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2021 Florida Statutes (Including 2021B Session)
Chapter 395
HOSPITAL LICENSING AND REGULATION
HOSPITAL LICENSING AND REGULATION
CHAPTER 395
HOSPITAL LICENSING AND REGULATION
PART I
HOSPITALS AND OTHER LICENSED FACILITIES(ss. 395.001-395.3041)
PART II
TRAUMA(ss. 395.40-395.51)
PART III
RURAL HOSPITALS(ss. 395.602-395.6061)
PART IV
PUBLIC MEDICAL ASSISTANCE TRUST FUND(ss. 395.701-395.7017)
PART V
FAMILY PRACTICE TEACHING HOSPITALS(ss. 395.805-395.807)
PART I
HOSPITALS AND OTHERLICENSED FACILITIES
395.001 Legislative intent.
395.002 Definitions.
395.003 Licensure; denial, suspension, and revocation.
395.004 Application for license; fees.
395.0056 Litigation notice requirement.
395.009 Minimum standards for clinical laboratory test results and diagnostic X-ray results; prerequisite for issuance or renewal of license.
395.0091 Alternate-site testing.
395.0161 Licensure inspection.
395.0162 Inspection reports.
395.0163 Construction inspections; plan submission and approval; fees.
395.0185 Rebates prohibited; penalties.
395.0191 Staff membership and clinical privileges.
395.0192 Duty to notify physicians.
395.0193 Licensed facilities; peer review; disciplinary powers; agency or partnership with physicians.
395.0195 Access of chiropractic physicians to diagnostic reports.
395.0197 Internal risk management program.
395.1011 Identification, segregation, and separation of biomedical waste.
395.1012 Patient safety.
395.1021 Treatment of sexual assault victims.
395.1023 Child abuse and neglect cases; duties.
395.1024 Patients consenting to adoptions; protocols.
395.1025 Infectious diseases; notification.
395.1027 Regional poison control centers.
395.1031 Emergency medical services; communication.
395.1041 Access to emergency services and care.
395.1051 Duty to notify patients.
395.1052 Patient access to primary care and specialty providers; notification.
395.1053 Postpartum education.
395.1055 Rules and enforcement.
395.1056 Plan components addressing a hospital’s response to terrorism; public records exemption; public meetings exemption.
395.106 Risk pooling by certain hospitals and hospital systems.
395.1065 Criminal and administrative penalties; moratorium.
395.107 Facilities; publishing and posting schedule of charges; penalties.
395.10973 Powers and duties of the agency.
395.2050 Routine inquiry for organ and tissue donation; certification for procurement activities; death records review.
395.301 Price transparency; itemized patient statement or bill; patient admission status notification.
395.3015 Patient records; form and content.
395.302 Patient records; penalties for alteration.
395.3025 Patient and personnel records; copies; examination.
395.3035 Confidentiality of hospital records and meetings.
395.3036 Confidentiality of records and meetings of entities that lease public hospitals or other public health care facilities.
395.3037 Definitions.
395.3038 State-listed stroke centers; notification of hospitals.
395.30381 Statewide stroke registry.
395.3039 Advertising restrictions.
395.3041 Emergency medical services providers; triage and transportation of stroke victims to a stroke center.
395.001 Legislative intent.—It is the intent of the Legislature to provide for the protection of public health and safety in the establishment, construction, maintenance, and operation of hospitals and ambulatory surgical centers by providing for licensure of same and for the development, establishment, and enforcement of minimum standards with respect thereto.
History.—ss. 26, 30, ch. 82-182; ss. 2, 98, ch. 92-289; s. 1, ch. 98-303; s. 23, ch. 2018-24.
395.002 Definitions.—As used in this chapter:
(1) “Accrediting organizations” means national accreditation organizations that are approved by the Centers for Medicare and Medicaid Services and whose standards incorporate comparable licensure regulations required by the state.
(2) “Agency” means the Agency for Health Care Administration.
(3) “Ambulatory surgical center” means a facility, the primary purpose of which is to provide elective surgical care, in which the patient is admitted to and discharged from such facility within 24 hours, and which is not part of a hospital. However, a facility existing for the primary purpose of performing terminations of pregnancy, an office maintained by a physician for the practice of medicine, or an office maintained for the practice of dentistry may not be construed to be an ambulatory surgical center, provided that any facility or office which is certified or seeks certification as a Medicare ambulatory surgical center shall be licensed as an ambulatory surgical center pursuant to s. 395.003.
(4) “Biomedical waste” means any solid or liquid waste as defined in s. 381.0098(2)(a).
(5) “Clinical privileges” means the privileges granted to a physician or other licensed health care practitioner to render patient care services in a hospital, but does not include the privilege of admitting patients.
(6) “Department” means the Department of Health.
(7) “Director” means any member of the official board of directors as reported in the organization’s annual corporate report to the Florida Department of State, or, if no such report is made, any member of the operating board of directors. The term excludes members of separate, restricted boards that serve only in an advisory capacity to the operating board.
(8) “Emergency medical condition” means:
(a) A medical condition manifesting itself by acute symptoms of sufficient severity, which may include severe pain, such that the absence of immediate medical attention could reasonably be expected to result in any of the following:
1. Serious jeopardy to patient health, including a pregnant woman or fetus.
2. Serious impairment to bodily functions.
3. Serious dysfunction of any bodily organ or part.
(b) With respect to a pregnant woman:
1. That there is inadequate time to effect safe transfer to another hospital prior to delivery;
2. That a transfer may pose a threat to the health and safety of the patient or fetus; or
3. That there is evidence of the onset and persistence of uterine contractions or rupture of the membranes.
(9) “Emergency services and care” means medical screening, examination, and evaluation by a physician, or, to the extent permitted by applicable law, by other appropriate personnel under the supervision of a physician, to determine if an emergency medical condition exists and, if it does, the care, treatment, or surgery by a physician necessary to relieve or eliminate the emergency medical condition, within the service capability of the facility.
(10) “Hospital-based off-campus emergency department” means a facility that:
(a) Provides emergency services and care;
(b) Is owned and operated by a licensed hospital and operates under the license of the hospital; and
(c) Is located on separate premises from the hospital.
(11) “General hospital” means any facility which meets the provisions of subsection (13) and which regularly makes its facilities and services available to the general population.
(12) “Governmental unit” means the state or any county, municipality, or other political subdivision, or any department, division, board, or other agency of any of the foregoing.
(13) “Hospital” means any establishment that:
(a) Offers services more intensive than those required for room, board, personal services, and general nursing care, and offers facilities and beds for use beyond 24 hours by individuals requiring diagnosis, treatment, or care for illness, injury, deformity, infirmity, abnormality, disease, or pregnancy; and
(b) Regularly makes available at least clinical laboratory services, diagnostic X-ray services, and treatment facilities for surgery or obstetrical care, or other definitive medical treatment of similar extent, except that a critical access hospital, as defined in s. 408.07, shall not be required to make available treatment facilities for surgery, obstetrical care, or similar services as long as it maintains its critical access hospital designation and shall be required to make such facilities available only if it ceases to be designated as a critical access hospital.
However, the provisions of this chapter do not apply to any institution conducted by or for the adherents of any well-recognized church or religious denomination that depends exclusively upon prayer or spiritual means to heal, care for, or treat any person. For purposes of local zoning matters, the term “hospital” includes a medical office building located on the same premises as a hospital facility, provided the land on which the medical office building is constructed is zoned for use as a hospital; provided the premises were zoned for hospital purposes on January 1, 1992.
(14) “Hospital bed” means a hospital accommodation which is ready for immediate occupancy, or is capable of being made ready for occupancy within 48 hours, excluding provision of staffing, and which conforms to minimum space, equipment, and furnishings standards as specified by rule of the agency for the provision of services specified in this section to a single patient.
(15) “Initial denial determination” means a determination by a private review agent that the health care services furnished or proposed to be furnished to a patient are inappropriate, not medically necessary, or not reasonable.
(16) “Intensive residential treatment programs for children and adolescents” means a specialty hospital accredited by an accrediting organization as defined in subsection (1) which provides 24-hour care and which has the primary functions of diagnosis and treatment of patients under the age of 18 having psychiatric disorders in order to restore such patients to an optimal level of functioning.
(17) “Licensed facility” means a hospital or ambulatory surgical center licensed in accordance with this chapter.
(18) “Lifesafety” means the control and prevention of fire and other life-threatening conditions on a premises for the purpose of preserving human life.
(19) “Managing employee” means the administrator or other similarly titled individual who is responsible for the daily operation of the facility.
(20) “Medical staff” means physicians licensed under chapter 458 or chapter 459 with privileges in a licensed facility, as well as other licensed health care practitioners with clinical privileges as approved by a licensed facility’s governing board.
(21) “Medically necessary transfer” means a transfer made necessary because the patient is in immediate need of treatment for an emergency medical condition for which the facility lacks service capability or is at service capacity.
(22) “Person” means any individual, partnership, corporation, association, or governmental unit.
(23) “Premises” means those buildings, beds, and equipment located at the address of the licensed facility and all other buildings, beds, and equipment for the provision of hospital or ambulatory surgical care located in such reasonable proximity to the address of the licensed facility as to appear to the public to be under the dominion and control of the licensee. For any licensee that is a teaching hospital as defined in s. 408.07, reasonable proximity includes any buildings, beds, services, programs, and equipment under the dominion and control of the licensee that are located at a site with a main address that is within 1 mile of the main address of the licensed facility; and all such buildings, beds, and equipment may, at the request of a licensee or applicant, be included on the facility license as a single premises.
(24) “Private review agent” means any person or entity which performs utilization review services for third-party payors on a contractual basis for outpatient or inpatient services. However, the term shall not include full-time employees, personnel, or staff of health insurers, health maintenance organizations, or hospitals, or wholly owned subsidiaries thereof or affiliates under common ownership, when performing utilization review for their respective hospitals, health maintenance organizations, or insureds of the same insurance group. For this purpose, health insurers, health maintenance organizations, and hospitals, or wholly owned subsidiaries thereof or affiliates under common ownership, include such entities engaged as administrators of self-insurance as defined in s. 624.031.
(25) “Service capability” means all services offered by the facility where identification of services offered is evidenced by the appearance of the service in a patient’s medical record or itemized bill.
(26) “At service capacity” means the temporary inability of a hospital to provide a service which is within the service capability of the hospital, due to maximum use of the service at the time of the request for the service.
(27) “Specialty bed” means a bed, other than a general bed, designated on the face of the hospital license for a dedicated use.
(28) “Specialty hospital” means any facility which meets the provisions of subsection (13), and which regularly makes available either:
(a) The range of medical services offered by general hospitals but restricted to a defined age or gender group of the population;
(b) A restricted range of services appropriate to the diagnosis, care, and treatment of patients with specific categories of medical or psychiatric illnesses or disorders; or
(c) Intensive residential treatment programs for children and adolescents as defined in subsection (16).
(29) “Stabilized” means, with respect to an emergency medical condition, that no material deterioration of the condition is likely, within reasonable medical probability, to result from the transfer of the patient from a hospital.
(30) “Urgent care center” means a facility or clinic that provides immediate but not emergent ambulatory medical care to patients. The term includes:
(a) An offsite facility of a facility licensed under this chapter, or a joint venture between a facility licensed under this chapter and a provider licensed under chapter 458 or chapter 459, that does not require a patient to make an appointment and is presented to the general public in any manner as a facility where immediate but not emergent medical care is provided.
(b) A clinic organization that is licensed under part X of chapter 400, maintains three or more locations using the same or a similar name, does not require a patient to make an appointment, and holds itself out to the general public in any manner as a facility or clinic where immediate but not emergent medical care is provided.
(31) “Utilization review” means a system for reviewing the medical necessity or appropriateness in the allocation of health care resources of hospital services given or proposed to be given to a patient or group of patients.
(32) “Utilization review plan” means a description of the policies and procedures governing utilization review activities performed by a private review agent.
(33) “Validation inspection” means an inspection of the premises of a licensed facility by the agency to assess whether a review by an accrediting organization has adequately evaluated the licensed facility according to minimum state standards.
History.—ss. 1, 4, ch. 82-125; ss. 26, 30, ch. 82-182; s. 33, ch. 87-92; s. 52, ch. 88-130; s. 4, ch. 89-527; s. 12, ch. 90-295; ss. 3, 98, ch. 92-289; s. 724, ch. 95-148; s. 23, ch. 98-89; s. 37, ch. 98-171; s. 2, ch. 98-303; s. 102, ch. 99-8; s. 206, ch. 99-13; s. 4, ch. 2002-400; s. 1, ch. 2005-81; s. 37, ch. 2007-230; s. 2, ch. 2011-122; s. 4, ch. 2012-66; s. 1, ch. 2012-160; s. 24, ch. 2018-24; s. 6, ch. 2019-138; s. 1, ch. 2021-112.
395.003 Licensure; denial, suspension, and revocation.—
(1)(a) The requirements of part II of chapter 408 apply to the provision of services that require licensure pursuant to ss. 395.001-395.1065 and part II of chapter 408 and to entities licensed by or applying for such licensure from the Agency for Health Care Administration pursuant to ss. 395.001-395.1065. A license issued by the agency is required in order to operate a hospital or ambulatory surgical center in this state.
(b)1. It is unlawful for a person to use or advertise to the public, in any way or by any medium whatsoever, any facility as a “hospital” or “ambulatory surgical center” unless such facility has first secured a license under this part.
2. This part does not apply to veterinary hospitals or to commercial business establishments using the word “hospital” or “ambulatory surgical center” as a part of a trade name if no treatment of human beings is performed on the premises of such establishments.
(2)(a) In addition to the requirements in part II of chapter 408, the agency shall, at the request of a licensee, issue a single license to a licensee for facilities located on separate premises. Such a license shall specifically state the location of the facilities, the services, and the licensed beds available on each separate premises. If a licensee requests a single license, the licensee shall designate which facility or office is responsible for receipt of information, payment of fees, service of process, and all other activities necessary for the agency to carry out the provisions of this part.
(b) The agency shall, at the request of a licensee that is a teaching hospital as defined in s. 408.07, issue a single license to a licensee for facilities that have been previously licensed as separate premises, provided such separately licensed facilities, taken together, constitute the same premises as defined in s. 395.002. Such license for the single premises shall include all of the beds, services, and programs that were previously included on the licenses for the separate premises. The granting of a single license under this paragraph may not in any manner reduce the number of beds, services, or programs operated by the licensee.
(c) Intensive residential treatment programs for children and adolescents which have received accreditation from an accrediting organization as defined in s. 395.002(1) and which meet the minimum standards developed by rule of the agency for such programs shall be licensed by the agency under this part.
(3) In addition to the requirements of s. 408.807, after a change of ownership has been approved by the agency, the transferee shall be liable for any liability to the state, regardless of when identified, resulting from changes to allowable costs affecting provider reimbursement for Medicaid participation or Public Medical Assistance Trust Fund Assessments, and related administrative fines.
(4) The agency shall issue a license that specifies the service categories and the number of hospital beds in each bed category for which a license is received. Such information shall be listed on the face of the license. A licensed facility shall not operate a number of hospital beds greater than the number indicated by the agency on the face of the license without approval from the agency under conditions established by rule.
(5)(a) Adherence to patient rights, standards of care, and examination and placement procedures provided under part I of chapter 394 shall be a condition of licensure for hospitals providing voluntary or involuntary medical or psychiatric observation, evaluation, diagnosis, or treatment.
(b) Any hospital that provides psychiatric treatment to persons under 18 years of age who have emotional disturbances shall comply with the procedures pertaining to the rights of patients prescribed in part I of chapter 394.
(c) A hospital that provides birthing services shall affirm in writing as part of the application for a new, provisional, or renewal license that the hospital shall comply with s. 382.013(2)(c), which includes assisting unmarried parents who request assistance in executing a voluntary acknowledgment of paternity. No fine or other sanction under s. 395.1065 may be imposed on a hospital for noncompliance with s. 382.013(2)(c).
(d) A hospital, an ambulatory surgical center, a specialty hospital, or an urgent care center shall comply with ss. 627.64194 and 641.513 as a condition of licensure.
(6)(a) A specialty hospital may not provide any service or regularly serve any population group beyond those services or groups specified in its license. A specialty-licensed children’s hospital that is authorized to provide pediatric cardiac catheterization and pediatric open-heart surgery services may provide cardiovascular service to adults who, as children, were previously served by the hospital for congenital heart disease, or to those patients who are referred for a specialized procedure only for congenital heart disease by an adult hospital, without obtaining additional licensure as a provider of adult cardiovascular services. The agency may request documentation as needed to support patient selection and treatment. This subsection does not apply to a specialty-licensed children’s hospital that is already licensed to provide adult cardiovascular services.
(b) A specialty-licensed children’s hospital that has licensed neonatal intensive care unit beds and is located in District 5 or District 11, as defined in s. 408.032, as of January 1, 2018, may provide obstetrical services, in accordance with the pertinent guidelines promulgated by the American College of Obstetricians and Gynecologists and with verification of guidelines and compliance with internal safety standards by the Voluntary Review for Quality of Care Program of the American College of Obstetricians and Gynecologists and in compliance with the agency’s rules pertaining to the obstetrical department in a hospital and offer healthy mothers all necessary critical care equipment, services, and the capability of providing up to 10 beds for labor and delivery care, which services are restricted to the diagnosis, care, and treatment of pregnant women of any age who have documentation by an examining physician that includes information regarding:
1. At least one fetal characteristic or condition diagnosed intra-utero that would characterize the pregnancy or delivery as high risk including structural abnormalities of the digestive, central nervous, and cardiovascular systems and disorders of genetic malformations and skeletal dysplasia, acute metabolic emergencies, and babies of mothers with rheumatologic disorders; or
2. Medical advice or a diagnosis indicating that the fetus may require at least one perinatal intervention.
This paragraph shall not preclude a specialty-licensed children’s hospital from complying with s. 395.1041 or the Emergency Medical Treatment and Active Labor Act, 42 U.S.C. s. 1395dd.
(7) In addition to the requirements of part II of chapter 408, whenever the agency finds that there has been a substantial failure to comply with the requirements established under this part or in rules, the agency is authorized to deny, modify, suspend, and revoke:
(a) A license;
(b) That part of a license which is limited to a separate premises, as designated on the license; or
(c) Licensure approval limited to a facility, building, or portion thereof, or a service, within a given premises.
(8) A hospital may not be licensed or relicensed if:
(a) The diagnosis-related groups for 65 percent or more of the discharges from the hospital, in the most recent year for which data is available to the Agency for Health Care Administration pursuant to s. 408.061, are for diagnosis, care, and treatment of patients who have:
1. Cardiac-related diseases and disorders classified as diagnosis-related groups in major diagnostic category 5;
2. Orthopedic-related diseases and disorders classified as diagnosis-related groups in major diagnostic category 8;
3. Cancer-related diseases and disorders classified as discharges in which the principal diagnosis is neoplasm or carcinoma or is for an admission for radiotherapy or antineoplastic chemotherapy or immunotherapy; or
4. Any combination of the above discharges.
(b) The hospital restricts its medical and surgical services to primarily or exclusively cardiac, orthopedic, surgical, or oncology specialties.
(c) A hospital classified as an exempt cancer center hospital pursuant to 42 C.F.R. s. 412.23(f) as of December 31, 2005, is exempt from the licensure restrictions of this subsection.
(9) A hospital licensed as of June 1, 2004, shall be exempt from subsection (8) as long as the hospital maintains the same ownership, facility street address, and range of services that were in existence on June 1, 2004. Any transfer of beds, or other agreements that result in the establishment of a hospital or hospital services within the intent of this section, shall be subject to subsection (8). Unless the hospital is otherwise exempt under subsection (8), the agency shall deny or revoke the license of a hospital that violates any of the criteria set forth in that subsection.
(10) The agency may adopt rules implementing the licensure requirements set forth in subsection (8). Within 14 days after rendering its decision on a license application or revocation, the agency shall publish its proposed decision in the Florida Administrative Register. Within 21 days after publication of the agency’s decision, any authorized person may file a request for an administrative hearing. In administrative proceedings challenging the approval, denial, or revocation of a license pursuant to subsection (8), the hearing must be based on the facts and law existing at the time of the agency’s proposed agency action. Existing hospitals may initiate or intervene in an administrative hearing to approve, deny, or revoke licensure under subsection (8) based upon a showing that an established program will be substantially affected by the issuance or renewal of a license to a hospital within the same district or service area.
History.—ss. 26, 30, ch. 82-182; s. 47, ch. 83-218; s. 4, ch. 83-244; ss. 34, 40, ch. 87-92; ss. 4, 98, ch. 92-289; s. 29, ch. 96-169; s. 3, ch. 98-303; s. 5, ch. 2002-400; s. 23, ch. 2004-350; s. 1, ch. 2004-383; s. 21, ch. 2005-39; s. 2, ch. 2005-81; s. 1, ch. 2005-256; s. 38, ch. 2007-230; s. 1, ch. 2007-248; s. 4, ch. 2009-223; s. 5, ch. 2012-66; s. 40, ch. 2013-14; s. 6, ch. 2013-153; s. 5, ch. 2016-222; s. 25, ch. 2018-24; s. 3, ch. 2020-156; s. 2, ch. 2021-112.
395.004 Application for license; fees.—In accordance with s. 408.805, an applicant or licensee shall pay a fee for each license application submitted under this part, part II of chapter 408, and applicable rules. The amount of the fee shall be established by rule. The license fee required of a facility licensed under this part shall be established by rule at the rate of not less than $9.50 per hospital bed, nor more than $30 per hospital bed, except that the minimum license fee shall be $1,500.
History.—ss. 26, 30, ch. 82-182; s. 6, ch. 91-282; ss. 5, 98, ch. 92-289; s. 4, ch. 98-303; s. 39, ch. 2007-230.
395.0056 Litigation notice requirement.—Upon receipt of a copy of a complaint filed against a hospital as a defendant in a medical malpractice action as required by s. 766.106(2), the agency shall:
(1) Review its adverse incident report files pertaining to the licensed facility that is the subject of the complaint to determine whether the facility timely complied with the requirements of s. 395.0197; and
(2) Review the incident that is the subject of the complaint and determine whether it involved conduct by a licensee which is potentially subject to disciplinary action.
History.—s. 2, ch. 2003-416.
395.009 Minimum standards for clinical laboratory test results and diagnostic X-ray results; prerequisite for issuance or renewal of license.—
(1) As a requirement for issuance or renewal of its license, each licensed facility shall require that all clinical laboratory tests performed by or for the licensed facility be performed by a clinical laboratory appropriately certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments and the federal rules adopted thereunder.
(2) Each licensed facility, as a requirement for issuance or renewal of its license, shall establish minimum standards for acceptance of results of diagnostic X rays performed by or for the licensed facility. Such standards shall require licensure or registration of the source of ionizing radiation under the provisions of chapter 404.
(3) The results of clinical laboratory tests and diagnostic X rays performed prior to admission which meet the minimum standards required by law shall be accepted in lieu of routine examinations required upon admission and in lieu of clinical laboratory tests and diagnostic X rays which may be ordered by a physician for patients of the licensed facility.
History.—ss. 26, 30, ch. 82-182; s. 25, ch. 83-215; ss. 6, 98, ch. 92-289; s. 26, ch. 2018-24.
395.0091 Alternate-site testing.—The agency, in consultation with the Board of Clinical Laboratory Personnel, shall adopt by rule the criteria for alternate-site testing to be performed under the supervision of a clinical laboratory director. At a minimum, the criteria must address hospital internal needs assessment; a protocol for implementation, including the identification of tests to be performed and who will perform them; selection of the method of testing to be used for alternate-site testing; minimum training and education requirements for those who will perform alternate-site testing, such as documented training, licensure, certification, or other medical professional background not limited to laboratory professionals; documented inservice training and initial and ongoing competency validation; an appropriate internal and external quality control protocol; an internal mechanism for the central laboratory to identify and track alternate-site testing; and recordkeeping requirements. Alternate-site testing locations must register when the hospital applies to renew its license. For purposes of this section, the term “alternate-site testing” includes any laboratory testing done under the administrative control of a hospital but performed out of the physical or administrative confines of the central laboratory.
History.—s. 27, ch. 2018-24.
395.0161 Licensure inspection.—
(1) In addition to the requirement of s. 408.811, the agency shall make or cause to be made such inspections and investigations as it deems necessary, including:
(a) Inspections directed by the federal Centers for Medicare and Medicaid Services.
(b) Validation inspections.
(c) Lifesafety inspections.
(d) Licensure complaint investigations, including full licensure investigations with a review of all licensure standards as outlined in the administrative rules. Complaints received by the agency from individuals, organizations, or other sources are subject to review and investigation by the agency.
(e) Emergency access complaint investigations.
(2) The agency shall accept, in lieu of its own periodic inspections for licensure, the survey or inspection of an accrediting organization, provided the accreditation of the licensed facility is not provisional and provided the licensed facility authorizes release of, and the agency receives the report of, the accrediting organization. The agency shall develop, and adopt by rule, criteria for accepting survey reports of accrediting organizations in lieu of conducting a state licensure inspection.
(3) In accordance with s. 408.805, an applicant or licensee shall pay a fee for each license application submitted under this part, part II of chapter 408, and applicable rules. With the exception of state-operated licensed facilities, each facility licensed under this part shall pay to the agency, at the time of inspection, the following fees:
(a) Inspection for licensure.—A fee shall be paid which is not less than $8 per hospital bed, nor more than $12 per hospital bed, except that the minimum fee shall be $400 per facility.
(b) Inspection for lifesafety only.—A fee shall be paid which is not less than 75 cents per hospital bed, nor more than $1.50 per hospital bed, except that the minimum fee shall be $40 per facility.
(4) The agency shall coordinate all periodic inspections for licensure made by the agency to ensure that the cost to the facility of such inspections and the disruption of services by such inspections is minimized.
History.—ss. 26, 30, ch. 82-182; s. 28, ch. 90-344; ss. 7, 98, ch. 92-289; s. 5, ch. 98-303; s. 41, ch. 2007-230; s. 28, ch. 2018-24.
Note.—Former s. 395.006.
395.0162 Inspection reports.—
(1) Each licensed facility shall maintain as public information, available upon request, records of all inspection reports pertaining to that facility. Copies of such reports shall be retained in its records for not less than 5 years from the date the reports are filed and issued.
(2) Any records, reports, or documents which are confidential and exempt from s. 119.07(1) shall not be distributed or made available for purposes of compliance with this section unless or until such confidential status expires.
(3) A licensed facility shall, upon the request of any person who has completed a written application with intent to be admitted to such facility, any person who is a patient of such facility, or any relative, spouse, guardian, or surrogate of any such person, furnish to the requester a copy of the last inspection report filed with or issued by the agency pertaining to the licensed facility, as provided in subsection (1), provided the person requesting such report agrees to pay a reasonable charge to cover copying costs, not to exceed $1 per page.
History.—ss. 26, 30, ch. 82-182; s. 29, ch. 90-344; ss. 8, 98, ch. 92-289; s. 212, ch. 96-406.
Note.—Former s. 395.008.
