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System Design to
Produce Safer Care:
Culture, Measurement
and Infrastructure
1st Symposium IHI-Einstein: Implementation an...
Safety as a Systems Property
Safety is not measured by the
number of times you fall through
the ice…
The Story of “David”
5yr boy with known Sickle Cell disease
Goes to emergency department of the local
hospital with leg pa...
The Story of “David”
Same day - doctor is called back by parents, draws the correct blood test –
shows very low Hb (3.5), ...
Case failure or
System failure?
Trends
and
Patterns
(run charts,
statistical analysis,
qualitative study)
System Structure
(pattern of interrelationship a...
Attribution Error
A fault in the interpretation of observations,
seen everywhere, is to suppose that every
event (defect, ...
How do we know if what happened
here is special cause or common
cause (happening throughout the
organization)?
11
Using the information from the case,
what data would we like to have
about system performance?
What processes failed?
Are ...
Model 1: “Bad Apples” theory =
someone to blame
Source: Robert Lloyd, Ph.D.
13
Reject
defectives
Requirement,
Specificatio...
But what happens to the remaining
system after removing “bad apples”?
14
Increase
Fear
Micro-
manage
Kill the
Messenger
Fi...
Source: Robert Lloyd, Ph.D.
15
QualityBetter Worse
Action taken
on all
occurrences
Model 2: “bad system” theory = system t...
Infrastructure: Portfolio
Management and Execution
16
In Order to Reduce Patient Harm and
Mortality…
We have to know what changes, when
taken together, will help us accomplish
...
The Intuitive Structure
Very Large System
“Meso-
System”
“Meso-
System”
“Meso-
System”
Project
Project Project
ProjectProj...
Example: System Medication
Safety
Med.
reconciliation
Hospitals
SYSTEM Medication Safety
Rehab Offices
Standardized
dosing...
Example: Hospital Medication
Safety
Med.
reconciliation
Med Surg
Hospital Medication Safety
Surgery Pharm
IV pumps
VTE
On ...
Issues
Tier 3:
Projects
Team organization and capacity matter.
Front-line leadership is critical.
Measures tracked over ti...
Issues
Tier 2:
Portfolio
Middle Management key.
What are the “drivers” of the outcomes we want?
Outcomes tracked over time...
Issues
Tier 1:
Big Dot
Aims of strategic importance to the system as a
whole.
“Big Dot” measure of progress.
Executive, Bo...
Measurement for Safer Care
The purpose of collecting and
displaying data is to make better
decisions…
Coronary Artery Bypass Graft
Mortality Rate (%)
Jan ‘02 Jan ‘03
5.9%
1.1%
Coronary Artery Bypass Graft
0
1
2
3
4
5
6
7
Jan-02
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Jan-03
CABG Mortality Rate...
Coronary Artery Bypass Graft
0
1
2
3
4
5
6
7
Jan-02
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Jan-03
CABG Mortality Rate...
Coronary Artery Bypass Graft
0
1
2
3
4
5
6
7
Jan-02
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
Dec
Jan-03
CABG Mortality Rate...
There is no single measure of
safety, but early warning signals
can be valuable and should be
maintained and heeded.
Berwi...
Monitoring and Measuring
Measurement: data from the past, almost always
driving using the rear view mirror;
Example: Plott...
Monitoring and Measuring
When asked if your organisation is safe, what exactly do
you want to know to answer that question...
• Has patient care been safe in the past?
• Are our clinical systems and processes reliable?
• Is care safe today?
• Will ...
The 5 questions…
Safe in the Past: psychological and physical
measures
Reliability: ‘failure free operation over time’ app...
“…As every clinician and manager knows,
problems and crises that potentially threaten
safety occur on a daily or even hour...
What are your sources of data?
Do you have the full picture?
Infection
rates
Mortality
review
Risk
management
Root cause
analysis
Readmission
data
Death and harm
What are important an...
Possible structures for information integration
Board
Senior Leaders
Middle Managers
Frontline Staff
Greater
outcome
focus...
The Culture of Safety
39
40
*Adapted from Safeskies 2001, “Aviation Safety Culture,” Patrick
Hudson, Centre for Safety Science, Leiden University
P...
