# Presentation: 648191

## Patient Safety Interventions

**Adapted from John Gosbee, MD, MS**
**VA National Center for Patient Safety**
- _[John.](mailto:John.Gosbee@med.va.gov)__[Gosbee](mailto:John.Gosbee@med.va.gov)__[@med.](mailto:John.Gosbee@med.va.gov)__[va](mailto:John.Gosbee@med.va.gov)__[.](mailto:John.Gosbee@med.va.gov)__[gov](mailto:John.Gosbee@med.va.gov)_**     **_[www.](http://www.patientsafety.gov/)__[patientsafety](http://www.patientsafety.gov/)__[.](http://www.patientsafety.gov/)__[gov](http://www.patientsafety.gov/)_

**John Gosbee, MD, MS**
**VA National Center for Patient Safety**
- _[John.](mailto:John.Gosbee@med.va.gov)__[Gosbee](mailto:John.Gosbee@med.va.gov)__[@med.](mailto:John.Gosbee@med.va.gov)__[va](mailto:John.Gosbee@med.va.gov)__[.](mailto:John.Gosbee@med.va.gov)__[gov](mailto:John.Gosbee@med.va.gov)_**     **_[www.](http://www.patientsafety.gov/)__[patientsafety](http://www.patientsafety.gov/)__[.](http://www.patientsafety.gov/)__[gov](http://www.patientsafety.gov/)_

## 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

## 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

**Notes:**
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. 

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 (often?) make mistakes that lead to injury or death of a patient.

Gopher, D., M. Olin, Y. Badhi, et al., 1989.  The Nature and Causes of Human Errors in a Medical Intensive Care Unit.  In Proceedings of the Human Factors and Ergonomics Society 33rd Annual Meeting. Santa Monica, CA: Human Factors and Ergonomics Society.  
	Excellent, but hard to obtain, research paper on a prospective study of adverse events and close calls in an Israeli hospital ICU:  direct observation, self report, failure modes analysis. 

Andrews.  Annals of Internal Medicine.  Still looking

## 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

## 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

**Notes:**
Use an example from everyday life to quickly give examples here

Not the intent to cover all details, just refresh to the students the context for learning about interventions

## 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

**Notes:**
Forklift story from occupational safety texts and presentations
Many dollars spent on painting brighter yellow, new lights, louder beeps
People were still in loading area to take break from assembly line without being seen “loafing”
Trying to get sensation back in hand, since new tool was causing minor nerve entrapment
Tool was changed, nobody hiding in loading area, no more “targets”

Bates has presented that initially CPOE screens for KCl were used the same way residents were ordering on paper - -but that has always been wrong and the nurses and pharmacists had resigned themselves to adjust it before being dispensed.   With CPOE, there was less human intervention and help...  
Bates DW, Teich JM, Lee J, et al.  The impact of computerized physician order entry on medication error prevention.  J Am Med Informatics Assoc.  1999;6:313-321. 

## 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

**Notes:**
Cohen, M.  1999.  Over-reliance on Pharmacy Computer Systems May Place Patients at Great Risk.  ISMP Medication Safety Alert! 4(3): 1. 

## 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

**Notes:**
A slide on a “Do not Cut Here” patch is forthcoming

## “Quotes” from Adverse Events

- “Tell the nursing student to attach the oxygen mask and tubing to the green spigot”

- Remember, this is air.

**Notes:**
Conflicting inputs (label and color) cause confusion.  

## 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

**Notes:**
Q:  Why haven’t these problems been solved?
A:  As in literature review for EBM, it requires clinician’s evaluation of recommendations – not a blanket solution

## 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)

## 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

## 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

## 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.

## 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.

## 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.

## 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 administered.

## 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

**Notes:**
See more complete list of weaker, intermediate, and stronger interventions towards the end of this slide set

## Human Factors Engineering and “Countermeasures” (Mower example)

- Warning: Lost Fingers

- Grass comes out
- from here

**Notes:**
Need picture of cartoon or actual warning label that looks like severed fingers

## Human Factors Engineering and “Actions”

**Warnings and labels** (watch out!)
**Training** (don’t 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**???

**Notes:**
Warnings:  For lawn mower the only “good thing” about the warning label is it looks just like the injury
Warning labels either no effect or little effect in hundreds of human factors engineering studies
	Wogalter MS, Young SL, Laughery KR.  Human Factors Perspectives on Warnings, Volume 2.  Santa Monica, CA: The Human Factors and 	Ergonomics Society, 2001.  [Order online at www.hfes.org].

