Root Cause Analysis in Healthcare, Thesis of Marketing Research

The Root Cause Analysis (RCA) process in healthcare, which is a systematic approach to determine causative factors and identify system flaws that can be corrected to prevent adverse events. the six-step RCA process and how it can be used to identify causative and contributing factors in adverse events. It also provides an improvement plan for preventing future adverse events and discusses Lewin's change theory. useful for healthcare students and professionals who want to learn about RCA and how it can be used to improve patient safety.

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C489
C489 Organizational Systems and Quality Leadership
SAT Task 2
Western Governors University
Organizational Systems and Quality Leadership SAT Task 2
A. Root Cause Analysis
The Institute for Healthcare Improvement (IHI) has identified a Root Cause Analysis
(RCA) as a systematic approach to determine causative factors and identify system flaws that can
be corrected to prevent adverse events. (Institute for Healthcare Improvement, n.d.). The RCA is
a retrospective approach that focuses on system causes rather than blaming others by considering
all contributing factors within the work environment that led to the event. The focus is to identify
system flaws to prevent future adverse events. (Institute for Healthcare Improvement, n.d.).
A1. RCA Steps
The Root Cause Analysis team is from all organizational levels who have a fundamental
knowledge of the processes and issues involved in the adverse event and consists of 4 – 6 mixed
professionals. (Institute for Healthcare Improvement, n.d.). The RCA involves a six-step process.
Step 1 is collecting the data in an accurate, organized, and complete manner to draw a picture
such as a flowchart to determine what happened to cause the event. The data comes from staff
reports, incident reports, and medical record review. (Institute for Healthcare Improvement,
n.d.). Step 2 is to gather data to determine what should have happened or would have happened if
actions implemented by the staff and the hospital would have completed a proper system process.
By creating a flowchart with this data and comparing it with the chart from the first step, the
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C489 Organizational Systems and Quality Leadership SAT Task 2 Western Governors University Organizational Systems and Quality Leadership SAT Task 2 A. Root Cause Analysis The Institute for Healthcare Improvement (IHI) has identified a Root Cause Analysis (RCA) as a systematic approach to determine causative factors and identify system flaws that can be corrected to prevent adverse events. (Institute for Healthcare Improvement, n.d.). The RCA is a retrospective approach that focuses on system causes rather than blaming others by considering all contributing factors within the work environment that led to the event. The focus is to identify system flaws to prevent future adverse events. (Institute for Healthcare Improvement, n.d.). A1. RCA Steps The Root Cause Analysis team is from all organizational levels who have a fundamental knowledge of the processes and issues involved in the adverse event and consists of 4 – 6 mixed professionals. (Institute for Healthcare Improvement, n.d.). The RCA involves a six-step process. Step 1 is collecting the data in an accurate, organized, and complete manner to draw a picture such as a flowchart to determine what happened to cause the event. The data comes from staff reports, incident reports, and medical record review. (Institute for Healthcare Improvement, n.d.). Step 2 is to gather data to determine what should have happened or would have happened if actions implemented by the staff and the hospital would have completed a proper system process. By creating a flowchart with this data and comparing it with the chart from the first step, the

team can determine the differences and where the problems may have occurred. (Institute for Healthcare Improvement, n.d.). Step 3 is to determine the underlying causative factors by asking “why” five times. The RCA team looks at the most likely or direct cause and the contributing or indirect in nature cause to determine the underlying factors that lead to the adverse/sentinal event. The contributing factors can include work environment, patient characteristics, and team factors. (Institute for Healthcare Improvement, n.d.). A flowchart used for exploring and identifying possible causes is the fishbone diagram, known as the cause and effect diagram. (Institute for Healthcare Improvement, n.d.). Step 4 is to create a causal statement that reflects the contributing factors the cause is linked to, as identified in step 3, to the undesirable outcome. The causal statement consists of three separate parts: the cause or reason the event occurred, the effect or what may have led to something else happening, and the event or what led to this outcome. (Institute for Healthcare Improvement, n.d.). The causal statement is what links the cause back to the adverse/sentinel event that led to the RCA. (Institute for Healthcare Improvement, n.d.). Step 5 is to create a recommended list of changes in the system that would prevent the event's future occurrence. Examples of changes include standardization of equipment, developing new policies, checklists, simplifying processes, and educating the staff. (Institute for Healthcare Improvement, n.d.). Step 6 is to improve the system process by clarifying, organizing, and summarizing the data in the correct order it occurred to present it to the organizational leaders and individuals involved in the unpleasant outcome. (Institute for Healthcare Improvement, n.d.). A2. Causative and Contributing Factors After reviewing the listed scenario, it is apparent that Nurse J and DR. T did not follow the facility’s moderate/analgesia conscious sedation policy concerning drug selection and acceptable drug dose range. Per the facility’s policy, MR. B should have been monitored via

