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