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Dialysis Water Pre-treatment

for In-Centre and Satellite Haemodialysis Units in NSW:

A Set of Guidelines

WATER PRE-TREATMENT, FOR DIALYSIS IN N.S.W. A SET OF GUIDELINES AND STANDARDS

June 2008

Acknowledgement: These guidelines have been developed under the auspices of the NSW Greater Metropolitan Clinical Taskforce Renal Services Network This work has been largely produced from the efforts of: Kevin Pull, Engineer, Liverpool Hospital Sydney Mark Seward, Senior Electronics Technician, Hunter Area Dialysis Technical Services Michael Suranyi, Nephrologist, Liverpool Hospital Sydney The completion of the document was overseen by the Water Guidelines Working Group of the Renal Services Network, and has had considerable input from the NSW Senior Hmodialysis Technicians Group.

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WATER PRE-TREATMENT, FOR DIALYSIS IN N.S.W. A SET OF GUIDELINES AND STANDARDS

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PREFACE
The purpose of this document is to provide guidelines for safe water pre-treatment for patients receiving hmodialysis therapy. This includes the design, operation and maintenance for water pre-treatment systems. Appropriate water quality is one of the most important aspects of ensuring safe and effective delivery of haemodialysis. Haemodialysis may expose the patient to more than 300 lt of water per week across the semipermeable membrane of the haemodialyser. Healthy individuals seldom have a weekly oral intake of water above 12 lt. The near 30 times increase in water exposure to dialysis patients requires control and monitoring of water quality to avoid excesses of known or suspected harmful elements being carried in the water and transmitted to the patient. The water to be used for the preparation of haemodialysis fluids needs treatment to achieve the appropriate quality. The water treatment is provided by a water pre-treatment system which may include various components such as sediment filters, water softeners, carbon tanks, micro-filters, ultraviolet disinfection units, reverse osmosis units, ultrafilters and storage tanks. The components of the system will be determined by the quality of feed water and the ability of the overall system to produce and maintain appropriate water quality. Failure to ensure adequate water quality may have dire consequences to patient safety and welfare. Patients undergoing haemodialysis may show signs and symptoms caused by water contamination, which can lead to patient injury or death. Some of the important possible signs and symptoms due to water contamination are listed below in Table 1. TABLE 1: Hmodialysis Risks associated with Water Contamination 1 Possible Water Contaminants Aluminium, chloramine, copper, zinc Aluminium, fluoride Copper, nitrates, chloramine Calcium, sodium Bacteria, endotoxin, nitrates Low pH, sulfates Calcium, magnesium Aluminium Bacteria, calcium, copper, endotoxin, low pH, magnesium, nitrates, sulfates, zinc Aluminium, fluoride, endotoxin, bacteria, chloramine

Symptoms Anaemia Bone Disease Hmolysis Hypertension Hypotension Metabolic acidosis Muscle weakness Neurological deterioration Nausea and vomiting Death

The guidelines in this document are based on the AAMI standards, as the minimum acceptable standard for the pre-treatment of water for hmodialysis. Use of more rigorous standards is acceptable for systems in NSW - and is strongly recommended.

NOTE: Revised from Food and Drug Administration (FDA). (1989). A manual on water treatment for hemodialysis.
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WATER PRE-TREATMENT, FOR DIALYSIS IN N.S.W. A SET OF GUIDELINES AND STANDARDS

June 2008

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WATER PRE-TREATMENT, FOR DIALYSIS IN N.S.W. A SET OF GUIDELINES AND STANDARDS

June 2008

CONTENTS
PREFACE EXECUTIVE SUMMARY Section 1: 1.1 1.2 1.3 1.4 1.5 1.6 1 6

SCOPE and GENERAL ..................................................................................................8

SCOPE .........................................................................................................................................8 APPLICATION ..............................................................................................................................8 INNOVATION................................................................................................................................8 EXCLUSION .................................................................................................................................8 REFERENCED DOCUMENTS.....................................................................................................8 DEFINITIONS ...............................................................................................................................9 PLANNING ....................................................................................................................12

Section 2: 2.1 2.2 2.3

GENERAL...................................................................................................................................12 CONSIDERATIONS ...................................................................................................................12 COMPONENTS ..........................................................................................................................12 2.3.1 Feed water temperature control. .............................................................................12 2.3.2 Back flow preventer .................................................................................................12 2.3.3 Multimedia depth filter .............................................................................................12 2.3.4 Water softener .........................................................................................................13 2.3.5 Brine tank ................................................................................................................14 2.3.6 Carbon tanks ...........................................................................................................15 2.3.7 Pre-filter ...................................................................................................................18 2.3.8 Reverse osmosis (RO) pump and motor.................................................................18 2.3.9 RO membranes .......................................................................................................18 2.3.10 RO systems .............................................................................................................19 2.3.11 Distribution System..................................................................................................19 2.3.12 Ultraviolet irradiator (UV).........................................................................................19 2.3.13 Submicron and ultrafiltration....................................................................................20 2.3.14 Distribution piping systems......................................................................................20 2.3.15 Disinfection of the distribution piping systems ........................................................20 2.3.16 Disinfection protection .............................................................................................21 2.3.17 Deionisers................................................................................................................21 PERFORMANCE REQUIREMENTS ............................................................................22

Section 3: 3.1 3.2

GENERAL...................................................................................................................................22 WATER TESTING ......................................................................................................................24 3.2.1 Water hardness. ......................................................................................................24 3.2.2 Chlorine and Chloramine.........................................................................................24 3.2.3 Bacteria and endotoxin testing. ...............................................................................28 3.2.4 Chemical contaminant and heavy metal levels testing. ..........................................28 QUALITY CONTROL ....................................................................................................30

Section 4: 4.1

GENERAL...................................................................................................................................30

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4.2

POLICIES AND PROCEDURES ................................................................................................30 4.2.1 Education.................................................................................................................30 4.2.2 Operation of the water pre-treatment systems........................................................30 4.2.3 Obtaining suitable water samples. ..........................................................................30 4.2.4 Testing of samples. .................................................................................................30 4.2.5 Recording and trending results. ..............................................................................30 4.2.6 Identifying trends in results......................................................................................30 4.2.7 Action when high test results are obtained. ............................................................31 4.2.8 Occupational Health and Safety principles. ............................................................31 4.2.9 Committee meetings. ..............................................................................................31 4.2.10 Audits, training and continuing education. ..............................................................31 SERVICING AND MAINTENANCE ..............................................................................32

Section 5: 5.1 5.2

GENERAL...................................................................................................................................32 TECHNICAL CONSIDERATIONS ..............................................................................................32 5.2.1 Safety requirements ................................................................................................32 5.2.2 Labeling and documentation requirements .............................................................32 5.2.3 Device markings ......................................................................................................32 5.2.4 Product literature .....................................................................................................32 5.2.5 Maintenance ............................................................................................................33 5.2.6 Water pre-treatment system changes. ....................................................................33 WATER UTILITY COMMUNICATIONS......................................................................................34 RECORDINGS ..............................................................................................................35

5.3

Section 6:

APPENDICES ........................................................................................................................................36 I Members of Guidelines Working Party & NSW Senior Hmodialysis Technicians Group II III IV Sample Contact List for Water Quality Samples of OH&S Statements, Policy & Procedures, and Maintenance Log Sample Chart for Recording measurement of Total Chlorine

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Executive Summary:
Dialysis staff should have a fundamental understanding of water pre-treatment for haemodialysis, and participate in the rational design and safe running of haemodialysis water pre-treatment plants Written policies, practices and procedures shall be in place for the safe operation of the dialysis water pre-treatment system. Dialysis staff shall be trained and deemed to be competent in the safe operation of the dialysis water pre-treatment system. Dialysis related practices shall be regularly audited. The AAMI standards are the accepted minimum standards for water pre-treatment for haemodialysis. Haemodialysis should never take place without, at a minimum: a multimedia filter, carbon filtration, a 1 micron filter and reverse osmosis. Further filtration may be used at the discretion of individual units, to further extend the life of the equipment. Dialysis water quality shall be regularly tested, according to these guidelines. To ensure safe chlorine and chloramine levels in pre-treated water, water for haemodialysis shall be tested according to these guidelines. This will occur, after the start of each dialysis shift, once the water plant is fully running, using appropriate recommended techniques. All chlorine and/or chloramine testing results shall be recorded in a suitable format. Written policies, practices and procedures shall be in place covering the protocol and methodology for chlorine and/or chloramine testing and the appropriate responses to results showing a high concentration of chlorine and/or chloramine. Dialysis staff shall be trained and deemed to be competent in water quality risk management. Education inservice should be held on an annual basis. All servicing, maintenance, interventions and changes to the water pre-treatment plant shall be recorded in water pre-treatment Logbook, available in a convenient location. Water quality and plant function shall be reviewed by a multidisciplinary committee made up at least of senior nursing, medical and technical staff and other appropriate stakeholders on a monthly basis, and minutes kept. Minutes should be circulated to appropriate health service authorities, to indicate safe running of the dialysis room and the dialysis water pre-treatment plant.

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Section 1: SCOPE and GENERAL


1.1 SCOPE
The recommendations in this document are based on the maximum level of known or suspected harmful contaminants which may be present in product water to be used for the preparation of dialysing fluids as specified by AAMI. The document details the water pre-treatment systems and practices needed to achieve and maintain these levels. This document contains information on the items to be used to treat water for the preparation of concentrates and dialysate, and the devices used to store and distribute this treated water. This document seeks to prevent the use of options that could be hazardous to dialysis patients. For example, when this document is followed, it should prevent patient poisoning caused by formulation of dialysate with water containing high levels of harmful contaminants. The provision of hmodialysis occurs in many different settings. This document is designed primariily for the larger dialysis units. Although a common standard for chemical and microbiological quality of product water should apply in all settings, there is recognition that the need for portability may necessitate relaxation of some of the product water quality standards in a mobile acute dialysis setting. When less rigorous product water quality standards are allowed, the onus is on the dialysis staff to ensure appropriate product water quality is maintained through increased monitoring and maintenance of the water pre-treatment system.

1.2 APPLICATION
This document applies to dialysis water pre-treatment systems used in purpose-built haemodialysis facilities. This document is directed towards patient facilities and manufacturers of water pretreatment systems for such haemodialysis facilities.

1.3 INNOVATION
It is not intended that this document impose unnecessary restrictions on the use of new or unusual materials or methods, providing that all the performance requirements of this document are maintained.

1.4 EXCLUSION
Haemodialysis standards apart from dialysis water pre-treatment systems for purpose built haemodialysis facilities are excluded from the scope of this document. A Supplement: Water Pretreatment Standards for Home Haemodialysis, has been developed to accompany these guidelines. While important, guidelines for the NSW setting for testing of dialysate and standards for haemodiafiltration, etc, remain to be formulated.

1.5 REFERENCED DOCUMENTS


International Organization for Standardization, Water for haemodialysis and related therapies, ISO 13959 : 2002, International Organization for Standardization, Geneva. American National Standards Institute, Water treatment equipment for hemodialysis applications, ANSI/AAMI RD62; 2001, Association for the Advancement of Medical Instrumentation, Arlington, Virginia. American National Standards Institute, Hemodialysis systems, ANSI/AAMI RD5; 2003, Association for the Advancement of Medical Instrumentation, Arlington, Virginia. American National Standards Institute 2004, Dialysate for hemodialysis, ANSI/AAMI RD52; 2004, Association for the Advancement of Medical Instrumentation, Arlington, Virginia.

