CLCR Calls 2020 Archive
- Jasmine Chaitram, CDC Division of Laboratory Systems (DLS)
Clinical Laboratory Surge Testing Survey
- Corey Meyer, Gryphon Scientific
Electronic Laboratory Reporting for COVID-19: Summary Findings from the CSTE COVID-19 ELR Capabilities and Needs Assessment
- Brooke Beaulieu, Council of State and Territorial Epidemiologists (CSTE)
Updates from the Infectious Diseases Pathology Branch
- Jana Ritter and Hannah Bullock, CDC Division of High-Consequence Pathogens and Pathology (DHCPP)
Q&A Panel
- Ren Salerno, CDC Division of Laboratory Systems (DLS)
- Jason Hall, CDC Division of Preparedness and Emerging Infections (DPEI)
- Tim Stenzel, U.S. Food and Drug Administration (FDA)
- Amy Zale, Centers for Medicare & Medicaid Services (CMS)
Welcome
- Jasmine Chaitram, CDC Division of Laboratory Systems (DLS)
Expanded Screening Testing
- Peggy Honein, State, Tribal, Local, and Territorial Support, CDC COVID-19 Emergency Response
BinaxNOW™ COVID-19 Rapid Antigen Test Utilization Rapid Query
- Marcus Plescia, Association of State and Territorial Health Officials (ASTHO)
COVID-19 Diagnostic Data Project
- John Wiley, Data Robot
- Kristen Honey, CDC Office of the Assistant Secretary of Health (OASH)
- Nick Ipiotis, CDC Office of the Chief Information Officer (OCIO)
Managing Laboratory Supply Shortage Issues
- RADM Michael Iademarco, Joint Coordination Cell (JCC) Testing and Diagnostics Workgroup
CMS Update – Enforcement Discretion Guidance
- Amy Zale, Centers for Medicare & Medicaid Services (CMS)
Welcome
- Jasmine Chaitram, CDC Division of Laboratory Systems (DLS)
CMS Reimbursement Update
- Sarah Harding and Sarah Shirey-Losso, Centers for Medicare & Medicaid Services (CMS)
Individualized Quality Control Plan (IQCP) Q&A
- Amy Zale, Centers for Medicare and Medicaid Services (CMS)
COVID-19 Antigen Tests – Lessons Learned
- Reynolds (Ren) Salerno, CDC Division of Laboratory Systems (DLS)
FDA Update
- Tim Stenzel, U.S. Food and Drug Administration (FDA)
Welcome
- Jasmine Chaitram, CDC Division of Laboratory Systems (DLS)
ASM’s Clinical Microbiology Supply Shortage Collection (CMSSC) Tool: Identifying Lab Supply Shortages in Real Time
- Melissa Miller, American Society for Microbiology (ASM)
Evaluating the Sofia SARS Antigen FIA for Asymptomatic and Symptomatic SARS-CoV-2 Testing on Two University Campuses – Wisconsin, Sep 29 – Oct 9, 2020
- Ian Pray, Wisconsin Department of Health Services
FDA Update
- Tim Stenzel, U.S. Food and Drug Administration (FDA)
Welcome
- Jasmine Chaitram, CDC Division of Laboratory Systems (DLS)
CMS Reimbursement Update
- Sarah Harding, Centers for Medicare & Medicaid Services (CMS)
College of American Pathologists (CAP) Microbiology Committee Perspective: Caution Must Be Used in Interpreting the Cycle Threshold (Ct) Value
- Daniel Rhoads, Cleveland Clinic
FDA Update
- Sara Brenner and Toby Lowe, U.S. Food and Drug Administration (FDA)
Welcome
- Jasmine Chaitram, CDC Division of Laboratory Systems (DLS)
National Healthcare Safety Network (NHSN) Point-of-Care Test Reporting Tool for COVID-19 in Long-Term Care Facilities
- Kathy Bridson, CDC Division of Healthcare Quality Promotion (DHQP)
2020-2021 Influenza Testing Issues
- Tim Uyeki, CDC Influenza Division (ID)
Effects of Increased SARS-CoV-2 Testing on Laboratory Services: An Emerging Infections Network (EIN) Survey
- Dan Diekema, University of Iowa
FDA Update
- Tim Stenzel, U.S. Food and Drug Administration (FDA)
How Does CDC Use COVID-19 Laboratory Testing Data?
