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 podiatric medical
board establishes the following rule for physicians licensed under chapter
18.22 RCW who perform surgical procedures and use analgesia or sedation in
office-based settings. This rule does not apply to any office-based procedures
performed with the use of general anesthesia.
(2) Definitions. The following terms used in
this subsection apply throughout this rule unless the context clearly indicates
otherwise:
(a) "Board" means the podiatric
medical board.
(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. 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.
(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" or "analgesia" 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 or
intramuscular medications, or both.
(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, 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 a podiatric physician
licensed under chapter 18.22 RCW.
(3) Exemptions. This rule does not apply to
physicians when:
(a) Performing surgery and
medical procedures that require only minimal sedation (anxiolysis) or
analgesia, or infiltration of local anesthetic around peripheral
nerves;
(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 using
general anesthesia. General anesthesia cannot be a planned event in an
office-based surgery setting. Facilities in which physicians perform procedures
in which general anesthesia is a planned event are regulated by rules related
to hospitals, or hospital-associated surgical centers licensed under chapter
70.41 RCW, or ambulatory surgical facilities licensed under chapter 70.230
RCW.
(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 below the
ankle.
(5) Accreditation
or certification. Within three hundred sixty-five calendar days of the
effective date of this rule, 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 from one of the following:
(a) The Joint Commission (JC);
(b) The Accreditation Association for
Ambulatory Health Care (AAAHC);
(c)
The American Association for Accreditation of Ambulatory Surgery Facilities
(AAAASF); or
(d) The Centers for
Medicare and Medicaid Services (CMS).
(6) Presence of an anesthesiologist or
anesthetist. For procedures requiring spinal or major conduction anesthesia
above the ankle, a physician authorized under chapter 18.71 or 18.57 RCW or a
certified registered nurse anesthetist authorized under chapter 18.79 RCW must
administer the anesthesia. Under
RCW
18.22.035(4)(b), podiatrists
shall not administer spinal anesthetic or any anesthetic that renders the
patient unconscious.
(7)
Qualifications for administration of sedation and analgesia shall include:
(a) Completion of a continuing medical
education course in conscious sedation; or
(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 (e.g., advanced cardiac life support
(ACLS), pediatric advanced life support (PALS) or advanced pediatric life
support (APLS)) 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.
(9) Sedation assessment and management.
(a) 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.
(b) Licensed health care practitioners
intending to produce a given level of sedation should be able to "rescue"
patients who enter a deeper level of sedation than intended.
(c) If a patient enters into a deeper level
of sedation than planned, the licensed health care practitioner 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, the heart rate and blood pressure are within
acceptable values.
(10)
Separation of surgical and monitoring functions.
(a) The physician performing the surgical
procedure must not provide the anesthesia or monitoring.
(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
transfer 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:
(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 post-operative 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) Type of sedation or anesthesia
used;
(ii) Drugs (name and dose)
and time of administration;
(iii)
Documentation at regular intervals of information obtained from the
intraoperative and post-operative 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
18.22.015 and
18.130.050. 11-01-141, §
246-922-650, filed 12/21/10, effective
1/21/11.
