CHAPTER 395

395.001 Legislative intent. It is the intent of the Legislature to provide for the protection of public health and safety in the establishment, construction, maintenance, and operation of hospitals and ambulatory surgical centers by providing for licensure of same and for the development, establishment, and enforcement of minimum standards with respect thereto. History. — ss. 26, 30, ch. 82-182; ss. 2, 98, ch. 92-289; s. 1, ch. 98-303; s. 23, ch. 2018-24. 395.002 Definitions. As used in this chapter: (1) “Accrediting organizations” means national accreditation organizations that are approved by the Centers for Medicare and Medicaid Services and whose standards incorporate comparable licensure regulations required by the state. (2) “Agency” means the Agency for Health Care Administration. (3) “Ambulatory surgical center” means a facility, the primary purpose of which is to provide elective surgical care, in which the patient is admitted to and discharged from such facility within 24 hours, and which is not part of a hospital. However, a facility existing for the primary purpose of performing terminations of pregnancy, an office maintained by a physician for the practice of medicine, or an office maintained for the practice of dentistry may not be construed to be an ambulatory surgical center, provided that any facility or office which is certified or seeks certification as a Medicare ambulatory surgical center shall be licensed as an ambulatory surgical center pursuant to s. 395.003. (4) “Biomedical waste” means any solid or liquid waste as defined in s. 381.0098(2)(a). (5) “Clinical privileges” means the privileges granted to a physician or other licensed health care practitioner to render patient care services in a hospital, but does not include the privilege of admitting patients. (6) “Department” means the Department of Health. (7) “Director” means any member of the official board of directors as reported in the organization’s annual corporate report to the Florida Department of State, or, if no such report is made, any member of the operating board of directors. The term excludes members of separate, restricted boards that serve only in an advisory capacity to the operating board. (8) “Emergency medical condition” means: (a) A medical condition manifesting itself by acute symptoms of sufficient severity, which may include severe pain, such that the absence of immediate medical attention could reasonably be expected to result in any of the following: 1. Serious jeopardy to patient health, including a pregnant woman or fetus. 2. Serious impairment to bodily functions. 3. Serious dysfunction of any bodily organ or part. (b) With respect to a pregnant woman: 1. That there is inadequate time to effect safe transfer to another hospital prior to delivery; 2. That a transfer may pose a threat to the health and safety of the patient or fetus; or 3. That there is evidence of the onset and persistence of uterine contractions or rupture of the membranes. (9) “Emergency services and care” means medical screening, examination, and evaluation by a physician, or, to the extent permitted by applicable law, by other appropriate personnel under the supervision of a physician, to determine if an emergency medical condition exists and, if it does, the care, treatment, or surgery by a physician necessary to relieve or eliminate the emergency medical condition, within the service capability of the facility. (10) “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: (a) Offers services more intensive than those required for room, board, personal services, and general nursing care, and offers facilities and beds for use beyond 24 hours by individuals requiring diagnosis, treatment, or care for illness, injury, deformity, infirmity, abnormality, disease, or pregnancy; and (b) Regularly makes available at least clinical laboratory services, diagnostic X-ray services, and treatment facilities for surgery or obstetrical care, or other definitive medical treatment of similar extent, except that a critical access hospital, as defined in s. 408.07, shall not be required to make available treatment facilities for surgery, obstetrical care, or similar services as long as it maintains its critical access hospital designation and shall be required to make such facilities available only if it ceases to be designated as a critical access hospital. However, the provisions of this chapter do not apply to any institution conducted by or for the adherents of any well-recognized church or religious denomination that depends exclusively upon prayer or spiritual means to heal, care for, or treat any person. For purposes of local zoning matters, the term “hospital” includes a medical office building located on the same premises as a hospital facility, provided the land on which the medical office building is constructed is zoned for use as a hospital; provided the premises were zoned for hospital purposes on January 1, 1992. (13) “Hospital-based off-campus emergency department” means a facility that: (a) Provides emergency services and care; (b) Is owned and operated by a licensed hospital and operates under the license of the hospital; and (c) Is located on separate premises from the hospital. (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: (a) The range of medical services offered by general hospitals but restricted to a defined age or gender group of the population; (b) A restricted range of services appropriate to the diagnosis, care, and treatment of patients with specific categories of medical or psychiatric illnesses or disorders; or (c) Intensive residential treatment programs for children and adolescents as defined in subsection (16). (29) “Stabilized” means, with respect to an emergency medical condition, that no material deterioration of the condition is likely, within reasonable medical probability, to result from the transfer of the patient from a hospital. (30) “Urgent care center” means a facility or clinic that provides immediate but not emergent ambulatory medical care to patients. The term includes: (a) An offsite facility of a facility licensed under this chapter, or a joint venture between a facility licensed under this chapter and a provider licensed under chapter 458 or chapter 459, that does not require a patient to make