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Diagnostic Safety in an

EHR-Enabled Health Care System

Mark L. Graber, MD FACP Senior Fellow, RTI International Professor Emeritus, SUNY Stony Brook School of Medicine Founder and President, Society to Improve Diagnosis in Medicine (SIDM)

Gordon D. Schiff, MD Internist Associate Director, Center for Patient Safety Research and Practice Brigham and Women’s Hospital Associate Professor of Medicine Harvard Medical School Hardeep Singh, MD MPH Chief, Health Policy, Quality and

Informatics Program Houston VA Center for Innovations in Quality, Effectiveness and Safety, and Baylor College of Medicine

PATIENT SAFETY AWARENESS WEEK

(2)

Introduction

Mark L. Graber, MD FACP

Senior Fellow, RTI International

Professor Emeritus, SUNY Stony Brook

School of Medicine

Founder and President, Society to

Improve Diagnosis in Medicine (SIDM)

PATIENT SAFETY AWARENESS WEEK

DIAGNOSTIC ERROR WEBCAST SERIES

(3)

3

Our vision:

Diagnosis should be accurate, timely, efficient, and SAFE.

To learn more:

Annual conference: Diagnostic Error in Medicine

Dx Error listserv

New journal: DIAGNOSIS

(4)

Diagnosis and Electronic Medical Records

Its role in promoting

diagnostic quality

Gordy Schiff

Its role in finding and

studying diagnostic errors

(5)

Diagnostic Safety in an EHR-Enabled

Health Care System

Gordon D. Schiff, MD

Internist and Associate Director

Center for Patient Safety Research and Practice

Brigham and Women’s Hospital

Associate Professor of Medicine

Harvard Medical School

PATIENT SAFETY AWARENESS WEEK

DIAGNOSTIC ERROR WEBCAST SERIES

(6)
(7)
(8)
(9)
(10)
(11)

11

Marshal Wolf -Brigham

Dr. Gregory House

(12)

Don Berwick

Former President and CEO

Institute for Healthcare

Improvement (IHI)

Former Director Centers

for Medicare & Medicaid

Services

(13)

13

Don Berwick

Boston Globe 7/14/2002

Genius diagnosticians make great stories,

but they don't make great health care.

The idea is to make accuracy reliable,

not heroic

(14)
(15)

15

Safer practice can only come

about from acknowledging the

potential for error and building in

error reduction strategies at each

stage of clinical practice

(16)

Time Pressures, Distractions, Interruptions Pt. Presentation Signal:Noise Ambient Conditions Difficult diagnoses Micro environment: IT,

staff, teamwork, support systems Training Prior Experience Self-awareness limitations Dx Errors

(17)

17

1. Access/Presentation

Denied care

Delayed presentation

2. History

Failure/delay in

eliciting c

ritical piece of history data

Inaccurate/misinterpretation "

Suboptimal weighing “

Failure/delay to follow-up “

3. Physical Exam

Failure/delay in eliciting critical physical exam finding

Inaccurate/misinterpreted "

Suboptimal weighing “

Failure/delay to follow-up “

4. Tests (Lab/Radiology)

Ordering

Failure/delay in ordering needed test(s)

Failure/delay in performing ordered test(s)

Suboptimal test sequencing

Ordering of unnecessary test(s)

Performance

Sample mixup/mislabeled (eg wrong patient)

Technical errors/poor processing of specimen/test

Erroneous lab/radiol reading of test

Failed/delayed communication of test

Clinician processing

Failed/delayed follow-up of test

Erroneous clinician interpretation of test

5. Assessment

Hypothesis Generation

Failure/delay in

considering

important diagnosis

Suboptimal weighing/prioritizing

Too much weight to low(er) probability/priority dx

Too little consideration of high(er) probability/priority dx

Too much weight on

competing

diagnosis

Recognizing Urgency/Complications

Failure to appreciate urgency/acuity of illness

Failure/delay in recognizing complication(s)

