Patient Safety Presentation to 2007 Veterans Health Association NSQIP Meeting - includes information on wrong site surgery, retained surgical items, human factors, and other topics

1. 1
Patient Safety Presentation for
NSQIP SCNR Conference
Noel Eldridge, MS
VA National Center for Patient Safety
September 25, 2007

2. 2
Outline
• Background on Patient Safety, in general
and VA’s program
• Patient Safety Data and Information on
Surgery Topics
• Intro to Human Factors Engineering and
Actions to Prevent Adverse Events
• Wrap-up

3. 3
What is Safety?
• Safety is Freedom from Accidental Injury.
• Patient Safety Improvement is dedicated to
making patients free from accidental injury
as they receive healthcare.
– Not performing the wrong operation
– Not accidentally putting MRSA bacteria onto a
patient’s skin
– Preventing fall injuries, etc.

4. 4
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)

5. 6
NY Times and W. Post
• 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

6. 7
CDC’s Latest Estimate (2007)
• The estimated deaths associated with
healthcare-associated infections [for 2002] in
U.S. hospitals were 98,987: of these,
• 35,967 were for pneumonia,
• 30,665 for bloodstream infections,
• 13,088 for urinary tract infections,
• 8,205 for surgical site infections, and
• 11,062 for infections of other sites.
– Public Health Reports, March–April 2007, pp 160-166

7. 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!!!!

8. 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”?

9. 10
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10. 11

11. 12
NAVAL AVIATION MISHAP RATE
776 aircraft
destroyed in
1954
FY 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
Class
A
Mishaps/100,000
Flight
Hours

12. 13

13. 14
Three Important Questions
1. What Happened?
2. Why Did it Happen?
3. What Should We Do to Prevent it
from Happening Again?
(The answers are based on the
results of a local accident
investigation, such as a Root Cause
Analysis.)

14. 15
Three Other
Important Questions
1. What Happened?
2. What was Supposed to Happen?
3. What Usually Happens?
These questions are good for understanding
the role of the “normalization of deviance,”
i.e., a culture of ignoring the rules, e.g.,
Beltway norm of 70 mph when “speed limit” is
55 mph.

15. 16
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.”)

16. 17
VA Annual Events Reported
(including close calls) is Still Going Up

17. 18
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

18. 19
Most VA Reports are Actual “SAC 1s”
(events with little or no harm, or close calls)

19. 20
The Value of Close Calls in Safety
Close calls can provide “sentinel” information
without or before the “Sentinel Event.”

20. 21
Patient Safety System Design

21. 22
Patient Safety System Design

22. 23
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.

23. 24
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

24. 25
OIG Report on Patient
Safety in the Operating Room
www.va.gov/oig/54/reports/VAOIG-05-00379-91.pdf

25. 26
Purpose of the OIG Review
• To “determine whether”:
1. “facility leaders established and implemented
effective policies, procedures, and guidelines to
ensure patient safety in the OR”;
2. “facility leaders established surgical improvement
program and identifies potential problem areas
needing improvement; and
3. “there was coordination between Supply,
Processing, and Distribution (SPD) and the OR”
Eight (8) VAMCs Visited by OIG Staff

26. 27
Summary of Findings
• Issue 1: Compliance
with VHA Directives,
AORN Guidelines, &
JCAHO Standards
• Issue 2: Surgical
Performance
Improvement Program
• Issue 3: SPD
Coordination with the
OR

27. 28
Accentuating the Negative
• Ensuring Correct Surgery
– We found that …two (of 8) facilities… had policies that only
addressed side/site verification.
– We found that two (of 8) facilities… had incident or near
miss incorrect surgery events in fiscal year (FY) 2005.
• The first facility reviewed the event of the wrong site surgery and
determined that (a) the surgeon did not possess the consent form when
the site was marked, (b) the nurse circulator did not mention the
variance between the marked site and the consent, and (c) a time-out
briefing with the informed consent was not performed.
• At the second facility, a patient had the wrong eye anesthetized
(blocked)…The incident was reviewed and monitors were developed
and implemented to ensure the correct site was identified and marked.
• Related JCAHO Finding from 2006 Surveys
– 12 of 33 (36%) VAMCs received RFIs for “Universal
Protocol” (11 Time-outs and 1 Mark Operative Site).

