AFL 20-53.3 From the California Department of Public Health
September 12, 2020
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 20-53.2)
All Facilities Letter (AFL) Summary
- This AFL provides recommendations from the California Department of Public Health (CDPH) for SNFs developing COVID-19 Mitigation Plans. This includes recommendations for baseline, screening, and response-driven testing of SNF residents and HCP to prevent spread of infection in the facility.
- This revision updates and clarifies testing guidelines to align with the Centers for Medicare and Medicaid Services (CMS) interim final rule on facility and resident COVID-19 testing and terminology from new Centers for Disease Control and Prevention (CDC) testing guidance, and includes the use of point of care (POC) antigen test instruments.
General Testing Guidance
SNFs have been severely impacted by COVID-19, with outbreaks causing high morbidity and mortality. The vulnerable nature of the SNF population combined with the inherent risks of congregate living in a healthcare setting requires aggressive efforts to limit COVID-19 exposure and to prevent the spread of COVID-19 within SNFs.
Establishing a plan for baseline, screening, and response-driven testing of SNF residents and HCP is necessary to protect the vulnerable SNF population. 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.
CDPH recommends SNFs include testing strategies informed by the CDC recommendations and CMS requirements in their COVID-19 Mitigation plans (announced in AFL 20-52). This plan should be developed in conjunction with CDPH and their local health department (LHD) and include:
Baseline Testing of SNF Residents and HCP
- SNFs were directed to conduct baseline testing for all SNF residents and HCP for any facility that did not have a positive case and report the results of the testing to CDPH by June 30, 2020. The baseline testing results can be found at the SNF baseline testing website.
Testing for Newly Admitted and Readmitted Residents
- Testing 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 of 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.
- Residents newly admitted from the hospital should be quarantined[1] 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 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 occupational health program, and there is no suspected or confirmed COVID-19 transmission among patients or staff at the hospital.
- SNF has verified (via the LHD or hospital) that the hospital is implementing a process for screening new admissions and monitoring patients for hospital-onset COVID-19, and has designated COVID-19 unit(s) with dedicated staff and minimal cross-over.
- Testing and quarantine are not required for residents readmitted after hospitalization, or who leave the SNF for ambulatory care (e.g., emergency department or clinic) visits unless there is suspected or confirmed COVID-19 transmission at the outside facility as verified with their LHD.
- Testing and quarantine are not required for hospitalized residents that 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) screening testing[2] and cohorting for residents that regularly leave the SNF for dialysis, as well as screening testing for residents following hospitalization or ED visit.
Arrangements with Laboratories to Process Tests
- The test used should be an authorized nucleic acid or antigen detection assay for SARS-CoV-2 virus used as recommended for testing in nursing homes by CDC, with results obtained rapidly (e.g., within 48 hours).
- SNFs may use the Point of Care (POC) antigen testing instruments distributed by the Department of Health and Human Services for testing in the SNF in accordance with CDPH guidance. POC testing must be ordered by a licensed health care provider operating under their scope of practice. Antibody (aka serology testing) test results should not be used to diagnose someone with an active SARS-CoV-2 (the virus that causes COVID-19) infection.
Plans for Use and Follow-up of Test Results, including:
- How results will be explained to the resident or HCP
- How to communicate information about any positive cases of residents or HCP in the facility to family members or responsible parties
- How results (positive or negative) will be tracked for residents and HCP at the facility, and methods for reporting results to CDPH and the LHD
- How results will be used to guide implementation of infection control measures, resident placement, and HCP and resident cohorting
- How results will be communicated to ensure appropriate management when residents are transferred to other congregate settings
- A procedure for addressing residents or HCP that decline or are unable to be tested (e.g., symptomatic resident refusing testing in a facility with positive COVID-19 cases should be managed with transmission-based precautions).
- Plans to address potential staffing shortages for positive HCP who are excluded from work
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 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).
- Residents that test positive and are asymptomatic should be isolated for 10 days from the date of their positive test, as long as they have not subsequently developed symptoms, in which case the symptoms-based criteria for discontinuing isolation should be applied.
- For residents previously diagnosed with COVID-19 who remain asymptomatic after recovery, retesting is not recommended within three months after the date of symptom onset for the initial COVID-19 infection or date of positive test for individuals who never developed symptoms; in addition, quarantine is not necessary for these individuals in the event of close contact with an infected person.