6. Referral/Consultation

Failed/Delayed in needed referral

Inappropriate/unneeded referral

Suboptimal consultation diagnostic performance

Failed/delayed communication/followup of consultation

7. Followup

Failure to refer patient to close/safe setting/monitoring

Failure/delay in timely follow-up/rechecking of patient

(18)

Where

in Diagnostic Process

(~Anatomic localization)

1. Access/Presentation

Denied care

Delayed presentation

2. History

Failure/delay in

eliciting c

ritical piece of history data

Inaccurate/misinterpretation "

Suboptimal weighing “

Failure/delay to follow-up “

3. Physical Exam

Failure/delay in eliciting critical physical exam finding

Inaccurate/misinterpreted "

Suboptimal weighing “

Failure/delay to follow-up “

4. Tests (Lab/Radiology)

Ordering

Failure/delay in ordering needed test(s)

Failure/delay in performing ordered test(s)

Suboptimal test sequencing

Ordering of unnecessary test(s)

Performance

Sample mixup/mislabeled (eg wrong patient)

Technical errors/poor processing of specimen/test

Erroneous lab/radiol reading of test

Failed/delayed communication of test

Clinician processing

Failed/delayed follow-up of test

Erroneous clinician interpretation of test

5. Assessment

Hypothesis Generation

Failure/delay in

considering

important diagnosis

Suboptimal weighing/prioritizing

Too much weight to low(er) probability/priority dx

Too little consideration of high(er) probability/priority dx

Too much weight on

competing

diagnosis

Recognizing Urgency/Complications

Failure to appreciate urgency/acuity of illness

Failure/delay in recognizing complication(s)

6. Referral/Consultation

Failed/Delayed in needed referral

Inappropriate/unneeded referral

Suboptimal consultation diagnostic performance

Failed/delayed communication/followup of consultation

7. Followup

Failure to refer patient to close/safe setting/monitoring

Failure/delay in timely follow-up/rechecking of patient

What

Went Wrong

(19)

19

Where

in Diagnostic Process

(~Anatomic localization)

1. Access/Presentation

Denied care

Delayed presentation

2. History

Failure/delay in

eliciting c

ritical piece of history data

Inaccurate/misinterpretation "

Suboptimal weighing “

Failure/delay to follow-up “

3. Physical Exam

Failure/delay in eliciting critical physical exam finding

Inaccurate/misinterpreted "

Suboptimal weighing “

Failure/delay to follow-up “

4. Tests (Lab/Radiology)

Ordering

Failure/delay in ordering needed test(s)

Failure/delay in performing ordered test(s)

Suboptimal test sequencing

Ordering of unnecessary test(s)

Performance

Sample mixup/mislabeled (eg wrong patient)

Technical errors/poor processing of specimen/test

Erroneous lab/radiol reading of test

Failed/delayed communication of test

Clinician processing

Failed/delayed follow-up of test

Erroneous clinician interpretation of test

5. Assessment

Hypothesis Generation

Failure/delay in

considering

important diagnosis

Suboptimal weighing/prioritizing

Too much weight to low(er) probability/priority dx

Too little consideration of high(er) probability/priority dx

Too much weight on

competing

diagnosis

Recognizing Urgency/Complications

Failure to appreciate urgency/acuity of illness

Failure/delay in recognizing complication(s)

6. Referral/Consultation

Failed/Delayed in needed referral

Inappropriate/unneeded referral

Suboptimal consultation diagnostic performance

Failed/delayed communication/followup of consultation

7. Followup

Failure to refer patient to close/safe setting/monitoring

Failure/delay in timely follow-up/rechecking of patient

What

Went Wrong

(20)

Preventing/Mitigating Diagnosis Errors

Fertile Fields to Plow

More reliable test result f/up

Improving patient follow-up & feedback

Re-engineered clinical documentation, EMR

Learning from mistakes, recalibration

Diagnosis time out

Just-in-time knowledge, consultations

Enhanced role for the patient

(21)
(22)

El-Kareh

Schiff

BMJ QS 2013

(23)
(24)

Priority to

“rapidly improve

EHR usability

and functionality

(25)
(26)

Residents, rushing to complete numerous tasks for large numbers of patients, have

sometimes pasted in the medical history and the history of the present illness from

someone else’s note even before the patient arrives at the clinic. Efficient? Yes. Useful?

