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AACC University

The conference before the conference

Sunday, July 31

Don’t have time to attend the full AACC Annual Scientific Meeting conference? AACC University features 12 sessions that you can attend on Sunday, July 31 without paying the full meeting registration fee. And as a bonus, if you take an AACC University course, you are also invited to attend the Sunday Plenary Session and the AACC Community Opening Mixer.

Limited seating is available and registration fees apply to each session. View pricing and register for AACC University today.

Morning Sessions

Afternoon Sessions

Morning Sessions

10:30 a.m. – 12 p.m.

Bleeding and Clotting: An Introduction to Coagulation 191001
This course will provide a basic review of the physiology of hemostasis, including platelet function, the coagulation cascade, and thrombolysis. Common routine laboratory tests, such as PT, aPTT, Activated Clotting Time, and D-dimer will be described, and strategies for diagnosis of common bleeding and thrombotic disorders will be outlined.

Moderated by William Winter, MD, FCAP, FACB, DABCC, Univ. of Florida, Gainesville.

Speakers: The Biology of Coagulation, William Winter, MD, FCAP, FACB, DABCC; Assessment of the Coagulation Cascade in the Core Laboratory, James Faix, MD, Montefiore Medical Center, Bronx, NY.

Hot Topics in Laboratory Regulations191002
Developed in cooperation with the AACC Government Relations Committee, CLSI

A number of recent regulatory changes have impacted clinical laboratory operations, including IQCPs, laboratory-developed tests, and the use of glucose meters on critically ill patients. In this session, the government and laboratory perspectives will be presented and the audience encouraged to pose questions for open debate.

Moderated by James Nichols, PhD, DABCC, FACB, Vanderbilt University Medical Center, Nashville, TN.

Speakers: A Laboratory Perspective on Current Regulatory Topics, James Nichols, PhD, DABCC, FACB; A Government Perspective on Current Regulatory Topics, Karen Dyer, BA, MT(ASCP), DLM, Centers for Medicare and Medicaid Services, Baltimore, MD.

Getting the Most Out of Verification Studies for FDA Approved Methods191003
This session will discuss how to achieve the most from required verification studies of commercial methods. The primary studies will be reviewed focusing on the relevant CLSI protocols and the application of clinically based quality goals. Finally, common challenges will be discussed focusing on ways to avoid them and practical solutions.

Moderated by Nils Person, PhD, FACB, Siemens Healthcare Diagnostics, Madison, NJ.

Speakers: Method Verification: Getting Good Data, Avoiding Pitfalls, Nils Person, PhD, FACB; Selection of Performance Goals, Sten Westgard, MS, Westgard QC, Inc., Madison, WI.

The Impact of Preanalytical Variables on Critical Care Point of Care Testing191004
The primary purpose of point-of-care testing (POCT) is to generate results quickly for immediate intervention, vital in critical care. As in central laboratories, preanalytical variability poses a challenge. This session presents common variables, impact on critical care testing (blood gases, co-oximetry, potassium, ionized calcium), and methods for reducing the potential for errors due to preanalytical issues.

Moderated by Ana Stankovic, MD, PhD, BD Diagnostics, Franklin Lakes, NJ.

Speakers: Overview of Preanalytical Variables in Point of Care Testing, Ana Stankovic, MD, PhD; Improving Point of Care Testing for Critical Care, John Toffaletti, PhD, DABCC, Duke University Health System, Durham, NC.

Laboratory Director Boot Camp—What, When, Why, and How to Validate New Tests and Meet Regulatory Requirements191005
Developed in cooperation with the College of American Pathologists

Laboratory Director Boot Camp will provide attendees with the knowledge and skills to deploy new clinical laboratory tests in clinical chemistry, coagulation, and molecular diagnostics in their laboratories. The faculty will provide a general overview of the CLIA and CAP regulatory requirements for the implementation of new tests, including conducting test validation, defining the analytical measurement range (as appropriate for quantitative assays), establishing reference ranges, and meeting the requirements for ongoing monitoring of test performance including participation in proficiency testing. Faculty will offer examples from the areas of clinical chemistry, molecular diagnostics, and coagulation, and relate the general principles to specific tests in these areas.

Moderated by Keri Donaldson, MD, Penn State Milton S. Hershey Medical Center, Hershey, PA.

Speakers: Wieslaw Furmaga, MD, University of Texas Health Science Center, San Antonio; Keri Donaldson, MD.

Laboratory Management Overview: The Challenging Landscape and the Keys Like IQCP, Harmonization and Lean Six Sigma Strategies191006
This session discusses the global challenges in the laboratory and provides solutions by Individualized Quality Control Plan (IQCP), IFCC's global harmonization of patient’s results, and Lean–Six Sigma. The session will examine recent developments in two regulatory areas in the U.S.: IQCP and the FDA’s oversight of laboratory-developed tests.

Moderated by Barnali Das, MD, DNB, PGDM, Member, IFCC C-STFT.

Speakers: Recent Changes in the U.S. Laboratory Regulatory Arena: IQCP and LDTs, Anthony Killeen, MD, PhD, University of Minnesota, Minneapolis; How to Cut the Extra Flab From Your Lab Platter: Lean-Six Sigma Paves the Way, Barnali Das, MD, DNB, PGDM, Kokilaben Dhirubhai Ambani Hospital, Mumbai, Maharashtra, India; Towards Global Harmonization of Patient's Results in Laboratory Medicine: IFCC's Perspective, Graham Beastall, PhD, BSc, EurClinChem, FRCPath,FRCP, CBE, Laboratory Medicine Consulting, Glasgow, United Kingdom.

