The Science of Patient Safety

Dr. Mohamed Mosaad Hasan

MD, MPH, CPHQ, CPPS, GBSS

Objectives

• Outline major principles for systems thinking and reliable design

• Describe human error categories and explain ways in which human factors engineering impacts safe process design

• Differentiate improvement models that have been utilized outside and inside of the healthcare industry

CASE #1

• 35 year old male• Seeking opthamology referral• Lab results for a different patient were

reviewed

CASE #2

• 52 year old patient

• History of GI bleeds and ulcers

• Prescribed an NSAID

System

Hazards

• Hazard activities (i.e., behaviors) or conditions that pose threat of harm

• Sometimes hazards lie hidden in the system, and sometimes they are quite obvious

44,000- 98,0000

Healthcare World before 1999-2000

• Quality/safety assumed to be excellent.

• No business case to improve safety/quality.

• No local expertise, research or best practices.

• Little concerted effort by board, C-suite or physicians to improve quality/safety

• Combination of wrong mental model and no incentive leads to predictable results

Healthcare World Now

• Growing business case for safety/quality

• Steady progression from relatively weak pressures (social pressure, accreditation w/ low chance to fail,

transparency), eventually settling on “all of the above”

plus payment changes

• Capacity building: people, tools, measures and IT

• Transition from quality/safety to value

• Recognition of need to remake delivery system to

survive/succeed in new healthcare world

Why Is This So Hard?

• Medicine is complex

• High degree of uncertainty

• Care across the continuum is challenging

• Diversity of workforce and

complexity of patients

Definition of Insanity

• Insanity: doing the same thing over and over again and expecting different results.

Albert Einstein

Error Causation and Prevention

• Most preventable harm to patients receiving healthcare today is caused by the unsafe acts of the various Practitioners who are trying to help them.

Human Error – James Reason

Systems Thinking

Refers to thinking in terms of: Interdependencies Interactions Sequences

Systems Thinking

Provides a conceptual framework to help see and understand relationships

Helps to avoid simplistic solutions to complex problems

Focus on interdependencies

Reliability Science

Definition of Reliability:

“the extent to which an experiment, test, or measuring procedure yields the same results on repeated trials”

By Institute for Healthcare Improvement

“Failure free operation over time”

Relation to IOM’s aims: effectiveness, timeliness, and patient-centeredness.

High Reliability Organization (HRO)

• Organizations despite functioning in complex, hazardous environments, have very low error rates

• Examples: airline industry, nuclear power, chemical plants, aircraft carriers.

One small error can lead to catastrophic consequences for not only the employees but also for the general public.

PRINCIPLES OF RELIABILITY SCIENCE

• Anticipation: used to detect an error before it occur.

• Containment: control the consequences of errors

Checklists and other Systems

Let me read your order Back to you.

The Culture of Low Expectations

“We suspect that these physicians and nurses had become accustomed to poor communication and teamwork. A ‘culture of low expectations’ developed in which participants came to expect a norm of faulty and incomplete exchange of information [which led them to conclude] that these red flags signified not unusual, worrisome harbingers but rather mundane repetitions of the poor communication to which they had become inured.”

Drs. Mark Chassin and Elise Becher

Annals of Internal Medicine, 2002

Human Factors

• Human factors engineering focuses on human beings and their interaction with each other, products, equipment, procedures, and the environment.

• Human factors leverages what we know about human behavior, abilities, limitations, and other characteristics to ensure safer, more reliable outcomes.

Sleep Deprivation

Interruptions

Memory Issues

Forcing Functions

• Be more careful, or….

• Redesign the breaks

Error Proofing

1. Simplification

2. Standardization

3. Reduce reliance on memory

4. Improve access to information

5. Use forcing functions and constraints

Error Proofing

6. Use visual controls

7. Leverage high-performance teams

8. Deploy redundancies

9. Eliminate environmental factors

10. Make errors more visible

PI approaches

Common CharactersPlannedSystematicCollaborativeOrganization-wide

Planned

ORGANIZEDDOCUMENTED

Systematic

PLANNINGPRIORITIZATIONASSESSMENTIMPLEMENTINGMAINTENANCE

ORGANIZATION WIDE

ALL LEADERSENTIRE ORGANIZATIONIMPORTANT FUNCTIONS

COLLABORATIVE

DEPARTMENTSSETTINGSDISCIPLINES

Model for Improvement

Three Questions

1) What is the aim?

