4731-25-03 Standards for surgery using moderate sedation/analgesia.

(A) A physician or podiatric physician performing procedures or surgery in the office setting during which moderate sedation/analgesia is administered shall:

(1) Demonstrate sufficient education, training and experience needed to conform to the minimal standards of care of similar practitioners under the same or similar circumstances by meeting at least one of the following criteria:

(a) Holding current privileges at a local hospital accredited by the joint commission on accreditation of healthcare organizations or the American osteopathic association or at a local ambulatory surgical facility licensed by the department of health for the procedure or surgery being performed;

(b) Being board certified by a specialty board recognized by the American board of medical specialties or the American osteopathic association or, if a podiatric physician, is board certified by the American board of podiatric surgery; and the surgery or procedure being performed is generally recognized as being within the usual course of practice of that specialty;

(c) Having successfully completed a residency training program approved by the accreditation council for graduate medical education of the American medical association or the American osteopathic association or, if a podiatric physician, having successfully completed at least a twelve month residency in podiatric surgery approved by the council on podiatric medical education; and the surgery or procedure being performed is generally recognized as being within the usual course of practice of that specialty; or

(d) Having successfully completed a didactic course supplemented by direct hands-on, monitored experience in the surgery or procedure being performed, and the surgery or procedure being performed is generally recognized as being within the usual course of practice of the specialty of the physician.

(2) Have current (within the immediately previous two years) advanced cardiac life support/advanced trauma life support training, or, in the case of pediatric patients under the age of thirteen, have current (within the immediately previous two years) pediatric advanced life support training.

(3) Ensure that assisting personnel are competent to administer and monitor moderate sedation/analgesia and to manage emergencies such as loss of airway, compromise of cardiovascular functions or anaphylaxis.

(4) A physician or podiatric physician performing surgeries or procedures using moderate sedation/analgesia in the office setting shall:

(a) Hold privileges to provide moderate sedation/analgesia from a local hospital accredited by the joint commission on accreditation of healthcare organizations or the American osteopathic association or from a local ambulatory surgical facility licensed by the department of health; or

(b) Have documented evidence of having completed at least five hours of category I continuing medical education relating to the delivery of moderate sedation/analgesia during the current or most recent past biennial registration period, such requirement to become effective on the one-hundred-eighty-first day following the effective date of this rule.

(B) Moderate sedation/analgesia may be administered in the office setting by only the following:

(1) A physician who holds privileges to provide moderate sedation/analgesia from a local hospital accredited by the joint commission on accreditation of healthcare organizations or the American osteopathic association or from a local ambulatory surgical facility licensed by the department of health;

(2) A certified registered nurse anesthetist who is acting under the supervision of and in the immediate presence of a physician or podiatric physician;

(3) A registered nurse who is acting under the supervision and in the immediate presence of a physician or podiatric physician, provided that such registered nurse shall only administer specifically prescribed doses of drugs selected by the physician or podiatric physician who shall be continuously present in the anesthetizing location during the administration of those drugs.

(C) The person administering and monitoring the moderate sedation/analgesia shall be at all times present in the anesthetizing location with the patient and cannot be the practitioner while performing the surgery or procedure. Further, the person administering and monitoring the moderate sedation/analgesia shall meet the training requirements of paragraph (A)(2) of this rule.

(D) A violation of any provision of this rule, as determined by the board, shall constitute "a departure from, or the failure to conform to, minimal standards of care of similar practitioners under the same or similar circumstances, whether or not actual injury to a patient is established," as that clause is used in division (B)(6) of section 4731.22 of the Revised Code.

Effective: 01/01/2004
R.C. 119.032 review dates: 01/01/2009
Promulgated Under: 119.03
Statutory Authority: 4731.05
Rule Amplifies: 4731.22