1. No category

Human error reduction- How to
translate it into better cardiac
outcomes
Today the role of Sol Aronson will be played by
Gary Roach, Kaiser San Francisco
Sol Aronson, Duke University
Why does it really matter
• Headlines like this
The FOCUS Initiative
Dead By Mistake In California
State Collects Data; Some Charge It's UnderReported
Flawless Operative Cardiovascular
Unified Systems
Human Error Reduction in
Cardiovascular Surgery
Hearst Newspapers/San Francisco California August 8, 2009
Society of Cardiovascular
Anesthesiologists Foundation
FOCUS STEERING COMMITTEE
SCA and SCAF MISSION
“IMPROVE PATIENT CARE”
• Cardiovascular patients are unsafe due to:
Chair
Bruce D. Spiess, M.D.
Alan F. Merry, M.D.
University of Auckland
VCU Medical Center
Christina T. Mora Mangano
James H. Abernathy, M.D.
Medical University of South Carolina
Solomon Aronson, M.D.
Duke University Medical Center
Paul G. Barash, M.D.
Yale Medical School
Steven N. Konstadt, M.D.
Maimonides Medical Center
– Collective lack of knowledge:
• When none of us know how to treat this disease/event
Stanford University
• We improve patient safety here through research
Nancy A. Nussmeier, M.D.
SUNY Upstate Medical Center
Gary W. Roach, M.D.
Kaiser Permanente
Thor Sundt, M.D.
– Individual lack of knowledge:
• When the collective intelligence knows how to treat,
but the individual practitioner is unaware
• We improve patient safety here through education
Mayo Clinic
Joyce A. Wahr, M.D.
Clinical Strategies
1
SCA and SCAF MISSION
“IMPROVE PATIENT CARE”
• Cardiovascular patients are unsafe due to:
– Human error:
• “To err is human”
• Irreducible rate of occurrence, and not due to lack of
knowledge
• We must improve patient safety by designing
processes to capture and correct error before harm
occurs
• “Individuals can and will forever commit errors, but
teams have the ability to be flawless.”
Locating Errors through
Networked Surveillance (LENS)
Reducing Human Error In
Cardiovascular Care
Preparation for August 13th, 2009 Meeting
– John Nance
Suggested Reading
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Carayon P, Hundt A, Karsh B, Gurses AP, Alvarado C, Smith M and Brennan P. Work system and
patient safety: The SEIPS Model and Design Approach. Quality and Safety in Health Care.
2006;15 (Suppl. 1): i50-i58.
Flin R, Burns C, Mearns K, Yule S, Robertson EM. Measuring safety climate in health care. Qual.
Saf. Health Care. 2006;15:109-115.
Gurses AP, Seidl K, Vaidya V, Bochicchio G, Harris A, Hebden J, and Xiao Y. Systems ambiguity
and guideline compliance: A qualitative study of how intensive care units follow evidencebased guidelines to reduce healthcare-associated infections. British Medical Journal.
2008;17(5):351.
Health Care Criteria for Performance Excellence. Baldridge National Quality Program. 2009.
Web. 06 August 2009. http://www.baldrige.nist.gov/HealthCare_Criteria.htm.
Nieva VF, Sorra J. Safety culture assessment: a tool for improving patient safety in healthcare
organizations. Qual Saf. Health Care. 2003;12:ii17-ii23.
Pronovost PJ, Goeschel CA, Marsteller J, Sexton B, Pham JC and Berenholtz SM. Framework for
Patient Safety Research and Improvement. Circulation, Jan 2009;119: 330-37.
Singla AK, Barrett TK, Weissman JS, Campbell EG. Assessing Patient Safety Culture: A Review
and Synthesis of the Measurement Tools. J Patient Saf. 2006;2:105-115.
Additionally, to gain a better understanding surrounding the theories related to value-based
management, please peruse the following websites:
–
–
http://www.valuebasedmanagement.net/methods_quinn_competing_values_framework.html
http://www.valuebasedmanagement.net/methods_vroom_expectancy_theory.html
Slide 9
Bristol & Winnipeg: Two Disasters
Across the Pond
• Pediatric cardiac surgical deaths
– Bristol: 30-35 more deaths than avg. (1984-95)
– Winnipeg: 12 deaths over 1 year
• Bristol
– Anesthetist raised concerns in 1988
– Internal conflicts resulted in Dept of Health
involvement
– Temporary moratorium not until 1995
– premise that quality of clinical care cannot be taken for CMAJ; 165: 1461.
granted in any specialty or location
Walshe, Quality in Health Care; 10: 250.
