1. Checklists, Protocols, and Patient Safety
James P. Bagian, MD, PE
Chief Patient Safety and Systems Innovation Officer
Director, Center for Health Engineering & Patient Safety
University of Michigan

2. It’s Not Rocket Science University of Michigan
Checklists, Protocols,
and
Patient Safety
It’s Not Rocket Science
James P. Bagian, M.D., P.E.
University of Michigan

3. Overview Problem Contributing Factors Programmatic Components
Specific Examples
Opportunities

4. Patient Safety - The Problem
Not New 4

6. Medicare – Adverse Events 2010
13.5% Adverse Events (Serious Events)
13.5% Temporary Harm
1.5% die (15,000/month ~ 180,000/yr)
Bottomline – The Problem Is Still Here

7. Where Healthcare Was/Is
Cottage Industry Mentality
Virtually Total Reliance on:
Professional/Individual Responsibility
Individual Perfection
Train and Blame
Little Understanding of Systems Relative to People and Processes
Ignorance vs Arrogance
Culturally Different!!!! 7

8. Program Elements
Goal –

9. Program Elements
Goal – Prevent Inadvertent Harm To Patient While Under Our Care

10. Program Elements
Goal – Prevent Inadvertent Harm To Patient While Under Our Care
Culture Not Compliance
Identify Barriers
Reporting Systems

12. Combating Shame: Blameworthy Concept
Safety Reports Only For Systems Improvement
Safety Report Kept Confidential/Nonpunitive As Long As Not Deemed ‘Intentionally Unsafe’
Criminal Act
Under Influence of Alcohol or Illicit Drugs
Purposely Unsafe
Supervisory System Is A Parallel Process
May Not Use Identified Info From Safety Report

13. Patient Safety System Design
THE "MISHAP DIAMOND"
Weak Program Model
Severity
Frequency
Type A
Type C
Type B
Incidents
Close
Calls 13

14. Patient Safety System Design
THE "MISHAP PYRAMID"
Strong Program Model
Frequency
Severity
Type A
Type C
Type B
Incidents
Close
Calls 14

15. Program Elements
Goal – Prevent Inadvertent Harm To Patient While Under Our Care
Culture Not Compliance
Identify Barriers
Reporting Systems
Systems-based Solutions

16. Safety & Human Error: Cornerstones
People Don’t Come to Work to Hurt Someone or Make a Mistake
Must Keep Asking “Why?” 16

17. Safety – Human Error Hindsight Bias
Use the Forklift Analogy
The A320 story
Look for True Cause 17

18. Causation/Actions: Who vs.What &Why
Action focused on correcting individual

21. 21

22. Behavior Response
When I say “UP”, everyone raise your hand AND slap it back down as quickly as you can
Do 4 or 5 times. Hit table the same time. Last time only hit table (some will raise hands). 22

23. This Was Not An Aerobic Exercise
Demonstrates: “paired associate learning”
Pattern recognition. Taking shortcuts. Do we have any systems where we do repetitive actions that might have more than one action?
Demonstrates a low level brain response. Training yields a low level auto response, telling someone not to do something under these conditions won’t be effective. 23

24. Causation/Actions: Who vs.What &Why
‘Whose Fault Is This?’
Actions focused on correcting individual
‘Corrects’ only after problem occurs
Limited scope of action and generalizability
What & Why
Actions focus on systems level causation
Widespread applicability
Stronger preventive strategy 24

25. Operating Room

26. How Did We Do? - VA
Neily et al. Incorrect Surgical Procedures …Arch Surg 2009 Nov;144(11):

27. VA –

28. What Did We Learn? - VA
Incorrect Surgery Associated With Noncompliance
Actions needed well before entering OR
Timeout period is too late in many cases
Systems-based approaches beyond individual
Involvement of all disciplines
Structured communication that drives discussion – Medical Team Training (MTT)
-Briefings & Debriefings –

29. VHA NCPS Medical Team Training Program 2005 -2010
170 Facilities
193 Learning Sessions
13,882 VHA Staff
MTT Medical Team Training JULY 2010
Mean = 74 Attendees Per Learning Session
Largest One Day Session = 208 (Baltimore, MD Jan 14, 2010)
Largest Facility Attendance = 356 (Dallas, TX December 9-11, 2008) 29

30. Communication
Communication Identified As Principal Factor >70% Of RCAs
Medical Team Training (MTT) Developed To Improve Results
Crew Resource Management Principles
AND
Briefings and De-Briefings

31. Supporting Long Term Memory
Checklists
Put knowledge in the world vs. in the head
Recognition is better than recall
Tool to Guide and Improve Communication
Checklist Philosophy
“Read and Verify” checklists
“Read and Do” checklists 31

32. IV Insertion Checklist
Before Insertion
Patient Identification……………………………..CONFIRMED
Correct Side………………………………………CONFIRMED
Catheter Size……………………………………..CONFIRMED
Equipment…………………………………………AT BEDSIDE
Patient……………………………………………..BRIEFED
After Insertion
Tourniquet…………………………………………REMOVED
Line………………………………………………...FLUSHED
Pump……………………………………………….SET (with fluids)
Sharps………………………………………………DISPOSED
Site…………………………………………………..LABELED
Documentation…………………………………….COMPLETE 32

