Hospitals, Who Regulates Them?

Hospitals are one of the most regulated organizations in this country, and for good reason: the healthcare environment is one of the most complex in terms of services, equipment, and maintenance. As such, they must meet rigorous standards at the federal, state, and local levels. These standards are set by various agencies and regulatory groups and comprise five different areas of the hospital as an institution, from construction to patients and staffing. An overview of these five main areas follows.

Construction

Before a hospital can even be built, it must have a Certificate of Need, which is a regional assessment that has been made into a law that shows the need for hospital beds in a geographic area. This assessment is based on data from the Department of Housing and Urban Development (HUD).

Once the need is established, building permits must be approved, and the structure is designed using best practices set forth by the Facility Guidelines Institute for Design and Construction (FGI). The design must meet the Health Care Facilities Code and Life Safety Code. Finally, the building must meet National Fire Protection Association safety standards.

Supplies and Equipment

Now that the building is up and running, it needs to be stocked with equipment, supplies, medicine, and furniture. It’s probably no surprise that the Food and Drug Administration regulates anything that touches or enters a patient’s body — not just food and drugs, but also medical devices that stay inside the body (for example, a pacemaker) and syringes.

The Drug Enforcement Administration (DEA) regulates access to controlled substances like medicine and other pharmaceuticals, including the shipment, storage, and distribution of them. Likewise the Environmental Protection Agency (EPA) has authority over cleaning supplies and any product that makes public health claims.

Telecommunications, which range from phone calls to telemetry (collecting data from remote locations and sending it to a receiving device for monitoring), are regulated by the Federal Communications Commission (FCC). They also provide broadband to underserved communities for telehealth purposes. The ambulances are regulated by the Department of Transportation and emergency helicopters by the Federal Aviation Administration.

Medical Staff

Next comes the hospital staff. Each type of medical field has its own certification process, but once those medical professionals are in the building, they fall under a few other regulatory agencies. The Department of Labor governs employee pay here, just like any other field of employment.

And OSHA, the Occupational Safety and Health Administration, ensures the safety of employees by creating standards for environmental working conditions that must be met. Those posters with lists and charts hanging in most, if not all, workplaces in this country — it’s the same for hospital employees. No one wants to slip on a wet floor because a bright yellow, mini sandwich board sign wasn’t placed there.

Patients

Here come the patients! There are many regulatory bodies that monitor health procedures and treatments. The hospital must meet these healthcare requirements in order to receive Medicare and Medicaid reimbursement. The hospital’s accreditation is provided by three national groups, most notably The Joint Commission.

Health and Human Services (HHS) provides grants for underserved patient outreach. A hospital can perform transplant surgeries by meeting the standards of the Organ Procurement and Transplantation Network. The National Research Corporation collects patient feedback through a subdivision called the Consumer Assessment of Healthcare Providers and System.

Administration

Finally, the behind-the-scenes staffing, or hospital administration, has various regulatory groups. Medical Administrative Contractors, or MACs, help hospitals file reimbursements. The IRS authorizes tax-exempt status for nonprofit hospitals and helps them educate patients on payment assistance options.

The Federal Trade Commission (FTC) protects patients from unfair practices and healthcare monopolies, just like it protects the general consumer population from poor business conduct. The Treasury Department monitors charitable donations, and both they and the IRS regulate financial assistance through the Affordable Care Act.

The SEC regulates investors and the stock markets where for-profit healthcare companies are traded. And the FBI handles healthcare fraud, including insurance fraud.

The construction and operation of a hospital concerns many regulatory agencies that make sure the patient has the safest and best quality care possible. Hospitals are very complex environments that require involvement from various fields of service — medical, administrative, technological, environmental, to name a few.

Without some oversight from all of these regulating bodies, many things can go wrong. Hospitals could not be the safe haven and life-saving resource they are if they were not governed by these groups.

They can only be as good as the people that run them and work in them, but given the margin of human error, it helps mediate that risk to have multiple sources of accountability. In this case, the more the better: quantity equals quality. And ultimately, that amounts to peace of mind for everyone.