395.0163 Construction inspections; plan submission and approval; fees.—
(1)(a) The design, construction, erection, alteration, modification, repair, and demolition of all public and private health care facilities are governed by the Florida Building Code and the Florida Fire Prevention Code under ss. 553.73 and 633.206. In addition to the requirements of ss. 553.79 and 553.80, the agency shall review facility plans and survey the construction of any facility licensed under this chapter. The agency shall make, or cause to be made, such construction inspections and investigations as it deems necessary. The agency may prescribe by rule that any licensee or applicant desiring to make specified types of alterations or additions to its facilities or to construct new facilities shall, before commencing such alteration, addition, or new construction, submit plans and specifications therefor to the agency for preliminary inspection and approval or recommendation with respect to compliance with applicable provisions of the Florida Building Code or agency rules and standards. The agency shall approve or disapprove the plans and specifications within 60 days after receipt of the fee for review of plans as required in subsection (2). The agency may be granted one 15-day extension for the review period if the director of the agency approves the extension. If the agency fails to act within the specified time, it shall be deemed to have approved the plans and specifications. When the agency disapproves plans and specifications, it shall set forth in writing the reasons for its disapproval. Conferences and consultations may be provided as necessary.
(b) All outpatient facilities that provide surgical treatments requiring general anesthesia or IV conscious sedation, that provide cardiac catheterization services, or that are to be licensed as ambulatory surgical centers shall submit plans and specifications to the agency for review under this section. All other outpatient facilities must be reviewed under this section, except that those that are physically detached from, and have no utility connections with, the hospital and that do not block emergency egress from or create a fire hazard to the hospital are exempt from review under this section. This paragraph applies to applications for which review is pending on or after July 1, 1998.
(2) The agency is authorized to charge an initial fee of $2,000 for review of plans and construction on all projects, no part of which is refundable. The agency may also collect a fee, not to exceed 1 percent of the estimated construction cost or the actual cost of review, whichever is less, for the portion of the review which encompasses initial review through the initial revised construction document review. The agency is further authorized to collect its actual costs on all subsequent portions of the review and construction inspections. The initial fee payment shall accompany the initial submission of plans and specifications. Any subsequent payment that is due is payable upon receipt of the invoice from the agency.
History.—ss. 26, 30, ch. 82-182; s. 7, ch. 91-282; ss. 9, 98, ch. 92-289; s. 5, ch. 98-89; s. 6, ch. 98-303; s. 21, ch. 2000-141; s. 9, ch. 2000-305; s. 27, ch. 2001-62; s. 34, ch. 2001-186; s. 3, ch. 2001-372; s. 42, ch. 2007-230; s. 134, ch. 2013-183; s. 29, ch. 2018-24.
Note.—Former s. 395.007.
395.0185 Rebates prohibited; penalties.—
(1) It is unlawful for any person to pay or receive any commission, bonus, kickback, or rebate or engage in any split-fee arrangement, in any form whatsoever, with any physician, surgeon, organization, or person, either directly or indirectly, for patients referred to a licensed facility.
(2) The agency shall enforce subsection (1). In the case of an entity not licensed by the agency, administrative penalties may include:
(a) A fine not to exceed $1,000.
(b) If applicable, a recommendation by the agency to the appropriate licensing board that disciplinary action be taken.
History.—ss. 26, 30, ch. 82-182; ss. 10, 98, ch. 92-289; s. 42, ch. 2013-18.
395.0191 Staff membership and clinical privileges.—
(1) No licensed facility, in considering and acting upon an application for staff membership or clinical privileges, shall deny the application of a qualified doctor of medicine licensed under chapter 458, a doctor of osteopathic medicine licensed under chapter 459, a doctor of dentistry licensed under chapter 466, a doctor of podiatric medicine licensed under chapter 461, or a psychologist licensed under chapter 490 for such staff membership or clinical privileges within the scope of his or her respective licensure solely because the applicant is licensed under any of such chapters.
(2)(a) Each licensed facility shall establish rules and procedures for consideration of an application for clinical privileges submitted by an advanced practice registered nurse licensed under part I of chapter 464, in accordance with the provisions of this section. No licensed facility shall deny such application solely because the applicant is licensed under part I of chapter 464 or because the applicant is not a participant in the Florida Birth-Related Neurological Injury Compensation Plan.
(b) An advanced practice registered nurse who is certified as a registered nurse anesthetist licensed under part I of chapter 464 shall administer anesthesia under the onsite medical direction of a professional licensed under chapter 458, chapter 459, or chapter 466, and in accordance with an established protocol approved by the medical staff. The medical direction shall specifically address the needs of the individual patient.
(c) Each licensed facility shall establish rules and procedures for consideration of an application for clinical privileges submitted by a physician assistant licensed pursuant to s. 458.347 or s. 459.022. Clinical privileges granted to a physician assistant pursuant to this subsection shall automatically terminate upon termination of staff membership of the physician assistant’s supervising physician.
(d) Each hospital shall meet the requirements of the Medicare and Medicaid Conditions of Participation for Hospitals under 42 C.F.R. s. 482.51(a)(3) as they apply to registered nurses performing circulating duties in the operating room and as provided in the interpretive guidelines provided by the United States Department of Health and Human Services. A circulating nurse shall be present in the operating room for the duration of a surgical procedure.
(3) When a licensed facility requires, as a precondition to obtaining staff membership or clinical privileges, the completion of, eligibility in, or graduation from any program or society established by or relating to the American Medical Association or the Liaison Committee on Graduate Medical Education, the licensed facility shall also make available such membership or privileges to physicians who have attained completion of, eligibility in, or graduation from any equivalent program established by or relating to the American Osteopathic Association.
(4) Nothing herein shall restrict in any way the authority of the medical staff of a licensed facility to review for approval or disapproval all applications for appointment and reappointment to all categories of staff and to make recommendations on each applicant to the governing board, including the delineation of privileges to be granted in each case. In making such recommendations and in the delineation of privileges, each applicant shall be considered individually pursuant to criteria for a doctor licensed under chapter 458, chapter 459, chapter 461, or chapter 466, or for an advanced practice registered nurse licensed under part I of chapter 464, or for a psychologist licensed under chapter 490, as applicable. The applicant’s eligibility for staff membership or clinical privileges shall be determined by the applicant’s background, experience, health, training, and demonstrated competency; the applicant’s adherence to applicable professional ethics; the applicant’s reputation; and the applicant’s ability to work with others and by such other elements as determined by the governing board, consistent with this part.
(5) The governing board of each licensed facility shall set standards and procedures to be applied by the licensed facility and its medical staff in considering and acting upon applications for staff membership or clinical privileges. These standards and procedures shall be available for public inspection.
(6) Upon the written request of the applicant, any licensed facility that has denied staff membership or clinical privileges to any applicant specified in subsection (1) or subsection (2) shall, within 30 days of such request, provide the applicant with the reasons for such denial in writing. A denial of staff membership or clinical privileges to any applicant shall be submitted, in writing, to the applicant’s respective licensing board.
(7) There shall be no monetary liability on the part of, and no cause of action for injunctive relief or damages shall arise against, any licensed facility, its governing board or governing board members, medical staff, or disciplinary board or against its agents, investigators, witnesses, or employees, or against any other person, for any action arising out of or related to carrying out the provisions of this section, absent intentional fraud.
(8) The investigations, proceedings, and records of the board, or agent thereof with whom there is a specific written contract for the purposes of this section, as described in this section shall not be subject to discovery or introduction into evidence in any civil action against a provider of professional health services arising out of matters which are the subject of evaluation and review by such board, and no person who was in attendance at a meeting of such board or its agent shall be permitted or required to testify in any such civil action as to any evidence or other matters produced or presented during the proceedings of such board or its agent or as to any findings, recommendations, evaluations, opinions, or other actions of such board or its agent or any members thereof. However, information, documents, or records otherwise available from original sources are not to be construed as immune from discovery or use in any such civil action merely because they were presented during proceedings of such board; nor should any person who testifies before such board or who is a member of such board be prevented from testifying as to matters within his or her knowledge, but such witness cannot be asked about his or her testimony before such a board or opinions formed by him or her as a result of such board hearings.
(9)(a) If the defendant prevails in an action brought by an applicant against any person or entity that initiated, participated in, was a witness in, or conducted any review as authorized by this section, the court shall award reasonable attorney’s fees and costs to the defendant.
(b) As a condition of any applicant bringing any action against any person or entity that initiated, participated in, was a witness in, or conducted any review as authorized by this section and before any responsive pleading is due, the applicant shall post a bond or other security, as set by the court having jurisdiction of the action, in an amount sufficient to pay the costs and attorney’s fees.
History.—ss. 26, 30, ch. 82-182; s. 48, ch. 83-218; s. 1, ch. 85-99; s. 2, ch. 85-175; s. 1, ch. 86-26; s. 1, ch. 86-287; s. 42, ch. 87-92; s. 2, ch. 88-361; s. 18, ch. 90-263; s. 5, ch. 91-22; ss. 11, 98, ch. 92-289; s. 725, ch. 95-148; s. 38, ch. 97-264; s. 5, ch. 98-49; s. 181, ch. 98-166; s. 93, ch. 2000-318; s. 3, ch. 2003-416; s. 1, ch. 2006-133; s. 23, ch. 2018-106; s. 1, ch. 2019-136.
Note.—Former s. 395.011.
395.0192 Duty to notify physicians.—A hospital shall notify each obstetrical physician who has privileges at the hospital at least 120 days before the hospital closes its obstetrical department or ceases to provide obstetrical services.
History.—s. 2, ch. 2016-113.
395.0193 Licensed facilities; peer review; disciplinary powers; agency or partnership with physicians.—
(1) It is the intent of the Legislature that good faith participants in the process of investigating and disciplining physicians pursuant to the state-mandated peer review process shall, in addition to receiving immunity from retaliatory tort suits pursuant to s. 456.073(12), be protected from federal antitrust suits filed under the Sherman Anti-Trust Act, 15 U.S.C.A. ss. 1 et seq. Such intent is within the public policy of the state to secure the provision of quality medical services to the public.
(2) Each licensed facility, as a condition of licensure, shall provide for peer review of physicians who deliver health care services at the facility. Each licensed facility shall develop written, binding procedures by which such peer review shall be conducted. Such procedures shall include:
(a) Mechanism for choosing the membership of the body or bodies that conduct peer review.
(b) Adoption of rules of order for the peer review process.
(c) Fair review of the case with the physician involved.
(d) Mechanism to identify and avoid conflict of interest on the part of the peer review panel members.
(e) Recording of agendas and minutes which do not contain confidential material, for review by the Division of Health Quality Assurance of the agency.
(f) Review, at least annually, of the peer review procedures by the governing board of the licensed facility.
(g) Focus of the peer review process on review of professional practices at the facility to reduce morbidity and mortality and to improve patient care.
(3) If reasonable belief exists that conduct by a staff member or physician who delivers health care services at the licensed facility may constitute one or more grounds for discipline as provided in this subsection, a peer review panel shall investigate and determine whether grounds for discipline exist with respect to such staff member or physician. The governing board of any licensed facility, after considering the recommendations of its peer review panel, shall suspend, deny, revoke, or curtail the privileges, or reprimand, counsel, or require education, of any such staff member or physician after a final determination has been made that one or more of the following grounds exist:
(a) Incompetence.
(b) Being found to be a habitual user of intoxicants or drugs to the extent that he or she is deemed dangerous to himself, herself, or others.
(c) Mental or physical impairment which may adversely affect patient care.
(d) Being found liable by a court of competent jurisdiction for medical negligence or malpractice involving negligent conduct.
(e) One or more settlements exceeding $10,000 for medical negligence or malpractice involving negligent conduct by the staff member.
(f) Medical negligence other than as specified in paragraph (d) or paragraph (e).
(g) Failure to comply with the policies, procedures, or directives of the risk management program or any quality assurance committees of any licensed facility.
(4) Pursuant to ss. 458.337 and 459.016, any disciplinary actions taken under subsection (3) shall be reported in writing to the Division of Health Quality Assurance of the agency within 30 working days after its initial occurrence, regardless of the pendency of appeals to the governing board of the hospital. The notification shall identify the disciplined practitioner, the action taken, and the reason for such action. All final disciplinary actions taken under subsection (3), if different from those which were reported to the agency within 30 days after the initial occurrence, shall be reported within 10 working days to the Division of Health Quality Assurance of the agency in writing and shall specify the disciplinary action taken and the specific grounds therefor. The division shall review each report and determine whether it potentially involved conduct by the licensee that is subject to disciplinary action, in which case s. 456.073 shall apply. The reports are not subject to inspection under s. 119.07(1) even if the division’s investigation results in a finding of probable cause.
(5) There shall be no monetary liability on the part of, and no cause of action for damages against, any licensed facility, its governing board or governing board members, peer review panel, medical staff, or disciplinary body, or its agents, investigators, witnesses, or employees; a committee of a hospital; or any other person, for any action taken without intentional fraud in carrying out the provisions of this section.
(6) For a single incident or series of isolated incidents that are nonwillful violations of the reporting requirements of this section or part II of chapter 408, the agency shall first seek to obtain corrective action by the facility. If correction is not demonstrated within the timeframe established by the agency or if there is a pattern of nonwillful violations of this section or part II of chapter 408, the agency may impose an administrative fine, not to exceed $5,000 for any violation of the reporting requirements of this section or part II of chapter 408. The administrative fine for repeated nonwillful violations may not exceed $10,000 for any violation. The administrative fine for each intentional and willful violation may not exceed $25,000 per violation, per day. The fine for an intentional and willful violation of this section or part II of chapter 408 may not exceed $250,000. In determining the amount of fine to be levied, the agency shall be guided by s. 395.1065(2)(b).
(7) The proceedings and records of peer review panels, committees, and governing boards or agent thereof which relate solely to actions taken in carrying out this section are not subject to inspection under s. 119.07(1); and meetings held pursuant to achieving the objectives of such panels, committees, and governing boards are not open to the public under the provisions of chapter 286.
(8) The investigations, proceedings, and records of the peer review panel, a committee of a hospital, a disciplinary board, or a governing board, or agent thereof with whom there is a specific written contract for that purpose, as described in this section shall not be subject to discovery or introduction into evidence in any civil or administrative action against a provider of professional health services arising out of the matters which are the subject of evaluation and review by such group or its agent, and a person who was in attendance at a meeting of such group or its agent may not be permitted or required to testify in any such civil or administrative action as to any evidence or other matters produced or presented during the proceedings of such group or its agent or as to any findings, recommendations, evaluations, opinions, or other actions of such group or its agent or any members thereof. However, information, documents, or records otherwise available from original sources are not to be construed as immune from discovery or use in any such civil or administrative action merely because they were presented during proceedings of such group, and any person who testifies before such group or who is a member of such group may not be prevented from testifying as to matters within his or her knowledge, but such witness may not be asked about his or her testimony before such a group or opinions formed by him or her as a result of such group hearings.
(9)(a) If the defendant prevails in an action brought by a staff member or physician who delivers health care services at the licensed facility against any person or entity that initiated, participated in, was a witness in, or conducted any review as authorized by this section, the court shall award reasonable attorney’s fees and costs to the defendant.
(b) As a condition of any staff member or physician bringing any action against any person or entity that initiated, participated in, was a witness in, or conducted any review as authorized by this section and before any responsive pleading is due, the staff member or physician shall post a bond or other security, as set by the court having jurisdiction of the action, in an amount sufficient to pay the costs and attorney’s fees.
(10)(a) A hospital’s compliance with the requirements of this chapter or s. 766.110(1) may not be the sole basis to establish an agency or partnership relationship between the hospital and physicians who provide services within the hospital.
(b) A hospital may create an agency relationship with a physician by written contract signed by the hospital and:
1. The physician;
2. A health care professional association; or
3. A corporate medical group and its employees.
A written contract is not the exclusive means to establish an agency or partnership relationship between a hospital and any other person described in this paragraph.
History.—ss. 26, 30, ch. 82-182; s. 1, ch. 82-402; s. 3, ch. 85-175; s. 3, ch. 88-1; s. 2, ch. 88-277; s. 4, ch. 89-162; s. 14, ch. 90-344; ss. 12, 13, 98, ch. 92-289; s. 726, ch. 95-148; s. 213, ch. 96-406; s. 24, ch. 98-89; s. 21, ch. 98-166; s. 13, ch. 2000-160; s. 43, ch. 2007-230.
Note.—Former s. 395.0115.
395.0195 Access of chiropractic physicians to diagnostic reports.—Each hospital shall set standards and procedures which provide for reasonable access by licensed chiropractic physicians to the reports of diagnostic X rays and laboratory tests of licensed facilities, subject to the same standards and procedures as other licensed physicians. However, this section does not require a licensed facility to grant staff privileges to a chiropractic physician.
History.—ss. 26, 30, ch. 82-182; ss. 14, 98, ch. 92-289; s. 255, ch. 98-166.
Note.—Former s. 395.014.
395.0197 Internal risk management program.—
(1) Every licensed facility shall, as a part of its administrative functions, establish an internal risk management program that includes all of the following components:
(a) The investigation and analysis of the frequency and causes of general categories and specific types of adverse incidents to patients.
(b) The development of appropriate measures to minimize the risk of adverse incidents to patients, including, but not limited to:
1. Risk management and risk prevention education and training of all nonphysician personnel as follows:
a. Such education and training of all nonphysician personnel as part of their initial orientation; and
b. At least 1 hour of such education and training annually for all personnel of the licensed facility working in clinical areas and providing patient care, except those persons licensed as health care practitioners who are required to complete continuing education coursework pursuant to chapter 456 or the respective practice act.
2. A prohibition, except when emergency circumstances require otherwise, against a staff member of the licensed facility attending a patient in the recovery room, unless the staff member is authorized to attend the patient in the recovery room and is in the company of at least one other person. However, a licensed facility is exempt from the two-person requirement if it has:
a. Live visual observation;
b. Electronic observation; or
c. Any other reasonable measure taken to ensure patient protection and privacy.
3. A prohibition against an unlicensed person from assisting or participating in any surgical procedure unless the facility has authorized the person to do so following a competency assessment, and such assistance or participation is done under the direct and immediate supervision of a licensed physician and is not otherwise an activity that may only be performed by a licensed health care practitioner.
4. Development, implementation, and ongoing evaluation of procedures, protocols, and systems to accurately identify patients, planned procedures, and the correct site of the planned procedure so as to minimize the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient’s diagnosis or medical condition.
(c) The analysis of patient grievances that relate to patient care and the quality of medical services.
(d) A system for informing a patient or an individual identified pursuant to s. 765.401(1) that the patient was the subject of an adverse incident, as defined in subsection (5). Such notice shall be given by an appropriately trained person designated by the licensed facility as soon as practicable to allow the patient an opportunity to minimize damage or injury.
(e) The development and implementation of an incident reporting system based upon the affirmative duty of all health care providers and all agents and employees of the licensed health care facility to report adverse incidents to the risk manager, or to his or her designee, within 3 business days after their occurrence.
(2) The internal risk management program is the responsibility of the governing board of the health care facility. Each licensed facility shall hire a risk manager who is responsible for implementation and oversight of the facility’s internal risk management program and who demonstrates competence, through education or experience, in all of the following areas:
(a) Applicable standards of health care risk management.
(b) Applicable federal, state, and local health and safety laws and rules.
(c) General risk management administration.
(d) Patient care.
(e) Medical care.
(f) Personal and social care.
(g) Accident prevention.
(h) Departmental organization and management.
(i) Community interrelationships.
(j) Medical terminology.
(3) In addition to the programs mandated by this section, other innovative approaches intended to reduce the frequency and severity of medical malpractice and patient injury claims shall be encouraged and their implementation and operation facilitated. Such additional approaches may include extending internal risk management programs to health care providers’ offices and the assuming of provider liability by a licensed health care facility for acts or omissions occurring within the licensed facility. Each licensed facility shall annually report to the agency and the Department of Health the name and judgments entered against each health care practitioner for which it assumes liability. The agency and Department of Health, in their respective annual reports, shall include statistics that report the number of licensed facilities that assume such liability and the number of health care practitioners, by profession, for whom they assume liability.
(4) The agency shall adopt rules governing the establishment of internal risk management programs to meet the needs of individual licensed facilities. Each internal risk management program shall include the use of incident reports to be filed with an individual of responsibility who is competent in risk management techniques in the employ of each licensed facility, such as an insurance coordinator, or who is retained by the licensed facility as a consultant. The individual responsible for the risk management program shall have free access to all medical records of the licensed facility. The incident reports are part of the workpapers of the attorney defending the licensed facility in litigation relating to the licensed facility and are subject to discovery, but are not admissible as evidence in court. A person filing an incident report is not subject to civil suit by virtue of such incident report. As a part of each internal risk management program, the incident reports shall be used to develop categories of incidents which identify problem areas. Once identified, procedures shall be adjusted to correct the problem areas.
(5) For purposes of reporting to the agency pursuant to this section, the term “adverse incident” means an event over which health care personnel could exercise control and which is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred, and which:
(a) Results in one of the following injuries:
1. Death;
2. Brain or spinal damage;
3. Permanent disfigurement;
4. Fracture or dislocation of bones or joints;
5. A resulting limitation of neurological, physical, or sensory function which continues after discharge from the facility;
6. Any condition that required specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent; or
7. Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient’s condition prior to the adverse incident;
(b) Was the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient’s diagnosis or medical condition;
(c) Required the surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage was not a recognized specific risk, as disclosed to the patient and documented through the informed-consent process; or
(d) Was a procedure to remove unplanned foreign objects remaining from a surgical procedure.
(6)(a) Each licensed facility subject to this section shall submit an annual report to the agency summarizing the incident reports that have been filed in the facility for that year. The report shall include:
1. The total number of adverse incidents.
2. A listing, by category, of the types of operations, diagnostic or treatment procedures, or other actions causing the injuries, and the number of incidents occurring within each category.
3. A listing, by category, of the types of injuries caused and the number of incidents occurring within each category.
4. A code number using the health care professional’s licensure number and a separate code number identifying all other individuals directly involved in adverse incidents to patients, the relationship of the individual to the licensed facility, and the number of incidents in which each individual has been directly involved. Each licensed facility shall maintain names of the health care professionals and individuals identified by code numbers for purposes of this section.
5. A description of all malpractice claims filed against the licensed facility, including the total number of pending and closed claims and the nature of the incident which led to, the persons involved in, and the status and disposition of each claim. Each report shall update status and disposition for all prior reports.
(b) The information reported to the agency pursuant to paragraph (a) which relates to persons licensed under chapter 458, chapter 459, chapter 461, or chapter 466 shall be reviewed by the agency. The agency shall determine whether any of the incidents potentially involved conduct by a health care professional who is subject to disciplinary action, in which case the provisions of s. 456.073 shall apply.
(c) The report submitted to the agency must also contain the name of the risk manager of the licensed facility, a copy of its policy and procedures which govern the measures taken by the facility and its risk manager to reduce the risk of injuries and adverse incidents, and the results of such measures. The annual report is confidential and is not available to the public pursuant to s. 119.07(1) or any other law providing access to public records. The annual report is not discoverable or admissible in any civil or administrative action, except in disciplinary proceedings by the agency or the appropriate regulatory board. The annual report is not available to the public as part of the record of investigation for and prosecution in disciplinary proceedings made available to the public by the agency or the appropriate regulatory board. However, the agency or the appropriate regulatory board shall make available, upon written request by a health care professional against whom probable cause has been found, any such records which form the basis of the determination of probable cause.
(7) Any of the following adverse incidents, whether occurring in the licensed facility or arising from health care prior to admission in the licensed facility, shall be reported by the facility to the agency within 15 calendar days after its occurrence:
(a) The death of a patient;
(b) Brain or spinal damage to a patient;
(c) The performance of a surgical procedure on the wrong patient;
(d) The performance of a wrong-site surgical procedure;
(e) The performance of a wrong surgical procedure;
(f) The performance of a surgical procedure that is medically unnecessary or otherwise unrelated to the patient’s diagnosis or medical condition;
(g) The surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage is not a recognized specific risk, as disclosed to the patient and documented through the informed-consent process; or
(h) The performance of procedures to remove unplanned foreign objects remaining from a surgical procedure.
The agency may grant extensions to this reporting requirement for more than 15 days upon justification submitted in writing by the facility administrator to the agency. The agency may require an additional, final report. These reports shall not be available to the public pursuant to s. 119.07(1) or any other law providing access to public records, nor be discoverable or admissible in any civil or administrative action, except in disciplinary proceedings by the agency or the appropriate regulatory board, nor shall they be available to the public as part of the record of investigation for and prosecution in disciplinary proceedings made available to the public by the agency or the appropriate regulatory board. However, the agency or the appropriate regulatory board shall make available, upon written request by a health care professional against whom probable cause has been found, any such records which form the basis of the determination of probable cause. The agency may investigate, as it deems appropriate, any such incident and prescribe measures that must or may be taken in response to the incident. The agency shall review each incident and determine whether it potentially involved conduct by the health care professional who is subject to disciplinary action, in which case the provisions of s. 456.073 shall apply.
(8) The agency shall publish on the agency’s website, no less than quarterly, a summary and trend analysis of adverse incident reports received pursuant to this section, which shall not include information that would identify the patient, the reporting facility, or the health care practitioners involved. The agency shall publish on the agency’s website an annual summary and trend analysis of all adverse incident reports and malpractice claims information provided by facilities in their annual reports, which shall not include information that would identify the patient, the reporting facility, or the practitioners involved. The purpose of the publication of the summary and trend analysis is to promote the rapid dissemination of information relating to adverse incidents and malpractice claims to assist in avoidance of similar incidents and reduce morbidity and mortality.
(9) The internal risk manager of each licensed facility shall:
(a) Investigate every allegation of sexual misconduct which is made against a member of the facility’s personnel who has direct patient contact, when the allegation is that the sexual misconduct occurred at the facility or on the grounds of the facility.
(b) Report every allegation of sexual misconduct to the administrator of the licensed facility.
(c) Notify the family or guardian of the victim, if a minor, that an allegation of sexual misconduct has been made and that an investigation is being conducted.
(d) Report to the Department of Health every allegation of sexual misconduct, as defined in chapter 456 and the respective practice act, by a licensed health care practitioner that involves a patient.
(10) Any witness who witnessed or who possesses actual knowledge of the act that is the basis of an allegation of sexual abuse shall:
(a) Notify the local police; and
(b) Notify the hospital risk manager and the administrator.
For purposes of this subsection, “sexual abuse” means acts of a sexual nature committed for the sexual gratification of anyone upon, or in the presence of, a vulnerable adult, without the vulnerable adult’s informed consent, or a minor. “Sexual abuse” includes, but is not limited to, the acts defined in s. 794.011(1)(h), fondling, exposure of a vulnerable adult’s or minor’s sexual organs, or the use of the vulnerable adult or minor to solicit for or engage in prostitution or sexual performance. “Sexual abuse” does not include any act intended for a valid medical purpose or any act which may reasonably be construed to be a normal caregiving action.
(11) A person who, with malice or with intent to discredit or harm a licensed facility or any person, makes a false allegation of sexual misconduct against a member of a licensed facility’s personnel is guilty of a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.
(12) In addition to any penalty imposed pursuant to this section or part II of chapter 408, the agency shall require a written plan of correction from the facility. For a single incident or series of isolated incidents that are nonwillful violations of the reporting requirements of this section or part II of chapter 408, the agency shall first seek to obtain corrective action by the facility. If the correction is not demonstrated within the timeframe established by the agency or if there is a pattern of nonwillful violations of this section or part II of chapter 408, the agency may impose an administrative fine, not to exceed $5,000 for any violation of the reporting requirements of this section or part II of chapter 408. The administrative fine for repeated nonwillful violations may not exceed $10,000 for any violation. The administrative fine for each intentional and willful violation may not exceed $25,000 per violation, per day. The fine for an intentional and willful violation of this section or part II of chapter 408 may not exceed $250,000. In determining the amount of fine to be levied, the agency shall be guided by s. 395.1065(2)(b).
