(u) Obstetrical suite.
(1) Architectural requirements.
(A) General. When obstetrical services are
provided, the obstetrical suite shall be located and arranged to preclude
unrelated traffic through the suite. Regardless of the clinical model used for
labor, delivery, recovery and postpartum, a hospital offering such services
shall be able to demonstrate the availability of one room designed, equipped
and held in reserve for emergency, caesarean section deliveries. This room
shall be located either in the labor and delivery suite or surgical
suite.
(B) Caesarean section
(c-section) operating room(s). A minimum of one dedicated c-section operating
room shall be located in either the obstetrical or surgical suite. This room
shall have a minimum clear floor area of 360 square feet with a minimum
dimension of 18 feet exclusive of built-in shelves or cabinets. There shall be
no direct access between operating rooms.
(C) Delivery room(s). A minimum of one
delivery room shall be provided in every obstetrical suite. The delivery room
shall have a minimum clear floor area of 300 square feet with a minimum
dimension of 16 feet exclusive of fixed and moveable cabinets and built-in
shelves. In facilities having only one c-section operating room, the delivery
room shall be designed to function as an emergency c-section operating room.
When two c-section operating rooms are provided, the delivery room requirement
may be omitted.
(D) Infant
resuscitation area. An infant resuscitation space shall be provided within the
c-section operating room; delivery room; labor, delivery, and recovery room
(LDR); and labor, delivery, recovery and postpartum room (LDRP) with a minimum
clear floor area of 40 square feet in addition to the required area of each
room or may be provided in a separate but immediately accessible room with a
clear floor area of 150 square feet.
(E) Labor room(s). A minimum of two labor
beds shall be provided for each delivery room. Each labor room shall be
designed for one or two beds with a minimum clear floor area of 120 square feet
per bed.
(i) An LDR or LDRP may be
substituted for a labor room.
(ii)
In facilities having only one delivery room, one of the two required labor beds
shall be in a separate room with a minimum clear floor area of 160 square feet
to serve as an emergency vaginal delivery room. Medical gas outlets shall be
the same as for delivery room.
(iii) Each labor room shall contain a
lavatory equipped with hands-free operable controls. Each labor room shall have
direct access to a toilet room. One toilet room may serve two labor
rooms.
(iv) Labor rooms shall be
arranged so that doors are visible from a nurses work station.
(v) A minimum of one shower shall be provided
for each four labor beds. Each shower room shall contain a toilet and hand
washing fixture with hands-free operable controls.
(F) Recovery room(s). Recovery room(s) shall
contain not less than two beds. There shall be enough space for baby and crib
and a chair for the support person. Visual privacy of the new family shall be
provided. LDRs or LDRPs may be substituted for recovery rooms.
(i) In multiple recovery patient stations,
the clearance between the side of a bed/gurney and a wall/partition shall be a
minimum of five feet. The clearance between sides of beds/gurneys shall be a
minimum of six feet. The minimum distance at the foot of the bed/gurney shall
not be less than eight feet for single load area/room or twelve feet for double
load area/room. Four feet of the passage space at the foot of the bed may be
shared between two beds/gurneys. The fixed and movable cabinets and shelves
shall not encroach upon the bed/gurney clear floor space/area. The requirements
of this clause are illustrated in Table 8, Diagram N of §
133.169(h)
of this title.
(ii) A nurse station
and charting area shall be provided and arranged to permit staff visual
observation of recovery beds.
(iii)
A work counter, facilities for dispensing medicine, storage for supplies and
equipment, and a clinical sink with bedpan-flushing device shall be
provided.
(iv) One hand washing
fixture with hands-free operable controls shall be provided for every three
recovery beds or fraction thereof. Fixtures shall be uniformly
distributed.
(v) There shall be
cubicle curtains at each station for patient privacy.
(G) Postpartum and antepartum suite.
Postpartum and antepartum patient suites shall be provided in accordance with
subsection (t)(1)(B) of this section.
(H) LDR.
(i) When provided, each LDR room shall have
controlled access and shall be located so that a patient may be transported to
the c-section operating room without the need to pass through other functional
areas.
