national project prior to legislation
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Legislation and the establishment of an open and learning culture in health care
Henning Boje Andersen1 and Niels Hermann2
1Risø National Laboratory, Roskilde, Denmark
2 National Board of Health, Copenhagen, Denmark
Annual Conference of the Society for Risk Analysis - Europe:INNOVATION AND TECHNICAL PROGRESS: BENEFIT WITHOUT RISK?
11-13 September 2006, Ljubljana, Slovenia
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National project prior to legislationNationally funded project 2001-02:• Focus group interviews with doctors and nurses • Questionnaire survey • Overview of international literature on reporting
systems in medicine and other domains • Recommendations for a reporting system at the
national level and local levels
Prooject partners: DSI Institute of Health Care; Danish Inst. of Medical Simulation, Herlev Hospital; Risø National Lab., Denmark
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Project background & impactBackground:
Rise in awareness in DK about patient safety in 2000/2001
Project received support from:The Danish Ministry of the Interior and Health and County of Copenhagen
Impact: Project recommandation have been incorporated in the proposal for a new law in Denmark about adverse incident reporting and the support of learning systems
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Survey: Data collection (1:2)Doctors and nurses employed in all hospitals in
4 Danish Counties,Jan.- Feb. 2002Respondents recruited from
• University Hospitals of Copenhagen County (about 1/3) • All General Hospitals in 3 counties (nearly 2/3)
Major specialties included - distinguishable in data:• Anaesthesiology• Internal medicine• Orthopedic surgery• General surgery• Gynecology
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Survey: Data collection (2:2)
Number of questionnaires
Response rateDistributed Received
Actual scanned sample
Doctors 1537 711 703 46%
Nurses 2482 1320 1305 53%
Total 4019 2031 2008 51%
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The survey instrument: Adverse Events Questionnaire (AEQ)
1. Four casesUK case about disclosure to the pt; a near-miss incidenta mild outcome incident; and a severe outcome event
2. Models of reporting 3. Reasons for not reporting4. Patients’ requirements5. Reactions (pos/neg) towards staff from leaders 6. Attitudes to errors and factors impacting on
safety
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Three Models of Reporting
• Anonymity: reporter not known to anyone else – written, unsigned report
• Strict confidentiality: reporter known only to person(s) appointed as ”receiver”
• Limited confidentiality: identity of reporter known only to ”receiver”, but revealed to authorities if event involves ”gross negligence” or a crime
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ModelDegree of disclosure
Possibility of addtional
information about event
Possibility of feedback to
reporter
Anonymity: reporter not known
Name/identity unknown to everyone else
No additional information due to anonymity
No feedback due to anonymity
Strict confidentiality: reporter known only to ”receiver”
”Receiver” may not communicate name
Additional information possible
Personal feedback possible
Limited confidentiality: identity revealed if ”gross negligence”
”Receiver” may/must give away name/ID in ”severe” cases
Additional information possible
Personal feedback possible
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Which of the three models do you prefer? (p<0.001, Chi2)
18%
44%
34%
5%9%
38%
47%
7%
Anonymous Strictly confidential Limited confidential Don't know
Doctor (N=687) Nurse (N=1283)
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What would you prefer w.r.t. disclosure of the name of the dept./ward? (p<0.001, Chi2)48%
37%
15%
42%
34%
25%
The name of the ward/dept. ismade known
The name of the ward/dept. isnot made known
Don’t know
Doctor (N=684) Nurse (N=1284)
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(11) Do you wish the "recipient" to belong to your own profession? (p<0.001, Chi2)
89%
1%
10%
70%
3%
27%
Yes No Not important
Doctor (N=686) Nurse (N=1270)
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(12) Who should be the “recipient” and provide feedback to the reporting health care staff member? (p<<0.001, Chi2)
26%29%
15%
23%
39%
13%
21% 19%
My leader Appointed person in mydept./ward
Appointed person in myhospital
Appointed personindependent of the
hospital
Doctor (N=640) Nurse (N=1181)
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(13) Which of the reporting regimes would you prefer? (p<0.004, Chi2)
7%
66%
2%
25%
12%
61%
2%
25%
Only mandatory Mandatory +discretionary
Only discretionary Discretionary + guideline
Doctor (N=665) Nurse (N=1283)
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Reasons for not reporting (1:2)• We have no tradition in my department for bringing up
adverse events/errors• When I am busy I forget to bring up adverse
events/errors • The patient may file a complaint• I don’t know who is responsible for bringing up
adverse events/errors• I might get a reprimand• It might have consequences for my future
employment or career• It wouldn’t help the patients that I bring up my own
events/errors
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Reasons for not reporting (2:2)• It might get out and the press might start writing about it• The adverse event/error may become reported to the
medical licensing board• It is too cumbersome to bring up adverse events/errors• One does not feel confident about bringing up adverse
events/errors in our department• I do not wish to appear as an incompetent doctor [nurse]
• Bringing up adverse events/errors is not going to lead to any improvement in our ward/dept.
