AFL 20-66.1 From the California Department of Public Health
March 8, 2021
TO: Skilled Nursing Facilities
Distinct Part Skilled Nursing Facilities
End Stage Renal Disease Dialysis Facilities
Chronic Dialysis Clinics
SUBJECT: Updated Guidance for the Provision of Home Dialysis Services in a Skilled Nursing Facility
(This AFL supersedes AFL 20-66)
AUTHORITY: Title 42 Code of Federal Regulations (CFR) Part 494
Health and Safety Code section 1225(c)(1)
Title 22 California Code of Regulations (CCR) section 72401
All Facilities Letter (AFL) Summary
- This AFL notifies skilled nursing facilities (SNFs) and dialysis clinics of updated guidance from the Centers for Medicare and Medicaid Services (CMS) regarding the provision of dialysis services to SNF residents through a collaborative arrangement between the SNF and a qualified dialysis facility.
- This revision clarifies that dialysis services in SNFs can only be administered at the resident’s bedside and that any Office of Statewide Health Planning and Development (OSHPD) clearances must be received prior to providing dialysis services.
This AFL updates guidelines for SNFs and dialysis clinics for the provision of hemodialysis and peritoneal dialysis services in SNFs as optional services allowed by state regulation.
Residents of a SNF licensed by the California Department of Public Health (CDPH) may receive dialysis treatments through the following primary options:
- In-center dialysis services in a Medicare-certified End Stage Renal Disease dialysis facility (ESRD) or a licensed-only Chronic Dialysis Clinic (CDC)
- This may involve either transporting the resident to and from an off-site ESRD or CDC for dialysis treatments or to a location within or proximate to the SNF building that is dedicated for and separately approved as a dialysis facility providing in-center dialysis
- Home dialysis services in a SNF
- Home hemodialysis or peritoneal dialysis services rendered in a SNF under a collaborative arrangement with an approved ESRD or CDC by trained and qualified personnel who have received training and competency verification from the dialysis facility. Dialysis services in SNFs can only be administered at the resident’s bedside and must follow all federal and state laws.
In recent years, CMS has released updated guidance through memoranda and revisions to the State Operations Manual (SOM) to allow a dialysis facility meeting federal standards and approved for a home dialysis training and support modality to provide dialysis services to SNF residents in the SNF “home” setting. SOM Chapter 2, section 2271 (PDF) and Appendix PP, section 483.25(l) (PDF) issue specific requirements for dialysis facilities and SNFs for the administration of dialysis care to SNF residents. This guidance provides detailed information on the requirements for this service, including, but not limited to, the following:
- The dialysis facility’s home training and support modality, compliant with Title 42 CFR Part 494 including Title 42 CFR section 494.100: Care at Home
- Delineation of responsibilities between the dialysis facility and the SNF
- Components of the written agreement between the dialysis facility and the SNF
- Collaborative development of policies and procedures for dialysis service delivery equivalent to dialysis facility standards of care
- Qualifications, training, and competency verification of dialysis supervisors and administering personnel
- Requirements for onsite supervision and administration of dialysis services according to dialysis modality
- Coordination of care between the dialysis facility and the SNF, including the coordination of dialysis facility and SNF interdisciplinary teams and the development of procedures to maintain ongoing communication and handle emergencies
- Safety protocols, and emergency plans that address staffing, patient care, equipment failure, and supplies
In the collaborative arrangement, the dialysis facility is ultimately responsible for the safe delivery of dialysis to the SNF resident, the quality and safety of the dialysis treatments, management of the resident’s dialysis-related conditions, and provision and maintenance of all equipment necessary for the resident’s dialysis treatment. The SNF is responsible for providing a safe environment for the dialysis treatments, monitoring the resident before, during, and after dialysis treatments for possible complications and responding appropriately, and providing all non-dialysis related care. Both the dialysis facility and the SNF are responsible for ensuring the ongoing communication and collaboration necessary to provide dialysis care coordination to each SNF resident receiving dialysis treatments.
Although no additional approval is required from CMS for a qualified, federally-certified dialysis facility to enter into an arrangement with a SNF to provide dialysis services to SNF residents, CMS requires the dialysis facility to notify CDPH of any arrangement by submitting Form CMS 3427 End Stage Renal Disease Application and Survey and Certification Report (PDF) to CDPH.
SNFs seeking to provide peritoneal or hemodialysis services must apply for approval of the optional service. This optional service will only be available to residents of the facility and not to the general public. Any SNF seeking to initiate the provision of dialysis services in a SNF must submit a change of service application to CDPH’s Centralized Applications Branch (CAB) to request state approval to add the service to the facility’s license. Prior to submitting the application, the facility must contact OSHPD for certification of the building standards. Permission granted in AFL 20-32.1 allowing SNFs to submit an application and begin providing care prior to obtaining approval and licensure by CDPH during the pandemic does not apply to adding dialysis services. The facility must submit their application and have an onsite survey conducted prior to providing services. Facilities should refer to CDPH’s Licensing and Certification Application Process webpage for guidance on all application requirements. Direct questions regarding application requirements to CAB at CAB@cdph.ca.gov.
If you have any questions about this AFL, please contact your local district office.
Original signed by Heidi W. Steinecker
Heidi W. Steinecker
- AFL 07-23 Dialysis Services in Skilled Nursing Facilities
- State Operations Manual, Chapter 2 – The Certification Process (PDF)
- State Operations Manual, Appendix PP – Guidance to Surveyors for Long Term Care Facilities (PDF)
- Form CMS 3427 End Stage Renal Disease Application and Survey and Certification Report (PDF)
- Contact OSHPD