Root Cause Analysis RCA2; NPSF. Salma Al- Khani, B.Sc, MHHA, CPHQ Medica7on Safety Officer King Faisal Specialist Hospital & Research Center

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1 Root Cause Analysis RCA2; NPSF Salma Al- Khani, B.Sc, MHHA, CPHQ Medica7on Safety Officer King Faisal Specialist Hospital & Research Center

2 RCA2 Why this? Why now: Same pa2ent safety problems recur Root cause analysis has been used with highly variable success Lack of standardized approach Failure to iden2fy systems level causes Superficial solu2ons/countermeasures Poor implementa2on of solu2ons Lack of follow- up

3 RCA has been advocated for >15 years with highly variable success Need to get real improvement New approach needed Root Cause Analyses & ACTION (RCA2)

4 NPSF Ini7a7ve RCA2 Risk- based rather than severity- based Systems- based approach Goal is real ACTION & Improvement Sustainable results

5 RCA elements Risk- based priori2za2on Non- puni2ve Timing & Team Membership Determina2on of : - What Happened? - Why It Happened? - What Ac2ons to Prevent Future Occurrence? Formula2on and Implementa2on of Stronger Ac2ons Follow- up Measurement Sustainment

6 Risk- Based Priori7za7on Why? How? - Severity vs Likelihood (Probability) - Importance of Close Calls - Actual vs Poten2al

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8 Severity Assessment Code (SAC) Near Miss: Did not reach the pa2ent Minor: No harm, require increased level of care.. Moderate: Changes in vital signs, decrease level of consciousness, Addi2onal medica2on, invasive diagnos2c procedure.. Major: Cardiac changes, fractures, transfer to higher level of care, cri2cal laboratory value, LOS Serious: Cardiac or respiratory arrest, wrong pa2ent, gas embolism, Death.

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10 Non- Puni2ve

11 Non puni7ve: Why? Transparent Criteria Concept of Blameworthiness/Just Culture

12 Timing

13 Timing: Having an established RCA2 team in place or mechanism to convene one quickly allows for a rapid appropriate response. Be prepared. The pa2ent is the first priority - Medical care and treatment - Disclosure to the pa2ent and family Make the environment safe Preserve evidence - Sequester medical equipment - Find out what has occurred

14 Timing: Needs to be appropriately resourced. A commitment to the RCA2 process. Review process should begin within 72 hours. Completed within days. Scheduled mee2ngs in place. 1½ to 2 hours for each mee2ng. RCA process takes more than 1 mee2ng. Requires team member work between mee2ngs.

15 Team Membership

16 Team Membership Fundamental knowledge of subject area and RCA process. Conflict of interest minimized should not include those that are part of event. Consider limited membership: 4-6 team members. Team lead: Experienced and skilled

17 Why use flow diagram: Ensures the team has a common understanding of the adverse event Permits the team to conduct a gap analysis Provides a plaform to build upon Can act as a road map for the analysis

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19 Interviewing

20 Interviewing Requires Prepara2on and Thought by RCA2 team Experienced Interviewers can be invaluable, it is a skill Just the Facts Be a Good Listener

21 Causa7on

22 Causa7on determina7on: Systems- based approach Human Factors Engineering techniques Timeline graphical representa2on Triggering Ques2ons Interviews: staff, pa2ents, others Literature Past experience

23 Rules of causa7on: Cause and Effect Human Error Must Have Preceding Cause Failure to Follow Procedure By Itself Is NOT a Root Cause Nega2ve Descriptors Aren t Ac2onable Failure To Act Is Not A Cause Without Pre- exis2ng Requirement To Act Why, Why, Why

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25 Ac2ons: The most important step Aim - Prevent recurrence - Reduce risk of recurrence - Probability and/or severity Ensure each ac2on coupled to cause Use ac2on hierarchy - Focus on strength of ac2on No censorship!

26 Human Factor Engineering and Ac:ons Warnings and labels (watch out!) Training (don t do that) Procedure changes (work around that) Interlock, lock- in, lock- out, etc (let me design it so you can not do that forcing func2ons) Is there one right ac2on??? Weaker Stronger

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28 Measuring EffecGveness

29 We Manage What We Measure AcGons Without Measure Cannot Show Success

30 Measurement Doesn t Have to be Complicated Make the Measures Specific and Understood

31 Measuring EffecGveness: Accountability is Key A specific person By a date certain Know what will be measured, how it will be measured, by whom it will be measured, and date it will be measured.

32 Process Measures - focus on how well and how ooen interven2on(s) are carried out. Outcome Measures what will occur because the designed and selected interven2ons are performed Clinical Outcomes - clinical results that you will see as a result of the selected interven2ons

33 Examples Process Measure: 85% of staff will be compliant with the established pa2ent rounding process within 4 weeks of training and implementa2on Outcome Measure: There will be 25% fewer falls in the 3th quarter, when compared to the 1st quarter of the calendar year

34 Measuring EffecGveness Need to Know Has their been compliance with the Ac2on Items? Were Ac2on Items Effec2ve? Is further Correc2ve Ac2on Needed? Should their be a different approach?

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36 Provide Feedback on Results To Leadership To Staff To Pa2ents and Families Celebrate Wins! Maintain the Gain - Sustainment

37 Leadership and Boards Leadership: Leadership support crigcal to success Who? CEO and Board What? Approval of ac2ons Ra2onale for ac2ons not approved Considering organiza2on- wide applicability How? Assess ac2ons against Hierarchy Be cognizant of red flags

38 Warning Signs of an Ineffec7ve RCA2 Contribu2ng factors absent or lack suppor2ng data or informa2on. Human error iden2fied as causing the event. Causal statements do not comply with Five Rules of Causa2on No stronger or intermediate strength ac2ons are iden2fied. No correc2ve ac2ons are iden2fied, or the correc2ve ac2ons do not address iden2fied system vulnerabili2es. Ac2on follow- up is assigned to a group and not to an individual. Ac2ons do not have comple2on dates or meaningful measures. The event review took longer than 45 days to complete. There is lirle confidence that correc2ve ac2on will significantly reduce the risk of future occurrences of similar events.

39 Swiss Cheese Model of Accident Causation Unsafe Medication Practices Hand Protocols or written orders Lack of System safeguard Policy & procedure Clumsy Technology Triggers Medication Errors