Slide 10
Lessons learned from pediatric
cardiac surgery
• Errors exist at all levels of cardiac surgery programs:
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Hiring procedures
Lack of monitoring
Lack of complaints procedure
Low caseloads/experience
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Create “organizational culture of quality”
Strong and effective clinical leadership
Strong corporate focus
Resource investment
• Need effective systems of clinical audit
• Need strong and shared vision/ values about QI
• Involve patients in their care
• Credentials do not equal experience: Continue education
in quality for all providers
CMAJ; 165: 1461.
Communication: Lack of
redundancy
• Event: Duke, February 2003, case of Jessica
Santillan
– 17 year-old Hispanic female with restrictive
cardiomyopathy and pulmonary hypertension underwent
heart-lung transplantation with ABO incompatibility that
was realized at the end of the surgery
– Underwent immunosuppressive therapy and a second
heart-lung transplantation within 2 weeks, but died shortly
afterward
Moss. Quality in Health Care; 7: 119.
Walshe. Quality in Health Care;10: 250.
Coulter. BMJ; 324: 648.
Slide 11
Slide 12
2
Communication: Lack of
redundancy
• Event: Children’s Medical Center of Dallas/Baylor,
July 2002, case of Jeanella Aranda
Communication: Lack of
redundancy
Data collection:
– Both cases
• Results of the Root Cause Analysis
• Reported in the lay press (NY Times, US News and World Report)
– 1 year-old with liver hamartoma resection with
complications that required liver transplantation
– Partial liver donation came from her father
– Findings of lack of redundant communication
• Santillan case: Surgeon claimed responsibility, but there were
numerous points in organ procurement where blood type
information was optional (and missed)
• Aranda case: Laboratory mix-up confused mother’s and
father’s blood types, leading to miscommunication
– ABO incompatibility was realized 19 days post-op by her
mother, who noted the blood type being transfused; the
infant died on the following day
Slide 13
Communication: Lack of
redundancy
•
•
•
•
•
•
•
•
•
Baker, T. (2005). The medical malpractice myth: Jesica and Jeanella. In T. Baker, The medical
malpractice myth (pp. 4-6). Chicago, IL: University of Chicago Press. URL:
http://books.google.com/books?id=oscj8zwYkgC&pg=PA4&lpg=PA4&dq=children's+medical+center+dallas+aranda&source=bl&ots=Nb0b
p074uw&sig=_3LzvhMECkGUjw2icLMyNApxFko&hl=en&ei=FbjkSerLEZzmlQf_6pDgDg&sa=X&oi=book_
result&ct=result&resnum=1#PPA6,M1
Campion, E.W. (2003). A death at Duke. N Engl J Med, 348(12), 1083-1084. (Perspectives)
Comarow, A. (2003, Jul 28-Aug 4). Jesica's story. One mistake didn't kill her--the organ donor system
was fatally flawed. US News World Rep, 135(3), 51-54, 56, 58.
Grady, D., Altman, L.A. (2003, March 23). Suit Says Transplant Error Was Cause in Baby's Death. NY
Times, A23. URL: http://www.nytimes.com/2003/03/12/us/suit-says-transplant-error-was-cause-inbaby-s-death.html
Grenny, J. (2003). Silence kills [White paper]. Retrieved from
http://academy.clevelandclinic.org/Portals/40/Silence_Kills.pdf
Powell, C.S. (2003). The death at Duke. N Engl J Med, 348(25), 2578-2579; Author reply 2578-9
Resnick, D. (2003 Jul/Aug). The Jesica Santillan tragedy: lessons learned. Hastings Cent Rep, 33(4),
15-20.
Sade, R. (2003). Why illegal aliens get a place in line. Duke case involved a serious medical error, not
a transplant policy violation. Mod Healthc, 33, 13,16.
