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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 System in Transfusion Medicine “To Err is Human “ Institute of Medicine Report 1999

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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


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“To Err is Human “Institute of Medicine Report1999

  • Identify and learn from errors through reporting systems — both mandatory and voluntary.


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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


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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


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Ubiquitous Calls for Reporting Systems

  • Kennedy bill

  • IOM report

  • JCAHO

  • 15 States and counting

    • Illinois


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Types of Events

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


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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


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Misadventures

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


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No Harm Events

The event actually occurred but no harmwas done.


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Near Miss Events

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


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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


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Recovery — planned or unplanned

Study of recovery actions is valuable.

  • Planned recovery

    • built into our processes

  • Unplanned recovery

    • lucky catches


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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


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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. ...


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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


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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


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Types of Errors

  • Active Errors

    • Skill based

    • Rule based

    • Knowledge based

  • Latent Errors (conditions or failures)

    • Technical

    • Organizational

  • Other (patient/donor related and “other”)


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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


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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


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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


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Types of Errors

  • Active Errors

    • Skill based

    • Rule based

    • Knowledge based

  • Latent Errors (conditions or failures)

    • Technical

    • Organizational

  • Other (patient/donor related and “other”)


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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)


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The Titanic — a Disaster

waiting to happen ...


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Titanic Latent Conditions

  • Inadequate number of lifeboats


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Titanic Latent Conditions

  • No transverse overheads on water tight bulkheads


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Titanic Latent Conditions

  • No shake down cruise to train crew


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Titanic Latent Conditions

  • No training for officers on handling of large single rudder ships


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Titanic Latent Conditions

  • Only one radio channel


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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


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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


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Relationship of DSL to ESL

Risk

DSL

ESL

Information


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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


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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


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Just Culture:A Delicate Balancing Act

Voluntary

Reporting

Discipline

Open

Communication

Professional

Accountability


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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



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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


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Investigation

A Transfusion Error (labeling)


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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).


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A Labeling Error

Xerox of blood unit labels

Front of unit

Back of Unit


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Failure: Labeling Sequence

  • “Labels for each bag are to be separated by tearing at marked brackets...”


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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


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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


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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


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Organizational (Latent)

Organizational

  • OEX External

  • OK Transfer of Knowledge

  • OP Protocols

  • OM Management Priorities

  • OC Culture


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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


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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



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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


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Severity Level & Causes

Severity Level 2

Severity Level 1

Severity Level 3


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Distribution of Causes

Petrochemical Processing Plant

Transfusion

n = 563

n = 1,238


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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


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MERS-TM WEB Site

www.mers-tm.net