Interim Additional Guidance for Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed COVID-19 in Outpatient Hemodialysis Facilities

Summary of Recent Changes

Background

This information is provided to clarify SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), infection prevention and control (IPC) recommendations that are specific to outpatient hemodialysis facilities. This information complements, but does not replace, the general CDC IPC recommendations for SARS-CoV-2 available in Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic.

This guidance is based on the currently available information about SARS-CoV-2. This approach will be refined and updated as more information becomes available and as response needs change in the United States. It is important to stay informed about SARS-CoV-2 to prevent introduction and minimize spread in your dialysis facility. Consult with public health authorities to understand if transmission of SARS-CoV-2 is occurring in your community.

As part of routine infection control, outpatient dialysis facilities should have established policies and practices to reduce the spread of contagious respiratory and other pathogens.

Implement Universal Source Control Measures

• Source control refers to use of masks or medical facemasks to cover a person’s mouth and nose to prevent spread of respiratory secretions when they are breathing, talking, sneezing, or coughing. Because of the potential for asymptomatic and pre-symptomatic transmission, source control measures are recommended for everyone in a healthcare facility, even if they do not have symptoms of COVID-19.
  • Patients and visitors should, ideally, wear their own mask (if tolerated) upon arrival to and throughout their stay in the facility. If they do not have a mask, they should be offered a medical facemask or mask, as supplies allow.
    • Masks (including medical facemasks) should not be placed on young children under age 2, anyone who has trouble breathing, or anyone who is unconscious, incapacitated or otherwise unable to remove the mask without assistance.
  • Healthcare personnel (HCP) should wear a medical facemask at all times while they are in the healthcare facility, including in breakrooms or other spaces where they might encounter co-workers.
    • When available, medical facemasks are preferred over masks for HCP as medical facemasks offer both source control and protection for the wearer against exposure to splashes and sprays of infectious material from others.
    • Masks should NOT be worn instead of a respirator or medical facemask if more than source control is needed.
    • Respirators with exhalation valves are not recommended for source control; If only a respirator with an exhalation valve is available and source control is needed, cover the exhalation valve with a medical facemask, or a mask that does not interfere with the respirator fit. ​

Screening, Triage, and Management of Individuals with Suspected or Confirmed SARS-CoV-2 Infection

CDC has created an FAQ that addresses when options to shorten quarantine for contacts of persons with SARS-CoV-2 infection might be considered in healthcare settings.

• Implement processes for identifying and triaging individuals with suspected or confirmed SARS-CoV-2 infection before arrival.
  • Remind HCP not to report to work when they are ill and to notify occupational health services if they have an unprotected exposure to someone with SARS-CoV-2 infection (either in the community or in the dialysis facility).
  • Instruct patients to call ahead to report close contact in the past 14 days with someone with SARS-CoV-2 infection or symptoms of COVID-19 so the facility can be prepared for their arrival or triage them to a more appropriate setting (e.g., an acute care hospital).
  • Because these exposed patients could go on to develop SARS-CoV-2 infection, they should be cared for using all personal protective equipment (PPE) and precautions described for a patient with confirmed SARS-CoV-2 infection, even if viral testing is negative during their 14-day quarantine period. This includes remaining at least 6 feet from other patients at all times in the facility. Unless the exposed patients are confirmed to have SARS-CoV-2 infection, they should not be cohorted with patients with confirmed SARS-CoV-2 infection. If the exposed patients develop SARS-CoV-2 infection, full SARS-CoV-2 precautions should be followed until the patients meet criteria to discontinue Transmission-Based Precautions. Options to shorten quarantine are discussed here.
  • Post signs at clinic entrances and strategic places around the facility with instructions for patients and visitors who have symptoms of COVID-19 or who have had close contact with someone with SARS-CoV-2 infection to alert staff so appropriate precautions can be implemented.
  • Provide patients, HCP, and visitors with instructions (in appropriate languages) about screening and triage procedures, including information about the importance of practicing source control, maintaining a distance of at least 6 feet from all other persons whenever possible, and performing frequent hand hygiene.
    • Instructions should include how to use masks and medical facemasks, how to use tissues to cover nose and mouth when coughing or sneezing (if a mask cannot be tolerated), how to dispose of tissues and contaminated items in waste receptacles, and how and when to perform hand hygiene.
  • Position supplies close to dialysis chairs and nursing stations to promote adherence to hand and respiratory hygiene and cough etiquette. These include tissues and no-touch receptacles for disposal of tissues and hand hygiene supplies (e.g., alcohol-based hand sanitizer).
  • Make sure triage procedures are compliant with HIPAA guidance. While the process for screening and triage depends on facility layout and staffing, the general steps include:
    • Placing a staff member near all entrances (outdoors if weather and facility layout permit), or in the waiting room area, to ensure everyone (patients, HCP, visitors) is screened for symptoms consistent with COVID-19 or close contact with someone with SARS-CoV-2 infection before they enter the treatment area and ensure they are practicing source control.
      • Confirm absence of symptoms consistent with COVID-19. Fever is either measured temperature ≥100.0^◦F or subjective fever.
      • Ask them if they have been advised to self-quarantine because of exposure to someone with SARS-CoV-2 infection.
    • Properly manage anyone with symptoms of COVID-19 or who has been advised to self-quarantine:
      • HCP should return home and should notify occupational health services to arrange for further evaluation.
      • Visitors should be restricted from entering the facility.
      • Patients should be managed as described under Patient Placement below.