The Human Component:
Appropriate Accountability:
Fair and Just Culture
Accountability – Fair and Just Culture
Clear, simple rules - “one set” that apply to
everyone.
Four questions:
- Was there...
Drawing the Bright Line
Malicious
Substance Use
Conscious unsafe act
Substitution Test could 2-3 others make
the same mist...
Organizational Fairness/Just Culture
Differentiate between:
Unsafe individuals
• Reckless behaviors
• Risky behaviors
Unsa...
1. First, exclude individuals with impaired judgment or whose actions might be malicious. (These cases must be
managed usi...
2. Second, use best judgment to categorize each action as either Reckless, Risky or Unintentional based on the
definitions...
3. Third, perform a Substitution Test by asking at least 3 others with similar skills if they, in a similar situation,
wou...
The Blame Cycle
Mgt. even
even more
convinced
that…
People seen to
choose erroneous
course of action
Deliberate actions
de...
Use of the Machine
Typically, 2 machines for each 13 room hallway
Nurse has 5 patients placed throughout the unit
On avera...
PERFORMANCE
ACCIDENT
System Migration to Unsafe Practices to
VERYUNSAFESPACE
The
guidelines
and policy-
take meds
out for ...
Why the migration to less safe
practices?
Policy unmanageable
Nurses did not have the time to make several trips back
and ...
What migrations occur in your practice
area and hospital?
The two stories with very different
endings…
54
55
Why did this end so well?
55
…and this so badly?
pacColumbia
Destroyed February 1,
2003
The history of foam-problem decisions shows
how NASA first began and then continued
flying with foam losses, so that flyin...
Over the course of 22 years, foam
strikes were normalized to the point
where they were simply a maintenance
issue – a conc...
Culture
The culture of wanting to know the truth
The courage to face reality
Listening to staff and patients
• Commit to knowing the ‘thickness of your ice’
• Build a portfolio of safety work and capability at every
level
• Improve...
System design to produce safer care culture meassurement and infrastructure for safety
System design to produce safer care culture meassurement and infrastructure for safety
System design to produce safer care culture meassurement and infrastructure for safety
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System design to produce safer care culture meassurement and infrastructure for safety

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Apresentação de Carol Haraden durante o SIMPÓSIO EINSTEIN-IHI: Implantação e Disseminação de Programas de Segurança do Paciente aconteceu de 3 a 5 de novembro de 2013, em São Paulo - Brasil.
Carol Haraden é PhD, Vice Presidente do Institute for Healthcare Improvement (IHI), é membro do time responsável por desenvolver desenhos inovadores no cuidado ao paciente. Atualmente, ela lidera os trabalhos do IHI na Escócia, Sul da Inglaterra, Dinamarca e Estados Unidos.

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System design to produce safer care culture meassurement and infrastructure for safety

  1. 1. System Design to Produce Safer Care: Culture, Measurement and Infrastructure 1st Symposium IHI-Einstein: Implementation and Scale Up of Patient Safety Programs November 4, 2013 Carol Haraden, PhD Vice President
  2. 2. Safety as a Systems Property
  3. 3. Safety is not measured by the number of times you fall through the ice…
  4. 4. The Story of “David” 5yr boy with known Sickle Cell disease Goes to emergency department of the local hospital with leg pain Dx Sickle crisis - admitted to hospital for IV fluids and pain relief Next morning pain is worse, and David noticed to be jaundiced. Doctor asks for blood count and second analgesic is added Lab tech unable to draw blood for blood count, says someone else will come, but no one does. Doctor not notified - leaves for day without drawing blood for test Next morning, jaundice is worse, patient is weak, another doctor is called, draws blood for other tests – but blood count is not determined
  5. 5. The Story of “David” Same day - doctor is called back by parents, draws the correct blood test – shows very low Hb (3.5), needs emergency blood transfusion No blood available at hospital (new policy blood had to come from central blood bank), Parents offer to collect blood declined – hospital driver sent to pick up blood. No blood after 2 hours, parents frantic. Reassured Further 2 hour delay - driver runs other errands while picking up blood Pain is much worse – parents question narcotic scheduling – nurse replies “following doctor’s orders” David now weak, confused, agitated, laboured breathing Parents frantic. Get nurses to call driver – dropping staff off at homes Blood arrives – wrong type – whole blood vs packed cells Transfusion starts - 36h after initial FBC order 20 min later David dies; primary reasons –heart failure and respiratory failure secondary to severe anaemia
  6. 6. Case failure or System failure?
