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DIAGNOSTIC ERROR AND IT
STRATEGIES TO MITIGATE RISK
Pathology Informatics 2012
Paul L Epner
AGENDA
Background
 Diagnostic Errors
 Diagnostic Errors and the Clinical Laboratory
 Diagnostic Errors, the Clinical Laboratory and IT
 Summary

©2012 Paul Epner LLC
2
Institute of Medicine. (2012). Best Care at Lower Cost: The Path to Continuously Learning Health Care in
America. (M. Smith, R. Saunders, L. Stuckhardt, & J. M. Mcginnis, Eds.) (p. 450). Washington DC: The
National Academies Press.
$750 BILLION
3
BACKGROUND: MACRO TRENDS
U.S. healthcare costs continue to rise
 The aging population portends increases in demand
for healthcare in general including laboratory services
 Prevalence of multiple chronic conditions will further
increase demand
 Increases in longevity are linked to longer durations
of poor health and will increase demand
 Shortages of primary care physicians will drive
increased use of physician extenders, hospitalists and
specialists with unclear impact
 Indicators of cost effectiveness are unfavorable for
the US and will continue to put pressure on budgets

4
THE RISING COST OF DIAGNOSIS
5
J. K. Iglehart, “Health insurers and medical-imaging policy--a work in progress.,” The
New England journal of medicine, vol. 360, no. 10, pp. 1030-7, Mar. 2009.
THE
LIKELY LABORATORY EXPERIENCE
Increased test volume
 Fewer laboratory professionals
 More centralization (more remote)
 More automation
 Continually increasing focus on cost
 Less integration into the clinical situation

The result is an increasingly factory-like experience:
tube-in, number-out
6
THE “LAB-AS-FACTORY” MISSION STATEMENT
To provide accurate, timely test
results at the lowest possible cost
What’s wrong with this?
Where’s the why?
7
AN ALTERNATIVE VIEW OF THE LAB’S
MISSION
To rapidly and efficiently enable the
accurate diagnosis of conditions,
the selection of appropriate
treatments and the effective
monitoring of health status.*
Where’s cost?
8
*P Epner, “Impact of Laboratory Services on Diagnostic Errors,” CLMA’s ThinkLab, Las Vegas 2011
WHERE DO WE FOCUS?
Monitoring Screening
Diagnosis/Treatment
Selection/Risk
Stratification
Value
9
DIAGNOSTIC ERRORS DEFINED
Diagnostic errors are defined as misdiagnosis, missed
diagnosis, or delayed diagnosis1
 Diagnostic errors occur in 10-15% of cases2

Diagnostic Errors
Falls
1Graber,
M. L. et al, “Diagnostic error in
internal medicine,” Archives of internal
medicine, vol. 165, July, 2005.
2Berner, E. S., & Graber, M. L,
“Overconfidence as a cause of diagnostic
error in medicine,” American Journal of
Medicine, vol. 121, 2008, S2-S23.
Rx Errors
Wrong Site
Surgery
10
IT
COULD GET WORSE
 Aging
population means more diagnoses
 Increasing chronic comorbidities mean
diagnostic complexity
 Decreasing number of primary care physicians
combined with emphasis on “cost
effectiveness” means less time with patients
 Focus on overuse could mean less focus on
appropriate use
11
DIAGNOSTIC
ERRORS ARE CLASSIFIED INTO ONE OF THREE
TYPES

Cognitive Errors (74% in this study)



Systematic Errors (65%)
Technical failures and equipment problems
 Organizational flaws



Faulty knowledge
Faulty data gathering
Faulty synthesis
No Fault Errors (7%)
Masked or unusual presentation of disease
 Patient-related error (uncooperative, deceptive)

Source: M.L. Graber, N. Franklin, and R. Gordon, “Diagnostic error in internal medicine.,”
Archives of internal medicine, vol. 165, Jul. 2005, pp. 1493-9.
12
HOW MANY OF YOU HAVE ENCOUNTERED
DIAGNOSTIC ERRORS?
13
TO UNDERSTAND THE LABORATORY’S POTENTIAL TO REDUCE
DX ERRORS, WE MUST UNDERSTAND ITS ROLE IN DIAGNOSIS
In a study of 248 hospitalized patients, 246 had
definitive diagnosis within 3 months of
hospitalization.
 The primary determinant of diagnosis for 215 with
“exact” in-hospital diagnosis was:





History and Physical – 48.4%
Radiologic exam – 33.5%
Blood test or culture – 9.8%
Study limitations
did not examine diagnostic error
 did not examine time to diagnosis
 did not examine appropriate use of diagnostic tools

14
Source: Wahner-Roedler, D. L.et al. (2007). Who makes the diagnosis? The role of clinical skills and
diagnostic test results. Journal of evaluation in clinical practice, 13(3)
OLDER STUDIES YIELD COMPARABLE RESULTS
80 prospective outpatient cases
 Final diagnosis made


Confidence in diagnosis rose with more information
Following history – 7.1 (scale of 1 to 10)
 Following physical – 8.2
 Following laboratory – 9.3


Following history - 61 (76%)
 Following physical – 10 (12%)
 Following laboratory – 9 (11%)

Some evidence that skill in conducting history and
physical is decreasing while reliance on data is
increasing
15
Source: M.C. Peterson, J.H. Holbrook, D. Von Hales, N.L. Smith, and L.V. Staker, “Contributions of the history, physical
examination, and laboratory investigation in making medical diagnoses.,” The Western journal of medicine, vol. 156, Feb. 1992.
YET WE KNOW THAT DIAGNOSTIC ERRORS OCCUR
ACROSS THE DIAGNOSTIC PROCESS
N= 583 Cases
16
G. D. Schiff et al., “Diagnostic error in medicine: analysis of 583 physician-reported errors.,” Archives of
internal medicine, vol. 169, no. 20, pp. 1881-7, Nov. 2009.
MALPRACTICE CASES PROVIDE FURTHER DATA
Of 307 closed cases (ambulatory) studied because they alleged missed or
delayed diagnosis, 181 did involve diagnostic errors that harmed patients
17
Source: T. GANDHI, A. KACHALIA, E.J. Thomas, A.L. Puopolo, C. Yoon, T. Brennan, and D. Studdert, “Missed and delayed
diagnoses in the ambulatory setting: A study of closed malpractice claims.,” Annals of internal medicine, vol. 145, 2006.
THE MECHANISMS FOR LABORATORY-RELATED DIAGNOSTIC
ERRORS HAVE BEEN DEFINED*
Inappropriate test is ordered
 Appropriate test is not ordered
 Appropriate test result is not properly utilized

Knowledge deficit
 Failure of synthesis
 Misleading result
 Systematic failure

Appropriate test result utilization is delayed
 Appropriate test result is wrong

The impact is the same: Delayed diagnosis, delayed or
inappropriate treatment, increased costs, patient harm
*Adapted from P Epner and M Astion, “Focusing on Test Ordering Practices to Cut
Diagnostic Errors,” Clinical Laboratory News, vol. 38, no. 7, July 2012
18
FAILURE TO RETRIEVE: “ORPHAN” TEST RESULTS
Study1 of 2644 patients at 2 tertiary care hospitals
of which 1095 had 2033 test results (lab, radiology)
return after discharge
 191 of results were potentially actionable (9%)
 61% of respondents with potentially actionable
results were unaware of results
 A systematic review2 found failure to follow-up was
a significant problem for in-patients, for in-patients
being discharged and for ED patients.

19
Roy, E.G. Poon, A.S. Karson, Z. Ladak-Merchant, R.E. Johnson, S.M. Maviglia, and T.K. Gandhi, “Patient safety
concerns arising from test results that return after hospital discharge.,” Annals of internal medicine, vol. 143, Jul. 2005.
2Callen, J., Georgiou, A., Li, J., & Westbrook, J. I. (2011). The safety implications of missed test results for hospitalised
patients: a systematic review. BMJ quality & safety, 20(2), 194–9.
1C.L.
EXAMPLES OF CAUSATIVE FACTORS: TEST CHOICES
“I may order 20 tests commonly and I may order an additional 10-20
tests [occasionally], so I may be using 40 tests that I feel comfortable
that I’m not wasting time or money or resources.”
20
OTHER CAUSATIVE FACTORS: NOMENCLATURE

