Reminder: CDC, CMS Issue New Guidance Affecting Infection Control Practices – Testing, Visitation, Source Control

The Centers for Disease Control and Prevention (CDC) recently released updates to infection control guidance. In turn, the Centers for Medicare and Medicaid Services (CMS) updated its own guidance for nursing homes in those subject areas to align with CDC’s new recommendations.

Please see the summary below. Stay tuned for more information as it becomes available.

CDC notes that these updates have been made to reflect the high levels of vaccine- and infection-induced immunity and the availability of effective treatments and prevention tools.

The key changes outlined in the new CDC guidance for COVID-19 infection prevention and control update, also incorporated into CMS guidance (see QSO 20-38-NH Revised for CMS testing updates, 20-39-NH Revised for visitation updates) include:

  • Vaccination status no longer is used to inform source control, screening testing, or post-exposure (e.g., work restriction, quarantine) recommendations.
  • Standalone guidance for nursing homes is being archived and any setting-specific recommendations has been added to Section 3 of the main guidance.

SOURCE CONTROL CHANGES:
  • When community transmission levels are high, source control is recommended for everyone in areas where they could encounter patients. Health care personnel could choose not to wear source control when in areas restricted from patient access (if Community Levels aren’t also high and don’t meet criteria below).
  • When community transmission levels are not high, source control is recommended for individuals who:
  • Have suspected or confirmed respiratory infection.
  • Had close contact with someone with COVID-19 for 10 days after contact.
  • Reside or work in an area of the facility experiencing COVID-19 outbreak.
  • Have otherwise had source control recommended by public health.
  • Even if not otherwise required by the facility, individuals should always be allowed to wear source control based on personal preference.

UNIVERSAL PPE CHANGES:
  • Consider implementing PPE when Community Transmission levels are high.
  • N95 in select situations (e.g., aerosol-generating procedures such as nebulizer treatments).
  • Eye protection during patient care encounters.

TESTING CHANGES:
  • Series of 3 tests recommended for asymptomatic individuals following exposure to someone with COVID-19 infection.
  • Testing is recommended immediately (but generally not earlier than 24 hours after the exposure) and, if negative, again 48 hours after the first negative test, and, if negative, again 48 hours after the second negative test. This will typically be at day 1 (where day of exposure is day 0), day 3, and day 5.
  • Testing is generally not recommended for asymptomatic individuals who have recovered in the prior 30 days.
  • If testing, antigen test is recommended.
  • Antigen test is also recommended for those within 31-90 days of infection.

Note: The Centers for Medicare & Medicaid Services (CMS) released an update to QSO Memo QSO-22-25-CLIA​​ which rescinds enforcement discretion for the use of SARS-CoV-2 tests not FDA approved for use among asymptomatic individuals outside of the test’s instructions for use.

At the start of the pandemic, some but not all of the SARS-CoV-2 Point-of-Care (POC) Antigen (Ag) tests were limited to use on individuals who are symptomatic. Thus, in December 2020, CMS released a memo saying it would use enforcement discretion to allow providers with CLIA Certificate of Waiver to use these tests outside of the FDA approved manufacturer’s use. CMS has now rescinded this memo as many POC Ag tests are now approved for both symptomatic patients AND serial screening of asymptomatic patients making the waiver no longer necessary.

AHCA/NCAL recommends that all LTC providers operating with a CLIA Certificate of Waiver using SARS-CoV-2 POC Ag tests check the manufacturer’s instructions for the tests they have on hand to ensure they FDA approved for both symptomatic and asymptomatic individuals. If not, they must restrict the use of the tests to situations consist​ent with FDA approval. Providers should check the FDA list for allowed uses of existing antigen tests and use them consistent with the FDA and manufacturer’s approval. Providers that violate the manufacturer’s use may be subject to enforcement actions related to the facility’s CLIA Certificate of Waiver.

