IT WAS ONCE POSSIBLE TO KNOW ALL INFORMATION RELATED TO DIAGNOSIS & MANAGEMENT OF CLINICAL DISORDERS

1
Consultation by Clinical Pathologists on
Laboratory Test Selection and Result
Interpretation Michael Laposata, M.D.,
PhD Edward and Nancy Fody Professor of
Pathology Professor of Medicine Vanderbilt
University School of Medicine Pathologist in
Chief, Vanderbilt University Hospital
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Consultation by Clinical Pathologists on
Laboratory Test Selection and Result
Interpretation Michael Laposata, M.D., PhD I
have no disclosures to make that are relevant to
this presentation and will make no reference to
any specific product or company with which I am
connected.
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• Consultation by Clinical Pathologists on
• Laboratory Test Selection and Result
  Interpretation
• Learn how to assist doctors in selecting the
  correct
• laboratory tests.
• Appreciate the value of a personalized, patient
  specific
• interpretation of test results in complex
• clinical laboratory evaluations.
• Learn current developments which will have a
  potentially
• great effect on interpretive services in 2011and
  beyond.

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• Consultation by Clinical Pathologists on
• Laboratory Test Selection and Result
  Interpretation
• Reflex testing is which of the following?
• The performance of a group of tests in a panel.
• The performance of tests ordered each day
• on the same patient for a week.
• c) The performance of tests from a single
  sample in
• which one test result indicates the next test to
  be
• performed.
• Testing a group of patients with similar findings
  
• with the same test panel.

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Error between result
Has the right test
receipt and action?
been ordered?
Action
Interpretation
Ordering
Reporting
Collection
Analysis
Identification
Preparation
Transportation
The nine steps in the performance of any
laboratory
test. The brain-to-brain turnaround time loop.
Lundberg
, 1981
6
Two major unmet needs of clinicians from the
clinical laboratory Consultation on
Appropriate test selection Correct
interpretation of test results
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The clinical environment -- Today and Yesterday
8
1960
Is There a Need for Advice on Test Selection and
Result Interpretation ?
Test Menus
Radiology Chest/Abdominal Films
Bone X-rays
Lab Medicine Test Menu lt 100 Assays

Anatomic Pathology Autopsy/Biopsy/Surgical
Pathology

9
2011
Is There a Need for Advice on Test Selection and
Result Interpretation?
Test Menus
Radiology Dozens of imaging modalities

Lab Medicine Test Menu gt 2000 Assays without
the impending thousands of genetic tests

Anatomic Pathology Autopsy/Biopsy/Surgical

Pathology/Cytopathology
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Consequences of Vast Array of Testing Options
Doctors pick unnecessary tests or miss the
necessary ones
Dozens of approaches emerge for diagnosis of the
same condition some better than others
The correct diagnosis may be achievable promptly,
but it is missed or very commonly delayed, with
adverse clinical consequences to the patient
and/or adverse financial consequences to the
institution.
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Diagnostic Test Advice Has Been Provided for a
Long Time in Radiology and Anatomic Pathology -
but not in Lab Medicine
Within Radiology Treating doctors informally
consult radiologists about diagnostic testing.
Within Anatomic Pathology Treating doctors can
learn best testing among biopsy, surgical
pathology, cytopathology because further
testing such as immunochemistry, is guided by
pathologist and not treating doctor.

12
Patient safety errors associated with incorrect
laboratory test selection and misinterpretation
of test results have been largely unrecognized
for 20 years  A 40-year review of the
literature
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The number of articles written per decade since
1970 that discussed the problem of too many
tests being ordered (left bar in pair) and the
number of papers written offering a solution to
the problem (right bar in pair)
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• The number of articles written per decade since
  1970 that discussed the problem of errors in test
  selection (left bar in pair) and the number of
  papers written offering a solution to the problem
  (right bar in pair)

15

• The number of articles written per decade since
  1970 that discussed the problem
• of errors in test result interpretation (left bar
  in pair) and the number of papers written
  offering a solution to the problem (right bar in
  pair)

16

• Number of articles written per decade since 1970
  regarding the adverse outcomes as a result of
  errors in test selection and result
  interpretation

