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

51

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: pbarach@gmail.com