• Follow local regulations regarding reporting newly identified infections to public health authorities.

Placement of Patients with Suspected or Confirmed SARS-CoV-2 Infection

• Ideally facilities should have areas for all patients to wait separated by at least 6 feet. Medically stable patients might opt to wait in a personal vehicle or outside the healthcare facility where they can be contacted by mobile phone when it is their turn to be seen.
• Patients with suspected or confirmed SARS-CoV-2 infection or who have reported close contact should be brought back to an appropriate treatment area as soon as possible in order to minimize time in waiting areas. If they must wait, facilities should ensure the following:
  • Patients with confirmed SARS-CoV-2 infection can be cohorted together (e.g., in the same waiting room); however, they should maintain at least 6 feet of separation from other patients at all times in the dialysis facility.
  • Patients with suspected SARS-CoV-2 infection and patients who have had close contact with someone with SARS-CoV-2 infection should also maintain at least 6 feet of separation from each other and from other patients at all times in the dialysis facility.
• Separation should be maintained in the treatment area. Facilities should consider separating all patients by 6 feet during dialysis treatments, especially in areas with moderate to substantial community transmission.

• Ideally, a patient with suspected or confirmed SARS-CoV-2 infection or who has reported close contact would be dialyzed in a separate room (if available) with the door closed.
  • Hepatitis B isolation rooms should only be used for these patients if: 1) the patient is hepatitis B surface antigen positive or 2) the facility has no patients on the census with hepatitis B infection who would require treatment in the isolation room.
  • If a separate room is not available, the patient with suspected or confirmed SARS-CoV-2 infection or who reported close contact should be treated at a corner or end-of-row station, away from the main flow of traffic (if available). The patient should be separated by at least 6 feet from the nearest patient (in all directions).

• If a hemodialysis facility is dialyzing more than one patient with confirmed SARS-CoV-2 infection, consideration should be given to cohorting these patients and the HCP caring for them together in the same section of the unit and/or on the same shift (e.g., consider the last shift of the day). Only patients with confirmed SARS-CoV-2 infection should be cohorted together. Patients who report close contact with someone with SARS-CoV-2 infection and patients with symptoms for whom SARS-CoV-2 infection has not been confirmed, should not be cohorted with patients with confirmed SARS-CoV-2 infection or with each other as their diagnosis is uncertain. These patients should be dialyzed at a station that is at least 6 feet from others in all directions.

Recommended PPE When Caring for a Patient with Suspected or Confirmed SARS-CoV-2 Infection

• HCP caring for patients with suspected or confirmed SARS-CoV-2 infection or who have reported close contact with someone with SARS-CoV-2 infection should use all of the following:
  • N95 or equivalent or higher-level respirator (or medical facemask if a respirator is not available)
    • A mask (e.g., a cloth face covering) is NOT considered PPE and should not be worn by HCP when PPE is indicated.
    • In times of shortage, special care should be taken to ensure that respirators are reserved for situations where respiratory protection is most important, such as performance of aerosol generating procedures on patients with suspected or confirmed SARS-CoV-2 infection or provision of care to patients with other infections for which respiratory protection is strongly indicated (e.g., tuberculosis, measles, varicella).
    • Respirators should be worn by fit-tested personnel in the context of a respiratory protection program; Consider implementing a respiratory protection program that is compliant with the OSHA respiratory protection standard for employees if not already in place. The program should include medical evaluations, training, and fit testing.
  • Eye protection (i.e., goggles, a face shield that covers the front and sides of the face).
    • Protective eyewear (e.g., safety glasses, trauma glasses) with gaps between glasses and the face might not protect eyes from all splashes and sprays.
    • Personal glasses and contact lenses are NOT adequate eye protection.

• Gloves
• Isolation gown
  • The isolation gown should be worn over or instead of the cover gown (e.g., laboratory coat, gown, or apron with incorporate sleeves) that is normally worn by hemodialysis personnel. If there are shortages of gowns, they should be prioritized for initiating and terminating dialysis treatment, manipulating access needles or catheters, helping the patient into and out of the station, and cleaning and disinfection of patient care equipment and the dialysis station.
  • When gowns are removed, place the gown in a dedicated container for waste or linen before leaving the dialysis station. Disposable gowns should be discarded after use. Cloth gowns should be laundered after each use.

