In 3 sentences: The document discusses patient safety in the VA system and why focusing on patient safety is important. It provides statistics on the size of the VA system and notes that medical errors harm millions of people each year, costing billions of dollars. The document advocates using a systems approach and human factors engineering to improve patient safety, rather than just policies or individual blame, in order to have the biggest impact on preventing future harm.

1. Patient Safety:
Why Bother?
Noel Eldridge, MS for
James P. Bagian, MD, PE
Chief Patient Safety Officer
Director, VA National Center for Patient Safety
February 28, 2007
james.bagian@va.gov & noel.eldridge@va.gov
www.patientsafety.gov

2. (Jimi couldn’t make it today. You got Noel.)
James Bagian, MD, PE
Director, VHA National Center for Patient Safety
Noel Eldridge
Executive Officer, NCPS

3. VA Statistics (FY 2005)
 7.7M enrollees, 5.3M uniques
 VA Medical Centers (Hospitals): 156
 Admissions: 587,000
 Community Based Outpatient Clinics: 708
 Outpatient Visits: 57.5M
 Rx Dispensed (30-day equiv): 231M
 Lab Tests: 215.9M
 Total FTE: 197,800

4. Veterans Health AdministrationVeterans Health Administration
2211 Veterans Integrated Service NetworksVeterans Integrated Service Networks
I J 2 0 0 2N A N U A R Y
W E R E IN T E G R A T E D A N D
R E N A M E D
V IS N 1 3 1 4
V IS N 2 3
S A N D

5. Patient Safety Background and VA
Information on Reporting

6. Institute of Medicine Goals
1. Safe – “avoiding injuries to patients from the care
that is intended to help them”
2. Timely
3. Efficient
4. Effective
5. Equitable
6. Patient-Centered
 (from Crossing the Quality Chasm, 2001)

7. NY Times and W. Post This Week
 Medication Reconciliation & Adverse Events
– “Unintentional drug poisonings accounted for
nearly 20,000 deaths in 2004, said the CDC,
making the problem now the second-leading
cause of accidental death in the United States,
after automobile accidents.”
• W. Post – 2/27/07
– “In August 2006, the Institute of Medicine of the
National Academies released a major study on
medication errors in American hospitals that found
that adverse drug events harm more than 1.5
million people and kill several thousand a year,
costing at least $3.5 billion annually.”
• NY Times – 2/25/07

8. Where Healthcare Was/Is
 Cottage Industry Mentality
 Virtually Total Reliance on:
– Professional/Individual Responsibility
– Individual Perfection
– Train and Blame
 Little Understanding of Systems
Relative to People and Processes
– Ignorance vs. Arrogance
Culturally Different!!!!

9. Where Does a
Culture of Safety Exist?
 Would you agree to fly on a bankrupt
airline to save $100?
 Would you agree to get elective surgery
at a bankrupt hospital to save $100?
 Are your answers different? If so, why?
 Do you trust the airline “system” of
regulators, managers, pilots, and
mechanics in a different way than you
trust the healthcare “system”?

10. Sad Comment at amazon.com
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CAN YOU IMAGINE THE EQUIVALENT FOR AN AIRLINE TRIP?

12. NAVAL AVIATION MISHAP RATE
776 aircraft
destroyed in
1954
FY 50-96FY 50-96
Fiscal Year
2.39
39 aircraft
destroyed in
1996
0
10
20
30
40
50
60
50 65 80 96
Angled Carrier Decks
Naval Aviation Safety Center
NAMP est. 1959
RAG concept initiated
NATOPS initiated 1961
Squadron Safety program
System Safety
Designated Aircraft
ACT
HFC’s
ClassAMishaps/100,000FlightHours

14. Three Important Questions
1. What Happened?
2. Why Did it Happen?
3. What Should We Do to Prevent it from
Happening Again?

15. Typical Healthcare Approach
 New Policies, Regulations,Reporting
Systems, Training
 Good First Step But…..
– Lack of Systems Insight
– Superficial Solutions (?Answers)
– Inadequate Follow-Up
– Lost Opportunity

16. Goal Selection
 Clear
– Not Confused With Tactics
 Compelling
– Relevance To Those Who Must Take Action
– Early Stakeholder Involvement in Goal Definition
 Reinforced By Leadership
– Visible Participation
• All levels – not hierarchical

17. Goal: Prevent Harm
VA Patient Safety Advisory - August 8, 2000
 Item: Medtronic Dual Chamber Temporary
Pacemaker model 5388
 Specific Concerns: The Medtronic Dual Chamber
Temporary Pacemaker model 5388 may become
inactive if a button is touched while it is in "self test"
mode. If this occurs the pacemaker display freezes,
will not work properly and displays an error code of
0004. At this point the pacemaker cannot be turned
off. In order to correct the situation the battery
drawer has to be opened. Only removal of the
battery clears the error and turns the pacemaker off.
It may then be restarted.

