##### Patient Safety Introduction

# Instructors Guide

By John Gosbee, Bentzi Karsh, Anne Tomolo

VA National Center for Patient Safety

<John.Gosbee@med.va.gov> 734-930-5893
[www.patientsafety.gov](http://www.patientsafety.gov/)

##### Background and Rationale

Most students and teachers expect an introduction and overview when they
are presented with new material. Most introductory lectures to teach
patient safety include information about the "epidemiology" of adverse
events, definitions of key terms, descriptions of major initiatives, and
the "culture" of safety. My attempts to stop these potentially
mind-numbing lectures have been mostly futile. I can't even stop myself!
What we can hope to do is provide enough relevance and interaction to
whet their appetite. We can also provide links and examples of material
that they can return to once their brains have been " flipped 180
degrees" in subsequent modules.

A little theory goes a long way and one crystal-clear application takes
you a long way. It is unclear that even a full-time patient safety
manager needs to know the several types of "slips" as defined by James
Reason or Donald Norman. On the other hand, it is easy to see that using
one or two applicable examples can capture and keep enough audience
attention so they really listen about patient safety concepts, such as
safety culture. For instance, using the example of medical device false
alarms with students and residents in the middle of their ICU rotation.
Parts of this Module A easily fit as the introduction to Modules B-F.

##### 

# Learner Objectives

1.  Understand the definition and scope of patient safety

2.  Become familiar with the epidemiology of adverse events in
    healthcare

3.  Build a good foundation for understanding the systems approach to
    patient safety

4.  Understand the role of close calls

5.  Learn about high reliability organizations

6.  Understand the basics of how to prevent, eliminate, and/or reduce
    adverse events and hazards

##### Applicability

The introductory material is likely applicable to everyone working or
learning in the health care setting. Some could argue to include more
theory for those receiving advanced degrees, but I know of no data to
suggest this.

##### Constraints and Lessons Learned

Keep it real. Keep it applicable. Sacrifice completeness for engagement.

####### 

####### Brief Description

This module includes the scope and nature of most adverse events,
overview of major initiatives, and relevance to the audience. It is an
introduction into culture of safety and systems thinking.

**[Module Outline]{.underline}**

# Pick one or more Subsections based on this needs assessment

-   Read a case that you are familiar with and that hits home with your
    audience, and ask:

    -   What are the types of errors associated with this case?

    -   Where did these errors occur?

    -   What systems were involved?

    -   What information do you need to identify the risks for these
        errors?

-   For instance, what should we do if these things happen?

    -   Nurse gives 10x overdose

    -   Physician removes left versus right kidney

    -   Respiratory therapist inadvertently hooks up patient to medical
        air instead of oxygen

##### Subsections

Subsection #1: Definition and Scope of Patient Safety

Subsection #2: Patient Safety Epidemiology

Subsection #3: Systems Approach to Patient Safety

Subsection #4: Reducing harm by identifying and controlling hazards

Subsection #5: High reliability organizations

Subsection #6: Intro to Patient Safety Tools

##### Anne Tomolo's Experience (Cleveland VA)

-   4-6 residents rotate every two weeks for urgent care rotation

-   Initial experience using Module A

-   Evolution (back to the future)

-   Recent experience using Module A

**Definition and Scope of Patient Safety**

-   They give theirs

-   You tell them the fancy ones

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-   You tell them human factors and other safety specialists believe
    there is no such thing as "error"; but rather the "flip side" of
    human performance

**Patient Safety Epidemiology**

-   Retrospective studies (Brennan, et al, 1991))

    -   2-4% of hospitalizations

    -   10-40% including close calls

-   Cross-sectional (Ely, et al 1995)

    -   50% with survey of Family Practice docs 2-20 years experience

-   Prospective studies (Gopher, et al, 1991)

    -   ICU observation: 1.7 events/patient/day

    -   Internal Medicine rounds: 50% of all admitted patients with 1-10
        events

    -   Australian study in ED: observer couldn't write down the events
        or close calls he saw fast enough to keep up with his paperwork

**Systems Approach to Patient Safety**

##### What is the difference between focusing on the person and focusing on the system?

-   Person approach

    -   Focus on individuals

    -   Blaming individuals for forgetfulness, inattention, or
        carelessness, poor production

    -   Methods: poster campaigns, writing another procedure,
        disciplinary measures, threat of litigation, retraining, blaming
        and shaming

    -   Target: Individuals

-   System approach

    -   Focus on the conditions under which individuals work

    -   Building defenses to avert errors/poor productivity or mitigate
        their effects

    -   Methods: creating better systems

    -   Targets: System (team, tasks, workplace, organization)

### 

##### Reducing harm by identifying and controlling hazards

-   What is a [hazard]{.underline}?

