laboratory solutions summit - American Association for Clinical

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laboratory solutions summit - American Association for Clinical
LABORATORY SOLUTIONS SUMMIT:
Value-based Clinical Lab Models
AACC’s Lab Solutions Summit virtual conference showcases stories from lab
professionals and others about how changes in test strategy, technology, process
or management improved specified patient or healthcare outcomes.
TABLE OF CONTENTS
ACKNOWLEDGEMENTS
Program Chair and Program Committee............................................3
Exhibitors...............................................................................................3
PROGRAM SCHEDULE
Day 1, Wednesday, September 16........................................................4
Day 2, Thursday, September 17.............................................................6
SPEAKER BIOS AND DISCLOSURES
Ramy Arnout, Michael Astion, Patrick Bossuyt, Robert Christenson,
Anuj Dalal .............................................................................................8
Paul Epner, Andrew Georgiou, Michael Hallworth, Andrea Rita
Hovarth .................................................................................................9
Michael Kanter, Michael Laposata, Gary Procop, Robert Schmdt......
.............................................................................................................10
Mitchell Scott, Hardeep Singh, Denise L. Uettwiller-Geiger................11
POSTER ABSTRACTS
Poster Abstracts 1— 3.........................................................................12
Poster Abstracts 4 — 5........................................................................13
Poster Abstracts 6 — 7........................................................................14
Poster Abstracts 8 — 9 .......................................................................15
Poster Abstracts 10 — 12....................................................................16
CONTINUING EDUCATION RECORDING FORM......................................18
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ACKNOWLEDGEMENTS
Program Chair - Michael Hallworth, MA, MSc, MCB, FRCPath
Program Chair - Michael Hallworth, MA, MSc, MCB, FRCPath
Michael Hallworth is a Clinical Biochemist who has recently retired from the post of Consultant Clinical Scientist to
the Shrewsbury and Telford Hospital NHS Trust, based at the Royal Shrewsbury Hospital, Shrewsbury, Shropshire, UK.
He worked in the National Health Service for almost 40 years, and is a past President of the European Communities
Confederation of Clinical Chemistry and Laboratory Medicine (EFCC) and past Chairman of the UK Association for
Clinical Biochemistry.
Program Committee Members
Alex Chin, PhD, DABCC
Calgary Laboratory Services/University of Calgary (Calgary, AB,
Canada)
Paul Epner, M.Ed, MBA
Society to Improve Diagnosis in Medicine (Chicago, IL)
Andrea Rita Horvath MD, PhD, EurClinChem, FRCPath,
FRCPA
Prince of Wales Hospital (Sydney, Australia)
David Koch, PhD, DABCC, FACB
Grady Memorial Hospital and Emory University (Atlanta, GA)
EXHIBITORS
www.orthoclinical.com
Ortho Clinical Diagnostics serves the transfusion medicine
community and laboratories around the world. We’re a leading
provider of total solutions for screening, diagnosing, monitoring and
confirming diseases early, before they put lives at risk.
Ortho-Clinical Diagnostics, Inc. has U.S. headquarters in Raritan, NJ
and operations in Rochester, NY, Pompano Beach, FL, Strasbourg,
France and Pencoed, Wales, Ortho Clinical Diagnostics has more
than 4,500 employees worldwide. We are dedicated to investing
significant resources to continuously improve our products and
develop solutions to address unmet medical needs.
quality of life.
For nearly 70 years, Ortho Clinical Diagnostics has provided the
global healthcare community with the means to make more
informed decisions. We’ve pioneered some of the most important,
life-impacting advances in diagnostics—from our earliest work in
blood typing to the latest developments in laboratory systems.
Today, we’re focused on creating innovative new diagnostic
products, improving existing ones, advancing your knowledge and
shaping the future of diagnostics within global healthcare. Your
work—and ours—is all about changing lives, together.
Our single focus is to help hospitals, laboratories and blood centers
worldwide deliver results that help patients experience a better
http://www.visiun.com/
Visiun, Inc. is a management consulting firm providing strategic
information and professional services to the laboratory industry,
helping clients to achieve their financial and operational
performance objectives. With over 50 years of experience in
healthcare and information technology, as well as recognized
expertise in financial management, research and analytical
services, we have developed a broad range of innovative services,
many of which are unique in the industry.
http://clsi.org/
A not-for-profit membership organization, the Clinical and
Laboratory Standards Institute (CLSI) brings together the global
laboratory community for a common cause: fostering excellence
in laboratory medicine. We do so by facilitating a unique process
of developing clinical laboratory testing standards based on input
from and consensus among industry, government, and health care
professionals.
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For over 40 years, our members, volunteers, and customers have
made CLSI a respected, transformative leader in the development
and implementation of clinical laboratory testing standards.
Through our unified efforts, we will continue to set and uphold
the standards that drive quality test results, enhance patient care
delivery, and improve the public’s health around the world.
PROGRAM GUIDE - Wednesday, September 16
9:00 AM
INTRODUCTION
Patient-Centered Laboratory Medicine: Surviving the Shift to Value-Driven Healthcare
Paul Epner, MBA, MEd, Executive Vice President, Society to Improve Diagnosis in Medicine, Chicago, IL
„„How to create a framework that responds to the call for improved patient outcomes
„„How to use the framework to set priorities for your laboratory
9:30 AM
KEYNOTE ADDRESS
The Evaluation of Laboratory Tests: From Information to Effectiveness
Patrick Bossuyt, PhD, Academic Medical Center of the University of Amsterdam, Netherlands
„„Explain how the evaluation of lab tests and other medical tests is changing
„„Evolution from an emphasis on analytical performance, to the recognition that decisions should be guided
by the consequences of testing on patient-important health outcomes
10:15 AM
Content Expert Sessions, Virtual Exhibits, Poster Session and Chats
SESSION 1
10:45 AM
Surveying the Landscape of Inappropriate Laboratory Testing
Ramy Arnaout, MD, PhD, Beth Israel Deaconess Medical Center, Boston, MA
„„
„„
11:30AM
(Session supported by Instrumentation Laboratory)
The scope and causes of inappropriate testing being performed by clinical labs
Report from a 15-year meta-analysis that examined over- and under-utilization of lab testing
Curbing Inappropriate Testing in Your Organization: Solutions That Work
Gary Procop, MD, Cleveland Clinic, Cleveland, OH
„„Review commonly used tools for controlling inappropriate test utilization, both IT-based and managementbased
„„Discuss strategies for leveraging information technology to change physician behavior
„„Identify which tools and strategies have been proven to be most effective for ensuring appropriate utilization
12: 15 PM
PLUGS: A Local Utilization Management Initiative with National Impact
Michael Astion, MD, Seattle Children’s Hospital, Seattle WA
„„Identify areas of laboratory testing where misordering of tests frequently occurs
„„Name interventions to improve the value of testing for patients
„„Describe the role of genetic counselors in improving lab test ordering
„„Describe the national endeavor known as PLUGS, the Pediatric Laboratory Utilization Guidance Service
1:00 PM
Content Expert Sessions, Virtual Exhibits, Poster Session and Chats
SESSION 2
1:45 PM
(Session supported by Instrumentation Laboratory)
The Safety Implications of Missed Test Results and What is Being Done About It
Andrew Georgiou, Australian Institute of Health Innovation, Macquarie University,
Sydney, Australia
„„Frequency and consequences of “missed” test results (a missed test result is one that is reported but not
acted on)
„„ Failures of organizational and communications processes in following up on test results
„„Roles and responsibilities of lab professionals in communicating critical and significant test results
2:30 PM
Strategies and Solutions for Following Up on Test Results
Anuj K. Dalal, MD, Brigham and Women’s Hospital, Boston, MA
„„Using clinical information systems to follow up on results, improve processes and increase the effectiveness of
care
„„Designing good test result follow-up processes and using information technology to reduce harm caused by
missing results
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PROGRAM GUIDE - Wednesday, September 16
3:15 PM Content Expert Sessions, Virtual Exhibits, Poster Session and Chats
Hear About Real World Projects and Be Inspired—Oral Abstract Presentations
3:30 PM How an Acute-Care Hospital Reduced Unnecessary Testing by 6.5%
Charles Miraglia, MD, Chief Medical Officer, hc1.com, Indianapolis, IN
SPECIAL TOPIC: The Role of the Lab in Reducing Diagnostic Errors
4:00 PM Reducing Diagnostic Errors in Health IT-Enabled Health Care: Calling Labs to Action
