House Bill hb0771
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Florida House of Representatives - 2001 HB 771
By Representative Rubio
1 A bill to be entitled
2 An act relating to health care regulation;
3 amending s. 395.002, F.S.; revising definitions
4 relating to hospital licensing and regulation;
5 amending ss. 395.003 and 400.102, F.S.;
6 restricting persons who may initiate or
7 intervene in an action on an application for
8 licensure of a health care facility, program,
9 or service; creating s. 395.0095, F.S.;
10 providing minimum standards for specified
11 impatient services; specifying requirements for
12 cardiac catheterization and angioplasty, open
13 heart surgery, inpatient comprehensive medical
14 rehabilitation, inpatient general psychiatric
15 services, inpatient substance abuse services,
16 neonatal intensive care services, specialty
17 burn units, heart transplantation, liver
18 transplantation, kidney transplantation, and
19 bone marrow transplantation; amending s.
20 400.071, F.S.; providing additional
21 requirements for application for a nursing home
22 license; amending s. 400.121, F.S.; restricting
23 persons who may initiate or intervene in an
24 action on an application for licensure of a
25 nursing home facility, program, or service;
26 providing penalties for failure of a nursing
27 home to demonstrate financial feasibility in
28 its application for licensure; amending s.
29 400.605, F.S.; providing for an expedited
30 licensure process for community-based hospice
31 services; amending s. 400.606, F.S.; providing
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1 additional requirements for application for
2 licensure of a hospice; deleting language
3 relating to certificate of need to conform to
4 the act; restricting persons who may initiate
5 or intervene in an action or application for
6 licensure of a hospice; providing penalties for
7 failure of a hospice to demonstrate financial
8 feasibility in its application for licensure;
9 repealing ss. 408.031, 408.032(2), (3), (4),
10 (6), and (7), 408.034, 408.035, 408.036,
11 408.0361, 408.037, 408.038, 408.039, 408.040,
12 408.041, 408.042, 408.043, 408.044, 408.045,
13 408.0455, and 651.118, F.S., relating to
14 requirements for certificate-of-need review and
15 approval for health care facilities and
16 services; repealing s. 154.245, F.S., relating
17 to certificates of need required as a condition
18 of certain bond validation; amending s.
19 408.033, F.S.; revising provisions relating to
20 local and state health planning; amending ss.
21 20.42, 154.205, 154.213, 154.219, 159.27,
22 189.415, 395.0191, 395.1055, 395.603, 395.604,
23 395.605, 400.23, 400.602, 400.6085, 430.705,
24 430.708, and 651.021, F.S., to conform to the
25 repeal of certificate-of-need requirements and
26 the process of certificate-of-need review;
27 amending ss. 383.50, 394.4787, 395.602,
28 395.701, 400.051, 409.905, 468.505, and
29 766.316, F.S.; correcting cross references;
30 providing a grandfather clause for specified
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1 inpatient services; providing an effective
2 date.
3
4 Be It Enacted by the Legislature of the State of Florida:
5
6 Section 1. Section 395.002, Florida Statutes, is
7 amended to read:
8 395.002 Definitions.--As used in this chapter:
9 (1) "Accrediting organizations" means the Joint
10 Commission on Accreditation of Healthcare Organizations, the
11 American Osteopathic Association, the Commission on
12 Accreditation of Rehabilitation Facilities, and the
13 Accreditation Association for Ambulatory Health Care, Inc.
14 (2) "Acute detoxification services" means hospital
15 inpatient services provided under the direction of a physician
16 intended to treat the physiological effects of acute alcohol
17 or drug intoxication during or immediately after the acute
18 intoxication.
19 (3) "Adolescent" means a person who is at least 14
20 years of age but under 18 years of age.
21 (4) "Adult" means a person who is 18 years of age or
22 older.
23 (5)(2) "Agency" means the Agency for Health Care
24 Administration.
25 (6)(3) "Ambulatory surgical center" or "mobile
26 surgical facility" means a facility the primary purpose of
27 which is to provide elective surgical care, in which the
28 patient is admitted to and discharged from such facility
29 within the same working day and is not permitted to stay
30 overnight, and which is not part of a hospital. However, a
31 facility existing for the primary purpose of performing
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1 terminations of pregnancy, an office maintained by a physician
2 for the practice of medicine, or an office maintained for the
3 practice of dentistry shall not be construed to be an
4 ambulatory surgical center, provided that any facility or
5 office which is certified or seeks certification as a Medicare
6 ambulatory surgical center shall be licensed as an ambulatory
7 surgical center pursuant to s. 395.003. Any structure or
8 vehicle in which a physician maintains an office and practices
9 surgery, and which can appear to the public to be a mobile
10 office because the structure or vehicle operates at more than
11 one address, shall be construed to be a mobile surgical
12 facility.
13 (7)(4) "Applicant" means an individual applicant, or
14 any officer, director, or agent, or any partner or shareholder
15 having an ownership interest equal to a 5-percent or greater
16 interest in the corporation, partnership, or other business
17 entity.
18 (8)(5) "Biomedical waste" means any solid or liquid
19 waste as defined in s. 381.0098(2)(a).
20 (9) "Bone marrow transplantation" means administration
21 of human blood precursor cells and stem cells to a patient in
22 order to restore normal hematological and immunological
23 functions following ablative therapy with curative intent.
24 Human blood precursor cells may be obtained from the patient
25 in an autologous transplant or from a medically acceptable
26 related or unrelated donor, and may be derived from bone
27 marrow, circulating blood, or a combination of bone marrow and
28 circulating blood. If chemotherapy is an integral part of the
29 treatment involving bone marrow transplantation, the term
30 "bone marrow transplantation" includes both the
31 transplantation and the chemotherapy.
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1 (10) "Burn team" means a team consisting of, at a
2 minimum, a burn care physician, nursing staff, and burn care
3 rehabilitation therapy staff.
4 (11) "Burn unit" means a discrete unit within a
5 hospital that occupies designated physical space separate from
6 other areas of the hospital. A burn unit shall have a minimum
7 of five dedicated burn beds and shall be equipped and staffed
8 to provide specialized care solely for severely burned
9 persons.
10 (12) "Cardiac catheterization" means a medical
11 procedure requiring the passage of a catheter into one or more
12 cardiac chambers of the left and right heart, with or without
13 coronary arteriograms, for the purpose of diagnosing
14 congenital or acquired cardiovascular diseases, or for
15 determining measurement of blood pressure flow. Cardiac
16 catheterization also includes the selective catheterization of
17 the coronary ostia with injection of contrast medium into the
18 coronary arteries.
19 (13) "Cardiac catheterization program" means an
20 institutional health service that is provided by or on behalf
21 of a health care facility and that consists of one or more
22 laboratories that comprise a room or suite of rooms, and has
23 the equipment and staff required to perform cardiac
24 catheterization serving inpatients and outpatients. A cardiac
25 catheterization program performing angioplasty services, or
26 other types of therapeutic cardiac procedures, shall have the
27 additional necessary equipment and staff to perform
28 angioplasty procedures.
29 (14)(6) "Clinical privileges" means the privileges
30 granted to a physician or other licensed health care
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1 practitioner to render patient care services in a hospital,
2 but does not include the privilege of admitting patients.
3 (15) "Complex neonatal surgery" means any surgical
4 procedure performed upon a neonate by a practitioner with
5 surgical credentials, licensed under chapter 458 or chapter
6 459, that is associated with entering into or traversing a
7 body cavity, such as the abdomen, thorax, or cranium, with a
8 requirement for either general anesthesia or conscious
9 sedation. Such procedures shall be performed only in hospitals
10 licensed to provide Level III neonatal services.
11 (16) "Comprehensive medical rehabilitation inpatient
12 services" means an organized program of integrated intensive
13 care services provided by a coordinated multidisciplinary team
14 to patients with severe physical disabilities, such as stroke;
15 spinal cord injury; congenital deformity; amputation; major
16 multiple trauma; fracture of femur (hip fracture); brain
17 injury; polyarthritis, including rheumatoid arthritis;
18 neurological disorders, including multiple sclerosis, motor
19 neuron diseases, polyneuropathy, muscular dystrophy, and
20 Parkinson's disease; and burns.
21 (17) "Coronary angioplasty" means a hospital inpatient
22 procedure requiring the dilation of narrowed segments of the
23 coronary vessels, via a balloon-tipped catheter.
24 (18)(7) "Department" means the Department of Health.
25 (19)(8) "Director" means any member of the official
26 board of directors as reported in the organization's annual
27 corporate report to the Florida Department of State, or, if no
28 such report is made, any member of the operating board of
29 directors. The term excludes members of separate, restricted
30 boards that serve only in an advisory capacity to the
31 operating board.
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1 (20)(9) "Emergency medical condition" means:
2 (a) A medical condition manifesting itself by acute
3 symptoms of sufficient severity, which may include severe
4 pain, such that the absence of immediate medical attention
5 could reasonably be expected to result in any of the
6 following:
7 1. Serious jeopardy to patient health, including a
8 pregnant woman or fetus.
9 2. Serious impairment to bodily functions.
10 3. Serious dysfunction of any bodily organ or part.
11 (b) With respect to a pregnant woman:
12 1. That there is inadequate time to effect safe
13 transfer to another hospital prior to delivery;
14 2. That a transfer may pose a threat to the health and
15 safety of the patient or fetus; or
16 3. That there is evidence of the onset and persistence
17 of uterine contractions or rupture of the membranes.
18 (21)(10) "Emergency services and care" means medical
19 screening, examination, and evaluation by a physician, or, to
20 the extent permitted by applicable law, by other appropriate
21 personnel under the supervision of a physician, to determine
22 if an emergency medical condition exists and, if it does, the
23 care, treatment, or surgery by a physician necessary to
24 relieve or eliminate the emergency medical condition, within
25 the service capability of the facility, available 24 hours a
26 day, 7 days a week.
27 (22)(11) "General hospital" means any facility which
28 meets the provisions of subsection (24)(13) and which
29 regularly makes its facilities and services available to the
30 general population.
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1 (23)(12) "Governmental unit" means the state or any
2 county, municipality, or other political subdivision, or any
3 department, division, board, or other agency of any of the
4 foregoing.
5 (24)(13) "Hospital" means any establishment that:
6 (a) Offers services more intensive than those required
7 for room, board, personal services, and general nursing care,
8 and offers facilities and beds for use beyond 24 hours by
9 individuals requiring diagnosis, treatment, or care for
10 illness, injury, deformity, infirmity, abnormality, disease,
11 or pregnancy; and
12 (b) Regularly makes available at least clinical
13 laboratory services, diagnostic X-ray services, and treatment
14 facilities for surgery or obstetrical care, or other
15 definitive medical treatment of similar extent.
16
17 However, the provisions of this chapter do not apply to any
18 institution conducted by or for the adherents of any
19 well-recognized church or religious denomination that depends
20 exclusively upon prayer or spiritual means to heal, care for,
21 or treat any person. For purposes of local zoning matters,
22 the term "hospital" includes a medical office building located
23 on the same premises as a hospital facility, provided the land
24 on which the medical office building is constructed is zoned
25 for use as a hospital; provided the premises were zoned for
26 hospital purposes on January 1, 1992.
27 (25)(14) "Hospital bed" means a hospital accommodation
28 which is ready for immediate occupancy, or is capable of being
29 made ready for occupancy within 48 hours, excluding provision
30 of staffing, and which conforms to minimum space, equipment,
31 and furnishings standards as specified by rule of the agency
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1 for the provision of services specified in this section to a
2 single patient.
3 (26) "Inactive license" means a license issued to a
4 hospital that will be temporarily unable to provide a service
5 but is reasonably expected to resume the service. Such
6 designation may be made for a period not to exceed 12 months,
7 but may be renewed by the agency for up to 6 additional
8 months. Requests for an inactive license must be submitted to
9 the agency and approved by the agency prior to any suspension
10 of services.
11 (27)(15) "Initial denial determination" means a
12 determination by a private review agent that the health care
13 services furnished or proposed to be furnished to a patient
14 are inappropriate, not medically necessary, or not reasonable.
15 (28)(16) "Intensive residential treatment programs for
16 children and adolescents" means a specialty hospital
17 accredited by the Joint Commission on Accreditation of
18 Healthcare Organizations which provides 24-hour care and which
19 has the primary functions of diagnosis and treatment of
20 patients under the age of 18 having psychiatric disorders in
21 order to restore such patients to an optimal level of
22 functioning.
23 (29) "Level II neonatal intensive care unit bed" means
24 a patient care station within a neonatal intensive care unit
25 with the capability of providing neonatal intensive care
26 services to ill neonates of 1,000 grams birthweight or over,
27 which is staffed to provide at least 6 hours of nursing care
28 per neonate per day and has the capability of providing
29 ventilator assistance and Level II neonatal intensive care
30 services.
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1 (30) "Level III neonatal intensive care bed" means a
2 patient care station within a neonatal intensive care unit
3 with the capability of providing neonatal intensive care
4 services to severely ill neonates regardless of birthweight,
5 which is staffed to provide 12 or more hours of nursing care
6 per neonate per day and Level III neonatal intensive care
7 services.
8 (31)(17) "Licensed facility" means a hospital,
9 ambulatory surgical center, or mobile surgical facility
10 licensed in accordance with this chapter.
11 (32)(18) "Lifesafety" means the control and prevention
12 of fire and other life-threatening conditions on a premises
13 for the purpose of preserving human life.