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-   In safety, a HAZARD is anything that can put somebody or something
    at risk of damage or injury or harm.

-   In medicine we call hazards [risk factors]{.underline}.

    -   Why focus on hazards and harm?

-   In medicine, if we want to reduce the incidence rate of a disease we

    -   Look for risk factors

    -   Figure out how they contribute to the disease

    -   Figure out how to reduce or eliminate the risk factor.

-   In safety, if we want to reduce adverse events, we

    -   Look for hazards

    -   Figure out if they contribute to the adverse events

    -   Figure out how to reduce or eliminate the hazard.

# 

# How do you control hazards?

## CONTROL THEM so that they cannot do harm

## To control hazards, we prefer to follow the safety engineering "hierarchy of hazard control"

### Eliminate hazard

### Guard against hazard

### Train to avoid hazards

### Warn against hazard

##### High reliability organizations

-   Patient Safety Challenges

    -   Medicine Views Errors as Failings Which Deserve Blame - Fault

    -   Train and blame mentality pervades

    -   Corrective Actions Focus on Individual

    -   No Blood No Foul Philosophy

-   Many in health care ignore or downplay close calls

    -   Jim Bagian quote: "Experience is the best teacher... But if we
        wait for adverse events, who pays the tuition? The patient"

-   A More Productive Approach

    -   People Don't Come to Work to Hurt Someone or Make a Mistake

    -   Systems Issues \> Individual's Fault or Problem

    -   Common vulnerabilities that can be found and fixed for EVERYONE,
        not just one person/place

-   Models that help (somewhat) explain systems approach (broader,
    deeper thinking):

    -   Swiss cheese by Reason (see next page)

    -   Modified Reason diagram with granite and screen door barriers,
        instead of Swiss cheese (Gosbee)

-   Lots of books and articles...harder to actually teach or get across
    to an audience not listening

    -   Use Module B exercise

    -   Use Module D exercise

-   Lessons and stories from VA Patient Safety (RCA) training (see
    examples in slides)

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-   I am more partial to giving examples of

    -   How remedies that seem to have lots of evidence meet resistance
        from frontlines

    -   Root cause analyses keep finding the issues of communication
        between various disciplines and the failure to "speak up" when
        something looks "out of whack"

**Reasons for the focus on close calls** (not-so-obvious)

-   10-100 times as frequent

-   Indirect marker for HRO, culture of safety

-   People more willing to talk, help

-   Giant step towards prospective patient safety measures ("pre" close
    call)

**Intro to Patient Safety Tools**

-   Discussion of VA and affiliate university safety programs

    -   Root cause analysis (RCA)

    -   What happened, why did it happen, what can be done?

    -   Triggered from actual events and close calls with "severe"
        potential

    -   In VA, protected from discovery and confidential

-   Close call reporting

    -   In VA, when in doubt, call and talk to your patient safety
        manager

    -   Standards or goals of national organizations (e.g., JCAHO)

-   Dangerous abbreviations, patient mix-ups, free-flow IV pumps, etc.

**Problem-oriented safety record** (as an analogy to SOAP structure)

-   Subjective

    -   Interviewing people involved in the event or close call with
        open-ended questions

-   ROS

    -   VA NCPS Triage Questions for RCAs

-   Objective

    -   Simulations to recreate event

-   Assessment

    -   Root causes and contributing factors

-   Plan

    -   Actions, countermeasures (hopefully evidenced based)

    -   Outcomes measurement

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-   Provides a "hook" to a well-ingrained method of decision making

-   Differences in what happened, what was expected (policy), what
    usually happens (norms)

-   See Handout "cards" and poster for Module F -- Safety Case
    Conferences

**[Class Exercise (at end of session)]{.underline}**

**Telling stories in a structured fashion**

***Summary and Rationale.*** The [major portion of the
learning]{.underline} occurs when students or residents list and comment
on their experiences with adverse events or close calls. It is important
that these are not second or third hand stories. This exercise will
require that they know enough detail to describe the circumstances
leading to the event or close call, and the clinical and personal
consequences and follow-up. Structured discussion will allow the group
to understand the dynamics among three key pieces: 1) story elements; 2)
the root cause(s); and 3) possible or actual countermeasures. This
discussion also allows teachable moments to introduce and reinforce
several principles, including: human factors and safety engineering
concepts; systems view for root cause analysis; effective development of
countermeasure types (e.g., warnings, interlocks); and the limitations
of blame and train mentality.

