Interim SARS-CoV-2 Testing Guidelines for Patients in Outpatient Hemodialysis Facilities

Summary of Recent Changes

December 16, 2020

  • Added language about timing and frequency with which to perform SARS-CoV-2 testing on  asymptomatic individuals who have had prolonged close contact with someone with SARS-CoV-2 infection.
  • Added link to FAQ addressing when options to reduce quarantine for contacts of persons with SARS-CoV-2 infection might be considered in healthcare settings.

Note: This document is intended to provide guidance on the appropriate use of testing among patients undergoing outpatient hemodialysis.  It does not dictate the determination of payment decisions or insurance coverage of such testing, except as may be otherwise referenced (or prescribed) by another entity or federal or state agency.

Patients with end stage renal disease (ESRD) on maintenance dialysis are at high risk for serious illness and death related to infection with SARS-CoV-2, the virus that causes COVID-19. Most patients on maintenance dialysis undergo hemodialysis three times a week at outpatient dialysis centers. At each treatment, dialysis facilities should assess patients for symptoms consistent with COVID-19 or exposure to others with SARS-CoV-2 infection.

Testing for SARS-CoV-2 in respiratory specimens can detect current infections (referred to here as viral testing) among patients in outpatient dialysis facilities. Viral testing of patients in outpatient dialysis facilities, with authorized nucleic acid or antigen detection assays, can be an important addition to other infection prevention and control (IPC) recommendations aimed at preventing SARS-CoV-2 from entering dialysis facilities, detecting cases quickly, and stopping transmission.  This guidance is based on currently available information about SARS-CoV-2 and will be refined and updated as more information becomes available.

Testing conducted at dialysis facilities should be implemented in addition to recommended IPC measures. Not all dialysis facilities can perform on-site testing; however, all facilities should have a plan for testing patients for SARS-CoV-2 (e.g., identify where patients will be referred for testing if the dialysis facility cannot perform onsite testing).

Testing practices (including performing tests and reporting results) should aim for rapid turnaround times (i.e., less than 48 hours) in order to facilitate effective interventions. Collecting a new specimen for a second test in the same patient more than once in a 24-hour period is generally not recommended unless the second test is being used to confirm an initial result (e.g., nucleic acid detection to confirm antigen test result).  Antibody (serologic) test results should not be used to diagnose an active SARS-CoV-2 infection or to inform IPC actions.

While this guidance focuses on testing patients undergoing hemodialysis at outpatient hemodialysis facilities, several of the recommendations – such as testing patients with signs or symptoms of COVID-19 and testing asymptomatic close contacts – should also be applied to ESRD patients undergoing home dialysis (i.e., home hemodialysis or peritoneal dialysis).

CMS has suggested that routine testing could be considered for nursing home residents who regularly leave the facility including for dialysis. Centers who dialyze these patients should have a plan to address residents who are found to be infected with SARS-CoV-2, including working to establish lines of communication so that results of resident testing are rapidly communicated and acted on.

For additional guidance addressing other non-healthcare settings, refer to the CDC guidance addressing Communities, Schools, Workplaces and Events. Guidance for testing healthcare personnel (HCP) is available in the Interim Guidance on Testing Healthcare Personnel for SARS-CoV-2.

Testing patients with signs or symptoms of COVID-19

  • Every time a patient presents to the facility for a dialysis treatment, evaluate for any COVID-19 symptoms. Perform viral testing of any patient who has signs or symptoms of COVID-19.
    • Clinicians should use professional judgment to determine if a patient has signs or symptoms consistent with COVID-19 and whether the patient should be tested. Individuals with ESRD and COVID-19 may not show common symptoms such as fever or respiratory symptoms.  Some patients might present with only mild symptoms or other less common symptoms. Even mild signs and symptoms (e.g., sore throat) of a possible SARS-CoV-2 infection should prompt consideration for testing
    • Clinicians are encouraged to consider testing for other causes of respiratory illness, such as influenza, in addition to testing for SARS-CoV-2.
    • Patients should be cared for by HCP using all personal protective equipment (PPE) and precautions described for patients with confirmed SARS-CoV-2 infection while waiting for results of the test to return.