Most Ag tests are currently approved for testing among individuals with symptoms of COVID-19 or serial testing on asymptomatic individuals (e.g. tested twice over three days with at least 24 hours (and no more than 48 hours) between tests). The FDA website has a list​ of all manufacturers with Ag tests where facilities can find the manufacturer’s instructions for use. Providers may want to consider purchasing Ag tests that can be used in all situations to avoid inadvertently misusing antigen tests.​

WHCA/WiCAL has reached out to state officials to share providers’ confusion over two somewhat inconsistent directives, the first being QSO20-38-NH Revised, which states, “Routine testing of asymptomatic staff is no longer recommended but may be performed at the discretion of the facility,” and the second being this new CLIA guidance, which states, “CMS is rescinding the enforcement discretion that allowed Certificate of Waiver labs to perform SARS-CoV-2 molecular and antigen Point of Care (POC) tests on asymptomatic individuals outside of the test’s authorization.”

Initial response from the state includes:

        • Facilities should review the instructions for use (IFU) on the antigen tests they have in-house and may use on asymptomatic individuals. Some packages may indicate that they cannot be used for asymptomatic individuals at all except under an emergency use authorization and some kits may say they can be used for asymptomatic individuals when done as part of a serial testing process (at least 2 tests in a specific timeframe).The CMS guidance would essentially mean that the antigens used under emergency use authorization should stop, but those that still meet the intended packaging instructions could be used in that manner.
        • The CMS memo guidance was updated to align with the CDC health care settings guidance released on Friday, which no longer recommends blanket routine testing for staff. It leaves it to the discretion of the facility instead. Facilities should take into consideration any policies or procedures they have in place that name routine screening as part of those exempted from the CMS vaccine mandate, however.

SCREENING TESTING CHANGES:
  • No longer recommending asymptomatic screening testing of nursing home personnel who have not had a recognized exposure.
  • Screening testing remains recommended for new admissions to nursing homes when community transmission levels are high.

QUARANTINE/WORK RESTRICTION CHANGES:
  • No longer routinely recommending quarantine (for patients) or work restriction (for healthcare personnel) for asymptomatic individuals following COVID-19 exposures.
  • Continue to emphasize:
  • Monitoring for symptoms.
  • Series of 3 tests.
  • Continued use of source control for 10 days following the exposure.
  • Prompt isolation or work restriction if symptoms develop or testing is positive for COVID-19 infection.

SETTINGS SUCH AS ASSISTED LIVING/GROUP HOMES:
  • Long term care settings (excluding nursing homes) whose staff provide “non-skilled personal care” like that provided by family members in the home (e.g., many assisted living communities, group homes), should follow guidance for high-risk congregate care settings.
  • Visiting or shared health care personnel who enter the setting to provide health care to one or more residents (e.g., physical therapy, wound care, intravenous injections, or catheter care provided by home health agency nurses) should follow the health care IPC recommendations in the guidance.

The following Interim Guidance for Managing Healthcare Personnel with COVID-19 Infection or Exposure to COVID-19, include:
  • In most circumstances, asymptomatic HCP with higher-risk exposures do not require work restriction.
  • Updated recommendations for testing frequency to detect potential for variants with shorter incubation periods and to address the risk for false negative antigen tests in people without symptoms.
In addition, the following key points were noted in the updated Strategies to Mitigate Healthcare Personnel Staffing Shortages | CDC.
  • Conventional strategies were updated to advise that, in most circumstances, asymptomatic health care personnel (HCP) with higher-risk exposures do not require work restriction, regardless of their vaccination status; therefore, the contingency and crisis strategies about earlier return to work for these HCP was removed.

AHCA WEBINAR

The American Heath Care Association (AHCA) held a members-only webinar on Friday, September 30. Central. Senior members of the AHCA Quality & Regulatory team reviewed recent updates to COVID-19 guidance for nursing homes from the Centers for Disease Control and Prevention and Centers for Medicare & Medicaid Services.

Members may view the recorded webinar HERE.

 

Posted in Regulatory