- (a) A facility shall meet the requirements of this subchapter and Subchapter Z of this chapter (relating to Physical Plant and Construction Requirements). A facility may follow more stringent requirements than the minimum standards required by this subchapter.
- (b) The facility medical director and biomedical technical staff 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 and ensure the dialysate is correctly formulated and meets the requirements of all applicable quality standards.
- (c) The facility medical director and biomedical technical staff shall each ensure that policies and procedures related to water treatment, dialysate, and reuse are understandable and accessible to the operators, and the training program includes quality testing, risks, and hazards of improperly prepared concentrate and bacterial issues.
- (d) Facility staff shall inform the facility owner, medical director, biomedical technical staff, and any other staff members as required by facility policy before any alteration of, or any device being added to, the water system.
Source Note:The provisions of this §507.32 adopted to be effective December 23, 2025, 50 TexReg 8289.