(13) The agency shall have access to all licensed facility records necessary to carry out the provisions of this section. The records obtained by the agency under subsection (6), subsection (7), or subsection (9) are not available to the public under s. 119.07(1), nor shall they be discoverable or admissible in any civil or administrative action, except in disciplinary proceedings by the agency or the appropriate regulatory board, nor shall records obtained pursuant to s. 456.071 be available to the public as part of the record of investigation for and prosecution in disciplinary proceedings made available to the public by the agency or the appropriate regulatory board. However, the agency or the appropriate regulatory board shall make available, upon written request by a health care professional against whom probable cause has been found, any such records which form the basis of the determination of probable cause, except that, with respect to medical review committee records, s. 766.101 controls.
(14) The meetings of the committees and governing board of a licensed facility held solely for the purpose of achieving the objectives of risk management as provided by this section shall not be open to the public under the provisions of chapter 286. The records of such meetings are confidential and exempt from s. 119.07(1), except as provided in subsection (13).
(15) The agency shall review, as part of its licensure inspection process, the internal risk management program at each licensed facility regulated by this section to determine whether the program meets standards established in statutes and rules, whether the program is being conducted in a manner designed to reduce adverse incidents, and whether the program is appropriately reporting incidents under this section.
(16) There shall be no monetary liability on the part of, and no cause of action for damages shall arise against, any risk manager for the implementation and oversight of the internal risk management program in a facility licensed under this chapter or chapter 390 as required by this section, for any act or proceeding undertaken or performed within the scope of the functions of such internal risk management program if the risk manager acts without intentional fraud.
(17) A privilege against civil liability is hereby granted to any risk manager or licensed facility with regard to information furnished pursuant to this chapter, unless the risk manager or facility acted in bad faith or with malice in providing such information.
(18) If the agency, through its receipt of any reports required under this section or through any investigation, has a reasonable belief that conduct by a staff member or employee of a licensed facility is grounds for disciplinary action by the appropriate regulatory board, the agency shall report this fact to such regulatory board.
(19) It shall be unlawful for any person to coerce, intimidate, or preclude a risk manager from lawfully executing his or her reporting obligations pursuant to this chapter. Such unlawful action shall be subject to civil monetary penalties not to exceed $10,000 per violation.
History.—s. 3, ch. 75-9; s. 3, ch. 76-168; s. 2, ch. 76-260; s. 1, ch. 77-64; s. 1, ch. 77-457; s. 286, ch. 79-400; s. 3, ch. 81-318; ss. 9, 52, ch. 85-175; s. 2, ch. 86-287; s. 6, ch. 88-1; s. 3, ch. 88-97; s. 3, ch. 88-277; s. 14, ch. 89-527; s. 16, ch. 90-344; s. 23, ch. 92-33; ss. 15, 16, 98, ch. 92-289; s. 1, ch. 95-319; s. 214, ch. 96-406; s. 25, ch. 98-89; s. 22, ch. 98-166; s. 14, ch. 2000-160; s. 63, ch. 2001-277; s. 4, ch. 2003-416; s. 44, ch. 2007-230; s. 30, ch. 2018-24.
Note.—Former ss. 395.18, 768.41; s. 395.041.
395.1011 Identification, segregation, and separation of biomedical waste.—Each licensed facility shall comply with the requirements contained in s. 381.0098. Any transporter or potential transporter of such waste shall be notified of the existence and locations of such waste.
History.—ss. 2, 4, ch. 82-125; s. 53, ch. 88-130; ss. 18, 98, ch. 92-289.
Note.—Former s. 395.0101.
395.1012 Patient safety.—
(1) Each licensed facility must adopt a patient safety plan. A plan adopted to implement the requirements of 42 C.F.R. s. 482.21 shall be deemed to comply with this requirement.
(2) Each licensed facility shall appoint a patient safety officer and a patient safety committee, which shall include at least one person who is neither employed by nor practicing in the facility, for the purpose of promoting the health and safety of patients, reviewing and evaluating the quality of patient safety measures used by the facility, and assisting in the implementation of the facility patient safety plan.
(3)(a) Each hospital shall provide to any patient or patient’s representative identified pursuant to s. 765.401(1) upon scheduling of nonemergency care, or to any other stabilized patient or patient’s representative identified pursuant to s. 765.401(1) within 24 hours of the patient being stabilized or at the time of discharge, whichever comes first, written information on a form created by the agency which contains the following information available for the hospital for the most recent year and the statewide average for all hospitals related to the following quality measures:
1. The rate of hospital-acquired infections;
2. The overall rating of the Hospital Consumer Assessment of Healthcare Providers and Systems survey; and
3. The 15-day readmission rate.
(b) A hospital shall also provide to any person, upon request, the written information specified in paragraph (a).
(c) The information required by this subsection must be presented in a manner that is easily understandable and accessible to the patient and must also include an explanation of the quality measures and the relationship between patient safety and the hospital’s data for the quality measures.
(4) Each licensed facility must, at least biennially, conduct a patient safety culture survey using the applicable Survey on Patient Safety Culture developed by the federal Agency for Healthcare Research and Quality. Each facility shall conduct the survey anonymously to encourage completion of the survey by staff working in or employed by the facility. Each facility may contract to administer the survey. Each facility shall biennially submit the survey data to the agency in a format specified by rule, which must include the survey participation rate. Each facility may develop an internal action plan between conducting surveys to identify measures to improve the survey and submit the plan to the agency.
History.—s. 6, ch. 2003-416; s. 43, ch. 2016-10; s. 4, ch. 2019-138; s. 1, ch. 2020-134.
395.1021 Treatment of sexual assault victims.—Any licensed facility which provides emergency room services shall arrange for the rendering of appropriate medical attention and treatment of victims of sexual assault through:
(1) Such gynecological, psychological, and medical services as are needed by the victim.
(2) The gathering of forensic medical evidence required for investigation and prosecution from a victim who has reported a sexual battery to a law enforcement agency or who requests that such evidence be gathered for a possible future report.
(3) The training of medical support personnel competent to provide the medical services and treatment as described in subsections (1) and (2).
Such licensed facility shall also arrange for the protection of the victim’s anonymity while complying with the laws of this state and may encourage the victim to notify law enforcement personnel and to cooperate with them in apprehending the suspect.
History.—ss. 26, 30, ch. 82-182; ss. 19, 98, ch. 92-289; s. 5, ch. 2011-220.
Note.—Former s. 395.0201.
395.1023 Child abuse and neglect cases; duties.—Each licensed facility shall adopt a protocol that, at a minimum, requires the facility to:
(1) Incorporate a facility policy that every staff member has an affirmative duty to report, pursuant to chapter 39, any actual or suspected case of child abuse, abandonment, or neglect; and
(2) In any case involving suspected child abuse, abandonment, or neglect, designate, at the request of the department, a staff physician to act as a liaison between the hospital and the Department of Children and Families office which is investigating the suspected abuse, abandonment, or neglect, and the Child Protection Team, as defined in s. 39.01, when the case is referred to such a team.
Each general hospital and appropriate specialty hospital shall comply with the provisions of this section and shall notify the agency and the department of its compliance by sending a copy of its policy to the agency and the department as required by rule. The failure by a general hospital or appropriate specialty hospital to comply shall be punished by a fine not exceeding $1,000, to be fixed, imposed, and collected by the agency. Each day in violation is considered a separate offense.
History.—s. 4, ch. 84-226; s. 1, ch. 85-65; s. 36, ch. 92-78; ss. 20, 98, ch. 92-289; s. 2, ch. 97-237; s. 141, ch. 98-403; s. 110, ch. 2014-19; s. 59, ch. 2019-3.
Note.—Former s. 395.0205.
395.1024 Patients consenting to adoptions; protocols.—
(1) Each licensed facility shall adopt a protocol that at a minimum provides for facility staff to be knowledgeable of the waiting periods, revocation and the contents of the consent to adoption as contained in s. 63.082(4), and describes the supportive and unbiased manner in which facility staff will interact with birth parents and prospective adoptive parents regarding the adoption, in particular during the waiting period required in s. 63.082(4)(b) before consenting to an adoption.
(2) The protocol shall be in writing and be provided upon request to any birth parent or prospective adoptive parent of a child born in the facility.
History.—s. 39, ch. 2001-3.
395.1025 Infectious diseases; notification.—Notwithstanding the provisions in s. 381.004, if, while treating or transporting an ill or injured patient to a licensed facility, an emergency medical technician, paramedic, or other person comes into direct contact with the patient who is subsequently diagnosed as having an infectious disease, it shall be the duty of the licensed facility receiving the patient to notify the emergency medical technician, paramedic, or his or her emergency medical transportation service employer, or other person of the individual’s exposure to the patient within 48 hours, or sooner, of confirmation of the patient’s diagnosis and to advise him or her of the appropriate treatment, if any. Notification made pursuant to this section shall be done in a manner which will protect the confidentiality of such patient information and shall not include any patient’s name.
History.—s. 1, ch. 85-157; s. 3, ch. 92-171; ss. 21, 98, ch. 92-289; s. 727, ch. 95-148.
Note.—Former s. 395.0147.
395.1027 Regional poison control centers.—
(1) There shall be created three certified regional poison control centers, one each in the north, central, and southern regions of the state. Each regional poison control center shall be affiliated with and physically located in a certified Level I trauma center. Each regional poison control center shall be affiliated with an accredited medical school or college of pharmacy. The regional poison control centers shall be coordinated under the aegis of the Division of Children’s Medical Services in the department.
(2) Each regional poison control center shall provide the following services:
(a) Toll-free access by the public for poison information.
(b) Case management of poison cases.
(c) Professional consultation to health care practitioners.
(d) Prevention education to the public.
(e) Data collection and reporting.
(3) Upon request, a licensed facility or health care practitioner shall release to a regional poison control center any patient information that is relevant to the episode under evaluation for purposes of treatment or that is necessary for case management of poison cases and other patient information that is necessary to comply with the data collection and reporting requirements of this section and the professional organization that certifies poison control centers in accordance with federal law.
(4) The Legislature hereby finds and declares that it is in the public interest to shorten the time required for a citizen to request and receive directly from designated regional poison control centers telephonic management advice for acute poisoning emergencies. To facilitate rapid and direct access, telephone numbers for designated regional poison control centers shall be given special prominence. The local exchange telecommunications companies shall print immediately below “911” or other emergency calling instructions on the inside front cover of the telephone directory the words “Poison Information Center,” the logo of the American Association of Poison Control Centers, and the telephone number of the local, if applicable, or, if not local, other toll-free telephone number of the Florida Poison Information Center Network. This information shall be outlined and be no less than 1 inch in height by 2 inches in width. Only those facilities satisfying criteria established in the current “Criteria for Certification of a Regional Poison Center” set by the American Association of Poison Control Centers, and the “Standards of the Poison Information Center Program” initiated by the Division of Children’s Medical Services Prevention and Intervention of the Department of Health shall be permitted to list such facility as a poison information center, poison control center, or poison center. Those centers under a developmental phase-in plan shall be given 2 years from the date of initial 24-hour service implementation to comply with the aforementioned criteria and, as such, will be permitted to be listed as a poison information center, poison control center, or poison center during that allotted time period.
(5) By October 1, 1999, each regional poison control center shall develop a prehospital emergency dispatch protocol with each licensee defined by s. 401.23(13) in the geographic area covered by the regional poison control center. The prehospital emergency dispatch protocol shall be developed by each licensee’s medical director in conjunction with the designated regional poison control center responsible for the geographic area in which the licensee operates. The protocol shall define toxic substances and describe the procedure by which the designated regional poison control center may be consulted by the licensee. If a call is transferred to the designated regional poison control center in accordance with the protocol established under this section and s. 401.268, the designated regional poison control center shall assume responsibility and liability for the call.
History.—s. 18, ch. 89-283; s. 1, ch. 90-192; ss. 22, 98, ch. 92-289; s. 1, ch. 94-147; s. 97, ch. 95-143; s. 1, ch. 98-7; s. 103, ch. 99-8; s. 15, ch. 2000-153; s. 24, ch. 2004-350; s. 2, ch. 2005-256; s. 84, ch. 2012-184.
Note.—Former s. 395.038.
395.1031 Emergency medical services; communication.—Each licensed hospital with an emergency department must be capable of communicating by two-way radio with all ground-based basic life support service vehicles and advanced life support service vehicles that operate within the hospital’s service area under a state permit and with all rotorcraft air ambulances that operate under a state permit. The hospital’s radio system must be capable of interfacing with municipal mutual aid channels designated by the Department of Management Services and the Federal Communications Commission.
History.—ss. 23, 99, ch. 92-289; s. 72, ch. 95-143; s. 99, ch. 98-279.
395.1041 Access to emergency services and care.—
(1) LEGISLATIVE INTENT.—The Legislature finds and declares it to be of vital importance that emergency services and care be provided by hospitals and physicians to every person in need of such care. The Legislature finds that persons have been denied emergency services and care by hospitals. It is the intent of the Legislature that the agency vigorously enforce the ability of persons to receive all necessary and appropriate emergency services and care and that the agency act in a thorough and timely manner against hospitals and physicians which deny persons emergency services and care. It is further the intent of the Legislature that hospitals, emergency medical services providers, and other health care providers work together in their local communities to enter into agreements or arrangements to ensure access to emergency services and care. The Legislature further recognizes that appropriate emergency services and care often require followup consultation and treatment in order to effectively care for emergency medical conditions.
(2) INVENTORY OF HOSPITAL EMERGENCY SERVICES.—The agency shall establish and maintain an inventory of hospitals with emergency services. The inventory shall list all services within the service capability of the hospital, and such services shall appear on the face of the hospital license. Each hospital having emergency services shall notify the agency of its service capability in the manner and form prescribed by the agency. The agency shall use the inventory to assist emergency medical services providers and others in locating appropriate emergency medical care. The inventory shall also be made available to the general public. On or before August 1, 1992, the agency shall request that each hospital identify the services which are within its service capability. On or before November 1, 1992, the agency shall notify each hospital of the service capability to be included in the inventory. The hospital has 15 days from the date of receipt to respond to the notice. By December 1, 1992, the agency shall publish a final inventory. Each hospital shall reaffirm its service capability when its license is renewed and shall notify the agency of the addition of a new service or the termination of a service prior to a change in its service capability.
(3) EMERGENCY SERVICES; DISCRIMINATION; LIABILITY OF FACILITY OR HEALTH CARE PERSONNEL.—
(a) Every general hospital which has an emergency department shall provide emergency services and care for any emergency medical condition when:
1. Any person requests emergency services and care; or
2. Emergency services and care are requested on behalf of a person by:
a. An emergency medical services provider who is rendering care to or transporting the person; or
b. Another hospital, when such hospital is seeking a medically necessary transfer, except as otherwise provided in this section.
(b) Arrangements for transfers must be made between hospital emergency services personnel for each hospital, unless other arrangements between the hospitals exist.
(c) A patient, whether stabilized or not, may be transferred to another hospital which has the requisite service capability or is not at service capacity, if:
1. The patient, or a person who is legally responsible for the patient and acting on the patient’s behalf, after being informed of the hospital’s obligation under this section and of the risk of transfer, requests that the transfer be effected;
2. A physician has signed a certification that, based upon the reasonable risks and benefits to the patient, and based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another hospital outweigh the increased risks to the individual’s medical condition from effecting the transfer; or
3. A physician is not physically present in the emergency services area at the time an individual is transferred and a qualified medical person signs a certification that a physician, in consultation with personnel, has determined that the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual’s medical condition from effecting the transfer. The consulting physician must countersign the certification;
provided that this paragraph shall not be construed to require acceptance of a transfer that is not medically necessary.
(d)1. Every hospital shall ensure the provision of services within the service capability of the hospital, at all times, either directly or indirectly through an arrangement with another hospital, through an arrangement with one or more physicians, or as otherwise made through prior arrangements. A hospital may enter into an agreement with another hospital for purposes of meeting its service capability requirement, and appropriate compensation or other reasonable conditions may be negotiated for these backup services.
2. If any arrangement requires the provision of emergency medical transportation, such arrangement must be made in consultation with the applicable provider and may not require the emergency medical service provider to provide transportation that is outside the routine service area of that provider or in a manner that impairs the ability of the emergency medical service provider to timely respond to prehospital emergency calls.
3. A hospital shall not be required to ensure service capability at all times as required in subparagraph 1. if, prior to the receiving of any patient needing such service capability, such hospital has demonstrated to the agency that it lacks the ability to ensure such capability and it has exhausted all reasonable efforts to ensure such capability through backup arrangements. In reviewing a hospital’s demonstration of lack of ability to ensure service capability, the agency shall consider factors relevant to the particular case, including the following:
a. Number and proximity of hospitals with the same service capability.
b. Number, type, credentials, and privileges of specialists.
c. Frequency of procedures.
d. Size of hospital.
4. The agency shall publish proposed rules implementing a reasonable exemption procedure by November 1, 1992. Subparagraph 1. shall become effective upon the effective date of said rules or January 31, 1993, whichever is earlier. For a period not to exceed 1 year from the effective date of subparagraph 1., a hospital requesting an exemption shall be deemed to be exempt from offering the service until the agency initially acts to deny or grant the original request. The agency has 45 days from the date of receipt of the request to approve or deny the request. After the first year from the effective date of subparagraph 1., if the agency fails to initially act within the time period, the hospital is deemed to be exempt from offering the service until the agency initially acts to deny the request.
(e) Except as otherwise provided by law, all medically necessary transfers shall be made to the geographically closest hospital with the service capability, unless another prior arrangement is in place or the geographically closest hospital is at service capacity. When the condition of a medically necessary transferred patient improves so that the service capability of the receiving hospital is no longer required, the receiving hospital may transfer the patient back to the transferring hospital and the transferring hospital shall receive the patient within its service capability.
(f) In no event shall the provision of emergency services and care, the acceptance of a medically necessary transfer, or the return of a patient pursuant to paragraph (e) be based upon, or affected by, the person’s race, ethnicity, religion, national origin, citizenship, age, sex, preexisting medical condition, physical or mental handicap, insurance status, economic status, or ability to pay for medical services, except to the extent that a circumstance such as age, sex, preexisting medical condition, or physical or mental handicap is medically significant to the provision of appropriate medical care to the patient.
(g) Neither the hospital nor its employees, nor any physician, dentist, or podiatric physician shall be liable in any action arising out of a refusal to render emergency services or care if the refusal is made after screening, examining, and evaluating the patient, and is based on the determination, exercising reasonable care, that the person is not suffering from an emergency medical condition or a determination, exercising reasonable care, that the hospital does not have the service capability or is at service capacity to render those services.
(h) A hospital may request and collect insurance information and other financial information from a patient, in accordance with federal law, if emergency services and care are not delayed. No hospital to which another hospital is transferring a person in need of emergency services and care may require the transferring hospital or any person or entity to guarantee payment for the person as a condition of receiving the transfer. In addition, a hospital may not require any contractual agreement, any type of preplanned transfer agreement, or any other arrangement to be made prior to or at the time of transfer as a condition of receiving an individual patient being transferred. However, the patient or the patient’s legally responsible relative or guardian shall execute an agreement to pay for emergency services or care or otherwise supply insurance or credit information promptly after the services and care are rendered.
(i) Each hospital offering emergency services shall post, in a conspicuous place in the emergency service area, a sign clearly stating a patient’s right to emergency services and care and the service capability of the hospital.
(j) If a hospital subject to the provisions of this chapter does not maintain an emergency department, its employees shall nevertheless exercise reasonable care to determine whether an emergency medical condition exists and shall direct the persons seeking emergency care to a nearby facility which can render the needed services and shall assist the persons seeking emergency care in obtaining the services, including transportation services, in every way reasonable under the circumstances.
(k)1. Emergency medical services providers may not condition the prehospital transport of any person in need of emergency services and care on the person’s ability to pay. Nor may emergency medical services providers condition a transfer on the person’s ability to pay when the transfer is made necessary because the patient is in immediate need of treatment for an emergency medical condition for which the hospital lacks service capability or when the hospital is at service capacity. However, the patient or the patient’s legally responsible relative or guardian shall execute an agreement to pay for the transport or otherwise supply insurance or credit information promptly after the transport is rendered.
2. A hospital may enter into an agreement with an emergency medical services provider for purposes of meeting its service capability requirements, and appropriate compensation and other reasonable conditions may be negotiated for these services.
(l) Hospital personnel may withhold or withdraw cardiopulmonary resuscitation if presented with an order not to resuscitate executed pursuant to s. 401.45. Facility staff and facilities shall not be subject to criminal prosecution or civil liability, nor be considered to have engaged in negligent or unprofessional conduct, for withholding or withdrawing cardiopulmonary resuscitation pursuant to such an order. The absence of an order not to resuscitate executed pursuant to s. 401.45 does not preclude a physician from withholding or withdrawing cardiopulmonary resuscitation as otherwise permitted by law.
(m)1. A hospital-based off-campus emergency department may not hold itself out to the public as an urgent care center and must clearly identify itself as a hospital emergency department, using, at a minimum, prominent lighted external signage that includes the word “EMERGENCY” or “ER” in conjunction with the name of the hospital. If a hospital-based off-campus emergency department is located on the same premises as an urgent care center, the signage may also identify the urgent care center.
2. A hospital-based off-campus emergency department shall conspicuously post signs at locations that are readily accessible to and visible by patients outside the entrance to the facility and in patient waiting areas which state the following: “THIS IS A HOSPITAL EMERGENCY DEPARTMENT.” Unless the hospital-based off-campus emergency department shares a premises and a public entrance with an urgent care center, the signs must also state the following: “THIS IS NOT AN URGENT CARE CENTER. HOSPITAL EMERGENCY DEPARTMENT RATES ARE BILLED FOR OUR SERVICES.” The signs must also specify the facility’s average facility fee, if any, and notify the public that the facility or a physician providing medical care at the facility may be an out-of-network provider. The signs must be at least 2 square feet in size, and the text must be in at least 36 point type.
3. Except as provided in this subparagraph, any advertisement for a hospital-based off-campus emergency department must include the following statement: “This emergency department is part of (insert hospital name).” Unless the hospital-based off-campus emergency department is located on the same premises as an urgent care center that is advertised in the same advertisement, the advertisement must also include the following statement: “This is not an urgent care center. Its services and care are billed at hospital emergency department rates.” Any billboard advertising a hospital-based off-campus emergency department which measures at least 200 square feet must include the following statement in clearly legible contrasting color text at least 15 inches high: “(INSERT NAME OF HOSPITAL) EMERGENCY DEPARTMENT.” Unless the hospital-based off-campus emergency department is located on the same premises as an urgent care center that is advertised on the same billboard, such billboard must also include the following statement in clearly legible contrasting color text at least 15 inches high: “THIS IS NOT AN URGENT CARE CENTER.”
4. The agency shall post on its website, and annually update, information that describes the differences between a hospital-based off-campus emergency department and an urgent care center. Each hospital shall post a link to such information in a prominent location on its website. Such description must include:
a. At least two examples illustrating the impact on insured and insurer paid amounts of inappropriate utilization of nonemergent services and care in a hospital emergency department setting compared to utilization of nonemergent services and care in an urgent care center;
b. An interactive tool to locate local urgent care centers; and
c. What to do in the event of a true emergency.
(4) RECORDS OF TRANSFERS; REPORT OF VIOLATIONS.—
(a)1. Each hospital shall maintain records of each transfer made or received for a period of 5 years. These records of transfers shall be included in a transfer log, as well as in the permanent medical record of any patient being transferred or received.
2. Each hospital shall maintain records of all patients who request emergency care and services, or persons on whose behalf emergency care and services are requested, for a period of 5 years. These records shall be included in a log, as well as in the permanent medical record of any patient or person for whom emergency services and care is requested.
(b) Any hospital employee, physician, other licensed emergency room health care personnel, or certified prehospital emergency personnel who knows of an apparent violation of this section or the rules adopted under this section shall report the apparent violation to the agency within 30 days following its occurrence.
(c) A hospital, government agency, or person shall not retaliate against, penalize, institute a civil action against, or recover monetary relief from, or otherwise cause any injury to:
1. A physician or other person for reporting in good faith an apparent violation of this section or the rules adopted under this section to the agency, hospital, medical staff, or any other interested party or government agency;
2. A physician who refuses to transfer a patient if the physician determines, within reasonable medical probability, that the transfer or delay caused by the transfer will create a medical hazard to the patient; or
3. A physician who effectuates the transfer of a patient if the physician determines, within a reasonable medical probability, that failing to transfer the patient will create a medical hazard to the patient.
(5) PENALTIES.—
(a) The agency may deny, revoke, or suspend a license or impose an administrative fine, not to exceed $10,000 per violation, for the violation of any provision of this section or rules adopted under this section.
(b) Any person who suffers personal harm as a result of a violation of this section or the rules adopted hereunder may recover, in a civil action against the responsible hospital administrative or medical staff or personnel, damages, reasonable attorney’s fees, and other appropriate relief. However, this paragraph shall not be construed to create a cause of action beyond that recognized by this section and rules adopted under this section as they existed on April 1, 1992.
(c) Any hospital administrative or medical staff or personnel who knowingly or intentionally violates any provision of this section commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.
(d)1. Any hospital, or any physician licensed under chapter 458 or chapter 459, who suffers a financial loss as a direct result of a violation by a physician or a hospital of a requirement of this section may, in a civil action against the physician or the hospital, obtain damages for financial loss of charges and such equitable relief as is appropriate, including reasonable attorney’s fees and costs.
2. If the defendant prevails in an action brought by the hospital or physician pursuant to this paragraph, the court may award reasonable attorney’s fees and costs to the defendant.
(e) A physician licensed under chapter 458 or chapter 459 who negligently or knowingly violates any requirement of this section relating to the provision of emergency services and care shall be deemed in violation of the provisions of such chapters for any of the following violations:
1. Failure or refusal to respond within a reasonable time after notification when on call.
2. Failure or refusal to sign a certificate of transfer as required by this section.
3. Signing a certificate of transfer stating that the medical benefits to be reasonably expected from a transfer to another facility outweigh the risks associated with the transfer, when the physician knew or should have known that the benefits did not outweigh the risks as required by this section.
4. Misrepresentation of an individual’s condition or other information when requesting a transfer.
Any fine collected for a violation of this section, including any fine collected from a physician licensed under chapter 458 or chapter 459, shall be deposited into the Public Medical Assistance Trust Fund.
(f) In determining whether a licensee is deemed in violation of this section and in assessing any penalties for violation, the agency shall consider, and the licensee may offer as an affirmative defense or in mitigation, whether the licensee has established that the alleged violation arose from the unanticipated changes in service capability or other factors beyond the licensee’s control.
(6) RIGHTS OF PERSONS BEING TREATED.—
(a) A hospital providing emergency services and care to a person who is being involuntarily examined under the provisions of s. 394.463 shall adhere to the rights of patients specified in part I of chapter 394 and the involuntary examination procedures provided in s. 394.463, regardless of whether the hospital, or any part thereof, is designated as a receiving or treatment facility under part I of chapter 394 and regardless of whether the person is admitted to the hospital.
