Hotel Industry Workshops Schedule (as of July 21, 2014) Tuesday, July 29, 7:00 am

Got Sigma? Are you really getting the Right Results, First Time, Every Time? Presented by: Abbott Laboratories Location: Hyatt Regency Chicago, Grand Ballroom E, F Speakers: Sten Westgard, Director Client Services, Westgard QC, Inc. Sharon Cox, Core Lab Supervisor, Saint Francis Health System Patrick Vanschoyck, MD, Physician, Harvard Family Physicians Session Overview: Workshop describes how Sigma concepts and metrics provide guidance for method validation performance, designing/selecting statistical quality control (QC) procedures, prioritizing applications of risk analysis, and formulating total QC strategies and plans. In the clinical laboratory, Sigma metrics are used to predict assay quality during the selection process and to measure actual observed quality during routine use. Optimal QC rules can be selected on the basis of Sigma metrics, improving patient safety, reducing assay time and costs, and increasing proficiency testing success. Physicians assume quality is inherent in lab results; sigma metrics provide confidence in the results. Transforming your laboratory and building a competitive advantage through process innovation Presented by: Beckman Coulter, Inc. Location: Hyatt Regency Chicago, Regency Ballroom B Speakers: Thomas Arena, Chief Strategy Officer, hc1.com Catherine Salomone-Ochsner, Danaher Business Systems Leader, Session Overview: In business, adverse market and regulatory conditions prove to be the same demise of some organizations while at the same time provide a spring board for others to succeed beyond expectations. Successful ventures build sustainable competitive advantage. With ever growing pressures to cut costs while improving quality and outcomes, laboratories face the most challenging environment in recent memory. This round table session will highlight how focused process improvement and performance metrics stand as the foundation for building lasting and sustainable competitive advantage in laboratory operations.

Tuesday, July 29, 7:00 am (continued) LEAN and Efficient Urine Processes: One Laboratory's Efforts to Enhance Productivity with Lean/Six Sigma and Automation Presented by: BD Location: Hyatt Regency Chicago, Grand Ballroom B Speakers: Theresa Ohrmund, Laboratory Director, Lakeland Regional Medical Center Session Overview: Urinalysis is one of the most commonly performed tests, and is both timeconsuming and labor-intensive. Lakeland Regional Medical Center's goals were to reduce variability in urinalysis turnaround times, maximize staff productivity and improve customer satisfaction. This workshop discusses the initiation and achievement of these goals by employing Lean Six Sigma methodology to identify opportunities for improvement and eliminate waste and non-value added activities in the workflow process. Additionally, following full automation of the laboratory, the turnaround time for macroscopic urinalysis decreased by 68.7% and qualitative urine. hCG by 33.3%. These efforts enhanced overall urinalysis processes, staff satisfaction, arid patient care.

Workshop Title: Celebrating 20 years of achievement in cardiac disease diagnostics – The HyTest Cardiac Award nominees and a brief history of cardiac research. Presented by: HyTest Ltd. Location: Hyatt Regency Chicago, Grand Ballroom A Speaker: Fred Apple PhD, Medical Director Clinical Laboratories Hennepin County Medical Center Professor Laboratory Medicine & Pathology University of Minnesota School of Medicine Session Overview: During the last two decades, many talented scientists and practitioners have contributed to significant advancements in cardiac disease diagnostics and management. HyTest has supported these achievements through active research and collaboration with the scientific community and by providing state of the art reagents for the IVD industry. The HyTest Cardiac Award celebrates extraordinary achievements in cardiac disease research. The award nominees will be announced during this session. Dr. Fred Apple will review their most significant achievements, and show how cardiac research has led to advancements in cardiac disease management that have affected the lives of hundreds of thousands of families.

