value-based clinical lab modelsaacc.6connex.com/event/local-files/348/824/1442344134908_91_.pdf ·...

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.

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TABLE OF CONTENTS

ACKNOWLEDGEMENTSProgram Chair and Program Committee............................................3Exhibitors...............................................................................................3

PROGRAM SCHEDULEDay 1, Wednesday, September 16........................................................4Day 2, Thursday, September 17.............................................................6

SPEAKER BIOS AND DISCLOSURESRamy Arnout, Michael Astion, Patrick Bossuyt, Robert Christenson, Anuj Dalal .............................................................................................8Paul Epner, Andrew Georgiou, Michael Hallworth, Andrea Rita Hovarth .................................................................................................9Michael Kanter, Michael Laposata, Gary Procop, Robert Schmdt...................................................................................................................10Mitchell 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

EXHIBITORS

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.

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.

Our single focus is to help hospitals, laboratories and blood centers worldwide deliver results that help patients experience a better

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.

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.

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.

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.

www.orthoclinical.com

http://www.visiun.com/

http://clsi.org/

Alex Chin, PhD, DABCCCalgary Laboratory Services/University of Calgary (Calgary, AB, Canada)

Paul Epner, M.Ed, MBASociety to Improve Diagnosis in Medicine (Chicago, IL)

Andrea Rita Horvath MD, PhD, EurClinChem, FRCPath, FRCPAPrince of Wales Hospital (Sydney, Australia)

David Koch, PhD, DABCC, FACBGrady Memorial Hospital and Emory University (Atlanta, GA)

Program Committee Members

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PROGRAM GUIDE - Wednesday, September 16

9:00 AM

9:30 AM

10:15 AM

10:45 AM

11:30AM

12: 15 PM

1:00 PM

1:45 PM

2:30 PM

INTRODUCTIONPatient-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

KEYNOTE ADDRESSThe 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

Content Expert Sessions, Virtual Exhibits, Poster Session and Chats

SESSION 1 (Session supported by Instrumentation Laboratory)

Surveying the Landscape of Inappropriate Laboratory TestingRamy Arnaout, MD, PhD, Beth Israel Deaconess Medical Center, Boston, MA

� 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 WorkGary Procop, MD, Cleveland Clinic, Cleveland, OH

� Review commonly used tools for controlling inappropriate test utilization, both IT-based and management-based

� 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

PLUGS: A Local Utilization Management Initiative with National ImpactMichael 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


SESSION 2 (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

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

3:30 PM

4:00 PM

5:00 PM

1:05 PM


Hear About Real World Projects and Be Inspired—Oral Abstract PresentationsHow 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 ErrorsReducing 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

END OF DAY ONE

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PROGRAM GUIDE - Thursday, September 17

9:00 AM

9:45 AM

10:30 AM

10:45 AM

11: 30 AM

12:15 PM

1:00 PM

1:45 PM

SESSION 3 - Performing Evidence-based Test Evaluation (Session supported by Instrumentation Laboratory)

Testing a Test – A Framework for Biomarker EvaluationAndrea 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

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


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 KnowledgeUsing 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


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

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

2:45 PM

3:30 PM

3:45 PM

4:30 PM

5:00 PM

Hear About Real World Projects and Be Inspired—Oral Abstract PresentationsComprehensive 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

Virtual Exhibits, Poster Session and Chats

Hear About Real World Projects and Be Inspired—Oral Abstract PresentationsScreen with Reflex to Better Test Utilization: A Cost Analysis of Thyroglobulin Testing Strategies

Jennifer L. Powers, PhD, University of Utah, Salt Lake City, UT

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

Closing Summary and Call to ArmsMichael 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

END OF CONFERENCE

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SPEAKER BIOS AND DISCLOSURES

Ramy Arnaout, MD, PhDArnaout 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, PhDAcademic 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

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.


Robert Christenson, PhDUniversity 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 CAP-accredited 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 peer-reviewed 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.


Anuj K. Dalal, MDBrigham 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

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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


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 AHRQ-funded Diagnostic Error in Medicine (DEM) 2014 Conference.


Andrew Georgiou, PhDAustralian 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

the Australian Association of Academic General Practice (2002-2004), and a Member of the Australian Association of Gerontology (2011-present)


Michael Hallworth, MA, MSc, MCB, FRCPathRoyal 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).


Andrea Rita Horvath MD, PhD, FRCPath, FRCPAPrince 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.


Michael Kanter, MDSouthern 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


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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.


Michael Laposata, MD, PhDUniversity 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.


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.

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.


Robert Schmidt, MD, PhD, MBAUniversity 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.


Mitchell Scott, PhDUniversity of Washington in St. Louis, MO

Dr. Scott is co-medical director of clinical chemistry and decentralized testing at Barnes-Jewish 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.


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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.


Denise L. Uettwiller-GeigerJohn 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.

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POSTER ABSTRACTS

Poster Abstract 1 A New Theory For Reference Intervals and Analyte Test Reporting Based on Clinical Risks Derived from Readily-Available EMR DataA. 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’sP. 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. Catheter-associated urinary tract infections (CAUTIs) account up to 75% of all UTIs. Long term complications of CAUTI include longer hospital stays,

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 non-catheter 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 PatientsA. 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 2012-2014 at a major academic medical center in the northeast and a regional hospital in the southwest. Primary outcomes were in-hospital 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

13

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.


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?

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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 analysisD. 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

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


Screen with Reflex to Better Test Utilization: A Cost Analysis of Thyroglobulin Testing StrategiesJ. 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 TgAb-negative 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

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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 bloodGrady 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 antigen-matched 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 high-throughput 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 five-times 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-of-region 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 time-consuming, 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.

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.

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Poster Abstract 10

Using Point-of-Care Glucose Meters in the Critically Ill: Assessing Meter Performance in the Clinical ContextD. 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 MarkerS. 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 best-case 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 RatesJ. 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

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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 concentration-specific HI thresholds for aspartate aminotransferase (AST) and direct bilirubin (DBIL) on the Cobas® 6000/8000 chemistry platforms (Roche Diagnostics) and (ii) compare rule-based concentration-dependent 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

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.

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CONTINUING EDUCATION RECORDING FORM

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 documentation of CE, including California, Florida, Louisiana, Montana, Nevada, North Dakota, Rhode Island, Tennessee, and West Virginia. 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. 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.

� Continuing education credits must be obtained within 90 days of the event (by December 16, 2015).

2. 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. � Enter each CE code you recorded on this form. The final screen will be your certificate, which you may print out and/or save to your computer.

Questions? If you have questions about continuing education credit, contact the AACC Professional Education department at [email protected].

CONTINUING EDUCATION CREDIT INSTRUCTIONS

Presentation Title(CE Credit not available for the poster presentations or exhibits.)

CE Code (displayed at the end of each presentation) – be sure to write down this code.

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