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Challenge 1Too many lab tests from which to
select
In the last decade it has become virtually
impossible to have enough facts in ones brain
to provide optimum care
The rapid growth of molecular testing begins
Amount of information available
Amount of information possible to know
1990
2000
2009
Modified from Dr. Bill Stead
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What is the challenge introduced with the
availability of molecular diagnostic testing
?The example of cystic fibrosis
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The Diagnosis of Cystic Fibrosis in the Mid-1980s

• Use of the sweat chloride test
• No genetic testing

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The Diagnosis of Cystic Fibrosis in the Mid-1990s

• Use of the sweat chloride test
• Genetic testing for less than 50 mutations

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The Diagnosis of Cystic Fibrosis in the Mid-2000s

• Use of the sweat chloride test
• Genetic testing for hundreds of mutations
• would be informative because minor cystic
  fibrosis mutations have become associated with
  chronic sinusitis and chronic pancreatitis -
• But testing for these indications is not often
  performed

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The Diagnosis of Cystic Fibrosis in the Mid-2000s

• Use of the sweat chloride test
• Genetic testing for hundreds of mutations
• would be informative because minor cystic
  fibrosis mutations have become associated with
  chronic sinusitis and chronic pancreatitis
• And now, it is realized that individual
  mutations are now classified into groups 1 to 5
  and treatment for patients in these groups may be
  different !

23
CDC sponsored activities to improve patient
safety by reducing incorrect test selection and
misinterpretation of test results

• The Clinical Laboratory Integration into
  Healthcare CollaborativeTM is currently active
• And
• Each of its projects to improve the correct
  selection of laboratory tests and the
  interpretation of test results is briefly
  described in this presentation

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Challenge 1Too many lab tests from which to
select
Project to illustrate the challenge of correct
test selection for clinicians There are many
tests in diagnostic coagulation how difficult
is correct test selection for evaluation of a
patient with a prolonged PTT ?
Project co-leaders Marisa Marques and Michael
Laposata
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Challenge 1Too many lab tests from which to
select
3 experts in clinical coagulation were asked to
independently design algorithms for evaluation of
a prolonged PTT The hypothesis was that a simple
algorithm could be used to help clinicians
correctly select tests to effectively evaluate
such patients

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Is this the correct evaluation of a prolonged PTT
for every patient?
Degrade heparin in sample and repeat PTT -if the
PTT normalizes, heparin is the cause
PTT mixing study (5050 mix of patient normal
plasma)
PTT remains prolonged
PTT Normalizes
Factor deficiency-measure factors VIII, IX, XI,
and XII
Inhibitor, most often a Lupus anti-coagulant may
be a Factor VIII inhibitor if PTT mixing study
first normalizes and then becomes
prolonged Perform tests for specific inhibitor
suggested by results of PTT mixing study
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Challenge 1Too many lab tests from which to
select

• The experts concluded that one universal
  algorithm failed to suggest the correct tests to
  evaluate a prolonged PTT in a large percentage of
  cases-
• Clinical variables limited in number
• also needed to be considered to order the correct
  tests
• Notably, whether the patient is bleeding, is an
  inpatient or outpatient, and if the patient is a
  neonate
• Three different algorithms had to be designed to
  maximize the likelihood for correct test
  selection to evaluate a prolonged PTT

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Challenge 1Too many lab tests from which to
select

• Conclusion Even in the absence of molecular
  testing in the evaluation of a prolonged PTT,
  selection of the correct tests to evaluate a
  prolonged PTT is a significant challenge for most
  clinicians
• Because there is not only a large number of tests
  to consider,
• but depending on the clinical circumstances,
  different large groups of tests may need to be
  considered
• Even for the simple evaluation of a prolonged PTT

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Challenge 1Too many lab tests from which to
select

• Potential Solution
• Extensive development of acceptable testing
  algorithms developed by experts for clinicians to
  use
• That actually makes it difficult to order the
  incorrect tests as an Iphone Application !

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Challenge 2 Inconsistent test nomenclature
across laboratories for the same test

• With the large number of names and abbreviations
  for the same test
• How can the clinician know with certainty if the
  test selected is the desired one ?

