(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...
(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.
Cont'd...
(21) If used, hot water disinfection systems shall utilize AAMI quality water, be capable of delivering hot water at the temperature and for the exposure time specified and in accordance with the manufacturer's direction for use; and be monitored for temperature and time of exposure to hot water as specified by the manufacturer. Temperature of the water shall be monitored at a point furthest from the water heater, where the lowest water temperature is likely to occur. The water temperature shall be measured each time a disinfection cycle is performed. A record that verifies successful completion of the heat disinfection shall be maintained. The frequency of disinfection shall be performed at least monthly.
  (22) After chemical disinfection, a mechanism shall be incorporated to ensure that the equipment and the system are restored to a safe condition prior to using the equipment and the product water being used for dialysis applications. The results of all absence testing shall be documented. The frequency of disinfection shall be performed at least monthly. A mechanism shall be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period.
  (23) Users shall establish a procedure for regular disinfection of the line between the outlet from the water distribution system and the back of the dialysis machine.
  (24) Samples of product water used for dialysis shall be submitted for chemical analysis every six months, and after a change of the reverse osmosis membranes, and shall demonstrate that the quality of the product water used to prepare dialysate, concentrates from powder, or to reprocess dialyzers for multiple use meets §4.1.1 (concerning Maximum level of chemical contaminants in water) of the American National Standards Institute, Water Treatment Equipment for Hemodialysis Applications, RD52:2004 Edition, published by the AAMI.
    (A) Samples for chemical analysis shall be collected at the most distal point in each water distribution loop. All other outlets from the distribution loops shall be inspected to ensure that the outlets are fabricated from compatible materials. Appropriate containers and pH adjustments shall be used to ensure accurate determinations. New facilities or facilities that add or change the configuration of the water distribution system shall draw samples at the most distal point for each water distribution loop, and then every six months thereafter.
    (B) Additional chemical analysis shall be submitted when any modification or change to the configuration of the existing system are made to the water treatment system, or if the percent rejection of a reverse osmosis system decreased 5.0% or more from the percent rejection measured at the time the water sample for the preceding chemical analysis was taken.
  (25) Facility records shall include all test results and evidence that the medical director has reviewed the results of the water quality testing and directed corrective action when indicated.
  (26) Only persons qualified by the education or experience described in §117.46(f) of this title (relating to Qualifications of Staff) may operate, repair, or replace components of the water treatment system.
(c) Dialysate.
  (1) The facility shall develop, implement, maintain, and evaluate quality assessment and performance improvement (QAPI) procedures to ensure ongoing conformance to policies and procedures regarding dialysate quality.
  (2) Each facility shall set all hemodialysis machines to use only one family of concentrates. When new machines are put into service or the concentrate family or concentrate manufacturer is changed, dialysate samples shall be taken from each machine, and shall be sent to a laboratory for verification of the dialysate electrolyte values.
  (3) Prior to each patient treatment, staff shall verify the dialysate conductivity and pH of each machine with an independent device.
  (4) Bacteriological testing shall be conducted.
    (A) For newly installed bicarbonate concentrate mixing and delivery systems, weekly testing shall be conducted for one month to verify that bacteria and endotoxin levels are consistently within the allowed limits. Responsible facility staff shall develop a schedule to ensure each hemodialysis machine is tested quarterly for bacterial growth and the presence of endotoxins. Hemodialysis machines of home patients, conventional and integrated dialysis systems, shall be cultured monthly until results not exceeding 200 colony forming units per milliliter are obtained for three consecutive months, and thereafter quarterly samples shall be cultured. This subparagraph does not apply to closed systems as defined in §117.2(11) of this title (relating to Definitions).
    (B) Dialysate shall contain less than 200 CFU/ml and an endotoxin concentration of less than 2 EU/ml. The action level for total viable microbial count shall be 50 CFU/ml, and the action level for endotoxin concentration shall be 1 EU/ml.
    (C) Disinfection and retesting shall be done when bacterial or endotoxin counts exceed the action levels. The medical director shall be notified. Additional samples shall be collected when there is a clinical indication of a pyrogenic reaction and/or septicemia.
  (5) Only a qualified licensed nurse may use an additive to increase concentrations of specific electrolytes in the acid concentrate. Mixing procedures shall be followed as specified by the additive manufacturer. When additives are prescribed for a specific patient, the container holding the prescribed acid concentrate shall be labeled with the name of the patient, the final concentration of the added electrolyte, the date the prescribed concentrate was made, and the name of the person who mixed the additive.
