LAC 46:XLV.7309
LAC 46:XLV.7309. Prerequisite Conditions
Cite as La. Admin. Code tit. 46, pt. XLV, § 7309
A. For all office-based surgical procedures, the level of sterilization shall meet current OSHA requirements.
B. Complete medical records and documentation must be maintained for each surgical procedure including anesthesia records when applicable. For Level I, Level II, and Level III cases, the medical record must include written informed consent from the patient reflecting the patient’s knowledge of identified risks, consent to the procedure, type of anesthesia, and anesthesia provider.
C. The physician must maintain a log of all Level II and Level III surgical procedures performed, which must include a confidential patient identifier, the type of procedure performed, the type of anesthesia used, the duration of the procedure, the type of postoperative care, and any surgical events. The log and all surgical records shall be provided to investigators of the Louisiana State Board of Medical Examiners upon request.
D. In any liposuction procedure, the physician is responsible for determining the appropriate amount of supernatant fat to be removed from the patient. Using the tumescent method of liposuction, the physician must fully document the anticipated amount of material to be removed in a manner consistent with recognized standards of care. Post-operatively, any deviation from the anticipated amount, and the reason for deviation, must be fully documented in the operative report. Morbidly obese patients should have liposuction performed in a hospital setting unless the physician can document significant advantage to an alternative setting.
E. A policy and procedure manual must be maintained in the office and updated annually. The policy and procedure manual must contain provisions for:
1. duties and responsibilities of all personnel;
2. cleaning and infection control;
3. a written response plan for emergencies within the facility;
4. personnel training in emergency procedures; and
5. transfer agreements.
F. The performing physician shall report to the board any surgical event that occurs within the office-based surgical setting. This report shall be made within 15 days after the occurrence of a surgical event on a form designated by the board. The filing of a report of surgical event as required by this rule does not, in and of itself, constitute an acknowledgment or admission of malpractice, error, or omission. Upon receipt of the report, the Board may, in its discretion, obtain patient and other records pursuant to authority granted by the Medical Practice Act and pertinent administrative rules.
G. In offices where Level II and Level III office-based surgery is performed, a sign must be prominently posted in the office which states that the office is a doctor’s office regulated pursuant to the rules of the Louisiana State Board of Medical Examiners. This notice must also appear prominently within the required patient informed consent.
H. Office surgery facilities should adhere to recognized standards and best practices.