18. Typical Missing Features
 Clear Understanding of Goal
 Preventive Approach
 Field Understanding & Buy-In
 Systems Approach
 Sustainability
 Trust/Culture of Safety

19. Safety System Design
 High Reliability Organizations
 Role of Reporting
– Learning or Accountability?
 Systems-Based Solutions
– Patient Centered – DUH!!!!
 Importance of Close Calls

20. VA Patient Safety Data & Feedback
 Incidents reported have monotonically
increased since reporting to NCPS
started in 2000.
 VA inpatient mortality down ~35%
from 1999 to 2006.
– (Remember: “Correlation is not causation.”)

21. VA Annual Events Reported
(including close calls) is Still Going Up

22. Safety Assessment Code
(SAC)
Severity &
Probability
Catastrophic Major Moderate Minor
Frequent 3 3 2 1
Occasional 3 2 1 1
Uncommon 3 2 1 1
Remote 3 2 1 1

23. The Value of Close Calls in Safety
Close calls can provide “sentinel” information
without or before the “Sentinel Event.”

24. Patient Safety System Design

25. Patient Safety System Design

26. Most VA Reports are Actual “SAC 1s”
(events with little or no harm, or close calls)

27. Which Events get RCAs?
 Many RCAs
are done on
events that
are not
Actual 3s.
 Numbers are
surprisingly
constant
since 2001.
 Is fewer
actual SAC3s
since 2001 &
2002 good
news?
Maybe.

28. RCA Categories (Coded by NCPS)
Selected Event (FY 2005) for Individual RCAs Percent
Fall 13.9%
Delay in Treatment/Diagnosis/Surgery 10.7%
High Alert Adverse Drug Events 10.5%
Unexpected Death 7.2%
Misidentification 6.3%
Missing Patient 4.9%
Hospital Acquired Infections 4.7%
Outpatient Suicide 3.4%
Correct Surgery 3.3%
65.0%

29. What about the Adverse Events and
Close Calls that don’t get “RCAed”?
 In VA Aggregated Reviews are
performed at the local level, one per
quarter on:
1. Adverse Drug Events
2. Missing and Wandering Patients
3. “Parasuicidal” Events
4. Falls
– (When they are not “SAC 3” events)

30. Guiding Principles For Patient
Safety System
Learning, Not Accountability System
Reporting System Characteristics
• Non-punitive - Confidential and De-identified
• Internal and External
Importance of Close Call
Reports Should Emphasize Narratives
Interdisciplinary Review Teams
About Identifying Vulnerabilities NOT
Statistics
Prompt Feedback
Open to All Comers

31. What comes from RCAs?
1. Local Fixes and Learning
2. Local Insight into Better Methods for
Improvement and the Tractability of
Problems (not like the weather)
3. VA-wide Alerts and Advisories
4. Systemwide Learning and Informed
policymaking

32. VA RCA data on Incorrect Surgical
Procedures (2001 – 2005)
 In-Operating Room: 33%
 Out-of-Operating Room: 42%
 Eye Procedures (can be either setting): 25%

33. What was Wrong? (2001-2005)
26 27
16
10
22
0
5
10
15
20
25
30
Wrong
Patient
Wrong
Side
Wrong
Site
Wrong
Procedure
Wrong
Implant
Percent
EXAMPLES…
Patient: Similar
Diagnosis or
Name
Side: Other
Side Similar
Diagnosis
Site: On Spine
or Hand/Wrist
Procedure:
Biopsy vs.
Cystoscopy
Implant: Lens

34. VA RCA data on Retained
Surgical Items, 2000-2005
Sponge
, 52
Towel,
5
Other,
8

35. Human Factors and Strength of Actions

36. Safety & Human Error:
Challenges
 Healthcare Views Errors as Failings
Which Deserve Blame - Fault
 Train and Blame Mentality
 Blind Adherence To Rules
 Corrective Actions Focusing on
Individual
 No Blood No Foul Philosophy

37. Safety & Human Error:
Cornerstones
 People Don’t Come to Work to Hurt
Someone or Make a Mistake
 Must Keep Asking “Why?”

