| (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. |
