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Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretatio 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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Page 1: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Consultation by Clinical Pathologists on

Laboratory Test Selection and Result Interpretation

Michael Laposata, M.D., PhDEdward and Nancy Fody Professor of PathologyProfessor of Medicine

Vanderbilt University School of MedicinePathologist in Chief, Vanderbilt University Hospital

Consultation by Clinical Pathologists on

Laboratory Test Selection and Result Interpretation

Michael Laposata, M.D., PhDEdward and Nancy Fody Professor of PathologyProfessor of Medicine

Vanderbilt University School of MedicinePathologist in Chief, Vanderbilt University Hospital

Page 2: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

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 thispresentation and will make no reference to any specific

product or company with which I am connected.

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 thispresentation and will make no reference to any specific

product or company with which I am connected.

Page 3: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

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.

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.

Page 4: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation

Reflex testing is which of the following?

a) The performance of a group of tests in a panel.b) 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.d) Testing a group of patients with similar findings

with the same test panel.

Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation

Reflex testing is which of the following?

a) The performance of a group of tests in a panel.b) 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.d) Testing a group of patients with similar findings

with the same test panel.

Page 5: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Lundberg, 1981

Error between resultreceipt and action?

Has the right testbeen ordered?

Action

The nine steps in the performance of any laboratorytest. The brain-to-brain turnaround time loop.

Interpretation

Reporting

Analysis

PreparationTransportation

Identification

Collection

Ordering

Page 6: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Two major unmet needs of clinicians from the clinical laboratory

Consultation on :

Appropriate test selection

Correct interpretation of test results

Two major unmet needs of clinicians from the clinical laboratory

Consultation on :

Appropriate test selection

Correct interpretation of test results

Page 7: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

The clinical environment --

Today and Yesterday

The clinical environment --

Today and Yesterday

Page 8: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

1960 1960

Is There a Need for Advice on Test Selection and Result Interpretation ?

Radiology: Chest/Abdominal Films Bone X-rays

Test Menus

Lab Medicine: Test Menu < 100 Assays

Anatomic Pathology: Autopsy/Biopsy/Surgical Pathology

Page 9: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

2011 2011

Is There a Need for Advice on Test Selection and Result Interpretation?

Radiology: Dozens of imaging modalities

Test Menus

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

Anatomic Pathology: Autopsy/Biopsy/Surgical Pathology/Cytopathology

Page 10: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Consequences of Vast Array of Testing Options

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.

Page 11: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Diagnostic Test Advice Has Been Provided for a Long Time in Radiology and Anatomic Pathology

- but not in Lab Medicine

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.

Page 12: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

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

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

Page 13: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

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)

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)

Page 14: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

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)

Page 15: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

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)

Page 16: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

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

Page 17: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Amount of information

available

Amount of information possible to

knowModified from Dr. Bill Stead

1990 2000 2009

The rapid growthof molecular testing begins

In the last decade it has become virtually impossible to have enough facts in one’s brain to provide optimum care

In the last decade it has become virtually impossible to have enough facts in one’s brain to provide optimum care

Challenge # 1:Too many lab tests from which to select

Challenge # 1:Too many lab tests from which to select

Page 18: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

What is the challenge introduced with the availability of molecular

diagnostic testing ?

The example of cystic fibrosis

What is the challenge introduced with the availability of molecular

diagnostic testing ?

The example of cystic fibrosis

Page 19: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

The Diagnosis of Cystic Fibrosis in the Mid-1980s

The Diagnosis of Cystic Fibrosis in the Mid-1980s

• Use of the sweat chloride test

• No genetic testing

Page 20: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

The Diagnosis of Cystic Fibrosis in the Mid-1990s

The Diagnosis of Cystic Fibrosis in the Mid-1990s

• Use of the sweat chloride test

• Genetic testing for less than 50 mutations

Page 21: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

The Diagnosis of Cystic Fibrosis in the Mid-2000s

The Diagnosis of Cystic Fibrosis in the Mid-2000s

• Use of the sweat chloride test

• Genetic testing for hundreds of mutationswould 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

Page 22: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

The Diagnosis of Cystic Fibrosis in the Mid-2000s

The Diagnosis of Cystic Fibrosis in the Mid-2000s

• Use of the sweat chloride test

• Genetic testing for hundreds of mutationswould 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 !

