OAR 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.]

Source: Rule 333-700-0120 — Facility Safety and Emergency Preparedness, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-700-0120.

333‑700‑0000
Statement of Purpose 333‑700‑0004
Referenced Codes and Standards 333‑700‑0005
Definitions 333‑700‑0010
Application for Licensure 333‑700‑0015
Annual License Fee 333‑700‑0017
Application Review 333‑700‑0018
Approval of License Application 333‑700‑0019
Denial of License Application 333‑700‑0020
Expiration and Renewal of License 333‑700‑0025
Denial or Revocation of a License 333‑700‑0030
Discontinuance and Recommencement of Operation of Outpatient Renal Dialysis Facilities 333‑700‑0035
Return of Facility License 333‑700‑0040
Classification 333‑700‑0045
Hearings 333‑700‑0050
Adoption by Reference 333‑700‑0053
Complaints 333‑700‑0057
Investigations 333‑700‑0060
Surveys 333‑700‑0061
Violations 333‑700‑0062
Informal Enforcement 333‑700‑0063
Formal Enforcement 333‑700‑0064
Civil Penalties 333‑700‑0072
Waivers 333‑700‑0073
Outpatient Mobile Dialysis 333‑700‑0075
Administrative Authority and Management 333‑700‑0080
Quality Assessment and Performance Improvement 333‑700‑0085
Patient Care Plan 333‑700‑0090
Medical Records 333‑700‑0095
Medical Director of an Outpatient Renal Dialysis Facility 333‑700‑0100
Patient Care Staff 333‑700‑0105
Minimal Service Requirements for an Outpatient Renal Dialysis Facility 333‑700‑0110
Infection Control 333‑700‑0115
Patients’ Rights, Responsibilities and Family Education 333‑700‑0120
Facility Safety and Emergency Preparedness 333‑700‑0125
Reuse of Hemodialyzers and other Dialysis Supplies 333‑700‑0131
Physical Environment Requirements
Last Updated

Jun. 8, 2021

Rule 333-700-0120’s source at or​.us