Current through Register Vol. 63, No. 11, November 1, 2024
Section 333-535-0015 - Physical Environment Requirements(1)(a) On and after January 1, 2020, any person proposing to construct a new hospital, or proposing to make certain alterations or additions to an existing hospital, must, before commencing new construction, alterations, or additions, comply with OAR chapter 333, division 675 and these rules.(b) A hospital may choose to comply with these revised standards on or after October 1, 2019.(2) Only the portion of an existing hospital that is being altered or renovated and any impacted ancillary areas required to ensure full functionality of the hospital must meet the requirements in sections (3) through (7) of this rule.(3) An applicant or a licensed hospital must comply with the 2018, Facility Guidelines Institute (FGI), Guidelines for Design and Construction of Hospitals, and the 2018, FGI, Guidelines for Design and Construction of Outpatient Facilities, adopted by reference, including all references to part, subpart, sections, subsections, paragraphs, subparagraphs and appendices except as specified in sections (4) through (7) of this rule. References in FGI to "and/or" mean "or."(4) The following chapters, sections, paragraphs, subparagraphs or appendices of the 2018, FGI, Guidelines for Design and Construction of Hospitals are deleted in their entirety: (a) Subsection A.1.2-2.1.2.1;(b) Subsection 1.2-2.1.2.3;(e) Paragraph (2)(b) in subsection 2.1-2.8.2.1;(f) Subsection 2.1-2.8.10.2;(g) Paragraph (b) in subsection A2.1-7.2.4;(h) Paragraph (2) in subsection A2.1-8.3.3.1;(i) Subsections 2.2-3.1.2 through 2.2-3.1.2.8;(j) Subsection 2.2-3.1.8.17;(k) Paragraph (4) in subsection A2.2-3.3.1.1;(l) Paragraphs (1) and (2) in subsection 2.2-3.10.8.14;(o) Subsection 2.7-3.1.2.(5) The following amendments or additions are made to the 2018, FGI, Guidelines for Design and Construction of Hospitals, as adopted and incorporated by reference. All references to part, subpart, sections, paragraphs, subparagraphs and appendices relate to the 2018, FGI, Guidelines for Design and Construction of Hospitals. (a) Amend section 1.1-2 to read: "New Construction. Project submittal criteria shall comply with OAR 333-675-0000. Projects with any of the following scopes of work shall be considered new construction and shall comply with the requirements in the Guidelines for Design and Construction of Hospitals:"(b) Amend subsection 1.1-3.1.1.2 to read: "Major renovation projects. Project submittal criteria shall comply with OAR 333-675-0000. Projects with either of the following scopes of work shall be considered a major renovation and shall comply with the requirements for new construction in the Guidelines for Design and Construction of Hospitals to the extent possible as determined by the authority having jurisdiction: (1) A series of planned changes and updates to the physical plant of an existing facility. (2) A renovation project that includes modification of an entire building or an entire area in a building to accommodate a new use or occupancy."(c) Amend subsection 1.1-3.1.2.1 to read: "Where major structural elements make total compliance impractical or impossible, exceptions shall be considered in accordance with the Oregon Administrative Rules specific to the physical environment of the type of hospital under consideration."(d) Amend subsection 1.1-3.1.2.2 to read: "Minor renovation or replacement work shall be permitted to be exempted from the requirements in Section 1.1-3.1.1 (Compliance Requirements) provided they meet the criteria specified in OAR 333-675-0000(2) or (3) and do not reduce the level of health and safety in an existing facility."(e) Amend subsection 1.1-3.1.4 to read: "Temporary Waivers. When parts of an existing facility essential to continued overall facility operation cannot comply with particular standards during a renovation project, a temporary waiver of those standards shall be permitted as determined by the authority having jurisdiction if patient care and safety will not be jeopardized as a result. Reference Oregon Administrative Rules specific to the physical environment of the type of hospital under consideration."(f) Amend section 1.1-8 to include the following codes and standards: (A) "ASHRAE 62.1: The Standards for Ventilation and Indoor Air Quality (2016)."(B) "Building Industry Consulting Services International (BICSI) Standards (2018)."(C) "NFPA 50: Standard for Bulk Oxygen Systems at Consumer Sites (2001)."(D) "NFPA 99: Health Care Facilities Code (2012 as adopted by CMS)."(E) "NFPA 101: Life Safety Code (2012 as adopted by CMS)."(g) Amend paragraph (a) in subsection A1.2-2.1.1 to read: "(a) All projects, large and small, require a functional program to guide the design. The length and complexity of the functional program will vary greatly depending on project scope."(h) Amend subsection 1.2-2.1.2.1 to read: "The governing body shall be responsible for having a functional program developed, documented, and updated. The governing body may delegate documentation of the functional program to consultants with subject matter expertise. The governing body shall review and approve the functional program."(i) Add subsection 1.2-2.2.7.4 to read: "A description of the following: (a) Special design feature(s);(b) Occupant load, numbers of staff, patients, visitors and vendors;(c) Issue of privacy/confidentiality for patient;(d) In treatment areas, describe: (B) Design considerations for equipment;(C) Requirements where the circulation patterns are a function of asepsis control; and(D) Highest level of sedation, if applicable."(j) Amend subsection 1.2-4.1.1.2 to read: "To support this goal, an interdisciplinary team shall develop a safety risk assessment (SRA). A copy of the SRA shall accompany instruction documents submitted to the Oregon Health Authority, Facility Planning and Safety program."(k) Add paragraphs (1) through (4) and amend subsection 1.2-4.6.1 to read: "Behavioral and Mental Health Elements of the Safety Risk Assessment. The SRA report shall identify areas where patients at risk of mental health injury and suicide will be served. Elements of the assessment shall include but not be limited to: (1) A statement explaining the psychiatric population groups served;(2) A discussion of the capability for staff visual supervision of patient ancillary areas and corridors;(3) A discussion of the risks to patients, including self-injury, and the project solutions employed to minimize such risks; and(4) A discussion of building features and equipment, including items which may be used as weapons, that is intended to minimize risks to patients, staff and visitors."