CLCR Calls 2020 Archive

December 28, 2020
Agenda
Welcome
  • 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)

December 28, 2020

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December 14, 2020
Agenda

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)

December 14, 2020 Meeting Materials

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November 30, 2020
Agenda

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)

November 30, 2020

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November 16, 2020
Agenda

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)

November 16, 2020 Meeting Materials

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November 2, 2020
Agenda

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)

November 2, 2020 Meeting Materials

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October 19, 2020
Agenda

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)

October 19, 2020 Meeting Materials

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September 28, 2020
Agenda

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)

September 28, 2020 Meeting Materials

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September 14, 2020
Agenda

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)

September 14, 2020 Meeting Materials

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August 31, 2020
Agenda

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)

August 31, 2020 Meeting Materials

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August 17, 2020
Agenda
Welcome
  • 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)

August 17, 2020 Meeting Materials

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August 3, 2020
Agenda
Welcome
  • 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)

August 3, 2020 Meeting Materials

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July 20, 2020
Agenda
Welcome
  • 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)

July 20, 2020 Meeting Materials

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July 6, 2020
Agenda
Welcome
  • 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

July 6, 2020 Meeting Materials

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June 22, 2020
Agenda

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

June 22, 2020 Meeting Materials

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June 15, 2020
Agenda

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)

June 15, 2020 Meeting Materials

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June 8, 2020
Agenda

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)

June 8, 2020 Meeting Materials

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June 1, 2020
Agenda

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

June 1, 2020 Meeting Materials

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May 11, 2020
Agenda

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)

May 11, 2020 Meeting Materials

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May 4, 2020
Agenda

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)

May 4, 2020 Meeting Materials

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April 27, 2020
Agenda

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)

April 27, 2020 Meeting Materials

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April 20, 2020
Agenda

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)

April 20, 2020 Meeting Materials

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April 13, 2020
Agenda

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

April 13, 2020 Meeting Materials

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April 6, 2020
Agenda

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

April 6, 2020 Meeting Materials

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March 30, 2020
Agenda

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

March 30, 2020 Meeting Materials

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