an appointment and is presented to the general public in any manner as a facility where immediate but not emergent medical care is provided. (b) A clinic organization that is licensed under part X of chapter 400, maintains three or more locations using the same or a similar name, does not require a patient to make an appointment, and holds itself out to the general public in any manner as a facility or clinic where immediate but not emergent medical care is provided. (31) “Utilization review” means a system for reviewing the medical necessity or appropriateness in the allocation of health care resources of hospital services given or proposed to be given to a patient or group of patients. (32) “Utilization review plan” means a description of the policies and procedures governing utilization review activities performed by a private review agent. (33) “Validation inspection” means an inspection of the premises of a licensed facility by the agency to assess whether a review by an accrediting organization has adequately evaluated the licensed facility according to minimum state standards. History. — ss. 1, 4, ch. 82-125; ss. 26, 30, ch. 82-182; s. 33, ch. 87-92; s. 52, ch. 88-130; s. 4, ch. 89-527; s. 12, ch. 90-295; ss. 3, 98, ch. 92-289; s. 724, ch. 95-148; s. 23, ch. 98-89; s. 37, ch. 98-171; s. 2, ch. 98-303; s. 102, ch. 99-8; s. 206, ch. 99-13; s. 4, ch. 2002-400; s. 1, ch. 2005-81; s. 37, ch. 2007-230; s. 2, ch. 2011-122; s. 4, ch. 2012-66; s. 1, ch. 2012-160; s. 24, ch. 2018-24; s. 6, ch. 2019-138; s. 1, ch. 2021-112; 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. (b)1. It is unlawful for a person to use or advertise to the public, in any way or by any medium whatsoever, any facility as a “hospital” or “ambulatory surgical center” unless such facility has first secured a license under this part. 2. This part does not apply to veterinary hospitals or to commercial business establishments using the word “hospital” or “ambulatory surgical center” as a part of a trade name if no treatment of human beings is performed on the premises of such establishments. (2)(a) In addition to the requirements in part II of chapter 408, the agency shall, at the request of a licensee, issue a single license to a licensee for facilities located on separate premises. Such a license shall specifically state the location of the facilities, the services, and the licensed beds available on each separate premises. If a licensee requests a single license, the licensee shall designate which facility or office is responsible for receipt of information, payment of fees, service of process, and all other activities necessary for the agency to carry out the provisions of this part. (b) The agency shall, at the request of a licensee that is a teaching hospital as defined in s. 408.07, issue a single license to a licensee for facilities that have been previously licensed as separate premises, provided such separately licensed facilities, taken together, constitute the same premises as defined in s. 395.002. Such license for the single premises shall include all of the beds, services, and programs that were previously included on the licenses for the separate premises. The granting of a single license under this paragraph may not in any manner reduce the number of beds, services, or programs operated by the licensee. (c) Intensive residential treatment programs for children and adolescents which have received accreditation from an accrediting organization as defined in s. 395.002(1) and which meet the minimum standards developed by rule of the agency for such programs shall be licensed by the agency under this part. (3) In addition to the requirements of s. 408.807, after a change of ownership has been approved by the agency, the transferee shall be liable for any liability to the state, regardless of when identified, resulting from changes to allowable costs affecting provider reimbursement for Medicaid participation or Public Medical Assistance Trust Fund Assessments, and related administrative fines. (4) The agency shall issue a license that specifies the service categories and the number of hospital beds in each bed category for which a license is received. Such information shall be listed on the face of the license. A licensed facility shall not operate a number of hospital beds greater than the number indicated by the agency on the face of the license without approval from the agency under conditions established by rule. (5)(a) Adherence to patient rights, standards of care, and examination and placement procedures provided under part I of chapter 394 shall be a condition of licensure for hospitals providing voluntary or involuntary medical or psychiatric observation, evaluation, diagnosis, or treatment. (b) Any hospital that provides psychiatric treatment to persons under 18 years of age who have emotional disturbances shall comply with the procedures pertaining to the rights of patients prescribed in part I of chapter 394. (c) A hospital that provides birthing services shall affirm in writing as part of the application for a new, provisional, or renewal license that the hospital shall comply with s. 382.013(2)(c), which includes assisting unmarried parents who request assistance in executing a voluntary acknowledgment of paternity. No fine or other sanction under s. 395.1065 may be imposed on a hospital for noncompliance with s. 382.013(2)(c). (d) A hospital, an ambulatory surgical center, a specialty hospital, or an urgent care center shall comply with ss. 627.64194 and 641.513 as a condition of licensure. (6)(a) A specialty hospital may not provide any service or regularly serve any population group beyond those services or groups specified in its license. A specialty-licensed children’s hospital that is authorized to provide pediatric cardiac catheterization and pediatric open-heart surgery services may provide cardiovascular service to adults who, as children, were previously served by the hospital for congenital heart disease, or to those patients who are referred for a specialized procedure only for congenital heart disease by an adult hospital, without obtaining additional licensure as a provider of adult cardiovascular services. The agency may request documentation as needed to support patient selection and treatment. This subsection does