Preface
This is the third edition of CSA Z364.5, Safe installation and operation of haemodialysis and peritoneal dialysis in a home setting. It supersedes the previous editions published in 2017 and 2010.
Home haemodialysis and peritoneal dialysis (home dialysis) are installed and carried out through a variety of practices. While the basic requirements are fundamentally similar among organizations, methodologies can vary. This Standard has been developed to provide nephrology personnel with a Standard for improving the quality of home haemodialysis and peritoneal dialysis treatment, and to provide expert guidance to Canadians undergoing these treatments.
The major differences between this edition and the previous edition include
a) new requirements in Clause 14.4for generators used to provide power in home settings;
b) new requirements in Clause 16.5for remote monitoring;
c) a new Annex B that provides an example of a home assessment checklist, with accompanying edits to Clause 5;
d) a new Annex C that provides further guidance when installing generators in home settings;
e) new requirements on using risk management when performing initial home assessments and repeating them on a regular basis; and
f) updated standard references throughout the Standard.
CSA Group acknowledges that the development of the second edition of this Standard was made possible by the financial support of 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 has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.
Scope
1.1 Inclusions
This Standard specifies requirements for the safe installation and operation of haemodialysis 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 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 Exclusions
This Standard is not intended to apply to haemodialysis or peritoneal dialysis performed in a hospital or a dialysis clinic setting, or in a long-term care facility.
1.3 Terminology
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.
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