Or. Admin. R. 333-700-0130 - Construction Requirements

(1) Applicability. This rule shall apply to:

(a) All outpatient renal dialysis facilities that apply for an initial license from the Division on or after February 1, 2015; and

(b) All outpatient renal dialysis facilities that propose a major alteration and submit plans to the Division on or after February 1, 2015. In the event of a major alteration, this rule shall apply only to the areas to be altered and not to other areas of the facility.

(2) All facilities subject to this rule must comply with all applicable Oregon state building codes, occupancy Business Group B, Ambulatory Care Facility.

(3) Minimum facility requirements are as follows:

(a) Facility Location & Accessibility.

(A) The facility shall be located to allow for prompt access by ambulances and buses, including wheelchair-lift equipped vehicles, without the need for patients to traverse across vehicular pathways or parking areas. If this requirement cannot be satisfied, the project sponsor shall propose an alternate plan showing that patient safety shall not be compromised;

(B) The dialysis unit shall be located in a separate building or section of the facility that is free of traffic by non-related persons;

(C) Accessible parking shall be provided for patients and visitors that complies with the Oregon Structural Specialty Code;

(D) Building access and all patient use areas shall be designed and constructed in accordance with chapter 11 of the Oregon Structural Specialty Code for accessibility; and

(E) Corridors, doorways, and stairways serving the unit shall be sized to allow at least one exit route for emergency medical personnel to transport a patient by stretcher to an ambulance.

(b) Treatment Areas.

(A) Dialysis stations must meet the following minimum criteria:

(i) Individual patient treatment areas shall be at least 80 square feet in size with a minimum of 4 feet 0 inches of open space available at the foot of the recliner or hospital bed;

(ii) Hand washing stations that are readily available for staff use shall be provided within the treatment area. At a minimum, one hand washing station shall be provided for every four patients and appropriately located to facilitate hand washing between each patient contact;

(B) Patient care staff station(s) shall be located within the dialysis treatment area. Each station shall be no higher than 3 feet 8 inches and allow visual observation of all patients; and

(C) To prevent contact transmission of infectious materials, the treatment area must include an Isolation Room that meets the following minimum requirements:

(i) Provides a door and walls that go to the floor, but not necessarily the ceiling, and allows for visual monitoring of the patient;

(ii) Accommodates only one patient; and

(iii) Contains a hand washing station located in each patient room.

(4) To ensure adequate patient support, the facility shall provide the following:

(a) Adequate waiting space with a minimum seating capacity of one seat or wheelchair space for every two patient stations;

(b) An accessible toilet for patients that is convenient to the waiting room and includes an emergency nurse call annunciated to the patient care staff station;

(c) Dedicated space for a patient scale; and

(d) Dedicated space for wheelchair storage.

(5) To ensure adequate general support areas, the facility shall provide the following:

(a) Clean supply room with space for bulk storage of necessary medical supplies. If the room is used to prepare patient care supplies, it must contain a hand washing station and work counter;

(b) Soiled holding room or area for medical waste storage that includes a mechanism to sanitize hands;

(c) Secure medications storage that includes a dedicated refrigerator and hand washing station;

(d) Emergency cart and equipment storage located close to the patient treatment area, readily accessible by staff, and not located in an exit path;

(e) Access to a janitor closet with a floor sink or service sink and adequate space for cleaning supplies within or close to the unit;

(f) Adequate equipment storage and service room or area. Space allocated for bio-medical interventions shall not be in proximity to patients while they are undergoing dialysis;

(g) When dialyzer reprocessing is practiced, space for reuse equipment, work counter and hand washing station. Additional sinks shall be provided as defined by the facility's reprocessing program;

(h) Solution mixing and preparation area for central concentrate delivery system or individual preparation, sized to meet the facility's needs;

(i) Dedicated space for central or individual water treatment equipment with waste drain sized to meet equipment requirements;

(j) Dedicated staff toilet that includes a hand washing station within or near the treatment area;

(k) If a home training program is offered, the facility shall provide separate, 120 square foot training room(s) each with a hand washing station, counter space and separate drain for fluid disposal that is constructed to prevent crosscontamination of the hand washing station. In addition, at least one convenient program office and general support space shall be provided to meet program needs, and an emergency nurse call, annunciated at the patient care staff station, or the home training office, shall be provided in each home training room;

(l) Staff office; and

(m) Consultation space available for private conferences with patients and their families.

