AGENCY FOR HEALTH CARE ADMINISTRATION
Health Facility and Agency Licensing
RULE NO.:RULE TITLE:
59A-3.065Definitions
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 45 No. 61, March 28, 2019 issue of the Florida Administrative Register.
The following sections of the proposed rule will be changed to read:
59A-3.065 Definitions.
In addition to definitions contained in chapters 395 and 408, part II, F.S., the following definitions shall apply specifically to hospitals, as used in rules 59A-3.065-.310, F.A.C.:
(1) “Adult congenital patient” means a person age 18 years and over who previously received pediatric cardiac services for congenital heart disease, or who was referred for specialized procedures for congenital heart disease. A hospital authorized to provide pediatric cardiac services may provide the services to adult congenital patients regardless of the age of the patient.
(2) “Adult” means a person age 18 years and older.
(1) renumbered to (3)
(4)(2) “Agency” or “AHCA” means the Agency for Health Care Administration (AHCA).
(3) through (4) renumbered (5) through (6)
(7) “Bone Marrow Transplantation” means human blood precursor cells administered to a patient to restore normal hematological and immunological functions following ablative or nonablative therapy with curative or life-prolonging intent. Human blood precursor cells may be obtained from the patient in an autologous transplant or from a medically acceptable related or unrelated donor, and may be derived from bone marrow, circulating blood, or a combination of bone marrow and circulating blood.
(5) through (7) renumbered (8) through (10)
(11) “Complex Neonatal Surgery” means any surgical procedure performed upon a neonate by a practitioner credentialed to perform surgical procedures licensed under the provisions of Chapters 458 or 459, F.S., which is associated with entry into or traversing a body cavity, such as the abdomen, thorax, or cranium, with a requirement for either general anesthesia or conscious sedation. Such procedures shall only be performed in hospitals licensed under the provisions of Chapter 395, F.S., providing Level III or Level IV Neonatal Intensive Care Services. Specific licensure pursuant to Rules 59A-3.246 or 59A-3.248 is required to perform pediatric transplants or pediatric cardiac services, respectively.
(8) through (10) renumbered (12) through (14)
(15) “Diagnostic cardiac catheterization procedure” means a medical procedure requiring the passage of a catheter into one or more cardiac chambers of the left and right heart, with or without coronary arteriograms, for the purpose of diagnosing congenital or acquired cardiovascular diseases, or for determining measurement of blood pressure flow. Cardiac catheterization also includes the selective catheterization of the coronary ostia with injection of contrast medium into the coronary arteries. A single session with a patient in the hospital’s cardiac catheterization procedure room, irrespective of the number of specific procedures performed during the session shall be counted as one procedure.
(11) through (17) renumbered (16) through (22)
(18) “General hospital” as defined in section 395.002(10), F.S., means any facility which meets the provisions of subsection (29) and which regularly makes its facilities and services available to the general population.
(19) through (20) renumbered (23) through (24)
(25) “Immediately available” means on the premises where pediatric cardiac services are being performed.
