or more than a decade, the New York State Society of Anesthesiologists (NYSSA) has sought to enhance the safety of office-based surgery. In 2000, guidelines were adopted by the Department of Health (Department) that include recommendations for anesthesia, presurgical and postsurgical evaluations, monitoring equipment, informed consent, emergency protocols and credentialing. The guidelines survived legal challenges, and in 2004, New York’s highest court upheld the validity of the guidelines.

NYSSA continued to advance its commitment to patient safety, which recently resulted in the enactment of legislation that creates additional safeguards for patients undergoing office surgeries. A. 7948/S. 6052 defines office-based surgery as any surgical or other invasive procedure requiring general anesthesia, moderate sedation or deep sedation and any other liposuction procedure that is performed in a location other than a hospital. This legislation requires full accreditation by a nationally recognized accrediting agency and adverse event reporting. An adverse event includes patient death within 30 days; unplanned transfer to a hospital; unscheduled hospital admission within 72 hours of the surgery or for longer than 24 hours; or any other serous or life-threatening event. Licensees (physicians, physician assistants and special assistants) must report adverse events to the Department’s patient safety center within one business day of the occurrence. The reported data is confidential and cannot be released except under limited circumstances.

Additionally, accrediting agencies shall report to the Department, at a minimum, aggregate data on adverse events for all office-based surgical practices accredited by the agencies. The Department may disclose reports of the aggregate data to the public. Lastly, the Department’s commissioner must adopt and enforce regulations to effectuate this legislation. If such rule would affect the scope of practice of a health care practitioner (other than physicians, physician assistants or special assistants), the regulation must be made with the concurrence of the Commissioner of Education.

Congratulations to NYSSA, especially Scott B. Groudine, M.D., and Rebecca S. Twersky, M.D., for their commitment to this issue.

Office-Based Surgery Regulations Proposed in Indiana
Indiana’s office-based surgery proposed regulation is the culmination of six years of discussions by interested parties concerning the need to regulate the office-based setting. The Indiana Society of Anesthesiologists has been a major player throughout the process. In August, the Medical Licensing Board of Indiana will conduct a public hearing on the proposal. Per Indiana law, the proposed rule must be reviewed by Indiana’s budget agency and approved by the governor before it becomes law.

The proposed rule applies to any facility, clinic, office or other setting where procedures are performed that require moderate sedation/analgesia, deep sedation/analgesia, general anesthesia or regional anesthesia. Regional anesthesia would include local or superficial nerve blocks if the total dosage administered exceeds the recommended maximum dosage per body weight described in the manufacturer’s package insert.

Because sedation is a continuum, practitioners intending to produce a given level of sedation would be able to rescue a patient whose level of sedation becomes deeper than initially intended. Practitioners (M.D./D.O.) administering regional anesthesia or supervising or directing the administration of regional anesthesia would be knowledgeable about the risks of regional anesthesia and the interventions required to correct adverse physiological consequences that may occur. Additionally, health care providers could not administer or monitor anesthetic agents containing alkylphenols unless the provider is trained in the administration of general anesthesia and is not involved in the conduct of the procedure.

As of January 1, 2010, accreditation would be required by an accrediting agency approved by the medical licensing board. To approve an accreditation agency, the board would ensure that the certification program, at a minimum, includes the following standards for anesthesia, procedures and facilities and equipment:

Standards for Anesthesia: With respect to anesthesia, practitioners would select patients for office surgery by criteria, including the ASA Physical Status Classification System. The level of anesthesia would be appropriate for the patient, procedure, setting, educational training of the personnel and equipment available.

The health care provider administering anesthesia would be licensed, qualified and working within the provider’s scope of practice. If a nonphysician provider administers anesthesia, the provider would be under the direction and supervision of a practitioner. If the nonphysician provider is a nurse anesthetist, the nurse would be under the direction and in the immediate presence of a practitioner (M.D./D.O.).

A health care provider who administers anesthesia and practitioner who performs the procedure or directs or supervises the administration of anesthesia would maintain current training in advanced resuscitation techniques (advanced cardiac life support [ACLS] or pediatric advanced life support [PALS]).

At least one person with ACLS or PALS training would be immediately available until the patient is discharged. In addition to the health care provider performing the procedure, sufficient numbers of qualified health care providers would be present to evaluate the patient, assist with the procedure, administer and monitor anesthesia, and recover the patient. Other health care providers involved would maintain training in basic cardiopulmonary resuscitation, at a minimum.

Patients who have pre-existing medical or other conditions who may be at particular risk for complications would be referred to a hospital, ambulatory surgical center (ASC) or another office-based setting appropriate for the procedure and the administration of anesthesia.

The health care provider administering anesthesia or supervising or directing the administration of anesthesia would: perform the preanesthetic examination and evaluation or ensure that it has appropriately been performed by a qualified health care provider; develop the anesthesia plan or personally review and concur with the plan if developed by a nurse anesthetist; and remain physically present during the operative period and immediately available until the patient is discharged from anesthesia care.

Standards for Procedures: Procedures performed in the office setting would be provided by qualified health care providers and would be of a duration and complexity that permit patients to be discharged in less than 24 hours.

Standards for Facilities and Equipment: Practitioners who perform a procedure requiring anesthesia or who direct or supervise the administration of anesthesia would have admitting privileges at a local hospital, transfer agreement with another practitioner who has admitting privileges or an emergency transfer agreement with a local hospital. Such practitioner would demonstrate competency by maintaining privileges at an accredited or licensed hospital or ASC for the procedure to be performed. Alternatively, the governing body of the office would be responsible for a peer-review process for privileging practitioners based on nationally recognized credentialing standards. Practitioners would have appropriate education and training and would ensure that informed consent is obtained prior to performance of the procedure.

Written procedures for peer revieiw to determine the appropriateness of clinical decision making and quality of care would be established and reviewed at least annually. Lastly, agreements with local emergency medical services (EMS) would be in place to transfer patients to the hospital should an emergency arise. EMS agreements would be re-signed at least annually.

Lisa Percy, J.D., manages state affairs for ASA’s Office of Governmental and Legal Affairs in Washington, D.C.