14 (33)(19) "Managing employee" means the administrator
15 or other similarly titled individual who is responsible for
16 the daily operation of the facility.
17 (34) "Maternal-fetal medical specialist" means a
18 board-certified obstetrician who is qualified by training,
19 experience, or special-competence certification in
20 maternal-fetal medicine.
21 (35)(20) "Medical staff" means physicians licensed
22 under chapter 458 or chapter 459 with privileges in a licensed
23 facility, as well as other licensed health care practitioners
24 with clinical privileges as approved by a licensed facility's
25 governing board.
26 (36)(21) "Medically necessary transfer" means a
27 transfer made necessary because the patient is in immediate
28 need of treatment for an emergency medical condition for which
29 the facility lacks service capability or is at service
30 capacity.
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1 (37)(22) "Mobile surgical facility" is a mobile
2 facility in which licensed health care professionals provide
3 elective surgical care under contract with the Department of
4 Corrections or a private correctional facility operating
5 pursuant to chapter 957 and in which inmate patients are
6 admitted to and discharged from said facility within the same
7 working day and are not permitted to stay overnight. However,
8 mobile surgical facilities may only provide health care
9 services to the inmate patients of the Department of
10 Corrections, or inmate patients of a private correctional
11 facility operating pursuant to chapter 957, and not to the
12 general public.
13 (38) "Neonatal care services" means the aspect of
14 perinatal medicine pertaining to the care of neonates.
15 Hospital units providing neonatal care are classified
16 according to the intensity and specialization of the care that
17 can be provided. The agency distinguishes three levels of
18 neonatal care services:
19 (a) "Level I neonatal services" means well-baby care
20 services, which include subventilation care, intravenous
21 feedings, and lavage to neonates. Level I neonatal services do
22 not include ventilator assistance except for resuscitation and
23 stabilization. Upon beginning ventilation, the hospital shall
24 implement a patient treatment plan, which shall include the
25 transfer of the neonate to a Level II or Level III neonatal
26 intensive care service at such time that it becomes apparent
27 that ventilation assistance will be required beyond the
28 neonate's resuscitation and stabilization. The hospital shall
29 establish a triage procedure to assess the need for transfer
30 of obstetrical patients to facilities with Level II or Level
31 III neonatal intensive care services prior to their delivery
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1 where there is an obstetrical indication that resuscitation
2 will be required for their neonates. Facilities limited to
3 Level I neonatal services may only perform Level I neonatal
4 services.
5 (b) "Level II neonatal intensive care services" means
6 services that include the provision of ventilator services and
7 at least 6 hours of nursing care per day. Level II services
8 shall be restricted to neonates of 1,000 grams birthweight and
9 over, with the following exception: ventilation may be
10 provided in a facility with Level II neonatal intensive care
11 services for neonates of less than 1,000 grams birthweight
12 only while waiting to transport the baby to a facility with
13 Level III neonatal intensive care services.
14 (c) "Level III neonatal intensive care services" means
15 services that include the provision of continuous
16 cardiopulmonary support services, 12 or more hours of nursing
17 care per day, complex neonatal surgery, neonatal
18 cardiovascular surgery, pediatric neurology and neurosurgery,
19 and pediatric cardiac catheterization. These services may not
20 be performed in a facility with Level II neonatal intensive
21 care services only. Facilities with Level III neonatal
22 intensive care services may perform all neonatal care
23 services. A facility with Level III neonatal intensive care
24 services that does not provide treatment of complex major
25 congenital anomalies that require the services of a pediatric
26 surgeon, or pediatric cardiac catheterization and
27 cardiovascular surgery, shall enter into a written agreement
28 with a facility providing Level III neonatal intensive care
29 services in the same or the nearest service area for the
30 provision of these services. All other services shall be
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1 provided at each licensed facility with Level III neonatal
2 intensive care services.
3 (39) "Neonatologist" means a physician who is
4 certified, or is eligible for certification, by an appropriate
5 board in the area of neonatal-perinatal medicine.
6 (40) "Open heart surgery operation" means surgical
7 procedures that treat conditions such as congenital heart
8 defects and heart and coronary artery diseases, including
9 replacement of heart valves, cardiac vascularization, and
10 cardiac trauma. One open heart surgery operation equals one
11 patient admission to the operating room. Open heart surgery
12 operations are classified under the following, Medicare
13 diagnostic-related groups: 104, 105, 106, 107, 108, and 109.
14 (41) "Organs" means heart, kidney, liver, bone marrow,
15 lung, heart and lung, pancreas and islet cells, and
16 intestines.
17 (42) "Pediatric patient" means a patient under 18
18 years of age.
19 (43)(23) "Person" means any individual, partnership,
20 corporation, association, or governmental unit.
21 (44)(24) "Premises" means those buildings, beds, and
22 equipment located at the address of the licensed facility and
23 all other buildings, beds, and equipment for the provision of
24 hospital, ambulatory surgical, or mobile surgical care located
25 in such reasonable proximity to the address of the licensed
26 facility as to appear to the public to be under the dominion
27 and control of the licensee.
28 (45)(25) "Private review agent" means any person or
29 entity which performs utilization review services for
30 third-party payors on a contractual basis for outpatient or
31 inpatient services. However, the term shall not include
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1 full-time employees, personnel, or staff of health insurers,
2 health maintenance organizations, or hospitals, or wholly
3 owned subsidiaries thereof or affiliates under common
4 ownership, when performing utilization review for their
5 respective hospitals, health maintenance organizations, or
6 insureds of the same insurance group. For this purpose,
7 health insurers, health maintenance organizations, and
8 hospitals, or wholly owned subsidiaries thereof or affiliates
9 under common ownership, include such entities engaged as
10 administrators of self-insurance as defined in s. 624.031.
11 (46) "Psychiatric disorder" means a disorder coded in
12 any subclassification of category 290 or coded in any
13 subclassification of categories 293 through 302 or coded in
14 any subclassification of categories 306 through 316, in Axis I
15 or Axis II, consistent with the diagnostic categories defined
16 in the Diagnostic and Statistical Manual of Mental Disorders;
17 or equivalent codes in the following subclassifications in the
18 International Classification of Disease: category 290,
19 category 293 through 302, or category 306 through 316.
20 (47) "Psychiatric inpatient services" means inpatient
21 services provided under the direction of a psychiatrist or
22 clinical psychologist to persons whose sole diagnosis or, in
23 the event of more than one diagnosis, whose principal
24 diagnosis, as defined in the Diagnostic and Statistical Manual
25 of Mental Disorders, is a psychiatric disorder.
26 (48) "Research hospital" means a hospital that devotes
27 clearly defined space, staff, equipment, and other resources
28 for research purposes and has documented teaching affiliations
29 with an accredited school of medicine in Florida or another
30 state.
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1 (49) "Research program" means an organized program
2 that conducts clinical trial research, collects treatment
3 data, assesses outcome data, and publishes statistical reports
4 showing research activity and findings.
5 (50)(26) "Service capability" means all services
6 offered by the facility where identification of services
7 offered is evidenced by the appearance of the service in a
8 patient's medical record or itemized bill.
9 (51)(27) "At service capacity" means the temporary
10 inability of a hospital to provide a service which is within
11 the service capability of the hospital, due to maximum use of
12 the service at the time of the request for the service.
13 (52)(28) "Specialty bed" means a bed, other than a
14 general bed, designated on the face of the hospital license
15 for a dedicated use.
16 (53)(29) "Specialty hospital" means any facility which
17 meets the provisions of subsection (24) (13), and which
18 regularly makes available either:
19 (a) The range of medical services offered by general
20 hospitals, but restricted to a defined age or gender group of
21 the population;
22 (b) A restricted range of services appropriate to the
23 diagnosis, care, and treatment of patients with specific
24 categories of medical or psychiatric illnesses or disorders;
25 or
26 (c) Intensive residential treatment programs for
27 children and adolescents as defined in subsection (28) (16).
28 (54)(30) "Stabilized" means, with respect to an
29 emergency medical condition, that no material deterioration of
30 the condition is likely, within reasonable medical
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1 probability, to result from the transfer of the patient from a
2 hospital.
3 (55) "Substance abuse disorder" means a disorder coded
4 in any subclassification of categories 291, 292, 303, 304, or
5 305 in Axis I or Axis II consistent with the diagnostic
6 categories defined in the Diagnostic and Statistical Manual of
7 Mental Disorders; or equivalent codes in any subclassification
8 of categories 291, 292, 303, 304, or 305 consistent with the
9 diagnostic categories defined in the International
10 Classification of Diseases.
11 (56) "Substance abuse inpatient services" means
12 services provided under the direction of a professional
13 trained and experienced in substance abuse services, including
14 a psychiatrist, a physician certified by the American Society
15 of Addiction Medicine, a Certified Addictions Professional, a
16 clinical psychologist, a clinical social worker as defined in
17 s. 491.003, or a certified master social worker as defined in
18 s. 491.0145, to persons whose sole diagnosis or, in the event
19 of more than one diagnosis, whose principal diagnosis, as
20 defined in the Diagnostic and Statistical Manual of Mental
21 Disorders, is a substance abuse disorder.
22 (57) "Teaching hospital" means any hospital that meets
23 the conditions specified in s. 408.07(44).
24 (58) "Temporary license" means a license issued
25 pending the final disposition of a hospital license suspension
26 or revocation proceeding.
27 (59) "Tertiary health service" means a health service
28 that, due to its high level of intensity, complexity,
29 specialized or limited applicability, and cost, should be
30 limited to, and concentrated in, a limited number of hospitals
31 to ensure the quality, availability, and cost-effectiveness of
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1 such service. Tertiary health services include organ
2 transplantation, specialty burn units, neonatal intensive care
3 units, comprehensive rehabilitation, and medical and surgical
4 procedures considered experimental or developmental in nature.
5 (60) "Transplantation program" means surgical services
6 by a hospital through which one or more types of organ
7 transplants are provided to one or more patients, and the
8 offering of some or all phases of bone marrow transplantation.
9 (61)(31) "Utilization review" means a system for
10 reviewing the medical necessity or appropriateness in the
11 allocation of health care resources of hospital services given
12 or proposed to be given to a patient or group of patients.
13 (62)(32) "Utilization review plan" means a description
14 of the policies and procedures governing utilization review
15 activities performed by a private review agent.
16 (63)(33) "Validation inspection" means an inspection
17 of the premises of a licensed facility by the agency to assess
18 whether a review by an accrediting organization has adequately
19 evaluated the licensed facility according to minimum state
20 standards.
21 Section 2. Subsection (9) is added to section 395.003,
22 Florida Statutes, to read:
23 395.003 Licensure; issuance, renewal, denial, and
24 revocation.--
25 (9) In administrative proceedings on an application to
26 license any health care facility or program or to provide any
27 service or take any other action requiring health care
28 facility licensure authority, only the applicant is entitled
29 to an administrative hearing on its application. No other
30 person may initiate or intervene in any action to determine
31 whether such an application should be approved or denied.
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1 Section 3. Section 395.0095, Florida Statutes, is
2 created to read:
3 395.0095 Minimum standards for specified inpatient
4 services.--
5 (1) INPATIENT SERVICES.--The following inpatient
6 services when provided by a hospital licensed under this
7 chapter shall be subject to the requirements specified in this
8 section and in s. 395.003 and shall be separately listed on
9 the hospital license:
10 (a) Cardiac catheterization and angioplasty. The
11 license shall indicate whether the service is for adults or
12 for children.
13 (b) Open heart surgery. The license shall indicate
14 whether the service is for adults or for children.
15 (c) Inpatient comprehensive medical rehabilitation.
16 The license shall indicate the number of beds dedicated to
17 this service.
18 (d) Inpatient general psychiatric services. The
19 license shall indicate whether the service is for adults or
20 for children and adolescents, and the number of beds dedicated
21 to service for adults or for children and adolescents.
22 (e) Inpatient substance abuse services. The license
23 shall indicate whether the service is for adults or for
24 children and adolescents, and the number of beds dedicated to
25 service for adults or for children and adolescents.
26 (f) Neonatal intensive care services. The license
27 shall indicate whether the services are Level I, Level II, or
28 Level III, and the number of beds dedicated to each level.
29 (g) Specialty burn units. The license shall indicate
30 the number of beds dedicated to this service.
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1 (h) Heart transplantation. The license shall indicate
2 whether the service is for adults or for children.
3 (i) Liver transplantation. The license shall indicate
4 whether the service is for adults or for children.
5 (j) Kidney transplantation. The license shall indicate
6 whether the service is for adults or for children.
7 (k) Bone marrow transplantation. The license shall
8 indicate whether the service is for adults or for children.
9 (2) REQUIREMENTS FOR CARDIAC CATHETERIZATION AND
10 ANGIOPLASTY.--
11 (a) Each cardiac catheterization program shall be
12 capable of providing immediate endocardiac catheter pacemaking
13 in cases of cardiac arrest or heart failure, and pressure
14 recording for monitoring and evaluating valvular disease.
15 (b) Each cardiac catheterization program shall provide
16 a range of noninvasive cardiac or circulatory diagnostic
17 services within the hospital itself, including:
18 1. Hematology studies or coagulation studies.
19 2. Electrocardiography.
20 3. Chest X-ray.
21 4. Blood gas studies.
22 5. Clinical pathology studies and blood chemistry
23 analysis.