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NSW Department of Health, Health Facility Guideline: Renal Dialysis Unit, NSW Department of Health, North Sydney, N.S.W. (2006)
http://healthdesign.com.au/nsw.hfg/hfg_content/guidelines/hfg_b_renal_dialysis_unit_460_484.pdf

Amato, RL 'Water treatment for hemodialysis, , including the latest AAMI standards', Nephrology Nursing Journal, 2001: vol. 28, no. 6, pp. 619-29. European Best Practice Guidelines 'Section IV. Dialysis fluid purity', 2002, Nephrol Dial Transplant, 2002, vol. 17 [Suppl 7], pp. 45-62: (official publication of the European Dialysis and Transplant Association - European Renal Association).

1.6 DEFINITIONS
AAMI Association for the Advancement of Medical Instrumentation. chlorine that is chemically combined, such as in chloramine combined chlorine compounds. No direct test exists for measuring combined chlorine, but it can be measured indirectly by measuring both total and free chlorine and calculating the difference. Chloramine is a combined chlorine. device disinfection an individual water purification unit, such as a softener, carbon tanks, reverse osmosis unit. the destruction of pathogenic and other kinds of micro organisms by thermal or chemical means. Disinfection is a less lethal process than sterilization, since it destroys most recognized pathogenic micro organisms, but not necessarily all microbial forms. This definition of disinfection is equivalent to low-level disinfection in the Spalding classification. any medical, nursing, allied health and technical staff who are involved in providing the dialysis service

dialysis staff

empty bed contact time (EBCT) a measure of how much contact time there is between particles, such as activated carbon, and water as the water flows through a bed of the particles. EBCT is calculated from the equation: EBCT = Volume/Flow. Where EBCT is in minutes (min), Volume is in litres (lt) and flow is in litres per minute (lt/min) The volume of particles needed to achieve a specified EBCT can be calculated from the equation: Volume (lt) = Time (min) x Flow (lt/min). The calculation needs to take into account the maximum expected water flow rate. endotoxins substances which produce an inflammatory host response. Endotoxins are lipopolysaccharides, consisting of a polysaccharide chain covalently bound to lipid A and which form the major component of the outer cell wall of gram-negative bacteria. Endotoxins can acutely activate both humoral and cellular host defences, leading to a syndrome characterized by fever, shaking chills, hypotension, multiple organ failure, and even death if allowed to enter the circulation in a sufficient dose. Long-term exposure to low levels of endotoxin has been implicated in a chronic inflammatory response, which may contribute to some of the long-term complications seen in haemodialysis. However, the mechanisms of this process remain incompletely understood. water supplied to a water pre-treatment system. dissolved molecular chlorine. indicates an option.

feed water free chlorine may

product water - water which has been processed completely through a water pre-treatment system and distributed to haemodialysis equipment. reverse osmosis (RO) the process of forcing water from one side of a semi-permeable membrane to the other, producing purified water by leaving behind the dissolved solids and organic particles. The equipment that performs this process is frequently referred to as the RO. (See Section 2.3) shall indicates a statement that is mandatory, within these guidelines.

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should trending

indicates a recommendation. reviewing results to identify a general direction or tendency. Trending may be done on a graph with the results being obtained by averaging the last ten test results. The trending result will show if there is any slight change of test results over time.

water pre-treatment system a collection of water purification devices and associated piping, pumps, valves, gauges, etc. that together produce water for hmodialysis applications and deliver it to point of use.

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Section 2: PLANNING
2.1 GENERAL
Nephrologists shall have a fundamental understanding of the water pre-treatment required for haemodialysis. Nephrologists should participate in the rational planning, design, operation and maintenance of water pre-treatment systems. Planning the design, operation and maintenance of water pre-treatment system shall be done very early in the setting up of a Renal Dialysis Unit. From October 2007 water pre-treatment systems shall be listed, registered or included on the Australian Register of Therapeutic Goods (ARTG) in order to be supplied for that purpose. Responsibility for the safe and effective design and running of water pre-treatment systems is shared between ALL dialysis staff, including dialysis water consultants.

2.2 CONSIDERATIONS
Planning consideration for the design and installation of the water pre-treatment system shall include, but not necessarily be limited to, the following:1. The quality of the feed water. 2. The pressure of the feed water. 3. The maximum water flow, including expected future growth in the number of patients to be treated. 4. Average water flow per day also including expected future growth. 5. Space required to safely install and operate the water pre-treatment plant. 6. Drainage required. 7. The weight of the water pre-treatment plant and the ability of the floor to safely support that weight. 8. Water quality monitoring systems. 9. The capacity of the power supply for the water pre-treatment plant. 10. Facilities to safely service and maintain the water pre-treatment plant. 11. Water distribution loop. The above information should be gathered by a competent dialysis water pre-treatment plant contractor or provider. With this information the contractor or provider will be able to determine the type, size, volume, weight and location for the safe operation of the water pre-treatment plant. While it is true for all measurements on a water pre-treatment system, it is especially important to include the expected parameters for water quality on the log and record sheets. Trend analysis is also vital for documenting water pre-treatment systems. It allows the patient facility to be more proactive, seeing a problem arising, rather than putting out fires.

2.3 COMPONENTS
2.3.1 Feed water temperature control. In areas where they experience high feed water temperatures it may be necessary to use a heat exchanger to cool the feed water. Where the feed water is cold it can be heated by mixing hot and cold water with a thermostatic mixing valve. Back flow preventer All water pre-treatment systems require a form of back flow prevention device. This device prevents the water in the water pre treatment system from flowing back into the source water supply system. This can be achieved with the use of a reduced pressure zone device (RPZD) or a break tank with an air gap. Multimedia depth filter Large particulates of 10 microns or greater that cause the feed water to be turbid - such as dirt, silt, colloidal matter (suspended matter) - are removed by a multimedia filter, sometimes referred to as a depth bed filter. Large particulates can clog the carbon and softener tanks, destroy the RO pump, and foul the RO membrane.
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2.3.2

2.3.3

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Many feed waters, in spite of their apparent clarity, carry a large amount of suspended particulate matter that can adversely affect pre-treatment and RO performance. A silt density index (SDI) test measures and evaluates how rapidly a screen becomes clogged on a particular water source. Most RO membrane manufacturers recommend that feed water SDI not exceed a value of 5.0. Multimedia filters contain multiple layers of various sized rocks ranging from sand to gravel that literally trap the large particles as the water is filtered downward. All the tiers are constructed of different sized media so that not all the particulates are collected at the top but rather distributed through the media bed, a phenomenon known as depth filtration. By using a stratified bed, increasingly smaller particles are captured, the entire bed is used, and the filter is not rapidly clogged. An automatic multimedia filter is back-washed on a preset time schedule (when the system is not in use) so that the media is cleansed and renewed regularly. By redirecting the water flow upward (back-washing), the tightly packed bed is lifted so that the lighter material floats to the top and out to drain. The media, chosen for its size and density, then resettles in its ordered layers when the process is complete. Multimedia filters should be back-washed at frequent intervals. The frequency of backwashing the multimedia filter depends on the amount of particulates in the feed water. Backwashing can be programmed by a time clock on the filter tank or a signal from the central RO. If a time clock on the tank is used, the time on the clock should be read and recorded daily. Compare the time on the tank head to real time and adjust as necessary. Situations such as power failures can reset the backwash time to occur during patient treatment. No patient harm would occur, but patients treatments would be delayed as the RO would have no water flow. Pressure gauges on the inlet and outlet of the tank should be fitted to monitor pressure drop (delta pressure). The size of the multimedia filter shall be determined by a competent dialysis water pretreatment plant contractor or provider. 2.3.4 Water softener Softeners work on an ion exchange basis where calcium and magnesium are replaced with sodium. The resin beads within the tank have a high affinity for the cations calcium and magnesium (both divalent) present in the feed water and release two sodium ions (monovalent) for one calcium or magnesium captured. High levels of calcium and magnesium in the feed water cause the water to be hard. Hardness is measured in grains per gallon (grain literally taken from the precipitate left from evaporated water being the size of a grain of wheat) or mg/L and is generally expressed as CaCO3 (calcium carbonate) for uniformity purposes. To a lesser degree, softeners will remove other polyvalent cations such as iron. Water containing calcium and magnesium form scale deposits on the RO membrane and eventually foul the membrane. Once mineral deposits form on the RO membrane, the percent rejection (membrane performance) and product water quality, measured as total dissolved solids (TDS), conductivity, or resistivity, decline. Mineral scale can become permanent and decrease the life expectancy of the RO membrane if not cleaned. Some feed waters can foul an RO membrane in hours, turning it literally to stone. However, sodium chloride does not deposit scale on the RO membrane, so the softener is placed before the RO to protect the RO. Softeners are sized in grains of capacity; 1 cubic foot (cu. ft.) of resin equals 30,000 grains of hardness exchange capability. Analysis of the level of CaCO3 in the feed water is important

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for determining the size of the softener. A formula can be used to calculate how long the softener will last before needing regeneration. Softeners are always placed before the carbon tank, on the chlorinated/chloraminated water side, in order to impede microbial growth, decreasing the bacterial bio-burden to the RO membrane. Decreased softener resin life may occur if exposed to detrimental levels of chlorine or chloramine in the incoming water. Therefore, the softener may be placed after the carbon tank if the incoming chlorine and/or chloramine levels dictate. The softener needs regenerating on a routine basis with concentrated sodium chloride solution (brine) before the resin capacity is used up. Also, like multimedia filters, during normal operation, the water flows downward through the resin and tightly packs the resin beads. Before the regeneration process, the resin is backwashed to loosen the media and clean any particulates from the tank. After the back-washing step, the brine solution is drawn into the tank to regenerate the resin. The calcium and magnesium are forced off the resin beads even though they possess a stronger bond than sodium because they are overwhelmed by the amount of sodium ions. Next, the excess salt solution is rinsed out of the tank. Regeneration is usually performed every day the softener is used and at a time when the water treatment system is not in use. Most dialysis facilities use a permanent softener that incorporates a brine tank and a control head that executes the automatic regeneration cycle. Automatically regenerated softeners should be fitted with a regeneration lock-out device to prevent the regeneration process during patient treatments. Regeneration can be programmed by a time clock on the softener tank or a signal from the central RO. If a time clock on the tank is used the time on the clock should be read and recorded daily. Compare the time on the tank head to real time and adjust as necessary. Situations such as power failures can reset the regeneration time to occur during patient treatment. Pressure gauges on the inlet and outlet of the tank should be fitted to monitor pressure drop (delta pressure). Portable exchange softeners (softeners that are regenerated off-site) are sometimes used in areas that regulate the amount of sodium and chloride discharged to drain. In this case, the softener tank will be replaced on a routine basis and will not have a control head or brine tank. They may also be used on single patient portable systems in acute dialysis for quick turn-around and ease. Water hardness of both feed and product water should be less than 35 mg/L [2 grains per gallon (gpg)] and may be tested and recorded monthly so trends can be monitored and corrective action taken as necessary. Should a decision be taken not to test monthly, then water hardness should be tested 6-monthly or after a carbon tank is changed, which ever occurs first. Record and trend the water hardness test results. When water hardness tests are done, it is best to test the softened water twice - once in the morning to determine that the softener did regenerate and once at the end of the day to prove that the softener performed adequately all day. Hardness tests should be performed on fresh water, not water that has sat in the tank for extended periods. Start the water pretreatment system approximately 15 to 30 minutes (shorter interval for portable systems) prior to drawing the sample. If the hardness test reads above 35 mg/L, the softener may need regenerating before use. Central RO systems may have an inbuilt continuous water hardness meter. 2.3.5 Brine tank The brine tank contains salt pellets and water to create the super saturated salt solution used for softener regeneration. Fifteen pounds of salt is required to regenerate one cubic foot of resin (30,000 grain capacity). Only refined, pellet-shaped salt should be used in

