Chemical & Chlorine Sampling
of Dialysis Water
December 2017
Developed by the BCPRA Hemodialysis Committee
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BC Provincial Renal Agency • BCRenalAgency.ca December 2017
Table of Contents
1.0 Scope of Guideline...........................................................................................................................................1
2.0 Summary of the Literature & Internet ..............................................................................................................1
3.0 Definitions & Abbreviations ..............................................................................................................................1
4.0 Recommendations .......................................................................................................................................... 2
5.0 Procedure .......................................................................................................................................................
5.1 Sample Collection ...........................................................................................................................................
5.2 Follow-up on Sample Results ......................................................................................................................... 5
5.3 Documentation ............................................................................................................................................... 9
6.0 References ...................................................................................................................................................... 9
7.0 Sponsors .......................................................................................................................................................... 9
IMPORTANT INFORMATION
This BCPRA guideline/resource was developed to support equitable, best practice care for patients with chronic kidney
disease living in BC. The guideline/resource promotes standardized practices and is intended to assist renal programs
in providing care that is reflected in quality patient outcome measurements. Based on the best information available at
the time of publication, this guideline/resource relies on evidence and avoids opinion-based statements where possible;
refer to www.bcrenalagency.ca for the most recent version.
For information about the use and referencing of BCPRA provincial guidelines/resources, refer to
http://bit.ly/28SFr4n.
!
BC Provincial Renal Agency
700-1380 Burrard Street
Vancouver, BC
V6Z 2H3
(BCPRA)
Phone: 604-875-7340
Email: [email protected]
Web: BCRenalAgency.ca
Facebook.com/BCRenalAgency
@BCRenalAgency
Youtube.com/BCRenalAgency
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BC Provincial Renal Agency • BCRenalAgency.ca December 2017
1.0 Scope of Guideline
This guideline applies to in-centre and community
dialysis units (CDUs) that provide hemodialysis (HD)
and/or hemodialfiltration (HDF). It is applicable to both
adult and pediatric units.
The purpose of this guideline is to support the
implementation of common standards and processes
for chemical and chlorine sampling of dialysis water
within BC’s HD units. It also provides standards
and processes for follow-up of test results when
contaminants exceed acceptable limits.
2.0 Summary of the Literature &
Internet
Patients undergoing conventional hemodialysis three
times per week are exposed to 300-600 litres of water
per week, depending on their prescription (Coulliette,
2013). More than 90% of the dialysate delivered to the
dialyzer is water (Layman-Amato, 2013).
The source of water used in HD consists basically of
drinking water, purified by various techniques, whose
composition and quality depend on its origin. Water
treatment systems employ several physical and/or
chemical processes either singly or in combination.
These systems may be portable units or large facility
systems.
The quality of the source water can change from
season to season or even day to day (Layman-Amato,
2013). Monitoring of the quality of water used for
dialysis is a vital aspect of hemodialysis treatment.
Minerals in the water can be toxic to patients and
harmful to equipment.
3.0 Definitions & Abbreviations
Chloramine: Dierence between total chlorine and
free chlorine.
Chlorine, combined: Chlorine that is chemically
combined, such as chloramine compounds.
Chlorine, free: Portion of chlorine in a solution that
has not chemically combined with other substances;
dissolved molecular chlorine.
Chlorine, total: Sum of combined chlorine and free
chlorine.
Dialysis water: Water that has been treated to meet
the requirements of the CSA standard and is suitable
for HD use in applications.
Disinfection: Destruction of pathogenic and other
kinds of microorganisms by thermal or chemical
means.
Feed water: Water supplied to a water treatment
system or an individual component of a water
treatment system.
Hemodialysis (HD): Form of renal replacement
therapy in which waste solutes are removed primarily
by diusion from blood flowing on one side of a
membrane into dialysis fluid flowing on the other side.
PSLS: Patient Safety & Learning System.
