Csa Z364.6-23

CSA Z364.
6:23
Nati anal Standard of Canada
Q.Jality management for kidney dialysis

providers
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CSAZ364.6:23
February 2023
Title: Q.Jality management for kidney dialysis pro.tiders
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National Standard of Canada
CSAZ364.6:23
QJality management for kidney
dialysis providers
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ICS 11.020.01
ISBN 978-1-4883-4728-3
© 2023 Canadian Standards Association

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CSA Z364.6:23 Q.Jality managerrent fcr kidney dialysis pr0v1iders
Contents
Technical Corrmittee on Kidney Dalysis 5
Sul:x:omnittee on QJality Manag=ment for Kidney Dalysis 7
Preface 9
1 Scope 11
1. 1 General 11
1.2 Supplemental requirements 11
1.3 Appli cable health care facilities (HCFs) 11
1.4 Terninologj 12
2 Reference publications 12
3 Defi nitions 14
4 QJality manag=ment system (QMS) 16

4. 1 General 16
4. 1. 1 Corrponents of QV1S 16
4. 1.2 Responsibilities of dialysis provider 17
4.2 Dxumentation and records 17
4.2. l General 17
4.2.2 Storag= and retention 18
4.2. 3 Control of records 18
4.3 Policies 18
4.4 Procedures 19
4.4. 1 General 19
4.4.2 Development, approval, and distribution 20
4. 5 Senior manag=ment responsibilities 22
4. 5. 1 General 22
4. 5. 2 Gient focus 22
4. 5. 3 QJality policy 22
4.5.4 Planning 22
4. 5. 5 Key performance indicators (KPis) 22
4. 5. 6 Responsibility, authority, and comnunication 22
4. 5. 7 Manag=ment representative 22
4. 5.8 Internal comnunication 23
4. 5.9 Manag=ment review 23
4.6 Resource manag=ment 23
4. 6. 1 Competency of personnel 23
4.6.2 Technical manag=r qualifications 24
4.6. 3 Qg:mizational chart 24
4.7 Environmental conditions and infrastructure 24
4. 7. 1 Infrastructure requirements 24
4.7.2 Environment and infrastructure design guidelines 24
4.7. 3 Equipment manufacturer's infrastructure and rronitoring requirements 24
February 2023 © 2023 canadian Standards Asscx:iatioo 1

4. 7.4 Emerg=ncy preparedness 25

4.8 Risk rranag=ment 25
4.9 Cient comrunication 25
4.10 Introduction of new product or processes 25
4.11 Purchasing 25
4.12 Cient property 26
4.13 Measurement, analysis, and irrprovement 26
4. 14 Audits 26
4. 14. 1 General 26
4. 14.2 Internal audit 26
4. 14.3 External audit 26
4.15 Analysis of data 26
4.16 Irrprovement 26
4.16.1 General 26
4.16.2 Corrective action 27
4.16.3 Preventive action 27
5 Evaluation and purchase of kidney dial ysis products and equipment 27

5. 1 General 27
5. 1. 1 Evaluation and purchase procedures of dialysis products 27
5. 1.2 Reg.ilatory requirements for dialysis products and medical equipment 27
5. 1. 3 Purchase agreements 27
5. 1.4 Water for hernxlialysis 28
5.2 Medical equipment 28
5.2. 1 Evaluation of medical equipment 28
5.2.2 Review of rranufacturer's written instructions 28
5.2. 3 Evaluation criteria of medical equipment 28
5.3 Consurrable products 29
5.3. 1 Evaluation of consurrable products 29
5.3.2 Evaluation criteria of consurrable products 29
5.4 Manufacturer's instructions 29
5.4. 1 General 29
5.4.2 Treatment procedures 29
5. 5 Loaned, reusable medical devices 29
6 Personnel 30
6. 1 General 30
6. 1. l Appi cability 30
6. 1.2 Q..Ja lified personnel 30
6. 1. 3 Policies and procedures 30
6.1.4 Nurber of qualified and experience personnel
.. 30
6. 1. 5 Approval of medical and technical PJ!icies and procedures 30
6. 1. 6 0-ganizations chart 30
6. 1.7 Imrunizations 30
6.2 Q..Ja lifications 31
6.2. 1 Supervisory personnel 31
6.2.2 Kidney dialysis personnel 31
6.3 0-ientation, training and continuing education 31
6.3. 1 General 31

6.3.2 Personnel training prog-ams 31

6.3. 3 Effectiveness of personnel training prog-ams 31
6.3.4 Qientation, training and continuing education procedures 31
6.3. 5 Monitoring and documentation 31
6.3. 6 Procedures for handling incidents 32
6.3. 7 Dxumentation 32
6.4 Corrpetency assessment 32
6.4. 1 General 32
6.4.2 Participation in personnel proficiency testing prog-am 33
6.4. 3 Proficiency test results 33
6.4.4 Remedial action 33
6.4. 5 Record keeping 33
6. 5 O:cupational health and safety 33
6. 5. 1 General 33
6. 5.2 Sharps 33
6. 5. 3 Spills of hazardous substances 33
6.6 Routine infection prevention and control practices 34
6.6. 1 General 34
6.6.2 I-land hygene 35
6.7 Attire 35
6.7. 1 Personal protective equipment (PPE) 35
6.7.2 Glaves 36
7 Workflow design and equipment manag=ment 36

7. 1 O:cupational health and safety 36
7.2 Equipment maintenance and quality assurance 37
7.2. 1 Maintenance prog-am 37
7.2.2 Maintenance facility requirement 37
7.2. 3 Testing devices and instruments used in repair and maintenance 37
7.2.4 Scheduled maintenance 37
7.2. 5 Repair and maintenance record 37
7.2. 6 Repair and maintenance service 38
7.3 Equipment cleaning and disinfection 38
7.3. 1 External equipment surface disinfections 38
7.3.2 f-o/draulic fluid path disinfections 38
7.3. 3 Blood tubing transducer protectors 39
7.4 Dalysis fluid quality 39
8 Process verification, monitoring and adverse events 39

8. 1 Process verification 39
8.2 Recalls and alerts 40
8.2. 1 General 40
8.2.2 Recall procedure 40
8.2. 3 Recall order 41
8.2.4 Recall report 41
9 Storag= 41
9. 1 General 41
9.2 Inventory control 41

9.3 Dstribution 41
Annex A (inforrrative) -Risk rranagarrent 42

Technical Committee on Kidney Dialysis

J. Bellamy Grand River l-lospital, Chair
Kitchener, 01tano, c.anada
c.ategory User Managerrent
J. Maahs Baxter, Vice-Oiair

Richrrond Hill, 01tario, c.anada
c.ategory Producer Interest
D. M. Braley 0-illia Soldiers' Merrorial l-lospital,

0-illia, 01tario, c.anada
c.ategory User L.abJur
M. D. Diwan Halton Healthcare, l\bn-voting

O:ikville, 01tario, c.anada
E. DJppler Alberta Health Services,

c.alg:iry, Alberta, c.anada
P. Farrell Central Health, l\bn-voting

Grand Falls-Windsor, f\FLD, c.anada
G. Fotiou Mackenzie Health Richrrond Hill l-lospital,

Richrrond Hill, 01tario, c.anada
G. Friederichs Fresenius Medical c.are l\brth Arrerica,

Lawrence, Massachusetts, USA
c.ategory Producer Interest
S. Hirernath University of Ottawa and Ottawa l-lospital,

Ottawa, 01tario, c.anada
c.ategory General Interest
S. Kurkjian 01tario Health,

Toronto, 01tario, c.anada
c.ategory Gc:Nernrrent and/or Regulatory Authority
H. La Fave Peterboroug, Rajonal Health Centre,

PeterborouCh, 01tario, c.anada
c.ategory User L.abJur

K Landry Fresenius Medical Care Canada,

Richrrond Hill, Oltario, Canada
C Leduc Nkkiso Canada, Nkkiso f\brth America,

Ottawa, Oltario, Canada
Category Producer Interest
R Levesque G-lUM (Centre hospitalier de l'Universite de

Montreal),
Montreal, QJebec, Canada
Category General Interest
M. Manocchio L.aboratoire de sante publique du QJebec,

Sainte-Anne-de-Bellevue, QJebec, Canada
Category Gc:wernrrent and/or Regulatory Authority
J. Pi9iin Providence Health Care - Biorredical Engneering f\bri-voting

Vancouver, British Colurrbia, Canada
J. QJintero Comrrunity Health and Services Centre, f\bri-voting

Kelowna, British Colurrbia, Canada
S. Savoie Service N=w Brunswick, f\bri-voting

Moncton, N=w Brunswick, Canada
D. Song Health Canada,

Ottawa, Oltario, Canada
Category Gc:wernrrent and/or Regulatory Authority
C Sullivan SGS Canada Inc,

Lakefield, Oltario, Canada
Category General Interest
S. Treesh London Health Sciences Centre,

London, Oltario, Canada
Category User Labour
S. Yun Fraser Health - Renal Services, f\bri-voting

Surrey, British Colurrbia, Canada
T. Qasim CSA Group, Prqject Manager

Toronto, Oltario, Canada

Subcommittee on Q.Jality [\/lanagement for

Kidney Dialysis
J. Maahs Baxter, Chair
Richrrond Hill, Oitario, Canada
J. Bellat"ro/ Grand River Hospital,

Kitchener, Oitano, Canada
D. M. Braley Oillia Soldiers' Merrorial f-bspital,

Oillia, Oitario, Canada
P. Butt Western Health,

Corner Brook, Newfoundland and Labrador, Canada
E. D:>ppler Alberta Health Services,

Calg:iry, Alberta, Canada
G. Fotiou Mackenzie Health Richrrond Hill Hospital,

C Graansma Qdni Labs,

Kitchener, Oitario, Canada
H. La Fave Peterboroug, Rajonal Health Centre,

Peterborougi, Oitario, Canada
K Landry Fresenius Medical Care Canada,

C Leduc Nkkiso Canada, Nkkiso l\bth America,

Ottawa, Oitario, Canada
R Levesque G-IUM (Centre hospitalier de l'Universite de

Montreal),
Montreal, QJebec, Canada
M. Manocchio L..aboratoire de sante publique du QJebec,

Sainte-Anne-de-Bellevue, QJebec, Canada
J. Pi9iin Providence Health Care - Biomedical Engneering