Project co-leaders Elissa Passiment and James
Meisel
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Existing nomenclature options for vitamin D and
its multiple forms
In addition The number of
abbreviations created for laboratory
information systems for vitamin D and
its multiple forms is almost limitless

• Vitamin D2ErgosterolVitamin
  D3Cholecalciferol25-0H vitamin D225-0H vitamin
  D325-0H vitamin D25 hydroxy vitamin D225
  hydroxy vitamin D325 hydroxy vitamin D1,25
  (OH)2 vitamin D21,25 (OH)2 vitamin D31,25 (OH)2
  vitamin D1,25 dihydroxy vitamin D21,25
  dihydroxy vitamin D31,25 dihydroxy vitamin
  DVitamin D 25 Hydroxy D2 and D3Vitamin D 1,25
  Dihydroxy

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Challenge 2 Inconsistent test nomenclature
across laboratories for the same test

• Potential solution
• Software development that processes clinician
  test requests and compares named tests to those
  in a large indexed database of names and
  abbreviations and asks the clinician
• Did you mean if there is any uncertainty

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Challenge 3Significant variability in
clinician use of laboratory tests

• It is important to determine what practicing
  clinicians know about laboratory test selection
  and result interpretation
• A project was initiated to survey clinicians
• to determine the opportunity for improved
  assistance
• on laboratory test selection and result
  interpretation
• This would include laboratory consultation and
  enhanced decision support
• Project leader John Hickner

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Challenge 3Significant variability in
clinician use of laboratory tests

• Establish from focus groups of physicians
  behind the glass, key challenges physicians
  face in laboratory test ordering and result
  reporting / interpretation
• Then
• Use results of the national survey of primary
  care physicians to identify strategies that
  lessen those challenges

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Methods

• Subject areas
• Atlanta
• Laboratory test ordering and result
  interpretation
• San Antonio
• Laboratory test ordering
• Ann Arbor
• Laboratory test interpretation

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Challenge 3Significant variability in
clinician use of laboratory tests

• Results from behind the glass interviews
  indicate that
• Some physicians continue to use only routine
  tests for diagnosis and are confident with their
  knowledge about a limited number of test results 
• Some physicians understand their lack of
  knowledge in test ordering and test
  interpretation but turn most frequently to
  resources, such as online resources and
  colleagues, for help 
• Nearly all physicians do not think of consulting
  with the laboratory but are very desirable of
  expert information from laboratory directors, if
  it were easily available.

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Behind the Glass Comments

• Issues with accessing and communicating with
  laboratories
• You dont talk to a Radiologist or Pharmacist
  in a hospital, you talk to a colleague. You talk
  to a lab, its a black box
• Access and relationships with laboratory
  professionals
• I dont think about say calling the clinical
  pathologist. They have not made themselves
  available to help me I dont know who they are
• Difficulties in accessing and communicating with
  laboratory professionals
• Getting through the maze on the telephone with
  the laboratory is difficult.

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Behind the Glass Comments

• Follow-up testing information and reflex testing,
  when appropriate
• theres no follow-up, its up to us, if we miss
  itWhy couldnt they have some reminder system in
  the lab for abnormal results?
• Using laboratory consultation for advice is less
  common and pathologists and other laboratory
  professionals are generally seen as somewhat
  inaccessible than other medical professionals

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Questionnaire Development

• Questionnaire development by core Focus Group
  team
• CDC representatives
• Expert consultants
• Survey research experts
• Development process included
• Iterative refinement of drafts by core team
• Cognitive testing with primary care physicians
• Expert review by national authorities

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Survey Methods

• National sample of Family Practice and Internal
  Medicine physicians drawn from AMA Master File
• Target sample size of 1600 cases
• Survey delivered via Web
• Full OMB approval
• Robust statistical design to support analysis

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Potential Solutions

• Prioritize the problems identified by users of
  the clinical laboratory as the results emerge at
  the end of 2011
• Address them with appropriate resources

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Challenge 4 Lack of data on the impact of
advice on test selection and result
interpretation

• The Prospective Generation of Data to Test
  Whether
• Failing to order necessary laboratory tests
  delays diagnosis, appropriate treatment and/or
  worsens patient outcomes
• and if
• Inappropriate utilization of laboratory test
  results delays diagnosis, appropriate treatment
  and/or worsens patient outcomes

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Research on Improvements in Test Selection and
Result Interpretation by Clinicians (ITSRI)

• Do Errors in Test Selection and Result
  Interpretation Adversely Affect Patient Outcome ?
  