(l) Amend paragraph (d) in subsection A1.2-5.4.5 to read: "(d) In facilities with multi-bed rooms, family consultation rooms or grieving rooms, in addition to family lounges, should be provided to permit patients and families to communicate privately."(m) Amend paragraph (2)(a) in subsection 2.1-2.8.2.1 to read: "(a) At least one hand-washing station shall be provided within 20 feet and not through a door. See section 2.1-7.2.2.8 (Hand-washing stations) for requirement."(n) Amend paragraph (1) in subsection 2.1-2.8.7.3 to read: "(1) At least one hand-washing station shall be provided for every four patient care stations or fewer."(o) Amend subsection 2.1-2.8.10.1 to read: "Ice-making equipment shall be of the self-dispensing type."(p) Amend paragraph (1) in subsection 2.1-2.8.12.3 to read: "(1) Hand-washing station."(q) Amend subsection 2.1-4.2.8.7 to read: "A hand-washing station(s) shall be provided within each separate room where open medication is prepared for administration except where prohibited by OAR chapter 855, division 045; USP 797 or USP 800. Where a hand-wash station is prohibited in the compounding room, a hand-wash station(s) shall be provided in an anteroom."(r) Add paragraph (5) to subsection 2.1-4.3.1.3 to read: "(5) All offered dietary services shall comply with Oregon Health Authority Food Sanitation Rules, chapter 333, division 150 and other authorities having jurisdiction."(s) Add subparagraphs (2)(a) through (c) in subsection 2.1-5.2.2.2 to read: "(a) Washers/extractors. Washers/extractors shall be located between the soiled linen receiving and clean process areas. Washers/extractors shall provide a temperature of at least 160 degrees Fahrenheit for a minimum of 25 minutes or include use of a chemical disinfectant; (b) Dryers; (c) Supply storage. Storage shall be provided for laundry supplies."(t) In subsection 2.1-5.4.1.3:(A) Add subparagraphs (1)(a)(i) and (ii) to read: "(i) Wall base shall be integral and coved with the floor, tightly sealed to the wall, and constructed without voids that can harbor insects. (ii) Shall have hand sanitation dispenser in or adjacent to interior regulated waste storage spaces."(B) Amend subparagraph (2)(a) to read: "(a) Illumination per Illuminating Engineering Society of North America (IES) standards."(C) Add paragraph (4) to read: "(4) Regulated waste management shall be in accordance with the requirements of OAR chapter 333, division 056."(u) Amend subsection 2.1-6.2.7.1 to read: "Storage. A designated area located out of the required corridor width and directly accessible to the entrance shall be provided for storage of at least one wheelchair."(v) Add paragraph (4) to subsection 2.1-7.2.2.11 to read: "(4) All imaging facilities and radiation producing equipment installations must comply with OAR chapter 333, divisions 100 through 123, and be licensed by the Oregon Health Authority, Radiation Protection Services program."(w) Add subsection 2.1-7.2.2.15 to read: "Work Surfaces: Work Areas. Where a work space, work area, work counter, or work surface is provided, it shall have a minimum of 4 square feet (.37 square meter) of contiguous clear surface for each person programmed to work in the space at the same time. A mobile cart meeting these requirements shall be permitted."(x) Add subparagraphs (xi) through (xvi) to subparagraph (7)(a) in subsection 2.1-7.2.3.1 to read: "(xi) Bathing and toilet rooms. (xii) Soiled workrooms and soiled hold rooms. (xiii) Environmental services rooms. (xiv) Pharmacy clean and anterooms. (xv) Emergency department trauma rooms. (xvi) Emergency department exam/treatment rooms."(y) Amend paragraph (2) in subsection 2.1-8.3.3.1 to read: "Stored fuel is required and storage capacity shall permit continuous operation for at least 96 hours. An Extended Stay Center shall provide fuel for emergency power to meet longest expected patient stay."(z) Amend subsection 2.1-8.3.5.2 to read: "Electronic health record system servers and centralized storage. This equipment shall be provided with an uninterruptible power supply and connected to the essential electrical system."(aa) Amend paragraph (2) in subsection 2.1-8.4.2.5 to read: "(2) Heated potable water distribution system serving patient care areas shall be under constant recirculation to provide continuous hot water at each hot water outlet and shall meet the standards specified in Table A2.1-a."(bb) In subsection 2.1-8.4.2.6:(A) Amend subparagraph (1)(a) to read: "(a) Where sanitary or storm drainage piping is installed above the ceiling of, or exposed in, operating and delivery rooms, procedure rooms, trauma rooms, nurseries, central kitchens, sterile processing facilities, Class 2 and 3 imaging rooms, electronic mainframe rooms (TSERs and TECs), main switchgear and electrical rooms, electronic data processing areas, or electric closets, the piping shall have special provisions (e.g., double wall containment piping or oversized drip pans) to protect the space below from leakage and condensation."(B) Add subparagraph (1)(c) to read: "(c) FM 1680 compliant no-hub couplings shall be acceptable in lieu of standards specified in paragraphs (a) and (b)."(cc) Add subparagraph (2)(c)(v) in subsection 2.2-2.2.4.6 to read: "(v) Hidden alcoves are prohibited."(dd) Amend paragraph (3) in subsection 2.2-3.1.3.3 to read: "(3) The triage area, room or bay shall be a minimum of 80 square feet and shall include the following:"(ee) Amend subsection 2.2-3.1.4.3 to read: "Secure holding room. If psychiatric services are provided, a secure holding room shall be provided and it shall meet the following requirements. (1) The location of the secure holding room(s) shall facilitate staff observation and monitoring of patients in these areas.(2) The secure holding room shall have a minimum clear floor area of 60 square feet (5.57 square meters) with a minimum wall length of 7 feet (2.13 meters) and a maximum wall length of 11 feet (3.35 meters).(3) This room shall be designed to prevent injury to patients. (a) All finishes, light fixtures, vents and diffusers, and sprinklers shall be impact-, tamper-, and ligature-resistant.(b) There shall not be any electrical outlets, medical gas outlets, or similar devices.(c) There shall be no sharp corners, edges, or protrusions, and the walls shall be free of objects or accessories of any kind.(d) Patient room doors shall swing out and shall have hardware on the exterior side only.(e) A small impact-resistant view panel or window shall be provided in the door for discreet staff observation of the patient.(4) Door openings shall be provided in accordance with Section 2.1-7.2.2.3 (2)(a)(i) (Door openings-Minimum for patient rooms and diagnostic and treatment areas...)."