1. Orthopaedic Surgery Safety Update 2012
Fall Meeting
AAOS
Orthopaedic Surgery Safety Update
2012
William J Robb III MD
Chair
AAOS Orthopaedic Surgery Safety Summit
AAOS Patient Safety Committee

2. Disclosure Consultant – Blue Cross Blue Shield Association
TJR - Centers of Distinction Program
Consultant (Unpaid) - Smith and Nephew
Investor – emmi Solutions
Chair – AAOS Orthopaedic Surgery Safety Summit
Chair – AAOS Patient Safety Committee

3. Is there an Orthopaedic Surgery Safety Problem 2012
Is there an Orthopaedic Surgery Safety Problem 2012? Media ABC News Report - Maryland 2012
Report on Surgical Errors
CMS - only 14% errors reported in hospitals
Advised patients ask about checklists
Report
SSI’s shoulder surgery
Wrong site pediatric eye surgery

4. Is there an Orthopaedic Surgery Safety Problem 2012
Is there an Orthopaedic Surgery Safety Problem 2012? HealthGrades
>350,000 patient safety errors/year
Cost $9B
1/10 safety errors results deaths
>100,000 surgical error deaths/year
Top 5% Hospitals – only 43% reduction safety incidents
Wrong Site Surgery (WSS) rates - 1/20,000 surgeries
Hospital SSI rates 2-3%
NO evidence safety/quality improvement

5. Is there an Orthopaedic Surgery Safety problem 2012?JC
Wrong Site/Procedure/Patient Surgery (WSS)
Mandatory State –bsed WSS Reporting
Minnesota (48 - WSS)
Pennsylvania (58 - WSS)
35.4 WSS/wk. in US (estimated)

6. JC Sentinel Events Data Base 2007-2011 54 Orthopaedic WSS

7. Is there a Orthopaedic Surgery Safety Problem 2012
Is there a Orthopaedic Surgery Safety Problem 2012? Hospital Data JC
>7 wrong site/side/level/implant/procedure/patient surgeries /day
System errors – NOT Surgeon errors
Most frequent causes:
inadequate/missing surgical information
scheduling discrepancies/errors
irregularities in pre-op holding process
inadequate/absent surgical site marking
poor communication
distractions in OR
inadequate/absent OR process/‘time-out’
Mark Chassin MD, MPP, MPH

8. Is there an Orthopaedic Surgery Safety problem 2012?
ABOS Certification/Recertification Data Base – 2011
WSS Rate - 1/30,000 orthopaedic surgeries
NO CHANGE

9. Surgical Safety/Quality/Value Timeline
AAOS - ‘Sign Your Site’ Program - (safety)
IOM Report - To Error is Human: Building a Safer
Health System – (safety)
(44-88,00 deaths in hospitals/year from medical errors)
IOM Report – Crossing the Quality Chasm: A New
Health System for the 21st Century (quality)
VA National Directive to reduce Risk WSS (safety)
JCAHO – ‘Universal Protocol’ (safety/quality)
SCOAP** (safety/quality)
voluntary hospital-based surgical safety/quality – Washington

10. Surgical Safety/Quality/Value Timeline
SCIP* (quality)
mandated national surgical quality standards
WHO ‘Safe Surgery-Saves Lives’ (safety/quality)
Checklist Manifesto –Atul Gwande MD (safety and quality)
Berwick*** CMS Administrator (safety/quality/value)
CMS payments - financial penalties for Never Events
CMS/PQRS payments – financial incentives for ‘quality reporting’
2012 – CMS Public Quality Data Reporting Program (safety/quality/value)
Hospital SSI Rates
Surgical Re-admission Rates
* Surgical Care Outcome Assessment Program – Washington State Hospital Association
** Surgical Care Improvement Program – US Department of Health and Human Services
*** Former President and CEO, Institute for Healthcare Improvement (IHI)

11. Evidence Surgical Safety/Quality/Value Programs are Effective
2006 – Central Line Checklists – Peter Pronovost MD
Reduction central line infections - 40% to <1%
2008 – WHO ‘Safe Surgery - Saves Lives’ - Atul Gwande MD
50% reduction surgical mortality/complications (multi-nation study)
2010 – Surgical Care Outcomes Assessment Program (SCOAP)
Universal Protocol (UP) adopted in all Washington OR’s
< Complications - appendectomy, colectomy, bariatric surgery
< Hospital Costs

