AFL 20-53.5 From the California Department of Public Health
August 3, 2021
TO: Skilled Nursing Facilities
SUBJECT: Coronavirus Disease 2019 (COVID-19) Mitigation Plan Recommendations for Testing of Health Care Personnel (HCP) and Residents at Skilled Nursing Facilities (SNF)
(This AFL supersedes AFL 20-53.4)
All Facilities Letter (AFL) Summary
- This AFL provides updated recommendations from the California Department of Public Health (CDPH) for SNFs conducting diagnostic screening testing of SNF health care personnel (HCP), and response-driven testing of SNF residents and HCP to prevent spread of COVID-19 in the facility informed by CDC recommendations and CMS requirements.
- This AFL updates and clarifies CDPH routine diagnostic screening testing guidance for SNF HCP based upon their individual COVID-19 vaccination status and the SNF’s percentage of residents and HCP that are fully vaccinated.
- This revision includes reference to the July 26, 2021 Public Health Order requiring SARS-CoV-2 diagnostic screening testing for SNF healthcare personnel (HCP) that are unvaccinated or incompletely vaccinated.
Updated Testing Guidance Based Upon Progress with COVID-19 Vaccination
Routine SARS-CoV-2 diagnostic screening testing of SNF HCP, and response testing of SNF residents and HCP have been essential to protect the vulnerable SNF population. The purpose of this AFL revision is to update testing recommendations for SNF residents and HCP in the context of COVID-19 vaccination.
SNF HCP and residents were among the first groups prioritized for COVID-19 testing and vaccination as soon as vaccines became available in late December 2020. California SNFs have made progress vaccinating their HCP and residents, with approximately 82% (low-end estimate based on available data) of all California skilled nursing facility (SNF) residents fully vaccinated* as of May 6, 2021. Estimates of the interim effectiveness of currently authorized mRNA COVID-19 vaccines in preventing SARS-CoV-2 infection range between 86%-90% [1-3], regardless of symptomatic status. Overall COVID-19 incidence statewide, and incidence and outbreaks in SNFs, have declined dramatically since January 2021 and currently remain stably low as of the release of this revised AFL.
Rationale
Interpretation and management of positive molecular tests in asymptomatic, fully vaccinated HCP tested as part of routine screening can be challenging. Although COVID-19 vaccination will not influence the results of viral (nucleic acid or antigen) COVID-19 tests and positive tests should not be attributed to the COVID-19 vaccine, CDPH has observed fully vaccinated asymptomatic HCP testing positive by molecular tests with Cycle Threshold (Ct) values >34 suggesting that the person has a low viral load and is unlikely to be infectious to others. The usefulness of routine diagnostic screening testing of asymptomatic HCP who are fully vaccinated as a measure to reduce transmission risk and prevent outbreaks in SNF without current COVID-19 cases is accordingly limited. CDC and CMS now no longer require routine diagnostic screening testing for asymptomatic HCP who are fully vaccinated (i.e., ≥2 weeks following receipt of the second dose in a 2-dose series, or ≥2 weeks following receipt of one dose of a single-dose vaccine).
In addition to the guidance provided below, facilities must comply with requirements set forth in the July 26, 2021 Public Health Order requiring diagnostic screening testing of unvaccinated and incompletely vaccinated HCP. For information on these requirements, please see AFL 21-28.
Updated Routine Diagnostic Screening Testing of HCP
SNFs may discontinue routine diagnostic screening testing of asymptomatic HCP who are fully vaccinated and work in a facility where ≥70% of residents and ≥70% of HCP are fully vaccinated; otherwise, routine diagnostic screening testing of asymptomatic HCP should continue in all HCP regardless of their vaccination status. SNFs that modify their routine diagnostic screening testing program for HCP must understand that:
- Routine diagnostic screening testing at a minimum weekly cadence should continue for SNF HCP who are unvaccinated or partially vaccinated. SNFs should implement strategies to increase and maintain vaccination coverage among HCP as high as possible, including verifying vaccination status of new hires, and offering education, listening sessions, counseling, and vaccination at every opportunity, even to those HCP who have previously refused.