(b) Each hospital with an emergency department shall develop a best practices policy to promote the prevention of unintentional drug overdoses. The policy may include, but is not limited to:
1. A process to obtain the patient’s consent to notify the patient’s next of kin, and each physician or health care practitioner who prescribed a controlled substance to the patient, regarding the patient’s overdose, her or his location, and the nature of the substance or controlled substance involved in the overdose.
2. A process for providing the patient or the patient’s next of kin with information about licensed substance abuse treatment services, voluntary admission procedures under part IV of chapter 397, involuntary admission procedures under part V of chapter 397, and involuntary commitment procedures under chapter 394.
3. Guidelines for emergency department health care practitioners authorized to prescribe controlled substances to reduce the risk of opioid use, misuse, and addiction.
4. The use of licensed or certified behavioral health professionals or peer specialists in the emergency department to encourage the patient to seek substance abuse treatment.
5. The use of Screening, Brief Intervention, and Referral to Treatment protocols in the emergency department.
This paragraph may not be construed as creating a cause of action by any party.
(7) EMERGENCY ROOM DIVERSION PROGRAMS.—Hospitals may develop emergency room diversion programs, including, but not limited to, an “Emergency Hotline” which allows patients to help determine if emergency department services are appropriate or if other health care settings may be more appropriate for care, and a “Fast Track” program allowing nonemergency patients to be treated at an alternative site. Alternative sites may include health care programs funded with local tax revenue and federally funded community health centers, county health departments, or other nonhospital providers of health care services. The program may include provisions for followup care and case management.
History.—s. 6, ch. 88-186; s. 1, ch. 89-296; s. 68, ch. 91-224; s. 4, ch. 91-249; ss. 24, 25, 98, ch. 92-289; s. 30, ch. 96-169; s. 2, ch. 96-199; s. 10, ch. 96-223; s. 182, ch. 98-166; s. 2, ch. 99-331; s. 1, ch. 2000-295; s. 5, ch. 2004-297; s. 3, ch. 2017-54; s. 89, ch. 2020-2; s. 3, ch. 2021-112.
Note.—Former s. 395.0142.
395.1051 Duty to notify patients.—An appropriately trained person designated by each licensed facility shall inform each patient, or an individual identified pursuant to s. 765.401(1), in person about adverse incidents that result in serious harm to the patient. Notification of outcomes of care that result in harm to the patient under this section shall not constitute an acknowledgment or admission of liability, nor can it be introduced as evidence.
History.—s. 7, ch. 2003-416.
395.1052 Patient access to primary care and specialty providers; notification.—A hospital shall:
(1) Notify each patient’s primary care provider, if any, within 24 hours after the patient’s admission to the hospital.
(2) Inform the patient immediately upon admission that he or she may request to have the hospital’s treating physician consult with the patient’s primary care provider or specialist provider, if any, when developing the patient’s plan of care. Upon the patient’s request, the hospital’s treating physician shall make reasonable efforts to consult with the patient’s primary care provider or specialist provider when developing the patient’s plan of care.
(3) Notify the patient’s primary care provider, if any, of the patient’s discharge from the hospital within 24 hours after the discharge.
(4) Provide the discharge summary and any related information or records to the patient’s primary care provider, if any, within 14 days after the patient’s discharge summary has been completed.
History.—s. 5, ch. 2019-138.
395.1053 Postpartum education.—A hospital that provides birthing services shall incorporate information on safe sleep practices and the possible causes of Sudden Unexpected Infant Death into the hospital’s postpartum instruction on the care of newborns and provide to each parent the informational pamphlet on infant and childhood eye and vision disorders created by the department pursuant to s. 383.14(3)(i).
History.—s. 4, ch. 2013-62; s. 3, ch. 2020-79.
395.1055 Rules and enforcement.—
(1) The agency shall adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this part, which shall include reasonable and fair minimum standards for ensuring that:
(a) Sufficient numbers and qualified types of personnel and occupational disciplines are on duty and available at all times to provide necessary and adequate patient care and safety.
(b) Infection control, housekeeping, sanitary conditions, and medical record procedures that will adequately protect patient care and safety are established and implemented.
(c) A comprehensive emergency management plan is prepared and updated annually. Such standards must be included in the rules adopted by the agency after consulting with the Division of Emergency Management. At a minimum, the rules must provide for plan components that address emergency evacuation transportation; adequate sheltering arrangements; postdisaster activities, including emergency power, food, and water; postdisaster transportation; supplies; staffing; emergency equipment; individual identification of residents and transfer of records, and responding to family inquiries. The comprehensive emergency management plan is subject to review and approval by the local emergency management agency. During its review, the local emergency management agency shall ensure that the following agencies, at a minimum, are given the opportunity to review the plan: the Department of Elderly Affairs, the Department of Health, the Agency for Health Care Administration, and the Division of Emergency Management. Also, appropriate volunteer organizations must be given the opportunity to review the plan. The local emergency management agency shall complete its review within 60 days and either approve the plan or advise the facility of necessary revisions.
(d) Licensed facilities are established, organized, and operated consistent with established standards and rules.
(e) Licensed facility beds conform to minimum space, equipment, and furnishings standards as specified by the department.
1(f) All hospitals submit such data as necessary to conduct certificate-of-need reviews required under part I of chapter 408. Such data shall include, but shall not be limited to, patient origin data, hospital utilization data, type of service reporting, and facility staffing data. The agency may not collect data that identifies or could disclose the identity of individual patients. The agency shall utilize existing uniform statewide data sources when available and shall minimize reporting costs to hospitals.
(g) Each hospital has a quality improvement program designed according to standards established by their current accrediting organization. This program will enhance quality of care and emphasize quality patient outcomes, corrective action for problems, governing board review, and reporting to the agency of standardized data elements necessary to analyze quality of care outcomes. The agency shall use existing data, when available, and shall not duplicate the efforts of other state agencies in order to obtain such data.
(h) Licensed facilities make available on their Internet websites, and in a hard copy format upon request, a description of and a link to the patient charge and performance outcome data collected from licensed facilities pursuant to s. 408.061.
(i) All hospitals providing organ transplantation, neonatal intensive care services, inpatient psychiatric services, inpatient substance abuse services, or comprehensive medical rehabilitation meet the minimum licensure requirements adopted by the agency. Such licensure requirements must include quality of care, nurse staffing, physician staffing, physical plant, equipment, emergency transportation, and data reporting standards.
(2) Separate standards may be provided for general and specialty hospitals, ambulatory surgical centers, and statutory rural hospitals as defined in s. 395.602.
(3) The agency shall adopt rules that establish minimum standards for pediatric patient care in ambulatory surgical centers to ensure the safe and effective delivery of surgical care to children in ambulatory surgical centers. Such standards must include quality of care, nurse staffing, physician staffing, and equipment standards. Ambulatory surgical centers may not provide operative procedures to children under 18 years of age which require a length of stay past midnight until such standards are established by rule.
(4) The agency shall adopt rules with respect to the care and treatment of patients residing in distinct part nursing units of hospitals which are certified for participation in Title XVIII (Medicare) and Title XIX (Medicaid) of the Social Security Act skilled nursing facility program. Such rules shall take into account the types of patients treated in hospital skilled nursing units, including typical patient acuity levels and the average length of stay in such units, and shall be limited to the appropriate portions of the Omnibus Budget Reconciliation Act of 1987 (Pub. L. No. 100-203) (December 22, 1987), Title IV (Medicare, Medicaid, and Other Health-Related Programs), Subtitle C (Nursing Home Reform), as amended. The agency shall require level 2 background screening as specified in s. 408.809(1)(e) pursuant to s. 408.809 and chapter 435 for personnel of distinct part nursing units.
(5) The agency shall adopt rules with respect to the care and treatment of clients in intensive residential treatment programs for children and adolescents and with respect to the safe and healthful development, operation, and maintenance of such programs.
(6) The agency shall enforce the provisions of part I of chapter 394, and rules adopted thereunder, with respect to the rights, standards of care, and examination and placement procedures applicable to patients voluntarily or involuntarily admitted to hospitals providing psychiatric observation, evaluation, diagnosis, or treatment.
(7) No rule shall be adopted under this part by the agency which would have the effect of denying a license to a facility required to be licensed under this part, solely by reason of the school or system of practice employed or permitted to be employed by physicians therein, provided that such school or system of practice is recognized by the laws of this state. However, nothing in this subsection shall be construed to limit the powers of the agency to provide and require minimum standards for the maintenance and operation of, and for the treatment of patients in, those licensed facilities which receive federal aid, in order to meet minimum standards related to such matters in such licensed facilities which may now or hereafter be required by appropriate federal officers or agencies in pursuance of federal law or promulgated in pursuance of federal law.
(8) Any licensed facility which is in operation at the time of promulgation of any applicable rules under this part shall be given a reasonable time, under the particular circumstances, but not to exceed 1 year from the date of such promulgation, within which to comply with such rules.
(9) The agency may not adopt any rule governing the design, construction, erection, alteration, modification, repair, or demolition of any public or private hospital, intermediate residential treatment facility, or ambulatory surgical center. It is the intent of the Legislature to preempt that function to the Florida Building Commission and the State Fire Marshal through adoption and maintenance of the Florida Building Code and the Florida Fire Prevention Code. However, the agency shall provide technical assistance to the commission and the State Fire Marshal in updating the construction standards of the Florida Building Code and the Florida Fire Prevention Code which govern hospitals, intermediate residential treatment facilities, and ambulatory surgical centers.
(10) The agency shall establish a pediatric cardiac technical advisory panel, pursuant to s. 20.052, to develop procedures and standards for measuring outcomes of pediatric cardiac catheterization programs and pediatric cardiovascular surgery programs.
(a) Members of the panel must have technical expertise in pediatric cardiac medicine, shall serve without compensation, and may be reimbursed for per diem and travel expenses.
(b) Voting members of the panel shall include: 3 at-large members, and 3 alternate at-large members with different program affiliations, including 1 cardiologist who is board certified in caring for adults with congenital heart disease and 2 board-certified pediatric cardiologists, neither of whom may be employed by any of the hospitals specified in subparagraphs 1.-10. or their affiliates, each of whom is appointed by the Secretary of Health Care Administration, and 10 members, and an alternate for each member, each of whom is a pediatric cardiologist or a pediatric cardiovascular surgeon, each appointed by the chief executive officer of the following hospitals:
1. Johns Hopkins All Children’s Hospital in St. Petersburg.
2. Arnold Palmer Hospital for Children in Orlando.
3. Joe DiMaggio Children’s Hospital in Hollywood.
4. Nicklaus Children’s Hospital in Miami.
5. St. Joseph’s Children’s Hospital in Tampa.
6. University of Florida Health Shands Hospital in Gainesville.
7. University of Miami Holtz Children’s Hospital in Miami.
8. Wolfson Children’s Hospital in Jacksonville.
9. Florida Hospital for Children in Orlando.
10. Nemours Children’s Hospital in Orlando.
Appointments made under subparagraphs 1.-10. are contingent upon the hospital’s compliance with this section and rules adopted thereunder, as determined by the Secretary of Health Care Administration. A member appointed under subparagraphs 1.-10. whose hospital fails to comply with such standards may serve only as a nonvoting member until the hospital complies with such standards. A voting member may serve a maximum of two 2-year terms and may be reappointed to the panel after being retired from the panel for a full 2-year term.
(c) The Secretary of Health Care Administration may appoint nonvoting members to the panel. Nonvoting members may include:
1. The Secretary of Health Care Administration.
2. The Surgeon General.
3. The Deputy Secretary of Children’s Medical Services.
4. Any current or past Division Director of Children’s Medical Services.
5. A parent of a child with congenital heart disease.
6. An adult with congenital heart disease.
7. A representative from each of the following organizations: the Florida Chapter of the American Academy of Pediatrics, the Florida Chapter of the American College of Cardiology, the Greater Southeast Affiliate of the American Heart Association, the Adult Congenital Heart Association, the March of Dimes, the Florida Association of Children’s Hospitals, and the Florida Society of Thoracic and Cardiovascular Surgeons.
(d) The panel shall meet biannually, or more frequently upon the call of the Secretary of Health Care Administration. Such meetings may be conducted telephonically, or by other electronic means.
(e) The duties of the panel include recommending to the agency standards for quality of care, personnel, physical plant, equipment, emergency transportation, and data reporting for hospitals that provide pediatric cardiac services.
(f) Beginning on January 1, 2020, and annually thereafter, the panel shall submit a report to the Governor, the President of the Senate, the Speaker of the House of Representatives, the Secretary of Health Care Administration, and the State Surgeon General. The report must summarize the panel’s activities during the preceding fiscal year and include data and performance measures on surgical morbidity and mortality for all pediatric cardiac programs.
(g) Panel members are agents of the state for purposes of s. 768.28 throughout the good faith performance of the duties assigned to them by the Secretary of Health Care Administration.
(11) The Secretary of Health Care Administration shall consult the pediatric cardiac technical advisory panel for an advisory recommendation on any certificate of need applications to establish pediatric cardiac surgical centers.
(12) Based on the recommendations of the pediatric cardiac technical advisory panel, the agency shall adopt rules for pediatric cardiac programs which, at a minimum, include:
(a) Standards for pediatric cardiac catheterization services and pediatric cardiovascular surgery including quality of care, personnel, physical plant, equipment, emergency transportation, data reporting, and appropriate operating hours and timeframes for mobilization for emergency procedures.
(b) Outcome standards consistent with nationally established levels of performance in pediatric cardiac programs.
(c) Specific steps to be taken by the agency and licensed facilities when the facilities do not meet the outcome standards within a specified time, including time required for detailed case reviews and the development and implementation of corrective action plans.
(13) A pediatric cardiac program shall:
(a) Have a pediatric cardiology clinic affiliated with a hospital licensed under this chapter.
(b) Have a pediatric cardiac catheterization laboratory and a pediatric cardiovascular surgical program located in the hospital.
(c) Have a risk adjustment surgical procedure protocol following the guidelines established by the Society of Thoracic Surgeons.
(d) Have quality assurance and quality improvement processes in place to enhance clinical operation and patient satisfaction with services.
(e) Participate in the clinical outcome reporting systems operated by the Society of Thoracic Surgeons and the American College of Cardiology.
(14)(a) The Secretary of Health Care Administration may request announced or unannounced site visits to any existing pediatric cardiac surgical center or facility seeking licensure as a pediatric cardiac surgical center through the certificate of need process, to ensure compliance with this section and rules adopted hereunder.
(b) At the request of the Secretary of Health Care Administration, the pediatric cardiac technical advisory panel shall recommend in-state physician experts to conduct an onsite visit. The Secretary may also appoint up to two out-of-state physician experts.
(c) A site visit team shall conduct an onsite inspection of the designated hospital’s pediatric medical and surgical programs, and each member shall submit a written report of his or her findings to the panel. The panel shall discuss the written reports and present an advisory opinion to the Secretary of Health Care Administration which includes recommendations and any suggested actions for correction.
(d) Each onsite inspection must include all of the following:
1. An inspection of the program’s physical facilities, clinics, and laboratories.
2. Interviews with support staff and hospital administrators.
3. A review of:
a. Randomly selected medical records and reports, including, but not limited to, advanced cardiac imaging, computed tomography, magnetic resonance imaging, cardiac ultrasound, cardiac catheterization, and surgical operative notes.
b. The program’s clinical outcome data submitted to the Society of Thoracic Surgeons and the American College of Cardiology pursuant to s. 408.05(3)(l).
c. Mortality reports from cardiac-related deaths that occurred in the previous year.
d. Program volume data from the preceding year for interventional and electrophysiology catheterizations and surgical procedures.
(15) The Surgeon General shall provide quarterly reports to the Secretary of Health Care Administration consisting of data from the Children’s Medical Services’ critical congenital heart disease screening program for review by the advisory panel.
(16) Each provider of diagnostic cardiac catheterization services shall comply with rules adopted by the agency which establish licensure standards governing the operation of adult inpatient diagnostic cardiac catheterization programs. The rules must ensure that such programs:
(a) Comply with the most recent guidelines of the American College of Cardiology and American Heart Association Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories.
(b) Perform only adult inpatient diagnostic cardiac catheterization services and will not provide therapeutic cardiac catheterization or any other cardiology services.
(c) Maintain sufficient appropriate equipment and health care personnel to ensure quality and safety.
(d) Maintain appropriate times of operation and protocols to ensure availability and appropriate referrals in the event of emergencies.
(e) Demonstrate a plan to provide services to Medicaid and charity care patients.
(17) Each provider of adult cardiovascular services or operator of a burn unit shall comply with rules adopted by the agency which establish licensure standards that govern the provision of adult cardiovascular services or the operation of a burn unit, as applicable. At a minimum, such rules must address staffing, equipment, physical plant, operating protocols, the provision of services to Medicaid and charity care patients, accreditation, licensure periods and fees, and enforcement of minimum standards.
(18) In establishing rules for adult cardiovascular services, the agency shall include provisions that allow for:
(a) The establishment of two hospital program licensure levels, a Level I program that authorizes the performance of adult percutaneous cardiac intervention without onsite cardiac surgery and a Level II program that authorizes the performance of percutaneous cardiac intervention with onsite cardiac surgery.
(b)1. For a hospital seeking a Level I program, demonstration that, for the most recent 12-month period as reported to the agency, the hospital has provided a minimum of 300 adult inpatient and outpatient diagnostic cardiac catheterizations or, for the most recent 12-month period, has discharged or transferred at least 300 patients with the principal diagnosis of ischemic heart disease and that it has a formalized, written transfer agreement with a hospital that has a Level II program, including written transport protocols to ensure safe and efficient transfer of a patient within 60 minutes.
2.a. A hospital located more than 100 road miles from the closest Level II adult cardiovascular services program is not required to meet the diagnostic cardiac catheterization volume and ischemic heart disease diagnosis volume requirements in subparagraph 1. if the hospital demonstrates that it has, for the most recent 12-month period as reported to the agency, provided a minimum of 100 adult inpatient and outpatient diagnostic cardiac catheterizations or that, for the most recent 12-month period, it has discharged or transferred at least 300 patients with the principal diagnosis of ischemic heart disease.
b. A hospital located more than 100 road miles from the closest Level II adult cardiovascular services program does not need to meet the 60-minute transfer time protocol requirement in subparagraph 1. if the hospital demonstrates that it has a formalized, written transfer agreement with a hospital that has a Level II program. The agreement must include written transport protocols to ensure the safe and efficient transfer of a patient, taking into consideration the patient’s clinical and physical characteristics, road and weather conditions, and viability of ground and air ambulance service to transfer the patient.
3. At a minimum, the rules for adult cardiovascular services must require nursing and technical staff to have demonstrated experience in handling acutely ill patients requiring intervention, based on the staff member’s previous experience in dedicated cardiac interventional laboratories or surgical centers. If a staff member’s previous experience is in a dedicated cardiac interventional laboratory at a hospital that does not have an approved adult open heart surgery program, the staff member’s previous experience qualifies only if, at the time the staff member acquired his or her experience, the dedicated cardiac interventional laboratory:
a. Had an annual volume of 500 or more percutaneous cardiac intervention procedures.
b. Achieved a demonstrated success rate of 95 percent or greater for percutaneous cardiac intervention procedures.
c. Experienced a complication rate of less than 5 percent for percutaneous cardiac intervention procedures.
d. Performed diverse cardiac procedures, including, but not limited to, balloon angioplasty and stenting, rotational atherectomy, cutting balloon atheroma remodeling, and procedures relating to left ventricular support capability.
(c) For a hospital seeking a Level II program, demonstration that, for the most recent 12-month period as reported to the agency, the hospital has performed a minimum of 1,100 adult inpatient and outpatient cardiac catheterizations, of which at least 400 must be therapeutic catheterizations, or, for the most recent 12-month period, has discharged at least 800 patients with the principal diagnosis of ischemic heart disease.
(d) Compliance with the most recent guidelines of the American College of Cardiology and the American Heart Association guidelines for staffing, physician training and experience, operating procedures, equipment, physical plant, and patient selection criteria, to ensure patient quality and safety.
(e) The establishment of appropriate hours of operation and protocols to ensure availability and timely referral in the event of emergencies.
(f) The demonstration of a plan to provide services to Medicaid and charity care patients.
(g) For a hospital licensed for adult diagnostic cardiac catheterization that provides Level I or Level II adult cardiovascular services, demonstration that the hospital is participating in the American College of Cardiology’s National Cardiovascular Data Registry or the American Heart Association’s Get with the Guidelines–Coronary Artery Disease registry and documentation of an ongoing quality improvement plan ensuring that the licensed cardiac program meets or exceeds national quality and outcome benchmarks reported by the registry in which the hospital participates. A hospital licensed for Level II adult cardiovascular services must also participate in the clinical outcome reporting systems operated by the Society for Thoracic Surgeons.
(19) The agency may adopt rules to administer the requirements of part II of chapter 408.
History.—ss. 26, 30, ch. 82-182; s. 5, ch. 83-244; ss. 40, 49, ch. 83-334; s. 41, ch. 87-92; s. 27, ch. 90-344; ss. 27, 98, ch. 92-289; s. 28, ch. 93-129; s. 24, ch. 93-211; s. 1, ch. 94-317; s. 31, ch. 96-169; s. 6, ch. 98-89; s. 99, ch. 98-200; s. 7, ch. 98-303; s. 104, ch. 99-8; ss. 22, 135, ch. 2000-141; ss. 34, 37, ch. 2001-186; ss. 3, 6, ch. 2001-372; s. 6, ch. 2004-297; s. 47, ch. 2007-230; s. 271, ch. 2011-142; s. 1, ch. 2017-151; s. 32, ch. 2018-24; s. 60, ch. 2019-3; ss. 2, 3, ch. 2019-136; s. 7, ch. 2019-138; s. 2, ch. 2020-134; s. 4, ch. 2020-156.
Note.—Former s. 395.005.
395.1056 Plan components addressing a hospital’s response to terrorism; public records exemption; public meetings exemption.—
(1)(a) Those portions of a comprehensive emergency management plan that address the response of a public or private hospital to an act of terrorism as defined by s. 775.30 held by the agency, a state or local law enforcement agency, a county or municipal emergency management agency, the Executive Office of the Governor, the Department of Health, or the Division of Emergency Management are confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
(b) Information made confidential and exempt by this subsection may be disclosed by a custodial agency to another state or federal agency to prevent, detect, guard against, respond to, investigate, or manage the consequences of any attempted or actual act of terrorism, or to prosecute those persons who are responsible for such attempts or acts.
(c) Portions of a comprehensive emergency management plan that address the response of a public or private hospital to an act of terrorism include those portions addressing:
1. Security systems or plans;
2. Vulnerability analyses;
3. Emergency evacuation transportation;
4. Sheltering arrangements;
5. Postdisaster activities, including provisions for emergency power, communications, food, and water;
6. Postdisaster transportation;
7. Supplies, including drug caches;
8. Staffing;
9. Emergency equipment; and
10. Individual identification of residents, transfer of records, and methods of responding to family inquiries.
(2) Those portions of a comprehensive emergency management plan that address the response of a public hospital to an act of terrorism as defined by s. 775.30 held by that public hospital are exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution. Portions of a comprehensive emergency management plan that address the response of a public hospital to an act of terrorism include those portions addressing:
(a) Security systems or plans;
(b) Vulnerability analyses;
(c) Emergency evacuation transportation;
(d) Sheltering arrangements;
(e) Postdisaster activities, including provisions for emergency power, communications, food, and water;
(f) Postdisaster transportation;
(g) Supplies, including drug caches;
(h) Staffing;
(i) Emergency equipment; and
(j) Individual identification of residents, transfer of records, and methods of responding to family inquiries.
(3) The public records exemptions provided by this section are remedial in nature, and it is the intent of the Legislature that the exemptions apply to plans held by a custodial agency before, on, or after the effective date of this section.
(4) That portion of a public meeting which would reveal information contained in a comprehensive emergency management plan that addresses the response of a hospital to an act of terrorism is exempt from s. 286.011 and s. 24(b), Art. I of the State Constitution.
(5) The certification by the Governor, in coordination with the Department of Health, of the sufficiency of a comprehensive emergency management plan that addresses the response of a hospital to an act of terrorism is not exempt.
History.—s. 1, ch. 2001-362; s. 1, ch. 2006-109; s. 272, ch. 2011-142; s. 10, ch. 2017-37.
395.106 Risk pooling by certain hospitals and hospital systems.—
(1) Notwithstanding any other provision of law, any two or more hospitals licensed in this state and located in this state may form an alliance for the purpose of pooling and spreading liabilities of its members relative to property exposure, implementing self-insurance coverage for its members, or securing such property insurance coverage for the benefit of its members, provided an alliance that is created:
(a) Has annual premiums in excess of $3 million.
(b) Maintains a continuing program of premium calculation and evaluation and reserve evaluation to protect the financial stability of the alliance in an amount and manner determined by consultants using catastrophic (CAT) modeling criteria or other risk-estimating methodologies, including those used by qualified and independent actuaries.
(c) Causes to be prepared annually a fiscal year-end financial statement based upon generally accepted accounting principles and audited by an independent certified public accountant within 6 months after the end of the fiscal year.
(d) Has a governing body comprised entirely of member entities whose representatives on such governing body are specified by the organizational documents of the alliance.
(2) For purposes of this section, the term:
(a) “Alliance” means a corporation, association, limited liability company, or partnership or any other legal entity formed by a group of eligible entities.
(b) “Property coverage” means property coverage provided by self-insurance or insurance for real or personal property of every kind and every interest in such property against loss or damage from any hazard or cause and against any loss consequential to such loss or damage.
(3) An alliance that meets the requirements of this section is not subject to any provision of the insurance code.
(4) An alliance that meets the requirements of this section is not an insurer for purposes of participation in or coverage by the Florida Insurance Guaranty Association established in part II of chapter 631. Alliance self-insured coverage is not subject to insurance premium tax, and any such alliance formed pursuant to this section may not be assessed for purposes of s. 215.555 or s. 627.351.
(5) Reinsurance companies complying with s. 624.610 may issue coverage directly to an alliance self-insuring its liabilities under this section. An alliance purchasing reinsurance shall be considered an insurer for the sole purpose of entering into such reinsurance contracts. Contracts of reinsurance issued to an alliance under this section shall receive the same tax treatment as reinsurance contracts issued to insurance companies. However, the purchase of reinsurance coverage by an alliance self-insuring pursuant to this section shall not be construed as authorizing an alliance to otherwise act as an insurer.
History.—s. 6, ch. 2007-1; s. 2, ch. 2008-220.
395.1065 Criminal and administrative penalties; moratorium.—
(1) In addition to s. 408.812, any person establishing, conducting, managing, or operating any facility without a license under this part commits a misdemeanor and, upon conviction, shall be fined not more than $500 for the first offense and not more than $1,000 for each subsequent offense, and each day of continuing violation after conviction shall be considered a separate offense.
(2)(a) The agency may impose an administrative fine, not to exceed $1,000 per violation, per day, for the violation of any provision of this part, part II of chapter 408, or applicable rules. Each day of violation constitutes a separate violation and is subject to a separate fine.
(b) In determining the amount of fine to be levied for a violation, as provided in paragraph (a), the following factors shall be considered:
1. The severity of the violation, including the probability that death or serious harm to the health or safety of any person will result or has resulted, the severity of the actual or potential harm, and the extent to which the provisions of this part were violated.