  7. 7. Trends and Patterns (run charts, statistical analysis, qualitative study) System Structure (pattern of interrelationship among key components of the system: hierarchy, process flows, mental models) Leverage for Improvement Systems: Leverage for Improvement Events (crisis, anecdotes, problems)
  8. 8. Attribution Error A fault in the interpretation of observations, seen everywhere, is to suppose that every event (defect, mistake, accident) is attributable to someone (usually the one nearest at hand), or is related to some special event. The fact is most troubles with service and production lie in the system. - Deming (1986),p. 315) 10
  9. 9. How do we know if what happened here is special cause or common cause (happening throughout the organization)? 11
  10. 10. Using the information from the case, what data would we like to have about system performance? What processes failed? Are they unreliable throughout the organization? 12
  11. 11. Model 1: “Bad Apples” theory = someone to blame Source: Robert Lloyd, Ph.D. 13 Reject defectives Requirement, Specification or Threshold No action taken here QualityBetter Worse QualityBetter Worse ? Better care
  12. 12. But what happens to the remaining system after removing “bad apples”? 14 Increase Fear Micro- manage Kill the Messenger Filter the Information QualityBetter Requirement, Specification or Threshold Worse Reject defects? The Cycle of Fear
  13. 13. Source: Robert Lloyd, Ph.D. 15 QualityBetter Worse Action taken on all occurrences Model 2: “bad system” theory = system to blame (work on all parts of the system)
  14. 14. Infrastructure: Portfolio Management and Execution 16
  15. 15. In Order to Reduce Patient Harm and Mortality… We have to know what changes, when taken together, will help us accomplish this aim. 17
  16. 16. The Intuitive Structure Very Large System “Meso- System” “Meso- System” “Meso- System” Project Project Project ProjectProject Project Project Project Tier 1 Tier 2 Tier 3
  17. 17. Example: System Medication Safety Med. reconciliation Hospitals SYSTEM Medication Safety Rehab Offices Standardized dosing Family Capacity Self med Correct list availability Patient capability Tier 1: Big Dot Tier 2: Portfolio Tier 3: Projects
  18. 18. Example: Hospital Medication Safety Med. reconciliation Med Surg Hospital Medication Safety Surgery Pharm IV pumps VTE On time antibiotics Standardized dosing availability Admix Tier 1: Big Dot Tier 2: Portfolio Tier 3: Projects
  19. 19. Issues Tier 3: Projects Team organization and capacity matter. Front-line leadership is critical. Measures tracked over time and visible. Senior leaders remove obstacles. Clear changes important. Ability to run PDSA cycles.
  20. 20. Issues Tier 2: Portfolio Middle Management key. What are the “drivers” of the outcomes we want? Outcomes tracked over time. “Connecting the Dots” – Putting the learning together. Continual readjustment of portfolio. Strong linkage to finance.
  21. 21. Issues Tier 1: Big Dot Aims of strategic importance to the system as a whole. “Big Dot” measure of progress. Executive, Board and Senior Leader engagement. Vision and the associated structural changes. Strong linkage to finance. Managing the learning, the politics, and the risks.
  22. 22. Measurement for Safer Care
  23. 23. The purpose of collecting and displaying data is to make better decisions…
  24. 24. Coronary Artery Bypass Graft Mortality Rate (%) Jan ‘02 Jan ‘03 5.9% 1.1%
  25. 25. Coronary Artery Bypass Graft 0 1 2 3 4 5 6 7 Jan-02 Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan-03 CABG Mortality Rate: Clinic I
  26. 26. Coronary Artery Bypass Graft 0 1 2 3 4 5 6 7 Jan-02 Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan-03 CABG Mortality Rate: Clinic II
  27. 27. Coronary Artery Bypass Graft 0 1 2 3 4 5 6 7 Jan-02 Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan-03 CABG Mortality Rate: Clinic III
  28. 28. There is no single measure of safety, but early warning signals can be valuable and should be maintained and heeded. Berwick Report: Promise to learn, Commitment to Act (2013)
  29. 29. Monitoring and Measuring Measurement: data from the past, almost always driving using the rear view mirror; Example: Plotting your average driving speed on a run chart over a month Monitoring: real time understanding of the situation so that management can be more dynamic Example: Using the speedometer to gauge speed as you drive.
