Keynote talk delivered at New Jersey Hospital Association Seminary on Improving Surgical Safety & Patient Outcomes held on September 25, 2013 at their Conference Center in Princeton New Jersey. Over physicians, administrators, nurses and perioperative services providers in attendance.

1. Reducing Surgical-Related Harm
Through Improved Quality of Care
C. Daniel Smith, MD
New Jersey Hospital Association Partnership for Patients
Improving Surgical Safety and Patient Outcomes
September 25, 2013
1

2. • No financial or other relationship with any
product or treatment discussed in this talk
Conflict of Interest / Disclosure

3. Disclaimers
• I am not a quality or safety expert
• I am a surgeon and an innovator (really an early
adoptor)..innovation in practice, leadership
• Leading change at Mayo in Florida for 7 years
• Mayo in Florida has become a significant positive
outlier in many outcomes and safety measures
(NSQIP, FCIP, Leapfrog, USNWR, etc.)
• I will not tell you anything today you don’t already
know

4. Surgeon Characteristics
• Intelligent – typically at top of medical school class
• Well educated – competitive course of training, typically
10+ years postgraduate
• Strong – emotionally and physically demanding work
• Confident – Patients don’t want an unsure surgeon
• Action oriented – Like to fix problems and see
immediate results
• Unique – No one else in medicine quite the same

5. Surgeon Characteristics
• Big ego – it takes a big ego to cut people open. “Anyone
else does this and they go to jail, patients pay us to do this”
• Solo predator – had to compete for limited training
opportunities. The person next to you may take away your
future.
• OCD and Paranoid – healthy traits to prevent doing
something stupid or leaving something behind
• Martyr – uniquely retain the full spectrum of patient care.
“The rest of medicine is going to shift work and separate
inpatient/outpatient teams”
• Special – “other than God, no one else can see and touch
what’s inside my body”

6. Today’s Goals/Objectives
• Construct for pursuing improved
outcomes / safety in surgery
• Case study in SSI reduction
• Establishing a culture of safety
• Q&A
6

7. Healthcare Delivery Goals
7
To provide the right care
To the right patient
At the right time
In the right place
Value =
Quality*
Cost
*Outcomes, Safety, Service

8. How Are We Doing?
• 44,000-98,000 Americans die in
hospitals as result of medical
error
• $37.6 billion from adverse events
• $17 billion preventable adverse
events
• More die from medical error than
from highway accidents or breast
cancer
November 1999

9. Never Events in Surgery
Electrical /
Thermal Injury
Specimen
Error
Medication
Error
Blood Products
Error
Patient
Fall
Drug Diversion
Wrong Site
Surgery
Wrong Patient
Surgery
Wrong
Procedure
Retained
Foreign Body
Operative
Death

10. Never Events in Surgery
312 Never Events reported to
Minnesota Department of Health
2007-2008

11. Never Events in Surgery
Surgery 2013;153:465-72.

12. Never Events in Surgery
A surgeon in the United States leaves a foreign
object such as a sponge or towel inside a
patient's body after an operation 39 times a week,
performs the wrong procedure on a patient 20
times a week, and operates on the wrong body
site 20 times a week.
Surgery 2013;153:465-72.

13. Healthcare Delivery Goals
13
To provide the right care
To the right patient
At the right time
In the right place
Value =
Quality*
Cost
*Outcomes, Safety, Service

14. Healthcare Delivery Goals
14
Value =
Quality*
Cost*Outcomes, Safety, Service

15. Value Equation – Quality Defined
• Outcome – a final result; end product
• Safety – freedom from harm, danger or
injury
• Service – the action of helping or doing
work for someone
15

16. Value Equation – Quality Measured
• Outcome
• Safety
• Service
16
Unexpected return to OR
Transfusion requirement
LOS
OR time
Complication

17. Value Equation – Quality Measured
• Outcome
• Safety
• Service
17
Never events
UP compliance
STOP sign compliance

18. Value Equation – Quality Measured
• Outcome
• Safety
• Service
18
Patient satisfaction survey
Call to appointment
Door-to-OR

19. Value Equation – Quality Quantified
• Outcome
• Safety
• Service
19
Unexpected return to OR
Transfusion requirement
LOS
OR time
Complication
Never events
UP compliance
STOP sign compliance
Patient satisfaction survey
Call to appointment
Door-to-OR

20. Value Equation – Quality Quantified
• Outcome
• Safety
• Service
20
Unexpected return to OR
Transfusion requirement
LOS
OR time
Complication
Never events
UP compliance
STOP sign compliance
Patient satisfaction survey
Call to appointment
Door-to-OR
Assign a relative value to each
Plug into value equation
Plot changes/progress over time