- Testing should continue to be performed for HCP with signs or symptoms consistent with COVID-19, regardless of their vaccination status.
- Testing should continue to be performed for HCP with higher-risk exposures to SARS-CoV-2 (i.e., as part of response testing); asymptomatic fully vaccinated HCP with higher-risk exposures do not need to be excluded from work following their exposure (AFL 21-08.3).
SNFs must daily monitor the percentage of their residents and HCP that are fully vaccinated and resume routine diagnostic screening testing of all HCP (regardless of vaccination status) within one week if the percentage of residents and HCP fully vaccinated drops below 70%. Testing should continue for at least 2 weeks and continue until meeting the required ≥70% of residents and HCP are fully vaccinated for one full week. SNFs should implement strategies to maintain vaccination coverage ≥70% or as high as possible among residents and HCP by verifying vaccination dates and status of new admissions, and offering education, listening sessions, counseling, and vaccination at every opportunity to residents and HCP, even to those residents or HCP who have previously refused.
Testing and Quarantine for Newly Admitted and Readmitted Residents
CDC has also updated testing and quarantine guidance for newly admitted and readmitted residents, based on their vaccination status.
- Testing and quarantine is no longer required for newly admitted and readmitted residents if they are fully vaccinated and have not had prolonged close contact (within 6 feet for a cumulative total of 15 minutes or more over a 24-hour period) with someone with SARS-CoV-2 infection within the prior 14 days.
- Testing is still recommended for unvaccinated or partially vaccinated newly admitted residents prior to admission, including transfers from hospitals or other healthcare facilities. If the hospital does not test the patient within 72 hours prior to transfer, the SNF must test upon admission. Results for asymptomatic patients tested in the hospital do not have to be available prior to SNF transfer. SNFs may not require a negative test result prior to accepting a new admission. If tested at the hospital, two negative tests are not required prior to transfer.
- Unvaccinated or partially vaccinated residents newly admitted from the hospital should be quarantined in single rooms or a separate observation area (“yellow-observation”) for 14 days from the date of last potential exposure and then retested. If negative, the resident can be released from quarantine.
- SNFs may consider acute care hospital days as part of the quarantine observation period for unvaccinated or partially vaccinated new admissions as long as the following criteria are met:
- SNF is in regular communication with their local health department (LHD) and/or the hospital infection preventionist and/or occupational health program, and there is no suspected or confirmed COVID-19 transmission among patients or staff at the hospital.
- Testing and 14-day quarantine are recommended for unvaccinated or partially vaccinated residents readmitted after hospitalization or who leave the SNF for more than 24 hours, as well as for residents who leave the SNF for ambulatory care (e.g., emergency department, outpatient procedures, dialysis or other clinic visits) when there is suspected or confirmed COVID-19 transmission at the outside facility.
- Testing and quarantine are not required for hospitalized residents who tested positive for COVID-19 and met criteria for discontinuation of isolation and precautions prior to SNF admission or readmission.
- SNFs should consider periodic (for example, weekly) diagnostic screening testing for unvaccinated and partially vaccinated residents who regularly leave the SNF for dialysis; in the absence of suspected or confirmed COVID-19 transmission at the dialysis center, residents who leave the facility for dialysis do not need to be quarantined in a “yellow-observation” or “yellow-exposed” area.
Diagnostic Testing for Symptomatic Individuals
Residents or HCP with signs or symptoms potentially consistent with COVID-19 should be tested immediately to identify current infection, regardless of their vaccination status; SNFs should not delay testing of symptomatic individuals until scheduled diagnostic screening or response-driven testing.
Response Testing
As soon as possible after one (or more) COVID-19 positive individuals (resident or HCP) is identified in a facility, serial retesting of all residents and HCP who test negative upon the prior round of testing (regardless of their vaccination status) should be performed every 3-7 days until no new cases are identified among residents in sequential rounds of testing over 14 days; the facility may then resume their previous routine diagnostic screening testing schedule for HCP.
