|Petition Title||Revisions to regulations for office-based anesthesia|
|Date Filed||8/8/2014 [Transmittal Sheet]|
|Petitioner||Michael Jurgensen for the Medical Society of Virginia|
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;
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.
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.
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.
|Comment Period||Ended 10/8/2014 0 comments|
|Agency Decision||Initiate a regulatory change [Transmittal Sheet]|
|Agency Decision Summary||
The intent of the Board is to address the need for additional public protection in the administration of office-based anesthesia. Specific amendments recommended by the petitioner will be considered, as well as comments received on the petition and on the NOIRA.
|Associated regulatory action||Requirements for office-based anesthesia Latest Stage: Final|
|Name / Title:||Elaine Yeatts / Agency Regulatory Coordinator|
9960 Mayland Drive
|Telephone:||(804)367-4688 FAX: (804)527-4434 TDD: ()-|