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RULE §117.32Water Treatment, Dialysate Concentrates, and Reuse

      (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.

  (14) Ultraviolet (UV) lights, if used, shall be monitored at the frequency in accordance with the manufacturer's direction for use, and shall have an endotoxin reducing filter located down stream of the device. A log sheet shall be used to record monitoring.

  (15) Water treatment system piping shall be labeled to indicate the contents of the pipe and direction of flow.

  (16) The water treatment system shall be continuously monitored during patient treatment and be guarded by audible and visual alarms which can be seen and heard in the dialysis treatment area should water quality drop below specific parameters. Quality monitor sensing cells shall be located at the last component of the water treatment system and at the beginning of the distribution system. No water treatment components that could affect the quality of the product water as measured by this device shall be located after the sensing cell.

  (17) When deionization tanks do not follow a reverse osmosis system, parameters for the rejection rate of the membranes shall assure that the lowest rate accepted would provide product water in compliance with §4.1.1 (concerning Maximum level of chemical contaminants of water) of the American National Standards Institute, Dialysate for Hemodialysis, RD 52:2004 Edition published by the AAMI.

  (18) A facility shall maintain written logs of the operation of the water treatment system for each treatment day. The log book shall include each component's operating parameter and the action taken when a component is not within the facility's set parameters.

  (19) Microbiological testing of product water shall be conducted.

    (A) Routine microbiological testing shall be conducted monthly. For a newly installed water distribution system, or when any repairs, modifications or changes to the configuration has been made to an existing system, weekly testing shall be conducted for one month to verify that bacteria and endotoxin levels are consistently within the allowed limits. Changes to components that are designed to be replaced on a routine schedule such as filters, ultrafilters and ultraviolet lamps do not require a period of more frequent testing.

    (B) At a minimum, sample sites chosen for the testing shall include the beginning of the distribution piping, the product water in the reuse room, at any site of concentrate mixing, and the end of the distribution piping.

    (C) Samples shall be collected prior to sanitization/disinfection of the water treatment system, and the dialysis machines. Water testing results shall be routinely trended and reviewed by the medical director in order to determine if results seem questionable or if there is an opportunity for improvement. The medical director shall determine if there is a need for retesting. If internal testing is performed with repeated results of "no growth" for three consecutive months, the testing shall be validated via an outside laboratory. A calibrated loop may not be used in microbiological testing of water samples. Colonies shall be counted using a magnifying device.

    (D) Product water used to prepare dialysate, concentrates from powder, or to reprocess dialyzers for multiple use shall contain a total viable microbial count less than 200 colony forming units (CFU)/millimeter (ml) and an endotoxin concentration less than 2 endotoxin units (EU)/ml. The action level for the total viable microbial count in the product water shall be 50 CFU/ml and the action level for the endotoxin concentration shall be 1 EU/ml.

    (E) If the action levels described at subparagraph (D) of this paragraph are observed in the product water, the medical director shall be notified and corrective measures shall be taken promptly to reduce the levels into an acceptable range.

    (F) All bacteria and endotoxin results shall be recorded on a log sheet in order to identify trends that may indicate the need for corrective action.

  (20) If ozone generators are used to disinfect any portion of the water or dialysate delivery system, the ozone generator shall be capable of delivering ozone at the concentration and for the exposure time specified and in accordance with the manufacturer's direction for use. Testing based on the manufacturer's direction shall be used to measure the ozone concentration each time disinfection is performed, to include testing for safe levels of residual ozone at the end of the disinfection cycle. Testing for ozone in the ambient air shall be conducted on a periodic basis as recommended by the manufacturer. The records of all testing shall be maintained in a log. The frequency of disinfection shall be performed at least monthly.


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