12. Evidence Safety/Quality/Value Programs are Effective
2010 – Northern New England Cardiovascular Disease Study
Group
improved Cardiovascular surgery outcomes - participating medical centers
2011 – VA Surgical Safety Program
reduced surgical errors 25%

13. AAOS Orthopaedic Surgery Safety/Quality Survey 2011
Survey Goals
Assess safety/quality in orthopaedics
Evaluate differences by:
sub-specialty
length of practice
practice type
Evaluate orthopaedic leadership attitudes regarding safety/quality
Assess orthopaedic safety practices/culture /errors
Identify opportunities/barriers for change

14. Survey Participants

15. Participating Practice Types

16. Participating Orthopaedic Sub-Specialties

17. Participant Surgical Settings

18. Results Positive Findings
>90% use Universal Protocol (UP) in Hospital OR’s
82% Believe UP Improves Surgical Safety/Quality
No differences in utilization/understanding UP by:
Years in practice
Sub-specialty

19. Results Negative Findings
Surgical errors reported ALL orthopaedic settings
Most ‘undereducated’ safety science
<50% UP use in surgi-centers - rare in office/procedure rooms
Few surgeon safety leaders/champions
Younger surgeons < team communication knowledge

20. Model Safe Orthopaedic Surgical Care

21. Historical Orthopaedic Surgery Culture
Surgical Processes
Highly variable surgical techniques
Surgeon specific care plans
Surgeon-centric care
Data
Experience/ Memory driven
Limited systematic data collection
Communication
‘Top-down’ surgical hierarchy
Limited shared decision making

22. Model Orthopaedic Surgery ‘Culture of Safety’
Surgical Processes
Standardized techniques
Reliable evidence/ consensus-based care plans
System-centric care
Data
Systematic data collection and analysis
Active data management demonstrating improvement/s
Communication
Shared authority ‘team model’
Delegated responsibilities
Transparency

23. Definition Safe Orthopaedic Surgical Care
Safe surgical care is:
surgical care delivered with a highly reliable surgical system
designed to reduce, with a goal of eliminating,
preventable harm/s
continuously monitored through safety data collection
effectively integrating interfaces between surgical:
patient and family
physicians, surgeons and staff
suppliers and equipment
and environments.*
* Modified from Dev Raheja - Safer Hospital Care

24. Definition Quality Orthopaedic Surgical Care
Quality Surgical Care is:
standardized surgical care based upon
medical evidence and/or
consensus-based ‘best’ surgical practices
continually improved through innovation
validated through surgical quality data collection and analysis
achieving optimal composite surgical outcomes

25. Definition Value Orthopaedic Surgical Care
Value in surgical care:
focused on patient-centered outcomes
evaluated continually with surgical benchmarking
supported by only essential resources ($$$)
effectively coordinated through the entire surgical care episode*
* Modified from Michael Porter – Redefining Healthcare

26. Relationship Safety, Quality and Value
Optimal Outcomes with ONLY Essential Resources
Quality
Reliable Care Improvement Systems
Safety
Organized Error Elimination

27. What is needed to improve Orthopaedic Surgical Safety?
Change historical orthopaedic surgical behaviors
Implement surgical safety science and behaviors into ALL orthopaedic settings
Shift focus from ‘surgeon’ to ‘team’ performance
Establish sustainable ‘culture’ of surgical safety
Build and maintain orthopaedic safety/quality data bases
Validate safety programs in orthopaedic settings
Collaboration with other safety stakeholder organizations

28. Key Elements Orthopaedic Surgical Safety
(1) Communication – effective surgical team communication
(2) Consent – accurate timely informed consent
(3) Confirmation – proper surgical site marking/identification
(4) Checklists – use validated standardized processes
(5) Concentration – focused team without distraction
(6) Collection – systematic safety/quality data collection
Submitted to CORR 10/2012 – Kuo, Robb

