In response to media coverage of dramatic adverse outcomes following office-based procedures, New York has enacted a new law which will require: (i) the accreditation of all facilities where outpatient surgical (and other invasive) procedures are performed and (ii) the reporting of certain adverse outcomes to state authorities. The statutes reporting requirement becomes effective on January 14, 2008 and the accreditation requirements must be met on or before July 14, 2009. The enactment represents a dramatic change for practitioners performing procedures under general anesthesia, conscious sedation, and/or deep sedation.

A commitment of time and other resources will undoubtedly be required to avoid the imposition of onerous sanctions attendant to non-compliance. Indeed, while compliance may prove costly, non-compliance will be deemed Professional Misconduct and could, in certain circumstances, result in loss of licensure.

The new statute defines "office-based surgery" to include all surgical and other invasive procedures performed: (i) in a location other than a hospital and (ii) where general anesthesia, deep (also referred to as "conscious") sedation and/or moderate sedation is employed.

Thus, while the statute exempts procedures performed with local anesthesia from its accreditation and reporting requirements, it nonetheless cuts across a wide variety of disciplines. Indeed, it will apply to many including surgeons, internists (performing colonoscopies and endoscopies), ophthalmologists and some dermatologists. The law has not yet been extended to podiatrists, dentists, oral surgeons and chiropractors (performing adjustments under general anesthesia). However, it does apply to anesthesiologist that assist in such procedures and they should be guided accordingly.
Practices offering-office based surgical (or other invasive) procedures will be required to maintain full accreditation by one of several nationally recognized accrediting agencies. Although the accreditation agencies have not yet been named, they will be designated by the Commissioner of Health in the weeks to come. Such practices will also be required to report to the Department of Health any:

(i) patient death within thirty days; (ii) unplanned transfer of a patient to a hospital; (iii) unscheduled hospital admission that occurs within 72 hours of the procedure (and where the admission exceeds 24 hours); and/or (iv) any other serious or life-threatening event following a procedure.

Additionally, the new law authorizes the Commissioner of Health to "adopt, promulgate or enforce" rules and regulations necessary to assure compliance. Therefore, it is likely that The Clinical Guidelines for Office-Based Surgical Procedures promulgated in December, 2000, will be adopted under this provision and carry the full force and effect of law. The Guidelines contain specific recommendations for accreditation, anesthesia, peri-operative care, monitoring equipment, informed consent and emergency care, and may be accessed at http://www.health.state.ny.us/nysdoh/obs/obs.htm

Under existing law, the Office of Professional Medical Conduct (OPMC) and the Office of Professional Discipline (OPD) have broad discretion to conduct on-site inspections and review patient charts to assure compliance with existing law. Accordingly, a dramatic increase in both on-site inspections and record requests is likely to follow. If you are contacted by OPMC or OPD, it would be prudent to consult counsel before permitting an inspection, providing records or providing any other requested information.

Thus, before undergoing a review by the Joint Commission for Hospital Accreditation (or any agency approved by the Commissioner of Health to grant accreditation), practices where office-based procedures are performed are well-advised to consult counsel who may retain an independent consultant to:

(i) undertake a review of the practice’s existing procedures, equipment and facilities; (ii) determine whether additional staff should be hired; (iii)implement written policies and procedures; and (iv) provide in-service training to all staff members concerning new procedures.

By retaining counsel to facilitate such review, all findings and suggestions are deemed confidential and protected by the attorney-client privilege. Given the draconian nature of the potential sanctions, "an ounce of prevention may be worth a pound of cure" and physicians are well-advised to strive for compliance well before the statute’s effective date.
Douglas M. Nadjari is the partner in the law firm of Jacobson, Goldberg & Kulb, LLP and has tried dozens of complex civil and criminal cases to a successful verdict. Prior to joining the firm, Mr. Nadjari was a partner in a major medical malpractice defense firm. He also served as Supervisor and Deputy Chief of the Major Frauds, Homicide and Felony Trial Bureaus in the Office of the Kings County District Attorney.