Sloane, A. (2003). Grading Duke: "A" for acknowledgment. J Health Law, 36(4), 627-645.
Slide 14
Wong et al. studies, 2006-2009
• Three studies of “precursor events”-- events
that precede and are requisite for adverse
events
• Precursor events occurred more often in
cases with death or near miss outcomes
than with no adverse outcomes
• A new surgical center had more precursor
events than established centers but quickly
reduced them
Wong, Eur J Cardiothorac Surg; 29: 447.
Wong, Surgery; 141: 715.
Wong, Surgery; 145: 131.
Slide 15
Slide 16
Wong et al. 2006
• Prospective anonymous reporting of
precursor events in the COR
• 3 University affiliated teaching facilities
• Reports could come from any member of the
team.
• Data collected 4/2003-5/2004
• 464 cardiac procedures with 1,627 reports of
problematic precursor events (990 unique)
• Mean was 3.5 + 3.9 events
Wong, Eur J Cardiothorac Surg; 29: 447.
Slide 17
Precursor events
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•
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•
•
•
•
•
•
33.3% prior to incision
31.2% while on Bypass
15.7% post bypass
90% were compensated for
30.9% not discussed by the team
Nurses primary reporters - 28%
Anesthesiologist reports – 20.4%
Perfusionist reports – 16.3
Surgeons, residents, PA/NP- reports 35.3
Wong, Eur J Cardiothorac Surg; 29: 447.
Slide 18
3
Major vs. Minor Events
Minor
Missing ID stickers
Contaminated SG
Incorrect booking
Incorrect count
Dropping a retractor
Bleeding from leg
Asking for the wrong valve
And many others…
Major
Perforating IVC with a chest tube
CPB pump failure
Making vein graft too short
Revising anastomosis secondary to bleeding
Clot formation in heart while on pump
Inotrope running out unnoticed
Giving epinephrine instead of lidocaine bolus
Wong, Eur J Cardiothorac Surg; 29: 447.
Wong et al. 2007
• Same data as 2006
• Relationship of precursor events (PE) to adverse outcomes
• Cases with outcomes of death or near miss complications
had more PE’s
• Distribution of PE’s:
– 36% management
– 29% technical
– 23% environment-related
• “Most affected person” in PE’s
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–
–
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41% Surgeon
28% Anesthesiologist
21% Nurse
9% Perfusionist
Slide 19
Wong, Surgery; 141: 715.
Slide 20
Wong et al. 2009
• Same data as 2006 study
• Across the first 101 cases at a new surgical
center, precursor events were reduced from
9.4 to 2
• Stable PE’s at 2 established comparisons
• Decreased environment-related,
communication and management PE’s
• Global reductions of PE’s for all team
members
Human Factors Analysis & Classification
System (HFACS) for Cardiac Surgery
• Showed applicability of a human factors model
(HFACS) for error detection in cardiac surgery
• HFACS model originally developed for use in
aviation
• Structured interviews with 68 clinicians
• Unsafe acts (skill-based errors, routine violations,
etc.) in cardiac surgery associated with following
factors:
– Organizational influences (climate, resource
management, etc.)
– Unsafe supervision (inadequate, etc.)
– Preconditions to unsafe acts (environment,
teamwork, etc.)
Wong, Surgery; 145: 131.
ElBardissi. Ann Thorac Surg; 83:1412.
Slide 21
Slide 22
Surgical Flow Disruptions and Errors
Surgical Flow Disruptions and Errors
• Identified surgical flow disruptions
• Events
– Surgical flow disruptions: System design factors
– Surgical errors: Technical events in which
intended outcome was not achieved
• Data collection:
– Convenience sample of 31 cardiac surgical
operations
– Observed by one individual who stood at the
patient’s head
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–
–
–
–
Teamwork (52%)
Extraneous interruptions (17%)
Supervisory/training related issues (12%)
Equipment and technology (11%)
Resource-based issues (8%)
• Surgical errors increase with surgical flow disruptions
(r=0.47*)
• Teamwork/communication
– Only significant predictor of number of surgical errors
(standardized Beta= 0.7 with p<0.000)
– Follow-up data analysis conducted on disruptions related to
teamwork/communication
Wiegmann. Surgery; 142: 658.