Hardeep Singh, MD, MPH, Houston VA Center for Innovation and Baylor College of Medicine, Houston, TX
„„Describe types of diagnostic errors in health IT-enabled health systems
„„Discuss the implications of diagnostic errors
„„Identify potential solutions or frameworks for mitigating patient safety risks related to diagnostics errors
5:00 PM
1:05 PM
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END OF DAY ONE
PROGRAM GUIDE - Thursday, September 17
9:00 AM
SESSION 3 - Performing Evidence-based Test Evaluation
(Session supported by Instrumentation Laboratory)
Testing a Test – A Framework for Biomarker Evaluation
Andrea Rita Horvath MD, PhD, FRCPath, FRCPA, Prince of Wales Hospital, Sydney,
Australia
„„Review of key terms, principles and components involved in developing an evidence-based test/biomarker
evaluation process
„„How evaluating analytical and clinical performance, as well as clinical effectiveness and cost-effectiveness,
can create a dynamic cycle for test evaluation in the context of providing better patient outcomes
„„ Defining clinical goals and how the intended application of a test or biomarker in the clinical pathway
should drive each component of test evaluation
9:45 AM
Evaluating the Impact of Analytical Performance on Patient Outcomes
Mitchell Scott, PhD, University of Washington in St. Louis, MO
„„Discuss how to examine the impact of assay performance on outcomes, how difficult this is to do, and what
types of tests to focus on
„„Review of a recent study of troponin assays as an example of measurable outcomes
„„Review modeling studies on glucose meters and predicted outcomes
10:30 AM
Content Expert Sessions, Virtual Exhibits, Poster Session and Chats
10:45 AM
Assessing the Clinical Effectiveness of Biomarkers
Robert Christenson, PhD, University of Maryland Medical Systems, Baltimore, MD
„„How to measure the impact of test/biomarker clinical performance on patient outcomes
„„Reviewing, producing and synthesizing the evidence for using tests/biomarkers
„„Information about assessing clinical effectiveness from the CDC’s Laboratory Medicine Best Practices Initiative
SESSION 4 - From Data to Information; From Information to Clinical Knowledge
11: 30 AM
Using Laboratory Data for Outcomes Improvement Initiatives
Michael Kanter, MD, Southern California Permanente Medical Group, Los Angeles, CA
„„How lab data can be used to promote preventive care in an outpatient population
„„The components of an outpatient safety net program and what the laboratory can do to improve patient
safety in this setting
„„Examples of how a major healthcare organization has measured the impact of its preventive service efforts in
colon cancer screening
12:15 PM
1:00 PM
Content Expert Sessions, Virtual Exhibits, Poster Session and Chats
Navigating the Healthcare Landscape: Transition from Volume to High-Value Patient Outcomes
Denise Uettwiller-Geiger, PhD, DLM(ASCP), Director of Laboratory Services and Clinical Trials, John T.
Mather Memorial Hospital, Port Jefferson, NY
„„Discuss how leveraging technology can improve quality and value based patient outcomes
„„Measure the direct impact of laboratory test results on organizational performance
„„Examine the value of laboratory within the evolving healthcare environment
„„Describe how the laboratory can contribute to performance driven healthcare
1:45 PM
Cost-Effectiveness Analysis for Diagnostic Testing
Robert Schmidt, MD, PhD, MBA, University of Utah School of Medicine and ARUP Laboratories, Salt Lake
City, UT
„„Review the basic types of analyses that support cost-effectiveness analysis
„„Describe the opportunities and challenges in applying cost-effectiveness analysis to diagnostic tests
„„How to critically evaluate a cost-effectiveness analysis
„„ Real-world examples of how lab data is being used to determine if certain lab testing strategies are cost effective
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PROGRAM GUIDE - Thursday, September 17
2:30 PM
Hear About Real World Projects and Be Inspired—Oral Abstract Presentations
Comprehensive Biomarker Testing Supports Reductions in Adverse Clinical Events with No Increase in
Total Cost of Care
Stephen A. Varvel, PhD, CCRP, Health Diagnostic Laboratory, Richmond, VA
2:45 PM
Virtual Exhibits, Poster Session and Chats
Hear About Real World Projects and Be Inspired—Oral Abstract Presentations
3:30 PM
Screen with Reflex to Better Test Utilization: A Cost Analysis of Thyroglobulin Testing Strategies
Jennifer L. Powers, PhD, University of Utah, Salt Lake City, UT
3:45 PM
Utilization of Clinical Laboratory Services in a World with New Rules: Overutilization, Underutilization
and the Impact of Both on Patient Outcomes and Healthcare Costs
Michael Laposata, MD, University of Galveston, TX
„„Review how the overuse and underuse of laboratory testing affects costs and patient outcomes
„„Describe what a diagnostic management team is, the services it provides and how it works in practice to
provide better patient care
„„Provide information on how to bring the leaders in your organization from anatomic pathology, clinical
pathology, radiology and other relevant departments together to provide this value-added service
„„Examples of how diagnostic management teams have improved patient care
4:30 PM
Closing Summary and Call to Arms
Michael Hallworth, MA, MSc, MCB, FRCPath, Royal Shrewsbury Hospital, Shrewsbury, Shropshire, United
Kingdom
„„Summary of lessons learned from the conference, and what lab professionals can do to apply this
information to projects in their own organizations
5:00 PM
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END OF CONFERENCE
SPEAKER BIOS AND DISCLOSURES
Ramy Arnaout, MD, PhD
Arnaout Lab, Boston, MA
Ramy Arnaout, MD, DPhil, is Assistant Professor
of Pathology at BIDMC and Harvard Medical
School, Associate Director of the Clinical
Microbiology Laboratories at BIDMC, and
cofounder of the Department of Pathology’s
Genomic Medicine Initiative. An alumnus of
MIT, he received his doctorate in mathematical
(systems) biology from Oxford University on a
Marshall Scholarship and his MD from Harvard Medical School as a
Soros Fellow. He completed residency in pathology at Brigham and
Women’s Hospital and postdoctoral work at the Broad Institute of
MIT and Harvard.
Disclosure: Disclosed no relevant financial relationships.
Michael Astion, MD, PhD
Seattle Children’s Hospital, Seattle, WA
Dr. Astion is medical director in the department
of laboratories at Seattle Children’s Hospital
and clinical professor of laboratory medicine
at the University of Washington. For almost
two decades he was the director of reference
laboratory services at the University of
Washington. His work is divided among
clinical service, teaching, and research and development. He
has authored more than 20 software titles, 40 peer-reviewed
papers, and 40 editorials. His software, which has been translated
into several languages, includes both laboratory tutorials and
competency assessment exams. These materials are now used by
more than 40,000 clinical laboratory workers annually in 1500 labs
as part of the Medical Training Solutions laboratory training library.
He is the editor of Patient Safety Focus, which appears quarterly
in AACC’s Clinical Laboratory News. He is currently working with
the insurance industry to create utilization management rules for
clinical laboratory testing. He is one of the founders of the Pediatric
Laboratory Utilization Guidance Service (PLUGS), which helps
pediatric hospitals and clinics increase the value of lab testing.
Dr. Astion is a frequent speaker at professional meetings on issues
related to test utilization, test interpretation, laboratory economics
and outreach, and medical errors. He has received the American
Society for Clinical Laboratory Science Theriot Award for Excellence
in Media twice for his educational software. He has received AACC
awards for outstanding contributions to patient safety and to
management science. A frequent winner of the AACC outstanding
speaker award, Dr. Astion has been active in the AACC, including
as a symposium organizer for the 2005 Annual Meeting Organizing
Committee and head of the patient safety taskforce.
Disclosure: Speaker has disclosed receiving grant/research
support from EviCore and will mention products and services of
this company.
Patrick Bossuyt, PhD
Academic Medical Center of the University of
Amsterdam, Netherlands
Prof. Patrick Bossuyt is from the Department
of Clinical Epidemiology, Biostatistics and
Bioinformatics, Academic Medical Center,
Amsterdam, Netherlands and specialises in
clinical epidemiology and systematic reviews and diagnostic
tests. Prof. Bossuyt is full professor in Clinical Epidemiology of the
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University. He also acts as Head of the Division of Public Health and
Clinical Methods. He is widely recognised for his contributions to the
methodology of medical test evaluations. Dr. Bossuyt initiated the
STARD project, which developed the STARD guidelines for reporting
test accuracy studies. Dr. Bossuyt gives advice to several government
and regulatory bodies. He has co-authored over 700 research
articles in peer-reviewed and indexed journals, and has successfully
supervised more than 80 PhD students. For 10 years Dr. Bossuyt was
Dean of Graduate Studies, overseeing the training of 1200 active
PhD students in AMC. His research interests include methodology of
systematic reviews and meta-analyses of diagnostic test accuracy.
