333-700-0120 Facility Safety and Emergency Preparedness (1) The physical environment in which dialysis services are furnished must afford and maintain a functional, clean, sanitary, safe, and comfortable setting for patients, staff, and the public. At minimum, the facility shall satisfy the following requirements: (a) Hot water used for hand washing shall have a water temperature between 105 and 120 degrees Fahrenheit; (b) All facilities shall have a smoke detection system; (c) At least one NFPA 10 compliant portable fire extinguisher shall be installed for every eight patient stations in locations that are readily accessible to staff without leaving the treatment area; (d) All interior and exterior materials and surfaces and all equipment necessary for the health, safety and comfort of patients shall be kept clean and in good repair. Examples include, but are not limited to: floors, walls, roofs, ceiling, windows, furnishings and equipment; (e) Floor surfaces shall be relatively level and free of tripping hazards; (f) All buildings shall be maintained in good condition with sound structural integrity; and (g) The facility shall be in compliance with local codes, laws and ordinances. (2) All electrical and other equipment used in the facility must be maintained free of defects that could be a potential hazard to patients or personnel. There must be an established program of preventive maintenance of equipment used in dialysis and related procedures in the facility. Facilities shall follow the manufacturers' recommendations for preventive maintenance for all equipment. (3) The areas used by patients shall be maintained in good repair and kept free of hazards such as those created by damaged or defective parts of the building. (4) The facility must be able to demonstrate that water and equipment used for dialysis meets the water and dialysate quality standards and equipment requirements found in the American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) 13959:2014, Water for Hemodialysis and Related Therapies, and the ANSI/AAMI 26722:2014, Water Treatment Equipment for Hemodialysis and Related Therapies,," adopted by reference. (5) Any adverse results identified by the water quality monitoring system shall be addressed and corrected immediately. Documentation of these corrections shall be maintained in a designated area for review. (6) Testing of the water in dialysis facilities must comply with the requirements of Table 1 of this rule. (7) Treatment areas shall be designed and equipped to provide adequate and safe dialysis therapy, as well as privacy and comfort for patients. The space for treating each patient must be sufficient to accommodate medically necessary emergency equipment and personnel to treat the patient in the event of an emergency. There must be sufficient space in the facility for safe storage of dialysis supplies. (8) Chronic dialysis patients shall be dialyzed in chairs that can be reclined so that the patient's head is lower than his/her feet, except when the patient is dialyzed in a hospital bed. (9) There shall be a nursing station or staff monitoring station from which all patients receiving dialysis can be continuously monitored during the course of treatment. (10) Heating and ventilation systems shall be capable of maintaining adequate and comfortable temperatures. (11) Each facility utilizing a central-batch delivery system must provide, either on the premises or through affiliation agreement or arrangement sufficient individual delivery systems for the treatment of any patient requiring special dialysis solutions. (12) Each facility shall develop and maintain an emergency preparedness program that complies with 42 CFR 494.62 and the emergency planning and preparedness requirements in accordance with the Oregon Fire Code, as defined by the Department of State Police, Office of State Fire Marshal in Oregon Administrative Rules chapter 837, division 40. (13) The facility must have a backup water treatment plan that can be demonstrated to meet Association for the Advancement of Medical Instrumentation (AAMI) standards. [ED. NOTE: To view attachments referenced in rule text, click here to view rule.] Statutory/Other Authority: ORS 441.015 & 441.025 Statutes/Other Implemented: ORS 441.025 History: PH 18-2019, amend filed 10/01/2019, effective 01/01/2020 PH 3-2015, f. 1-16-15, cert. ef. 2-1-15 PH 4-2012, f. 3-30-12, cert. ef. 4-1-12 PH 13-2008, f. & cert. ef. 8-15-08 PH 7-2003, f. & cert. ef. 6-6-03