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Reliability: Keeping Our Promises

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Starting at the Beginning:Two Promises We Make to Our Patients

We will do everything that we know will help.

We will do nothing that will harm.

Copyright, The Reinertsen Group3

How well do we keep our promises?

• Help: –55% –10-1

• Harm: –1%–14.6%–200,000 +

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How Hazardous Is Health Care?How Hazardous Is Health Care?(Leape)(Leape)

1

10

100

1,000

10,000

100,000

1 10 100 1,000 10,000 100,000 1,000,000 10,000,000

Number of encounters for each fatality

Tota

l liv

es lo

st p

er y

ear

REGULATEDDANGEROUS(>1/1000)

ULTRA-SAFE(<1/100K)

HealthCare

Mountain Climbing

Bungee Jumping

Driving

Chemical Manufacturing

Chartered Flights

Scheduled Airlines

European Railroads

Nuclear Power

Are we seeing all the harm? Inpatient Surgical Record Review of 854 patients in 11 US hospitals…

• Found 14.6% of patients had a Surgical Adverse Event (SAE)

• 44% of SAEs caused increase LOS or readmit

• 8.7% required life-saving intervention or resulted in permanent harm or death

• “…Most of the events identified by Trigger Tool review had not been detected or reported via any other existing mechanism.”

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References• McGlynn EA, SM Asch, J Adams, J Keesey, J Hicks, A

DeCristofaro, EA Kerr: The Quality of Health Care Delivered to Adults in the United States. New England Journal of Medicine 2003, 348: 2635-2645

• Zhan C, Miller MR. Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization. JAMA. 2003;290:1868-1874

• Amalberti R, Y Auroy, D Berwick, P Barach. Five System Barriers to Achieving Ultrasafe Health Care Ann. Int. Med. 2005; 142: 756-764

• Griffin, FA and DC Classen. Detection of adverse events in surgical patients using the trigger tool approach. Qual. Saf. Health Care 2008; 17: 252-8

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Reliability:

Defect-free operation, over time, regardless of…

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How How ReliableReliable is Health Care? (Amalberti, Nolan) is Health Care? (Amalberti, Nolan)

Chaos 10-1 10-2 10-3 , 10-4 10-5

Processes are largely custom-crafted each time

Standard specs, training, trying hard

Standard process; redundancy, habits and patterns…

HRO culture; Obsession with failure, deference to expertise…

Loss of identity

Each doctor writes individual orders, gives to RN

5 people describe 5 processes; feedback on compliance

5 people describe 1 process; multi-disc. rounds

External approval necessary for certain orders

Equivalent

actor

Preventing, treating acute and chronic disease in US

Surgical checklists and harm

Best hospitals Core Measures

ADEs per 1000 doses, blood banking

Safety in anesthesia

Let’s talk about the catastrophic processes—the

right side of this table.Could we do better than this?

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What is possible in safety? Commercial Aviation

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Unplanned Automatic SCRAMRate – US Nuclear Power Plants

Year

Scr

ams

per

7,0

00

ho

urs

The unplanned automatic scrams per 7,000 hrs critical indicator tracks the median scram (automatic shutdown) ratefor approximately one year (7,000 hrs) of operation. Unplanned automatic scrams result in thermal and hydraulictransients that affect plant systems. The scram rate has been significantly reduced since 1980. In 2000, 59% of operating plants had zero automatic scrams.

Source: Statistics Show US Nuclear Power Plants Always Improving, Nuclear News, May 2001 12

776 aircraftdestroyed in

1954

Fiscal Year

1.64

15 aircraftdestroyed in

2008

0

10

20

30

40

50

60

50 65 80 08

Angled Carrier Decks

Naval Aviation Safety Center

NAMP est. 1959

RAG concept initiated

NATOPS initiated 1961

Squadron Safety program

System Safety Designated Aircraft

ACT

HFC’s

Cla

ss A

Mis

hap

s/10

0,00

0 F

ligh

t H

ou

rsNaval Aviation Mishap Rate

Source: www.safetycenter.navy/mil ORM Flight Mishap Rate

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US Nuclear Powered Submarines

5,500 cumulative years of nuclear reactor ops

127 million miles submerged (264 round trips to moon)

Operated by 20 year oldsZero reactor accidents

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Highly Reliable Organizations (HROs) “operate under very trying conditions all

the time and yet manage to have fewer than their fair share of

accidents.”

Copyright 2006 Healthcare Performance Improvement, LLC.ALL RIGHTS RESERVED.