High Sensitivity CRP synonyms
Ultrasensitive CRP
 Cardiac CRP
 Test abbreviations: hsCRP, CRH, HSC

Alkaline Phosphatase synonyms






Alkaline Phos blood
Alkaline phosphomonoesterase
Alkaline phosphohydrolase
Alkaline phenyl phosphatase
Test abbreviations: ALP,Alk Phos, AP, AKP

Within single physician office, multiple test
synonyms exist driven by multiple payers
“If I want Panel A it should look like Panel A in another lab and maybe you’ve
ordered the right panel but now they’ve changed insurance and you’re
ordering from a different lab. How [do you] identify what you’re getting?”
21
NOMENCLATURE
:
D
1,25 dihydroxy vitamin D2
1,25 dihydroxy vitamin D3
1,25 dihydroxy vitamin D
Vitamin D 25 Hydroxy D2
Vitamin D 25 Hydroxy D3
Vitamin D 1,25 Dihydroxy
Calcifdiol
Vitamin D2
Vitamin D3
25-0H vitamin D2
25-0H vitamin D3
25-0H vitamin D
25 hydroxy vitamin D2
25 hydroxy vitamin D3
25 hydroxy vitamin D
1,25 (OH)2 vitamin D2
1,25 (OH)2 vitamin D3
1,25 (OH)2 vitamin D
OPTIONS FOR VITAMIN
Calcidiol
Cholecalciferol
“I was forced to look through all these panels and frankly I had no
idea which one it was …I was totally frustrated. They had 6 different
things that all looked the same to me. And if you called them to find
out...that would be hopeless.”
22
THE FRAMEWORK SUGGESTS IT INTERVENTIONS

Inappropriate test ordered or appropriate test not
ordered





Test result not utilized properly or fully

CPOE design
Algorithms, clinical pathways, guidelines
Reflex testing
Data mining
Inter-physician variance analysis
Interpretive comments
 EMR interface
 Trigger tools


Test result delayed or not retrieved
Process monitor
 Discharge monitor

23
CPOE DESIGN
Many studies have shown requisition user interface
is an effective way to change utilization.
 Most studies measure reduction in cost or test
volume without examining patient harm.
 One study focused on impact of panels and future
ordering, but assessed patient impact.*

24
*Neilson, E. G., Johnson, K. B., Rosenbloom, S. T., Dupont, W. D., Talbert, D., Giuse, D. A., Kaiser, A., et al. (2004).
The impact of peer management on test-ordering behavior. Annals of internal medicine, 141(3), 196–204.
GEISINGER USES LOCALLY DEVELOPED GUIDELINES WITH
CLINICAL DECISION SUPPORT
25
Source: Jones, Jay, “Lab Enterprise Analytics,” Executive War College 2009
ORDERING PATTERNS CHANGED
Source: Jones, Jay, “Lab Enterprise Analytics,” Executive War College 2009
26
“SIMPLE” ALGORITHMS CAN EASILY BECOME COMPLEX
Clinical variables drive six distinct but potentially
overlapping algorithms for prolonged PTT





Evaluation preoperatively of an asymptomatic prolonged PTT
Evaluation of a persistently prolonged PTT with bleeding
Evaluation of a persistently prolonged PTT without bleeding
Evaluation of an elderly patient without bleeding history
accompanied by sudden development of soft tissue
hematomas and/or persistent and significant gastrointestinal
or genitourinary hemorrhage
Evaluation of hospitalized newborn with prolonged PTT
Evaluation of a unexplained prolonged PTT following
multiple, appropriate workups; searching for rare diagnoses
Source: Tcherniantchouk, O., Laposata, M., & Marques, M. B. (2012). The isolated
prolonged PTT. American journal of hematology.