successful left hip reduction at 4:25 pm. MR. B tolerated the procedure well, is sedated but not on oxygen. At 4:30 pm, the patient is resting comfortably in no distress. MR. B is placed on a pulse oximeter and an automatic blood pressure machine that is programmed for every five minutes. Nurse J allows the son to sit with the patient while the staff attends to other ED patients. At 4:35 pm, MR. B's oxygen saturation level is 92% on room air, and his blood pressure is 110/62. MR. B's respirations are not monitored, and he is not on an ECG monitor. While taking care of other patients, including a recent patient admission in respiratory distress, MR. B’s pulse oximeter alarms showing an oxygen saturation level of 85%. The LPN enters MR. B's room resets the alarm and checks his blood pressure without notifying Nurse J. At 4:43 pm, Nurse J is informed by the son that MR. B’s monitor is alarming. Nurse J notes MR. B is not breathing, blood pressure is 58/30, has no palpable pulse, and his oxygen saturation level is 79%. A STAT CODE is called, cardiopulmonary resuscitation (CPR) is started, and MR. B is intubated. After 30 minutes of interventions, MR. B doesn’t respond to noxious stimuli, blood pressure is 110/70, ECG shows sinus rhythm, pupils are fixed and dilated, he is not breathing independently, and is dependent on the ventilator. MR. B is transferred for advanced care to another facility, and seven days later, he was noted to have brain death. Life support was removed per the family’s wishes, and MR. B died. Step 2 is to determine what should have happened. (Institute for Healthcare Improvement, n.d.). DR. T and Nurse J should have followed the facility’s moderate/analgesia conscious sedation policy of medication selection and acceptable dosing. A continuous ECG monitor/pulse oximeter and blood pressure should have been placed on MR. B until he was fully awake with stable vital signs and ready for discharge. Nurse J should have requested additional backup staff when the ED became overwhelmed with patients, and the LPN should have notified Nurse J of MR. B's monitor alarming. Step 3 is to determine causes. (Institute for Healthcare Improvement, n.d.). The causative factors are lack of ECG monitoring after receiving moderate

conscious sedation and lack of staff to monitor MR. B adequately. Some contributory factors include task-related, work environment, and patient characteristics. From the scenario, the task- related factor is that the hospital policy’s moderate conscious sedation policy was not followed by DR. T and Nurse J. (Institute for Healthcare Improvement, n.d.). Medscape states diazepam is given preoperatively at 10mg intramuscularly (IM) before surgery. Postoperatively diazepam 5- 10mg IV is initially given then every 3-4 hours as needed. (Medscape, n.d.). Medscape states that for moderate to severe pain, give hydromorphone 0.2 – 1mg IV every 2-3 hours; however, patients with prior opioid exposure may require higher doses. (Medscape, n.d.). The half-life of diazepam is 20 - 70 hours. (Medscape, n.d.). When combining diazepam with opiate medication, diazepam can potentially cause significant opioid-related respiration depression. (Medscape, n.d.). The LPN did not inform Nurse J that MR. B's monitor’s alarm was showing low oxygen saturation and low blood pressure in a prompt manner. The work environment factor is the team was overwhelmed and understaffed; therefore, they could not monitor and take care of MR. B per the hospital's moderate sedation policy requirements. The patient characteristics are MR. B's weight, history of chronic back pain, and oxycodone use could have made him resistant to selecting medications and their dosing, potentially resulting in delayed sedation reaction. Step 4 is to develop causal statements (Institute for Healthcare Improvement, n.d.). From the scenario, causal statement 1 is the hospital's moderate sedation policy for continuous blood pressure, pulse oximetry, and ECG monitoring was not followed correctly by Nurse J. Not following the sedation policy resulted in the patient’s vital sign changes not being recognized in a prompt manner leading to an undesirable outcome. Statement 2 is the team was overwhelmed with other emergencies within the ED. The team could not monitor the patient’s vital signs and level of consciousness as required by the hospital's moderate sedation policy, which led to late

