P reventing and managing errors and adverse events in ICU

1. Preventing and managing errors and adverse events in ICU Prof Quirino PIACEVOLI From information to action

2. Purposes of reporting An effective reporting system is the corner stone of safe practice and, within a hospital or other health-care organization, a measure of progress towards achieving a safety culture.

3. Why should individuals or health-care organization report adverse events and errors? If the event is reported and the findings from the investigation are entered in to a database, the event can be aggregated with similar incidents to elucidate common underlying causes. A variety of solutions could emerge, ranging from medical and nursing practice standards.

4. Core concepts • fundamental role of patient safety reporting systems is to announce patient safety by learning from failures of the health care system • reporting must be safe. Individuals who report incidences must not be punished or suffer other ill-effects from reporting • reporting is only of value if it leads to a constructive response. • meaningful analysis, learning and dissemination of lessons learned requires expertise and other human and financial resources.

5. Key messages • the primary purpose of patient safety reporting system is to learn from experience • a reporting system must produce a visible, useful response to justify the resources expended and to stimulate reporting • the most important function of reporting system is to use the results of data analysis and investigation to formulate and disseminate recommendations for system change.

6. What is reported • adverse events: is an injury realted to medical management, in contrast to a complication of desease • errors: has been defined as “the failure of a planned action to completed as intended or the use of a wrong plan to achieve an aim • near miss or close call: is a serious error or mishap that has the potential to cause an adverse event, but fails to do so by chance or because it was intercepted • hazards and unsafe condition: is another way to achieve prevention without the need to learn from an injury

7. Safety Assessment Code Matrix PROBABILITY

8. Czech Republic • Type of reporting system:Mandatory and voluntary reporting only for 2 years in 50 hospitals • What is reported: reportable events include nosocomial infections, adverse drug reactions, trasfusion reactions and medical equipment failures • How they report: simple statistics of adverse events

9. Denmark • Type of reporting system:Mandatory (Act on Patient Safety in the Danish Health Care System from January 1th 2004) • What is reported: events resulting from treatment by or stay in a hospital • How they report: to the National database with the identified reports

10. England and Wales • Type of reporting system:the National Reporting and Learning System (NRLS) has been developed by the National Patients Safety Agency (NPSA) to promote an open reporting culture • What is reported: any unintended or unexpected incident that could have or did lead to harm for one or more patients • How they report: to the National database

11. The Netherlands • Type of reporting system:non-punitive, voluntary reporting system for adverse events. A mandatory system also exist for reporting serious adverse events • What is reported: serious adverse events • How they report: by mail, fax or phone

12. Ireland • Type of reporting system:liability under a Clinical Indemnity Scheme (CIS) • What is reported: events arising as consequence of provision of or failure to provide clinical care that results in injury, disease, disability, death, near misses • How they report: to local risk management personnel

13. Slovenia • Type of reporting system:voluntary • What is reported: sentinel events include: unexpected death, major permanent loss of function, suicide, hemolytic transfusion reaction, surgery on a wrong patient or body part • How they report: to the Ministry of Health

14. Sweden • Type of reporting system:mandatory • What is reported: sentinel events include: unexpected death, major permanent loss of function, suicide, hemolytic transfusion reaction, surgery on a wrong patient or body part • How they report: paper format via mail or fax to the National Board of Health and Welfare

15. A DATABASE MANAGEMENT SYSTEM FOR ADVERSE EVENTS: AN ITALIAN EXPERIENCE Results of the run in period (December 1999 to December 2006) Prof. Quirino Piacevoli

16. A national on going project of total quality improvement is underway in several Italian Hospitals since 1999 • Risk Management involving both patients and health care professionals is an important aspect of a total quality concept in order to: • increase the standard of care • improve efficiency in organization • obtain better resource allocation • reduce legal exposure Risk Management Prof. Q. Piacevoli

17. Objective of clinical risk management • To identify major risk factors in Italian Hospitals • To measure their frequency • To identify causes and facilitating conditions • To propose realistic solutions capable of reducing risks Prof. Q. Piacevoli