• Project leader Paul Epner

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Research on Improvements in Test Selection and
Result Interpretation by Clinicians (ITSRI)

• Studies will be performed in multiple
• clinical areas
• Hepatitis, Coagulation, Autoimmunity, Thyroid,
• Tumor Markers
• In several medical centers

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Research on Improvements in Test Selection and
Result Interpretation by Clinicians (ITSRI)

• To establish a system in pilot studies which
  estimates the magnitude of the problems of
  incorrect test selection and result
  interpretation
• To use the data from the pilot studies to
  establish an assessment system for errors in test
  selection and result interpretation across the
  field of laboratory medicine

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Challenge 5Limited teaching of laboratory
medicine in US medical schools

• A project will be performed to collect data from
  medical schools in the US that reveal
• The amount of instruction on test selection and
• result interpretation
• And
• The courses in which such training exists
• Project Co-leaders Brian Smith and John Hickner

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What is taught to students becoming physicians in
the US?

• The limited knowledge of clinicians about how
  the laboratory functions and how to interpret
  test results may have arisen because the
  pathology taught in medical school is
  predominantly anatomic pathology
• To pass, most medical students must know what a
  heart looks like under the microscope after a
  heart attack and not what blood tests are
  needed to diagnose a heart attack
• But no one does a heart biopsy to diagnose a
  heart attack!

48
Challenge 5Limited teaching of laboratory
medicine in US medical schools

• In the coming months, the survey will be
  prepared and sent to all medical schools in the
  United States
• Medical students in the individual schools will
  assist in the completion of the survey of the
  curriculum
• Collaborators from the American Medical Student
  Association and the American Association of
  Medical Colleges will assist in the design and
  distribution of the survey

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Survey Methods
Goal Survey all 133 allopathic and 26
osteopathic U.S medical schools Letter to Deputy
Dean for Education, Course Director for
Laboratory Medicine Pathology, accompanied by
letter of support from CDC Recruit one medical
student (via AMSA) per school to help complete
the survey. Incentive lottery for 3 iPads for
the students (not the faculty) Analyze survey and
subdivide by basic demographics
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Potential Solutions
Include a required rotation in the clinical years
that involves exposure to the diagnostic
specialties, including laboratory
medicine Include laboratory medicine concepts in
the pre-clinical curriculum in some way
51
Challenge 6Lack of training on clinical
consultation during laboratory medicine residency
and clinical fellowships

• Major goals of this project in the coming months
  for
• pathology residents
• To collect from educators and residents
  perceptions about components of training that
  promote the trainees' ability to provide
  consultative service in laboratory medicine
• To observe resident training activities
  identified by educators of residents as promoting
  the trainees' ability to provide consultative
  service

Project co-leaders Robert Hoffman and Michael
Laposata
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Survey Design

• Goals
• To study in multiple academic institutions,
  assess resident training activities identified by
  the program as providing education in
  consultative practice in clinical pathology.
• Method
• Observational study
• Solicit participation from program directors
• Observe practices identified

53
Design

• Method
• 14 accredited programs within 300 miles of
  Nashville, 8 States in Southeast and Midwest
• Email to program directors soliciting
  participation
• Project in support of a CDC-sponsored work group
• IRB-approved
• No right answers
• Looking for practices and barriers to
  implementation
• Participating sites not to be named in
  presentations
• Follow-up emails if no response
• Arrange visits to observe training activities

54
Results

• 14 programs contacted
• 8 responses
• 5 declined participation
• 3 site visits
• 6 non-responders even after follow-up

55
Some responses from decliners

• You would be surprised to see how little
  consultation there is.
• Nothing to show.
• CP people are not interested in participating.
• After two requests to CP faculty, no interest in
  participation.
• Visit not feasible at this time per department
  leadership.