Vancouver, British Colurrbia, Canada

J. QJintero Co rmu nity Health and Services Centre,

Kelowna, British Columbia, C.anada
S. Savoie Service l\ew Brunswick,

Moncton, l\ew Brunswick, C.anada
D. Song Health C.anada,

Ottawa, 01tario, C.anada
C Sullivan SGS C.anada Inc,

Lakefield, 01tario, C.anada
S. Yun Fraser Health-Renal Services,

Surrey, British Columbia, C.anada
T. Qasim CSA Group, Prqject Manager

Toronto, 01tario, C.anada

Preface
This is the second edition of CSA.Z364.6, QJality managerrent for kidney dialysis providers. It is the core
Standard in a series of CSA. Group Standards for a quality manag=rrent system (QVIS) for kidney dialysis
processes and equiprrent. It supersedes the previous edition published in 2017.
The function of a QVIS is to establish consistency in, and control of, required processes and
docurrentation 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 chang=s to this edition:

a) updated standard references;
b) updated requirerrents in dause �to address disinfected rredical equiprrent and supplies;
c) updated requirerrents in dause Z to address equiprrent maintenance; and
d) updated definitions in aause }
CSA. Group acknowledg=s that the developrrent of this Standard was made possible by the financial
support of the governrrents of Alberta, British Colurrbia, Manitoba, f\Jew Brunswick, f\Jewfoundland and
Labrador, f\brthwest Territories, t\bva Scotia, f'..l.mavut, Oitario, Prince Edward Island, QJebec,
Saskatchewan, and Yukon as administered by the Canadian /lg=ncy for D-ugs and Technologes in Health
(CADTH).
This Standard was prepared by the Subcommittee on QJality Manag=rrent for Kidney Dalysis, under
the jurisdiction of the Technical Cormlttee on Kidney Dalysis and the Stratajc Steering Cormlttee on
Health Care Technologf and Systems, and has been formally approved by the Technical Committee.
This Standard has been developed in corrpliance with Standards Council of Canada requirerrents for
National Standards of Canada. It has been published as a N:ltional Standard of Canada by CSA. Group.
r---.btes:
1) Use of the singular dres not exclude the pural (and vice versa) when the sense allONs.
2) Although the intended prirrary apf)ication of this Standard is stated in its Sc�, it is irrp:xtant to note that it
rerrains the resp::>ns iality of the users of the Standard tojudge its suitaality for their particular p.Jqxlse.
3) This Standard was devel� Oj consensus, which is defined Oj CSA Policy giverning standardization -Code
of glOd practice for standardization as Sllbstantial agreerrent. Consensus impies much rmre than a simpe
rrajority, but not necessarily unanirrity''. It is consistent with this definition that a rrember rray be included in
the Technical Cormittee list and yet not be in full agreerrent with all clauses of this Standard
4) To subrrit a request for interpretation of this Standard, pease send the follONing inforrration to
inquiries@csagroup.org and include Request for interpretation" in the suqect line:
a) define the problern rraking reference to the specific clause, and, where appropriate, include an
illustrative sketch;
b) pro.tide an expanation of circumstances surrounding the actual field condition; and
c) where possitJe, phrase the request in such a way that a specific 9es" or l'lo" answer will address the
issue.
Cormittee interpretations are processed in accordance with the CSA Drectives and g.Jidelines
giverning standardization and are availatJe on the G.Jrrent Standards Activities page at
standardsactivities.csa.ca.
5) This Standard is suqect to review within five years fran the date of p..1tJication. Suggestions for its
irrµo.terrent will be referred to the appropriate cornrrittee. To subrrit a proposal for change, pease send the
follONing inforrration to inquiries@csagroup.org and include Proposal for change" in the suqect line:
a) Standard designation (number);

b) relevant clause, table, and/or figure nurrber;

c) wording of the prC>pJSed change; and
d) rationale for the change.

CSAZ364.6:23
QJality management for kidney dialysis
providers
1 Scope
1.1 General
This Standard is intended to form the basis of a Q'V1S within a health care or home setting for the
purpose of providing safe, reliable kidney dialysis treatments.
NJte: A corrprehensive Q\ilS can b::! achieved when this Standard is used in corrbina tion with the fdlONing related
Standards:
a) CAl\VCSA.-02.2 NJ. 60601-1;
b) CAl\VCSA.-02.2 NJ. 60601-2-16;
c) CAl\VCSA.-02.2 NJ. 60601-2-39;
d) CSA. ISO 8637-1;
e) CSA.1508637-2;
f) CSA. Z23500-1;
g) CSA.Z23500-2;
h) CSA. Z23500-3;
i) CSA.Z23500-4;
j) CSA. Z23500-5;
k) CSA.Z364.2.l;
I) CSA.Z364.5; and
m) CSA. ZBOOO.
1.2 Supplemental requirements

ff, part of a Q'V1S, 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 limted to,
a) hospital dialysis centres;
b) regonal dialysis clinics;

c) trauma centres;
d) emerg:ncy care facilities;
e) medical clinics, with or without overni9it 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;
I) 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 rh:ly'' is used to express an option or that which is permssible
within the limts of the Standard.
l\btes accorrpanying clauses do not include requirements or alternative requirements; the purpose of a
note accorrpanying a clause is to separate from the text explanatory or informative material.
l\btes 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.
2 Reference publications
This Standard refers to the following publications, and where such reference is made, it shall be to the
edition listed below, including all amendments published thereto.
CSA. Group
CAN/C5A.-Q2.2 NJ. 60601-1:14 (R2018)
Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
CAN/C5A.-Q2.2 NJ. 60601-2-16: 19

Medical electrical equipment-Part 2-16: Particular requirements for the basic safety and essential
performance of haemodialysis, haemodiafiltration, and haemofiltration equipment
CAN!C5A.-Q2.2 NJ. 60601-2-39:09 (R2019)

Medical electrical equipment-Part 2-39: Particular requirements for basic safety and essential
performance of peritoneal dialysis equipment
CANIC5A.-Q2.2 NJ. 80601 series

Medical electrical equipment

CSAIS08637-1:21
Extracoqx>real systems for blood purification-Part 1: l-laemx:lialysers, haemx:liafilters, haerrofilters
and haerroconcentrators
CSAIS08637-2:21
Extracorporeal systems for blood purification-Part 2: Extracorporeal blood circuit for haemx:lialysers,
haemx:liafilters and haerrofilters
CSAISO 14971:21
Medical devices-.Application of risk m:inagerrent to medical devices
Z317.1:21
Special requirerrents for purrbing installations in health care facilities
Z364.2.1-13 (R2018)
Monitoring system for hemx:lialysis equiprrent
Z364.5:22
Safe installation and operation of hemx:lialysis and peritoneal dialysis in a horre setting
ZB000-18
Canadian health care facilities
Z23500-1:20
Preparation and quality m:inagerrent of fluids for haemx:lialysis and related therapies-Part 1:
General requirerrents
Z23500-2:20
Preparation and quality m:inagerrent of fluids for haemx:lialysis and related therapies-Part 2: Water
treatrrent equiprrent for haemx:lialysis applications and related therapies
Z23500-3:20
Preparation and quality m:inagerrent of fluids for haemx:lialysis and related therapies-Part 3: Water
for haemx:lialysis and related therapies
Z23500-4:20
Preparation and quality m:inagerrent of fluids for haemx:lialysis and related therapies-Part 4:
Concentrates for haemx:lialysis and related therapies
Z23500-5:20
Preparation and quality m:inagerrent of fluids for haemx:lialysis and related therapies-Part 5: QJality
of dialysis fluid for haemx:lialysis and related therapies
ANNA (American f'Jephrol� l'llrses Association)

Core wrriculum for f'Jephrology NJrsing, 7th Edition, 2020
Health Canada
GUICE-0028
deaning validation guidelines. Available at:
http://www hc-sc.g::. ca/dhp-rrps/comp!i-conforny'qnp-bpf/validation/CJJi 0028 tc-tm-€nqphp

Spill or Leak - Errergency Preparedness, 2008. Available at:

http://www. hc-sc.g:.: ca/ewh-semt/pubs/occup-travail/spil I leak-devers fuite/i ndex-enqphp
Workplace Hazardous Materials Inforrration System (WHMIS). Available at:

http://www. hc-sc. g::. ca/ewh-semt/occup-travail/whmis-si rrdut/i ndex-enqphp
ORNAC (q:>erati ng Room NJrses Association of Canada)

rnNAC standards, guidelines, and position staterrents for perioperative registered nurses, 15th Edition,
2021
Publ ic Health Ag;ncy of Canada

Canadian Immunization Guide, 2021. Available at:
http://www.phac-as{X.g::. ca/publicat/cig-g:i/index-enqphp
3 Definitions
The following definitions shall apply in this Standard:
Caregver -an individual responsible for rreeting the physical, rredical, and psychologcal needs of a
dependent person (i.e., a dialysis client). The carajver can be a related or unrelated person.
Concentrate -a rrixture of electrolytes and/or corrµ:iu nds that, when diluted with dialysis water in
the ratio listed on the concentrate label, yields dialysis fluid.
Dialysis fl uid -aqueous fluid containing electrolytes and, usually, buffer and gucose, which is intended
to exchang; solutes with blood during dialysis.
t\btes:
1) The term dialysis fluid' is used throoghrut: this Standard to mean fluid made fran dialysis water and
caicentrates that is delivered to a dialyzer by a dialysis fluid delivery system In this Standard, dialysis fluid'
is used to refer to what is alternatively called dialysate", dialysis sdution", or dialyzing fluid".
2) Dalysis fluid entering a dialyzer is referred to as fresh dialysis fluid". Fluid leaving a dialyzer is referred to as
S'pent dialysis fluid".
3) Dalysis fluid does not include prepackaged parenteral fluids used in some renal replacement therapies (e.g.,
herrodiafiltration and hemofiltration).
Dialysis provider -a health care facil ity responsible for the care of a client underg:>ing dialysis.
t\bte: A third-party supplier can be contracted to deliver home dialysis services, b.Jt the ultimate res!XJ11S i bility for
client ootcomes rests with the dialysis prCNider.
Dialysis water -water that has been treated to meet the requirerrents of CSA.Z23500-3 and is suitable
for use in hemodialysis applications, including preparation of dialysis fluid, reprocessing of dialyzers,
preparation of concentrates, and preparation of substitution fluid for on-li ne convective therapies.
Dialyzer (hemodialyzer) -a medical device that is equipped with a serri-perrreable rrembrane and
used for perforrring hemodialysis.
Errerg;ncy preparedness -a continuous cycle of planning org:mizing training equipping exercising

evaluating and taking corrective action in an effort to ensure effective coordination during incident
response.

Endotoxin -a major corrµ:>nent of the outer cel l wall of g-am-neg:itive bacteria.

