1. Patient Safety: state of art and perspectives in Italy Carlo Liva Dpt Quality & Accreditation Rome - Italy

2. National Agency for Regional Health Systems National Agency for Regional Health Systems The ASSR - National Agency for Regional Health Care Systems, founded in 1995 by a National Decree, provides support to National and Regional Health Services by: Analysing quality, effectiveness and efficiency of services offered to the public Promoting innovation in health care Performing research projects aimed at analysing/comparing the different regional health care systems. Regions can give their advice for nominating Assrs Chair, Management Board and Director, but the ultimate word is by the National Ministry of Health

3. Quick worsening of the problem Medical errors always existed, but in the last 5 years, the situation took a turn for the worse: - Patient-physician relationship has changed - Health expectations (quantity and quality) increased - Scientific literature reports about high number of deaths due to medical errors - Rapid increase of insurance costs

4. 2004 – Situation for Insurance Companies Association Costs for Insurance Companies 413 millions euros Requests2,5 billions euros Lawsuits12.000 Patients involved320.000

5. Inabitans: 1.180.000. Actual cost for insurance in Regional Health System is about 15 millions euros (12 in 2003) ARSARS

6. Situation of Complaints for Citizens Organisations Situation of Complaints for Citizens Organisations (source: Cittadinanzattiva) 3,03,1Neurology 4,82,5Cardiosurgery 4,97,1Cardiology 5,53,5Dentistry 8,25,5Oculistics 12,013,8Gen. Surgery 13,210,1Gynaecology 13,310,1Oncology 18,518,2Orthopaedy 20041999

7. National Groups National Ministry of Healths Special Committee ASSRs Research project Regional Ministries of Healths Committee on Clinical Risk Management (RM)

8. National activities 2003: National Ministry of Health Committee on Clinical Risk 2004: first paper - classification of errors - methods for risk analysis - clinical risk management - technical papers on sectorial risk 2006: monitoring sentinel events

9. ASSRs Research on Risk Management Promotion of innovation and risk management (2005-2007) University of Turin University of Rome (Tor Vergata) Gutenberg (Private Co.) 10 Regions: Toscana Emilia Romagna Veneto Campania Friuli Venezia Giulia Lombardia Puglia Piemonte Abruzzo Lazio

10. Main objectives of research Consensus on classification and management of adverse events Models for identification and analysis of adverse events Analysis of existing organizational models To test and spread good practicies

11. Regional activities Regional activities (1) Most Regions are taking measures to deal with patients safety problems in health organizations. Their main objectives are to: 1. Reduce or stabilize lawsuits and costs for insurance 2. Improve quality of services related to safety Programs are managed at different levels: At a macro level: In 4 Regions by Regional Agencies for Health Services (Emilia, Veneto, Friuli, Piemonte) In 2 by Special Units of Regional Ministry of Health (Toscana, Campania). At a meso level: In others by Local Health Trust or Hospital level A National Committees survey has shown that in 86% of hospitals there are activities on risk management, usually within Quality Units/Office

12. LOMBARDIA: In 2004 a Regional Act on risk management was issued; Regional database for adverse events. Regional Guide lines on risk management In every hospital: person in charge for risk management, risk management team in each departments, committee for adverse events assessment, maps of risks EMILIA-ROMAGNA: Clinical Risk is managed within the regional quality system and it is widespread and well organized A regional system for Incident Reporting (IR) was implemented in high risk departments Use of FMEA & FMECA Educational Campaigns VENETO: RM in regional accreditation program, with guidelines IR system Use of HDR for safety indicators and to track adverse events FRIULI-VENEZIA GIULIA Regional Risk Management Programs IR use of HDR for safety indicators Specific campaigns (use of complaints, use of drugs, trasfusion etc.) Regional activities Regional activities (2)

13. Tuscany Clinical Risk Management System Each Hospital has: A Clinical Risk Manager A CRManagement Working Group A Patient Safety Committee Facilitators in each departments for developing M&M review and Clinical Audit Collaboration with forensic medical doctors and administrators for assessing litigations

14. A L E T Pi L Pu C V F Regions Activities in Regions

15. Some of research projects on Quality Indicators ASSRs Researches on indicators ASSRs Researches on indicators Hospital Performance (2003) Ambulatory and Primary Care (2004) Record Linkage (2005) Continuity of Care (2006)

16. Two levels of Analysis First Level Indicators (outcome) Medical Record Evaluation Evaluation Second Level Indicators (process) (process) Quality of Medical Records Medical RecordsHDR

18. The numbers of the research 708 Outcome (discharge status) 8.737 Quality of Medical Records 687 Diagnosis and proc. validation 8.923 Process indicators Medical Records 100.000(DQE) 6.682.181HDR Quality control on ICD9CM coding Records2002

19. Implementation problems with Safety Indicators In Italy hospital discharge records do not use E Codes, thus two indicators cannot be used In Italy hospital discharge records do not use E Codes, thus two indicators cannot be used Coding style and awareness of adverse effects heavily affect a second group of indicators, which are useful only if a Risk Management System has been implemented Coding style and awareness of adverse effects heavily affect a second group of indicators, which are useful only if a Risk Management System has been implemented A third class of indicators (Mortality in low mortality DRGs and Failure to rescue) have been proved to be very useful at the present stage of development of the informative system A third class of indicators (Mortality in low mortality DRGs and Failure to rescue) have been proved to be very useful at the present stage of development of the informative system

20. How to use Safety Indicators The size of occurence of Failure to rescue or Mortality in low mortality DRGs makes every case to be treated as a sentinel event The size of occurence of Failure to rescue or Mortality in low mortality DRGs makes every case to be treated as a sentinel event No statistical rate is reported No statistical rate is reported Risk adjustment is not used for comparative purposes: variability of secondary diagnoses coding and outcome classification bias can produce misleading adjusted rates estimates Risk adjustment is not used for comparative purposes: variability of secondary diagnoses coding and outcome classification bias can produce misleading adjusted rates estimates A high proportion of coding errors was discovered in Failure to rescue and Mortality in low mortality DRGs: these indicators have high sensitivity and low specificity A high proportion of coding errors was discovered in Failure to rescue and Mortality in low mortality DRGs: these indicators have high sensitivity and low specificity

21. Most safety indicators are useful if a risk management system has been implemented Most safety indicators are useful if a risk management system has been implemented Two safety indicators (Failure to rescue and Mortality in low mortality DRGs) have shown to be provisionally useful, that is at the present stage of informative system development Two safety indicators (Failure to rescue and Mortality in low mortality DRGs) have shown to be provisionally useful, that is at the present stage of informative system development Risk adjustment can be used in order to estimate the difference between expected rate and the occurrence of the event, not to adjust the rate Risk adjustment can be used in order to estimate the difference between expected rate and the occurrence of the event, not to adjust the rate Conclusion about Safety Indicators

24. Thank you for your attention