29. AAOS Surgical Safety Program 2012
2011 Fall Board Workshop
TeamSTEPPS
80 Hospital/Surgicenter training sites
2012 Spring Board Workshop
Develop orthopaedic checklists
Establish/collaborate orthopaedic safety data bases
Surgical Safety Board Oversight Work Group
Chair - Dr. Fred Azar
Orthopaedic Surgery Safety Summit
Chicago – 2012
Orthopaedic Surgery Sub-Specialty Pilot Programs
Validate Pilot Safety Programs

30. Orthopaedic Safety Summit Goals
Unify orthopaedics regarding safety
Reduce errors/ ‘preventable harm/s’
wrong site/side/level/procedure/implant/patient surgery
surgical complications
readmissions
Establish surgical safety as a specialty priority
Improve orthopaedic outcomes
Collaborate with other surgical safety stakeholder organizations

31. Participating/Presenting Organizations
1. American College of Surgeons (ACS) 2. Surgical Care Outcomes Assessment Program (SCOAP) 3. Centers for Disease Control and Prevention (CDC) 4. Centers for Medicare and Medicaid Services (CMS) 5. Agency for Healthcare Research and Quality (AHRQ) 6. The Joint Commission (TJC) 7. Ambulatory Surgical Center Association (ASCA) 8. Accreditation Association for Ambulatory Healthcare (AAAH) 9. Association of Operating Room Nurses (AORN) 10. Webster Healthcare Consulting 11. Pascal Metrics

32. Participating Orthopaedic Organizations
1. American Academy of Orthopaedic Surgeons (AAOS) 2. American Association for Hand Surgery (AAHS) 3. American Orthopaedic Foot and Ankle Society (AOFAS) 4. American Association of Hip and Knee Surgery (AAHKS) 5. American Orthopaedic Society for Sports Medicine (AOSSM) 6. American Shoulder and Elbow Society (ASES) 7. American Society for Surgery of the Hand (ASSH) 8. American Spinal Injury Association (ASIA) 9. Arthroscopy Association of North America (AANA) 10. Cervical Spine Research Society (CSRS) 11. Hip Society (HS) 12. Knee Society (KS)

33. Participating Orthopaedic Organizations
13. Limb Lengthening and Reconstruction Society (LLRS) 14. Musculoskeletal Tumor Society (MSTS) 15. North American Spine Society (NASS) 16. Orthopaedic Trauma Association (OTA) 17. Pediatric Orthopaedic Society of North America (POSNA) 18. Scoliosis Research Society (SRS) 19. Society of Military Orthopaedic Surgeons (SMOS) 20. American Academy of Orthopaedic Surgeons (AAOS) Board of Directors (BOD) Board of Specialty Societies (BOS) Board of Councilors (BOC) Council on Research and Quality (CoRQ) Patient Safety Committee (PSC)

34. Summit Work Group Safety Projects
Hand/Foot Ankle – Opioid Abuse
Hip/Knee/Tumor – SSI Prevention ‘Bundle’
Pediatrics – Peds Patient/ Family Checklist
Spine – Wrong Level Spine Surgery
Sports – ‘UP’ in Surgicenters
Trauma – Hip Fracture

35. Patient Safety Summit Next Steps Develop Pilot Projects
Explore data relationships
ACS, SCOAP
Explore Global SSI Prevention Program
CDC, AHRQ, AAOS
Unified Orthopaedic Safety Information Statement
Explore BOS Safety role

36. Safety Barriers Surgeon resistance to change
Inadequate surgeon knowledge
Limited utilization of surgical team safety science
Limited surgeon data contribution and benchmarking
Inadequate surgeon leadership

37. Orthopaedic Surgical Safety Journey
Safety is no Accident
AAOS Sign Your Site Program 1997

39. Paradigm Shifts Orthopaedic Safety Programs Education
Orthopaedic education programs
New focus/balance safety, quality and value science in all
orthopaedic education programs/products
Orthopaedic Quality Institute
Safety Summit
Standardization system-based focus vs. implant/surgical technique focus

40. Paradigm Shifts Orthopaedic Safety Programs Data
New safety/quality data programs
CMS Public Reporting (PACA)
national benchmarking
regional benchmarking (by state)
HVHC - Dartmouth Institute – private benchmarking collaborative
System performance vs. surgeon performance
System focus ‘prevention harm’ vs. ‘good results’
Deming – count bad light bulbs not good light bulbs
Patient outcomes vs. surgeon outcomes reporting
Multi-center vs. single center trials reporting