not apply to a specialty-licensed children’s hospital that is already licensed to provide adult cardiovascular services. (b) A specialty-licensed children’s hospital that has licensed neonatal intensive care unit beds and is located in District 5 or District 11, as defined in s. 408.032, as of January 1, 2018, may provide obstetrical services, in accordance with the pertinent guidelines promulgated by the American College of Obstetricians and Gynecologists and with verification of guidelines and compliance with internal safety standards by the Voluntary Review for Quality of Care Program of the American College of Obstetricians and Gynecologists and in compliance with the agency’s rules pertaining to the obstetrical department in a hospital and offer healthy mothers all necessary critical care equipment, services, and the capability of providing up to 10 beds for labor and delivery care, which services are restricted to the diagnosis, care, and treatment of pregnant women of any age who have documentation by an examining physician that includes information regarding: 1. At least one fetal characteristic or condition diagnosed intra-utero that would characterize the pregnancy or delivery as high risk including structural abnormalities of the digestive, central nervous, and cardiovascular systems and disorders of genetic malformations and skeletal dysplasia, acute metabolic emergencies, and babies of mothers with rheumatologic disorders; or 2. Medical advice or a diagnosis indicating that the fetus may require at least one perinatal intervention. This paragraph shall not preclude a specialty-licensed children’s hospital from complying with s. 395.1041 or the Emergency Medical Treatment and Active Labor Act, 42 U.S.C. s. 1395dd. (7) In addition to the requirements of part II of chapter 408, whenever the agency finds that there has been a substantial failure to comply with the requirements established under this part or in rules, the agency is authorized to deny, modify, suspend, and revoke: (a) A license; (b) That part of a license which is limited to a separate premises, as designated on the license; or (c) Licensure approval limited to a facility, building, or portion thereof, or a service, within a given premises. (8) A hospital may not be licensed or relicensed if: (a) The diagnosis-related groups for 65 percent or more of the discharges from the hospital, in the most recent year for which data is available to the Agency for Health Care Administration pursuant to s. 408.061, are for diagnosis, care, and treatment of patients who have: 1. Cardiac-related diseases and disorders classified as diagnosis-related groups in major diagnostic category 5; 2. Orthopedic-related diseases and disorders classified as diagnosis-related groups in major diagnostic category 8; 3. Cancer-related diseases and disorders classified as discharges in which the principal diagnosis is neoplasm or carcinoma or is for an admission for radiotherapy or antineoplastic chemotherapy or immunotherapy; or 4. Any combination of the above discharges. (b) The hospital restricts its medical and surgical services to primarily or exclusively cardiac, orthopedic, surgical, or oncology specialties. (c) A hospital classified as an exempt cancer center hospital pursuant to 42 C.F.R. s. 412.23(f) as of December 31, 2005, is exempt from the licensure restrictions of this subsection. (9) A hospital licensed as of June 1, 2004, shall be exempt from subsection (8) as long as the hospital maintains the same ownership, facility street address, and range of services that were in existence on June 1, 2004. Any transfer of beds, or other agreements that result in the establishment of a hospital or hospital services within the intent of this section, shall be subject to subsection (8). Unless the hospital is otherwise exempt under subsection (8), the agency shall deny or revoke the license of a hospital that violates any of the criteria set forth in that subsection. (10) The agency may adopt rules implementing the licensure requirements set forth in subsection (8). Within 14 days after rendering its decision on a license application or revocation, the agency shall publish its proposed decision in the Florida Administrative Register. Within 21 days after publication of the agency’s decision, any authorized person may file a request for an administrative hearing. In administrative proceedings challenging the approval, denial, or revocation of a license pursuant to subsection (8), the hearing must be based on the facts and law existing at the time of the agency’s proposed agency action. Existing hospitals may initiate or intervene in an administrative hearing to approve, deny, or revoke licensure under subsection (8) based upon a showing that an established program will be substantially affected by the issuance or renewal of a license to a hospital within the same district or service area. History. — ss. 26, 30, ch. 82-182; s. 47, ch. 83-218; s. 4, ch. 83-244; ss. 34, 40, ch. 87-92; ss. 4, 98, ch. 92-289; s. 29, ch. 96-169; s. 3, ch. 98-303; s. 5, ch. 2002-400; s. 23, ch. 2004-350; s. 1, ch. 2004-383; s. 21, ch. 2005-39; s. 2, ch. 2005-81; s. 1, ch. 2005-256; s. 38, ch. 2007-230; s. 1, ch. 2007-248; s. 4, ch. 2009-223; s. 5, ch. 2012-66; s. 40, ch. 2013-14; s. 6, ch. 2013-153; s. 5, ch. 2016-222; s. 25, ch. 2018-24; s. 3, ch. 2020-156; s. 2, ch. 2021-112. 395.004 Application for license; fees. In accordance with s. 408.805, an applicant or licensee shall pay a fee for each license application submitted under this part, part II of chapter 408, and applicable rules. The amount of the fee shall be established by rule. The license fee required of a facility licensed under this part shall be established by rule at the rate of not less than $9.50 per hospital bed, nor more than $30 per hospital bed, except that the minimum license fee shall be $1,500. History. — ss. 26, 30, ch. 82-182; s. 6, ch. 91-282; ss. 5, 98, ch. 92-289; s. 4, ch. 98-303; s. 39, ch. 2007-230. 395.0056 Litigation notice requirement. Upon receipt of a copy of a complaint filed against a hospital as a defendant in a medical malpractice action as required by s. 766.106(2), the agency shall: (1) Review its adverse incident report files pertaining to the licensed facility that is the subject of the complaint to determine whether the facility timely complied with the requirements of s. 395.0197; and (2) Review the incident that is the subject of the complaint and determine whether it involved conduct by a licensee which is potentially subject to disciplinary action. History. — s. 2, ch. 2003-416. 