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Involving patients in Root Cause
Analysis
The role of the regulator
Sandra Mulder, MD
Dutch Healthcare Inspectorate
Gothenburg, April 15th 2016,
Conflict of Interests
None
Special thanks to
Josje Kok, iBMG
Ian Leistikow
Involving patients in Root Cause Analysis, the role of the regulator, April 15 2016
The Dutch context
1. Health care providers are responsible for quality and safety of care
2. Health care inspectorate assesses quality and safety according to regulation
3. Health care providers are obliged to report sentinel events to inspectorate
hospitals perform AE analysis
inspectorate judges quality of report
Involving patients in Root Cause Analysis, the role of the regulator, April 15 2016
WHO Principles of Patient Safety Incident Analysis
• Process
• Reconstruction
• Analysis
• Conclusion with recommended improvements
• Report
Involving patients in Root Cause Analysis, the role of the regulator, April 15 2016
WHO Principles of Patient Safety Incident Analysis
• Process
• Reconstruction
• Analysis
• Conclusion with recommended improvements
• Report
PATIENT
Involving patients in Root Cause Analysis, the role of the regulator, April 15 2016
Experiences in the Netherlands
Hospitals:
Some initial reluctance to involve patients in reconstruction
Once implemented, most hospitals acknowledge the added
value
Fear of legal measures when giving patients the AE analysis
report
Involving patients in Root Cause Analysis, the role of the regulator, April 15 2016
Experiences in the Netherlands
Patients/family:
Some distrust of patients in fair process
Difficult for patients to understand difference between AE and
medical complication
Difficult for patients to understand difference between AE
analysis and complaint/financial claim
Involving patients in Root Cause Analysis, the role of the regulator, April 15 2016
Experiences in the Netherlands
Increase in engaging patients in reconstruction of AE
Involving patients in Root Cause Analysis, the role of the regulator, April 15 2016
2013-2015: engaging patients
n = 1700 reports
Experiences in the Netherlands
Increase in sharing AE reports with the patient
Involving patients in Root Cause Analysis, the role of the regulator, April 15 2016
2013-2015: informing patients
n = 1700 reports
sm.mulder@igz.nltwitter:@smulder
Patient involvement in RCA – what canorganisations do
Dr Carla Veldkamp
C.Veldkamp@cwz.nl
• Manager of quality and safety, Canisius-Wilhelmina Ziekenhuis
• Chair of Santeon Alert System, Santeon Hospitals
Conflict of interests
NONE
Special thanks to Ian Leistikow and Josje Kok
and all the RCA-investigators of the Santeon Hospitals
• Canisius-Wilhelmina Ziekenhuis• Catharina Ziekenhuis• Martini Ziekenhuis• Medisch Spectrum Twente• Onze Lieve Vrouwe Gasthuis• St Antonius Ziekenhuis
Santeon Alert System- Striving to be a best practice on the management of
serious adverse events
- Sharing RCA reports with each other all year round, twice a year meetings in which we do the alerts –warnings what could happen to you
- Exchange of improvements
Root Cause Analysis in my hospital• RCA’s since 2007
• Review of patient record• Interviews with all staff involved
• Patient involved in RCA since april 2013
• Try out with patient who is a pilot by profession andskilled in analysing aviation incidents
It is never just an interview… • The patient/family view may vary highly from view of staff
• Patient/family also experience distortions in eyewitness memory –difficult to adress
• What is the right timing when a patient is severely ill of has died?
• Family might get angry or even aggressive
• Questions from the patient/family must be adressed in RCA
Development over time
Disclosure
Disclosure tostaff
Disclosure topatient
depending on….
Disclosurealways
Analysis
Review record
Interview staff
Interview patient
Patientrepresentative
on team
Patient on RCA team
Reporting
Orally
Condensedform
Full report
Support
Patient/family
Second victim
Third victim
How? When?
By who?Mandatory?
Survey: 115 respondents from 20 countries
Most respondents work at a hospital (83 %)
Disclosure• 46 % will disclose as soon as they recognize the adverse
outcome
• 36 % will disclose as soon as they think something went wrong in the quality of care, so after initial investigation
Strong preference for disclosing face-to-face
Disclosing is mostly done by the patients’ doctorSeconded by the person who made the mistake and management
Are patients involved in RCA?• 68 % of the respondents involve patients in RCA always
or depending on the situation
• 32 % will not involve patients
Dilemma ‘s
• Danish law requires that the patients involved remain anonymous
• Difficult to involve family after the patient died – some respondents say they only perform RCA when patient has died
How are patients involved in RCA• 49 respondents will involve patient passively (interview,
gives input for reconstruction of events) • 6 respondents will involve patients actively (member of
committee, active in analysis)
Sharing results of RCA with patients
84 % will share results with the patient/family
Does your organization have a formally organized support system in place?
