General Resources and Updates

Find links to key resources and updates regarding COVID-19 guidance, as well as information about events and on-demand recordings.

Clinical Resources

ASCP 2021 Comprehensive National COVID-19 Testing and Support Strategy

ASCP 2020 National COVID-19 Diagnostic Testing and Support Strategy

ASCP COVID-19 Recommendations - NEW! Recommendations added April 5, 2021

FDA Policy for Diagnostic Tests for Coronavirus Disease-2019 During the Public Health Emergency

FDA FAQs on Diagnostic Testing for SARS-CoV-2

FDA Coronavirus Disease 2019 (COVID-19) In Vitro Diagnostics Emergency Use Authorizations

https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests (FDA)

CDC COVID-19 Information for Laboratories webpage

CDC Testing Strategies for SARS-CoV-2 webpage

CDC Serology Testing for COVID-19 webpage

CDC Guidance on Postmortem Specimen Collection From Deceased Persons with Known or Suspected COVID-19

CDC Interim Guidance for Rapid Antigen Testing for SARS-CoV-2

CDC Guidance for SARS-CoV-2 Point-of-Care Testing

CDC Interim Guidance for Use of Pooling Procedures in SARS-CoV-2 Diagnostic, Screening, and Surveillance Testing

CDC Guidance for Reporting SARS-CoV-2 Sequencing Results

https://ascpcdn.s3.amazonaws.com/static/ISTP/ASCP_Covid-19_data_web.pdf

CDC Laboratory Training - Includes laboratory trainings relevant to COVID-19

Care and Treatment Resources

Duration of Isolation and Precautions for Adults with COVID-19

FDA Guidance Document - Investigational COVID-19 Convalescent Plasma: Guidance for Industry

COVIDPlasma.org - Includes information on the rapidly evolving therapy of COVID-19 convalescent plasma

CDC LOCS Lab Alert: Do Not Use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) (CDC LOCS (Laboratory Outreach Communication System) Lab Alert)

All Blood Specimen Collection Tubes Added to the FDA Medical Device Shortage List (FDA update)

CDC LOCS Lab Alert: Stop Using LuSys Laboratories COVID-19 Tests (CDC LOCS (Laboratory Outreach Communication System) Lab Alert, republished on ASCP News)

CDC LOCS Lab Advisory: Increased Testing for SARS-CoV-2 (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

Update: SARS-CoV-2 Omicron Variant: Impact on COVID-19 Tests (FDA update)

CDC LOCS Lab Alert: CDC Update on the SARS-CoV-2 Omicron Variant (CDC LOCS (Laboratory Outreach Communication System) Lab Alert)

CDC LOCS Lab Alert: Ellume Issues Voluntary Recall of Specific Lots of Ellume COVID-19 Home Tests (CDC LOCS (Laboratory Outreach Communication System) Lab Alert)

CDC LOCS Lab Advisory: CDC Updates SARS-CoV-2 Variant Classifications (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Advisory: Shortage of COVID-19 Rapid Tests May Increase Demand for Laboratory Testing (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Advisory: SARS-CoV-2 Variant Classification Updates (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Laboratory Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing (CDC LOCS (Laboratory Outreach Communication System) Laboratory Alert)

CDC LOCS Lab Alert: FDA Revokes EUA for Curative SARS-CoV-2 Assay (CDC LOCS (Laboratory Outreach Communication System) Lab Alert)

CDC LOCS Lab Advisory: CDC Classifies SARS-CoV-2 Variant B.1.617.2 (Delta) a Variant of Concern (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory

CDC LOCS Lab Alert: Stop Using Innova SARS-CoV-2 Antigen Rapid Qualitative Test (CDC LOCS (Laboratory Outreach Communication System) Lab Alert

Update: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests (FDA update)

CDC LOCS Lab Advisory: CDC Updates Testing Strategies for SARS-CoV-2 Web Page (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Advisory: New Guidance for Reporting SARS-CoV-2 Sequencing Results (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Update: CMS Posts FAQ for Reporting Sequencing Results for SARS-CoV-2 Variants (CDC LOCS (Laboratory Outreach Communication System) Lab Update)