(6) Minimum facility finish requirements are as follows:

(a) Wall materials in all patient treatment areas shall be cleanable;

(b) Water treatment area walls and floors shall be designed and constructed to prevent water from migrating to other areas during normal operating conditions; and

(c) All soiled holding room, medical waste storage area, and janitor closet flooring shall be seamless with an integral coved wall base.

(7) Minimum maintenance and housekeeping requirements are as follows:

(a) All building components and equipment shall be maintained in good repair and free from obvious hazards to patients and staff; and

(b) All dialysis equipment shall be maintained in accordance with the manufacturer's recommendations, and each dialysis machine shall be cleaned after each use in accordance with the facility's written policies and procedures.

(8) Minimum mechanical and plumbing requirements are as follows:

(a) All heating, ventilation and cooling systems shall comply with the Oregon Mechanical Specialty Code and shall be maintained in full compliance;

(b) Hot water used for hand washing shall have a water temperature between 105 and 120 degrees Fahrenheit; and

(c) All water treatment and dialysate concentrate equipment and distribution systems shall be in compliance with Association for the Advancement of Medical Instrumentation standards at all times. Floor drain(s) shall also be provided in these area(s):

(A) No dead end loops or unused branches are allowed in the purified water distribution system;

(B) Product water distribution system shall be constructed of materials that do not contribute chemicals, such as aluminum, copper, lead, and zinc or bacterial contaminants to the purified water;

(C) When used, storage tanks shall have a conical or bowl shaped base and shall drain from the lowest point of the base;

(d) If piped-in oxygen or vacuum systems are included, they shall be installed in accordance with chapter 4 of the National Fire Protection Association, NFPA 99 and the Oregon Plumbing Specialty Code;

(e) Dialyzer reuse space, if provided, shall not recirculate air, and shall be provided with an exhaust to the outside as required for the reprocessing methods utilized;

(f) To minimize patient discomfort, heating, cooling and ventilation systems shall be designed to minimize drafts and temperature changes at treatment stations; and

(g) Hand washing stations shall be trimmed with fittings that are operable without use of the hands. Note: wrist blade controls are not considered to be operable without the use of hands.

(9) Minimum electrical requirements are as follows:

(a) All electrical installations shall comply with the Oregon Electrical Specialty Code and shall be maintained in full compliance;

(b) Emergency power for evacuation lighting, the fire alarm system and the dedicated receptacle for the emergency cart shall be provided. Lighting levels at patient stations, staff support stations and paths of egress shall be five-foot candles minimum for a minimum of 90 minutes;

(c) Provisions shall be made to allow connection to an alternate power source. The point of connection shall be immediately accessible to the exterior. The alternate power source shall provide on-going power for the lighting required in subsection (9)(b) of this rule and continued provision of dialysis services;

(d) An independent ground fault interrupter shall be provided for each dialysis machine; and

(e) Hospital-grade electrical outlets shall be provided for all dialysis equipment connections.

(10) Minimum structural, Fire & Life Safety Code and maintenance requirements are as follows:

(a) The facility shall be constructed to comply with the Oregon Structural Specialty Code and shall be maintained in full compliance;

(b) All dialysis treatment spaces shall be located on the ground floor unless the space to be licensed qualifies as a "Business Group B, Ambulatory Care Facility" occupancy class under the Oregon Structural Specialty Code and, if certified by the Centers for Medicare and Medicaid, is certified as an "Ambulatory Health Care Occupancy" under the National Fire Protection Association, NFPA 101 Life Safety Code;

(c) The facility shall not be located adjacent to a "hazardous occupancy" as defined under the Oregon Structural Specialty Code unless the space to be licensed qualifies as a "Business Group B, Ambulatory Care Facility" occupancy class under the Oregon Structural Specialty Code and, if certified by the Centers for Medicare and Medicaid, is certified as an "Ambulatory Health Care Occupancy" under the National Fire Protection Association, NFPA 101 Life Safety Code; and

(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.

Notes

Or. Admin. R. 333-700-0130

PH 7-2003, f. & cert. ef. 6-6-03; PH 13-2005, f. 8-10-05, cert. ef. 8-15-05; PH 4-2012, f. 3-30-12, cert. ef. 4-1-12; PH 3-2015, f. 1-16-15, cert. ef. 2/1/2015; PH 18-2019, repeal filed 10/01/2019, effective 1/1/2020

Statutory/Other Authority: ORS 441.015, 441.025 & 441.060

Statutes/Other Implemented: ORS 441.025 & 441.060