2. Actions taken by the licensee to correct the violations or to remedy complaints.
3. Any previous violations of the licensee.
(c) The agency may impose an administrative fine for the violation of s. 641.3154 or, if sufficient claims due to a provider from a health maintenance organization do not exist to enable the take-back of an overpayment, as provided under s. 641.3155(5), for the violation of s. 641.3155(5). The administrative fine for a violation cited in this paragraph shall be in the amounts specified in s. 641.52(5), and the provisions of paragraph (a) do not apply.
(3) In accordance with part II of chapter 408, the agency may impose an immediate moratorium on elective admissions to any licensed facility, building, or portion thereof, or service, when the agency determines that any condition in the facility presents a threat to public health or safety.
(4) In seeking to impose penalties against a facility as defined in s. 394.455 for a violation of part I of chapter 394, the agency is authorized to rely on the investigation and findings by the Department of Health in lieu of conducting its own investigation.
(5) The agency shall impose a fine of $500 for each instance of the facility’s failure to provide the information required by rules adopted pursuant to s. 395.1055(1)(g).
History.—ss. 26, 30, ch. 82-182; ss. 28, 98, ch. 92-289; s. 32, ch. 96-169; s. 105, ch. 99-8; s. 9, ch. 2000-252; s. 7, ch. 2004-297; s. 48, ch. 2007-230; s. 4, ch. 2019-136.
Note.—Former s. 395.018.
395.107 Facilities; publishing and posting schedule of charges; penalties.—
(1) For purposes of this section, the term “facility” means:
(a) An urgent care center as defined in s. 395.002; or
(b) A diagnostic-imaging center operated by a hospital licensed under this chapter which is not located on the hospital’s premises.
(2) A facility must publish and post a schedule of charges for the medical services offered to patients.
(3) The schedule of charges must describe the medical services in language comprehensible to a layperson. The schedule must include the prices charged to an uninsured person paying for such services by cash, check, credit card, or debit card. The schedule must be posted in a conspicuous place in the reception area and must include, but is not limited to, the 50 services most frequently provided. The schedule may group services by three price levels, listing services in each price level. The posting may be a sign, which must be at least 15 square feet in size, or may be through an electronic messaging board. If a facility is affiliated with a licensed hospital under this chapter, the schedule must include text that notifies the insured patients whether the charges for medical services received at the center will be the same as, or more than, charges for medical services received at the affiliated hospital. The text notifying the patient of the schedule of charges shall be in a font size equal to or greater than the font size used for prices and must be in a contrasting color. The text that notifies the insured patients whether the charges for medical services received at the center will be the same as, or more than, charges for medical services received at the affiliated hospital shall be included in all media and Internet advertisements for the center and in language comprehensible to a layperson.
(4) The posted text describing the medical services must fill at least 12 square feet of the posting. A facility may use an electronic device or messaging board to post the schedule of charges. Such a device must be at least 3 square feet, and patients must be able to access the schedule during all hours of operation of the facility.
(5) A facility that is operated and used exclusively for employees and the dependents of employees of the business that owns or contracts for the facility is exempt from this section.
(6) The failure of a facility to publish and post a schedule of charges as required by this section shall result in a fine of not more than $1,000, per day, until the schedule is published and posted.
History.—s. 3, ch. 2011-122; s. 2, ch. 2012-160; s. 2, ch. 2016-234.
395.10973 Powers and duties of the agency.—It is the function of the agency to:
(1) Adopt rules pursuant to ss. 120.536(1) and 120.54 to implement this part and part II of chapter 408 conferring duties upon it.
(2) Develop a model risk management program for health care facilities which will satisfy the requirements of s. 395.0197.
(3) Enforce the special-occupancy provisions of the Florida Building Code which apply to hospitals, intermediate residential treatment facilities, and ambulatory surgical centers in conducting any inspection authorized by this chapter and part II of chapter 408.
History.—ss. 38, 53, ch. 85-175; s. 32, ch. 88-166; s. 183, ch. 90-363; s. 4, ch. 91-429; s. 88, ch. 92-289; s. 28, ch. 98-89; s. 203, ch. 98-200; s. 23, ch. 2000-141; s. 34, ch. 2001-186; s. 3, ch. 2001-372; s. 49, ch. 2007-230; s. 35, ch. 2018-24.
Note.—Former s. 626.943.
395.2050 Routine inquiry for organ and tissue donation; certification for procurement activities; death records review.—
(1) Every general hospital, and every specialty hospital that offers the range of medical services offered by a general hospital but only to a portion of the population restricted by age or gender, licensed under this chapter shall comply with the requirements of s. 765.522 pertaining to requests for organ or tissue donation.
(2) Every hospital licensed under this chapter that is engaged in the procurement of organs, tissues, or eyes shall comply with the certification requirements of ss. 765.541-765.546.
(3) Each organ procurement organization designated by the federal Health Care Financing Administration and licensed by the state shall conduct an annual death records review in the organ procurement organization’s affiliated donor hospitals. The organ procurement organization shall enlist the services of every Florida licensed tissue bank and eye bank affiliated with or providing service to the donor hospital and operating in the same service area to participate in the death records review.
History.—s. 3, ch. 95-423; s. 56, ch. 2002-1; s. 36, ch. 2003-1.
395.301 Price transparency; itemized patient statement or bill; patient admission status notification.—
(1) A facility licensed under this chapter shall provide timely and accurate financial information and quality of service measures to patients and prospective patients of the facility, or to patients’ survivors or legal guardians, as appropriate. Such information shall be provided in accordance with this section and rules adopted by the agency pursuant to this chapter and s. 408.05. Licensed facilities operating exclusively as state facilities are exempt from this subsection.
(a) Each licensed facility shall make available to the public on its website information on payments made to that facility for defined bundles of services and procedures. The payment data must be presented and searchable in accordance with, and through a hyperlink to, the system established by the agency and its vendor using the descriptive service bundles developed under s. 408.05(3)(c). At a minimum, the facility shall provide the estimated average payment received from all payors, excluding Medicaid and Medicare, for the descriptive service bundles available at that facility and the estimated payment range for such bundles. Using plain language, comprehensible to an ordinary layperson, the facility must disclose that the information on average payments and the payment ranges is an estimate of costs that may be incurred by the patient or prospective patient and that actual costs will be based on the services actually provided to the patient. The facility’s website must:
1. Provide information to prospective patients on the facility’s financial assistance policy, including the application process, payment plans, and discounts, and the facility’s charity care policy and collection procedures.
2. If applicable, notify patients and prospective patients that services may be provided in the health care facility by the facility as well as by other health care providers who may separately bill the patient and that such health care providers may or may not participate with the same health insurers or health maintenance organizations as the facility.
3. Inform patients and prospective patients that they may request from the facility and other health care providers a more personalized estimate of charges and other information, and inform patients that they should contact each health care practitioner who will provide services in the hospital to determine the health insurers and health maintenance organizations with which the health care practitioner participates as a network provider or preferred provider.
4. Provide the names, mailing addresses, and telephone numbers of the health care practitioners and medical practice groups with which it contracts to provide services in the facility and instructions on how to contact the practitioners and groups to determine the health insurers and health maintenance organizations with which they participate as network providers or preferred providers.
(b)1. Upon request, and before providing any nonemergency medical services, each licensed facility shall provide in writing or by electronic means a good faith estimate of reasonably anticipated charges by the facility for the treatment of the patient’s or prospective patient’s specific condition. The facility must provide the estimate to the patient or prospective patient within 7 business days after the receipt of the request and is not required to adjust the estimate for any potential insurance coverage. The estimate may be based on the descriptive service bundles developed by the agency under s. 408.05(3)(c) unless the patient or prospective patient requests a more personalized and specific estimate that accounts for the specific condition and characteristics of the patient or prospective patient. The facility shall inform the patient or prospective patient that he or she may contact his or her health insurer or health maintenance organization for additional information concerning cost-sharing responsibilities.
2. In the estimate, the facility shall provide to the patient or prospective patient information on the facility’s financial assistance policy, including the application process, payment plans, and discounts and the facility’s charity care policy and collection procedures.
3. The estimate shall clearly identify any facility fees and, if applicable, include a statement notifying the patient or prospective patient that a facility fee is included in the estimate, the purpose of the fee, and that the patient may pay less for the procedure or service at another facility or in another health care setting.
4. Upon request, the facility shall notify the patient or prospective patient of any revision to the estimate.
5. In the estimate, the facility must notify the patient or prospective patient that services may be provided in the health care facility by the facility as well as by other health care providers that may separately bill the patient, if applicable.
6. The facility shall take action to educate the public that such estimates are available upon request.
7. Failure to timely provide the estimate pursuant to this paragraph shall result in a daily fine of $1,000 until the estimate is provided to the patient or prospective patient. The total fine may not exceed $10,000.
The provision of an estimate does not preclude the actual charges from exceeding the estimate.
(c) Each facility shall make available on its website a hyperlink to the health-related data, including quality measures and statistics that are disseminated by the agency pursuant to s. 408.05. The facility shall also take action to notify the public that such information is electronically available and provide a hyperlink to the agency’s website.
(d)1. Upon request, and after the patient’s discharge or release from a facility, the facility must provide to the patient or to the patient’s survivor or legal guardian, as appropriate, an itemized statement or a bill detailing in plain language, comprehensible to an ordinary layperson, the specific nature of charges or expenses incurred by the patient. The initial statement or bill shall be provided within 7 days after the patient’s discharge or release or after a request for such statement or bill, whichever is later. The initial statement or bill must contain a statement of specific services received and expenses incurred by date and provider for such items of service, enumerating in detail as prescribed by the agency the constituent components of the services received within each department of the licensed facility and including unit price data on rates charged by the licensed facility. The statement or bill must also clearly identify any facility fee and explain the purpose of the fee. The statement or bill must identify each item as paid, pending payment by a third party, or pending payment by the patient, and must include the amount due, if applicable. If an amount is due from the patient, a due date must be included. The initial statement or bill must direct the patient or the patient’s survivor or legal guardian, as appropriate, to contact the patient’s insurer or health maintenance organization regarding the patient’s cost-sharing responsibilities.
2. Any subsequent statement or bill provided to a patient or to the patient’s survivor or legal guardian, as appropriate, relating to the episode of care must include all of the information required by subparagraph 1., with any revisions clearly delineated.
3. Each statement or bill provided pursuant to this subsection:
a. Must include notice of hospital-based physicians and other health care providers who bill separately.
b. May not include any generalized category of expenses such as “other” or “miscellaneous” or similar categories.
c. Must list drugs by brand or generic name and not refer to drug code numbers when referring to drugs of any sort.
d. Must specifically identify physical, occupational, or speech therapy treatment by date, type, and length of treatment when such treatment is a part of the statement or bill.
(2) Each itemized statement or bill must prominently display the telephone number of the medical facility’s patient liaison who is responsible for expediting the resolution of any billing dispute between the patient, or the patient’s survivor or legal guardian, and the billing department.
(3) If a licensed facility places a patient on observation status rather than inpatient status, the licensed facility must immediately notify the patient of such status using the form adopted under 42 C.F.R. s. 489.20 for Medicare patients or a form adopted by agency rule for non-Medicare patients. Such notification must be documented in the patient’s medical records and discharge papers. The patient’s survivor or legal guardian must be notified of observation services through discharge papers, which may also include brochures, signage, or other forms of communication for this purpose.
(4) A licensed facility shall make available to a patient all records necessary for verification of the accuracy of the patient’s statement or bill within 10 business days after the request for such records. The records must be made available in the facility’s offices and through electronic means that comply with the Health Insurance Portability and Accountability Act of 1996, 42 U.S.C. s. 1320d, as amended. Such records must be available to the patient before and after payment of the statement or bill. The facility may not charge the patient for making such verification records available; however, the facility may charge its usual fee for providing copies of records as specified in s. 395.3025.
(5) Each facility shall establish a method for reviewing and responding to questions from patients concerning the patient’s itemized statement or bill. Such response shall be provided within 7 business days after the date a question is received. If the patient is not satisfied with the response, the facility must provide the patient with the contact information of the agency to which the issue may be sent for review.
(6) A hospital shall post on its website:
(a) The names and hyperlinks for direct access to the websites of all health insurers and health maintenance organizations for which the hospital contracts as a network provider or participating provider.
(b) A statement that:
1. Services may be provided in the hospital by the facility as well as by other health care practitioners who may separately bill the patient;
2. Health care practitioners who provide services in the hospital may or may not participate with the same health insurers or health maintenance organizations as the hospital; and
3. Prospective patients should contact the health care practitioner who will provide services in the hospital to determine which health insurers and health maintenance organizations the practitioner participates in as a network provider or preferred provider.
(c) As applicable, the names, mailing addresses, and telephone numbers of the health care practitioners and medical practice groups with which it contracts to provide services in the hospital, and instructions on how to contact the practitioners and groups to determine which health insurers and health maintenance organizations they participate in as network providers or preferred providers.
History.—ss. 26, 30, ch. 82-182; ss. 29, 98, ch. 92-289; s. 729, ch. 95-148; s. 183, ch. 98-166; s. 8, ch. 2004-297; s. 13, ch. 2006-261; s. 4, ch. 2008-47; s. 1, ch. 2015-109; s. 6, ch. 2016-222; s. 1, ch. 2016-234; s. 8, ch. 2019-138.
Note.—Former s. 395.015.
395.3015 Patient records; form and content.—Each hospital operated by the agency or by the Department of Corrections shall require the use of a system of problem-oriented medical records for its patients, which system shall include the following elements: basic client data collection; a listing of the patient’s problems; the initial plan with diagnostic and therapeutic orders as appropriate for each problem identified; and progress notes, including a discharge summary. The agency shall, by rule, establish criteria for such problem-oriented medical record systems in order to ensure comparability among facilities and to facilitate the compilation of statewide statistics.
History.—ss. 26, 30, ch. 82-182; ss. 30, 98, ch. 92-289.
Note.—Former s. 395.016.
395.302 Patient records; penalties for alteration.—
(1) Any person who fraudulently alters, defaces, or falsifies any medical record, or causes or procures any of these offenses to be committed, commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.
(2) A conviction under subsection (1) is also grounds for restriction, suspension, or termination of license privileges.
History.—ss. 25, 52, ch. 85-175; s. 69, ch. 91-224; ss. 31, 98, ch. 92-289.
Note.—Former s. 395.0165.
395.3025 Patient and personnel records; copies; examination.—
(1) Any licensed facility shall, upon written request, and only after discharge of the patient, furnish, in a timely manner, without delays for legal review, to any person admitted therein for care and treatment or treated thereat, or to any such person’s guardian, curator, or personal representative, or in the absence of one of those persons, to the next of kin of a decedent or the parent of a minor, or to anyone designated by such person in writing, a true and correct copy of all patient records, including X rays, and insurance information concerning such person, which records are in the possession of the licensed facility, provided the person requesting such records agrees to pay a charge. The exclusive charge for copies of patient records may include sales tax and actual postage, and, except for nonpaper records that are subject to a charge not to exceed $2, may not exceed $1 per page. A fee of up to $1 may be charged for each year of records requested. These charges shall apply to all records furnished, whether directly from the facility or from a copy service providing these services on behalf of the facility. However, a patient whose records are copied or searched for the purpose of continuing to receive medical care is not required to pay a charge for copying or for the search. The licensed facility shall further allow any such person to examine the original records in its possession, or microforms or other suitable reproductions of the records, upon such reasonable terms as shall be imposed to assure that the records will not be damaged, destroyed, or altered.
(2) This section does not apply to records maintained at any licensed facility the primary function of which is to provide psychiatric care to its patients, or to records of treatment for any mental or emotional condition at any other licensed facility which are governed by the provisions of s. 394.4615.
(3) This section does not apply to records of substance abuse impaired persons, which are governed by s. 397.501.
(4) Patient records are confidential and must not be disclosed without the consent of the patient or his or her legal representative, but appropriate disclosure may be made without such consent to:
(a) Licensed facility personnel, attending physicians, or other health care practitioners and providers currently involved in the care or treatment of the patient for use only in connection with the treatment of the patient.
(b) Licensed facility personnel only for administrative purposes or risk management and quality assurance functions.
(c) The agency, for purposes of health care cost containment.
(d) In any civil or criminal action, unless otherwise prohibited by law, upon the issuance of a subpoena from a court of competent jurisdiction and proper notice by the party seeking such records to the patient or his or her legal representative.
(e) The agency upon subpoena issued pursuant to s. 456.071, but the records obtained thereby must be used solely for the purpose of the agency and the appropriate professional board in its investigation, prosecution, and appeal of disciplinary proceedings. If the agency requests copies of the records, the facility shall charge no more than its actual copying costs, including reasonable staff time. The records must be sealed and must not be available to the public pursuant to s. 119.07(1) or any other statute providing access to records, nor may they be available to the public as part of the record of investigation for and prosecution in disciplinary proceedings made available to the public by the agency or the appropriate regulatory board. However, the agency must make available, upon written request by a practitioner against whom probable cause has been found, any such records that form the basis of the determination of probable cause.
(f) The Department of Health or its agent, for the purpose of establishing and maintaining a trauma registry and for the purpose of ensuring that hospitals and trauma centers are in compliance with the standards and rules established under ss. 395.401, 395.4015, 395.4025, 395.404, 395.4045, and 395.405, and for the purpose of monitoring patient outcome at hospitals and trauma centers that provide trauma care services.
(g) The Department of Children and Families, its agent, or its contracted entity, for the purpose of investigations of or services for cases of abuse, neglect, or exploitation of children or vulnerable adults.
(h) A local trauma agency or a regional trauma agency that performs quality assurance activities, a panel or committee assembled to assist a local trauma agency, or a regional trauma agency performing quality assurance activities. Patient records obtained under this paragraph are confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
(i) Organ procurement organizations, tissue banks, and eye banks required to conduct death records reviews pursuant to s. 395.2050.
(j) The Medicaid Fraud Control Unit in the Department of Legal Affairs pursuant to s. 409.920.
(k) The Department of Financial Services, or an agent, employee, or independent contractor of the department who is auditing for unclaimed property pursuant to chapter 717.
(l) A regional poison control center for purposes of treating a poison episode under evaluation, case management of poison cases, or compliance with data collection and reporting requirements of s. 395.1027 and the professional organization that certifies poison control centers in accordance with federal law.
(5) The Department of Health may examine patient records of a licensed facility, whether held by the facility or the Agency for Health Care Administration, for the purpose of epidemiological investigations. The unauthorized release of information by agents of the department which would identify an individual patient is a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.
(6) Patient records shall contain information required for completion of birth, death, and fetal death certificates.
(7)(a) If the content of any record of patient treatment is provided under this section, the recipient, if other than the patient or the patient’s representative, may use such information only for the purpose provided and may not further disclose any information to any other person or entity, unless expressly permitted by the written consent of the patient. A general authorization for the release of medical information is not sufficient for this purpose. The content of such patient treatment record is confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
(b) Absent a specific written release or authorization permitting utilization of patient information for solicitation or marketing the sale of goods or services, any use of that information for those purposes is prohibited.
(8) Patient records at hospitals and ambulatory surgical centers are exempt from disclosure under s. 119.07(1), except as provided by subsections (1)-(5).
(9) A licensed facility may prescribe the content and custody of limited-access records which the facility may maintain on its employees. Such records shall be limited to information regarding evaluations of employee performance, including records forming the basis for evaluation and subsequent actions, and shall be open to inspection only by the employee and by officials of the facility who are responsible for the supervision of the employee. The custodian of limited-access employee records shall release information from such records to other employers or only upon authorization in writing from the employee or upon order of a court of competent jurisdiction. Any facility releasing such records pursuant to this part shall be considered to be acting in good faith and may not be held liable for information contained in such records, absent a showing that the facility maliciously falsified such records. Such limited-access employee records are exempt from the provisions of s. 119.07(1) for a period of 5 years from the date such records are designated limited-access records.
(10) The home addresses, telephone numbers, and photographs of employees of any licensed facility who provide direct patient care or security services; the home addresses, telephone numbers, and places of employment of the spouses and children of such persons; and the names and locations of schools and day care facilities attended by the children of such persons are confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution. However, any state or federal agency that is authorized to have access to such information by any provision of law shall be granted such access in the furtherance of its statutory duties, notwithstanding the provisions of this subsection. The Department of Financial Services, or an agent, employee, or independent contractor of the department who is auditing for unclaimed property pursuant to chapter 717, shall be granted access to the name, address, and social security number of any employee owed unclaimed property.
(11) The home addresses, telephone numbers, and photographs of employees of any licensed facility who have a reasonable belief, based upon specific circumstances that have been reported in accordance with the procedure adopted by the facility, that release of the information may be used to threaten, intimidate, harass, inflict violence upon, or defraud the employee or any member of the employee’s family; the home addresses, telephone numbers, and places of employment of the spouses and children of such persons; and the names and locations of schools and day care facilities attended by the children of such persons are confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution. However, any state or federal agency that is authorized to have access to such information by any provision of law shall be granted such access in the furtherance of its statutory duties, notwithstanding the provisions of this subsection. The licensed facility shall maintain the confidentiality of the personal information only if the employee submits a written request for confidentiality to the licensed facility.
History.—ss. 26, 30, ch. 82-182; s. 2, ch. 83-108; s. 1, ch. 83-269; s. 42, ch. 85-175; s. 3, ch. 87-399; s. 5, ch. 88-1; s. 1, ch. 88-208; s. 1, ch. 89-85; s. 2, ch. 89-218; s. 2, ch. 89-275; s. 3, ch. 89-283; s. 15, ch. 90-344; s. 22, ch. 92-33; ss. 32, 98, ch. 92-289; s. 24, ch. 93-39; s. 19, ch. 93-177; s. 44, ch. 94-218; s. 2, ch. 94-260; s. 1051, ch. 95-148; s. 2, ch. 95-319; s. 3, ch. 95-387; s. 125, ch. 95-418; s. 4, ch. 95-423; s. 33, ch. 96-169; s. 216, ch. 96-406; s. 37, ch. 97-237; s. 23, ch. 98-166; s. 1, ch. 99-371; s. 15, ch. 2000-160; s. 2, ch. 2000-163; ss. 68, 120, ch. 2000-349; s. 40, ch. 2000-367; s. 10, ch. 2001-222; s. 141, ch. 2001-277; s. 108, ch. 2003-402; s. 1, ch. 2004-43; s. 71, ch. 2004-265; s. 144, ch. 2004-390; s. 3, ch. 2005-256; s. 1, ch. 2009-172; s. 111, ch. 2014-19; s. 28, ch. 2017-151.
Note.—Former s. 395.017.
395.3035 Confidentiality of hospital records and meetings.—
(1) All meetings of a governing board of a public hospital and all public hospital records shall be open and available to the public in accordance with s. 286.011 and s. 24(b), Art. I of the State Constitution and chapter 119 and s. 24(a), Art. I of the State Constitution, respectively, unless made confidential or exempt by law.
(2) The following records and information of any hospital that is subject to chapter 119 and s. 24(a), Art. I of the State Constitution are confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution:
(a) Contracts for managed care arrangements under which the public hospital provides health care services, including preferred provider organization contracts, health maintenance organization contracts, exclusive provider organization contracts, and alliance network arrangements, and any documents directly relating to the negotiation, performance, and implementation of any such contracts for managed care or alliance network arrangements. As used in this paragraph, the term “managed care” means systems or techniques generally used by third-party payors or their agents to affect access to and control payment for health care services. Managed-care techniques most often include one or more of the following: prior, concurrent, and retrospective review of the medical necessity and appropriateness of services or site of services; contracts with selected health care providers; financial incentives or disincentives related to the use of specific providers, services, or service sites; controlled access to and coordination of services by a case manager; and payor efforts to identify treatment alternatives and modify benefit restrictions for high-cost patient care.
(b) A strategic plan the disclosure of which would be reasonably likely to be used by a competitor to frustrate, circumvent, or exploit the purpose of the plan before it is implemented and which is not otherwise known or cannot otherwise be legally obtained by the competitor. However, documents that are submitted to the hospital’s governing board as part of the board’s approval of the hospital’s budget, and the budget itself, are not confidential and exempt.
(c) Trade secrets, as defined in s. 688.002, including reimbursement methodologies and rates.
(d) Documents, offers, and contracts, not including contracts for managed care, that are the product of negotiations with nongovernmental entities for the payment for services when such negotiations concern services that are or may reasonably be expected by the hospital’s governing board to be provided by competitors of the hospital. If the governing board is required to vote on the documents, offers, or contracts, this exemption expires 30 days prior to the date of the meeting at which the hospital’s governing board is scheduled to take the vote.
(3) Those portions of a governing board meeting at which negotiations for contracts with nongovernmental entities occur or are reported on when such negotiations or reports concern services that are or may reasonably be expected by the hospital’s governing board to be provided by competitors of the hospital are exempt from the provisions of s. 286.011 and s. 24(b), Art. I of the State Constitution. All governing board meetings at which the board is scheduled to vote to accept, reject, or amend contracts, except managed care contracts, shall be open to the public. All portions of any board meeting which are closed to the public shall be recorded by a certified court reporter. The reporter shall record the times of commencement and termination of the meeting, all discussion and proceedings, the names of all persons present at any time, and the names of all persons speaking. No portion of the meeting shall be off the record. The court reporter’s notes shall be fully transcribed and maintained by the hospital records custodian within a reasonable time after the meeting. The transcript shall become public 1 year after the termination or completion of the term of the contract to which such negotiations relate or, if no contract was executed, 1 year after termination of the negotiations.
(4)(a) Those portions of a board meeting at which one or more written strategic plans that are confidential pursuant to subsection (2) are discussed, reported on, modified, or approved by the governing board are exempt from s. 286.011 and s. 24(b), Art. I of the State Constitution.
(b) All portions of any board meeting which are closed to the public pursuant to this subsection shall be recorded by a certified court reporter. The reporter shall record the times of commencement and termination of the meeting, all discussion and proceedings, the names of all persons present at any time, and the names of all persons speaking. No portion of the meeting shall be off the record. The court reporter’s notes shall be fully transcribed and maintained by the hospital records custodian within a reasonable time after the meeting. The closed meeting shall be restricted to discussion, reports, modification, or approval of a written strategic plan. The transcript shall become public 3 years after the date of the board meeting or at an earlier date if the strategic plan discussed, reported on, modified, or approved at the meeting has been publicly disclosed by the hospital or implemented to the extent that confidentiality of the strategic plan is no longer necessary. If a discrete part of a strategic plan has been publicly disclosed by the hospital or has been implemented to the extent that confidentiality of that portion of the plan is no longer necessary, then the hospital shall redact the transcript and release only that part which records discussion of the nonconfidential part of the strategic plan, unless such disclosure would divulge any part of the strategic plan that remains confidential.
(c) This subsection does not allow the boards of two separate public entities to meet together in a closed meeting to discuss, report on, modify, or approve the implementation of a strategic plan that affects both public entities.
(5) Any public records, such as tape recordings, minutes, and notes, generated at any governing board meeting or portion of a governing board meeting which is closed to the public pursuant to this section are confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution. All such records shall be retained and shall cease to be exempt at the same time as the transcript of the meeting becomes available to the public.
