| (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. Cont'd... |
