barach.human factors hma talk sept 4
TRANSCRIPT
Patient Safety: A Human Factors Approach
Sept 4, 2015
Paul Barach, BSc, MD, MPH, Maj ( ret.) Clinical Professor
Wayne State University School of Medicine
Himalaya Mountaineering: Reliability: 99%, Mortality: 1:100
Commercial Large-‐Jet Avia8on: Reliability: 99.9999%, Mortality: 1:10,000,000
4
No system
beyond this point
10-2 10-3 10-4 10-5 10-6
Civil Aviation
Nuclear Industry
Railways (France)
Chartered Flight
Road Safety
Chemical Industry (total)
Fatal risk
ED/ Medical risk (total)
Anesthesiology ASA1
Pedi Cardiac Surgery Patient ASA 3-5
Fatal Iatrogenic adverse events
Very unsafe Ultra safe
Average rate per exposure of catastrophes and associated deaths in various industries and human acAviAes
Unsafe Safe
Hymalaya mountaineering
Microlight spreading activity
NICU
Does the day of surgery matter for outcomes ?
operations performed on Fridays were associated with a higher 30-day mortality rate than those performed on Mondays through Wednesdays:
2.94% vs. 2.18%; Odds ratio, 1.36; 95% CI, 1.24–1.49)
March 27, 1977: KLM 747-‐200 and Pan Am 747-‐100; Tenerife, Canary Islands: 578 dead
Collision KLM 747-‐200 and Pan Am 747-‐100; 1977, Tenerife, Canary Islands: 578 dead
contribu8ng factors: • bomb threat Las Palmas • poor visibility (mist)
• runway ligh8ng out of order • airport extremely crowded
• (many planes parked on the taxiways)
• impa8ence / hurry / irrita8on (we’ve waited too long….)
• ambiguous communica8on “you are ‘cleared’ “ -‐-‐-‐ for what? “is he not clear then…?”
• Steep hierarchy gradient
• emergency pa8ent arrives in ER -‐-‐> OR
• anesthesia understaffed • OR overbooked • anesthesia induc8on takes very
long (we’ve waited too long…. get on with it)
• instruments not ready • ambiguous communica8on
I thought you said: ‘give protamine’.….
• Steep hierarchy gradient ?
Recognize this ?
Introduction to Human Factors l ‘To say accidents are due to human failing is
like saying falls are due to gravity. It is true but it does not help us prevent them’ Trevor Kletz
l Human factors engineering is about designing the workplace and the equipment in it to accommodate for limitations of human performance
Scope of Human Factors
Role of Human Factors l User-Centered Design
l Systems designed to fit people (not vice-versa). l Reduces training time. l Minimizes human error. l Improves comfort, safety, and productivity.
Sensation & Perceptual Capabilities Red Light, Green Light, Stop! Visual Complexity
Affordances Bathroom Blunder
Problem: Look & placement afford behaviors other than those intended
Cognitive Ability
Problem: Decision making under time stress
Avoidable confusion is everywhere…
US Department of Veteran affairs
16
FATIGUE MANAGEMENT Anesthesia and fatigue
Australian Incident MonitotingStudy, 1987-‐1997 MORRIS & Morris, Anaesth.Intensive Care 2000
Nature of incidents
Relative percentage of advense eventsONo fatigueOFatigue
5 10 15 20 25 30%
Fluid error
Drug error
Dose error
Obstructions
Approaches to Problem-Solving
l Equipment Design – change physical equipment l Task Design – change how task is accomplished l Environmental Design – change features of the work
environment such as temperature, lighting, sound l Training – change worker behavior by providing skills
and teaching procedures l Selection – recognizes individual differences in ability to
accomplish work
“If an error is possible, someone will make it. The designer must assume that all possible errors will occur and design so as to minimize the chance of the error in the first place, or its effects once it gets made” Norman, The Design of Everyday Things, 2001
Congenital Heart Surgery and Human Factors
• Bristol Infirmary Inquiry report (2000): 30% of children undergoing heart surgery were given less than adequate care characterized by a lack of communication, leadership, and teamwork
• Manitoba Pediatric Cardiac Inquest (2001) linked human factors to less than adequate care
• Duke, heart-lung ABO incompatible transplant, US
• Radboud Medical Centre, Nimegen, Netherlands
Congenital HD discharge mortality, 2011 l Ventricular septal defect (VSD) repair -- 0.6% (range, 0% to
5.1%), l Tetralogy of Fallot (TOF) repair --1.1% (range, 0% to 16.7%), l Complete atrioventricular canal repair (AVC)-- 2.2% (range, 0% to
20%), l Arterial switch operation (ASO)-- 2.9% (range, 0% to 50%), l ASO --VSD-- 7.0% (range, 0% to 100%), l Fontan operation --1.3% (range, 0% to 9.1%), l Truncus arteriosus repair-- 10.9% (0% to 100%), l Norwood procedure-- 19.3% (range, 0% to 100%). l Mortality rates between centers for the Norwood procedure, for
which the Bayesian-estimated range (95% probability interval) after risk-adjustment was 7.0% (3.7% to 10.3%) to 41.6% (30.6% to 57.2%).