Tuesday, July 29, 7:00 am (continued) Hemoglobin A1c – Seeking Accuracy and Efficiency in Clinical Practice Presented by: Roche Diagnostics Location: Fairmont Chicago, Crystal Room Speaker: Thomas E. Burgess, Ph.D. DABCC, FACB, Technical Director, Quest Diagnostics Session Overview: With the increasing demand of Hemoglobin A1c testing in the clinical laboratory, it is important to have a result that delivers confidence and efficiency. This workshop will focus on the reliability and utilization of A1c testing methods used today in the clinical laboratory setting. Discussion will be centered around the clinical and operational advantages, as well as the ease of implementation of the Roche Tina-Quant HbA1c assay. Discover Point of Care Testing Presented by: Samsung Electronics Location: Hyatt Regency Chicago, Regency Ballroom A Speakers: Kent Lewandrowski, Associate Chief-Lab & Molecular Medicine, Massachusetts General Hospital Kenneth E. Blick, Professor of Pathology,Director of Clinical Chemistry & Immunoassay/Endocrine Laboratories, Oklahoma Health and Science Center Session Overview: Explore the benefits and limitations of point-of-care-testing and how we can maximize the efficiency of POCT. Discuss how near-patient testing has improved the healthcare services within and outside the hospital.

Tuesday, July 29, 7:00 am (continued)

Population-management Informatics: Managing Chronic Disease Risk and CMS Quality Metrics Presented by: Siemens Location: Fairmont, Gold Room Speakers: Greg Killian, Sr. Director – Population Health & Care Management, Siemens Medical Solutions USA Greg R. Schneider, MBA, Director Policy & Reimbursement, Siemens Medical Solutions USA Session Overview: Healthcare providers are relying on information technology solutions to successfully achieve the CMS quality metrics of cost reduction and improved quality and population health. Population health management informatics is proving to be integral in assessing chronic disease risk across the beneficiary population and identifying the diagnostic tests needed for clinical-care gap management. We will review healthcare reform and the CMS quality metrics and the utility of population health management within the changing healthcare environment. We will discuss how disease risk assessment and diagnostic testing are key in a preventive-care strategy aligned with the CMS quality metric goals. Register Now! (Please note all hotel industry workshops are open to registered attendees of AACC Annual Meeting & Clinical Lab Expo).

Thermo Fisher Scientific: Update on Autoimmunity Diagnostics Presented by: Thermo Fisher Scientific Location: Hyatt Regency Chicago, Regency Ballroom D Speakers: Henry Homburger, MD, Phadia Immunology Reference Laboratory, Medical Director, Thermo Fisher Scientific Prof. Ger Pruijn, Basic Science Researcher, Radboud University Nijmegen Session Overview: Thermo Fisher Scientific presents novel and improved diagnostic options in the differentiation of connective tissue disease, as well as a comparative view of a rising assay. First, a brief presentation on enhanced ANA serology and its impact on specificity and utility will be given. Next, an historical and comparative look at a key test for rheumatoid arthritis will provide the audience with adequate context and information in choosing the most appropriate assay for their patient population. Finally, using rheumatoid arthritis as a model, a preview of how multiplexed diagnostics can help in identifying subtypes of disease to improve therapy and outcomes, is discussed.