Recommended PPE When Caring for Patients Not Suspected to Have SARS-CoV-2 Infection

• HCP working in facilities located in areas with moderate to substantial community transmission are more likely to encounter asymptomatic or pre-symptomatic patients with SARS-CoV-2 infection. If SARS-CoV-2 infection is not suspected in a patient presenting for care (based on symptom and exposure history), HCP should follow Standard Precautions and additional precautions routinely recommended for hemodialysis facilities (e.g., wearing a gown, gloves, and face shield during catheter connection) (and Transmission-Based Precautions if required based on the suspected diagnosis).
  They should also:

• Wear eye protection and medical facemask to ensure the eyes, nose, and mouth are all protected from exposure to respiratory secretions during patient care encounters.
• Wear an N95 or equivalent or higher-level respirator, instead of a medical facemask for aerosol generating procedures (refer to Which procedures are considered aerosol generating procedures in healthcare settings FAQ)
• HCP working in facilities located in areas with minimal to no community transmission, should continue to adhere to Standard and Transmission-Based Precautions, including use of eye protection and/or an N95 or equivalent or higher-level respirator based on anticipated exposures and suspected or confirmed diagnoses. Universal use of a medical facemask for source control is recommended for HCP.

Cleaning & Disinfection

Current procedures for routine cleaning and disinfection of dialysis stations are appropriate for patients with SARS-CoV-2 infection; however, it is important to validate that the product used for surface disinfection is active against SARS-CoV-2external icon. Facilities should ensure they are following the manufacturer’s label instructions for proper use and dilution of the disinfectant. The manufacturer’s instructions are specific to the product and should be followed (e.g., this might not necessarily conform to a 1:100 or 1:10 dilution); some products do not require preparation or dilution and are sold as “ready to use.” The product you are currently using may need to be used at a different concentration or a different contact time.

• Refer to List Nexternal icon on the EPA website for EPA-registered disinfectants that have qualified under EPA’s emerging viral pathogens program for use against SARS-CoV-2.
  • When using products from List N, ensure the products also have a bloodborne pathogen claim (e.g., hepatitis B, HIV).
  • Note about List N: Products may be marketed and sold under different brand names, but if they have the same EPA registration number, they are the same product.

Staff should be educated, trained, and have competency assessed for all cleaning and disinfection procedures in the facility. Ensure staff use appropriate PPE according to manufacturer’s recommendations when cleaning.

• Include training on routine cleaning and disinfection of the dialysis station as well as any high touch surfaces that can often missed such as scale and waiting areas.
• Important reminders from the Environmental Surface Disinfection in Dialysis Facilities: Notes for Clinical Managers pdf icon[402 KB, 2 pages] and Checklist: Dialysis Station Routine Disinfection pdf icon[750 KB, 2 pages]:
  • Routine disinfection of surfaces at the station should occur with no patient present to reduce the opportunities for cross-contamination and to avoid exposing patients to disinfectant fumes.
  • If visible blood or other soil is present, surfaces must be cleaned prior to disinfection.

Ensure that routine cleaning and disinfection procedures are followed consistently and correctly for patients with suspected or confirmed SARS-CoV-2 infection or who report close contact to someone with SARS-CoV-2 infection.

• Any surfaces, supplies, or equipment such as dialysis machines located within 6 feet of symptomatic patients should be disinfected or discarded appropriately.
• Disposable medical supplies brought to the dialysis station should be discarded.
• All non-dedicated, non-disposable medical equipment used for patient care should be cleaned and disinfected according to manufacturer’s instructions and facility policies.
• Follow standard operating procedures for the containment and disposal of used PPE and regulated medical waste.
• If linens or disposable cover sheets are used on the dialysis chairs, follow standard procedures for containing and/or laundering used items.

Additional information about recommended practices for terminal cleaning of rooms and PPE to be worn by those performing the cleaning and disinfection is available in the Healthcare Infection Prevention and Control FAQs for COVID-19.

Response to Newly Identified Patients or HCP with SARS-CoV-2 Infection

Facilities should have a process to respond to patients or HCP with newly identified SARS-CoV-2 infection, including assessing risk to others in the facility who may have had close contact with infected individuals.

• Individuals with COVID-19 symptoms are considered potentially infectious beginning 2 days before symptoms first appeared until they meet criteria to discontinue Transmission-Based Precautions (for patients) or to Return to Work (HCP).
• If the infected individual did not have symptoms, collecting information about when they could have been exposed can help inform the estimated period when they were infectious.
  • If an exposure is identified: The individual can be considered potentially infectious beginning 2 days after the exposure until criteria to discontinue Transmission-Based Precautions or Return to Work are met.
  • If the date of exposure cannot be determined: For the purposes of contact tracing, it is reasonable to use a cutoff of 2 days before the specimen testing positive for SARS-CoV-2 was collected as the starting point, continuing until the criteria to discontinue Transmission-Based Precautions or Return to Work are met.