No.

This capacity to manipulate the electronic record makes it far too easy for trainees to

avoid taking their own histories and coming to their own conclusions about what might

be wrong. Senior physicians also cut and paste from their own notes, filling each note

with the identical medical history, family history, social history, and review of systems.

Writing in a personal and independent way forces us to think and formulate our ideas.

Notes that are meant to be focused and selective have become voluminous and

templated, distracting from the key cognitive work of providing care.

Such charts may satisfy the demands of third-party payers, but they are the product of a

word processor, not of physicians’ thoughtful review and analysis. They may be

(27)

27

Although the intent may be to ensure thoroughness, in the new electronic sea of results,

it becomes difficult to find those that are truly relevant. A colleague at a major cancer

center that recently switched to electronic medical records said that chart review during

rounds has become nearly worthless. He bemoaned the vain search through

meaningless repetition in multiple notes for the single line that represented a new

development. “It’s like ‘Where’s Waldo?’ ” he said bitterly.

Ironically, he has started to handwrite a list of new developments on index cards so that

he can refer to them at the bedside.

...we have observed the electronic medical record become a powerful

vehicle for perpetuating erroneous information, leading to diagnostic errors that gain

momentum when passed on electronically

(28)

These problems, we believe, will only worsen, for even as

we are pressed to see more patients per hour and to work

with greater “efficiency,” we must respond to demands for

detailed documentation to justify our billing and protect

ourselves from lawsuits. Though the electronic medical

record serves these exigencies, it simultaneously risks

compromising care by fostering a generic approach to

diagnosis and treatment.

The worst kind of electronic medical record requires

filling in boxes with little room for free text. Although

completing such templates may help physicians survive

a report-card review, it directs them to ask restrictive

questions rather than engaging in a narrative-based,

open-ended dialogue. Such dialogue can be key to

making the correct diagnosis and to understanding which

treatment best fits a patient’s beliefs and needs.

(29)

29

Perhaps most important, we should be cautious in using

templates that constrain creative clinical thinking and promote

automaticity. We must be attentive to the shift in focus

demanded by electronic medical records, which can lead

clinicians to suspend thinking, blindly accept diagnoses, and fail

to talk to patients in a way that allows deep, independent

probing.

The computer should not become a barrier between physician

and patient; as medicine incorporates new technology, its

focus should remain on interaction between the sick and the

healer. Practicing “thinking” medicine takes time, and

electronic records will not change that. We need to make this

technology work for us, rather than allowing ourselves to work

for it.

(30)
(31)

31

Role for Electronic

Documentation

Goals and Features of Redesigned Systems

Providing access to

information

Ensure ease, speed, and selectivity of information searches; aid cognition through aggregation, trending, contextual relevance, and minimizing of superfluous data.

Recording and sharing assessments

Provide a space for recording thoughtful, succinct assessments, differential diagnoses, contingencies, and unanswered questions; facilitate sharing and review of assessments by both patient and other clinicians.

Maintaining dynamic patient history

Carry forward information for recall, avoiding repetitive pt

querying and recording while minimizing erroneous copying and pasting

Maintaining problem lists Ensure that problem lists are integrated into workflow to allow for continuous updating.

Tracking medications Record medications patient is actually taking, patient responses to medications, and adverse effects to avert misdiagnoses and ensure timely recognition of medication problems.

Tracking tests Integrate management of diagnostic test results into note

workflow to facilitate review, assessment, and responsive action as well as documentation of these steps.