RO: Reverse osmosis. Water is pushed through a
membrane with pores small enough to remove most
contaminants, including ions.
Chemical & Chlorine Sampling of Dialysis Water
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BC Provincial Renal Agency • BCRenalAgency.ca December 2017
Chemical & Chlorine Sampling of Dialysis Water
4.0 Recommendations
Recommendation #1: Sample dialysis water for chemicals and chlorine as per the schedule on Table 1
(based on CSA-ISO).
Table 1: Components, Method & Frequency for Cleaning and Disinfecting Water
Treatment Equipment
Sample Frequency
Chemical sampling • Upon installation of a water treatment system or replacement of RO membranes. Testing
should be initiated prior to patient use and, ideally, the results received prior to using for
dialysis. If results are not possible, dialysis may proceed pending results.
• Annually thereafter.
Chlorine sampling
(manual or
automated)
• RO system:
• Beginning of each treatment day.
1
For units that run 24/7, unit to determine time of day for
sampling.
• Changes to feed water (e.g., during construction or a policy or technology change within
the city water treatment system).
• After completing work on the carbon tank treatment system.
• Portable ROs:
• Prior to every treatment.
• After replacing carbon filters.
Automated systems are acceptable but performance should be verified annually.
1
Testing for total chlorine should be performed at the beginning of each treatment day prior to the patient’s initiating treatment.
Where chloramine is used to disinfect the potable water supply at a level of 1 mg/l or more, testing should be repeated prior to
the beginning of each patient shift; if there are no set patient shifts, testing should be performed approximately every 4 h during
operation. More frequency monitoring could be appropriate during temporary operation with a single carbon bed, which can occur
following breakthrough of the first bed. In such instances, testing is performed on water exiting the second carbon bed in a series-
connected pair. The decision to change the frequency of monitoring should be based on the past performance of the system and on
whether changes in feed-water quality have occurred. Samples should be drawn when the system has been operating for a least 15
min. The analysis should be performed onsite, since total chlorine levels will decrease if the sample is not assayed promptly. Results of
monitoring should be recorded in a log sheet.
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BC Provincial Renal Agency • BCRenalAgency.ca December 2017
Chemical & Chlorine Sampling of Dialysis Water
Recommendation #2: Utilize the standards on Table 2 for maximum acceptable concentrate levels (based
on CSA-ISO).
Table 2:
Maximum Acceptable Concentrations of Chemicals & Chlorine in Dialysis Water
Sample Maximum Acceptable Concentrations (mg/L) t
Chemical sample
Contaminants with documented toxicity to HD
• Aluminum 0.01
• Copper 0.1
• Fluoride 0.2
• Lead 0.005
• Nitrate (as N) 2
• Sulfate 100
• Zinc 0.1
Electrolytes normally included in dialysis fluid
• Calcium 2 (0.05 mmol/L)
• Magnesium 4 (0.15 mmol/L)
• Potassium 8 (0.2 mmol/L)
• Sodium 70 (3.0 mmol/L)
Trace elements
• Antimony 0.006
• Arsenic 0.005
• Barium 0.1
• Beryllium 0.0004
• Cadmium 0.001
• Chromium 0.014
• Mercury 0.0002
• Selenium 0.09
• Silver 0.005
• Thallium 0.002
Total chlorine
sample
Maximum acceptable concentration: Less than 0.1 mg/L.
Action level: Greater than 0.05 mg/L.
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BC Provincial Renal Agency • BCRenalAgency.ca December 2017
5.0 Procedure
Biomedical Technologists, Renal Dialysis Technicians,
Renal Nurses and other personnel or external service
providers who are trained and have demonstrated
competency in dialysis water procedures may
collect samples for chlorine testing and perform the
necessary actions should test results exceed maximum
acceptable concentrations.
Biomedical Technologists, Renal Dialysis Technicians
and other personal or external service providers who
are trained and have demonstrated competency in
dialysis water procedures may also collect samples for
chemical testing.