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dialysis applications. Other salts (e.g., rock salt) may contain too many impurities, such as soil. The salt level in the brine tank should be inspected daily and maintained as needed. As long as there is undissolved salt present, the solution is considered supersaturated. Ascertain that a salt bridge has not formed in the tank by tapping on the top of the salt in the tank. If a salt bridge has formed, the softener will not regenerate to full capacity and will not soften for the expected duration of time. Record the level of the water in the brine tank and the amount of salt used daily. 2.3.6 Carbon tanks Carbon tanks are required to remove chlorine additives from the feed water. Chlorine and chloramine are added to the city water supply for disinfection purposes. In drinking water, these additives allow us to drink the water with minimal risk of becoming ill from a parasite or pathogenic bacteria. However, there are some drawbacks to the disinfectants themselves. For instance, chlorine can combine with other organic chemicals to form carcinogenic trihalomethanes. For this reason, chloramine, a combined chlorine that cannot combine with other chemicals, has become the major disinfectant of drinking water in recent years. However, chloramine takes a longer contact time with (activated charcoal) carbon for adsorption, compared to chlorine. Since the initiation of chloramine use, there have been more reported incidents of haemolysis and related symptoms in patients due to chloramine exposure than from chlorine, though chlorine is harmful also. Even if chloramine is not normally present in the feed water, chloramine can form naturally from chlorine combining with ammonia from decomposing vegetation. Chloramine may also be added unexpectedly to the feed water, especially in those municipal suppliers using surface water. Therefore, always test for total chlorine and never just free chlorine alone. Beside the deleterious effects in patients, both chlorine and chloramine are not removed by RO and actually damage the thin film-type RO membranes. Therefore they shall be removed before the RO system. Carbon media, often referred to as granular activated carbon (GAC), will remove chlorine and chloramine that are almost always present in the feed water through a chemical process termed adsorption. As the input water flows downward through the GAC, solutes diffuse from the fluid into the pores of the carbon and become adsorbed or attached to the structure. As a side benefit, along with chlorine and chloramine, many other low molecular weight organic chemicals such as herbicides, pesticides, and industrial solvents will be adsorbed. GAC can be made from different organic material such as bituminous coal, coconut shells, peach pits, wood, bone, and lignite that have been exposed to excessive temperatures (pyrolysis). It is then acid washed to remove the ash and to etch the carbon to increase the porosity and therefore the absorbency of the GAC. All carbon used for dialysis should be acid washed, especially carbon derived from bone, wood, or coal, as these tend to leach metals such as aluminium when they are not acid washed and exposed to water. Steam activated carbon should not be used as it can leach detritus (fines) which clog filters and RO. Steam activated carbon can also leach heavy metals which, when removed by the RO, cause damage to the RO. Catalytic carbon (CC) which has a high porosity may be used in carbon tanks. The volume of CC should be the same as calculated for GAC. The use of CC, which is more expensive, can add an additional degree of safety by its more rapid and extensive removal of chlorine and chloramine. GAC is rated in terms of an iodine number, which measures the ability of the GAC to adsorb low molecular weight, small organic substances like iodine and subsequently, chlorine and chloramine. The higher the iodine number, the more chlorine and chloramine will be adsorbed. An iodine number of 900 or greater is recommended for the removal of

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chlorine and chloramine. Peroxide number is another rating system that is closely associated with the carbons ability to adsorb chlorine and chloramine. When other forms of carbon are used, the manufacturer shall provide performance data to demonstrate that each adsorption bed has the capacity to reduce the chloramine concentration in the feed water to less than 0.1 mg/L when operating at the maximum anticipated flow rate for the maximum time interval between scheduled testing of the product water for chloramines. Another rating system that is pertinent to dialysis is the abrasion number, which reflects the ability of activated carbon to withstand degradation - the higher the number, the more resistant to breakdown. Since there is frequent back-washing associated with carbon used for dialysis, a durable carbon such as acid washed bituminous coal should be considered. AAMI recommends the use of virgin carbon and not carbon that has been reburned by the manufacturer. Carbon is used in many, more toxic applications than dialysis and can be recycled and reburned by vendors. Reburnt or reprocessed carbon can retain impurities that may be toxic to patients. Regenerated carbon shall not be used. An appropriate exposure time of the water flow through the carbon tank is imperative in order for the chlorine and chloramine to be adsorbed adequately and is expressed as empty bed contact time (EBCT). A minimum of 10 minutes EBCT is recommended by AAMI for the removal of both chlorine and chloramine. Two equal sized tanks, in an in-series configuration, with the first tank feeding into the second tank, shall be the standard set-up, one as the worker (lead tank) and one for back-up (polisher, lag tank), with each tank having at least 5 minutes EBCT. Using the Imperial System the contact time can be measured using the input flow rate (Q) in gallons per minute (gpm) and the amount of the carbon media in cu. ft. (V). EBCT=V x 7.48 Q The two carbon tanks are connected in series to allow water to be tested for chlorine content as it passes between the two tanks. By using this two carbon tank configuration failure of the lead (first) carbon tank, indicated by a high level of chlorine in the water between the two tanks, will be detected early. By passing the water subsequently through the lag (second) carbon tank this prevents high levels of chlorine or chloramine from reaching the patient, while prompt action is taken to replace the failed carbon. Metric System carbon tank volume calculations can be carried out as follows:1. The initial calculation for carbon volume is done by first knowing the maximum water flow requirement with all dialysis and RO machines within the Dialysis Unit operating at the same time. 2. The volume of carbon is calculated by VC = F x EBCT. Where, VC = carbon volume in litres, F = water flow in litres per minute, EBCT = carbon bed contact time in minutes.

3. With the volume of carbon known the volume of the total carbon tanks can be calculated. Carbon tanks should contain no more than 50% carbon by volume. The total carbon tanks volume is calculated by VT = 2VC. Where, VT = total tank volume in litres, VC = carbon volume in litres. 4. An example calculation can be done using the above formula. With a water flow rate of 40 lt/min (F) and a EBCT of 10 minutes, VC = F x EBCT VC=40 x 10 = 400lt

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Therefore carbon volume is 400lt Now total tank volume VT = 2VC. = 800lt In this example each carbon tank needs to have a capacity of 400lt and contain 200lt of carbon. A 400lt tank could be about 1800mm high with a diameter of 750mm. Volume of tank = area x height). (Area of a circle = r2. (Diameter of tank(M)= 2 x sq. root of [volume(M3) divided by divided by height(M)]).

According to AAMI and the FDA, portable single patient systems are exempt from this standard since one-to-one monitoring typically exists and 10 minute EBCT may not be practical (AAMI, FDA). Therefore, smaller tanks may be substituted along with more frequent total chlorine testing. One caveat - small carbon cartridge type filters should not be used alone, they have minimal EBCT for adsorption and are not appropriate for high flow rates. In NSW a Health Department edict has directed that no carbon tank for home or individual machine use shall be smaller than 21 Litres capacity. GAC has the ability to become saturated with chlorine and/or chloramine to a point where any further absorption is not possible. This saturation usually occurs over time, but may occur suddenly, and shows up as increasing levels of chlorine and/or chloramine in the water leaving the carbon tanks. The safest technique to minimise the possibility of high levels of chlorine being present in the water is to rotate the carbon tanks out on a routine basis, for example every six months. The lead (first) tank is taken out of service and the lag (second) carbon tank is relocated to the lead (first) position. The carbon in the removed tank is replaced and this tank is then returned to the lag (second) carbon tank position. This will ensure that the lag (second) carbon tank is filled with new carbon every six months. Also the maximum time any carbon tank is without exposure to chlorinated water is no more than six months, which in turn will minimise the level of bacteria that may form in a carbon tank. As an added precaution, individual renal units may decide to replace all carbon after six months of use. As a minimum, carbon shall be replaced on a 12 monthly basis or earlier if high chlorine concentrations are experienced. When new carbon is installed in a tank it shall be back-washed thoroughly to remove the ash and carbon fines (small pieces of carbon) that will damage the RO membrane. At least an eight hour backwash is suggested. Bypass valves placed on the piping to carbon tanks that allow the feed water to completely bypass the carbon tanks are unsafe, and should not be used. Carbon tanks should be back-washed at frequent intervals, (at least weekly) to reduce the impact of channel formation, to remove debris and expose un-reacted charcoal surface. Biological fouling is inherent problem with GAC because it is an organic medium, and with the chlorine and chloramine removed from the water, bacteria grow. Channelling, accumulation of debris and bacteria all cause the carbon surface area to be underused. Therefore, carbon tanks are backwashed on a routine basis to fluff the bed, clean the debris out, and expose unused sides of the carbon particles. Back-washing does not regenerate the carbon when it is exhausted it simply exposes unused sides of the carbon. If the carbon tank cannot be back-washed, the carbon media should be changed on a more frequent basis. During back-washing the water pre-treatment plant cannot be used. Back-washing can be programmed by a time clock on the filter tank or a signal from the central RO. If a time clock on the tank is used the time on the clock should be read and recorded daily. Compare the time on the tank head to real time and adjust as necessary. Situations such as power
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failures can reset the backwash time to occur during patient treatment. This could expose patients to high levels of chlorine or chloramine. Pressure gauges on the inlet and outlet of the tank should be fitted to monitor pressure drop (delta pressure). 2.3.7 Pre-filter Pre-filters are particulate filters positioned after all the pre-treatment and immediately before the RO pump and RO membrane. Carbon fines, resin beads, and other debris exiting the pre-treatment destroy the pump and foul the RO membrane. Typically, pre-filters range in pore size from 1 to 5 microns. Two gauges monitor the inlet versus the outlet pressures across the filter. If the delta pressure increases by eight over new filter pressure differential, the filter is clogged and needs replacement. Pre-filters are inexpensive insurance against damaging more expensive items downstream in the system. Therefore, pre-filters shall be changed on a monthly basis before the pressure differential indicates or earlier if a high pressure differential indicates. Inspect the used filters centre tube for soiling. If foreign material is present, the filter was over burdened and shall be replaced sooner next time. All filter changes shall be recorded in the Log Book. Reverse osmosis (RO) pump and motor The RO pump increases water pressure across the RO membrane to increase both product water flow and rejection characteristics of the RO membrane. RO systems typically operate between 200-250 PSI. It is important that RO pumps are made of high-grade stainless steel, inert plastics, and carbon graphite-wetted parts. Brass, aluminium, and mixed metal pumps will leach contaminants into the water and are not compatible with peracetic acid type disinfectants. Never allow RO pumps to operate whilst dry, as this will cause irreparable damage. RO membranes The reverse osmosis (RO) membrane is the heart of the system. It produces the purified water through a process of reverse osmosis, which is the opposite of osmosis. Osmosis is a naturally occurring phenomenon involving the flow of water from a less concentrated compartment (e.g., non-salty side) to the more concentrated compartment (e.g., salty side) across a semi-permeable membrane to equilibrate the two solutions. In reverse osmosis, concentrated water is forced to flow in the opposite or unnatural direction across a semipermeable membrane by means of high pressure. Natural osmotic flow is overcome and pure water passes through the membrane leaving the dissolved solids (salts, metals, etc.) and other constituents behind on the concentrated side. Depending on the amount of product water needed, the RO system will have one or more RO membranes. RO membranes reject dissolved inorganic elements such as ions of metals, salts, and chemicals and organics including bacteria, endotoxins and viruses. Rejection of charged ionic particles ranges from 95-99/o, whereas contaminants such as organics that have no charge are rejected at a greater than 200 molecular weight cut-off. Ionic contaminants are highly rejected compared to neutrally-charged particles, and polyvalent ions are more readily rejected than monovalent ions. Thin film (TF) RO membranes made of polyamide (PA) are the most common type used in haemodialysis. These RO membranes are made with a thin, dense, semipermeable membrane over a thick porous substructure for strength and spiral wound around a permeate collecting tube. The spiral design allows for a large surface area in a small space. TF RO membrane will degrade when exposed to oxidants such as chlorine and/or chloramine and, therefore, shall be preceded by carbon tanks. Care shall be taken with the use of peracetic acid products used for disinfection, as they will oxidize the RO membrane if used above a 1% dilution or if iron deposits reside on the RO membrane.

