CSA Z364.6:23

Preface 

This is the second edition of CSA Z364.6, Quality management for kidney dialysis providers . It is the core Standard in a series of CSA Group Standards for a quality management system (QMS) for kidney dialysis processes and equipment. It supersedes the previous edition published in 2017. The function of a QMS is to establish consistency in, and control of, required processes and documentation in order to provide quality products and services. The main audience of this Standard comprises health care providers involved in kidney dialysis services and the users and clients of the dialysis service. The following are the major changes to this edition: a) updated standard references; b) updated requirements in Clause 9 to address disinfected medical equipment and supplies; c) updated requirements in Clause 7 to address equipment maintenance; and d) updated definitions in Clause 3. CSA Group acknowledges that the development 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 and 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 General 

This Standard is intended to form the basis of a QMS within a health care or home setting for the purpose of providing safe, reliable kidney dialysis treatments. 

Note: A comprehensive QMS can be achieved when this Standard is used in combination with the following related Standards: a) CAN/CSA-C22.2 No. 60601-1; b) CAN/CSA-C22.2 No. 60601-2-16; c) CAN/CSA-C22.2 No. 60601-2-39; d) CSA ISO 8637-1; e) CSA ISO 8637-2; f) CSA Z23500-1; g) CSA Z23500-2; h) CSA Z23500-3; i) CSA Z23500-4; j) CSA Z23500-5; k) CSA Z364.2.1; l) CSA Z364.5; and m) CSA Z8000. 

1.2 Supplemental requirements 

As part of a QMS, this Standard includes requirements for a) quality management, including i) policies and procedures; ii) documentation; iii) roles and responsibilities; iv) management review; v) personnel qualifications and training; and vi) adverse event management (e.g., recalls); b) occupational health and safety; c) evaluation and purchase of dialysis equipment and medical devices; d) infection prevention and control; e) work areas and equipment; f) environmental conditions; and g) utilities (e.g., power supply and water quality). 

1.3 Applicable health care facilities (HCFs) 

This Standard applies to health care or home settings where kidney dialysis therapies occur, including, but not limited to, a) hospital dialysis centres; b) regional dialysis clinics; c) trauma centres; d) emergency care facilities; e) medical clinics, with or without overnight stay or observation; f) nursing homes; g) long-term care facilities; h) assisted-living facilities; i) mental health facilities; j) rehabilitation facilities; k) chronic care facilities; l) group homes; m) hospice care facilities; n) stand-alone dialysis clinics; and o) client homes. 

1.4 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.