41. Paradigm Shifts Orthopaedic Safety Programs Clinical
New standardized system-based interdisciplinary surgical
care programs
Geisinger ProvenCare
Patient contract
Intermountain Health System
ACO’s
‘Bundled Care’ products
NorthShore University HealthSystem
Care reliability (LOS, Costs)
Complication prevention
Readmission management

42. AAOS Orthopaedic Surgery Safety Summit Chicago, 2012
6 Ortho Sub-Specialty Work Groups
Conference Calls. April - July
Safety Webinar
Tuesday, July 31
Safety Summit
Sunday, August 5 - Monday, August 6

43. Hand – Foot/Ankle Work Group
Opioid misuse/abuse
Orthopaedic prescribing practices
Orthopaedic education
Build consensus standards
Collaboration – national organizations/federal government/advocacy

44. Is there an Orthopaedic Surgery Safety Problem 2012
Is there an Orthopaedic Surgery Safety Problem 2012? Orthopaedic Evidence
Orthopaedic surgical outcomes highly variable - by surgeon/hospital/healthcare system/region
Limited local, regional, national orthopaedic safety/quality data
Slow adoption Safety/Quality communication and process
Few recognized surgeon safety leaders/champions

45. Hip, Knee, Tumor Work Group
SSI Prevention ‘bundle’
Pre-op checklist
Diabetic optimization
smoking cessation
OR checklist
Skin Prep
Antibiotic optimization
Post-op checklist
Wound care optimization
PIM/OKO modules
Collaboration – AHRQ, AAHKS, HS, KS, MSTS, CMS, AORN

46. Pediatric Work Group Patient/Family Checklist
10-15 elective procedures
Focus – patient safety, quality, value
Collaboration – POSNA, SRS, Peds Hospitals
Pilot Study

47. Spine Work Group (SMaX) Wrong-level Surgery Prevention
Sign Mark and X-ray
(SMaX)
OR Checklist
Confirmation with imaging
Pilot Study
Develop PIM
Collaboration - NASS
Educate

48. Sports Work Group Universal Protocol (UP)- Surgicenters & Offices
Pilot Project
Scheduling
Pre-op Holding OR
Patient focus
Collaboration – AOSSM,
AANA, JC

49. Trauma Work Group Hip FX Quality Pathway SSI Prevention Hip FX PIM/s
Checklists/order-sets
Pilot Study
SSI Prevention
New SSI Quality ‘bundle’
Pilot study
Hip FX PIM/s
Collaboration - CDC, AHRQ, OTA, AGS

50. AAOS Safe Orthopaedic Surgical Programs
Surgical Team Communication
effective patient and surgical team communication
TeamSTEPPS
human factors supporting a Culture of Safety
distraction-free/focused OR environment
Standardized Surgical Processes
accurate timely patient-centered informed consent
proper marking and confirmation of:
site - side - level - implant - procedure - patient
regular use standardized surgical checklists
Surgical Data
Systematic surgical data collection and analysis

51. Orthopaedic Safety Summit Ortho Sub-Specialty Work Groups
Hand/Foot-Ankle David Ring MD Hip/Knee/Tumor Mark Froimson MD Pediatrics Kit Song MD Spine Paul Huddleston MD Sports Laurence Higgins MD Trauma Steve Olson MD

52. CMS NorthShore THR/TKR All-Cause Readmissions
consensus building among surgeons
collaboration hospital administration
surgical team communication
patient-centered care with optimized outcomes
reducing/controlling unnecessary costs
validate innovation improvements
surgeon self reporting - safety/quality/value data

53. Thanks

54. Historical ‘Unsafe’ Surgical Behaviors
Process - surgical techniques/care plans - highly variable
surgeon-unique
Data -surgical care experience-based
little/no surgical data collection/analysis
Communication - surgical authority hierarchal
surgeon ‘top down’ to surgical team

55. Model Needed for ‘Safe’ Surgical Behaviors
Process - surgical techniques/care plans standardized and evidence/consensus-based ‘best’ practices
consistent/reliable
Data - surgical data systemically collected and analyzed
improvements data/active management driven
Communication - Surgeon authority shared in ‘team model’
surgeon as leader supporting transparency and authority
delegation