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How do they do that?

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Processes: workflow scheduling,

complexity…

Culture and Structure: hierarchy, transparency,

safety rules, accountability…

The Swiss Cheese ModelAdapted from James Reason Managing the Risk of

Organizational Accidents 1997

Harm

Human error(slip, lapse, reliance on

memory, confirmation

bias…)

Technology and Environment: error

proofing, distractions…

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1200 mg Tobramycin IV

Nurse doesn’t check dose closely in rush to get all QD doses in at 8

am

Culture: error has happened before; no

one questions 1200 mg in IV bag rather than

irrigation

Renal failure,death

Pharmacist clicks 1200 rather than 120 mg on computer

picklist

Rx Computer system accepts “1200 mg IV”

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Errors, Harm, Negligence, and Intent

ErrorsSkill basedRule based

Knowledge based

Harm

Negligence, Reckless Disregard Intent

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Two Key Approaches to Higher Levels of Reliability for “Immediately

Catastrophic” Processes

Harm

2. Work as leaders to detect and plug

the holes in processes, structures,

cultures, and technologies

1. Accept that human error will

occur. Use human factors engineering to

reduce the likelihood of it, and develop a

culture of accountability 20

Working both the Sharp End and the Blunt End

# 1Reduce likelihood of individual behavior failures•Competency•Consciousness•Communication•Compliance•Critical thinking

#2 Find and Fix system “latent errors”•Structure•Culture•Policy/protocol•Process•Technology & environment

Adapted from Kerry Johnson, HPIpyance.21

Reducing the likelihood of skill-based (automatic) errors

─Fatigue: work schedules

─Distractions: “do not disturb”

─Error-proofing, design: Separating IV and topical dose forms in computer

─Visual signals

Stop, Think, Act and Review

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Reducing the likelihood of rules-based errors

• Make it easy to comply with the rule

• Increase the perception of “likelihood of being observed” while carrying out the rule

• Increase the perception of the risk of non-compliance

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Accountabilityfrom Leaders

Accountabilityfrom Self

Accountabilityfrom Peers

Establish Accountability

OptimalAccountability

Healthcare Performance Improvement

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How How ReliableReliable is Health Care? (Amalberti, Nolan) is Health Care? (Amalberti, Nolan)

Chaos 10-1 10-2 10-3 , 10-4 10-5

Processes are largely custom-crafted each time

Standard specs, training, trying hard

Standard process; redundancy, habits and patterns…

HRO culture; Obsession with failure, deference to expertise…

Loss of identity

Each doctor writes individual orders, gives to RN

5 people describe 5 processes; feedback on compliance

5 people describe 1 process; multi-disc. rounds

External approval necessary for certain orders

Equivalent

actor

Preventing, treating acute and chronic disease in US

Surgical checklists and harm

Best hospitals Core Measures

ADEs per 1000 doses, blood banking

Safety in anesthesia

Let’s look at the left side of this table

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Discussion for NAPH Leaders

• Describe the reliability of a safety process your teams are currently working to improve. Where does that process fall on the reliability grid?

• What are your current ideas for making the process more reliable?

• What is your aim: how reliable are you trying to become?

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Why do we get “stuck” at low levels of reliability?

• We tend to rely on vigilance and hard work

• We focus on outcomes rather than process

• We fail to design and implement standard work

• We don’t understand and use sophisticated designs for reliability

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Improvement Concepts Associated with 10-1 Performance

• Common equipment• Standard order sets• Care protocols and pathways• Written policies/procedures • Personal check lists• Feedback of information on compliance• Suggestions to work harder, pay closer attention…

next time• Awareness and training

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Improvement Concepts Associated with 10-2 Performance

• Build decision aids and reminders into the system

• Make the desired action the default• Redundancy• Scheduling• Take advantage of existing habits and

patterns of work• Standardize who, where, when…not just

what (Standard work, not standard specs)

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Examples of Level 2 Concepts for CHF or CAP

• Decision aids or reminders in real time: – Standing order set is placed on front of chart

when decision to admit is made

• Desired action the default:– All patients with diagnosis of pneumonia will

get pneumovax by nurse, with or without specific order

• Redundancy: – Multidisciplinary rounds on every patient daily– Home visit to check on meds after 48 hours

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Examples of Level 2 Concepts for CHF or CAP (2)

• Scheduling:– Make a discharge appointment for all patients at

least 24 hours prior to discharge• Smooths nursing workflow• Starts process of discharge instructions well in advance• Engages family members in planning

• Take advantage of existing habits and patterns– Visual cue to “start pre-op antibiotics” based on

measured flow of pre-op work31

Example of Level 2 Concepts

• Bundles–clusters of evidence based services

in space and time, treated as “all or none” e.g. “sterile technique in the OR”, ventilator bundle…

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Key Learning Points for Leaders

• Hard work and vigilance alone will condemn the team to 10-1 performance at best

• 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

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Why is health care so unreliable?