24 (c) At a minimum, each cardiac catheterization program
25 shall include:
26 1. A special procedure X-ray room.
27 2. A film storage and darkroom for proper processing
28 of films.
29 3. X-ray equipment with the capability in
30 cineangiocardiography, or equipment with similar capabilities.
31 4. An image intensifier.
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1 5. An automatic injector.
2 6. A diagnostic X-ray examination table for special
3 procedures.
4 7. An electrocardiograph.
5 8. A blood gas analyzer.
6 9. A multichannel polygraph.
7 10. Emergency equipment, including, at a minimum, a
8 temporary pacemaker unit with catheters, ventilitory
9 assistance devices, and a direct current defibrillator.
10 (d) Each cardiac catheterization program shall have
11 the capability of rapid mobilization of the study team within
12 30 minutes for emergency procedures, 24 hours a day, 7 days a
13 week.
14 (e) Each cardiac catheterization program shall provide
15 a minimum of 300 catheterizations annually.
16 (f) Each hospital providing cardiac catheterization
17 must be fully accredited by the Joint Commission on
18 Accreditation of Health Care Organizations for special care
19 units, or be accredited by the American Osteopathic
20 Association.
21 (g) Each hospital providing a cardiac catheterization
22 program shall have the following staff available:
23 1. A program director, board-certified or
24 board-eligible in internal medicine or in radiology with
25 subspecialty training in cardiology or cardiovascular
26 radiology. The program director for programs performing
27 pediatric cardiac catheterization shall be board-eligible or
28 board-certified by the Sub-Board of Pediatric Cardiology of
29 the American Board of Pediatrics or the American Osteopathic
30 Association in the area of pediatric cardiology.
31
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1 2. A physician, board-certified or board-eligible in
2 cardiology or radiology, or with specialized training in
3 cardiac catheterization and angiographic techniques, who will
4 perform the examination.
5 3. Support staff, specially trained in critical care
6 of cardiac patients, with a knowledge of cardiovascular
7 medication and an understanding of catheterization and
8 angiographic equipment.
9 4. Support staff highly skilled in conventional
10 radiographic techniques and angiographic principles, and
11 knowledgeable in every aspect of catheterization and
12 angiographic instrumentation, with a thorough knowledge of the
13 anatomy and physiology of the circulatory system.
14 5. Support staff for patient observation, handling of
15 blood samples, and performing blood gas evaluation
16 calculations.
17 6. Support staff for monitoring physiologic data and
18 alerting the physician of any changes.
19 7. Support staff to perform systematic tests and
20 routine maintenance on cardiac catheterization equipment, who
21 must be available immediately in the event of equipment
22 failure during a procedure.
23 8. Support staff trained in photographic processing
24 and in the operation of automatic processors used for both
25 sheet and cine film.
26 9. A medical review committee that reviews medical
27 invasive procedures such as endoscopy and cardiac
28 catheterization.
29 (h) Cardiac catheterization programs licensed in a
30 facility not licensed for open heart surgery must submit, as
31 part of their licensure application, a written protocol for
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1 the transfer of emergency patients to a hospital providing
2 open heart surgery that is within 30 minutes travel time via
3 air or ground emergency transportation vehicle, under average
4 travel conditions.
5 (i) Cardiac catheterization programs that include the
6 provision of coronary angioplasty, valvuloplasty, or ablation
7 of intracardiac bypass tracts must be located within a
8 hospital licensed to provide open heart surgery.
9 (j) Pediatric cardiac catheterization programs must be
10 located in a hospital in which pediatric open heart surgery is
11 being performed.
12 (3) REQUIREMENTS FOR OPEN HEART SURGERY.--
13 (a) Each hospital providing an open heart surgery
14 program must have the capability to provide a full range of
15 open heart surgery operations, including, at a minimum:
16 1. Repair or replacement of heart valves.
17 2. Repair of congenital heart defects.
18 3. Cardiac revascularization.
19 4. Repair or reconstruction of intrathoracic vessels.
20 5. Treatment of cardiac trauma.
21 (b) Each open heart surgery program must document its
22 ability to implement and apply circulatory assist devices such
23 as intra-aortic balloon assist and prolonged cardiopulmonary
24 partial bypass.
25 (c) Each hospital with an open heart surgery program
26 shall provide the following services:
27 1. Cardiology, hematology, nephrology, pulmonary
28 medicine, and treatment of infectious diseases.
29 2. Pathology, including anatomical, clinical, blood
30 bank, and coagulation laboratory services.
31 3. Anesthesiology, including respiratory therapy.
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1 4. Radiology, including diagnostic nuclear medicine.
2 5. Neurology.
3 6. Inpatient cardiac catheterization.
4 7. Noninvasive cardiographics, including
5 electrocardiography, exercise stress testing, and
6 echocardiography.
7 8. Intensive care.
8 9. Emergency care available 24 hours per day for
9 cardiac emergencies.
10 (d) Each open heart surgery program shall be available
11 for elective open heart operations 8 hours per day, 5 days a
12 week. Each open heart surgery program shall possess the
13 capability for rapid mobilization of the surgical and medical
14 support teams for emergency cases, 24 hours per day, 7 days a
15 week.
16 (e) Open heart surgery shall be available for
17 emergency open heart surgery operations within a maximum
18 waiting period of 2 hours.
19 (f) Open heart surgery shall be available to all
20 persons in need. A patient's eligibility for open heart
21 surgery shall be independent of his or her ability to pay.
22 (g) Each hospital providing an open heart surgery
23 program must be accredited by the Joint Commission on
24 Accreditation of Healthcare Organizations for special care
25 units, or be accredited by the American Osteopathic
26 Association.
27 (h) Each hospital providing open heart surgery must
28 document that adequate numbers of properly trained personnel
29 shall be available to perform in the following capacities
30 during open heart surgery:
31
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1 1. A cardiovascular surgeon, board-certified by the
2 American Board of Thoracic Surgery, or board-eligible.
3 2. A physician to assist the operating surgeon.
4 3. A board-certified or board-eligible
5 anesthesiologist trained in open heart surgery.
6 4. A registered nurse or certified operating room
7 technician trained to serve in open heart surgery operations
8 and perform circulating duties.
9 5. A perfusionist to perform extracorporeal perfusion,
10 or a physician or a specially trained nurse, technician, or
11 physician assistant under the supervision of the operating
12 surgeon to operate the heart-lung machine.
13 (i) Following an open heart surgery operation,
14 patients shall be cared for in an intensive care unit that
15 provides 24-hour nursing coverage, with at least one
16 registered nurse for every two patients, during the first
17 hours of postoperative care for both adult and pediatric
18 cases. There shall be at least two cardiac surgeons on the
19 staff of a hospital with an adult open heart surgery program,
20 at least one of whom is board-certified and the other at least
21 board-eligible. One of these surgeons must be on call at all
22 times. There shall be at least one board-certified or
23 board-eligible pediatric cardiac surgeon on the staff of a
24 hospital with a pediatric open heart surgery program. A
25 clinical cardiologist must be available for consultation to
26 the surgical team and responsible for the medical management
27 of patients, as well as the selection of suitable candidates
28 for surgery along with the cardiovascular surgical team.
29 Backup personnel in cardiology, anesthesiology, pathology,
30 thoracic surgery, and radiology shall be on call in case of an
31 emergency. Twenty-four hour per day coverage must be arranged
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1 for the operation of the cardiopulmonary bypass pump. All
2 members of the team caring for cardiovascular surgical
3 patients must be proficient in cardiopulmonary resuscitation.
4 (j) Each open heart surgery program shall provide a
5 minimum of 250 open heart surgeries annually.
6 (4) REQUIREMENTS FOR COMPREHENSIVE MEDICAL
7 REHABILITATION INPATIENT SERVICES.--
8 (a) Each specialty hospital providing comprehensive
9 medical rehabilitation inpatient services shall have a minimum
10 total capacity of 40 beds.
11 (b) Each general hospital providing comprehensive
12 medical rehabilitation inpatient services shall have a minimum
13 of 20 comprehensive medical rehabilitation beds.
14 (c) Each hospital providing comprehensive medical
15 rehabilitation inpatient beds shall participate in the
16 Medicare and Medicaid programs.
17 (d) Comprehensive medical rehabilitation inpatient
18 services must be provided under a medical director of
19 rehabilitation who is a board-certified or board-eligible
20 physiatrist with at least 2 years of experience in the medical
21 management of inpatients requiring rehabilitation services.
22 (e) In addition to the required physician services,
23 comprehensive medical rehabilitation inpatient services shall
24 include at least the following provided by qualified
25 personnel:
26 1. Rehabilitation nursing.
27 2. Physical therapy.
28 3. Occupational therapy.
29 4. Speech therapy.
30 5. Social services.
31 6. Psychological services.
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1 7. Orthotic and prosthetic services.
2 (f) Each hospital providing comprehensive medical
3 rehabilitation inpatient services shall be accredited by the
4 Commission on Accreditation of Rehabilitation Facilities
5 consistent with the standards applicable to comprehensive
6 inpatient rehabilitation or specialized inpatient
7 rehabilitation, as applicable to the facility.
8 (5) REQUIREMENTS FOR PSYCHIATRIC INPATIENT SERVICES.--
9 (a) Admission to hospital units providing psychiatric
10 inpatient services is limited to persons whose sole diagnosis
11 or, in the event of more than one diagnosis, whose principal
12 diagnosis, as defined in the Diagnostic and Statistical Manual
13 of Mental Disorders, is a disorder coded in any
14 subclassification of category 290 or coded in any
15 subclassification of categories 293 through 302 or coded in
16 any subclassification of categories 306 through 316, in Axis I
17 or Axis II, consistent with the diagnostic categories defined
18 in the Diagnostic and Statistical Manual of Mental Disorders,
19 incorporated herein by reference; or equivalent codes in the
20 following subclassifications in the International
21 Classification of Disease, incorporated herein by reference:
22 category 290, category 293 through 302, or category 306
23 through 316. Psychiatric patients in need of medical or
24 surgical care may be treated in acute care medical or surgical
25 beds for their medical or surgical care needs or in a
26 psychiatric services unit if the unit is properly staffed and
27 equipped to care for the medical or surgical problem.
28 (b) Each specialty hospital providing psychiatric
29 inpatient services, or each intensive residential treatment
30 program for children and adolescents licensed as a specialty
31 hospital, shall have a minimum total capacity of 25 beds. The
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1 minimum capacity of a specialty hospital providing psychiatric
2 inpatient services may include beds used for substance abuse
3 inpatient services.
4 (c) Psychiatric inpatient services, whether provided
5 directly by the hospital or under contract, shall include, at
6 a minimum, emergency screening services, pharmacology,
7 individual therapy, family therapy, activities therapy,
8 discharge planning, and referral services.
9 (d) A separately organized unit for psychiatric
10 inpatient services for adults shall have a minimum of 15 beds.
11 A separately organized unit for psychiatric inpatient services
12 for children and adolescents shall have a minimum of 10 beds.
13 (e) As required by s. 394.4785(2), facilities
14 providing psychiatric inpatient services to children must have
15 beds and common areas designated for children that cannot be
16 used by adults. Adolescents may be treated in the units
17 designated for children. Adolescents may only be treated in
18 units designated for psychiatric inpatient services for adults
19 if the admitting physician indicates that such placement is
20 medically indicated, or for reasons of safety.
21 (f) Each hospital providing psychiatric inpatient
22 services shall be accredited by the Joint Commission on
23 Accreditation of Healthcare Organizations consistent with the
24 standards applicable to psychiatric services provided in
25 inpatient settings for adults or for children and adolescents.
26 (g) Each hospital providing psychiatric inpatient
27 services shall also provide outpatient services, either
28 directly or through written agreements with community
29 outpatient mental health programs, such as local
30 psychiatrists, local psychologists, community mental health
31 programs, or other local mental health outpatient programs.
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1 (h) Each hospital providing psychiatric inpatient
2 services shall have a screening program to assess the most
3 appropriate treatment for the patient. Patients with a dual
4 diagnosis of a psychiatric disorder and a substance abuse
5 disorder shall be evaluated to determine the types of
6 treatment needed, the appropriate treatment setting, and, if
7 necessary, the appropriate sequence of treatment for the
8 psychiatric and substance abuse disorders.
9 (6) REQUIREMENTS FOR SUBSTANCE ABUSE INPATIENT
10 SERVICES.--
11 (a) Each specialty hospital providing substance abuse
12 inpatient services shall have a minimum total capacity of 25
13 beds, which may include beds used for psychiatric inpatient
14 services.
15 (b) Beds used for acute detoxification services in
16 general hospitals shall be considered a subset of the total
17 number of general acute care beds.
18 (c) Substance abuse inpatient services, whether
19 provided directly by the hospital or under contract, shall
20 include, at a minimum, emergency screening services; treatment
21 planning services; pharmacology, if appropriate; individual
22 therapy; family therapy; discharge planning; referral
23 services, including written referral agreements for
24 educational and vocational services; and occupational and
25 recreational therapies.
26 (d) A separately organized unit for substance abuse
27 inpatient services for adults shall have a minimum of 10 beds.
28 A separately organized unit for substance abuse inpatient
29 services for children and adolescents shall have a minimum of
30 five beds.
31
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1 (e) Each hospital providing substance abuse inpatient
2 services to children must have beds and common areas
3 designated for children that cannot be used by adults.
