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Barach.Human factors HMA talk Sept 4

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Barach.Human factors HMA talk Sept 4

  1. 1. Patient Safety: A Human Factors Approach Sept 4, 2015 Paul Barach, BSc, MD, MPH, Maj ( ret.) Clinical Professor Wayne State University School of Medicine
  2. 2. Himalaya  Mountaineering:   Reliability:  99%,  Mortality:  1:100  
  3. 3. Commercial  Large-­‐Jet  Avia8on:   Reliability:  99.9999%,  Mortality:  1:10,000,000  
  4. 4. 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
  5. 5. 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)
  6. 6. March  27,  1977:   KLM  747-­‐200  and  Pan  Am  747-­‐100;  Tenerife,   Canary  Islands:    578  dead  
  7. 7. 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  ?    
  8. 8. 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
  9. 9. Scope of Human Factors
  10. 10. 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.
  11. 11. Sensation & Perceptual Capabilities Red Light, Green Light, Stop! Visual Complexity
  12. 12. Affordances Bathroom Blunder Problem: Look & placement afford behaviors other than those intended
  13. 13. Cognitive Ability Problem: Decision making under time stress
  14. 14. Avoidable confusion is everywhere… US Department of Veteran affairs
  15. 15. 16 FATIGUE MANAGEMENT Anesthesia  and    fatigue Australian  Incident  MonitotingStudy,  1987-­‐1997  MORRIS  &  Morris,  Anaesth.Intensive Care  2000 Nature of incidents Relative percentage of advense events ONo fatigue OFatigue 5 10 15 20 25 30% Fluid  error Drug  error Dose  error Obstructions
  16. 16. 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
  17. 17. “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
  18. 18. 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
  19. 19. 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.
  20. 20. 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
  21. 21. 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?
  22. 22. ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! ! Expert Performance Model Causer J. Expertise in medicine: using the expert performance approach to improve simulation training. Medical Teacher, 2014
  23. 23. DOMAINS OF PROJECT Organizational Sociology Human Factors Engineering Industrial Psychology Applied Organizational Psychology Cardiovascular Anesthesia and Surgery
  24. 24. System Threats Organisation Environment Task Patient Major Problem Adverse Event Minor Problem Human Errors Technical Non-Technical Barach P, et al. 2011
  25. 25. Cx off RPA MPA RIGHT LEFT HEAD FEET
  26. 26. Teamwork in the Cardiac Operating Theatre S 1A SN P ACR 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
  27. 27. 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
  28. 28. 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
  29. 29. 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  
  30. 30. 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
  31. 31. 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
  32. 32. 37Draft 4-2-04 Pediatric Cardiovascular Surgical Care Our 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. Cardiologist Presents Case at Cardiac Cath Conference Does Child Need Surgery? Cardiologist Notifies Child/ Family About Surgery Child Arrives for Surgical Clinic Visit Child Arrives for Pre-Op Hospital Visit Child Arrives for Surgery (day of, unless from NICU or PICU) (T, W, TH) (H&P, pre-op teaching, schedule surgery, reserve room for surgery ) Child and Family Wait in Pre-op Holding Room (M400) Transport child to OR Family to Surgical Waiting Room PICU Receives Patient Information From Surgery, Via NP PICU Receives Multiple Updates From Surgery, Via NP Report (what happened in OR, what lines, etc.) OR team transports child to PICU Child arrives in PICU and is stabilized Discharged Home (from PICU, Intermediate, or Floor) No Surgery Child has Appointment with Cardiologist Cardiologist Follows-Up with Child/Family Nurse Sets up PICU First Follow-Up in Clinic (1-2 weeks post discharge) Cardiologist Makes Referral for Surgery NP Calls Family to Answer Questions and Schedule Clinic Visit Yes Diagnostic Evaluation Complete? Completed while Child on Table Yes No Discharge Planning Begins - Case Managers Pull Census Report Page 2 Page 3 Pre-op events and initial sedation CHD detected prenatally, in NICU, by pediatrician, or other modes of presentation RESULTS Barach P. Anesthesia and Analgesia, 2007
  33. 33. Technical Aspects l  CTA based observational tool l  Checklist with narrative Schraagen JM, et al, 2009.
  34. 34. 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  
  35. 35. 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
  36. 36. 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%
  37. 37. 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
  38. 38. Outcom e 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.
  39. 39. Fig. 4 The distribution of types of major events 0 5 10 15 C ardiovascular Ventilation BleedingLine Placem ent SurgicalTechn... C ardiopulm onar... Blood P roduct C om m unication... C ognitiveInstrum ent M edication Echo SterilityM onitoring Transport Type of the event Numberofevents Fig. 5 The distribution of types of minor events 0 100 200 300 C om m unication... Instrum ent Line Placem ent SterilityC ardiopulm onar... Transport M onitoring C ardiovascular Ventilation SurgicalTechn... C ognitiveM edication Blood P roduct BleedingEcho Type of the event Numberofevent 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
  40. 40. 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)
  41. 41. Non Technical skills--NOTECHS Tool – 2 dimensions (total 4)
  42. 42. Role of Situation Awareness Barach P, Weinger M, 2007
  43. 43. NOTECHS Tool – Part 2 2 dimensions (total 4) Schraagen, JM, et al 2009, 2010
  44. 44. 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
  45. 45. 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
  46. 46. 51
  47. 47. 52
  48. 48. 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
  49. 49. 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
  50. 50. Solet J. and Barach P., 2012
  51. 51. 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.
  52. 52. 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
  53. 53. “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
  54. 54. Please contact me at Email: pbarach@gmail.com

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