1. Leading Change and Improving Reliability--
Steve Narang, MD MHCM Chief Executive Officer Banner Good Samaritan Medical Center
Leading Change and Improving Reliability--
Delivering the Right Care to the Right Patient at the Right Time

3. The Iceberg…. …Now it is complex, effective and potentially dangerous”
. “Medicine used to be simple, ineffective and relatively safe…
…Now it is complex, effective and potentially dangerous”
Sir Cyril Chantler
UK Health Policy Advisor
Former Dean, Guy’s, King’s and St. Thomas Medical and Dental Schools
The Iceberg….

6. Scientific understanding
The Iceberg…
Scientific understanding
Progress
Time
Implementation Gap
Patient care
So we start out by noticing an area of focus. This focus for quality improvement projects should develops from recognition of a gap between the level of care that is optimal and best supported by the evidence contrasted with the care that is actually being delivered to our patients.
We are all here today because we know that management of hyperglycemia in the hospital is one of these areas. What is actually being done, is far from what is supported in the literature.
How do we ultimately bridge that gap? It can be accomplished by using qi principles and following steps that have been determined to be essential by those who have gone before you.

7. The Iceberg… Most advanced healthcare system in the world
High Cost, Low Quality
For the money the United States spends on healthcare, about $2.5 trillion a year – the quality of care is unacceptably low
Each year as many as 15 million patients harmed in some manner by America’s healthcare system

9. Deaths Due to Surgical or Medical Mishaps per 100,000 Populationb b b a b b
a2003
b2002
Source: The Commonwealth Fund, 2004 data calculated from OECD Health Data 2006.

10. Variation in Cardiac Care from State to State
Cardiac Surgery Report. Lebanon, NH: The Dartmouth Institute for Health Policy and Clinical Practice, 2005.

11. 98.1 50 65 80 67

12. The Iceberg is Melting….
Doing the right thing,
the right way,
at the right time,
in the right amount,
for the right patient
that does not result
in harm to the patient
The Iceberg is Melting….

13. Those of us who work in the health-care chains will have to contend with new protocols and technology rollouts every six months, supervisors and project managers, and detailed metrics on our performance. Patients won’t just look for the best specialist anymore; they’ll look for the best system

14. “Health Care Needs a Escape Fire….”

15. Average Rate Per Exposure of Catastrophes and Associated Deaths Per Activity (“Reliability”) Amalberti, et al. Ann Intern Med.2005;142:

16. “Reliability is failure free operation over time
“Reliability is failure free operation over time.” David Garvin Harvard Business School

18. Observation: The reliability of applying known or required processes commonly is 10-1 (80%) or worse(When dealing with non-catastrophic processes) 18

19. Example of 3 Step Design in Implementing the Ventilator Bundle
                                                                           
RT built into 1 hour scheduled vent checks as a)
Integrate daily goals with MDR to identify defects as a
Feedback on compliance
Education
Baseline
Baseline
Baseline
Baseline

20. Framework for Reliable Design
Process is the action point of all improvement methodologies
Reliability occurs by design not by accident

21. Starting Labels of Reliability
Chaotic process: Failure in greater than 20% of opportunities
10-1: 80 or 90 percent success. 1 or 2 failures out of 10 opportunities
10-2: 5 failures or less out of 100 opportunities
10-3: 5 failures or less out of 1000 opportunities
10-4: 5 failures or less out of 10,000 opportunities
(These are IHI definitions and are not meant to be the true mathematical equivalent)

22. Reasons for the Reliability Gap In Healthcare
Current Improvement methods in healthcare are highly dependent on vigilance and hard work
The focus on benchmarked outcomes tends to exaggerate the reliability within healthcare hence giving both clinicians and leadership a false sense of security
Permissive clinical autonomy creates and allows wide performance margins
The use of deliberate designs to achieve articulated reliability goals seldom occurs

24. Improvement Concepts Associated with 10-1 Performance (Primarily can be described as intent, vigilance, and hard work)
Common equipment, standard order sheets, multiple choice protocols, and written policies/procedures
Personal check lists
Feedback of information on compliance
Suggestions of working harder next time
Awareness and training

