8/8/2014 3:27 pm Date / Time filed with the Register of Regulations | VA.R. Document Number: R____-______ |
Virginia Register Publication Information
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Transmittal Sheet: Response to Petition for Rulemaking
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Initial Agency Notice
Agency Decision
Promulgating Board: | Board of Medicine |
Regulatory Coordinator: | Elaine J. Yeatts (804)367-4688 elaine.yeatts@dhp.virginia.gov |
Agency Contact: | Elaine Yeatts Agency Regulatory Coordinator (804)367-4688 elaine.yeatts@dhp.virginia.gov |
Contact Address: | Department of Health Professions 9960 Mayland Drive Suite 300 Henrico, VA 23233 |
Chapter Affected: | |
18 vac 85 - 20: | Regulations Governing the Practice of Medicine, Osteopathy, Podiatry, and Chiropractic |
Statutory Authority: |
State: Chapter 29 of Title 54.1 Federal: |
Date Petition Received | 08/08/2014 |
Petitioner | Michael Jurgensen for the Medical Society of Virginia |
Part VIII. Office-Based Anesthesia.
18VAC85-20-320. General provisions.
A. Applicability of requirements for office-based anesthesia.
1. The administration of topical anesthesia, local anesthesia, minor conductive blocks,
or minimal sedation/anxiolysis, not involving a drug-induced alteration of consciousness
other than minimal preoperative tranquilization, is not subject to the requirements
for office-based anesthesia. A health care practitioner administering such agents
shall adhere to an accepted standard of care as appropriate to the level of anesthesia
or sedation, including evaluation, drug selection, administration and management of
complications.
2. The administration of moderate sedation/conscious sedation, deep sedation, general
anesthesia, or regional anesthesia consisting of a major conductive block are subject
to these requirements for office-based anesthesia. The administration of 300 or more
milligrams of lidocaine or equivalent doses of local anesthetics shall be deemed to
be subject to these requirements for office-based anesthesia.
3. Levels of anesthesia or sedation referred to in this chapter shall relate to the
level of anesthesia or sedation intended and documented by the practitioner in the
pre-operative anesthesia plan.
B. A doctor of medicine, osteopathic medicine, or podiatry administering office-based
anesthesia or supervising such administration shall:
1. Perform a preanesthetic evaluation and examination or ensure that it has been performed;
2. Develop the anesthesia plan or ensure that it has been developed;
3. Ensure that the anesthesia plan has been discussed with the patient or responsible
party pre-operatively and informed consent obtained;
4. Ensure patient assessment and monitoring through the pre-, peri-, and post-procedure
phases, addressing not only physical and functional status, but also physiological
and cognitive status;
5. Ensure provision of indicated post-anesthesia care; and
6. Remain physically present or immediately available, as appropriate, to manage complications
and emergencies until discharge criteria have been met, and
7. Document any complications occurring during surgery or during recovery in the medical
record.
C. All written policies, procedures and protocols required for office-based anesthesia
shall be maintained and available for inspection at the facility.
18VAC85-20-340. Procedure/anesthesia selection and patient evaluation.
A. A written protocol shall be developed and followed for procedure selection to include
but not be limited to:
1. The doctor providing or supervising the anesthesia shall ensure that the procedure
to be undertaken is within the scope of practice of the health care practitioners
and the capabilities of the facility.
2. The procedure or combined procedures shall be of a duration and degree of complexity
that shall not exceed eight hours and that will permit the patient to recover and
be discharged from the facility in less than 24 hours.
3. The level of anesthesia used shall be appropriate for the patient, the surgical
procedure, the clinical setting, the education and training of the personnel, and
the equipment available. The choice of specific anesthesia agents and techniques shall
focus on providing an anesthetic that will be effective, appropriate and will address
the specific needs of patients while also ensuring rapid recovery to normal function
with maximum efforts to control post-operative pain, nausea or other side effects.
