Clinic Design

Three Big Mistakes To Avoid When Developing a Hyperbaric Facility
Outpatient-focused specialty clinics have been around in some form or another since there were hospitals. Architects and builders know what is expected from a design and code compliance standpoint for a typical clinic, but when you add a hyperbaric oxygen (HBO) component, failure to understand and comply with the unique physical and regulatory requirements of a HBO program can be very costly.

Taking a hyperbaric facility from concept to completion without triggering an unplanned cost or delay event can be done, provided your design/build team has a thorough understanding of the critical components of a facility. Let’s look at three of the major pitfalls that can derail a program before it gets started:

#1 Not Knowing the Codes and Regulations

There is an alphabet soup of agencies and organizations that influence either the construction and marketing of hyperbaric chambers or the facilities that house them. Some of the standards published are recommendations only, while others are incorporated into law.

• Chamber construction: American Society of Mechanical Engineers (ASME)
• Marketing/Sales: Food and Drug Administration (FDA)
• Facility Design: American Institute of Architects (AIA), Undersea and Hyperbaric Medical Society (UHMS)
• Construction and Operations: National Fire Protection Association (NFPA)

Compliance with ASME and FDA rules is generally not an issue for new chambers, though occasionally you may run across an older multiplace chamber that was constructed prior to FDA oversight. A “pre-amendment” or “grandfathered” chamber may be used, but may trigger a closer inspection by regulators. The most common issues will be related to design and construction of the facility that houses the chambers.

Virtually every state references the NFPA standards, often through law, but not every state accepts the most current version, or has incorporated it into law due to legislative delays. You should determine which version is applicable to your facility to avoid conflicts. Some regulatory agencies may choose to apply a more recent standard despite a specific statutory citation.

AIA standards are applied by many states, but there are problems with the nomenclature used in the hyperbaric section. In addition, the AIA language is included as an Annex, which is supposed to be explanatory, rather than a Standard, which has more weight (from a regulatory standpoint). In fact, there is no Standard in the AIA document, but in the absence a Standard, some AHJ’s apply the Annex language, which can impact layout and design of the hyperbaric suite.

In addition to national standards, some states (Texas, Arkansas, and North Carolina) and localities have their own specific regulations regarding hyperbaric facilities. The language of these state-specific regulations is often at odds with standard industry nomenclature – for example, what the industry might consider the “foot” end of a monoplace chamber would be referred to as the “head” end.

Codes and standards often cross-reference (and contradict) each other, and often, the Authority Having Jurisdiction (AHJ) (which can range from a state healthcare agency to local fire marshal) may have limited understanding of what a hyperbaric chamber is or impose a more stringent requirement based on their interpretation of a particular standard.

#2 Not Knowing the Space

If your facility will be added to an existing building, it’s critical that you know the conditions of the space before starting construction. Blueprints may not accurately reflect as-built conditions or dimensions. There may be structural elements that cannot be removed, or hazardous materials such as asbestos that must be removed or abated.

Hyperbaric chambers, particularly multiplace systems or multiple monoplace chambers, can impose substantial structural loads that may require reinforcement of floors. A structural analysis should be conducted as part of the design phase of the project.
Oxygen supply and piping systems should be carefully evaluated to determine whether the existing system can accommodate the demands imposed by a hyperbaric facility. It is not uncommon to find a liquid oxygen system with an undersized supply tank or piping, which can lead to a complete overhaul of the hospital’s oxygen supply system. In some cases, it can be more cost-effective to install a dedicated oxygen supply for the hyperbaric facility rather than attempting to tie in to an existing system.

How will you get the chamber(s) into the facility? Is there a clear route from the loading dock/delivery area to the site? Are corridors wide enough to allow turns around corners? If the facility is located on an upper or
lower floor, are the elevators large enough to accommodate the equipment? Nothing is worse than having a shiny new facility on the 4th floor and discovering that the chambers are a foot longer than the elevator.

#3 Not Pre-Clearing the Plans

Once you’ve established a design, determined that the building will support the chamber(s), and verified that you can get the chambers into the site, take some time to have your plans reviewed by the AHJs – before construction begins. This is particularly important in areas that do not require pre-construction approval. Meeting with the agencies and individuals that will inspect the facility and issue certificates of occupancy can help you avoid issues that could delay your project.

The degree to which a given AHJ understands the nuances of hyperbaric facilities varies substantially. In areas with a strong hyperbaric presence, regulators are familiar with the applicable codes, and presuming that you’ve designed the facility to conform, approval is a simple process. If you find that the AHJ is unfamiliar with hyperbaric facilities, tactful education during a pre-approval conference can save you thousands of dollars and time delays.

In areas with few hyperbaric programs or inexperienced AHJs, the process can be frustrating. A common problem is misinterpretation or misapplication of code. The AHJ knows that NFPA standards apply, they look up the hyperbaric standard (Chapter 20 of NFPA 99), but fail to see that there are differences between the housing requirements for Class A (multiplace) and Class B (monoplace) chambers.

Pre-clearance is particularly important in areas that have their own specific regulations. For example, North Carolina requires that any electrical device have Underwriters’ Laboratories (UL) or similar approval. Until recently, no hyperbaric chamber manufacturer had such approval, and in order to operate a chamber in the state, a separate test had to be conducted on each chamber before it could be put into service. North Carolina has also imposed more stringent requirements on monoplace chamber exhaust hoses, requiring that these hoses be constructed of heat-resistant materials.

Regardless of what a particular code or standard says, the ultimate authority over your facility is the AHJ, and they have the power to shut down your project or allow it to proceed. Having an architect and builder who have both an understanding of applicable codes and close working relationships with AHJs can make the difference between a smooth opening or a costly delay.

There are a few approaches to avoid these mistakes:
• Discuss the regulatory and design issues with your architect and project manager to determine how familiar they are with the unique requirements of a hyperbaric facility. If they’ve never been involved with a hyperbaric project, they should start their research as soon as possible. Chamber manufacturers and oxygen suppliers are generally happy to provide assistance with design and specifications, particularly if you’ve agreed to buy their products.
• If you’re concerned about bias from vendors, you might find it reasonable to hire an independent consultant to advise you on specific issues related to project development. An “outside set of eyes” reviewing design or construction issues may find ways to save you thousands of dollars or weeks of time, at a relatively minimal upfront cost.
• For those who would prefer not to deal with these issues, there is always the turnkey contract approach. Some contract operators will tell you that a hyperbaric project is too complex for you to develop on your own (they are not, but do require you to do more work). A good contract operator will have a team in place that includes experts in facility development and construction, and be prepared to coordinate with the design/build team to expedite program development, since delays and costs impact them as much as you.
Whichever approach you choose, a small investment of time or dollars before breaking ground can lead to a program that is completed on time and on budget.

Steve Wood’s 25-year career in hyperbaric medicine has ranged from working as a clinician to building hyperbaric chambers to managing hyperbaric and wound care contract service providers. He is President of Hyperbaric Safety Systems, Inc. a firm specializing in hyperbaric technical consulting and development of innovative safety accessories for hyperbaric chambers.