Biden COVID-19 Strategy Includes Key Elements of ASCP National Testing Strategy, and New Workforce Initiative (ASCP News)

CDC LOCS Lab Advisory: CDC Publishes New Web Pages on Genomic Surveillance for SARS-CoV-2 Variants (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Advisory: CMS Updates CLIA Surveyor Guidance for SARS-CoV-2 Test Result Reporting (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Advisory: FDA Updates Reporting Guidance, Authorizes Update to IFU for CDC Influenza SARS-CoV-2 Multiplex Assay (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Alert: FDA Issues Safety Letter about Genetic Variants of SARS-CoV-2 and False Negative Results with Molecular Tests (CDC LOCS (Laboratory Outreach Communication System) Lab Alert)

CDC LOCS Lab Alert: FDA Issues Safety Letter about Genetic Variants of SARS-CoV-2 and False Negative Results with Molecular Tests (CDC LOCS (Laboratory Outreach Communication System) Lab Alert)

CDC LOCS Lab Advisory: FDA Authorizes Pooling for the CDC 2019-nCoV Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

COVID-19 Update: FDA Updates Antigen Template for Test Developers (FDA bulletin)

CDC LOCS Lab Advisory: CDC Publishes New Web Page on Point-of-Care Testing for COVID-19 (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Alert: FDA Suspends Review of EUA Requests for Laboratory-Developed Tests for SARS-CoV-2 (CDC LOCS (Laboratory Outreach Communication System) Lab Alert)

CMS Releases New Tools to Streamline Certification for Labs Testing for COVID-19 (CMS press release)

CDC LOCS Lab Advisory: LOINC In-Vitro Diagnostic (LIVD) Codes for SARS-CoV-2 Antigen Tests (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Update: New Clarification on Guidelines for Testing for SARS-CoV-2 (COVID-19) (CDC LOCS (Laboratory Outreach Communication System) Lab Update)

CDC LOCS Laboratory Update: CMS Publishes New CLIA FAQs (CDC LOCS (Laboratory Outreach Communication System) Laboratory Update)

CDC LOCS Laboratory Alert: FDA Issues Safety Letter about Thermo Fisher Scientific TaqPath COVID-19 Combo Kit (CDC LOCS (Laboratory Outreach Communication System) Laboratory Alert)

CDC LOCS Lab Advisory: New COVID-19 Antigen Testing Guidance (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Update: FDA Issues COVID-19 Testing and Policy Updates (CDC LOCS (Laboratory Outreach Communication System) Lab Update)

CDC LOCS Lab Advisory: CDC Releases New Test Pooling Guidance for SARS-CoV-2 (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing (FDA news release)

CDC LOCS Lab Advisory: FDA Amends Instructions for Use of CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

https://www.cdc.gov/csels/dls/locs/2020/fda_updates_faqs_about_testing_for_sars-cov-2.html (CDC LOCS (Laboratory Outreach Communication System) Lab Update)

CDC LOCS Lab Advisory: CDC Multiplex Assay Receives Authorization from FDA (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Update: FDA and CMS Update on Pooling for Diagnostic and Surveillance Testing for SARS-CoV-2 (CDC LOCS (Laboratory Outreach Communication System) Lab Update)

Experts Identify Steps to Expand and Improve Antibody Tests in COVID-19 Response (NIH news release)

CDC LOCS Lab Advisory: FDA Posts Information from Independent Evaluations of COVID-19 Serological Tests (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Advisory: CDC Releases Interim Guidance for Coronavirus Disease (COVID-19) Antibody Testing CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests (FDA news release)

CDC LOCS Lab Advisory: CDC Posts New Information about Serology Testing for COVID-19 (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

Antibody Test Oversight and Use for COVID-19 (FDA fact sheet)

FDA Voices: Insight into FDA’s Revised Policy on Antibody Tests: Prioritizing Access and Accuracy (FDA Voices - Perspectives From FDA Leadership and Experts)

