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Patient Safety Interventions


Follow five 'Rules' of thumb (heuristics) for developing root cause statements. 5/8/09 ... Practical rules of thumb. If you're not sure its safe, it's not safe ... – PowerPoint PPT presentation

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Title: Patient Safety Interventions

Patient Safety Interventions
  • John Gosbee, MD, MS
  • VA National Center for Patient Safety

Adapted from John Gosbee, MD, MS VA National
Center for Patient Safety
  • Identify ineffective, but commonly proposed,
    patient safety interventions
  • Understand the relative effectiveness of classes
    of safety interventions
  • Become familiar with the difficulty of measuring
    the effectiveness of safety interventions
  • Understand the methods and importance of outcomes
    measurement and difficulty with implementation

  • Rationale for including this module
  • Solid root cause analyses better interventions
  • Human factors framework for interventions
  • Common themes for interventions (team training)
  • Outcomes measurement and difficulty with

Why Should you Know about Patient Safety
  • People may inadvertently waste your time
  • Your patients are not protected enough
  • ACGME believes you have a leadership role
  • Your patients believe you have a leadership role

Core Processes in Root Cause Analyses Failure
Mode and Effects Analyses
  • What happened or what usually happens?
  • Why did something go wrong or how could it go
  • What do we do about it?
  • Intervention
  • How do we know we made a difference?
  • Intervention effectiveness

Unintended Consequences of Obvious Interventions
  • Forklift story
  • Workers getting hit in loading dock area
  • Rusty vehicles painted, alarms turned up
  • No decrease in collisions, why?
  • Computerized Order Entry at Boston hospital
  • Initially increase Potassium adverse events
  • Oooohh, the nurses and pharmacists used to help

Computers Will Fix Things?
  • ISMP survey analysis of 307 pharmacy computer
  • 10 test cases of drug-drug interactions and other
    unsafe medication orders
  • From easy to detect to hard to detect
  • Only FOUR passed all 10 tests
  • Reasons were many
  • Hard-to-use human-computer interfaces
  • Unrealistic resources allocated to properly
    maintain and use the systems

Professional Guidelines and Policies Will Help?
  • Compressed gas safety guidance
  • Ignore the color, read the label
  • See the next two slides
  • Surgery department Policies
  • Surgeon sign the wrong side
  • Patient sign the right side (oops, correct
  • Your stories

Quotes from Adverse Events
  • Tell the nursing student to attach the oxygen
    mask and tubing to the green spigot

Remember, this is air.
Can you really ignore the color?
  • Ignore the color in some cases, focus on the
  • Summary from an ECRI Alert
  • Color is not fool-proof, only read and trust the
  • Guideline from the Compressed Gas Association

Why are Many Interventions Off Base?
  • Safety is not always common sense
  • Root cause analyses are unintentionally
  • Body of knowledge is thin
  • What are the real problems (need)
  • Which solutions work in the real world (the need
    being addressed)

Common root cause analyses (RCA) pitfalls
  • 3 separate studies have found similar
    vulnerabilities in RCAs
  • GE occupational injury investigations
  • Heavy focus on problems that analysts see as
  • Such as policy and training issues
  • Field Guide handbook by Dekker
  • People focus on specific event, not the broader
    type of event
  • Comfortable illusion that fixing the person
    solves the problem
  • Initial analysis of RCAs coming into NCPS
  • Common violation of policy, lack of training,
  • Uncommon architectural or device changes,
    engineering solutions

Root Cause Statements and Interventions (Actions)
  • These activities are intertwined
  • Making root cause statements accurate and precise
    is best pathway to effective actions
  • Similar to Diagnosis Treatment
  • Address why something occurred, not who is
  • Follow five Rules of thumb (heuristics) for
    developing root cause statements

Rule 1. Clearly show the cause and effect
  • If you eliminate or control this root
    cause/contributing factor will you prevent or
    minimize future events?
  • WRONG A resident was fatigued.
  • CORRECT Residents are routinely scheduled for 80
    hour work weeks as a result, the fatigued
    residents are more likely to misread
    instructions, which led to an incorrect tube

Rule 2. Use specific and accurate descriptors
for what occurred, rather than negative words
  • Avoid words such as poorly, inadequately,
    haphazardly, improperly, carelessness,
  • Avoid the human tendency to use short-hand
  • WRONG Poorly written manual
  • CORRECT The training manual was not indexed,
    used a font that was difficult to read, and did
    not include any technical illustrations as a
    result the manual was rarely used and did not
    improve performance by the equipment operators.

Rule 3. Identify the preceding cause(s), not the
human error.
  • WRONG The resident made a dosage error.
  • CORRECT Due to no automated software to check
    the dosage limits and no cognitive aids on
    dosing, there was a likelihood of this dosing
    error, which resulted in three times the
    appropriate level of insulin being ordered and

Rule 4. Identify the preceding cause(s) of
procedure violations.
  • Procedural violation (not following rules) can
    not be directly managed
  • The cause of the procedural violation can be
    directly managed
  • Violating a procedure is often because of a local
    norm (group expectation)
  • Address the incentives that created the norm.

Rule 4. Identify the preceding cause(s) of
procedure violations.
  • WRONG The techs did not follow the procedure
    for CT scans.
  • CORRECT Noise and confusion in the prep area and
    production pressures to quickly complete CT scans
    increased the probability of missing steps in the
    CT scan protocol this resulted in an air
    embolism by inadvertent use of an empty syringe.

Rule 5. Failure to act is only causal when there
is a pre-existing duty to act.
  • WRONG The nurse did not check the STAT orders
    every half hour.
  • CORRECT The absence of an established procedure
    for nurses to check the STAT orders on the
    printer created the vulnerability that urgent
    orders would not be administered this resulted
    in the BOLUS of antibiotics not being

Human Factors and Safety Engineering
  • Understand that we are usually trading bad set of
    problems with better set of problems
  • Disciplines to help guide your diagnosis AND
  • Guidelines about relative effectiveness
  • Weaker interventions
  • Intermediate interventions
  • Stronger interventions
  • Tools to prototype and pilot before making things

Human Factors Engineering and Countermeasures
(Mower example)
Warning Lost Fingers
Grass comes out from here
Human Factors Engineering and Actions
  • Warnings and labels (watch out!)
  • Training (dont do that)
  • Procedure changes (work around that)
  • Interlock, lock-in, lock-out, etc (let me design
    it so you can not do that)
  • What is the best action???

Consistent theme of communication and team work
  • Practical rules of thumb
  • If youre not sure its safe, its not safe
  • Two challenge rule
  • Formal techniques
  • Medical Team Management (Similar to Crew Resource
    Management in aviation)
  • Other training (Med Teams, CRM type training in
    OR simulators Stanford, Harvard)

How Should you Judge a Safety Intervention?
  • Leape, et al (Patient Safety world)
  • Common sense, analogies to other domains
  • Many EBM approaches can not work
  • Shojania, et al (Evidence-Based Medicine world)
  • Common sense burned us in the past
  • They use many of the examples listed above (which
    were developed for this presentation before
    reading this article)
  • Both have points but both are ignorant of the
    full role human factors engineering needs to play…

Judging Interventions
  • Be specific, concrete, and clear
  • Give to a cold reader and confirm that they
    understand the actions and could implement
  • Specifically address the root cause/contributing
  • Test the actions or simulate process changes
    prior to full system-wide implementation
  • Check with the process owners

Judging Effectiveness
  • There are general guidelines to anticipate
  • Weaker Intermediate Stronger
  • They are relative
  • The only choice might be weaker
  • However, if no remedy is in place, it is still
  • But, weaker choices should be last resort

Weaker Actions
  • Double checks
  • Warnings and labels
  • New procedure/memorandum/policy
  • Training
  • Additional study/analysis
  • This list is not all-inclusive and does not
    represent absolute truth

Intermediate Actions
  • Checklist/cognitive aid 
  • Increase in staffing/decrease in workload 
  • Redundancy
  • Enhanced communication (e.g., read back)
  • Software enhancements/modifications
  • Eliminate look and sound-a-likes
  • Eliminate/reduce distractions (e.g., sterile
    medical environment)

Stronger Actions
  • Architectural/physical plant changes 
  • Tangible involvement and action by leadership in
    support of patient safety
  • Simplify the process and remove unnecessary steps
  • Standardize on equipment or process or care-maps
  • New device with usability testing before
  • Engineering control or interlock (forcing

Architectural/physical plant changes
Standardize equipment or process or care-map
All of them Could be Weak or Ineffective Actions
  • Changing our own behavior is biggest hurdle (we
    met the enemy and the enemy is us?)
  • Safety culture change is necessary condition
  • Most actions are easily worked around
  • Many RCAs find intervention being ignored,
  • Nearly worthless steps to get change
  • Reminder systems
  • CME
  • Printed materials

Common themes for design deficiencies (human
factors engineering flaws)
  • Consistency of labels, buttons, widgets
  • Readable and understandable labels
  • Obvious and understandable model
  • Avoiding Getting lost or unclear automation
  • What is it doing? and Why is it doing that?
  • Avoiding mode errors
  • Avoiding negative transfer of training
  • Considering environment of use

Common themes for Patient Safety Interventions
  • If it deals with medical devices or software
  • Interventions have to address one of the previous
  • Training will not help (palliative care)
  • If you rely on warning labels or heads-up
    meetings to address these design flaws…
  • Watch out, you will see the event again

Consistent theme of communication and team work
  • Practical rules of thumb
  • If youre not sure its safe, its not safe
  • Two challenge rule
  • Formal techniques
  • Medical Team Management (Similar to Crew Resource
    Management in aviation)
  • Other training (Med Teams, CRM type training in
    OR simulators Stanford, Harvard)

Outcomes Measurement
  • Process measures
  • Easiest, but weakest
  • Example measure that the door handle was
  • Vulnerability (indirect) measures
  • Harder to do, but stronger
  • Example measure per cent of technicians are less
  • Close call or adverse event measures
  • Hardest, but the gold standard
  • Example measure per cent of code teams that go
    to the wrong place

How do you Implement your Good Ideas?
  • Good ideas are hard…
  • Making them work in real life is a job for
  • Hercules
  • Freud
  • Work with your patient safety manager
  • At the VA, they can help you and will ask for
    your help
  • At your university, it is very similar…

Connection to other Modules and Activities
  • Background and tools for RCA small group
  • Background and link to Usability testing
  • Necessary prep for evidenced-based journal club
    arguments that offer light, not just heat

  • Many proposed interventions are palliative care
  • Additional training and scaring people should not
    be the result of adverse event investigations
  • Beware that safety is not always common sense
  • HFE helps develop stronger interventions
  • Better root cause better interventions