***Some tips and insights:***

-   Instructor should tell and analyze their story first, then learners

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-   Emphasize you don't need to know if it was them, a colleague, or
    unknown

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-   Keep repeating these key questions

    -   What happened?

    -   Why did they think it happened?

    -   What could be done about it?

-   DO NOT allow blame, easy fixes, loose thinking (banish the "who"
    questions)

-   Start to introduce five rules of causation, triage questions

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-   Interject findings from human error/performance theory and taxonomy

-   Be prepared with types of root causes and countermeasures they may
    not bring up

## **Draw the following type of table on a white board or flip chart**

+--------------------+--------------+---------------+-----------------+
| **Adverse          | **Co         | **Root Causes | **C             |
| Event/Close Call** | nsequences** | and           | ountermeasure** |
|                    |              | Contributing  |                 |
|                    |              | Factors**     |                 |
+--------------------+--------------+---------------+-----------------+
| *(Your example, if | Patient      | Fatigue and   | Computerized    |
| you don't have     | nervous and  | inexperience  | order entry     |
| one)* Ordered      | few bruises  |               | that checks for |
| Clonidine 1.0 mg,  |              | Missed steps  | unusual doses   |
| instead of 0.1 mg  | Embarrassed, | and checks in |                 |
| in middle of       | reprimanded  | getting and   | Resident must   |
| night; patient     |              | giving        | be standing     |
| falling down and   | Rest of      | medications   | when taking     |
| pharmacist alerted | \"team\"     |               | late night      |
| physician that     | ignored it   |               | calls           |
| dose was x10       |              |               |                 |
+--------------------+--------------+---------------+-----------------+
| *(Example of what  | No           | Over          | Started         |
| they might say)*   | arrhythmias  | dependence on | carrying 3x5    |
| Failed to find out |              | memory        | cards with      |
| about an abnormal  | Reprimanded  |               | reminders to    |
| potassium level    |              | Possible flaw | gather crucial  |
| until next day     |              | in            | data            |
|                    |              | notification  |                 |
|                    |              | process       |                 |
+--------------------+--------------+---------------+-----------------+
| (etc.)             |              |               |                 |
+--------------------+--------------+---------------+-----------------+

**[Additional Instructor Preparation]{.underline}**

##### Incorporating Theory and Practice: a "New Look" at Error and Safety

Dekker (2002) in his *Field Guide to Human Error Investigations*
provides

-   Great analysis of why most safety ideas and practices fail.

-   Tools to help avoid pitfalls of safety analysis

-   Words and phrasing that can take hours or days to develop clearly
    yourself

Basically, it is three related concepts:

-   Human error is a symptom of trouble deeper in the system (it is the
    starting point, not the end)

-   To explain failure, do NOT try to find where people went wrong

-   Find how people's assessment and action made sense at the time,
    given the circumstances that surrounded them

**Human Error Theories** (Reason, 1990)

James Sully (1881) "Cognitive Illusions"

\- Eye, ear, and brain are all inherently imperfect

\- One of the first to codify human error

\- Fallacies of human thought were analogous to visual illusions

\- He applied common explanatory principles

Sigmund Freud (1896)

\- Unconsciously held wish that "forces" us to say or do the wrong stuff

\- His views dominated understanding of error for 60 years (or more)

Kahneman, Wickens, Reason (1960-1990)

\- Know what is normal human performance, and you can explain abnormal
(errors)

\- Reservoir and multiple resource theories of cognition and attention
(see below)

\- Schemata and recognition-primed decision making theories

Reasoning is governed more by similarity-matching than by logic

**Human Performance Theories** (Reason, 1990)

Reservoir theory = brain fills up with tasks and interpretation of
sensory input until "full," then future work causes tasks to "spill
over" with resulting errors (poor performance)

Multiple resource theory = different resource areas of the brain can be
"filled up" with tasks and interpretations more or less independently
(e.g., auditory, visual)

Advance theories = hard to make these models simple, relevant, and
predictive (i.e., useful)

**Human Error Taxonomies** (Norman, 1988 and Riegelman, 1991**)**

**Slips** = result from automatic behavior, when you mean to do the
right thing and something goes awry. Usually a small thing and somewhat
easy to self detect.

\- Capture errors (after playing cards a lot, you count
5,6,7,8,9,10,Jack,Queen,\...)