Slide 23
Wiegmann. Surgery; 142: 658.
Slide 24
4
Teamwork/communication
related disruptions
• Surgeon-technical team failures (51%)
• Patient/procedure information (20%)
• Surgeon-anesthesiologist communication
(15%)
• Surgeon-perfusionist communication (10%)
• Handoffs (4%)
– Initiating CPB
– Weaning the patient from CPB
ElBardissi. European Journal of
Cardio-thoracic Surgery; 34:1027.
Works Consulted
(2001). Error and blame: the Winnipeg inquest. CMAJ, 165(11), 1461, 1463.
Baker, T. (2005). The medical malpractice myth: Jesica and Jeanella. In T. Baker, The medical
malpractice myth (pp. 4-6). Chicago, IL: University of Chicago Press. URL:
http://books.google.com/books?id=oscj8zwYkgC&pg=PA4&lpg=PA4&dq=children's+medical+center+dallas+aranda&source=bl&ots
=Nb0bp074uw&sig=_3LzvhMECkGUjw2icLMyNApxFko&hl=en&ei=FbjkSerLEZzmlQf_6pDgDg&s
a=X&oi=book_result&ct=result&resnum=1#PPA6,M1
Campion, E.W. (2003). A death at Duke. N Engl J Med, 348(12), 1083-1084. (Perspectives)
Comarow, A. (2003, Jul 28-Aug 4). Jesica's story. One mistake didn't kill her--the organ donor
system was fatally flawed. US News World Rep, 135(3), 51-54, 56, 58.
Coulter, A. (2002). After Bristol: putting patients at the centre. BMJ, 324, 648–651.
ElBardissi, A.W., Wiegmann, D.A., Dearani, J.A., Daly, R.C., and Sundt, T.M.,3rd. (2007). Application
of the Human Factors Analysis and Classification System Methodology to the Cardiovascular
Surgery Operating Room. Ann Thorac Surg, 83:1412-1419.
ElBardissi, A.W., Wiegmann D.A., Henrickson S., Wadhera R., Sundt T.M.,3rd. (2008). Identifying
methods to improve heart surgery: an operative approach and strategy for implementation
on an organizational level. European Journal of Cardio-thoracic Surgery, 34, 1027-1033.
Grady, D., Altman, L.A. (2003, March 23). Suit Says Transplant Error Was Cause in Baby's Death. NY
Times, A23. URL: http://www.nytimes.com/2003/03/12/us/suit-says-transplant-error-was-causein-baby-s-death.html
Grenny, J. (2003). Silence kills [White paper]. Retrieved from
http://academy.clevelandclinic.org/Portals/40/Silence_Kills.pdf
Slide 25
Works Consulted
Kohn, L.T., Corrigan, J., Donaldson, M.S. (1999). To Err Is Human: Building a Safer Health System.
Available from: http://books.google.com/books?id=1NSGBPzemrYC
Moss, F. (1998). Learning from tragedies. Qual Health Care, 7(3), 119-120.
Powell, C.S. (2003). The death at Duke. N Engl J Med, 348(25), 2578-2579; Author reply 2578-9
Resnick, D. (2003 Jul/Aug). The Jesica Santillan tragedy: lessons learned. Hastings Cent Rep,
33(4), 15-20.
Sade, R. (2003). Why illegal aliens get a place in line. Duke case involved a serious medical
error, not a transplant policy violation. Mod Healthc, 33, 13,16.
Sloane, A. (2003). Grading Duke: "A" for acknowledgment. J Health Law, 36(4), 627-645.
Solis-Trapala, I.L., Carthey, J., Farewell, V.T., de Leval, M.R. (2007). Dynamic modelling in a
study of surgical error management. Stat Med, 26(28), 5189-5202.
Walshe, K., & Offen, N. (2001). A very public failure: lessons for quality improvement in
healthcare organisations from the Bristol Royal Infirmary. Qual Health Care, 10(4), 250-256.
Wiegmann, D.A., ElBardissi, A.W., Dearani, J.A., Daly, R.C., and Sundt, T.M.,3rd. (2007).
