Current through Register Vol. 24-18, September 15, 2024
(1) Purpose. The
purpose of this rule is to promote and establish consistent standards,
continuing competency, and to promote patient safety. The board of osteopathic
medicine and surgery establishes the following rule for physicians licensed
under chapter 18.57 RCW who perform surgical procedures and use anesthesia,
analgesia or sedation in office-based settings.
(2) Definitions. The definitions in this
subsection apply throughout this section unless the context clearly requires
otherwise:
(a) "Board" means the board of
osteopathic medicine and surgery.
(b) "Deep sedation" or "analgesia" means a
drug-induced depression of consciousness during which patients cannot be easily
aroused but respond purposefully following repeated or painful stimulation. The
ability to independently maintain ventilatory function may be impaired.
Patients may require assistance in maintaining a patent airway, and spontaneous
ventilation may be inadequate. Cardiovascular function is usually
maintained.
(c) "General
anesthesia" means a state of unconsciousness intentionally produced by
anesthetic agents, with absence of pain sensation over the entire body, in
which the patient is without protective reflexes and is unable to maintain an
airway, and cardiovascular function may be impaired. Sedation that
unintentionally progresses to the point at which the patient is without
protective reflexes and is unable to maintain an airway is not considered
general anesthesia.
(d) "Local
infiltration" means the process of infusing a local anesthetic agent into the
skin and other tissues to allow painless wound irrigation, exploration and
repair, and other procedures, including procedures such as retrobulbar or
periorbital ocular blocks only when performed by a board eligible or board
certified ophthalmologist. It does not include procedures in which local
anesthesia is injected into areas of the body other than skin or muscle where
significant cardiovascular or respiratory complications may result.
(e) "Major conduction anesthesia" means the
administration of a drug or combination of drugs to interrupt nerve impulses
without loss of consciousness, such as epidural, caudal, or spinal anesthesia,
lumbar or brachial plexus blocks, and intravenous regional anesthesia. Major
conduction anesthesia does not include isolated blockade of small peripheral
nerves, such as digital nerves.
(f)
"Minimal sedation" means a drug-induced state during which patients respond
normally to verbal commands. Although cognitive function and coordination may
be impaired, ventilatory and cardiovascular functions are unaffected. Minimal
sedation is limited to oral, intranasal, or intramuscular
medications.
(g) "Moderate
sedation" or "analgesia" means a drug-induced depression of consciousness
during which patients respond purposefully to verbal commands, either alone or
accompanied by tactile stimulation. No interventions are required to maintain a
patent airway, and spontaneous ventilation is adequate. Cardiovascular function
is usually maintained.
(h)
"Office-based surgery" means any surgery or invasive medical procedure
requiring analgesia or sedation, including, but not limited to, local
infiltration for tumescent liposuction, performed in a location other than a
hospital or hospital-associated surgical center licensed under chapter 70.41
RCW, or an ambulatory surgical facility licensed under chapter 70.230
RCW.
(i) "Physician" means an
osteopathic physician licensed under chapter 18.57 RCW.
(3) Exemptions. This rule does not apply to
physicians when:
(a) Performing surgery and
medical procedures that require only minimal sedation (anxiolysis), or
infiltration of local anesthetic around peripheral nerves. Infiltration around
peripheral nerves does not include infiltration of local anesthetic agents in
an amount that exceeds the manufacturer's published recommendations.
(b) Performing surgery in a hospital or
hospital-associated surgical center licensed under chapter 70.41 RCW, or an
ambulatory surgical facility licensed under chapter 70.230 RCW.
(c) Performing surgery utilizing or
administering general anesthesia. Facilities in which physicians administer
general anesthesia or perform procedures in which general anesthesia is a
planned event are regulated by rules related to a hospital or
hospital-associated surgical center licensed under chapter 70.41 RCW, an
ambulatory surgical facility licensed under chapter 70.230 RCW, or a dental
office under WAC
246-853-655.
(d) Administering deep sedation or general
anesthesia to a patient in a dental office under WAC
246-853-655.
(e) Performing oral and maxillofacial
surgery, and the physician:
(i) Is licensed
both as a physician under chapter 18.57 RCW and as a dentist under chapter
18.32 RCW;
(ii) Complies with
dental quality assurance commission regulations;
(iii) Holds a valid:
(A) Moderate sedation permit; or
(B) Moderate sedation with parenteral agents
permit; or
(C) General anesthesia
and deep sedation permit; and
(iv) Practices within the scope of their
specialty.
(4)
Application of rule. This rule applies to physicians practicing independently
or in a group setting who perform office-based surgery employing one or more of
the following levels of sedation or anesthesia:
(a) Moderate sedation or analgesia;
or
(b) Deep sedation or analgesia;
or
(c) Major conduction
anesthesia.
(5)
Accreditation or certification.
(a) A
physician who performs a procedure under this rule must ensure that the
procedure is performed in a facility that is appropriately equipped and
maintained to ensure patient safety through accreditation or certification and
in good standing from an accrediting entity approved by the board.