Tuesday, July 29, 6:00 pm Children are not small adults: The need for Pediatric Reference intervals. Presented by: Abbott Laboratories Location: Hyatt Regency Chicago, Grand Ballroom EF Speaker: Khosrow Adeli, PhD, FCACB, DABCC, FACB , Head, Division of Clinical Biochemistry, Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Hospital for Sick Children James H. Nichols, Ph.D., DABCC, FACB, Professor of Pathology, Microbiology and Immunology, Medical Director, Clinical Chemistry, Vanderbilt University School of Medicine John C. Baker, MT (ASCP), Manager, Core Laboratory Science & Technology, Tacoma, WA Session Overview: This workshop describes the unmet need for pediatric reference intervals and the solution – the CALIPER study (Canadian Laboratory Initiative for Pediatric Reference Intervals), a large country-wide study. Reference intervals for 40 clinical chemistry analytes and 23 immunoassays have been determines using samples from 120 males and 120 females in each of six age groups from birth to 18 years of age. Expected Outcomes: 1. Understand the elements of a large reference interval study conducted according to CLSI C28. 2. Utilize current pediatric intervals derived from a large Canadian national study. 3. Apply CALIPER interval to local populations in laboratories around the world. Presentation 1: “Basics of How to Set Up Mass Spectrometry in the Clinical Laboratory” Presentation 2: “Tips to Justify the Purchase of Mass Spectrometry Instrumentation: How to Speak the Language that Makes Cents (Sense) to Hospital Administrators” Presented by: AB SCIEX Location: Hyatt Regency Chicago, Grand Ballroom CD South Speakers: Geza S. Bodor, MD, Professor of Pathology, University of Colorado, Denver Dr. Paul Jannetto, Mayo Foundation Session Overview: The adoption of mass spectrometry in the hospital laboratory is rapidly growing as lab directors realize the power of this technology to improve the accuracy of test results for low-level analytes and to bring esoteric tests in-house that are currently being sent out. The goal of this workshop is to educate lab directors interested in mass spectrometry and show what’s involved with setting up the technology, and how to justify its adoption to hospital administration. Register Now! (Please note all hotel industry workshops are open to registered attendees of AACC Annual Meeting & Clinical Lab Expo).

Tuesday, July 29, 6:00 pm (continued) Hemoglobin A1c: Quality and Automation Presented by: Bio-Rad Laboratories, Inc. Location: Hyatt Regency Chicago, Grand Ballroom CD North Speakers: Michael Smith MBL, MLS (ASCP), Supervisor, Laboratory, Unity Point Health – Des Moines Methodist | Lutheran | Methodist West | Blank Children’s | John Stoddard Cancer Center Dr. Jeanne Rhea, Emory University (Emory Clinical Translational Research Lab) Tony Prestigiacomo, Division R&D Manager, Bio-Rad Laboratories, Inc. Session Overview: Laboratories are looking for both quality and automation in hemoglobin A1c testing. Implementing high quality products with the right level of automation saves laboratories money. Quality provides better patient outcomes and reduces laboratory follow-up on poor results, while automation improves customer service and reduces labor. This workshop will focus on the value that automated, high quality results bring to laboratories.

Development of multiple immunoassay solutions in response to the rapidly changing market for New Psychoactive Substances (NPS), and their application in routine laboratory workflow. Presented by: Randox Laboratories US LTD.\ Location: Hyatt Regency Chicago, Grand Ballroom B Speaker: Lynne Stewart, Randox Toxicology Ltd Session Overview: New Psychoactive Substances (NPS) have become the largest single challenge facing the toxicologist and toxicology laboratory. A vast array of compounds that are constantly evolving, changing and sidestepping legislation, have proved increasingly difficult for toxicologist to add to routine analysis. This workshop, will overview the new multi-target immunoassay approach that allows for accurate detection of a huge number of the NPS compounds, and the application of Biochip Array Technology ensuring ease of workflow for the laboratory.

Tuesday, July 29, 6:00 pm (continued) NT-proBNP: Analytical and Clinical Considerations for Improving Patient Care Presented by: Roche Diagnostics Corporation Location: Fairmont Chicago, Crystal Room

Speakers:

Robert L. Fitzgerald, PhD, DABCC, Professor of Pathology, University of California-San Diego Lori B. Daniels, MD, MAS, FACC, Director, Coronary Care Unit, Associate Professor of Medicine, Division of Cardiology, Associate Professor of Family and Preventive Medicine, Division of Epidemiology, University of California Session Overview: The presentation will discuss analytical metrics to use when choosing an assay for your hospital and how NT-proBNP can supplement your judgment in the management of HF patients. Androgen Excess Syndromes and Chemotherapy-induced Cardiotoxicity: Important Issues Impacting Women’s Health Presented by: Siemens Location: Fairmont, Gold Room Speakers: Alison L. Woodworth, Ph.D., DABCC, FACB, Director, Esoteric Chemistry, Assistant Professor of Pathology, Vanderbilt University Medical Center Dr. Susana Dent , Medical Oncologist at The Ottawa Hospital Session Overview: Cancer and infertility are major health concerns among women. This workshop will explore androgen excess disorders, which are a common cause of infertility, as well as cardiotoxicity (CTX), which is one of the most severe complications of cancer treatment. During • • • •