4 Adolescents may be treated in the units designated for
5 children. Adolescents may only be treated in units designated
6 for substance abuse inpatient services for adults if the
7 admitting physician indicates that such placement is medically
8 indicated, or for reasons of safety.
9 (f) Each hospital providing substance abuse inpatient
10 services shall be accredited by the Joint Commission on
11 Accreditation of Healthcare Organizations consistent with the
12 standards applicable to substance abuse services provided in
13 inpatient settings for adults or for children and adolescents.
14 (g) Each hospital providing substance abuse inpatient
15 services shall also provide outpatient or referral services,
16 either directly or through written agreements with community
17 outpatient substance abuse programs, such as local
18 psychiatrists, other physicians trained in the treatment of
19 psychiatric or substance abuse disorders, local psychologists,
20 community mental health programs, or other local substance
21 abuse outpatient programs.
22 (h) Each hospital providing substance abuse inpatient
23 services shall have a screening program to assess the most
24 appropriate treatment for the patient. Patients with a dual
25 diagnosis of a substance abuse disorder and a psychiatric
26 disorder shall be evaluated to determine the types of
27 treatment needed, the appropriate treatment setting, and, if
28 necessary, the appropriate sequence of treatment for the
29 substance abuse and psychiatric disorders.
30 (7) REQUIREMENTS FOR NEONATAL INTENSIVE CARE
31 SERVICES.--
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1 (a) No hospital shall be licensed for Level III
2 neonatal intensive care services unless the hospital also
3 provides Level II neonatal intensive care services. A
4 hospital may be licensed for Level II neonatal intensive care
5 services without providing Level III services.
6 (b) Each hospital providing Level II or Level III
7 neonatal intensive care services shall ensure developmental
8 followup on patients after discharge to monitor the outcome of
9 care and assure necessary referrals to community resources.
10 (c) Each hospital providing Level III neonatal
11 intensive care services shall have a Level III neonatal
12 intensive care unit of at least 15 beds, and shall have 15 or
13 more Level II neonatal intensive care unit beds. A hospital
14 shall not be licensed for Level III neonatal intensive care
15 services only. Each hospital providing only Level II neonatal
16 intensive care services shall have a Level II neonatal
17 intensive care unit with a minimum of 10 beds.
18 (d) A hospital shall not be licensed for Level III
19 neonatal intensive care services unless the hospital had a
20 minimum service volume of 1,500 live births for the most
21 recent 12-month period ending 6 months prior to licensure.
22 Specialty children's hospitals are exempt from the
23 requirements of this paragraph.
24 (e) A hospital shall not be licensed for Level II
25 neonatal intensive care services unless the hospital had a
26 minimum service volume of 1,000 live births for the most
27 recent 12-month period ending 6 months prior to the licensure.
28 Children's specialty hospitals are exempt from the
29 requirements of this paragraph.
30 (f) Level II neonatal intensive care services shall be
31 directed by a neonatologist or a group of neonatologists who
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1 are on active staff of the hospital with unlimited privileges
2 and provide 24-hour coverage and who are either
3 board-certified or board-eligible in neonatal-perinatal
4 medicine.
5 (g) Level III neonatal intensive care services shall
6 be directed by a neonatologist or a group of neonatologists
7 who are on active staff of the hospital with unlimited
8 privileges and provide 24-hour coverage and who are either
9 board-certified or board-eligible in neonatal-perinatal
10 medicine. In addition, hospitals with Level III neonatal
11 intensive care services shall be required to maintain a
12 maternal-fetal medical specialist on active staff of the
13 hospital with unlimited staff privileges. Children's specialty
14 hospitals are exempt from the provisions of this paragraph.
15 (h) The nursing staff in Level II and Level III
16 neonatal intensive care units shall be under the supervision
17 of a head nurse with experience and training in neonatal
18 intensive care nursing. The head nurse shall be a registered
19 professional nurse. At least one-half of the nursing
20 personnel assigned to each work shift in Level II and Level
21 III neonatal intensive care units must be registered nurses.
22 Nurses in Level II and Level III neonatal intensive care units
23 shall be trained to administer cardiorespiratory monitoring,
24 assist in ventilation, administer intravenious fluids, provide
25 preoperative and postoperative care of newborns requiring
26 surgery, manage neonates being transported, and provide
27 emergency treatment of conditions such as apnea, seizures, and
28 respiratory distress.
29 (i) At least one certified respiratory care
30 practitioner or respiratory therapist with expertise in the
31 care of neonates shall be available at each hospital with
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1 Level II or Level III neonatal intensive care services at all
2 times. There shall be at least one respiratory therapist
3 technician for every four infants receiving assisted
4 ventilation.
5 (j) Blood gas determination shall be available and
6 accessible on a 24-hour basis in each hospital with Level II
7 or Level III neonatal intensive care services.
8 (k) Each hospital providing Level II or Level III
9 neonatal intensive care services shall provide onsite, on a
10 24-hour basis, X-ray, obstetric ultrasound, and clinical
11 laboratory services. Anesthesia shall be available on an
12 on-call basis within 30 minutes. Clinical laboratory services
13 shall have the capability to perform microstudies.
14 (l) Each hospital providing Level II or Level III
15 neonatal intensive care services shall have a dietician or
16 nutritionist to provide information on patient dietary needs
17 while in the hospital and to provide the patient's family
18 instruction or counseling regarding the appropriate
19 nutritional and dietary needs of the patient after discharge.
20 (m) Each hospital providing Level II or Level III
21 neonatal intensive care services shall make available the
22 services of the hospital's social services department to
23 patients' families, which services shall include, at a
24 minimum, family counseling and referral to appropriate
25 agencies for services. Children potentially eligible for the
26 Medicaid, Children's Medical Services, or developmental
27 services programs shall be referred to the appropriate
28 eligibility personnel for eligibility determination.
29 (n) Each hospital providing Level II or Level III
30 neonatal intensive care services shall provide in-hospital
31 intervention services for infants identified as being at high
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1 risk for developmental disabilities, which shall include
2 developmental assessment, intervention, and parental support
3 and education.
4 (o) Each hospital providing Level II or Level III
5 neonatal intensive care services shall have an
6 interdisciplinary staff responsible for discharge planning.
7 Each hospital shall designate a person responsible for
8 discharge planning.
9 (p) Each hospital with a Level II neonatal intensive
10 care unit shall have a nurse-to-neonate ratio of at least 1:4
11 in that unit at all times. At least 50 percent of the nurses
12 shall be registered nurses.
13 (q) Each hospital with a Level III neonatal intensive
14 care unit shall have a pediatric cardiologist who is either
15 board-certified or board-eligible in pediatric cardiology
16 available for consultation at all times.
17 (r) Each hospital with a Level III neonatal intensive
18 care unit shall have a nurse-to-neonate ratio of at least 1:2
19 in that unit at all times. At least 50 percent of the nurses
20 shall be registered nurses.
21 (s) A hospital providing only Level II neonatal
22 intensive care services shall provide documentation of a
23 transfer agreement with a hospital providing Level III
24 neonatal intensive care services in the same or the nearest
25 service district, for patients in need of Level III services.
26 Hospitals providing Level III neonatal intensive care services
27 shall not unreasonably withhold consent to transfer agreements
28 that provide for transfers based upon availability of service
29 in the Level III hospital and that will be applied uniformly
30 to all patients requiring transfer to Level III.
31
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1 (t) All neonates of 1,000 grams birthweight or less
2 shall be transferred to a facility with Level III neonatal
3 intensive care services. Neonates weighing more than 1,000
4 grams requiring one or more Level III services shall also be
5 transferred to a facility with Level III neonatal intensive
6 care services. If a facility with a Level III neonatal
7 intensive care service refuses to accept the tranfer patient,
8 the facility with the Level II neonatal intensive care service
9 shall be found in compliance with this paragraph upon a
10 showing of continuous good faith effort to transfer the
11 patient, as documented in the patient's medical record.
12 Facilities with Level II neonatal intensive care services may
13 perform only Level I neonatal intensive care services and
14 Level II neonatal intensive care services.
15 (u) Each hospital providing Level II or Level III
16 neonatal intensive care services shall be accredited by the
17 Joint Commission on Accreditation of Health Care Organizations
18 consistent with the standards applicable to providing Level II
19 or Level III neonatal intensive care services.
20 (8) REQUIREMENTS FOR BURN UNITS.--
21 (a) Each hospital with a licensed burn unit shall
22 ensure that appropriate aftercare services are available to
23 the burn care patients in order to ensure a continuum between
24 hospitalization and the rehabilitation phase. These services
25 include, at a minimum, social services consultation,
26 vocational counseling, and physical rehabilitation services.
27 (b) Each hospital with a designated burn unit shall
28 provide a public burn prevention program. This requirement
29 may be met by assuring that such programs are made available
30 through other organizations in the service delivery area.
31
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1 (c) Burn unit services shall be available on a
2 24-hour, 7-days-a-week, basis.
3 (d) Each hospital with a licensed burn unit shall have
4 the following staff available:
5 1. A medical director who is board-certified or
6 board-eligible in general or plastic surgery with at least 2
7 years of experience in the management of burn patients.
8 2. One full-time registered nurse with 2 years'
9 intensive care or equivalent experience.
10 3. One full-time physical therapist with training in
11 the management of burn patients.
12 4. Surgical support personnel shall be available for
13 consultation as needed in the following surgical specialities:
14 a. Cardiothoracic.
15 b. Neurologic.
16 c. Obstetrics-gynecologic.
17 d. Ophthalmic.
18 e. Oral.
19 f. Orthopaedic.
20 g. Otorhinolaryngologic.
21 h. Pediatric.
22 i. Plastic.
23 j. Urologic.
24 (e) Each hospital with a licensed burn unit shall have
25 the following nonsurgical support personnel available, as
26 needed, for consultation in the following specialties:
27 1. Anesthesiology.
28 2. Cardiology.
29 3. Emergency medicine.
30 4. Gastroenterology.
31 5. Hematology.
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1 6. Infectious disease.
2 7. Internal medicine.
3 8. Nephrology.
4 9. Neurology.
5 10. Nutrition.
6 11. Occupational therapy.
7 12. Pathology.
8 13. Pediatrics.
9 14. Psychiatry or psychology.
10 15. Pulmonary.
11 16. Radiology.
12 17. Respiratory therapy.
13 (f) Each hospital providing burn unit services shall
14 be accredited by the Joint Commission on Accreditation of
15 Health Care Organizations consistent with the standards
16 applicable to providing burn unit services.
17 (9) REQUIREMENTS FOR ORGAN TRANSPLANTATION PROGRAMS.--
18 (a) Each hospital with a licensed transplantation
19 program, regardless of the type of transplantation program,
20 shall have:
21 1. Staff and other resources necessary to care for the
22 patient's chronic illness prior to transplantation, during
23 transplantation, and in the postoperative period. Services
24 and facilities for inpatient and outpatient care shall be
25 available on a 24-hour basis.
26 2. If cadaveric transplantation will be part of the
27 transplantation program, a written agreement with an organ
28 acquisition center for organ procurement is required. A
29 system by which 24-hour call can be maintained for assessment,
30 management, and retrieval of all referred donors, cadaver
31 donors, or organs shared by other transplantation or organ
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1 procurement agencies is mandatory. Applicants for a bone
2 marrow transplantation program are exempt from the
3 requirements of this subparagraph.
4 3. An age-appropriate, adult or pediatric intensive
5 care unit that includes facilities for prolonged reverse
6 isolation when required.
7 4. A clinical review committee for evaluation and
8 decisionmaking regarding the suitability of a candidate for
9 transplantation.
10 5. Written protocols for patient care for each type of
11 organ transplantation program, including, at a minimum,
12 patient selection criteria for patient management and
13 evaluation during the prehospital, in-hospital, and immediate
14 postdischarge phases of the program.
15 6. Detailed therapeutic and evaluative procedures for
16 the acute and long-term management of each transplantation
17 program patient, including the management of commonly
18 encountered complications.
19 7. Equipment for cooling, flushing, and transporting
20 organs. If cadaveric transplantations are performed,
21 equipment for organ preservation through mechanical perfusion
22 is necessary. This requirement may be met through an agreement
23 with an organ procurement agency. Applicants for a bone marrow
24 transplantation program are exempt from the requirements of
25 this subparagraph.
26 8. An onsite tissue-typing laboratory, or a
27 contractual arrangement with an outside laboratory within the
28 state, that meets the requirements of the American Society of
29 Histocompatibility.
30 9. Pathology services with the capability of studying
31 and promptly reporting the patient's response to the organ
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1 transplantation surgery and analyzing appropriate biopsy
2 material.
3 10. Blood banking facilities.
4 11. A program for the education and training of staff
5 regarding the special care of transplantation patients.
6 12. Education programs for patients and their
7 families, and the patient's primary care physician, regarding
8 aftercare for transplantation patients.
9 (b) Each hospital with a licensed transplantation
10 program, regardless of the type of transplantation program,
11 shall have:
12 1. A staff of physicians with expertise in caring for
13 patients with end-stage disease requiring transplantation.
14 The staff shall have medical specialties or subspecialties
15 appropriate for the type of transplantation program to be
16 established. The program shall employ a transplant physician,
17 and a transplant surgeon, if applicable, as defined by the
18 United Network for Organ Sharing. A physician with 1 year of
19 experience in the management of infectious diseases in the
20 transplantation patient shall be a member of the transplant
21 team.
