Long-Term Care Facility COVID-19 Testing Requirements and Revised COVID-19 Focused Survey Tool
- On Aug. 25, 2020, the Centers for Medicare and Medicaid Services (CMS) published an interim final rule with a comment period (IFC) establishing new Long-Term Care Facility COVID-19 Testing Requirements for Staff and Residents.
- CMS has added 42 CFR §483.80(h), which requires that the facility test all residents and staff for COVID-19. Noncompliance related to this new requirement will be cited at new tag F886.
- CMS is also revising the COVID-19 Focused Survey for Nursing Homes tool for surveyors to assess facility compliance with the new testing requirements.
The following summarizes important information about the requirements of the new 42 CFR §483.80(h) as provided in the CMS Memo to State Survey Agencies dated Aug. 26, 2020. For the full text of the Memo, you may access it at https://www.cms.gov/files/document/qso-20-38-nh.pdf
In the IFC, Long-Term Care Facilities (LTC) are required to test residents and staff, including individuals providing services under arrangement, and volunteers, for COVID-19 based on parameters and frequency set forth by the HHS Secretary. At a minimum, the facility must:
- Conduct testing based on parameters set forth by the Secretary, including but not limited to:
- Testing frequency;
- The identification of any individual specified in this regulation diagnosed with COVID-19 in the facility;
- The identification of any individual specified in this regulation with symptoms consistent with COVID-19 or with known or suspected exposure to COVID-19;
- The criteria for conducting testing of asymptomatic individuals specified in this regulation, such as the positivity rate of COVID-19 in a county;
- The response time for the test results, and,
- Other factors specified by the Secretary that help identify and prevent the transmission of COVID-19.
The facility must also:
- Conduct testing in a manner that is consistent with current standards of practice for conducting COVID-19 tests;
- For each instance of testing:
- Document that testing was completed and the results of each staff test;
- Document in the resident records that testing was offered, completed (as appropriate to the resident's testing status), and the results of each test.
- Upon the identification of an individual with symptoms consistent with COVID-19, or who tests positive for COVID-19, take actions to prevent the transmission of COVID-19.
- Have procedures for addressing residents and staff, including individuals providing services under arrangement, and volunteers, who refuse testing or are unable to be tested.
- 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.
Facilities can meet the testing requirements through the use of rapid point-of-care (at or near the site of resident care) diagnostic testing devices or through an arrangement with an off-site laboratory. For a facility to conduct point-of-care testing with its own staff and equipment, the facility must have a CLIA Certificate of Waiver. In addition, rapid point-of-care testing devices are prescription use tests under the Emergency Use Authorization and must be ordered by a healthcare professional licensed under the applicable state law or a pharmacist under HHS guidance. Accordingly, the facility must have an order from a healthcare professional or pharmacist to perform a point-of-care COVID-19 test on an individual.
If a facility does not have the ability to conduct point-of-care testing, it must have an arrangement with a laboratory to conduct the tests. To ensure rapid infection control response, the facility should select laboratories that can quickly process large numbers of tests with rapid reporting of results (within 48 hours).
Facility Staff to be Tested:
The term "facility staff" includes employees, consultants, contractors, volunteers, and caregivers who provide care and services to residents on behalf of the facility, and students in the facility's nurse aide training programs or from affiliated academic institutions.
Additional Testing Details:
The testing guidance in the tables below provided by CMS represents the minimum testing expected. Facilities may consider other factors, such as the positivity rate in an adjacent (i.e., neighboring) county, to test at a frequency that is higher than required. State and local officials may also direct facilities to monitor other factors that increase the risk of COVID-19 transmission, such as rates of Emergency Department visits of individuals with COVID-19-like symptoms.
Table 1: Testing Summary
|Testing Trigger||Staff||Residents||Symptomatic individual identified||Staff with signs and symptoms must be tested||Residents with signs and symptoms must be tested||Outbreak (Any new case arises in facility)||Test all staff that previously tested negative until no new cases are identified*||Test all residents that previously tested negative until no new cases are identified*||Routine testing||According to Table 2 below||Not recommended, unless the resident leaves the facility routinely
*For outbreak testing, all staff and residents should be tested, and all staff and residents that tested negative should be retested every 3 to 7 days until testing identifies no new cases among staff or residents for a period of at least 14 days since the most recent positive result.
Table 2: Routine Testing Intervals Vary by Community COVID-19 Activity Level