A new emergency final rule with a comment period went into effect on September 2, 2020, making significant changes to the Infection Control Requirements for Participation for long-term care facilities. CMS has also published accompanying guidance to facilities on how to manage the requirements imposed by the new rule. All nursing facilities need to understand and work to implement the new rules and guidance immediately.
Long-Term Care Facility Testing Requirements
The new rule imposes COVID-19 testing requirements on all long-term care facilities for all residents and staff. For purposes of these requirements, staff includes all employees, volunteers, and contractors working at the physical plant of the facility but does not include any remote or offsite employees, volunteers, or contractors. CMS has asked for comments about what testing criteria this new requirement should impose on facilities.
All testing should be done in a manner consistent with current “professional standards of practice” for COVID-19 testing. Since COVID-19 testing practices are still evolving, the standards of practice in place at the time the test was conducted will be applied during surveys or audits for purposes of this requirement. All tests that the facility conducts should be documented in the appropriate resident’s medical record, employee file, or, for individuals providing services at the facility under contract, as provided for under that contract.
The accompanying guidance directs facilities should tailor the frequency of their testing of residents and staff to the specific situation the facility faces. Asymptomatic residents do not ordinarily need to be tested unless they “frequently leave the facility”. This could mean residents who routinely receive dialysis or other services outside the facility. Facilities should routinely test staff based on the testing positivity rate of the county the facility lies in. Facilities should monitor their county’s positivity rate every first and third Monday of the month. However, if the facility identifies a symptomatic individual on-site, the facility should test all symptomatic residents and staff. If the facility has any new confirmed case of COVID-19 in a staff member or a new nursing home onset case of COVID-19 in a resident, the facility should test all residents and staff every three to seven days until there are no new COVID-19 positives for at least 14 days since the last positive test. Asymptomatic staff and residents who have recovered from COVID-19 do not need to be tested for COVID-19 again for three months after original onset of their COVID-19 symptoms. After these three months have passed, the resident should return to normal testing protocol.
Staff who are positive for COVID-19, present symptoms consistent with COVID-19, or have been exposed to COVID-19 should be restricted from coming into work. The return to work criteria established by the CDC should be followed when determining when it is safe for these staff to return to the building. Further, positive, symptomatic, and exposed residents should be appropriately cohorted and isolated to prevent the spread of COVID-19 within the facility. The facility should avoid sharing staff between these cohorted groups. Virginia facilities should also comply with Virginia Department of Labor and Industry emergency regulations addressing workplace safety specific to COVID-19.
The guidance anticipates that some residents and staff may refuse to be tested or be unable to be tested due to medical or anatomical contraindications. Facilities will be required to have procedures in place to address these individuals who refuse or are unable to be tested. Symptomatic staff who refuse to be tested should be prevented from entering the building until the CDC’s return to work criteria are met. If Outbreak Testing (as defined in the guidance) has been triggered, any staff who refuse to be tested should be prevented from entering the building until the facility has no new positive test results for a period of 14 days. Symptomatic residents who refuse to be tested should be placed on transmission-based protocols. If a resident refuses to comply with Outbreak Testing, CMS directs that a facility be extremely vigilant in ensuring a 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.
Facilities will be required to coordinate the obtaining and processing of tests with local and state health departments and local certified laboratories as necessary, especially if the facility is experiencing a shortage of testing supplies or capabilities. The facility’s infection prevention and control plan must take into consideration access to, and acquiring of, adequate testing supplies and any arrangements necessary to conduct, process, and receive test results prior to the administration of the required tests.
CMS notes that, despite the rigorous testing requirements, facilities are still required to provide adequate staffing to maintain and provide a safe environment for both staff and residents. To meet this requirement, facilities will need to assess their ability to replace workers who are temporarily or permanently not able to work with appropriately trained personnel. This assessment should include the minimum number of staff the facility needs to continue to provide and maintain a safe environment.
Documentation of Compliance with the Testing Requirements
To demonstrate compliance during an inspection and help avoid penalties, facilities should make sure that they are constantly documenting all the tests they are completing and the policies and procedures they have in place to comply with these testing requirements. At a minimum, the facility should document:
The results of tests must be documented in accordance with standards for protected health information at all times. Resident test results must be documented in the resident’s medical record. All staff, contractor, and volunteer test results must be documented in a secure manner.
CMPs for Failure to Report COVID-19 Data
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. 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).
CMS will enforce the new reporting requirements by imposing CMPs on facilities who do not report data about COVID-19 in the facility to the CDC National Healthcare Safety Network database weekly as required every time the facility fails to report. A per instance CMP of $1,000 will be imposed the first time the facility fails to report. The amount of the individual per instance CMP will rise by $500 every time the facility is non-compliant with this reporting requirement. A maximum $6,500 CMP can be levied for a violation of this reporting requirement. A Plan of Correction will not be required for this non-compliance and CMP.
These regulatory changes are a new chapter in CMS’s continued efforts to combat the COVID-19 pandemic in nursing facilities. For months, nursing facilities have been implementing measures to keep their residents and staff as safe and healthy as possible during the pandemic. In addition to ensuring that services, testing resources, and policies and procedures in line with the new requirements are in place and followed by all staff, facilities should take immediate steps to review all contracts with vendors currently providing on-site services and modify those contracts as necessary to comply with the new testing documentation requirements. Facilities should ensure that they have the appropriate procedures in place to conduct, document, and track the COVID-19 tests they complete and to report COVID-19 information to the CDC database.
If you or your practice have any questions about this new final rule or would like assistance submitting a comment, please contact Peter Mellette, Harrison Gibbs, Elizabeth Dahl Coleman, or Scott Daisley at Mellette PC.
This client alert is for general educational purposes only. It is not intended to provide legal advice specific to any situation you may have and the linked Client Advisory does not cover all provisions of the final rule and accompanying guidance. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice.
 CMS indicated that these final criteria may include, but would not be limited to 1) testing frequency; 2) identification of residents and staff in the facility diagnosed with COVID-19, 3) identification of residents or staff in the facility with symptoms consistent with COVID-19 or with known or suspected exposure to COVID-19, 4) criteria for conducting testing of asymptomatic residents and staff, and 5) response time for test results.
 See Table 2 in the Guidance Document. If the county positivity rate falls to a lower testing tier, the facility should continue testing at the higher frequency until the county positivity remains in the lower testing tier for two consecutive weeks.
 The Guidance refers to this as “Outbreak Testing.”