If the infected individual is a HCP:

• Patients who were within 6 feet of the infected HCP for a total of 15 minutes (close contact) should be considered potentially exposed. In general, they should be dialyzed separated from other patients by at least 6 feet and cared for by HCP using all recommended PPE for SARS-CoV-2 until 14 days after their last exposure.
  • If the exposed patient was wearing a medical facemask (instead of a mask) during the entire exposure, a risk assessment should be performed (considerations for risk assessment can be found here). Patients in this group with lower risk exposures could be monitored for the development of symptoms without other precautions.
  • If the patient was wearing a mask (instead of a medical facemask) or not wearing any type of face covering (mask or medical facemask), then they should be considered an unprotected close contact.
  • If the exposed patient develops SARS-CoV-2 infection, they should be cared for using all recommended PPE for SARS-CoV-2 until the patient meets criteria for discontinuation of Transmission-Based Precautions.
  • Exposed patients determined to be close contacts should be advised to self-quarantine at home for 14 days after their last contact with someone with SARS-CoV-2 infection, other than when they need to leave their home for hemodialysis treatments or other necessary medical appointments.
• Perform a risk assessment and apply work restrictions for other HCP who were exposed to the infected provider based on whether these HCP had prolonged, close contact and what PPE they were wearing. More detailed information is available in the Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19.

If the infected individual is a patient:

• Patients who were within 6 feet of the infected patient for a total of 15 minutes (close contact) should be considered potentially exposed, even if masks were worn. In general, exposed patients should be dialyzed separated from other patients by at least 6 feet and cared for by HCP using all recommended PPE for SARS-CoV-2 until 14 days after their last exposure.
• If the exposed patient was wearing a medical facemask instead of a mask, a risk assessment (as described above) can be considered to determine if precautions are necessary.  If they develop SARS-CoV-2 infection they should be cared for using all recommended PPE for SARS-CoV-2 until the patient meets criteria for discontinuation of Transmission-Based Precautions.

• Perform a risk assessment and apply work restrictions for HCP who were exposed to the infected patient based on whether these HCP had prolonged, close contact and what PPE they were wearing. More detailed information is available in the Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19
• Exposed patients determined to be close contacts should be advised to self-quarantine at home for 14 days after their last contact with someone with SARS-CoV-2 infection, other than when they need to leave their home for hemodialysis treatments or other necessary medical appointments.

Identifying outbreaks of SARS-CoV-2 infection within the dialysis facility

• Since patients or HCP can develop a SARS-CoV-2 infection due to exposure outside of the dialysis facility, identifying transmission within a dialysis facility can be challenging. People with SARS-CoV-2 infection, epidemiologic links within the dialysis facility, and no other identified exposures suggest that transmission might have occurred within the dialysis facility. Any transmission within a dialysis facility should be considered an outbreak.
• If an outbreak is suspected, facilities should consider using PPE recommended for care of patients with suspected or confirmed SARS-CoV-2 infection for all patients in the facility pending further investigation and testing. Notify local public health authorities of suspected or confirmed outbreaks in the dialysis facility.
• If facilities experience large numbers of newly infected HCP or patients over short periods of time (e.g., one week), universal PPE use and/or facility-wide testing might also be considered (especially in facilities located in areas with moderate or substantial transmission).

Definitions:

• Mask: Textile (cloth) face coverings that are intended to keep the person wearing one from spreading respiratory secretions when talking, sneezing, or coughing. They are not PPE, and it is uncertain whether masks protect the wearer. Guidance on design, use, and maintenance of masks is available.
• Medical Facemask: Medical facemasks are PPE and are often referred to as surgical masks or procedure masks. Use medical facemasks according to product labeling and local, state, and federal requirements. FDA-cleared surgical masks are designed to protect against splashes and sprays and are prioritized for use when such exposures are anticipated, including surgical procedures. Some medical facemasks that are not regulated by FDA, such as some procedure masks, which are typically used for isolation purposes, may not provide protection against splashes and sprays.
• Respirator: A respirator is a personal protective device that is worn on the face, covers at least the nose and mouth, and is used to reduce the wearer’s risk of inhaling hazardous airborne particles (including dust particles and infectious agents), gases, or vapors. Respirators are certified by the CDC/NIOSH, including those intended for use in healthcare.

• Substantial community transmission: Large scale community transmission, including communal settings (e.g., schools, workplaces)
• Minimal to moderate community transmission: Sustained transmission with high likelihood or confirmed exposure within communal settings and potential for rapid increase in cases
• No to minimal community transmission: Evidence of isolated cases or limited community transmission, case investigations underway; no evidence of exposure in large communal setting

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