2) How will we know a change is an

improvement?

3) What changes can we make that will result in

an improvement?

SHEWHART (PDCA) AND DEMING MODEL (PDSA)

P = PLAN D = DO (PILOT) CHECK OR STUDY ACT

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Shewhart Cycle

Plan

Do

Check

Act

1. Identify customer needs/expectations

2. Describe the current process

3. Measure and analyze data

4. Identify improvement opportunities

5. Identify root causes of problems

6. Generate and choose solutions

7. Plan and implement a pilot of the solutions

8. Evaluate results of pilot9. Draw conclusions

10. Standardize the change

11. Monitor the change and hold the gains

The Tradiotnal PDCA Model

FOCUS – PDCA MODEL

F = FIND A PROBLEM O = ORGANIZE TEAM C = CLARIFY YOUR KNOWLEDGE ABOUT THE

PROCESS U = UNDERSTAND SOURCES OF VARIATION S = SELECT THE PROCESS IMPROVEMENT

PLAN THE NECESSARY STEPS DO ALL NECESSARY TO IMPLEMENT CHECK THE RESULT OF ACTION ACT FULLY IMPLEMENT

(Useful for REDESIGN of a new process or QI)

F.O.C.U.S.

→Find an improvement project (initiative): – Review related standards & documents – Analysis of collected data – Identify problems & desired outcomes

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F. O .C.U.S.

→Organize ad hoc (task force) team:– Identify & involve stakeholders (e.g.

physicians, nurses, administrative …etc) – Cover all related departments to the

improvement initiative– Select team members who best do or know

the process to be improved

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O

F.O.C.U.S.

→ Clarify current process & desired outcomes:– Fully understand the current process by

all team member– Draw flow chart to clarify the process

variation/problem– Collect data from all affected areas

relevant to process & desired outcomes

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C

F.O.C.U.S.

Understand Process Variation, Root Causes & Desired Outcomes

F.O.C.U.S.

→Select the best practice procedure:– Analyze alternative solutions related to

process improvement– Choose the best solution that will achieve

desired outcome– Develop approval with a summary of

required information about expected outcomes, resources needed, time-frame, responsibilities ..etc

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S

P.D.C.A.

Plan the improvement project:

P.D.C.A.

Do the improvement project:

P.D.C.A.

Check the results:

P.D.C.A.

Act to hold gains or re-adjust

FOCUS_PDCA

Lean Methodology

• LEAN: An effective approach for improving patient safety by process design that improves reliability through standard work, mitigation, and continuous improvement

Focus Area of Lean

Lean: Lean pioneered by Toyota, focuses on the efficient

operation of the entire value chain. Focus areas:

– Remove non-value added steps to: Reduce cycle time Improve quality

– Align production with demand– Reduce inventory– Improve process safety and efficiency

Six Sigma

Core Attributes for Safe, Reliable Systems

• Well-defined workflows

• Mistake-proofing principles

• Measurement strategy

• Team members who share responsibility to provide safe, reliable care

The Science of Patient Safety

• New concepts: science of error causation (“systems thinking”), complex systems, human factors, cognitive psychology, applied informatics…

• New attitudes: teamwork, discipline, professionalism, balancing “no blame” with accountability, disclosure…

• New skills: error analysis, leadership, change management...

“We think that the anxiety, demoralization, and sense of loss of control that afflict too many healthcare professionals today directly come not from finding themselves to be participants in systems of care, but rather from finding themselves lacking the skills and knowledge to thrive as effective, proud, and well-oriented agents of change in those systems…. A physician equipped to help improve healthcare will be not demoralized, but optimistic; not helpless in the face of complexity, but empowered; not frightened by measurement, but made curious and more interested; not forced by culture to wear the mask of the lonely hero, but armed with confidence to make a better contribution to the whole.”

Berwick and Finkelstein, Acad Med, 2010