Event Reporting and Patient Safety:

1. Event Reporting and Patient Safety: You Can’t fix it If You Don’t Know About it! Harold S. Kaplan MD Columbia University hsk18@columbia.edu Supported by an NHLBI RO1 Grant for Event Reporting Systemin Transfusion Medicine

2. “To Err is Human “Institute of Medicine Report1999 • Identify and learn from errors through reporting systems — both mandatory and voluntary.

3. Congressional Action • Senate Bill 2038 - Medical Error Reduction Act of 2000 • Senate Bill 2378 - Stop All Frequent Errors (SAFE) • Patient Safety Improvement Act -(Kennedy) Voluntary, non-punitive environment to share safety information without fear of reprisal

4. Interest in Other Countries • Great Britain- An Organization with a Memory • Report of the chief medical officer on learning from adverse events in the National Health Service • Australia - The Quality in Australian Heath Care Study

5. Ubiquitous Calls for Reporting Systems • Kennedy bill • IOM report • JCAHO • 15 States and counting • Illinois

6. Types of Events MERS-TM is designed to capture all types of events.

7. Heinreich’s Ratio1 It has been proposed that reporting systems could be evaluated on the proportion of minor to more serious incidents reported 2 • 1 Major injury • 29 Minor injuries • 300 No-injury accidents 1 29 300 1. Heinreich HW Industrial Accident Prevention, NY And London 1941 2. An Organization With a Memory, A report of an expert group on learning from adverse events in the NHS chaired by the Chief Medical Officer, The Stationary Office, London 2000

8. Misadventures The event actually happened and some levelof harm — possibly death — occurred.

9. No Harm Events The event actually occurred but no harmwas done.

10. Near Miss Events The potential for harm may have been present, but unwanted consequences were preventedbecause somerecovery actionwas taken.

11. Misadventure Return to Normal Technical Failure Near Miss Yes Adequate Defenses? Human Error Dangerous Situation Yes No Adequate Recovery? Developing Incident Organizational Failure No Van der Schaaf’s Incident Causation Model

12. Recovery — planned or unplanned Study of recovery actions is valuable. • Planned recovery • built into our processes • Unplanned recovery • lucky catches

13. Six-Year Old Killed by Flying O2 Cylinder in MRI Suite • A Unique “one-off” event? • VA experience • FDA and other reports • Near misses unlikely to be reported

14. Near Misses Or No Harm Events With MRI • When workers dismantled an MRI machine recently at the University of Texas, they discovered dozens of pens, paper clips, keys and other metal objects clustered inside. ...

15. Purpose of an Event Reporting System • Useful data base to study system’s failure points • Many more near misses than actual bad events • Source of data to study human recovery • Dynamic means of understanding system operations

16. Types of Errors • Active— are errors committed by those in direct contact with the human-system interface (human error) • Latent—are the delayed consequences of technical and organizational actions and decisions

17. Types of Errors  • Active Errors • Skill based • Rule based • Knowledge based • Latent Errors (conditions or failures) • Technical • Organizational • Other (patient/donor related and “other”)

18. Skill-based Error Failure in the performance of a routine task that normally requires little conscious effort Example — locking your keys in the car because you’re distracted by someone calling your name

19. Rule-based Error Failure to carry out a procedure or protocol correctly or choosing the wrong rule Example — not waiting your turn at a 4-way stop sign

20. Knowledge-based Error Failure to know what to do in a new situation (problem solving at conscious level) Example —not knowing what to do when the traffic light is out

21. Types of Errors • Active Errors • Skill based • Rule based • Knowledge based • Latent Errors (conditions or failures) • Technical • Organizational • Other (patient/donor related and “other”) 

22. Technical Problems with physical items such as equipment, software, or paper-based material Example — design flaw in software Organizational Problems resulting from organizational elements — culture, procedures, leadership decisions Example — unclear procedure Latent Errors (conditions or failures)