Jacobs et al Ann Thorac Surg 2011;92:2184–92.
Pediatric Cardiac Surgery A highly complex, low error-tolerant
l Highly dependent upon a sophisticated organizational structure, coordinated efforts of team members, and high levels of cognitive and technical performance
l High-risk populations such as neonates in particular, exhibit a fragile physiology
l Human factors, institution and surgeon-specific volumes, complexity of cases, and systems failures have been linked to variable outcomes
-deLeval 2000; Walsh 2001
Research questions l How do teams learn and recover so well?
l How do adverse conditions, mediated by team and task processes, lead to negative outcomes (non-routine events and negative team outcomes)?
l Can we reduce the negative outcomes by means of
an intervention focused at the team level (non-technical skills) or through the conditions adjustment loop?
!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
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Expert Performance Model
Causer J. Expertise in medicine: using the expert performance approach to improve simulation training. Medical Teacher, 2014
DOMAINS OF PROJECT
Organizational Sociology
Human Factors Engineering
Industrial Psychology
Applied Organizational Psychology
Cardiovascular Anesthesia and Surgery
System Threats Organisation Environment Task Patient
Major Problem
Adverse Event
Minor Problem
Human Errors Technical Non-Technical
Barach P, et al. 2011
Cx off RPA
MPA
RIGHT
LEFT
HEAD
FEET
Teamwork in the Cardiac Operating Theatre
S
1A
SN
P
AC R
Perfusion HLM
Anaesthetic Workstation
2A
AR
Pumps & Drips
Coding for TEAMS: S1=Primary Surgeon, S2=Assisting Surgeon1 S3=Assisting Surgeon2 A1=Anesthetist A2=Anesthetic Nurse P1=Perfusionist P2=Perfusionist N1= Assisting Nurse N2=Circulating Nurse
Observation Method • 2 HF trained PHD observers • Handwritten notes • Scoring case complexity (1-25) • Coding case outcome at discharge (1-4) • Technical and non-technical skills • High interrater reliability/kappy >0.7
Schraagen, JM, et al, 2010, 2011
Observation Data l 102 cases-Boston Children’s; U of Chicago and U of Miami
l 9/1/05 - 12/30/07 l 102 cases l ~ 700 hours of observations l @1300 annotated events l ~ 70%: < 1 year old l Mean case complexity - 11.7 (range 3.5-24.5)
l 42 cases, Netherlands l 10/08-3/10 l 200 hours of observations l Mean case complecity, 10.7 l 400 events
Galvan C, Bache E, Mohr J, Barach P. Progress Pediatric Cardiology, 2005;20:13-20.; Schrageen J, Barach P. 2009
My ‘Idiot’s Guide’ to Human factors: l ‘Hard Stuff’:
l people interacAng with machines l People interacAng with computers l People interacAng with automaAon
l ‘So_ Stuff’: l People working with people:
l Team performance l handovers l Culture
Safety/learning at the “Coal Face”
l Initiation of bypass without sufficient heparin is catastrophic
l Hospital A l Surgeon: Heparin please l Anaesthetist: Okay, heparin l Anaesthetist: Heparin going in l Surgeon: Are we ready to go on bypass? l Anaesthetist: Yes, ready l Perfusionist: Yes, I’m ready
l Hospital B: l Surgeon: Okay? l Anaesthetist: Yes l Surgeon: Alright then
“It’s fine if you know how we do it here.”
“About 6 months ago when we had a bit of an incident with someone new, but they weren’t here long.”
