Join Us for Our
Next Meeting on June 14
at Kings Contrivance Community Association
Amherst House, Huntington Room
7251 Eden Brook Drive, Columbia, MD 21046
Network with your peers and join us for this Meeting
Agenda | RSVP | Vendor Sponsorships | Directions
9:30am
Breakfast/Registration
10:00am
Opening Remarks
10:15am
Clinical Mass Spectrometry for Beginners
Dr. William Clarke, PhD, MBA, DABCC | Bio
This entry level talk will discuss the utility of mass spectrometry in the clinical laboratory; describe the process of LC-MS for clinical analyses; and list the advantages and disadvantages of clinical LC-MS.
1.0 CEU | P.A.C.E. Form
11:15am
Vendor Break
11:45am
100% Connectivity in Point of Care Testing
is Achievable
Chris Nooney, MBA/MHA,MT(AMT) | Bio
Point of Care Testing programs/departments are continually looking for way to add productivity and efficiency while not only maintaining or reducing cost. The use of a middleware solution can eliminate time spent creating, documenting, and reviewing paper logs and enhance compliance information gathering during regulatory inspections.
1.0 CEU | P.A.C.E. Form
12:45pm
Lunch/Vendor Break
1:30pm
FDA Presentation on the 510(k) process for
waived and non-waived POCT
Tamara Pinkney, MT(ASCP) | Bio
Scientific Reviewer, Hematology Branch
Division of Immunology and Hematology Devices
Jacqueline Cleary MT(ASCP) | Bio
Scientific Reviewer, Immunology Branch
Division of Immunology and Hematology Devices
Center for Devices and Radiological Health
Office of In Vitro Diagnostics and Radiological Health
U.S. Food and Drug Administration
This presentation will focus on FDA clearance processes for POC tests, including requirements for clinical and analytical validation. Participants will be provided examples of waived and non-waived POC tests. The presentation will also highlight the review process used for the clearance of the first CLIA waived hematology analyzer.
1.0 CEU | P.A.C.E Form
2:45pm
Vendor Break
3:30pm
Regulatory Roundtable | Peer review and audience participation
'Are You Stumped by Regulations or Inspections?' ...
If so bring your checklist questions for group discussions and solutions for your next inspection. We will take questions from Joint Commission, COLA, and CAP checklists. All are welcome to fill out the green Regulatory Roundtable Submission forms (found at the KEYPOCC table near the entrance).
4:15pm
Closing Remarks
4:30pm
Adjourn
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Vendor Showcase and/or Table or Speaker Sponsorship
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Directions
Kings Contrivance Community Association
Amherst House, Huntington Room
7251 Eden Brook Drive, Columbia, MD 21046
Speaker Bios William Clarke, PhD, MBA, DABCC
Associate Professor of Pathology
Johns Hopkins University School of Medicine
Dr. Clarke received his Ph.D. in Analytical Chemistry from the University of Nebraska in Lincoln in 2000, followed by a post-doctoral fellowship in Clinical Chemistry at the Johns Hopkins School of Medicine, ending in 2002. In addition, he received an MBA focused on medical services management from the Carey School of Business at Johns Hopkins in 2007. Following his post-doctoral fellowship, he remained at Johns Hopkins, where he is an Associate Professor in the Department of Pathology, as well as the director of both Point-of-Care Testing and Clinical Toxicology for the hospital. Dr. Clarke is board certified in Clinical Chemistry by the American Board of Clinical Chemistry, and is a Fellow of the American Association for Clinical Chemistry. His research interests include clinical mass spectrometry, method development and evaluation for therapeutic drug monitoring, clinical toxicology, point-of-care testing, and development/validation of biomarkers for use in drug management. Dr. Clarke has published as author or co-author over 100 peer-reviewed manuscripts or book chapters, is the Editor of textbook Contemporary Practice in Clinical Chemistry, and is the Editor-in-Chief of the journal Practical Laboratory Medicine.
Christiane “Chris” Nooney, MBA/MHA, MT(AMT)
DUH POC Supervisor, Duke Hospital, DukeHealth
Chris Nooney received her AAS in Medical Laboratory Technology from the Mississippi Gulf Coast Community College, Jackson County Campus, she received her BS in Health Occupations Teacher Education from North Carolina State University, and her MBA/MHA from Pfeiffer University. Chris has a long career working in varies areas of the clinical laboratory from phlebotomist to Supervisor. Currently she is the Point of Care Testing Supervisor for Duke Hospital, DukeHealth. She is also an active member of the North Carolina POC Network and is a Member-at-Large for the AACC Critical and Point of Care Testing Division.
Tamara Pinkney, MT(ASCP), Scientific Reviewer, Hematology Branch
Division of Immunology and Hematology Devices
Center for Devices and Radiological Health Office of In Vitro Diagnostics and Radiological Health
U.S. Food and Drug Administration
Tamara Pinkney is a Scientific Reviewer in the Hematology Branch of the Division of Immunology and Hematology Devices in FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR) where she reviews a variety of medical devices and assays for hematological, coagulation, and evaluation of other body fluids. Ms. Pinkney joined the FDA in 2015 with 10 years of clinical laboratory experience, including expertise in hematology and urinalysis testing. She served as a lead technologist in the Hematology laboratory at Walter Reed National Military Medical Center. Prior to her time at Walter Reed, Ms. Pinkney worked as a generalist in the Core laboratory at Palmetto Health Baptist. Ms. Pinkney is an ASCP certified Medical Technologist and holds a BS in Biology from the University of SC, Columbia and a Certificate of Completion from Palmetto Health Baptist School of Medical Technology.
Jacqueline Cleary MT(ASCP), Scientific Reviewer, Immunology Branch Division of Immunology and Hematology Devices
Center for Devices and Radiological Health Office of In Vitro Diagnostics and Radiological Health
U.S. Food and Drug Administration
Jacqueline Cleary is a Scientific Reviewer in the Immunology and Flow Cytometry Branch of the Division of Immunology and Hematology Devices in FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR) where she reviews a variety of medical devices and assays for immunology and flow cytometry. Mrs. Cleary joined the FDA in 2014 with 28 years of clinical laboratory experience, including expertise in flow cytometry testing. She served as a technologist in the Flow Cytometry laboratory at Department of Laboratory Medicine at the Clinical Center at National Institutes of Health. Prior to her time at NIH, Mrs. Cleary worked as a histocompatibility technologist for cross-matching for transplant at the Washington Hospital Center. Mrs. Cleary is an A-6 ASCP certified Medical Technologist and holds a BS in Medical Technology from the University of Maryland, Baltimore.
Return to PointofCare.net Home Page • Last updated: 05/18/2018 • Questions: editor@pointofcare.net
