Current through Register Vol. 49, No. 18, September 16, 2024
(1) All new
ambulatory surgical centers and additions to and remodeling of existing
licensed ambulatory surgical centers shall be designed to provide all of the
facilities required by this rule and fire-safety standards, arranged to
accommodate with maximum convenience all of the functions required by this rule
and arranged to provide comfortable, attractive, sanitary, fire-safe, secure
and durable facilities for the patients. This rule is applicable to ambulatory
surgical centers which began operation or construction or renovation of a
building to operate an ambulatory surgical center on any date after April 12,
1990. Existing ambulatory surgical centers licensed by the Department of Health
prior to April 12, 1990 shall be maintained in compliance with the rules under
which they were initially licensed and are not required to comply with the
construction requirements for new ambulatory surgical centers until they are
remodeled or expanded. The Department of Health, within its discretion and for
good reason, may grant exceptions to this rule. These exceptions shall be in
writing and shall be made a part of the Department of Health records for the
facility.
(A) General Construction-Related
Authorities.
1. Construction of all
ambulatory surgical centers and additions to or remodeling of ambulatory
surgical centers shall comply with all local and state regulations and
codes.
(B) Planning and
Construction Procedure.
1. Plans and
specifications complying with
19
CSR 30-30.040 shall be prepared for the construction
of all ambulatory surgical centers and any additions to and remodeling of
ambulatory surgical centers. Plans for ambulatory surgical centers which in
addition to other surgical procedures will offer abortion services shall
incorporate facilities for patient counseling as required for licensed abortion
facilities in
19
CSR 30-30.070(2)(Z). The plans and
specifications shall be prepared by an architect or a professional engineer
licensed to practice in Missouri. The plans and specifications shall have
received written approval of the Department of Health prior to the submission
of an application for licensure of the new facility. The license for a new
ambulatory surgical center will not be issued prior to the facility being
inspected and found in substantial compliance with this rule.
2. The Department of Health shall be notified
within five (5) days after construction begins. If construction of the project
is not started within one (1) year after the date of approval of the plans and
specifications, the plans and specifications shall be amended if necessary to
comply with the then current regulations before construction work commences
(see
19
CSR 30-30.040 Preparation of Plans and Specifications
for Ambulatory Surgical Centers).
(C) Site.
1. Adequate vehicular and pedestrian access
shall be provided within the lot lines to the main entrance, ambulance
entrance, community activities and services, including loading and unloading
space for delivery trucks. Roads, walks, ramps and entrances shall be
accessible to the physically handicapped. Details for accommodation of the
handicapped shall be consistent with the guidelines contained in A
Guidebook to: The Minimum Federal Guidelines & Requirements for Accessible
Design published January 6, 1981, by the United States Architectural
and Transportation Barriers Compliance Board.
2. Adequate off-street parking shall be
provided. Space shall be provided at the ratio of two (2) spaces for each
patient cart in the recovery room plus parking space to accommodate the maximum
number of staff on duty at any one (1) time. A minimum of two (2)
handicapped-accessible parking spaces shall be provided for use by the staff
and patients.
3. Plans for proposed
new ambulatory surgical centers and additions to ambulatory surgical centers
should be reviewed by the local fire protection agency assigned to that area.
Fire lanes shall be provided and kept clear to provide immediate access for
fire-fighting equipment.
(D) General Design-Facilities.
1. The arrangement of the physical plant
shall provide for separation of the administrative, business and public areas
from patient service areas.
A. Administrative
area-at a minimum shall consist of a business office with information center
and telephone, administrator's office, medical records storage (may be in
patient service area), sufficient to satisfy the requirements of
19
CSR 30-30.020(1)(F) 4., lobby and
waiting room, telephone available to public, handicapped-accessible public
toilets for each sex, handicapped-accessible drinking fountain, and janitor's
closet.
