also go through the processes of this course work and patient scenario.
As was reiterated in this course, and at my hospital, the RCA and FMEA processes were not in any way punitive towards the caregivers involved in the adverse event but rather were exceedingly beneficial. The entire RCA and FMEA process I went through at my work benefitted the entire hospital and resulted in the implementation of several improvement initiatives regarding what to do after a fall.
Any professional nurse should embrace the use of the RCA and FMEA processes because they are empowering. The RCA and FMEA processes allow any person, but specifically, a nurse caring for their patient, to demonstrate leadership qualities by advocating for process change based on the events leading up to and after an event. A professional nurse will carefully reflect on the RCA and FMEA processes occurring before or after any adverse event to consider all elements for change that could alter or prevent adverse events from occurring in the future.
- AM Nurse. (2014). Improved patient outcomes, savings from nurse-led initiatives. American Nurse, 46(4), 4. Available from http://search.ebscohost.com.wgu.idm.oclc.org/login.aspx?direct=true&db=ccm&AN=103909709&site=eds-live&scope=site
- Arnstein, P. (2010). Balancing analgesic efficacy with safety concerns in the older patient. Pain Management Nursing, 11(2), S11–S22. doi:10.1016/j.pmn.2010.03.003
- Chaverneff, F. (2019, January 11). Benzodiazepine and opioid prescribing in the elderly: What are the risks? Retrieved from https://www.clinicalpainadvisor.com/home/conference-highlights/painweek-2017/benzodiazepine-and-opioid-prescribing-in-the-elderly-what-are-the-risks/
- Institute for Healthcare Improvement. (n.d. – a). Failure Modes and Effects Analysis (FMEA) Tool. (n.d.). Available from http://www.ihi.org/resources/Pages/Tools/FailureModesandEffectsAnalysisTool.aspx
- Institute for Healthcare Improvement. (n.d. – b). Patient Safety 104: Root Cause and Systems Analysis. Retrieved from https://srm–c.na60.content.force.com/servlet/fileField?id=0BE0c000000LYai
- Schein, E. H. (1999). Kurt Lewin’s Change Theory in the field and in the classroom: Notes toward a model of managed learning. Reflections, 1(1), 59–74. doi: 10.1162/152417399570287
- Schneider, A. (Producer). (2017, October 31). Failure modes and effects analysis. Available from https://wgu.hosted.panopto.com/Panopto/Pages/Viewer.aspx?id=675fb8c8-60db-49bd-a1e0-d2201cc45c05
- Western Governors University. (n.d.). Patient Scenario. Available from https://tasks.wgu.edu/student/001036767/course/10460005/task/1235/overview