(ff) Amend paragraph (4) in subsection 2.2-3.1.8.2 to read: "(4) Visual observation of all traffic into and within the unit shall be provided from the nurse station through direct or indirect visual observation."(gg) Amend subsection 2.2-3.1.8.12 to read: "A soiled workroom(s) shall be provided for the exclusive use of the emergency department in accordance with Section 2.1-2.8.12 (Soiled Workroom or Soiled Holding Room)."(hh) Amend paragraph (4) in subsection 2.2-3.2.8.2 to read: "(4) Soiled workroom. A soiled workroom shall be provided in accordance with Section 2.1-2.8.12 (Soiled Workroom or Soiled Holding Room)."(ii) Add subparagraphs (4)(a) through (c) to subsection 2.2-3.3.1.1 to read: "(a) Unrestricted area: Any area of the surgery department that is not defined as semi-restricted or restricted. These areas shall include a central control point for designated personnel to monitor the entrance of patients, personnel, and materials into the semi-restricted areas; staff changing areas; a staff lounge; offices; waiting rooms or areas; pre- and postoperative patient care areas; and access to procedure rooms (e.g., endoscopy procedure rooms, laser treatment rooms). Street clothes are permitted in these areas. Public access to unrestricted areas may be limited based on the facility's policy and procedures. (b) Semi-restricted area: Peripheral areas that support surgical services. These areas shall include storage for equipment and clean and sterile supplies; work areas for processing instruments; sterile processing facilities; hand scrub stations; corridors leading from the unrestricted area to the restricted area of the surgical suite; and entrances to staff changing areas, pre- and postoperative patient care areas, and sterile processing facilities. The semi-restricted area of the surgical suite is entered directly from the unrestricted area past a nurse station or from other areas. Semi-restricted areas have specific HVAC design requirements associated with the intended use of the space (see Part 3: ANSI/ASHRAE/ASHE 170: Ventilation of Health Care Facilities). Personnel in the semi-restricted area shall wear surgical attire and cover all head and facial hair. Access to the semi-restricted area shall be limited to authorized personnel and patients accompanied by authorized personnel. (c) Restricted area: A designated space contained within the semi-restricted area and accessible only through a semi-restricted area. The restricted area includes operating and other rooms in which operative or other invasive procedures are performed. Restricted areas have specific HVAC design requirements associated with the intended use of the space (see Part 3: ASHRAE/ASHE 170). Personnel in the restricted area shall wear surgical attire and cover head and facial hair. Masks shall be worn when the wearer is in the presence of open sterile supplies or of persons who are completing or have completed a surgical hand scrub. Only authorized personnel and patients accompanied by authorized personnel shall be admitted to this area."(jj) In subsection 2.2-3.3.10.3: (A) Amend paragraph (1) to read: "(1) A changing area that includes the following shall be provided for patients. (a) Toilet(s); (b) Space for changing or gowning."(B) Add paragraph (3) to read: "(3) Individual, lockable storage shall be provided for patients' belongings."(kk) Add subparagraph (1)(c)(i) to subsection 2.2-3.4.1.3 to read: "(i) A minimum of 1 foot 6 inches between the view window and the outside partition edge shall be provided."(ll) Amend paragraph (2) in subsection 2.2-3.5.8.15 to read: "(2) Each examination room shall be equipped with a hand-washing station and a work counter."(mm) Amend subsection 2.2-3.10.2.4 to read: "Patient privacy. Space shall be available to accommodate provisions for patient privacy including when patients are examined or treated and body exposure is required. Privacy must be provided for the use of a bedpan or commode during dialysis, initiating and discontinuing treatment when the vascular access is placed in an intimate area, for physical exams, and for sensitive communications. There should be sufficient numbers of privacy screens or other methods of visual separation available and used to afford patients full visual privacy when indicated."(nn) Add subparagraphs (1)(a) and (b) to subsection 2.2-3.10.2.5 to read: "(a) Wrist blade controls are not considered to be operable without the use of the hands. (b) Exception: Home training room hand-wash stations may be trimmed with residential style, ADA compatible controls."(oo) Add subsection 2.2-3.10.2.6 to read: "Body Fluid Disposal Sink. A fluid disposal sink shall be provided in each hemodialysis treatment area or room. Sink design including signage and location shall be constructed to prevent cross-contamination of the hand washing station."(pp) Add subsection 2.2-3.10.2.7 to read: "Emergency Equipment. Emergency cart and equipment storage located close to the patient treatment area, readily accessible by staff, and not located in an exit path." (qq) In subsection 2.2-3.10.3.2: (A) Amend paragraph (3) to read: "(3) Separate sink with identifying signage that it is for fluid disposal."(B) Add paragraph (4) to read: "(4) Emergency nurse call."(rr) Amend reference to subsections 2.2-3.10.4 - 2.2.3.10.7 to read: (A) "2.2-3.10.4 Special Patient Care Rooms."(B) "2.2-3.10.4.1 Isolation Room."(C) "2.2-3.10.4.1.1 An isolation room shall be provided for Hepatitis B positive (HBV+) patients to prevent contact transmission of HBV+ blood spills and other body fluids. The isolation room shall meet the following requirements: (1) Provides a door and walls that go to the floor, but not necessarily the ceiling, and allows for visual monitoring of the patient;(2) Accommodates only one patient;(3) A hand washing station; and(4) A separate sink shall be provided within the isolation room for fluid disposal. Sink design including signage and location shall be constructed to prevent cross-contamination of the hand washing station."(D) "2.2-3.10.4.1.2 The isolation room shall have a minimum clear floor area of 120 square feet."(E) "2.2-3.10.4.1.3 The isolation room shall allow for direct observation of the patient by staff from a patient care staff station. Direct observation must include patient face and insertion point."(F) "2.2-3.10.5 - 2.2-3.10.7 Reserved".(ss) Amend paragraph (2) in subsection 2.2-3.10.8.2 to read: "(2) The nurse station(s) shall be no higher than 3 feet 8 inches and be designed to provide direct visual observation of all individual dialysis treatment bays. Direct observation must include patient face and insertion point."(tt) Amend subsection 2.2-3.10.8.12 to read: "Soiled holding room. A soiled holding room shall be provided in accordance with Section 2.1-2.8.12 (Soiled Workroom or Soiled Holding Room)."