2.3.8

2.3.9

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The colder the incoming water, the more resistant it is to cross the RO membrane, thereby decreasing purified water production. Adequate water pre-treatment, pH control, and cleanliness of the RO membrane surface also influence performance of the membrane. TF membranes have a wide pH tolerance of 2-11; however, the optimum pH range for membrane performance is between 5.0-8.5. High alkalinity also enhances scaling of the RO membrane surface. Scale deposits such as calcium and magnesium salts and silt composed of colloidal matter, metals such as iron, and organics and dirt will accumulate on and eventually foul the RO membrane. Routine cleaning and disinfection will insure proper functioning and will extend the life of the RO membrane and reduce bacterial growth in the system, which can harm patients. RO membrane performance is measured by percent rejection, and final product water quality can be measured by either conductivity in micro-siemens/cm or total dissolved solids (TDS) displayed as mg/L or parts per million (PPM). AAMI recommends both percent rejection and water quality monitors be used. They should be continuously displayed with audible and visual alarms with set points that can be heard in the patient care area. 2.3.10 RO systems RO systems may be a single central RO or individual ROs attached to each dialysis machine. Many dialysis units will require a Central RO unit as well as several individual ROs for mobile dialysis machines to provide dialysis eg in ICU/CCU/private room etc. Central ROs are useful for dialysis units with 6 chairs or more, to reduce costs associated with maintenance and repair of individual ROs. Individual (single) ROs give more flexibility and mobility, but require more maintenance and repair. Distribution System RO distribution systems can be grouped into two categories, direct feed and indirect feed. A direct feed system directly delivers the product water from the RO unit to the loop for distribution. Unused product water can be recirculated back to the input of the RO unit for conservation reasons. An indirect feed system involves a storage tank that accumulates the product water and delivers it to the distribution loop. Unused portions of the product water are recirculated back into the storage tank. The RO unit will stop and start filling the tank by receiving signals from the high and low level switches on the storage tank. According to AAMI, storage tanks should be made of inert materials that do not contaminate the purified water, and the bottoms should be conical shaped for complete emptying. The size of the tank should be in proportion to meet the facilities peak demands, no larger. Tight fitting lids and hydrophobic submicron vent filters inhibit air borne microbes from entering the tank (AAMI). 2.3.12 Ultraviolet irradiator (UV). UV is a low pressure mercury vapour lamp enclosed in a quartz sleeve that is required to emit a germicidal 254 nm wavelength and provide a dose of radiant energy of 30 milliwattsec/cm2 in order to kill bacteria (AAMI). The device shall be sized for the maximum anticipated flow rate according to the manufacturers instructions. The UV is able to penetrate the cell wall of the bacteria and alter the DNA to either kill it or render it unable to replicate. It is possible for some species of bacteria to become resistant to UV irradiation. Also, UV does not destroy endotoxin, and it may even increase the level as a result of the destruction if the bacteria cell wall where endotoxins harbour. Therefore, UV should be followed, at some point, by ultrafiltration. Biofilm, a protective slime coating that bacteria secrete, will also reduce the effectiveness of UV.

2.3.11

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Regular maintenance of the UV device includes continuous monitoring of radiant energy output that activates an audible and visual alarm, routine cleaning of the quartz sleeve and replacing the lamp at least annually or sooner if recommended by the manufacturer. 2.3.13 Submicron and ultrafiltration. A submicron filter reduces the level of bacteria in the final product water, whereas an ultrafilter removes both bacteria and endotoxin. Both are membrane filters that can be cross flow types with a feed stream and reject stream or a dead-ended design with one stream. The housing should be opaque to inhibit algae growth. When using submicron and ultra filters, AAMI recommends they are validated for medical use. In the industry, there are nominal and absolute ratings for ultra filters and submicron filters. Absolute ratings are more appropriate for dialysis applications. Also, filters that are not for medical use may contain preservatives that require up to 2000 litres of water to rinse thoroughly. Since ultrafilters have tighter pores, they inherently have low flows and high delta pressures across the membrane. They will decrease flow velocity in the loop if not designed and staged properly. Alternatively, ultrafiltration gives added benefit and extra protection when placed at points of use. Submicron and ultrafilters, even though they remove microbes, are targets for bacterial infestation if not routinely disinfected or replaced. All submicron and ultrafilters shall be changed on a monthly basis. Inspect the used filters centre tube for soiling. If dirt is present, the filter was over burdened and shall be replaced sooner next time. All filter changes shall be recorded in the Log book. 2.3.14 Distribution piping systems. Though there continue to be some water treatment systems that have non-returning lines that go to drain, a continuous loop design is recommended by AAMI. Dead-ends or multiple branches shall not exist in the distribution system, as these are places for bacteria biofilm to grow. Highly purified water is very aggressive and will leach metals and chemicals it comes in contact with. Polyvinyl chloride (PVC) is the most common piping material to use as it is low cost and has a relatively inert nature. Other substances that may be used, but not limited to, are high-grade stainless steel (SS), polypropylene (PP), cross linked polyethylene (PEX), polyvinylidene fluoride (PVDF), and glass. No copper, brass, aluminium, or other toxic substances shall be used in the piping. The inner surface of the joint connections should be as smooth as possible to avoid microbiological adhesion, such as chamfered connections, and the use of simple wall outlets with the shortest possible fluid path and minimum pipe fittings are recommended (AAMI). Flow velocity should be evaluated quarterly and the loop visually inspected for incompatible materials that may have been inadvertently added. Have loop repairs performed by personnel or reputable plumbers and all materials used inspected for compatibility. Disinfection should always follow any invasive repair to the system.

2.3.15

Disinfection of the distribution piping systems Disinfection of the distribution piping system shall happen on a regular basis. The type of distribution piping system and the disinfection method to be used will influence how often disinfection is carried out. There are two types of disinfection methods. 1. Chemical disinfection. When the manufacturer recommends chemical disinfectants, means shall be provided to restore the equipment and the system in which it is installed to a safe condition relative to residual disinfectant prior to the product water being used for dialysis applications. When recommending chemical disinfectants, the chemical manufacturer shall also recommend methods for testing for residual levels of the disinfectants.

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2.

Hot water disinfection When used to control bacterial proliferation in water treatment, storage, and distribution systems, the water heater of a hot water disinfection system shall be capable of delivering hot water at the temperature and for the exposure time specified by the manufacturer (minimum distribution loop temp 60 C). PVC piping shall not be used with heat disinfection. However, PVDF, SS, PEX and PP piping can be used with heat disinfection. Heat disinfection will not remove established biofilms, but is convenient, requires little rinse time and can thus be used more often to prevent biofilm formation. An occasional chemical disinfection might still be necessary. Moving to heat disinfection of storage and distribution pipework (rather than chemical) should be considered in all new installations

2.3.16

Disinfection protection When disinfection is accomplished automatically by chemical disinfectant, including ozone, or by high temperature procedures, activation of the disinfection system shall result in activation of a warning system and measures to prevent patient exposure to an unsafe condition. Deionisers Deionisers were previously commonly used but should not now be used as part of a haemodialysis water pre-treatment system. Deionisers produce water of high ionic quality, but do not remove bacteria and endotoxins. In fact bacteria and endotoxin levels may increase requirement for ultrafilters, UV systems, etc. to ensure bacteria/endotoxins are removed. The risk of operating deionisers to exhaustion may cause ions previously removed to be re-released back into the water. An accurate sensitive conductivity monitor is required to ensure appropriate warning of this. Deionisers may also cause wide pH shifts to occur.

2.3.17

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Section 3: PERFORMANCE REQUIREMENTS


3.1 GENERAL
The quality of feed water and its variation shall be determined in order to design an appropriate water pre-treatment system to meet the needs of patients undergoing dialysis. The feed water quality shall be periodically monitored thereafter to assure continued appropriate water pre-treatment. The quality of the product water, as specified below, shall be verified upon installation of a water pre-treatment system. Regular testing of product water quality and monitoring of any trend in the results shall be carried out. These tests measure contaminant concentration in the water pre-treatment system. The results of the tests are compared with the concentration levels detailed below in the Table 3.1.
Table 3.1 Maximum contaminant concentration levels in the dialysis water pre-treatment system, post RO and submicron and ultrafilters. AAMI maximum concentration for dialysis water (mg/L) 2 4 8 70 0.006 0.05 0.1 0.0004 0.001 0.014 0.005 0.0002 0.09 0.005 0.01 0.1 0.5 0.1 0.2 2.0 100 0.1 0.1 200 cfu/ml (action level 50 cfu/ml) 2EU/ml (action level 1EU/ml)

Contaminant
Calcium Magnesium Potassium Sodium Antimony Arsenic Barium Beryllium Cadmium Chromium Lead Mercury Selenium Silver Aluminium Chloramines Chlorine Copper Fluoride Nitrate (as Nitrogen) Sulphate Tin Zinc Bacteria Endotoxin

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There are components within the dialysis water pre-treatment system that are able to remove or lower the concentration of the listed contaminants. The X in Table 3.2 indicates which contaminant is removed by each component of the dialysis water pre-treatment system.
Table 3.2: Contaminant removed by each component of the dialysis water pre-treatment system Contaminant Aluminium Arsenic Barium Cadmium Calcium Chloramines Chlorine Chromium Copper Fluoride Lead Magnesium Mercury Nitrate Potassium Selenium Silver Sodium Sulphate Zinc Viruses Organic contaminants Endotoxins Bacteria Particles Component of water pre-treatment system Sand Filter Softener Carbon Tank RO Unit X X X X X X X X X X X X X X X X X X X X X X X X X X X X X X UV light

Table 3.3 details in general terms, the component, function and requirements of dialysis water pretreatment systems. Haemodialysis shall never be performed in in-centre and satellite units unless all Essential components are on line. Table 3.3 Components of a dialysis water pre-treatment system.
COMPONENT Multi-media depth filter Softener Carbon tank 1 Micron filter UV light RO Unit FUNCTION Particle removal Hardness correction with brine tank (Ca/Mg Na) Removes Chlorine and Chloramine Filters particles larger than 1 micron. Kills bacteria Removes ions, bacteria, heavy metals, endotoxins REQUIREMENT

Essential
Where required

Essential Essential
Common

Essential

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3.2 WATER TESTING


Table 3.4 Summary of recommended water testing frequency for dialysis water pre-treatment system. Water Test Water hardness, pre and post softener Chlorine Bacteria Endotoxin Chemical contaminant and heavy metal levels Frequency During design and commissioning. Six monthly or after carbon change. During commissioning. At least once per dialysis shift During commissioning. Monthly. During commissioning. Six monthly. During commissioning. Six monthly or after carbon or RO change.