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Clinical Laboratory Integration into Healthcare
CollaborativeTM

• James L. Meisel, MD
• Boston Medical Center
• Elissa Passiment, EdM
• American Society for Clinical
  Laboratory Science
• Brian Smith, MD
• Yale School of Medicine

• Co-Lead John Hickner, MD, MSc
• Cleveland Clinic
• Co-Lead Michael Laposata, MD, PhD
• Vanderbilt University Hospital
• Scott Endsley MD, MSc 
• Cleveland Clinic
• Paul Epner, MEd, MBA
• Paul Epner, LLC
• Marisa B. Marques, MD
• University of Alabama at Birmingham

57
Collaborative Group Support

• CDC
• Julie Taylor Leader of CDC Team
• Diane Bosse
• MariBeth Gagnon
• James Peterson
• Anne Pollock
• Pam Thompson

• Altarum
• Kim Bellis
• Beth Costello
• Fabian D'Souza
• Jim Lee
• Dana Loughrey
• Megan Shaheen
• Tom Wilkinson

58
An Overview of Existing and Planned Diagnostic
Management Teams -- at Vanderbilt
59

• Diagnostic Management Teams introduce a system
  which minimizes the risk for
• Underutilization and Overutilization of tests
• Misinterpretation of Test Results because
• There is limited knowledge about the significance
  of the test results in achieving a specific
  diagnosis
• There is uncertainty or lack of knowledge about
  whether a result truly reflects a disease state
  or a condition do the results reflect false
  positives or false negatives because of
  analytical interferences
• like drugs or hemolysis from difficult sample
  collection
• or clinical conditions like hyperlipidemia,
  pregnancy, or an acute phase response

60
Coagulation Rounds
Multiple Attendings
Coagulation Lab
Expert Driven, Patient Specific
Diagnostic Interpretation
Neurology
Rheumatology
Cardiology
Ob-Gyn
Hematology Oncology
Financial Benefits On Test Selection On
Diagnosis But Difficult to Quantify
Diagnostic Test Selection Algorithms Selected by
Treating Physicians
61
Hematopathology Rounds
Multiple Attendings
Expert Driven, Patient Specific Interpretation of
Tests From Multiple Laboratories Synthesized by
the Hematopathologist
Histopathology
Cytogenetics
Flow Cytometry
Molecular Genetics
Diagnostic Test Selection by Hematopathologists
Financial Benefits Easily Quantifiable for Test
Selection
Hematologic-Oncologists Presented With Case of
Hematologic Malignancy
Less Easily Quantifiable for Improved
Diagnostic Speed and Accuracy
62
Transfusion Medicine Rounds
Multiple Attendings
Blood Bank
Expert Driven, Patient Specific
Interpretations on Appropriateness
of Transfusion, Adverse Events Associated With
Transfusion, and Identify Underlying Diagnosis
All Clinical Services Providing Blood Products
With Dominant Users Including Surgery/Anesthesia,
Hematology/Oncology, Emergency Department
Financial Benefits Improved Utilization Of Blood
Products Easily Quantified
A Review of all Preoperative Cases With Prolonged
PT or PTT or Low Platelet Count to Establish
Diagnosis and Develop Treatment Plan for Excess
Bleeding
Less Easily Quantifiable for Improved
Diagnostic Speed and Accuracy
63
Microbiology Rounds
Multiple Attendings
Microbiology Laboratories (Including Virology
and Molecular Infectious Disease)
Expert Driven, Patient Specific
Interpretations (With Regular Follow Up by
DMT) For Clinically or Diagnostically Complex
Cases Define Ad Hoc Now and Formally With
Increased Experience
All Clinical Services Evaluating Patients for
Infectious Disease With Infectious
Disease Division as Prominent User
Financial Benefits Improved Use of
Antibiotics Could be Quantified
Less Easily Quantifiable for Improved
Diagnostic Speed and Accuracy
64
On The Drawing Board For Anatomic Pathology The
Diagnosis of Cancer in Multiple Organs and Tissues
Multiple Attendings
Expert Driven, Patient-Specific Interpretation
of Tests From Multiple Areas Synthesized by the
Pathologist
Histopathology
Cytogenetics
Molecular Genetics
Immunohisto chemistry
Diagnostic Test Selection by Pathologists
Financial Benefits Increased Diagnostic Speed
and Accuracy May be Highly Recognized by
Oncologists
Oncologist Presented With Case of Malignancy
in Organ
65
Coagulation Rounds
Multiple Attendings
Coagulation Lab
Expert Driven, Patient Specific
Diagnostic Interpretation
Neurology
Rheumatology
Cardiology
Ob-Gyn
Hematology Oncology
Financial Benefits On Test Selection On
Diagnosis But Difficult to Quantify
Diagnostic Test Selection Algorithms Selected by
Treating Physicians
66
Coagulation Rounds Predominant Case Material
For All Clinical Services For the patient with a
prolonged PT, PTT or both what is the
explanation for the prolongation and, possibly,
what is the risk of bleeding or thrombosis?
67
Coagulation Rounds Predominant Case Material
Hematology and any clinical service including
surgery For the adult or pediatric patient with
a deep vein thrombosis and or pulmonary embolism
is a hypercoagulable state contributory to the
thrombotic event? Do the test results suggest
the need for lifelong anticoagulation?
68
Coagulation Rounds Predominant Case Material
For any clinical service including surgery
For the bleeding patient - Does the
patient have von Willebrands
disease? Does the patient have a
platelet function disorder?
Does the patient have a coagulation
factor defiency and if so, what is the
cause of the defiency? Does the
patient have DIC?
69
Coagulation Rounds Predominant Case Material
Neurology For thrombotic strokes is there a
hypercoagulable state contributing to
cause(s) for stroke?
70
Coagulation Rounds Predominant Case Material
Obstetrics Gynecology For the woman with
pregnancy losses is there a hypercoagulable
state to explain the fetal loss(es)
71
Coagulation Rounds Predominant Case Material
Renal For pre-transplant evaluation is
there a hypercoagulable state that would
cause us to remove this patient from the
transplant list?
72
Coagulation Rounds Predominant Case Material
Rheumatology For the adult or pediatric patient
with autoimmune disease is there an
antiphospholipid antibody that presents an
increased thrombotic risk in this patient?
73
Coagulation Rounds Predominant Case Material
For Pediatrics In the bruised child is there
any evidence of a bleeding disorder to account
for the bruising or is child abuse more likely?
74
Coagulation Rounds Impact on Test Selection