r--.t.b e: Endotoxins are lipqx>lysaccharides, which caisist of a PJ!ysaccharide chain mtalently boond to lipid A
Endotoxins can aa.rtely activate ooth hurmral and cellular host defenses, leading to a syndrare characterized by
fever, shaking, chills, hypotension, rrultipe crgan failure, and even death if allONed to enter the circulatim in a
sufficient cbse.
l-lealth care faci lity -a set of physical infrastructure elements supporting the delivery of health-related
services.
l-lealth care setting -any location where health care is provided, including emerg:ncy care, pre
hospital care, hospital, long-term care, home care, arrbulatory care, and facilities and locations in the
corrrrunity where care is provided (e.g, educational institutions, residential and correctional facilities,
dental offices, and physician's offices).
r--.t.b e: D=finitims of health care settings can o.terlap, as sare settings pro.tide a range of care, such as chrmic care
cr arrt:iulatory care pro.tided in acute care, and corrp ex care pro.tided in lmg-term care. See Gause 1.3 fcr a list of
different types of health care settings.
l-lemodiafi ltration (HDF) -form of renal replacement therapy in which waste solutes are rerroved
from blood by a combination of diffusion and convection through a high-flux membrane.
r--.t.b e: �ffusive solute rerno.tal is achieved using a dialysis fluid stream as in hermdialysis. Convective solute
rerno.tal is achieved by adding ultrafiltratim in excess of that needed to obtain the desired weight loss; fluid
balance is maintained by infusing a repacerrent solutim into the blcx::x:J either befcre the dialyzer (pre-dilutim
hermdiafiltratim), after the dialyzer (post-dilutim hermdiafiltratim), cr a corri:Ji natim of the two (rrixed dilutim
hermdiafiltratim).
l-lemodialysis (HD) -a form of renal replacement therapy in which waste solutes are rerroved
primarily by diffusion from blood flONing on one side of a merrbrane into dialysis fluid flONing on the
other side.
r--.t.b e: Fluid rerno.tal that is sufficient to obtain desired weight loss is achieved by establishing a hydrostatic
pressure gradient across the rrerrbrane. This fluid rerno.tal pro.tides sare additimal waste solute rerno.tal,
particularly fcr solutes of greater rrdecular weight.
l-lemofi ltration (HF) -a form of renal replacement therapy in which waste solutes are rerroved from
blood by convection.
r--.t.b es:
1) Convective transpcrt is achieved by ultrafiltratim throogh a high-flux rrerrbrane. Fluid balance is maintained
by infusing a repacerrent solutim into the blcx::x:J either befcre the hermfilter {pre-dilutim hermfiltratim) cr
after the hermfilter (post-dilutim hermfiltratim).
2) There is no dialysis fluid stream in hermfiltratim.
Home dialysi s - hemodialysis or peritoneal dialysis performed in a home setting
Manufacturer -an entity that designs, manufactures, fabricates, assembles, forrrulates, or processes a
finished device and then supplies it.
r--.t.b e: rvlanufacturers include, but are not lirrited to, entities that pro.tide cmtract sterilizatim, installatim,
relabelling, remanufacturing, repacking, cr specificatim developrrent services, and initial distributcrs of fcreign
entities perfcrrring these functims. The term l'tlanufacturing" does not co.ter preparatim of concentrates from
prepackaged dry cherricals at a dialysis facility cr handling of b.Jlk concentrates at a dialysis facility after
respmsiality fcr the concentrate is transferred from the manufacturer to the user.
Material safety data sheet (MSDS) -a form that specifies procedures for the safe handling of a
substance and data on its properties. The areas covered i nclude toxicity, health effects, first aid,
reactivity, storag:, disposal, protective equipment, and spill-handling procedures.

Peritoneal dialysis (PD) -a form of dialysis that uses the peritoneal merrbrane in the abdomen for
rerroval of toxins and fluid. Sterile dialysis fluids are instilled, dwell, and are drained (exchanged).
Personal protective equipment (PPE) - protective clothing or equipment (e.g, goves, masks, face
shields, and g::>gjes) primarily designed to protect the wearer from exposure to bodily fluid
contamnation, aerosolized contamnants, and infection.
Personnel - health care workers and professionals who perform technical and operational functions
associated with in-centre or home dialysis.
Pol icy -a concise formal statement of principles that indicates how a dialysis provider will act in a
particular area of its operation, thereby providing personnel with an approved way of operating in
relation to a particular matter.
Standard operati ng procedures (SOPs) -the collected operating procedures of a health care facility,
maintained in a format that allows them to be used as a reference by dialysis provider personnel.
Substitution fluid -fluid used in hemofiltration and hemodiafiltration treatments that is infused
directly into the patient's blood as a replacement for the fluid that is rerroved from the blood by
ultrafiltration.
Notes:
1) In this Standard, substitution fluid'' is used to refer to what is alternatively called substitution solution" or
r"eplacerrent solution".
2) Substitution fluid can also be used for bolus adrrinistration, prirring of an extracorporeal bkxx:l circuit, and
returning blood to the d ient at the end of a treatrrent.
Supplier -a person or entity that is the source of goods or services, in this case, the source of dialysis
equipment, solutions, and accessories.
Workplace l-lazardous Materials Information System (WHMIS) -Canada's national hazard

corrrnJn ication standard.
Note: The key elerrents of the system are cautionary labelling of containers of WHl\lllS-controlled products, the
pro.tision of material safety data sheets (MSC5s), and worker education and site-specific training programs.
4 QJality management system (QMS)
4.1 General
4.1.1 Components of Qf'v1S

All health care settings performng any kidney dialysis function(s) shall establish, document, and
implement a qvlS, and maintain its effectiveness in accordance with the requirements of this Standard.
The qvlS shall include

a) policies and procedures, reviewed at specified intervals;
b) a chart outlining the org:inizational structure of the kidney dialysis department responsibilities
within the health care setting
c) requirements for management and staff qualifications, including roles, responsibilities, and
accountabi I ity;
d) a process for continual improvement;
e) client-focused approach, requirements, and services;

f) a comrunication plan for internal and external stakeholders;

g) perforrrance indicators, and a means to measure and rronitor (e.g, audits performed by internal
and external sources);
h) processes for
i) chan92 control;
ii) corrplaint handling
iii) rrana92ment of adverse events;
iv) rrana92ment of drugs and products; and
v) recalls of products, either rranufactured or purchased;
i) infection prevention and control;
j) occupational and environmental health and safety; and
k) a process for reg...dar rrana92ment review of
i) client issues and foll01N-up;
ii) resources, to ensure they are adequate;
iii) key perforrrance indicators (KPls);
iv) any chan92s that could affect the Q'vlS (e.g, new products, or rralfunctions or chan92s to
state, equipment, or packagng);
v) foll01N-up actions from previous rrana92ment review;
vi) preventive actions based on risk analysis; and
vii) documented actions and oqjectives that were the result of the rrana92ment review and that
will foster continual improvement.
l\bte: The main function of the Q'VlS is to establish consistency in, and contrd of, the required processes and
dcx:urrentation in order to prcx:luce quality prcx:lucts that rreet dient and regulatory requirerrents. A Q'VlS gives
assurance that the departrrent's p::llicies, procedures, and processes are in corrlJli ance with Canadian standards,
and that its prcx:lucts and services will pro.tide the highest rxissible degree of safety and quality to clients and staff.
4.1.2 Responsibilities of dialysis provider

/ls described in Oauses 4.2 to 4.16, the dialysis provider shall
a) identify the processes needed for the Q'vlS and their application;
b) determine the sequence and interaction of these processes;
c) determine the criteria and methods needed to ensure that both the operation and control of these
processes are effective;
d) ensure the availability of resources and inforrration necessary to support the operation and
rronitori ng of these processes;
e) rronitor, measure, and analyze these processes;
f) irrplement actions necessary to achieve planned results and to rraintain the effectiveness of these
processes;
g) analyze, evaluate, control, and rronitor risk (see Annex� for rrore inforrration on risk
rrana92ment); and
h) document all aspects of the program
4.2 Documentation and records
4.2.1 General
4.2.1.1 Document control procedure

The dialysis provider shall establish and rraintain a document control procedure that includes protocols
for changng or revising its standard operating procedures (SG's). Chan92s and revisions to operating
procedures shall be reviewed by relevant personnel, dated, and signed by an authorized person. The

document control procedure shall indicate the personnel responsible for reviewing chang=s, the
frequency of reviews, and the approval process.
4.2.1.2 T rack ing of changes and revisions

The document control procedure shall provide for tracking of all chang=s and revisions to the dialysis
provider's sa>s. It shall describe the numbering system to be used, the means for unique designation
and control of versions, and the criteria to be used for a chang= in version number. It shall also include a
distribution list of the personnel who are to receive copies of new or revised operating procedures.
4.2.1.3 Communications of SOPs

All copies of sa>s in circulation shall be numbered and controlled to ensure that none are overlooked
when chang=s are introduced. Each copj shall bear an authorizing signature, with the name of the
person signing indicated lajbly on the document. All copies shall be updated simultaneously to include
handwritten chang=s or typed revisions.
4.2. 1.4 Removal and replacement of superseded procedures

When a new sa> is irrplemented, all copies of superseded procedures shall be removed and replaced
with the current authorized version. If an operating procedure becomes obsolete and is not being
replaced, all copies shall be withdrawn, and the affected personnel shall be notified in writing Approval
by authorized persons shall be documented for all replacements.
4.2.2 Storage and retention

Master copies of the current sa>s and all superseded or obsolete procedures shall be archived.
Procedures shall be in place for the identification, collection, filing storag=, and maintenance of any
working documents used in the preparation of operating procedures.
Note: Dxurrent retention p-ocedures can also be suqect to legal requirer-rents.
4.2.3 Control of records

There shall be a policy that outlines
a) what records shall be maintained;
b) how long they shall be maintained; and
c) their location.
Records shall remain legble, readily identifiable, and retrievable.
A policy on control of records shall be developed in consultation with the health care setting's leg:il
advisers and risk manag=ment personnel. This policy shall be in accordance with the authorities having
jurisdiction.
4.3 Policies
The dialysis provider shall establish and maintain written policies in accordance with accepted principles
of risk manag=ment and documented competencies to ensure the safety, quality, and efficacy of
dialysis, reg:irdless of method [e.g, hemodialysis (HD) and peritoneal dialysis (PD)] and location, and to
ensure the safety of personnel, clients, and caregvers. These policies shall address, but not be lirrited
to, the following topics:
a) qualification and training of personnel;
b) delineation and assignment of personnel responsibil ities;
c) competency and capability of clients and carajvers;
d) delineation of client and caregver responsibilities;

e) establishment, validation, and maintenance of processes;

f) health and safety of personnel, clients, and carajvers;
g) care environment (home or in-centre);
h) emerg=ncy planning
i) adverse event surveillance and reporting
j) quality manag=ment;
k) records manag=ment;
I) quality control;
m) personnel and manag=ment responsibilities;
n) evaluation and purchase and life-cycle manag=ment of medical devices and equipment;
o) infection prevention and control;
p) occupational health and safety;
q) environmental conditions and infrastructure;
r) conting=ncy planning
s) requirements for working with sulxontractors (if used), whether they operate within or outside the
health care setting and
t) manag=ment and reporting of incidents requiring attention or action.
These policies shall be integrated with the health care setting's existing policies. If reprocessing of
reusable devices is being performed by an external or internal sulxontractor, the sulxontractor shal l be
required, at a m ni mull\ to conform to this Standard.
4.4 Procedures
4.4.1 General
4.4.1. 1 SOPs
The dialysis provider shall establish and maintain sa:>s for each activity that affects the safety, quality,
and efficacy of dialysis, reg:irdless of method or location, and the safety of personnel, clients, and
carajvers. The operating procedures shall include, but not be limted to, the areas covered by Causes .2
to 2 as they apply to the specific activities and functions.
4.4.1.2 Review and approvals of SOPs

The dialysis provider's sa:>s shall be reviewed and approved by its senior manag=ment. Senior
manag=ment shall ensure that all of the dialysis provider's personnel fol ION these operating
procedures.
Note: The specific level of rnanagerrent resr:onsible fcr the activities referred to in this Gause will depend on the
size and crganizational structure of the dialysis prCNider. The dialysis prCNider's overall p:ll i des should define the
lines of authcrity, as well as delegation of resp:xisiolities (where apPicable).
4.4.1.3 tvlaintenance of SOPs

D:xumentation of the dialysis provider's sa:>s including the forms used as part of its sa:>s shall be
, ,
maintained in accordance with Causes 4.2.2 and 4.2.3.