Disclosure: Disclosed no relevant financial relationships.
Robert Christenson, PhD
University of Maryland School of Medicine,
Baltimore, MD
Dr. Christenson is Professor of Pathology and
Professor of Medical and Research Technology
at the University of Maryland School of Medicine
in Baltimore, Maryland. Clinically, Dr. Christenson
is Director of the Clinical Chemistry, Toxicology,
and Core Laboratories at the University of
Maryland Medical Center, where he is also
Medical Director of Point of Care Services. Dr. Christenson has an
active research program in the area of biomarkers of cardiovascular
disease and renal dysfunction. Dr. Christenson directs the Clinical
Chemistry Research Laboratory, a CLIA-licensed and CAPaccredited research laboratory at University of Maryland School of
Medicine that specializes in Government and Industry sponsored
clinical trials. Dr. Christenson also directs the University of Maryland
School of Medicine’s ComACC training program and is active in the
Pathology Residency Program.
Dr. Christenson holds four patents and has published over 265 peerreviewed manuscripts, over 250 abstracts, 4 books, and 50 book
chapters and monographs. He is an associate editor for the journal
Clinical Biochemistry and has served for 10 years on the editorial
board member for Clinical Chemistry Journal and chaired the
editorial board of AACC’s Clinical Laboratory News.
Disclosure: Disclosed no relevant financial relationships.
Anuj K. Dalal, MD
Brigham and Women’s Hospital, Boston, MA
Dr. Anuj K Dalal is an Instructor of Medicine
at Harvard Medical School and Associate
Physician at Brigham and Women’s Hospital
(BWH) in the Division of General Medicine
and Primary Care and a member of the BWH
Hospitalist Service. He completed residency
training in internal medicine at the Hospital of
the University of Pennsylvania in 2004. Since
joining the Division of General Medicine and Primary Care in 2007
he has received formal training in clinical effectiveness research
and medical informatics. Dr. Dalal’s current research focuses on
evaluating innovations and technology aimed at improving the
delivery of care in the transitions of care setting. Specifically, he
is working on implementing and evaluating health information
technology (HIT) innovations to improve test result management
and care team communication in the inpatient and care transitions
settings.
Dr. Dalal was one of the first recipients of the BWH HIT Innovations
Program grants to develop an automated email notification system
SPEAKER BIOS AND DISCLOSURES
for the results of tests pending at discharge. He was Principal
Investigator on an AHRQ grant in which he rigorously evaluated the
impact of this notification system and demonstrated substantial
improvement in awareness of these test results by responsible
physicians.
Currently, Dr. Dalal is a member of the Communicating Clinically
Significant Test Results (CCSTR) Task Force charged with improving
management of test results across Partners Healthcare. He is also
working on new technology-based initiative to improve patient
engagement and care team communication via use of a novel,
web-based patient-centered toolkit and microblog. Finally, Dr.
Dalal is the BWH site Principal Investigator of the Hospital Medicine
Reengineering Network, a multi-center collaborative whose
purpose is to develop a distributed data network to benchmark
hospital-based risk-adjusted outcomes and conduct comparative
effectiveness research
Disclosure: Disclosed no relevant financial relationships.
Paul Epner, MBA, MEd
Society to Improve Diagnosis in Medicine,
Chicago, IL
Paul Epner is a strategic planning consultant
in healthcare with special expertise in the
field of laboratory medicine. Previously he
spent 31 years with the Diagnostics Division of
Abbott Laboratories working in the U.S., Japan
and China. His final position at Abbott was as
Director of Healthcare Improvement Initiatives in
which he focused on solving problems facing the clinical laboratory
profession. Today, he continues to focus his efforts on redefining the
role of clinical laboratorians to focus more directly on improved
patient outcomes. This work has led him to the field of diagnostic
errors. Paul currently serves as President of the Clinical Laboratory
Management Association (CLMA) and as Chairman of the AHRQfunded Diagnostic Error in Medicine (DEM) 2014 Conference.
Disclosure: Disclosed no relevant financial relationships.
Andrew Georgiou, PhD
Australian Institute of Health Innovation,
Macquarie University, Sydney, Australia
Andrew Georgiou, PhD, is an Associate
Professor at the Centre for Health Systems and
Safety Research, in the Australian Institute of
Health and Innovation of Macquarie University,
Sydney, Australia. His research interests in the
area of quality health care include: involvement
in the formulation, piloting and validation of
high level health outcome indicators for the monitoring of health
care in the areas of stroke, aged care, asthma and myocardial
infarction within the National Health Service (NHS), England. In the
area of public health research: high level data analysis in diabetes
and cardiovascular disease in Australian general practice and
myocardial infarction within the UK health system. In the area of
health informatics: evaluation of hospital wide electronic medical
ordering and results reporting systems with particular emphasis
on Australian pathology. In the area of aged care, the role that
IT can play in enhancing the coordination of quality care for
older people. He is a fellow of the Australian College of Health
Informatics (2005-present), a Fellow of the Australian College of
Health Service Executives (2002-present), a Member of the Public
Health Association of Australia (2002-present), a Member of the
British Medical Informatics Society (1999-present), a Member of
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the Australian Association of Academic General Practice (20022004), and a Member of the Australian Association of Gerontology
(2011-present)
Disclosure: Disclosed no relevant financial relationships.
Michael Hallworth, MA, MSc, MCB,
FRCPath
Royal Shrewsbury Hospital, Shrewsbury,
Shropshire, United Kingdom
Michael J. Hallworth, MA, MSc, MCB, FRCPath,
is a Consultant Biochemist (retired), Royal
Shrewsbury Hospital Consultant Biochemist
(retired), and Chair of the IFCC Task Force on
the Impact of Laboratory Medicine on Clinical
Management and Patient Outcomes. He is also
an active member of AACC (currently serving as Chair of the Lab
Solutions Summit virtual conference), the Association for Clinical
Biochemistry (ACB, the UK professional society), the Royal College of
Pathologists and the European Federation of Clinical Chemistry and
Laboratory Medicine. Mr. Hallworth was instrumental in launching the
UK version of Lab Tests Online, was given the UK Healthcare Scientist
of the Year Award in 2008, and has served as both Vice-Chair and
Chair of the AACC Annual Meeting Organizing Committee ( in 2007
and 2010, respectively).
Disclosure: Disclosed no relevant financial relationships.
Andrea Rita Horvath MD, PhD,
FRCPath, FRCPA
Prince of Wales Hospital, Sydney, Australia
Professor Horvath has been clinical director
at SEALS Department of Clinical Chemistry, at
the Prince of Wales Hospital in Sydney since
December 2009. She is Honorary Professor at the
University of Sydney and a Conjoint Professor in
the School of Medical Sciences of the University
of New South Wales. She spent altogether 8 years in Britain, first as
a scientist in London (1988-1990), later as a chemical pathologist
trainee in Sheffield (1993-1994), and subsequently as lecturer in
clinical biochemistry at Oxford University (1995-1998). She headed
the Department of Laboratory Medicine at the University of Szeged
in Hungary for 11 years (1998-2009) before moving to Australia.
She has been a member (1999-2002) and between 2003-2008 the
chair of the Committee on Evidence-based Laboratory Medicine of
the International Federation of Clinical Chemistry and Laboratory
Medicine. In 2005-2007 she acted as Secretary of the European
Communities Confederation of Clinical Chemistry and Laboratory
Medicine (EC4). She was the president of the Hungarian Society
of Laboratory Medicine between 2005-2008. She was president
of the European Federation of Clinical Chemistry and Laboratory
Medicine (2009-2011) and currently she serves as immediate past
president of EFCC.
Disclosure: Disclosed no relevant financial relationships.
Michael Kanter, MD
Southern California Permanente Medical
Group, Los Angeles, CA
Dr. Michael Kanter is Southern California
Permanente Medical Group’s (SCPMG) Medical
Director of Quality & Clinical Analysis. He is
SPEAKER BIOS AND DISCLOSURES
responsible for the coordination and support of medical care programs,
quality assessment and improvement, technology assessment, clinical
practice guideline development, population care management,
member health education, continuing and graduate medical
education, and clinical research activities for the Southern California
Region of Kaiser Permanente, which serves 3.5 million members. Dr.