- Jason Hall, CDC Division of Preparedness and Emerging Infections (DPEI) and Ed Lockhart, CDC Division of Laboratory Systems (DLS)
Welcome
- Jasmine Chaitram, CDC Division of Laboratory Systems (DLS)
CLSI Resources for COVID-19 Testing
- James Nichols, Clinical Laboratory Standards Institute (CLSI)
CMS Update – Testing and Reporting Questions
- Regina Van Brakle and Amy Zale, Centers for Medicare & Medicaid Services (CMS)
Updates and Priorities for the Laboratory Task Force, CDC COVID-19 Emergency Response
- Leslie Dauphin, Laboratory Task Force, CDC COVID-19 Emergency Response
FDA Update
- Tim Stenzel, U.S. Food and Drug Administration (FDA)
Welcome
- Jasmine Chaitram, CDC Division of Laboratory Systems (DLS)
CMS Update on Interim Final Rule – Laboratory Reporting
- Regina Van Brakle and Amy Zale, Centers for Medicare & Medicaid Services (CMS)
Technical Guidance for Implementation of Laboratory Data Reporting
- Mike Waters, Testing and Diagnostics Task Force, U.S. Department of Health and Human Services (HHS)
Laboratory Data Reporting for COVID-19 – A Clinical Laboratory Experience
- Jordan Olson, Geisinger Health System, Department of Laboratory Medicine
FDA Update
- Tim Stenzel, U.S. Food and Drug Administration (FDA)
Welcome
- Jasmine Chaitram, CDC Division of Laboratory Systems (DLS)
AMP SARS-CoV-2 Molecular Testing Follow-up Survey
- Robyn Temple-Smolkin, Association for Molecular Pathology (AMP)
CMS Update – CLIA Rule for Reporting COVID-19 Test Results
- Regina Van Brakle and Amy Zale, Centers for Medicare & Medicaid Services (CMS)
Laboratory Training Update
- Joe Rothschild, CDC Division of Laboratory Systems (DLS)
FDA Update
- Tim Stenzel, U.S. Food and Drug Administration (FDA)
- Jasmine Chaitram, CDC Division of Laboratory Systems (DLS)
Antigen Testing – Video Update
- Reynolds (Ren) Salerno, CDC Division of Laboratory Systems (DLS)
New CDC FAQs
- Jasmine Chaitram, CDC Division of Laboratory Systems (DLS)
Review of Required Data Elements for Laboratory Reporting
- Sara Brenner, U.S. Department of Health and Human Services (HHS)
Status and Federal Procurement of Testing Supplies
- Tammy Beckham, U.S. Department of Health and Human Services (HHS)
FDA Update
- Tim Stenzel, U.S. Food and Drug Administration (FDA)
- Jasmine Chaitram, CDC Division of Laboratory Systems
Update on Laboratory Data Reporting
- Sara Brenner, HHS Laboratory Reporting
Pooling Update
- Reynolds (Ren) Salerno, CDC Division of Laboratory Systems
- Amy Zale, Centers for Medicare and Medicaid Services
- Toby Lowe, U.S. Food and Drug Administration
Risk Assessment
- Bev Dickson, Texas Health Presbyterian Hospital
FDA Update
- Tim Stenzel, U.S. Food and Drug Administration (FDA)
- Jasmine Chaitram, CDC Division of Laboratory Systems
Autopsies and Public Health Importance for COVID-19
- Roose Martines, CDC Division of High-Consequence Pathogens and Pathology (DHCPP)
- Sarah Reagan-Steiner, CDC Division of High-Consequence Pathogens and Pathology (DHCPP)
COVID-19 Samples: Packaging and Shipping Issues
- Stuart Streck, U.S. Department of Transportation
FDA Update
- Tim Stenzel and Sara Brenner, Food and Drug Administration (FDA)
- Jasmine Chaitram, CDC Division of Laboratory Systems
Update on CDC Serology Guidance
- Lyle Petersen, CDC Emergency Response Task Force
FDA Update
- Sara Brenner and Tim Stenzel, U.S. Food and Drug Administration (FDA)
Biosafety for Autopsies and Pathophysiology
- Jody Hooper, Johns Hopkins University
COVID-19 Safety in the Laboratory Environment