(6) For purposes of this section, the term “strategic plan” means any record which describes actions or activities to:
(a) Initiate or acquire a new health service;
(b) Materially expand an existing health service;
(c) Acquire additional facilities by purchase or by lease;
(d) Materially expand existing facilities;
(e) Change all or a material part of the use of an existing facility or a newly acquired facility;
(f) Acquire another health care facility or health care provider;
(g) Merge or consolidate with another health care facility when the surviving entity is an entity that is subject to s. 24, Art. I of the State Constitution;
(h) Enter into a shared service arrangement with another health care provider; or
(i) Any combination of paragraphs (a)-(h).
The term “strategic plan” does not include records that describe the existing operations of a hospital or other health care facility which implement or execute the provisions of a strategic plan, unless disclosure of any such document would divulge any part of a strategic plan which has not been fully implemented or is a record that is otherwise exempt from the public records laws. Such existing operations include, without limitation, the hiring of employees, the purchase of equipment, the placement of advertisements, and the entering into contracts with physicians to perform medical services. Records that describe operations are not exempt, except as specifically provided in this section.
(7) If the governing board of the hospital closes a portion of any board meeting pursuant to subsection (4) before placing the strategic plan or any separate component of the strategic plan into operation, the governing board must give notice of an open meeting in accordance with s. 286.011, and conduct the meeting to inform the public, in general terms, of the business activity that is to be implemented. If a strategic plan involves a substantial reduction in the level of medical services provided to the public, the meeting notice must be given at least 30 days prior to the meeting at which the governing board considers the decision to implement the strategic plan.
(8) A hospital may not approve a binding agreement to implement a strategic plan at any closed meeting of the board. Any such approval must be made at a meeting open to the public and noticed in accordance with s. 286.011.
(9)(a) No less than once every 3 months, the hospital shall report in writing to the governing board on the number of records for which a public records request has been made and the records have been declared to be confidential under the provisions of this section. For each such record, the hospital shall provide the governing board with a general description of the record, the date on which the record became confidential, whether the public will have access to the record at a future time, and, if so, on what date the public will be granted access to such record. The hospital shall also report in writing to the governing board each record that had been confidential to which the public has been granted access since the hospital’s last report to the board. For each such record to which the public now has access, the hospital shall give a general description of the record and the date on which the record became confidential. The governing board of the hospital shall retain copies of these reports for 5 years from the date on which the report was made to the governing board of the hospital. If the governing board of a public hospital is comprised of members who are appointed, the board shall transmit each report to the official or authority that appoints the members to the governing board within 10 working days after the date on which the governing board received the report from the hospital.
(b) The governing board of the hospital shall maintain a written list of the meetings or portions of meetings that were closed under the provisions of this section. For each such meeting or portion of meeting, the governing board shall list the date on which the meeting was closed, the approximate length of time the meeting was closed, a general description of the subject of the meeting, the titles of the meeting participants, and a description of the format of the meeting. The governing board may purge information about a meeting from this list 5 years after the date on which the meeting was closed. If the governing board of a public hospital is comprised of members who are appointed, the board shall transmit the list required by this paragraph to the official or authority that appoints the members to the governing board no less than once every 3 months.
History.—s. 3, ch. 91-219; s. 2, ch. 93-87; s. 1, ch. 95-199; s. 217, ch. 96-406; s. 1, ch. 99-346; s. 42, ch. 2000-256; s. 9, ch. 2000-296; s. 1, ch. 2004-44.
Note.—Former s. 119.16.
395.3036 Confidentiality of records and meetings of entities that lease public hospitals or other public health care facilities.—The records of a private entity that leases a public hospital or other public health care facility are confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution, and the meetings of the governing board of a private entity are exempt from s. 286.011 and s. 24(b), Art. I of the State Constitution if the public lessor complies with the public finance accountability provisions of s. 155.40(18) with respect to the transfer of any public funds to the private lessee and if the private lessee meets at least three of the five following criteria:
(1) The public lessor that owns the public hospital or other public health care facility was not the incorporator or initial member of the private entity that leases the public hospital or other health care facility.
(2) The public lessor and the private lessee do not commingle any of their funds in any account maintained by either of them, other than the payment of the rent and administrative fees or the transfer of funds pursuant to subsection (5).
(3) Except as otherwise provided by law, the private lessee is not allowed to participate, except as a member of the public, in the decisionmaking process of the public lessor.
(4) The lease agreement does not expressly require the lessee to comply with ss. 119.07(1) and 286.011.
(5) The public lessor is not entitled to receive any revenues from the lessee, except for rental or administrative fees due under the lease, and the lessor is not responsible for the debts or other obligations of the lessee.
History.—s. 1, ch. 98-330; s. 6, ch. 2012-66.
395.3037 Definitions.—As used in this act, the term:
(1) “Department” means the Department of Health.
(2) “Agency” means the Agency for Health Care Administration.
History.—s. 2, ch. 2004-325.
395.3038 State-listed stroke centers; notification of hospitals.—
(1) The agency shall make available on its website and to the department a list of the name and address of each hospital that is certified by a nationally recognized certifying organization as an acute stroke ready center, a primary stroke center, a thrombectomy-capable stroke center, or a comprehensive stroke center. The list of stroke centers must include only those hospitals that have submitted documentation to the agency verifying their certification as an acute stroke ready center, a primary stroke center, a thrombectomy-capable stroke center, or a comprehensive stroke center, which may include, but is not limited to, any stroke center that offers and performs mechanical endovascular therapy consistent with the standards identified by a nationally recognized guidelines-based organization approved by the agency. Each hospital that has attested in an affidavit to the agency that it meets the criteria in this subsection must be certified by a nationally recognized accrediting organization by July 1, 2021.
(2)(a) If a hospital no longer chooses to be certified by a nationally recognized certifying organization or has not attained certification consistent with the criteria in subsection (1) as an acute stroke ready center, a primary stroke center, a thrombectomy-capable stroke center, or a comprehensive stroke center, the hospital shall notify the agency and the agency shall immediately remove the hospital from the list of stroke centers.
(b)1. This subsection does not apply if the hospital is unable to provide stroke treatment services for a period of time not to exceed 2 months. The hospital shall immediately notify all local emergency medical services providers when the temporary unavailability of stroke treatment services begins and when the services resume.
2. If stroke treatment services are unavailable for more than 2 months, the agency shall remove the hospital from the list of stroke centers until the hospital notifies the agency that stroke treatment services have been resumed.
(3) This act is not a medical practice guideline and may not be used to restrict the authority of a hospital to provide services for which it is licensed under chapter 395. The Legislature intends that all patients be treated individually based on each patient’s needs and circumstances.
History.—s. 3, ch. 2004-325; s. 3, ch. 2013-93; s. 1, ch. 2017-172; s. 1, ch. 2019-135.
395.30381 Statewide stroke registry.—
(1) Subject to a specific appropriation, the department shall contract with a private entity to establish and maintain a statewide stroke registry to ensure that the stroke performance measures required to be submitted under subsection (2) are maintained and available for use to improve or modify the stroke care system, ensure compliance with standards and nationally recognized guidelines, and monitor stroke patient outcomes.
(2) Each acute stroke ready center, primary stroke center, thrombectomy-capable stroke center, and comprehensive stroke center shall regularly report to the statewide stroke registry information containing nationally recognized stroke performance measures.
(3) The department shall require the contracted private entity to use a nationally recognized platform to collect data from each stroke center on the stroke performance measures required in subsection (2). The contracted private entity shall provide regular reports to the department on the data collected.
(4) A liability of any kind or character for damages or other relief shall not arise or be enforced against any acute stroke ready center, primary stroke center, thrombectomy-capable stroke center, or comprehensive stroke center by reason of having provided such information to the statewide stroke registry.
History.—s. 2, ch. 2017-172; s. 2, ch. 2019-135.
395.3039 Advertising restrictions.—A person may not advertise to the public, by way of any medium whatsoever, that a hospital is a state-listed stroke center unless the hospital has submitted documentation to the agency verifying that it is certified and meets the criteria as required in s. 395.3038.
History.—s. 4, ch. 2004-325; s. 3, ch. 2019-135.
395.3041 Emergency medical services providers; triage and transportation of stroke victims to a stroke center.—
(1) By June 1 of each year, the department shall send the list of acute stroke ready centers, primary stroke centers, thrombectomy-capable stroke centers, and comprehensive stroke centers to the medical director of each licensed emergency medical services provider in the state.
(2) The department shall develop a sample stroke-triage assessment tool. The department must post this sample assessment tool on its website and provide a copy of the assessment tool to each licensed emergency medical services provider. Each licensed emergency medical services provider must use a stroke-triage assessment tool that is substantially similar to the sample stroke-triage assessment tool provided by the department.
(3) The medical director of each licensed emergency medical services provider shall develop and implement assessment, treatment, and transport-destination protocols for stroke patients with the intent to assess, treat, and transport stroke patients to the most appropriate hospital. Such protocols must consider the capability of an emergency receiving facility to improve outcomes for those patients suspected of having an emergent large vessel occlusion.
(4) Each emergency medical services provider licensed under chapter 401 must comply with this section.
History.—s. 5, ch. 2004-325; s. 3, ch. 2017-172; s. 4, ch. 2019-135.
PART II
TRAUMA395.40 Legislative findings and intent.
395.4001 Definitions.
395.401 Trauma services system plans; approval of trauma centers and pediatric trauma centers; procedures; renewal.
395.4015 State regional trauma planning; trauma regions.
395.402 Trauma service areas; number and location of trauma centers.
395.4025 Trauma centers; selection; quality assurance; records.
395.403 Reimbursement of trauma centers.
395.4036 Trauma payments.
395.404 Reporting of trauma data; report to National Trauma Data Bank.
395.4045 Emergency medical service providers; trauma transport protocols; transport of trauma alert victims to trauma centers; interfacility transfer.
395.405 Rulemaking.
395.50 Quality assurance activities of trauma agencies.
395.51 Confidentiality and quality assurance activities of trauma agencies.
395.40 Legislative findings and intent.—
(1) The Legislature finds that there has been a lack of timely access to trauma care due to the state’s fragmented trauma system. This finding is based on the 1999 Trauma System Report on Timely Access to Trauma Care submitted by the department in response to the request of the Legislature.
(2) The Legislature finds that it is necessary to plan for and to establish an inclusive trauma system to meet the needs of trauma victims. An “inclusive trauma system” means a system designed to meet the needs of all injured trauma victims who require care in an acute-care setting and into which every health care provider or facility with resources to care for the injured trauma victim is incorporated. The Legislature deems the benefits of trauma care provided within an inclusive trauma system to be of vital significance to the outcome of a trauma victim.
(3) It is the intent of the Legislature to place primary responsibility for the planning and establishment of a statewide inclusive trauma system with the department. The department shall undertake the implementation of a statewide inclusive trauma system as funding is available.
(4) The Legislature finds that significant benefits are to be obtained by directing the coordination of activities by several state agencies, relative to access to trauma care and the provision of trauma care to all trauma victims. It is the intent of the Legislature that the department, the Agency for Health Care Administration, the Board of Medicine, and the Board of Nursing establish interagency teams and agreements for the development of guidelines, standards, and rules for those portions of the inclusive state trauma system within the statutory authority of each agency. This coordinated approach will provide the necessary continuum of care for the trauma victim from injury to final hospital discharge. The department has the leadership responsibility for this activity.
(5) In addition, the agencies listed in subsection (4) should undertake to:
(a) Establish a coordinated methodology for monitoring, evaluating, and enforcing the requirements of the state’s inclusive trauma system which recognizes the interests of each agency.
(b) Develop appropriate roles for trauma agencies, to assist in furthering the operation of trauma systems at the regional level. This should include issues of system evaluation as well as managed care.
(c) Develop and submit appropriate requests for waivers of federal requirements which will facilitate the delivery of trauma care.
(d) Develop criteria that will become the future basis for consultation between acute care hospitals and trauma centers on the care of trauma victims and the mandatory transfer of appropriate trauma victims to trauma centers.
(e) Develop a coordinated approach to the care of the trauma victim. This shall include the movement of the trauma victim through the system of care and the identification of medical responsibility for each phase of care for out-of-hospital and in-hospital trauma care.
(f) Require the medical director of an emergency medical services provider to have medical accountability for a trauma victim during interfacility transfer.
(6) Furthermore, the Legislature encourages the department to actively foster the provision of trauma care and serve as a catalyst for improvements in the process and outcome of the provision of trauma care in an inclusive trauma system. Among other considerations, the department is required to:
(a) Promote the development of at least one trauma center in every trauma service area.
(b) Promote the development of a trauma agency for each trauma region.
(c) Update the state trauma system plan at least annually by February.
History.—s. 193, ch. 99-397; s. 2, ch. 2004-259; s. 90, ch. 2020-2.
395.4001 Definitions.—As used in this part, the term:
(1) “Agency” means the Agency for Health Care Administration.
(2) “Charity care” or “uncompensated trauma care” means that portion of hospital charges reported to the agency for which there is no compensation, other than restricted or unrestricted revenues provided to a hospital by local governments or tax districts regardless of method of payment, for care provided to a patient whose family income for the 12 months preceding the determination is less than or equal to 200 percent of the federal poverty level, unless the amount of hospital charges due from the patient exceeds 25 percent of the annual family income. However, in no case shall the hospital charges for a patient whose family income exceeds four times the federal poverty level for a family of four be considered charity.
(3) “Department” means the Department of Health.
1(4) “High-risk patient” means a trauma patient with an International Classification Injury Severity Score of less than 0.85.
(5) “Interfacility trauma transfer” means the transfer of a trauma victim between two facilities licensed under this chapter, pursuant to this part.
(6) “International Classification Injury Severity Score” means the statistical method for computing the severity of injuries sustained by trauma patients. The International Classification Injury Severity Score shall be the methodology used by the department and trauma centers to report the severity of an injury.
(7) “Level I trauma center” means a trauma center that:
(a) Has formal research and education programs for the enhancement of trauma care; is verified by the department to be in substantial compliance with Level I trauma center and pediatric trauma center standards; and has been approved by the department to operate as a Level I trauma center.
(b) Serves as a resource facility to Level II trauma centers, pediatric trauma centers, and general hospitals through shared outreach, education, and quality improvement activities.
(c) Participates in an inclusive system of trauma care, including providing leadership, system evaluation, and quality improvement activities.
(8) “Level II trauma center” means a trauma center that:
1(a) Is verified by the department to be in substantial compliance with Level II trauma center standards and has been approved by the department to operate as a Level II trauma center or is designated pursuant to s. 395.4025(15).
(b) Serves as a resource facility to general hospitals through shared outreach, education, and quality improvement activities.
(c) Participates in an inclusive system of trauma care.
(9) “Local funding contribution” means local municipal, county, or tax district funding exclusive of any patient-specific funds received pursuant to ss. 154.301-154.316, private foundation funding, or public or private grant funding of at least $150,000 received by a hospital or health care system that operates a trauma center.
(10) “Pediatric trauma center” means a hospital that is verified by the department to be in substantial compliance with pediatric trauma center standards as established by rule of the department and has been approved by the department to operate as a pediatric trauma center.
(11) “Provisional trauma center” means a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a provisional Level I trauma center, Level II trauma center, or pediatric trauma center.
(12) “Trauma agency” means a department-approved agency established and operated by one or more counties, or a department-approved entity with which one or more counties contract, for the purpose of administering an inclusive regional trauma system.
(13) “Trauma alert victim” means a person who has incurred a single or multisystem injury due to blunt or penetrating means or burns, who requires immediate medical intervention or treatment, and who meets one or more of the adult or pediatric scorecard criteria established by the department by rule.
1(14) “Trauma caseload volume” means the number of trauma patients calculated by the department using the data reported by each designated trauma center to the hospital discharge database maintained by the agency pursuant to s. 408.061.
1(15) “Trauma center” means a hospital that has been verified by the department to be in substantial compliance with the requirements in s. 395.4025 and has been approved by the department to operate as a Level I trauma center, Level II trauma center, or pediatric trauma center, or is designated by the department as a Level II trauma center pursuant to s. 395.4025(15).
(16) “Trauma patient” means a person who has incurred a physical injury or wound caused by trauma and has accessed a trauma center.
(17) “Trauma scorecard” means a statewide methodology adopted by the department by rule under which a person who has incurred a traumatic injury is graded as to the severity of his or her injuries or illness and which methodology is used as the basis for making destination decisions.
(18) “Trauma transport protocol” means a document which describes the policies, processes, and procedures governing the dispatch of vehicles, the triage, prehospital transport, and interfacility trauma transfer of trauma victims.
(19) “Trauma victim” means any person who has incurred a single or multisystem injury due to blunt or penetrating means or burns and who requires immediate medical intervention or treatment.
History.—s. 1, ch. 2000-189; s. 3, ch. 2004-259; s. 58, ch. 2005-2; s. 14, ch. 2006-192; s. 1, ch. 2013-153; s. 4, ch. 2018-66.
1Note.—Section 14, ch. 2018-66, provides that “[i]f the provisions of this act relating to s. 395.4025(16), Florida Statutes, are held to be invalid or inoperative for any reason, the remaining provisions of this act shall be deemed to be void and of no effect, it being the legislative intent that this act as a whole would not have been adopted had any provision of the act not been included.”
395.401 Trauma services system plans; approval of trauma centers and pediatric trauma centers; procedures; renewal.—
(1)(a) The local and regional trauma agencies shall plan, implement, and evaluate trauma services systems, in accordance with this section and ss. 395.4015, 395.404, and 395.4045, which consist of organized patterns of readiness and response services based on public and private agreements and operational procedures. The department shall establish, by rule, processes and procedures for establishing a trauma agency and obtaining its approval from the department.
(b) The local and regional trauma agencies shall develop and submit to the department plans for local and regional trauma services systems. The plans must include, at a minimum, the following components:
1. The organizational structure of the trauma system.
2. Prehospital care management guidelines for triage and transportation of trauma cases.
3. Flow patterns of trauma cases and transportation system design and resources, including air transportation services, provision for interfacility trauma transfer, and the prehospital transportation of trauma victims. The trauma agency shall plan for the development of a system of transportation of trauma alert victims to trauma centers where the distance or time to a trauma center or transportation resources diminish access by trauma alert victims.
4. The number and location of needed trauma centers based on local needs, population, and location and distribution of resources.
5. Data collection regarding system operation and patient outcome.
6. Periodic performance evaluation of the trauma system and its components.
7. The use of air transport services within the jurisdiction of the local trauma agency.
8. Public information and education about the trauma system.
9. Emergency medical services communication system usage and dispatching.
10. The coordination and integration between the trauma center and other acute care hospitals.
11. Medical control and accountability.
12. Quality control and system evaluation.
(c) The department shall receive plans for the implementation of inclusive trauma systems from trauma agencies. The department may approve or not approve trauma agency plans based on the conformance of the plan with this section and ss. 395.4015, 395.404, and 395.4045 and the rules and definitions adopted by the department pursuant to those sections. The department shall approve or disapprove the plans within 120 days after the date the plans are submitted to the department. The department shall, by rule, provide an application process for establishing a trauma agency. The application must, at a minimum, provide requirements for the trauma agency plan submitted for review, a process for reviewing the application for a trauma agency, a process for reviewing the trauma transport protocols for the trauma agency, and a process for reviewing the staffing requirements for the agency. The department shall, by rule, establish minimum requirements for a trauma agency to conduct an annual performance evaluation and submit the results to the department.
(d) A trauma agency shall not operate unless the department has approved the local or regional trauma services system plan of the agency.
(e) The department may grant an exception to a portion of the rules adopted pursuant to this section or s. 395.4015 if the local or regional trauma agency proves that, as defined in the rules, compliance with that requirement would not be in the best interest of the persons served within the affected local or regional trauma area.
(f) A local or regional trauma agency may implement a trauma care system only if the system meets the minimum standards set forth in the rules for implementation established by the department and if the plan has been submitted to, and approved by, the department. At least 60 days before the local or regional trauma agency submits the plan for the trauma care system to the department, the local or regional trauma agency shall hold a public hearing and give adequate notice of the public hearing to all hospitals and other interested parties in the area to be included in the proposed system.
(g) Local or regional trauma agencies may enter into contracts for the purpose of implementing the local or regional plan. If local or regional agencies contract with hospitals for trauma services, such agencies must contract only with hospitals which are verified trauma centers.
(h) Local or regional trauma agencies providing service for more than one county shall, as part of their formation, establish interlocal agreements between or among the several counties in the regional system.
(i) This section does not restrict the authority of a health care facility to provide service for which it has received a license pursuant to this chapter.
(j) Any hospital which is verified as a trauma center shall accept all trauma victims that are appropriate for the facility regardless of race, sex, creed, or ability to pay.
1(k) It is unlawful for any hospital or other facility to hold itself out as a trauma center unless it has been so verified or designated pursuant to s. 395.4025(15).
(l) A county, upon the recommendations of the local or regional trauma agency, may adopt ordinances governing the transport of a patient who is receiving care in the field from prehospital emergency medical personnel when the patient meets specific criteria for trauma, burn, or pediatric centers adopted by the local or regional trauma agency. These ordinances must be consistent with s. 395.4045, ordinances adopted under s. 401.25(6), and the local or regional trauma system plan and, to the furthest possible extent, must ensure that individual patients receive appropriate medical care while protecting the interests of the community at large by making maximum use of available emergency medical care resources.
(m) The local or regional trauma agency shall, consistent with the regional trauma system plan, coordinate and otherwise facilitate arrangements necessary to develop a trauma services system.
(n) After the submission of the initial trauma system plan, each trauma agency shall, every 5th year, submit to the department for approval an updated plan that identifies the changes, if any, to be made in the regional trauma system.
(o) This section does not preclude a local or regional trauma agency from adopting trauma care system standards.
(2) The department shall adopt, by rule, standards for verification of trauma centers based on national guidelines, including those established by the American College of Surgeons entitled “Hospital and Prehospital Resources for Optimal Care of the Injured Patient” and published appendices thereto. Standards specific to pediatric trauma referral centers shall be developed in conjunction with Children’s Medical Services and adopted by rule of the department.
(3) The department may withdraw local or regional agency authority, prescribe corrective actions, or use the administrative remedies as provided in s. 395.1065 for the violation of any provision of this section and ss. 395.4015, 395.402, 395.4025, 395.403, 395.404, and 395.4045 or rules adopted thereunder. All amounts collected pursuant to this subsection shall be deposited into the Emergency Medical Services Trust Fund provided in s. 401.34.
History.—s. 1, ch. 82-60; s. 1, ch. 84-317; s. 1, ch. 85-65; s. 4, ch. 87-399; s. 1, ch. 88-186; s. 4, ch. 89-275; s. 5, ch. 89-283; s. 4, ch. 90-284; s. 36, ch. 92-78; ss. 35, 98, ch. 92-289; s. 730, ch. 95-148; s. 38, ch. 97-237; s. 8, ch. 98-89; s. 194, ch. 99-397; s. 2, ch. 2000-189; s. 25, ch. 2000-242; s. 4, ch. 2004-259; s. 2, ch. 2013-153; s. 10, ch. 2018-66.
1Note.—Section 14, ch. 2018-66, provides that “[i]f the provisions of this act relating to s. 395.4025(16), Florida Statutes, are held to be invalid or inoperative for any reason, the remaining provisions of this act shall be deemed to be void and of no effect, it being the legislative intent that this act as a whole would not have been adopted had any provision of the act not been included.”
Note.—Former s. 395.031.
395.4015 State regional trauma planning; trauma regions.—
(1) The department shall establish a state trauma system plan. As part of the state trauma system plan, the department shall establish trauma regions that cover all geographical areas of the state and have boundaries that are coterminous with the boundaries of the regional domestic security task forces established under s. 943.0312. These regions may serve as the basis for the development of department-approved local or regional trauma plans. However, the delivery of trauma services by or in coordination with a trauma agency established before July 1, 2004, may continue in accordance with public and private agreements and operational procedures entered into as provided in s. 395.401.
(2) The department shall consider the advice and recommendations of any affected local or regional trauma agency in developing the state trauma system plan.
(3) The department shall use the state trauma system plan as the basis for establishing a statewide inclusive trauma system.
History.—s. 5, ch. 87-399; s. 2, ch. 88-186; s. 1, ch. 88-303; s. 5, ch. 89-275; ss. 36, 98, ch. 92-289; s. 3, ch. 2000-189; s. 5, ch. 2004-259.
Note.—Former s. 395.032.
1395.402 Trauma service areas; number and location of trauma centers.—
(1) The Legislature recognizes the need for a statewide, cohesive, uniform, and integrated trauma system, as well as the need to ensure the viability of existing trauma centers when designating new trauma centers. Consistent with national standards, future trauma center designations must be based on need as a factor of demand and capacity.
(a) The following trauma service areas are established:
1. Trauma service area 1 shall consist of Escambia, Okaloosa, Santa Rosa, and Walton Counties.
2. Trauma service area 2 shall consist of Bay, Gulf, Holmes, and Washington Counties.
3. Trauma service area 3 shall consist of Calhoun, Franklin, Gadsden, Jackson, Jefferson, Leon, Liberty, Madison, Taylor, and Wakulla Counties.
4. Trauma service area 4 shall consist of Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, and Union Counties.
5. Trauma service area 5 shall consist of Baker, Clay, Duval, Nassau, and St. Johns Counties.
6. Trauma service area 6 shall consist of Citrus, Hernando, and Marion Counties.
7. Trauma service area 7 shall consist of Flagler and Volusia Counties.
8. Trauma service area 8 shall consist of Lake, Orange, Osceola, Seminole, and Sumter Counties.
9. Trauma service area 9 shall consist of Pasco and Pinellas Counties.
10. Trauma service area 10 shall consist of Hillsborough County.
11. Trauma service area 11 shall consist of Hardee, Highlands, and Polk Counties.
12. Trauma service area 12 shall consist of Brevard and Indian River Counties.
13. Trauma service area 13 shall consist of DeSoto, Manatee, and Sarasota Counties.
14. Trauma service area 14 shall consist of Martin, Okeechobee, and St. Lucie Counties.
15. Trauma service area 15 shall consist of Charlotte, Collier, Glades, Hendry, and Lee Counties.
16. Trauma service area 16 shall consist of Palm Beach County.
17. Trauma service area 17 shall consist of Broward County.
18. Trauma service area 18 shall consist of Miami-Dade and Monroe Counties.
(b) Each trauma service area must have at least one Level I or Level II trauma center. Except as otherwise provided in s. 395.4025(16), the department may not designate an existing Level II trauma center as a new pediatric trauma center or designate an existing Level II trauma center as a Level I trauma center in a trauma service area that already has an existing Level I or pediatric trauma center.
(c) Trauma centers, including Level I trauma centers, Level II trauma centers, Level II trauma centers with a pediatric trauma center, jointly certified pediatric trauma centers, and stand-alone pediatric trauma centers, shall be apportioned as follows:
1. Trauma service area 1 shall have three trauma centers.
2. Trauma service area 2 shall have one trauma center.
3. Trauma service area 3 shall have one trauma center.
4. Trauma service area 4 shall have one trauma center.
5. Trauma service area 5 shall have three trauma centers.
6. Trauma service area 6 shall have one trauma center.
7. Trauma service area 7 shall have one trauma center.
8. Trauma service area 8 shall have three trauma centers.
9. Trauma service area 9 shall have three trauma centers.
10. Trauma service area 10 shall have two trauma centers.
11. Trauma service area 11 shall have one trauma center.
12. Trauma service area 12 shall have one trauma center.
13. Trauma service area 13 shall have two trauma centers.
14. Trauma service area 14 shall have one trauma center.
15. Trauma service area 15 shall have one trauma center.
16. Trauma service area 16 shall have two trauma centers.
17. Trauma service area 17 shall have three trauma centers.
18. Trauma service area 18 shall have five trauma centers.
Notwithstanding other provisions of this chapter, a trauma service area may not have more than a total of five Level I trauma centers, Level II trauma centers, Level II trauma centers with a pediatric trauma center, jointly certified pediatric trauma centers, and stand-alone pediatric trauma centers. A trauma service area may not have more than one stand-alone pediatric trauma center.