Kanter received a B.S. Degree in 1976 in cybernetics from UCLA and his
M.D. from the University of California, San Francisco School of Medicine
in 1980. He’s board certified in Anatomic & Clinical Pathology. He has
authored multiple publications in peer reviewed journals and is a
frequent speaker on health care systems at the Institute for Healthcare
Improvement meetings.
Disclosure: Disclosed no relevant financial relationships.
Michael Laposata, MD, PhD
University of Texas Medical Branch, Galveston,
Texas
Dr. Michael Laposata is the Professor and Chair
of the Department of Pathology at the University
of Texas Medical Branch-Galveston and holder
of the 1955 School of Medicine Teaching
Profession Endowment.
He received his M.D. and Ph.D. from Johns
Hopkins University School of Medicine and
completed a postdoctoral research fellowship and residency in
Laboratory Medicine (Clinical Pathology) at Washington University
School of Medicine in St. Louis.
He took his first faculty position at the University of Pennsylvania
School of Medicine in Philadelphia in 1985, where he was an
Assistant Professor and Director of the hospital’s coagulation
laboratory. In 1989, he became Director of Clinical Laboratories at
the Massachusetts General Hospital and was appointed to faculty in
pathology at Harvard Medical School, where he became a tenured
full Professor of Pathology. Dr. Laposata joined Vanderbilt University
School of Medicine in 2008 where he was the Edward and Nancy
Fody Professor of Pathology and Medicine at Vanderbilt University
School of Medicine. Additionally, he was Pathologist-in-Chief at
Vanderbilt University Hospital and Director of Clinical Laboratories. His
research program, with more than 150 peer reviewed publications,
has focused on fatty acids and their metabolites. His research group
is focused on the study of fatty acid alterations in cystic fibrosis.
Dr. Laposata’s clinical expertise is in the field of blood coagulation,
with a special expertise in the diagnosis of hypercoagulable states.
Disclosure: Disclosed no relevant financial relationships.
Gary Procop, MD
Cleveland Clinic, Cleveland, OH
Gary W. Procop, MD, MS, is Chairman of the
Department of Clinical Pathology, Cleveland
Clinic, and Medical Director of the Molecular
Microbiology, Mycology
and
Parasitology
laboratories. He completed anatomic and clinical
pathology training at Duke University Medical
Center and a clinical microbiology fellowship at Mayo Clinic.
Dr. Procop is a Diplomate of the American Board of Pathology in
anatomic and clinical pathology, and in medical microbiology. He
is a Fellow of the American Academy of Microbiology, the College of
American Pathologists, the American Society for Clinical Pathology
the Royal Society for Tropical Medicine and Hygiene and the
Infectious Disease Society of America.
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Dr. Procop has given more than 350 scientific presentations and has
more than 120 published manuscripts,one book and 25 chapters
to his credit. His primary interests are the practical applications of
molecular diagnostic methods for the diagnosis and treatment of
infections, infectious disease pathology, mycology and parasitology.
Disclosure: Disclosed no relevant financial relationships.
Robert Schmidt, MD, PhD, MBA
University of Utah School of Medicine and ARUP
Laboratories, Salt Lake City, UT
Dr. Schmidt is an assistant professor of pathology
at the University of Utah School of Medicine.
He received his medical degree from the
University of Sydney in Sydney and completed
his residency training in clinical pathology at
the University Of Utah School of Medicine. He
received an MS in biochemical engineering at
the Massachusetts Institute of Technology, an MBA at the University
of Chicago, a PhD in operations management at the University of
Virginia, and an MMed in clinical epidemiology from the University
of Sydney.
Prior to completing medical school, Dr. Schmidt was an assistant
professor of operations management at the Carlson School of
Management at the University of Minnesota and an associate
professor of clinical operations management at the Marshall School
of Business at the University of Southern California. Dr. Schmidt’s
medical research focuses on diagnostic testing, specifically utilizing
his business background to complement medical knowledge in
performing evidence-based evaluation of diagnostic testing. His
research includes comparative effectiveness, cost-effectiveness,
and utilization analyses of diagnostic tests, as well as operations
and technology management related to diagnostic testing.
Disclosure: Disclosed no relevant financial relationships.
Mitchell Scott, PhD
University of Washington in St. Louis, MO
Dr. Scott is co-medical director of clinical
chemistry and decentralized testing at BarnesJewish Hospital and professor in the division
of laboratory medicine, in the department of
pathology and immunology at Washington
University in St. Louis.
He is co-director of the clinical chemistry
postdoctoral training program at Washington University, where he
has helped train more than 50 fellows and 100 residents. He has
served the AACC in many capacities, including on the Program
Coordinating Commission, Meetings Management Group, and
executive committee of the Clinical Chemistry Board of Editors,
as well as chair of the Membership Committee and the Division
Management Group.
Disclosure: Speaker has disclosed receiving research support
from Abbott Diagnostics, Instrumentation Laboratories, Siemen’s
Healthcare Diagnostics, and acting as a consultant for Becton
Dickinson and Instrumentation Laboratories.
SPEAKER BIOS AND DISCLOSURES
Hardeep Singh, MD, MPH
Houston VA Center for Innovation and Baylor
College of Medicine, Houston, TX
Hardeep Singh, M.D., M.P.H. is Chief of the
Health Policy, Quality & Informatics program
at the Houston VA Center of Innovation and
Associate Professor of Medicine at Baylor
College of Medicine. He is a practicing internist
and a nationally recognized leader in research,
policy and clinical practice initiatives related to
improving health care quality and patient safety. His research focuses
on understanding and reducing misdiagnosis in medicine, as well as
in using health information technology to deliver safe, effective and
high-quality patient care. For his groundbreaking multidisciplinary
research, Hardeep was awarded the prestigious Presidential Early
Career Award for Scientists and Engineers (PECASE), the highest
honor bestowed by the United States government on science and
engineering professionals in the early stages of their independent
research careers. He received the award from President Obama
in April 2014. Hardeep also received the AcademyHealth 2012
Alice S. Hersh New Investigator Award for high-impact research of
international significance.
Disclosure: Disclosed no relevant financial relationships.
Denise L. Uettwiller-Geiger
John T. Mather Memorial Hospital, Port Jefferson,
NY
Denise L. Uettwiller-Geiger is director of
clinical trials / clinical chemist, new business
development and technology acquisition at
John T. Mather Memorial Hospital, Port Jefferson,
New York. The laboratory at Mather Hospital processed more than
2.3 million lab tests in the past year. Geiger oversees new lab
technology and menu expansion, serves as principal investigator for
clinical trials conducted in the lab, and provides expert professional
education, guidance, and consultation to clinicians.
She received a Masters of Health Science from The State University
of New York at Stony Brook and a Doctorate in Biomedical Science
from Pacific Western University in Brentwood, California. In 2010, she
received the AACC Management Sciences Division Abstract Award
for Outstanding Project in Laboratory Management, the National
Academy of Clinical Biochemistry (NACB) Distinguished Abstracts
Award, and the Brookhaven Town Women’s Recognition Award for
Science. In 2011, she received the Best Lab Practice Award from
American Society Clinical Pathology. Geiger’s work in reducing
MRSA infection rates was selected as “most inspired” in the Siemens
2011 Inspired Healthcare Outcomes Challenge. She is the author of
more than 70 clinical journal articles and book chapters.
Disclosure: Speaker has disclosed receiving honoraria/expenses
from Cepheid, Sysmex, and Beckman Coulter. Speaker may discuss
the products and services of these companies only in the context
of describing achieved metrics with technology.
11
POSTER ABSTRACTS
Poster Abstract 1
A New Theory For Reference Intervals and Analyte Test
Reporting Based on Clinical Risks Derived from ReadilyAvailable EMR Data
A. B. Solinger, S. I. Rothman, G. Finlay. FAR Institute, Sarasota, FL
Background: Reference interval cut-points for general diagnostic
screening are usually determined by a methodology unrelated to
medical outcomes: the central 95% of test values for a “healthy”
cohort are defined as being the “Reference Interval” and the other
5% are flagged as “Low” or “High” to guide the physician toward
diagnosis. Problems with this method include difficulty of identifying
a healthy cohort, assembling the number of subjects required for
statistical power, and the leap of faith required to flag those outside
the central area (indefensible logically: the entire cohort is defined
as healthy a priori). These problems arise from an antiquated
methodology, established in an era long before access to electronic
medical records (EMR).