395.009 Minimum standards for clinical laboratory test results and diagnostic X-ray results; prerequisite for issuance or renewal of license. (1) As a requirement for issuance or renewal of its license, each licensed facility shall require that all clinical laboratory tests performed by or for the licensed facility be performed by a clinical laboratory appropriately certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments and the federal rules adopted thereunder. (2) Each licensed facility, as a requirement for issuance or renewal of its license, shall establish minimum standards for acceptance of results of diagnostic X rays performed by or for the licensed facility. Such standards shall require licensure or registration of the source of ionizing radiation under the provisions of chapter 404. (3) The results of clinical laboratory tests and diagnostic X rays performed prior to admission which meet the minimum standards required by law shall be accepted in lieu of routine examinations required upon admission and in lieu of clinical laboratory tests and diagnostic X rays which may be ordered by a physician for patients of the licensed facility. History. — ss. 26, 30, ch. 82-182; s. 25, ch. 83-215; ss. 6, 98, ch. 92-289; s. 26, ch. 2018-24. 395.0091 Alternate-site testing. The agency, in consultation with the Board of Clinical Laboratory Personnel, shall adopt by rule the criteria for alternate-site testing to be performed under the supervision of a clinical laboratory director. At a minimum, the criteria must address hospital internal needs assessment; a protocol for implementation, including the identification of tests to be performed and who will perform them; selection of the method of testing to be used for alternate-site testing; minimum training and education requirements for those who will perform alternate-site testing, such as documented training, licensure, certification, or other medical professional background not limited to laboratory professionals; documented inservice training and initial and ongoing competency validation; an appropriate internal and external quality control protocol; an internal mechanism for the central laboratory to identify and track alternate-site testing; and record-keeping requirements. Alternate-site testing locations must register when the hospital applies to renew its license. For purposes of this section, the term “alternate-site testing” includes any laboratory testing done under the administrative control of a hospital but performed out of the physical or administrative confines of the central laboratory. History. — s. 27, ch. 2018-24. 395.0161 Licensure inspection. (1) In addition to the requirement of s. 408.811, the agency shall make or cause to be made such inspections and investigations as it deems necessary, including: (a) Inspections directed by the federal Centers for Medicare and Medicaid Services. (b) Validation inspections. (c) Lifesafety inspections. (d) Licensure complaint investigations, including full licensure investigations with a review of all licensure standards as outlined in the administrative rules. Complaints received by the agency from individuals, organizations, or other sources are subject to review and investigation by the agency. (e) Emergency access complaint investigations. (2) The agency shall accept, in lieu of its own periodic inspections for licensure, the survey or inspection of an accrediting organization, provided the accreditation of the licensed facility is not provisional and provided the licensed facility authorizes release of, and the agency receives the report of, the accrediting organization. The agency shall develop, and adopt by rule, criteria for accepting survey reports of accrediting organizations in lieu of conducting a state licensure inspection. (3) In accordance with s. 408.805, an applicant or licensee shall pay a fee for each license application submitted under this part, part II of chapter 408, and applicable rules. With the exception of state-operated licensed facilities, each facility licensed under this part shall pay to the agency, at the time of inspection, the following fees: (a) Inspection for licensure. — A fee shall be paid which is not less than $8 per hospital bed, nor more than $12 per hospital bed, except that the minimum fee shall be $400 per facility. (b) Inspection for lifesafety only. — A fee shall be paid which is not less than 75 cents per hospital bed, nor more than $1.50 per hospital bed, except that the minimum fee shall be $40 per facility. (4) The agency shall coordinate all periodic inspections for licensure made by the agency to ensure that the cost to the facility of such inspections and the disruption of services by such inspections is minimized. History. — ss. 26, 30, ch. 82-182; s. 28, ch. 90-344; ss. 7, 98, ch. 92-289; s. 5, ch. 98-303; s. 41, ch. 2007-230; s. 28, ch. 2018-24. Note. — Former s. 395.006. 395.0162 Inspection reports. (1) Each licensed facility shall maintain as public information, available upon request, records of all inspection reports pertaining to that facility. Copies of such reports shall be retained in its records for not less than 5 years from the date the reports are filed and issued. (2) Any records, reports, or documents which are confidential and exempt from s. 119.07(1) shall not be distributed or made available for purposes of compliance with this section unless or until such confidential status expires. (3) A licensed facility shall, upon the request of any person who has completed a written application with intent to be admitted to such facility, any person who is a patient of such facility, or any relative, spouse, guardian, or surrogate of any such person, furnish to the requester a copy of the last inspection report filed with or issued by the agency pertaining to the licensed facility, as provided in subsection (1), provided the person requesting such report agrees to pay a reasonable charge to cover copying costs, not to exceed $1 per page. History. — ss. 26, 30, ch. 82-182; s. 29, ch. 90-344; ss. 8, 98, ch. 92-289; s. 212, ch. 96-406. Note. — Former s. 395.008. 