Cal. Code Regs. Tit. 16, § 1043.9.2 - Facility and Equipment Standards
All equipment shall be maintained, tested, and inspected according to the manufacturers' specifications. A facility in which minimal sedation is administered to pediatric patients pursuant to this article shall meet the standards set forth herein. In an office where minimal sedation is to be provided to pediatric patients, the required equipment, medication, and resuscitative capabilities shall be appropriately sized for use on a pediatric population.
(a) Facility and Equipment. A facility shall
possess:
(1) An operatory large enough to
adequately accommodate the pediatric patient, and permit a team consisting of at
least three individuals to freely move about the patient.
(2) A table or dental chair that permits the
patient to be positioned so the attending team can maintain the airway, quickly
alter a patient's position in an emergency, and provide a firm platform for the
management of cardiopulmonary resuscitation.
(3) A lighting system adequate to permit
evaluation of the pediatric patient's skin and mucosal color and a backup lighting
system that is battery powered and of sufficient intensity to permit completion of
any treatment that may be underway at the time of a general power failure.
(4) An appropriate functional suctioning device
that permits aspiration of the oral and pharyngeal cavities. A backup suction device
that can function at the time of general power failure must also be
available.
(5) A positive-pressure
oxygen delivery system capable of administering greater than 90% oxygen at a 10
liter/minute flow for at least sixty minutes (650 liter "E" cylinder), even in the
event of a general power failure. All equipment must be appropriate for use on and
capable of accommodating the pediatric patients being seen at the permit holder's
office.
(6) Inhalation sedation
equipment. If used in conjunction with oral sedation, it must have the capacity for
delivering 100%, and never less than 25%, oxygen concentration at a flow rate
appropriate for a pediatric patient's size and have a fail-safe system. The
equipment must be maintained and checked for accuracy at least
annually.
(b) An emergency
cart or kit available and readily accessible that shall include the necessary and
appropriate emergency drugs and size-appropriate equipment to resuscitate a
nonbreathing and unconscious pediatric patient and provide continuous support while
the pediatric patient is transported to a medical facility. Emergency drugs of the
following types shall be available:
(1)
Epinephrine,
(2)
Bronchodilator,
(3) Appropriate drug
antagonists,
(4)
Antihistaminic,
(5)
Anticholinergic,
(6)
Anticonvulsant,
(7) Oxygen,
and,
(8) Dextrose or other
antihypoglycemic.
(c)
Ancillary equipment must include the following:
(1) Oral airways capable of accommodating
pediatric patients of all sizes.
(2) A
sphygmomanometer with cuffs of appropriate size for pediatric patients of all
sizes.
(3) A precordial/pretracheal
stethoscope.
(4) A pulse
oximeter.
(d) A facility must
maintain the following records:
(1) An adequate
medical history and physical evaluation, updated prior to each administration of
pediatric minimal sedation. Such records shall include, but are not limited to, an
assessment including an evaluation of the airway, the age, sex, weight, physical
status (American Society of Anesthesiologists Classification), and rationale for
sedation of the pediatric patient and written informed consent of the parent or
legal guardian of the pediatric patient.
(2) Pediatric minimal sedation records shall
include baseline vital signs. If obtaining baseline vital signs is prevented by the
pediatric patient's physical resistance or emotional condition, the reason or
reasons must be documented. The records shall also include intermittent quantitative
monitoring and recording of oxygen saturation, heart and respiratory rates, blood
pressure as appropriate for specific techniques, the name, dose and time of
administration of all drugs administered including local and inhalation anesthetics,
the length of the procedure, any complications of oral sedation, and a statement of
the pediatric patient's condition at the time of discharge.
(3) Documentation that all emergency equipment is
checked to determine operability and safety for the patient consistent with the
manufacturer's recommendation.
(4)
Documentation that all drugs maintained at the facility are checked at least once a
quarter for expired drugs and an adequate supply of drugs based upon patient
demographics for the patient population served, which includes the number of
patients served at the facility and the age of patients served at the facility. For
the purposes of compliance with this subsection, documentation of adequate supply
shall include a written explanation of how the adequate supply was calculated by the
facility.
Notes
Note: Authority cited: Section 1614, Business and Professions Code. Reference: Sections 1647.30 and 1647.32, Business and Professions Code.
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