Event Reporting and Patient Safety:

1
Event Reporting and Patient Safety

• You Cant fix it If You Dont Know About it!

Harold S. Kaplan MD Columbia University hsk18_at_colu
mbia.edu
Supported by an NHLBI RO1 Grant for Event
Reporting System in 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
Heinreichs 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
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 Schaafs 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 systems 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 youre 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
Latent Errors (conditions or failures)

• 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

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
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
Experience With ASRs of BASIS

• Report rate
• 1990-1995
• gt 3X increase
• Severe/high risk - 1-6/93 to 1-6/95
• 2/3 decrease

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 CultureA 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
  patients safetyat risk

36
Transfusion Medicine Event Report Rate
Orientation
37
Causal Tree
Event
Failure side
Recovery side
and
Primary recovery action to stop adverse outcome
Primary action or decision
Primary action or decision
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
Unit isolated until label corrected
Labeling inadequately checked
Phlebotomist tore label in wrong place
and
and
Label poor markings
2nd shift Tech. saw label error
Notified supervisor
Inadequate SOP for checking label
Label provided poor feedback
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
Eindhoven Classification System

• 20 codes divided in
• Technical Factors
• Organizational Factors

• 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

• 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
Unit isolated until label corrected
Labeling inadequately checked
Phlebotomist tore label in wrong place
and
and
Label poor markings
2nd shift Tech. saw label error
Notified supervisor
Inadequate SOP for checking label
Label provided poor feedback
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
51
Distribution of Causes
Petrochemical Processing Plant
Transfusion
n 563
n 1,238
52
3 Major Applications of Event Reporting Systems

• Modeling - New unique events
• Monitoring - Event
• Type - identifies weak points of system
• Cause - guides choice of corrective action
• Mindfulness
• Awareness of hazards
• Active engagement, Ownership
• Feedback
• Effect on safety culture

T. van derSchaaf
53
MERS-TM WEB Site
www.mers-tm.net