395.0163 Construction inspections; plan submission and approval; fees. (1)(a) The design, construction, erection, alteration, modification, repair, and demolition of all public and private health care facilities are governed by the Florida Building Code and the Florida Fire Prevention Code under ss. 553.73 and 633.206. In addition to the requirements of ss. 553.79 and 553.80, the agency shall review facility plans and survey the construction of any facility licensed under this chapter. The agency shall make, or cause to be made, such construction inspections and investigations as it deems necessary. The agency may prescribe by rule that any licensee or applicant desiring to make specified types of alterations or additions to its facilities or to construct new facilities shall, before commencing such alteration, addition, or new construction, submit plans and specifications therefor to the agency for preliminary inspection and approval or recommendation with respect to compliance with applicable provisions of the Florida Building Code or agency rules and standards. The agency shall approve or disapprove the plans and specifications within 60 days after receipt of the fee for review of plans as required in subsection (2). The agency may be granted one 15-day extension for the review period if the director of the agency approves the extension. If the agency fails to act within the specified time, it shall be deemed to have approved the plans and specifications. When the agency disapproves plans and specifications, it shall set forth in writing the reasons for its disapproval. Conferences and consultations may be provided as necessary. (b) All outpatient facilities that provide surgical treatments requiring general anesthesia or IV conscious sedation, that provide cardiac catheterization services, or that are to be licensed as ambulatory surgical centers shall submit plans and specifications to the agency for review under this section. All other outpatient facilities must be reviewed under this section, except that those that are physically detached from, and have no utility connections with, the hospital and that do not block emergency egress from or create a fire hazard to the hospital are exempt from review under this section. This paragraph applies to applications for which review is pending on or after July 1, 1998. (2) The agency is authorized to charge an initial fee of $2,000 for review of plans and construction on all projects, no part of which is refundable. The agency may also collect a fee, not to exceed 1 percent of the estimated construction cost or the actual cost of review, whichever is less, for the portion of the review which encompasses initial review through the initial revised construction document review. The agency is further authorized to collect its actual costs on all subsequent portions of the review and construction inspections. The initial fee payment shall accompany the initial submission of plans and specifications. Any subsequent payment that is due is payable upon receipt of the invoice from the agency. History. — ss. 26, 30, ch. 82-182; s. 7, ch. 91-282; ss. 9, 98, ch. 92-289; s. 5, ch. 98-89; s. 6, ch. 98-303; s. 21, ch. 2000-141; s. 9, ch. 2000-305; s. 27, ch. 2001-62; s. 34, ch. 2001-186; s. 3, ch. 2001-372; s. 42, ch. 2007-230; s. 134, ch. 2013-183; s. 29, ch. 2018-24. Note. — Former s. 395.007. 395.0185 Rebates prohibited; penalties. (1) It is unlawful for any person to pay or receive any commission, bonus, kickback, or rebate or engage in any split-fee arrangement, in any form whatsoever, with any physician, surgeon, organization, or person, either directly or indirectly, for patients referred to a licensed facility. (2) The agency shall enforce subsection (1). In the case of an entity not licensed by the agency, administrative penalties may include: (a) A fine not to exceed $1,000. (b) If applicable, a recommendation by the agency to the appropriate licensing board that disciplinary action be taken. History. — ss. 26, 30, ch. 82-182; ss. 10, 98, ch. 92-289; s. 42, ch. 2013-18. 395.0191 Staff membership and clinical privileges. (1) No licensed facility, in considering and acting upon an application for staff membership or clinical privileges, shall deny the application of a qualified doctor of medicine licensed under chapter 458, a doctor of osteopathic medicine licensed under chapter 459, a doctor of dentistry licensed under chapter 466, a doctor of podiatric medicine licensed under chapter 461, or a psychologist licensed under chapter 490 for such staff membership or clinical privileges within the scope of his or her respective licensure solely because the applicant is licensed under any of such chapters. (2)(a) Each licensed facility shall establish rules and procedures for consideration of an application for clinical privileges submitted by an advanced practice registered nurse licensed under part I of chapter 464, in accordance with the provisions of this section. No licensed facility shall deny such application solely because the applicant is licensed under part I of chapter 464 or because the applicant is not a participant in the Florida Birth-Related Neurological Injury Compensation Plan. (b) An advanced practice registered nurse who is certified as a registered nurse anesthetist licensed under part I of chapter 464 shall administer anesthesia under the onsite medical direction of a professional licensed under chapter 458, chapter 459, or chapter 466, and in accordance with an established protocol approved by the medical staff. The medical direction shall specifically address the needs of the individual patient. (c) Each licensed facility shall establish rules and procedures for consideration of an application for clinical privileges submitted by a physician assistant licensed pursuant to s. 458.347 or s. 459.022. Clinical privileges granted to a physician assistant pursuant to this subsection shall automatically terminate upon termination of staff membership of the physician assistant’s supervising physician. (d) Each hospital shall meet the requirements of the Medicare and Medicaid Conditions of Participation for Hospitals under 42 C.F.R. s. 482.51(a)(3) as they apply to registered nurses performing