Page 23: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

CDC sponsored activities to improve patient safety by reducing incorrect test selection and

misinterpretation of test results

CDC sponsored activities to improve patient safety by reducing incorrect test selection and

misinterpretation of test resultsThe 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

Page 24: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Challenge # 1:Too many lab tests from which to select

Challenge # 1:Too many lab tests from which to select

Project to illustrate the challenge ofcorrect 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 to illustrate the challenge ofcorrect 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 LaposataProject co-leaders : Marisa Marques and Michael Laposata

Page 25: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Challenge # 1:Too many lab tests from which to select

Challenge # 1:Too many lab tests from which to select

3 experts in clinical coagulation were askedto independently design algorithms for

evaluation of a prolonged PTT

The hypothesis was that a simple algorithmcould be used to help clinicians correctly select

tests to effectively evaluate such patients

3 experts in clinical coagulation were askedto independently design algorithms for

evaluation of a prolonged PTT

The hypothesis was that a simple algorithmcould be used to help clinicians correctly select

tests to effectively evaluate such patients

Page 26: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

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 Normalizes PTT remains prolonged

PTT mixing study (50:50 mix of patient & normal plasma)

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

Page 27: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Challenge # 1:Too many lab tests from which to select

Challenge # 1:Too 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

Page 28: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Challenge # 1:Too many lab tests from which to select

Challenge # 1:Too 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

Page 29: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Challenge # 1:Too many lab tests from which to select

Challenge # 1:Too 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 !

Page 30: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Challenge # 2: Inconsistent test nomenclature across

laboratories for the same test

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 MeiselProject co-leaders : Elissa Passiment and James Meisel

Page 31: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Existing nomenclature options for vitamin D and its multiple forms

Existing nomenclature options for vitamin D and its multiple forms

:

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

In addition –

The number of abbreviationscreated for laboratory informationsystems for vitamin D and itsmultiple forms is almost limitless

In addition –

The number of abbreviationscreated for laboratory informationsystems for vitamin D and itsmultiple forms is almost limitless

Page 32: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Challenge # 2: Inconsistent test nomenclature across

laboratories for the same test

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

Page 33: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Challenge # 3:Significant variability in clinician use of laboratory tests

Challenge # 3:Significant 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 cliniciansto 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

Page 34: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Challenge # 3:Significant variability in clinician use of laboratory tests

Challenge # 3:Significant 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

Page 35: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

MethodsMethods

• Subject areas – Atlanta

• Laboratory test ordering and result interpretation

– San Antonio• Laboratory test ordering

– Ann Arbor• Laboratory test interpretation

Page 36: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Challenge # 3:Significant variability in clinician use of laboratory tests

Challenge # 3:Significant 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.

Page 37: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Behind the Glass CommentsBehind the Glass Comments

• Issues with accessing and communicating with laboratories“You don’t talk to a Radiologist or Pharmacist in a hospital, you talk to a colleague. You talk to a lab, it’s a black box…”

• Access and relationships with laboratory professionals

“I don’t think about say calling the clinical pathologist. They have not made themselves available to help me; I don’t know who they are”

• Difficulties in accessing and communicating with laboratory professionals

“Getting through the maze on the telephone [with the laboratory] is difficult.”

Page 38: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Behind the Glass CommentsBehind the Glass Comments

• Follow-up testing information and reflex testing, when appropriate

“there’s no follow-up, it’s up to us, if we miss it…Why couldn’t 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

Page 39: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Questionnaire DevelopmentQuestionnaire 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

Page 40: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Survey MethodsSurvey 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

Page 41: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Potential SolutionsPotential 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

Page 42: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Challenge # 4: Lack of data on the impact of advice on test selection and

result interpretation

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

Page 43: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

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

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

Page 44: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

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

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

Page 45: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

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

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

Page 46: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Challenge # 5:Limited teaching of laboratory medicine in US

medical schools

Challenge # 5:Limited 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

Page 47: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

What is taught to students becoming physicians in the US?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!

Page 48: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Challenge # 5:Limited teaching of laboratory medicine in US medical schools

Challenge # 5:Limited 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

Page 49: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Survey MethodsSurvey 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

Page 50: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Potential SolutionsPotential 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

Page 51: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Challenge # 6:Lack of training on clinical consultation during

laboratory medicine residency and clinical fellowships

Challenge # 6:Lack 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 LaposataProject co-leaders : Robert Hoffman and Michael Laposata

Page 52: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Survey Design: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

Page 53: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Design: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

Page 54: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Results:Results:

• 14 programs contacted– 8 responses

• 5 declined participation• 3 site visits

– 6 non-responders even after follow-up

Page 55: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Some responses from decliners: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.”