Testing asymptomatic patients with known or suspected exposure to an individual infected with SARS-CoV-2, including close and expanded contacts (e.g., there is an outbreak in the facility) to control transmission

  • Every time a patient presents to the facility assess for any recent exposure to others with SARS-CoV-2 infection.
    • Patients undergoing outpatient dialysis might have exposures to individuals with SARS-CoV-2 infection inside and outside of the dialysis facility. It is important that patients are screened for any potential exposures each time they undergo treatment so IPC measures can be promptly implemented and testing can be performed in an expeditious manner to prevent transmission to other patients or HCP.
    • Because of the potential for asymptomatic and pre-symptomatic transmission of SARS-CoV-2 infection to other vulnerable individuals and HCP in the dialysis facility, it is important that dialysis patients that have been close contacts of individuals with SARS-CoV-2 infection be quickly identified and tested for SARS-CoV-2 infection. Testing should be considered immediately after identification as a contact, and if negative, again about 5-7 days after last exposure or immediately if symptoms develop during quarantine.
      • Facilities should maintain at least 6 feet of separation between patients who had close contact with a person with SARS-CoV-2 infection and other patients during dialysis treatment; they should not be cohorted with each other or with patients with confirmed or suspected SARS-CoV-2 infection. HCP caring for patients who were close contacts of patients with SARS-CoV-2 infection should use all recommended personal protective equipment (PPE) for the care of patients with SARS-CoV-2 infection.
      • Because patients can develop SARS-CoV-2 infection at any point during their 14-day exposure period, such safeguards should remain in place for 14 days after the exposure event, even if viral testing of the exposed patient is negative during this time period. Options to shorten quarantine are discussed here.
      • If the exposed patient is within 90 days of being diagnosed with confirmed SARS-CoV-2 infection, has completed their recommended duration of isolation precautions, and is currently asymptomatic, they do not need to be tested or managed with Transmission-Based Precautions.  However, if these individuals develop new symptoms consistent with COVID-19 they should be placed on Transmission-Based Precautions, assessed, and potentially tested for SARS-CoV-2 if an alternate etiology is not identified.
      • Follow local regulations regarding reporting newly identified infections to public health authorities.
  • If there is an outbreak in the facility (i.e., evidence of transmission of SARS-CoV-2 infection in the dialysis facility or multiple patients or HCP with recent-onset SARS-CoV-2 infection), consider performing expanded viral testing of all patients and HCP in the dialysis facility or all patients and HCP that had dialysis treatments or worked on the same shift or day (i.e., expanded contacts beyond close contacts)
    • Since patients can develop a SARS-CoV-2 infection due to exposure outside of the dialysis facility, identifying transmission within a dialysis facility can be challenging. SARS-CoV-2 infections among healthcare personnel (HCP) or patients with epidemiologic links within the dialysis facility and no other identified exposures suggest that transmission may have occurred within the dialysis facility. Transmission within a dialysis facility should be considered an outbreak, and the health department should be notified.
    • Performing viral testing of all patients, as soon as transmission within the facility is suspected, will allow for identification of infected patients quickly, assisting in their clinical management and allowing rapid implementation of IPC interventions (e.g., isolation, cohorting, use of PPE) to prevent SARS-CoV-2 transmission.
      • Follow up testing (e.g., every 3 to 7 days) should be considered if additional SARS-CoV-2 infections are identified in the initial round of testing.
    • Facility-wide viral testing might identify asymptomatic and pre-symptomatic patients with SARS-CoV-2 infection; facility leadership should be prepared to continue to provide dialysis and isolate patients as needed.
    • Testing of HCP should also be included as part of the response to the outbreak. For additional details see the Interim Guidance on Testing Healthcare Personnel for SARS-CoV-2.
    • If viral testing capacity is limited, additional considerations can be used to direct testing.
      • For example, if cases are identified in patients on a particular dialysis schedule or shift (e.g., Monday/Wednesday/Friday), testing could be performed in all patients on that schedule instead of facility wide.
    • For considerations on performing expanded testing, See Performing Broad-Based Testing for SARS-CoV-2 in Congregate Settings, which can be adapted to dialysis settings.
    • Notify local public health authorities of suspected or confirmed outbreaks in the dialysis facility.

Testing to determine resolution of infection

In general, a symptom-based strategy should be used to guide the decision on when to discontinue Transmission-Based Precautions because, in most cases, the test-based strategy results in prolonged isolation of patients who continue to shed detectable SARS-CoV-2 RNA but are no longer infectious. A test-based strategy could be considered for some patients (e.g., those who are severely immunocompromised) in consultation with local infectious diseases experts if concerns exist for the patient being infectious for more than 10 to 20 days. In all other circumstances, the symptom-based strategy should be used to determine when to discontinue Transmission-Based Precautions.

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