Methods: We extracted in-hospital tests (first test after admission)
for serum potassium, sodium, and chloride (K, Na, Cl), discharge
dispositions and demographics for 375,747 adult patient visits
from Sarasota Memorial Hospital (Florida) EMR during the years
1998-2014. Similar extracts were performed at a major academic
medical center in the northeast and a regional hospital in the
southwest for 2012-2014. For each analyte, we calculated an
Outcome Risk function:OR(x) = (ONOwithinΔx) / (ONOwithoutΔx)
where ONOwithinΔx = odds of Negative Outcome for test results
within Δx;ONOwithoutΔx = odds of Negative Outcome for those not
within Δx;x = mean value of test results within an interval Δx;Negative
Outcome = all-cause in-hospital mortality. The finalOR(x) for each
analyte was determined using JMP software to generate logistic
regressions, adjusted for confounding variables.
Results: We found risk of mortality to be below average within these
analyte intervals:K = 3.4 to 4.4 mEq/L; Na = 136 to 144 mEq/L; Cl =
100 to 109 mEq/L.Further, we provide evidence-based risk estimates
(mortality odds ratios) for values outside of these cut-points.
Identical cut-points were found with other Negative Outcomes,
e.g.,1-year post-discharge mortality; and when using data from
other medical centers. Our high K cut-point is much lower than the
current standards (which vary from 5.1 to 5.4), but is in excellent
agreement with recent clinical studies of AMI patients.
Conclusions: We have sought a replacement methodology for
reference intervals from perspective of modern clinical chemistry,
and propose a novel method to associate risk of patient outcomes
with analyte test values. Gathering tests and outcomes from whole
populations via hospitals’ EMR’s, we avoid problems of defininga
“healthy” population, relying instead upon the analysis of big
data to determine clinically-safe reference interval cut-points. This
allows reference interval cut-points to be generated by calculation
of outcome risk functions and enables readily-available EMR
data to be utilized in situ, associating actual patient outcomes
with analyte values by each lab. We suggest replacing the old
population-distribution method with this risk-function method for
more meaningful guidelines from the lab to physicians.
Poster Abstract 2
Improving the diagnostic yield among catheter and
non-catheter associated UTI’s
P. Erdman, M. Riley, K. Donaldson. Penn State Hershey Medical
Center, Hershey, PA
Background: Urinary tract infections (UTIs) are one of the most
common types of healthcare associated infections. Catheterassociated urinary tract infections (CAUTIs) account up to 75% of all
UTIs. Long term complications of CAUTI include longer hospital stays,
12
patient discomfort and increased mortality/morbidity secondary to
disseminated infections both locally and systemically.
Methods: Using a Sysmex UF-1000i™ urine particle analyzer, we
examined a case series of CAUTI and SUTI (symptomatic or noncatheter associated) patients to model the likelihood of a positive
screen prior to the diagnosis of a UTI by culture. In the initial study, a
retrospective analysis of reviewed urine samples was collected over
three months. Data was reviewed from traditional urine culture and
urinalysis using the Sysmex UF-1000i™. Logistic regression was used
to define what parameters where predictive of a positive culture:
1). Trace bacteria, 2). Trace yeast and 3). WBC greater than 15 k/µL.
Using data mining, we identified81 patients with either CAUTI (26) or
SUTI (55) based on traditional urine culture. We then compared the
likelihood that a patient in either group would have a positive screen.
Results: In the initial study, 4088 results were obtained. Screen
performance revealed: a sensitivity of 98% (CI 97.4-98.4%), a
specificity of 93.7% (CI 92.1-94.9%) and a positive predictive value
(PPV) of 97.0% (CI 96.4%-97.6%). An ROC curve was obtained (see
Figure 1). The positive LR is 15.5 (CI 12.57-19.12). Among the CAUTI
patients, 100% had a positive screen on the UF-1000i™ and 90.9% of
the SUTI patients had a positive screen.
Conclusions: The UF-1000i™ particle analyzer shows a high PPV
and a high LR. Using a retrospective case series analysis, we confirm
these values with a 93% positive screen among culture positive
patients. This will allow clinicians to feel confident in accurately
interpreting a screen result and treat patients before waiting 24-48
hours for culture results.
Poster Abstract 3
High “Normal” Potassium Poses Mortality Risk for All Patients
A. B. Solinger, S. I. Rothman, G. Finlay. FAR Institute, Sarasota, FL
Background: Recent studies show increased mortality in acute
myocardial infarction (AMI) patients with serum potassium levels of
4.5-5.0 mEq/L, which is within the reference interval used by most
laboratories. These findings have created an unresolved controversy
challenging established potassium repletion therapeutic targets.
We hypothesize this higher risk is applicable generally, not just to
AMI patients.
Methods: Retrospective cohort study of 375,747 hospital visits at
Sarasota Memorial Hospital for years 1998-2014; and for years 20122014 at a major academic medical center in the northeast and
a regional hospital in the southwest. Primary outcomes were inhospital and one-year mortality. Models of mortality were generated
and fit by logistic regression, yielding multivariate adjusted odds
ratios for potassium-linked mortality.
Results: Utilizing logistic regression with adjustment for possible
confounding factors, our analysis for all patients, independent of
diagnosis, yields lowest mortality at potassium values from 3.5 to 4.5
mEq/L, with significantly higher risks beyond 4.5 mEq/L. For both the
AMI cohort and the non-AMI cohort, in-hospital all-cause mortality
odds ratios were above 1.8 (p<0.001) for potassium between 4.5
and 5.0 mEq/L (within the usual reference interval); and were
above 3 (p<0.001) for potassium between 5.0 and 5.4 mEq/L
(often considered within the reference interval). Adjusting for serum
Creatinine levels > 2.0 mg/dL produced the same high “normal”
mortality risks. Our findings hold for one-year post-discharge
mortality, a s well as in-hospital mortality. While the risk functions differ
in detail between AMI and other patients, we find that both show
minimum risk within the same cut-points, with substantial increased
risk above 4.5 mEq/L.
Conclusions: Our analysis extends the AMI finding: all patients have
an increased mortality risk for serum potassium levels above 4.5
POSTER ABSTRACTS
mEq/L. The etiology of death associated with mild hyperkalemia
remains unclear. Presence of renal insufficiency appears not to
account for this increased mortality. Without prospective studies, our
findings cannot establish safety or danger of potassium repletion
therapeutic targets.
Finally, we point out that standard reference intervals are not based
on patient risk, but are defined as the central 95% of test results for
a “healthy” cohort. Reference interval cut-points would be more
meaningful with a risk-based methodology.
Poster Abstract 4
Presenter
Comprehensive biomarker testing supports reductions
in adverse clinical events with no increase in total cost
of care
Varvel SA1, Thompson SM2, Thiselton DL1, Pottala JV1, Sasinowski M1,
McConnell JP1. 1Health Diagnostic Laboratory, Inc., Richmond, VA,
and 2University of Richmond, Richmond, VA
Early detection of cardiovascular disease (CVD) and diabetes,
along with aggressive disease state management, has been shown
to reduce adverse clinical events. In recent years, many physicians
have implemented comprehensive biomarker testing protocols to
assess risk factors, enable earlier detection and intervention, inform
treatment decisions, and promote patient engagement. We sought
to determine the effect of comprehensive biomarker assessment on
disease state management and total cost of care.
Health insurance claims data was used to evaluate cost of care and
clinical outcomes for two cohorts of 7,396 individuals, propensity
score-matched on demographic and comorbid conditions. The
control cohort included subjects that had at least two traditional lipid
panels between June 1, 2010 and February 28, 2013. The test cohort
included subjects that had undergone at least two comprehensive
biomarker assessments during the same time period. Subjects
had 12-36 months of follow-up data from the date of their baseline
blood draw. All biomarker screenings were conducted by the same
national reference laboratory (Health Diagnostic Laboratory, Inc.,
Richmond, VA).
Incidence of myocardial infarctions was 41% lower in the test cohort
than in controls (49 vs. 83, p < 0.001), while occurrence of diabetic
complications was 15% lower (988 vs 1135; p < 0.001). There was no
difference in total cost of care per person per month (PPPM) between
the two cohorts ($950 vs $957; p = 0.86), although cost of laboratory
testing was higher in the test cohort ($159 vs $61; p < 0.001).
Ambulatory care and emergency services costs were significantly
lower in the test cohort (13% and 19%, respectively; p < 0.01). The use
of comprehensive biomarker testing for early detection of CVD and
diabetes may thus improve disease state management and reduce
adverse clinical events without increasing total cost of care.
Poster Abstract 5
Presenter
How an Acute-Care Hospital Reduced Unnecessary
Testing by 6.5%.
