1. Healthcare Regulators – Support, Judge, Jury & Executioner? Jan Maarten van den Berg, MD Philippe Michel, MD, PhD

2. Links of interest NONE

3. The problem Data based on the Dutch situation Some operations are so complex that minimal experience is required 10 fold difference in mortality between 1/year and 20/year

4. You commission a report to analyze the problem and give recommendations on changes Dilemma We don’t know how what change: Yes No

5. The Health Care Council published the report on concentrating high risk procedures in 40 hospitals in 1991 Result: no change for 15 years. Yes Go to no(t enough)

6. Add Power: the government should set the minimal requirements: Not enough The problem is not enough power behind the change: Yes No

7. The government set the minimal requirements on valvular implants; The result: 10 > court cases; eventually all lost. All potential hospitals started procedure Yes Go to no(t enough)

8. Do more research! Not enough The problem is not enough evidence!: Yes No

9. Somebody already did: Approximately 6000 articles on volume And used lots of creativity: many different cut of points. Result: More fuel for discussions, unfit for decisions Yes Go to no(t enough)

10. The individual complexity of each operation is crucial Set minimal standards for each operation Yes No

11. Yes Every specialty sets it’s own standards: Result: – Lengthy discussions! (see evidence) – My operation is more complex than yours Race for higher numbers – Large number of variable standards with tendency to regression: Urology – Internal divisions in professional bodies Yes

12. One standard norm (20/year), with exceptions Result: – short discussions – Predictable outcome, anticipation possible – Large number of standards – But are standards followed? No: the critical process is learning of complex procedures

13. Minimum standards are compulsory (that’s why they are minimal) Yes No

14. Yes minimum standards are compulsory Result: – main discussion before acceptation – Gives authority to professional bodies – Encourages implementation – Large break in culture

15. Result: – delay in implementation. Appeal process first. – Inspection becomes arbiter of conflict – Main discussion after implementation – Discussion with small hospitals No: in exceptional circumstances (e.g. distance) a lower number is acceptable

16. First line of controll should be Insurers Government

17. Insurers First step in selective contracts Implementation within 1 (one) year Adhere to professionals standards – (if not see you in court) Involvement of patient bodies – If not suspicion of motives New system of data collection No final decision Insurers

18. Political process Appeal through parliament and courts First line: requires constant focus and manpower Good as second line, always in combination To flexible to serve as first line Government / inspection

19. Implementing standards has visible results Yes No

20. Concentrating Pancreatic resections halves national operative mortality (11 > 5% in 4 years) Concentrating Oesophaguscardia resections halves operative mortality (12 > 3% in 4 years in one region) For 10 interventions 30 day mortality 25% reduction Yes

21. There is no discernible difference in mortality in concentrating high volume /low risk operations. But lack of improvement is excellent indicator – What prevents people from learning? No

22. Summary of Dutch actions Report publication Minimal requirement publication Literature review publication Professional society decisions Minimum standard setting Control 22 Engage professionals and hospitals Bring evidence Involve professional societies Regulate Control objectives Action

23. Professional or administrative regulation? Solutions that are envisaged today may not apply tomorrow Changes start at the local level and depend on professional engagement Local improvement needs to link – the quality dimensions of efficacy, safety and access – to the patient’s pathway Now evidence that patient centeredness and involvement improve outcomes 23

24. 24 Designing safer health care through responsive regulation Healy J, Braithwaite J MJA 2006; 184: S56–S59

25. 25 National report Minimal requirements Minimum standard compulsory Prof societies defining their own requirements Literature review Control

26. Any missing initiatives you would advise Holland to do???

27. “Enforced self-regulation is often more promising than a “command and control” strategy. Research evidence on the responsive regulatory pyramid and its options offers lessons for health care policy makers and managers. Start at the base of the regulatory pyramid: try persuasion first; move up the pyramid to secure compliance, and then be willing to move back down. 27 Designing safer health care through responsive regulation Healy J, Braithwaite J MJA 2006; 184: S56–S59

28. Dilemma the problem is awareness: Publishing data on differences in mortality is enough? Yes No

29. The Amsterdam Academic Medical Centre (AMC) Published the result and published the change after publication in a number of leading dutch magazines: Change: 0 Go to no(t enough) Yes

30. Not enough There is evidence for a perfect cut off point The problem is the wrong concept: Yes No

31. Cut off points are an artifact out of the field of epidemiology Divide population in two groups and find a difference: The cut off point is the desciptor of the division, not the cause Yes insufficient perfect 5 per year

32. No: gradual change The limit is a policy decision! Mortality Numbers / year

33. In terms of conclusion… Policy reports change little Professional bodies should set the standard Enough research has to be be done The decision is political with professional bodies involvement A general standard is preferable Minimal standards are really minimal Insurers first line, inspection/regulator second Results can be spectacular for the right topics Administrative and professional regulation hand-in-hand … and don’t forget separate evaluation and decision bodies