3.2.1

Water hardness. The first test that is done for any dialysis water pre-treatment system is feed water hardness. Hardness shall be tested early to assist in the design of the water pre-treatment system, including whether a softener is required, and the volume of the vessel if it is required. Once the softener has been installed and in operation the product water hardness shall be tested and recorded to verify the operation of the softener. Water hardness does not greatly vary thereafter, as it depends on catchment area soil constituents and town water factors. Water hardness (feed and product water) may be tested and recorded monthly so trends can be monitored and corrective action taken as necessary. Should a decision be taken not to test monthly, than six monthly tests or tests after a carbon tank is changed, whichever occurs first, shall be carried out, the results shall be recorded and trended. When water hardness tests are done, it is best to test the softened water twice, once in the morning to determine that the softener did regenerate and once at the end of the day to prove that the softener performed adequately all day. Acceptable levels of hardness. Hardness tests for product water shall be less than 35 mg/L (2 grains per gallon (gpg)) hardness and performed on fresh water, not water that has been in the tank for extended periods. Start the water treatment system approximately 15 minutes (shorter interval for portable systems) prior to drawing the sample. If the hardness test reads above 35 mg/L, the softener may need regenerating before use. Central RO systems may have an inbuilt continuous water hardness meter.

3.2.2

Chlorine and Chloramine General. Chlorine and Chloramine are removed from water by passing the water through a bed of (activated charcoal) carbon. The water needs to be in contact with the carbon for this to occur. The contact time is a critical factor in determining the efficiency of the carbon to absorb the Chlorine and Chloramine. The longer the contact time the less Chlorine and Chloramine there will be in the water post carbon. As a minimum, all dialysis units shall have a facility to measure total chlorine. In-line Total Chlorine Meters should be considered for existing dialysis units and shall be installed in all new dialysis units.

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Test frequency and method. Tests for Chlorine and/or chloramine shall be done and recorded at least once per dialysis shift. The chlorine and/or chloramine tests shall, as a minimum, be done using the manual process photometer method but in addition an In-line Total Chlorine Meter is highly recommended. Test strips do not constitute an adequate test in the hospital or satellite dialysis unit, but may be appropriate for home dialysis purposes. Any tests need to be sufficiently reliable and repeatable to accurately ensure that chlorine and chloramine levels are not unacceptably elevated. When water should be tested. 1. Dialysis units that have individual RO units per patient. The best time to test the chlorine and/or chloramine concentration is after there has been maximum water flowing through the carbon tanks during a dialysis shift. This will give the highest chlorine and/or chloramine concentration as the water will be in contact with the carbon for the minimum time. This delay in testing should be no less than 15 minutes and may be as long as 30 minutes after the start of the dialysis shift (and all dialysis machines are on) and is to allow water that has been in the carbon tanks for some time to be flushed through the pre-filtration system. At least 30 minutes after a dialysis shift has commenced maximum water is usually flowing and is a true representation of the water being used for dialysis. 2. Dialysis units that uses a central RO. As above, the time to test the chlorine and/or chloramine concentration is when there is maximum water flow through the carbon tanks. When a direct feed RO is used the maximum water has usually been flowing for some time at least 15-30 minutes after a dialysis shift has commenced (and all dialysis machines are on). When an indirect feed RO is used the maximum water flow is when the RO is filling the storage tank. The water test should be done towards (but not after) the end of the filling cycle. Again this is to allow water that has been in the carbon tanks for some time (e.g. between filling cycles when minimal or no water is flowing) to be flushed through and only water with maximum flow rate to tested. The RO may be set up to provide a signal for when water tests will provide the most useful result. When water should not be tested. Testing for chlorine and/or chloramine concentration prior to a dialysis shift commencing will lead to false results. Prior to a dialysis shift commencing minimal or no water would have been flowing through the carbon tanks resulting in extended water/carbon contact time. Any extended water/carbon contact time will produce a reduced concentration of chlorine and/or chloramine in the water. Should there be a concern about the chlorine and/or chloramine concentration levels before starting a dialysis shift refer to the concentration results from the previous shift and if acceptable start the dialysis shift and carry out further tests as detailed in When water should be tested above. What water should be tested. In a system where the two carbon tanks are connected in an in- series configuration, with the lead (first) carbon tank feeding water into the lag (second) carbon tank, the water flowing between the two carbon tanks shall be tested, at least every dialysis shift. If the water sample point is some distance from the carbon tanks the sample water shall flow for at least a few minutes before it is tested. This minimal time is to ensure that any water in the sample pipe has been flushed out prior to the sample being taken. If there is any doubt about water quality the product water post RO must be tested, as the absolute indicator of patient safety.

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Additional water tests. To check the operation of the carbon, two additional water tests should be carried out. The water to be tested is the feed water to the lead (first) carbon tank and the product water post lag (second) carbon tank. These tests should be done at least once a week. Test results shall be recorded and trended. How water should be tested. There are a number of methods that can be used for chlorine measurement including, Process photometer, Amperometric with electrodes, and Titration. There is no test that can be used for directly testing the concentration of chloramines in water. The concentration of chloramines in water can only be derived from the equation, Chloramines = Total Chlorine Free Chlorine. The manual process photometer method can measure total and free chlorine and is the minimum accepted standard method. In-line Chlorine Meters can be used to measure total chlorine or free chlorine. Only In-lineChlorine Meters set up to measure total chlorine shall be used. The automatic process photometer method is recommended for in-line chlorine measurement. 1. Manual process photometer method. A standard test for chlorine in water is the manual process photometer method. This method uses a photometer and relies on chlorine reacting with diethyl-p-phenylene diamine (DPD) in buffered solution to produce a pink colour. This manual test method has an acceptable level of reliability, sensitivity, accuracy and repeatability and constitutes the lowest acceptable level of testing appropriate for a dialysis unit, capable of reliably detecting dangerously high levels of chlorine and/or chloramine. The manual test method for chlorine shall be done at least once per dialysis shift. Results shall be recorded and trended. This is also a requirement where in-line chlorine meters are used. The advantage of using this manual test method is that it is portable and economical. The disadvantages of using a manual Photometer are: When attempting to measure a total chlorine concentration of 0.5mg/L the accuracy is + 10%. When attempting to measure a total chlorine concentration of 0.1mg/L the accuracy is + 50%. The water sample can be contaminated by the container or stirring stick. The volume of water may not be consistent. DPD tablets or powder have an expiry date. The crushing time and the dissolving of the DPD tablet in the water is not consistent. The sample water may contain bubbles. The time to complete the total test may vary from test to test. 2. In-line Chlorine Meter. In-line Chlorine Meters continuously measure the total chlorine concentration in the sample water (between the two carbon tanks). When total chlorine tests are used as a single analysis the maximum level for both chlorine and chloramine should not exceed 0.1 mg/L. Since there is no distinction between chlorine and chloramine, this safely assumes that all chlorine present is chloramine (AAMI). Currently two types of In-Line Chlorine Meters are readily available: a) Amperometric method with electrodes. The advantages of using Amperometric method in-line chlorine meter are:-

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An in-line chlorine meter can be set up to continuously monitor total chlorine. A remote audible and visual remote alarm can be connected to the in-line chlorine meter. The disadvantages of using an in-line chlorine meter are: Lacks sensitivity and specificity uncertain Threshold is 0.1mg/L Requires regular and frequent calibration using titrator technology (ie shall be performed by a company technician). Low chlorine concentration levels cause the probe membrane to clog after a short period of operation. Could be within weeks of operation. Probe needs to be protected from fines by separate filter Probe needs to be replaced every 6 months. b) Automatic process photometer method. This method is based on the colorimetric measurement principle. Total chlorine is determined using the DPD method. The total chlorine measurement accuracy is + 0.01mg/L in the measuring range 0.00 to 1.00 mg/L. The measuring time is two minutes. The advantages of using Amperometric method in-line chlorine meter are: Absolute measurement, no calibration necessary Extended long term stability. Reliable method for measuring total chlorine. Low maintenance. The disadvantage of using Amperometric method in-line chlorine meter is: The need for reagents. 3. Titration. Titration method uses colour formation with reagents through titration. The advantage of Titration is: Absolute measurement depending on the sample provided. The disadvantages of Titration are: Mainly laboratory bench mounting Very expensive Requires operator input for every measurement Accuracy is dependant on the true sample provided without contamination.

Acceptable levels of chlorine and chloramine. The AAMI maximum level for chlorine is 0.5 mg/L and for chloramine is 0.1 mg/L. If using an In-line Chlorine Meter the acceptable maximum level for total chlorine is 0.1 mg/L. When trending of test results indicate an increase in the level of chlorine then the carbon shall be replaced earlier than twelve monthly Should an In Line Chlorine Meter produce a high test result at any time the following steps are suggested:1. Carry out manual process photometer test as a check on the high test result tests should be at three locations, a) between the two carbon tanks, b) post lag (second) carbon tank and c) post RO. Testing post RO is mandatory as the absolute indicator of patient safety. 2. Should the test results from 1. above be acceptable, continue patient treatment and carry out further tests in one hour. Implement the Dialysis Unit Policy should the manual test show a high result post lag (second) carbon tank or post RO, indicating a true high concentration of chlorine and/or chloramine reaching the patients.