Disruptions in surgical flow and their relationship to surgical errors: An exploratory
investigation. Surgery, 142, 658-665.
Wong, D. R., Ali, I. S., et al. (2009). Learning in a new cardiac surgical center: an analysis of
precursor events. Surgery, 145(2): 131-137.
Wong, D. R., Torchiana, D. F., et al. (2007). Impact of cardiac intraoperative precursor events
on adverse outcomes. Surgery, 141(6): 715-722.
Wong, D.R., Vander Salm, T.J. et al. (2006). Prospective assessment of intraoperative precursor
events during cardiac surgery. Eur J Cardiothorac Surg, 29(4): 447-455.
Slide 26
THE FOCUS INITIATIVE
• Flawless Operative Cardiovascular Unified Systems
Goal: To improve patient safety by human error reduction
The FOCUS initiative is a cooperative effort
designed to raise the bar for patient safety
through systems analysis and
human factors engineering.
Slide 27
THE FOCUS RFP PROCESS
• Request for Proposals elicited from 60 institutions
THE FOCUS PROJECT
COLLABORATORS
• Johns Hopkins chosen
(team led by Peter Pronovost)
• Six finalists selected
• “we seek a team of consultants with experience in the
field of human factors, observational method and
error analysis. . . To reduce human error in
cardiovascular care”
– SCA FOCUS RFP
“Nearly a decade after the
publication of this landmark
report (“To Err is Human”),
not a single healthcare
organization can provide a
credible answer to the
question: ‘Are we safer?’”
Peter Pronovost, MD, Ph.D.
Quality and Safety Research Group
Johns Hopkins University
5
SYSTEMS ERRORS
SYSTEM FAILURE
Multiple Errors Line Up
Communication between
resident and nurse
• Adverse outcomes
– rarely have a single cause
Inadequate training
and supervision
– are the result of multiple system errors that “line
up” to create a system failure
• A human factors engineering “lens” is needed to
find and analyze these ailments in the system
• Correction of system errors must focus on the
system processes, not the individuals
Catheter pulled with
Patient sitting
OUTCOME: Patient
suffers venous air
embolism
Lack of protocol
For catheter removal
Pronovost Annals IM 2004
Worst Aviation Disaster Ever, Canary Islands 1977
Is Aviation the appropriate model?
543 Dead
•
What If?
•
As with most airplane accidents, several seemingly small events occurred which, had any of them not
happened, the tragedy would have been prevented. For example:
•
If the bombing more than 100 miles away at another airport had not happened or if the phony threat of
another bombing had not been made, those planes never would have been at Los Rodeos.
•
If the Pan Am hadn't been 1 1/2 hours late out of Los Angeles, it would have arrived at Los Palmas before
the closure.
•
If the Pan Am had been allowed to remain in a holding pattern, it would not have been at Los Rodeos.
•
If the KLM hadn't taken the time to refuel, or if the weather hadn't deteriorated, the visibility would have
been higher when it took off.
•
If the Pan Am had been able to make it around the KLM when it was refueling, it wouldn't have been there
when the KLM was taking off.
•
If the Pan Am hadn't missed the third taxiway, it would have avoided a collision.
•
If the Pan Am and ATC hadn't been speaking at the same time, the KLM would have heard the instruction
to wait for clearance.
•
If the visibility had been even slightly better, both aircraft may have had enough time to avoid one another.
•
Still, the KLM almost missed the Pan Am
CRM Introduced
Elements of the Surgical Safety Checklist
Selected Process Measures before and after Checklist Implementation, According to Site
Haynes A et al. N Engl J Med 2009;360:491-499
Haynes A et al. N Engl J Med 2009;360:491-499
6
Outcomes before and after Checklist Implementation, According to Site
SYSTEM FACTORS IMPACT SAFETY
Institutional
Hospital
Departmental Factors
Work Environment
Team Factors
Individual Provider
Task Factors
Patient Characteristics
Haynes A et al. N Engl J Med 2009;360:491-499
Adapted from Vincent BMJ
OVERALL APPROACH
• Develop partnerships between SCA, Hopkins, other
societies (STS, AORN,ASECT to date), organizations,
and hospitals to create learning communities
• Identify hazards
– Literature review
LEARNING FROM ERROR REPORTING
• National Reporting and Learning System (NRLS)
– Web-based error reporting system in the United Kingdom
– Incident reports on a diverse and comprehensive range of
medical errors
– Currently over 1.5 million reports in the national database
• The largest known error reporting system in the world.