27
REFLEX TESTING IMPROVES EFFICIENCY AND
EFFECTIVENESS
Creating protocols for the sequential addition of
tests based on earlier results reduces diagnostic
delays and patient inconvenience while reducing
test volume
 Reflex testing can improve diagnostic accuracy
 The improvement in diagnostic accuracy is linked to
the threshold criteria and varies with the clinical
scenario

Source: R. Srivastava, W. a Bartlett, I.M. Kennedy, A. Hiney, C. Fletcher, and M.J.
Murphy, “Reflex and reflective testing: efficiency and effectiveness of adding on
laboratory tests.,” Annals of clinical biochemistry, vol. 47, May. 2010.
28
DATA MINING
Data mining is the process of nontrivial extraction of
implicit, previously unknown and potentially useful
information from data stored in repositories.1
 Strategies can be driven by published guidelines
 Retrospective study2 of more than 450,000 HPV tests
against new guideline published in 2004

HPV testing is contraindicated in women under age 21
 HPV testing is contraindicated without positive cytology.

Study showed multi-year improvements in compliance
 Data mining is a tool that identifies opportunities for
education or other interventions

S.J. and Siau,K., “A review of data mining techniques,” Industrial Management & Data
Systems, Vol. 101, January 2001.
2B.H. Shirts and B.R. Jackson, “Informatics methods for laboratory evaluation of HPV ordering
patterns with an example from a nationwide sample in the United States, 2003-2009.,” Journal
of pathology informatics, vol. 1, Jan. 2010.
1Lee,
29
PHYSICIAN-LEVEL PERFORMANCE FEEDBACK


1Lafata,

When physicians are given feedback on their test
ordering patterns compared to colleagues or guidelines,
test ordering behavior changes.
In one study1, clinicians were educated about the
laboratory tests needed to monitor patients on
antihypertensive medication. Additionally, they were
given feedback on their testing patterns. Appropriate
testing improved.
In another study2, quarterly feedback of practice
requesting rates for nine laboratory tests, enhanced with
educational messages were provided to primary care
physicians which proved to be an effective strategy for
reducing inappropriate testing
J.E. et al, “Academic detailing to improve laboratory testing among outpatient medication 30
users.,” Medical care, vol. 45, Oct. 2007.
2Thomas, R.E. et al, “Effect of enhanced feedback and brief educational reminder messages on
laboratory test requesting in primary care: a cluster randomised trial.,” Lancet, vol. 367, Jun. 2006.
INTERPRETIVE

Criteria for providing interpretive comments have been
described1



a decision on treatment is indicated by the results in
combination with the clinical details provided
a result is unexpected
a specific question has been posed but it is not obvious
whether the results provide the answer
a clinician has requested a test with which he/she is not
likely to be familiar
Areas where Interpretive reports are most relevant


COMMENTS
31
Piva and M. Plebani, “Interpretative reports and critical values.,” Clinica chimica acta;
international journal of clinical chemistry, vol. 404, 2009.
1E.
PENDING
LAB RESULTS: PROCESS MONITORING
Shifts the focus from catching failures e.g., clinical
event monitors to workflow process control
 Some efforts are ongoing: MSTART (Multi-Step Task
Alerting, Reminding, and Tracking)

32
*Tarkan, S., Plaisant, C., Shneiderman, B., & Hettinger, A. (2010). Improving Timely Clinical
Lab Test Result Management: A Generative XML Process Model to Support Medical Care.
PENDING LAB RESULTS: DISCHARGE MONITOR
Several attempts to create automated tools have been
tried with limited success
 Positive results were obtained with a system of email
notifications1
 A computer-based antimicrobial monitoring (CBAM)
system has been used to ensure positive microbiology
cultures receive attention with improved outcomes2
 Discharge systems need to alert both hospital-based
and primary care physician