(26)(21) “Inpatient beds” means accommodations with supporting services for patients who are admitted by physician order with the expectation that the patient would stay in excess of 24 hours and occupy a bed. Bed types include:
(a) “Acute care bed” means a bed for patients having short-term medical treatment of an acute illness or injury, or recovering from surgery or childbirth;
(b) “Adult psychiatric bed” means a bed within a physically and functionally distinct unit of a hospital for the exclusive use of inpatient psychiatric services to adult patients whose sole diagnosis or principal diagnosis is a psychiatric disorder;
(c) “Adult substance abuse bed” means a bed within a physically and functionally distinct unit of a hospital for the exclusive use of inpatient substance abuse services to adult patients whose sole diagnosis or principal diagnosis is a substance abuse disorder;
(d) “Child psychiatric bed” means a bed within a physically and functionally distinct unit of a hospital for the exclusive use of inpatient psychiatric services to pediatric patients whose sole diagnosis or principal diagnosis is a psychiatric disorder;
(e) “Child substance abuse bed” means a bed within a physically and functionally distinct unit of a hospital for the exclusive use of providing hospital inpatient substance abuse services to pediatric patients whose sole diagnosis or principal diagnosis is a substance abuse disorder;
(f) “Comprehensive medical rehabilitation bed” means a bed within a physically and functionally distinct unit of a hospital for the exclusive use of providing integrated intensive care services provided by a coordinated multidisciplinary team to patients with severe physical disabilities, such as stroke, spinal cord injury, congenital deformity, amputation, major multiple trauma, hip fracture, brain injury, polyarthritis (including rheumatoid arthritis), neurological disorders (including multiple sclerosis, motor neuron diseases, polyneuropathy, muscular dystrophy, and Parkinson's disease), and burns;
(g) “Intensive residential treatment program for children and adolescents bed” or “intensive residential treatment facility bed” or “IRTF bed” means a bed within a class IV hospital or a physically and functionally distinct unit within a class III psychiatric hospital for the diagnosis and treatment of pediatric patients having a psychiatric disorder in order to restore them to an optimal level of functioning;
(h) “Long term care bed” means an acute care bed within a Class I long term care hospital for the treatment of medically complex patients
(i) “Neonatal intensive care unit bed or NICU bed” means a patient care station within a physically and functionally distinct unit in which Level II, III, or IV Neonatal Intensive Care Services are provided;
(j) “Skilled nursing unit bed” means an acute care bed within a physically and functionally distinct unit in which short term care and rehabilitation services are provided by licensed practical nurses and registered professional nurses.
(27)(22) “Intensive residential treatment programs for children and adolescents” or “intensive residential treatment facilities” or “IRTF” means a specialty hospital restricted to providing intensive residential treatment programs for children and adolescents as defined in section 395.002(15), F.S.
(23) renumbered to (28)
(29)(24) “Long term care hospital” means a general hospital which: has an average length of inpatient stay greater than 25 days for all hospital beds.
(a) Meets the provisions of section 395.002(12), F.S.;
(b) Has an average length of inpatient stay greater than 25 days for all hospital beds; and,
(c) Meets the provisions of subsection 408.032(13), F.S. 59C-1.002(28), F.A.C.
(25) renumbered to (30)
(31) “Neonatal Care Services” means the aspect of perinatal medicine pertaining to the care of neonates. Hospitals providing neonatal care are classified according to the following intensity and specialization of the care that can be provided:
(a) “Level I Neonatal Services” means well-baby care services, which include sub-ventilation care, intravenous feedings, intravenous medications, and gavage to neonates. Level I services are restricted to neonates born at 35 weeks gestation or later and considered low risk. Level I Neonatal Services do not include ventilation assistance except for resuscitation and stabilization. Upon beginning ventilation, the hospital shall implement a patient treatment plan which shall include the transfer of the neonate to a hospital with Level II, III, or IV Neonatal Intensive Care Services at such time that it becomes apparent that ventilation assistance will be required beyond the neonate’s resuscitation and stabilization. The hospital shall establish a triage procedure to assess the need for transfer of obstetrical patients to hospitals with Level II, III, or IV Neonatal Intensive Care Services prior to their delivery where there is an obstetrical indication that resuscitation will be required for their neonates. Hospitals that do not have licensed NICU beds may only perform Level I neonatal services.
(b) “Level II Neonatal Intensive Care Services” means Level I neonatal services plus mechanical ventilation or continuous positive airway pressure for less than 24 hours. A Level II NICU must have at least one person at all times capable of providing either continuous positive airway pressure and/or mechanical ventilation for a brief period. Level II services are restricted to neonates born at greater than or equal to 32 weeks gestation, weigh greater than or equal to 1,500 grams birth weight, and/or who have physiologic immaturity or are moderately ill, but are expected to recover rapidly and not require any subspecialty services. All neonates born earlier than 32 weeks gestation, weigh less than 1,500 grams birth weight, and/or require one or more of the Level III or Level IV services shall be transferred to a hospital with Level III or Level IV Neonatal Intensive Care Services. Level II Neonatal Intensive Care Services may be provided for neonates born earlier than 32 weeks gestation, less than 1,500 grams birth weight, or require subspecialty services, but only while waiting to transport the neonate to a hospital with Level III or IV Neonatal Intensive Care Services.
