Page 1 of 12 ROOT CAUSE ANALYSIS (RCA)/COMPREHENSIVE ANALYSIS STEP 1 & 2 IDENTIFY THE SENTINEL/ADVERSE EVENT AND ESTABLISH A TEAM EVENT : Date of Event/Incident : Time of Event/Incident : Place of Event/Incident : CREDIBLE ANALYSIS TEAM PARTICIPANTS : includes representation from individuals that participate in the specialty and processes associated with the event (not individuals involved in the actual event) Leader (Quality Department) : Participants (clinical service specialty and care delivery process representatives): Approved by CEO: EXAMPLE: Attending Residents Ancillary services Front-line caregivers not associated with the event Ancillary staff Patient unit nurse manager/director/supervisor Representation from involved departments (laboratory, blood bank, radiology,etc) CONTINUE WITH ALL INVOLVED
Page 2 of 12 Patient representative not associated with the event Have all related areas been represented? Have all different types & level of knowledge represented in the team? Start Date: Completion Date: (timeframe for completion within 45 days of when the organization became aware of the event) STEP 3 COLLECT DATA & INFORMATION Interview : (Performed by QA team) 1. Patient 2. Family 3. Front-line caregivers involved in this event Documentation : (Performed by QA team) 1. Preliminary discussions/interview with staff and physician involved in event 2. Medical Record Review Findings 3. Discussion with patient/family/significant other s perspective of situation that led to event 4. Incident Report review 5. Related peer guidleines/standard of care/policies & procedures
Page 3 of 12 Comprehensive Analysis: Conduct a comprehensive and thorough RCA from the time of event and trace back to when the individual presented to the hospital, by continually asking WHY? UNTIL the team drills down to the root cause of the event (system and/or process). Should be conductive within a culture of safety and non-punitive environment. STEP 4 MAP /Flowchart the steps in the related event process as designed and then, flow chart the steps that had happened for this adverse event that had deviated from the designed process. STEP 5 Problem Identified Contributing Factors -Care Management Problem No. 1 2 3 EXAMPLE: CONTRIBUTING FACTORS EXAMPLE: Care Management Problems/contributing factors Instruments/Tools EXAMPLE: Emergency Room (ER) doctor did not write down the Differential Diagnosis (DD) to eliminate Other Acute Abdomen conditions on the medical record EXAMPLE: Emergency Room (ER) doctor gave 50 mg Ketesse (Dexketoprofen) which is contraindicated for the Gastritis diagnosis. EXAMPLE: Emergency Room (ER) Nurse did not perform blood sampling according to the standard procedure that led to hemolysis of the blood sample. 4 5 6 ADD ALL IDENTIFIED CONTRIBUTING FACTORS Analysis Mode 5 Whys 5 Whys 5 Whys DELETE EXAMPLE TEXT from provided tables and add the organization s identified contributing factors/problems for this event. STEP 6 CONTRIBUTING FACTORS (PROBLEM) used for a THOROUGH ANALYSIS DRILL DOWN TO SYSTEM/PROCESS WHY?
Page 4 of 12 5 WHYs FORM from proximal (frontline caregiver) cause to latent(system or process) cause EXAMPLE: No. WHY? 1 2 3 Problem 1 EXAMPLE: Why didn t the ER (Emergency Room) doctor write down the Differential Diagnosis (DD) to eliminate other acute abdomen conditions on the medical record? EXAMPLE: Why did the ER (Emergency Room) doctor forgot to write down the Differential Diagnosis (DD) on the medical record? EXAMPLE: Why is the monitoring system and the education on medical record documentation performed by the ER (Emergency Room) doctors are not optimum yet? EXAMPLE: Emergency Room (ER) doctor did not write down the Differential Diagnosis (DD) to eliminate Other Acute Abdomen conditions on the medical record EXAMPLE: Because the ER (Emergency Room) doctor forgot to write down the Differential Diagnosis (DD) on the medical record. EXAMPLE: Because the monitoring system and the education on medical record documentation performed by the ER (Emergency Room) doctors are not optimum yet EXAMPLE: Doctors are not required to attend educational sessions 4 EXAMPLE: Why are the doctors not required to attend the educational sessions? EXAMPLE: The medical staff oversight does not include the requirement.
Page 5 of 12 5 EXAMPLE: Why does the medical staff board not require physicians to attend hospital education? EXAMPLE: The requirement is part of the medical staff bylaws, but it has not been implemented system wide and is not followed-up in the medical staff office physician files. No. Why? 1 2 3 4 5 Problem 2 EXAMPLE: Emergency Room (ER) doctor gave 50 mg Ketesse (Dexketoprofen) which is contraindicated for the Gastritis diagnosis. No. WHY? 1 2 3 4 5 Problem 3 EXAMPLE: Emergency Room (ER) Nurse did not perform blood sampling according to the standard procedure that led to hemolysis of the blood sample. DELETE EXAMPLE TEXT from provided tables and add the organization s identified contributing factors/problems for this event to drill down to root causes that led to the event.