5.1 Sample Collection
Chemical Sampling
1. Collect samples when the system is operating
under stable conditions representing normal
operation.
2. Collect samples as follows:
• Feed water: Collect from source water, prior to the
first water treatment filter.
• Dialysis water: Collect from a point in the distal
segment of the loop, immediately prior to where
water returns to the RO, or immediately prior to
where the water re-enters the storage tank, if one
is present.
• For portable ROs, collect from the outlet of the
portable RO.
• For dual pass ROs, sample each RO in
standalone mode. In systems with other
membrane configurations, ensure each
membrane is sampled.
• Follow the laboratory’s instructions on collecting
and preserving the sample.
3. Send samples to the third party laboratory for
testing. Document actions and log all incoming
results. List of laboratories currently approved
(March 31, 2016) by the BC Provincial Health
Ocer for water testing is available at http://
lmlabs.phsa.ca/Documents/PHO%20Approved%20
Laboratory%20List.pdf (alphabetical order):
• Agat Laboratories
• ALS Environmental – Calgary, Ft St John,
Kamloops, Vancouver
• BCCDC PHMRL Environmental Microbiology
Laboratory
• C R D Water Services Laboratory
• Caro Analytical Services
• Exova Canada Inc.
• IG Micromed Environmental Inc.
• Maxxam Analytics - Burnaby, Victoria
• MB Laboratories Ltd.
• Metro Vancouver Water Laboratory
• North Island Laboratories
• Northern Laboratories (2010) Ltd.
• Passmore Laboratory Ltd.
Chlorine Sampling
1. Method used to measure chlorine levels must have
sucient sensitivity and specificity to detect levels
of 0.05 mg/L and higher (i.e., action level).
2. Collect samples when the system is operating
under stable conditions representing normal
operation.
• The RO must have been operating for at least
15 minutes.
• There must be flow through the carbon
filtration system during this 15 minute period.
3. Collect the sample after the first carbon tank or
carbon filter.
• Rinse the sample container at least once
before taking the sample.
Chemical & Chlorine Sampling of Dialysis Water
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BC Provincial Renal Agency • BCRenalAgency.ca December 2017
• Follow the collection procedure as per the
manufacturer’s guideline.
• Test the sample immediately after collection
as per the manufacturer’s guideline.
4. Record test results on the appropriate daily testing
log sheet.
5.2 Follow-up on Sample Results
Chemical Sampling
1. If the chemicals are within the maximum
acceptable concentrations (refer to Table 2),
resume routine sampling of dialysis water
annually.
• Suggest comparing results year on year
to proactively identify changes in the
membrane. Consider changes in the feed
water composition in making year on year
comparisons.
2. If the concentrations exceed the maximum
acceptable concentration, take corrective action.
a) If this is the 1st round of positive samples,
retake system or portable RO sample as soon
as possible.
b) If this is the 2nd round of positive samples:
• Notify the area renal manager,
nephrologist, biomedical &/or technical
lead, risk management/quality and
equipment vendor.
• Area renal manager and nephrologist to
determine suitability of water to continue
treatment. Complete PSLS report.
• Assess membrane and replace as needed.
• If membrane requires replacement,
replace it and retake sample.
• If membrane does not require
replacement, initiative
troubleshooting protocol:
• Collect and test samples from
other parts of the distribution loop
(applicable to RO systems only).
• Evaluate/correct sample collection
technique.
• Evaluate/correct water system
components.
• Retake system or portable RO sample.
Refer to algorithm in Table 3a: Chemical Sampling of
Dialysis Water.
Chlorine Sampling
1. If the total chlorine concentration is under the
action level (less than 0.05 mg/L), resume routine
chlorine sampling the following day. Note: 1 PPM is
equivalent to 1.0 mg/L.