Now it’s your turn – case study
Disclosure
Disclosure tostaff
Disclosure topatient
depending on….
Disclosurealways
Analysis
Review record
Interview staff
Interview patient
Patientrepresentative
on team
Patient on RCA team
Reporting
Orally
Condensedform
Full report
Support
Patient/family
Second victim
Third victim
How? When?
By who?Mandatory?
Take home message
More ways can exist next to each other
Just give it a try, don’t be discouraged by one disappointingexperience
Select the right patient/family for what you are about totry
Be prepared to be a change agent in your organisation
Read more on the subject
Zimmerman TM, Amori G. Including patients in root causeand system failure analysis: legal and psychologicalimplications. J Healthc Risk Manag. 2007;27(2):27-34
Munch DM. Patients and families can offer key insights in root cause analysis. Focus Patient Saf. 2004;7(4):6–7.
HCPro, Inc Mother: Patients want to help after errors. Briefings Patient Saf (Patient Saf Monit) 2007;8(10):1–2.
c.veldkamp@cwz.nlsm.mulder@igz.nl
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Survey on patient
involvement in RCAwoensdag 30 maart 2016
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Aanmaakdatum: woensdag 2 maart 2016
115Totale aantal reacties
Voltooide reacties: 82
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Q2: You work at a:Beantwoord: 113 Overgeslagen: 2
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Q2: You work at a:Beantwoord: 113 Overgeslagen: 2
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Q3: Your profession is:Beantwoord: 114 Overgeslagen: 1
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Q3: Your profession is:Beantwoord: 114 Overgeslagen: 1
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Q4: When would your organization in general disclose an adverse event
to a patient?
Beantwoord: 89 Overgeslagen: 26
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Q4: When would your organization in general disclose an adverse event
to a patient?
Beantwoord: 89 Overgeslagen: 26
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Q5: How does your organization disclose?Beantwoord: 89 Overgeslagen: 26
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Q5: How does your organization disclose?Beantwoord: 89 Overgeslagen: 26
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Q6: Who discloses?Beantwoord: 89 Overgeslagen: 26
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Q6: Who discloses?Beantwoord: 89 Overgeslagen: 26
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Q7: Does your organization involve the patient in the RCA?Beantwoord: 82 Overgeslagen: 33
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Q7: Does your organization involve the patient in the RCA?Beantwoord: 82 Overgeslagen: 33
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Q8: How does your organization involve the patient in the RCA?Beantwoord: 81 Overgeslagen: 34
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Q8: How does your organization involve the patient in the RCA?Beantwoord: 81 Overgeslagen: 34
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Q9: When does your organization involve the patient in the RCA?Beantwoord: 64 Overgeslagen: 51
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Q9: When does your organization involve the patient in the RCA?Beantwoord: 64 Overgeslagen: 51
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Q10: Who speaks to the patient to obtain information?Beantwoord: 74 Overgeslagen: 41
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Q10: Who speaks to the patient to obtain information?Beantwoord: 74 Overgeslagen: 41
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Q11: Does your organization share the results of the RCA with the
patient?
Beantwoord: 82 Overgeslagen: 33
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Q11: Does your organization share the results of the RCA with the
patient?
Beantwoord: 82 Overgeslagen: 33
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Q12: When does your organization share the results of the RCA with the
patient?
Beantwoord: 80 Overgeslagen: 35
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Q12: When does your organization share the results of the RCA with the
patient?
Beantwoord: 80 Overgeslagen: 35
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Q13: How does your organization share the results with the patient?
Beantwoord: 70 Overgeslagen: 45
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Q13: How does your organization share the results with the patient?
Beantwoord: 70 Overgeslagen: 45
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Q14: Who provides the informationBeantwoord: 71 Overgeslagen: 44
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Q14: Who provides the informationBeantwoord: 71 Overgeslagen: 44
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Q15: Does your organization have a formally organized support system in
place?
Beantwoord: 77 Overgeslagen: 38
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Q15: Does your organization have a formally organized support system in
place?
Beantwoord: 77 Overgeslagen: 38
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