CDC LOCS Lab Advisory: CMS Issues Additional Guidance on SARS-CoV-2 Laboratory Testing (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

American Society for Clinical Pathology Urges Creation of National Pandemic Testing Task Force (ASCP News)

ASCP National Test Strategy Included in Legislation Passed by Senate (ASCP News)

Important Information on the Use of Serological (Antibody) Tests for COVID-19 - Letter to Health Care Providers (FDA letter to health care providers)

CDC LOCS Lab Update: COVID-19 Laboratory Testing and Reporting Q&As and Specimen Collection Guidance (CDC LOCS (Laboratory Outreach Communication System) Lab Update)

The American Society for Clinical Pathology Calls on the Federal Government to Develop a National COVID-19 Diagnostic Testing and Support Strategy (ASCP News)

CDC LOCS Lab Update: FDA Clarifies CLIA-waived Status for Point-of-Care SARS-CoV-2 Tests Under Emergency Use Authorizations (CDC LOCS (Laboratory Outreach Communication System) Lab Update)

Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic (FDA statement) Read an ASCP News story on this topic here.

Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency (CMS memorandum)

Coronavirus (COVID-19) Update: FDA Provides More Regulatory Relief During Outbreak, Continues to Help Expedite Availability of Diagnostics (FDA statement)

Hologic’s Molecular Test for the Novel Coronavirus, SARS-CoV-2, Receives FDA Emergency Use Authorization (Hologic press release)

Roche’s Cobas SARS-CoV-2 Test Receives FDA Emergency Use Authorization (Roche press release)

CDC Preparing and Supporting Laboratories Responding to COVID-19 webpage

CDC COVID-19 Infection Control and PPE Guidelines

CDC COVID-19 Healthcare Professionals: Frequently Asked Questions and Answers – Includes information related to transmission and waste management

SHEA (The Society for Healthcare Epidemiology of America) COVID-19 FAQ – Includes information regarding how a person under investigation for COVID-19 should be managed, specifically as it relates to phlebotomy and the laboratory

CDC Laboratory Job Aids – Features laboratory preparedness and safety job aids relevant to COVID-19, including a video job aid about safely donning and doffing PPE.

CDC Laboratory Training – Includes laboratory preparedness, PPE, and safety laboratory trainings relevant to COVID-19.

CDC LOCS Lab Advisory: CDC Publishes New General Laboratory Safety Guidance (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Alert: DOT Issues Safety Notice for Transportation of COVID-19 Diagnostic Samples (CDC LOCS (Laboratory Outreach Communication System) Lab Alert)

CDC LOCS Lab Advisory: CDC Updates Laboratory Biosafety Guidelines and Questions & Answers (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Alert: Molecular Transport Media (MTM) and Cyanide Gas (CDC LOCS (Laboratory Outreach Communication System) Lab Alert)

CDC LOCS Lab Advisory: CDC Posts Updated Point-of-Care Testing Biosafety Guidelines for COVID-19 (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

The Joint Commission Statement on Universal Masking of Staff, Patients, and Visitors in Health Care Settings (The Joint Commission statement)

NIH Study Validates Decontamination Methods for Re-use of N95 Respirators (NIH media advisory)

Joint Commission Statement on Use of Face Masks Brought From Home (The Joint Commission statement)

"Shortages of Personal Protective Equipment in the COVID-19 Pandemic” (post from The Joint Commission Leading Hospital Improvement blog)

"Managing Critical Shortages of Personal Protective Equipment" (post from The Joint Commission On Infection Prevention & Control blog)

Payments & Reporting Resources

CDC LOCS Lab Alert: CDC Updates LOINC In Vitro Diagnostic (LIVD) Test Code Mapping Tool for SARS-CoV-2 Tests to Include SNOMED-CT Saliva Terms (CDC LOCS (Laboratory Outreach Communication System) Lab Alert