2. If the concentration exceeds the action level
(greater than 0.05 mg/L), notify biomed or a
renal dialysis technician. Biomed or renal dialysis
technician takes the following corrective action:
Dual tanks:
• If this is the 1st positive sample, retake sample as
soon as possible using a dierent lot of test strips.
• If this is the 2nd positive sample:
• Draw sample after carbon tank 2.
• Test sample. Record results.
• If the concentration is below the action level
(less than 0.05 mg/L):
• Continue with dialysis and notify the area
renal manager, nephrologist and risk
management/quality.
• Install new carbon tanks as soon as
possible. Measure chlorine levels every
3 hours while waiting for new tanks to
be installed and ensure level stays below
0.05 mg/L.
• If the concentration exceeds the action level
Chemical & Chlorine Sampling of Dialysis Water
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BC Provincial Renal Agency • BCRenalAgency.ca December 2017
(greater than 0.05 mg/L):
• Notify the area renal manager and
nephrologist. Determine next steps (e.g.,
shut renal unit until issue resolved).
• Complete PSLS.
• Record corrective actions and complete PSLS
report.
Portable ROs:
• If this is the 1st (or more) positive sample, replace
all carbon filters.
• Retake sample. Test. Record results.
• Notify the area renal manager, risk management/
quality and nephrologist.
• If the concentration is below the action level (less
than 0.05 mg/L), continue with dialysis.
• If the concentration exceeds the action level
(greater than 0.05 mg/L), the area renal manager
and nephrologist will advise re next steps (e.g.,
discontinue use of portable ROs until issue
resolved).
• Record corrective actions and complete PSLS
report.
Refer to algorithm in Table 3b: Chlorine Sampling of
Dialysis Water.
Chemical & Chlorine Sampling of Dialysis Water
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BC Provincial Renal Agency • BCRenalAgency.ca December 2017
Chemical & Chlorine Sampling of Dialysis Water
Table 3a:
Chemical Sampling of Dialysis Water
Send samples to 3
rd
party laboratory.
Document actions & incoming results
Results exceed maximum
allowable concentrations?
Refer to Table 2 in guideline for maximum allowable
concentrations.
Results reviewed by Area
Renal Manager & Infection
Control
Results reviewed by
Nephrologist
Resume routine annual
chemical testing
First round of positive samples?
Retake samples as soon
as possible
Notify Area Renal Manager,
Nephrologist, Biomed/Lead Tech, Risk
& Quality & Equipment Vendor.
Area Renal Manager & Nephrologist to
determine suitability of water to
continue treatment.
Complete PSLS report.
No Yes
No
Yes A
A
START: Collect samples upon installation of water treatment system & annually thereafter:
· Feed water: Collect source water, prior to the first water treatment filter.
· Dialysis water:
· Collect from distal segment of the water distribution loop, immediately prior to where
water returns to the RO, or immediately prior to where the water re-enters the storage
tank, if one is present.
· For portable ROs, collect sample from outlet of the portable RO.
· For dual pass RO
s, sample each RO in standalone mode. In systems with other
membrane configurations, ensure each membrane is sampled.
Assess membrane
Initiate troubleshooting protocol:
· Collect/test samples from other
parts of the distribution loop (RO
systems only).
· Evaluate/correct sample
collection technique.
· Evaluate/correct water system
components.
Retake samples as soon as possible
A
Replacement needed? Yes
No
Replace membrane
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BC Provincial Renal Agency • BCRenalAgency.ca December 2017
Results above 0.05 mg/L
(action level)?
Test chlorine immediately after
collecting the sample
Resume daily chlorine sampling
Results reviewed by Area Renal
Manager & Nephrologist monthly
1
st
positive sample?
Retake sample as
soon as possible using
a different lot of test
strips
Test sample. Record results.
Results exceed 0.05 mg/L
(action level)?
No
No
Yes
A
A
START: Collect sample each treatment day or, if using a portable RO, prior to every
treatment. Take sample from after the first carbon tank or carbon filter.