allows frequent monitoring such as making frequent rounds or a nurse/tech watching monitors at the nurse’s station to assess any changes in the patient's condition that would need interventions to prevent an undesirable outcome. 4. Clinical education needs to be provided to the LPN’s concerning notification to the primary nurses of abnormal vital signs and the documentation required. Early recognition of abnormal vital signs and early interventions could potentially prevent or significantly reduce an adverse event. B1. Change Theory Lewin’s change theory involves three different stages. (Cherry, 2019, p. 304). The first stage is the unfreezing change, which promotes identifying the problem and encourages awareness for change. (Cherry, 2019, p. 304). This stage involves gathering data concerning the issue, accurately assessing the situation, determining if change is necessary and making others aware a change is needed. Individuals must believe that improvement is possible before attempting a change. (Cherry, 2019, p. 304). In the scenario, improvement number 4 notes that communication needs to include primary nurses, LPN's, physicians, and leadership about MR. B's event to make them aware that unless a change occurs, there is a potential that this will happen again. The moving stage is the second stage. The change agent clarifies the need for change, explores different alternatives, sets specific goals with target end dates, creates the change plan, and implements the change. (Cherry, 2019, p. 304). The change agent supports and encourages everyone throughout the process, evaluates the change, and makes modifications as needed. (Cherry, 2019, p. 304). In the scenario, improvement number 2 notes the change agent will provide the staff with the new moderate conscious sedation checklist. Staff will be informed of the change via emails, checklist handouts, and staff meetings. Deadlines will be confirmed for each implementation step to promote compliance and gradual acceptance. (Cherry, 2019, p.

304). The change agent should be open to initial resistance and ask for suggestions or feedback from staff and make modifications. (Cherry, 2019, p. 304). The refreezing stage is the third stage. In this stage, the change agent integrates the change into the organization, and it becomes the current process. (Cherry, 2019, p. 304). In this stage, the change agent adopts new policies, engages and supports the staff, and requires compliance until the change is integrated into the organization’s daily work. The change agent needs to reinforce and assess compliance periodically to prevent the team from reverting to the old process. The change agent and leadership should reinforce the change to avoid an adverse event's reoccurrence without placing individual blame. (Cherry, 2019, p. 304). In the scenario, improvement 1 notes that annual education/training will reinforce the hospital's sedation policy and encourage understanding and compliance. The change agent can also monitor staff compliance by periodically reviewing medical record documentation or creating a questionnaire regarding the implementation according to the change. Monthly meetings could also be scheduled with leadership and staff to discuss the new change and concerns the team may have to ensure the new process runs smoothly. C. General Purpose of FMEA The Failure Modes and Effects Analysis (FEMA) tool aims to evaluate an organization's process for potential failures to prevent future adverse/sentinel events. (Institute for Healthcare Improvement, 2017). The FEMA tool is useful in evaluating an organization's new process before implementation. It is also valuable for assessing what type of impact a proposed change will make to an existing process. (Institute for Healthcare Improvement, 2017).

modes with the highest RPN's, the team can plan actions such as independent double checks, alert screens, barcoding on medications, and training staff to recognize early warning signs for failure to reduce harm. This allows the team to evaluate its impact in a safe environment by simulating the change verbally and before testing in a patient care setting. (Institute for Healthcare Improvement, 2017). FEMA can also track and monitor the total RPN's improvement over time and modify it as needed to reduce the risk of failure or harm. (Institute for Healthcare Improvement, 2017). C2. FMEA Table Please see the attached document. D. Intervention Testing The Plan – Do – Study – Act (PDSA) is the Model for Improvement testing phase. (Institute for Healthcare Improvement, n.d.). The PDSA cycle tests the change by planning a test, trying the plan on a small scale, observing the results, and learning from the results. This minimizes the risk of introducing a change into a complex system. It is essential to run frequent PDSA cycles to determine if the changes that are being made lead to improvement to prevent a potential failure. (Institute for Healthcare Improvement, n.d.). As noted in part B improvement number 2, the test intervention to provide a new moderate conscious sedation checklist is to plan ahead and have a new sedation checklist emailed to all individuals involved in the event and leadership before a scheduled meeting. (Institute for Healthcare Improvement, n.d.). Sending the checklist would allow the individuals involved to review the material before the meeting. At the meeting, copies of the sedation checklist would be handed out to all individuals involved in the event and leadership. This allows for clarification of all handout areas that need to be documented postoperatively and on discharge. Documentation should include types and times of