(b) The board may approve an accrediting
entity that demonstrates to the satisfaction of the board that it has all of
the following:
(i) Standards pertaining to
patient care, recordkeeping, equipment, personnel, facilities and other related
matters that are in accordance with acceptable and prevailing standards of care
as determined by the board;
(ii)
Processes that assure a fair and timely review and decision on any applications
for accreditation or renewals thereof;
(iii) Processes that assure a fair and timely
review and resolution of any complaints received concerning accredited or
certified facilities; and
(iv)
Resources sufficient to allow the accrediting entity to fulfill its duties in a
timely manner.
(c) A
physician may perform procedures under this rule in a facility that is not
accredited or certified, provided that the facility has submitted an
application for accreditation by a board-approved accrediting entity, and that
the facility is appropriately equipped and maintained to ensure patient safety
such that the facility meets the accreditation standards. If the facility is
not accredited or certified within one year of the physician's performance of
the first procedure under this rule, the physician must cease performing
procedures under this rule until the facility is accredited or
certified.
(d) If a facility loses
its accreditation or certification and is no longer accredited or certified by
at least one board-approved entity, the physician shall immediately cease
performing procedures under this rule in that facility.
(6) Competency. When an anesthesiologist or
certified registered nurse anesthetist is not present, the physician performing
office-based surgery and using a form of sedation defined in subsection (4) of
this section must be competent and qualified both to perform the operative
procedure and to oversee the administration of intravenous sedation and
analgesia.
(7) Qualifications for
administration of sedation and analgesia may include:
(a) Completion of a continuing medical
education course in conscious sedation;
(b) Relevant training in a residency training
program; or
(c) Having privileges
for conscious sedation granted by a hospital medical staff.
(8) At least one licensed health
care practitioner currently certified in advanced resuscitative techniques
appropriate for the patient age group must be present or immediately available
with age-size appropriate resuscitative equipment throughout the procedure and
until the patient has met the criteria for discharge from the facility.
Certification in advanced resuscitative techniques includes, but is not limited
to, advanced cardiac life support (ACLS), pediatric advanced life support
(PALS), or advanced pediatric life support (APLS).
(9) Sedation assessment and management.
Sedation is a continuum. Depending on the patient's response to drugs, the
drugs administered, and the dose and timing of drug administration, it is
possible that a deeper level of sedation will be produced than initially
intended.
(a) If an anesthesiologist or
certified registered nurse anesthetist is not present, a physician intending to
produce a given level of sedation should be able to "rescue" a patient who
enters a deeper level of sedation than intended.
(b) If a patient enters into a deeper level
of sedation than planned, the physician must return the patient to the lighter
level of sedation as quickly as possible, while closely monitoring the patient
to ensure the airway is patent, the patient is breathing, and that oxygenation,
heart rate and blood pressure are within acceptable values. A physician who
returns a patient to a lighter level of sedation in accordance with this
subsection (9)(b) does not violate subsection (10) of this section.
(10) Separation of surgical and
monitoring functions.
(a) The physician
performing the surgical procedure must not administer the intravenous sedation,
or monitor the patient.
(b) The
licensed health care practitioner, designated by the physician to administer
intravenous medications and monitor the patient who is under moderate sedation,
may assist the operating physician with minor, interruptible tasks of short
duration once the patient's level of sedation and vital signs have been
stabilized, provided that adequate monitoring of the patient's condition is
maintained. The licensed health care practitioner who administers intravenous
medications and monitors a patient under deep sedation or analgesia must not
perform or assist in the surgical procedure.
(11) Emergency care and transfer protocols. A
physician performing office-based surgery must ensure that in the event of a
complication or emergency:
(a) All office
personnel are familiar with a written and documented plan to timely and safely
transfer patients to an appropriate hospital.
(b) The plan must include arrangements for
emergency medical services and appropriate escort of the patient to the
hospital.
(12) Medical
record. The physician performing office-based surgery must maintain a legible,
complete, comprehensive, and accurate medical record for each patient.
(a) The medical record must include all of
the following:
(i) Identity of the
patient;
(ii) History and physical,
diagnosis and plan;
(iii)
Appropriate lab, X-ray or other diagnostic reports;
(iv) Appropriate preanesthesia
evaluation;
(v) Narrative
description of procedure;
(vi)
Pathology reports, if relevant;
(vii) Documentation of which, if any, tissues
and other specimens have been submitted for histopathologic
diagnosis;
(viii) Provision for
continuity of postoperative care; and
(ix) Documentation of the outcome and the
follow-up plan.
(b) When
moderate or deep sedation, or major conduction anesthesia is used, the patient
medical record must include a separate anesthesia record that documents:
(i) The type of sedation or anesthesia
used;
(ii) Name, dose, and time of
administration of drugs;
(iii)
Documentation at regular intervals of information obtained from the
intraoperative and postoperative monitoring;
(iv) Fluids administered during the
procedure;
(v) Patient
weight;
(vi) Level of
consciousness;
(vii) Estimated
blood loss;
(viii) Duration of
procedure; and
(ix) Any
complication or unusual events related to the procedure or
sedation/anesthesia.
Statutory Authority:
RCW
18.57.005 and
18.130.050. 11-01-117, §
246-853-650, filed 12/17/10, effective
1/17/11.