(uu) Amend subsection 2.2-3.10.8.14 to read: "An environmental services room shall be provided that meets the requirements in Section 2.1-2.8.14 (Environmental Services Room)."(vv) Amend subsection 2.2-3.10.8.19 to read: "An equipment repair and breakdown room shall be provided, and be equipped with the following: (1) Hand-washing station;(2) Treated water outlet for equipment maintenance and drain or clinical service sink for equipment connection and testing;(ww) Amend subparagraph (1)(a) in subsection 2.2-3.11.10.3 to read: "(a) Patient changing areas. Provisions for storing patients' belongings. Individual, lockable storage shall be provided."(xx) Amend subparagraph (1)(c) in subsection 2.2-3.13.10.3 to read: "(c) Provisions for hanging patients' clothing and individual, lockable storage for securing valuables."(yy) Amend paragraph (1) in subsection 2.5-2.2.2.6 to read: "(1) Each patient shall have access to a toilet room without having to enter a corridor."(zz) Amend subsection 2.5-2.3.2.1 to read: "Capacity. (1) The maximum number of beds per room shall be one unless the necessity of a two-bed arrangement has been demonstrated. Two beds per room shall be permitted where approved by the authority having jurisdiction.(2) Where renovation work is undertaken and the present capacity is more than one bed, the maximum room capacity shall be two beds."(aaa) Amend subsection 2.5-2.3.2.3 to read: "Patient toilet room.(1) Each patient shall have direct access to a toilet room.(2) One toilet room shall serve no more than two patient bedrooms and no more than four patients.(3) The toilet room shall contain a toilet and a hand-washing station.(4) Toilet room doors: (a) Where indicated by the safety risk assessment, toilet room doors shall be equipped with keyed locks that allow staff to control access to the toilet room.(b) Where a swinging door is used, the door to the toilet room shall swing outward or be double-acting."(bbb) Amend subsection 2.5-2.3.4 to read: "Outdoor Areas. An outdoor activity area shall be provided with a minimum of 50 square feet per patient but not less than 400 total square feet, see Section 2.5-2.2.3 (General Psychiatric Patient Care Unit-Outdoor Areas) for requirements."(ccc) Amend paragraph (1) in subsection 2.6-2.2.8.1 to read: "(1) The support areas noted shall be provided in or readily accessible to each patient care unit and meet the requirements in Section 2.2-2.2.8 (Support Areas for Medical/Surgical Patient Care Units) as amended in this section."(ddd) Amend subsection 2.7-3.1.3.1 to read: "Children's hospitals shall have facilities for the services they provide that meet the requirements in Section 2.2-3.1.3 (Emergency Department) as amended by the children's hospitals-specific emergency department requirements in this section."(eee) Amend subsection 2.7-3.1.3.6 to read: "Treatment room. Treatment rooms shall meet the requirements in Section 2.2-3.1.3.6(5) (Pediatric treatment rooms)."(fff) Amend subsection 2.8-1.3.7.4 to read: "Applicable local and state requirements. All imaging facilities and radiation producing equipment installations must comply with OAR chapter 333, divisions 100 through 123, and be licensed by the Oregon Health Authority, Radiation Protection Services program."(6) The following chapters, sections, paragraphs, subparagraphs or appendices of the 2018, FGI, Guidelines for Design and Construction of Outpatient Facilities are deleted in their entirety: (a) Subsection A1.2-2.1.2.1;(b) Subsection 1.2-2.1.2.3;(e) Paragraph (b) in subsection A2.1-3.6;(f) Subsection 2.1-3.8.10.2;(g) Paragraph (7) in subsection A2.1-7.2.2.8;(h) Subsection 2.4-6.2.2 through A2.4-6.2.3;(i) Subsection A2.7-3.1.1.4;(j) Subsection A2.10-3.4.1;(7) The following amendments or additions are made to the 2018, FGI, Guidelines for Design and Construction of Outpatient Facilities, as adopted and incorporated by reference. All references to part, subpart, sections, paragraphs, subparagraphs and appendices relate to the 2018, FGI, Guidelines for Design and Construction of Outpatient Facilities. (a) Amend section 1.1-2 to read: "Project submittal criteria shall comply with OAR 333-675-0000. Projects with any of the following scopes of work shall be considered new construction and shall comply with the requirements in the Guidelines for Design and Construction of Outpatient Facilities:"(b) Amend subsection 1.1-3.1.1.2 to read: "Major renovation projects. Project submittal criteria shall comply with OAR 333-675-0000. Projects with either of the following scopes of work shall be considered a major renovation and shall comply with the requirements for new construction in the Guidelines for Design and Construction of Outpatient Facilities to the extent possible as determined by the authority having jurisdiction:(1) A series of planned changes and updates to the physical plant of an existing facility,(2) A renovation project that includes modification of an entire building or an entire area in a building to accommodate a new use or occupancy."(c) Amend subsection 1.1-3.1.2.1 to read: "Where major structural elements make total compliance impractical or impossible, exceptions shall be considered in accordance with the Oregon Administrative Rules specific to the physical environment of the type of health care facility under consideration."(d) Amend subsection 1.1-3.1.2.2 to read: "Minor renovation or replacement work shall be permitted to be exempted from the requirements in Section 1.1-3.1.1 (Compliance Requirements) provided they meet the criteria specified in OAR 333-675-0000(2) or (3) and do not reduce the level of health and safety in an existing facility."(e) Amend paragraph (a) in subsection A1.2-2.1.1 to read: "(a) All projects, large and small, require a functional program to guide the design. The length and complexity of the functional program will vary greatly depending on project scope."(f) Amend subsection 1.2-2.1.2.1 to read: "The governing body shall be responsible for having a functional program developed, documented, and updated. The governing body may delegate documentation of the functional program to consultants with subject matter expertise. The governing body shall review and approve the functional program."(g) Add new subsection 1.2-2.2.7.4 to read: "A description of the following: (a) Special design feature(s);(b) Occupant load, numbers of staff, patients, visitors and vendors;(c) Issue of privacy/confidentiality for patient;(d) In treatment areas, describe: (B) Design considerations for equipment;(C) Requirements where the circulation patterns are a function of asepsis control; and(D) Highest level of sedation, if applicable;(e) For Outpatient Surgery facilities, the functional program must also describe: (A) Level of medical gas system per NFPA 99; and(B) Type of central electrical system."