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Recent Updates on Public Health Emergencies

September 9, 2022

HHS’ EUA Declaration of IVDs for Monkeypox: What Labs Need to Know
HHS’ declaration of emergency use authorization (EUA) of in vitro diagnostics (IVD) for monkeypox means that at this time, CLIA-certified laboratories may develop and perform a monkeypox test, provided the following requirements to perform tests of high complexity are met:

  • Test uses molecular PCR technology;
  • Test uses lesion swabs;
  • and the test has been appropriately validated.

In addition, the laboratory must notify the FDA of validation within five business days of offering the test (or, for currently-offered tests within this scope, notify the FDA within five business days from the date of this guidance) that it has appropriately validated such test. Notification should be done via email (MPXDx@fda.hhs.gov) with this subject line: “FDA Notification of Development and Validation of Monkeypox Test.”

The CAP has identified some additional key aspects to this guidance of potential interest to laboratories:

  • The policy does not apply to LDTs with home specimen collection or at-home tests or to tests using specimen types other than lesion swabs or technologies other than PCR; however, on a case-by-case basis, the FDA would consider if academic medical centers can offer such tests using a different specimen type or a different technology for laboratories directly involved in patient care.
  • A high-complexity CLIA-certified laboratory modifying a cleared or authorized monkeypox molecular diagnostic test, including one for which such laboratory is not the developer of the original test, and the modifications do not change the indication for use set forth in the 510(k) or EUA (e.g., including new/different extraction kits or instruments that would not be expected to change the indication for use) and do not change the analyte specific reagents (e.g., the modifications do not change the PCR primers and/or probes or enzymes), can use the LDTs without seeking an additional EUA.
    • FDA intends to notify developers by email if FDA declines to review, declines to issue, or otherwise decides not to authorize a supplemental EUA request for any reason, including lack of response or a determination that there is a lack of adequate data to support such request. If so notified, FDA generally expects developers to cease distributing and offering their modified test within 15 calendar days of the date of the FDA notification.

FDA is providing templates on its website with recommendations regarding validation testing that should be performed for diagnostic monkeypox tests. More details and information are available in this guidance.

August 23, 2022

CDC Lab Advisory: Monkeypox Virus Testing Considerations to Prevent False Positive Test Results. To prevent false positive test results, CDC recommends that laboratory professionals perform repeat testing to verify positive diagnostic results for Orthopoxvirus or Monkeypox virus DNA in specimens with high Cycle Threshold (Ct) values from persons who do not meet identified epidemiologic risk criteria for monkeypox.

Review laboratory test results (including raw data, PCR curves, etc.) carefully before you report results, states an advisory from the CDC’s laboratory advisory. Because molecular tests (e.g., real-time PCR tests) are very sensitive, cross-contamination is possible. If you obtain a high Ct value (generally ~34 or higher), CDC recommends to immediately re-extract and re-test to ensure there was no cross-contamination. CDC suggests this approach based on high Ct value alone, even in the absence of epidemiologic information. When possible, re-extract and re-test before you report results.

More information: Monkeypox; CDC Information for Laboratory Personnel.

August 9, 2022

Biden Administration Declares Monkey Pox a Public Health Emergency. Read more in the August 9 Advocacy Update, as well as the CDC’s 2022 Monkeypox Outbreak Situational Summary.

August 2, 2022

PHMSA Adds Monkeypox to “Special Topics” on Transporting Infectious Substances Overview Page.
The Pipeline and Hazardous Materials Safety Administration (PHMSA) at the U.S. Department of Transportation updated the Transporting Infectious Substances Overview page to include a Monkeypox section under “Special Topics.”

June 27, 2022

June 24, 2022

April 5, 2022

CAP Media Briefing: Preparing for Future Pandemics

CAP leading pathologists discussed the impact of the pandemic on laboratories and lessons learned to prepare for future pandemics and COVID variants. CAP leaders also discuss the impact of COVID on patient care as it highlighted the lack of access to laboratories, especially in underserved and vulnerable population. Watch the recording.

December 6, 2021

  • CAP committees update Q&A on at-home testing and COVID-19. Read here.

December 1, 2021

  • We hear you: CAP Responds to Your COVID-19 Questions. Read the Q & A.

October 21, 2021

  • The CAP makes changes to accreditation inspection cycles. Learn more.

September 10, 2021

  • The CAP’s Microbiology Committee updates its questions and answers for COVID-19 variants. View here.

August 20, 2021

  • We hear you: CAP Responds to Your COVID-19 Questions. Read the Q & A.

June 15, 2021

  • CAP recommendations for managing shortage of 3.2% sodium citrate blue top tubes. Learn more.