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Possible reasons for not bringing up adverse events/ errorsDoctors' response - ranked by mean response
56
44
46
37
42
39
38
38
35
36
31
25
27
26
26
24
25
19
21
22
20
23
20
17
23
18
6
12
10
13
9
12
14
14
13
12
15
11
15
9
10
17
15
20
17
17
21
20
21
26
28
24
2
4
2
7
7
8
7
5
7
10
10
11
13
0% 25% 50% 75% 100%
(g) Won't help the patients
(m) Won't lead to any improvementshere
(b) I forget it when I am busy
(k) Am not trustful about this in ourdept.
(c) The patient may file a complaint
(d) Don't know who is responsible forthis
(i) It may be reported to med. licensingboard
(j) It is too cumbersome
(f) Might have impacts on my career
(e) I might get a reprimand
(l) May appear as a poor doctor/nurse
(a) No tradition in my dept. for this
(h) The press might start writing aboutit
Disagree strongly Disagree Neutral Agree Agree strongly
1
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"The thought that I may make a mistake that may injure a patient seriously makes me consider changing my work" - How often?
doctors: p<<0,001 (Kruskal-Wallis). Nurses: p<0,012 (Mann-Whitney)
73%
57%
73%
64%
20%24%
38%
26%
33%
1% 2%5%
1%3%
Consultant Senior resident Resident Senior nurse Other nurseNever Now and then Often/very often
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The project group’s recommendations:
1. strictly confidential reporting 2. name/identity not disclosed outside the ward /
department 3. sharp distinction between disciplinary and
learning functions of reporting 4. mandatory reporting of critical events 5. in addition, discretionary reporting to be
encouraged6. reporting made locally, enabling dialogue with
and feedback to the reporting staff 7. data transmitted in an anomymous format into
a national database of adverse events
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Project results and Legislation • Main finding: A definite willingness to report adverse events into some type
of confidential system • At the time of the survey, no system to receive event reports for learning
and patient safety• Recommendations incorporated into Danish Patient Safety Act (January
2004): – personnel are required to report– personnel may not be subjected to investigation or disciplinary action on the basis of
reporting– reporting is confidential or anonymous as chosen by reporting health care staff
member
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Does the legislation and its implementation live up to expectations?
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Increasing number of reports received during the first two years of operation
0
500
1000
1500
2000
2500
3000
3500
1 2 3 4 5 6 7 8
2004 - 2005: quarters Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2004 2005
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Safety Assessment Codes (SAC scores)[Veterans Health Administation]
Severity/ Probability
Cata-strophic
MajorMode-rate
Minor
Frequent 3 3 2 1
Occasional 3 2 1 1
Uncommon 3 2 1 1
Remote 3 2 1 1
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Distribution of SAC scores on 9096 reports received in 2005
3 %
17 %
76 %
4 %
SAC 1
SAC 2
SAC 3
no score
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Local prevention measures
Proposals for prevention based on the 9096 reported incidents in 2005
Type of incident Hospital proposals
County proposals National proposals
Medication 248 6 5 Surgical and invasive procedures
63 0 3
Other serious incident 326 4 2 TOTAL 637 10 10
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How does the new system perform?
• Receives very large number of reports
• Considerable activity at local and regional levels – though varying across counties
• National intiatives especially via the Danish Patient Safety Society
• Feedback and alerts primarily from local/regional level
• Next step: extension to health sector outside hospitals