In this week’s Ftag of the Week on the CMSCG Blog, we will continue to review the newly implemented F886 COVID-19 Testing – Residents & Staff. First, let’s continue to discuss testing. Here are some key points:
- 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. This is consistent with current CDC recommendations.
- Individuals who have been determined to be potentially infectious should be evaluated and remain isolated until they meet established criteria for discontinuation of isolation or discontinuation of transmission-based precautions, depending on the circumstances.
- It is not required that facilities test visitors, but CMS notes that facilities may test to facilitate visitation. However, resident and staff testing should be prioritized, and facilities should ensure they have adequate testing supplies to meet requirements before they consider testing visitors.
Conducting Testing
- Facilities are required to provide or obtain lab services to meet the needs of its residents. If the facility provides its own lab services or performs lab tests, it must have a current CLIA certificate appropriate for the level of testing that is being performed.
- A physician order must be obtained for COVID-19 testing. If there are issues related to lab orders or point-of-care testing, surveyors will investigate at F773.
- Point-of-Care tests must be ordered by a licensed healthcare professional. The facility must have an order from a healthcare professional or pharmacist to perform a rapid POC COVID-19 test.
- Tests must be conducted in accordance with nationally recognized guidelines. There are multiple guidelines from the CDC listed in the QSO Memo.
- There are two types of diagnostic tests that detect active virus. One is a molecular test and the other is an antigen test. Antibody tests do not identify active coronavirus infections, so conducting an antibody test on a staff member or resident does not meet the requirements under this regulation.
- The IG for this regulation states that for resident tests, the approach taken when selecting the test should be person-centered.
- During specimen collection, the facility must maintain proper infection control and use recommended PPE, including an N95 or higher-level respirator (or facemask if respirator is not available), eye protection, gloves and a gown. The specimen should be collected and stored, if necessary, in accordance CDC guidelines and the manufacturer’s instructions for the test. The QSO Memo includes multiple links to CDC guidance on proper specimen collection for your reference.
Reporting Results
- Facilities that are conducting tests under a CLIA certificate of waiver must follow the regulations which require labs to report data for all tests that are completed for every individual who is tested. CMS issued an accompanying QSO Memo along with this one regarding updated requirements for reporting of COVID tests by CLIA labs, including what nursing homes are required to do.
- Facilities are required to report COVID-19 information to the CDC NHSN. This must happen even if the facility is reporting data in accordance with the above-mentioned CLIA requirements.
- If a surveyor identifies a concern related to reporting new or suspected cases of COVID-19 to residents or their representatives, the surveyor will investigate under F885.
- If there are concerns related to reporting of communicable diseases or outbreaks, including to meet contract tracing requirements, surveyors are instructed to investigate under F880.
Documentation Requirements
Documentation must be completed to show compliance with testing requirements set out under this regulation. While there is flexibility in how the facility may document conducting of tests, the results must be documented in accordance with standards for protected health information (PHI). This means that for residents, the facility is required to document test results in the resident’s medical record and for staff, the facility should document the test results in a secure manner.
- For staff – Documentation must be completed to show that testing was completed and the results of each staff test are included
- The IG states that facilities should prioritize testing for any individuals who are regularly in the facility and have contact with residents.
- If an individual is being tested elsewhere, the facility is still responsible for obtaining documentation that the testing was completed during required timeframes that corresponds to the facility’s testing frequency.
- For routine staff testing, documentation should include –
- Facility’s county positivity rate
- Corresponding testing frequency indicated
- Date(s) that testing was performed for all staff and the results of each test
- For residents – Documentation must reflect that testing was offered and completed (as appropriate to the resident’s testing status). Documentation should be put in the resident’s record, including the results of each test.
- When there is a new COVID-19 case in the facility –
- 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 re-tested
- The results of all tests
- All residents and staff that tested negative must be re-tested every 3 to 7 days until there are no new cases of COVID-19 infection identified by testing among residents or staff for at least 14 days since the most recent positive result was identified.
- Refusals – The facility’s procedures for addressing staff and residents who refuse testing or are unable to be tested must be documented. The facility must document any staff or residents who refused or were unable to be tested and how those cases were addressed by the facility.
- When there is a shortage of testing supplies, the facility must document that it contacted state and local health departments to assist with testing efforts.
The requirements for testing seem to be increasingly time-consuming and burdensome for providers as we continue to navigate our way through the COVID-19 PHE, but for the foreseeable future, it seems that testing requirements will not be going away anytime soon. Don’t forget that your individual state’s regulations – which supersede federal requirements – may be more restrictive than these federal requirements, so it is important to watch for guidance from your state health department to ensure you are in compliance with all testing requirements.
You can view the full regulatory guidance for F886 in this CMS QSO Memo. If you missed Part 1 of our Ftag of the Week, please click here to view that post on the CMSCG Blog.