Page 6 of 12 ANALYSIS FRAMEWORK This template is provided as an aid in organizing the steps in a root cause analysis. Not all possibilities and questions will apply in every case, and there may be others that will emerge in the course of the analysis. However, all possibilities and questions should be fully considered in your quest for root cause and risk reduction. As an aid to avoiding loose ends, the three columns on the right are provided to be checked off for later reference: Root cause? should be answered yes of No for each finding. A root cause is typically a finding related to a process or system that has a potential for redesign to reduce risk. If a particular finding that is relevant to the event is not a root cause, be sure that it is addressed later in the analysis with a Why? question. Each finding that is identified as a root cause should be considered for an action and addressed in the action plan. Ask Why? should be checked off whenever it is reasonable to ask why the particular finding occurred (or didn t occur when it should have) in other words, to drill down further. Each item checked in this column should be addressed later in the analysis with a Why? question. It is expected that any significant findings that are not identified as root causes themselves have roots. Take action? should be checked for any finding that can reasonably be considered for a risk reduction strategy. Each item checked in this column should be addressed later in the action plan. It will be helpful to write the number of the associated Action Item on page 3 in the Take Action? column for each of the findings that requires an action. Level of Analysis Questions Findings Root Cause? Ask Why? Take Action What happened? Sentinel Event What are the details of the event? (Brief description) When did the event occur? (Date, day of week, time) What area/service was impacted?
Page 7 of 12 Why did it happen? What were the most proximate factors? The process or activity in which the event occurred. (Example: Blood administration; admission process; hand-off communications between attending and covering MD) What are the hospital s outlined steps-protocol for this process, as designed? (A flow diagram may be helpful here) 1. What steps designed into the process were involved in (contributed to) the event? 2. What steps designed into the process/ protocol were omitted in the event process? 3. What steps were part of the event process that were not part of the intended designed process? (Typically special cause variation) Human factors What human factors were relevant to the outcome?
Page 8 of 12 Equipment factors How did the equipment performance affect the outcome? Controllable environmental factors Uncontrollable external factors What factors directly affected the outcome? Are they truly beyond the organization s control? Other Are there any other factors that have directly influenced this outcome? What other areas or services are impacted Level of Analysis Questions Findings Root Cause? Ask Why?
Page 9 of 12 Why did that happen? What systems and processes underlie those proximate factors? (Common cause variation here may lead to special cause variation in dependent processes) Human Resources issues To what degree are staff properly qualified and currently competent for their responsibilities? How did actual staffing compare with ideal levels? What are the plans for dealing with contingencies that would tend to reduce effective staffing levels? To what degree is staff performance in the operant process addressed? Level of Analysis Questions Findings Root Cause? How can orientation and inservice training be improved? Ask Why?
Page 10 of 12 Information management issues To what degree is all necessary information available when needed? Accurate? Complete? Unambiguous? To what degree is communication among participants adequate? Environment al management issues To what degree was the physical environment appropriate for the processes being carried out? What systems are in place to identify environmental risks? Leadership issues: - Corporate culture - Encourageme nt of communicati on What emergency and failuremode responses have been planned and tested? To what degree is the culture conducive to risk identification and reduction? What are the barriers to communication of potential risk factors?
Page 11 of 12 - Clear communicati on of priorities Uncontrollab le factors To what degree is the prevention of adverse outcomes communicated as a high priority? How? What can be done to protect against the effects of these uncontrollable factors? ACTION PLAN For each of the findings identified in the analysis as needing an action, indicate the planned action expected, implementation date and associated measure of effectiveness. OR. If after consideration of such a finding, a decision is made not to implement an associated RISK REDUCTION STRATEGIES (PROBLEM# AND ACTION PLAN) Action Item #1: Action Item #2: Action Item #3: Action Item #4: Action Item #5: MEASURES OF EFFECTIVENESS D A I
Page 12 of 12 risk reduction strategy, indicate the rationale for not taking action at this time. Check to be sure that the selected measure will provide data that will permit assessment of the effectiveness of the action. Consider whether pilot testing of a planned improvement should be conducted. Improvements to reduce risk should ultimately be implemented in all areas where applicable, not just where the event occurred. Identify where the improvements will be implemented Action Item #6: Action Item #7: Action Item #8: Cite any policies & procedures, Peer Clinical Guidelines, law and regulations, or journal articles that were considered in developing this