| (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... |