  30. 30. Monitoring and Measuring When asked if your organisation is safe, what exactly do you want to know to answer that question? Asking five critical questions can help you understand the different dimensions of safety in your organisation.
  31. 31. • Has patient care been safe in the past? • Are our clinical systems and processes reliable? • Is care safe today? • Will care be safe in the future? • Are we responding and improving?
  32. 32. The 5 questions… Safe in the Past: psychological and physical measures Reliability: ‘failure free operation over time’ applies to measures of behaviour, processes and systems Safe Today: Sensitivity to operations- the information and capacity to monitor safety on an hourly or daily basis Safe in Future: Anticipation and preparedness- the ability to anticipate, and be prepared for, problems Improving: Integration and learning: the ability to respond to, and improve from, safety information
  33. 33. “…As every clinician and manager knows, problems and crises that potentially threaten safety occur on a daily or even hourly basis, such as a sudden influx of very sick patients, staff sickness or equipment breakdowns.” Berwick Report: Promise to learn, Commitment to Act (2013)
  34. 34. What are your sources of data? Do you have the full picture?
  35. 35. Infection rates Mortality review Risk management Root cause analysis Readmission data Death and harm What are important and recurrent issues? Who has the data? Incident reports
  36. 36. Possible structures for information integration Board Senior Leaders Middle Managers Frontline Staff Greater outcome focus Relevant process and outcome measures Higher level outcome measures Greater process focus
  37. 37. The Culture of Safety 39
  38. 38. 40 *Adapted from Safeskies 2001, “Aviation Safety Culture,” Patrick Hudson, Centre for Safety Science, Leiden University PATHOLOGICAL Who cares as long as we’re not caught Chronically Complacent REACTIVE Safety is important. We do a lot every time we have an accident CALCULATIVE We have systems in place to manage all hazards PROACTIVE Anticipating and preventing problems before they occur Constantly Vigilant GENERATIVE Safety is how we do business around here Constantly Vigilant Evolution of A Culture of Safety and Reliability 40
  39. 39. The Human Component: Appropriate Accountability: Fair and Just Culture
  40. 40. Accountability – Fair and Just Culture Clear, simple rules - “one set” that apply to everyone. Four questions: - Was there malice involved? - Was the individual knowingly impaired? - Was there a conscious unsafe act? - Did the person(s) make a mistake that someone of similar skill and training could make under those circumstances?
  41. 41. Drawing the Bright Line Malicious Substance Use Conscious unsafe act Substitution Test could 2-3 others make the same mistake in similar circumstances? Repeat Events Remediate / replace Safe Harbor – Systems Approach Reason, James
  42. 42. Organizational Fairness/Just Culture Differentiate between: Unsafe individuals • Reckless behaviors • Risky behaviors Unsafe systems Pascal Metrics
  43. 43. 1. First, exclude individuals with impaired judgment or whose actions might be malicious. (These cases must be managed using other appropriate avenues – i.e. employee assistance programs for substance abuse and psychosocial problems, legal authorities for cases with possible criminal intent.) IMPAIRED JUDGMENT The caregiver's thinking was impaired - by illegal or legal substances - by cognitive impairment - by severe psychosocial stressors MALICIOUS ACTION The caregiver wanted to cause harm. • Discipline is warranted if illegal substances were used. • The caregiver's mindset and performance should be evaluated to determine whether a temporary work suspension would be helpful. • Help should be actively offered to the caregiver. • Discipline and/or legal proceedings are warranted. • The caregiver's duties should be suspended immediately. The Fair Evaluation and Response Chart slide-45Pascal Metrics Pascal MetricsPartially adapted from David Marx
  44. 44. 2. Second, use best judgment to categorize each action as either Reckless, Risky or Unintentional based on the definitions in the Chart. The categorization determines the general level of culpability and possible disciplinary actions, however these general categories require further analysis as below prior to making a final decision. RECKLESS ACTION The caregiver knowingly violated a rule and/or made a dangerous or unsafe choice. The decision appears to be self serving and to have been made with little or no concern about risk. RISKY ACTION The caregiver made a potentially unsafe choice. Their evaluation of relative risk appears to be erroneous. UNINTENTIONAL ERROR The caregiver made or participated in an error while working appropriately and in the patients' best interests • The caregiver is accountable and needs re-training. Discipline may be warranted • The caregiver should participate in teaching others the lessons learned. • The caregiver is accountable and should receive coaching. • The caregiver should participate in teaching others the lessons learned. • The caregiver is not accountable. • The caregiver should participate in investigating why the error occurred and teach others about the results of the investigation. The Fair Evaluation and Response Chart Partially adapted from David Marx. slide-46 Pascal Metrics
