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