38. Safety – Human Error
Technical
Individual
Team
Profession
Institution
Policies/Procedures
Accident
LATENT
FAILURES
DEFENSES
Incomplete
procedures
Regulatory
narrowness
Mixed
Messages
Production
pressures
Responsibility
shifting
Inadequate
training
Attention
Distractions
Clumsy
Technology
Deferred
Maintenance

39. Patient Safety - Strategy
 Invite People to Play
– Problem Recognition
– Remove Barriers (Punitive, Difficulty, Black
Hole Effect)
– Learning NOT Accountability System
 Importance of Close Call
 Blameworthy Definition
 Training (Middle thru Top Management)
Leadership At All Levels
 Human Factors Approach
– Tools That Guide Behavior

40. Changing Culture
Tools
Behavior
Attitude
CULTURE!!!

41. Prioritize
 Risk Based
– Severity
– Probability
 Must Make Sense
– Business Processes
– Regulatory Environment

42. Systematic
 Cause and Effect
 Human Error Must Have Preceding
Cause
 Failure to Follow Procedure By Itself Is
NOT a Root Cause
 Negative Descriptors Aren’t Actionable
 Failure To Act Is not Cause Without
Pre-existing Requirement To Act
 Why,Why,Why

43. Causation/Actions:
Who vs.What &Why
 Who
– ‘Whose Fault Is This?’
– Actions focused on correcting individual
– ‘Corrects’ only after problem occurs
– Limited scope of action and generalizability
 What & Why
– Actions focus on systems level causation
– Widespread applicability
– Stronger preventive strategy

44. Intentionally Unsafe Acts
 “…events that result from: a criminal act; a
purposefully unsafe act; an act related to
alcohol or substance abuse by an impaired
provider and/or staff; or events involving
alleged or suspected patient abuse of any
kind.”
 Intentionally Unsafe Acts are off-limits to
Patient Safety (RCA) review, everything else
is within limits

45. On Being Human

46. Behavior Response
 When I say “up”, everyone raise
your hand as quickly as you
can

47. This was not an aerobic exercise
 Demonstrates: “paired associate
learning”

48. Medical Software Correlation
- Pharmacist uses 95% of time.
- “Enter” button enters data.
- Pharmacist uses 5% of time.
- “Spacebar” enters data.

53. “Take-away” on Human Factors…
 Considering and acting on knowledge
regarding human capabilities,
limitations, and tendencies when
designing and operating devices and
systems
 Not always “common sense”

54. 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 – forcing
functions)
 Is there one right action???
Weaker
Stronger

55. Actions & Interventions

56. Stronger
Actions
• Architectural/physical plant changes
• New devices with usability testing before purchasing
• Engineering control or interlock (forcing
functions)
• Simplify the process and remove unnecessary steps
• Standardize on equipment on process or caremaps
• Tangible involvement and action by
leadership in support of patient safety
Intermediate
Actions
• Redundancy
• Increase in staffing/decrease in workload
• Software enhancements/modifications
• Eliminate/reduce distractions (sterile medical
environment)
• Checklist/cognitive aid
• Eliminate look and sound-alikes
• Readback
• Enhanced documentation/communication
Weaker
Actions
• Double checks
• Warnings and labels
• New procedure/memorandum/policy
• Training
• Additional study/analysis

57. Strong Action: Brake and Automatic
Transmission Connection

58. “Simple” Engineering Solutions at
Disneyworld Resorts (Motels)

59. Simple Engineering Solutions at
Disneyworld Resorts (Motels)
Now I need a car roof
that’s round!

60. Blue tubing does not fit here or here…it only fits here

61. Alert based on “wrong-tube” RCAs
 Veterans Health Administration Warning System
 Published by VA Central Office
 AL06-012 April 6, 2006
– Item: Mix-up (wrong route of administration) of bladder
irrigation with intravenous (IV) infusions
– Specific Incidents: Since 2001, VA facilities have reported
five cases of accidental infusion into an IV line or PICC line.
Amphotericin B (Attachment #1) was given intravenously
when it was intended for irrigation of the bladder via a
catheter. The same adverse event could occur with Glycine.
Amphotericin B and Glycine are both contraindicated in
patients with kidney or liver disease and when Amphotericin
B is infused via IV line, it can induce serious complications
(e.g., kidney failure).

62. Look-alikes (different “eye-drops”)
Sound-alikes (e.g., Flomax and Flonase)

63. Redundancy vs. Double-check
in Spelunking (Caving)
 Two choices of
equipment
1. One flashlight 
batteries checked twice
2. One flashlight  and
one headlamp

64. Lawnmower cut-off switch

65. Experience is an Expensive Teacher

66. Management Involvement
 Formalized, Not Ad Hoc
 Safety Permeates the Fabric of All
Activities
 Relentless

67. Safety System Design

68. Action AssessmentAssessment
 Characteristics of Actions
– Temporary vs. Permanent
– Procedural vs. Physical
 Action Evaluation
– Process
– Outcome

69. Business Case for Patient Safety

70. Is There A Business Case?
 YOU BET!!!
 Examples:
– “Easy CAP” CO2 Detector
• $154/detected esophageal intubation
– RCA/40person-hrs X 12RCA/yr
• 0.25FTEE