(c) “Level III Neonatal Intensive Care Services” means Level II services plus the capability of providing sustained life support and ongoing assisted ventilation for periods longer than 24 hours, which include continuous conventional ventilation, high-frequency ventilation, and/or inhaled nitric oxide. Level III services must include advanced imaging capabilities with urgent interpretation. Level III services are restricted to infants born less than or equal to 32 weeks of gestation, weigh less than 1,500 grams birth weight, and/or have a critical illness regardless of gestational age or birth weight. Hospitals with Level III services must have the staff listed in subsection 59A-3.249(3), F.A.C. available to provide emergency care as needed, and may provide complex neonatal surgery excluding pediatric cardiac services as defined in this rule.
(d) “Level IV Neonatal Intensive Care Services” means Level III services plus the hospital must have the capability to provide continuous onsite surgical repair of complex congenital or acquired conditions in neonates.
(32) “NICU” means Neonatal Intensive Care Unit.
(26) through (28) renumbered (33) through (35)
(36)(29) “Organ” means a body part such as a heart, kidney, pancreas, liver, intestine, or lung that requires vascular reanastomosis.
(30) through (32) renumbered (37) through (39)
(40) “Pediatric cardiac services” means integrated hospital services providing age-appropriate diagnostic and interventional cardiac catheterization and cardiovascular surgical services on the premises of the hospital and available 24 hours per day, 7 days per week to pediatric and adult congenital patients. Hospitals providing pediatric cardiac services must have the capability to provide treatment of penetrating and blunt force cardiac injury, valvuloplasty, echocardiography, cardiac electrophysiology, advanced cardiac imaging, post-operative intensive care, and outpatient cardiac clinic services. For the purpose of Rule 59A-3.248, F.A.C., cardiovascular surgical services do not include heart transplantation.
(41) “Pediatric” means a person under the age of 18 years.
(33) through (37) renumbered (42) through (46)
(38) “Premises” means those buildings, beds, and facilities located at the main address of the licensee and all other buildings, beds, and facilities for the provision of hospital care located in such reasonable proximity to the main address of the licensee as to appear to the public to be under the dominion and control of the licensee.
(39) through (45) renumbered (47) through (53)
(54)(46) “Rehabilitation hospital” means a Class III specialty hospital in which an organized program of integrated intensive care services is provided by a coordinated multidisciplinary team to patients with severe physical disabilities, such as stroke; spinal cord injury; congenital deformity; amputation; major multiple trauma; fracture of femur (hip fracture); brain injury; polyarthritis, including rheumatoid arthritis; neurological disorders, including multiple sclerosis, motor neuron diseases, polyneuropathy, muscular dystrophy, and Parkinson’s disease; and burns as defined under rule 59C-1.039(2)(d), F.A.C.
(55) “Research Hospital” means a hospital which devotes clearly defined space, staff, equipment, and other resources for research purposes and has documented teaching affiliations with an accredited school of medicine in Florida or another state.
(56) “Research Program” means an organized program that conducts clinical trial research, collects treatment data, assesses outcome data, and publishes statistical reports showing research activity and findings.
(47) renumbered to (57)
(48) “Rural hospital” means a general hospital which meets the definition of section 395.602(2)(b), F.S.
(49) through (51) renumbered (58) through (60)
(61) “Teaching Hospital” means any hospital which the Secretary of the Agency for Health Care Administration has determined meets the conditions specified in section 408.07(44), F.S.
(52) through (54) renumbered (62) through (64)
(65)(66) “Transplantation Program” means the offering of administrative, medical, surgical, and support services by a hospital through which one or more types of organ transplants are provided to one or more patients; and the offering of some or all phases of bone marrow transplantation.
(66)(67) “Ventilation assistance” means the use of invasive and non-invasive equipment to support breathing until the patient’s respiratory functions become sufficient.
(67) The Agency will review this rule five years from the effective date and repromulgate, amend or repeal the rule as appropriate, in accordance with Section 120.54, F.S. and Chapter 1-1, F.A.C.
Rulemaking Authority 395.1055 FS. Law Implemented 395.1023, 395.1055 FS. History–New 9-4-95, Formerly 59A-3.201, Amended 10-16-14,_______.