(h) Amend subsection 1.2-4.1.1.2 to read: "To support this goal, an interdisciplinary team shall develop a safety risk assessment (SRA). A copy of the SRA shall accompany construction documents submitted to the Oregon Health Authority, Facility Planning and Safety program."(i) Add paragraphs (1) through (4) and amend subsection 1.2-4.6.1 to read: "Behavioral and Mental Health Elements of the Safety Risk Assessment. The SRA report shall identify areas where patients at risk of mental health injury and suicide will be served. Elements of the assessment shall include but are not limited to: (1) A statement explaining the psychiatric population groups served;(2) A discussion of the capability for staff visual supervision of patient ancillary areas and corridors;(3) A discussion of the risks to patients, including self-injury, and the project solutions employed to minimize such risks; and(4) A discussion of building features and equipment, including items which may be used as weapons, that is intended to minimize risks to patients, staff and visitors."(j) Add subparagraph (3)(f) to subsection 2.1-3.2.1.2 to read: "(f) Work counter that complies with 2.1-7.2.2.15 (Work Surfaces)."(k) Add paragraph (4) to subsection 2.1-3.2.2.7 to read: "(4) Provision for in-room storage of supplies and equipment used in procedure room. May be fixed cabinets or movable cart(s)."(l) Amend paragraph (12) in subsection 2.1-3.2.2.8 to read: "(12) Soiled holding. A dedicated soiled hold room or space for holding soiled materials shall be provided that is separate from the clean storage area."(m) Amend paragraph (4) in subsection 2.1-3.2.2.10 to read: "(4) Storage for patients' belongings. Provisions shall be made for securing patients' personal effects during procedures. Individual, lockable storage shall be provided."(n) Amend subsection 2.1-3.2.3.8: (A) Subparagraph (1)(b) to read: "(b) Sharing of these support areas with other clinical services in the facility shall be permitted. An ambulatory surgical center (ASC) that is Medicare-certified must be distinct from any other health care facility or office-based physician practice as required in 42 CFR 416.2 and 42 CFR 416.44(a)(2) and (b)"; and(B) Paragraph (12) to read: "(12) Soiled workroom meeting requirements in 2.1-3.8.12. A room for holding soiled material shall be provided that is separate from the clean storage area."(o) Amend paragraph (4) in subsection 2.1-3.2.3.10 to read: "(4) Storage for patients' belongings. Provisions shall be made for securing patients' personal effects during surgery. Individual, lockable storage shall be provided."(p) Amend 2.1-3.5.1.3 subparagraph (1)(c) to read: "(c) Shielded view window. The control alcove or room shall include a shielded view window designed to provide a full view of the examination/procedure table and the patient at all times, including a full view of the patient during imaging activities (e.g., when the table is tilted or the chest X-ray is in use). Where protected alcoves with view windows are required, a minimum of 1 foot 6 inches between the view window and the outside partition edge shall be provided."(q) Amend paragraph (3) in subsection 2.1-3.5.2.1 to read: "(3) Where imaging procedures meeting Class 3 criteria are performed, a room(s) that meets the requirements for the applicable imaging suite and for an operating room (see Section 2.1-3.2.3) shall be provided. These imaging rooms shall comply with the following: (a) Be sized to accommodate the personnel and equipment planned to be in the room during procedures.(b) Have a minimum clear floor area of 600 square feet (55.74 square meters) with a minimum clear dimension of 20 feet (6.10 meters).(c) Where renovation work is undertaken and it is not possible to meet the above minimum standards, these rooms shall have a minimum clear floor area of 500 square feet (46.50 square meters) with a minimum clear dimension of 20 feet (6.10 meters).(d) Fixed encroachments into the minimum clear floor area. Fixed encroachments shall be permitted to be included when determining the minimum clear floor area for an operating room as long as: (i) There are no encroachments into the sterile field.(ii) The encroachments do not extend more than 12 inches (30.5 centimeters) into the minimum clear floor area outside the sterile field.(iii) The encroachment width along each wall does not exceed 10 percent of the length of that wall."(r) Add paragraph (5) to subsection 2.1-3.5.4.4 to read: "(5) Where patients change in the mammography room, privacy shall be provided."(s) Add new subsection 2.1-3.6.2.4 to read: "Hybrid imaging/therapy systems. Where external beam radiation therapy systems are combined with a concurrent imaging option (e.g., CT or MRI), the full design criteria for both contributing imaging/therapy devices shall be applied to the hybrid service."(t) Amend subsection A2.1-3.6.8.16 to read: "Other support areas for radiation therapy. In addition to the optional support areas in the main text, the following support areas may be needed to support radiation therapy services: (a) Dosimetry equipment area or storage for calibration phantoms.(b) Workstation/nutrition station."(u) Add new subsection 2.1-3.6.8.17 to read: "Additional Support Areas. (1) Control room or area: (a) All external beam radiation therapy treatment and simulator rooms shall have a control room or area.(b) Control room shall have visual and audio contact with patient in the treatment room. Visual contact may be direct or by video link.(2) Treatment planning and record room, if provided, shall be sized to meet manufacturers' dosimetry system requirements.(3) Consultation room shall be provided for radiation therapy suite."(v) Amend subsection 2.1-3.8.2.5 to read: "Hand-wash station shall be provided within 20 feet, not through a door. See section 2.1-7.2.2.8 (Hand-washing stations) for requirements."(w) Amend paragraph (1) in subsection 2.1-3.8.7.3 to read: "(1) At least one hand-washing station shall be provided for every four patient care stations or fewer."(x) Amend subsection 2.1-3.8.10.1 to read: "Ice-making equipment shall be of the self-dispensing type."(y) Amend paragraph (1) in subsection 2.1-3.8.12.3 to read: "(1) Hand-washing station."(z) Amend paragraph (2) in subsection 2.1-4.1.2.3 to read: "(2) Additional hand-washing stations shall be provided within 20 feet of each workstation where specimens or reagents are handled."(aa) Add paragraph (2) in subsection 2.1-4.1.8.1 to read: "(2) Refrigeration for storage of reagents, controls and patient specimens as necessary."