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A Healthy Dose of Compliance

Compliance with government regulations keeps healthcare facilities healthy for patients and shareholders alike.

By Matt Alderton

Like a caterpillar in a chrysalis, healthcare is in the midst of a major metamorphosis. What once was delivered to patients exclusively by physicians in hospitals or privately owned doctor’s offices is now being delivered by a diverse array of professionals — nurses, nurse practitioners, physicians assistants and pharmacists — in a diverse array of settings: outpatient surgery centers, retail health clinics, urgent care facilities and community pharmacies.

Joe Fairley, Laser Facility Management

“If you look really hard in your community, you’re going to see the changes that have been happening in healthcare over the last couple of years,” said Joe Fairley, Vice President of Business Development at Laser Facility Management, which provides facilities management services to clients in a wide variety of industries, including healthcare. “One of the biggest changes is that healthcare is now a retail business. Your local CVS, for example, now has a MinuteClinic inside it. Walgreens is doing the same thing by setting up clinics with VillageMD.”

No matter how much healthcare changes, however, at least one thing remains the same: regulation.

Along with financial services, transportation and energy, healthcare is one of the most regulated industries in the world. And rightly so, said Robert Blakey, Director and Senior Instructor at FM College, a continuing education provider whose training offerings for FMs include a course in healthcare facilities management. Regulators establish rules and standards not for the sake of burdening healthcare operations, he said, but rather to ensure the health and safety of patients and clinicians.

“It’s all about the patient and their care experience,” Blakey explained.

Failure to comply with government regulations could endanger not only patients, but also the business itself.

That’s because most healthcare operations are funded primarily by insurance. “If you want to get paid, you’ve got to comply with the standards, and most of the standards in the United States have evolved from the Medicare and Medicaid policies of the U.S. Department of Health,” Blakey explained.

The stakes are high. But with ample information and appropriate planning, healthcare FMs can ensure that their facilities are fully compliant and ready for anything.

Where to Begin

You can’t comply with regulations if you don’t know they exist. Compliance therefore begins with awareness.

There are two primary considerations that can help you begin the process of identifying relevant regulations: facility location and facility type.

Location is important because it determines jurisdiction. “We’re not just talking about federal agencies,” Fairley said. “We’re also talking about state agencies and municipal agencies. If you have a facility in Chicago, for example, who should you be looking to for answers? Is it Chicago? Is it Cook County? Or is it Illinois?”

In the case of regional or national chains, having multiple locations can mean answering to many different regulators with many different rules and requirements.

Joshua Brackett, Banner Health and Legacy FM

The type of facility you run also matters, according to Joshua Brackett, System Regulatory Director at Banner Health, one of the largest nonprofit healthcare systems in the country, and Co-founder and Chief Code Geek at Legacy FM, which develops healthcare facility-specific training and empowerment programs for FM teams across the country. Although fire- and life safety-related regulations typically are universal across facility types, other requirements can be specific to certain healthcare operations.

“For example, a fire door is a fire door must be inspected to NFPA 80 [the National Fire Protection Association’s standard for fire doors] annually,” Brackett said. “However, there are systems that exist in some facilities that don’t in others. For example, compounding pharmacies are held to USP-797 or USP-800 [U.S. Pharmacopeia’s standards for handling compounded and hazardous drugs in healthcare settings], which has stringent pressure, temperature and humidity requirements.”

The universe of potential regulators is large and diverse. At the federal level alone, healthcare facilities may be responsible to the Centers for Medicare & Medicaid Services (CMS), which oversees all Medicare- and Medicaid-certified providers and suppliers; the Joint Commission (or any other deemed accrediting organization (AO) that is under CMS’s oversight), which accredits and certifies more than 22,000 healthcare organizations and programs in the United States; the Occupational Safety and Health Administration (OSHA), which regulates workplace safety; not to mention the U.S. Drug Enforcement Agency (DEA), the U.S. Food and Drug Administration (FDA), the U.S. Environmental Protection Agency (EPA) and many more, all of which regulate the physical healthcare environment.

To make sense of the “alphabet soup” that is healthcare regulation, Fairley recommended conducting a needs assessment wherein you break your facility down to its individual components — for example, HVAC, fire protection and waste disposal — then identify relevant regulators by way of reverse engineering.

“There are several good training programs that can help you get the basic knowledge you need,” Blakey added, citing as examples the Certified Healthcare Operations Professional (CHOP) program from Det Norske Veritas (DNV) and the Certified Healthcare Facility Manager (CHFM) program from the American Society for Healthcare Engineering (ASHE), which is the largest professional membership group under the American Hospital Association (AHA).

Achieving an ‘Always-Ready’ Mindset

Once you’ve determined who your regulators are and what regulations apply, the next step is designing processes and procedures that ensure compliance.

“A building is really just a list of assets and the people interacting with those assets,” explained Fairley, who recommends taking inventory of all the assets in your facility, then developing standard operating procedures that govern how employees, patients and others should engage with them. If you have an exam room, for example, you’ll need procedures for cleaning, restocking and disposal of medical waste, just to name a few.

Standard operating procedures (SOPs) are critical because regulators don’t just infer compliance with standards and regulations. Rather, they enforce it — typically through inspections, which can happen at a moment’s notice.

“Most inspections are a surprise inspection, with the idea being that you need to be in compliance 100% of the time,” Blakey said.

Echoed Fairley, “It’s almost like you have to have eyes in the back of your head, because anybody who walks in the door could be someone who’s there to review, inspect or audit. And for some facilities, there could be 10 different entities who could show up for that purpose at any time.”

Still, there is a cadence to most inspections that can help FMs prepare, even if they can’t predict. “There is a cycle for how these inspections are conducted,” Blakey continued. “So while you don’t know exactly which day they’re going to come out, most of us have figured out there’s a window of a few months during which time we’re expecting an inspection.”

The local fire marshal, for example, typically performs a building evaluation once per year, according to Brackett. CMS, on the other hand, might survey your facility more or less often.

“If it is CMS directly, then it is scheduled to be an annual survey,” Brackett said. “However, CMS has third-party contractors known as accrediting organizations (AOs) that help validate that facilities meet the federal law known as the Conditions of Participation to receive government (Medicare and Medicaid) funding. These AOs set their own standards and CMS validates them. The Joint Commission, for example, surveys every three years. However, DNV surveys every year.”

Given the erratic nature of inspections, it’s important to have an always-ready mindset, according to Blakey, who recommended regular self-inspections as a way to cultivate vigilance and preparedness. “This could be something you as an FM leader do for your facilities, or it could be something where you hire an outside expert,” he said, adding that self-inspections can build confidence by affirming areas where you’re compliant and competence by identifying areas where you need improvement.

The final piece of the puzzle is training. “It’s not just the facilities manager who needs to know this stuff. It’s everyone who’s working in the facility,” explained Blakey, who said inspectors may approach employees at random in order to ask questions. “It’s important that policies and procedures aren’t just written down in a book and put on a shelf. There needs to be alignment between what’s written down and what your actions are in the facility.”

Therein lies the secret to healthcare compliance: It’s not just about identifying relevant regulations or developing policies and procedures in response. Rather, it’s about seeing your facility through the eyes of regulators — all day, every day.

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