CMS Issues Additional Guidance on Staff Testing and Reporting Requirements
Earlier this week, we reported that the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with a comment period that revises regulations in several areas for long term care facilities and other providers.
As highlighted this rule establishes a new requirement for long term care facilities for COVID-19 testing of residents and staff. CMS did not establish a specific frequency or criteria for testing in the rule but listed potential criteria that will be considered and addressed further in guidance.
The regulations are effective immediately upon their publication at the Office of the Federal Register. Most of the new regulations are applicable only for the duration of the COVID-19 public health emergency. CMS is providing a 60-day comment period for public input on these requirements.
Read here a more detailed analysis and summary of additional provisions in the rule.
CMS Issues Two QSO Memos on Staff Testing and CLIA Reporting Requirements
#1 QSO Memo 20-38-NH: Complying with 483.80(h) Testing of Staff Regulations and New F-tag (F-886)
CMS issued a QSO memo 20-38 that outlines details on how to comply with new interim final rule 483.80(h) requiring COVID-19 testing of staff. AHCA has summarized the guidance, but we recommend members read the entire QSO memo as this regulation goes into effect as soon as the interim final rule is published in the Federal register.
At a high level, the QSO memo outlines:
CMS is requiring facilities to conduct three types of testing:
Symptomatic Testing: Test any staff or residents who have signs or symptoms of COVID-19 (facility must continue screening all staff, residents and other visitors).
Outbreak Testing: Test all staff and residents in response to an outbreak (defined any single new infection in staff or any nursing home onset infection in a resident) and continue to test all staff and residents that tested negative every 3-7 days until 14 days has passed since the most recent positive result.
CMS has also provided requirements related to the following, which are further explained in AHCA’s summary here.
- Types of tests (antigen and PCR)
- Definition of facility staff (staff and contractors or vendors who regularly provide care and services)
- Documenting issues with test supplies and shortages
- Dealing with refusals by residents or staff
- Reporting requirements
- Documenting test results
- Conducting tests
- Documenting/demonstrating compliance at F886
#2 QSO Memo 20-37-NH: Requirements of Reporting by Clinical Laboratory Improvement Amendments (CLIA) Certified Labs
CMS issued a QSO memo 20-37 that describes the survey frequency and citations and fines for not compliance with CLIA regulations related to POC antigen testing. AHCA’s summary is available here.