- Reynolds (Ren) Salerno, CDC Division of Laboratory Systems
Welcome
- Nancy Anderson, CDC Division of Laboratory Systems
Opening Remarks
- Jay Butler, MD, Deputy Director for Infectious Diseases, CDC
FDA Update
- Tim Stenzel and Sara Brenner, U.S. Food and Drug Administration (FDA)
Laboratory Workforce: Short Term Impact vs. Long Term Trends
- Jim Flanigan, American Society of Clinical Laboratory Science (ASCLS)
DLS Laboratory Training Resources
- Senia Wilkins, CDC Division of Laboratory Systems
Welcome
- Jasmine Chaitram, CDC Division of Laboratory Systems
FDA Update
- Tim Stenzel and Sara Brenner, U.S. Food and Drug Administration (FDA)
Laboratory Biosafety Update
- Bill Arndt, CDC Division of Laboratory Systems
COVID-19 Surveys Update
- Barbara Schwarzer, The Joint Commission
Summary of SARS-CoV-2 Molecular Testing Survey
- Robyn Temple-Smolkin, Association for Molecular Pathology (AMP)
Welcome
- Jasmine Chaitram, CDC Division of Laboratory Systems
Reporting and CARES Act Update
- Jason Hall, CDC Division of Preparedness and Emerging Infections (DPEI)
FDA Update
- Tim Stenzel and Sara Brenner, U.S. Food and Drug Administration (FDA)
COVID-19 & Cytology Labs
- Liron Pantanowitz, Director of Anatomic Pathology, The University of Michigan
College of American Pathologists (CAP) Laboratory Accreditation Update
- Richard M. Scanlan, Chair, CAP Council on Accreditation
CMS Billing Update
- Sarah Shirey-Losso, Centers for Medicare and Medicaid Services (CMS)
Welcome
- Jasmine Chaitram, CDC Division of Laboratory Systems
Opening Remarks
- Dr. Robert Redfield, Director, CDC
Supply Chain Update
- Brad Smith, Centers for Medicare and Medicaid Services (CMS)
- Tammy Beckham, U.S. Department of Health and Human Services (HHS)
FDA Updates
- Tim Stenzel, U.S. Food and Drug Administration (FDA)
- Sara Brenner, U.S. Food and Drug Administration (FDA)
Serology Testing Update
- Chris Elkins, CDC Laboratory Task Force for the COVID-19 Response
- Vicki Olson, CDC Laboratory Task Force for the COVID-19 Response
Maintaining Connections and Supporting Laboratories during the COVID-19 Pandemic
- Kathy Nucifora, COLA
Welcome
- Jasmine Chaitram, CDC Division of Laboratory Systems
Lab Reporting to Government Health Agencies During a Pandemic
- Corrisa Miliander, Mayo Clinic Laboratories
State Reporting Requirements for COVID-19
- Janet Hamilton, Council of State and Territorial Epidemiologists (CSTE)
Updates to Reporting Requirements to HHS Protect
- Jason Hall, CDC Division of Preparedness and Emerging Infections (DPEI)
CLIA Updates
- Karen Dyer, Centers for Medicare and Medicaid Services (CMS)
Updated Policy for Serology Testing
- Tim Stenzel and Sara Brenner, U.S. Food and Drug Administration (FDA)
Welcome and Introductions
- Jasmine Chaitram, CDC Division of Laboratory Systems
Addressing Covid-19: Perspective From A Scientific Society
- Robin Patel, President, the American Society for Microbiology (ASM)
Testing Strategies and Priorities
- Greg Armstrong, CDC Deputy Incident Manager for the COVID-19 Response
Laboratory Testing Supply Chain Update
- Brad Smith, Centers for Medicare and Medicaid Services (CMS)
Expanding SARS-CoV-2 Testing in the District
- Tony Tran, District of Columbia Public Health Laboratory
Laboratory Biosafety Update
- Bill Arndt, CDC Division of Laboratory Systems
CLIA Updates
- Karen Dyer, Centers for Medicare and Medicaid Services (CMS)
Welcome and Introductions
- Jasmine Chaitram, CDC Division of Laboratory Systems
Diagnostic and Serology Testing: Addressing Problems and Challenges