23. The Titanic — a Disaster waiting to happen ...

24. Titanic Latent Conditions • Inadequate number of lifeboats

25. Titanic Latent Conditions • No transverse overheads on water tight bulkheads

26. Titanic Latent Conditions • No shake down cruise to train crew

27. Titanic Latent Conditions • No training for officers on handling of large single rudder ships

28. Titanic Latent Conditions • Only one radio channel

29. Active Error Event Latent Conditions Events Happen When: Blunt end actions and decisions — latent underlying conditions + Sharp end actions and decisions — active human failure = Event

30. The Iceberg Model In Transfusion • 1/2,000,000 fatalities • 1/30,000 ABO incompatible txns • 1/12,000 incorrect units transfused 1/2000,000 1/30,000 1/12,000 Near-Miss Events

31. Relationship of DSL to ESL Risk DSL ESL Information

32. Report rate 1990-1995 > 3X increase Severe/high risk - 1-6/93 to 1-6/95 2/3 decrease Experience With ASRs of BASIS DSL INFO ESL RISK

33. Lessons Learned From Aviation 5 Factors Determine Quantity/ Quality of Incident Reports • Indemnity • Confidentiality • Separate from regulator • Feedback • Ease Feeling of Trust Motivation Reason J

34. Just Culture:A Delicate Balancing Act Voluntary Reporting Discipline Open Communication Professional Accountability

35. How Just Culture is Different • Acknowledges that mistakes (human errors) do not equal intent to harm • Applies reckless conduct standard • Disciplines individuals whoknowingly put patient’s safetyat risk

36. Transfusion Medicine Event Report Rate Orientation

37. Causal Tree Event Failure side Recovery side and Primary action or decision Primary action or decision Primary recovery action to stop adverse outcome Antecedents and and Antecedent recovery action Antecedent recovery action Root Cause Root Cause Root Cause Codes

38. Investigation A Transfusion Error (labeling)

39. A Transfusion Error (labeling) • Medical Technologist on the 2nd shift was releasing blood units from quarantine to inventory noticed an out-of-sequence transfer label numbered on a unit of red blood cells (rbc).

40. A Labeling Error Xerox of blood unit labels Front of unit Back of Unit

41. Failure: Labeling Sequence • “Labels for each bag are to be separated by tearing at marked brackets...”

42. Causal Tree Unit of RBC almost released with out-of-sequence transfer label # Failure side Recovery side and Labeling inadequately checked Phlebotomist tore label in wrong place Unit isolated until label corrected and and Inadequate SOP for checking label Label: poor markings Label provided poor feedback 2nd shift Tech. saw label error Notified supervisor

43. Classification & Description • Use Eindhoven Classification Model Medical Version for root cause coding • 20 codes divided into • Latent (Technical, Organizational) • Human Factors • Other • Aim for 3-7 root cause codes for each event, a mixture of active and latent

44. 20 codes divided in: Technical Factors Organizational Factors Eindhoven Classification System • Human Factors • Knowledge Based • Rule Based • Skill Based • Other Factors • Patient Related Factors • Unclassifiable

45. Organizational (Latent) Organizational • OEX External • OK Transfer of Knowledge • OP Protocols • OM Management Priorities • OC Culture

46. Technical Factor? Technical codes Yes No Organizational Factor? Organizational codes Yes No Human codes Human Behavior? Yes No Patient/Donor Related or Unclassifiable • First Question • Second Question • Third Question

47. Causal Tree Unit of RBC almost released with out-of-sequence transfer label # Failure side Recovery side and Labeling inadequately checked Phlebotomist tore label in wrong place Unit isolated until label corrected and and Inadequate SOP for checking label Label: poor markings Label provided poor feedback 2nd shift Tech. saw label error Notified supervisor OP TD TD HSS

48. Correction of Label Error

49. Event Severity Level (ESL)Actual or Potential Level of Harm • Level 1 ((High) • Fatal outcome or serious injury • Level 2 (Medium) • Minor, transient injury • Level 3 (Low) • No ill effects, no harm

50. Severity Level & Causes Severity Level 2 Severity Level 1 Severity Level 3