B. Patient service areas-at
a minimum shall consist of two (2) or more patient change areas per sex with
access to toilets; secure storage facilities for each patient's street clothing
and belongings; staff lounge with storage for staff's clothing and personal
effects, and handwashing facilities; examination room of at least one hundred
(100) square feet with handwashing facilities; pre-operative holding room sized
for at least two (2) patients per operating room with each patient location
being at least thirty-five (35) square feet; janitors' closet with sufficient
space for equipment for maintaining the patient service area; laboratory,
unless provisions have been made for off-premises laboratory services;
postanesthesia recovery room with handwashing facilities, sized to accommodate
at least two (2) patient stretchers per operating room with three feet (3') of
clear space around the sides and foot of each stretcher; nurses' work station
with medication storage and preparation facilities, storage space for emergency
equipment; doctors' dressing room, toilet and handwashing facilities arranged
to provide a one (1)-way traffic pattern so that personnel entering from
outside surgery can change and move directly into the surgical suite corridor;
nurses' dressing room, toilet and handwashing facilities; one (1) scrub-up
facility for each operating room; materials processing facilities including a
decontamination utility room with workcounter, sink, clinic sink with bedpan
cleanser and space for holding soiled materials and trash, and a pass-thru
window to an adjacent clean workroom with workcounter, sink, high speed
sterilizer and space for storing sterilized and packaged clean supplies; and
one (1) or more operating rooms.
(I)
Operating rooms shall have a floor area of not less than two hundred
twenty-five (225) square feet with a minimum dimension of not less than fifteen
feet (15').
(II) The administration
of general anesthetics in new ambulatory surgical centers is restricted to
nonflammable agents. Any new ambulatory surgical center desiring to administer
flammable anesthetics shall first receive the written permission of the
Missouri Department of Health and will be required to include National Fire
Protection Association (NFPA) safety design features for flammable
anesthetizing locations into the building.
C. Support facilities-space for mechanical
equipment, standby electric generator with automatic transfer switch, medical
gas storage, housekeeping supply storage and a general storage room providing
at least one hundred (100) square feet per operating room.
(E) General Design-Details.
1. A continuous system of unobstructed
corridors and aisles shall extend through the enclosed portion of each story of
the facility, connecting all rooms and spaces with each other and with all
entrances, exitways and elevators except that mechanical equipment space need
not be connected to the corridor system. Corridors providing access to
operating rooms and postanesthesia recovery rooms shall be at least eight feet
(8') wide, all other corridors shall be at least five feet (5') wide.
2. At least two (2) exits, remote from each
other, shall be provided for each floor.
3. Exit doors and doors to operating rooms
and recovery rooms shall be at least forty-four inches (44") wide. All other
doors through which patients and personnel will pass shall be at least
thirty-two inches (32") wide.
4.
The width of stairways except stairways, to mechanical spaces, shall not be
less than forty-four inches (44").
5. Exit discharge doors shall swing in the
direction of exit traffic.
6.
Ceilings in operating rooms shall not be less than nine feet (9'). Ceilings in
all other rooms shall not be less than eight feet (8'), except that ceilings in
corridors and storage rooms may be seven feet six inches (7' 6").
7. Ceilings in operating rooms shall have a
smooth washable surface. All other ceilings may be of acoustical
material.
8. The floor finish in
operating rooms shall be seamless with an integral base covered with the floor
and tightly sealed with the wall.
9. Walls shall be smooth and easily
cleanable. Walls in operating rooms and recovery rooms shall have waterproof
painted, glazed or similar washable surfaces.
10. Floors in the lobby, waiting room and
offices shall be easily cleanable. Floors in operating rooms and recovery rooms
shall be smooth, slip-resistant and washable.
11. Wall and ceiling surfaces of all required
corridors and exitways shall be of a material treated so it does not have a
flame-spread classification of more than twenty-five (25) according to the
method for the Fire Hazard Classification of Building
Materials of Underwriters' Laboratories, Inc. Rooms and small office
spaces shall have wall and ceiling surfaces with a flame-spread rating of not
more than seventy-five (75) when tested according to American Society of
Testing and Materials (ASTM) Standard E-84. All floor covering shall have a
minimum flame-spread rating of forty-five one hundredths (0.45) watts per
square centimeter when tested according to NFPA 253-1978 (Flooring Radiant
Panel Test).