Page 56: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Clinical Laboratory Integration into Healthcare CollaborativeTMClinical Laboratory Integration into Healthcare CollaborativeTM

• 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

• James L. Meisel, MD Boston Medical Center

• Elissa Passiment, EdM

American Society for Clinical Laboratory Science

• Brian Smith, MD

Yale School of Medicine

Page 57: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Collaborative Group SupportCollaborative Group Support

Altarum

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

CDC

Julie Taylor – Leader of CDC Team

• Diane Bosse

• MariBeth Gagnon

• James Peterson

• Anne Pollock

• Pam Thompson

Page 58: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

An Overview of Existing and Planned Diagnostic Management

Teams --

at Vanderbilt

An Overview of Existing and Planned Diagnostic Management

Teams --

at Vanderbilt

Page 59: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

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

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

Page 60: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Coagulation Rounds Coagulation Rounds

Coagulation Lab

Neurology

Multiple Attendings

Expert Driven, PatientSpecific Diagnostic

Interpretation

Diagnostic Test SelectionAlgorithms

Selected by TreatingPhysicians

Financial Benefits:On Test Selection

On DiagnosisBut Difficult to

Quantify

Cardiology

HematologyOncology

Ob-Gyn

Rheumatology

Page 61: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Hematopathology RoundsHematopathology Rounds

Expert Driven,Patient Specific Interpretation

of Tests FromMultiple Laboratories Synthesized

by the Hematopathologist

Financial Benefits:Easily Quantifiablefor Test Selection

Less Easily Quantifiablefor Improved Diagnostic

Speed and Accuracy

Diagnostic Test Selectionby Hematopathologists

Hematologic-OncologistsPresented With Case

of Hematologic Malignancy

Histopathology

Molecular Genetics

Cytogenetics FlowCytometry

Multiple Attendings

Page 62: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Transfusion Medicine RoundsTransfusion Medicine Rounds

Expert Driven,Patient Specific Interpretations

on Appropriateness ofTransfusion, Adverse Events

Associated With Transfusion, andIdentify Underlying Diagnosis

Financial Benefits:Improved UtilizationOf Blood ProductsEasily Quantified

Less Easily Quantifiablefor Improved Diagnostic

Speed and Accuracy

A Review of allPreoperative Cases WithProlonged PT or PTT or

Low Platelet Count toEstablish Diagnosis and

Develop Treatment Plan for Excess Bleeding

All Clinical Services ProvidingBlood Products – With

Dominant Users IncludingSurgery/Anesthesia,

Hematology/Oncology,Emergency Department

Multiple AttendingsBlood Bank

Page 63: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

All Clinical Services EvaluatingPatients for Infectious Disease –

With Infectious DiseaseDivision as Prominent User

Microbiology RoundsMicrobiology Rounds

Microbiology Laboratories(Including Virology and

Molecular Infectious Disease)

Multiple Attendings

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

Financial Benefits:Improved Use of Antibiotics

Could be Quantified

Less Easily Quantifiablefor Improved Diagnostic

Speed and Accuracy

Page 64: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Expert Driven,Patient-Specific

Interpretation of TestsFrom Multiple Areas –

Synthesized by the Pathologist

Financial Benefits:Increased Diagnostic Speed and Accuracy May be Highly Recognized by Oncologists

Diagnostic Test Selectionby Pathologists

OncologistPresented With Case

of Malignancy inOrgan

Histopathology

Immunohisto chemistry

Cytogenetics MolecularGenetics

Multiple Attendings

On The Drawing Board For Anatomic Pathology: The Diagnosis of Cancer in Multiple Organs and Tissues

On The Drawing Board For Anatomic Pathology: The Diagnosis of Cancer in Multiple Organs and Tissues

Page 65: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Coagulation Rounds Coagulation Rounds

Coagulation Lab

Neurology

Multiple Attendings

Expert Driven, PatientSpecific Diagnostic

Interpretation

Diagnostic Test SelectionAlgorithms

Selected by TreatingPhysicians

Financial Benefits:On Test Selection

On DiagnosisBut Difficult to

Quantify

Cardiology

HematologyOncology

Ob-Gyn

Rheumatology

Page 66: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Coagulation Rounds – Predominant Case Material

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?