(2)(a) By May 1, 2018, the department shall establish the Florida Trauma System Advisory Council to promote an inclusive trauma system and enhance cooperation among trauma system stakeholders. The advisory council may submit recommendations to the department on how to maximize existing trauma center, emergency department, and emergency medical services infrastructure and personnel to achieve the statutory goal of developing an inclusive trauma system.
(b)1. The advisory council shall consist of 12 members appointed by the Governor, including:
a. The State Trauma Medical Director.
b. A standing member of the Emergency Medical Services Advisory Council.
c. A representative of a local or regional trauma agency.
d. A trauma program manager or trauma medical director who is actively working in a trauma center and who represents an investor-owned hospital with a trauma center.
e. A trauma program manager or trauma medical director who is actively working in a trauma center and who represents a nonprofit or public hospital with a trauma center.
f. A trauma surgeon who is board-certified in an appropriate trauma or critical care specialty and who is actively practicing medicine in a Level II trauma center who represents an investor-owned hospital with a trauma center.
g. A trauma surgeon who is board-certified in an appropriate trauma or critical care specialty and actively practicing medicine who represents a nonprofit or public hospital with a trauma center.
h. A representative of the American College of Surgeons Committee on Trauma who has pediatric trauma care expertise.
i. A representative of the Safety Net Hospital Alliance of Florida.
j. A representative of the Florida Hospital Association.
k. A physician licensed under chapter 458 or chapter 459 who is a board-certified emergency medicine physician who is not affiliated with a trauma center.
l. A trauma surgeon who is board-certified in an appropriate trauma or critical care specialty and actively practicing medicine in a Level I trauma center.
2. No two members may be employed by the same health care facility.
3. Each council member shall be appointed to a 3-year term; however, for the purpose of providing staggered terms, of the initial appointments, four members shall be appointed to 1-year terms, four members shall be appointed to 2-year terms, and four members shall be appointed to 3-year terms.
(c) The department shall use existing and available resources to administer and support the activities of the advisory council. Members of the advisory council shall serve without compensation and are not entitled to reimbursement for per diem or travel expenses.
(d) The advisory council shall convene no later than June 1, 2018, and shall meet at least quarterly.
History.—ss. 5, 15, ch. 90-284; ss. 37, 98, ch. 92-289; s. 195, ch. 99-397; s. 26, ch. 2000-242; s. 6, ch. 2004-259; s. 100, ch. 2008-4; s. 5, ch. 2018-66.
1Note.—Section 14, ch. 2018-66, provides that “[i]f the provisions of this act relating to s. 395.4025(16), Florida Statutes, are held to be invalid or inoperative for any reason, the remaining provisions of this act shall be deemed to be void and of no effect, it being the legislative intent that this act as a whole would not have been adopted had any provision of the act not been included.”
Note.—Former s. 395.033.
1395.4025 Trauma centers; selection; quality assurance; records.—
(1) For purposes of developing a system of trauma centers, the department shall use the 18 trauma service areas established in s. 395.402. The department shall designate those hospitals that are to be recognized as trauma centers.
(2)(a) The department shall prepare an analysis of the Florida trauma system by August 31, 2020, and every 3 years thereafter, using the hospital discharge database described in s. 408.061 for the most current year and the most recent 5 years of population data for the state available from the American Community Survey 5-Year Estimates by the United States Census Bureau. The department’s report must, at a minimum, include all of the following:
1. The population growth for each trauma service area and for the state.
2. The number of high-risk patients treated at each trauma center within each trauma service area, including pediatric trauma centers.
3. The total number of high-risk patients treated at all acute care hospitals, including nontrauma centers, in each trauma service area.
4. The percentage of each trauma center’s sufficient volume of trauma patients, as described in subparagraph (3)(d)2., in accordance with the International Classification Injury Severity Score for the trauma center’s designation, inclusive of the additional caseload volume required for those trauma centers with graduate medical education programs.
(b) The department shall make available all data, formulas, methodologies, calculations, and risk adjustment tools used in preparing the report.
(3)(a) The department shall notify each acute care general hospital and each local and each regional trauma agency in a trauma service area with an identified need for an additional trauma center that the department is accepting letters of intent from hospitals that are interested in becoming trauma centers. The department may accept a letter of intent only if there is statutory capacity for an additional trauma center in accordance with subsection (2), paragraph (d), and s. 395.402. Letters of intent must be postmarked no later than midnight October 1 of the year in which the department notifies hospitals that it plans to accept letters of intent.
(b) By October 15, the department shall send to all hospitals that submitted a letter of intent an application package that will provide the hospitals with instructions for submitting information to the department for selection as a trauma center. The standards for trauma centers provided for in s. 395.401(2), as adopted by rule of the department, shall serve as the basis for these instructions.
(c) In order to be considered by the department, applications from those hospitals seeking selection as trauma centers, including those current verified trauma centers that seek a change or redesignation in approval status as a trauma center, must be received by the department no later than the close of business on April 1 of the year following submission of the letter of intent. The department shall conduct an initial review of each application for the purpose of determining whether the hospital’s application is complete and the hospital is capable of constructing and operating a trauma center that includes the critical elements required for a trauma center. This critical review must be based on trauma center standards and must include, but need not be limited to, a review as to whether the hospital is prepared to attain and operate with all of the following components before April 30 of the following year:
1. Equipment and physical facilities necessary to provide trauma services.
2. Personnel in sufficient numbers and with proper qualifications to provide trauma services.
3. An effective quality assurance process.
(d) Except as otherwise provided in this part, the department may not approve an application for a Level I trauma center, Level II trauma center, Level II trauma center with a pediatric trauma center, jointly certified pediatric trauma center, or stand-alone pediatric trauma center if approval of the application would exceed the limits on the numbers of Level I trauma centers, Level II trauma centers, Level II trauma centers with a pediatric trauma center, jointly certified pediatric trauma centers, or stand-alone pediatric trauma centers set forth in s. 395.402(1). However, the department shall review and may approve an application for a trauma center when approval of the application would result in a total number of trauma centers which exceeds the limit on the number of trauma centers in a trauma service area as set forth in s. 395.402(1), if the applicant demonstrates and the department determines that:
1. The existing trauma center’s actual caseload volume of high-risk patients exceeds the minimum caseload volume capabilities, including the additional caseload volume for graduate medical education critical care and trauma surgical subspecialty residents or fellows, by more than two times the statutory minimums listed in sub-subparagraphs 2.a.-d. or three times the statutory minimum listed in sub-subparagraph 2.e., and the population growth for the trauma service area exceeds the statewide population growth by more than 15 percent based on the American Community Survey 5-Year Estimates by the United States Census Bureau for the 5-year period before the date the applicant files its letter of intent; and
2. A sufficient caseload volume of potential trauma patients exists within the trauma service area to ensure that existing trauma centers caseload volumes are at the following levels:
a. For Level I trauma centers in trauma service areas with a population of greater than 1.5 million, a minimum caseload volume of the greater of 1,200 high-risk patients admitted per year or, for a trauma center with a trauma or critical care residency or fellowship program, 1,200 high-risk patients admitted plus 40 cases per year for each accredited critical care and trauma surgical subspecialty medical resident or fellow.
b. For Level I trauma centers in trauma service areas with a population of less than 1.5 million, a minimum caseload volume of the greater of 1,000 high-risk patients admitted per year or, for a trauma center with a critical care or trauma residency or fellowship program, 1,000 high-risk patients admitted plus 40 cases per year for each accredited critical care and trauma surgical subspecialty medical resident or fellow.
c. For Level II trauma centers and Level II trauma centers with a pediatric trauma center in trauma service areas with a population of greater than 1.25 million, a minimum caseload volume of the greater of 1,000 high-risk patients admitted or, for a trauma center with a critical care or trauma residency or fellowship program, 1,000 high-risk patients admitted plus 40 cases per year for each accredited critical care and trauma surgical subspecialty medical resident or fellow.
d. For Level II trauma centers and Level II trauma centers with a pediatric trauma center in trauma service areas with a population of less than 1.25 million, a minimum caseload volume of the greater of 500 high-risk patients admitted per year or, for a trauma center with a critical care or trauma residency or fellowship program, 500 high-risk patients admitted plus 40 cases per year for each accredited critical care and trauma surgical subspecialty medical resident or fellow.
e. For pediatric trauma centers, a minimum caseload volume of the greater of 500 high-risk patients admitted per year or, for a trauma center with a critical care or trauma residency or fellowship program, 500 high-risk patients admitted per year plus 40 cases per year for each accredited critical care and trauma surgical subspecialty medical resident or fellow.
The International Classification Injury Severity Score calculations and caseload volume must be calculated using the most recent available hospital discharge data collected by the agency from all acute care hospitals pursuant to s. 408.061. The agency, in consultation with the department, shall adopt rules, for trauma centers and acute care hospitals for the submission of data required for the department to perform its duties under this chapter.
(e) If the department determines that the hospital is capable of attaining and operating with the components required in paragraph (c), the applicant must be ready to operate in compliance with state trauma center standards no later than April 30 of the year following the department’s initial review and approval of the hospital’s application to proceed with preparation to operate as a trauma center. A hospital that fails to comply with this subsection may not be designated as a trauma center.
(4) By May 1, the department shall select one or more hospitals that submitted an application found acceptable by the department based on initial review for approval to prepare to operate with the components required in paragraph (3)(c). If the department receives more applications than may be approved, the department must select the best applicant or applicants from the available pool based on the department’s determination of the capability of an applicant to provide the highest quality patient care using the most recent technological, medical, and staffing resources available and which is located the farthest away from an existing trauma center in the applicant’s trauma service area to maximize access. The number of applicants selected is limited to available statutory need in the specified trauma service area as designated in paragraph (3)(d) or s. 395.402(1).
(5) Following its initial review, the department shall conduct an in-depth evaluation of all applications found acceptable in the initial review. The applications shall be evaluated against criteria enumerated in the application packages as provided to the hospitals by the department. An applicant may not operate as a provisional trauma center until the department completes the initial and in-depth reviews and approves the application through those review stages.
(6) Within 1 year after the hospital begins operating as a provisional trauma center, a review team of out-of-state experts assembled by the department shall make onsite visits to all provisional trauma centers. The department shall develop a survey instrument to be used by the expert team of reviewers. The instrument must include objective criteria and guidelines for reviewers based on existing trauma center standards such that all trauma centers are assessed equally. The survey instrument must also include a uniform rating system that reviewers must use to indicate the degree of compliance of each trauma center with specific standards, and to indicate the quality of care provided by each trauma center as determined through an audit of patient charts. In addition, hospitals being considered as provisional trauma centers must meet all the requirements of a trauma center and must be located in a trauma service area that has a need for such a trauma center.
(7) Based on recommendations from the review team, the department shall approve for designation a trauma center that is in compliance with trauma center standards, as established by department rule, and with this section. Each trauma center shall be granted a 7-year approval period during which time it must continue to maintain trauma center standards and acceptable patient outcomes as determined by department rule. An approval, unless sooner suspended or revoked, automatically expires 7 years after the date of issuance and is renewable upon application for renewal as prescribed by rule of the department.
(8) Only an applicant or hospital with an existing trauma center in the same trauma service area or in a trauma service area contiguous to the trauma service area where the applicant has applied to operate a trauma center may protest a decision made by the department with regard to whether the application should be approved, or whether a need has been established pursuant to the criteria in paragraph (3)(d). Hearings held under this subsection shall be conducted in the same manner as provided in ss. 120.569 and 120.57. Cases filed under chapter 120 may combine all disputes between parties.
(9) Notwithstanding any provision of chapter 381, a hospital licensed under ss. 395.001-395.3025 that operates a trauma center may not terminate or substantially reduce the availability of trauma service without providing at least 180 days’ notice of its intent to terminate such service. Such notice shall be given to the department, to all affected local or regional trauma agencies, and to all trauma centers, hospitals, and emergency medical service providers in the trauma service area. The department shall adopt by rule the procedures and process for notification, duration, and explanation of the termination of trauma services.
(10) Except as otherwise provided in this subsection, the department or its agent may collect trauma care and registry data, as prescribed by rule of the department, from trauma centers, hospitals, emergency medical service providers, local or regional trauma agencies, or medical examiners for the purposes of evaluating trauma system effectiveness, ensuring compliance with the standards, and monitoring patient outcomes. A trauma center, hospital, emergency medical service provider, medical examiner, or local trauma agency or regional trauma agency, or a panel or committee assembled by such an agency under s. 395.50(1) may, but is not required to, disclose to the department patient care quality assurance proceedings, records, or reports. However, the department may require a local trauma agency or a regional trauma agency, or a panel or committee assembled by such an agency to disclose to the department patient care quality assurance proceedings, records, or reports that the department needs solely to conduct quality assurance activities under s. 395.4015, or to ensure compliance with the quality assurance component of the trauma agency’s plan approved under s. 395.401. The patient care quality assurance proceedings, records, or reports that the department may require for these purposes include, but are not limited to, the structure, processes, and procedures of the agency’s quality assurance activities, and any recommendation for improving or modifying the overall trauma system, if the identity of a trauma center, hospital, emergency medical service provider, medical examiner, or an individual who provides trauma services is not disclosed.
(11) Out-of-state experts assembled by the department to conduct onsite visits are agents of the department for the purposes of s. 395.3025. An out-of-state expert who acts as an agent of the department under this subsection is not liable for any civil damages as a result of actions taken by him or her, unless he or she is found to be operating outside the scope of the authority and responsibility assigned by the department.
(12) Onsite visits by the department or its agent may be conducted at any reasonable time and may include but not be limited to a review of records in the possession of trauma centers, hospitals, emergency medical service providers, local or regional trauma agencies, or medical examiners regarding the care, transport, treatment, or examination of trauma patients.
(13) Patient care, transport, or treatment records or reports, or patient care quality assurance proceedings, records, or reports obtained or made pursuant to this section, s. 395.3025(4)(f), s. 395.401, s. 395.4015, s. 395.402, s. 395.403, s. 395.404, s. 395.4045, s. 395.405, s. 395.50, or s. 395.51 must be held confidential by the department or its agent and are exempt from the provisions of s. 119.07(1). Patient care quality assurance proceedings, records, or reports obtained or made pursuant to these sections are not subject to discovery or introduction into evidence in any civil or administrative action.
(14) The department may adopt, by rule, the procedures and process by which it will select trauma centers. Such procedures and process must be used in selecting trauma centers and must be consistent with subsections (1)-(9) except in those situations in which it is in the best interest of, and mutually agreed to by, all applicants within a service area and the department to reduce the timeframes.
(15) Notwithstanding the procedures established pursuant to subsections (1)-(14), hospitals located in areas with limited access to trauma center services shall be designated by the department as Level II trauma centers based on documentation of a valid certificate of trauma center verification from the American College of Surgeons. Areas with limited access to trauma center services are defined by the following criteria:
(a) The hospital is located in a trauma service area with a population greater than 600,000 persons but a population density of less than 225 persons per square mile;
(b) The hospital is located in a county with no verified trauma center; and
(c) The hospital is located at least 15 miles or 20 minutes travel time by ground transport from the nearest verified trauma center.
(16)(a) Notwithstanding the statutory capacity limits established in s. 395.402(1), the provisions of subsection (8), or any other provision of this part, an adult Level I trauma center, an adult Level II trauma center, a Level II trauma center with a pediatric trauma center, a jointly certified pediatric trauma center, or a stand-alone pediatric trauma center that was verified by the department before December 15, 2017, is deemed to have met the trauma center application and operational requirements of this section and must be verified and designated as a trauma center.
(b) Notwithstanding the statutory capacity limits established in s. 395.402(1), the provisions of subsection (8), or any other provision of this part, a trauma center that was not verified by the department before December 15, 2017, but that was provisionally approved by the department to be in substantial compliance with Level II trauma standards before January 1, 2017, and is operating as a Level II trauma center, is deemed to have met the application and operational requirements of this section for a trauma center and must be verified and designated as a Level II trauma center.
(c) Notwithstanding the statutory capacity limits established in s. 395.402(1), the provisions of subsection (8), or any other provision of this part, a trauma center that was not verified by the department before December 15, 2017, as a Level I trauma center but that was provisionally approved by the department to be in substantial compliance with Level I trauma standards before January 1, 2017, and is operating as a Level I trauma center is deemed to have met the application and operational requirements of this section for a trauma center and must be verified and designated as a Level I trauma center.
(d) Notwithstanding the statutory capacity limits established in s. 395.402(1), the provisions of subsection (8), or any other provision of this part, a trauma center that was not verified by the department before December 15, 2017, as a pediatric trauma center but was provisionally approved by the department to be in substantial compliance with the pediatric trauma standards established by rule before January 1, 2018, and is operating as a pediatric trauma center is deemed to have met the application and operational requirements of this section for a pediatric trauma center and, upon successful completion of the in-depth and site review process, shall be verified and designated as a pediatric trauma center. Notwithstanding subsection (8), no existing trauma center in the same trauma service area or in a trauma service area contiguous to the trauma service area where the applicant is located may protest the in-depth review, site survey, or verification decision of the department regarding an applicant that meets the requirements of this paragraph.
(e) Notwithstanding the statutory capacity limits established in s. 395.402(1) or any other provision of this part, a hospital operating as a Level II trauma center after January 1, 2017, must be designated and verified by the department as a Level II trauma center if all of the following apply:
1. The hospital was provisionally approved after January 1, 2017, to operate as a Level II trauma center, and was in operation on or before June 1, 2017;
2. The department’s decision to approve the hospital to operate a provisional Level II trauma center was in litigation on or before January 1, 2018;
3. The hospital receives a recommended order from the Division of Administrative Hearings, a final order from the department, or an order from a court of competent jurisdiction that it was entitled to be designated and verified as a Level II trauma center; and
4. The department determines that the hospital is in substantial compliance with the Level II trauma center standards, including the in-depth and site reviews.
Any provisional trauma center operating under this paragraph may not be required to cease trauma operations unless a court of competent jurisdiction or the department determines that it has failed to meet the trauma center standards, as established by department rule.
(f) Notwithstanding the statutory capacity limits established in s. 395.402(1), or any other provision of this act, a joint pediatric trauma center involving a Level II trauma center and a specialty licensed children’s hospital which was verified by the department before December 15, 2017, is deemed to have met the application and operational requirements of this section for a pediatric trauma center and shall be verified and designated as a pediatric trauma center even if the joint program is dissolved upon the expiration of the existing certificate and the pediatric trauma center continues operations independently through the specialty licensed children’s hospital, provided that the pediatric trauma center meets all requirements for verification by the department.
(g) Nothing in this subsection shall limit the department’s authority to review and approve trauma center applications.
History.—ss. 6, 15, ch. 90-284; s. 78, ch. 91-282; ss. 38, 98, ch. 92-289; s. 1, ch. 94-129; s. 3, ch. 94-260; s. 1052, ch. 95-148; s. 27, ch. 95-398; s. 218, ch. 96-406; s. 125, ch. 96-410; s. 106, ch. 99-8; s. 4, ch. 2000-189; s. 7, ch. 2004-259; s. 3, ch. 2013-153; s. 6, ch. 2018-66; s. 61, ch. 2019-3.
1Note.—Section 14, ch. 2018-66, provides that “[i]f the provisions of this act relating to s. 395.4025(16), Florida Statutes, are held to be invalid or inoperative for any reason, the remaining provisions of this act shall be deemed to be void and of no effect, it being the legislative intent that this act as a whole would not have been adopted had any provision of the act not been included.”
Note.—Former s. 395.0335.
1395.403 Reimbursement of trauma centers.—
(1) All verified trauma centers shall be considered eligible to receive state funding when state funds are specifically appropriated for state-sponsored trauma centers in the General Appropriations Act. Effective July 1, 2010, the department shall make payments from the Emergency Medical Services Trust Fund under s. 20.435 to the trauma centers. Payments shall be in equal amounts for the trauma centers approved by the department as of July 1 of the fiscal year in which funding is appropriated. In the event a trauma center does not maintain its status as a trauma center for any state fiscal year in which such funding is appropriated, the trauma center shall repay the state for the portion of the year during which it was not a trauma center.
(2) Trauma centers eligible to receive distributions from the Emergency Medical Services Trust Fund under s. 20.435 in accordance with subsection (1) may request that such funds be used as intergovernmental transfer funds in the Medicaid program.
(3) In order to receive state funding, a hospital must be a verified trauma center and shall:
(a) Agree to conform to all departmental requirements as provided by rule to assure high-quality trauma services.
(b) Agree to report trauma data to the National Trauma Data Bank.
(c) Agree to accept all trauma patients, regardless of ability to pay, on a functional space-available basis.
(4) A trauma center that fails to comply with any of the conditions listed in subsection (3) or the applicable rules of the department may not receive payments under this section for the period in which it was not in compliance.
History.—ss. 7, 15, ch. 90-284; s. 79, ch. 91-282; s. 92, ch. 92-33; ss. 39, 98, ch. 92-289; s. 19, ch. 98-89; s. 8, ch. 2004-259; s. 10, ch. 2010-161; s. 7, ch. 2018-66.
1Note.—Section 14, ch. 2018-66, provides that “[i]f the provisions of this act relating to s. 395.4025(16), Florida Statutes, are held to be invalid or inoperative for any reason, the remaining provisions of this act shall be deemed to be void and of no effect, it being the legislative intent that this act as a whole would not have been adopted had any provision of the act not been included.”
Note.—Former s. 395.034.
395.4036 Trauma payments.—
1(1) Recognizing the Legislature’s stated intent to provide financial support to the current verified trauma centers and to provide incentives for the establishment of additional trauma centers as part of a system of state-sponsored trauma centers, the department shall utilize funds collected under s. 318.18 and deposited into the Emergency Medical Services Trust Fund of the department to ensure the availability and accessibility of trauma services throughout the state as provided in this subsection.
(a) Funds collected under s. 318.18(15) shall be distributed as follows:
1. Twenty percent of the total funds collected during the state fiscal year shall be distributed to verified trauma centers that have a local funding contribution as of December 31. Distribution of funds under this subparagraph shall be based on trauma caseload volume for the most recent calendar year available.
2. Forty percent of the total funds collected shall be distributed to verified trauma centers based on trauma caseload volume for the most recent calendar year available. The determination of caseload volume for distribution of funds under this subparagraph shall be based on the hospital discharge data for patients who meet the criteria for classification as a trauma patient reported by each trauma center pursuant to s. 408.061.
3. Forty percent of the total funds collected shall be distributed to verified trauma centers based on severity of trauma patients for the most recent calendar year available. The determination of severity for distribution of funds under this subparagraph shall be based on the department’s International Classification Injury Severity Scores or another statistically valid and scientifically accepted method of stratifying a trauma patient’s severity of injury, risk of mortality, and resource consumption as adopted by the department by rule, weighted based on the costs associated with and incurred by the trauma center in treating trauma patients. The weighting of scores shall be established by the department by rule.
(b) Funds collected under s. 318.18(5)(c) and (20) shall be distributed as follows:
1. Thirty percent of the total funds collected shall be distributed to Level II trauma centers operated by a public hospital governed by an elected board of directors as of December 31, 2008.
2. Thirty-five percent of the total funds collected shall be distributed to verified trauma centers based on trauma caseload volume for the most recent calendar year available. The determination of caseload volume for distribution of funds under this subparagraph shall be based on the hospital discharge data for patients who meet the criteria for classification as a trauma patient reported by each trauma center pursuant to s. 408.061.
3. Thirty-five percent of the total funds collected shall be distributed to verified trauma centers based on severity of trauma patients for the most recent calendar year available. The determination of severity for distribution of funds under this subparagraph shall be based on the department’s International Classification Injury Severity Scores or another statistically valid and scientifically accepted method of stratifying a trauma patient’s severity of injury, risk of mortality, and resource consumption as adopted by the department by rule, weighted based on the costs associated with and incurred by the trauma center in treating trauma patients. The weighting of scores shall be established by the department by rule.
(2) Funds deposited in the department’s Emergency Medical Services Trust Fund for verified trauma centers may be used to maximize the receipt of federal funds that may be available for such trauma centers. Notwithstanding this section and s. 318.14, distributions to trauma centers may be adjusted in a manner to ensure that total payments to trauma centers represent the same proportional allocation as set forth in this section and s. 318.14. For purposes of this section and s. 318.14, total funds distributed to trauma centers may include revenue from the Emergency Medical Services Trust Fund and federal funds for which revenue from the Administrative Trust Fund is used to meet state or local matching requirements. Funds collected under ss. 318.14 and 318.18 and deposited in the Emergency Medical Services Trust Fund of the department shall be distributed to trauma centers on a quarterly basis using the most recent calendar year data available. Such data shall not be used for more than four quarterly distributions unless there are extenuating circumstances as determined by the department, in which case the most recent calendar year data available shall continue to be used and appropriate adjustments shall be made as soon as the more recent data becomes available.
(3)(a) Any trauma center not subject to audit pursuant to s. 215.97 shall annually attest, under penalties of perjury, that such proceeds were used in compliance with law. The annual attestation shall be made in a form and format determined by the department. The annual attestation shall be submitted to the department for review within 9 months after the end of the organization’s fiscal year.
(b) Any trauma center subject to audit pursuant to s. 215.97 shall submit an audit report in accordance with rules adopted by the Auditor General.
(4) The department, working with the Agency for Health Care Administration, shall maximize resources for trauma services wherever possible.
History.—s. 7, ch. 2005-194; s. 16, ch. 2006-192; s. 4, ch. 2009-138; s. 79, ch. 2010-5; s. 11, ch. 2010-161; s. 8, ch. 2018-66.
1Note.—Section 14, ch. 2018-66, provides that “[i]f the provisions of this act relating to s. 395.4025(16), Florida Statutes, are held to be invalid or inoperative for any reason, the remaining provisions of this act shall be deemed to be void and of no effect, it being the legislative intent that this act as a whole would not have been adopted had any provision of the act not been included.”
1395.404 Reporting of trauma data; report to National Trauma Data Bank.—
(1) Each trauma center shall participate in the National Trauma Data Bank, and the department shall solely use the National Trauma Data Bank for quality and assessment purposes.
(2) Each trauma center and acute care hospital shall report to the department all transfers of trauma patients and the outcomes for such patients.
(3) Each trauma center and acute care hospital shall report to the department’s brain and spinal cord injury central registry, consistent with the procedures and timeframes of s. 381.74, any person who has a moderate-to-severe brain or spinal cord injury, and shall include in the report the name, age, residence, and type of disability of the individual and any additional information that the department finds necessary.
History.—s. 7, ch. 87-399; s. 3, ch. 88-186; s. 1, ch. 88-303; s. 10, ch. 90-344; ss. 41, 98, ch. 92-289; s. 3, ch. 94-324; s. 4, ch. 95-387; s. 28, ch. 95-398; s. 219, ch. 96-406; s. 16, ch. 2000-153; s. 21, ch. 2002-22; s. 25, ch. 2004-350; s. 59, ch. 2005-2; s. 9, ch. 2018-66.