12. Paper towel
dispensers and soap dispensers shall be provided at all lavatories used for
handwashing.
(F) Fire
Safety Construction-Specifications and Details.
1. One (1)-story buildings shall be of not
less than Type II (111) construction as described in the Standard on
Types Building Construction 1979 published by the NFPA. Fully
sprinklered one (1)-story buildings may be of type II (000)
construction.
2. Multistory
buildings shall be of not less than Type II (222) construction. Fully
sprinklered multistory buildings may be of not less than Type II (111)
construction.
3. Walls enclosing
stairways, elevator shafts, other vertical openings between floors and boiler
rooms shall be of construction having a fire rating not less than that required
for the structure.
4. The number of
stories in any building housing an ambulatory surgical center shall be
determine by counting the number of occupiable levels in the structure
regardless of their location above or below grade.
5. Ambulatory surgical centers with a floor
area of two thousand (2000) square feet or more shall be divided by one
(1)-hour rated walls into at least two (2) smoke zones; each zone not exceeding
one hundred fifty feet (150') in any dimension. Each smoke zone shall have at
least one (1) means of egress which discharges directly to the
outside.
6. In a building of
multitenant occupancy, the ambulatory surgical center and the entirety of the
surgical center's access to exit system shall be separated from other tenants
by walls having a fire-resistance rating of at least one (1) hour.
7. Smoke detectors shall be installed in all
habitable spaces in the ambulatory surgical center and in the access to exit
corridor system at intervals not exceeding seventy-five feet (75') and no more
than thirty feet (30') from the ends of corridors.
(G) Elevators.
1. If patient services are located on any
floor other than the grade level, at least one (1) elevator is to be
provided.
2. Inside dimensions of
the elevator shall be at least five feet by seven feet (5'x7') clear inside to
accommodate a wheeled stretcher and attendants. The elevator car door shall
have a clear opening of not less than forty-four inches (44").
(H) Electrical Requirements.
1. Every room, including storage rooms,
corridors and all other areas shall be sufficiently illuminated to facilitate
efficient performance of all necessary work.
2. Operating and recovery rooms shall have
general lighting in addition to special lighting units at the surgical tables
and for each recovery unit.
3. All
sources of light and power in the operating room shall comply with the
Standard for the use of Inhalation Anesthetics (Flammable and
Nonflammable 1978) published by the NFPA.
4. An approved automatically-operated,
electrically-powered fire alarm system which will alert all areas of the
facility when activated shall be installed including audible and visual alarm
devices located throughout the ambulatory surgical center and its
access-to-exit corridor system, manual pull stations near each exit door. The
fire alarm system shall be interconnected with all required smoke detectors and
extinguishment systems, if provided. The fire alarm system shall be connected
directly to the fire department or a dispatch service.
5. An intercom, nurse call system or other
means of communication connecting each operating room and the recovery room
area to a constantly staffed location shall be installed to summon assistance
during emergencies.
6. A generator
with on-site fuel storage for at least four (4) hours of operation under load
shall be provided as an emergency source of electricity and connected by an
automatic transfer switch to certain circuits for lighting and power. The
emergency electrical service shall be installed and arranged so that full
voltage and frequency is available and supplying power to emergency loads
within ten (10) seconds after normal power is interrupted. Emergency electric
services shall be provided for the following:
A. Lighting-exitways, including exit signs;
all operating room lights; all recovery room lights; minimal task lighting in
all clinical areas; generator set location; and elevator if required;
and
B. Power-all alarm systems;
receptacles in operating and recovery rooms; the operating room communication
system; the pump for central suction system, if provided; and elevator, if
required.
(I)
Heating, Ventilating and Air-Conditioning Equipment.
1. Air-conditioning, heating and ventilating
equipment shall be provided, maintained and operated so as to provide an
adequate degree of comfort to all occupants.
2. All air delivered to operating rooms shall
be delivered at or near the ceiling of the room served and all air returned or
exhausted shall be removed near the floor level. At least two (2) return or
exhaust outlets shall be used in each operating room and located not closer
than three inches (3") to the floor and not more than twelve inches (12") above
the floor.
