Testing COVID-19
      Back to home
      1. KBH Knowledge Center
      2. COVID-19
      3. Testing COVID-19

      COVID-19 Testing General Information

      COVID-19 Testing

      Overview and General Information

      The spread of COVID-19 from the community and within the health center is challenging. COVID-19 testing will be an instrumental aspect that will assist facilities in prompt detection of cases in order to implement actions to reduce the exposure and to halt transmission within the facility whenever possible.

       

      The Centers for Medicare & Medicaid Services (CMS) published an interim final rule (https://www.cms.gov/medicareprovider-enrollment-and-certificationsurveycertificationgeninfopolicy-and-memos-states-and/interim-final-rule-ifc-cms-3401-ifc-additional-policy-and-regulatory-revisions-response-covid-19 ) establishing Long-Term Care (LTC) Facility Testing Requirements for Staff and Residents on August 25, 2020.

       

      An update to the testing guidance includes: “CMS Updates COVID-19 Testing Methodology for Nursing Homes” on September 29, 2020: https://www.cms.gov/newsroom/press-releases/cms-updates-covid-19-testing-methodology-nursing-homes

       

      CMS has added a new requirement at F886 COVID-19 Testing to include:

      “The LTC facility must test residents and facility staff, including individuals providing services under arrangement and volunteers, for COVID-19. At a minimum, for all residents and facility staff, including individuals providing services under arrangement and volunteers, the LTC facility must:

      (1) Conduct testing based on parameters set forth by the Secretary, including but not limited to:

      (i) Testing frequency;

      (ii) The identification of any individual specified in this paragraph diagnosed with COVID19 in the facility;

      (iii) The identification of any individual specified in this paragraph with symptoms consistent with COVID-19 or with known or suspected exposure to COVID-19;

      (iv) The criteria for conducting testing of asymptomatic individuals specified in this paragraph, such as the positivity rate of COVID-19 in a county;

      (v) The response time for test results; and

      (vi) Other factors specified by the Secretary that help identify and prevent the transmission of COVID-19.

      (2) Conduct testing in a manner that is consistent with current standards of practice for conducting COVID-19 tests;

      (3) For each instance of testing:

      (i) Document that testing was completed and the results of each staff test; and

      (ii) Document in the resident records that testing was offered, completed (as appropriate to the resident’s testing status), and the results of each test.

      (4) Upon the identification of an individual specified in this paragraph with symptoms consistent with COVID-19, or who tests positive for COVID-19, take actions to prevent the transmission of COVID-19.

       

      (5) Have procedures for addressing residents and staff, including individuals providing services under arrangement and volunteers, who refuse testing or are unable to be tested.

      (6) When necessary, such as in emergencies due to testing supply shortages, contact state and local health departments to assist in testing efforts, such as obtaining testing supplies or processing test results.”1

       

      CMS has indicated that “healthcare facilities using Point of Care COVID-19 testing devices under a CLIA Certificate of Waiver, including nursing homes, pharmacies, or other settings will be required to report test results under this regulation.”2 In addition, CMS indicates, “All CLIA-certified laboratories that perform or analyze any test that is intended to detect SARSCoV-2 or to diagnose a possible case of COVID-19 (e.g., molecular, antigen, antibody) are required to report, regardless of the type of laboratory (type of CLIA certificate) performing the testing.”2

       

      The Centers for Disease Control and Prevention has updated reporting requirements for SARS-CoV-2 tests on December 28, 2020:

      “Every COVID-19 testing site is required to report to the appropriate state or local public health department every diagnostic and screening test performed to detect SARS-CoV-2 or to diagnose a possible case of COVID-19. POC testing may be performed with a Clinical Laboratory Improvement Amendments (CLIA)  certificate of waiver, but reporting of test results to state or local public health departments are mandated by the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

      CMS-certified long-term care facilities may submit point-of-care SARS-CoV-2 testing data, including antigen testing data, to CDC’s National Healthcare Safety Network (NHSN). This CDC- and CMS-preferred pathway to submit data to CDC’s NHSN applies only to CMS-certified long-term care facilities. Test data submitted to NHSN will be reported to appropriate state and local health departments using standard electronic laboratory messages. Other types of LTC facilities may also report testing data in NHSN for self-tracking or to fulfill state or local reporting requirements, if any. While NHSN is the CDC- and CMS-preferred pathway, Medicare and Medicaid-certified LTC facilities may submit data through the other mechanisms described in the Current Methods of Submission section of HHS Laboratory Reporting Guidance to meet the reporting requirements.”4

       

      Facilities will need to have knowledge regarding the types of testing. The Centers for Disease Control and Prevention indicates, “The “gold standard” for clinical diagnostic detection of SARS-CoV-2 remains RT-PCR. Thus, it may be necessary to confirm an antigen test result with a nucleic acid test, especially if the result of the antigen test is inconsistent with the clinical context.”3

       

