The FDA Odyssey for LDTs: “If you serve too many masters, you’ll soon suffer.”- Homer

Dr. Annette S. Kim, MD, PhD

Director, Division of Diagnostic Genetics and Genomics, Henry Clay Bryant Professor of Pathology- University of Michigan, Michigan Medicine, Ann Arbor, MI

DESCRIPTION:

This session with briefly present the historical background for the FDA claims to authority to regulate LDTs, discuss the FDA Ruling on IVDs, and enumerate issues with the ruling and current litigation strategies.

OBJECTIVES:

• Describe the history of the FDA claims to authority to regulate laboratory developed procedures
• Enumerate the steps to the 4 year phase-out of enforcement discretion and the exclusions to the FDA ruling
• Analyze the impact of the FDA ruling

LEVEL OF INSTRUCTION:

INTERMEDIATE= Refresher course; some basic knowledge required

CE CONTACT HOURS:  1 hour

Novel influenza viruses isn’t just for the birds: Detection of high pathogen avian Influenza in humans

Diana K. Riner Ph.D., M.Sc., PHLD(ABB)

Virology/Immunology Section Manager, Bureau of Laboratories, Michigan Department of Health and Human Services, Lansing, MI

DESCRIPTION:

This session will cover an overview on commonly circulating influenza viruses, describe the emergence of various novel influenza viruses including low and highly pathogenic avian influenza viruses and how they are detected within a clinical laboratory setting and safety considerations for performing this testing.

OBJECTIVES:

• Summarize influenza viruses and how novel influenza viruses emerge
• Describe what clinical testing methods are available for influenza testing and the role of public health laboratories play in performing novel influenza testing and influenza surveillance
• Evaluate biosafety in regards to novel influenza viruses

LEVEL OF INSTRUCTION:

INTERMEDIATE= Refresher course; some basic knowledge required

CE CONTACT HOURS:  1 hour

Cyberattacks: Is Your Laboratory Prepared?

DESCRIPTION:

Cyberattacks on healthcare organizations are a growing threat and can have serious consequences for patients and healthcare providers. To limit the impact on patient care, laboratories need to define processes and procedures to be followed in the event of an extended downtime.

OBJECTIVES:

• Recognize the impact of a cyberattack on the healthcare system and patient care
• Define processes and procedures for an extended downtime
• Develop mitigation strategies to minimize effects on patient safety and quality assurance

LEVEL OF INSTRUCTION:

INTERMEDIATE= Refresher course; some basic knowledge required

CE CONTACT HOURS:  1 hour

Cases in Antimicrobial Susceptibility Testing

Ziad Daoud, PhD, FACSc., SM(ASCP)cm, FRCPath

Director of Microbiology-MyMichigan Health System, Midland, MI

DESCRIPTION:

I will present challenging real-life antimicrobial susceptibility testing (AST) cases, highlighting complex, tricky, and occasionally misleading results from daily clinical practice. This presentation aims to analyze and discuss these cases, providing insights and solutions to enhance understanding and decision-making in clinical settings.

OBJECTIVES:

• Identify and recognize important mechanisms of resistance (ESBL, AmpC, CRE, carbapenemase, etc)
• Ascertain the logical link between the susceptibility to different antibiotics
• Evaluate some resistance profiles in GNB

LEVEL OF INSTRUCTION:

INTERMEDIATE= Refresher course; some basic knowledge required

CE CONTACT HOURS:  1 hour

Bio-What!? Crime, Terrorism, Weapons, and War

Jason Wholehan, MLS(ASCP)CM
Bioterrorism Training Coordinator, Michigan Department of Health and Human Services, Lansing, MI

DESCRIPTION:

An entertaining look into the history of biological threats this session will discuss historical cases related to the use of biological agents in terrorism and warfare. We will trace these events to the current landscape related to biological threats and their regulations.

OBJECTIVES:

• Describe and define different Bio-threats
• Discuss how events from the past have shaped our understanding of warfare and terrorism
• Interpret the current regulatory landscape for biological agents

LEVEL OF INSTRUCTION:

INTERMEDIATE= Refresher course; some basic knowledge required

CE CONTACT HOURS:  1 hour