- Carmen L. Wiley, President, American Association for Clinical Chemistry (AACC)
Serology Testing Available at Quest Diagnostics
- Ann Salm, Quest Diagnostics
LabCorp Home Collection Kits
- Brian Krueger, LabCorp
Laboratory Biosafety Update
- Bill Arndt, CDC Division of Laboratory Systems
Update on Serology Testing, Point-of-Care Testing, and Laboratory Data Harmonization
- Tim Stenzel and Sara Brenner, U.S. Food and Drug Administration (FDA)
Welcome and Introductions
- Jasmine Chaitram, CDC Division of Laboratory Systems
Laboratory Biosafety Update: Autopsy and Anatomic Pathology Guidance for COVID-19
- Bill Arndt, CDC Division of Laboratory Systems
COVID-19 Emergency Preparedness and Recovery Planning in Anatomic Pathology
- Vinita Parkash, Yale University School of Medicine
COVID-19 at Alameda Health System
- Valerie Ng, Alameda Health System
COVID-19 Coding and Reimbursement
- Sarah Shirey-Losso, Centers for Medicare and Medicaid Services (CMS)
Updates on Review Process, Quality, Validation, and Serology Testing
- Tim Stenzel and Sara Brenner, U.S. Food and Drug Administration (FDA)
Welcome and Introductions
- Jasmine Chaitram, CDC Division of Laboratory Systems
The Reference Lab Experience: Lessons Learned and Ongoing Lessons
- Marc Couturier, ARUP Laboratories
New York State Public Health Laboratory Experience
- Kirsten St. George, New York State Public Health Laboratory at Wadsworth
Serology Testing Update
- Michele Owen, CDC Laboratory Task Force
Category B vs. Materials of Trade (MOT) Specimen Packaging and Shipping
- Stuart Streck, U.S. Department of Transportation (DOT)
Home Specimen Collection Kits, Home Testing, Serology, Point-of-Care Testing, and Other Topics
- Tim Stenzel and Sara Brenner, U.S. Food and Drug Administration (FDA)
Working with Healthcare Providers to Obtain Demographic Data
- Janet Hamilton, Council for State and Territorial Epidemiologists (CSTE)
Laboratory Biosafety Update for COVID-19
- Bill Arndt, CDC Division of Laboratory Systems
Welcome and Introductions
- Jasmine Chaitram, CDC Division of Laboratory Systems
Performance Evaluation of Commercially Developed Serology Tests
- Michele Owen, CDC Laboratory Task Force
Updates and Responses to Submitted Questions on Diagnostics and Testing
- Tim Stenzel, U.S. Food and Drug Administration (FDA)
Additional CLIA Guidance for Testing Laboratories
- Karen Dyer, Centers for Medicare & Medicaid Services (CMS)
COVID-19 Response – Hospital System on the Front Lines
- James (Jim) Crawford, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
Health, Lake Success, New York
Nebraska’s Public Health Laboratory Response
- Peter Iwen, Nebraska State Public Health Laboratory
Reporting Testing Data to CDC
- Jasmine Chaitram, CDC Division of Laboratory Systems
Laboratory Biosafety Update for COVID-19
- Bill Arndt, CDC Division of Laboratory Systems
Welcome and Introductions
- Jasmine Chaitram, CDC Division of Laboratory Systems
Serology Testing, Updated Testing Guidance, Nasal Swabs
- Wendi Kuhnert-Tallman, CDC Laboratory Task Force
Emergency Use Authorizations (EUAs) for Serology Tests and At-Home/Self-Collection Tests
- Tim Stenzel, U.S. Food and Drug Administration (FDA)
New CLIA Guidance and Validating Tests for Laboratories Responding to COVID-19
- Karen Dyer, Centers for Medicare & Medicaid Services (CMS)
Supporting Epidemiologic and Surveillance Needs
- Janet Hamilton, Council of State and Territorial Epidemiologists (CSTE)
Laboratory Biosafety Update
- Bill Arndt, CDC Division of Laboratory Systems