(32)

Role for Electronic

Documentation

Goals and Features of Redesigned Systems

Ensuring coordination and

continuity

Aggregate and integrate data from all care episodes and fragmented encounters to permit thoughtful synthesis.

Enabling follow-up Facilitate patient education about potential red-flag symptoms; track follow-up.

Providing feedback Automatically provide feedback to clinicians upstream, facilitating learning from outcomes of diagnostic decisions.

Providing prompts Provide checklists to minimize reliance on memory and directed questioning to aid in diagnostic thoroughness and problem solving.

Providing placeholder for resumption of work

Delineate clearly in the record where clinician should resume work after interruption, preventing lapses in data collection and thought process.

(33)

33

Schiff A J Med 2008

Open Loop System

Water goes on the same

time each day, regardless

of whether it is raining or

lawn is flooded

(34)
(35)

35

Diagnosis Essentials Checklist

1. Essential Data Elements

- Elements of Hx, P.exam, tests data that

should be reliably obtained for

every

pt presenting with given sx. In

many situations can reliably be done w/ computer questionnaire.

2. Don’t miss diagnoses

- critical dx can present w/ sx that are fatal or

have serious consequences if not recognized and rx promptly. These

dx should be considered in every patient with that symptom.

3. Red flag symptoms -

sx or findings (e.g. back pain with new urinary

incontinence in cancer patient) that may indicate serious condition &

should lead to heightened suspicion/evaluation for don’t miss dx.

Schiff & Leape Acad Med 2012 Schiff BMJ Safety & Qual 2012

(36)

Diagnosis Essentials Checklist

4. Potential drug causes

- meds that can cause the symptom. High %

sx med side effects, yet infrequently considered.

5. Required referrals

- When is specialist expertise or technology

needed to adequately and safely evaluate the patient? Includes

possible rare conditions that only specialists have sufficient

experience or where required testing (biopsy or endoscopy)

6. Patient follow-up instructions and plan

- Warnings that patients

should receive regarding specific symptoms that should lead them to

return or call. These should be in writing and include a time frame.

(e.g. call if you develop rash or fever, or if you are not improved in 48

hours)

(37)

37

Fatigue Checklist (27 diagnoses)

Don’t miss

*

Often missed

Pr

ev

alenc

e

Ely Acad Med 2010

Obstructive sleep apnea

♠Depression, anxiety Deconditioning

*Drugs (beta blocker, clonidine, alcohol) Chronic fatigue syndrome, fibromyalgia

♠*Infections, infectious mononucleosis, hepatitis, pneumonia, mastitis

♠Pregnancy ♠*Anemia Vitamin D deficiency ♠Hypothyroidism, hyperthyroidism ♠Hypokalemia, hyponatremia ♠*Myocardial infarction ♠Celiac disease

♠Disturbance of calcium, phosphorus, magnesium

♠Polymyalgia rheumatica/Temporal arteritis Parkinson disease

Hypogonadism Myasthenia gravis

♠*Heart failure, myocarditis Pulmonary, hepatic, renal failure Restless legs syndrome

Multiple sclerosis

♠Carbon monoxide

♠Adrenal insufficiency, Addison’s disease B12 deficiency

♠Botulism

(38)

Role for Electronic

Documentation

Goals and Features of Redesigned Systems

Calculating Bayesian

probabilities

Embed calculator into notes to reduce errors and minimize biases in subjective estimation of diagnostic probabilities.

Providing access to information sources

Provide instant access to knowledge resources through context-specific “info buttons” triggered by keywords in notes that link user to relevant textbooks and guidelines.

Offering second opinion or consultation

Integrate immediate online or telephone access to consultants to answer questions related to referral triage, testing strategies, or definitive diagnostic assessments.

Increasing efficiency More thoughtful design, workflow integration, easing and

distribution of documentation burden could speed up charting, freeing time for communication and cognition.