(bb) Amend subsection 2.1-4.2.8.7 to read: "A hand-washing station(s) shall be provided within each separate room where open medication is prepared for administration except where prohibited by OAR chapter 855, division 045; USP797 or USP 800. Where a hand-wash station is prohibited in the compounding room, a hand-wash station(s) shall be provided in an anteroom."(cc) Amend paragraph (2) in subsection 2.1-4.3.2.4 to read: "(2) Clean/sterile medical/surgical supply receiving room or area. A room or area shall be provided for receiving/unpacking clean/sterile supplies received from outside the department or facility. This room or area may not be located inside clean storage."(dd) Amend paragraph (1) in subsection 2.1-4.4.2.1 to read: "(1) This area shall be large enough to accommodate the following:(a) Washer/extractor(s). Washers/extractors shall provide a temperature of at least 160 degrees Fahrenheit for a minimum of 25 minutes or include use of a chemical disinfectant.(c) Supply storage. Storage shall be provided for laundry supplies.(d) Any plumbing equipment needed to meet the temperature requirements in Section 2.1-8.4.2.5(4) (Water temperature)."(ee) Add subparagraphs (1)(b) through (1)(e) in subsection 2.1-5.2.1.3 to read: "(b) Wall base shall be integral and coved with the floor, tightly sealed to the wall, and constructed without voids that can harbor insects. (c) The regulated waste storage spaces shall have lighting and exhaust ventilation, be safe from weather, animals and unauthorized entry. (d) Regulated waste management shall be in accordance with the requirements of OAR chapter 333, division 056. (e) Refrigeration requirements for such holding facilities, if provided, shall comply with local and state regulations."(ff) Amend subsection 2.1-5.3.1.2 to read: "Environmental services room provisions. Environmental services room shall be a minimum of 35 square feet. Each environmental services room shall be provided with the following: (1) Service sink or floor-mounted mop sink;(2)* Provisions for storage of supplies and housekeeping equipment;(3) Hand-washing station or hand sanitation dispenser."(gg) Amend paragraph (2) in subsection 2.1-7.2.2.1 to read: "(2) Corridors used for stretcher and gurney transport shall have a minimum corridor or aisle width of 6 feet (1.83 meters). This requirement is not applicable to birth centers (see 2.4-7.2.1.1) or renal dialysis centers (see 2.10-3.2.1.5)."(hh) In subsection 2.1-7.2.2.8: (A) Amend subparagraph (1)(b) to read: "(b) The number and placement of hand sanitation dispensers shall be determined by an ICRA."(B) Add paragraph (8) to read: "(8) Mirrors are not permitted at scrub, clinical or other staff use hand-wash stations, with the exception of staff toilets."(ii) Add paragraph (4) in section subsection 2.1-7.2.2.11 to read: "(4) All imaging facilities and radiation producing equipment installations must comply with OAR chapter 333, divisions 100 through 123, and be licensed by the Oregon Health Authority, Radiation Protection Services program."(jj) Add subsection 2.1-7.2.2.15 to read: "Work Surfaces. Work areas. Where a work space, work area, work counter, or work surface is provided, it shall have a minimum of 4 square feet (.37 square meter) of contiguous clear surface for each person programmed to work in the space at the same time. A mobile cart meeting these requirements shall be permitted."(kk) Add subparagraphs (6)(a)(ix) through (xii) in subsection 2.1-7.2.3.1 to read: "(ix) Protective environment rooms; (x) Bathing and toilet rooms; (xi) Soiled workrooms and soiled hold rooms; (xii) Environmental services room; (xiii) Pharmacy clean and anterooms."(ll) Add subparagraph (1)(c)(ix) in subsection 2.1-7.2.3.2 to read: "(ix) Bathing and toilet rooms."(mm) Add paragraph (4) in subsection 2.1-8.2.1.2 to read: "(4) Extended Stay Centers".(nn) Amend subsection 2.1-8.7.1 and add paragraph (2) to read: "(1) Where an outpatient facility is located on more than one floor or on a floor other than an entrance floor at grade level, at least one elevator shall be provided. (2) Installation and testing of elevators shall comply with the Oregon Elevator Code."(oo) Add subsection A2.1-8.7.1 to read: "Consideration should be given to dedicating and separating elevator types by function, such as those for the public, patients, staff, and materials (for example, clean versus soiled flows), as the diverse uses affect both operational efficiency and cross-contamination and infection control issues."(pp) Amend subsection 2.1-8.7.5.1 and add paragraph (2) to read: "(1) Elevator call buttons and controls shall not be activated by heat or smoke. (2) Each elevator, except those for material handling, shall be equipped with an independent keyed switch for staff use for bypassing all landing button calls and responding to car button calls only."(qq) Amend section 2.2-3.8.11.3 to read: "A clean workroom may be shared with other clinical services in the same building, in accordance with state and federal regulations."(rr) Amend subsection 2.2-3.10.2.2 to read: "This patient toilet room shall be permitted to serve waiting areas in clinics with five or fewer examination rooms."(ss) Amend paragraph (1) to subsection 2.2-4.3.3.1 to read: "(1) Provision of an area instead of a room shall be permitted to meet the requirements in sections 2.1-4.3.3.1 (A room for breakdown...) and 2.1-4.3.3.2 (A room for on-site storage...). Breakdown area may not be located in clean workroom or clean storage."(tt) Amend subsection 2.2-5.2.3 to read: "Location of storage for hazardous waste (red bag trash) and sharps shall be behind a closed door. An exam room shall not be used for cumulated storage of hazardous waste and sharps."(uu) Amend subsection 2.4-1.2 to read: "Functional Program. See section 1.2-2 and 2.1-1.2 (Functional Program) for requirements."(vv) Amend subsection 2.4-2.2.4 to read: "Privacy. Windows or doors within a normal sightline that would permit observation into the room shall be designed for mother and newborn privacy. See 2.1-3.1.2 (Patient Privacy) for additional requirements."(ww) Amend subsection 2.4-2.2.6 to read: "Bathrooms. Each birthing room shall have direct access to a private bathroom that meets the requirements in 2.1-3.10.2 (Patient Toilet Room(s)) and includes the following:"(xx) Amend subsection 2.4-2.2.6.1 to read: "Hand-washing station. See Section 2.1-7.2.2.8 (Hand-washing stations) and Section 2.1-8.4.3.2 (Hand-washing station sinks) for requirements."(yy) Amend subsection 2.4-2.2.6.3 to read: "Shower or tub. See Section 2.1-8.4.3.3 (Showers and tubs) for requirements."