Key Points

• 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.

Testing:

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

*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

*This frequency presumes the availability of point-of-care testing on-site at the facility or where off-site testing turnaround is

If the 48-hour turnaround time cannot be met due to community testing supply shortages, limited access, or inability of laboratories to process tests within 48 hours, the facility should have documentation of its efforts to obtain quick turnaround test results with the identified laboratory or laboratories and contact with the local and state health departments.

Facilities should monitor their county positivity rate every other week (e.g., first and third Monday of every month) and adjust the frequency of performing staff testing according to Table 2.

Refusal of Testing:

Refusal By Staff: Facilities must have policies and procedures in place to address staff who refuse testing. Procedures should ensure that staff who have signs or symptoms of COVID-19 and refuse testing are prohibited from entering the building until the return to work criteria are met. The facility should follow its occupational health and local jurisdiction policies with respect to asymptomatic staff who refuse routine testing.

Refusal By Residents: Residents (or their representative) may exercise their rights to decline COVID-19 testing in accordance with the requirements under 42 CFR §483.10(c)(6). In discussing testing with residents, staff should use person-centered approaches when explaining the importance of testing for COVID-19. Facilities must have procedures in place to address residents who refuse testing. Those procedures should ensure that residents who have signs or symptoms of COVID-19 and refuse testing are placed on Standard and Transmission-Based Precautions (TBPs) until the criteria for discontinuing TBP have been met.

Reporting Test Results:

Facilities conducting tests under a CLIA certificate of waiver are subject to regulations that require laboratories to report data for all testing completed for each individual tested. For additional information on reporting requirements, see: https://www.cms.gov/files/document/covid-faqs-snf-testing.pdf

In addition to reporting in accordance with CLIA requirements, facilities must continue to report COVID-19 information to the CDC's National Healthcare Safety Network (NHSN).

Documentation of Testing:

Facilities must demonstrate compliance with the testing requirements by doing the following:

• For symptomatic residents and staff, document the date(s) and time(s) of the identification of signs or symptoms, when testing was conducted, when results were obtained, and the actions the facility took based on the results.
• Upon identification of a new COVID-19 case in the facility (i.e., outbreak), document the date the case was identified, the date that all other residents and staff are tested, the dates that staff and residents who tested negative are retested, and the results of all tests.
• For staff routine testing, document the facility's county positivity rate, the corresponding testing frequency indicated (e.g., every other week), and the date each positivity rate was collected. Also, document the date(s) that testing was performed for all staff and the results of each test.
• Document the facility's procedures for addressing residents and staff that refuse testing or are unable to be tested, and document any staff or residents who refused or were unable to be tested and how the facility addressed those cases.
• When necessary, such as in emergencies due to testing supply shortages, document that the facility contacted state and local health departments to assist in testing efforts, such as obtaining testing supplies or processing test results.
• Facilities may document the conducting of tests in a variety of ways, such as a log of county positivity rates, schedules of completed testing, and/or staff and resident records. However, the results of the tests must be documented in accordance with standards for protected health information. For residents, the facility must document testing results in the medical record. For staff, including individuals providing services under arrangement and volunteers, the facility must document testing results in a secure manner consistent with requirements specified in §483.80(h)(3).

Surveying for Compliance:

Compliance will be assessed through the following process using the COVID-19 Focused Survey for Nursing Homes:

• Surveyors will ask for the facility's documentation noted in the "Documentation of Testing" section above, and review the documentation for compliance.
• Surveyors will also review records of those residents and staff selected as a sample as part of the survey process.
• If possible, surveyors are to observe how the facility conducts testing in real-time. In this process, surveyors will assess if the facility is conducting testing and specimen collection in a manner that is consistent with current standards of practice for conducting COVID-19 tests, such as ensuring PPE is used correctly to prevent the transmission of the virus. If observation is not possible, surveyors are to interview an individual responsible for testing and inquire on how testing is conducted (e.g., "what are the steps taken to conduct each test?").
• If the facility has a shortage of testing supplies or cannot obtain test results within 48 hours, the surveyor is to ask for documentation that the facility contacted state and local health departments to assist with these issues.

Facilities that do not comply with the testing requirements in §483.80(h) will be cited for noncompliance at F tag 886. Additionally, enforcement remedies (such as civil money penalties) will be imposed based on the resident outcome (scope and severity of the noncompliance).

If the facility has documentation that demonstrates their attempts to perform and/or obtain testing in accordance with these guidelines (e.g., timely contacting state officials, multiple attempts to identify a laboratory that can provide testing within 48 hours), surveyors should not cite the facility's lack of resources.

COVID-19 Focused Survey for Nursing Homes Tool:

CMS is revising the COVID-19 Focused Survey for Nursing Homes tool to reflect the new testing requirements implemented by the IFC, as well as other updates, to help ensure an effective assessment of the facility's compliance. The revisions include the selection of a number of residents as a sample to review the facility's application of the standards on that sample to ensure the facility is implementing the appropriate infection prevention standards.

CMS is also revising the survey process to include the assessment of compliance with the requirements for facilities to designate one or more individuals as the infection preventionist(s) (IPs) who are responsible for the facility's infection prevention and control program as required by 42 CFR §483.80(b). Noncompliance related to this requirement will be cited at tag F882.