Fall Meeting

AAOS

Orthopaedic Surgery Safety Update

2012

William J Robb III MDChair

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?

MediaABC 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? 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)

Wrong finger

Wrong side, other

Wrong side, knee

Other

Wrong side, ankle

Wrong level

Wrong side, hip

Wrong organ

Wrong patient

0

5

10

15

20

25

30

35

40

34

30

27

24

109 9

1 1

JC Sentinel Events Data Base 2007-2011

54 Orthopaedic WSS

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 SaferHealth System – (safety)(44-88,00 deaths in hospitals/year from medical errors)

2001 - IOM Report – Crossing the Quality Chasm: A NewHealth 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

HistoricalOrthopaedic 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

ModelOrthopaedic 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 ValueValue

Optimal Outcomes with ONLY

Essential Resources

QualityReliable Care Improvement

Systems

SafetyOrganized 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

6 C’s (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/AnkleWork 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?

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, TumorWork 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

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 Checklists/order-sets Pilot Study

SSI Prevention New SSI Quality ‘bundle’ Pilot study

Hip FX PIM/s Collaboration - CDC, AHRQ, OTA, AGS

AAOSSafe 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 SafetyOutcomes 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