PART I HOSPITALS AND OTHER LICENSED FACILITIES

PART II TRAUMA

PART III RURAL HOSPITALS

PART IV PUBLIC MEDICAL ASSISTANCE TRUST FUND

PART V FAMILY PRACTICE TEACHING HOSPITALS

CHAPTER 395

395.001 Legislative intent.

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.

(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:

(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) “General hospital” means any facility which meets the provisions of subsection (12) and which regularly makes its facilities and services available to the general population.

(11) “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.

(12) “Hospital” means any establishment that:

(13) “Hospital-based off-campus emergency department” means a facility that:

(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 (12), and which regularly makes available either:

(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:

(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; s. 38, ch. 2022-4.

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.

(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.

(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.

(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.

(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:

(8) A hospital may not be licensed or relicensed if:

(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.

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.

(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.

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:

(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:

(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.

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.

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.

(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.

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:

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.

(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.

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.

395.0192 Duty to notify physicians.

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:

(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:

(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).

(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.

(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.

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.

395.0195 Access of chiropractic physicians to diagnostic reports.

History. — ss. 26, 30, ch. 82-182; ss. 14, 98, ch. 92-289; s. 255, ch. 98-166.

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:

(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:

(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:

(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:

(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:

(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:

(10) Any witness who witnessed or who possesses actual knowledge of the act that is the basis of an allegation of sexual abuse shall:

(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.

(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; s. 15, ch. 2022-165.

395.1011 Identification, segregation, and separation of biomedical waste.

History. — ss. 2, 4, ch. 82-125; s. 53, ch. 88-130; ss. 18, 98, ch. 92-289.

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:

(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.

(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).

History. — ss. 26, 30, ch. 82-182; ss. 19, 98, ch. 92-289; s. 5, ch. 2011-220.

395.1023 Child abuse and neglect cases; duties.

(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.

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.

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.

History. — s. 1, ch. 85-157; s. 3, ch. 92-171; ss. 21, 98, ch. 92-289; s. 727, ch. 95-148.

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:

(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 as defined in s. 401.23 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; s. 9, ch. 2022-35.

395.1031 Emergency medical services; communication.

History. — ss. 23, 99, ch. 92-289; s. 72, ch. 95-143; s. 99, ch. 98-279.

395.1041 Access to and ensurance of emergency services; transfers; patient rights; diversion programs; reports of controlled substance overdoses.

(1) LEGISLATIVE INTENT. —

(2) INVENTORY OF HOSPITAL EMERGENCY SERVICES. —

(3) EMERGENCY SERVICES; DISCRIMINATION; LIABILITY OF FACILITY OR HEALTH CARE PERSONNEL. —

(4) RECORDS OF TRANSFERS; REPORT OF VIOLATIONS. —

(5) PENALTIES. —

(6) RIGHTS OF PERSONS BEING TREATED. —

(7) EMERGENCY ROOM DIVERSION PROGRAMS. —

(8) REPORTING OF CONTROLLED SUBSTANCE OVERDOSES. —

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; s. 3, ch. 2022-28; s. 83, ch. 2023-8.

395.1051 Duty to notify patients.

History. — s. 7, ch. 2003-416.

395.1052 Patient access to primary care and specialty providers; notification.

(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.

History. — s. 4, ch. 2013-62; s. 3, ch. 2020-79.

395.1054 Birthing quality improvement initiatives.

History. — s. 6, ch. 2022-69.

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:

(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.

(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:

(13) A pediatric cardiac program shall:

(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.

(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:

(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:

(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; s. 15, ch. 2022-5.

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.

(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:

(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.

395.1057 Patients’ right to choose COVID-19 treatment alternatives.

History. — s. 4, ch. 2023-43.

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:

(2) For purposes of this section, the term:

(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.

395.1061 Professional liability coverage.

(1) As used in this section, the term:

(2) Each hospital, unless exempted under paragraph (3)(b), must demonstrate financial responsibility for maintaining professional liability coverage to pay claims and costs ancillary thereto arising out of the rendering of or failure to render medical care or services and for bodily injury or property damage to the person or property of any patient arising out of the activities of the hospital or arising out of the activities of covered individuals, to the satisfaction of the Agency for Health Care Administration, by meeting one of the following requirements:

(3)(

a) Each hospital, unless exempted under paragraph (b), shall provide evidence of compliance and remain in continuous compliance with the professional liability coverage provisions of this section. The Agency for Health Care Administration may not issue or renew the license of any hospital that does not provide evidence of compliance or that provides evidence of insufficient coverage.

(4) A hospital system may meet the professional liability coverage requirement with an escrow account, insurance, or self-insurance policies if the $10,000 per claim and $2.5 million annual aggregate are met for each hospital in the hospital system.

History. — s. 10, ch. 2022-138.

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.

(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; s. 37, ch. 2022-5; s. 84, ch. 2023-8.

395.107 Facilities; publishing and posting

schedule of charges; penalties.

(1) For purposes of this section, the term “facility” means:

(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.

(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.

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.

(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:

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.

395.3015 Patient records; form and content.

History. — ss. 26, 30, ch. 82-182; ss. 30, 98, ch. 92-289.

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.

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:

(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.

(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.

395.3027 Patient immigration status data collection.

(1) Each hospital that accepts Medicaid must include a provision on its patient admission or registration forms for the patient or the patient’s representative to state or indicate whether the patient is a United States citizen or lawfully present in the United States or is not lawfully present in the United States. The inquiry must be followed by a statement that the response will not affect patient care or result in a report of the patient’s immigration status to immigration authorities.

(2) Each hospital must submit a quarterly report to the agency within 30 days after the end of each calendar quarter which reports the number of hospital admissions or emergency department visits within the previous quarter which were made by a patient who indicated that he or she was a citizen of the United States or lawfully present in the United States, was not lawfully present in the United States, or declined to answer.

(3) By March 1 of each year, the agency shall submit a report to the Governor, the President of the Senate, and the Speaker of the House of Representatives which includes the total number of hospital admissions and emergency department visits for the previous calendar year for which the patient or patient’s representative reported that the patient was a citizen of the United States or lawfully present in the United States, was not lawfully present in the United States, or declined to answer.

The report must also describe information relating to the costs of uncompensated care for aliens who are not lawfully present in the United States, the impact of uncompensated care on the cost or ability of hospitals to provide services to the public, hospital funding needs, and other related information.

(4) The agency may adopt rules relating to the format and information to be contained in quarterly reports and the acceptable formats for hospitals to use in requesting information regarding a patient’s immigration status on hospital admission or registration forms. The rules may not require the disclosure of patient names or any other personal identifying information to the agency.

History. — s. 5, ch. 2023-40.

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:

(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.

(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:

(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.

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.

395.3036 Confidentiality of records and meetings of entities that lease public hospitals or other public health care facilities.

(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.

(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.

(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.

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.

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:

(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:

History. — s. 193, ch. 99-397; s. 2, ch. 2004-259; s. 90, ch. 2020-2.

395.4001

Definitions.

(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:

(8) “Level II trauma center” means a trauma center that:

(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.

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.

(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.

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.

395.402 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.

(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.

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.

395.4025 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:

(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.

(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:

(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.

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.

395.403 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 tr