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

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

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

Is there an Orthopaedic Surgery Safety Problem 2012 Is there an Orthopaedic Surgery Safety Problem 2012? HealthGrades - 2010 >350,000 patient safety errors/year 2006-2008 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 2000-2010

Is there an Orthopaedic Surgery Safety problem 2012? JC 2009-2010 Wrong Site/Procedure/Patient Surgery (WSS) Mandatory State –bsed WSS Reporting Minnesota (48 - WSS) Pennsylvania (58 - WSS) 35.4 WSS/wk. in US (estimated)

JC Sentinel Events Data Base 2007-2011 54 Orthopaedic WSS

Is there a Orthopaedic Surgery Safety Problem 2012 Is there a Orthopaedic Surgery Safety Problem 2012? Hospital Data JC - 2011 >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

Is there an Orthopaedic Surgery Safety problem 2012? ABOS Certification/Recertification Data Base – 2011 WSS Rate - 1/30,000 orthopaedic surgeries NO CHANGE 2000-2011

Surgical Safety/Quality/Value Timeline 1997 - AAOS - ‘Sign Your Site’ Program - (safety) 1999 - IOM Report - To Error is Human: Building a Safer Health System – (safety) (44-88,00 deaths in hospitals/year from medical errors) 2001 - IOM Report – Crossing the Quality Chasm: A New Health System for the 21st Century (quality) 2003 - VA National Directive to reduce Risk WSS (safety) 2004 - JCAHO – ‘Universal Protocol’ (safety/quality) 2004 - SCOAP** (safety/quality) voluntary hospital-based surgical safety/quality – Washington

Surgical Safety/Quality/Value Timeline 2007 - SCIP* (quality) mandated national surgical quality standards 2007 - WHO ‘Safe Surgery-Saves Lives’ (safety/quality) 2009 - Checklist Manifesto –Atul Gwande MD (safety and quality) 2010 - 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)

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

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% - 2006-2009

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

Survey Participants

Participating Practice Types

Participating Orthopaedic Sub-Specialties

Participant Surgical Settings

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

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

Model Safe Orthopaedic Surgical Care

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

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

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

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

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

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

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

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

AAOS Surgical Safety Program 2012 2011 Fall Board Workshop TeamSTEPPS 80 Hospital/Surgicenter training sites 2012-2014 2012 Spring Board Workshop Develop orthopaedic checklists Establish/collaborate orthopaedic safety data bases Surgical Safety Board Oversight Work Group 2012-2014 Chair - Dr. Fred Azar Orthopaedic Surgery Safety Summit Chicago – 2012 Orthopaedic Surgery Sub-Specialty Pilot Programs Validate Pilot Safety Programs 2012-2014

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

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

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)

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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Thanks

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

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

Model Orthopaedic Surgical Safety

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

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

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

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)

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

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

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

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

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)

Results Wrong Site/Procedure Errors 2010-11 - Wrong Site/Procedure Surgeries Hospital OR’s - 0.4/yr. Surgi-Center OR’s - 0.25/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)

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