(zz) Add subsection 2.4-2.2.7 to read: "Documentation and Charting. Accommodations for written or electronic documentation shall be provided in the birthing room or at a nurse station. See Section 2.1-3.8.3 (Documentation Area) for requirements."(aaa) Amend subsection 2.4-2.8.7 to read: "Hand-Washing Stations. Hand-washing stations shall be located in, next to, or directly accessible to staff work area(s) and not through a door."(bbb) Amend subsection 2.4-2.8.10.2 to read: "Ice shall be served from self-dispensing ice-makers."(ccc) Amend subsection 2.4-2.8.11 to read: "Clean Workroom or Clean Work Area. A clean work area or clean workroom shall be provided in accordance with Section 2.1-3.8.11 (Clean Workroom or Clean Supply Room)."(ddd) Amend subsection 2.4-2.8.13.4 to read: "Emergency equipment storage. See Section 2.1-3.8.13.4 (Emergency equipment storage) for requirements."(eee) Amend subsection 2.4-2.8.14 to read: "Environmental Services Room. An environmental services room that meets the requirements in Section 2.1-5.3.1.2 (Environmental services room provisions) shall be provided for the exclusive use of the birth center."(fff) Amend reference to subsections 2.4-4.1 - 2.4-4.3 to read: "2.4-4.1 - 2.4-4.2 Reserved".(ggg) Add subsection 2.4-4.3 to read: "Sterile Processing".(hhh) Add subsection 2.4-4.3.1 to read: "Facilities for On-Site Sterile Processing. Where sterile processing is performed on-site, see Section 2.1-4.3 (Sterile Processing) for requirements."(iii) Add subsection 2.4-4.3.2 to read: "Support Areas for Birthing Centers Using Off-Site Sterile Processing. For Birthing Centers where sterile processing services are provided off-site, see Section 2.1-4.3.3 (Support Areas for Outpatient Facilities Using Off-Site Sterile Processing) for requirements."(jjj) Add paragraph (3) in subsection 2.4-4.5.2.1 to read: "(3) Shall meet the requirements of the Oregon Food Sanitation Rules OAR 333-150-0000."(kkk) Amend subsection 2.4-6.2 to read: "Public Areas. Public areas shall be provided in accordance with Section 2.1-6.2 (Public Areas)."(lll) Amend subsection 2.4-7.1 to read: "Building Codes. The birth center shall be permitted to fall under the business occupancy provisions of applicable life safety and building codes. Building design and construction shall comply with local, state, and federal guidelines."(mmm) Amend subsection 2.4-7.2 to read: "Architectural Details and Surfaces. See Section 2.1-7.2 (Architectural Details, Surfaces, and furnishings) for requirements."(nnn) Amend section 2.4-8 to read: "Building Systems. See Section 2.1-8 (Building Systems) for requirements."(ooo) Amend subsection 2.4-8.3.1 to read: "Lighting. (1) The birthing room shall provide lighting capable of providing at least 70 foot-candles in the delivery and newborn care area(s). (2) Exam light(s) shall be provided for each birthing room."(ppp) Amend subsection 2.4-8.7 to read: "Elevators. Where elevators are provided, elevator cars shall have minimum inside dimensions of 5 feet 8 inches (1.73 meters) wide by 7 feet 6 inches (2.29 meters) deep. Installation and testing of elevators shall comply with the Oregon Elevator Code."(qqq) Amend paragraph (1) in subsection 2.5-3.2.3.1 to read: "(1) A dedicated triage space. The triage space or bay shall be a minimum 80 square feet."(rrr) Amend subsection 2.5-3.2.3.3 to read: "Hand-washing station. The triage area(s) shall be directly accessible to a hand-washing station(s) that complies with Section 2.1-3.8.7 (Hand-Washing Station). Hand-wash stations shall be provided in each triage room if rooms are provided."(sss) Amend subsection 2.7-1.2.3 and add paragraph (2) to read: "Shared Services. (1) If the outpatient surgery facility is part of an acute care hospital or other medical facility, services shall be permitted to be shared to minimize duplication as acceptable to authorities having jurisdiction.(2) If the facility is an ASC: An ASC is a distinct entity and must be separate and distinguishable from any other health care facility or office-based physician practice. Medicare-certified ASCs are subject to specific requirements related to sharing spaces with another health care facility or office-based physician practice. An ASC that is Medicare-certified must be distinct from any other health care facility or office-based physician practice as required in 42 CFR 416.2 and 42 CFR 416.44(a)(2) and (b)."(ttt) Add subsection 2.7-3.1.1.5 to read: "Areas in the outpatient surgery facility. (1) Unrestricted area: Any area of the surgery facility that is not defined as semi-restricted or restricted. These areas shall include a central control point for designated personnel to monitor the entrance of patients, personnel, and materials into the semi-restricted areas; staff changing areas; a staff lounge; offices; waiting rooms or areas; pre- and postoperative patient care areas; and access to procedure rooms (e.g., endoscopy procedure rooms, laser treatment rooms). Street clothes are permitted in these areas. Public access to unrestricted areas may be limited based on the facility's policy and procedures.(2) Semi-restricted area: Peripheral areas that support surgical services. These areas shall include storage for equipment and clean and sterile supplies; work areas for processing instruments; sterile processing facilities (if on-site sterile processing is provided); hand scrub stations; corridors leading from the unrestricted area to the restricted area; and entrances to staff changing areas, pre- and postoperative patient care areas, and sterile processing facilities. The semi-restricted area is entered directly from the unrestricted area past a nurse station or from other areas. Semi-restricted areas have specific HVAC design requirements associated with the intended use of the space (see Part 3: ANSI/ASHRAE/ASHE 170: Ventilation of Health Care Facilities). Personnel in the semi-restricted area shall wear surgical attire and cover all head and facial hair. Access to the semi-restricted area shall be limited to authorized personnel and patients accompanied by authorized personnel.(3) Restricted area: A designated space contained within the semi-restricted area and accessible only through a semi-restricted area. The restricted area includes operating and other rooms in which operative or other invasive procedures are performed. Restricted areas have specific HVAC design requirements associated with the intended use of the space (see ANSI/ASHRAE/ASHE 170: Ventilation of Health Care Facilities). Personnel in the restricted area shall wear surgical attire and cover head and facial hair. Masks shall be worn when the wearer is in the presence of open sterile supplies or of persons who are completing or have completed a surgical hand scrub. Only authorized personnel and patients accompanied by authorized personnel shall be admitted to this area."