56. Model Orthopaedic Surgical Safety

57. How? Introduce OR behaviors benefitting entire surgical team
Embrace safety science in orthopaedic practices
Own orthopaedic surgical safety data and errors
Shift focus surgeon to surgical care system improvement
Celebrate improvements
Partner with patient, stakeholder and safety organizations

58. Safety Summit No! cultural change resistance
other industries safety change > decade
Options
embrace change – improve care
resist change – accept regulatory mandates/financial penalties
Safety Summit designed to
expand safety practices introduced by AAOS in 1997
build new orthopaedic specific safety ‘tools’
affirm orthopaedic leadership/commitment

59. Safety Summit Summary Overview
Participant Recognition: Prioritize Safety for ALL orthopaedic settings
6 sub-specialty work groups : PILOT new orthopaedic safety programs
Safety collaboration - CMS, AHRQ, JCAHO, ACS, SCOAP
Unify Orthopaedic community :
UNIFIED Orthopaedic Safety Information Statement
BOS and AAOS collaboration new safety programs /products

60. Summit Safety Outcomes Summary
Unified Position Statement on Orthopaedic Surgical Safety
Develop funding support for Work Group pilot safety programs
Continue communication CMS, JCAHO, AHRQ
Explore partnering with ACS/SCOAP for surgical safety data
Explore ongoing support and coordination of the Orthopaedic Safety programs
? new BOS Safety Committee
Collaborate with AAOS Surgical Safety TeamSTEPPS Communication Program (80 Centers/3 years)

61. Safety Recommendations Trauma Work Group
Recommend to AAOS - SSI Prevention Guideline
Develop SSI Prevention Checklist (Bundle)
Antibiotic management HbA1C/Hypergylcemia Management
Surgical warming (>35c.) Albumin/Nutritional management
Smoking Cessation Blood manageent
Pilot a Standardized Hip Fracture Patient Care Pathway
Standardized Order Sets
Pre-op
Post-op
Discharge
Hip Fracture PIM
Goals: decreased LOS, decreased costs and improved Fx outcomes

62. Safety Recommendations Sports Work Group
Develop a Surgical Safety Program for Ambulatory Surgery Centers
Collaborate with JCAHO, ASCA
Develop training modules
Collaborate with AAOS TeamSTEPPS training program
Currently only 50% of orthopaedic surgicenters use Universal Protocol

63. Safety Recommendations Spine Work Group
Recommend to AAOS - SSI Infection Prevention Guideline
Pilot - Wrong Level Spine Surgery Checklist
Define imaging requirements
Define ‘wrong level’ surgery
Define exception/outlier management – obesity, retained implants

64. Safety Recommendations Pediatric Work Group
Pilot a Family/Patient Focused Peri-operative Checklist
Pre-op
Care team review
Consent,
Team huddle
Surgical
Post-op surgeon review
Post-op
Care plan review
Discharge
Follow-up appointment
10-15 pilot centers identified
Potential funding sources identified

65. Safety Recommendations Hip/Knee/Tumor Work Group
Recommend to AAOS - SSI Prevention Guideline
Develop SSI Prevention education products
OKO
PIM
With AHRQ pilot Pre-op Optimization SSI Prevention
Checklist (Bundle):
Obesity (BMI>40 counseling)
Smoking Cessation (Pre-op counseling/cessation)
Diabetic Management (Optimize Pre-op HbA1C <7)
Anemia Assessment (for pre-op Hb<10)

66. Results Wrong Site/Procedure Errors
Wrong Site/Procedure Surgeries
Hospital OR’s - 0.4/yr.
Surgi-Center OR’s /yr.
Office Procedure Rooms – 0.05/yr.
Career - Wrong Site/Procedure Surgeries
Hospital OR’s – estimated -1/20,000 surgeries
Surgi-Center OR’s – estimated -1/80,000 surgeries
Office Procedure Rooms – insufficient data (rare)

67. Safety Recommendations Hand/Foot-Ankle Work Group
Develop an comprehensive opioid drug misuse/abuse
management and education program to:
decrease peri-operative opioid drug events,
improve orthopaedic outcome satisfaction
reduce opioid dependency/abuse
80% of worlds opioid drugs consumed in US
Opioids - #1 cause of accidental death in young adults in US