B. A written protocol shall be developed for patient evaluation to include but not
be limited to:
1. The preoperative anesthesia evaluation of a patient shall be performed by the health
care practitioner administering the anesthesia or supervising the administration of
anesthesia. It shall consist of performing an appropriate history and physical examination,
determining the patient's physical status classification, developing a plan of anesthesia
care, acquainting the patient or the responsible individual with the proposed plan
and discussing the risks and benefits.
2. The condition of the patient, specific morbidities that complicate anesthetic management,
the specific intrinsic risks involved, and the nature of the planned procedure shall
be considered in evaluating a patient for office-based anesthesia.
3. Patients who have pre-existing medical or other conditions that may be of particular
risk for complications shall be referred to a facility appropriate for the procedure
and administration of anesthesia. Nothing relieves the licensed health care practitioner
of the responsibility to make a medical determination of the appropriate surgical
facility or setting.
C. Office-based anesthesia shall only be provided for patients in physical status
classifications for Classes I, II and III. Patients in Classes IV and V shall not
be provided anesthesia in an office-based setting.
18VAC85-20-350. Informed consent.
Prior to administration, the anesthesia plan shall be discussed with the patient
or responsible party by the health care practitioner administering the anesthesia
or supervising the administration of anesthesia. Informed consent for the nature and
objectives of the anesthesia planned shall be in writing and obtained from the patient
or responsible party before the procedure is performed. Such consent shall include
a discussion of discharge planning and what care or assistance the patient is expected
to require after discharge. Informed consent shall only be obtained after a discussion
of the risks, benefits, and alternatives, contain the name of the anesthesia provider
and be documented in the medical record.
The surgical consent forms shall be executed by the patient or the responsible party
and shall contain a statement that the doctor performing the surgery is board certified
or board eligible by one of the ABMS boards and list which board or contain a statement
that doctor performing the surgery is not board certified or board eligible.
The surgical consent forms shall indicate whether the surgery is elective, medically
necessary, or if a consent is obtained in an emergency, the nature of the emergency.
18VAC85-20-370. Emergency and transfer protocols.
A. There shall be written protocols for handling emergency situations, including medical
emergencies and internal and external disasters. All personnel shall be appropriately
trained in and regularly review the protocols and the equipment and procedures for
handling emergencies.
B. There shall be written protocols for the timely and safe transfer of patients to
a prespecified hospital or hospitals within a reasonable proximity. For purposes
of this section "reasonable proximity" shall mean a licensed general hospital capable
of providing necessary services within 30 minutes notice to the hospital. There shall
be a written or electronic transfer agreement with such hospital or hospitals.
18VAC85-20-380. Discharge policies and procedures.
A. There shall be written policies and procedures outlining discharge criteria. Such
criteria shall include stable vital signs, responsiveness and orientation, ability
to move voluntarily, controlled pain, and minimal nausea and vomiting.
B. Discharge from anesthesia care is the responsibility of the health care practitioner
providing or the doctor supervising the anesthesia care and shall only occur when:
(i) patients have met specific physician-defined criteria; and (ii) ordered by the
health care practitioner providing or the doctor supervising the anesthetic care.
C. Written instructions and an emergency phone number shall be provided to the patient.
Patients shall be discharged with a responsible individual who has been instructed
with regard to the patient's care.
D. At least one person trained in advanced resuscitative techniques shall be immediately
available until all patients are discharged.
Agency Plan
The petition will be published on September 8, 2014 in the Register of Regulations
and also posted on the Virginia Regulatory Townhall at www.townhall.virginia.gov to
receive public comment ending October 8, 2014.
Following receipt of all comments on the petition to amend regulations, the Board
will decide whether to make any changes to the regulatory language. This matter will
be on the Board's agenda for its meeting on October 16, 2014.
Publication Date | 09/08/2014 (comment period will also begin on this date) |
Comment End Date | 10/08/2014 |