21. The Value Equation Realized
21
Value =
Quality*
Cost
*Outcomes, Safety, Service
Unexpected return to OR
Transfusion requirement
LOS
OR time
Complication
Never events
UP compliance
STOP sign compliance
Patient satisfaction survey
Call to appointment
Door-to-OR
5.6 =
1350
241
*Outcomes, Safety, Service

22. Outcomes in Surgery
22

23. Outcomes Improvement in Surgery
23
Processes
• Six Sigma
• LEAN
• CQI
• SCIP
• NSQIP
• BPBC
Standardizing a process
will result in improved
outcomes…generalized
from manufacturing

24. Outcomes Improvement in Surgery
24
Processes
• Six Sigma
• LEAN
• CQI
• SCIP
• NSQIP
• BPBC
A recent study performed across 112
Veterans Affairs hospitals and involving a
total of 60,853 operations found that the
implementation of the SCIP infection-
prevention measures did not yield
measurable improvement in SSIs at the
patient or hospital level or an improvement
in adjusted SSI rates over the im-
plementation period.
“although the processes measured are best
practices and should continue, they might be
too simplistic or blunt to discriminate hospital
quality”
Ann Surg 2011;254(3):494–9

25. Outcomes Improvement in Surgery
25
Processes Culture
• Process Improvement
• “Just do it”
• PDSA
• Rapid cycles of
change
≠
• Six Sigma
• LEAN
• CQI
• SCIP
• NSQIP
• BPBC

26. Outcomes Improvement in Surgery
26
SSI Case Study
Thompson KM, Oldenburg WA, Deschamps C, Rupp, W,
Smith CD. Chasing zero: the drive to eliminate surgical
site infections. Ann Surg 2011;254(3):430–6

27. Healthcare Associated Infections
• 1.7 million infections costing $45 billion
• Surgical site infections 2nd
most common HAI
• SSI is 2nd
only to medication error as adverse
event in hospitalized patient
• Estimated cost of additional $3,000 per SSI
infection
• Best practices for reducing SSI remains illusive
27

28. SSI Reduction Project - Aim
• Test the hypothesis that development of an
organized structure to facilitate rapid
development and diffusion of multiple
infection prevention strategies simultaneously
would result in lower rates of surgical site
infection
28

29. SSI Reduction Project - Aim
• Test the hypothesis that development of an
organized structure to facilitate rapid
development and diffusion of multiple
infection prevention strategies simultaneously
would result in lower rates of surgical site
infection
29
No single Process (e.g., SCIP) will
eliminate SSIs.
A BUNDLE of care based on Change &
Quality Improvement principles is more
likely to work.
Pursue an “SSI Elimination Bundle”

30. Mayo Clinic Culture
• Fully integrated healthcare practice
• Physician leadership (CEO)
• All physicians salaried
• No productivity-based financial
compensation adjustment
• Day-to-day operations managed by MD led
committees
30

31. Mayo Clinic Florida
• 214 bed hospital (19 ORs) and outpatient
practice within a single complex/campus
• 11,000 admissions/ year: 55% surgical
• Single electronic medical record and order
entry throughout practice
• 12,000 operations/year – complex case mix
(e.g., 150 liver transplants, 1,200 NS, 900
GISurg)
31

32. Surgical Site Infections - Background
32
SSIRate(infections/100surgeries)
New CEO
New Hospital

33. CEO Imperatives
• Focus on quality and safety
• “Just do it”
• Rapid cycle change
• Eliminate healthcare associated infections
• Leverage organization’s core values (needs of
patient come first, teamwork)
33

34. SSI Reduction Project - Design
• Project embedded in existing quality/safety
management structure
• Steering committee to oversee all aspects of project
including metrics and impact of interventions
• Evidence-based modifiable risk factors identified and
gap analysis performed
• Specific targets for improvement identified
• Multidisciplinary workgroups (frontline workers)
assigned each target
34

35. SSI Reduction Project - Design
• Pre-op (8)
• Holding (2)
• Intra-op (11)
• Post-op (3)
• Surgeon Specific (3)
35
Potential Interventions