Place residents into three separate cohorts based on the test results, accordingly, and regardless of their vaccination status:
- Positive result, for the duration of the resident’s isolation period (“red” area); fully vaccinated residents who test positive and are asymptomatic should be isolated and observed for development of symptoms while additional evaluation is conducted in consultation with the local health department.
- Negative result but exposed within the last 14 days (“yellow-exposed” area); in general, all residents on the unit or wing where a case was identified in a resident or HCP are considered exposed and should remain in their current rooms unless sufficient private rooms are available.
- Negative result without known exposure within the last 14 days and recovered residents who have completed their isolation period (“green” area).
Red Area: The COVID-19 positive cohort should be housed in a separate area (building, unit or wing) of the facility and have dedicated HCP who do not provide care for residents in other cohorts and should have separate break rooms and restrooms if possible.
Housing symptomatic individuals undergoing COVID-19 testing: If available, private rooms should be prioritized for residents with symptoms consistent with COVID-19, while testing is pending.
NOTE: SNFs that currently do not have any positive cases and do not have a current need for a red area should remain prepared to quickly reestablish the red area and provide care for, and accept admission of, COVID-19 positive residents.
Residents or HCP with previous positive tests: Facilities should follow CDC guidance to determine when a resident or HCP who tests positive should be included in subsequent facility-wide response testing (e.g., in response to a new outbreak). Residents or HCP who had a positive viral test in the past three months and are now asymptomatic do not need to be retested as part of facility-wide testing. Testing of asymptomatic residents and HCP should be considered again (e.g., in response to an exposure) only after three months have passed from the date of onset of the prior infection. For residents or HCP who develop new symptoms consistent with COVID-19 during the three months after the date of initial symptom onset, if an alternative etiology cannot be identified, then retesting can be considered in consultation with the medical director, infectious disease or infection control experts. Quarantine, isolation and transmission-based precautions may also be considered during this evaluation based on consultation with the medical director or an infection control expert, especially in the event symptoms develop within 14 days after close contact with an infected person.
Procedures for the Duration of Isolation of Residents and Work Exclusion of HCP Who Test Positive:
Residents Who Test Positive for COVID-19
- Residents who test positive and are symptomatic should be isolated (regardless of their vaccination status) until the following conditions are met:
- At least 10 days have passed since symptom onset; AND
- At least 24 hours have passed since resolution of fever without the use of fever-reducing medications; AND
- Any other symptoms have improved
- NOTE: The timeframe from symptom onset could be extended to up to 20 days for individuals who are severely immunocompromised (e.g., currently receiving chemotherapy, or recent organ transplant), or who had critical illness (e.g., required intensive care).
- Fully vaccinated residents who test positive and are asymptomatic should be isolated and observed for development of symptoms while additional evaluation is conducted in consultation with the local health department.
HCP Who Test Positive for COVID-19
- HCP who test positive and are symptomatic should be excluded from work, regardless of their vaccination status. They may return to work after the following conditions are met:
- At least 10 days have passed since symptom onset; AND
- At least 24 hours have passed since resolution of fever without the use of fever-reducing medications; AND
- Any other symptoms have improved
- NOTE: The timeframe from symptom onset could be extended to up to 20 days for individuals who are severely immunocompromised (e.g., currently receiving chemotherapy, or recent organ transplant), or who had critical illness (e.g., required intensive care).
- Fully vaccinated HCP who test positive and are asymptomatic should be excluded from work and observed for development of symptoms while additional evaluation is conducted in consultation with the local health department.
- If staffing shortages are present, HCP who test positive and are asymptomatic can continue to work following CDC Guidance on Mitigating Staffing Shortages, as long as they are only caring for residents with confirmed COVID-19, preferably in a cohort setting. Asymptomatic positive HCP must maintain separation from other HCP as much as possible (for example, use a separate breakroom and restroom) and wear a facemask for source control at all times while in the facility. Asymptomatic positive HCP may not care for residents who have not tested COVID-19 positive until at least 10 days from the date of their positive test.