Afternoon Sessions

1:30 – 4 p.m.

Best Practices in Continuous Laboratory Compliance192007
Developed in cooperation with the College of American Pathologists

What is your proficiency testing (PT) telling you? In this course, faculty will describe ways to avoid critical PT failures (cease testing), optimal methods for performing Alternative Assessment of Performance (AAP) when commercial PT is not available, and strategies to get the most out of internal self-inspections.

Moderated by Brad Karon, MD, PhD, FCAP, FACB, Mayo Clinic, Rochester, MN.

Speakers: Preventing Critical Proficiency Testing Failures, Brad Karon, MD, PhD, FCAP, FACB; Best Practices in Alternative Assessment of Performance, Christina Wojewoda, MD, FCAP, University of Vermont Medical Center, Burlington; Improving the Quality and Value of the Laboratory Self-Inspection, Selwyn Baptist, MD, FCAP, St. Barnabas Medical Center, Livingston, NJ.

Documenting Analytical Performance of Lab Developed Tests192008
This session will cover validating and documenting the analytical performance of laboratory developed tests and other highly complex methods. It will focus on the use of relevant CLSI guidelines as well as the development of clinically-based quality requirements. The course will also provide specific recommendations for avoiding common issues in study design and data analysis.

Moderated by Nils Person, PhD, FACB, Siemens Healthcare Diagnostics, Madison, NJ.

Speakers: Validation Studies for LDTs: What Is Needed and How to Avoid Common Challenges, Nils Person, PhD, FACB; Developing Quality Goals for Lab Developed Tests, Sten Westgard, MS, Westgard QC, Inc., Madison, WI.

Troubleshooting Clinical Laboratory Errors: Collaborative Case Studies192009
Developed in cooperation with the AACC Management Sciences and Patient Safety Division

Preanalytical and analytical errors may affect specimen quality and test results. Why do these errors happen? This collaborative workshop presents actual case studies to identify the causes of common errors to begin to develop strategies to eliminate or minimize them.

Moderated by Sol Green, PhD, FACB, BD Preanalytical Systems, Franklin Lakes, NJ.

Speakers: Troubleshooting the Sources of Preanalytical Variability, Sol Green, PhD, FACB; Troubleshooting and Reducing Analytical Errors, Jack Zakowski, PhD, Beckman Coulter, Inc., Brea, CA; Laboratory Interferences: Clinical Cases, Geoffrey Baird, MD, PhD, University of Washington, Seattle.
Expanding Point-of-Care Testing in Healthcare Systems for Patient Centered Care192010
Developed in cooperation with the AACC Critical and Point-of-Care Testing Division

Point-of-care (POC) testing is evolving. Key considerations for new POC test requests and essential managerial tools for high-quality assurance and regulatory compliance will be discussed in an interactive format using an audience response-system and group discussions of practical POC testing scenarios.

Moderated by Nichole Korpi-Steiner, PhD, DABCC, FACB, University of North Carolina, Chapel Hill.

Speakers: One POCT Request, 2 Requests, 3 Requests, 4, Nichole Korpi-Steiner, PhD, DABCC, FACB; Five POCT Sites, 6 Sites, 7 Sites, More! Peggy Mann, MS, BS, MT(ASCP), University of Texas Medical Branch, Galveston; Eight POCT Errors, 9 Errors, 10 Errors, Whoa! Jeanne Mumford, MT(ASCP), The Johns Hopkins Hospital, Baltimore, MD.

Troubleshooting for Clinical LC-MS/MS Laboratories192011
This session will present the theory and practical advice for identifying and preventing the root causes of common problems with clinical LC-MS/MS assays and instruments.  Approximately 80% of the course will occur with attendees in small discussion groups for problem solving and troubleshooting of LC-MS/MS cases drawn from the practice of the faculty members. Cases that might present a risk to patient safety will be included.

Moderated by Judith Stone, PhD, ABCC, MT(ASCP), UCSD Toxicology Laboratory, San Diego, CA.

Speakers: Troubleshooting Cases From 20 to 2,000 Samples/Day, Judith Stone, PhD, ABCC, MT(ASCP); Troubleshooting Cases From A Large Reference Laboratory, Frederick Strathmann, PhD, DABCC, Univ. of Utah and ARUP Laboratories, Inc., Salt Lake City; Troubleshooting Cases From An Academic Medical Center, Autumn Breaud, MSc, MT(ASCP), The Johns Hopkins Hospital, Baltimore, MD.

The ABC's of Installing an Automation Line192012
This session will provide laboratory directors and managers an outline of the steps required to update or install chemistry automation, based on the speakers’ own experiences. The session will discuss selection of an automation line, development of an implementation schedule, and approaches to successful project completion while avoiding or overcoming common hurdles.

Moderated by Danyel Tacker, PhD, FACB, DABCC, West Virginia University, Morgantown.

Speakers: How to Select/Evaluate Chemistry Automation Solutions - Avoiding "Eeny Meeny Miney Mo,” Danyel Tacker, PhD, FACB, DABCC; How to Realistically Plan Out the Project – Creating the Bones, Joshua Hayden, PhD, DABCC, Weill Cornell Medical College, New York; How to Put (and Keep) the Plan in Place – Keeping it on the Rails, Sarah Hackenmueller, PhD, DABCC, University of Wisconsin, Madison.