n October 13, 2006, the Oregon Board of Medical Examiners (BME) adopted office-based surgery regulations. Oregon is the 22nd state to regulate the office-based setting via regulations, statutes or guidelines. Oregon’s rules address patient safety, selection of appropriate patients and procedures, discharge, medical records, emergency care and transfer protocols, quality assessment, and facility equipment and administration.

The rules provide that licensees of the BME who provide office-based invasive procedures are accountable for the welfare and safety of their patients. The licensees must demonstrate qualifications and competency for the procedures to be performed by becoming, or being board-certified by, a member of the American Board of Medical Specialties (ABMS). Alternatively, the governing body of the facility is responsible for a peer-review process for privileging physicians based on nationally recognized credentialing standards.

Facilities in which surgeries or procedures (other than minor procedures) are performed must be accredited by an organization recognized by the Oregon BME, national or state organization (Joint Commission on Accreditation of Healthcare Organizations, Accreditation Association for Ambulatory Health Care, American Association for Accreditation of Ambulatory Surgery Facilities, American Osteopathic Association, Institute for Medical Quality or Oregon Medical Association).

With respect to anesthesia, licensees must ensure that practitioners administering deep sedation or anesthesia and/or monitoring the patient shall not play an integral role in performing the procedure. At least one physician who is currently certified in advanced resuscitative techniques appropriate for the patient’s age group must be present or immediately available with age/size-appropriate resuscitative equipment until the patient has met the facility’s discharge criteria. Other medical personnel with direct patient contact must be trained in basic life support, at a minimum. The rules place responsibility on the facility’s governing body to provide health care providers who have appropriate education and training to administer moderate sedation/analgesia, deep sedation/analgesia or general anesthesia. Informed consent for the anesthesia planned and surgery to be performed must be obtained from the patient only after a discussion of the risks, benefits and alternatives.

The rules provide guidance in selecting appropriate office procedures and patients. The licensee of the BME who performs the surgical procedure and/or anesthetic must evaluate and document the patient’s condition and the potential risks associated with the treatment plan. The licensee must be satisfied that the procedure is within the scope of practice of the health care providers, facility’s capabilities and condition of the patient.

The licensee performing the procedure must determine that the patient is safe to be discharged from the office. The licensee also must ensure that all office personnel are familiar with a written documented plan for the timely and safe transfer of patients to a nearby hospital if necessary. This plan must include arrangements for emergency medical services and appropriate escort of the patient to the hospital.

Illinois — The Illinois Department of Public Health issued a proposal that would amend the ambulatory surgical treatment center regulations. The proposal would require a qualified physician to be present until all patients are medically discharged. Additionally, discharge criteria would be defined by the facility’s qualified consulting committee. Under existing law, the qualified physician must be present during the operative and postoperative periods for all patients.

Tennessee — The Tennessee Board of Medical Examiners has issued a proposal that would amend its office-based surgery regulations with respect to Level III surgical procedures. The duration of Level III surgeries would be less than four hours; existing law allows six hours. Level III surgeries would receive a site survey by the Department of Health. To qualify as a site for Level III surgery, all physicians who propose to perform such surgery would submit to the board the following: procedures to be performed, specialty board certification or board eligibility of the physicians performing procedures, verification of medical malpractice coverage and verification of hospital staff privileges.

Physicians performing Level III surgeries would inform and obtain written informed consent that the facility is not licensed by the state and explain the risks, benefits and alternatives. The informed consent form would include acknowledgement by the patient or patient’s representative that he or she has been informed of the option to have the surgery performed in a licensed facility.
Lastly the rules and regulations governing ambulatory surgical treatment centers relative to infection control, life safety, patient rights, hazardous waste, and equipment and supplies would apply to offices performing Level III procedures.