25. Improvement Concepts Associated with 10-2 Performance (Uses human factors and reliability science to design sophisticated failure prevention, failure identification, and mitigation)
Decision aids and reminders built into the system
Desired action the default (based on scientific evidence)
Redundant processes utilized
Scheduling used in design development
Habits and patterns know and taken advantage of in the design
Standardization of process based on clear specification and articulation is the norm

28. Hard work and vigilance although commendable is not a good design principle
If 10-2 change concepts do not make up at least 25% of the improvement effort on a given project require the team to rethink the design
Key Learning Points

29. Reasons for the Reliability Gap In Healthcare
Current Improvement methods in healthcare are highly dependent on vigilance and hard work
The focus on benchmarked outcomes tends to exaggerate the reliability within healthcare hence giving both clinicians and leadership a false sense of security
Permissive clinical autonomy creates and allows wide performance margins
The use of deliberate designs to achieve articulated reliability goals seldom occurs

30. Biology Protects Us All defects in process do not lead to bad outcomes
Healthcare tends to look at outcomes and not the reliability of the process leading to outcomes (handwashing is an example)
Benchmark to best practice not aggregate averages
Biology Protects Us

31. If you accept benchmark level performance in your organization you compare yourself against mediocrity and foster 10-1 performance in non catastrophic processes
Benchmark against the industry best, but also insist on reliable processes
Measure processes against a specific reliability goal (10-2)
Measure linked processes using the “all or none” rule
Key Learning Points

32. Reasons for the Reliability Gap In Healthcare
Current Improvement methods in healthcare are highly dependent on vigilance and hard work
The focus on benchmarked outcomes tends to exaggerate the reliability within healthcare hence giving both clinicians and leadership a false sense of security
Permissive clinical autonomy creates and allows wide performance margins
The use of deliberate designs to achieve articulated reliability goals seldom occurs

33. Health Care Processes Current - Desired - variation
Variable, lots of autonomy
not owned,
poor if any
feedback for improvement, constantly altered by individual changes, performance stable at low levels
Desired - variation
based on clinical criteria, no individual autonomy to change the process,
process owned from start to finish,
can learn from defects before harm occurs, constantly improved by collective wisdom - variation
Health Care Processes
Terry Borman, MD Mayo Health System

34. René Amalberti: Premises
“Unconstrained” human performance (guided by personal discretion, only) is worse than 10-2
Constrained human performance can reach 10-2

35. A single standardized process within the acceptable science is superior to allowing multiple processes while we decide which is the best because it allows testing and training
Key Learning Point

36. Why not 10-2 or better for your patients
Why not 10-2 or better for your patients? Why not YOU being a leader in the 10-2 model? Where to start?

37. Reasons for the Reliability Gap In Healthcare
Current Improvement methods in healthcare are highly dependent on vigilance and hard work
The focus on benchmarked outcomes tends to exaggerate the reliability within healthcare hence giving both clinicians and leadership a false sense of security
Permissive clinical autonomy creates and allows wide performance margins
The use of deliberate designs to achieve articulated reliability goals seldom occurs

38. The Three Step Design for Reliability
Design Techniques
Steps
1-Identify the process to standardize
2-Segment the population to test the
design for anomalies
3-Use both 10-1 and 10-2 concepts
Prevent initial failure by standardizing the process to achieve 10-1 (step 1)
1-Utilize a robust 10-2 concept to make visible failures from step 1 after step 1 has achieved 10-1 reliability
2-Once the failure is identified, apply an action to mitigate the failure
Identify failures in step 1 and apply an action to achieve 10-1 for these failures (step 2)
1-Identify common failures
2-Develop a method to measure and study failures
3-Utilize knowledge of common failures to redesign either step 1 or step 2
In either step 1 and/or step 2 detect the failures, and use the knowledge from analysis of the failures to redesign (step 3)