Healthcare Personnel Who Test Positive for COVID 19
- In general, HCP with COVID-19 should be excluded from work for the duration of their isolation period.
- 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.
- HCP who test positive and are symptomatic should be excluded from work. 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).
- For HCP previously diagnosed with COVID-19 who remain asymptomatic after recovery, retesting is not recommended within three months after the date of symptom onset for the initial COVID-19 infection or date of positive test for individuals who never developed symptoms; in addition, quarantine is not necessary for these individuals in the event of close contact with an infected person.
Diagnostic Testing for Symptomatic Individuals
- Residents or HCP with signs or symptoms consistent with COVID-19 should be tested immediately to identify current infection; SNFs should not delay testing of symptomatic individuals until scheduled screening or response-driven testing.
Screening Testing of SNF HCP
In facilities without any positive COVID-19 cases: implement a minimum weekly screening testing of all HCPs.
- In facilities with a positive COVID-19 case, implement response-driven testing as described, below.
- Additional testing considerations may include regular screening testing of residents who frequently leave the facility for dialysis or other services.
Response-driven 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 should be performed every seven days until no new cases are identified among residents in two sequential rounds of testing; the facility may then resume their regular screening testing schedule for HCP.
For residents:
- If testing capacity is not sufficient to serially retest all residents, prioritize response testing of residents on the same unit(s) where COVID-19 positive residents or HCP were identified.
- Two sequential rounds of negative response testing among residents is generally considered evidence that transmission has been halted among residents; if positive HCP are identified in subsequent response-testing rounds after transmission has been halted among residents, the SNF may consider more targeted response testing of residents only on the same unit(s) where the positive HCP were identified, in consultation with their LHD.
Place residents into three separate cohorts based on the test results, accordingly:
- Positive result, for the duration of the resident’s isolation period (“red” area)
- 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 testing: If available, private rooms should be prioritized for residents with symptoms consistent with COVID-19, while testing is pending.
Residents with previous positive tests: Facilities should follow CDC guidance to determine when a resident who tests positive should be included in subsequent facility-wide response testing (e.g., in response to a new outbreak). Residents 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 should be considered again (e.g., in response to an exposure) only if it is three months after the date of onset of the prior infection. For residents 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 infectious disease or infection control experts. Quarantine, isolation and transmission based precautions, may also be considered during this evaluation based on consultation with an infection control expert, especially in the event symptoms develop within 14 days after close contact with an infected person.
For Healthcare Personnel
- If testing capacity is not sufficient to serially retest all HCP, prioritize testing HCP who worked on the unit with COVID-19 positive residents or are known to work at other healthcare facilities with cases of COVID-19.
HCP with a previous positive test: 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 should be considered again (e.g., in response to an exposure) only if it is three months after the date of onset of the prior infection. For 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 infectious disease or infection control experts.
SNFs should submit proposed COVID-19 testing plans to their local Licensing and Certification Program District Office. An administrator or other appropriate representative, who physically works in the SNF, must submit a scanned copy of the mitigation plan and attestation. As testing and mitigation strategies change based on updated CDC or CMS guidance, revised plans will need to be submitted.
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. Per Title 17 section 2505 of the California Code of Regulations, any entity performing SARS-CoV-2 testing is required to report both positive and non-positive results to public health. For additional information on reporting requirements see:
- Frequently Asked Questions: COVID-19 Testing at Skilled Nursing Facilities/ Nursing
- Interim Final Rule (IFC), CMS-3401-IFC, Updating Requirements for Reporting of SARS-CoV-2 Test Results by CLIA Laboratories, and Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
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. All residents and staff that tested negative are expected to be retested until testing identifies no new cases of COVID-19 infection among staff or residents for a period of at least 14 days since the most recent positive result (see section on Response-driven Testing above).
- For staff routine (screening) testing, document the facility’s county positivity rate, the corresponding testing frequency indicated (e.g., every week), and the date each positivity rate was collected. Also, document the date(s) that testing was performed for all staff, and the results of each test.
- 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-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 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 Heidi W. Steinecker
Heidi W. Steinecker
Deputy Director
Resources:
- 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
- Baseline, Surveillance and Response-driven COVID-19 Testing of SNF Residents and HCP Flow Chart (PDF)
- 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
[1] CDC Defines quarantine as separate and restrict the movement of people who were exposed to a contagious disease to see if they become sick. https://www.cdc.gov/quarantine/index.html
[2] 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.