  (6) All components used in concentrate preparation systems (including mixing and storage tanks, pumps, valves, and piping) shall be fabricated from materials (e.g., plastics or appropriate stainless steel) that do not interact chemically or physically with the concentrate so as to affect its purity, or with the germicides used to disinfect the equipment. The use of materials that are known to cause toxicity in hemodialysis such as copper, brass, galvanized material, and aluminum is prohibited.
  (7) Facility policies shall address means to protect stored dialysate components (acid concentrates, bicarbonate concentrates, or bulk storage of dialysate components) from tampering or from degeneration due to exposure to extreme heat or cold.
  (8) Procedures shall be developed, implemented, and enforced:
    (A) to control the transfer of acid concentrates from the delivery container to the storage tank and prevent the inadvertent mixing of different concentrate formulations. The storage tanks shall be clearly labeled;
    (B) the tank and associated plumbing shall form an integral system to prevent contamination of the acid concentrate; and
    (C) the storage tank and inlet and outlet connections, if remote from the tank, shall be secured and clearly labeled.
  (9) Concentrate mixing systems shall include a purified water source, a suitable drain, and a ground fault protected electrical outlet.
    (A) Operators of mixing systems shall use personal protective equipment as specified and in accordance with the manufacturer's direction for use during all mixing processes.
    (B) The manufacturer's directions for use of a concentrate mixing system shall be followed, including instructions for mixing the powder with the correct amount of water. The number of bags or weight of powder added shall be determined and recorded.
    (C) The mixing tank shall be clearly labeled to indicate the fill and final volumes required to correctly dilute the powder.
    (D) Systems for preparing either bicarbonate or acid concentrate from powder shall be monitored according to the manufacturer's directions for use, to ensure compliance with paragraph (11)(A) of this subsection.
    (E) Concentrates shall not be used or transferred to holding tanks or distribution systems until all tests are completed per manufacturer's specifications and in accordance with the manufacturer's directions for use. The results of the tests shall be documented, with the signature of the person who completed the tests.
    (F) If a facility designs its own system for mixing concentrates, procedures shall be developed and validated using an independent laboratory to ensure proper mixing of the concentrate, including establishment of acceptable limits for tests of proper concentration.
  (10) Acid concentrate mixing tanks shall be designed to allow the inside of the tank to be rinsed when changing concentrate formulas.
    (A) Acid mixing systems shall be designed and maintained to prevent rust and corrosion.
    (B) Acid concentrate mixing tanks shall be emptied completely and rinsed with product water before mixing another batch of concentrate to prevent cross contamination between different batches.
Cont'd...
(C) Acid concentrate mixing equipment shall be disinfected as specified by the equipment manufacturer or, in the case where no specifications are given, as defined by facility policy.
    (D) Records of disinfection and rinsing of disinfectants to safe residual levels shall be maintained.
  (11) Bicarbonate concentrate mixing tanks shall have conical or bowl-shaped bottoms and shall drain from the lowest point of the base. The tank design shall allow all internal surfaces to be disinfected and rinsed.
    (A) Bicarbonate concentrate mixing tanks shall not be pre-filled the night before use, and mixed solution shall not remain in mixing or holding tanks overnight.
    (B) If disinfectant remains in the mixing tank overnight, this solution shall be completely drained, the tank rinsed and tested for residual disinfectant prior to preparing the first batch of that day of bicarbonate concentrate.
    (C) The container shall be emptied and rinsed with product water prior to mixing a new batch of bicarbonate solution, and unused portions of bicarbonate concentrate shall not be mixed with fresh concentrate.
    (D) At a minimum, bicarbonate distribution systems shall be disinfected weekly. More frequent disinfection shall be done if required in accordance with the manufacturer's direction for use, or if dialysate culture results are above the action level.
    (E) If jugs are reused to deliver bicarbonate concentrate to individual hemodialysis machines:
      (i) jugs shall be emptied of concentrate, rinsed, and inverted to drain at the end of each treatment day;
      (ii) pick-up tubes shall be rinsed and allowed to air dry at the end of each treatment day;
      (iii) at a minimum, jugs and pick-up tubes shall be disinfected weekly, more frequent disinfection shall be considered by the facility QAPI committee if dialysate culture results are above the action level; and
      (iv) following disinfection, jugs shall be drained, rinsed free of residual disinfectant, and inverted to dry. Pick-up tubes shall be rinsed free of residual disinfectant and allowed to air day. Testing for residual disinfectant shall be done and documented.