CDC LOCS Lab Alert: CDC Updates LOINC In Vitro Diagnostic (LIVD) Test Code Mapping Tool for SARS-CoV-2 Tests (CDC LOCS (Laboratory Outreach Communication System) Lab Alert, republished on ASCP News)

CDC LOCS Lab Advisory: Guidance for LOINC In-Vitro Diagnostic (LIVD) Code Selection for Laboratories Using Laboratory-Developed Tests (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Advisory: Update on COVID-19 Laboratory Reporting Requirements (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Advisory: Updated LOINC In-Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Test Results (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Advisory: HHS Issues New CARES Act Guidance (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

HHS Announces New Laboratory Data Reporting Guidance for COVID-19 Testing (HHS press release)

CDC LOCS Lab Advisory: New COVID-19 Data Tracker Website for Laboratories (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

COVID-19: Modified Ordering Requirements for Laboratory Billing (MLN Connects - Official CMS News from the Medicare Learning Network® (MLN))

CDC LOCS Lab Advisory: Updated LOINC In Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Test Results (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CDC LOCS Lab Advisory: New LOINC In-Vitro Diagnostic (LIVD) Test Code Mapping for SARS-CoV-2 Test Results (CDC LOCS (Laboratory Outreach Communication System) Lab Advisory)

CMS Increases Medicare Payment for High-Production Coronavirus Lab Tests (CMS press release)

Trump Administration Provides Financial Relief for Medicare Providers (CMS press release)

CMS Open Payments COVID-19 Announcement (CMS FAQs)

CMS Announces Relief for Clinicians, Providers, Hospitals and Facilities Participating in Quality Reporting Programs in Response to COVID-19 (CMS press release)

Career Resources

The ASCP Career Center provides the most up-to-date job opportunities as well a place where jobseekers can set up a job profile that employers can find.
Access ASCP Career Center

The ASCP Mentorship Program connects ASCP members for professional guidance and support. The mentorship program connects individuals with specific skills and experience (mentors) with individuals looking to grow in their careers by learning from others (mentees).
Learn More

View the results of a recent ASCP survey to learn more about changes in testing, staffing, and retention of laboratory professionals during the COVID-19 pandemic.
Learn More

During this challenging time, ASCP is offering free access to an ASCP Leadership Institute course on burnout prevention, management, and resources.
Learn More

Grant Resources

Non-federal

Federal

Funding Announcements

Impact of Technology and Digital Media (TDM) Exposure/Usage on Child and Adolescent Development (P01 Clinical Trial Optional) (RFA-HD-22-009)

NIH: Rapid Acceleration of Diagnostics (RADx) Initiative for COVID-19

Notices of Special Interest

Notice of Special Interest (NOSI): Social, Behavioral, and Economic Impact of COVID-19 in Underserved and Vulnerable Populations (NOT-MH-21-330)

Notice of Special Interest (NOSI): Competitive Revision and Administrative Supplements to Existing NICHD HIV Grants and Cooperative Agreements to Understand HIV Health Impacts of COVID-19 (NOT-HD-21-037)

Notice of Special Interest (NOSI): Promoting Vaccine Access, Acceptance and Uptake among Children, Adolescents, Pregnant and Lactating Women, and Persons with Disabilities (NOT-HD-21-038)

Notice of Special Interest (NOSI) HIV/AIDS in the Era of COVID-19: When Pandemics Collide (NOT-AI-21-057)

Notice of Special Interest (NOSI) Announcing the Availability of Administrative Supplements and Urgent Competitive Revisions for Research on the 2019 Novel Coronavirus (NOT-DA-21-041)

Notice of Special Interest (NOSI): COVID-19 Related School Disruptions Impact on Mental Health, Cognitive, Social, and Emotional Development of Children (NOT-MH-21-225)

Notice of Special Interest (NOSI): Availability of Emergency Competitive Revisions for the Clinical and Translational Science Award (CTSA) Program to Address COVID-19 Public Health Needs (NOT-TR-21-022)

Notice of Special Interest (NOSI): Neurological and Neurocognitive Sequelae from SARS-CoV-2 Infection and COVID-19 in Aging and Age-Related Neurodegeneration (NOT-AG-21-016)