April 7, 2021

  • We hear you: CAP Responds to Your COVID-19 Questions. Read the Q & A.

March 29, 2021

  • Medical examiner and coroner guidance for FEMA coverage for COVID-19-related funeral expenses. Learn more.

March 22, 2021

  • The CAP urges Congress to stop Medicare budget sequester cuts for duration of pandemic. Read here.

March 11, 2021

  • CAP survey reveals COVID-19 testing supply shortages disrupt 45% of laboratories. See survey.

March 2, 2021

  • The CAP introduces a new Quality Cross Check program for SARS‑CoV‑2 antigen. Learn more.

February 26, 2021

  • We hear you: CAP Responds to Your COVID-19 Questions. Read the Q & A.

February 23, 2021

  • CAPcast: A Team Leader’s Insight to CAP’s Hybrid & Virtual Inspections. Listen here.

February 19, 2021

  • Paycheck Protection Program application deadlines for first or second time borrowers has changed to March 31, 2021. Learn more.

February 16, 2021

  • CAP committees update Q&A on at-home testing and COVID-19. Read here.

February 3, 2021

  • The CAP Autopsy Committee updates the COVID-19 Autopsy Guideline statement including changes to fee-for-service autopsy list. Review here.

February 2, 2021

  • The CAP detailed its priorities on combating the COVID-19 pandemic following the release of the White House’s national strategy. Read more.

January 14, 2021

  • Inspectors and inspectees share their perspectives on CAP virtual inspections. View here.
  • The CAP makes document review easier for virtual inspections with SharePoint. Learn more.

January 11, 2021

  • We hear you: CAP Responds to Your COVID-19 Questions. Read the Q & A.

January 5, 2021

  • Watch this short presentation on how to plan for and manage your virtual CAP inspection. Learn more.

December 29, 2020

  • CAP Microbiology Committee develops questions and answers regarding Ct values. Read here.

December 18, 2020

  • We hear you: CAP Responds to Your COVID-19 Questions. Read the Q & A.
  • Learn more about modified inspection processes. Review here.
  • CAP urges pathologists and laboratory professionals take advantage of access to vaccine. Read here.

December 15, 2020

  • Pathologists and laboratory personnel in initial phase to receive COVID-19 vaccination. See here.

December 14, 2020

  • Learn which checklist(s) are used to inspect COVID-19 related testing. Read here.
  • Caution Must Be Used in Interpreting the Cycle Threshold (Ct) Value. Learn more.

November 30, 2020

  • The CAP compiles virtual inspection FAQs. Learn more.

November 3, 2020

  • Read the latest about “CAP in the News and on Social Media”. View here.
  • We hear you: CAP Responds to Your COVID-19 Questions. Read the Q & A.

October 28, 2020

  • The CAP adds virtual inspections for CLIA-licensed laboratories. Learn more.
  • The CAP introduces Quality Cross Check—SARS-CoV-2 Serology (COVSQ). Read here.

October 21, 2020

  • The CAP announces international virtual inspections for non-CLIA laboratories. Read here.

October 19, 2020

October 15, 2020

  • New webinar: Coping With COVID-19 Part 2; Laboratory Workforce Impacts. Register now.

October 14, 2020

  • We hear you: CAP Responds to Your COVID-19 Questions. Read the Q & A.

October 6, 2020

September 28, 2020

  • We hear you: CAP Responds to Your COVID-19 Questions. Read the Q & A.

September 24, 2020

September 23, 2020

  • Listen to the Quality Cross Check SARS-CoV-2 Testing CAPcast to help you manage instrumentation. Listen here.
  • We hear you: CAP Responds to Your COVID-19 Questions. Read the Q & A.

September 14, 2020

  • The CAP offers three SARS-CoV-2 PT programs (molecular, serology, and antigen) and one Quality Cross Check program in molecular. Learn more.

September 11, 2020

  • The CAP urges laboratories to review the new requirements for reporting SARS-CoV-2 test results during the public health emergency.
  • We hear you: CAP Responds to Your COVID-19 Questions. Read the Q & A.
  • CAP Informatics and Pathology Electronic Reporting (PERT) Committees update answers to questions about COVID-19 reporting requirements. See here.

September 3, 2020

  • The CAP’s Microbiology Committee updates its COVID-19 topic center with guidance on screening and surveillance. Visit here.
  • We hear you: CAP Responds to Your COVID-19 Questions. Read the Q & A.
  • CAP Informatics and Pathology Electronic Reporting (PERT) Committees update answers to questions about COVID-19 reporting requirements. See here.

    August 28, 2020

    • The CAP Demands Rationale from CDC on COVID-19 Testing Guidance. Learn more.
    • The CAP Opposes HHS Lab Penalties and for COVID-19 Reporting Requirements. Read here.
    • CAP Informatics and Pathology Electronic Reporting (PERT) Committees answer questions about COVID-19 reporting requirements.  See here.

