Current through Register 2024 Notice Reg. No. 12, March 22, 2024
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.
1. New
section filed 8-16-2022; operative 8-16-2022 pursuant to Government Code
section
11343.4(b)(3)
(Register 2022, No. 33).
Note: Authority cited: Section
1614,
Business and Professions Code. Reference: Sections
1647.30
and
1647.32,
Business and Professions Code.