71. Devices to prevent Out-of-OR Esophageal
Intubations are Cost-Effective
Description Equation =
Numerator Cost to implement (11,000
[# of codes] x $10)
$110,000
Denominator Number of recognized
events (assuming 100%
prevention effectiveness)
715
Cost-Effectiveness
Measure
$110,000 / 715 $154
Interpretation
It will cost $154 to detect one
unanticipated esophageal intubation
($10 per use at a rate of 6.5%)

72. Benefit-Cost of Patient Safety
 National Center for Patient Safety,
Regional Patient Safety Officers, Facility
Patient Safety Managers, Local RCA
teams
~$130k per VA Medical Center (0.1%)
If this is a VA facility’s budget
This is Patient
Safety’s Share

73. Some Interventions have Zero Cost
Use of Antimicrobial Soap in VAMCs
43
19
38
3 16
81
0
10
20
30
40
50
60
70
80
90
Use Antimicrobial
Soap Only
Use Non-
antimicrobial
Soap Only
Use Both Types
of Soap
Percent(N=~120)
Dec-03
May-04
See Hand Hygiene Tools on www.patientsafety.gov

74. Summary and Wrap up

75. Sustainable Systems Approach
 Problem Identification
 Clear Goal Definition
 Involvement Of All Sectors
 Identify Systems Influences
 Identify Systems Controls
 Identify Constraints
 Critique – Go To Worst Critics Early On
 Pilot – Volunteers First Then Others
 Evaluate

76. Critical Elements
 Safe for Reporters/Participants
 Prioritization Method
 What is Blameworthy
 Not About Fault – 3 W’s
 Human Factors Engineering Tools
– Triage Cards, RCA Method
 Concur/Not Concur (Mgmt/Leadership)
 Feedback
 Dedicated Patient Safety Duties

77. Closing Thoughts
 Not About Errors!!!
 Counting reports is not the objective,
identifying Vulnerabilities is
– Hope they increase
–Analysis, Action, & Feedback
are the key
 Prevention NOT Punishment
 Cultural change is the key – takes time
Safety is the Foundation
Upon which Quality is Built

78. Safety as the Foundation?
 Quality programs can ensure that we use
evidence-based medicine to determine
which cardiac patients…
– Are prescribed the most appropriate of many
medications, and/or
– Get angioplasty with or without drug-eluting or
bare metal stents, and/or
– Get CABG surgery
 But if they get surgical site and/or urinary
tract infections, and/or fall in the hospital…
– Can you call this High Quality Care???

79. Why Bother?
1. The Problem is Real
2. You Can Do Things to Make it
Better
“They say that time changes
things, but you actually have to
change them yourself”
Andy Warhol

80. Recently we have received a number of questions about whether is
it legal to buy facial tissues. At issue is whether or not the facial tissues are considered personal items.
We have discussed this issue with Department logistic and financial staff as well as VHA clinical staff.
The following provides a basis for the decision that was reached:
For patient-care areas and areas frequented by those who come in direct contact with patients, facial tissues should be considered
similarly to other expendable supplies that VA workers may use as they perform their duties during work hours. For example, VA
supplies disposable respirators, gloves, and surgical scrubs and gowns, all of which are employed by staff to protect patients from the
spread of infectious agents. This type of expenditure is clearly appropriate. On the second point, recent guidance from the CDC,
JCAHO, the National Health Information Center of the Department of Health and Human Services, and the American Lung Association
have all included recommendations for using tissues to cover coughs and sneezes to prevent the spread of infectious agents. First
among these infectious agents are viruses that cause upper respiratory infections such as cold and flu, but another agent of concern is
Staph. aureus (SA), including methicillin-resistant SA (MRSA), either of which can cause skin and wound infections. Various estimates
put the percentage of healthcare workers whose nasal passages are colonized with SA at about 30-40%. (The percent colonized by
MRSA is not well described and seems likely to vary widely.) SA and MRSA can be expelled from the nose during a sneeze and live for
days or weeks on substrates such as clothes, linens, curtains, countertops, and other environmental surfaces where they can be picked
up on hands or transferred to other surfaces and eventually patients. Using a tissue to reduce the dispersion of droplets and the gross
contamination of hands or clothes is imperfect but is widely recommended as a basic measure to control the spread of infectious agents.
Conclusion: Facial tissues to be used in patient care areas and
areas frequented by those who come in direct contact with patients
can be purchased with appropriated funds. This memo should not be taken as a mandate
to generate any new requirement to provide tissues in specific locations or at any pre-set density. Decisions on this topic should be
made locally and incorporate local circumstances and considerations.
(Agreed upon by: Fiscal, Accounting, Legal, Network Clinical
Managers, Public Health, Environment of Care, Infectious
Diseases, Patient Safety, in about 3 weeks.)

81. Are we there yet?
“From a certain point forward there
is no longer any turning back. That
is the point that must be reached”
- Franz Kafka

82. Have a Safe Trip Home!
San Diego