    August 27, 2020

    • See the latest news from the Advocacy and legislative front. Read more.
    • The CAP recommends a modified inspection process to adapt to the current climate in health care and to provide for increased safety measures. Learn more.

    August 24, 2020

    • The CAP’s Microbiology Committee updates its COVID-19 topic center. Visit here.
    • Expected 2020 Shipping Dates for proficiency testing. View updates.
    • We hear you: CAP Responds to Your COVID-19 Questions. Read the Q & A.

    August 18, 2020

    • The CAP’s Microbiology Committee launches a COVID-19 topic center. Visit here.

    August 7, 2020

    • The CAP’s Microbiology Committee provides guidance on pooled testing. Read the guidance.

    August 5, 2020

    July 24, 2020

    • Webinar: Coping with COVID-19 Impacts on the Pathologist Workforce. Register now.

    July 21, 2020

    • Update for domestic and international PT customers on shipping, testing, and due date information. Read more.

    July 16, 2020

    • CAP US Inspections information update. See here.

    July 9, 2020

    • We hear you: CAP Responds to Your COVID-19 Questions. Read the Q & A.

    June 29, 2020

    • The CAP is monitoring trends to better inform leaders, elected officials, and government regulators of the challenges laboratories are facing. See June and April surveys results.
    • The CAP seeks clarity from the Department of Health and Human Services on new guidance specifying clinical laboratory reporting of COVID-19 test results along with other clinical data elements. Read letter.

    June 17, 2020

    • Recording of our webinar Navigating Implementation of SARS-CoV-2 Testing in Your Laboratory now available. Access the webinar.

    June 15, 2020

    • CAP Members address COVID-19 issues. Watch here.
    • CAP members talk about financial assistance during COVID-19. See videos.
    • CAP members discuss remote working during COVID-19. Watch here.

    June 12, 2020

    • Post COVID-COVID – Will We Be Better Prepared for Round Two?
      Thursday, June 25 2020; 2:00 PM - 3:00 PM (CT)
      The key objectives of this roundtable are to evaluate best practices of recovery in the immediate post-COVID crisis and propose a preparedness plan to sustain a resurgence of the pandemic.
      Learn more and register

    June 9, 2020

    June 5, 2020

    • CAP Resuming Routine US Inspections. Read More.

    June 1, 2020

    May 26, 2020

    • COVID-19 fee-for-service autopsy list compiled by the CAP Autopsy Committee. Review the list.
    • Convalescent Plasma: Identifying the Laboratory’s Role in this Potential COVID-19 Treatment. Listen to the CAPcast.

    May 21, 2020

    • New webinar: You’ve Been Asked to Implement SARS-CoV-2 Antibody Testing: What You Need to Know Register now
    • New webinar: Navigating Implementation of SARS-CoV-2 Testing in Your Laboratory Sign up
    • We hear you: CAP Responds to Your COVID-19 Questions Read the Q & A
    • See information on the federal Loan Forgiveness: Paycheck Protection Program in the Practice Resources for Pathologists tab Learn more
    • Twitter Chat Wrap-Up: How Pathologists Can Navigate COVID-19-Related Practice Management Challenges See highlights

    May 20, 2020

    May 19, 2020

    • CAP introduces Serology PT program for the detection of antibodies against SARS‑CoV‑2 Learn more

    May 14, 2020

    May 13, 2020

    • CAP Statement on the Current Role of Serologic Testing for SARS-CoV-2 Read statement
    • We hear you: CAP Responds to Your COVID-19 Questions Read the Q & A

    May 8, 2020

    • Webinar: CAP survey confirms COVID-19 testing challenges Watch now
    • CAP President Patrick Godbey, MD, FCAP featured in news on testing challenges See News Clip

    May 6, 2020

    April 29, 2020

    • Adding Tests for COVID-19 to Your Laboratory’s Activity Menu Here’s how
    • We hear you: CAP Responds to Your COVID-19 Questions Read the Q & A

    April 28, 2020

    • CAP Foundation Announces John H. Rippey Grant for Expedited Research: The Impact of Laboratory Testing for SARS-CoV-2 on Quality & Patient Safety Apply here

    April 24, 2020

    • See the latest updates to our Practice Resources for Pathologists Review here
    • We hear you: CAP Responds to Your COVID-19 Questions Read the Q & A
    • Read the latest about “CAP in the News and on Social Media” View here

    April 22, 2020

    • Review the latest Advocacy News and Legislative Alerts related to COVID-19 Read here