33. Why Do a Briefing? Establish a platform for common understanding
Gives people permission to be frank & honest
Gets everyone on the same page
Provides a structure for collaborative planning
Creates a shared mental model
Briefings help team members form a shared mental model…to get on the same sheet of music.
Briefings are a way of acknowledging every team member and the perspective / knowledge they bring to the group.
Briefings provide the team leader with ALL the information needed to make the best decision or plan.
*Comparing flight crew pre-brief (eg. What if there is bad weather or what if we lose an engine, etc? What do you do? What do I do?) If these people who don’t know each other should brief, why shouldn’t OR teams brief?
Briefings helps each team member form a shared mental model – each knowing what to expect, who will be doing what, what the contingency plans will be, etc. 33

34. Briefings
Dialogue among principals using concise, relevant information to promote clear and effective communication
- Real time
- Face-to-face
- All team members present
- All team members participate
A briefing offers the structure and format for a dialog to occur!
It is a discussion – not a one-way report or presentation.
It is intentional and focused – a review of very specific issues such as reviewing timelines, goals, and/or contingency plans. 34

35. OR Policy Changed to Require Attending Surgeon in OR

36. Checklist-Driven Pre-Op Briefing

37. Asking the Right Question
“Any questions?” VS
“What is your biggest concern for today?”

39. Post-Op Debriefing Attending surgeon Anesthesiologist/CRNA Circulator
Entire Surgical Team
Attending surgeon
Anesthesiologist/CRNA
Circulator
Scrub nurse/tech
Resident, PA, perfusionist, others
Guided by checklist (specialty specific)
What went well? What did not go well? What did we learn? What can we do to improve our processes?
Timing – when patient is stable before attending leaves (update prior to patient leaving OR)
Method to track debrief items and follow-up:
UH Leadership Group 39

40. Post-Op Debriefing What it is NOT: What it IS:
Chance to whine about people
Chance to collect statistics for statistics sake
What it IS:
Tool to identify problems that impact patient care
Tool to solve problems as a team

41. Checklist-Driven Post-Op Debriefing

44. Medical Team Training Safety Attitudes Questionnaire* *
In this clinical area, it is easy to speak up.
I would feel safe being a patient here. *
P < 0.05 paired, Students t-test
N = 3138 Questionnaires

45. Nursing Turnover
P = 0.02
45 Operating Rooms and 35 Intensive Care Units
Pre = 12 Months Prior to Learning Session
Post = 12 Months Following Learning Session

46. Outcomes – Morbidity / Mortality
Observed / Expected Mortality Ratios
P = 0.03
As teams gain experience with the preoperative briefing guided by a checklist (MTT exposure) the adjusted surgical morbidity and mortality in that facility decreases significantly.
Quarters of MTT 46

48. VA – vs
Reported Adverse Events dramatically reduced
Reported Close Calls increased

49. VA –

50. MTT – Facility Level Impact
67% High Impact on OR Staff
73% High Impact on OR Patients
69% of OR Teams Improved Teamwork
66% of OR Teams Report Improved Efficiency
Eqpt Util (61%), Starts (35%), Duration (19%)
Safety Attitudes Questionnaire (SAQ)
Significant Improvement (p<0.001):
Working Conditions, Perception of Mgmt, Job Satisfaction, Safety Climate, & Teamwork

51. Neily et al. Assoc. Between MTT and Surg Mortality. JAMA

53. MTT Impact - VA N=108 Institutions; 74 MTT, 34 Control
MTT 50% greater decrease in mortality & morbidity than Control
Dose-response –
0.5 deaths/1000 procedures less per quarter p=0.001
0.6 deaths/1000 procedures per increase in briefing/debriefing p=0.001
70% Reduction in reported OR related harm

54. Summary – Gaps & Opportunities
Systems Approach – Surgical issues must be dealt with in the extended peri-operative period, not solely in the OR
Entire System of care must be Examined and Engineered with desired results in mind – avoid unintended consequences
Team Training – start in initial training & sustain
More than SBAR – Leadership Must Be Involved
Checklist-guided briefings and debriefings
Can’t rely on individuals being careful (vigilant)
Compliance – Trust But Verify
Consequences for Deliberate Non-Compliance

55. Conclusions
Starting At The Top, Assure Staff At All Levels Possess Competence Regarding
Formulating Appropriate Causal Statements
Creating Corrective Plans With Systems-Based Actions
Basic Human Factors Engineering Concepts
Team and Communication Skills
Implement Tools That Emphasize High Quality, Safe Patient Care Is First Priority (e.g.- MTT)
Create System To Reinforce & Reward Concept That Quality and Safety Are Everyone's Job

56. It’s Not Rocket Science
Move From:
Resistance
It’s Not Rocket Science
Pro forma Compliance
True Cultural Adoption

57. In Perspective - Einstein
Problems – “The significant problems we face cannot be solved at the same level of thinking we were at when we created them.”
“Insanity: doing the same thing over and over again and expecting different results”
Value – “Not everything that can be counted counts, and not everything that counts can be counted.” 57

58. In Perspective - Goethe
“Knowing is not enough; we must apply. Willing is not enough; we must do." 58

59. In Perspective - Meade
“Never doubt that a small group of thoughtful committed people can change the world; indeed it’s the only thing that ever has!” 59