1. Anne Mette Dons, MD Head of Department Supervision and Patient Safety
The Danish Health and Medicines Agency - also a supervisory organisation 
Anne Mette Dons, MD
Head of Department
Supervision and Patient Safety

2. The Danish Population 5.4 million inhabitants
1 million younger than17 years
1 million over 60 years
5 regions and
98 municipalities

3. Structure and roles Ministry of Health and Prevention
Political prioritisation, financial frame, legislation
The Danish Health and Medicines Agency
The health professional knowledge. The highest health authority. Delivers Independent Advise and Supervision. Monitoring health Care. Regulation and approval of drugs and medical devices
The Regions
Run the Hospitals, psychiatry, GP’s and specialised healthcare
The Municipalities
Prevention, rehabilitation, nursing and dependency treatment

4. The Danish Health and Medicines Agency
Established in 2012
Merging
National Board of Health and The Danish Medicines Agency
National Board of Health was established in 1909

5. Health sector and Health personnel
The new Agency covers many areas
We cover:
The Health Care Sector
Health Care Personnel

6. We are One central department Three regional departments
Supervision and Patient Safety
Three regional departments
Regional Public Health Medical Officers
East
North
South
9th of February

7. Main obligations of The National Board of Health (The Health Act)
Surveillance
Counseling
Supervision
§ 2 Overvågning Følge sundhedsforholdene
Jf. Professor Lars Nordskov Nielsen i boneloc-sagen
Tilsynsforpligtigelsen:
indhente oplysninger
foretage undersøgelser, herunder inspektioner
Orientere vedkommende myndighed ved mangler/overtrædelser
forudsætter et aktivt tilsyn
Interventionstilsynet bygger på professor Lars Nordskov’s fortolkning af centralstyrelseslovens § 2 -
§ 3 Rådgivning Yder rådgivning og anden bistand i sundhedsfaglige spørgsmål til offentlige myndigheder
§ 4 Tilsyn Tilsyn med enkelt personers sundhedsfaglige virksomhed
Individorienteret
Baseret på det personlige ansvar jf. aut. lovene
Reaktionstilsyn
Forudsætter hændelser før reaktion

8. Other institutions in Patient Safety/rights
National Agency
for Patients'
Rights and Complaints
The Patient
Insurance
Association
Forskellige forslag til ændringer:
Lægeforeningen
Sundhedsministeriet
lagt på is til efteråret

9. IKAS – the Danish Health Care Quality Programme
An accreditation programme since 2005
So far hospitals, pre-hospital care, pharmacists
A collaboration between the Central government and the Danish regions
Governed by Board
the Danish Health and Medicines Authority,
the Ministry of Health, the Danish Regions,
LGDK (Local Government Denmark),
the Danish Organisation of Private Hospitals
the Association of Danish Pharmacies.

10. Only incidence reports Means
Supervision from
Only incidence reports
Almost only with focus on malpractice
Means
Revocation of authorisation due to illness, abuse or severe malpractice (danger for patients)
Limitation of the prescription right
Issuing of Statutory Orders and Binding Guidelines
Fratagelse af ordinationsret

11. Now - The Whole Bunch…
Risk Areas
Risk Organisations
Risk personnel

12. How did we get there? The PRESS
Almost all changes in legislation came after a scandal

13. What did we get?
A clear range of sanctions from “intensified supervision” to revocation of authorisation of the individual health personnel ( )
Inspection of nursery homes (2002)
Inspection of cosmetic treatment clinics (2008)
Inspection of clinics or hospitals where doctors perform private medical treatments (2012)
Sanctions to boards: Injunction as to which patient safety requirements the board has to comply with. DHMA can temporarily suspend the practice in whole or in part.

14. Risk Personnel - Malpractice
DHMA decides if there is to be an investigation
Can be on the basis of complaints
Often in writing, response is mandatory
Un-announced inspection possible
Publication of all sanctions on the web site

15. Risk organisation
Is the incident due to the organisation and not the individual?
Working conditions
Local manuals
Collaboration within the hospital

16. Risk Areas – Focused inspections
Yearly subjects, chosen from complaints, insurance, incidents, adverse events
Examples
Patients rights, Safe medication, documentation in medical records, use of antipsychotic medicine

17. Risk areas - examples Identification of patients Resuscitation
Constraint in psychiatry
Mammography
Imaging
Psycho-pharmacological treatment
Treatment of substance abuse 17

18. Information National Board of Health Supervision Sundhedsstyrelsen
National Agency
for Patients'
Rights and Complaints
The Patient Insurance Association
Health Personnel
Adverse events
Dentist complaint system
National patient diagnoses and treatment registrar
The scientific societies
The Accreditation programme (IKAS)
The Press
Surveillance
National Board
of Health
Supervision
Sundhedsstyrelsen
Guidance
Supervision .

19. Quality and supervision
Good Quality
Acceptable medical standard
Supervision
Bad Quality

20. Challenges or miss-match
Speed
Muscles
Action
Is it possible to meet all expectations in a time with financial cuts?

21. The first changes
In 2007 the Public Health Medical Officers merged with the DHMA
15 institutions  5 departments in DHMA
Still separate electronic filing system
Transfer of cases between departments
2010 Project “active supervision”

22. Changes in Supervision 2011
More action and no duplication of work processes
Regional departments are always first instance in the handling of an incidence or inspection
Two coordinating work-groups with people from both the central and the regional departments
Use of new technology e.g. common filing system and video conferences
Goal: to strengthen patient safety, enhance quality and uniform processes and incident handling

23. Right now Task Force since 1 June 2013 Weekly meeting
Employees from the Central Department and the Regional Department
To ensure rapid progress
Emphasis on action plan in all cases
The Central Department has the coordinating responsibility
New clear performance targets

24. How do we meet the challenge?
Focusing the supervision within the legislative measures
Be open about what we can not do within our financial frame?