Yesterday, CMS released guidance related to Long-Term Care (LTC) facility COVID-19 testing requirements and a revised COVID-19 Focused Survey Tool. CMS has added a new regulation at 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.
This regulation requires facilities to conduct testing based on parameters, including but not limited to:
- Testing frequency
- The identification of any individual diagnosed with COVID19 in the facility;
- The identification of any individual with symptoms consistent with COVID-19 or with known or suspected exposure to COVID-19;
- The criteria for conducting testing of asymptomatic individuals, such as the positivity rate of COVID-19 in a county;
- The response time for test results; and
- Other factors specified by the Secretary that help identify and prevent the transmission of COVID-19.
Facilities must conduct testing in a manner that is consistent with current standards of practice for conducting COVID-19 tests. For each instance of testing, facilities must:
- Document that testing was completed and the results of each staff test; and
- 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, facilities must take actions to prevent the transmission of COVID-19. Facilities must have procedures for addressing residents and staff, including individuals providing services under arrangement and volunteers, who refuse testing or are unable to be tested and when necessary, such as in emergencies due to testing supply shortages, facilities must 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 (POC) diagnostic testing devices (only if the facility has a CLIA Certificate of Waiver) or through an arrangement with an offsite laboratory.
Regardless of the frequency of testing being performed or the facility’s COVID-19 status, facilities must continue to screen all staff (each shift), each resident (daily), and all persons entering the facility, such as vendors, volunteers, and visitors, for signs and symptoms of COVID-19. When prioritizing individuals to be tested, facilities should prioritize staff and residents with signs and symptoms of COVID-19 first, then perform testing triggered by an outbreak (any new case arising in facility), and then routine testing.
Staff and residents with signs or symptoms of COVID-19 must be tested. Staff are expected to be restricted from the facility pending the results of the COVID-19 testing and if confirmed, follow the CDC criteria for return to work. Residents with signs or symptoms should be placed on transmission-based precautions and once test results are obtained, the facility must take appropriate action based on the results.
For testing triggered by an outbreak (a new COVID-19 infection in any staff or resident), all staff and residents should be tested, and all staff and residents that tested negative should be retested every 3 days to 7 days until testing identifies no new cases of COVID-19 infection among staff or residents for a period of at least 14 days since the most recent positive result. For individuals who test positive, repeat testing is not recommended, instead, facilities should follow CDC guidance for discontinuing transmission-based precautions and the CDC criteria for return to work.
Routine testing should be based on the extent of the virus in the community; therefore, facilities should use their county positivity rate in the prior week as the trigger for staff testing frequency. Reports of COVID-19 county-level positivity rates will be available on the following website by August 28, 2020 (see section titled, “COVID-19 Testing”): https://data.cms.gov/stories/s/COVID-19-Nursing-Home-Data/bkwz-xpvg
For facilities in counties with positivity rate <5% in the past week, staff testing must be completed at least once a month. For those in counties with positivity rate of 5-10% in past week, testing must be completed at least once a week and for those in counties with positivity rates >10%, twice a week testing is required. This frequency presumes availability of point of care testing on-site at the facility or availability of off-site testing with a turnaround time <48 hours. If the 48-hour turn-around time cannot be met due to community testing supply shortages, limited access or inability of laboratories to process tests within 48 hours, the facility must 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.
Routine testing of asymptomatic residents is not recommended unless prompted by a change in circumstances, such as the identification of a confirmed COVID-19 case in the facility. Facilities may consider testing asymptomatic residents who leave the facility frequently, such as for dialysis or chemotherapy. Facilities should inform resident transportation services (such as non-emergency medical transportation) and receiving healthcare providers (such as hospitals) regarding a resident’s COVID-19 status to ensure appropriate infection control precautions are followed.
All facilities should begin routine testing all staff at the prescribed frequency based on the county positivity rate reported in the past week. Facilities must 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. If the county positivity rate increases to a higher level of activity, the facility must begin testing staff at the prescribed frequency as soon as the criteria for the higher activity are met. If the county positivity rate decreases to a lower level of activity, the facility must continue testing staff at the higher frequency level until the county positivity rate has remained at the lower activity level for at least two weeks before reducing testing frequency.
Staff and residents who have recovered from COVID-19 and are asymptomatic do not need to be retested for COVID-19 within 3 months after symptom onset. Until more is known, testing should be encouraged again (e.g., in response to an exposure) 3 months after the date of symptom onset with the prior infection.
For residents or staff who test positive, facilities should contact the appropriate state or local entity for contact tracing. While not required, facilities may test residents’ visitors to help facilitate visitation while also preventing the spread of COVID-19. Facilities should prioritize resident and staff testing and have adequate testing supplies to meet required testing, prior to testing resident visitors.
For the purpose of the new testing requirements, “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. For the purpose of testing “individuals providing services under arrangement and volunteers,” facilities should prioritize those individuals who are regularly in the facility (e.g., weekly) and have contact with residents or staff. If a vendor or volunteer receives testing from another source, the facility is still required to obtain documentation that the required testing was completed during the timeframe that corresponds to the facility’s testing frequency.
Facilities must have procedures in place to address staff and residents 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. If outbreak testing has been triggered and a staff member refuses testing, the staff member should be restricted from the building until the procedures for outbreak testing have been completed. In discussing testing with residents, staff should use person-centered approaches when explaining the importance of testing for COVID-19. Procedures should ensure that residents who have signs or symptoms of COVID-19 and refuse testing are placed on TBP until the criteria for discontinuing TBP have been met. If outbreak testing has been triggered and an asymptomatic resident refuses testing, the facility should be extremely vigilant, such as through additional monitoring, to ensure the resident maintains appropriate distance from other residents, wears a face covering, and practices effective hand hygiene until the procedures for outbreak testing have been completed. If a resident has symptoms consistent with COVID-19 or has been exposed to COVID-19, or if there is a facility outbreak and the resident declines testing, he or she should be placed on or remain on TBP until he or she meets the symptom-based criteria for discontinuation.
The guidance includes documentation that CMS expects facilities to maintain in regards to testing that surveyors will ask for during the COVID-10 Focused Survey, which includes:
- 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. All residents and staff that tested negative are expected to be retested until testing identifies no new cases of COVID-19 infection among staff or residents for a period of at least 14 days since the most recent positive result (see section Testing of Staff and Residents in response to an outbreak above).
- 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.