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3.2.3

Bacteria and endotoxin testing. Bacterial levels shall be tested monthly at the points where all haemodialysis equipment connects to the distribution piping system (post RO, post water loop). This includes dialysis machines, bicarbonate filling stations, etc. Bacteria levels shall not exceed 200 colony forming units/ml (CFU/ml) - with an action level of 50 CFU/ml. Samples shall be assayed within 30 minutes of collection, or be immediately stored at a temperature between 1C and 5C and assayed within 24 hours of collection on a regular schedule; not less than monthly is suggested. Total viable counts (standard plate counts) shall be obtained using conventional microbiological assay procedures (pour plate, spread plate membrane filter techniques, commercial samplers including dip test devices etc.). Discussions should occur with the local microbiological laboratory on actual technique. The calibrated loop technique is not accepted. Culture media shall be tryptic soy agar or equivalent. Blood culture media are not appropriate. Colonies shall be counted after 48 hours incubation at 35C to 37C. Recheck at 72 hours if negative after 48 hours. The above method has proved effective in assuring safety for many years, and is the standard practice. Other authorities believe that a different method designed to detect water-borne organisms using a membrane filtration technique, filtering 500ml to 1000ml of water and culturing on low-nutrient medium such as R2A agar and incubating for 5 days or longer at 28C to 32C is preferable and more appropriate. This technique is rational and also acceptable. Total viable microbial counts in product water should be performed monthly and shall not exceed 200 CFU/ml. Endotoxins should be measured 6-monthly. According to AAMI the endotoxin content in product water shall not exceed 2 IU/ml, or as required by national legislation or similar. These measurements apply to sampling at the point of delivery to haemodialysis equipment (post RO, post water loop). At the outlet of water treatment (post RO), no more than 1 IU/ml is the requirement. When monitoring haemodialysis equipment, rotation among sites should assure that each is tested with a cycle of several months. The presence of endotoxins can be tested using the Limulus Amoebocyte Lysate (LAL) assay. The European Best Practice Guidelines have somewhat more stringent criteria than AAMI. They are indicated here for comparison. Many Australian dialysis units now seek to conform to these more stringent guidelines. MICROORGANISMS CFU/ml Max CFU/ml Action ENDOTOXINS EU/ml or IU/ml Max EU/ml or IU/ml Action AAMI:RD52 200 50 EDTNA/ERCA based on EP 100 25 (typ)

2 1

0.25 0.03

3.2.4

Chemical contaminant and heavy metal levels testing. For the purpose of testing of chemical contaminants and heavy metal levels, it may be sufficient to collect sample(s) at a point chosen so that the effects of the water pre-treatment system and the piping are completely included (eg post RO, post water loop). Chemical Contaminant and Heavy metal testing shall be done as part of the commissioning procedure for any new water pre-treatment system. Once the water pre-treatment system is in operation, testing shall be done six monthly or at the time of carbon /RO change, whichever is earlier - and recorded in the Log Book.

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WATER PRE-TREATMENT, FOR DIALYSIS IN N.S.W. A SET OF GUIDELINES AND STANDARDS

June 2008

Refer above to Table 3.1 Maximum contaminant concentration levels in the dialysis water pre-treatment system post RO and submicron and ultrafilters. Table 3.5 details the type of test to be used to measure the concentration of each contaminant. Other test methods may be used provided they have been shown to be of comparable precision and reproducibility. Appropriate containers and pH adjustments shall be used to ensure accurate determinations. Table 3.5 Test Methods for Contaminants
Contaminant Aluminium Arsenic Barium Cadmium Calcium Chlorine and chloramines Chromium Copper Test name LeGendre and Alfrey (1976) Atomic absorption (gaseous hydride) Atomic absorption (gaseous furnace) Atomic absorption (gaseous furnace) EDTA titrimetric method or atomic absorption (direct aspiration) or ionspecific electrode DPD ferrious titrimetric DPD calorimetric methods Atomic absorption (gaseous furnace) Atomic absorption (direct aspiration) Neocuprocine method Fluoride Electrode method SPADNS method Lead Magnesium Mercury Nitrate (N) Potassium Selenium Silver Sodium Sulfate Tin Zinc Atomic absorption (graphite furnace) Atomic absorption (direct aspiration) Flameless cold vapour technique (atomic absorption) Brucine method or cadmium reduction method Atomic absorption (direct aspiration) or flame photometric method or ion-specific electrode Atomic absorption (gaseous hydride) or atomic absorption (graphite furnace) Atomic absorption (graphite furnace) Atomic absorption (direct aspiration or flame photometric method or ion-specific method) Turbidimetric method Atomic absorption (graphite furnace) Atomic absorption (direct aspiration) dithizone method

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WATER PRE-TREATMENT, FOR DIALYSIS IN N.S.W. A SET OF GUIDELINES AND STANDARDS

June 2008

Section 4: QUALITY CONTROL


4.1 GENERAL
Every haemodialysis unit shall have written policies and procedures for the safe operation of the water pre-treatment systems, including:- education policies, obtaining suitable water samples, testing of samples, recording and trending results, identifying trends in results, action to be taken when high test results are obtained and Occupational Health and Safety principles. Medical, nursing and technical staff working in dialysis units share responsibility for the safe operation of the water pretreatment plant and shall participate together in regular committee meetings to review the safe operation of the water pre-treatment plant. Dialysis nurses should participate in audits and ongoing training, continuing education and accreditation.

4.2 POLICIES AND PROCEDURES


4.2.1 Education. Dialysis nursing staff shall be educated and approved for clinical competency in the operation and maintenance of the water pre-treatment systems. All other persons involved in the water pre-treatment system shall be educated in the operation of their area of responsibility. All education shall be recorded and the records maintained within the dialysis unit. Operation of the water pre-treatment systems. The operation of the water pre-treatment system shall only be carried out by persons who have been trained and accredited. Records of who is responsible for the operation of all or part of the water pre-treatment system shall be maintained within the dialysis unit. Obtaining suitable water samples. Water samples for testing shall be obtained from the appropriate location as detailed in the operational policies and procedures for the dialysis unit. These policies and procedures shall include information on how to collect the water sample, where the sample is collected from, what the water sample is collected in and how the sample is maintained up to the time it is tested. Testing of samples. Testing of water samples shall be carried out by trained and accredited persons or accredited laboratories. The dialysis unit shall maintain records of persons who have been trained and accredited and full details of accredited laboratories. The records shall be maintained within the dialysis unit. Recording and trending results. All water test results shall be recorded and trended over time. Trending may be done on a graph (eg with the results being obtained by averaging the last ten test results). The trending result will show if there is any slight changes of test results over time. The test results and trending graphs should be maintained near the water pre-treatment system. [See Template for recording chlorine and chloramine levels, at Appendix IV] Identifying trends in results. The trended water test results shall be reviewed by an approved staff member on a regular basis. Regular reviewing of results should show any trend that may require intervention to prevent contaminated product water reaching the haemodialysis equipment or patients.

4.2.2

4.2.3

4.2.4

4.2.5

4.2.6

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4.2.7

Action when high test results are obtained. Every dialysis unit shall have written policies and procedures in place to detail what action is required when any test result is high. It is essential that any high results are promptly communicated to responsible senior staff. Occupational Health and Safety principles. Every dialysis unit shall have safe work method statements for every procedure to be undertaken on the water pre-treatment system. Safe work method statements shall be developed while carrying out a risk management procedure. These safe work method statements shall be followed by all persons working on any part of the water pre-treatment system. There shall also be safe work method statements for persons collecting and testing water samples. All contractors shall complete a site induction and a written risk management procedure before commencing any work on the water pre-treatment system. Records of all risk management procedures, safe work method statements, contractor inductions, etc shall be maintained within the dialysis unit. [See Examples at Appendix III, to assist managing OH&S requirements]

4.2.8

4.2.9

Committee meetings. On a monthly basis, water quality and the safe functioning of the water pre-treatment system shall be reported to a multidisciplinary committee made up of senior nursing, medical and technical staff and other appropriate stakeholders, any issues resolved and the minutes kept. These minutes should be circulated to appropriate health service authorities, to indicate safe running of the dialysis room and the dialysis water pre-treatment plant.

4.2.10 Audits, training and continuing education. The operation of the water pre-treatment systems and the ongoing training of persons involved in the operation of the system shall be audited on a 12 monthly basis. Audit reports and recommendations shall be reviewed and managed by the water pre-treatment committee.

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WATER PRE-TREATMENT, FOR DIALYSIS IN N.S.W. A SET OF GUIDELINES AND STANDARDS

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Section 5: SERVICING AND MAINTENANCE


5.1 GENERAL
Water pre-treatment systems require regular supervision, maintenance and servicing. Each water pretreatment system shall have a log book with careful written records documenting every intervention, repair, servicing or maintenance procedure. All servicing, maintenance, interventions and changes to the water pre-treatment system shall be locally recorded in water pre-treatment room records. [See sample Maintenance Schedule, at Appendix III]

5.2 TECHNICAL CONSIDERATIONS


5.2.1 Safety requirements Each water treatment device shall exhibit the following minimum safety requirements: Monitors shall be designed so that the monitor cannot be disabled while a patient is at risk, except for brief, necessary periods of manual control with the operator in constant attention. The sound emitted by audible alarms shall be at least 65 db(A) at three (3) metres from the nurses station, and it shall not be possible to silence these alarms for more than five (5) minutes. Labeling and documentation requirements NOTEThe term labelling, as used in this document, includes any written material accompanying any water treatment device or system, such as instructions for use and operators manuals, or any instructions or control feature markings attached to the device or system. Device markings All water outlets in a dialysis unit shall be labelled to indicate treated or untreated water. The following information shall accompany each water treatment device or system. Items 1 through 4 shall be directly affixed to the device or system or, in the case of disposable elements, to the immediate packaging, whereas items 5 and 6 may be provided in accompanying product literature. 1. Name and address of manufacturer. 2. Trade name and type of device. 3. Model and serial number. 4. A warning that product literature should be read before use (if appropriate). 5. Prominent warnings about substances (e.g., germicides) that shall be removed from the device before using the product water for dialysis. 6. Identification of fitting type or specification when necessary to prevent improper connections. 5.2.4 Product literature The manufacturer shall provide literature to each patient facility that contains, but is not necessarily limited to, the following information: A description of the device or system, including a list of monitors, alarms and component devices provided as standard equipment. A schematic diagram of the device or system showing the location of any valves, in-line monitors or sampling ports. Operating specifications, such as maximum and minimum input water temperature, pressure and flow rate, limits on input water quality, pressure of product water at various flow rates, and maximum output of product water.
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5.2.2

5.2.3

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Detailed instructions for use including initial start-up; testing and calibration; operation and meaning of alarms; operational adjustments to monitors, alarms and controls and connections to other equipment. An explicit statement of the relationship between feed water quality and product water quality for the chemical contaminants listed in Table 3.1. The minimum quality of feed water required for the system to produce product water meeting the chemical requirements of Table 3.1. A warning that although a water pre-treatment system may produce water of sufficient quality to meet the requirements of Table 3.1, distribution of the water may degrade its quality to the point where it no longer meets the requirements of Table 3.1 if the distribution system is not maintained appropriately. In the case of systems whose product water is proportionally related to feed water quality, warnings that feed water quality shall be monitored. Since changes in product water may exceed acceptable limits if feed water deteriorates significantly, the patient facility shall be responsible for monitoring the feed water quality. For automatically regenerated water treatment devices, identification of the mechanism (for example, lockout valves) that prevents excessive levels of contaminants entering the product water during regeneration. In the case of ultraviolet (UV) irradiators, a requirement that the manufacturer disclose the effectiveness of the device in killing specific bacteria under specified operating conditions, and a recommendation that UV irradiators be followed by an ultrafilter or other bacteria-reducing and endotoxin-reducing device. In the case of hot water disinfection systems, a requirement that the manufacturer disclose the effectiveness of the system in killing specific bacteria under specified operating conditions. Typical life expectancy, capacity, or indication of the end of life of components that are nondurable or require periodic regeneration or reconstitution and a statement that additional information on component life expectancy or capacity relative to the patient facilities typical feed water is available upon request.

5.2.5

Maintenance Other maintenance and service instructions, including recommended preventive maintenance procedures and schedules, recommended monitoring schedules, troubleshooting guidelines intended for the patient facility, service information, a recommended spare parts list and a warning of the consequences if maintenance instructions are not followed. Information about germicides and cleaning agents known to be compatible with materials used in the device, as well as information about chemicals with which materials used in the device are incompatible.