(ii) Each LDR room shall be
designed for single occupancy and have a minimum clear floor area of 200 square
feet exclusive of the infant resuscitation area, built-in shelves or cabinets,
alcove, vestibule or other adjoining rooms. The minimum clear room dimension
shall not be less than 11 feet.
(iii) A hand washing fixture with hands-free
operable controls shall be provided in each LDR room.
(iv) Each LDR shall have direct access to and
exclusive use of a bathroom with a shower, or tub with shower, hand washing
fixture with hands-free operable controls and a toilet.
(I) LDRP. When provided, each LDRP room shall
have controlled access and shall be located on an exterior wall and have a
window in accordance with subsection (t)(2)(A)(iv) and (v) of this section.
(i) Each room shall be designated for single
occupancy and have a minimum clear floor area of 260 square feet exclusive of
the infant resuscitation area, built-in shelves or cabinets, alcove,
vestibules, or other adjoining rooms. The minimum clear room dimension shall
not be less than 11 feet.
(ii) A
hand washing fixture with hands-free operable controls shall be provided in
each LDRP room.
(iii) Each LDRP
shall have direct access to and exclusive use of a bathroom with a shower, or
tub with shower, hand washing fixture with hands-free operable controls and a
toilet.
(J) Isolation
rooms. When patients who have airborne infectious diseases are treated, an
isolation room shall be provided in the obstetrical suite which complies with
the functional space requirements as specified in subparagraphs (G) -
(I) of this paragraph, and with the
ventilation requirements for infection isolation rooms in Table 3 of §
133.169(c)
of this title.
(K)
Nursery suite. One infant station for each LDRP and each postpartum bed shall
be provided in the nursery. Nurseries shall be located and arranged convenient
to the postpartum nursing unit and near or part of the obstetrical suite. The
nurseries shall be located and arranged to preclude the need for nonrelated
pedestrian traffic. Each nursery unit shall meet the following
requirements.
(L) Full-term
nursery. A full-term nursery shall have a maximum of 16 infant stations. The
clearance between the side of a bassinet and a wall/partition shall be a
minimum of two feet six inches. The clearance between sides of bassinets shall
be a minimum of four feet. The minimum distance at the foot of the bassinet
shall not be less than five feet for single load area/room or seven feet for
double load area/room. Three feet of the passage space at the foot of the
bassinet may be shared between two bassinets. The requirements of this
subparagraph are illustrated in Table 8, Diagram I of §
133.169(h)
of this title. Additional area shall be provided to accommodate workroom
functions if these are located within the nursery area as specified in
subparagraph (N)(iv) of this paragraph.
(i)
When a rooming-in program is used, the total number of bassinets in full-term
nursery units shall be not less than one bassinet for every two LDRP and
postpartum beds.
(ii) When a
rooming-in program is used but all infants are returned to the nursery at
night, a reduction in bassinets shall not be allowed.
(iii) There shall be one lavatory with
hands-free operable controls for each six infant stations or fraction thereof.
Fixtures shall be uniformly distributed but not in the clear floor area of the
infant stations.
(iv) An
observation window to permit the viewing of infants from public areas shall be
provided. The public viewing areas shall not encroach into the egress
corridor.
(M) Continuing
care nursery suite. Hospitals with 25 or more maternity beds shall provide a
continuing care nursery for infants requiring close observation. The suite
shall have a maximum of 16 infant stations. The clearance between the side of
the bassinet and a wall/partition shall be a minimum of three feet. The
clearance between sides of bassinets shall be a minimum of six feet. The
minimum distance at the foot of the bassinet shall not be less than six feet
for single load area/room or nine feet for double load area/room. Three feet of
the passage space at the foot of the bassinet may be shared between two
bassinets. The requirements of this subparagraph are illustrated in Table 8,
Diagram J of §
133.169(h)
of this title. Additional area shall be provided to accommodate workroom
functions if these are located within the nursery area as specified in
subparagraph (N)(iv) of this paragraph.