Reporting Test Results
Facilities conducting tests under a Clinical Laboratory Improvement Amendments of 1988 (CLIA) certificate of waiver are subject to regulations that require laboratories to report data for all testing completed, for each individual tested. CDPH has updated the requirements for reporting non-positive COVID-19 antigen results:
- Any laboratories conducting SARS-CoV-2 antigen testing must report all positive test results through the CalREDIE Electronic Laboratory Reporting system (ELR) within eight hours from the time the laboratory notifies the health care provider or other person authorized to receive the report.
- Reporting of non-positive (negative, indeterminate, and specimen unsatisfactory) antigen test results through the CalREDIE Electronic Laboratory Reporting system (ELR) is encouraged, but not required.
During focused infection control surveys, surveyors will be monitoring whether the facility is complying with the CLIA laboratory reporting requirements and reporting any concerns to the CMS Division of Clinical Laboratory Improvement and Quality. 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), in accordance with 42 CFR § 483.80(g)(1)–(2). SNFs must demonstrate their compliance with testing requirements by documenting the following information:
- 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.
- 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.
- When a 48 hour turnaround time for testing cannot be met due to testing supply shortages, the facility should document its efforts to obtain quick turnaround test results with the identified laboratory or laboratories and contact to the local and state health department.
SNFs have submitted proposed COVID-19 testing plans to their local Licensing and Certification Program District Office. Although CDPH is no longer conducting separate mitigation surveys, SNFs should continue use of the strategies developed as part of their SNF Mitigation plans and integrate them into their infection control and emergency preparedness plans. As testing and mitigation strategies change based on updated CDC or CMS guidance, updated plans and policies and procedures will need to be revised.
SNFs must understand that testing does not replace or preclude other infection prevention and control interventions, including monitoring all HCP and residents for signs and symptoms of COVID-19, universal masking by HCP and residents for source control, use of recommended personal protective equipment, and environmental cleaning and disinfection. When testing is performed, a negative test only indicates an individual did not have detectable infection at the time of testing; individuals might have SARS-CoV-2 infection that is still in the incubation period or could have ongoing or future exposures that lead to infection.
SNFs may submit any questions about infection prevention and control of COVID-19 to the CDPH Healthcare-Associated Infections Program via email at HAIProgram@cdph.ca.gov or novelvirus@cdph.ca.gov.
If you have any questions about this AFL, please contact the CDPH Healthcare-Associated Infections Program via email at HAIProgram@cdph.ca.gov.
If you have any questions about state testing prioritization plans, please contact the Testing Taskforce at testing.taskforce@state.ca.gov.
Sincerely,
Original signed by Cassie Dunham
Cassie Dunham
Acting Deputy Director
Resources:
- CDPH Updated Testing Guidance
- CalREDIE Manual Lab Reporting Module (PDF)
- CMS QSO 20-38 (PDF)
- CDC Duration of Isolation and Precautions for Adults with COVID-19
- CDC Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection (Interim Guidance)
- AFL 20-52 COVID-19 Mitigation Plan Implementation and Submission Requirements for SNFs and Infection Control Guidance for HCP
- Lab Resources for Testing
- Department of Managed Health Care COVID-19 Testing FAQ (PDF)
- Department of Managed Health Care COVID-19 webpage
- CDC Nursing Homes Testing Recommendations
- CDC Long-Term Care Facility Wide Testing
- Nursing Home Preparing for COVID-19
- CDC Guidance on Mitigating Staffing Shortages
- CDPH Guidance on the Use of Antigen Tests for Diagnosis of Acute COVID-19
- Public Health Order
[1] People are considered fully vaccinated for COVID-19: two weeks or more after they have received the second dose in a 2-dose series (Pfizer-BioNTech or Moderna or vaccine authorized by the World Health Organization), or two weeks or more after they have received a single-dose vaccine (Johnson and Johnson [J&J]/Janssen ).
[2] CDC Defines quarantine as separate and restrict the movement of people who were exposed to a contagious disease to see if they become sick. CDC Quarantine and Isolation
[3] According to CDC, screening testing is performed to identify persons who may be contagious so that measures can be taken to prevent further transmission, for example in a congregate living setting such as a skilled nursing facility. This was referred to as surveillance testing in prior versions of this AFL. The terminology change aligns with new CDC testing guidance.