Reiff T.1 and Miraglia C.2 1St. Vincent Seton Specialty Hospital,
Indianapolis, IN, 2 hc1.com, Indianapolis, IN
Results: St. Vincent Seton Specialty Hospital, an acute, long-term
hospital located in the Midwest, reduced unnecessary testing by
6.5% in 2014 compared to 2013.
Background: Like many hospitals, St. Vincent Seton needed to get
a step ahead of the dramatic “volume to value” shift. With patients
often remaining in the hospital for greater than 30 days or potentially
even longer, repeat testing is a significant aspect of both patient
care and hospital costs.
The hospital needed a way to arm its physicians with the knowledge
necessary to order the right tests and panels at the right time
rather than repeating them out of habit. Yet with critical data
stored among several different systems, continually mining this
information in order to provide ongoing guidance to physicians was
extremely time consuming. In order to instantly identify trends and
opportunities for improvement at both the physician and patient
level, the hospital needed to gain a holistic profile of each patient
while easily accessing the wealth of intelligence trapped among
various systems.
Solution: Since activating the hc1® Healthcare Relationship Cloud™,
St. Vincent Seton can now view the hospital’s overall performance,
individual physician performance, and holistic patient profiles with
a click of the button.
Answers to critical questions, such as the below, are now instantly
available to the St. Vincent Seton team:
• Which panels are repeatedly being ordered despite several
normal test results within the panel?
• Which physicians are ordering the highest number of
unnecessary panels?
• How do they compare to their peers?
• How is their behavior changing based on feedback from the
clinicians?
• How are we performing from a cost containment standpoint?
• What are the tests, results, and costs associated with each
patient?
• Are our average costs per patient per day trending in the right
direction?
13
POSTER ABSTRACTS
For example, a physician may initially determine that a patient
should receive a complete metabolic panel (CMP) in order to
monitor kidney function.
However, specific tests within the panel may repeatedly show as
normal.
Rather than continuing to test with the CMP, Reiff’s team is able to
use this intelligence in order to provide real-time feedback to the
physician (i.e., they may suggest only utilizing a blood creatinine
and BUN test) and then monitor how the physician modifies his or
her approach after receiving this information.
With the ability to keep a real-time pulse on utilization and cost
metrics, St. Vincent Seton is able to ensure that patients receive the
highest level of care while positively impacting the efficiency of its
organization.
Poster Abstract 6
Association between laboratory test turnaround time and
emergency department length of stay: a retrospective US
electronic health database analysis
D. Mitra1, E. Erdal1, V. Khangulov2, R. Tuttle1. 1Becton, Dickinson and
Company, Franklin Lakes, NJ, 2Boston Strategic Partners, Inc.,
Boston, MA
Background: Rapid and accurate diagnosis is critical to providing
timely and appropriate care in the emergency department (ED).
Longer lengths of stay (LOS) in the ED correlate with higher inpatient
service admission rates and additional inpatient LOS [1-2] ‘Treat and
release’ patients (i.e. patients treated in the ED and subsequently
discharged rather than admitted to inpatient services) represent
a large proportion of ED visits in the US. In spite of the importance
of laboratory test results in guiding patient management, there is
currently a lack of studies examining the association between
laboratory test turnaround time (TAT) and ED LOS. The objective
of the present study was to examine the relationship between
laboratory test TAT and ED LOS via retrospective analysis of a ‘treat
and release’ ED population from a large US electronic health record
(EHR) database (Cerner Health Facts®).
Methods: ED visits from 2012 were included in the analysis if the
patient was ≥18 years old, ≥1 laboratory test was ordered during
the visit, ED LOS was <7 h, and the patient was discharged to
home or the care of their family/caregiver. Laboratory test TAT for
each patient was defined as the overall TAT (time between first
test order and last returned result) for all tests ordered within 30
min of the first test ordered. LOS was defined as the time elapsed
between ED admission and discharge. The relationship between
TAT and LOS was examined via linear regression modeling, with
and without adjustment for confounders, including patient and
hospital characteristics. For regression analyses, the strength of
the relationship between the TAT and LOS was assessed based on
the statistical significance of the slope coefficient(p-value of <0.05
denoted statistical significance).
Results: In total, 463,712 patient visits in the database met the
defined inclusion criteria. After adjustment for confounders,
regression modeling revealed a positive, statistically significant
relationship between laboratory test TAT and ED LOS, such that a 10
min decrease in laboratory test TAT was associated with a 6.7 min
reduction in ED LOS (p<0.0001). Examination of mean and median
ED LOS revealed a similar relationship, and a 30 min decrease in
laboratory test TAT from 61-75 min to 31-45 min resulted in a 19 min
decrease in median ED LOS (from 226 to 207 min).
Conclusion: The results of this analysis reveal a statistically significant
association between laboratory test TAT and ED LOS, and suggest
that laboratory test TAT is a key factor to consider during any efforts
14
to improve ED efficiency. These results highlight the importance of
developing and measuring shared TAT metrics between the ED and
laboratories to help reduce LOS, as well as the potential benefits of
processes aimed at improving laboratory efficiency. In order to more
fully understand the implications of lab TAT and LOS reductions in
different hospitals, future studies investigating the impact of lab TAT
on factors such as wait time and ED throughput are warranted.
1. Carrier E et al. JAMA Intern Med 2014; 174:1843-6
2. Liew D et al. Med J Aust 2003; 179:524-6
Poster Abstract 7
Presenter
Screen with Reflex to Better Test Utilization: A Cost Analysis
of Thyroglobulin Testing Strategies
J. L. Powers, F. G. Strathmann, J. A. Straseski. University of Utah, Salt
Lake City, UT
Background: Determination of thyroglobulin (Tg) concentration is
important for monitoring recurrence of thyroid cancer. In traditional
immunoassay detection of Tg, accurate quantitation may be
affected if Tg antibodies (TgAb) are present in the patient sample.
Quantitation of Tg by liquid chromatography – tandem mass
spectrometry (LC-MS/MS) accurately measures Tg in TgAb-positive
patients by eliminating this possible interference. Typically, Tg and
TgAb quantitation can be ordered separately or as part of a
reflex in which TgAb status is determined first. In reflex testing, if the
patient sample is negative for TgAb, then Tg is quantified using an
immunoassay; if positive, Tg is determined using LC-MS/MS. This may
have important implications for overall cost since immunoassay
testing is often less expensive than LC-MS/MS analysis.
Methods: To examine this we reviewed ordering patterns for almost
100,000 unique patients after reflex testing became available in our
laboratory. Cost analysis was performed using an average of list
prices from three different laboratories.
Results: For this data set, 90,312 orders for reflex testing occurred
compared to 11,279 separate orders for Tg by LC-MS/MS. From
the reflex testing subset, 11% of the samples were TgAb-positive
and therefore reflexed to LC-MS/MS for Tg quantitation. For TgAbnegative samples, the reflex to immunoassay for Tg quantitation
resulted in a total cost savings of over $9 million compared to the
cost if LC-MS/MS were utilized when not required for accurate
quantitation. There were also 49,018 standalone orders for TgAb, of
which approximately 5% also ordered Tg by LC-MS/MS. In this subset,
10% of samples were positive for TgAb, showing good agreement
with the percent TgAb-positives seen in the reflex testing subset. Of
this group, 64% represented separate orders on the same date. It is
possible these clinicians were unaware of the reflex testing option
offered by the laboratory. Since the overwhelming majority (90%)
of samples in this subset were TgAb-negative, had these samples
been ordered as part of a reflex test and sent to immunoassay
for Tg quantitation, a total savings of almost $300,000 could have
been realized. For patients known to be TgAb-positive, reflex testing
is unnecessary and Tg is best quantified using LC-MS/MS. In the
subset of separately ordered TgAb and Tg by LC-MS/MS with a
previously known TgAb result, 12% were TgAb-positive. Less than
half of these samples represented TgAb results obtained within the
past six months.
Conclusion: In summary, the majority of clinicians utilized the reflex
testing option for Tg which resulted in tremendous cost savings
since, according to our data, only approximately 10% of patients
were TgAb-positive. A smaller percentage of clinicians ordered
TgAb and Tg separately by LC-MS/MS when the antibody status
was either unknown (ordered the same day) or was previously
determined to be negative, resulting in unnecessary utilization of
POSTER ABSTRACTS
the more expensive LC-MS/MS testing. These data provide a current
example that identifying situations in which using more expensive
testing methods (e.g. LC-MS/MS) is most appropriate leads to more
economical use of valuable health care resources.
Poster Abstract 8
Mass-scale red cell genotyping of blood donors
enhances provision of antigen-matched blood
Grady SA. BloodCenter of Wisconsin, Milwaukee, WI.