  (12) All mixing tanks, bulk storage tanks, dispensing tanks, and containers for single hemodialysis treatments shall be labeled as to the contents.
    (A) Prior to batch preparation, a label shall be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling shall remain on the mixing tank until the tank has been emptied.
    (B) Bulk storage/dispensing tanks shall be permanently labeled to identify the chemical composition or formulation of their contents.
    (C) At a minimum, single-machine containers shall be labeled with sufficient information to differentiate the contents from other concentrate formulations used in the facility and permit positive identification by users of container contents.
  (13) Permanent records of batches produced shall be maintained to include the concentrate formula produced, the volume of the batch, lot number(s) of powdered concentrate packages, the manufacturer of the powdered concentrate, date and time of mixing, test results, person performing mixing, and expiration date (if applicable).
  (14) If acid and bicarbonate concentrates are prepared in the facility, preventive maintenance shall be completed in accordance with the manufacturer's direction for use. Records shall be maintained indicating the date, time, person performing the procedure, and the results (if applicable).
(d) Reuse of hemodialyzers and related devices.
  (1) Reuse practice in a facility shall comply with the American National Standards Institute (ANSI), Reuse of Hemodialyzers, Third Edition, ANSI/AAMI RD47:2002 and RD47:2002/A1:2003, published by the AAMI.
  (2) Dialyzer manufacturer's labeling shall be reviewed to determine if a specific dialyzer requires special considerations.
  (3) A transducer protector shall be replaced when wetted during a dialysis treatment, and shall be used for one treatment only. Equipment with internal transducer protectors shall be inspected quarterly to ensure that it has not been contaminated.
  (4) Arterial lines may be reused only when the arterial lines are labeled to allow for reuse by the manufacturer, and the manufacturer-established protocols for the specific line have been approved by the United States Food and Drug Administration.
  (5) The water supply in the reuse room shall incorporate a check valve to prevent chemical agents used from inadvertently back flowing into the water distribution system.
  (6) Ventilation systems in the reuse room shall be connected to an exhaust system to the outside which is separate from the building exhaust system, have an exhaust fan located at the discharge end of the system, and have an exhaust duct system of noncombustible corrosion-resistant material as needed to meet the planned usage of the system. Exhaust outlets shall be above the roof level and arranged to minimize recirculation of exhaust air into the building.
  (7) A facility shall establish, implement, and enforce a policy for dialyzer reuse criteria (including any facility-set number of reuses allowed), which is included in patient education materials and posted in the waiting room and patient treatment areas. A dialyzer may be reused only if that dialyzer's original volume is measured and recorded prior to its first use, and the volume of that dialyzer is used as the basis for discard for that dialyzer.
  (8) A facility shall consider and address the health and safety of patients sensitive to disinfectant solution residuals.
  (9) A facility shall provide each patient with information regarding the reuse practices at the facility and the opportunity to have questions answered.
  (10) A facility shall restrict the reprocessing room to authorized personnel during the reprocessing of dialyzers.
  (11) A facility shall obtain written informed consent of the patient or legal representative.
(e) If a facility participates in centralized reprocessing at a different location, in which dialyzers from multiple facilities are reprocessed at one site, the facility shall:
  (1) ensure direct communication with the medical director at the centralized reprocessing center and the facility's medical director;
  (2) require the use of automated reprocessing facility;
  (3) maintain responsibility and accountability for the entire reuse process;
  (4) adopt, implement, and enforce policies to ensure that the transfer and transport of used and reprocessed dialyzers to and from the off-site location does not increase contamination of the dialyzers, staff, or the environment;
  (5) assure that each dialyzer is returned to the appropriate facility or patient home, and, in the case of home patients who participate in a dialyzer reprocessing program, a system shall be established to verify that the correct dialyzers are being returned to each patient's home; and
  (6) provide department staff access to the off-site reprocessing site as part of a facility inspection.

Source Note: The provisions of this §117.32 adopted to be effective July 6, 2010, 35 TexReg 5835