1Note.—Section 14, ch. 2018-66, provides that “[i]f the provisions of this act relating to s. 395.4025(16), Florida Statutes, are held to be invalid or inoperative for any reason, the remaining provisions of this act shall be deemed to be void and of no effect, it being the legislative intent that this act as a whole would not have been adopted had any provision of the act not been included.”
Note.—Former s. 395.035.
395.4045 Emergency medical service providers; trauma transport protocols; transport of trauma alert victims to trauma centers; interfacility transfer.—
(1) Each emergency medical services provider licensed under chapter 401 shall transport trauma alert victims to hospitals approved as trauma centers, except as may be provided for either in the department-approved trauma transport protocol of the trauma agency for the geographical area in which the emergency medical services licensee provides services or, if no such department-approved trauma transport protocol is in effect, as provided for in a department-approved provider’s trauma transport protocol.
(2) A trauma agency may develop a uniform trauma transport protocol that is applicable to the emergency medical services licensees providing services within the geographical boundaries of the trauma agency. Development of a uniform trauma protocol by a trauma agency shall be through consultation with interested parties, including, but not limited to, each approved trauma center; physicians specializing in trauma care, emergency care, and surgery in the region; each trauma system administrator in the region; each emergency medical service provider in the region licensed under chapter 401, and such providers’ respective medical directors.
(3) Trauma alert victims shall be identified through the use of a trauma scoring system, including adult and pediatric assessment as specified in rule of the department. The rule shall also include the requirements of licensed emergency medical services providers for performing and documenting these assessments.
(4) The department shall specify by rule the subjects and the minimum criteria related to prehospital trauma transport, trauma center or hospital destination determinations, and interfacility trauma transfer transport by an emergency medical services provider to be included in a trauma agency’s or emergency medical service provider’s trauma transport protocol and shall approve or disapprove each such protocol. Trauma transport protocol rules pertaining to the air transportation of trauma victims shall be consistent with, but not limited to, applicable Federal Aviation Administration regulation. Emergency medical services licensees and trauma agencies shall be subject to monitoring by the department, under ss. 395.401(3) and 401.31(1) for compliance with requirements, as applicable, regarding trauma transport protocols and the transport of trauma victims.
(5) If there is no department-approved trauma agency trauma transport protocol for the geographical area in which the emergency medical services license applicant intends to provide services, as provided for in subsection (1), each applicant for licensure as an emergency medical services provider, under chapter 401, must submit and obtain department approval of a trauma transport protocol prior to the department granting a license. The department shall prescribe by rule the submission and approval process for an applicant’s trauma transport protocols whether the applicant will be using a trauma agency’s or its own trauma transport protocol.
(6) If an air ambulance service is available in the trauma service area in which an emergency medical service provider is located, trauma transport protocols shall not provide for transport outside of the trauma service area unless otherwise provided for by written mutual agreement. If air ambulance service is not available and there is no agreement for interagency transport of trauma patients between two adjacent local or regional trauma agencies, both of which include at least one approved trauma center, then the transport of a trauma patient with an immediately life-threatening condition shall be to the most appropriate trauma center as defined pursuant to trauma transport protocols approved by the department. The provisions of this subsection shall apply only to those counties with a population in excess of 1 million residents.
(7) Prior to an interfacility trauma transfer, the emergency medical services provider’s medical director or his or her designee must agree, pursuant to protocols and procedures in the emergency medical services provider’s trauma transport protocol, that the staff of the transport vehicle has the medical skills, equipment, and resources to provide anticipated patient care as proposed by the transferring physician. The emergency medical services provider’s medical director or his or her designee may require appropriate staffing, equipment, and resources to ensure proper patient care and safety during transfer.
(8) The department shall adopt and enforce all rules necessary to administer this section. The department shall adopt and enforce rules to specify the submission and approval process for trauma transport protocols or modifications to trauma transport protocols by trauma agencies and licensed emergency medical services providers.
History.—s. 6, ch. 87-399; s. 1, ch. 88-303; ss. 42, 98, ch. 92-289; s. 196, ch. 99-397; s. 5, ch. 2000-189; s. 28, ch. 2001-62; s. 57, ch. 2002-1.
Note.—Former s. 395.036.
395.405 Rulemaking.—The department shall adopt and enforce all rules necessary to administer ss. 395.401, 395.4015, 395.402, 395.4025, 395.403, 395.404, and 395.4045.
History.—s. 7, ch. 89-275; s. 17, ch. 89-283; s. 2, ch. 90-187; s. 1, ch. 90-192; s. 8, ch. 90-284; ss. 43, 98, ch. 92-289; s. 6, ch. 2000-189; s. 36, ch. 2009-223.
Note.—Former s. 395.037.
395.50 Quality assurance activities of trauma agencies.—
(1) As used in this section, the term “entity” means a local trauma agency or a regional trauma agency that performs quality assurance activities, or a panel or committee assembled to assist a local trauma agency or a regional trauma agency in performing quality assurance activities in accordance with a plan approved under s. 395.401.
(2) A hospital or an emergency medical services provider shall disclose records and reports of patient care, transport, and treatment to an entity, and a hospital or an emergency medical services provider may disclose to an entity and to one another its own quality assurance proceedings, records, or reports. However, this section does not require a hospital or an emergency medical services provider to disclose to an entity its own quality assurance proceedings, records, or reports prepared under s. 395.0191, s. 395.0193, s. 401.265, s. 401.30, s. 401.425, or s. 766.101.
(3) A local trauma agency or regional trauma agency may assemble a panel or committee to assist in performing the tasks authorized by an approved plan under s. 395.401.
(4) The investigations, proceedings, records, and reports obtained or made by any entity under this section are not subject to discovery or introduction into evidence in a civil or administrative action that arises out of a matter that is the subject of evaluation and review by the entity, and a person who attends a meeting of the entity may not testify in any such civil or administrative action as to any evidence or other matter produced or presented during the proceedings of the entity or as to any findings, recommendations, evaluations, opinions, or other actions of the entity or any members thereof. However, information, documents, or records provided to the entity from a source external to the entity are not immune from discovery or use in a civil or administrative action, and a person who is a member of the entity may testify in such action as to matters within his or her knowledge, but may not be asked about his or her testimony before the entity or about information obtained from or opinions formed by him or her as a result of participating in activities conducted by the entity.
(5)(a) There is no monetary liability on the part of, and no cause of action arises against, any person, including a person who acts as a witness, incident reporter to, or investigator for an entity for any act or proceeding undertaken or performed within the scope of the functions of the entity if the action is taken without intentional fraud or malice.
(b) The provisions of this section do not supersede the provisions of s. 768.28.
(6) Except as provided in subsection (4), this section does not confer immunity from liability on a person for services performed outside his or her capacity as a member of an entity or upon a person who acts as a witness for, incident reporter to, or investigator for the entity for any act or proceeding undertaken or performed outside the scope of the functions of the entity.
(7) If the defendant prevails in an action brought by a person against a person who initiated, participated in, was a witness in, or conducted any review as authorized by this section, the court shall award reasonable attorney’s fees and costs to the defendant.
(8) Nothing in this section, ss. 395.4001-395.405, or s. 395.51 prohibits admitting into evidence patient care, transport, or treatment records or reports, or records or reports of the department in any civil or administrative action brought by or involving the department, excluding the name, residence or business address, telephone number, social security or other identifying number, or photograph of any person or the spouse, relative, or guardian of such person or other patient-specific information that otherwise identifies the patient, either directly or indirectly.
History.—s. 2, ch. 94-129; s. 1053, ch. 95-148; s. 7, ch. 2000-189.
395.51 Confidentiality and quality assurance activities of trauma agencies.—
(1) All information which is confidential by operation of law and which is obtained by a local or regional trauma agency or a panel or committee assembled by a local or regional trauma agency pursuant to s. 395.50, shall retain its confidential status and be exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
(2) All information which is confidential by operation of law and which is obtained by a hospital or emergency medical services provider from a local or regional trauma agency or a panel or committee assembled by a local or regional trauma agency pursuant to s. 395.50, shall retain its confidential status and shall be exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution.
(3) Portions of meetings, proceedings, reports, and records of a local or regional trauma agency, or a panel or committee assembled by a local or regional trauma agency pursuant to this chapter, which relate solely to patient care quality assurance are confidential and exempt from the provisions of s. 286.011, and s. 24(b), Art. I of the State Constitution and are confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution, respectively. Patient care quality assurance, for the purpose of this section, shall include consideration of specific persons, cases, incidents relevant to the performance of quality control, and system evaluation.
History.—s. 4, ch. 94-260; s. 220, ch. 96-406.
PART III
RURAL HOSPITALS395.602 Rural hospitals.
395.603 Rural hospital impact statement.
395.6061 Rural hospital capital improvement.
395.602 Rural hospitals.—
(1) LEGISLATIVE FINDINGS AND INTENT.—
(a) The Legislature finds that rural hospitals are the nucleus or “backbone” of rural health care systems. Public health programs and physicians depend on rural hospitals to meet many of their medical needs. Rural hospitals are usually the only source of emergency medical care in rural areas for life-threatening situations and play a crucial role in attracting physicians to rural areas. The Legislature deems the benefits derived from these features to be truly significant as rural counties with hospitals have lower accidental death rates and lower incidence of low birth weight than rural counties without hospitals. In addition, rural hospitals enhance their communities beyond the scope of health care as they are among the largest employers in rural areas and substantially foster economic development and growth. For these reasons, the Legislature finds that rural hospitals are widely viewed as integral to the welfare of rural communities. However, the rural health care system is experiencing significant instability as the financial viability of many of these hospitals is threatened. The Legislature finds that sharply declining occupancy rates, increasing dependence on Medicaid and Medicare reimbursements, liability concerns, frequent changes in ownership, high levels of bad debt, greater competition on more sophisticated levels with urban hospitals, and physician and personnel staffing problems threaten the existence of some rural hospitals.
(b) It is the intent of the Legislature to ease the burdens experienced by rural hospitals in personnel staffing by:
1. Providing financial incentives under the Medical Education Tuition Reimbursement Program in order to increase the number of primary care physicians and nurses in rural areas; and
2. Requiring a study of problems unique to rural hospitals generated by existing licensure and certification requirements for allied health care practitioners in the state.
(c) In addition, it is the intent of the Legislature to ease the severe financial constraints being experienced by some rural hospitals by extending Medicaid reimbursements to rural hospital swing-beds and establishing the full utilization, when feasible, of rural hospital services by departmental primary care programs and programs serving the elderly citizens of the state.
(d) Furthermore, the Legislature encourages the department to actively foster the provision of health care services in rural areas and serve as a catalyst for improved health services to citizens in rural areas of the state. Among other considerations, the department is encouraged to:
1. Promote the location and relocation of health care practitioners in rural areas.
2. Further analyze the financial viability of rural hospitals and their continued existence in rural counties.
3. Integrate policies related to physician workforce, hospitals, primary care, and state regulatory functions.
4. Collect relevant data on rural health care issues for use in departmental policy development.
5. Propose solutions for problems affecting health care delivery in rural areas.
(2) DEFINITIONS.—As used in this part, the term:
(a) “Rural area health education center” means an area health education center (AHEC), as authorized by Pub. L. No. 94-484, which provides services in a county with a population density of up to 100 persons per square mile.
(b) “Rural hospital” means an acute care hospital licensed under this chapter, having 100 or fewer licensed beds and an emergency room, which is:
1. The sole provider within a county with a population density of up to 100 persons per square mile;
2. An acute care hospital, in a county with a population density of up to 100 persons per square mile, which is at least 30 minutes of travel time, on normally traveled roads under normal traffic conditions, from any other acute care hospital within the same county;
3. A hospital supported by a tax district or subdistrict whose boundaries encompass a population of up to 100 persons per square mile;
4. A hospital classified as a sole community hospital under 42 C.F.R. s. 412.92, regardless of the number of licensed beds;
5. A hospital with a service area that has a population of up to 100 persons per square mile. As used in this subparagraph, the term “service area” means the fewest number of zip codes that account for 75 percent of the hospital’s discharges for the most recent 5-year period, based on information available from the hospital inpatient discharge database in the Florida Center for Health Information and Transparency at the agency; or
6. A hospital designated as a critical access hospital, as defined in s. 408.07.
Population densities used in this paragraph must be based upon the most recently completed United States census. A hospital that received funds under s. 409.9116 for a quarter beginning no later than July 1, 2002, is deemed to have been and shall continue to be a rural hospital from that date through June 30, 2021, if the hospital continues to have up to 100 licensed beds and an emergency room. An acute care hospital that has not previously been designated as a rural hospital and that meets the criteria of this paragraph shall be granted such designation upon application, including supporting documentation, to the agency. A hospital that was licensed as a rural hospital during the 2010-2011 or 2011-2012 fiscal year shall continue to be a rural hospital from the date of designation through June 30, 2025, if the hospital continues to have up to 100 licensed beds and an emergency room.
(c) “Swing-bed” means a bed which can be used interchangeably as either a hospital, skilled nursing facility (SNF), or intermediate care facility (ICF) bed pursuant to 42 C.F.R. parts 405, 435, 440, 442, and 447.
(3) USE OF FUNDS.—It is the intent of the Legislature that funds as appropriated shall be utilized by the department for the purpose of increasing the number of primary care physicians, physician assistants, certified nurse midwives, nurse practitioners, and nurses in rural areas, either through the Medical Education Reimbursement and Loan Repayment Program as defined by s. 1009.65 or through a federal loan repayment program which requires state matching funds. The department may use funds appropriated for the Medical Education Reimbursement and Loan Repayment Program as matching funds for federal loan repayment programs for health care personnel, such as that authorized in Pub. L. No. 100-177, s. 203. If the department receives federal matching funds, the department shall only implement the federal program. Reimbursement through either program shall be limited to:
(a) Primary care physicians, physician assistants, certified nurse midwives, nurse practitioners, and nurses employed by or affiliated with rural hospitals, as defined in this act; and
(b) Primary care physicians, physician assistants, certified nurse midwives, nurse practitioners, and nurses employed by or affiliated with rural area health education centers, as defined in this section. These personnel shall practice:
1. In a county with a population density of no greater than 100 persons per square mile; or
2. Within the boundaries of a hospital tax district which encompasses a population of no greater than 100 persons per square mile.
If the department administers a federal loan repayment program, priority shall be given to obligating state and federal matching funds pursuant to paragraphs (a) and (b). The department may use federal matching funds in other health workforce shortage areas and medically underserved areas in the state for loan repayment programs for primary care physicians, physician assistants, certified nurse midwives, nurse practitioners, and nurses who are employed by publicly financed health care programs that serve medically indigent persons.
History.—ss. 32, 33, 35, 39, ch. 88-294; s. 1, ch. 89-296; s. 9, ch. 89-527; s. 14, ch. 90-295; ss. 45, 98, ch. 92-289; s. 731, ch. 95-148; s. 1, ch. 98-14; s. 1, ch. 98-21; s. 33, ch. 98-89; s. 2, ch. 99-209; s. 1, ch. 2000-227; s. 29, ch. 2001-62; s. 983, ch. 2002-387; s. 1, ch. 2003-258; s. 3, ch. 2005-81; s. 8, ch. 2006-261; s. 51, ch. 2007-230; s. 13, ch. 2009-223; s. 2, ch. 2013-48; s. 1, ch. 2014-57; s. 1, ch. 2015-225; s. 3, ch. 2016-65; s. 12, ch. 2016-234; s. 4, ch. 2017-129; s. 38, ch. 2018-24; s. 6, ch. 2018-112; s. 5, ch. 2020-156.
Note.—Former s. 395.102.
395.603 Rural hospital impact statement.—In formulating and implementing policies and rules that may have significant impact on the ability of rural hospitals to continue to provide health care services in rural communities, the agency, the department, or the respective regulatory board adopting policies or rules regarding the licensure or certification of health care professionals shall provide a rural hospital impact statement. The rural hospital impact statement shall assess the proposed action in light of the following questions:
(1) Do the health personnel affected by the proposed action currently practice in rural hospitals or are they likely to in the near future?
(2) What are the current numbers of the affected health personnel in this state, their geographic distribution, and the number practicing in rural hospitals?
(3) What are the functions presently performed by the affected health personnel, and are such functions presently performed in rural hospitals?
(4) What impact will the proposed action have on the ability of rural hospitals to recruit the affected personnel to practice in their facilities?
(5) What impact will the proposed action have on the limited financial resources of rural hospitals through increased salaries and benefits necessary to recruit or retain such health personnel?
(6) Is there a less stringent requirement which could apply to practice in rural hospitals?
(7) Will this action create staffing shortages, which could result in a loss to the public of health care services in rural hospitals or result in closure of any rural hospitals?
History.—s. 8, ch. 89-527; s. 1, ch. 90-192; ss. 46, 47, 98, ch. 92-289; s. 98, ch. 97-101; s. 39, ch. 2018-24; s. 7, ch. 2018-112.
Note.—Former s. 395.103.
395.6061 Rural hospital capital improvement.—There is established a rural hospital capital improvement grant program.
(1) A rural hospital as defined in s. 395.602 may apply to the department for a grant. The grant application must provide information that includes:
(a) A statement indicating the problem the rural hospital proposes to solve with the grant funds;
(b) The strategy proposed to resolve the problem;
(c) The organizational structure, financial system, and facilities that are essential to the proposed solution;
(d) The projected longevity of the proposed solution after the grant funds are expended;
(e) Evidence of participation in a rural health network as defined in s. 381.0406;
(f) Evidence that the rural hospital has difficulty in obtaining funding or that funds available for the proposed solution are inadequate;
(g) Evidence that the grant funds will assist in maintaining or returning the hospital to an economically stable condition or that any plan for closure or realignment of services will involve development of innovative alternatives for the discontinued services;
(h) Evidence of a satisfactory record-keeping system to account for grant fund expenditures within the rural county;
(i) A rural health network plan that includes a description of how the plan was developed, the goals of the plan, the links with existing health care providers under the plan, indicators quantifying the hospital’s financial well-being, measurable outcome targets, and the current physical and operational condition of the hospital.
(2) Each rural hospital as defined in s. 395.602 shall receive a minimum of $100,000 annually, subject to legislative appropriation, upon application to the Department of Health, for projects to acquire, repair, improve, or upgrade systems, facilities, or equipment.
(3) Any remaining funds shall annually be disbursed to rural hospitals in accordance with this section. The Department of Health shall establish, by rule, criteria for awarding grants for any remaining funds, which must be used exclusively for the support and assistance of rural hospitals as defined in s. 395.602, including criteria relating to the level of uncompensated care rendered by the hospital, the participation in a rural health network as defined in s. 381.0406, and the proposed use of the grant by the rural hospital to resolve a specific problem. The department must consider any information submitted in an application for the grants in accordance with subsection (1) in determining eligibility for and the amount of the grant, and none of the individual items of information by itself may be used to deny grant eligibility.
(4) The department shall ensure that the funds are used solely for the purposes specified in this section. The total grants awarded pursuant to this section shall not exceed the amount appropriated for this program.
History.—s. 1, ch. 99-209.
PART IV
PUBLIC MEDICAL ASSISTANCE TRUST FUND395.701 Annual assessments on net operating revenues for inpatient and outpatient services to fund public medical assistance; administrative fines for failure to pay assessments when due; exemption.
395.7016 Annual appropriation.
395.7017 Rulemaking authority.
395.701 Annual assessments on net operating revenues for inpatient and outpatient services to fund public medical assistance; administrative fines for failure to pay assessments when due; exemption.—
(1) For the purposes of this section, the term:
(a) “Agency” means the Agency for Health Care Administration.
(b) “Gross operating revenue” or “gross revenue” means the sum of daily hospital service charges, ambulatory service charges, ancillary service charges, and other operating revenue.
(c) “Hospital” means a health care institution as defined in s. 395.002(13), but does not include any hospital operated by a state agency.
(d) “Net operating revenue” or “net revenue” means gross revenue less deductions from revenue.
(e) “Total deductions from gross revenue” or “deductions from revenue” means reductions from gross revenue resulting from inability to collect payment of charges. Such reductions include bad debts; contractual adjustments; uncompensated care; administrative, courtesy, and policy discounts and adjustments; and other such revenue deductions, but also includes the offset of restricted donations and grants for indigent care.
(2)(a) There is imposed upon each hospital an assessment in an amount equal to 1.5 percent of the annual net operating revenue for inpatient services for each hospital, such revenue to be determined by the agency, based on the actual experience of the hospital as reported to the agency. Within 6 months after the end of each hospital fiscal year, the agency shall certify the amount of the assessment for each hospital. The assessment shall be payable to and collected by the agency in equal quarterly amounts, on or before the first day of each calendar quarter, beginning with the first full calendar quarter that occurs after the agency certifies the amount of the assessment for each hospital. All moneys collected pursuant to this subsection shall be deposited into the Public Medical Assistance Trust Fund.
(b) There is imposed upon each hospital an assessment in an amount equal to 1 percent of the annual net operating revenue for outpatient services for each hospital, such revenue to be determined by the agency, based on the actual experience of the hospital as reported to the agency. While prior year report worksheets may be reconciled to the hospital’s audited financial statements, no additional audited financial components may be required for the purposes of determining the amount of the assessment imposed pursuant to this section other than those in effect on July 1, 2000. Within 6 months after the end of each hospital fiscal year, the agency shall certify the amount of the assessment for each hospital. The assessment shall be payable to and collected by the agency in equal quarterly amounts, on or before the first day of each calendar quarter, beginning with the first full calendar quarter that occurs after the agency certifies the amount of the assessment for each hospital. All moneys collected pursuant to this subsection shall be deposited into the Public Medical Assistance Trust Fund.
(3) The agency shall impose an administrative fine, not to exceed $500 per day, for failure of any hospital to pay its assessment by the first day of the calendar quarter on which it is due. The failure of a hospital to pay its assessment within 30 days after the assessment is due is ground for the agency to impose an administrative fine not to exceed $5,000 per day.
(4) The purchaser, successor, or assignee of a facility subject to the agency’s jurisdiction shall assume full liability for any assessments, fines, or penalties of the facility or its employees, regardless of when identified. Such assessments, fines, or penalties shall be paid by the employee, owner, or licensee who incurred them, within 15 days of the sale, transfer, or assignment. However, the purchaser, successor, or assignee of the facility may withhold such assessments, fines, or penalties from purchase moneys or payment due to the seller, transferor, or employee, and shall make such payment on behalf of the seller, transferor, or employee. Any employer, purchaser, successor, or assignee who fails to withhold sufficient funds to pay assessments, fines, or penalties arising under the provisions of chapter 408 shall make such payments within 15 days of the date of the transfer, purchase, or assignment. Failure by the transferee to make payments as provided in this subsection shall subject such transferee to the penalties and assessments provided in chapter 408. Further, in the event of sale, transfer, or assignment of any facility under the agency’s jurisdiction, future assessments shall be based upon the most recently available prior year report or audited actual experience for the facility. It shall be the responsibility of the new owner or licensee to require the production of the audited financial data for the period of operation of the prior owner. If the transferee fails to obtain current audited financial data from the previous owner or licensee, the new owner shall be assessed based upon the most recent year of operation for which 12 months of audited actual experience are available or upon a reasonable estimate of 12 months of full operation as calculated by the agency.
(5) A statutory teaching hospital that had 100,000 or more Medicaid covered days during the most recent fiscal year may elect to have its assessment imposed pursuant to subsection (2) deducted from any Medicaid disproportionate share payment due to such hospital for the quarter ending 6 months after the assessment due date. If the assessment is greater than the disproportionate share payment, or if no disproportionate share payment is due the hospital, the difference, or full amount of the assessment in cases in which no payment is due, shall be paid on or before the date the disproportionate share payment is made or would have been made.
(6) Outpatient radiation therapy services provided by a hospital subject to this section are exempt from the provisions of this section.
History.—ss. 6, 7, ch. 84-35; s. 1, ch. 85-65; s. 3, ch. 91-48; s. 61, ch. 91-221; s. 93, ch. 92-33; s. 36, ch. 92-78; ss. 51, 98, ch. 92-289; s. 9, ch. 98-89; s. 1, ch. 98-192; s. 17, ch. 2000-153; s. 16, ch. 2000-256; ss. 65, 81, ch. 2001-277; s. 52, ch. 2007-230; s. 42, ch. 2018-24; s. 8, ch. 2021-112.
Note.—Former s. 395.101.
395.7016 Annual appropriation.—The Legislature shall appropriate each fiscal year from either the General Revenue Fund or the Agency for Health Care Administration Tobacco Settlement Trust Fund an amount sufficient to replace the funds lost due to the reduction by chapter 2000-256, Laws of Florida, in the assessment on hospitals under s. 395.701 and to maintain federal approval of the reduced amount of funds deposited into the Public Medical Assistance Trust Fund under s. 395.701 as state match for the state’s Medicaid program.
History.—s. 20, ch. 2000-256; s. 7, ch. 2020-156.
395.7017 Rulemaking authority.—The agency may adopt rules pursuant to ss. 120.536 and 120.54 to implement the provisions of this part, which shall include the authority to define terms and determine the date of imposition and the determination of the process for determination, collection, and imposition of the Public Medical Assistance Trust Fund assessment and related fines.
History.—s. 1, ch. 2009-55.
PART V
FAMILY PRACTICE TEACHING HOSPITALS395.805 Definitions.
395.806 Designation of family practice teaching hospitals.
395.807 Retention of family practice residents.
395.805 Definitions.—As used in this act, the term:
(1) “Agency” means the Agency for Health Care Administration.
(2) “Family practice teaching hospital” means a freestanding, community-based hospital licensed under this chapter that offers a 3-year family practice residency program accredited through the Residency Review Committee of the Accreditation Council of Graduate Medical Education or the Council on Postdoctoral Training of the American Osteopathic Association.
History.—s. 2, ch. 94-182.
395.806 Designation of family practice teaching hospitals.—
(1)(a) A hospital that offers a family practice residency program of at least 18 positions for resident family practice physicians is eligible for designation as a family practice teaching hospital.
(b) A hospital seeking designation as a family practice teaching hospital must submit documentation and an application to the Agency for Health Care Administration in the manner the agency determines.
(c) To maintain the designation as a family practice teaching hospital, a hospital must offer a residency program of at least 24 positions for resident family practice physicians within 5 years after the initial designation. The agency shall terminate the designation of a hospital that does not meet the requirements of this paragraph.
(2)(a) A family practice teaching hospital must fill at least 90 percent of its positions for resident family practice physicians.
(b) A family practice teaching hospital that has residency programs other than family practice must maintain at least 60 percent of its total residents in family practice.
History.—s. 3, ch. 94-182; s. 34, ch. 95-146; s. 19, ch. 98-89.
395.807 Retention of family practice residents.—
(1) A family practice teaching hospital must have a documented plan for retaining family practice residents in the state.
(2)(a) The director of the agency shall appoint a seven-member family practice physician retention advisory committee, consisting of a faculty member of a family practice teaching hospital, an active family practice resident, a member of the Florida Academy of Family Physicians, a member of the Florida Society of the American College of Osteopathic Family Physicians, a family practice physician who practices in an urban area, a family practice physician who practices in a rural area, and the residency director of a family practice residency program.
(b) The committee shall develop a program for recruiting minority physicians into family practice residency programs and shall promote further efforts to retain and place minority physicians into local communities.
History.—s. 4, ch. 94-182; s. 104, ch. 2010-102.