-- --
4.4.1.4 Emergency plan

The dialysis provider shall have an emerg=ncy plan that specifies procedures to be follONed in response
to situations or incidents that could jeopardize
a) the ability to provide dialysis services;
b) the safety or quality of dialysis; or

c) the safety of personnel, clients, or caregvers.
4.4.2 Development, approval, and distribution
4.4.2.1 Establishment and maintenance of SOP s

The dialysis provider shall develop and maintain procedures for the establishrrent and maintenance of
its SCPs.
4.4.2.2 Components of SOPs

Each SCP should be clear, concise, and written in a consistent format. Each SCP shall include
a) the narre of the dialysis provider;
b) the title and purpose of the operating procedure;
c) a unique identification number for the docurrent, which shall indicate the revision number (if
applicable);
d) its i rnplerrentation date and (if applicable) revision date(s);
e) the signature of the authorizing person(s) and the date of authorization;
f) numbering for each pag:! (specified in relation to the total number of pag:!s);
g) a clear outline of the steps to be followed in the operating procedure; and
h) clearly defined responsibilities for actions that require checking review, or approval.
q:>erating procedure instructions shall be consistent with the information requirerrents and capabilities
of the recording rrethods (e.g, worksheets, forms, or corrµrter screens) used for the procedure.
4.4.2.3 Availability of SOP s

The dialysis provider's SCP manual shall be available to all personnel at all tirres to cover the activities
they perform at all locations. q:>erating procedures shall be machine printed or be electronically
accessible, with a master copy protected by manag:!rrent and, if electronically accessible, protected
within an information manag:!rrent system l-landwritten chang:!s may be temporarily made when
needed for immediate clarification, i mproverrent, or correction of a procedure; however, all such
chang:!s shall be dated and initialed by an authorized person. The operating procedure should be
revised to include any handwritten chang:!s not later than 12 months from the date they were made.
Note: The requirerrent for rrachine i:xinting or for electronic accessibility is intended to ensure that the i:xocedures
in use have a:>en forrrally accepted and f.XJl:fahed tJy those responsible for the dialysis i:xCNider's activities. The
i:xocedures as i:xinted rray be rrade available to personnel in electronic forrrat.
4.4.2.4 Document control system

The dialysis provider's SCP manual shall be distributed and maintained using a docurrent control
system that ensures that all operating procedures in use are current and authorized.
4.4.2.5 Updates to SOP s

New SCPs and i mportant chang:!s to the existing SCPs shall be implerrented only after the required
approval has been obtained and training of relevant personnel is complete.
4.4.2.6 SOPs for the generation on-line fluids

SCPs shal l also be written for the g:!neration of sterile on-line fluids for prining and/or
hemodiafiltration (HDF). These SCPs should encorrµ:iss all validation and verification activities involving
components in the production and delivery of sterile on-line fluids during treatrrent, including HD
machines, water systems, and consumables such as tubing sets, dialyzers, and drug products (acid and

bic.arbonate concentrates). They shall be written for each service or production process provided by the
dialysis provider.
t\bte: The p..1rpose of a procedure is to ensure the consistency of each prcd.Jct, process, and/or service pro.tided.
4.4.2.7 Distribution of SOPs

Procedures shall be rraintained in a printed form (e.g, in binders, rranuals, or monogaphs) or
electronic form The procedures shall be placed in a central loc.ation where they are readily accessible. A
rraster copy shall be rraintained elsewhere at a specified secure loc.ation.
4.4.2.8 Periodic review of SOP s

Procedures shall be reviewed and updated at intervals specified by the health c.are setting to rerrain
current. The time frame for this review and update shall be stated in the health c.are setting's policies.
Applic.able procedures shall be reviewed in response to

a) any accident, error, or adverse event that is related to a function £P"erned by the procedure;
b) changes in applic.able laws, regulatory requirements, standards, written rranufacturer's
instructions for use, or research that contributes to improved practice and safety;
c) results obtained from internal or external audits; and
d) other conditions or situations as defined in the health c.are setting's policies.
t\bte: Accidents and errors are occurrences that cruld adversely affect the safety, efficacy, or quality of the
reprocessing systern or the safety of clients or personnel. The health care setting should also rronitor trends in the
occurrence of less serirus accidents or errors, as these can help in the early identification of problem;.
4.4.2.9 Deviations from normal operating procedures

The Q'v1S shall ensure that any deviations from norrral operating procedures, such as errors and
accidents, are identified, investig:ited, and evaluated, and that corrective action is taken when required.
This process shall be documented.
4.4.2.10 Review and update of procedures

The review and update of procedures shall be performed by a knowledgeable individual (e.g, multi
disciplinary team or quality corrnittee) who has the authority to rrake necessary changes to ensure
conforrrance with current or new requirements and/or changes in practice. All procedures involving
infection prevention and control shall be reviewed by the health c.are setting's infection control
corrnittee or infection control personnel.
4.4.2.11 OJ tsourcing procedures

If the health c.are setting outsources to a contractor or a third-party org:inization a process that involves
the perforrrance of functions that could affect the quality or safety of its services, the health c.are
setting shall be able to demonstrate that the contractor's or third-party org:inization's perforrrance of
these functions meets the health c.are setting's Q'v1S requirements.
t\btes:
1) AA outsrurced process is a norrn.31 part of the quality system that is given to another entity to corrpl ete.
2) A health care pro.tider and a contractor or third-party organization should execute, and review on a pericx:lic
basis, a quality agreerrent that identifies respective qvlS corrpl i ance roles and resrnnsi alities.
4.4.2.12 Process control

Procedures for process control shall contain, but not be l i mited to, the following elements:
a) change control;

b) corri:ietency testing progarn and

c) quality control.
4.5 Senior ma na gement responsibilities
4.5.1 General
Manag:ment responsibility shall be defined. Manag:ment of the health care setti ng shall pr011ide
evidence of its corrnitment to the development and implementation of the Q'V1S and maintaining its
effectiveness by
a) cormu nicating to the entire orgmization the irrµ:>rtance of meeting client, as wel l as statutory
and regulatory, requirements;
b) establishing a quality policy;
c) ensuring that KPls are established (see Cause 4.5.5);
d) conducting manag:ment reviews; and
e) ensuring the availability of resources.
4.5.2 Client focus

Manag:ment shall ensure that client requirements are determned and are met. dient focus should be
the oqective of all members of the dialysis pravider.
4.5.3 QJ ality policy

Manag:ment shall ensure that the quality p::>l icy
a) is appropriate to the purp::>Se of the dialysis pravider;
b) pravides a framework for establishing and reviewing KPls;
c) is cormunicated and understood within the dialysis pravider; and
d) is reviewed for continuing suitability.
4.5.4 Planning
Manag:ment shall ensure that the Q'V1S is planned, implemented, and, when required, updated.
4.5.5 K ey performance indicators ( K Pl s)

Key performance indicators shall be measurable and consistent with the quality p::>l icy.
t\bte: The fdlONing are exarrples of KPis:
a) cdle<:ting infmnation al:xx.rt: service vdurnes and patterns of medical devices used;
b) reviewing q::ierational plans, service vdurnes, and availalle equipment to deterrrine dialysis services offered;
c) reviewing sa>s; and
d) rronitoring client corrpl a ints, occupational health and safety incidents, recalls, and positive bidogical tests.
4.5.6 Responsibility, authority, and communication

Manag:ment shall ensure that the level of resp::in sibility of each individual staff member or goup is
formally defined, documented, and comn.micated. The definition of resp::>n sibility shall specify the
degee of authority necessary to evaluate quality problems and to initiate, recommend, and pravide
effective corrective and preventive action. Each staff member shall be responsible for the quality of
performance of his or her functions within the dialysis pravider's department or progam
4.5.7 Management representative

Manag:ment shall designate an individual responsible for
a) ensuring that processes needed for the Q'V1S are established, implemented, and maintained;

b) ref'.X)rting to rrana92ment on the perforrrance of the Q'vlS and any need for improvement;
c) ensuring awareness of client focus and reg...datory requirements throughout the dialysis provider's
prograrn and
d) l iaising with external parties on rratters relating to the Q'vlS.
4.5.8 I nternal communication

Mana92ment shall ensure that appropriate comrunication processes are established within the
program and that comrunication takes place regarding the effectiveness of the Q'vlS.
4.5.9 Management review
4.5.9.1 General
Mana92ment shall review the dialysis provider's Q'vlS at planned intervals to ensure its continuing
suitability, adequacy, and effectiveness. This review shall include assessing opfX>rtunities for
improvement and the need for chan92s to the Q'vlS (e.g, chan92s to the quality fX>licy or KPls). Records
from rrana92ment reviews shall be rraintained. See Oause 4.2.
r---.t.b e: Key stakeholders (e.g., clients and external parties) rray be included in the rranagerrent review when
apprq:riate.
4.5.9.2 Review input

Mana92ment review of the dialysis provider's Q'vlS shall include inforrration on
a) results of audits;
b) client feedback;
c) process perforrrance, and product conformty and nonconformty;
d) status of preventive and corrective actions;
e) follow-up actions from previous rrana92ment reviews;
f) chan92s that could affect the Q'vlS (e.g, scheduling chan92s or new equipment);
g) recommendations for improvement;
h) resource planning and
i) new or revised regulatory requirements.
4.5.9.3 Review output

The refX>rt from the rrana92ment review shall include any decisions and actions related to
a) improvements or corrective actions needed to rraintain the effectiveness of the Q'vlS and its
processes (e.g, policies, procedures, and audits);
b) resfX>nses to audit findings, nonconforrrance refX>rts, and client feedback; and
c) resource requirements.
4.6 Resource management
4.6.1 Competency of personnel

Personnel performng work affecting product quality and treatment outcomes shall be deemed
competent on the basis of appropriate education, trai ning skills, and experience. See Oause .§.
The dialysis provider shall

a) determine the necessary competence for personnel performng work affecting product quality and
treatment outcomes;
b) provide training or take other actions to satisfy these needs;
c) evaluate the effectiveness of the training or other actions taken;

d) ensure that its personnel are aware of

i) the relevance and irrportance of their activities; and
ii) how they contribute to the achievement of the KPls; and
e) maintain appropriate records of education, training skills, and experience. See Oause 4.2.
4.6.2 Technical mana ger qualifications

The dialysis provider's technical manager (e.g, nursing manager, charge technologst, or supervisor)
shall meet the qualifications required by provincial or territorial governing bodies and the dialysis
provider's policies and procedures. If such expertise is not available in-house, the dialysis provider shall
arrange for consultative services with a qualified specialist.
r'-bte: The dialysis prCNider's p.'.)licies and procedures should S!=ffify the requirerrents fcr the technical rranager's
educatim and experience in dialysis technology.
4.6.3 0-ganiza tional chart

Areas of responsibility and lines of authority shall be identified on an org:inizational chart. The names,
qualifications, and job descriptions of personnel and thei r alternates shal l be documented. Persons in
responsible positions shall have adequate authority to discharge their responsibilities. The dialysis
provider's SCPs shall provide for alternate personnel to carry out the duties and functions of
management personnel in their absence.
4.7 Environmental conditions and infrastructure
4.7.1 I nfrastructure requirements

The health care setting shall determne, provide, and maintain the infrastructure needed to achieve
conformty to product requirements.
r'-bte: Infrastructure includes, as apf:)icable,
a) buildings, wcrkspaces, and associated utilities;
b) process equiprrent, including hardware and software;
c) supp:rt services (e.g., transrxrt and comn.micatim); and
d) stcrage of supf:)ies.
The dialysis provider shall establish documented requirements for maintenance activities (e.g,
preventive maintenance of dialysis water equipment), including requirements related to the frequency
of these activities, the personnel designated to perform preventive maintenance, and the review of
maintenance records when such activities or lack thereof can affect product quality. Records of such
maintenance shall be maintained (see Oause 4.2).
4.7.2 Environment and infrastructure design guidelines

