In this subtitle, the following terms have the meanings indicated. Terms Defined. “Department” means the Maryland Department of Health. “Facility” means a freestanding ambulatory care facility as defined in §B(4) of this regulation. “FDA” means the Food and Drug Administration of the U.S. Department of Health and Human Services. “Freestanding ambulatory care facility” means a: Freestanding surgical facility; Freestanding endoscopy facility; Freestanding facility utilizing major medical equipment; Freestanding birthing center; or Freestanding kidney dialysis center. “Health care practitioner” means a person who is licensed, certified, or otherwise authorized under the Health Occupations Article, Annotated Code of Maryland, to provide health care services in the ordinary course of business or practice of a profession. “License” means a document issued by the Secretary to a person to operate a freestanding ambulatory care facility. “Physician” means an individual licensed to practice medicine in this State under Health Occupations Article, Title 14, Annotated Code of Maryland. “Secretary” means the Secretary of Health or the Secretary's designee. "Unexpected adverse outcomes” means unanticipated negative outcomes, related to a patient's medical treatment and not related to the natural course of the patient’s illness or underlying disease condition.