Following red blood cell transfusion, patients can become
alloimmunized. That frequency is significantly higher for chronically
transfused patients, such as patients with Sickle Cell Disease
(SCD). Alloimmunization can be addressed by providing antigenmatched blood, thereby reducing exposure to immunogenic
antigens. Historically, time-consuming serological techniques to
create blood donor databases are often limited in the ability to
provide antigen-matched red cells due to the restricted size of
the database. BloodCenter of Wisconsin (BCW) performed highthroughput genotyping of donor blood, providing extensive blood
type information on a mass scale.
BCW used a nanofluidic microarray system to genotype over
43,000 blood donors for 42 blood group antigens, and continued
to phenotype 14 additional antigens. A computer algorithm
translated the genotype data into alleles with predicted blood
group phenotypes. Using this mass-scale genotyping approach to
screen units, the antigen information generated was roughly fivetimes greater than the phenotype information accumulated over 30
years. Now at any time point, BCW has antigen information on 30%
of donor red cell units in inventory1.
Following the genotype database implementation, BCW fulfilled
99.8% (n=5,672 patients) of all antigen negative requests during
a 3 year period within the service area1. This service offers direct
economic benefit to hospitals, which can avoid extensive out-ofregion charges that can accompany specialty product orders.
Furthermore, Milwaukee is home to a significant SCD clinic that has
focused on improved SCD patient outcomes through outpatient
care and management, rather than relying on expensive acute
health care resources2. An aspect of this program is performing
red cell pheresis in management of pain crisis. Local historic policy
for episodic transfusion of an SCD patient is to provide Rh/Kell
antigen-matched blood. To drop the Rh/Kell matched blood policy
for these chronically transfused patients potentially increases the
risk of alloimmunization, impacting patient transfusion care. BCW’s
genotype database was able to maintain Rh/Kell antigen-matching
even when SCD patients were managed with high-volume red cell
exchange transfusions. This practice mitigated alloimmunization
while improving quality of life for these patients.
The database also supports a secure, web-based Antigen Query
portal. The portal provided genotype information for blood in
hospital inventories. The Transfusion Service had the ability to rapidly
locate antigen-negative units in their inventory for 14 of the most
common antigens, and confirmed and crossmatched only those
units identified from the portal. Antigen Query eliminated timeconsuming, costly phenotyping processes avoiding the delay
associated with shipping units from the blood center.
A mass-scale genotyping for blood donors and generation of a
corresponding electronic database has the potential to transform
the provision of antigen-negative units, while effectively avoiding
the risk of alloimmunization to red blood cell antigens for chronic
transfusion. Extending a network of red cell genotyped blood to
other blood centers could enable broad scale rapid access to
compatible blood, improving transfusion safety1.
15
References
1.Flegel, WA, Gottschall, JL, Denomme, GA. Integration of red cell
genotyping into the blood supply chain: a population-based
study. The Lancet Haematology. June 2015; Vol. 2, No. 7.
2.Koch, KL, Karafin, MS, Simpson, P, Field, J. Intensive management
of high-utilizing adults with sickle cell disease lowers admissions.
American Journal of Hematology. March 2015; Vol. 90, No.3.
Poster Abstract 9
“False-Positive” Calprotectin Results May Be Indicative of
Crohn’s Disease in the Small Bowel
Freedman DB; Asser LA; Housley D; Edwards B; Johnson M.
Calprotectin is increasingly used in the diagnostic assessment of
patients with symptoms suggestive of inflammatory bowel disease.
The key use of the test relates to its very high negative predictive
value, allowing accurate differentiation of functional (irritable bowel)
from organic disease (inflammatory bowel) (IBD) and avoidance
of unnecessary endoscopic procedures. Patients with increased
calprotectin typically proceed to endoscopy for full evaluation and
to ascertain the aetiology of disease. If colonoscopy is normal,
then a patient’s calprotectin result would typically be classified as
a false positive, with rates of up to 9% being quoted in the literature.
Since much of the GI tract is not assessed by colonoscopy, we have
reviewed such patients using small bowel capsule endoscopy
(SBCE) to evaluate the small bowel and to reassess the false
positive rate. 21 patients with at least two raised faecal calprotectin
results (BÜHLMANN fCAL™ ELISA) and normal colonoscopy and
gastroscopy had further evaluation of the small bowel using SBCE.
Results:
Small bowel findings Number
%
SB enteropathy
(including Crohns)
12
57.14
Angiodysplasia
2
9.52
Malignancy
1
4.76
Normal
6
28.6
TOTAL
21
100
The data suggests that 71.4% of patients frequently diagnosed as
a false positive faecal calprotectin may have identifiable pathology
in the small bowel. Specifically in relation to patients in whom IBD
is considered to have been excluded, 57.14% may have crohns
disease confined to the small bowel.
Conclusion: The false positive rate of faecal calprotectin for the
diagnosis of IBD is significantly lower than previously thought.
Undiagnosed and untreated IBD will progress to complex disease
involving stricturing, obstruction, perforation, fistula formation,
malnutrition and cancer. This natural history of IBD means that
undiagnosed patients are more likely to require surgical intervention
and intestinal resection. Due to the difficulties of accessing and
diagnosing small bowel disease, laboratory testing of faecal
calprotectin will play a pivotal role in detecting such pathology.
Monitoring is usually through use of abdominal imaging which may
also be replaced by laboratory testing. This will increase the likelihood
of patients achieving remission post-medical management rather
than requiring surgical management of complex and advanced
disease.
POSTER ABSTRACTS
Poster Abstract 10
Using Point-of-Care Glucose Meters in the Critically Ill:
Assessing Meter Performance in the Clinical Context
D. B. Schmolze, G. L. Horowitz, N. V. Tolan. Beth Israel Deaconess
Medical Center, Boston, MA
Background: Point of care (POC) glucose meters are widely used
in hospitals to aid in monitoring blood glucose levels. Recent
publication of FDA draft guidelines, setting stringent accuracy
requirements for manufacturers of POC glucose meters to be used
in hospitals, has again raised concerns of off-label use, particularly
in “critically ill” patients.
Methods: In order to evaluate the accuracy of results obtained from
meters in our institution by our end-users, we matched six months
of POC glucose results using the Precision Xceeed Pro Blood
Glucose POC system (Abbott Diabetes Care Ltd., Alameda, CA)
with central laboratory glucose data that was obtained by either
the Roche Cobas Modular P Gluco-quant Glucose/Hexokinase
(Roche Diagnostics, Indianapolis, IN) or the RAPIDLab 1265 Blood
Gas (Siemens AG, Munich, Germany). In an effort to reduce the
likelihood of changes in blood glucose concentrations due to
clinical interventions occurring between POC and lab glucose
samples, we minimized the difference between the collection times
and restricted our analysis to samples collected no more than 10
minutes apart. We evaluated the correlation between the POC
and lab glucose pairs using Thiel-Sen linear regression analysis
and interpreted the differences in a clinical context using the
Clarke Error Grid (CEG). We also evaluated the performance in the
critically ill, based on location (non-ICU vs. ICU) and other relevant
laboratory results (sodium, bicarbonate, lactate, hematocrit, pO2)
collected within 24 hours of the POC/lab glucose pair. Finally, as
a quality assessment of each individual glucose meter in use at
our institution, we also prepared CEGs by serial number for those
meters with at least ten POC/lab glucose pairs.
Results: Our final dataset comprised 860 records, obtained
from 41 unique hospital locations, 97 unique glucose meters,
and 452 unique patients. From an analytical perspective, the
agreement within the POC/lab glucose pairs was far from ideal,
where the correlation of the POC glucose results to the laboratory
concentrations was described by the equation: y=0.93x+15.27, and
r2=0.65. However, when analyzed with the CEG, the overwhelming
majority (802/860, 93.3%) of these discrepancies were found to be
clinically insignificant. No relationship was found between severity
of illness and degree of discrepancy, by non-ICU or ICU location
(p>0.5) nor abnormalities in the additional laboratory results
obtained (p>0.1). Finally, no significant biases were observed for
any particular meter and all displayed a predominance of POC/
lab glucose pairs that fell within Clarke zones A and B.
Conclusions: Evaluating POC glucose meter performance in a
clinical context, rather than in a strictly analytical manner, offers a
more robust determination of the accuracy necessary to effectively
manage hospitalized patients, especially in the absence of “tight
glycemic control” protocols. Our data suggests that the meters used
in our institution are performing well, allowing for the advantages
of real-time blood glucose monitoring and outweighing the limited
instances of potential clinical errors. Another interesting aspect of
this performance evaluation is that it provides a mechanism for
ongoing quality assurance and would identify specificmeters that
may not be performing optimally.