(39)

39

Summary – Areas for Improvement Where EMR

Could Help

Tighten gaps so less likely to fall through cracks; safety

nets for those that do.

Operationalize, create safety around dx uncertainty

Redesign follow-up; feedback

Open door, pull systems for patients

e-curbside just-in-time consults for clinicians

Improve info access; decrease cognitive burden w/

smarter display.

Learn from and share mistakes/pitfalls

Engage the patient in all of above

(40)

Diagnostic Safety in EHR-based

Healthcare: “Missed Test Results”

Hardeep Singh, MD MPH

Chief Health Policy Quality and Informatics Program,

Houston Veterans Affairs Health Services Research &

Development Center of Excellence

Michael E. DeBakey VA Medical Center & BCM

Director, Houston VA Patient Safety Center of Inquiry

PATIENT SAFETY AWARENESS WEEK

DIAGNOSTIC ERROR WEBCAST SERIES

(41)

41

Doctors sometimes miss electronic test results

By Julie Steenhuysen

CHICAGO | Mon Sep 28, 2009 5:51pm EDT

(Reuters) - Part of the appeal of electronic medical records is that they can help doctors keep track of test results and avoid medical errors, but a study released on Monday suggests that doctors

sometimes ignore electronic warnings about abnormal test results. Researchers found doctors failed to follow up on nearly 8

percent of electronic alerts that a patient had something abnormal on an X-ray, mammogram, computed tomography or CT or magnetic resonance imaging or MRI scan that needed quick attention.

"Just the fact that you can use technology to deliver a piece of information from the radiologist to a doctor doesn't mean it will be taken care of," said Dr. Hardeep Singh of the Baylor College of Medicine in Houston, whose study appears in the Archives of Internal Medicine.

"The electronic health record system is a huge improvement from previous paper-based systems," but it is not perfect, Singh said in a telephone interview.

President Barack Obama has made electronic medical records a centerpiece of his health reform efforts, promising nearly $1.2 billion to help doctors and hospitals make the switch from paper-based records.

(42)

Objective

Discuss why we need a multi-faceted “socio-technical”

approach to reduce “missed” tests results in EHRs

Discuss examples of strategies to address missed test

results in EHR-based health care

(43)

43

Objective

Discuss why we need a multi-faceted “socio-technical”

approach to reduce “missed” tests results in EHRs

Discuss examples of strategies to address missed test

(44)

Errors of Test Results Follow-up

Failure to follow-up abnormal test results: up to 36%

Communication breakdowns prevalent but also a

problem IT can solve!

Will technology eliminate failures to follow-up test

results?

(45)

45

Alert in “View

Alert” window

Case Study

(46)

“View Alert” Window

Example of an abnormal imaging alert

(47)

47

Case Study Background

Hypothesized that unacknowledged alerts are indicators

for missed test results (vs. acknowledged results that

can serve as “read receipts”)

Queried an alert repository of abnormal imaging results

Outcomes determined with assumption:

Acknowledged

took action

(48)

Quantitative Data Assessment

Outcomes: documented response /follow-up action on

record review and phone calls

Findings:

Providers did not acknowledge receipt of 368 of 1,017

of transmitted alerts

45/368 unacknowledged alerts lost to follow-up at 4

weeks

Next study hypothesis: Timely follow-up higher when

providers acknowledge the alert

(49)

49

Findings…

Evaluation of 1,163 outpatient abnormal lab & 1,196

abnormal imaging result alerts

7% abnormal labs lacked timely follow-up

8% abnormal imaging lacked timely follow-up

Follow-up in acknowledged vs. unacknowledged alerts?

(50)
(51)

51

Digging Deeper Qualitatively…

“One of the issues is just the

sheer volume of alerts, and

there’s a number of alerts that

in all honesty [you] really don’t

have any business seeing.”