(i)
The continuing care nursery shall be located on an exterior wall and shall have
a window(s). In the nursery, one window may serve more than one bassinet. The
window sill height shall not exceed five feet above the floor. Bassinets shall
not be located more than 50 feet from an exterior window. A newborn's view to
outside windows shall be direct. When partitions are used, the newborn's view
to the outside windows may be through no more than two separate clear vision
panels.
(ii) The continuing care
nursery shall not be located within a full-term nursery.
(iii) There shall be a minimum of one
lavatory with hands-free operable controls for each four infant stations or
fraction thereof. Fixtures shall be uniformly distributed but not in the clear
floor area of the infant stations.
(N) General requirements for nurseries. Each
nursery regardless of type shall meet the following requirements:
(i) Observation windows to permit the viewing
of infants from public areas for full-term nurseries and from workroom(s) into
adjacent nurseries shall be provided. Windows between nurseries may be provided
for the convenience of staff observation.
(ii) Ten square feet per bassinet shall be
provided for convenient, accessible storage for linens, infant supplies, and
equipment.
(iii) A room for
consultation, demonstration, breast feeding or breast pumping shall be provided
convenient to the unit. A counter with sink with hands-free operable controls,
refrigeration and freezer, storage for pump and attachments, and educational
materials shall be provided in or convenient to the room.
(iv) Each nursery room shall be served by a
connecting workroom(s). The workroom shall contain scrubbing and gowning
facilities at the entrance for staff and housekeeping personnel, work counter,
refrigerator, storage for supplies, and hand washing fixture with hands-free
operable controls. One workroom may serve no more than two nursery rooms
provided that required services are convenient to each. No nursery shall open
directly into another nursery.
(v)
The workroom serving the full-term and continuing care nurseries may be omitted
if equivalent work and storage areas and facilities, including those for
scrubbing and gowning, are provided within that nursery at the entrance. Space
required for work areas located within the nursery is in addition to the area
required for infant care. Adequate provisions shall be made for storage of
emergency carts and equipment, and for sanitary storage and disposal of soiled
waste for the nursery.
(vi)
Charting and dictation facilities shall be provided for physicians and nurses.
This may be in a separate room or part of the workroom.
(vii) An examination/treatment room or space
shall be provided and shall contain a work counter, storage, and lavatory
equipped for hand washing with hands-free operable controls. The
examination/treatment room or space shall have a minimum clear area of 80
square feet in addition to the required area of each workroom exclusive of
fixed and movable cabinets and shelves. The examination treatment space shall
be located within the nursery.
(viii) An airborne infection isolation room
is required in at least one level of nursery care and the neonatal critical
care unit. The isolation room shall be enclosed and separated from the nursery
unit with provisions for observation of the infant from adjacent nurseries or
control area(s). The minimum size of the room shall be 120 square feet of clear
floor area. The isolation room shall contain cabinets, a work counter, and a
hand washing fixture with hands-free operable controls. Fixed and moveable
cabinets and shelves shall not encroach upon bed/gurney clear floor space/area.
The isolation room shall comply with the ventilation requirements in Table 3 of
§
133.169(c)
of this title.
(ix) A housekeeping
room shall be provided for the exclusive use of the nursery.
(O) Neonatal critical care unit
(NCCU). When an NCCU is provided, the unit shall comply with the following.
(i) The NCCU shall be conveniently located
near the obstetrical suite and be arranged to preclude unrelated
traffic.
(ii) Each room and ward
shall be located on an exterior wall and shall have a window. In a ward, one
window may serve more than one patient. The window sill height shall not exceed
five feet above the floor. Patient beds shall not be located more than 50 feet
from an exterior window. Patients' views to outside windows shall be direct.
When partitions are used, the patient's direct view to the exterior may be
through no more than two separate clear vision panels. Window shall be in
accordance with subsection (t)(2)(A)(v) of this section.
(iii) The NCCU shall have a clearly
identified public entrance and reception area arranged to permit visual
observation and contact with all traffic entering the unit. Gowning facilities,
lockers, and scrub area shall be provided at each public entrance to the
patient care area(s) of the NCCU. All scrub sinks shall be provided with
hands-free operable controls and large enough to contain splashing.