    April 21, 2020

    April 20, 2020

    • Learn more about what CAP-accredited laboratories need to do in light of CMS’ suspension of most inspections until further notice Read eAlert
    • Read the latest about “CAP in the News and on Social Media” View here
    • We hear you: CAP Responds to Your COVID-19 Questions Read the Q & A

    April 17, 2020

    • Learn from the CAP’s Microbiology Committee Chair how we developed proficiency testing for SARS-CoV-2 Listen to the CAPcast
    • New section: Practice Resources for Pathologists, for you and your practice to help ease the burden during COVID-19 Visit now

    April 16, 2020

    • CMS suspends most inspections until further notice, see “CAP US Inspections” information Read more
    • We hear you: CAP Responds to Your COVID-19 Questions Read the Q & A

    April 15, 2020

    • The CAP urges Congress to provide further financial and economic assistance to pathology practices Read the story
    • The CAP offers guidance for using a biologic safety cabinet See best practices
    • We hear you: CAP Responds to Your COVID-19 Questions Read the Q & A

    April 14, 2020

    • COVID-19 fee-for-service autopsy list compiled by the CAP Autopsy Committee Review the list

    April 13, 2020

    April 10, 2020

    April 9, 2020

    • CAP launches new PT Program for the Detection of SARS-CoV-2 Read more
    • Autopsy Committee releases COVID-19 Autopsy Guideline Statement Read the Statement
    • We hear you: CAP Responds to Your COVID-19 Questions Read the Q & A

    April 8, 2020

    •  CAP strongly supports Senate legislation to increase the Paycheck Protection Program. Read our statement
    •  Updated Guidance for COVID-19 Testing for CAP-Accredited Laboratories. Get the latest guidance
    • CAP accreditation programs offer clarification for remote review and quality control during COVID-19. Read the alert

    April 7, 2020

    • We hear you: CAP Responds to Your COVID-19 Questions Read the Q & A
    • The Informatics Committee adds an additional resource related to COVID-19. Read more

    April 6, 2020

    April 3, 2020

    • Coming Soon: New PT Program for the Detection of SARS CoV-2. Read more
    • Answers to Your Questions about Small Business Assistance During COVID-19. Read more
    • Remote sign-out of cases with Digital Pathology FAQs published. Read the FAQs
    • Subject matter experts from the Informatics Committee compile resources for COVID-19. Read more

    April 2, 2020

    • The Cytopathology Committee offers some considerations for cytopathology services during COVID-19. Read the update
    • We hear you: CAP Responds to Your COVID-19 Questions Read the Q & A
    • See updated information in the “For CAP PT Customers” section on our main COVID page. Read more
    • New, free virtual lecture series for pathology residents occurring each weekday in April at 10:00 AM CDT. Get the details
    • CAP members and Junior members can access a range of eLearning courses covering AP, CP and laboratory management topics during the month of April at no charge. Learn more and enroll 
    • The Laboratory Medical Direction course is rescheduled for November 4-5, 2020 at the Hyatt Regency Chicago. Learn about the course
    • The Ultrasound-Guided Fine-Needle Aspiration (USFNA) course is rescheduled for November 14-15, 2020 at CAP Headquarters, Northfield, IL. Learn about the course

    April 1, 2020

    March 30, 2020

    • Learn about our COVID-19 response shared during the March 26, 2020 State Pathology Society Presidents webinar. Access the webinar
    • Digital & Computational Pathology and Informatics Committees provide remote sign-out guidance. Read the guidance document
    • We hear you: CAP Responds to Your COVID-19 Questions Read the Q & A

    March 27, 2020

    • Pushing for Pathologists on Multiple Fronts During COVID-19 Crisis: A letter to CAP members from CAP President Patrick E. Godbey, MD, FCAP Read the letter
    • Transfusion, Apheresis and Cellular Therapy Committee provides information on concerns for the national blood supply. Read the update
    • In Historic Stimulus Bill, Congress Fixes COVID-19 Coverage Sought by CAP, Lab Groups Read the update
    • We hear you: CAP Responds to Your COVID-19 Questions Read the Q & A
    • In a CAPCast interview Richard Scanlan, MD, FCAP discusses his experiences bringing COVID-19 testing online at his institution, including some lessons learned.
      Listen to the interview

    March 26, 2020

    • Webinar: Our COVID-19 Response Presented to State Pathology Society Presidents Access the webinar
    • The CAP led an organized advocacy campaign that persuaded the federal government to allow pathologists to work remotely. Read the full story
    • We are responding to your question about COVID-19. Read the Q & A

    March 25, 2020

    • CAP updates test activity menu code in Guidance for COVID-19 Testing for CAP-Accredited Laboratories. Get the latest guidance

    March 24, 2020