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    Patient Safety Analysis Training:

    A DoD/AHRQ Partnership

    Module 1:Introduction to Patient Safety Analysis

    and Event Management

    Harold S. Kaplan

    Barbara Rabin Fastman

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    Module Outline

    Medical ErrorGrowing concerns

    Types of events and errors; terminology

    Medical Event ManagementSources of event data

    Event reporting systems

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    Objectives

    Participants will be able to: Explain how studying medical events

    can provide information to improve patientsafety

    Define the various types of events and errors

    Explain the goals and critical elements of aneffective event reporting system

    Describe the event management process

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    Growing Public Concern

    About Medical Errors Headlines in newspapers

    about human error in

    hospitals Numerous articles in the

    medical literature

    Governmental attention

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    Annual Accidental Deaths

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    To Err is Human

    Institute of

    MedicineReport 1999

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    Report

    Recommendations Establish a national focus of

    research, tools, and protocols to enhanceknowledge base about patient safety

    Create safety systems inside healthcare organizations through implementation ofsafe practices at the delivery level

    Identify and learn from errors throughreporting systems both mandatory andvoluntary

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    Errors Provide Useful Information

    We can learn more from our failures thanfrom success

    Our processes can be improved

    when studied Give me a fruitful error

    anytime, full of seeds,

    bursting with its own

    corrections. You can keepyour sterile truth to yourself.

    Vilfred Pareto

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    Types of Events

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    Misadventures

    The event actually

    happened, and some

    level of harmevenpossibly

    deathoccurred.

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    No Harm Events

    The event actually

    occurred, but no

    harm was done.

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    Near Miss Events

    The potential forharm may have beenpresent, butunwantedconsequences wereprevented because a

    recovery actionwas taken.

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    Recovery:

    Planned or Unplanned Planned recovery

    built into our

    processes

    Unplanned recovery

    lucky catches

    Study of recoveryactions is valuable.

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    Dangerous SituationsAn accident waiting to happen

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    Exercise:

    A patient is taken to the OR. The

    wristband is checked, and it is realizedthat the wrong patient was brought in.

    Misadventure?

    No-harm event?

    Near miss?

    Planned recovery?

    Unplanned recovery?

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    Exercise:

    A patient is found sitting on the floor ofhis room. He claims that he fell. He did

    not hit his head. He is examined, andthere are no signs of injury.

    Misadventure?

    No-harm event?

    Near miss?

    Planned recovery?

    Unplanned recovery?

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    Types of Errors

    Activeerrors committed by those

    in direct contact with the human-

    system interface (human error)

    Latentdelayed consequences oftechnical and organizational actions

    and decisions

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    Events Happen When:

    latentunderlying conditions

    +active human failure

    = Event

    ActiveError

    LatentConditions

    Event

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    Sharp End Active Failures

    Individuals at the sharp end are in direct

    contact with the human-system interface

    They administer care to patientsTheir actions and decisions may result in

    active failures

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    Types of Errors

    Active (Human) Errors skill-based

    rule-based

    knowledge-based

    Latent Errors (conditions orfailures) technical

    organizational

    Other (patient 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 youre 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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    Rule-Based vs.

    Skill-Based Error Curve

    Knowledge-based

    Errors

    Time

    Skill-based

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    Blunt End Latent Failures

    Individuals at the blunt end take actions

    and/or make decisions that affect technical

    and organizational policies and procedures These actions and decisions may result in

    latent failures

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    Types of Errors

    Active (Human) Errors skill-based

    rule-based

    knowledge-based

    Latent Errors (conditions orfailures) technical

    organizational Other (patient related and

    other)

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    Latent Categories

    (conditions or failures) Technicalproblems with physical items

    example: design flaw in software

    Organizationalproblems resulting from decisional elements

    example - unclear procedure

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    Latent Examples

    Technical incorrect installation of equipment

    faulty seals on a blood bag

    forms that are difficult to use

    Organizational decisions made by a regulatory body

    way in which new staff is oriented rational management decisions thatmay still contribute to an event

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    Event

    Example

    Management decision to delay

    computerization

    Patient readmitted; penicillin allergy

    Chart unavailable

    Patient given penicillin; allergic reaction

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    Exercise:

    An experienced physician is ordering a

    medication. She is interrupted by a telephone

    call. When she gets back to reading thetubes, she has a mental slip and orders the

    med for the wrong patient. What kind of

    mistake is this?