(iv) A control station shall be provided in a
central area and shall have space for counters and storage, and shall have
convenient access to a hand washing fixture with hands-free operable controls.
The control station may be combined with or include centers for reception,
communication and patient monitoring.
(v) NCCU patients may be housed in private
rooms or a room with multiple bassinets or cribs. Each unit shall not exceed 24
bassinets or cribs. There shall be at least one enclosed private room for every
six bassinets or cribs.
(vi) A
single-bassinet/crib patient NCC room shall have a minimum clear floor area of
120 square feet per bassinet/crib exclusive of work counter, vestibule, sink
and aisle. A minimum of 12 feet width shall be provided for the head wall for
each bed.
(vii) In a
multiple-bassinet/crib room/ward the clearance between the side of a sleeping
unit and a wall/partition shall be a minimum of five feet. The clearance
between sides of sleeping units shall be a minimum of eight feet. The minimum
distance at the foot of the bassinet shall not be less than ten feet for single
load area/room or sixteen feet for double load area/room. Four feet of the
passage space at the foot of the bassinet may be shared between two bassinets.
The fixed and moveable cabinets and shelves shall not encroach upon the
bassinet/crib clear floor space/area. The requirements of this clause are
illustrated in Table 8, Diagram K of §
133.169(h)
of this title.
(viii) A minimum of
one isolation room shall be provided with a minimum clear floor area of 120
square feet per bassinet/crib exclusive of work counter, vestibule, sink and
aisle. A minimum of 12 feet width shall be provided for the head wall for each
bed. A toilet room is not required.
(ix) A lavatory equipped for hand washing
with hands-free operable controls shall be provided in each single-bed room. In
rooms with multiple beds, one lavatory with hands-free operable controls for
each four patient stations or fraction thereof shall be provided. These
lavatories shall be located convenient to infant stations.
(x) Each NCCU shall be served by a connecting
workroom containing gowning facilities at the entrance for staff and
housekeeping personnel, a work space with counter, storage facilities, a
lavatory or sink equipped for hand washing with hands-free operable controls,
and individual closet or lockers for personal effects of nursing personnel. One
workroom may serve not more than two NCCUs.
(xi) A storage space for infant formula shall
be provided. This functional space may be outside the NCCU but shall be
available for use at all times.
(xii) A breast feeding or pump room shall be
provided convenient to the unit. Provision shall be made, either within the
room or conveniently located nearby, for a sink with hands-free operable
controls, counter, refrigeration and freezer, storage for pump and attachments,
and educational materials.
(xiii) A
room(s) shall be provided within the NCCU for parents and infants for extended
private time together and the room is not considered a patient room. The
room(s) shall have direct access to toilet facilities and a hand washing
fixture with hands-free operable controls. The room(s) shall have a sleeping
area for at least one parent, and sufficient space for the infant's
bassinet/crib and equipment. The room(s) shall have electrical and medical gas
outlets as specified for NCCU bassinet/cribs. This room(s) shall have direct
communication with the NCCU staff.
(xiv) Twenty square feet of equipment storage
shall be provided for each patient station. The storage areas shall be out of
the way of the corridor traffic.
(xv) Charting and dictation space shall be
provided for physicians and nurses.
(xvi) A respiratory therapy work area and
storage room shall be provided.
(xvii) Blood gas lab facilities shall be
immediately accessible to the NCCU.
(xviii) A staff lounge shall include toilet
facilities with a hand washing fixture with hands-free operable controls. The
lounge(s) shall be located so that staff may be recalled quickly to the patient
area in emergencies. Toilet facilities may be shared as long as privacy is
maintained for changing areas.
(xix) Physicians and other staff on 24-hour
on-call work schedules shall be provided with sleeping rooms with access to a
shower(s), toilet(s), and lavatory(ies). If on-call room(s) are not within the
NCCU served, a dedicated telephone or intercom system shall connect the on-call
room(s) to the NCCU.
(xx) A waiting
room/area shall be provided and contain toilet room(s) with hand washing
facilities. Waiting room/area maybe shared with other waiting room/areas if
conveniently located.
(xxi) A
consultation room shall be provided, if not provided elsewhere in the
suite.