\- Description errors (throw dirty clothes in toilet, not hamper)

\- Data-driven errors (dial a room number on the door right in front of
you)

\- Associative activation errors (phone rings, you yell for someone to
come in)

\- Loss of activation errors (forget why you walked into a room)

\- Mode errors (trying to increase TV volume on remote control, while in
VCR mode)

\- Also covered in the Reminder Section of the medical informatics
curriculum

**Mistakes** = result from conscious deliberation, you make the wrong
decision and do the wrong thing for a particular situation. Usually a
large thing and may be almost impossible to self detect.

\- Cognitive limitations, such as anchoring, less emphasis on negative
evidence, etc.

\- Often an ingrained limitation due to short-cuts and generalizations
that are usually

helpful in dealing with complex sets of data

\- Sometimes mixed with slips

\- Covered in much more depth in Diagnostic Decision Support Systems
Section of

the medical informatics curriculum

# [Patient Safety Introduction References]{.underline} 

1.  Wu AW, Folkman S, McPhee SJ, Lo B. Do house officers learn from
    their mistakes? *JAMA*. 1991;265:2089-2094. Good discussion and set
    of recommendations for encouraging more appropriate handling of
    fairly frequent resident mishaps.

2.  Ely JW, Levinson W, Elder NC, Mainous AG. Perceived causes of family
    physician's errors. *J Fam Pract.* 1995;40(4):337-44. Very telling
    and chilling subjective, retrospective study of how well-intentioned
    professionals can sometimes make mistakes that lead to injury or
    death of a patient.

3.  Donchin Y, Gopher D, Olin M, Badihi Y, Biesky M, Sprung CL, et al. A
    look into the nature and causes of human errors in the intensive
    care unit. Crit Care Med 1995; 23: 294-300 Excellent research paper
    on a prospective study of adverse events and close calls in an
    Israeli hospital ICU: direct observation, self report, failure modes
    analysis.

4.  Casey S. *Set Phasers on Stun and Other True Tales of Design,
    Technology, and Human Error*. Santa Barbara, CA: Aegean
    Publishing, 1993. Great, gut-wrenching stories of how bad design
    results in bad consequences. The first chapter is a good account of
    the design flaws that led to the fairly well-known cases where
    patients died of radiation therapy overdoses in the early 1990s.

5.  Weeks WB, Bagian JP. Developing a culture of safety in the Veterans
    Health Administration. *Eff Clin Pract.* 2000 Nov-Dec;3(6):270-6. A
    good introduction and summary of healthcare and the culture of
    safety and organizational issues that have thwarted past efforts.
    Nice list of references.

6.  Norman DA. *The Design of Everyday Things*. New York: Basic Books,
    Inc.; 1988. Still the most readable and engaging account of why so
    many systems are not designed with human characteristics and
    limitations in mind. A very good primer on our understanding of
    human error, with everyday examples.

7.  Dekker S. *The Field Guide to Human Error Investigations.*
    Burlington, VT: Ashgate. 2002. The best book I ever read that
    incorporates theory and practice for patient safety.

8.  Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events
    and negligence in hospitalized patients. Results of the Harvard
    Medical Practice Study I. *N Engl J Med*. 1991;324:370-6. Considered
    a classic, although retrospective, study of the epidemiology of
    mishaps that occur in a wide variety of inpatient settings. Some of
    the analysis and recommendations fall short in the area of applying
    human factors principles and techniques, but the authors have since
    become more aware.

9.  Andrews LB, Stocking C, Krizek T, Gottlieb L, Krizek C, Vargish T,
    et al. An alternative strategy for studying adverse events in
    medical care. Lancet 1997; 349: 309-13. Unique method of watching
    and listening on working and teaching rounds with residents and
    attendings to reveal event rates of around 50% - with some patients
    encountering many events in a single hospital stay

10. Riegelman RK. *Minimizing Medical Mistakes: The Art of Medical
    Decision Making*. Boston, MA: Little, Brown and Co.; 1991. Very nice
    overview of the root causes and possible techniques to minimize
    adverse events related to decision making.

11. Bogner MS. Human Error in Medicine. Hillsdale, NJ: Lawrence Erlbaum
    Associates, Inc. 1994. Great overview, yet somewhat incomplete book
    about adverse events in healthcare. Some chapters and sections are
    practical, but mostly conceptual or research-oriented chapters
    written by several authors.

12. Reason, J.T. 1990. *Human Error.* Cambridge, England: Cambridge
    University Press. Conceptual book that covers the history of error
    research; applications of this knowledge with examples.