    Technical?

    Organizational?

    Human?

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    Exercise:

    A new infusion pump is introduced in thehospital. The nurse assigned to operate itduring the first week relies on an internal

    procedure to operate the instrument; however,the procedure is incomplete and leaves outcrucial information necessary for operation. .What kind of mistake is this?

    Technical?Organizational?

    Human?

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    The Titanic

    A disasterthat was

    set up

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    Latent Conditions on Titanic

    Inadequate number of lifeboats

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    Latent Conditions on Titanic

    No transverse overheads on water

    tight bulkheads

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    Latent Conditions on Titanic

    No shake down or practice cruise totrain crew

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    Latent Conditions on Titanic

    No training for officers on handling of

    large single rudder ships

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    Latent Conditions on Titanic

    Only one radio channel

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    Error Data Sources

    Event reporting systems

    Audits

    Medical records Observation

    Patient safety indicators

    Simulation

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    Event Reporting

    To what purpose?

    What are its critical elements?

    What are the barriers? How is the data used?

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    Goals of Event Management

    Prevent failure but if you cant,

    Make failure visible and

    Prevent adverse effects of failure or

    Mitigate the adverse effects

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    Three Major Functions of Event

    Reporting Systems Modeling of new or unique events

    Monitoring Events / Risks

    type, Cause, Change

    Mindfulness

    awareness of hazards

    active engagement, ownership

    feedback

    effect on safety culture

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    A Quality Event

    Reporting System

    Standardize reporting

    Provide tools that capture the full complexity

    of events in a way that is easy to understand Emphasize process improvement based on

    multiple rather than single events

    Collect events with and without harm, near-miss events, and dangerous situations

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    Compliance vs. Adoption

    Mandatory reporting: Staff merely comply when ordered to do so

    Voluntary reporting: Staff are engaged in patient safety efforts

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    Benefits ofNear Miss

    Event Reporting Tell us why misadventures donthappen

    Misadventures are often atypical. Near misses

    and no harm events give relative proportions ofclasses of system failures and help define risk

    Raise awareness of system hazards

    Data (and lessons) can be shared

    Chris Johnson, 2001

    University of Glasgow

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    The Event Management Process

    Detection

    Selection

    Investigation

    Classification & Description

    Computation

    Interpretation

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    Detection

    Basic event information is captured:

    where and when in process

    type of person involved

    narrative description

    how discovered

    event type/category

    contributing factors

    recovery/mitigation

    step(s)

    etc.

    Noticing and Recording the Event

    **Detection rates should be high**

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    Heinreichs Ratio1

    1 Major injury

    29 Minor injuries

    300 No-injury

    accidents

    300

    29

    1

    It has been proposed that reporting systems could be evaluated on

    the proportion of minor to more serious incidents.

    1. Heinreich HW Industrial Accident Prevention, NY And London 1941

    Detection

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    Selection

    If the detection level is high, there will be

    many events Events must be prioritized as to the type/depth

    of investigation it will receive

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    Investigation Options

    Routine Investigation

    collect standardized event information

    track and Trend

    Root Cause Analysis

    in-depth investigation

    build causal tree

    Selection

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    Rules for Filtering Events

    New, unique or worrisome

    Probability for patient harm (severity)