28. 29
Accentuating the Negative
• Disclosure of Adverse Events
– We found that three (of 8) facilities failed to
document disclosure of adverse surgical events.
• At one facility, two patients had to return to surgery
with partially retained drains. (no record of
disclosure)
• At a second facility, the surgeon administered a
regional block into the wrong eye. (no record of
disclosure)
• In the third facility, we reviewed three surgery-related
deaths that involved delay in diagnosis or
treatment… (no record of disclosure)

29. 30
OR Self-Assessment Tools #2 & 3
Summary Results (Local Policy Reviews)
Step 1: Informed Consent. (No. of Question = 6) 94%
Step 2: Marking the Site. (No. of Question = 7) 94%
Step 3: Patient Identification: (No. of Question 6) 94%
Step 4: Time out: (No. of Questions = 11) 90%
Step 5: Checking Imaging Date: (No. of Questions = 4) 96%
Overall Percent Met (Total No. of Questions = 34) 93%
Overall Percent Met (Total No. of Questions = 22) 87%
RESULTS FOR OR SELF-ASSESSMENT TOOL #2 :
VHA Directive 2004-028: Ensuring Correct Surgery and Invasive Procedures -
Blank's & NA's Excluded from Total Count
RESULTS FOR OR SELF-ASSESSMENT TOOL #3 :
VHA Directive 2006-030: Prevention of Retained Surgical Items - Blanks &
NA's Excluded from Total Count

30. 31
RESULTS FOR OR SELF-ASSESSMENT TOOL #4
(MISCELLANEOUS POLICIES AND PROCESSES REVIEWED BY OIG)
Blanks & NA's Excluded from Total Count
Percent
Met:
VAMC Policy Review for Environment of Care (VHA Design Standards
2004-VHA OR-HVAC Design Criteria) and (JCAHO EC 1.7). (No. of
Question = 9) 73%
Operating Room Equipment Management. (No. of Question = 5) 94%
Operating Room and Invasive Procedure Committee. (No. of
Question = 4) 88%
VHA Directive 2005-056 Morbidity and Mortality Peer Review. (No. of
Questions = 4) 96%
Resident Supervision (regarding Surgery). (No. of Questions = 4) 97%
Advanced Cardiovascular Life Support and Basic Life Support
(ACLS and BLS Certification). (No. of Questions = 2) 93%
Disclosure of Adverse Events (VHA Directive 2005-049). (No. of
Questions = 4) 91%
Supply Processing, and Distribution Coordination with the Operating
Room. (No. of Questions = 3) 79%
Overall Compliance Met (Total No. of Questions = 36) 87%
OR Self-Assessment Tool #4

31. 32
What “Not Met’s” Add Up To
(VHA-Wide)
• Self Assessment Tool #2 (Ensuring
Correct Surgery): 287 Not Met’s
• Self Assessment Tool #3 (Prevention of
Retained Surgical Items): 350 Not Met’s
• Self Assessment Tool #4 (Various Policies
and Processes): 506 Not Met’s
• This is over 1,100 Not Met’s (as of 7/2007)

32. 33
Ensuring Correct Surgery
• Draft data from a paper in preparation
• We have more data on this topic that
anyone else we have been able to find…

33. 34
Percents of Reports of In-OR Incorrect Surgeries
and Percent of Surgeries, by Specialty
3%
4%
5%
9%
10%
24%
38%
2%
2%
5%
20%
31%
11%
11%
0% 10% 20% 30% 40% 50%
Podiatry
Neurosurgery
Vascular Surgery
Urology
General Surgery
Orthopedics
Ophthalmology Percent of VA
Surgical Cases (6
yrs of Surgery
Package data)
Percent of In-OR
Adverse Events
Reported to
NCPS (5.5 yrs)

34. 35
Percentage of Adverse Events in the OR
and Not in the OR (n = 212 total)
0% 10% 20% 30% 40%
Other
Wrong Procedure
Wrong Site
Wrong Implant
Wrong Patient
Wrong Side
OR
Non OR

35. 36
Tentative Take-Home Points
• Reports of Eye and Orthopedic cases
overrepresented compared to number of cases.
• Reports of classic “wrong-side in OR” cases are
only 20-25% of reports.
• Wrong implants are a special issue and are
almost as commonly reported in OR.
• We didn’t get reports from VAMCs that said “We
did everything right and it happened anyway.”
– Mark virtually all sites!
– Always get real Informed Consent!
– Always do a real Time-out!

36. 37
Retained Surgical Items
• Data from 2000 to 2005 that was used in
policy (Directive) development
• Data from NCPS reports since Directive
issued (6/2006 to 6/2007)
• NSQIP web site data on this topic not
shown (under review)

37. 38
Data Submitted by VAMCs to NCPS
Retained Surgical Items,
by Type of Item, 2000-2005
Sponge,
52, 80%
Towel, 5,
8%
Other, 8,
12%

38. 39
Retained Items Reports to NCPS (6/06 to 6/07)
6/2006 thru 6/2007 Data Extracted from NCPS Database
-Actual Adverse Events -
OVER 300 REPORTS OF CLOSE CALLS NOT SHOWN
Number of Reports Submitted to NCPS
0
9
19
Towels
Sponges
Sharp, Instrument, Other
Note: Over 90% of reports (n=~400)
in this time period are close calls or
other no-harm incidents!