36. Pre-operative
1. Identify and treat all infections remote to
the surgical site before elective operation
2. Encourage smoking cessation within 30
days before procedure
3. Avoid immunosuppressive medications in
the perioperative period if possible
4. Preoperative antiseptic skin cleansing
5. Mechanical preparation of the colon for
colorectal surgery patients
6. Administer non-absorbable oral
antimicrobial agents on the day before
the operation
7. Screen and decolonize Staphylococcus
aureus carriers undergoing elective
procedures
8. Screen preop blood glucose levels in
patients undergoing select elective
procedures
Holding
9. Only remove hair that is will interfere
with the operation
10. Remove hair immediately before the
operation with clippers (SCIP 6)
Intra-operative
11. Select appropriate antibiotic based on the
surgical procedure (SCIP 2)
12. Increase dosing of prophylactic
antimicrobial agent for morbidly obese
patients
13. Administer prophylactic antimicrobial
agents IV on time (SCIP 1)
14. Use an appropriate antiseptic agent for
skin preparation
15. Maintain therapeutic levels of the
prophylactic antimicrobial agent
throughout the operation
16. Use at least 50% fraction of inspired
oxygen for select procedures
17. Keep OR doors closed during surgery
18. Maintain peri-operative normothermia
(SCIP 9)
19. Adhere to standard principles of
operating room asepsis
20. Optimize ventilation, environmental
cleaning and sterilization of surgical
equipment
21. Minimize flash sterilization
Post-operative
22. Adequately control serum blood glucose
levels in diabetic patients (SCIP 4)
23. Protect primary-closure incisions with a
sterile dressing for 24-48 hours
postoperatively
24. Discontinue the prophylactic
antimicrobial agent within 24 hours of
surgery (SCIP 3)
Surgeon Technique
25. Use appropriate antiseptic agent to
perform preoperative surgical scrub for
surgical team members
26. Handle tissue carefully and eradicate
dead space
27. Minimize operative time as much as
possible
Transparency
28. Feedback surgeon specific infection rates
SSI Reduction Project - Design
36

37. SSI Reduction Project - Design
Deploy in three phases concurrently
37
Phase One
Consistent delivery
of SCIP 1-3
interventions
Phase Two
Modifiable risk
factors with
scientific evidence
linked to SSI
reduction
Phase Three
Focus on intra-op
environment and
reporting
Preoperative
Evaluation
(POE) Clinic

38. SSI Reduction Project - Design
Deploy in three phases concurrently
38
Phase One
• Revise order sets
• On-time antibiotic
delivery
• EMR-based alerts
• Confirm antibiotics
during time out
• Clippers in OR
• Intraop normothermia
Phase Two
• S. aureus decolonization
• Standard periop skin
cleansing
• Intraop protocols for skin
prep, antibiotic dosing
and timing
• Hand hygiene
• Incision dressing – 24
hrs
Phase Three
• Intraop flow, attire,
coverings
• All-or-none metrics
Preoperative
Evaluation
(POE) Clinic

39. Management & Flow
39
Preop Bathing
Workgroup
CEO & Executive
Operations Team
Clinical Practice Quality
Oversight Committee
Healthcare Associated Infection
Prevention Steering Committee
Surgical Quality Subcommittee
(SSI Reporting Task Force)
Postop Dressing
Workgroup
SCIP 3
Workgroup

40. SSI Reduction Project - Communication
40
•CEO’s monthly Department Chair and
staff meetings
•HOS all staff meetings (MD, nursing,
support services)
•Standing item on Surgical Committee
agenda
•Workgroup reports to peers

41. SSI Reduction Project - Transparency
41

42. SSI Reduction Project – Data
• Trained infection control practitioners
• NHSN definitions to identify and classify SSI
• Baseline SSI data collected from May 2008 –
Dec 2008
• Data collected thru Jun 2010 and analyzed
• Comparison to baseline and rolling 6-month
average
42

43. SSI Reduction Project - Results
43
New Hospital

44. SSI Reduction Project - Results
44

45. SSI Reduction Project - Results
• Case volume, RVU and case complexity unchanged
thru project period
• Of 10 surgical services involved:
7 experienced decrease in SSI
2 experienced increase in SSI
1 experienced no change in SSI
45

46. SSI Reduction Project - Summary
• Tactics to rapidly identify and optimize delivery of
recommended SSI risk reduction strategies is
possible on large scale
• Significant reduction in SSI was achieved
71% decrease in Class I SSI
49% decrease in Class II SSI
57% overall decrease in SSIs
• Estimated institutional cost savings of $668,000 -
$1,634,000/year*
46
* From R Scott. The direct medical costs of Healthcare-Associated Infections in
U.S Hospitals and the Benefits of Prevention

47. SSI Reduction Project - Observations
• Methodology embedded in existing quality/safety
culture
• Executive leadership driven
• Electronic medical record
• Communication & Transparency
• Multidisciplinary team-based
development/deployment
• No competing or conflicting individual $ incentives
47