22 2. A program director who shall have a minimum of 1
23 year of formal training and 1 year of experience at a
24 transplantation program for the same type of organ
25 transplantation program proposed; except that an applicant for
26 a bone marrow transplantation program shall meet the
27 requirements in paragraph (h), paragraph (i), or paragraph
28 (j).
29 3. A staff with experience in the special needs of
30 children, if pediatric transplantations are performed.
31
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1 4. A staff of nurses and nurse practitioners with
2 experience in the care of chronically ill patients and their
3 families.
4 5. Contractual agreements with consultants who have
5 expertise in blood banking and are capable of meeting the
6 unique needs of transplant patients on a long-term basis.
7 6. Nutritionists with expertise in the nutritional
8 needs of transplant patients.
9 7. Respiratory therapists with expertise in the needs
10 of transplant patients.
11 8. Social workers, psychologists, psychiatrists, and
12 other individuals skilled in performing comprehensive
13 psychological assessments, counseling patients and families of
14 patients, providing assistance with financial arrangements,
15 and making arrangements for use of community resources.
16 (c) Each hospital with a licensed heart
17 transplantation program, in addition to meeting the
18 requirements specified in paragraphs (a) and (b), shall have
19 the following program personnel and services:
20 1. A board-certified or board-eligible adult
21 cardiologist or, in the case of a pediatric heart
22 transplantation program, a board-certified or board-eligible
23 pediatric cardiologist.
24 2. An anesthesiologist experienced in both open heart
25 surgery and heart transplantation.
26 3. A one-bed isolation room in an age-appropriate
27 intensive care unit.
28 (d) Each hospital with a licensed liver
29 transplantation program, in addition to meeting the
30 requirements specified in paragraphs (a) and (b), shall be a
31 teaching hospital or research hospital with training programs
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1 relevant to liver transplantation. The following services
2 shall be available in the hospital or through contractual
3 arrangements:
4 1. A department of gastroenterology, including
5 clinics, and adequately equipped procedure rooms.
6 2. Radiology services to provide complex biliary
7 procedures, including transhepathic cholangiography, portal
8 venography, and arteriography.
9 3. A laboratory with the capability of performing and
10 promptly reporting the results of liver function tests, as
11 well as required chemistry, hematology, and virology tests.
12 4. A patient convalescent unit for further monitoring
13 of patient progress for approximately 1 month after hospital
14 discharge following liver transplantation.
15 5. Staff for liver transplantation programs shall be
16 trained in the care of patients with hepatic diseases and
17 liver transplantation.
18 (e) Each hospital with a licensed kidney
19 transplantation program shall provide:
20 1. Renal dialysis, and preoperative and postoperative
21 care. Onsite dialysis under the supervision of a
22 board-certified or board-eligible nephrologist shall be
23 available on a 24-hour basis. If pediatric patients are
24 served, a separate pediatric dialysis unit shall be
25 established.
26 2. Outpatient services, including renal dialysis
27 services and ambulatory renal clinic services.
28 3. Ancillary services, including predialysis,
29 dialysis, and posttransplantation nutritional services;
30 bacteriologic, biochemical, and pathological services;
31 radiologic services; and nursing services with the capability
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1 of providing monitoring and support during dialysis and
2 assisting in home care, which shall include vascular access
3 and home dialysis management, when applicable.
4 (f) Each licensed adult kidney transplantation program
5 shall be under the direction of a physician with experience in
6 physiology, immunology, and immunosuppressive therapy relevant
7 to kidney transplantation.
8 1. The transplant surgeon shall be board-certified in
9 surgery or a surgical subspecialty and shall have a minimum of
10 18 months' training in a transplantation center.
11 2. The transplant team performing kidney
12 transplantation shall include physicians who are
13 board-certified or board-eligible in the areas of
14 anesthesiology, nephrology, psychiatry, vascular surgery, and
15 urology.
16 3. Additional support personnel that shall be
17 available include a nephrology nurse with experience in
18 nursing care of patients with permanent kidney failure and a
19 renal dietician.
20 4. A laboratory with the capability of performing and
21 promptly reporting bacteriologic, biochemical, and pathologic
22 analysis.
23 5. An anesthesiologist experienced in kidney
24 transplantation.
25 (g) Each licensed pediatric kidney transplantation
26 program shall have:
27 1. A medical director who is sub-board-certified or
28 sub-board-eligible in pediatric nephrology.
29 2. A dialysis unit head nurse with special training
30 and expertise in pediatric dialysis.
31
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1 3. Nurse staffing at a nurse-to-patient ratio of 1:1
2 in the pediatric dialysis unit.
3 4. A registered dietician with expertise in
4 nutritional needs of children with chronic renal disease.
5 5. A surgeon with experience in pediatric renal
6 transplantation.
7 6. A radiology service with specialized equipment for
8 obtaining X-rays on pediatric patients.
9 7. Education services, which shall include home and
10 hospital programs to ensure minimal interruption in schooling.
11 (h) Each hospital with a licensed pediatric allogeneic
12 or autologous bone marrow transplantation program must be a
13 teaching or research hospital with training programs relevant
14 to pediatric bone marrow transplantation. Each such hospital
15 shall meet the requirements specified in subparagraph 1.
16 Hospitals licensed for allogeneic programs shall meet the
17 additional requirements specified in subparagraph 2.
18 1. Requirements for each hospital with a licensed
19 pediatric allogeneic or autologous transplantation program:
20 a. Perform at least 10 pediatric transplants each
21 year. If both allogeneic and autologous pediatric transplants
22 are performed, at least 10 of each shall be projected.
23 b. Have a program director who is a board-certified
24 hematologist or oncologist with experience in the treatment
25 and management of pediatric acute oncological cases involving
26 high-dose chemotherapy or high-dose radiation therapy. The
27 program director must have formal training in pediatric bone
28 marrow transplantation.
29 c. Have clinical nurses with experience in the care of
30 critically ill immunosuppressed patients. Nursing staff shall
31 be dedicated to the program full time.
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1 d. Have an interdisciplinary transplantation team with
2 expertise in hematology, oncology, immunologic diseases,
3 neoplastic diseases including hematopoietic and lymphopoietic
4 malignancies, and nonneoplastic disorders. The team shall
5 direct permanent followup care of the bone marrow
6 transplantation patients, including the maintenance of
7 immunosuppressive therapy and treatment of complications.
8 e. Have age-appropriate inpatient transplantation
9 units for posttransplant hospitalization. Posttransplantation
10 care must be provided in a laminar air-flow room; or in a
11 private room with positive pressure, reverse isolation
12 procedures, and terminal high-efficiency particulate aerosol
13 filtration on air blowers. The designated transplant unit
14 shall have a minimum of two beds. The unit may be part of a
15 facility that also manages patients with leukemia or similar
16 disorders.
17 f. Have a radiation therapy division onsite that is
18 capable of sublethal X-irradiation, bone marrow ablation, and
19 total lymphoid irradiation. The division shall be under the
20 direction of a board-certified radiation oncologist.
21 g. Have an ongoing research program that is integrated
22 either within the hospital or by written agreement with a bone
23 marrow transplantation center operated by a teaching hospital.
24 The program must include outcome monitoring and long-term
25 patient followup.
26 h. Have an established research-oriented oncology
27 program.
28 2. Additional requirements for each hospital with a
29 licensed pediatric allogeneic transplantation program:
30 a. A laboratory equipped to handle studies including
31 the use of monoclonal antibodies, if this procedure is
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1 employed by the hospital, or T-cell depletion, separation of
2 lymphocyte and hematological cell subpopulations, and their
3 removal for prevention of graft-versus-host disease. The
4 requirements in this subparagraph may be met through
5 contractual arrangements.
6 b. An onsite laboratory equipped for the evaluation
7 and cryopreservation of bone marrow.
8 c. An age-appropriate patient convalescent facility to
9 provide a temporary residence setting for transplantation
10 patients during the prolonged convalescence.
11 d. An age-appropriate outpatient unit for close
12 supervision of discharged patients.
13 (i) Each hospital with a licensed adult allogeneic
14 bone marrow transplantation program must be a teaching or
15 research hospital. Each such hospital shall meet the
16 following requirements:
17 1. Perform at least 10 adult allogeneic transplants
18 each year.
19 2. Have a program director who is a board-certified
20 hematologist or oncologist with experience in the treatment
21 and management of adult acute oncological cases involving
22 high-dose chemotherapy or high-dose radiation therapy. The
23 program director must have formal training in bone marrow
24 transplantation.
25 3. Have clinical nurses with experience in the care of
26 critically ill immunosuppressed patients. Nursing staff shall
27 be dedicated to the program full time.
28 4. Have an interdisciplinary transplant team with
29 expertise in hematology, oncology, immunologic diseases,
30 neoplastic diseases including hematopoietic and lymphopoietic
31 malignancies, and nonneoplastic disorders. The team shall
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1 direct permanent followup care of the bone marrow
2 transplantation patients, including the maintenance of
3 immunosuppressive therapy and treatment of complications.
4 5. Have inpatient transplantation units for
5 posttransplantation hospitalization. Posttransplantation care
6 must be provided in a laminar air-flow room; or in a private
7 room with positive pressure, reverse isolation procedures, and
8 terminal high-efficiency particulate aerosol filtration on air
9 blowers. The designated transplant unit shall have a minimum
10 of two beds. The unit may be part of a facility that also
11 manages patients with leukemia or similar disorders.
12 6. Have a radiation therapy division onsite that is
13 capable of sublethal X-irradiation, bone marrow ablation, and
14 total lymphoid irradiation. The division shall be under the
15 direction of a board-certified radiation oncologist.
16 7. Have a laboratory equipped to handle studies
17 including the use of monoclonal antibodies, if this procedure
18 is employed by the hospital, or T-cell depletion, separation
19 of lymphocyte and hematological cell subpopulations, and their
20 removal for prevention of graft-versus-host disease. The
21 requirements in this subparagraph may be met through
22 contractual arrangements.
23 8. Have an onsite laboratory equipped for the
24 evaluation and cryopreservation of bone marrow.
25 9. Have an ongoing research program that is integrated
26 either within the hospital or by written agreement with a bone
27 marrow transplantation center operated by a teaching hospital.
28 The program must include outcome monitoring and long-term
29 patient followup.
30 10. Have an established research-oriented oncology
31 program.
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1 11. Have a patient convalescent facility to provide a
2 temporary residence setting for transplant patients during the
3 prolonged convalescence.
4 12. Have an outpatient unit for close supervision of
5 discharged patients.
6 (j) Each hospital with a licensed adult autologous
7 bone marrow transplantation program must be a teaching
8 hospital, a research hospital, or a community hospital having
9 a research program or affiliated with a research program.
10 Each hospital shall meet the following requirements:
11 1. Perform at least 10 adult autologous transplants
12 each year.
13 2. Have a program director who is a board-certified or
14 board-eligible hematologist or oncologist with experience in
15 the treatment and management of adult acute oncological cases
16 involving high-dose chemotherapy or high-dose radiation
17 therapy. The program director must have formal training in
18 bone marrow transplantation or have at least 1 year of
19 documented experience in performing autologous bone marrow
20 transplantation.
21 3. Have clinical nurses with experience in the care of
22 critically ill immunosuppressed patients. Nursing staff shall
23 be dedicated to the program full time.
24 4. Have an interdisciplinary transplantation team with
25 expertise in hematology, oncology, immunologic diseases,
26 neoplastic disease including hematopoietic and lymphopoietic
27 malignancies, and nonneoplastic disorders. The team shall
28 direct permanent followup care of the bone marrow
29 transplantation patients.
30 5. Have inpatient transplantation units for
31 posttransplant hospitalization. Posttransplantation care must
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1 be provided in a laminar air-flow room; or in a private room
2 with positive pressure, reverse isolation procedures, and
3 terminal high-efficiency particulate aerosol filtration on air
4 blowers. The designated transplant unit shall have a minimum
5 of two beds. The unit may be part of a facility that also
6 manages patients with leukemia or similar disorders.
7 6. Have a radiation therapy division onsite that is
8 capable of sublethal X-irradiation and total lymphoid
9 irradiation. The division shall be under the direction of a
10 board-certified radiation oncologist.
11 7. Have an ongoing research program that is integrated
12 either within the hospital or by written agreement with a bone
13 marrow transplantation center operated by a teaching hospital;
14 or the applicant may enter into an agreement with an
15 outpatient provider having a research program. Under the
16 agreement, the outpatient research program may perform
17 specified outpatient phases of adult autologous bone marrow
18 transplantation, including blood screening tests, mobilization
19 of stem cells, stem cell rescue, chemotherapy, and reinfusion
20 of stem cells.
21 8. Have an established research-oriented oncology
22 program.
23 (k) Each hospital with a licensed transplantation
24 program for lung, heart and lung, pancreas and islet cells, or
25 intestines shall be a teaching or research hospital with
26 training programs relevant to the type of organ
27 transplantation program proposed to be established. The
28 hospital shall have established interactive programs of basic
29 and applied research in organ failure, transplantation,
30 immunoregulatory responses, and related biology.
31
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1 (10)(a) SERVICES FOR LOW-INCOME PATIENTS.--Each
2 hospital providing a service described in this section, or
3 providing a distinct part skilled nursing unit, which hospital
4 has previously received a certificate of need for the service
5 requiring a specified minimum level of service to Medicaid,
6 indigent, or charity care patients, shall continue to provide
7 at least the required minimum level of service. The agency
8 shall monitor annual compliance with this requirement as part
9 of the certification activities described in subsection (13).