Poster Abstract 11
Cost-effectiveness Analysis in Prognosis of ST-Segment
Elevation Myocardial Infarction: Choice of Optimal
Laboratory Marker
S. Stankovic1, D. Trifunovic1, N. Bogavac-Stanojevic2, D. Lakic2, M.
Asanin1. 1Clinical Center of Serbia, Belgrade, Serbia, 2Faculty of
Pharmacy, Belgrade, Serbia
Background: The aim of this study was to explore discriminative
abilities of several biomarkers of inflamation and hemodynamic
stress as predictors for major adverse cardiovascular events (MACE)
in patients with ST-segment elevation myocardial infarction (STEMI)
treated by primary percutaneous coronary intervention (pPCI). Also,
to assess their cost-effectiveness compared with the RISK-PCI score
for the prediction of MACE during a 30-day follow-up after pPCI.
Methods: Using a decision model, we evaluated the costs, accuracy,
and cost-effectiveness of each model. The RISK-PCI score was
used as the baseline model. Other models were formed with the
consecutive addition of selected markers: myeloperoxidase (MPO),
high sensitive C-reactive protein, adiponectin, B-type natriuretic
peptide (BNP), N-terminal-proBNP to the baseline model. A bestcase model was formed from a combination of biomarkers to yield
the best patient stratification algorithm. All models were assessed by
their predictive probabilities using receiver operating characteristic
curves. To accomplish our goals, we recruited 150 STEMI patients
treated by pPCI. Composite 30-day major adverse cardiovascular
events (MACE) was defined as cardiac death, non-fatal reinfarction,
and target vessel revascularization.The analysis was performed from
a third-party payer perspective.
Results: Only two strategies had outstanding discriminative abilities:
the best-case model (RISK-PCI score+BNP+MPO) and RISK-PCI
score plus BNP with area under the curve (AUC) values of 0.869
and 0.851, respectively. The cost-effectiveness ratio varied between
5199 € per AUC for the baseline model to RSD 9011€ per AUC for
RISK-PCI score+NT-proBNP. After elimination of dominant strategies,
the incremental cost-effectiveness ratio (ICER) for the remaining
three strategies (baseline, RISK-PCI score plus BNP, and the best-case
model) were calculated. For the RISK-PCI score plus BNP, the ICER
(compared with the baseline model) was 18106 € per additional
accuracy calculated for 100 analyses. The ICER for the best-case
model (compared with the baseline model) was 84961€ per
additional accuracy calculated for 100 analyses. Strategy involving
hemodynamic stress biomarker BNP was more cost-effective than
strategies involving inflammatory markers. Sensitivity analysis
indicated that results were robust.
Conclusion: Our results support the feasibility of a multimarker
approach for MACE prediction in STEMI patients treated by pPCI.The
introduction of BNP in the clinical laboratory would be convenient
and cost-effective.
Poster Abstract 12
Establishment of Analyte- and Concentration-Specific
Hemolysis Index Thresholds for Aspartate Aminotransferase
(AST) and Direct Bilirubin (DBIL) Reduces Specimen
Rejection and Recollection Rates
J. N. Koop, D. R. Block, C. D. Birkestrand, L. J. Donato, B. S. Karon, R.
M. Jackson, C. D. Koch, D. T. Meier, A. M. Wockenfus, N. A. Baumann.
Mayo Clinic, Rochester, MN
Background: Interference due to hemolysis is a common reason
for specimen rejection in clinical laboratories. Assay manufacturers
provide instrument- and test-specific hemolysis index (HI) limits for
16
POSTER ABSTRACTS
interference in their instructions for use, however laboratories may
also perform interference studies to verify or establish hemolysis
tolerance limits. Automated hemolysis detection using serum indices
and rule-based algorithms based on analyte concentration and HI
may increase laboratory efficiency and reduce specimen rejection
rates.
Objectives:The aims of the study were to (i) determine concentrationspecific HI thresholds for aspartate aminotransferase (AST) and
direct bilirubin (DBIL) on the Cobas® 6000/8000 chemistry platforms
(Roche Diagnostics) and (ii) compare rule-based concentrationdependent algorithms to manufacturer recommended HI limits and
measure the impact on specimen rejection and recollection rates.
Methods: Residual specimens from physician-ordered AST or
DBIL (serum) and hematology (EDTA whole blood) testing were
used to prepare serum and hemolysate pools, respectively. Twelve
serum pools with AST concentrations between 27-770 U/L and 19
serum pools with DBIL concentrations between 0.1-9.7 mg/dL were
created. Hemolysate was prepared from washed red cells and
lysed by freeze-thaw (-70°C). Varying hemoglobin concentrations
were obtained by diluting hemolysate with water. Hemolysate (10%
by volume) was then added to serum pools with known analyte
concentrations to obtain HI ranging from 6 to 526. AST, DBIL and HI
were measured using the Cobas 6000/8000 c501/c701 chemistry
analyzers. The absolute and percent bias due to increasing HI
was calculated. Recovery within ±5 U/L or ±10% of initial AST value
and recovery within ±0.1 mg/dL (initial DBIL ≤0.3mg/dL) and ±0.2
mg/dL or 20% (initial DBIL >0.3 mg/dL) for DBIL were considered
acceptable. Specimen rejection and recollection rates were
calculated by applying manufacturer HI limits and the established
17
concentration-specific HI limits to results from physician-ordered AST
and DBIL tests performed in the Central Clinical Laboratory at Mayo
Clinic, Rochester, MN (January-February 2015).
Results: Concentration-specific HI thresholds were established for
AST <100 U/L, 100-200 U/L, 200-300 U/L and >300 U/L at HIs of 50,
100, 200 and 500, respectively. There were 10,605 orders for AST and
862 (8.1%) specimens would have been rejected and recollected
based on manufacturer’s recommendations (HI >20 for all AST
concentrations). By applying concentration-specifichemolysis limits
for AST, 154 (1.5%) specimens were rejected due to hemolysis, thus
eliminating recollection of 708 specimens (82% reduction). For DBIL,
HI tolerance limits of 70 and 50 were established for 0.0-0.3 mg/dL
and >0.3 mg/dL, respectively. Out of 7062 orders for DBIL, 494 (7.0%)
specimens would have been rejected based on manufacturer’s
recommendations (HI >30 for all DBIL concentrations). By applying
the concentration-specific hemolysis thresholds for DBIL, 188
(2.7%) specimens were rejected due to hemolysis, thus eliminating
recollection of 306 specimens (62% reduction). Conclusions:
Analyte- and concentration-specific hemolysis index thresholds
were established for AST and DBIL. Automated hemolysis detection
using HI and rule-based algorithms based on analyte concentration
significantly reduces specimen rejection and recollection rates due
to hemolysis. Additional downstream benefits include improved
turnaround time and cost savings associated with not having to
recollect patient specimens.
CONTINUING EDUCATION RECORDING FORM
CONTINUING EDUCATION CREDIT INSTRUCTIONS
Instructions for Obtaining ACCENT® Continuing Education Credit for Lab Solutions Summit - Value-based Clinical Lab Models: An AACC
Virtual Conference – September 16-17, 2015
ACCENT® credit hours
AACC designates this live webinar activity for a maximum of 11.5 ACCENT® credit hours towards the AACC Clinical Chemist’s Recognition
Award. AACC is an approved provider of continuing education (CE) for clinical laboratory scientists licensed in states that require
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ACCENT® credit is also recognized by several organizations: AAB, ABCC, ACS, AMT, ASCLS, ASCP, ASM, CAP, IFCC, and NRCC.
This form is for obtaining ACCENT® credit for the presentations (credit is not available to the poster presentations or exhibits).
AMA PRA Category 1 Credit™ is not available for this event.
1.
2.
Record the Presentations You View and CE Codes on this Form
„„ As you view each presentation, complete the information requested on this form below, including the CE code, which will be displayed
at the end of each presentation.
„„ Each presentation is accredited for 0.75 ACCENT® Credit, with exception of first and final presentations, accredited for 0.5 ACCENT®
Credit.
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Obtain Your Continuing Education Credits
„„After you have finished viewing all of the presentations, go to: http://direct.aacc.org/cevm/accent.aspx
„„Read through the steps and click on “Next Screen” at the bottom of the screen to proceed to the next screen.
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(CE Credit not available for the poster presentations or exhibits.)
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