Notice of Special Interest (NOSI): Availability of Urgent Competitive Revisions for Modeling Research on Coronavirus Disease 2019 (COVID-19) and the Causative Virus SARS-CoV-2 (NOT-GM-21-019)

Notice of Special Interest (NOSI): Long-Term Neurocognitive Consequences of COVID-19 in Individuals Living with HIV and Substance Use Disorders (NOT-DA-21-018)

Notice of Special Interest (NOSI): Administrative Supplements for the Clinical and Translational Science Award (CTSA) Program to Address COVID-19 Public Health Needs (NOT-TR-21-017)

Notice of Intent to Publish a Funding Opportunity Announcement for SARS-CoV-2, COVID-19 and Consequences of Alcohol Use (R21 Clinical Trials Not Allowed) NOT-AA-21-003)

Notice of Intent to Publish a Funding Opportunity Announcement for SARS-CoV-2, COVID-19 and Consequences of Alcohol Use (R01 Clinical Trials Not Allowed) (NOT-AA-21-001)

Notice of Special Interest (NOSI): Telehealth Strategies for Individuals with HIV and Substance Use Disorders (NOT-DA-21-019)

Notice of Special Interest (NOSI): Medical Consequences of Smoking and Vaping Drugs of Abuse in Individuals with HIV and COVID-19 (NOT-DA-21-017)

Notice of Special Interest (NOSI): Complement in Basic Immunology (CIBI) (NOT-AI-21-008)

Notice of Special Interest: Promoting Research on COVID-19 and Rheumatic, Musculoskeletal and Skin Diseases (NOT-AR-21-012)

Notice of Special Interest: Administrative Supplements for COVID-19 Impacted NIMH Research (NOT-MH-21-120)

Notice of Special Interest (NOSI): Effects of smoking and vaping on the risk and outcome of COVID19 infection (NOT-DA-20-084)

Notice of Special Interest: Emerging Viral Infections and their Impact on the Male and Female Reproductive Tract (NOT-HD-20-021)

Notice of Special Interest (NOSI): The Influence of Host Resilience on Heterogeneity of Acute Respiratory Distress Syndrome/Acute Lung Injury (ARDS/ALI) (NOT-HL-20-814)

Notice Announcing the Availability of Common Data Elements for Research Related to the Public Health Emergency caused by Coronavirus Disease 2019 (COVID-19) (NOT-MH-20-061)

Notice of Information: Contributing to the Global COVID-19 Crisis Response by Allowing Some NCI- supported Projects to be Redirected to COVID-19-related Research During the Crisis (NOT-CA-20-054)

Notice of Special Interest (NOSI) regarding the Availability of Emergency Competitive Revisions to Existing NIH Grants and Cooperative Agreements for Tissue Chips Research on the 2019 Novel Coronavirus (NOT-TR-20-017)

Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements for Tissue Chips Research on the 2019 Novel Coronavirus (NOT-TR-20-016)

Events & Recordings

In these uncertain times ASCP wants to ensure that all pathologists and laboratory professionals have the resources needed to take a leading role on the medical team. To help you through the challenges you are facing, ASCP has launched a new Virtual Town Hall Series. This series will address the main concerns affecting the laboratory team during this crisis and beyond. Visit the ASCP Virtual Town Hall Series webpage to access past town hall recordings and find information on upcoming town halls.
Access Virtual Town Hall Series

Inside the Lab is ASCP’s podcast focusing on current topics, such as COVID-19, showcasing the everyday laboratory professional and pathologist. The podcast’s goal is to generate thought-provoking discussions about topics relevant to the field of pathology and laboratory medicine.
Access Inside the Lab

FDA Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests (virtual events, on-demand presentations and transcripts)

CDC Clinical Laboratory COVID-19 Response Calls (virtual events, on-demand transcripts and recordings)

CMS COVID-19 Stakeholder Engagement Calls (virtual events, on-demand transcripts and recordings)