circulating duties in the operating room and as provided in the interpretive guidelines provided by the United States Department of Health and Human Services. A circulating nurse shall be present in the operating room for the duration of a surgical procedure. (3) When a licensed facility requires, as a precondition to obtaining staff membership or clinical privileges, the completion of, eligibility in, or graduation from any program or society established by or relating to the American Medical Association or the Liaison Committee on Graduate Medical Education, the licensed facility shall also make available such membership or privileges to physicians who have attained completion of, eligibility in, or graduation from any equivalent program established by or relating to the American Osteopathic Association. (4) Nothing herein shall restrict in any way the authority of the medical staff of a licensed facility to review for approval or disapproval all applications for appointment and reappointment to all categories of staff and to make recommendations on each applicant to the governing board, including the delineation of privileges to be granted in each case. In making such recommendations and in the delineation of privileges, each applicant shall be considered individually pursuant to criteria for a doctor licensed under chapter 458, chapter 459, chapter 461, or chapter 466, or for an advanced practice registered nurse licensed under part I of chapter 464, or for a psychologist licensed under chapter 490, as applicable. The applicant’s eligibility for staff membership or clinical privileges shall be determined by the applicant’s background, experience, health, training, and demonstrated competency; the applicant’s adherence to applicable professional ethics; the applicant’s reputation; and the applicant’s ability to work with others and by such other elements as determined by the governing board, consistent with this part. (5) The governing board of each licensed facility shall set standards and procedures to be applied by the licensed facility and its medical staff in considering and acting upon applications for staff membership or clinical privileges. These standards and procedures shall be available for public inspection. (6) Upon the written request of the applicant, any licensed facility that has denied staff membership or clinical privileges to any applicant specified in subsection (1) or subsection (2) shall, within 30 days of such request, provide the applicant with the reasons for such denial in writing. A denial of staff membership or clinical privileges to any applicant shall be submitted, in writing, to the applicant’s respective licensing board. (7) There shall be no monetary liability on the part of, and no cause of action for injunctive relief or damages shall arise against, any licensed facility, its governing board or governing board members, medical staff, or disciplinary board or against its agents, investigators, witnesses, or employees, or against any other person, for any action arising out of or related to carrying out the provisions of this section, absent intentional fraud. (8) The investigations, proceedings, and records of the board, or agent thereof with whom there is a specific written contract for the purposes of this section, as described in this section shall not be subject to discovery or introduction into evidence in any civil action against a provider of professional health services arising out of matters which are the subject of evaluation and review by such board, and no person who was in attendance at a meeting of such board or its agent shall be permitted or required to testify in any such civil action as to any evidence or other matters produced or presented during the proceedings of such board or its agent or as to any findings, recommendations, evaluations, opinions, or other actions of such board or its agent or any members thereof. However, information, documents, or records otherwise available from original sources are not to be construed as immune from discovery or use in any such civil action merely because they were presented during proceedings of such board; nor should any person who testifies before such board or who is a member of such board be prevented from testifying as to matters within his or her knowledge, but such witness cannot be asked about his or her testimony before such a board or opinions formed by him or her as a result of such board hearings. (9)(a) If the defendant prevails in an action brought by an applicant against any person or entity that initiated, participated in, was a witness in, or conducted any review as authorized by this section, the court shall award reasonable attorney’s fees and costs to the defendant. (b) As a condition of any applicant bringing any action against any person or entity that initiated, participated in, was a witness in, or conducted any review as authorized by this section and before any responsive pleading is due, the applicant shall post a bond or other security, as set by the court having jurisdiction of the action, in an amount sufficient to pay the costs and attorney’s fees. History. — ss. 26, 30, ch. 82-182; s. 48, ch. 83-218; s. 1, ch. 85-99; s. 2, ch. 85-175; s. 1, ch. 86-26; s. 1, ch. 86-287; s. 42, ch. 87-92; s. 2, ch. 88-361; s. 18, ch. 90-263; s. 5, ch. 91-22; ss. 11, 98, ch. 92-289; s. 725, ch. 95-148; s. 38, ch. 97-264; s. 5, ch. 98-49; s. 181, ch. 98-166; s. 93, ch. 2000-318; s. 3, ch. 2003-416; s. 1, ch. 2006-133; s. 23, ch. 2018-106; s. 1, ch. 2019-136. Note. — Former s. 395.011. 395.0192 Duty to notify physicians. A hospital shall notify each obstetrical physician who has privileges at the hospital at least 120 days before the hospital closes its obstetrical department or ceases to provide obstetrical services. History. — s. 2, ch. 2016-113. 