No recent heparin incidents
Catchpole K, 2011, in press
Process Mapping l Ovals are beginnings and ends
l Boxes are steps or activities
l Diamonds are decision points l Questions with yes/no answers
l Arrow indicates direction and sequence
37 Draft 4-2-04
Pediatric Cardiovascular Surgical CareOur aim is to improve the process of cardiovascular surgical care, starting with
the child's referral for surgery and ending with the child's first post-discharge follow-up visit.
CardiologistPresents Case at
Cardiac CathConference
Does ChildNeed
Surgery?
CardiologistNotifies Child/Family About
Surgery
Child Arrives forSurgical Clinic
Visit
Child Arrives forPre-Op Hospital
Visit
Child Arrives forSurgery (day of,
unless from NICUor PICU)
(T, W, TH)
(H&P, pre-op teaching,schedule surgery,reserve room for
surgery )
Child and FamilyWait in Pre-opHolding Room
(M400)
Transport childto OR
Family to SurgicalWaiting Room
PICU ReceivesPatient
Information FromSurgery, Via NP
PICU ReceivesMultiple UpdatesFrom Surgery,
Via NP
Report (whathappened in OR,what lines, etc.)
OR teamtransports child
to PICU
Child arrives inPICU and is
stabilized
DischargedHome (from
PICU,Intermediate, or
Floor)
No
Surgery
Child hasAppointment with
Cardiologist
CardiologistFollows-Up with
Child/Family
Nurse Sets upPICU
First Follow-Up in Clinic(1-2 weeks post discharge)
CardiologistMakes Referral
for Surgery
NP Calls Familyto Answer
Questions andSchedule Clinic
Visit
Yes
DiagnosticEvaluationComplete?
Completed whileChild on Table
Yes
NoDischarge
Planning Begins -Case Managers
Pull CensusReport
Page 2
Page 3
Pre-op eventsand initialsedation
CHD detectedprenatally, in NICU,by pediatrician, or
other modes ofpresentation
RESULTS
Barach P. Anesthesia and Analgesia, 2007
Technical Aspects l CTA based observational tool l Checklist with narrative
Schraagen JM, et al, 2009.
Risk Mapping and Risk analysis Main Prospective methods
l Work Domain Analysis l Preliminary hazard analysis (PHA) l Failure mode and effect analysis (FMEA) l failure mode effect and criticality analysis
(FMECA) l Hazard and operability study (HAZOP) l Hazard analysis and critical control point
(HACCP) l Probabilistic risk assessment (PRA)
39 Pascal Bonnabry, forum Romand, Lausanne 19.4.2005
Systems errors l Adverse outcomes
l rarely have a single cause l are the result of multiple system errors that
“line up” eventually to create a system failure l Correction of system errors must focus on
the system processes, not the individuals l A human factors engineering approach is
needed l Improvement mediated thru the
microsystem Carthey J, et al 2001; Catchpole K, et al 2007; Galvin C et al, 2005; Barach P, et al 2008, Schraagen J, et al, 2010, 2011
Anesthesiologist meets with patient in surgical holding area Pre-op events and premedication
Patient transported to OR
Patient enters OR Insertion of lines and induction of anesthesia
Patient prepared for surgery
Incision Dissection
Cannulation
Go on cardiopulmonary bypass (CPB) Identification of structures
Surgical repair
Off CPB Heparin reversed
Hemostasis
Chest closed Prepare for move and update ICU Team leaves with patient for ICU
Arrive at ICU ICU nurses take over
Anesthesiologist or surgeon gives ICU attending report
Transport to OR
Pre-Surgery/Anes. Induction
Surgery/Pre-Bypass
Surgery/Bypass
Surgery/Post-Bypass
Transport to ICU
Handoff
Process Flow Domain Major Events
2%
21%
12%
15%
45%
5%
0%
Major Team Failures
Paediatric Cardiac l Swab causes compression of right coronary artery l Ex-sanguination during post-bypass heamofiltering l Omission of key surgical step l Premature separation from bypass due to breakdown in teamwork l Aortic homograft ruptured during sternotomy l Incorrectly labeled homograft l Difficult management of activated clotting time Orthopaedics l Multiple uncertainty leads to teamwork and task breakdown.
Examples of minor failures implicated in major failure sequences:
Communication/co-ordination failures in 5 out of 8 major failures Absences in 4 out of 8 major failures Equipment failures in 4 out of 8 major failures Vigilance/awareness failures in 3 out of 8 major failures
Outcome N
Average case complexit
y (Aristotle
score)
Average length of surgery
Average No
of major events/
case
Average No of minor
events /case
1 50 10.5 200.7 1.06 15.3 2 7 14.3 190.3 1.23 17 3 9 13.6 174.9 1.00 13.6 4 4 18.7 330.1 2.25 11.5
Outcome scale: 1- excellent; 2-moderate ill; 3-severely ill; 4-death
Outcomes Related to Complexity and Number of Events
.