      “The first two SARS-CoV-2 antigen tests to receive FDA EUA are authorized for testing symptomatic persons within 5 days of symptom onset and there are limited data on antigen test performance in asymptomatic persons. However, given the transmission of SARS-CoV-2 from asymptomatic and presymptomatic nursing home residents and healthcare personnel (HCP) with SARS-CoV-2 infection, CDC is providing considerations for the use of antigen tests in asymptomatic persons during this public health emergency. Facilities should be aware of the FDA EUA  for antigen tests  and potential implications for the Clinical Laboratory Improvement Amendments (CLIA)  certificate of waiver when using antigen tests in asymptomatic individuals and in persons >5 days from symptom onset.”4

       

       

      The Centers for Disease Control and Prevention has provided “Guidance for SARS-CoV-2 Point-of-Care Testing, Updated December 26, 2020( https://www.cdc.gov/coronavirus/2019-ncov/lab/point-of-care-testing.html ) that recommends:

      • Performing a risk assessment prior to testing
      • Following all manufacturer’s instructions for performing the test
      • Performing regular quality control and instrument calibration consistent with the manufacturer’s recommendation
      • No reuse of used test devices, tubes, solutions, or swabs
      • If test or components are beyond the expiration date or damaged/discolored, they should be discarded
      • Change gloves between collection of specimens and after adding the specimen to the device
      • Storage and handling of reagents, specimens, kit contents and devices in accordance with manufacturer’s recommendations
      • Basic best practice approaches to testing
        • Following manufacturer’s recommendation
        • Decontamination/disinfection
        • Follow read and record results times
        • Waste handling
      • Tests that can be used for Point-of-Care testing
      • CLIA Certificate of Waiver requirements
      • Reporting Requirements for Point-of Care Testing

       

      Competencies which may be associated with COVID-19 Testing include but are not limited to:

       

      • Understanding of COVID-19 Types of Testing
      • Proper use of Personal Protective Equipment
      • Knowledge of proper hand hygiene practices
      • Specimen Collection
      • Use of Point-of-Care Antigen Testing Equipment
      • Cleaning and Disinfection
      • Reporting Antigen Testing
      • Documentation

       

      Staff Competencies with COVID-19 Testing include but are not limited to:

       

      • Ability to follow proper hand hygiene practices
      • Demonstration of ability to properly select and don and doff Personal Protective Equipment including proper use, removal, and storage of medical grade face masks
      • Demonstration of Specimen Collection
      • Demonstration of Point-of-Care COVID-19 Antigen testing
      • Ability to describe actions to prevent the transmission of COVID-19 with positive results

       

       

       

       

      References and Resources:

       

      1Centers for Medicare & Medicaid Services. Interim Final Rule (IFC), CMS-3401-IFC, Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency related to Long-Term Care (LTC) Facility Testing Requirements and Revised COVID19 Focused Survey Tool. QSO-20-38-NH. August 26, 2020: https://www.cms.gov/files/document/qso-20-38-nh.pdf

       

      2 Centers for Medicare & Medicaid Services. Interim Final Rule (IFC), CMS-3401-IFC, Updating Requirements for Reporting of SARS-CoV-2 Test Results by Clinical Laboratory Improvement Amendments of 1988 (CLIA) Laboratories, and Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency. QSO-20-37-CLIA, NH. August 26, 2020: https://www.cms.gov/files/document/qso-20-37-clianh.pdf

       

      3Centers for Disease Control and Prevention. Interim Guidance for Antigen Testing for SARS-CoV-2. December 16, 2020: https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html

       

      Centers for Disease Control and Prevention. Preparing for COVID-19 in Nursing Homes; November 20, 2020; https://cdc.gov/coronavirus/2019-ncov/hcp/long-term-care.html

       

      4Centers for Disease Control and Prevention. Considerations for Use of SARS-CoV-2 Antigen Testing in Nursing Homes. December 28, 2020: https://www.cdc.gov/coronavirus/2019-ncov/hcp/nursing-homes-antigen-testing.html

       

      Centers for Disease Control and Prevention. Guidance for SARS-CoV-2 Point-of-Care Testing. Updated December 26, 2020: https://www.cdc.gov/coronavirus/2019-ncov/lab/point-of-care-testing.html

       

      Centers for Disease Control and Prevention (CDC). Interim Guidelines for Collecting, Handling and Testing Clinical Specimens for COVID-19 Updated December 21, 2020: https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html

       

      Centers for Disease Control and Prevention (CDC). Interim Infection and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19 Pandemic. Updated December 14, 2020: https://www.cdc.gov/coronavirus/2019-ncov/infection-control/control-recommendations.html

       

      United States Food & Drug Administration (FDA). In Vitro Diagnostics EUAs: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-antigen

       

      United States Food & Drug Administration (FDA). Pooled Sample Testing and Screening Testing for COVID-19: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/pooled-sample-testing-and-screening-testing-covid-19