Z364.5-17

1 Scope 1.1 This Standard specifies requirements for the safe installation and operation of hemodialysis and peritoneal dialysis performed in a home setting. It is intended for use by dialysis providers, including health care workers and professionals who perform technical and operational functions associated with home dialysis, as well as stakeholders who have an interest in safety or related quality assurance (e.g., professional associations, regulators, and consumers). This Standard is intended to provide a comprehensive, integrated, and consistent management framework to ensure that a completed home dialysis set-up and its major systems meet the necessary technical and operational requirements. The major systems covered include a) quality management; b) home assessment; c) physical space requirements; d) plumbing requirements; e) water requirements; f) electrical requirements; g) supply storage and waste management; h) emergency preparedness; i) client and caregiver training; and j) documentation and records. 1.2 This Standard is not intended to apply to hemodialysis or peritoneal dialysis performed in a hospital or a regional dialysis clinic setting, or a long-term care facility. 1.3 In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the Standard; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the Standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.