1. THE ORGANISATIONAL CHANGES OF THE EXECUTIVE AGENCY FOR MEDICAL AUDIT BULGARIA Helsinki, 29-30.09.2015

2. Bulgaria Territory: 111 000 km2 Population: 7 202 198 (2014) Ethnic distribution: Bulgarians: 83.0% Turks: 9.0% Roma: 3.0% Others: 6.0%

3. Republic of Bulgaria In south-eastern Europe - part of the Balkan Peninsula Bordered: North Romania East Black sea West Serbia and The former Yugoslav Republic of Macedonia South Greece and Turkey

4. Bulgaria Economic development  GDP (BGN): 82.16 billion leva (2014)  GDP: 42 billion Euros (2014)  GDP per capita: 5 832 Euros (2014)  Health expenditures per capita: 283 Euros (2014)  Health expenditures as % of GDP: 3.98% (2014)

5. Health Population: 7.2 million (2014) Live births: 9.4 per 1,000 population (2014) Crude death rate: 15.1 per 1,000 population (2014) Life expectancy: 74.95 years Males at birth (2013): 71.3 years Females at birth (2013): 78.6 years

6. Executive Agency for Medical Audit (EAMA) Established in January, 2010 with Decree of the Council of Ministers as governmental institution under the MoH’s powerEstablished in January, 2010 with Decree of the Council of Ministers as governmental institution under the MoH’s power The EAMA supervises: all types of healthcare establishments in the countryall types of healthcare establishments in the country the National Health Insurance Fund (NHIF) with its 28 regional officesthe National Health Insurance Fund (NHIF) with its 28 regional offices the voluntary health insurance fundsthe voluntary health insurance funds

7. EAMA – Mission Continuous improvement of health care quality and safety. Constant control and monitoring of health care providers’ activities and also of the activities of compulsory and voluntary health insurance funds and motivates them to continuous improvement of their professionalism

8. EAMA – Vision To stimulate changes in health care in order to guarantee accessof BG’s citizens to health care services of good quality, safety, efficiency and effectiveness To stimulate changes in health care in order to guarantee access of BG’s citizens to health care services of good quality, safety, efficiency and effectiveness

9. EAMA – Values Our Values I nnovations A rrangement M oral O tgovornost (responsibility)

10. EAMA – Strategic Goals To develop a system for total quality management at a national level;To develop a system for total quality management at a national level; To initiate the legislation for quality management; To initiate the legislation for quality management; To avoid the dissemination of corrupt health care practices; To avoid the dissemination of corrupt health care practices; To develop data base in the field of health care quality; To develop data base in the field of health care quality; To develop medical errors’ reporting system; To motivate all health care partners to work for quality improvement of health care services, etc.To motivate all health care partners to work for quality improvement of health care services, etc.

11. EAMA – Staff The number of people working in the organisation – 68 The number of people working in the organisation – 68 4 Specialized and 1 Administrative Directorates 4 Specialized and 1 Administrative Directorates No regional offices No regional offices

12. EAMA Executive Director Deputy DirectorChief Secretary Administrative Directorate Quality Assurance Directorate Insurance & Patients Rights Directorate Medical audit of HC establishments Directorate Medical audit of hospitals Medical audit of out-patient care Insurance Rights Patients Rights Financing & IT Administration & Legislation

13. EAMA – Three stages in the development of the EAMA Ist stage: 2010 – 2013 Ist stage: 2010 – 2013 Q & PS issue; Q Strategy 2010-15; Q analysesQ & PS issue; Q Strategy 2010-15; Q analyses Patients RightsPatients Rights Register of medical errors based on people’s complaintsRegister of medical errors based on people’s complaints Training of staffTraining of staff Collaboration w/ other HC partnersCollaboration w/ other HC partners Open to the publicOpen to the public

14. EAMA – Three stages in the development of the EAMA Administrative structure to the MoHAdministrative structure to the MoH No Q & PS issueNo Q & PS issue No Q analysesNo Q analyses No collaboration w/ other HC partnersNo collaboration w/ other HC partners Limited staff trainingLimited staff training Limited openness to the publicLimited openness to the public IInd stage: 2013 – 2015 IInd stage: 2013 – 2015

15. EAMA – Three stages in the development of the EAMA Q & PS issue; up-date Q Strategy; Q analyses; Q indicatorsQ & PS issue; up-date Q Strategy; Q analyses; Q indicators Patients RightsPatients Rights Medical Errors Reporting System at national level w/ UBGPsMedical Errors Reporting System at national level w/ UBGPs Training of staff & HC professionalsTraining of staff & HC professionals Collaboration w/ other HC partnersCollaboration w/ other HC partners IIId stage: 2015 – IIId stage: 2015 –

