1. (a) Reuse practice in a facility shall comply with the standards listed in §507.30 of this subchapter (relating to Technical Standards) and the CMS Conditions for Coverage.
2. (b) Facility staff shall review the dialyzer manufacturer's labeling to determine whether a specific dialyzer requires special considerations.
3. (c) Facility staff shall reuse arterial lines only when the arterial lines are labeled for reuse by the manufacturer, and the manufacturer-established protocols for the specific line are approved by the United States Food and Drug Administration.
4. (d) 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.
5. (e) Ventilation systems in the reuse room shall meet the requirements of Subchapter Z of this chapter (relating to Physical Plant and Construction Requirements) and be connected to an exhaust system to the outside that 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.
6. (f) A facility shall establish, implement, and enforce a policy for dialyzer reuse criteria (including any facility-set number of reuses allowed) that is included in patient education materials and posted in the waiting room and patient treatment areas. A dialyzer may be reused only if the dialyzer's original volume is measured and recorded before its first use, and the volume of that dialyzer is used as the basis for discard for that dialyzer.
7. (g) A facility shall consider and address the health and safety of patients sensitive to disinfectant solution residuals.
8. (h) A facility shall provide each patient with information regarding the reuse practices at the facility and the opportunity to have questions answered.
9. (i) A facility shall restrict the reprocessing room to authorized personnel during the reprocessing of dialyzers.

10. (j) 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. (1) ensure direct communication with the medical director at the centralized reprocessing center and the facility medical director;
    2. (2) require the use of an automated reprocessing facility;
    3. (3) maintain responsibility and accountability for the entire reuse process;
    4. (4) adopt, implement, and enforce policies to ensure the transfer and transport of used and reprocessed dialyzers to and from the off-site location does not increase contamination of the dialyzers or the environment;
    5. (5) ensure that each dialyzer is returned to the appropriate facility or patient home, and a system shall be established to verify that the correct dialyzers are being returned to each patient's home in the case of home patients who participate in a dialyzer reprocessing program; and
    6. (6) provide Texas Health and Human Services Commission staff access to the off-site reprocessing site as part of a facility inspection.

Source Note:The provisions of this §507.35 adopted to be effective December 23, 2025, 50 TexReg 8289.