Training:  John Gosbee’s dad said to learn to be careful because if you are “stupid” and reach into the outflow, I am not taking you to the emergency room

Procedure change:  mow on dry days so grass would not get stuck; which is not easy in Spring, so worked around

Interlock:  the mower handle flip-down bar that comes up and kills the engine if you let go -> ask the class more than one will have tied it down; AND ask them why!!

Best action is to eliminate the hazard (metal blades), which was done for “weed whacker” lawn machines.  When tried on lawnmowers, the bigger plastic “whip” now caused denuding of the skin off the digit, instead of “Cleanly” cutting it off to be “easily” reattached.  
Others include replacing grass with rock garden, hiring someone else to mow, etc.

## Consistent theme of communication and team work

- Practical rules of thumb
- If you’re not sure its safe, it’s 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)

**Notes:**
University of Maryland, Yan Xaio and Colin McKenzie

Gifford BJ, Morey J, Risser D, Salisbury M.  Enhancing patinet safety through teamwork training.  J Healthc Risk Mana 2001; 21(4): 57-65.

Coats RD, Burd RS.  Intraoperative communication of residents with faculty:  perception versus reality.  J Surg Research, 2002; 104(1): 39-45 

[photo from Stanford’s OR simulator]

## 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...

**Notes:**
It takes a very interested class, but the points made in each article are worthy of a full class dicussion
However, residents or students could fully agree with either “camp”, but it will not necessarily help them take upon a larger role in patient safety within their hospital – “our” main goal!

Leape LL, Berwick DM, Bates DW.  What practices will most improve patient safety?  Evidence based medicine meets patient safety.  JAMA.  2001;288:501-507.

Shojania KG, Duncan BW, McDonald KM, Wachter RM..  Safe but sound.  Patient safety meets evidenced-based medicine.  JAMA.  2001;288:508-513. 

## “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

## “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

## 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 purchasing
- Engineering control or interlock (forcing functions)

## 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, disabled
- Nearly worthless steps to get “change”
- Reminder systems
- CME
- Printed materials

**Notes:**
Landry MD, Sibbald WJ.  Changing physician behavior: a review of patient safety in critical care medicine.  J Crit Care. 2002;17:138-145.
     From the AHRQ report "Making Health Care Safer", this article discusses the literature supporting the effectiveness of educational based techniques to change physician behavior: academic detailing, audit and feedback, local opinion and leader, reminder systems and printed materials.  The authors conclude the last is the least effective in changing behavior and more research is required to identify how safe practices may be integrated in physician behaviors.
Refs: 26 / Code: ADM; ERG

## 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

**Notes:**
[How to turn on the cell phone?  Use the “end” button]

Technology or other systems in the conference room, class room, or hospital unit can be great examples of each of these concepts

As the next slide proposes, knowing the HFE diagnosis is a real nice “detail” if you are going to redesign something or buy a “better” model

## 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

## Consistent theme of communication and team work

- Practical rules of thumb
- If you’re not sure its safe, it’s 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)

**Notes:**
University of Maryland, Yan Xaio and Colin McKenzie

Gifford BJ, Morey J, Risser D, Salisbury M.  Enhancing patinet safety through teamwork training.  J Healthc Risk Mana 2001; 21(4): 57-65.

Coats RD, Burd RS.  Intraoperative communication of residents with faculty:  perception versus reality.  J Surg Research, 2002; 104(1): 39-45 

## 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

## 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 exercise”
- Background and link to “Usability testing exercise”
- Necessary prep for evidenced-based journal club **arguments** that offer light, not just heat

## 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

**Notes:**
Palliative care analogy courtesy of Richard Cook, personal communication Spring 2002