395.0193 Licensed facilities; peer review; disciplinary powers; agency or partnership with physicians. (1) It is the intent of the Legislature that good faith participants in the process of investigating and disciplining physicians pursuant to the state-mandated peer review process shall, in addition to receiving immunity from retaliatory tort suits pursuant to s. 456.073(12), be protected from federal antitrust suits filed under the Sherman Anti-Trust Act, 15 U.S.C.A. ss. 1 et seq. Such intent is within the public policy of the state to secure the provision of quality medical services to the public. (2) Each licensed facility, as a condition of licensure, shall provide for peer review of physicians who deliver health care services at the facility. Each licensed facility shall develop written, binding procedures by which such peer review shall be conducted. Such procedures shall include: (a) Mechanism for choosing the membership of the body or bodies that conduct peer review. (b) Adoption of rules of order for the peer review process. (c) Fair review of the case with the physician involved. (d) Mechanism to identify and avoid conflict of interest on the part of the peer review panel members. (e) Recording of agendas and minutes which do not contain confidential material, for review by the Division of Health Quality Assurance of the agency. (f) Review, at least annually, of the peer review procedures by the governing board of the licensed facility. (g) Focus of the peer review process on review of professional practices at the facility to reduce morbidity and mortality and to improve patient care. (3) If reasonable belief exists that conduct by a staff member or physician who delivers health care services at the licensed facility may constitute one or more grounds for discipline as provided in this subsection, a peer review panel shall investigate and determine whether grounds for discipline exist with respect to such staff member or physician. The governing board of any licensed facility, after considering the recommendations of its peer review panel, shall suspend, deny, revoke, or curtail the privileges, or reprimand, counsel, or require education, of any such staff member or physician after a final determination has been made that one or more of the following grounds exist: (a) Incompetence. (b) Being found to be a habitual user of intoxicants or drugs to the extent that he or she is deemed dangerous to himself, herself, or others. (c) Mental or physical impairment which may adversely affect patient care. (d) Being found liable by a court of competent jurisdiction for medical negligence or malpractice involving negligent conduct. (e) One or more settlements exceeding $10,000 for medical negligence or malpractice involving negligent conduct by the staff member. (f) Medical negligence other than as specified in paragraph (d) or paragraph (e). (g) Failure to comply with the policies, procedures, or directives of the risk management program or any quality assurance committees of any licensed facility. (4) Pursuant to ss. 458.337 and 459.016, any disciplinary actions taken under subsection (3) shall be reported in writing to the Division of Health Quality Assurance of the agency within 30 working days after its initial occurrence, regardless of the pendency of appeals to the governing board of the hospital. The notification shall identify the disciplined practitioner, the action taken, and the reason for such action. All final disciplinary actions taken under subsection (3), if different from those which were reported to the agency within 30 days after the initial occurrence, shall be reported within 10 working days to the Division of Health Quality Assurance of the agency in writing and shall specify the disciplinary action taken and the specific grounds therefor. The division shall review each report and determine whether it potentially involved conduct by the licensee that is subject to disciplinary action, in which case s. 456.073 shall apply. The reports are not subject to inspection under s. 119.07(1) even if the division’s investigation results in a finding of probable cause. (5) There shall be no monetary liability on the part of, and no cause of action for damages against, any licensed facility, its governing board or governing board members, peer review panel, medical staff, or disciplinary body, or its agents, investigators, witnesses, or employees; a committee of a hospital; or any other person, for any action taken without intentional fraud in carrying out the provisions of this section. (6) For a single incident or series of isolated incidents that are nonwillful violations of the reporting requirements of this section or part II of chapter 408, the agency shall first seek to obtain corrective action by the facility. If correction is not demonstrated within the timeframe established by the agency or if there is a pattern of nonwillful violations of this section or part II of chapter 408, the agency may impose an administrative fine, not to exceed $5,000 for any violation of the reporting requirements of this section or part II of chapter 408. The administrative fine for repeated nonwillful violations may not exceed $10,000 for any violation. The administrative fine for each intentional and willful violation may not exceed $25,000 per violation, per day. The fine for an intentional and willful violation of this section or part II of chapter 408 may not exceed $250,000. In determining the amount of fine to be levied, the agency shall be guided by s. 395.1065(2)(b). (7) The proceedings and records of peer review panels, committees, and governing boards or agent thereof which relate solely to actions taken in carrying out this section are not subject to inspection under s. 119.07(1); and meetings held pursuant to achieving the objectives of such panels, committees, and governing boards are not open to the public under the provisions of chapter 286. (8) The investigations, proceedings, and records of the peer review panel, a committee of a hospital, a disciplinary board, or a governing board, or agent thereof with whom there is a specific written contract for that purpose, as described in this section shall not be subject to discovery or introduction into evidence in any civil or administrative action against a provider of professional health services arising out of the matters which are the subject of evaluation and review by such group or its agent, and a person who was in attendance at a meeting of such group or its agent may not be permitted or required to testify in any such civil or administrative action as to any evidence or other matters produced or presented during the proceedings of such group or its agent or as to any findings, recommendations, evaluations, opinions, or other actions