10 (b) The agency may, for good cause shown, modify the
11 minimum required level of service described in paragraph (a).
12 The agency shall, by rule, define the factors constituting
13 good cause for modification.
14 (11) HOSPITALS APPLYING FOR AN INITIAL LICENSE.--
15 (a) Each hospital providing a service described in
16 this section on the effective date of this act, or seeking to
17 establish such a service thereafter, must apply for an initial
18 license for the service. Hospitals with a current license
19 indicating beds dedicated to a service described in this
20 section, or beds dedicated to a distinct part skilled nursing
21 unit, must apply for initial licensure of the service within 3
22 months after the effective date of this act.
23 (b) Each hospital applying for an initial license for
24 comprehensive medical rehabilitation services, psychiatric
25 services, substance abuse services, neonatal intensive care
26 services, or a distinct part skilled nursing unit must, at the
27 time of application, affirm that at least 15 percent of annual
28 patient days in beds dedicated to the service will be Medicaid
29 patient days, and at least 15 percent of annual patient days
30 will be charity care patient days.
31
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1 (c) Each hospital applying for an initial license for
2 cardiac catheterization services, open heart surgery, a burn
3 unit, or an organ transplantation program must, at the time of
4 application, affirm that at least 15 percent of annual
5 admissions to those services will be Medicaid patients, and at
6 least a specified minimum percentage of annual admissions will
7 be charity care patients.
8 (d) The agency shall, by rule, establish exemptions to
9 the minimum annual percentage of service volumes required for
10 hospital compliance with paragraphs (b) and (c). In
11 establishing such standards, the agency shall give due
12 consideration to any existing commitments described in
13 subsection (10) and to clinical outcome data.
14 (e) In the case of a hospital with licensed beds
15 dedicated to comprehensive medical rehabilitation services,
16 psychiatric services, substance abuse services, or neonatal
17 intensive care services, the initial license may grant a
18 variance from the requirements of this section respecting the
19 minimum number of beds required for the service.
20 (f) The agency may, for good cause shown, grant a
21 temporary exemption to a hospital seeking an initial license
22 to provide a service described in this section and seeking to
23 comply with the requirements respecting minimum annual service
24 volume and accreditation. The exemption shall be for a
25 specified period of time, not to exceed 1 year from the date
26 of application for an initial or renewal license. Good cause
27 includes the current status of a hospital respecting these
28 services; provided that approval before July 1, 2001, under
29 the certificate-of-need program shall not, of itself,
30 constitute good cause for a temporary exemption.
31 (12) HOSPITALS APPLYING FOR A RENEWAL LICENSE.--
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1 (a) Each hospital licensed to provide comprehensive
2 medical rehabilitation services, psychiatric services,
3 substance abuse services, or neonatal intensive care services
4 must, at the time of license renewal, reaffirm or modify its
5 commitments regarding the percentage of annual patient days
6 which will be for Medicaid patients and the percentage of
7 annual patient days which will be for charity care patients.
8 The agency shall, by rule, define the factors constituting
9 good cause for modification of previous commitments.
10 (b) Each hospital licensed to provide cardiac
11 catheterization services, open heart surgery, a burn unit, or
12 an organ transplantation program must, at the time of license
13 renewal, reaffirm or modify its commitments regarding the
14 percentage of admissions which will be Medicaid patients and
15 percentage of admissions which will be charity care patients.
16 The agency shall, by rule, define the factors constituting
17 good cause for modification of previous commitments.
18 (13) CERTIFICATION OF COMPLIANCE.--Each hospital
19 licensed to provide a service described in this section shall
20 thereafter annually certify to the agency that it meets all
21 requirements described herein for that service, except as may
22 be noted by the facility. Misrepresentation of compliance is
23 subject to penalties imposed by the agency as provided in s.
24 395.003(8).
25 (14) NONCOMPLIANCE.--A hospital found to be out of
26 compliance with the requirements of this section is subject to
27 penalties imposed by the agency as provided in s. 395.003(8).
28 Section 4. Subsections (5) and (9) of section 400.071,
29 Florida Statutes, are amended, and subsections (11) and (12)
30 are added to said section, to read:
31 400.071 Application for license.--
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1 (5) The applicant shall furnish satisfactory proof of
2 financial ability to operate and conduct the home in
3 accordance with the requirements of this part and all rules
4 adopted under this part, and the agency shall establish
5 standards for this purpose. The agency also shall establish
6 documentation requirements, to be completed by each applicant,
7 that show anticipated facility revenues and expenditures, the
8 basis for financing the anticipated cash-flow requirements of
9 the facility, and an applicant's access to contingency
10 financing. An application for initial licensure of a nursing
11 home must contain a detailed financial projection including a
12 statement of the projected revenue and expenses for the first
13 2 years of operation after licensure of the facility.
14 (9) The agency may not issue a license to a nursing
15 home that fails to receive a certificate of need under the
16 provisions of ss. 408.031-408.045. It is the intent of the
17 Legislature that, in reviewing a license application for a
18 certificate-of-need application to add beds to an existing
19 nursing home facility, preference be given to the application
20 of a licensee who has been awarded a Gold Seal as provided for
21 in s. 400.235 or who meets the performance measures for the
22 Gold Seal award process, if the applicant otherwise meets the
23 review criteria specified in s. 408.035.
24 (11)(a) Each licensed nursing home that has received a
25 certificate of need before July 1, 2001, requiring a specified
26 minimum level of service to Medicaid, indigent, or charity
27 care patients shall continue to provide at least the required
28 minimum level of service. The agency shall monitor compliance
29 with this requirement as part of the certification activities
30 described in paragraph (d).
31
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1 (b) The agency may, for good cause shown, modify the
2 minimum required level of service described in paragraph (a).
3 The agency shall, by rule, define the factors constituting
4 good cause for modification.
5 (c)1. Each nursing home applying for an initial
6 license shall, at the time of application, affirm that at
7 least a specified minimum percentage of annual patient days
8 will be Medicaid patient days, and at least a specified
9 minimum percentage of annual patient days will be charity care
10 patient days.
11 2. Each nursing home applying for a renewal license
12 shall, at the time of application, reaffirm or modify its
13 commitments that a specified minimum percentage of annual
14 patient days will be Medicaid patient days, and a specified
15 minimum percentage of annual patient days will be charity care
16 patient days. The agency shall, by rule, define the factors
17 constituting good cause for modification of previous
18 commitments.
19 3. The agency shall, by rule, establish the minimum
20 annual percentage of service volumes required for nursing home
21 compliance with this paragraph. In establishing such
22 standards, the agency shall give due consideration to the
23 existing commitments described in paragraph (a).
24 (d) Each nursing home shall annually certify to the
25 agency that it has met the requirements of this subsection
26 except as may be noted by the facility. Misrepresentation of
27 compliance is subject to penalties imposed by the agency as
28 provided in s. 400.121.
29 (e) A nursing home found to be out of compliance with
30 the requirements of this subsection is subject to penalties
31 imposed by the agency as provided in s. 400.121.
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1 (12) The applicant for an initial license must certify
2 that it will license and operate the nursing home. For an
3 existing nursing home, the applicant must be the current
4 licenseholder of the facility.
5 Section 5. Subsection (3) is added to section 400.102,
6 Florida Statutes, to read:
7 400.102 Action by agency against licensee; grounds.--
8 (3) In administrative proceedings on an application to
9 establish any health care facility or program or to provide
10 any service or take any other action requiring health care
11 facility licensure authority, only the applicant is entitled
12 to an administrative hearing on its application. No other
13 person may initiate or intervene in any action to determine
14 whether such an application should be approved or denied.
15 Section 6. Subsections (7) and (8) are added to
16 section 400.121, Florida Statutes, to read:
17 400.121 Denial, suspension, revocation of license;
18 moratorium on admissions; administrative fines; procedure;
19 order to increase staffing.--
20 (7) In administrative proceedings on an application to
21 establish any nursing home or program or to provide any
22 service or take any other action requiring nursing home
23 facility licensure authority, only the applicant is entitled
24 to an administrative hearing on its application. No other
25 person may initiate or intervene in any action to determine
26 whether such an application should be approved or denied.
27 (8) Failure to demonstrate financial feasibility as
28 required by s. 400.071(5) is subject to agency action as
29 provided by this section.
30 Section 7. Paragraph (c) of subsection (2) of section
31 400.605, Florida Statutes, is amended to read:
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1 400.605 Administration; forms; fees; rules;
2 inspections; fines.--
3 (2) The agency shall:
4 (c) Issue hospice licenses to all applicants which
5 meet the provisions of this part and applicable rules. The
6 agency shall develop and implement an expedited license
7 application process for community-based hospice services.
8 Section 8. Subsections (1), (5), and (6) of section
9 400.606, Florida Statutes, are amended, and new subsections
10 (6), (7), and (8) are added to said section, to read:
11 400.606 License; application; renewal; conditional
12 license or permit; certificate of need.--
13 (1) A license application must be filed on a form
14 provided by the agency and must be accompanied by the
15 appropriate license fee as well as satisfactory proof that the
16 hospice is in compliance with this part and any rules adopted
17 by the department and proof of financial ability to operate
18 and conduct the hospice in accordance with the requirements of
19 this part. An application for initial licensure of a hospice
20 must contain a detailed financial projection, including a
21 statement of the projected revenue and expenses for the first
22 2 years of operation after licensure of the hospice. The
23 initial application must be accompanied by a plan for the
24 delivery of home, residential, and homelike inpatient hospice
25 services to terminally ill persons and their families. Such
26 plan must contain, but need not be limited to:
27 (a) The estimated average number of terminally ill
28 persons to be served monthly.
29 (b) The geographic area in which hospice services will
30 be available.
31
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1 (c) A listing of services which are or will be
2 provided, either directly by the applicant or through
3 contractual arrangements with existing providers.
4 (d) Provisions for the implementation of hospice home
5 care within 3 months after licensure.
6 (e) Provisions for the implementation of hospice
7 homelike inpatient care within 12 months after licensure.
8 (f) The number and disciplines of professional staff
9 to be employed.
10 (g) The name and qualifications of any existing or
11 potential contractee.
12 (h) A plan for attracting and training volunteers.
13 (i) The projected annual operating cost of the
14 hospice.
15 (j) A statement of financial resources and personnel
16 available to the applicant to deliver hospice care.
17
18 If the applicant is an existing health care provider, the
19 application must be accompanied by a copy of the most recent
20 profit-loss statement and, if applicable, the most recent
21 licensure inspection report.
22 (5) The agency shall not issue a license to a hospice
23 that fails to receive a certificate of need under the
24 provisions of ss. 408.031-408.045. A licensed hospice is a
25 health care facility as that term is used in s. 408.039(5) and
26 is entitled to initiate or intervene in an administrative
27 hearing.
28 (5)(6) A freestanding hospice facility that is
29 primarily engaged in providing inpatient and related services
30 and that is not otherwise licensed as a health care facility
31 shall be required to obtain a certificate of need. However, A
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1 freestanding hospice facility with six or fewer beds shall not
2 be required to comply with institutional standards such as,
3 but not limited to, standards requiring sprinkler systems,
4 emergency electrical systems, or special lavatory devices.
5 (6) In administrative proceedings on an application to
6 establish a hospice or hospice inpatient facility or program
7 or to provide any service or take any other action requiring
8 licensure authority, only the applicant is entitled to an
9 administrative hearing on its application. No other person may
10 initiate or intervene in any action to determine whether such
11 an application should be approved or denied.
12 (7) The applicant for an initial license must certify
13 that it will license and operate the hospice or hospice
14 inpatient facility. For an existing hospice, the applicant
15 must be the current licenseholder for the program.
16 (8) Failure to demonstrate financial feasibility as
17 required by subsection (1) is subject to agency action as
18 provided in s. 400.607.
19 Section 9. Sections 154.245, 408.031, 408.034,
20 408.035, 408.036, 408.0361, 408.037, 408.038, 408.039,
21 408.040, 408.041, 408.042, 408.043, 408.044, 408.045,
22 408.0455, and 651.118, Florida Statutes, and subsections (2),
23 (3), (4), (6), and (7) of section 408.032, Florida Statutes,
24 are repealed.
25 Section 10. Paragraphs (b) and (c) of subsection (1),
26 paragraphs (a) and (f) of subsection (2), and paragraph (b) of
27 subsection (3) of section 408.033, Florida Statutes, are
28 amended to read:
29 408.033 Local and state health planning.--
30 (1) LOCAL HEALTH COUNCILS.--
31 (b) Each local health council may:
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1 1. Develop a district or regional area health plan
2 that permits each local health council to develop strategies
3 and set priorities for implementation based on its unique
4 local health needs. The district or regional area health plan
5 must contain preferences for the development of health
6 services and facilities, which may be considered by the agency
7 in its review of certificate-of-need applications. The
8 district health plan shall be submitted to the agency and
9 updated periodically. The district health plans shall use a
10 uniform format and be submitted to the agency according to a
11 schedule developed by the agency in conjunction with the local
12 health councils. The schedule must provide for the development
13 of district health plans by major sections over a multiyear
14 period. The elements of a district plan which are necessary
15 to the review of certificate-of-need applications for proposed
16 projects within the district may be adopted by the agency as a
17 part of its rules.