• It helps test selection by involving reflex
  test
• algorithms and panels of related tests.
• It saves dollars on lab tests and tech time
• when it reduces unnecessary tests but it is
• impossible to know what unnecessary tests
• might have been ordered.
• It allows residents on the coagulation service
• to confer with doctors ordering tests that are
• likely to be uninformative, often before they
• are performed.

75
Coagulation Rounds Impact on Establishing a
Diagnosis

• It brings a subspecialist and a trainee into
• every case involving the special coagulation
• lab without need for a consult request
• simply by ordering the lab test .
• It identifies for the clinician a coagulation
• expert and related resident to call for a free
  
• curbside consultation, often connected to a
• narrative interpretation.

76
Coagulation Rounds Impact on Establishing a
Diagnosis

• It identifies a coagulation expert to provide
• continuing medical education in departmental
• seminars.

77
Preliminary Observations on Impact of Coagulation
DMT
R. Lawrence Van Horn, Ph.D, MPH, MBA Assoc. Prof.
of Economics and Management Exec. Dir. Of Health
Affairs The Owen Graduate School of Business
Administration  Director, Office of Sustainable
Health Care Finance Institute of Medicine
Public Health School of Medicine
78
Diagnostic Latency - I

• Tests ordered when patient admitted
• on Monday.
• Results back Tuesday with several
• abnormal results.
• Action taken on Wednesday with further
• evaluation.

79
Diagnostic Latency - II

• Diagnosis and discharge plan on Thursday.
• Patient gone by 3 PM.
• Length of Stay 4 days

80
No Diagnostic Latency - I

• Tests ordered when patient admitted on
• Monday.
• Results to coagulation rounds with
• preliminary interpretation by coagulation
• resident Monday at 400 p.m.
• Patient specific, expert driven narrative
• completed by 600 p.m. Monday and into
• medical record.

81
No Diagnostic Latency - II

• Further evaluation Tuesday.
• Discharge on Wednesday.
• Length of Stay 3 days

Limiting factor for some evaluations Not all
assays done daily Monday-Friday,
delaying narrative and increasing length of stay.
82
MSDRG 176 PE
83
MSDRG 65 Intracranial Hemorrhage
84
Can diagnostic management team activity be
exported to institutions that have many barriers
to implementation of such a service?
85
Whats in the Box from Vanderbilt? Test
selection algorithms and test panel
recommendations Enabling software for creation of
interpretations Reliable and simple connection to
Vanderbilt DMTs using Skype if possible Billing
information to collect revenue for
interpretations for as long as it is
available Templates for local physician surveys
of clinical benefits of the DMT service in the
receiving institution and for collection of
local data on savings from use of the diagnostic
service