16. EAMA – Three stages in the development of the EAMA 2010 – 2013 2013 – 20152015 – Q & PS issue; Q Strategy 2010-15; Q analyses + (Q indicators) Patients Rights + + Register of medical errors based on people’s complaints + Training of staff + (Limited) + & HC professionals (& HC professionals) Collaboration w/ other HC partners + Open to the public + (Limited) +

17. EAMA – Collaboration with HC Partners The EAMA works with the following institutions and partners: Ministry of Health; Ministry of Health; Regional Health Authorities – 28; Regional Health Authorities – 28; NHIF / RHIFs; NHIF / RHIFs; Executive Transplantation Agency; Executive Transplantation Agency; Scientific Societies of Medical Professionals; Scientific Societies of Medical Professionals; Union of BG Physicians / of BG Dentists; Union of BG Physicians / of BG Dentists; Prosecutor’s Office of Bulgaria; Prosecutor’s Office of Bulgaria; National Ombudsman; National Ombudsman; Ministry of Justice; Ministry of Justice; National Social Security Institute; National Social Security Institute; Patients’ Organizations. Patients’ Organizations.

18. EAMA – Q & PS The Role of the EAMA for Q & PS monitoring Developed checklists and inspects the performance of the health care establishments to assess the compliance to the requirements of the medical standards and Health Care Act;Developed checklists and inspects the performance of the health care establishments to assess the compliance to the requirements of the medical standards and Health Care Act; Periodically develops Q analyses related to a specific issue (i.e. AG, children, etc.) with recommendations for improvement;Periodically develops Q analyses related to a specific issue (i.e. AG, children, etc.) with recommendations for improvement; Works with the Scientific Societies of Medical Professionals to implement improvement activities in their domains.Works with the Scientific Societies of Medical Professionals to implement improvement activities in their domains.

19. EAMA – Q & PS The Role of the EAMA for Q & PS monitoring Future activities: To work on development of Medical Errors Reporting System at national level together with the Union of the BG Physicians;To work on development of Medical Errors Reporting System at national level together with the Union of the BG Physicians; To work on development of List of Q & PS Indicators;To work on development of List of Q & PS Indicators; To work on methodology for hospital ranking;To work on methodology for hospital ranking; To organize training and train HC professionals towards Q & PSTo organize training and train HC professionals towards Q & PS

20. EAMA – Organizational good practices Organisational good practices: Legislative initiatives for changes of the legislation towards Q & PS;Legislative initiatives for changes of the legislation towards Q & PS; Very good collaboration with other HC partners; Q improvement initiatives together with the Scientific Societies of Medical Professionals;Q improvement initiatives together with the Scientific Societies of Medical Professionals; Openness to the public and media;Openness to the public and media; Questionnaire on the website for assessment of our clients’ satisfactionQuestionnaire on the website for assessment of our clients’ satisfactionCons: One centralized structure at national level w/o regional officesOne centralized structure at national level w/o regional offices

21. EAMA – Openness to the public and media Publications of Q analyses and annual reports on the website: www.eama.bg;Publications of Q analyses and annual reports on the website: www.eama.bg;www.eama.bg Proactive to the media – flyers, explicative campaigns, press conferences;Proactive to the media – flyers, explicative campaigns, press conferences; Visiting hours to meet inspectors – every Thursday from 1 pm to 4 pm;Visiting hours to meet inspectors – every Thursday from 1 pm to 4 pm; Questionnaire on the website for assessment of our clients’ satisfactionQuestionnaire on the website for assessment of our clients’ satisfaction

22. EAMA – Pros and Cons of the organizational solutions Pros Put the Q & PS issue at the national level;Put the Q & PS issue at the national level; Involves HC partners in Q & PS initiatives;Involves HC partners in Q & PS initiatives; Increases the awareness of the public and media towards Q & PS;Increases the awareness of the public and media towards Q & PS; Legislative initiatives;Legislative initiatives; Increased trustIncreased trust Cons Increased number of complaintsIncreased number of complaints Increased workload of the inspectorsIncreased workload of the inspectors No increase of the human and financial resourcesNo increase of the human and financial resources

23. EAMA – Conclusion The most important result from the EAMA’s activities is that fear and mistrust of the health care professionals from that institution were replaced by gratitude and appreciation because the aim of the EAMA is not punishment but to guarantee access to health care of good quality and safety, protection of patients’ rights and dissemination of good practices. The most important result from the EAMA’s activities is that fear and mistrust of the health care professionals from that institution were replaced by gratitude and appreciation because the aim of the EAMA is not punishment but to guarantee access to health care of good quality and safety, protection of patients’ rights and dissemination of good practices.

24. THANK YOU FOR YOUR ATTENTION www.eama.bg www.eama.bg