(uuu) Amend 2.9-3.10.3.2 to read: "Provisions shall be made for securing patients' personal effects. Individual, lockable storage shall be provided."(vvv) Add subsection 2.10-1.1.4 to read: "Fire suppression sprinkler systems are required in Medicare certified dialysis facilities housed in multi-story buildings construction Types II(000), III(200), or V(000), as defined in the 2012 edition of NFPA 101 Life Safety Code, Table 21.1.6.1, and those housed in high-rise buildings over 75 feet in height."(www) Amend subsection 2.10-3.1 to read: "Examination Room. Where an exam room is provided, it shall meet the requirements in Section 2.1-3.2.1 (Examination room)."(xxx) Add subsection 2.10-3.2.1.4 to read: "Emergency Equipment. Emergency cart and equipment storage shall be located close to the patient treatment area, readily accessible by staff, and not located in an exit path. Emergency equipment shall also comply with 2.1-3.8.13.4 (Emergency equipment storage)."(yyy) Add subsection 2.10-3.2.1.5 to read: "Emergency transport of patient. 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. The identified corridor(s) shall be 44 inches minimum clear and any doors within the identified route shall have a minimum 42 inches door leaf width."(zzz) Add subsection 2.10-3.2.1.6 to read: "Patient Scale. Provide dedicated space for a patient scale." (aaaa) Amend subsection 2.10-3.2.4 to read: "Patient Privacy. Space shall be available to accommodate provisions for patient privacy including when patients are examined or treated and body exposure is required. Privacy must be provided for the use of a bedpan or commode during dialysis, initiating and discontinuing treatment when the vascular access is placed in an intimate area, for physical exams, and for sensitive communications. There should be sufficient numbers of privacy screens or other methods of visual separation available and used to afford patients full visual privacy when indicated."(bbbb) Amend subsection 2.10-3.2.5.1 to read: "Hand-washing stations shall be provided in accordance with Section 2.1-3.8.7 (Hand-Washing Station). (1) 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 the hands.(2) Exception: Home training room hand-wash stations may be trimmed with residential style controls." (cccc) Add subsection 2.10-3.2.6 to read: "Body Fluid Disposal Sink".(dddd) Add subsection 2.10-3.2.6.1 to read: "A fluid disposal sink shall be provided in each hemodialysis treatment area or room. Sink design including signage and location shall be constructed to prevent cross-contamination of the hand washing stations."(eeee) Amend subsection 2.10-3.3.2.3 to read: "Separate sink with identifying signage that it is for fluid disposal".(ffff) Add subsection 2.10-3.3.2.4 to read: "Emergency nurse call".(gggg) Amend subsection 2-10-3.4.1 to read: "Airborne Infection Isolation (AII) Room. If the ICRA calls for an airborne infection isolation (AII) room, an AII rooms shall be provided."(hhhh) Amend subsection 2.10-3.4.1.3 to read: "The AII room shall allow for direct observation of the patient by staff during treatment. Direct observation must include patient face and insertion point."(iiii) Add subsection 2.10-3.4.2 to read: "Isolation Room".(jjjj) Add subsection 2.10-3.4.2.1 to read: "An isolation room shall be provided for Hepatitis B positive (HBV+) patients to prevent contact transmission of HBV+ blood spills and other body fluids. The room shall meet the following requirements:(1) Provides a door and walls that go to the floor, but not necessarily the ceiling, and allows for visual monitoring of the patient;(2) Accommodates only one patient;(3) A hand washing station; and(4) A separate sink shall be provided within the isolation room for fluid disposal. Sink design and location shall be constructed to prevent cross-contamination of the hand washing station."(kkkk) Add subsection 2.10-3.4.2.2 to read: "The isolation room shall have a minimum clear floor area of 120 square feet."(llll) Add subsection 2.10-3.4.2.3 to read: "The isolation room shall allow for direct observation of the patient by staff from a patient care staff station. Direct observation must include patient face and insertion point."(mmmm) Amend subsection 2.10-3.8.2.2 to read: "The nurse station(s) shall be no higher than 3 feet 8 inches, designed to provide direct visual observation of all dialysis patient care stations. Direct observation must include patient face and insertion point."(nnnn) Amend subsection 2.10-5.2 to read: "Waste Management. See Section 2.1-5.2 (Waste Management) for requirements. Hand-washing station or hand sanitizer shall be provided within or adjacent to biohazardous waste storage area."(oooo) Amend reference to 2.10-6.3.1 - 2.10-6.3.2 to read: "2.10-6.3.1 Reserved".(pppp) Add subsection 2.10-6.3.2 to read: "Interview Space. See Section 2.1-6.3.2 (Interview space) for requirements)."(qqqq) Amend section 2.10-7 to read: "Architectural Details, Surfaces, and Furnishings. See Section 2.1-7 (Architectural Details, Surfaces, and furnishings) for requirements."(rrrr) Add subsection 2.10-8.3.1 to read: "General. For electrical system requirements, see Section 2.1-8.3 (Electrical Systems) and additional requirements in this section."(ssss) Add subsection 2.10-8.3.2 to read: "Reserved."(tttt) Add subsection 2.10-8.3.3 to read: "Emergency Electrical Power. (1) 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 and continued provision of dialysis services.(2) Power may be provided by an on-site generator or by means of a hitching post for connection to a portable generator provided under contract by others. Hitching post, if provided, must be located to allow connection without the need to leave a door or doors open during use."(uuuu) Add reference to subsections 2.10-8.3.4 - 2.10-8.3.5 to read: "Reserved."(vvvv) Add subsection 2.10-8.3.6 to read: "Electrical Receptacles. One of the eight required receptacles shall be a dedicated GFI circuit on emergency power for the dialysis machine. Hospital grade electrical outlets shall be provided for all dialysis equipment connections."(wwww) Amend subsection 2.12-1.2.1.2 to read: "Support areas may be shared in accordance with state and federal regulations."(xxxx) Amend subsection 2.13-1.3.7.4 to read: Applicable local and state requirements. All imaging facilities installations must comply with OAR chapter 333, divisions 100 through 123, and be licensed by the Oregon Health Authority, Radiation Protection Services program."Or. Admin. Code § 333-535-0015
PH 18-2019, adopt filed 10/01/2019, effective 1/1/2020STATUTES/OTHER IMPLEMENTED: ORS 441.060
STATUTES/OTHER IMPLEMENTED: ORS 441.060