18 2. Advise the agency on health care issues and
19 resource allocations.
20 3. Promote public awareness of community health needs,
21 emphasizing health promotion and cost-effective health service
22 selection.
23 4. Collect data and conduct analyses and studies
24 related to health care needs of the district, including the
25 needs of medically indigent persons, and assist the agency and
26 other state agencies in carrying out data collection
27 activities that relate to the functions in this subsection.
28 5. Monitor the onsite construction progress, if any,
29 of certificate-of-need approved projects and report council
30 findings to the agency on forms provided by the agency.
31
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1 5.6. Advise and assist any regional planning councils
2 within each district that have elected to address health
3 issues in their strategic regional policy plans with the
4 development of the health element of the plans to address the
5 health goals and policies in the State Comprehensive Plan.
6 6.7. Advise and assist local governments within each
7 district on the development of an optional health plan element
8 of the comprehensive plan provided in chapter 163, to assure
9 compatibility with the health goals and policies in the State
10 Comprehensive Plan and district health plan. To facilitate
11 the implementation of this section, the local health council
12 shall annually provide the local governments in its service
13 area, upon request, with:
14 a. A copy and appropriate updates of the district
15 health plan; and
16 b. A report of hospital and nursing home utilization
17 statistics for facilities within the local government
18 jurisdiction.; and
19 c. Applicable agency rules and calculated need
20 methodologies for health facilities and services regulated
21 under s. 408.034 for the district served by the local health
22 council.
23 7.8. Monitor and evaluate the adequacy,
24 appropriateness, and effectiveness, within the district, of
25 local, state, federal, and private funds distributed to meet
26 the needs of the medically indigent and other underserved
27 population groups.
28 8.9. In conjunction with the Agency for Health Care
29 Administration, plan for services at the local level for
30 persons infected with the human immunodeficiency virus.
31
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1 9.10. Provide technical assistance to encourage and
2 support activities by providers, purchasers, consumers, and
3 local, regional, and state agencies in meeting the health care
4 goals, objectives, and policies adopted by the local health
5 council.
6 11. Provide the agency with data required by rule for
7 the review of certificate-of-need applications and the
8 projection of need for health services and facilities in the
9 district.
10 (c) Local health councils may conduct public hearings
11 pursuant to s. 408.039(3)(b).
12 (2) FUNDING.--
13 (a) The Legislature intends that the cost of local
14 health councils be borne by application fees for certificates
15 of need and by assessments on selected health care facilities
16 subject to facility licensure by the Agency for Health Care
17 Administration, including abortion clinics, assisted living
18 facilities, ambulatory surgical centers, birthing centers,
19 clinical laboratories except community nonprofit blood banks
20 and clinical laboratories operated by practitioners for
21 exclusive use regulated under s. 483.035, home health
22 agencies, hospices, hospitals, intermediate care facilities
23 for the developmentally disabled, nursing homes, and
24 multiphasic testing centers and by assessments on
25 organizations subject to certification by the agency pursuant
26 to chapter 641, part III, including health maintenance
27 organizations and prepaid health clinics.
28 (f) The agency shall deposit in the Health Care Trust
29 Fund all health care facility assessments that are assessed
30 under this subsection and proceeds from the
31 certificate-of-need application fees. The agency shall
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1 transfer to the Department of Health an amount sufficient to
2 maintain the aggregate funding level for the local health
3 councils as specified in the General Appropriations Act. The
4 remaining certificate-of-need application fees shall be used
5 only for the purpose of administering the Health Facility and
6 Services Development Act.
7 (3) DUTIES AND RESPONSIBILITIES OF THE AGENCY.--
8 (b) The agency shall develop and maintain a
9 comprehensive health care database for the purpose of health
10 planning and for certificate-of-need determinations. The
11 agency or its contractor is authorized to require the
12 submission of information from health facilities, health
13 service providers, and licensed health professionals which is
14 determined by the agency, through rule, to be necessary for
15 meeting the agency's responsibilities as established in this
16 section.
17 Section 11. Subsection (3) of section 20.42, Florida
18 Statutes, is amended to read:
19 20.42 Agency for Health Care Administration.--
20 (3) The department shall be the chief health policy
21 and planning entity for the state. The department is
22 responsible for health facility licensure, inspection, and
23 regulatory enforcement; investigation of consumer complaints
24 related to health care facilities and managed care plans; the
25 implementation of the certificate of need program; the
26 operation of the State Center for Health Statistics; the
27 administration of the Medicaid program; the administration of
28 the contracts with the Florida Healthy Kids Corporation; the
29 certification of health maintenance organizations and prepaid
30 health clinics as set forth in part III of chapter 641; and
31 any other duties prescribed by statute or agreement.
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1 Section 12. Subsection (4) of section 154.205, Florida
2 Statutes, is amended to read:
3 154.205 Definitions.--The following terms, whenever
4 used in this part, shall have the following meanings unless a
5 different meaning clearly appears from the context:
6 (4) "Certificate of need" means a written advisory
7 statement issued by the Agency for Health Care Administration,
8 having as its basis a written advisory statement issued by an
9 areawide council and, where there is no council, by the Agency
10 for Health Care Administration, evidencing community need for
11 a new, converted, expanded, or otherwise significantly
12 modified health facility.
13 Section 13. Section 154.213, Florida Statutes, is
14 amended to read:
15 154.213 Agreements of lease.--In undertaking any
16 project pursuant to this part, the authority shall first
17 obtain a valid certificate of need evidencing need for the
18 project and a statement that the project serves a public
19 purpose by advancing the commerce, welfare, and prosperity of
20 the local agency and its people. No project financed under
21 the provisions of this part shall be operated by the authority
22 or any other governmental agency; however, the authority may
23 temporarily operate or cause to be operated all or any part of
24 a project to protect its interest therein pending any leasing
25 of such project in accordance with the provisions of this
26 part. The authority may lease a project or projects to a
27 health facility for operation and maintenance in such manner
28 as to effectuate the purposes of this part under an agreement
29 of lease in form and substance not inconsistent herewith.
30 (1) Any such agreement of lease may provide, among
31 other provisions, that:
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1 (a) The lessee shall at its own expense operate,
2 repair, and maintain the project or projects leased
3 thereunder.
4 (b) The rent payable under the lease shall in the
5 aggregate be not less than an amount sufficient to pay all of
6 the interest, principal, and redemption premiums, if any, on
7 the bonds that shall be issued by the authority to pay the
8 cost of the project or projects leased thereunder.
9 (c) The lessee shall pay all costs incurred by the
10 authority in connection with the acquisition, financing,
11 construction, and administration of the project or projects
12 leased, except as may be paid out of the proceeds of bonds or
13 otherwise, including, but without being limited to: Insurance
14 costs, the cost of administering the bond resolution
15 authorizing such bonds and any trust agreement securing the
16 bonds, and the fees and expenses of trustees, paying agents,
17 attorneys, consultants, and others.
18 (d) The terms of the lease shall terminate not earlier
19 than the date on which all such bonds and all other
20 obligations incurred by the authority in connection with the
21 project or projects leased thereunder shall be paid in full,
22 including interest, principal, and redemption premiums, if
23 any, or adequate funds for such payment shall be deposited in
24 trust.
25 (e) The lessee's obligation to pay rent shall not be
26 subject to cancellation, termination, or abatement by the
27 lessee until such payment of the bonds or provision for such
28 payment shall be made.
29 (2) Such lease agreement may contain such additional
30 provisions as in the determination of the authority are
31 necessary or convenient to effectuate the purposes of this
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1 part, including provisions for extensions of the term and
2 renewals of the lease and vesting in the lessee an option to
3 purchase the project leased thereunder pursuant to such terms
4 and conditions consistent with this part as shall be
5 prescribed in the lease. Except as may otherwise be expressly
6 stated in the agreement of lease, to provide for any
7 contingencies involving the damaging, destruction, or
8 condemnation of the project leased or any substantial portion
9 thereof, such option to purchase may not be exercised unless
10 all bonds issued for such project, including all principal,
11 interest, and redemption premiums, if any, and all other
12 obligations incurred by the authority in connection with such
13 project, shall have been paid in full or sufficient funds
14 shall have been deposited in trust for such payment. The
15 purchase price of such project shall not be less than an
16 amount sufficient to pay in full all of the bonds, including
17 all principal, interest, and redemption premiums, if any,
18 issued for the project then outstanding and all other
19 obligations incurred by the authority in connection with such
20 project.
21 Section 14. Subsection (1) of section 154.219, Florida
22 Statutes, is amended to read:
23 154.219 Revenue bonds.--
24 (1) The authority is authorized from time to time to
25 issue its negotiable revenue bonds for the purpose of paying
26 all or any part of the cost of any project or projects for
27 which a certificate of need has been obtained, or pursuant to
28 subsections (12) and (13) of s. 154.209 for the purpose of
29 paying all or any part of the cost of acquiring existing or
30 completed health facilities projects. In anticipation of the
31 sale of such revenue bonds, the authority may issue negotiable
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1 bond anticipation notes and may renew the same from time to
2 time, but the maximum maturity of any such note, including
3 renewals thereof, shall not exceed 5 years from the date of
4 issue of the original note. Such notes shall be paid from any
5 revenues of the authority available therefor and not otherwise
6 pledged or from the proceeds of sale of the revenue bonds of
7 the authority in anticipation of which they were issued. The
8 notes shall be issued in the same manner as the revenue bonds.
9 Such notes and the resolution or resolutions authorizing the
10 same may contain any provisions, conditions, or limitation
11 which a bond resolution of the authority may contain.
12 Section 15. Subsection (16) of section 159.27, Florida
13 Statutes, is amended to read:
14 159.27 Definitions.--The following words and terms,
15 unless the context clearly indicates a different meaning,
16 shall have the following meanings:
17 (16) "Health care facility" means property operated in
18 the private sector, whether operated for profit or not, used
19 for or useful in connection with the diagnosis, treatment,
20 therapy, rehabilitation, housing, or care of or for aged,
21 sick, ill, injured, infirm, impaired, disabled, or handicapped
22 persons, without discrimination among such persons due to
23 race, religion, or national origin; or for the prevention,
24 detection, and control of disease, including, without
25 limitation thereto, hospital, clinic, emergency, outpatient,
26 and intermediate care, including, but not limited to,
27 facilities for the elderly such as assisted living facilities,
28 facilities defined in s. 154.205(7)(8), day care and
29 share-a-home facilities, nursing homes, and the following
30 related property when used for or in connection with the
31 foregoing: laboratory; research; pharmacy; laundry; health
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1 personnel training and lodging; patient, guest, and health
2 personnel food service facilities; and offices and office
3 buildings for persons engaged in health care professions or
4 services; provided, if required by ss. 400.601-400.611 and ss.
5 408.031-408.045, a certificate of need therefor is obtained
6 prior to the issuance of the bonds.
7 Section 16. Subsection (3) of section 189.415, Florida
8 Statutes, is amended to read:
9 189.415 Special district public facilities report.--
10 (3) A special district proposing to build, improve, or
11 expand a public facility which requires a certificate of need
12 pursuant to chapter 408 shall elect to notify the appropriate
13 local general-purpose government of its plans either in its
14 5-year plan or at the time the application for license letter
15 of intent is filed with the Agency for Health Care
16 Administration pursuant to s. 408.039.
17 Section 17. Subsection (4) of section 383.50, Florida
18 Statutes, is amended to read:
19 383.50 Treatment of abandoned newborn infant.--
20 (4) Each hospital of this state subject to s. 395.1041
21 shall, and any other hospital may, admit and provide all
22 necessary emergency services and care, as defined in s.
23 395.002(21)(10), to any newborn infant left with the hospital
24 in accordance with this section. The hospital or any of its
25 licensed health care professionals shall consider these
26 actions as implied consent for treatment, and a hospital
27 accepting physical custody of a newborn infant has implied
28 consent to perform all necessary emergency services and care.
29 The hospital or any of its licensed health care professionals
30 is immune from criminal or civil liability for acting in good
31
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1 faith in accordance with this section. Nothing in this
2 subsection limits liability for negligence.
3 Section 18. Subsection (7) of section 394.4787,
4 Florida Statutes, is amended to read:
5 394.4787 Definitions; ss. 394.4786, 394.4787,
6 394.4788, and 394.4789.--As used in this section and ss.
7 394.4786, 394.4788, and 394.4789:
8 (7) "Specialty psychiatric hospital" means a hospital
9 licensed by the agency pursuant to s. 395.002(53)(29) as a
10 specialty psychiatric hospital.
11 Section 19. Subsection (10) of section 395.0191,
12 Florida Statutes, is amended to read:
13 395.0191 Staff membership and clinical privileges.--
14 (10) Nothing herein shall be construed by the agency
15 as requiring an applicant for a license certificate of need to
16 establish proof of discrimination in the granting of or denial
17 of hospital staff membership or clinical privileges as a
18 precondition to obtaining such license certificate of need
19 under the provisions of s. 408.043.
20 Section 20. Paragraph (h) of subsection (1) of section
21 395.1055, Florida Statutes, is amended to read:
22 395.1055 Rules and enforcement.--
23 (1) The agency shall adopt rules pursuant to ss.
24 120.536(1) and 120.54 to implement the provisions of this
25 part, which shall include reasonable and fair minimum
26 standards for ensuring that:
27 (h) All hospitals submit such data which as necessary
28 to conduct certificate-of-need reviews required under ss.