39. 40
Retained Sponges & Count Status
Retained Surgical Sponges (Only)
2000-2005
Final Counts
unclear, 17,
33%
No Counts
done, 3, 6%
Final Count
Incorrect, 12,
23%
Final Count
Correct, 20,
38%

40. 41
Retained Items & Count Status
All Retained Items & Count Status, 2000-2005
Incorrect Count,
12, 18%
Correct Count,
21, 33%
No Count (count
possible), 11,
17%
Count Status
Unclear, 17, 26%
Count
Impossible, 4,
6%

41. 42
Retained Items vs. Retained
Surgical Items: More Work Needed
• Sponges, clamps, and towels are “surgical
items”…
• But how about…
– miscellaneous “lines” and parts of lines and
catheters, blade of urethratome, “wires”, outflow
cannula, distal segment of “mediport”, etc.
– Many new reports of retained items are not
“classic” retained surgical items, i.e., not items
accidentally “left in” after surgery

42. 43
Tentative Take-Home Points
• Reporting of retained items increased after
Directive, especially reporting of unusual items,
as well as miscounts, close calls, and other no-
harm incidents
• Reporting of retained sponge actual adverse
events did not increase as other reporting
increased immensely.
• A minority of countable retained items resulted
from situations in which their count was certainly
correct.
– Incorrect counts should be taken very seriously.
• Another “methodical wound exploration” and a
dedicated radiograph when count is wrong (i.e.,
unreconciled)…

43. 44
Human Factors

44. 45
Textbook Human Factors
• Yes, there is a textbook.
– mine was in it’s 5th edition in 1987
• Established after World War II
• It’s usually taught in the Industrial
Engineering department
– Sometimes by unusual engineers
– Sometimes by practical psychologists
– Or anthropologists who decided they needed
to learn something that pays

45. 46
From Sanders and McCormick
• Human factors focuses on human beings and
their interaction with products, equipment
facilities, procedures, and environments used in
work and everyday living.
• Human factors seeks to change the things that
people use [rather than changing the people that
use the things] to better match human
capabilities, limitations, and needs.

46. 47
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

47. 48
Safety & Human Error:
Cornerstones
• People Don’t Come to Work to Hurt
Someone or Make a Mistake
• Must Keep Asking “Why?”

48. 49
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.

49. 50
On Being Human

50. 51
Behavior Response
• When I say “up”, raise your hand
as quickly as you can

51. 52
Basketball Video
• Count the passes from one player wearing
white to another player wearing white.
• How many passes did you see?

52. 53
Medical Software Correlation
- Pharmacist uses 95% of time.
- “Enter” button enters data.
- Pharmacist uses 5% of time.
- “Spacebar” enters data.

53. 54

54. 55

55. 56

56. 57

57. 58
Actions & Interventions

58. 59
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

59. 60
Strong Action: Brake and Automatic
Transmission Connection

60. 61
“Simple” Engineering Solutions at
Disneyworld Resorts (Motels)

61. 62
“Simple” Engineering Solutions at
Disneyworld Resorts (Motels)
Now I need a car
roof that’s round!

62. 63
Blue tubing does not fit here or here…it only fits here

63. 64
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).

64. 65
Look-alikes (different “eye-drops”)
Sound-alikes (e.g., Flomax and Flonase)

65. 66
Redundancy vs. Double-check
in Spelunking (Caving)
• Two choices of equipment
1. One flashlight  batteries
checked twice
2. One flashlight  and one
headlamp
WHICH ACTION IS STRONGER?

66. 67
Don’t Forget:
Action Assessment
• Characteristics of Actions
– Temporary vs. Permanent
– Procedural vs. Physical
• Action Evaluation
– Process
– Outcome

67. 68
Summary and Wrap up

68. 69
Closing Thoughts
• Counting reports is not the objective,
identifying local vulnerabilities is…
– Analysis, Action, & Feedback Matter
• Prevention NOT Punishment
– Do not drive down reporting of incidents and
problems and declare success
• Cultural change is the key…
• Safety is the Foundation Upon
which Quality is Built

69. 70
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???

70. 71
Why Bother?
1. The Problem is Real
2. We Can All Do Things to Make it Better
Really believing and communicating
these 2 points fosters a “culture of
safety” and a “culture change”.
Example: MADD, Seatbelt laws, applying
research, modifying roads, etc., decreased
auto accident death rate 75% over 40 years.

71. 72
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
“They say that time changes things, but you
actually have to change them yourself”
- Andy Warhol