– Error report data
– In depth observations at selected sites
• Design, implement and evaluate safety improvement
efforts
• Reviewed Errors in Cardiac Surgery
– 4,828 errors designated
– 999 identified as occurring in the operating room
• Disseminate broadly to all cardiac operating rooms
SUMMARY OF LITERATURE REVIEW
• Errors common and often lethal
• Distractions and disruptions limited ability to recover and increase
risk for harm
• Multiple types of hazards exists
– Organizational
PROACTIVE RISK ASSESSMENT –
LENS PROJECT
• Apply variety of “lenses” to identify hazards in
cardiac surgery
• Design, implement and evaluate interventions to
mitigate those hazards
– Cultural and group dynamics
– Interpersonal dynamics
– Training and supervision
• Broadly implement self assessment and risk
reduction tools
– Equipment
• High profile cases
• Apply methodology to other areas
• Generally used a single lens
7
RESEARCH STAGES of FOCUS
project
DOMAINS OF LENS PROJECT
• Stage 1: Observe cardiac procedures at 3-5
cardiac anesthesia sites
Organizational
Sociology
Applied
Organizational
Psychology
Human Factors
Engineering
• Stage 2: Based on analysis of observational studies,
select hazards for interventions
• Stage 3: Design, implement and evaluate safety
program at beta sites
Industrial
Psychology
Cardiovascular
Anesthesia
EARLY FINDINGS
• Stage 4: Broadly disseminate self assessment tool
and safety program
OPPORTUNITIES FOR IMPROVEMENT
APPLYING SCIENCE TO SAFETY
• Standardize routine processes
• Common concerns across cardiac operating
rooms and hospitals
– Prep
– Line placement
– Intra-operative transitions
• Identifying good practices
• Structure communication
• Provide training on medical devices
• Many opportunities to improve care
• Ensure correct interpretation of local policies
• Address distractions
• Schedule safely
• Opportunities for each lens
• Use horizontal space efficiently
• Optimize utilization of technology available for use (e.g. Smart IV
pumps)
NEXT STEPS
• Complete site visits and analysis of qualitative data
NEXT STEPS
• Complete site visits and analysis of qualitative data
– Data reviewed 8/13/09
• Develop Risk Assessment tool
– Numerous problems noted
• Lack of “huddles” and debriefing (1/20)
• Based on evidence, prioritize tools to be developed &
processes of care to be changed
• Numerous communication issues
• Conduct focus groups of experts to decide where to start
• Chlorhexidine vs. povidone (or even alcohol)
• Distractions/diversions
• Breaks in sterile technique
• Ergonomic issues
– Next step is to categorize and develop survey instruments
– Fall “Summitt”
• Design interventions, pilot test, & revise for ease of
implementation and management for all
• Link measurable processes of care and clinical outcomes
8
PARTNERS IN FOCUS
• Formalize participation – make FOCUS a collaborative
project
– Endorse FOCUS formally
• Invite members to participate in FOCUS committees
Thanks for your attention
– Public Relations, Data Analysis, Publication
• Contribute; identify sources of funding
– FOCUS will cost >$1.5M over 3-5 years from SCA
alone
– We need other intellectual and financial contributions
SCA AND SCAF:
PARTNERS IN FOCUS
• Society of Cardiovascular Anesthesiologists
CONTACT US
SCA Foundation
– Established in 1978
– ~7000 members worldwide
– Dedicated to:
• Excellence in patient care through education and research in
perioperative care for patients undergoing cardiothoracic and
vascular procedures.
2209 Dickens Road
Richmond, VA 23230
foundation@scahq.org
• SCA Foundation
www.scahqgive.org
– Established in 2007 to enhance funding for the missions of the Society
– In Nov 2007, assumed oversight and financial responsibility for FOCUS
– JHU contract signed in 2008; initial observations complete
804-565-6324
9