• We tend to rely on vigilance and hard work

• Greater focus on outcomes than process• We fail to design and implement standard

work• We don’t understand and use

sophisticated designs for reliability

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Outcomes versus Process

• Biology protects us: each process defect doesn’t necessarily lead to a bad outcome e.g. hand-washing

• Systems protect us…except when they don’t e.g. 1200 mg tobramycin i.v.

• Benchmarks reassure us…e.g. “2.0 BSI’s per 1000 line hours is better than the benchmark so our processes must be OK”

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Why is health care so unreliable?

• We tend to rely on vigilance and hard work

• We focus on outcomes rather than process

• We fail to design and implement standard work

• We don’t understand and use sophisticated designs for reliability

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Level 2 Concept: Standard WorkIs this what you mean by standardization?

• Months of meetings designing a care pathway, standing order set, protocol…

• Focus is on WHAT should be done (not HOW).• 10,000 copies of the final version are printed up.• Changes to the final version are discouraged.• Physicians are encouraged to “opt in”.• Even though the protocol or order set has never

been tested in the field

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Design Design Design Design Approve

Implement

Conference Rooms

Real World

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A Better Way to Standardize

• Spend no more than one meeting on “what”.• Start testing one way to do the “what” in the

field, on a small scale.• Encourage many rapid tests of change in

how, when, where, who…and in the what, if necessary…to make the standard way work well for 90% of doctors and nurses.

• Once you’ve got it right, expect all the doctors and nurses to use it (opt out if you have to, not “please opt in”).

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Design

Test and Modify

Test and Modify

Test and Modify

Approve(if necessary)

Conference Rooms

Real World

Implement

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“Practice the science of medicine as a team, and the

art of medicine as individuals.”

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OK…But what do Leaders do?• Choose the outcomes that you want to achieve• Hypothesize: process and outcome• Set reasonable timelines• Expect teams to

– Achieve process reliability at 95%– Use good design principles, not just vigilance and hard work– Test designs frequently, on small scale, not in one big spasm

• If the process gets to 95% and the outcome doesn’t improve…– Check the data on the process– Revise your theory

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A Key Question Leaders Should Ask

Is there a logical, evidence-based connection between the process the team is trying to improve, and the outcome you wish to achieve?

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Is this a good plan to reduce injuries from falls?

Outcome Goal

Key Drivers Processes

Decrease Falls

Reliable risk assessment of patients for falls

Red booties for at risk patients

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The Fact

There is no good medical evidence that risk assessment actually reduces falls!

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Evidence-Based Thinking!

Outcome Goals

Key Drivers Processes

Decrease Falls

Toileting in at risk patients

Every 2 hour toileting rounds on at risk patients

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Summary: To become more reliable for non-catastrophic processes…

• Choose a process that has a high likelihood of affecting the outcome of interest

• Set an aim for 10-2 reliability of the process• Move toward that aim in three steps:

1. Segment and standardize to get the basic process to solid 10-1 using Level I and Level II concepts

2. Identify remaining defects and mitigate them in real time to get to 10-2

3. Redesign the process to reduce likelihood of defects

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Where to read more….

• http://www.ihi.org/IHI/Topics/Reliability/

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Next Month:Thursday, May 23 9am PT/10am MT/11am CT/ 12am ET

When Things Go Really Wrong: Responding to Organizational CrisesWith special guest speaker Jim Conway!

Assignment:

• Find out if your organization has a crisis management plan for safety disasters.

Then ask:

• What is the plan for notifying the board? Which board members? When? By whom?

• Who will speak for the organization? Who is to speak to family members?

• What training is in place?

Be prepared to discuss your plans on the webinar.49

Leadership for Safety: Yes, It’s PersonalA Workshop for Boards, C-Suite, and Senior Leaders

June 19, 20138:00am – 5:00pm

Westin Diplomat Resort in Hollywood, FL

SAVE THE DATE!

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THANK YOU FOR JOINING US

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