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Involving patients in Root Cause Analysis The role of the regulator Sandra Mulder, MD Dutch Healthcare Inspectorate Gothenburg, April 15 th 2016,

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Page 1: Involving patients in Root Cause Analysisaws-cdn.internationalforum.bmj.com/pdfs/2016_G7.pdf2016/04/15  · analysis and complaint/financial claim Involving patients in Root Cause

Involving patients in Root Cause

Analysis

The role of the regulator

Sandra Mulder, MD

Dutch Healthcare Inspectorate

Gothenburg, April 15th 2016,

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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

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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

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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

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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

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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

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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

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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

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2013-2015: engaging patients

n = 1700 reports

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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

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2013-2015: informing patients

n = 1700 reports

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[email protected]:@smulder

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Patient involvement in RCA – what canorganisations do

Dr Carla Veldkamp

[email protected]

• Manager of quality and safety, Canisius-Wilhelmina Ziekenhuis

• Chair of Santeon Alert System, Santeon Hospitals

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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

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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

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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

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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

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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?

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Survey: 115 respondents from 20 countries

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Most respondents work at a hospital (83 %)

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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

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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

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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)

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Sharing results of RCA with patients

84 % will share results with the patient/family

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Does your organization have a formally organized support system in place?

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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?

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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

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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.

[email protected]@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