CSA Z364.5:17 (R2022)
Safe installation and operation of hemodialysis and peritoneal dialysis in a home setting
This is the second edition of CSA Z364.5, Safe installation and operation of hemodialysis and peritoneal dialysis in a home setting. It supersedes the previous edition, published in 2010.
Home hemodialysis and peritoneal dialysis (home dialysis) are nstalled and carried out through a variety of practices. While the basic requirements are fundamentally similar among organizations, the methodology varies. This Standard has been developed to provide nephrology personnel with a Standard for improving the quality of home hemodialysis and peritoneal dialysis treatment and providing expert guidance to Canadians undergoing these treatments.
The major differences between this edition and the previous edition include
a) moving quality management content to the new CSA Group Standard Z364.6; and
b) updates to current practices and health record requirements for home dialysis.
CSA Group acknowledges that the development of the second edition of this Standard was made possible, in part, by the financial support of Charles River, Baxter, and Mar Cor Purification, as well the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Québec, Saskatchewan, and Yukon as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH).
This Standard was prepared by the Subcommittee on Quality Management for Kidney Dialysis, under the jurisdiction of the Technical Committee on Kidney Dialysis and the Strategic Steering Committee on Health Care Technology & Systems, and has been formally approved by the Technical Committee.
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.
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.
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.