39. The “Set Up” for Reliability Exercise #1
Select a topic whose outcome you want to improve
Determine a high volume segment for initial design testing
Build a high level flow chart for that segment
Determine where the defects occur in the current system
Determine where your design work will begin with by identifying where the commonest defects occur
Verbalize the reliability

40. Topic: Ventilator Bundle
Segment: Medical ICU
Patient Placed on Ventilator
4 Elements of the bundle ordered
4 Elements of the bundle accomplished
Patient removed from ventilator
Of the 4 elements of the bundle, the head of the bed elevation is most commonly not accomplished
Our aim is to with a reliability of 95% or to achieve keeping the head of the bed elevated.

41. The Reliability Design Strategy
Prevent initial failure using intent and standardization
Identify defects (using redundancy) and mitigate
Measure and then communicate learning from defects back into the design process
The Reliability Design Strategy

42. New Standardization Concepts
Standardize to provide the appropriate infrastructure (the how, what, where, who and when)
The “what” we are standardizing is based on medical evidence
The “how” does not need medical evidence but rather systems knowledge
Initial standardized protocols are developed with small time investment by experts tested at a very small scale
Changes to the protocol in the initial stages should be required and encouraged
Defects are studied and used to redesign the process

43. Three Tier Design Strategy
Prevent initial failure using intent and standardization
Redundancy/contingency function (identify failure and mitigate)
Critical failure mode function (identify critical failures and then redesign)
Three Tier Design Strategy

44. Allows less than perfect design in the standardization step (we do not have to plan for every possible contingency)
Anticipates and allows failure in the prevent failure (standardization function) step
Allows a better balance of resource use (no need to spend months coming up with the perfect design)
Fosters the atmosphere of mitigation and recovery
Why the Step is Needed

45. Characteristics of “Redundancy Tools”
Require careful consideration since they do represent a form of “waste”
Needs to be connected to the process almost all the time (at least 10-1)
Requires a good prevent failure step (standardization function) before implementing a redundancy
Need to be truly independent
Need to be used or will no longer function as a good filter
Must follow with a mitigation strategy
Characteristics of “Redundancy Tools”

46. What we really mean by the redundancy/contingency step is the use of model 10-2 concepts

47. Model 10-2 Concepts Decision aids and reminders built into the system
Human Factors and Reliability Science: 10-2 Performance
(Designing sophisticated failure prevention, failure identification
and mitigation)
Decision aids and reminders built into the system
Desired action the default (based on evidence)
Redundant processes
Use fixed current scheduling in design
Take advantage of habits and patterns
Standardization of process based on clear specification and articulation

48. Examples:
Decision Aid Pop-ups: “Remember to give Flu Shot”, “Did you order a drug level?”
Default to the appropriate option: Patients get smoking cessation education whether physician orders or not.
Redundancy: Two people check narcotics, Order read back for verbal orders, second person verifies charge capture at the end of clinic
Checklists: Direct Admit Checklist, Handoff Checklist.
Scheduling: An area is scheduled to be cleaned every morning, does not need to be requested.
Real-Time ID of Failures: Identify and Mitigate Recommendations

49. Three Tier Design Strategy
Prevent initial failure using intent and standardization
Redundancy function (identify failure and mitigate)
Critical failure mode function (identify critical failures and then redesign)
Three Tier Design Strategy

50. Critical Failure Mode Essentials
A measurement of critical failure modes needs to be part of the initial design strategy
Assesses the defects that occur from the current design
Should be prioritized in terms of overall affect on the reliability of the process change
Should be used to redesign the process

51. Example of 3 Step Design in Implementing the Ventilator Bundle
                                                                           
Redundancy in the form of a check by RT built into 1 hour scheduled vent checks as a 10-2 change concept (step 2)
Integrate daily goals with MDR to identify defects as a 10-2 change concept (step 1)
Feedback on compliance as a 10-1 concept
Education as a 10-1 concept
Baseline
Example of using 10-1 and change concepts to initially reach a reliability of 10-1 then additionally using a robust 10-2 change concept (redundancy) to reach 10-2 reliability in the 4 elements of the ventilator bundle (Baptist Memorial, Memphis)