5.2.6

Water pre-treatment system changes. A warning that if, after installation and subsequent use, any component of the water pretreatment system is changed or replaced, the patient facility should conduct appropriate tests to ensure that the revised system meets the initial design criteria.

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WATER PRE-TREATMENT, FOR DIALYSIS IN N.S.W. A SET OF GUIDELINES AND STANDARDS

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5.3 WATER UTILITY COMMUNICATIONS


NSW Health recommends that hospitals and dialysis units provide contact details to their local water utility to avoid or minimise any adverse impact on patients if the water supply is interrupted or there is a significant change in chlorine or chloramine concentration. NSW Health recommends that water utilities communicate with hospitals and dialysis units when an interruption to water supply occurs or is planned to avoid or minimise any adverse impact on patients. Hospitals and dialysis units provided with water services by Sydney Water are notified of changes to water quality when chlorine or chloramine concentrations exceed the agreed maximum chlorine or chloramine concentration. Hospitals and dialysis units outside Sydney Waters area of operations should consult with their local water utility and provide details of a contact person to ensure notification of interruptions to water quality. These health care facilities should define the criteria for notification of interruption to water supply with their local water utility. Hospitals and dialysis units should inform their local water utility when a patient undergoes dialysis treatment at home and when treatment ceases. Procedures should be in place for home dialysis patients to inform their local water utility when dialysis treatment commences and when treatment ceases. Specific plans should be in place to provide alternative dialysis for any patient whose pre-treatment system suddenly becomes ineffective.

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WATER PRE-TREATMENT, FOR DIALYSIS IN N.S.W. A SET OF GUIDELINES AND STANDARDS

June 2008

Section 6: RECORDINGS
A MODEL DATA RECORDING SYSTEM FOR CHLORINE /CHLORAMINE MEASUREMENTS An Excel spreadsheet is a suitable data recording and trending document (See Appendix IV). NOTE: As the scale below is logarithmic, no zero results can be recorded, and any result less than 0.01 shall be recorded as 0.01.
TAP WATER : CHLORAMINE ANALYSIS (01-30 September, 2005)
10

0.1

0.01
(A) 1Sep (A) 2Sep (A) 3Sep (A) 5Sep (A) 6Sep (A) 7Sep (A) 8Sep (A) 9Sep (A) 10Sep (A) 12Sep (A) 13Sep (A) 14Sep (A) 15Sep (A) 16Sep (A) 17Sep (A) 19Sep (A) 20Sep (A) 21Sep (A) 22Sep (A) 23Sep (A) 24Sep (A) 26Sep (A) 27Sep (A) 28Sep (A) 29Sep (A) 30Sep

Total Chlorine

Free Chlorine

Chloramines

POST CARBON-1 : CHLORAMINE ANALYSIS (01-30 September, 2005)

10

0.1

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

(B )

(A )

1-Sep 2-Sep 3-Sep 5-Sep 6-Sep 7-Sep 8-Sep 9-Sep

10Sep

12Sep

13Sep

14Sep

15Sep

16Sep

17Sep

19Sep

20Sep

21Sep

22Sep

23Sep

24Sep

26Sep

27Sep

28Sep

29Sep

30Sep

Total Chlorine

Free Chlorine

Chloramines

On-Line Chlorine Metre

POST CARBON-2 : CHLORAMINE ANALYSIS (01-30 September, 2005)


10

0.1

0.01
(A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) (A) (B) 1-Sep 2-Sep 3-Sep 5-Sep 6-Sep 7-Sep 8-Sep 9-Sep 10Sep 12Sep 13Sep 14Sep 15Sep 16Sep 17Sep 19Sep 20Sep 21Sep 22Sep 23Sep 24Sep 26Sep 27Sep 28Sep 29Sep 30Sep

Total Chlorine

Free Chlorine

Chloramines

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(B )

0.01

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WATER PRE-TREATMENT, FOR DIALYSIS IN N.S.W. A SET OF GUIDELINES AND STANDARDS

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APPENDICES

APPENDIX I:

Members of Water Guidelines Working Party


A sub-group of the Dialysis Working Group, GMCT Renal Services Network

Mark Seward Kevin Pull Paul Kelly Patrick Wasielewski John Ward Michael Suranyi Ken Howlin Paul Snelling Adrian Gillin Robyn Caterson Cheryl Hyde Josephine Chow Sally Bristow Catharine Death Fidye Westgarth

Senior Electronics Technician, Hunter Area Dialysis Technical Services Bio-medical Engineer, Liverpool Hospital Senior Electronics Technician, Sydney Dialysis Centre Senior Electronics Technician, Dame Eadith Walker Centre Senior Electronics Technician, Royal Prince Alfred Hospital Director, Nephrology Dept, Liverpool Hospital Nephrologist, Liverpool Hospital Nephrologist, Royal Prince Alfred Hospital Nephrologist, Royal Prince Alfred Hospital Nephrologist, Royal North Shore Hospital Manager, Sydney Dialysis Centre NUM, Renal Unit, Liverpool Hospital Renal Manager (Northern), Hunter New England Are Health Service CNC, Westmead Hospital Service Manager, Renal Services Network

NSW Senior Hmodialysis Technicians Group


Mark Seward Paul Kelly Patrick Wasielewski Ian Mackie Rodney Brown Frank Zentrich Stephen Rabin Senior Electronics Technician, Hunter Area Dialysis Technical Services Senior Electronics Technician, Sydney Dialysis Centre Senior Electronics Technician, Dame Eadith Walker Centre Senior Electronics Technician, North Coast Area Health Service Senior Electronics Technician, HNEAHS (Northern Sector) Senior Electronics Technician, Wollongong Hospital Senior Electronics Technician, Prince of Wales Hospital

The document was widely circulated throughout NSW and ACT in July-August 2006, as Draft Version 4. Input from clinicians and technicians was greatly appreciated in the development of the final version.

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Appendices for Water Standards for In-Centre Haemodialysis

Appendix II: Place


Local Water Authority

List of important contact details for water quality issues Contact Details Phone No.

Satellite Units addresses & contact details

Appendices for Water Standards for In-Centre Haemodialysis Appendix III: OH&S Requirements - Examples

Safe Work Practices: TASK: Hazard ID No: HAZARDS:


Original Date Issued:

Name of

Dialysis Unit

Water Treatment Plant

(In-Centre)

Electrical, Infection control, Manual Handling, Ergonomics

SAFETY RULES
1. Run plant according to manufacturers instructions 2. Be aware of hazards, protruding pipes etc within plant area 3. Report any changes in gauges immediately to maintenance dept. 4. Attend all water checks and test according to manufacturers instructions 5. Wear appropriate footwear when dealing with large amounts of water within plant area

SAFE WORK PROCEDURE


1. Operate according to manufacturers instructions 2. Read operators manual prior to using equipment 3. Follow policies relating to water tests and checks in centre manual 4. Report any faults or malfunctions to maintenance dept. 5. Report any leakage from any part of the plant to maintenance dept 6. Use safe manual handling principles when moving equipment. Obtain assistance when required 7. Ensure maintenance service is attended as per contractual agreement 8. Always move slowly within the plant area 9. Be aware of confined areas between filters

Reviewed By: 1. [Name of person responsible for developing this document] 2. [Name of other person responsible for safety of staff]

Signature: .. Date: ...

Designation:..

Safe Work Practice Example provided by Westmead Hospital, 2006

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Appendices for Water Standards for In-Centre Haemodialysis

Safe Work Practices: TASK: Hazard ID No: HAZARDS:


Original Date Issued:

Name of

Dialysis Unit

Use of Pocket Portable Chlorine Meter

Manual Handling

SAFETY RULES:
1. Use equipment as per manufacturers instructions 2. Ensure equipment is not broken or damaged prior to use 3. Store equipment in designated container, when not in use 4. Report faulty equipment to NUM

SAFE WORK PROCEDURE:


1. 2. 3. 4. Use equipment in a well lit area Do not use if any parts of the equipment is damaged Use equipment as per manufacturers instructions, and as per policy statement in centre policy manual Clean and dry the bottles after use

Reviewed By: 1. [Name of person responsible for developing this document] 2. [Name of other person responsible for safety of staff]

Signature: .. Date: ...

Designation:..

Safe Work Practice Example provided by Westmead Hospital, 2006

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Appendices for Water Standards for In-Centre Haemodialysis


Example of Safe Work Practices System for Assessment and Management: Name of Workplace: RISK ANALYSIS FORM

Task:
Department:

CENTRAL WATER PLANT NURSING


Date:

Risk Rating Score:


1 2 3
No

5
N/A

Analysis Conducted by:

Location of Task:

Personal Protective Equipment issued: Yes

Renal Unit
Identification Assessment

Actions

Requirements of TASK
1. Plug in power outlet at all times connected to back up generator 2. Maintenance staff attend filter changes regularly & record changes 3. Maintenance staff disinfect water plant weekly/bi weekly & record/test 4. Nursing staff access remote panels in renal units auto heat function 5. Maintenance record book kept in water plant room and instruction books

Potential Hazards or Risks


1. Electrical shock/fault 2. Possible explosion or fire 3. Flood 4. Malfunction

Risk Management
1. Check maintenance book regularly 2. Do not use if any faults - Contact dialysis technician 3. Check for water leakages 4. Check maintenance record book ensure water plant has been disinfected and filters changed regularly 5. Regular maintenance

Log of ACTION Items, and Timeline: ACTION Required By Person & Date Copy to Manager Results Reviewed Manager Initial & Date Further Action: Yes / No

Safe Work Practice Example provided by HNEAHS, Northern Sector, 2006

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Appendices for Water Standards for In-Centre Haemodialysis


Examples of Policy and Procedures Documents, for Water Standards

WATER QUALITY:
Developed by: NURSING DIVISION, AREA RENAL SERVICES

Microbiological testing of reverse osmosis water


Distribution: Ref: Date Issued: Revise: Effective: Water Nov 2004 Nov 2006 Dec 2004

RATIONALE To ensure water quality used for haemodialysis is as recommended by the AAMI/CARI guidelines. Ensure that patients are not exposed to unsafe levels of contaminants. OUTCOME Monthly microbiological testing of reverse osmosis water is to be attended by renal unit nurses or Dialysis Technical Services only. Reverse Osmosis water (RO) specimens of water to be collected monthly for microbiological analysis. Results are to comply with AAMI (Association for the Advancement of Medical Instrumentation) standards for Haemodialysis water quality. Total viable microbial counts should not exceed 200 colony-forming units (cfu)/ml in water used for preparation of dialysate. EQUIPMENT Sterile Specimen container for each water outlet to be tested Specimen bag for each sample Completed pathology form stating the RO Plants MRN and that the sample is RO water to be tested for microculture, and copy to go to Dialysis Technical Services, AHS.

