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

System Design to Produce Safer Care: Culture, Measurement and Infrastructure1st Symposium IHI-Einstein: Implementation and Scale Up of Patient Safety Programs

November 4, 2013

Carol Haraden, PhD

Vice President

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 diseaseGoes to emergency department of the local hospital with leg painDx Sickle crisis - admitted to hospital for IV fluids and pain reliefNext morning pain is worse, and David noticed to be jaundiced. Doctor asks for blood count and second analgesic is addedLab 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 testNext morning, jaundice is worse, patient is weak, another doctor is called, draws blood for other tests – but blood count is not determined

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 transfusionNo 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. ReassuredFurther 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 breathingParents frantic. Get nurses to call driver – dropping staff off at homesBlood arrives – wrong type – whole blood vs packed cellsTransfusion starts - 36h after initial FBC order20 min later David dies; primary reasons –heart failure and respiratory failure secondary to severe anaemia

Case failure or System failure?

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)

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)

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How do we know if what happened here is special cause or common cause (happening throughout the

organization)?

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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?

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Model 1: “Bad Apples” theory = someone to blame

Source: Robert Lloyd, Ph.D.

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Reject defectives

Requirement,Specification or

Threshold

No action taken here

QualityBetter Worse QualityBetter Worse

? Better

care

But what happens to the remaining system after removing “bad apples”?

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Increase

Fear

Micro-

manage

Kill the

Messenger

Filter

the

Information

QualityBetter

Requirement,Specification or

Threshold

Worse

Reject defects?

The Cycle of Fear

Source: Robert Lloyd, Ph.D.

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QualityBetter Worse

Action taken on all

occurrences

Model 2: “bad system” theory = system to blame (work on all parts of the system)

Infrastructure: Portfolio Management and Execution

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In Order to Reduce Patient Harm and Mortality…

We have to know what changes, when taken together, will help us accomplish

this aim.

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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

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

Example: Hospital Medication Safety

Med.

reconciliation

Med Surg

Hospital Medication Safety

Surgery Pharm

IV pumps

VTEOn time

antibiotics

Standardized

dosing

availability

Admix

Tier 1:

Big Dot

Tier 2:

Portfolio

Tier 3:

Projects

IssuesTier 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.

IssuesTier 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.

IssuesTier 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.

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%


0

1

2

3

4

5

6

7

Jan-

02

Feb

Mar

Apr

May Ju

n

Jul

Aug

Sep

Oct

Nov

Dec

Jan-

03

CABG Mortality Rate: Clinic I


0

1

2

3

4

5

6

7Ja

n-0

2

Feb

Mar

Apr

May

Jun

Jul

Aug

Sep

Oct

Nov

Dec

Jan-0

3

CABG Mortality Rate: Clinic II


0

1

2

3

4

5

6

7

Jan-

02

Feb

Mar

Apr

May Ju

n

Jul

Aug

Sep

Oct

Nov

Dec

Jan-

03

CABG Mortality Rate: Clinic III

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)

Monitoring and MeasuringMeasurement: 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.

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.

• 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?

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

“…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)

What are your sources of data?

Do you have the full picture?

Infection

rates

Mortality

reviewRisk

management

Root cause

analysis

Readmission

data

Death and harm

What are important and recurrent issues?Who has the data?

Incident

reports

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

The Culture of Safety

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40*Adapted from Safeskies 2001, “Aviation Safety Culture,” Patrick Hudson, Centre for Safety Science, Leiden University

PATHOLOGICALWho cares as long as we’re not caught

Chronically Complacent

REACTIVESafety is important. We do a lot every

time we have an accident

CALCULATIVEWe have systems in place to manage all

hazards

PROACTIVEAnticipating and preventing problems

before they occur

Constantly Vigilant

GENERATIVESafety is how we do business around here

Constantly Vigilant

Evolution of A Culture of Safety and

Reliability

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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 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?

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

Organizational Fairness/Just Culture

Differentiate between:

Unsafe individuals

• Reckless behaviors

• Risky behaviors

Unsafe systems

Pascal Metrics

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

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.


in teaching others the lessons

learned.

• The caregiver is not accountable.


in investigating why the error

occurred and teach others about

the results of the investigation.


Partially adapted from David Marx. slide-46 Pascal Metrics

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 Substitution Test is a concept of James Reason.slide-47

Pascal Metrics

The Blame Cycle

Mgt. eveneven moreconvincedthat…

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

Use of the Machine

Typically, 2 machines for each 13 room hallwayNurse has 5 patients placed throughout the unitOn average, each patient has between 7-10 medications 2-4 times per dayNurse takes medications out 1 at a time

PERFORMANCE

ACCIDENT

System Migration to Unsafe Practices to

VE

RY

UN

SAF

ESP

AC

E

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 patientsmeds placed in pockets= ‘‘‘‘Illegal-Illegal’’’’ space Perceived

Vulnerability

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 dayThe medication cart had been taken awayNo one had studied medication administration patterns before installationSafe dispensing ≠ safe administration

What migrations occur in your practice area and hospital?

The two stories with very different endings…

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Why did this end so well?

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…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 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.

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.

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 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…

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

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