54. Level 3 Concepts: (Sophisticated Behavioral Designs)
Take advantage of habits and patterns
Make the system visible
Clear and unambiguous communication
Mindfulness – Weick and Sutcliffe:
“High Reliability Organizations”
Level 3 Concepts: (Sophisticated Behavioral Designs)

55. Attributes of High Reliability Organizations: Weick
1. Preoccupation with failure
2. Reluctance to simplify interpretations
3. Sensitivity to operations
4. Commitment to resilience
5. Deference to expertise
Weick, et al. Research in Organizational Behavior. 1999;21: Weick, Managing the Unexpected: Assuring High Performance in an Age of Complexity, Jossey Bass 2001

56. Attributes of High Reliability Organizations: Weick
1. Preoccupation with failure
Small failures are as important as large failures
Avoid complacency:
Success breeds confidence in a single way of doing things and generates complacency
Ex. “My patient has never had a Potassium overdose, so why should I change?”
Success narrows perceptions
Worry about normalization of unexpected events

57. Attributes of High Reliability Organizations: Weick
2. Reluctance to simplify interpretations
Closer attention to context leads to more differentiation of worldviews and mindsets
Look for the root cause, not the obvious cause
Ex. Dumb resident wrote a 10-fold overdose
Root Cause: “dumb” resident was up all night, in ED with seizing kid, called for verbal order, …

58. Attributes of High Reliability Organizations: Weick
2. Reluctance to simplify interpretations
Differentiation (diverse viewpoints) brings a varied picture of potential consequences  better precautions and responses to early warning signs.
Over dependency on insiders leads to simplification
Ex. This is how we do it at Good Sam….
Attributes of High Reliability Organizations: Weick

59. Attributes of High Reliability Organizations: Weick
3. Sensitivity to operations
Attentive to the front line where the real work gets done
Authority moves toward expertise:
Role of RNs
Role of Clinical MDs, PNPs
Role of Parents
Make continuous adjustments that prevent errors from accumulating and enlarging based upon reporting from operations, not the “master plan”

60. Attributes of High Reliability Organizations: Weick
4. Commitment to resilience
Develop capabilities to detect, contain, and bounce back from those inevitable errors that are part of an indeterminate world
Ex. Trigger tools (and automation)
A focus on intelligent reaction, improvisation
Correct errors before they worsen and cause more serious harm
Ex. “stop the line”

61. Attributes of High Reliability Organizations: Weick
5. Deference to expertise
Decisions are made on the front line, and authority migrates to the people with the most expertise, regardless of their rank
Avoidance of the structure of deference to the powerful, coercive, or senior

62. “Together these five processes produce a collective state of mindfulness. To be mindful is to have an enhanced ability to discover and correct errors that could escalate into a crisis.”
Mindfulness: Weick

63. consider what a resident in a busy pediatric emergency department might do when he is unable to determine whether an ear examination is normal or abnormal and the attending physician is not immediately available…(s/he) weighs the consequences of misdiagnosis for the patient, the humiliation of having to call the otolaryngology resident…loss of self-esteem by having to admit incompetence…
…A mindful conscious approach would be to cultivate awareness not only of the correct course of action but also of the factors that cloud the decision-making process. The mindful practitioner is mentally and technically better prepared for the next situation

64. …the most important difference among industries…lies in their willingness to abandon historical and cultural precedent and beliefs that are linked to performance and autonomy, in a constant drive toward a culture of safety…
Rene Amalberti, MD, PhD Cognitive Science Department, Bretigny-sur-Orge, France Amelberti et al. Ann Intern Med 2005;142:

66. Don’t let yourself be. Find something new to try, something to change
Don’t let yourself be. Find something new to try, something to change. Count how often it succeeds and how often it doesn’t. Write about it. Ask a patient or a colleague what they think about it. See if you can keep the conversation going (Atul Gawande,MD)
So how do you start???