PROCEDURE 1. Collect RO water sample from RO outlet in the storeroom using the hose provided (Inverell, Armidale and Moree). For TBH, specimen collected from end of loop in plant room by Dialysis Technical Services 2. Run the RO water for one minute then collect water sample in a sterile container. 3. Specific culture methods need to be applied to the sample (microculture) at 24hours and seven days. 4. Label specimen and send to lab (include the allocated MRN) 5. Results to be read by NUM or RN in charge and to be kept in each individual Renal Unit )so they can initiate 6. If count exceeds 200 cfu/ml contact Dialysis Technical Services (Phone No. further action. NOTE: The RO plant is assigned an MRN for pathology records. AKNOWLEDGEMENT/EVIDENCE Association for the Advancement of Medical Instrumentation (AAMI) Standards and recommended practices (Volume 3: Dialysis) HNEAHS - Senior Dialysis Technician; Rodney Brown Royal North Shore Hospital procedure and protocol manual for haemodialysis and haemodiafiltration 1999. CARI (caring for Australians with Renal Impairment) guidelines 2000

POLICY APPROVAL

AHS - Senior Dialysis Technician

Signed:

Date:

AHS - Renal Nurse Manager

Signed:

Date:

AHS - Director Renal Service

Signed:

Date:

Policy & Procedure Example provided by HNEAHS, Northern Sector, 2006

Page 1 of 1

Appendices for Water Standards for In-Centre Haemodialysis

WATER QUALITY:
Developed by: NURSING DIVISION, AREA RENAL SERVICES Distribution:

Microbiological testing of dialysate


Ref: Date Issued: Revise: Effective: Water Nov 2004 Nov 2006 Dec 2004

RATIONALE To ensure water quality used for haemodialysis is as recommended by the AAMI/CARI guidelines. Haemodialysis patients should not be exposed to unsafe levels of contaminants. A standard five-hour haemodialysis session with a dialysate flow of 500ml/minute will expose the patient to 150L water. High quality dialysate is important especially for high flux and haemodiafiltration where high backfiltration is present. OUTCOME Three monthly microbiology testing of dialysate from each dialysis machine is to be attended by renal unit nursing staff. Dialysate from each haemodialysis machine is to be collected for microbiology testing. Results are to comply with AAMI (Association for the Advancement of Medical Instrumentation) standards for proportioned dialysate exiting the dialyser. AAMI recommendation for microbial purity of dialysate: < 200 colony-forming units (cfu) /ml EQUIPMENT Sterile Specimen container for each machine 70% alcohol impregnated wipes (e.g. Isowipes) Specimen bag for each sample Completed pathology form stating machine name and its MRN and that the sample is dialysate to be tested for microculture, and copy of result to go to Dialysis Technical Services, AHS.

PROCEDURE 1. Every haemodialysis machine to have dialysate collected three monthly, in February, May, August and November 2. Collect prepared dialysate specimens after a minimum of three hours of dialysis, after patient runback After runback 3. Keep the haemodialysis machine in concentrate post dialysis, place into bypass and clean the venous port (blue port) with alcohol solution 70% (e.g. Isowipes). Take out of bypass and place fluid into sterile container 4. Label specimen and send to pathology 5. Results to be read by NUM or RN in charge and to be kept in each individual Renal Unit. If count exceeds 200 cfu/ml, remove machine from use and contact . Dialysis Technical Services (nearest location) on Phone No:

AKNOWLEDGEMENT/EVIDENCE Association for the Advancement of Medical Instrumentation (AAMI) Standards and recommended practices (Volume 3: Dialysis) NEAHS - Senior Dialysis Technician; Rodney Brown RNSH procedure and protocol manual for haemodialysis and haemodiafiltration 1999. CARI (caring for Australians with Renal Impairment) guidelines 2000 POLICY APPROVAL

AHS - Senior Dialysis Technician

Signed:

Date:

AHS - Renal Nurse Manager

Signed:

Date:

AHS - Director Renal Service

Signed:

Date:
Page 1 of 1

Policy & Procedure Example provided by HNEAHS, Northern Sector, 2006

Appendices for Water Standards for In-Centre Haemodialysis

Maintenance Record Log Book/Folder


for Management of Water Quality for Haemodialysis Name of Renal Unit
SECTION 1: Copies of Monthly Reports to Haemodialysis Management Committee

SECTION 2: Copies of Incident Reports, and periodic trend analysis every 6/12.

SECTION 3: Copies of Chlorine and Chloramine Monitoring

SECTION 4: Permanent Record of Filter Changes (pre-filters)

SECTION 5: Permanent Record of Carbon Filter Rotation

SECTION 6: Heavy Metal testing schedule (every 3/12) and record of Actions

Appendices for Water Standards for In-Centre Haemodialysis Appendix III: Log Sheet for managing Maintenance

Sample - SCHEDULE OF WATER TESTING for Haemodialysis Units


Six monthly results to be tabled as part of Quality Report to the Area Renal Services Committee. Test Chloramines at ring main* Frequency Daily Collected By Nursing staff Recording Collection result to be recorded by nursing staff in ward water quality register. Sample Points Any point from ring main Reported To NUM or person in charge of shift. Response To Abnormal Results Technician to repeat test with specialized equipment. If still positive, result will be reported to Manager Biomedical Services & Clinical Director of Nephrology. Unit closed until carbon filters are changed. Maintenance staff/technicians to advise NUM & Manager Biomedical Services. NUM will advise Clinical Director of Nephrology Services, technician and Manager of Biomedical Services Alert A confirmed positive result will close the In-centre Unit until both in-line carbon filters are changed.

Chloramines at midcarbon filters

Weekly

Maintenance staff (GBH & BDH) or technicians (LBH & TTH) Nursing staff

Recorded and signed by collector in ward water quality register.

After first carbon filter and before second carbon filter

NUM or person in charge of shift NUM or person in charge of shift

Break-through at mid-point requires saturated filter to be replaced.

Microbiology *

2nd week of each monthly

Laboratory results to NUM and Clinical Director of Nephrology. To be filed in ward water quality register.

Ring main and random machines. Samples need refrigeration if being transferred from GBH, BDH.

Endotoxins*

2nd week of each month

Nursing staff

Laboratory results to NUM and Clinical Director of Nephrology. To be filed in ward water quality register. Laboratory results to NUM and Clinical Director of Nephrology. To be filed in ward water quality register.

From infusate port on HDF machines and one sample from Ring Main

NUM or person in charge of shift NUMs

NUM will advise Clinical Director of Nephrology Services, technician and Manager of Biomedical Services

Heavy metals & trace elements*

Six monthly (May & Nov)

Technicians

2 samples inlet supply and post RO unit

NUMs

NUM will advise Clinical Director of Nephrology Services, technician and Manager of Biomedical Services

Confirmed CFU counts greater than 200 cfu/ml in the Ring Main will result in closure of the In-centre Unit until Ring Main is disinfected and retested for CFUs. Results > 200 cfu/ml in dialysate will result in machine disinfection and repeat testing. Positive result will mean the cessation of HDF until machine can be disinfected as per protocols. Positive ring main result using 0.25 EU/ml test sensitivity will result in closure of In-centre Unit until ring main can be disinfected. High levels post RO indicate membrane failure. Membrane may need replacing or descaling.

Example of Maintenance Log provided by Ian Mackie, NCAHS , 2008

Page 1 of 3

Appendices for Water Standards for In-Centre Haemodialysis Appendix III: Log Sheet for managing Maintenance Sample - Schedule of Maintenance for Reverse Osmosis Units
Procedure Backflushing of carbon tanks & sand filters Disinfect ion of ring main Frequency Daily Performed By Automated Record of Procedure Not recorded Instructions Response To Problems Report problems to Manager Biomedical Services, NUM and Site Maintenance Supervisor Test for residual sodium hypochlorite after disinfection technician to use residual test kit. Report problems to Manager Biomedical Services and NUM. Test for residual sodium hypochlorite must be negative before staff leave unit. Alert

Six monthly

Maintenance staff & technicians

Staff to record disinfection process and test result for residual sodium hypochlorite in log in RO room Staff to record disinfection and test result for residual Proxitane in log in RO room By maintenance staff in book in RO room

Reverse osmosis membrane treatment Replacement of carbon filters

Monthly

Technicians (LBH, TTH) Maintenance staff (GBH,BDH)

Test for residual Proxitane after disinfection using Residual Proxide test strips.

Report problem to Manager Biomedical Services and NUM

Test for residual Proxitane must be negative before staff leave unit.

Annually or as determined by chloramines test results

Maintenance staff

Report problem to Manager Biomedical Services, NUM and Site Maintenance Supervisor

Chloramine saturation of both carbon filters will result in Incentre Unit being closed until replacement filters are installed.

Example of Maintenance Log provided by Ian Mackie, NCAHS , 2008

Page 2 of 3

Appendices for Water Standards for In-Centre Haemodialysis Appendix III: Log Sheet for managing Maintenance

Recommended Schedule of Testing: Haemodialysis Machines & Home Haemodialysis Reverse Osmosis Units
Six monthly results to be tabled as part of Quality Report to the Area Renal Services Committee Test Chloramines Frequency Before the start of each treatment Collected By By patient patient trained during home training program Home haemodialysis RNs Results or Procedure Recorded Recorded in home dialysis record sheet Sample Sites And Instructions Post RO unit/pre haemodialysis machine Reported to Reviewed by home haemodialysis training unit staff on home visits. Response To Problems Patient to notify Home Haemodialysis nursing staff of positive result. Nursing staff will inform technician. If post RO CFU count > than 200 mls machine to be replaced or disinfected and re-sampled for CFUs. Audited By Nursing staff of Home Haemodialysis Training Unit.

Microbiology*

Prior to installation in the home and then at each routine home visit. Prior to installation in the home and then at each routine home visit. Annually

In-patient records in Home Training Unit

Sample 1) Post portable RO unit. 2) Dialysis machine at venous port

Laboratory results to Home Haemodialysis Unit

Nursing staff of Home Haemodialysis Training Unit

Endotoxins*

Home haemodialysis RNs

In-patient records in Home Training Unit

Dialysis machine at venous port

Laboratory results to Home Haemodialysis Unit

If endotoxins positive Hi-flux dialysis to cease return to standard dialyser. Technician to change U8000 filter and chemical disinfect machines. Haemodialysis Training Unit. Nursing staff to inform technician and Clinical Director of Nephrology.

Nursing staff of Home Haemodialysis Training Unit

Heavy metals & trace elements

Home haemodialysis technician

Replacement of carbon filters

Annually or as determined by chloramines test results

N/A

By home haemodialysis training unit staff in patient records By technician on service sheet

2 samples Inlet supply and post RO unit

Results to go from laboratory to home haemodialysis training unit

Technicians and Nursing staff of Home Haemodialysis Training Unit Technicians and Nursing staff of Home Haemodialysis Training Unit

N/A

Reported by technician to Manager, Biomedical Services and nursing staff from Home Haemodialysis Training Unit. Nursing staff to inform Clinical Director of Nephrology.

Nursing staff of Home Haemodialysis Training Unit

Example of Maintenance Log provided by Ian Mackie, NCAHS , 2008

Page 3 of 3

Appendices for Water Standards for In-Centre Haemodialysis

RO Water - Test Results for Measurement of Total Chlorine (mg/litre)


START Date: //..
0.9 0.85 0.8 0.75 0.7 0.65

FINISH Date: //.


Appendix IV : Manual Water testing Chart for Monitoring Test Results

.
0.6

Test Result (mg/l)

0.55 0.5 0.45 0.4 0.35 0.3 0.25 0.2

Total Chlorine (max) = 0.1


0.15 0.1 0.05 0

Date Total Chlorine: