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RULE §117.32Water Treatment, Dialysate Concentrates, and Reuse

(a) A facility shall meet the requirements of this section. A facility may follow more stringent requirements than the minimum standards required by this section.

  (1) The facility owner and medical director shall each demonstrate responsibility for the water treatment and dialysate supply systems to protect hemodialysis patients from adverse effects arising from known chemical and microbial contaminates that may be found in water and improperly prepared dialysate, to ensure that the dialysate is correctly formulated and meets the requirements of all applicable quality standards.

  (2) The facility owner and medical director shall each assure that policies and procedures related to water treatment, dialysate, and reuse are understandable and accessible to the operator(s), and that the training program includes quality testing, risks and hazards of improperly prepared concentrate, and bacterial issues.

  (3) The facility owner and medical director shall be informed prior to any alteration of, or any device being added to, the water system.

(b) These requirements apply to water intended for use in the delivery of hemodialysis, including the preparation of concentrates from powder at a dialysis facility and dialysate, and for reprocessing dialyzers for multiple use.

  (1) The design for the water treatment system in a facility shall be based on considerations of the source water for the facility and designed by a water quality professional with education, training, or experience in dialysis system design.

  (2) When a public water system supply is not used by a facility, the source water shall be tested by the facility at monthly intervals in the same manner as a public water system as described in 30 Texas Administrative Code, §290.104 (relating to Summary of Maximum Contaminant Levels, Maximum Residual Disinfectant Levels, Treatment Techniques, and Action Levels), and §290.109 (relating to Microbial Contaminants) as adopted by the Texas Commission on Environmental Quality.

  (3) The physical space in which the water treatment system is located shall be adequate to allow for maintenance, testing, and repair of equipment. If mixing of concentrates is performed in the same area, the physical space shall also be adequate to house and allow for the maintenance, testing, and repair of the mixing equipment and for performing the mixing procedure. Water distribution systems shall be configured as a continuous recirculation loop, and to minimize biofilm formation, there shall always be flow in a piping system, except during the backwash cycle of the carbon tanks for direct feed systems.

    (A) For indirect feed systems a minimum of three feet per second water flow shall be achieved in the distribution loop.

    (B) For direct feed systems a minimum of 1.5 feet per second water flow shall be achieved in the distribution loop.

    (C) This rule shall not apply to facilities providing only home training and support services utilizing single patient devices.

    (D) The water treatment and distribution system shall include appropriate pressure gauges, flow meters, sample ports, and other ancillary equipment necessary to allow monitoring of the performance of individual system components and the system as a whole, as determined by the facility medical director.

  (4) The water treatment system components shall be arranged and maintained so that bacterial and chemical contaminant levels in the product water do not exceed the standards for hemodialysis water quality described in §4.1.1 (concerning Maximum level of chemical contaminants in water) and §4.1.2 (concerning Bacteriology of water) of the American National Standards Institute (ANSI), Water Treatment Equipment for Hemodialysis Applications, RD52:2004 Edition, published by Association for the Advancement of Medical Instrumentation (AAMI). All documents published by the AAMI as referenced in this section may be obtained by writing the following address: 1110 North Glebe Road, Suite 220, Arlington, Virginia 22201.

    (A) Direct feed systems shall include a means of verifiably preventing retrograde flow of water into the distribution loop from the feed side of the reverse osmosis unit.

    (B) Dead-end piping (risers with no flow, branches with no fixture) shall not be installed. In any renovation work, dead-end piping shall be removed.

  (5) Written policies and procedures for the operation of the water treatment system shall be developed, approved by the medical director, implemented, and enforced. Parameters for the operation of each component of the water treatment system shall be developed in writing and known to the operator. Each major water system component shall be labeled in a manner that identifies the device; describes its function, how performance is verified, and actions to take in the event performance is not within an acceptable range. Facility's policy and/or procedure for the bypass valves for the carbon tanks and any other bypass valves considered to be critical by the medical director shall have a means to minimize the likelihood the device will be inadvertently bypassed during normal operation of the system.

  (6) The materials of any components of water treatment systems (including piping, storage, filters, and distribution systems) that contact the product water shall not interact chemically or physically so as to affect the purity or quality of the product water adversely. Such components shall be fabricated from unreactive materials (e.g., plastics) or appropriate stainless steel. The use of materials that are known to cause toxicity in hemodialysis, such as copper, brass, galvanized material, or aluminum, is prohibited at any point beyond the water treatment component used to remove contaminating metal ions (e.g., reverse osmosis system or deionizer).

  (7) Chemicals infused into the water such as iodine, acid, flocculants, and complexing agents shall be shown to be nondialyzable or shall be adequately removed from product water. Systems shall be monitored in accordance with the manufacturer's direction for use, and specific test procedures to verify removal of additives shall be provided and documented. Chemical injection systems shall include a means of regulating the metering pump to control the addition of chemical. This control system shall be designed to tightly control addition of the chemical. The control system shall ensure that chemical is added only when the water is flowing through the pre-treatment cascade and that it is added in fixed proportion to the water flow. If an automated control system is used to inject the chemical, there shall be an independent monitor of the controlling parameter.

  (8) Each water treatment system shall include reverse osmosis membranes or deionization tanks and a minimum of two carbon tanks in series. If the source water is from a private supply which does not use chlorine/chloramine, the water treatment system shall include reverse osmosis membranes or deionization tanks and a minimum of one carbon tank.

    (A) Reverse osmosis systems, if used, shall meet the standards in §6.2.7 (concerning Reverse Osmosis) of the American National Standards Institute, Dialysate for Hemodialysis RD 52:2004 Edition, published by the AAMI.

    (B) Deionization systems.

      (i) Deionization systems, if used, shall be monitored continuously to produce water of one megohm-centimeter (cm) or greater specific resistivity (or conductivity of one microsiemen/cm or less) at 25 degrees Celsius. An audible and visual alarm shall be activated in the facility to include the patient care area when the product water resistivity falls below this level and the product water stream shall be prevented from reaching any point of use.

      (ii) Patients shall not be dialyzed on deionized water with a resistivity less than 1.0 megohm-cm measured at the output of the final deionizer.

      (iii) Deionization tanks if used shall be a minimum of two mixed beds in series, and shall be used with resistivity monitors including audible and visual alarms placed pre and post the final deionization tank in the system and audible in the patient care area.

      (iv) Feed water for deionization systems shall be pretreated with activated carbon adsorption, or a comparable alternative, to prevent nitrosamine formation.

      (v) If a deionization system is the last process in a water treatment system, it shall be followed by an ultrafilter or other bacteria and endotoxin reducing device.

      (vi) Facilities shall ensure that all devices that are regenerated or reconstituted off site, such as deionizers, shall be disinfected at the time of regeneration or reconstitution, so that contaminated water is not reintroduced into the system after regeneration or reconstitution.

    (C) Carbon tanks.

      (i) The carbon tanks shall contain granular activated carbon, with a minimum iodine number of 900. Regenerated carbon shall not be used.

      (ii) A minimum of two carbon adsorption beds shall be installed in series with a sample port following the first bed. A sample port shall also be installed following the second bed for use in the event of free chlorine or cloramine breaking through the first bed.

      (iii) The total empty bed contact time (EBCT) shall be at least ten minutes, with the final tank providing at least five minutes EBCT at the maximum flow rate through the bed. Carbon adsorption systems used to prepare water for home dialysis or for portable dialysis systems are exempt from the requirement for the second carbon and a ten minute EBCT, if removal of chloramines to below 0.1 milligram (mg)/liter is verified before each treatment.

      (iv) A sample port shall also be installed following the second bed for use in the event of free chlorine or chloramine breaking through the first bed. Water from this port(s) shall be tested for chlorine/chloramine levels at the beginning of each treatment day prior to patients initiating treatment, prior to reprocessing of dialyzers, and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed every four hours during hours of operation.

      (v) Carbon beds are sometimes arranged as series-connected pairs of beds so that they need not be overly large. The beds within each pair are of equal size and water flows through them are parallel. In this situation, each pair of beds should have a minimum empty bed contact time of 5 minutes at the maximum flow rate through the bed. When series connected pairs of beds are used, the piping should be designed to minimize differences in the resistance to flow from inlet and outlet between each parallel series of beds to ensure that an equal volume of water flows through all beds.

      (vi) All samples for chlorine/chloramine testing shall be drawn when the water treatment system has been operating for at least 15 minutes.

      (vii) Tests for total chlorine, which include both free and combined forms of chlorine, may be used as a single analysis with the maximum allowable concentration of 0.1 mg/liter (L). Test results of greater than 0.5 parts per million (ppm) for chlorine or 0.1 ppm for chloramine from the port between the initial tank(s) and final tank(s) shall require testing to be performed at the final exit and replacement of the initial tank(s). Testing equipment, supplies and procedures shall be used in accordance with the manufacturer's directions for use.

      (viii) In a system without a holding tank, if test results at the exit of the final tank(s) are greater than the parameters for chlorine or chloramine described in this subparagraph, dialysis treatment shall be immediately terminated to protect patients from exposure to chlorine/chloramines, and the medical director shall be notified. In systems with holding tanks, if the holding tank tests less than 0.1 mg/L for total chlorine, the reverse osmosis (RO) may be turned off and the product water in the holding tank may be used to finish treatments in process. The medical director shall be notified.

      (ix) If means other than granulated carbon are used to remove chlorine/chloramine, the facility's governing body shall approve such use in writing after review of the safety of the intended method for use in hemodialysis applications. If such methods include the use of additives, there shall be evidence the product water does not contain unsafe levels of these additives.

  (9) Water softeners, if used, shall be tested at the end of the treatment day to verify their capacity to treat a sufficient volume of water to supply the facility for the entire treatment day, and shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration.

  (10) If used, the face(s) of timer(s) used to control any component of the water treatment or dialysate delivery system shall be visible to the operator at all times. Written evidence that timers are checked for operation and accuracy each day of operation shall be maintained.

  (11) Filter housings, if used during disinfectant procedures, shall include a means to clear the lower portion of the housing of the disinfecting agents. Filter housings shall be opaque.

  (12) Ultrafilters, or other bacterial reducing filters, if used, shall be fitted with pressure gauges on the inlet and outlet water lines to monitor the pressure drop across the membrane. Ultrafilters shall be included in routine disinfection procedures.

  (13) If used, storage tanks shall have a conical or bowl-shaped base, and shall drain from the lowest point of the base. Storage tanks shall have a tight-fitting lid, and be vented through a hydrophobic 0.2 micron air filter. A means shall be provided to effectively disinfect any storage tank installed in a water distribution system.


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