Draw sample after carbon tank 2
No
A
Contact Biomed or Renal Dialysis
Technician
Yes
Notify Area Renal Manager,
Nephrologist & Risk Management/
Quality
Yes
Area Renal Manager & Nephrologist to
determine next steps
Complete PSLS report
Continue with dialysis. Notify Area
Renal Manager, Nephrologist &
Risk Management & Quality
Install new carbon tanks (or
filters). Measure chlorine levels
q3h while waiting for new tanks to
be installed and ensure level stays
below 0.05 mg/L.
Dual Tank
System
Portable RO
System
Replace all carbon
filters
Retake sample. Test.
Record results
A
Results exceed
0.1 mg/L?
No
Shut down dialysis until
issue resolved
1
st
positive sample?
Retake sample as
soon as possible using
a different lot of test
strips
Yes
A
No
Chemical & Chlorine Sampling of Dialysis Water
Table 3b:
Chlorine Sampling of Dialysis Water
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BC Provincial Renal Agency • BCRenalAgency.ca December 2017
5.3 Documentation
All chemical analyses test results for feed and dialysis
water received from the third party laboratory and
all daily chlorine testing results are documented.
Processes are in place within the Health Authority for
designated individuals to review the results and take
action, if required.
6.0 References
CSA Standards (CSA)
CAN/CSA-ISO 13959-11-Water for haemodialysis and
related therapies (Adopted ISO 13959: 2009, 2nd
edition, 2009-04-15), Canadian Standards Association,
2011.
CAN/CSA-ISO 26722-11–Water treatment equipment
for hemodialysis applications and related therapies
(Adopted ISO 26722:2009, First edition, 2009-04-15),
Canadian Standards Association, 2011.
CAN/CSA-Z23500-12-Guidance for the preparation and
quality management of fluids for haemodialysis and
related therapies, Canadian Standards Association,
March 2012.
CAN/CSA-ISO 11663-11 - Quality of dialysis fluid for
hemodialysis and related therapies (Adopted ISO
11663:2009, First edition, 2009-04-15), Canadian
Standards Association, 2011.
Centers for Disease Control and Prevention (CDC),
Guidelines for Environmental Infection Control in
Health Care Facilities.
http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_
HCF_03.pdf (pages 59 - 65). Accessed Feb 24, 2016.
Laboratories Approved by BC Provincial Health Ocer
for Drinking Water Microbiology Testing, Enhanced
Water Quality Assurance, BC Centre for Disease
Control, June 30, 2015. Available online:
http://lmlabs.phsa.ca/NR/rdonlyres/33521F8F-
576A-4570-BAB6-F9F6D4D377A6/0/
PHOApprovedLaboratoryList.pdf.
Articles
Coulliette, A. and Arduino, M. (2013). Seminars in
Dialysis, 26:4 (July-August), p.p., 427-438. http://
onlinelibrary.wiley.com.ezproxy.library.ubc.ca/
doi/10.1111/sdi.12113/epdf. Accessed Sept 10, 2015.
Layman-Amato, R, Curtis, J and Payne, G (2013).
Nephrology Nursing Journal, 40:5 (September-October
2013), p. 383. https://tinyurl.com/yc9thcqu. Accessed
Sept 10, 2015
7.0 Sponsors
This BCPRA guideline/resource was developed to
support equitable, best practice care for patients with
chronic kidney disease living in BC. The guideline/
resource promotes standardized practices and
is intended to assist renal programs in providing
care that is reflected in quality patient outcome
measurements. Based on the best information
available at the time of publication, this guideline/
resource relies on evidence and avoid opinion-
based statements where possible; refer to www.
bcrenalagency.ca for the most recent version.
Developed by:
• a working group of biomedical/renal technicians
from across BC (one per health authority)
Approved by:
Chemical & Chlorine Sampling of Dialysis Water