3. The ventilation
systems shall be designed and balanced to provide the pressure relationship
shown in Table I.
4. For the
clinical areas, requirements for outdoor air changes may be deleted or reduced
and total air changes per hour supplied may be reduced to twenty-five percent
(25%) of the figures listed in Table I when the room is unoccupied and unused,
provided that indicated pressure relationships are maintained. An interconnect
with the general illumination light switch for each operating room shall be
included to insure that the required ventilation rates including outdoor air
are automatically resumed upon reoccupancy of the space. This does not apply to
certain areas such as toilets and storage which would be considered as in use
even though unoccupied.
TABLE I Pressure Relationships and Ventilation of
Certain Areas
Area Designation
|
Pressure Relationship to Adjacent Areas
|
Minimum Air
Changes of Outdoor
Air Per Hour
|
Minimum Total
Air Changes
Per Hour
|
All Air
Exhausted
Directly to Outdoors
|
Recirculated Within Room
|
Operating Room |
P |
5 |
15 |
Optional |
No |
Recovery |
P |
2 |
26 |
Optional |
No |
Patient Area Corridor |
E |
2 |
24 |
Optional |
No |
Treatment Room |
E |
2 |
6 |
Optional |
No |
Laboratory |
N |
2 |
6 |
Optional |
No |
Soiled Workroom |
N |
2 |
4 |
Yes |
No |
Clean Workroom |
P |
2 |
4 |
Optional |
Optional |
Toilet Room |
N |
10 |
Yes |
No |
Janitor's Closet |
N |
10 |
Yes |
No |
P=Positive N=Negative E=Equal
5. Ventilation systems for the surgical suite
which includes the operating rooms, surgical corridor and support areas, and
recovery rooms shall have two (2) filter beds. Filter bed no. 1 shall be
located upstream of the air-conditioning equipment and have an efficiency
rating of not less than twenty-five percent (25%). Filter bed no. 2 shall be
located downstream of the air-conditioning equipment and have an efficiency
rating of not less than ninety percent (90%). The ventilation systems serving
all other areas shall have at least one (1) filter having an efficiency rating
of not less than twenty-five percent (25%).
6. Space and access panels shall be provided
for the easy maintenance and replacement of all filters installed in the
ventilation equipment.
7. Ducts
supplying air to the operating suite and recovery rooms shall be externally
insulated downstream from the final filter.
8. Variable volume-ventilation systems may be
used only in the administrative areas of ambulatory surgical centers.
(J) Plumbing.
1. The requirements of the current edition of
the
National Plumbing Code shall be complied with insofar as
they may apply and to the extent they are not superseded by requirements
specifically stated in these regulations.
A.
Systems shall be designed to supply water to the fixtures and equipment on
every floor at a minimum pressure of fifteen pounds per square inch (15 psi)
during maximum demand periods.
B.
Each water service main, branch main, riser and branch to a group of fixtures
should be valved. Stop valves shall be provided at each fixture.
C. Hot, cold and chilled water piping and
waste piping on which condensation may occur shall be insulated. Insulation of
cold and chilled water lines shall include an exterior vapor barrier.
D. Backflow preventers (vacuum breakers)
shall be installed on hose bibbs and on all fixtures to which hoses or tubing
can be attached such as janitor's sinks and laboratory fixtures.
E. Hot water distribution systems with
recirculating loops and pumps shall be arranged to provide hot water service at
each fixture at all times.
F. The
hot water-heating equipment shall have sufficient capacity to supply the water
at temperatures between one hundred five degrees and one hundred fifteen
degrees Fahrenheit
(105oF-115oF) at a rate
not less than five (5) gallons per hour per recovery stretcher.
G. Lavatories and sinks in patient service
areas shall have the water supply spout mounted so that its discharge point is
a minimum distance of five inches (5") above the rim of the fixture. All
lavatories used by medical and nursing staff and food handlers except those in
public toilets shall be trimmed with valves which can be operated without the
use of hands.
H. Scrub sinks shall
be equipped with faucets which can be operated without the use of
hands.