Patient Safety Interventions

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Patient Safety Interventions

• John Gosbee, MD, MS
• VA National Center for Patient Safety
• John.Gosbee_at_med.va.gov www.patientsafety.gov

Adapted from John Gosbee, MD, MS VA National
Center for Patient Safety John.Gosbee_at_med.va.gov
www.patientsafety.gov
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Objectives

• 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

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Overview

• 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
  implementation

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Why Should you Know about Patient Safety
Solutions?

• 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

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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
  wrong?
• What do we do about it?
• Intervention
• How do we know we made a difference?
• Intervention effectiveness

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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

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Computers Will Fix Things?

• ISMP survey analysis of 307 pharmacy computer
  systems
• 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

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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
  side)
• Your stories

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Quotes from Adverse Events

• Tell the nursing student to attach the oxygen
  mask and tubing to the green spigot

Remember, this is air.
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Can you really ignore the color?

• Ignore the color in some cases, focus on the
  label
• Summary from an ECRI Alert
• Color is not fool-proof, only read and trust the
  label
• Guideline from the Compressed Gas Association

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Why are Many Interventions Off Base?

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

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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
  fixable
• 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,
  inattention
• Uncommon architectural or device changes,
  engineering solutions

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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
  responsible
• Follow five Rules of thumb (heuristics) for
  developing root cause statements

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Rule 1. Clearly show the cause and effect
relationship.

• 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
  insertion.

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Rule 2. Use specific and accurate descriptors
for what occurred, rather than negative words

• Avoid words such as poorly, inadequately,
  haphazardly, improperly, carelessness,
  complacently
• 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.

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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
  administered.

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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.

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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.

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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
  administered.

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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
  treatment
• Guidelines about relative effectiveness
• Weaker interventions
• Intermediate interventions
• Stronger interventions
• Tools to prototype and pilot before making things
  worse

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Human Factors Engineering and Countermeasures
(Mower example)
Warning Lost Fingers
Grass comes out from here
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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???

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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)

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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

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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
  factor
• Test the actions or simulate process changes
  prior to full system-wide implementation
• Check with the process owners

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Judging Effectiveness

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

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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

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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)

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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
  purchasing
• Engineering control or interlock (forcing
  functions)

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Types of Actions from RCAs
2003
1999 - 2002
N1692
N2602
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NCPS RCA/HFMEA Action Hierarchy
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Architectural/physical plant changes
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NCPS RCA/HFMEA Action Hierarchy
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NCPS RCA/HFMEA Action Hierarchy
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NCPS RCA/HFMEA Action Hierarchy
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NCPS RCA/HFMEA Action Hierarchy
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NCPS RCA/HFMEA Action Hierarchy
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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,
  disabled
• Nearly worthless steps to get change
• Reminder systems
• CME
• Printed materials

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Interventions

• Must specifically address the root
  cause/contributing factor
• Need to be specific, concrete, and clear
  understood by a cold reader
• Reality checked (with the process owners)
• Tested or simulated prior to full system-wide
  implementation

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Example of Better Weaker Actions
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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

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Common themes for Patient Safety Interventions

• If it deals with medical devices or software
• Interventions have to address one of the previous
  themes
• 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

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Outcomes Measurement

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

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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

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Conclusions

• 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