| (iii) A dedicated exhaust fan and an exhaust duct system
shall be provided for EO sterilizers. The exhaust outlet to the atmosphere
shall be located on the highest roof, directed upward, and not less
than 25 feet from any air intake. A legible warning sign shall be
provided to identify the exhaust stack on the roof.
(iv) An audible and visual alarm located in sterilizer
work area and a 24-hour staffed location shall be activated upon loss
of airflow in the exhaust system.
(C) Filtration requirements for air handling units
serving the central sterile supply suite shall be equipped with filters
having efficiencies equal to, or greater than specified in Table 4
of §133.169(d) of this title (relating to Tables).
(D) Duct linings exposed to air movement shall not
be used in ducts serving the central sterile supply suite unless terminal
filters of at least 90% efficiency are installed downstream of linings.
This requirement shall not apply to mixing boxes and acoustical traps
that have special coverings over such lining.
(4) Piping systems and plumbing fixtures. Piping systems
and plumbing fixtures shall be in accordance with §133.162(d)(4)
of this title. When medical gas systems are provided, the systems
shall comply with §133.162(d)(4) of this title and this paragraph.
(A) Drainage and waste piping shall not be installed
within the ceiling or installed in an exposed location in sterile
areas unless precautions are taken to protect the space below from
leakage and condensation from necessary overhead piping. Any required
secondary protection shall be labeled, "code required secondary drain
system" every 20 feet in a highly visible print or label.
(B) No plumbing lines may be exposed or on walls where
possible leaks would create a potential of contamination of the sterile
areas.
(C) The compressed air required for the decontamination
room shall not be connected to the medical air piping distribution
system such as supporting breathable air for respiratory assistance
needs, anesthesia machines, intermittent positive pressure breathing
machine (IPPB), etc. A separate compressed air supply source shall
be provided for maintenance and equipment needs for facility support
use.
(5) Electrical requirements. Electrical requirements
shall be in accordance with §133.162(d)(5) of this title and
this paragraph. Electrical circuit(s) to equipment in wet areas shall
be provided with ground fault circuit interrupters (GFCIs).
(d) Critical care unit.
(1) Architectural requirements.
(A) General. When a critical care unit(s) (CCU) (also
known as intensive care unit) is provided, the unit(s) may be classified
as general CCU, coronary CCU (CCCU) or pediatric CCU (PCCU). Requirements
for neonatal intensive care units (NCCU) are stated in subsection
(u) of this section.
(i) The CCU(s) shall be a separate suite(s) operated
separately from other units of the hospital. The location shall be
arranged to eliminate the need for through traffic.
(ii) When elevator transport is required for critically
ill patients, the size of the elevator cab, mechanisms and controls
shall meet the specialized needs.
(B) CCU services and facilities. The following services
and facilities shall apply to all classifications of CCUs unless otherwise
noted.
(i) The patient area (whether separate rooms, cubicles,
or multiple-bed space) shall have a minimum clear floor area of 200
square feet per bed exclusive of anterooms, vestibules, toilet rooms,
closets, lockers, wardrobes, and/or alcoves. A minimum of 13 feet
width shall be provided for the head wall for each bed.
(ii) When an open ward plan is used, at least one private
room for every six ward beds shall be provided for medical isolation
or psychological needs.
(iii) A minimum of one airborne infection isolation
room shall be provided for each type of CCU suite. The number of airborne
infection isolation rooms shall be determined based on an infection
control risk assessment. Each room shall comply with requirements
of subsection (t)(1)(C)(iii) and (iv) of this section. In addition,
the isolation room shall comply with clause (i) of this subparagraph.
(iv) When private rooms or cubicles are provided, view
panels in the door or walls of these rooms are required. Curtains
or other means shall be provided to cover the viewing panels when
visual privacy is required.
(v) For open ward environments in adult and pediatric
units, the clearance between a bed and a wall/partition shall be a
minimum of five feet. The clearance between sides of beds shall be
a minimum of eight feet. The minimum distance at the foot of the bed
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 requirement
at the foot of the bed may be shared between two beds. The multiple-bed
CCU wards shall contain cabinets, work counters, and hand washing
fixtures with hands-free operable controls. The fixed and moveable
cabinets and shelves shall not encroach upon the bed/gurney clear
floor space/area. The requirements of this clause are illustrated
in Table 8, Diagrams A and B of §133.169(h) of this title.
(vi) 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 view to the outside
window(s) may be through no more than two separate clear vision panels.
Windows shall be in accordance with subsection (t)(2)(A)(v) of this
section.
(vii) Hand washing fixtures with hands-free operable
controls shall be located in or adjacent to the nurse station, inside
of each room at the entrance of the room, and at a ratio of one fixture
to each three beds for an open ward layout. Hand washing fixtures
shall be sized to contain splashing and conveniently distributed throughout
the ward. When a combination modular swivel/fixed toilet and hand
washing fixture is provided, hospital administration shall provide
a letter (on hospital letterhead) indicating if the toilet is for
staff convenience (bed pan washing) or for patient use.
(I) If the toilet is for patient use, an additional
hand washing fixture shall be provided in each room at the entrance
of the room. If the modular toilet/hand washing unit is for patient
use, provision shall be made for patient privacy and odor control.
The toilet room exhaust shall be in accordance with Table 3 of §133.169(c)
of this title.
(II) When the modular toilet/hand washing unit is for
staff use, it shall be near the entrance to the room.
(viii) The nurse station shall be located to permit
direct visual observation of each patient served. Video cameras or
mirrors shall not be substituted for direct visual observation. The
nurse station shall have space for counters and storage. The counter
height shall not exceed 42 inches. The nurse station may be combined
with or include centers for reception and communication.
(ix) When individual nurse substations are provided
and located at each patient room(s), they shall be located to permit
direct visual observation of each patient served. The nurse substation
shall have space for a counter, storage space and a recessed sitting
space. The substation shall, at a minimum, be recessed one foot six
inches from the egress corridor.
(x) Storage and preparation of medication may be done
from a room, alcove area or from a self-contained 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 are not acceptable for hand washing.
(xi) An intravenous solution support shall be provided
at each patient crib, bed or bassinet. The intravenous solution shall
not be suspended directly over the patient.
(xii) Storage space shall be provided for emergency
equipment in the unit.
(C) CCCU. When a CCCU is provided, the CCCU shall comply
with the requirements contained in subparagraph (B) of this paragraph
and the following.
(i) Each CCCU bed shall be in a separate room. Equipment
for monitoring cardiac patients shall be provided by visual display
both at the bed location and at the nurse station.
(ii) Each coronary patient shall have direct access
to a toilet room and a hand washing fixture. Swivel type commodes
may be utilized in lieu of individual toilet rooms, but provision
must be made for patient privacy and odor control. The toilet room
exhaust rate shall be in accordance with Table 3 of §133.169(c)
of this title.
Cont'd... |
