1. Legislation and the establishment of an open and learning culture in health care Henning Boje Andersen 1 and Niels Hermann 2 1 Risø 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

2. 2 National project prior to legislation Nationally 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

3. 3 Project background & impact Background: 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

4. 4 Survey: Data collection (1:2) Doctors and nurses employed in all hospitals in 4 Danish Counties,Jan.- Feb. 2002 Respondents 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

5. 5 Survey: Data collection (2:2) Number of questionnaires Response rate DistributedReceived Actual scanned sample Doctors153771170346% Nurses24821320130553% Total40192031200851%

6. 6 The survey instrument: Adverse Events Questionnaire (AEQ) 1.Four cases UK case about disclosure to the pt; a near-miss incident a mild outcome incident; and a severe outcome event 2.Models of reporting 3.Reasons for not reporting 4.Patients’ requirements 5.Reactions (pos/neg) towards staff from leaders 6.Attitudes to errors and factors impacting on safety

7. 7 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

8. 8 Model Degree 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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14. 14 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

15. 15 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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18. 18 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 encouraged 6.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

19. 19 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

20. 20 Does the legislation and its implementation live up to expectations?

21. 21 Increasing number of reports received during the first two years of operation Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2004 2005

22. 22 Safety Assessment Codes (SAC scores) [Veterans Health Administation] Severity/ Probability Cata- strophic Major Mode- rate Minor Frequent3321 Occasional3211 Uncommon3211 Remote3211

23. 23 Distribution of SAC scores on 9096 reports received in 2005

24. 24 Local prevention measures

25. 25 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