Bognar A, Bacha E, Nevo I, Ahmad A, Barach P. Society of Cardiovascular Anesthesia, May 2005.
Fig. 4 The distribution of types of major events
0
5
10
15
Cardiovascular
Ventilation
Bleeding
Line Placement
Surgical Techn...
Cardiopulmonar...
Blood Product
Communication...
Cognitive
Instrument
Medication
EchoSterility
Monitoring
Transport
Type of the event
Num
ber o
f eve
nts
Fig. 5 The distribution of types of minor events
0
100
200
300
Communication...
Instrument
Line Placement
Sterility
Cardiopulmonar...
Transport
Monitoring
Cardiovascular
Ventilation
Surgical Techn...
Cognitive
Medication
Blood Product
Bleeding
Echo
Type of the event
Num
ber o
f eve
nt
Figure 4. 44% of major events were cardiovascular, ventilation and bleeding problems (patient related problems) Figure 5. 44 % of all minor events communication/ coordination and instrumentation problems were detected (not patient related problems)
Distribution of Major and Minor Events
Identifying non-technical skills Current approach:
l Mini STAR, e.g. l How well did you sleep last night? l Are you well-prepared? l Do you have any concerns about equipment, people,
process? l Safety Culture Assessment (U. Chicago)
l Patient Safety statements l Workload, staffing and supervision l Communication in the OR
l Detailed process checklist paediatric cardiac surgery
l Non-technical skills checklist (NOTECHS)
Non Technical skills--NOTECHS Tool – 2 dimensions (total 4)
Role of Situation Awareness
Barach P, Weinger M, 2007
NOTECHS Tool – Part 2
2 dimensions (total 4)
Schraagen, JM, et al 2009, 2010
Conceptual model based on Reason’s model showing the role of the environment as a latent condition or barrier to adverse events in health care settings. Sources: Dickerman and Barach (2008); Joseph et al 2008; Patti and Barach (2011); Cassin and Barach (2012); Sanchez and Barach (2012)
Socio-technical approach to safety and quality
Process Organisation – Task Allocation – Task sequence – Discipline and composure
Teamwork – Leadership – Involvement – Briefing
Threat and Error Management – Checklists – Predicting and Planning – Situation Awareness
Lessons from Nuclear Power and Aviation Technology Training Regimes
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52
High Reliability Organizations
l Environment rich with potential for errors l Unforgiving social and political environment l Learning through experimentation difficult l Complex processes l Complex technology
Weick, KE and Sutcliffe, KM, 1999
Mindfulness and Safety in HRO’s 1. Preoccupation with failure Regarding small, inconsequential errors as a symptom that something is wrong; finding the half-event 2. Sensitivity to operations Paying attention to what’s happening on the front line at the shop floor 3. Reluctance to simplify Encouraging diversity in experience, perspective, and opinion 4. Commitment to resilience
Developing capabilities to detect, contain, and bounce-back from events that do occur 5. Deference to expertise
Pushing decision making down to the person with the most related knowledge and expertise
Solet J. and Barach P., 2012
Human Factors Contributing to Mishaps
l Normalization of deviance l Poor communication l Production pressure l Fatigue and stress l Emergency operations l Inadequate provider experience l Inadequate familiarity with equipment, device, surgical procedure,
anesthetic technique l Lack of skilled assistance or supervision l Afferent overload (excess stimuli or noise) l Normalcy bias (assuming alarms are ‘false alarms’ l Faulty or absent policy and procedures
Prielipp R, Anesthesia & Analgesia. 2010;110(5):1499-1502.
Apply human factors thinking to your work environment
1. Human behaviour can be predicted with reasonable accuracy
2. Avoid reliance on memory 3. Make things visible 4. Review and simplify processes 5. Standardize common processes and procedures 6. Routinely use checklists 7. Decrease the reliance on vigilance
“No matter how well equipment is designed, no matter how sensible regulations are, no matter how much humans can excel in their performance, they can never be better than the system that bounds them.”
Captain Daniel Maurino, Human Factors Coordinator International Civil Aviation Organization
Please contact me at Email: [email protected]