The Lines of Office Compliance Have Never Been So Blurred, Or Carry Such Liability

Nov 06, 2019 at 03:45 pm by pj


What was once a very simple designation of “medical office” has been blurred. Just the term medical office used to mean a doctor’s office with clinical exam rooms where basic diagnostics, laboratory, and simple noninvasive minor procedures could be performed. The space was designed to include strategically located clean and dirty areas, and the patients flowed in and out of each as needed without even noticing the intentional layout of the structure. Compliance was maintained by training the staff in compliant behaviors that were in place from the opening of the medical office – no changes in operations meant no compromise to compliance occurred. Why are those simple days of compliance gone?

Today, a doctor’s office can be a beauty salon on one side, a weight loss clinic on the other, with a surgical room in the middle – all while still being known as a doctor’s office. The owner or owners are working hard to stay relevant and profitable in the dramatically changing landscape that is today’s healthcare industry. The once simple, clean and dirty designations are lost, and what the patient flows through is far more about aesthetics and spaces defined by convenience than any kind of state or federally compliant design. Status quo inertia is no longer adequate to maintain compliance. This problem is not an issue of putting up with overly enthusiastic regulations. People are getting infections and tragically dying from office-based treatments and procedures.


How is it that we got to this point?

The rise of medical equipment generating new revenue is a key challenge in offices maintaining compliance. Today, keeping the doors open requires more than just office consults. Patients need treatments and those treatments must generate revenue. The problem is that the equipment representative selling the newest laser or other money-making technology is not concerned about your sterile processing. They happily train the physician and staff, handing off the scope and saying it needs to be sterilized after each use, which meets their obligations. The dilemma is the new ‘money-maker’ was never considered during the design of the facility. The added table-top sterilizer or ultrasonic cleaner gets set-up next to the treatment bed, or on the counter in the breakroom because there is nowhere else in the practice to put them. As incidental as this may seem, failing to maintain compliant cleaning practices will be an issue with the new unannounced inspections the state can start in 2020.

The risks of new treatments that are poorly supported by the traditional medical office is nothing compared to the ever-expanding medical office approved surgeries. Over the last ten years, seemingly boundless new procedures are performed in office-based surgery (OBS). Equipment representatives are sure to tell you about having the right patient monitor, oxygen and defib units. However, it is not their job to warn you about functional space requirements to maintain compliant practices for these procedures. So how does a medical office add money-making equipment and perform revenue generating procedures, while ensuring they are maintaining a regulatory compliant facility that reduces the patient’s risk and the office’s exposure to liability?

The quick answer is OBS compliance has never been so compromised. That should not be news to doctors, nurses, or staff of a medical office. It is certainly not news to the state, who passed Senate Bill 732. This bill created section 458.328,FS Office Surgery Registration as of January 1, 2020. This allows for annual inspections by the Department of Health, which may be unannounced, and it empowers the Board of Medicine to impose fines and even revoke the designated physician’s license where failure to meet regulations are identified. The risks to the physician, their patients, and their practice is real, and the state is serious about taking action where non-compliance is determined.

Medical office compliance for OBS and the “Medical Office” has never been more important. Getting focused on developing and implementing policies and procedures that address regulations, standards, and best practices, as well as the functional design issues of the space is fundamental. Seriously taking on compliance can reveal simple solutions when the practice takes the time to identify the issues and options for addressing them. The practice cannot fix what is not identified as flawed. Establishing compliance is not difficult but it takes work. Actions like relocating equipment and setting-up protocols can create compliant space by distinguishing behaviors and designating operations. This is worth the work it takes.

Time and focus, can reduce liability, improve patient care, and perhaps even save the physician’s license. When compliance is done right, it can improve patient flow and improve the bottom line. It is not too late for many offices who perform OBS to fall in line and avoid fines and penalties from the new regulations. However, if the physician owner of the practice is waiting for the letter from the state advising them they have 45 days to respond, they will have crossed the line and there will be nothing blurry about it.


Tony Cowan is a Healthcare Risk Manager, the Director of Emergency Response Technologies for Clinics on Wheels™ at World Housing Solution, Inc. An experienced healthcare consultant, he supported hundreds of surgery centers to attain on-budget, on-time openings, passing state licensure, Medicare certification, and accreditation. Currently he develops and delivers mobile clinics to rural or disaster impacted areas that are medically compliant, can pass accreditation, and become part of the medical public health infrastructure for communities in need. Contact him at