Page 67: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Coagulation Rounds – Predominant Case Material

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?

Page 68: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Coagulation Rounds – Predominant Case Material

Coagulation Rounds – Predominant Case Material

For any clinical service including surgery

For the bleeding patient - Does the patient have von Willebrand’s 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?

Page 69: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Coagulation Rounds – Predominant Case Material

Coagulation Rounds – Predominant Case Material

Neurology

For thrombotic strokes – is there a hypercoagulable state contributing to cause(s) for stroke?

Page 70: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Coagulation Rounds – Predominant Case Material

Coagulation Rounds – Predominant Case Material

Obstetrics & Gynecology

For the woman with pregnancy losses – is there a hypercoagulable state to explain the fetal loss(es)

Page 71: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Coagulation Rounds – Predominant Case Material

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?

Page 72: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Coagulation Rounds – Predominant Case Material

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?

Page 73: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Coagulation Rounds – Predominant Case Material

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?

Page 74: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Coagulation Rounds Impact on Test Selection

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.

Page 75: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Coagulation Rounds Impact on Establishing a Diagnosis

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.

Page 76: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

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

Coagulation Rounds Impact on Establishing a Diagnosis

Coagulation Rounds Impact on Establishing a Diagnosis

Page 77: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

R. Lawrence Van Horn, Ph.D, MPH, MBAAssoc. Prof. of Economics and Management

Exec. Dir. Of Health AffairsThe Owen Graduate School of Business Administration

Director, Office of Sustainable Health Care FinanceInstitute of Medicine & Public Health

School of Medicine

Preliminary Observations on Impact of Coagulation DMT

Preliminary Observations on Impact of Coagulation DMT

Page 78: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

“Diagnostic Latency” - I“Diagnostic Latency” - I

• Tests ordered when patient admitted on Monday.

• Results back Tuesday with several abnormal results.

• Action taken on Wednesday with further evaluation.

Page 79: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

“Diagnostic Latency” - II“Diagnostic Latency” - II

• Diagnosis and discharge plan on Thursday. Patient gone by 3 PM.

Length of Stay: 4 days

Page 80: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

No Diagnostic Latency - INo Diagnostic Latency - I

• Tests ordered when patient admitted on Monday.

• Results to coagulation rounds with preliminary interpretation by coagulation resident Monday at 4:00 p.m.

• Patient specific, expert driven narrative completed by 6:00 p.m. Monday and into medical record.

Page 81: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

No Diagnostic Latency - IINo 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, delayingnarrative and increasing length of stay.

Page 82: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

0K 5K 10K 15K 20K 25K 30K 35K 40K 45K 50K 55K 60K 65K 70K 75K 80K 85K

TOTAL_CHARGES

0

1

2

3

4

5

6

7

8

9

los

Percent of Cases with LOSgreater or equal to 4 days

Jan - Jul (Before) 36.75%Aug - Dec (After) 12.50%Chi-sq significant at .05

Bottom Line:It appears that the changes in the median LOS aredue to truncation of the right tail.

Comparison of Length of Stay and Total Charges Pre and Post Aug 1, 2010

August 1

After

Before

MSDRG 176: PE MSDRG 176: PE

Page 83: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

10K 20K 30K 40K 50K 60K 70K 80K 90K 100K 110K 120K 130K 140K 150K 160K

TOTAL_CHARGES

0

5

10

15

20

los

Percent of Cases with LOSgreater or equal to 10 days

Jan - Jul (Before) 14.5%Aug - Dec (After) 2.25%Chi-sq significant at .05.

Bottom line:It appears that the changes in median LOS aredue to truncation of the right tail.

Comparison of Length of Stay and Total Charges Pre and Post Aug 1, 2010

August 1

After

Before

MSDRG 65 Intracranial HemorrhageMSDRG 65 Intracranial Hemorrhage

Page 84: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

Can diagnostic management team activity be exported to institutions that have many

barriers to implementation of such a service?

Can diagnostic management team activity be exported to institutions that have many

barriers to implementation of such a service?

Page 85: Consultation by Clinical Pathologists on Laboratory Test Selection and Result Interpretation Michael Laposata, M.D., PhD Edward and Nancy Fody Professor

“What’s 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

“What’s 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