Office-Based Surgery

Alert

The Deadline for Accreditiation is Approaching.

Pursuant to Public Health Law section 230-d, "Licensees" ( physicians, physician assistants and specialist assistants) who perform invasive or surgical procedures using more than minimal sedation must practice in an accredited setting. The Commissioner of Health designated The Joint Commission, the American Association for the Accreditation of Ambulatory Surgical Facilities (AAAASF) and the Accreditation Association for Ambulatory Health Care(AAAHC) as the organizations which are authorized to perform the accreditation of practices which meet the definition of Office Based Surgery. A licensee who fails to practice in an accredited setting after July 14, 2009 may be guilty of professional misconduct.

Practices are encouraged to seek accreditation early because the process takes several months.

How will the July 14, 2009 accreditation deadline impact entities in the following variety of circumstances?

1. An existing practice completed the accreditation inspection prior to the July 14, 2009 deadline but the inspection revealed that the practice is not in compliance with one or more of the accrediting agency's OBS standards?

   The practice cannot perform procedures requiring moderate or deep sedation or liposuction involving the removal of 500 cc of fat or more until the accrediting agency finds that the entity meets all of the standards upon a follow up inspection.

2. An existing practice submits an application for accreditation prior to the July 14, 2009 deadline but not early enough for the accrediting agency to be able to inspect the practice prior to that date.

   The practice cannot perform procedures involving moderate or deep sedation or liposuction involving the removal of 500 cc of fat or more until the accrediting agency has conducted an inspection and found the practice to be in compliance with the accrediting agencies OBS standards.

3. An existing accredited practice is moving to a new site on or after July 14, 2009. The answer depends on which of the accrediting agencies is conducting the accreditation review and whether the move involves only a new location or changes in staff, policies, and/or procedures as well.

   Any practice that believes it will be changing locations around the time of the deadline should contact the appropriate accrediting agency to discuss the practice's particular situation with the agency and, at a minimum, should give the accrediting agency a minimum of thirty days' advance notice of the move in order to schedule a timely inspection of the new site.

4. A provider or group of providers plans on opening a new OBS practice soon after July 14, 2009. The new practice will not be able to perform procedures requiring moderate or deep sedation or liposuction involving the removal of 500 cc of fat or more until the accrediting agency has conducted a preliminary inspection and has found the practice to be in compliance with the accrediting agency's OBS standards for initial accreditation purposes. Follow up accrediting procedures vary among the accrediting agencies so any practice that believes it that will be opening a new OBS practice shortly after July 14, 2009 should review the procedures followed by the three accrediting agencies in such circumstances in order to determine which process will best accommodate the practice under this circumstance.

   Licensees who perform surgeries or procedures in an office-based setting that fall within the scope of Public Health Law § 230-d should bear in mind that the July 14, 2009 deadline is a statutorily imposed deadline and that they are therefore at risk of being found guilty of professional misconduct pursuant to Education Law § 6530 (48) for performing such surgeries or procedures in an office that is not accredited after that date. This is why the Department has gone to great lengths to publicize the law's requirements and the types of procedures and surgeries that are subject to the statute.

Office-Based Surgery Adverse Event Reporting Reminders

Please use the correct form (dated 9/08).

The updated form for submitting an adverse event report is located at http://www.nyhealth.gov/forms/doh-4431.pdf. The Patient Safety Center is receiving many reports on an earlier version of the form. Updates to the form will be automatically reflected on the online form. This form may be completed from your browser page. The completed form may then be printed, signed and submitted.

Answer all applicable questions.

The Patient Safety Center has received numerous incomplete forms. The items most often left blank include the date of the adverse event, procedure codes, level of anesthesia and drug information, and bloodborne pathogen transmission information.

All Physicians, Physician Assistants and Specialist Assistants Must sign the form.

The Office-Based Surgery legislation requires that all physicians, PA's and SA's involved in the event being reported MUST sign the submitted adverse event report. If the PSC receives an unsigned form, we are requiring the adverse event report to be resubmitted and signed appropriately.

If you have submitted a report using an older version of the form, an incomplete form or a form signed by only one of the practitioners involved in the reported event, the PSC sends submitters a letter informing them of this mistake. At this time submitters who have made these errors are not required to re-submit the report, but they may be in the future. Practitioners who have a continued pattern of filing legally deficient reports may result in referral to the Office of Professional Medical Conduct.