this workshop, featured speakers will: - Define androgen excess (AE) syndromes - Discuss the role of the clinical laboratory in diagnosis and monitoring of AE syndromes - Define chemotherapy-induced cardiotoxicity - Discuss the effect of cardiotoxic drugs on myocardium

Register Now! (Please note all hotel industry workshops are open to registered attendees of AACC Annual Meeting & Clinical Lab Expo).

Tuesday, July 29, 6:00 pm (continued) Get MORE from your Clinical Research Mass Spec Applications – New HPLC and Mass Spectrometers for Your Lab Presented by: Thermo Fisher Scientific Location: Hyatt Regency Chicago, Regency Ballroom A Speaker: Marta Kozak, Clinical Application Manager, Thermo Fisher Scientific Session Overview: Attendees will learn about recent developments in liquid chromatography and mass spectrometry (LC-MS) instrumentation that focus on the most demanding aspects of clinical research by delivering the highest productivity day in and day out. Wednesday, July 30, 7:00 a.m. Early Intervention: Biomarkers Improve Quality of Life Presented by: Abbott Laboratories Location: Hyatt Regency Chicago, Grand Ballroom EF Speakers: Garry John, Professor, Norfolk and Norwich University Hospital Frederick Korley, MD, PhD., Assistant Professor, Johns Hopkins University School of Medicine Carlos Iribarren, MD, MPH, PhD., Senior Research Scientist, Northern California Kaiser Permanente Division of Research Session Overview: Chronic conditions such as diabetes and cardiovascular disease are major health care burdens. Diabetes significantly increases the risk for cardiovascular disease. Therefore, early detection and monitoring of diabetes results in decreased morbidity and mortality. Current guidelines recommend using HbA1c for the early diagnosis and monitoring of diabetes mellitus to curb the growing epidemic. In addition, the use of high sensitivity troponin-I for early rule-in/rule-out of myocardial infarction is recommended by recent ESC guidelines. Heart failure is often an outcome of MI and the combination of high sensitivity troponin-I and galectin-3 are prognostic for chronic heart failure and acute coronary syndrome. Expected Outcomes: 1. Understand the clinical utility of HbA1c for diagnosis and monitoring of diabetes. 2. Describe the advantage of high sensitivity troponin-I in acute setting.. 3. Comprehend the current evidence to support the prognostic use of galectin-3 and high sensitivity troponin-I in heart failure.

Wednesday, July 30, 7:00 a.m. (continued) Simplified Sample Preparation in the Simultaneous Measurement of Zinc, Bismuth, and Manganese in Whole Blood using ICP-MS Presented by: Agilent Technologies/ARUP Laboratories Location: Fairmont Chicago, Moulin Rouge Room Speaker: Micheal P. Scott, Clinical Market Development Manager, Agilent Technologies Carrie Haglock-Adler, R&D Specialist, ARUP Laboratories Session Overview: To achieve the required sensitivity from whole blood samples with Inductively Coupled Plasma-Mass Spectrometry (ICP-MS), historic extraction methods often required a time-consuming chemical and/or microwave digestion. This presentation will describe a method using a simplified dilution for the simultaneous analysis of Zn, Sb, Bi, and Mn in whole blood. Method improvements, including the use of Agilent 7700X, Niagara Plus discrete sampling unit, and goat blood in calibrators to achieve a matrix matched method, will be discussed. Method validation protocol and results will also be discussed, such as inter and intra-assay imprecision,