  45. 45. 3. Third, perform a Substitution Test by asking at least 3 others with similar skills if they, in a similar situation, would act similarly. If the answer is “No” the individual is accountable. If the answer is “We do it all the time” or answers are divided, assign accountability per below - and remember that an important goal is to ensure others perceive responses as fair: The system supports reckless action and requires fixing. The caregiver is probably less accountable for the action, and system leaders share in the accountability. The system supports risky action and requires fixing. The caregiver is probably less accountable for the action, and system leaders share in the accountability. The system supports error and requires fixing. The system's leaders are accountable and should apply error-proofing improvements. 4. Fourth, evaluate whether the individual has a history of unsafe or problematic acts. If they do, this may influence decisions about the appropriate responsibilities for the individual i.e. they may be in the wrong job. Organizations should have a reasonable and agreed upon statute of limitations for taking these actions into account. The Fair Evaluation and Response Chart The Substitution Test is a concept of James Reason. slide-47 Pascal Metrics
  46. 46. The Blame Cycle Mgt. even even more convinced that… People seen to choose erroneous course of action Deliberate actions deserve sanctions Exhort and punish those making errors Little or no effect on error rates Management view this as deliberate disregard of warnings, etc. STARTS HERE James Reason, 2000
  47. 47. Use of the Machine Typically, 2 machines for each 13 room hallway Nurse has 5 patients placed throughout the unit On average, each patient has between 7-10 medications 2-4 times per day Nurse takes medications out 1 at a time
  48. 48. PERFORMANCE ACCIDENT System Migration to Unsafe Practices to VERYUNSAFESPACE The guidelines and policy- take meds out for one pt. at a time Belief Systems Life Pressures INDIVIDUAL BENEFITS More than one patients meds placed in pockets= Legal/normal ‘ All patients meds placed in pockets = ‘‘‘‘Illegal- Illegal’’’’ space Perceived Vulnerability
  49. 49. Why the migration to less safe practices? Policy unmanageable Nurses did not have the time to make several trips back and forth to the machine several times a day The medication cart had been taken away No one had studied medication administration patterns before installation Safe dispensing ≠ safe administration
  50. 50. What migrations occur in your practice area and hospital?
  51. 51. The two stories with very different endings… 54
  52. 52. 55 Why did this end so well? 55
  53. 53. …and this so badly? pacColumbia Destroyed February 1, 2003
  54. 54. The history of foam-problem decisions shows how NASA first began and then continued flying with foam losses, so that flying with these deviations from design specifications was viewed as normal and acceptable…The parallels (with Challenger) are striking. The acceptance of events that are not supposed to happen is known as “normalization of deviance. Report of the Columbia Accident Investigation Board 8/26/03. P 130.
  55. 55. Over the course of 22 years, foam strikes were normalized to the point where they were simply a maintenance issue – a concern that did not threaten a mission’s success. Report of the Columbia Accident Investigation Board 8/26/03. P 181.
  56. 56. Culture The culture of wanting to know the truth The courage to face reality Listening to staff and patients
  57. 57. • Commit to knowing the ‘thickness of your ice’ • Build a portfolio of safety work and capability at every level • Improve the SYSTEM of safety AND events • Monitor AND measure • Get the best and most complete picture of the issues (data) and display in a way that is understandable and compelling • Train managers and leaders on use of the just culture decision tools • Have courage to face reality and speak the truth. • Listen to patients and families! Good places to start…

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