medication given, vital signs (blood pressure, oxygen saturation via pulse oximeter, ECG), and alertness level. (Institute for Healthcare Improvement, n.d.). Once the checklist handout has been discussed and questions answered, all individuals will sign that they have reviewed and understood the new moderate conscious sedation checklist. Having all individuals sign that they have reviewed and understood the sedation form and its requirements helps add accountability to every individual to ensure that all equipment is available to document vital signs, ECG, and consciousness post-op and discharge. This helps ensure compliance with the hospital policy. (Institute for Healthcare Improvement, n.d.). All emergency department staff involved in giving moderate conscious sedation and documenting on the checklist will turn the completed form into management at the end of each shift for six months. The next phase is the "do" phase. All completed moderate sedation checklists for every procedure will be audited weekly. This is when concerns/suggestions about the sedation checklist can be addressed by staff and leadership. (Institute for Healthcare Improvement, n.d.). The study phase is when the sedation checklists will be analyzed for adherence to the change. (Institute for Healthcare Improvement, n.d.). In this phase, leadership and staff will summarize the audit outcomes and current numbers and reflect on what was learned. (Institute for Healthcare Improvement, n.d.). The last phase is act. In this phase, based on what was learned from the audit, new modifications to the form will be put in place as needed, and a new test will be started on a larger scale. The latest modifications/changes will continue to be monitored and audited. This PDSA process will be ongoing to ensure that all staff follows the new sedation form, using all required equipment and documenting as required by hospital policy until leadership determines that this is no longer a concern. (Institute for Healthcare Improvement, n.d.). I would put a timeline of 1 year in place until further notice and evaluation. This data could be used to trend the types and amounts of medications used during

show leadership qualities by taking the initiative to help identify the organization’s system flaws, the organization’s process for potential failures to prevent future adverse events, and providing frontline nurses input. He or she can implement new changes by providing education and guidance to the frontline staff to improve patient healthcare while preventing future adverse events. This can help broaden the ideas and ensure each new change's effectiveness and compliance. F. Sources Advocate Aurora Health. (n.d.). Moderate Monitoring And Documentation Requirements. https://cme.advocateaurorahealth.org/content/moderate-monitoring-and-documentation- requirements Cherry, B. (2019). Chapter 17: Nursing Leadership and Management. In B. Cherry & S. Jacob (Eds.), Contemporary nursing: Issues, trends, & management (8th ed.) [Vitalsource learning resource] (p. 304). https://wgu.vitalsource.com/#/books/9780323554206/cfi/6/6!/4/14/376/2@0:61. Cherry, B. (2019). Chapter 17: Nursing Leadership and Management. In B. Cherry & S. Jacob (Eds.), Contemporary nursing: Issues, trends, & management (8th ed.) [Vitalsource learning resource] (p. 290). https://wgu.vitalsource.com/#/books/9780323554206/cfi/6/6!/4/14/376/2@0:61. Institute for Healthcare Improvement. (2017). QI Essentials Toolkit: Failure Modes and Effects Analysis (FMEA) Tool. http://www.ihi.org/resources/Pages/Tools/FailureModesandEffectsAnalysisTool.asp x Institute for Healthcare Improvement. (n.d.). QI Essentials Toolkit: Plan – Do -Study – Act (PDSA) Worksheet. http://www.ihi.org/resources/Pages/Tools/PlanDoStudyActWorksheet.asp x

Institute for Healthcare Improvement. (n.d.). Patient Safety 104: Root Cause and Systems Analysis. https://srm--c.na60.content.force.com/servlet/fileField?id=0BE0c000000LYai Medscape. (n.d.). Diazepam (RX). https://reference.medscape.com/drug/valium-diastat-diazepam-342902#