29 408.031-408.045. Such data shall include, but shall not be
30 limited to, patient origin data, hospital utilization data,
31 type of service reporting, and facility staffing data. The
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1 agency shall not collect data that identifies or could
2 disclose the identity of individual patients. The agency shall
3 utilize existing uniform statewide data sources when available
4 and shall minimize reporting costs to hospitals.
5 Section 21. Paragraph (c) of subsection (2) of section
6 395.602, Florida Statutes, is amended to read:
7 395.602 Rural hospitals.--
8 (2) DEFINITIONS.--As used in this part:
9 (c) "Inactive rural hospital bed" means a licensed
10 acute care hospital bed, as defined in s. 395.002(23)(12),
11 that is inactive in that it cannot be occupied by acute care
12 inpatients.
13 Section 22. Subsection (1) of section 395.603, Florida
14 Statutes, is amended to read:
15 395.603 Rules; rural hospital impact statement.--
16 (1) The agency shall establish, by rule, a process by
17 which a rural hospital, as defined in s. 395.602, that seeks
18 licensure as a rural primary care hospital or as an emergency
19 care hospital, or becomes a certified rural health clinic as
20 defined in Pub. L. No. 95-210, or becomes a primary care
21 program such as a county health department, community health
22 center, or other similar outpatient program that provides
23 preventive and curative services, may deactivate general
24 hospital beds. Rural primary care hospitals and emergency
25 care hospitals shall maintain the number of actively licensed
26 general hospital beds necessary for the facility to be
27 certified for Medicare reimbursement. Hospitals that
28 discontinue inpatient care to become rural health care clinics
29 or primary care programs shall deactivate all licensed general
30 hospital beds. All hospitals, clinics, and programs with
31 inactive beds shall provide 24-hour emergency medical care by
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1 staffing an emergency room. Providers with inactive beds
2 shall be subject to the criteria in s. 395.1041. The agency
3 shall specify in rule requirements for making 24-hour
4 emergency care available. Inactive general hospital beds
5 shall be included in the acute care bed inventory, maintained
6 by the agency for certificate-of-need purposes, for 10 years
7 from the date of deactivation of the beds. After 10 years have
8 elapsed, inactive beds shall be excluded from the inventory.
9 The agency shall, at the request of the licensee, reactivate
10 the inactive general beds upon a showing by the licensee that
11 licensure requirements for the inactive general beds are met.
12 Section 23. Subsection (1) of section 395.604, Florida
13 Statutes, is amended to read:
14 395.604 Other rural hospital programs.--
15 (1) The agency may license rural primary care
16 hospitals subject to federal approval for participation in the
17 Medicare and Medicaid programs. Rural primary care hospitals
18 shall be treated in the same manner as emergency care
19 hospitals and rural hospitals with respect to ss.
20 395.605(2)-(6)(a) and 395.605(2)-(8)(a), 408.033(2)(b)3., and
21 408.038.
22 Section 24. Subsections (5) and (7) of section
23 395.605, Florida Statutes, are amended to read:
24 395.605 Emergency care hospitals.--
25 (5) Rural hospitals that make application under the
26 certificate-of-need program to be licensed as emergency care
27 hospitals shall receive expedited review as defined in s.
28 408.032. Emergency care hospitals seeking relicensure as acute
29 care general hospitals shall also receive expedited review.
30 (7) Emergency care hospitals are exempt from
31 certificate-of-need requirements for home health and hospice
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1 services and for swing beds in a number that does not exceed
2 one-half of the facility's licensed beds.
3 Section 25. Paragraph (c) of subsection (1) of section
4 395.701, Florida Statutes, is amended to read:
5 395.701 Annual assessments on net operating revenues
6 for inpatient services to fund public medical assistance;
7 administrative fines for failure to pay assessments when due;
8 exemption.--
9 (1) For the purposes of this section, the term:
10 (c) "Hospital" means a health care institution as
11 defined in s. 395.002(24)(13), but does not include any
12 hospital operated by the agency or the Department of
13 Corrections.
14 Section 26. Paragraph (b) of subsection (1) of section
15 400.051, Florida Statutes, is amended to read:
16 400.051 Homes or institutions exempt from the
17 provisions of this part.--
18 (1) The following shall be exempt from the provisions
19 of this part:
20 (b) Any hospital, as defined in s. 395.002(22)(11),
21 that is licensed under chapter 395.
22 Section 27. Subsection (5) of section 400.23, Florida
23 Statutes, is amended to read:
24 400.23 Rules; evaluation and deficiencies; licensure
25 status.--
26 (5) The agency, in collaboration with the Division of
27 Children's Medical Services of the Department of Health, must,
28 no later than December 31, 1993, adopt rules for minimum
29 standards of care for persons under 21 years of age who reside
30 in nursing home facilities. The rules must include a
31 methodology for reviewing a nursing home facility under ss.
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1 408.031-408.045 which serves only persons under 21 years of
2 age. A facility may be exempt from these standards for
3 specific persons between 18 and 21 years of age, if the
4 person's physician agrees that minimum standards of care based
5 on age are not necessary.
6 Section 28. Subsection (6) of section 400.602, Florida
7 Statutes, is amended to read:
8 400.602 Licensure required; prohibited acts;
9 exemptions; display, transferability of license.--
10 (6) Notwithstanding s. 400.601(3), at any time after
11 July 1, 1995, any entity entitled to licensure under
12 subsection (5) may obtain a license for up to two additional
13 hospices in accordance with the other requirements of this
14 part and upon receipt of any certificate of need that may be
15 required under the provisions of ss. 408.031-408.045.
16 Section 29. Paragraph (b) of subsection (2) of section
17 400.6085, Florida Statutes, is amended to read:
18 400.6085 Contractual services.--A hospice may contract
19 out for some elements of its services. However, the core
20 services, as set forth in s. 400.609(1), with the exception of
21 physician services, shall be provided directly by the hospice.
22 Any contract entered into between a hospice and a health care
23 facility or service provider must specify that the hospice
24 retains the responsibility for planning, coordinating, and
25 prescribing hospice care and services for the hospice patient
26 and family. A hospice that contracts for any hospice service
27 is prohibited from charging fees for services provided
28 directly by the hospice care team that duplicate contractual
29 services provided to the patient and family.
30 (2) With respect to contractual arrangements for
31 inpatient hospice care:
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1 (b) Licensed beds designated for inpatient hospice
2 care through a contract Hospices contracting for inpatient
3 care beds shall not be required to obtain an additional
4 certificate of need for the number of such designated beds.
5 Such beds shall remain licensed to the health care facility
6 and be subject to the appropriate inspections.
7 Section 30. Subsection (8) of section 409.905, Florida
8 Statutes, is amended to read:
9 409.905 Mandatory Medicaid services.--The agency may
10 make payments for the following services, which are required
11 of the state by Title XIX of the Social Security Act,
12 furnished by Medicaid providers to recipients who are
13 determined to be eligible on the dates on which the services
14 were provided. Any service under this section shall be
15 provided only when medically necessary and in accordance with
16 state and federal law. Nothing in this section shall be
17 construed to prevent or limit the agency from adjusting fees,
18 reimbursement rates, lengths of stay, number of visits, number
19 of services, or any other adjustments necessary to comply with
20 the availability of moneys and any limitations or directions
21 provided for in the General Appropriations Act or chapter 216.
22 (8) NURSING FACILITY SERVICES.--The agency shall pay
23 for 24-hour-a-day nursing and rehabilitative services for a
24 recipient in a nursing facility licensed under part II of
25 chapter 400 or in a rural hospital, as defined in s. 395.602,
26 or in a Medicare certified skilled nursing facility operated
27 by a hospital, as defined by s. 395.002(22)(11), that is
28 licensed under part I of chapter 395, and in accordance with
29 provisions set forth in s. 409.908(2)(a), which services are
30 ordered by and provided under the direction of a licensed
31 physician. However, if a nursing facility has been destroyed
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1 or otherwise made uninhabitable by natural disaster or other
2 emergency and another nursing facility is not available, the
3 agency must pay for similar services temporarily in a hospital
4 licensed under part I of chapter 395 provided federal funding
5 is approved and available.
6 Section 31. Paragraph (b) of subsection (5) of section
7 430.705, Florida Statutes, is amended to read:
8 430.705 Implementation of the long-term care community
9 diversion pilot projects.--
10 (5) In selecting the pilot project area, the
11 department shall consider the following factors in the area:
12 (b) The number of certificates of need awarded for
13 nursing home beds for which renovation, expansion, or
14 construction has not begun.
15 Section 32. Section 430.708, Florida Statutes, is
16 amended to read:
17 430.708 Implementation of Medicaid community diversion
18 pilot projects Certificate of need.--To ensure that Medicaid
19 community diversion pilot projects result in a reduction in
20 the projected average monthly nursing home caseload, the
21 agency shall, in accordance with the provisions of s.
22 408.034(4):
23 (1) Reduce the projected nursing home bed need in each
24 certificate-of-need batching cycle in the community diversion
25 pilot project areas.
26 (1)(2) Reduce the conditions imposed on existing
27 nursing homes or those to be constructed, in accordance with
28 the number of projected community diversion slots.
29 (2)(3) Adopt rules to reduce the number of beds in
30 Medicaid-participating nursing homes eligible for Medicaid,
31
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1 through a Medicaid-selective contracting process or some other
2 appropriate method.
3 (4) Determine the feasibility of increasing the
4 nursing home occupancy threshold used in determining nursing
5 home bed needs under the certificate-of-need process.
6 Section 33. Paragraph (l) of subsection (1) of section
7 468.505, Florida Statutes, is amended to read:
8 468.505 Exemptions; exceptions.--
9 (1) Nothing in this part may be construed as
10 prohibiting or restricting the practice, services, or
11 activities of:
12 (l) A person employed by a nursing facility exempt
13 from licensing under s. 395.002(24)(13), or a person exempt
14 from licensing under s. 464.022.
15 Section 34. Paragraph (a) of subsection (2) of section
16 651.021, Florida Statutes, is amended to read:
17 651.021 Certificate of authority required.--
18 (2)(a) Before commencement of construction or
19 marketing for any expansion of a certificated facility
20 equivalent to the addition of at least 20 percent of existing
21 units, written approval must be obtained from the department.
22 This provision does not apply to construction for which a
23 certificate of need from the Agency for Health Care
24 Administration is required.
25 Section 35. Section 766.316, Florida Statutes, is
26 amended to read:
27 766.316 Notice to obstetrical patients of
28 participation in the plan.--Each hospital with a participating
29 physician on its staff and each participating physician, other
30 than residents, assistant residents, and interns deemed to be
31 participating physicians under s. 766.314(4)(c), under the
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1 Florida Birth-Related Neurological Injury Compensation Plan
2 shall provide notice to the obstetrical patients as to the
3 limited no-fault alternative for birth-related neurological
4 injuries. Such notice shall be provided on forms furnished by
5 the association and shall include a clear and concise
6 explanation of a patient's rights and limitations under the
7 plan. The hospital or the participating physician may elect to
8 have the patient sign a form acknowledging receipt of the
9 notice form. Signature of the patient acknowledging receipt of
10 the notice form raises a rebuttable presumption that the
11 notice requirements of this section have been met. Notice need
12 not be given to a patient when the patient has an emergency
13 medical condition as defined in s. 395.002(9)(b) or when
14 notice is not practicable.
15 Section 36. Grandfather clause.--A facility licensed
16 to provide any of the following services pursuant to a valid
17 certificate of need on June 30, 2001, shall continue to be
18 licensed to provide such service on and after the effective
19 date of this act:
20 (1) Bone marrow transplantation.
21 (2) Burn unit facilities.
22 (3) Cardiac catheterization programs.
23 (4) Level I and Level II neonatology.
24 (5) Comprehensive medical rehabilitation outpatient
25 services.
26 (6) Coronary angioplasty.
27 (7) Open heart surgery.
28 (8) Psychiatric inpatient services.
29 (9) Substance abuse inpatient services.
30 (10) Tertiary health services.
31 (11) Transplantation programs.
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1
2 Such facilities shall apply to the Agency for Health Care
3 Administration by October 1, 2001, for relicensure to provide
4 such services pursuant to the provisions of this act.
5 Section 37. This act shall take effect July 1, 2001.
6
7 *****************************************
8 HOUSE SUMMARY
9
Revises definitions relating to hospital licensing and
10 regulation. Restricts persons who may initiate or
intervene in actions or proceedings on an application for
11 licensure of a health care facility, program, or service.
Provides minimum standards and specifies requirements for
12 the following inpatient services: cardiac catheterization
and angioplasty, open heart surgery, inpatient
13 comprehensive medical rehabilitation, inpatient general
psychiatric services, inpatient substance abuse services,
14 neonatal intensive care services, specialty burn units,
and heart, liver, kidney, and bone marrow
15 transplantation. Provides additional licensure
application requirements for nursing homes and hospices.
16 Provides penalties for failure of a nursing home or
hospice to demonstrate financial feasibility in its
17 license application. Provides for an expedited licensure
process for community-based hospices. Repeals
18 requirements for certificate-of-need review and approval
for health facilities and services. Conforms provisions
19 relating to certificate-of-need review of proposed and
existing health facilities and services. See bill for
20 details.
21
22
23
24
25
26
27
28
29
30
31
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