What you need to operate in Florida

Facility licensing for a mobile clinic

Florida licenses the mobile clinic itself when it bills for care. Section 400.9905, Florida Statutes defines a clinic as an entity that provides health care services and “tenders charges for reimbursement,” and says the term “includes a mobile clinic and a portable equipment provider.” The same section lists the exemptions, among them entities licensed as hospitals under chapter 395, practices wholly owned by one or more licensed physicians (or by other named licensed practitioners, dentists included), qualifying nonprofit entities and government entities. The Agency for Health Care Administration’s Health Care Clinics page handles both the license (chapter 400 Part X, F.S., and chapter 59A-33, F.A.C.) and the certificate of exemption for operators who qualify. Decide which side of that line your unit falls on before the build; it changes the paperwork.

Certificate of need

Not applicable. AHCA’s Certificate of Need program overview states that the program currently regulates hospices, freestanding inpatient hospice facilities, skilled nursing facilities and intermediate care facilities for the developmentally disabled, and “does not regulate outpatient services, home health services, purchases of major medical equipment, assisted living facilities, and hospitals.” No review applies to a mobile clinic or imaging unit.

X-ray and mammography registration

Any unit carrying an X-ray, dental X-ray or mammography machine registers it with the Florida Department of Health’s radiation machine program under chapter 404, F.S., and chapter 64E-5, F.A.C. New machines are approved before they go into service (DH Form 1107), fees are paid annually online, and mammography machines are inspected every year; the Department performs the federal MQSA inspection under contract with the FDA. Ask the program how it registers a machine mounted in a vehicle that works at more than one address.

In every state, a unit that performs mammography must also hold a federal certificate under the Mammography Quality Standards Act before it examines its first patient. The FDA’s MQSA certification page sets out the order: accreditation by an FDA-approved body first, then the certificate, then annual inspection. In Florida the FDA itself issues the certificate.

Mobile dental permits

No specific mobile-unit permit found. Chapter 466, Florida Statutes mentions “mobile dental” units only as a setting in which hygienists may work, not as a facility the Board registers. A dental unit that bills third parties falls under the AHCA clinic license above unless it is wholly dentist-owned or otherwise exempt. Confirm with the Florida Board of Dentistry before you plan on operating without a filing.