    Probability of recurrence Potential for organizational risk

    Likelihood of recovery

    Expert judgment

    Detectability

    Combination of above

    Selection

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    Tool: Risk Matrix

    Selection

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    Tool: Fuzzy Matching

    Similarity functionthat identifies reportsthat are most similar

    to a selected or newevent

    If many similar events

    are identified, furtherinvestigation may berecommended

    Selection

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    Example of a Causal TreeInvestigation

    O Patient Given

    A Blood (& Dies)

    A+Unit notremoved

    from prior

    ER-case

    Head nurse

    distracted

    NoneA+ Unit left

    on infusion-

    pumpwith O units

    Blood unit not

    checked for

    type wheninfused

    Group specific

    blood ordered

    in chaoticsituation

    Greatconfusio

    n

    in ER

    Inexperienced nurses in

    ER due to

    strike

    SOP inextreme

    emergency

    inadequate

    A+Unitnot

    removed

    when O

    units hung

    Root CausesRoot Causes

    RecoveryRecoveryFailureFailure

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    Classification & Description

    Event classification affects availability of

    information for learning:

    Classifications trigger information processing

    routines that direct the decision makers

    attention

    Cl ifi i & D i i

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    Believing is Seeing

    You see what you expect to see

    You see what you have labels to see

    classification and expectation are key

    You see what you have the skills to manage

    Everything else is a blur

    There lies the developing unexpected event

    Classification & Description

    Weick K, Sutcliffe K, 2001

    Cl ifi i & D i i

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    Event Coding

    Assign descriptive event codes based on

    these criteria:

    where and when in the process anevent occurred

    Example: Pharmacy filled prescription incorrectly

    where and when in the process an event wasdiscovered

    Example: Almost administered the wrong medication

    Classification & Description

    Cl ifi ti & D i ti

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    Casual Coding

    Example: The Eindhoven Classification Model,Medical Version

    20 codes divided into:

    latent (Technical, Organizational)

    active (Human)

    other

    aim for 3-7 root cause codes for each event, a mixture

    of active and latent

    Classification & Description

    C t ti

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    Computation

    See patterns or trends in the

    data Focus on areas of risk

    Monitor any changes that

    have been implemented

    within the organization

    Looking at data in aggregate to see

    patterns and trends

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    C t ti

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    Types of Data

    Comparison and Analysis: Production of frequency distribution and

    trend charts

    Identification of events meeting a broad

    range of parameters (conjunctive queries)

    Similarity matching

    Computation

    Comp tation

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    Conjunctive Query

    Identification of events meeting broad

    range of user-specified parameters

    Indicates which items on the form tomatch against

    Example: Search for all medication

    omissionsdiscovered by an RNon a

    weekend

    Computation

    Computation

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    Usefulness of

    Similarity Matching For a routine event, if there are many similar

    events, do an RCA

    For a high-risk event, if there are similarevents that have already undergone an

    expanded investigation, link the cases rather

    than repeat the RCA

    Computation

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    ALERT!

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    Interpretation

    Using data to make measured system changes

    Computation reports provide information that

    identifies the high risk areas and trends

    In Interpretation, we explore these areas and

    trends in search of process improvement

    opportunities

    65

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    Dont Tamper

    Interpretation

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    Indications of Success

    Overall risk of events will decreaseover time as process improvementsare implemented

    Patterns of data will change thefrequency distributions ofconsequent, antecedent, and causal

    codes will change over time

    Interpretation

    Weick K, Sutcliffe K, 2001

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    Examples of Analysis Tools

    Root Cause Analysis (RCA)

    causal or risk trees

    Data Mining and Case-Based Reasoning (CBR)trend and cluster analysis

    Failure Mode and Effects Analysis (FMEA)

    Probabilistic Risk Assessment (PRA)

    Sense-Making

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    The Event Management Process

    Detection

    Selection

    Investigation

    Classification & Description

    Computation Interpretation

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    Summary

    Medical Errorgrowing concerns

    types of events and errors; terminology

    Medical Event Managementsources of event data

    event reporting systems

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    Thank you

    An Introduction to Medical Event

    Reporting-Module 1