(xxii) A housekeeping room
shall be provided exclusively within or immediately adjacent to the NCCU. It
shall not be shared with other nursing units or departments.
(P) Infant formula facilities.
Infant formula facilities shall meet the following requirements.
(i) When infant formula is prepared on site,
the infant formula preparation room shall contain a lavatory equipped for hand
washing with hands-free operable controls, warming facilities, refrigerator,
work counter, formula sterilizer, and storage facilities. The formula room may
be located near the nurseries or at another appropriate place within the
hospital. Direct access from the formula preparation room to any nursery room
is prohibited.
(ii) An infant
formula clean-up room shall be provided and include a hand washing fixture with
hands-free operable controls, facilities for bottle washing, a work counter,
and sterilization equipment.
(iii)
When commercial infant formula is used, the separate clean-up and formula
preparation rooms may be omitted. The storage and handling may be done in the
nursery workroom or in another appropriate room in the hospital that is
conveniently accessible at all hours.
(iv) A refrigerated storage and warming
facilities for infant formula shall be provided and be accessible for use by
nursery personnel at all times.
(Q) Service areas. The following service
areas shall be provided to support an obstetrical suite unless otherwise noted.
(i) Control station. The control station
shall be located to permit direct visual surveillance of all traffic which
enters the obstetrical suite.
(ii)
Office. A supervisor's office shall be provided.
(iii) Waiting room/area. A waiting room/area
shall be provided and contain toilet room(s) with hand washing facilities,
public telephone(s), and drinking fountain(s).
(iv) Scrub facilities. Two scrub stations
shall be within 5 feet of the entrance to each c-section operating room and
delivery room. Two scrub stations may serve two c-section operating rooms or
delivery rooms if the scrub stations are located adjacent to the entrance of
each c-section operating room or delivery room. Scrub facilities shall be
arranged to minimize any incidental splatter on nearby personnel or supply
carts. Viewing panels shall be provided for observation of c-section operating
rooms and delivery rooms from the scrub area.
(v) Sterilizing facilities. Sterilizing
facilities with high speed sterilizers shall be conveniently located to serve
all c-section operating rooms and delivery rooms. A work space and a hand
washing fixture with hands-free operable controls shall be included. High speed
autoclaves should only be used in an emergency situation (e.g. replacements
unavailable for dropped instruments). Sterilization facilities would not be
necessary when spare instruments are available.
(vi) Anesthesia workroom. An anesthesia
workroom shall be provided with work counter, sink with hands-free operable
controls, and storage space for small style D or E medical gas cylinders and
other anesthesia equipment.
(vii)
Medication station. Storage and distribution of medication may be done from a
medicine preparation room, medicine alcove area or from a self-contained
medicine dispensing unit but must be under visual control of nursing staff. A
work counter, hand washing fixture with hands-free operable controls,
refrigerator, and double-locked storage for controlled substances shall be
provided. Standard cup-sinks provided in many self-contained units are not
adequate for hand washing. The medication station may be shared with the clean
work room.
(viii) Nourishment
station. The nourishment station shall contain sink with hands-free operable
controls, work counter, self-dispensing ice machine, refrigerator, cabinets,
and not located in the clean work room. Space shall be included for temporary
holding of unused or soiled dietary trays. A nourishment station is not
required in the nursery suite.
(ix)
General storage room(s). A minimum of 50 square feet per operating room is
required for general storage space(s). The storage space is exclusive of soiled
holding, sterile supplies, clean storage, drug storage, locker rooms. In
addition to general storage, equipment storage shall be provided for labor, LDR
and LDRP rooms.
(x) Emergency
storage. Equipment used for emergencies shall be stored in a room or alcove
under direct visual control of the nursing staff.
(xi) Storage alcove. The alcove provided for
stretcher storage, portable X-ray equipment, warming devices, auxiliary lamps,
etc. shall be located out of direct line of traffic.