A. K., Schnipper, J. L., Poon, E. G., Williams, D. H., Rossi-Roh, K., Macleay, A., Liang, C. L., et al.
(2012). Design and implementation of an automated email notification system for results of tests pending at
discharge. Journal of the American Medical Informatics Association : JAMIA, 19(4), 523–8.
2Wilson, J. W., Marshall, W. F., & Estes, L. L. (2011). Detecting delayed microbiology results after hospital
discharge: improving patient safety through an automated medical informatics tool. Mayo Clinic proceedings.
Mayo Clinic, 86(12), 1181–5. doi:10.4065/mcp.2011.0415
1Dalal,
33
SOLUTIONS
ARE COMPLEX
–
EFFORTS ONGOING
Significant challenges remain
 Lack of effectiveness and implementation research
 Unintended consequences
 Diagnostic errors (general)
 DEM
 SIDM
 Diagnostic errors and the clinical laboratory
 AHRQ ACTION II
 CLIHC™
 ITSRI

34
35
DIAGNOSTIC ERROR IN MEDICINE (DEM)
November 11-14, 2012 – Baltimore
 AHRQ funded (partial)
 Agenda Highlights


Sessions that are lab focused
Sunday pre-conference workshop on clinical decision support
 Monday session on inappropriate testing
 Tuesday session on communicating test results


Keynote by Carolyn Clancy, Director, AHRQ
 Featured presentation by Peter Pronovost

For more information, visit Johns Hopkins CME:
http://www.hopkinscme.edu/CourseDetail.aspx/80028747

Join our LinkedIn Group: Diagnostic Error in Medicine
36
• www.improvediagnosis.org
• LinkedIn Group: Diagnostic Error in Medicine
37
AHRQ
FUNDED
RESEARCH






Awarded to RTI in
August, 2011; 18
month effort
Preliminary
literature search is
complete
Developing risk
assessment tools
which will be tested
in three sites:
Vanderbilt
Emory
Seattle Children’s
38
IDENTIFICATION
AND
PRIORITIZATION
OF
RISK
39
CLINICAL LABORATORY
INTEGRATION INTO
HEALTHCARE COLLABORATIVE


CDC sponsored
Seeking to break down the barriers between care
providers and laboratory professionals
Key initiatives are moving forward






A survey of medical schools to understand curricular changes
since 1992 involving laboratory medicine
A survey of pathology residency programs quantifying time
spent teaching consultation
A survey of primary care clinicians to quantify the barriers to
appropriate laboratory utilization
An initiative to define nomenclature issues and investigate
technology strategies for addressing them
An initiative that will develop and publish algorithms to guide
clinicians in the use of complex tests (with iPhone app)
An initiative that seeks to experimentally determine the
effectiveness of laboratory interventions on diagnostic error
reduction (ITSRI)

– CLIHC™
40
IMPROVEMENTS IN TEST SELECTION AND RESULTS
INTERPRETATION (ITSRI) – A RESEARCH AGENDA
Appropriate testing
 Appropriate interpretation


Strategic Intent
 Establish empirically the optimum role for
laboratory medicine’s physicians and scientists to
maximize positive patient outcomes
Identify evidence-based interventions that support
the optimum role
41
ITSRI STATUS
 Narrowed

Diagnostic Process Variation
Chief complaint specific
 Diagnosis specific
 Test domain specific


scope to diagnostic errors
 Catalyzing research
Intervention effectiveness
 Building
awareness
 Recruiting collaborators


NorthShore University HealthSystem
Virginia Commonwealth University
42
KEY
MESSAGES
Diagnostic error is a major patient safety problem
 The total testing process is a significant source of
diagnostic errors
 Pathology informaticians have an opportunity to

A number of interventions have been tried and
much has been learned about their effectiveness
 Choose your best fit and innovate
Improve patient outcomes
 Strengthen relationships with clinicians
 Reduce the level of risk in the health system
 Become indispensable stewards of clinical data


43
FINAL THOUGHT: THE GOAL
THE
CLINICAL LAB’S MISSION SHOULD NOT BE:
ALTHOUGH
THE
NECESSARY, IT IS NOT SUFFICIENT
CLINICAL LAB’S MISSION SHOULD BE:
To provide accurate, timely, low cost test results
To rapidly and efficiently enable the accurate
diagnosis of conditions, the selection of
appropriate treatments and the effective
monitoring of health status*
44
* Epner, Paul, “Impact of Laboratory Services on Diagnostic Errors,” ThinkLab ‘11
Questions?
45

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