48. SSI Reduction Project - Limitations
• Shotgun approach without defining specific actions
that correlate to results
• Absence of “All-or-None” metrics
• Observed reductions may be related to improved
culture, more attention from leadership, or
improved performance of surgical teams
• Short-term results
48

49. Value Equation – Quality Defined
• Outcome – a final result; end product
• Safety – freedom from harm, danger or
injury
• Service – the action of helping or doing
work for someone
49

52. Never Events in Surgery
A surgeon in the United States leaves a foreign
object such as a sponge or towel inside a
patient's body after an operation 39 times a week,
performs the wrong procedure on a patient 20
times a week, and operates on the wrong body
site 20 times a week.
Surgery 2013;153:465-72.

53. Safety in Surgery
53
Processes
• Time out
• Stop Sign
• Site Marking
• Universal protocol
• SBAR
• Crucial Conversations
• LEAN
• Six Sigma
Culture

54. Safety in Surgery
54
Processes
• Time out
• Stop Sign
• Site Marking
• Universal protocol
• SBAR
• Crucial Conversations
• LEAN
• Six Sigma
• Speak-up without fear
• Communication openness
• Shared behavior
expectations / goals
• Fair and just response to
errors
Culture
≠

55. Safety in Surgery
55
Processes
• Time out
• Stop Sign
• Site Marking
• Universal protocol
• SBAR
• Crucial Conversations
• LEAN
• Six Sigma
Culture
• Speak-up without fear
• Communication openness
• Shared behavior
expectations / goals
• Fair and just response to
errors

56. Safety in Surgery
56
Processes
• Time out
• Stop Sign
• Site Marking
• Universal protocol
• SBAR
• Crucial Conversations
• LEAN
• Six Sigma
Culture
• Speak-up without fear
• Communication openness
• Shared behavior
expectations / goals
• Fair and just response to
errors
• Trust
• How We Manage Errors

57. N o N o N o
Y e s
Y e s
N o Y e s
N o
Y e s
Y e s
Y e s
N o
N o
N o
Y e s
Y e s
N o
D im in is h in g
c u lp a b ilit y
D e c is io n T r e e f o r D e t e r m in in g C u lp a b ilit y o f U n s a f e A c t s
S a b o t a g e ,
m a le v o le n t
d a m a g e ,
s u ic id e , e t c .
S u b s t a n c e
a b u s e
w it h o u t
m it ig a t io n
S u b s t a n c e
a b u s e w it h
m it ig a t io n
P o s s ib le
r e c k le s s
v io la t io n
S y s t e m -
in d u c e d
v io la t io n
P o s s ib le
n e g lig e n t
e r r o r
S y s t e m -
in d u c e d
e r r o r
B la m e le s s
e r r o r
B la m e le s s
e r r o r b u t
c o r r e c t iv e
t r a in in g ,
c o u n s e lin g
n e e d e d
W e r e t h e
a c t io n s a s
in t e n d e d ?
U n a u t h o r iz e d
s u b s t a n c e ?
K n o w in g ly
v io la t e s a f e
o p e r a t in g
p r o c e d u r e s ?
P a s s
s u b s t it u t io n
t e s t ?
Y e s
H is t o r y
o f u n s a f e
a c t s ?
W e r e t h e
c o n s e q u e n c e s
a s in t e n d e d ?
M e d ic a l
c o n d it io n ?
W e r e p r o c e d u r e s
a v a ila b le ,
w o r k a b le ,
in t e llig ib le a n d
c o r r e c t ?
D e f ic ie n c ie s in
t r a in in g &
s e le c t io n o r
in e x p e r ie n c e ?
Reason, J., Managing the Risks of Organizational Accidents
Reason, J: Managing the Risk of
Organizational Accidents

58. Safety in Surgery
58
Processes
• Time out
• Stop Sign
• Site Marking
• Universal protocol
• SBAR
• Crucial Conversations
• LEAN
• Six Sigma
• Commitment Patient &
Colleagues
• Humility - Errors Inevitable
• Metacognition – Error
Prevention & Mitigation
Culture

59. Change in Surgery
59

60. Hazards of Leading of Change
60
“And one should bear in mind that there is nothing more difficult to
execute, nor more dubious of success, nor more dangerous to administer
than to introduce a new order to things; for he who introduces it has all
those who profit from the old order as his enemies; and he has only
lukewarm allies in all those who might profit from the new. ”
from Niccolo Machiavelli's "The Prince"