(xii) Obstetrical suite staff clothing change
rooms. Appropriately sized areas shall be provided for male and female
personnel working within the obstetrical suite. These areas shall contain
lockers, showers, toilets, hand washing fixtures with hands-free operable
controls, and space to change into scrub suits and boots. Separate
locker/changing rooms shall be provided for male and female staff. The shower
and toilet room(s) may be unisex. These areas shall be arranged to provide a
traffic pattern so that personnel entering from outside the obstetrical suite
can shower, change, and move directly into the restricted areas of the
obstetrical suite.
(xiii) Lounge. A
lounge shall be provided in hospitals with four or more obstetrical surgical
and delivery rooms. The lounge shall permit staff use without leaving the
obstetrical surgical suite or delivery suite and may be accessed from the
obstetrical suite staff clothing change rooms or staff changing room for
delivery suite. The lounge shall not have direct access from outside the
surgical suite. When the lounge is remote from the clothing change rooms,
toilet facilities and a hand washing fixture with hands-free operable controls
accessible from the lounge shall be provided.
(xiv) Staff toilet facilities. Toilet
facilities located in the obstetrical suite for exclusive staff use shall be
provided and contain hand washing facilities with hands-free operable controls.
The toilet room may be accessible from a staff lounge, when provided.
(xv) Nurses' toilet. A nurses' toilet room
shall be provided at the labor and recovery area(s) and shall include hand
washing fixture with hands-free operable controls.
(xvi) Dictation and report preparation area.
This may be accessible from the lounge area.
(xvii) On-call rooms. Physicians and staff on
24-hour on-call work schedules shall be provided with sleeping rooms with
access to a toilet, lavatory and shower. If not contained within the unit
itself, the area shall have a telephone or intercom connection to the
obstetrical suite(s).
(xviii) Clean
workroom or clean supply room. A clean workroom is required. It shall contain a
work counter, a hand washing fixture with hands-free operable controls, storage
facilities for clean supplies, and a space to package reusable items. The
storage for sterile supplies must be in a separated room. When the room is used
only for storage and holding as part of a system for distribution of clean and
sterile supply materials, the work counter and hand washing fixture may be
omitted.
(xix) Soiled workroom. The
soiled workroom shall be for the exclusive use of the obstetrical suite and
shall be in addition to the soiled workroom required for the obstetrical
surgical suite. The soiled workroom for the obstetrical c-section operating
room or delivery room suite shall not have direct connection with operating
rooms or other sterile activity rooms. The soiled workroom shall contain a
clinical sink with hands-free operable controls or equivalent flushing type
fixture, work counter, sink equipped for hand washing, waste receptacle, and
linen receptacle. There shall be a designated soiled workroom for the exclusive
use of the NCCU.
(xx) Housekeeping
rooms. A separate housekeeping room containing a floor receptor or service sink
and storage space for housekeeping supplies and equipment shall be provided for
the exclusive use of the obstetrical suite, the c-section operating room, and
nurseries (one for each).
(xxi)
Triage room. When triage services are provided, there shall be a minimum of one
triage room in the obstetrical suite.
(I) An
obstetrical triage room shall be a minimum clear floor area of 100 square feet
with a minimum dimension of nine feet. The obstetrical triage room shall
contain cabinets, work counter, examination light, and a hand washing fixture
with hands-free operable controls. The fixed and movable cabinets and shelves
shall not encroach upon the bed/gurney clear floor space/area.
(II) When a multiple-bed/gurney triage
patient station is provided, the clearance between the side of a bed/gurney and
a wall/partition shall be a minimum of three feet. The clearance between sides
of beds/gurneys shall be a minimum of six feet. The minimum distance at the
foot of the bed/gurney shall not be less than seven feet for single load
area/room or ten feet for double load area/room. Four feet of the passage space
at the foot of the bed may be shared between two beds/gurneys. The
multiple-bed/gurney triage room shall contain cabinets, medication storage,
work counter, examination light, and a hand washing fixture with hands-free
operable controls. The fixed and movable cabinets and shelves shall not
encroach upon the bed/gurney clear floor space/area. Privacy shall be provided
for each patient with cubicle curtains or movable screens. The requirements of
this subclause are illustrated in Table 8, Diagram D of §
133.169(h)
of this title.
(III) A patient in a
triage bed shall have access to a patient toilet room without entering the
corridor.