The dialysis provider's environment and infrastructure shall support its functions and needs, and corrply
with CSA Z23500-1, CSA Z23500-2, CSA Z23500-3, CSA Z23500-4, CSA Z23500-5, and CSA Z8000.
4.7.3 Equipment manufacturer's infrastructure and monitoring requirements

The equipment manufacturer's written recommendations for the infrastructure and its monitoring shall
be followed. Monitoring shall be determned by the health care setting the dialysis provider, and
applicable standards. Parameters defined in the equipment manufacturer's written recommendations
or defined by CSA Z23500-1, CSA Z23500-2, CSA Z23500-3, CSA Z23500-4, and CSA Z23500-5 shall be
monitored and results documented.
r'-bte: D=ternining what other pararreters require rrrnitcring will depend m the equiprrent and functimal
requirerrents in the dialysis departrrent, as well as incidents requiring analysis. D=signating the frequency of

testing and designating resi:xnsibility for the testing and ckxurrentation of results are corrpaients of quality
assurance.
4.7.4 Emergency preparedness

The health care setting shall have sa>s, including emergency preparedness, for the evaluation of, and
response to, incidents where environmental or infrastructure conditions are possible contributors to a
corrpronised dialysis water treatment process.
4.8 Risk management

The dialysis provider shall analyze, evaluate, control, and rronitor risk as a standard practice. All aspects
of risk management shall be documented
4.9 Client communication

The dialysis provider shall deternine and implement effective arrangements for comrunicating with,
and soliciting feedback from clients.
4.10 I ntroduction of new product or processes

The dialysis provider shall make a plan and consult with external parties when new products and
processes are implemented. The corrpati bility of the new product shall be deternined before purchase.
This plan shall be documented.
The dialysis provider shall deternine the

a) process steps;
b) verification requirements; and
c) responsibilities and authorities for approval of new product and processes (e.g, signing authority).
The dialysis provider shall deternine the applicable statutory and regulatory requirements, as well as
the manufacturer's i nstructions for use. See Cause 5.4.
A documented review shall be performed in accordance with the new product or process plan to ensure
that all requirements necessary to achieve a safe product or process introduction are fulfil led. If there
are requirements that cannot be met, there shall be a documented risk assessment approved by
management.
Verification shall be performed in accordance with planned arrangements to ensure that the new
product or processes have met the requirements. Records of the results of the verification and any
necessary actions shall be maintained (see Cause 4.2).
When a product or process changes, it shall be reviewed, verified, and, as appropriate, approved before
implementation. All changes shall be documented.
4.1 1 Purchasing
The dialysis provider shall evaluate and select suppliers based on their ability to supply product in
accordance with the dialysis provider's requirements. viteria for selection and evaluation shall be
established (see Cause _2). The dialysis provider shall ensure the adequacy of specified purchase
requirements prior to their comn.m ication to the supplier.
The dialysis provider shall verify that the product received complies with the product ordered.

4.12 Client property

The dialysis provider shall exercise care with client property while it is under the dialysis provider's
control or being used by the dialysis provider. If any client property is lost, damaged, or found to be
unsuitable for use, this shall be reported to the client and documented (see Gause 4.2).
4.13 Measurement, analysis, and improvement

The dialysis provider shall plan and irrplement processes for rronitoring measurement, analysis, and
i rrprovement of the quality system A mechanism shall be in place to provide input into the corrective
and preventive action processes. See Gause 4.16.
4.14 Audits
4.14.1 General
An audit progam shall take into account the status and i mportance of the specific processes and areas
to be audited, as wel l as the results of previous audits. The audit criteria, scope, frequency, and
methods shall be defined. The selection of auditors and conduct of audits shall ensure the oqjectivity
and irrpartiality of the audit process. To avoid the appearance of bias, a third-party auditor shall be
used.
The responsibilities and requirements for planning and conducting audits, for reporting results, and for
maintaining records (see Gause 4.2) shall be defined in a documented procedure.
The management responsible for the area being audited shall ensure that follovv-up actions are taken
without undue delay to elirrinate detected nonconforrrities and their causes. Follovv-up activities shall
include the documentation of the actions taken and the reporting of results.
4.14.2 I nternal audit

The dialysis provider shall conduct internal audits at planned intervals to deterrrine whether the
products and processes conform to SCPs and the QMS.
r--.bte: Audit cbservations shoold be rreasured against a risk-based analysis that allCNVs the prCNider to identify and
ccrrect deficiencies.
4.14.3 External audit

External audits for measuring progess and identifying areas for irrprovement shall be done on a
periodic basis. External audits shall be performed by a knovvl edgeable person from outside the dialysis
provider that has suffi cient experience and knowledge of QMS.
r--.bte: External audits may be conducted to establish a baseline rreasurerrent cr in resfXX1se to an adverse event.
4.15 Analysis of data

The dialysis provider shall establish documented procedures to deterrrine what data to collect, and hovv
and when to analyze this data (e.g, incident reporting systems, client corrplaint processes,
management reviews to analyze workload data).
4.16 I mprovement
4.16.1 General
The dialysis provider shall identify and irrplement any changes necessary to ensure and maintain the
continued suitability and effectiveness of the QMS (i.e., through the use of the quality policy, key

performance indicators, audit results, analysis of data, corrective and preventive actions, and
management review).
4.16.2 Corrective action

The dialysis provider shall take corrective action to eli mnate the cause of nonconformties in order to
prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformties
encountered.
A documented procedure shall be established to define requirements for

a) reviewing nonconformties (including client complaints);
b) determining the causes of nonconformties;
c) evaluating the need for action to ensure that nonconformties do not recur;
d) determining and implementing action needed, including if appropriate, updating documentation;
e) recording of the results of any investig:ition and of action taken (see Oause 4.2);
f) reviewing the corrective action taken and its effectiveness; and
g) criteria for recall of a nonconformng product (see Oause 8.2).
4.16.3 Preventive action

The dialysis provider shall determne preventive action to elimnate the causes of potential
nonconformties in order to prevent their occurrence.
t\bte: The resp:xisibility fcr addressing preventive actim is a full def:Ertrrent resp:xlSibility (e.g., technicians are a
soorce of infcrmatim 01 preventive actions).
5 Evaluation and purchase of kidney dialysis products and equipment
5.1 General
5.1.1 Evaluation and purchase procedures of dialysis products

The dialysis provider shall have procedures for the evaluation and purchase of dialysis products and
medical equipment (e.g, dialysis equipment, dialyzers). These procedures shall ensure compliance with
any provincial procurement requirements.
5.1.2 Regulatory requirements for dialysis products and medical equipment

Dalysis products and medical equipment not manufactured for medical use shall not be used on clients.
When purchasing dialysis products and medical equipment, the dialysis provider shall confirm that
a) it is approved for use in Canada;
b) the product has a valid medical device license (if applicable);
c) the seller has a medical establishment license; and
d) the products meet all applicable Canadian standards (e.g, CSA IS0 8637-1, CSA IS0 8637-2,
CSA Z23500-2, CSA Z23500-4, CAf\VCSA-Q2.2 l\b. 60601 series, and CAf\VCSA-Q2.2 80601 series).
5.1.3 Purchase agreements

Purchase agreements for medical equipment and consumables for performng dialysis shall be
developed in direct consultation with the multi-disciplinary team responsible for performng dialysis.

5.1.4 Water for hemodialysis

Selection, procurement, installation, review during installation, ongJing maintenance, and operation of
equiprrent related to the purification and distribution of water for HD shall be under the direction and
authority of the physician in charge of the dialysis program and/or the dialysis technical lead or
deleg:ite.
5.2 fv1edical equipment
5.2.1 Evaluation of medical equipment

Evaluation of medical equiprrent should involve representatives from a multi-disciplinary team that
includes, but is not limted to,
a) doctors;
b) nurses;
c) educators;
d) dialysis and/or biomedical technicians and/or techndogsts;
e) physical plant staff/engneers;
f) risk management personnel;
g) infection control personnel;
h) occupational health and safety personnel;
i) purchasing personnel; and
j) clients.
5.2.2 Review of manufacturer's written instructions

Before purchase or evaluation of new medical equiprrent, health care facility personnel shall review the
manufacturer's written instructions to ascertain that the proposed equiprrent meets current and future
treatment rrodalities requirements, and that the instructions
a) are corrplete and in accordance with the level of treatment rrodalities required for the device's
intended use;
b) are device-specific, legble, and understandable;
c) clearly indicate which parts need to be serviced and provide clear servicing instructions, including
illustrations where necessary,
d) include instructions for cleaning and disinfection, and the frequency of these activities;
e) are in accordance with the intended use of the device;
f) state whether or not the device is immersible;
g) specify the necessary materials (e.g, bloodlines, concentrate, and other accessories), the parts, and
the descaling agents for proper cleaning and maintenance of the device;
h) specify if there is a Ii mt to the nurrber of times the device can be reprocessed or if reprocessing
will contribute to degradation of the medical device; and
i) include preventive maintenance instructions.
5.2.3 Evaluation criteria of medical equipment

Evaluation criteria of medical equiprrent should include, but not be limted to
a) physical characteristics and utilities (size, weight, electrical povver, water supply, ventilation);
b) maintenance -corrective and preventive;
c) life cycle;
d) storage requirements;
e) software;
f) operational interface;
g) extracorporeal interface;

h) safety;
i) rrodalities;
j) client operation (in the case of home equipment); and
k) warranty.
5.3 Consumable products
5.3.1 Evaluation of consumable products

Evaluation of consurrable products should involve representatives from a multi-disciplinary team that
includes, but is not limted to
a) doctors;
b) nurses;
c) educators;
d) dialysis and/or biomedical technicians and/or techndajsts;
e) risk rranag:ment personnel;
f) infection control personnel; and
g) supply chain rranag:ment.
5.3.2 Evaluation criteria of consumable products

Evaluation criteria of consurrable products should include, but not be limted to
a) product perforrrance;
b) physical characteristics;
c) packagng
d) storag: requirements; and
e) suppliers, including
i) suppliers of lajstics;
ii) supply chain rranag:ment; and
iii) suppliers of conting:ncy inventory.
5.4 tvlanufacturer's instructions
5.4.1 General
The dialysis provider shall obtain device-specific rranufacturer's instructions (i.e., a user rranual) for
performng dialysis, which contain, at a mnimurn the inforrration required in c:A Z364.2. 1 and
c:A Z23500-2. The instructions shall be received and rraintained in printed form (e.g, in binders,
rranuals, or monographs) or in electronic forrrat, so as to facilitate device rraintenance, as well as
personnel training and education. The rranufacturer' s instructions shall be placed in a location where
they are readily accessible to those needing access, and they shall be updated as required.
5.4.2 Treatment procedures

The dialysis provider shall ensure that it can perform the treatment procedures as outlined by the
rranufacturer.
5.5 Loaned, reusable medical devices

Loaned, reusable medical devices supplied to the dialysis provider shall be rranaged in accordance with
this Standard and c:A Z364.2.1.

6 Personnel
6.1 General
6.1.1 Applicability
The requirements in Gause § shall apply equally to all personnel involved in the delivery of kidney
dialysis, wherever it is performed.
6.1.2 QJ alified personnel

Al l aspects of kidney dialysis shall be performed by qualified personnel under knOvVledgeable and
corrpetent supervision. In the case of home kidney dialysis, they shall be performed after training by,
and under the supervision of, corrpetent personnel.
r---.bte: Pro.tincial and other jurisdictimal cx:cupatimal health and safety legislatim and regulatims should be
cmsulted.
6.1.3 Policies and procedures

The dialysis provider shall have documented policies and procedures for personnel qualifications,
occupational health and safety, education, certification and training experience, and corrpetency
assessment for each errployee position. These procedures shall include clearly defined responsibilities,
be consistent with the requirements in Gause §, and be maintained as specified in aauses 4.3 and 4.4.
These policies shall indicate hOvV often each educational, training and corrpetency assessment process
shall occur.
6.1.4 Number of qualified and experience personnel

There shall be a sufficient nurrber of qualified and experienced personnel to carry out all tasks in
accordance with sa:>s. The nurrber of personnel shall be based on the nurrber of dialysis clients the
dialysis provider normally handles. Personnel shall have the documented education, training
experience, and skills necessary to ensure they can perform assigned duties.
6.1.5 Approval of medical and technical policies and procedures

A dialysis provider shall have a qualified physician, technical manager, or assigned delegite or
authorized corrmittee with physician representation responsible for approving all medical and technical
policies and procedures.
r---.bte: In Canada, licensing of P,ysicians is rerfcrrred by duly authcrized pro.tincial or territorial OOdies.
Q.Jalificatim can also include a certificate of srecial cornretence in neP,rolOJY.
6.1.6 0- ganizations chart

Areas of responsibility and lines of authority shall be identified on an org:inizational chart. The names,
qualifications, and job descriptions of personnel and their alternates shal l be documented. Persons in
responsible positions shall have adequate authority to discharge their responsibilities. The dialysis
provider's sa:>s shall provide for alternate personnel to carry out the duties and functions of
management personnel in their absence.
6.1.7 I mmunizations
The errployer shall ensure that kidney dialysis personnel have the appropriate immunizations and
maintain a current immunization status based on their duties and their potential exposure to infectious
agents. Hepatitis B immunization shall be provided for all kidney dialysis personnel.
r---.bte: For further informatim, see the Canadian Irrm.mization Guide.

6.2 Qualifications
6.2.1 Supervisory personnel

Personnel shall be prepared for supervisory responsibility throug, appropriate education, training and
experience. Minim.Jm qualifications should include recent
a) completion of formal training progams recogiized by the health care setting and experience and
demonstrated competency as a dialysis provider;
b) participation in manag=ment training progams (e. g., educational seminars, personnel
manag=ment and material manag=ment progams, and courses directly related to the position);
c) participation in in-service progams designed specifically for the department responsible for kidney
dialysis; and
d) training on occupational health and safety.
6.2.2 Kidney dialysis personnel

All personnel involved i n kidney dialysis shall be prepared for the functions that they perform throug,
appropriate education and training arrang=d by the dialysis provider.
6.3 0- ientation, training and continuing education
6.3.1 General
The dialysis provider shall identify training needs for all personnel and develop documented progams
for i nitial and ongoing training.
6.3.2 Personnel training programs

Training related to workplace safety, equipment operation and maintenance, and the dialysis provider's
quality assurance progam shall be included in the dialysis provider's personnel training progams.
6.3.3 Effectiveness of personnel training programs

The effectiveness of the personnel training progams shall be assessed at least annually.
6.3.4 0- ientation, training, and continuing education procedures

0-ientation, training and continuing education for all personnel involved in the kidney dialysis shall be
provided and documented. This should include information and instruction on all policies and
procedures pertinent to the errployee's role in the use and maintenance of dialysis products and
equipment, occupational health and safety, and infection prevention and control. The health care
setting's policies shall specify the requirements for, and frequency of, education, training and
competency assessments for each errployee involved in the transportation, cleaning and reprocessing
of dialysis devices.
The requirements of this Oause also apply to temporary personnel. Temporary personnel who have not
been fully trained and/or competency tested shall not use or supervise the use of dialysis devices.
6.3.5 Monitoring and documentation

Education, orientation, training and coni::ietency, as they apply to the individual responsibilities of
personnel, shall be monitored and documented for the following
a) QVlS elements that apply to daily practice, including
i) monitoring
ii) testing

iii) reporting
iv) corrective action; and
v) docurrentation;
b) infection prevention and control principles, including
i) routine practices;
ii) hand hygene;
iii) selection and use of personal protective equiprrent (PPE);
iv) handling of sharps and waste manag?rrent;
v) body fluids exposure, including prevention and actions to take should an exposure occur; and
vi) contamnation and cross-contamnation;
c) occupational health and safety, including
i) the workplace hazardous materials information system (WHrvtIS), including
1) the product identifiers of hazardous substances used in their health care setting and
2) hO\lV to read and interpret the information disclosed on labels and MSDS;
ii) prevention of exposure to sharps (see Oause 6. 5.2);
iii) prevention of exposure to chemcals;
iv) engneering controls;
v) procedures for the safe storag?, use, handling and disposal of hazardous substances and
solutions;
vi) i nstallation and preventive maintenance;
vii) hazard assessrrent; and
viii) post-exposure interventions, including
1) eyewash stations;
2) delug? shO\!Vers;
3) spill kits; and
4) environrrental considerations; and
d) decontamnation, including
i) selection and use of appropriate decontamnation ag?nts and rrethods;
ii) collection, transportation, and receipt of soiled rredical devices; and
iii) manual decontamnation of used rredical devices.
6.3.6 Procedures for handling incidents

Procedures for handling incidents (e.g, recalls, spills) shall include education, traini ng and competency
assessrrent relevant to the incident, and all steps taken shall be docurrented.
6.3.7 Documentation
Dxurrentation of qualification, training and continued competence shall be maintai ned. The results of
work reviews and any rerredial action required shall be docurrented and maintained.
6.4 Competency assessment
6.4.1 General
The dialysis provider shall create, maintain, and docurrent a formal competency assessrrent program
for personnel. Competency shall be assessed follO\!Vingtraining and at regular intervals thereafter. A
competency assessrrent program should evaluate theoretical and practical knO\!Vledg= of procedures
and should include, but not be limted to,
a) direct observation of performance;
b) monitoring of recording and refX>rting and
c) assessrrent of knO\!Vledg= of operati ng procedures and theory.

The effectiveness of the corrµ=tency assessment prog-am shall be evaluated at least biennial.
Evaluations shall be documented.
6.4.2 Participation in personnel proficiency testing program

The dialysis provider shall participate in a personnel proficiency testing prog-am Proficiency tests shall
be documented and the records retained in accordance with Gause 4.2. The dialysis provider shall
perform regular personnel work reviews. The review may include self-assessment by the errployee,
input from the errployee's direct supervisor and/ or colleagues, or direct observation by a qualified
observer. Results shall be reviewed with the errployee, and a plan for remedial action should be laid out
if needed.
6.4.3 Proficiency test results

Personnel qualified in dialysis shall be assigned to review and evaluate proficiency test results.
6.4.4 Remedial action

There shall be a plan for remedial action in the case of unsuccessful proficiency test performance.
6.4.5 Record keeping

D:x:umentation of qualification, training and continued competence shall be maintai ned. The results of
competency assessments and remedial measures to correct inadequate performance shall be
documented and retained.
6.5 CX:cupational health and safety
6.5 . 1 General
Personnel who have chronic respiratory conditions (e.g, asthma) should be assessed by the health care
setting's occupational and health personnel prior to working with cleaning ag:nts, cherrical
disinfectants, or cherrical sterilants.
6.5.2 Sharps
Care shall be taken when sharpening and/or handling reusable sharp medical devices. Vvhen working
with sharps, personnel shall
a) handle gass and other fragle oqjects carefully to prevent injury; and
b) discard chipped or broken gass devices or arrang: to have the chipped or broken gass devices
professionally repaired.
6.5.3 SpiI ls of hazardous substances
6.5.3 . 1 General
Health care settings shall have documented and readily accessible procedures, including WHMIS
requirements, for the manag:ment of a spill of a hazardous substance.
f\bte: Extrerre care should be taken to avoid contact with, or inhalation exf:X)Sure to, hazardous substances in the
course of normal operations. A spll of a hazardous substance has the p'.)tential to harm r:ersons, property, or the
environrrent. Major splls or accidents usually involve container rupture, caused either bf eq...ii prrent malfunction
cr careless handling. Q:Jtimal manager-rent of a hazardous substance spll involves prarpt, inforrred action based
upon a corrµehensive contingency pan prepared and learned in advance.

6.5.3.2 Precautions
Precautions shall be taken in cleaning up a spill of a hazardous substance and shall include the
following
a) training and education of all staff in the recognition and rrana9:!rrent of hazardous substances and
in the rrana9:!rrent of a spill;
b) preparation of acceptable rrethods for the containrrent and isolation of each type of spill;
c) provision of inforrration concerning individual hazardous substances and their cleanup. This
inforrration shall be readily accessible to all personnel and available on a 24 h basis;
d) ensuring that the appropriate equipment is available for
i) cleanup; and
ii) protection of personnel;
e) provision of cleanup procedures for each type of spi ll in the area where the spill is likely to occur;
f) a written procedure for the proper disposal of the cleanup waste. The procedure shall be prepared
in accordance with the waste rrana9:!rrent policy of the health care setting and
g) positioning spill rrana9:!rrent equipment and written procedures at a safe distance from potential
spill sites so they are accessible in an errer9:!ncy.
6.5.3.3 I ncident handling procedure

If a spill of a hazardous substance occurs,
a) internal action plans shall be irrplerrented, if necessary;
b) the person or persons designated for the cleanup shall be notified i mrediately. These persons shall
have specific training in the rrana9:!rrent of spills of hazardous substances; and
c) an errployee exposed to the spi l l of a hazardous substance shall be treated appropriately by
qualified personnel and rronitored by personnel with expertise in occupational health chemcal
exposures.
6.5.3.4 I ncident review and corrective actions

After a hazardous substance spill, the health care setting shall
a) docurrent all incidents of a spi l l of a hazardous substance for the purposes of record keeping
b) review the event and docurrent the action taken and the outcorres; and
c) fol low the dialysis provider's policies and processes when exposed to hazardous substances.
f\bte: Fcr further infcrmitim, see Health Canada's Spill or Leak -Ernerg2ncy Preparedness.
6.6 Routine infection prevention and control practices
6.6.1 General
6.6.1. 1 Exposure to blood and body substances

Procedures shall be in place to prevent worker exposure to blood and body substances. Procedures
shall be in place for i rrrnediate response to worker exposure to blood-borne path�ns.
6.6.1.2 T reatment, storage, or repair areas

When working in treatrrent, stora9:!, or repair areas, personnel shall
a) be rrade aware of the associated hazards;
b) wear the appropriate PPE to prevent being exposed to blood, body fluids, contamnated devices, or
chem ca ls;
c) wash the exposed area imrediately if they have been exposed to potentially infectious rraterial;
d) not eat, drink, srroke, apply cosrretics or lip bairn or handle contact lenses in the work area; and

e) not store food, drink, or personal belongngs in the work area.

r--.t.b e: Pro.tincial, territorial, and other jurisdictional occupational health and safety legislatim and regulations
should be consulted.
6.6.2 Hand hygiene

I-land hygene facilities shall be located at all entrances to and exits from dialysis areas, as well as in all
personnel support areas (e.g, the staff loung:). Personnel shall perform hand hygene before begnning
work, before breaks, and upon corrpletion of their work duties. Corrpliance with hand hygene should
be rronitored in accordance with health care setting's policies.
r--.t.b es:
1) Hand hygiene is the single ITC61: irrp:rtant procedure for preventing health-care-acquired infections in dients
and staff. Availaality of traditional hand hygiene facilities (e.g., designated hand-hygiene sinks), as well as
alcohol-based hand rubs, encoorages the practice of gc:x::id hand hygiene. The ideal frequency of hand hygiene
is unknoNn, but �rsmnel should wash their hands in situations such as the follONing:
a) after handling devices cmtarrinated or likely to be cmtarrinated with blcod, lxxly fluids, excretions, or
secretions;
b) after rem::M ng glo.tes;
c) after tooching the face;
d) before leaving and after returning to the dialysis area; and
e) after using the tdlet.
2) For further inform:1tim, see Health Canada's GUIDE-0028, Oeaning validation guidelines.
6.7 Attire
r--.t.b e: h:lapted from aw\C (2021) with �rrrissim.
6.7.1 Personal protective equipment ( P P E)
6.7.1. 1 General
Personal protective equipment worn by the dialysis provider shall be appropriate to the area task(s). For
example, personnel exposed to contaminated medical devices shall wear the following
a) goves appropriate to the task (e.g, chemical-resistant goves when handling chemicals such as
disinfectants or deterg:nts);
b) a g:irment with appropriate barrier properties for the job function and the task at hand ( e.g, a
backless g::NVn, j umpsuit, or surgcal g::NVn); and
c) either a ful l -face shield or a high-filtration, fluid-in1Jervious face mask, and protective eyewear.
r--.t.b e: Splashing or aerosol spray can occur at any tirre. Appropriate PPE pro.tides protectim from unex�ed
events.
6.7.1.2 Reusable P P E
Reusable PPE shall be cleaned at least daily or a s recorrrrended by the manufacturer a s part of its
ong:iing maintenance. Personnel wearing torn goves shall rerrove them immediately, perform hand
hygene, and don a new pair of goves. When the integity of goves, liquid-resistant g:irments, masks, or
protective eyewear is compromised, these PPE shall be replaced i rrrnediately.
f\bte: Cmtarrinated rredical devices are a soorce of rricro-aganism; that can infect �rsonnel throogh nicks, cuts,
or abrasions in the skin or throogh cmtact with the m.Jcoos rrentx-anes of the eyes, nose, or rra..rt h. Appropriate
attire rrinirrizes the i:otential for exi:osure to blocx:J-OOrne and other disease-prcx:Jucing organism;. Care should be
taken in putting on or taking off PPE, as PPE itself can be a soorce of contarrination.

6.7.1.3 Decontamination area

Prior to leaving the decontamnation area, personnel shall remove all PPE, taking care not to
contamnate their clothing or their skin, and shall perform hand hygene. Personnel shall be trained in
the proper sequence for removing and handling PPE.
6.7.1.4 Laundry facilities

A laundry approved by the health care setting shal I launder reusable personal protective attire.
6.7.1.5 P P E requirements for service personnel and visitors

All dialysis provider service personnel and visitors to dialysis areas shall wear protective attire or PPE
appropriate to the type of area, their activity in that area, and the amount of time they will be there
(e.g, protective eyewear when in i mmediate proximty to active patient care). They shall remove the
PPE and wash their hands on exiting the area.
6.7.2 Gloves
6.7.2.1 Removal of gloves

I-land hygene shall be performed follOvVing removal of go.tes.
l\bte: GICNes do not p-CNide absolute p-otection from chemcals and mcro-aganism;. Hand hygiene rem:Nes
p::>tentially hazarda.Js resid.Jes.
6.7.2.2 Style, fit, and type of glove

The style, fit, and type of go.te used shall prevent errployee contact with contamnants or hazardous
substances.
l\btes:
1) Task-approp-iate, liquid-proof glo;es can reduce the p::>tential of puncture, limt the mcrciJial burden on
hands, and decrease the risk of aoss-contamnation.
2) Oiemcal-resistant glo;es sha.Jld be used when handling disinfectant solutions.
3) \/\then choosing glo;es, the follONing points sha.Jld be cmsidered
a) glo;es are long ena.igh to co;er wrists and, in the case of handling chemcals, the forearm;;
b) glo;es are of sufficient weight to be highly tear-resistant;
c) glo;es allON adequate dexterity of the fingers; and
d) disp::>Sa bl e glo;es sha.Jld be used; if reusable glo;es are used, ensure they are decontamnated daily,
inspected for tears and holes, and are staff-specific.
7 Workflow design and equipment management
7.1 O::c upational health and safety

Dalysis areas shall be utilized with the intent to reduce the potential for adverse health events by
providing
a) sufficient and accessible space for
i) storing donning and doffing PPE;
ii) the movement of carts between work areas;
iii) general waste, biohazard waste, chemcal waste, and sharps disposal containers;
iv) storing portable equiprrent;
v) storage of chemcals;
vi) storing dialysis supplies; and
vii) patients' personal belongngs; and

b) environmental controls for

i) cherricals used in the dialysis areas;
ii) noise; and
iii) heating ventilation, and air conditioning (HVAQ.
7.2 Equipment maintenance and quality assurance
7.2.1 Maintenance program

The dialysis provider shall establish and maintain a maintenance service contract or an in-house
inspection and maintenance program The equipment manufacturer's instructions for maintenance and
inspection shall be followed for all equipment used in the health care and home dialysis setting
wherever located.
Maintenance and inspection procedures shall be performed only by personnel trained and qualified to
provide such services.
Note: This includes, but is not l imted to,
a) preventative and corrective maintenances;
b) replacerrent of parts or cooµinents;
c) the testing of blocd and/or hydraulic circuit operatim and rrooitoring cooµinents; and
d) electrical safety.
7.2.2 Maintenance facility requirement

The dialysis provider shall provide the necessary environment required for equipment maintenance
(e.g, sufficient space, utility connections).
7.2.3 Testing devices and instruments used in repair and maintenance

Testing devices and instruments used in repair and maintenance shall be calibrated or validated at
intervals recomnended by the manufacturer. Testing devices and instruments identification information
(manufacturer, model number, serial number, cal i bration date, and next calibration due date) shall be
recorded.
7.2.4 Scheduled maintenance

Medical equipment shall be maintained according to manufacturer's recomnended maintenance
schedule. My deviation shall be done under the guidance and direction of the medical director, the
health care facility adrrinistrator, and/or dedicated health care technolog; management team of the
dialysis provider.
Note: Al l eq.iiprrent eventually wears rut and can also break or malfunctim Certain types of equiprrent req.iire
scheduled maintenance to ensure they are working properly.
7.2.5 Repair and maintenance record

Repair and maintenance records shall be maintained in accordance with the dialysis provider program
and maintenance and inspection procedures of equipment shall
a) be kept current;
b) be readily available to the dialysis provider management; and
c) contain, but not be limited to, the following information:
i) equipment ID, model, serial number, and location;
ii) the date on which an inspection, correction, or maintenance procedure was initiated and
corrlJ!eted;
iii) the name of the person who carried out the inspection or maintenance procedure;

iv) corrµ:ments that were inspected and the extent of any maintenance procedures; and
v) the date that any required tests were performed, the results of the tests, and the sigiature of
a person qualified to authorize the release of the equipment for service.
7.2.6 Repair and maintenance service

The dialysis provider should include the following steps i n the development of its equipment repair and
maintenance program
a) The devices should be carefully inspected for wear and damag=.
b) l\bnconformng products should be identified using a repair tag or other means so as to ensure
that the item is not returned to service before it is repaired.
c) Areas of wear or damag= should be identified and the fault location indicated.
d) .AJI repair facilities (in-house or third-party) should be qualified by
i) confirming the types of devices that they can properly repair;
ii) the qualifications of their qualified personnel; and
iii) providing access to the parts necessary to ensure a satisfactory repair (in some cases, this
mght require a product to be returned to the orignal manufacturer for repair).
t\bte: It is likely that a dialysis pro.tider will use a variety of repair facilities, depending on the carpexity of
the product, required turnaround tirre, and access to unique or proprietary pa rts or service.
e) Upon return of the device after repair, the device shall be visually inspected and function tested
prior to being placed back into service as per manufacturer's instructions.
f) The required dialysis water quality tests and functional tests should be performed prior to placing
the device back into service as per manufacturer's i nstructions.
g) D::x:umentation of the repair service performed shal l be included.
t\bte: In sare cases, a repair date code can be rrarked on the rredical device to identify when a repair was
perforrred.
7.3 Equipment cleaning and disinfection
7.3.1 External equipment surface disinfections

Procedures shall be in place to disinfect the external surface of HD machines, peripheral equipment,
and accessories between each patient use or when being moved from a patient treatment area to
another location (e.g, technical lab, storag= location).
7.3.2 Hydraulic fluid path disinfections

The dialysis provider shall have a policy pertaining to the disinfection of internal hydraulic circuit that
prevents cross-contam nation between patients. The disi nfection procedures defined and validated by
the manufacturer shall be used when using online fluid production [e.g, HCf, hemofiltration (HF),
online primng] .
t\btes:
1) Careful attention shoJld be errphasized when deterrrining the frequency of disinfection of a dialysis
rrachine's internal hydraulic pathway. Modern dialysis rrachines produce fresh dialysate to the dialyzer;
hcwever, during a dialysis treatrrent, alarm conditions and other events could occur that cause the dialysate
flew to st�. D.Jring this tirre, fresh dialysate could be contarrinated with waste products from the dialyzer
through diffusion.
2) A.I I dialysis prCNiders shoJld disinfect the internal hydraulic pathway of the dialysis rrachine after each patient
shift. Dalysis prCNiders shoJld strive to pro.tide more frequent disinfection rather than less. Dalysis unit
operating hoJrs can be reviewed and adjusted to pro.tide the tirre necessary to allcw for rrachine disinfection
between patient shifts.

3) Policy considerations include, but are not linited tq

a) the follo.Ning internal hydraulic and patient risk factcrs:
i) effluent contanination during couping of the dialysate connectors post-treatment;
ii) diffusive flew of biological wastes upstream of the fresh dialysate connector;
iii) contanination of concentrates during treatment;
iv) nicrobial contanination thra.ighout the op=rating day;
v) ninor non-detectable blood leaks;
vi) unknoNn status of asyrrµornatic patient carriers of viruses and bacteria;
vii) op=rator errors; and
viii) rinsing not being considered equivalent to a disinfection;
b) disinfection of HD machine's inconing water hose and fluid circuit path to ensure corrp i ance with the
nicrobiological requirements of CSA Z23500-3; and
c) additional precautions needed to ensure the service technician's safety when handling patient fluid if the
dialysis pro.tider is not able to disinfect the HD machine.
7.3.3 B lood tubing transducer protectors

Procedures shall be in place to rerrove the HD m:ichine and be repaired when the blood tubing
transducer protector(s) comes into contact with saline or patient's blood, or have been breached with
any fluid.
f\bte: This may involve the inspection anc:Vor repacement of the transducer protector(s) as well as the disinfection
of any machine internal surface related to the transducer flew path.
7.4 Dialysis fluid quality

Dalysis fluid sarrlJling shall be done according to CSA Z23500-1. SarrlJ!ing results shall be rronitored
and reviewed on a regular basis and kept on record. Dalysis fluid sarrlJ!ing results shall
a) be kept current;
b) be readily available to the dialysis provider m:inagement; and
c) contain, but not be limited to, the follovvi ng inform:ition:
i) sarrlJ!ing location;
ii) m:ichine ID,
iii) sarrlJ!ing date; and
iv) test results.
8 Process verification, monitoring and adverse events
8 . 1 Process verification
The dialysis provider shall establish expected process outcomes and shal I verify that they have been
achieved.
f\btes:
1) Process verification is a key aspect of ensuring the safety of dialysis devices. Process verification" refers to
the integrated system of tests, controls, and backup procedures intended to ensure that dialysis medical
devices are safe for use. It begins with careful adherence to written procedures for maintenance, repair,
cleaning. disinfecting. sterilization, handling. storage, and transportation. It also includes monitoring of
critical points in each process to ensure that the procedures and processes are working correctly, as well as
careful record keeping and an effective recall procedure so that problems can be quickly identified and
appropriate action taken, thus ensuring client safety.
2) See Annex 6 fcr more information on risk management.

8.2 Recalls and alerts
8.2.1 General
8.2.1.1 Purpose of a recall

The purpose of a recall is to retrieve any rredical devices that fai l to meet the standard of quality for
use in health care. A recall in a health care setting might be necessary when rredical devices have been
inadequately repaired, maintained, or manufactured, or stored irrproperly, or when there is notification
of an alert or recall from the manufacturer or recognized org:mizations and government agencies such
as Health Canada.
8.2.1.2 Responses to applicable alerts

Responses to applicable alerts shall be managed in accordance with the dialysis provider's risk
management policies.
8.2.1.3 Distribution of information on alerts and recalls

Information on alerts and recalls should be circulated to the follovvi ng departments, i ndividuals, and any
others affected, as applicable:
a) purchasing
b) biorredical;
c) infection prevention and control;
d) risk management; and
e) health care professionals using the product.
8.2.1.4 Doubt about the safety of released medical devices

If there is doubt about the safety of released rredical devices, a recall shall be initiated. The recall shall
include notification of clients and physicians as appropriate, in accordance with the policy of the dialysis
provider.
8.2.1.5 QJar antining

Recalled items shall be quarantined pending the results of the investigation.
8.2.1.6 Unrepairable recalled medical devices

Recalled medical devices that cannot be made safe for use by repair (e.g, through manufacturer recall)
shall not be used on clients. The dialysis provider shall have a policy for handling these devices.
8.2.2 Recal I procedure

The dialysis provider recall procedure shall
a) be documenteq
b) outline the circumstances for issuing a recall order;
c) designate the personnel authorized to issue a recall order;
d) provide methods for designated personnel to determine the extent of a recall;
e) outline the procedure to be follovved when a recall is necessary; and
f) designate the personnel responsible for reporting on the execution of a recall order.

8.2.3 Recal I order
8.2.3.1 General
A recal l order shall
a) be documented and retained in accordance with the policy of the dialysis provider;
b) record the date and time that the equipment was taken out of seNice and the actions performed
(if applicable);
c) identify the medical devices to be recalled (e.g, throogi labels on packag.=s, device rrodel
nurrbers);
d) identify the departments to which the order applies;
e) record the kind and quantity of the medical devices to be recalled; and
f) specify the action (e.g, destruction of the medical device or return of the medical device to the
dialysis provider) to be taken by the person(s) receiving the order.
8.2.3.2 Externally repaired or maintained medical devices

If medical devices are repaired or rraintained externally, arrang.=ments shall be rrade to ensure that
a) records are rraintained in accordance with the policy of the dialysis provider and are available to
personnel; and
b) provision is rrade for the recall.
8.2.4 Recal I report

A report of the recall order shall
a) be documented and retained in accordance with the policy of the dialysis provider;
b) identify the circumstances that prorrpted the recall order;
c) list the medical devices included in the recall;
d) list the departments or individuals notified of the recall;
e) state, in terms of the total nurrber of medical devices intended to be recalled, the percentag.= of
medical devices actually located in the recall;
f) include an incident report for devices that were recalled but could not be col lected; and
g) specify the corrective action taken to prevent a recurrence.
9 Storage
9.1 General
The dialysis provider shall have procedures for storag.= of clean, disinfected, and sterile medical devices
as well as g.=neral storag.= for bulk supplies. These procedures shall include clearly defined
responsibilities, be consistent with the requirements in Gause 2, and be rraintained as specified in
aauses 4.3 and 4.4.
9.2 I nventory control

Each dialysis provider shall establish policies and procedures for inventory control and shelf life.
9 .3 Di str ibuti on
Procedures shall be established for the handling of clean, disinfected, and sterile supplies and devices.
Routine distribution of clean, disinfected, and/or sterilized medical supplies and devices to different
areas in the health care facility shall be performed using clean plastic bags or clean enclosed or covered
transportation carts, bins, or totes.

Annex A ( i nformative)
Ri s k ma na gement
r'\bte: This /:\nnex is not a rmndatay part of this Standard
A. 1 Concept of risk management

This Standard makes several references to risk manag=ment, and it cites the need to involve the health
care setting's risk manag=ment department i n the developrrent of policies and procedures. This Annex
reviews the concept of risk manag=ment.
Health care professionals and clients expect medical devi ces to function properly and not cause injury
or infection. In a properly staffed and equipped health care setting that has clear, validated instructions
from the device manufacturer, the conditions exist for a dialysis provider to meet this expectation.
When one or more of these conditions are not in place, the risk of error or failure can increase. Multiple
problems can quickly raise the potential risk to a point where the safety of clients and staff is
compronised.
k, part of their Q"v1S for dialysis pro.tiders, health care settings should be aware of and address
potential problems that could arise from linitations in their physical facilities, manufacturer's
instructions, staffing equiprrent, packagng or load configuration. Risk assessment, as a component of
risk manag=ment, can be a useful tool in helping to identify and evaluate these limitations.
Risk manag=ment" is defined in CSP.. ISO 14971 as the systematic application of manag=ment policies,
procedures and practices to the tasks of analyzing evaluating controlling and monitoring risk''. Risk
manag=ment begns with risk assessment, which has two components: risk analysis and risk evaluation.
Risk analysis involves the identification of potential risks, consideration of the l i kelihood of their
occurrence, and the possible consequences of such an occurrence. Risk evaluation involves comparing
identified risks ag:iinst the level of risk the health care setting is able to accept. The health care setting
then eng:ig=s in risk treatment or contrd, which specifies the chang=s or precautions needed to bring
risks into acceptable rang=s. Finally, the health care setti ng comn.micates the remaining risks to those
who night be affected, while continuing to monitor risk areas within its operations.
Because risk manag=ment can involve multiple departments and the consequences of risk manag=ment
decisions will affect the entire health care setting risk manag=ment is usually addressed across the
entire health care setting Risks are as likely to occur from a lack of coordination or commu nication
between departments as from the actions of a singe department. Therefore, the dialysis provider can
use risk assessment techniques to help identify and manag= risks at the departmental level. The
follovvi ng activities can help in this process:
a) risk identification - identifyi ng potential sources of failure and considering the consequences if
that failure does occur;
r'\bte: Since assurance is a prornbility function, it can be assurred that, at sorre tirre, a failure will occur.
b) risk analysis -consideration of the causes and sources of risk, their positive and neg:itive
consequences, and the likelihood that these consequences could occur;
c) risk evaluation -deternining which of the potential failures identified i n Items a) and b) require
manag=ment and the priority order in which to address thern
d) risk control -the selection and implementation of the plans or actions that are required to ensure
that failures are controlled; and

e) risk comn.mication -the exchang= of information and the informng of other concerned parties
(e.g, clients and staff) of situations that could affect their health or safety.
f\bte: The health care setting's recall prcxedure is one exarrpe of risk cormunicatirn.
Risk manag=ment activities can help a dialysis provider to irrprove its own operations; in addition, they
can provide useful information that can be used in developing and maintaining the health care setting's
larg=r risk manag=ment strateg;.

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Csa Z364.6-23

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Q.Jality management for kidney dialysis

Di scl ai mer a n d excl usion of l i a bi l i ty

I ntel l ectual property r i ghts a n d owner shi p

Author i zed use of t h i s docu ment

Title: Q.Jality management for kidney dialysis pro.tiders

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For further information on CSA Group services, write to

Published in February 2023 by CSA Groop

© 2023 Canadian Standards Association

Sul:x:omnittee on QJality Manag=ment for Kidney Dalysis 7

4 QJality manag=ment system (QMS) 16

February 2023 © 2023 canadian Standards Asscx:iatioo 1

4. 7.4 Emerg=ncy preparedness 25

5 Evaluation and purchase of kidney dial ysis products and equipment 27

February 2023 © 2023 canadian Standards Asscx:iatioo 2

6.3.2 Personnel training prog-ams 31

7 Workflow design and equipment manag=ment 36

8 Process verification, monitoring and adverse events 39

February 2023 © 2023 canadian Standards Asscx:iatioo 3

Annex A (inforrrative) -Risk rranagarrent 42

February 2023 © 2023 canadian Standards Asscx:iatioo 4

Technical Committee on Kidney Dialysis

J. Maahs Baxter, Vice-Oiair

D. M. Braley 0-illia Soldiers' Merrorial l-lospital,

M. D. Diwan Halton Healthcare, l\bn-voting

E. DJppler Alberta Health Services,

P. Farrell Central Health, l\bn-voting

G. Fotiou Mackenzie Health Richrrond Hill l-lospital,

G. Friederichs Fresenius Medical c.are l\brth Arrerica,

S. Hirernath University of Ottawa and Ottawa l-lospital,

S. Kurkjian 01tario Health,

H. La Fave Peterboroug, Rajonal Health Centre,

February 2023 © 2023 canadian Standards Asscx:iatioo 5

K Landry Fresenius Medical Care Canada,

C Leduc Nkkiso Canada, Nkkiso f\brth America,

R Levesque G-lUM (Centre hospitalier de l'Universite de

M. Manocchio L.aboratoire de sante publique du QJebec,

J. Pi9iin Providence Health Care - Biorredical Engneering f\bri-voting

J. QJintero Comrrunity Health and Services Centre, f\bri-voting

S. Savoie Service N=w Brunswick, f\bri-voting

D. Song Health Canada,

C Sullivan SGS Canada Inc,

S. Treesh London Health Sciences Centre,

S. Yun Fraser Health - Renal Services, f\bri-voting

T. Qasim CSA Group, Prqject Manager

February 2023 © 2023 canadian Standards Asscx:iatioo 6

Subcommittee on Q.Jality [\/lanagement for

J. Bellat"ro/ Grand River Hospital,

D. M. Braley Oillia Soldiers' Merrorial f-bspital,

P. Butt Western Health,

E. D:>ppler Alberta Health Services,

G. Fotiou Mackenzie Health Richrrond Hill Hospital,

C Graansma Qdni Labs,

H. La Fave Peterboroug, Rajonal Health Centre,

K Landry Fresenius Medical Care Canada,

C Leduc Nkkiso Canada, Nkkiso l\bth America,

R Levesque G-IUM (Centre hospitalier de l'Universite de

M. Manocchio L..aboratoire de sante publique du QJebec,

J. Pi9iin Providence Health Care - Biomedical Engneering

February 2023 © 2023 canadian Standards Asscx:iatioo 7