Mid-Atlantic Health Law TOPICS

When is an operating room not an operating room? When it is a "procedure room." For the owners of ambulatory surgery centers in Maryland, this distinction can make a world of difference. The only problem is, no one knows exactly what these terms mean.
The distinction between operating and procedure rooms has particular significance under Maryland's certificate of need (CON) program. Ambulatory surgery centers are exempt from CON requirements, meaning the center does not have to prove that the center is "needed" before it opens, as long as the center only has one operating room, even if the center also has one or more procedure rooms.
The Maryland Health Care Commission (HCC) recognizes that there is a difference between operating rooms and procedure rooms, and that some surgical procedures may and are performed in procedure rooms. The HCC, however, acknowledges the lack of a precise distinction between the two types of rooms.
The HCC's best guidance is that an "operating room" is "situated within a sterile corridor that can be appropriately used for 'open' or major surgical procedures usually involving general anesthesia [while 'procedure rooms'] typically refer to rooms which are appropriate only for minor surgical procedures, such as gastrointestinal endoscopy or other closed endoscopic procedures or many types of laser procedures, which do not require a sterile operating environment to be safely provided."
While there is no bright line defining the midpoint between the two types of rooms, the HCC will tell an inquiring health care entity whether a particular room qualifies as an "operating" or a "procedure" room. However, until and if the HCC sets new criteria, Maryland surgeons will have to proceed with caution, and rely on the ad hoc process now in place.