(52)
(53)

53

Multiple “Socio-Technical” Issues

Issue

Examples

Software

no functionality for saving, tracking, and

retrieving alerts

Content

too many unnecessary alerts

Usability

poor signal to noise ratio on screen

Workflow

“surrogate feature” to forward alerts when

providers out of office not used properly

Providers

lack of knowledge/training

Organizational

policies for follow-up ambiguous

(54)

Lessons from Research

EHR-based systems better than paper

Not achieving full potential mostly due to

non-technological reasons!

Need a sociotechnical model to improve safety

(55)

55

Hardware & Software

Personnel Content

Workflow & Communication

Ex ter na l Rules & R egul at ions Measurement & Monitoring Organizational Policies,

Procedures, & Culture

8-Dimensional Socio-Technical Model of Safe &

Effective EHR Use

(56)

Objective

Discuss why we need a multi-faceted “socio-technical”

approach to reduce “missed” tests results in EHRs

Discuss examples of strategies to address missed test

results in EHR-based health care

(57)
(58)

Experiences with National VA Policy Development

Align with team-based model of care

Leverage IT including for patient communication

Standardize when possible especially in high-risk

situations

Give more hands-on guidance on workflow and

processes

(59)

59

“SAFER Guides”

ONC-sponsored “Safety Assurance Factors for EHR

Resilience (SAFER) project”

Proactive risk assessment and guidance

Self-assessment; not meant to be regulatory

Focused on high-risk areas

Nine guides including

Test Results Reporting and

Follow-up

Singh et al BMC Med Inf 2013

(60)

The Checklist is structured as a quick way to enter and print your self-assessment. Your selections on the checklist will

automatically update the related section of the corresponding recommended practice worksheet. The Worksheet provides guidance on implementing the Practice.

(61)

61

Can EHR “Triggers” Help Us?

Finding Needles in a Haystack and Creating Safety Nets!

On a daily basis, thousands of patients have abnormal

test results

Can we electronically identify those likely to be

experiencing diagnostic delays and intervene?

(62)
(63)

63

Clinical laboratories must give patients access to their own lab-test results upon request, without going through the physician who ordered them, according to a new federal rule announced Monday by the Department of Health and Human Services.

The rule, first proposed in 2011, is part of an Obama administration effort to give patients more control over their own health information.

"Information like lab results can empower patients to track their health progress, make decisions with their health-care professionals and adhere to important treatment plans," said HHS Secretary Kathleen Sebelius.

The final rule amends two existing federal laws, the Health Insurance Portability and Accountability Act, known as HIPAA, and the Clinical Laboratory Improvement Amendments, or CLIA, which regulates most of the clinical testing labs in the U.S. Patient advocacy groups had also pushed for the change.

(64)

In Closing…

Missed test results in EHRs related to both technical

and non-technical reasons

A sociotechnical approach is needed to improve safety

& effectiveness of EHR-based test result follow-up

Proactive risk-assessment, EHR-based triggers and

patient engagement additional strategies to consider

for reducing test result follow-up errors

(65)

65

Thank You

Acknowledgements of Funding Support

Veterans Affairs Health Services Research &

Development

Veterans Affairs National Center for Patient Safety

National Institutes of Health/Agency for Healthcare

Research and Quality

Office of the National Coordinator for Health

Information Technology

(66)
(67)

67

Free Diagnostic Error Tools Available

Visit

www.npsf.org/psaw

to download free tools and resources for:

Patients and Families

Health Care Clinicians and Professionals

(68)

Please Join Us!

Wednesday, March 26 | 2:00–3:00 pm ET

How to Do a Root Cause Analysis of Diagnostic Error

Learn more and register at

www.npsf.org/psaw

.

PATIENT SAFETY AWARENESS WEEK

DIAGNOSTIC ERROR WEBCAST SERIES

(69)

The Patient Safety Awareness Week

Diagnostic Error Webcast Series has

been made possible thanks to the

generous sponsorship of the

Cautious Patient Foundation.

References

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