18. Multicentre research underway in eleven major Italian hospitals since 1999 • Specific potential risks were indentified in a pre-study phase and classified into 6 main categories • An “event declaration report” was created and staff were trained to compile the incident report • At the end of each year all reports were certified by auditors Methodology Prof. Q. Piacevoli

19. Total events classified by main categories Prof. Q. Piacevoli

20. Total events classified by main categories Over 61.518reports were completed in the Italian Hospitals, and a total of70.213 eventswere recorded.68.281 were classified as follows

21. Total events by main category The most frequent category is “inefficiency”; this area offers better margin for improvement with only some minor changes in organizational procedure Prof. Q. Piacevoli

22. Total events of errors/incidents for each macro category Trend from beginning of data collection The three time periods are similar and confirm the adverse events recorded earlier Prof. Q. Piacevoli

23. Total events per department Prof. Q. Piacevoli

24. Total events for each department Prof. Q. Piacevoli

25. Total events for each unit Prof. Q. Piacevoli

26. General surgery, followed by Orthopaedics and Oncology, have the highest number of risk events

27. Liability in Northern Europe

28. Total events in I.C.U. “by main category” 7.101 events in I.C.U.: The most frequent category is still “inefficiency”; multiple causes are identified as 24% system-based and 76% human factor based Prof. Q. Piacevoli

29. Adverse Events: Total data compared with I.C.U. data Prof. Q. Piacevoli

30. Total events breakdown in micro-categories in I.C.U. Prof. Q. Piacevoli

31. Total events breakdown in micro-categories in I.C.U.: Patient With the exception of “adverse drug events” which is difficult to identify even with accurate analysis, all other events can be managed with simple methodology in quality control Prof. Q. Piacevoli

32. Total events breakdown in micro-categories in I.C.U.: Equipment Although corrective factors have a more limited range of action compared to other categories, there is the opportunity to significantly reduce risk. Prof. Q. Piacevoli

33. Total events breakdown in micro-categories in I.C.U.:Equipment The number of events decreases when the complexity of the equipment increases, almost as if the level of staff attention is proportional to complexity Prof. Q. Piacevoli

34. Total events breakdown in micro-categories in I.C.U.:Equipment Prof. Q. Piacevoli

35. Total events breakdown in micro-categories in I.C.U.: Nursing An in depth analysis is necessary in order to further define the “other” category in order to decide follow up. Detailed analysis showed the need for training in manual procedures. Prof. Q. Piacevoli

36. Total events breakdown in micro-categories in I.C.U.: Inefficiency Prof. Q. Piacevoli

37. Total events breakdown in micro-categories in I.C.U.: Inefficiency Through behaviour change and reorganization (especially in procedure schedule) many inefficiencies can be avoided especially where due to poor communication and organization between OR team members. Prof. Q. Piacevoli

38. Total events breakdown in micro-categories in I.C.U.: Airway In the “other” category other specific problems related to the procedure have also been included together with events already included in other categories. Prof. Q. Piacevoli

39. Breakdown per micro category per total events in I.C.U.: Drugs Prof. Q. Piacevoli

40. Breakdown per micro category per total events in I.C.U.: Drugs With minor intervention ie. set rules for writing, colour coded labels and easily accessible guidelines in all departments , it is possible to reduce most of the mistakes belonging to this category. Prof. Q. Piacevoli

41. Risk Events and patient injury Prof. Q. Piacevoli

42. Risk events and patient injury 7.101 adverse events in I.C.U. were recorded for a total of 68.281 events and 61.518 reports, including also multiple injuries; 39,4% of the risk events caused patient injury.

43. Staff involved in risk reporting Prof. Q. Piacevoli

44. Staff involved in risk reporting Nurses, Anaesthetists and Surgeons seem to be most involved in risk events Prof. Q. Piacevoli

45. Total events for each macrocategory for error/ incident and time of shift change for nursing and medical staff Prof. Q. Piacevoli

46. Total events for each macrocategory for error/ incident and time of shift change for nursing and medical staff Shift change Nurses Doctors

47. If you want one year of prosperity, plant corn If you want ten years of prosperity, plant trees If you want 100 years of prosperity, cultivate men Ancient Chinese proverb Prof. Q. PIACEVOLI