of such group or its agent or any members thereof. However, information, documents, or records otherwise available from original sources are not to be construed as immune from discovery or use in any such civil or administrative action merely because they were presented during proceedings of such group, and any person who testifies before such group or who is a member of such group may not be prevented from testifying as to matters within his or her knowledge, but such witness may not be asked about his or her testimony before such a group or opinions formed by him or her as a result of such group hearings. (9)(a) If the defendant prevails in an action brought by a staff member or physician who delivers health care services at the licensed facility against any person or entity that initiated, participated in, was a witness in, or conducted any review as authorized by this section, the court shall award reasonable attorney’s fees and costs to the defendant. (b) As a condition of any staff member or physician bringing any action against any person or entity that initiated, participated in, was a witness in, or conducted any review as authorized by this section and before any responsive pleading is due, the staff member or physician shall post a bond or other security, as set by the court having jurisdiction of the action, in an amount sufficient to pay the costs and attorney’s fees. (10)(a) A hospital’s compliance with the requirements of this chapter or s. 766.110(1) may not be the sole basis to establish an agency or partnership relationship between the hospital and physicians who provide services within the hospital. (b) A hospital may create an agency relationship with a physician by written contract signed by the hospital and: 1. The physician; 2. A health care professional association; or 3. A corporate medical group and its employees. A written contract is not the exclusive means to establish an agency or partnership relationship between a hospital and any other person described in this paragraph. History. — ss. 26, 30, ch. 82-182; s. 1, ch. 82-402; s. 3, ch. 85-175; s. 3, ch. 88-1; s. 2, ch. 88-277; s. 4, ch. 89-162; s. 14, ch. 90-344; ss. 12, 13, 98, ch. 92-289; s. 726, ch. 95-148; s. 213, ch. 96-406; s. 24, ch. 98-89; s. 21, ch. 98-166; s. 13, ch. 2000-160; s. 43, ch. 2007-230. Note. — Former s. 395.0115. 395.0195 Access of chiropractic physicians to diagnostic reports. Each hospital shall set standards and procedures which provide for reasonable access by licensed chiropractic physicians to the reports of diagnostic X rays and laboratory tests of licensed facilities, subject to the same standards and procedures as other licensed physicians. However, this section does not require a licensed facility to grant staff privileges to a chiropractic physician. History. — ss. 26, 30, ch. 82-182; ss. 14, 98, ch. 92-289; s. 255, ch. 98-166. Note. — Former s. 395.014. 395.0197 Internal risk management program. (1) Every licensed facility shall, as a part of its administrative functions, establish an internal risk management program that includes all of the following components: (a) The investigation and analysis of the frequency and causes of general categories and specific types of adverse incidents to patients. (b) The development of appropriate measures to minimize the risk of adverse incidents to patients, including, but not limited to: 1. Risk management and risk prevention education and training of all nonphysician personnel as follows: a. Such education and training of all nonphysician personnel as part of their initial orientation; and b. At least 1 hour of such education and training annually for all personnel of the licensed facility working in clinical areas and providing patient care, except those persons licensed as health care practitioners who are required to complete continuing education coursework pursuant to chapter 456 or the respective practice act. 2. A prohibition, except when emergency circumstances require otherwise, against a staff member of the licensed facility attending a patient in the recovery room, unless the staff member is authorized to attend the patient in the recovery room and is in the company of at least one other person. However, a licensed facility is exempt from the two-person requirement if it has: a. Live visual observation; b. Electronic observation; or c. Any other reasonable measure taken to ensure patient protection and privacy. 3. A prohibition against an unlicensed person from assisting or participating in any surgical procedure unless the facility has authorized the person to do so following a competency assessment, and such assistance or participation is done under the direct and immediate supervision of a licensed physician and is not otherwise an activity that may only be performed by a licensed health care practitioner. 4. Development, implementation, and ongoing evaluation of procedures, protocols, and systems to accurately identify patients, planned procedures, and the correct site of the planned procedure so as to minimize the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient’s diagnosis or medical condition. (c) The analysis of patient grievances that relate to patient care and the quality of medical services. (d) A system for informing a patient or an individual identified pursuant to s. 765.401(1) that the patient was the subject of an adverse incident, as defined in subsection (5). Such notice shall be given by an appropriately trained person designated by the licensed facility as soon as practicable to allow the patient an opportunity to minimize damage or injury. (e) The development and implementation of an incident reporting system based upon the affirmative duty of all health care providers and all agents and employees of the licensed health care facility to report adverse incidents to the risk manager, or to his or her designee, within 3 business days after their occurrence. (2) The internal risk management program is the responsibility of the governing board of the health care facility. Each licensed facility shall hire a risk manager who is responsible for implementation and oversight of the facility’s internal risk management program and who demonstrates competence, through education or experience, in all of the following areas: (a) Applicable standards of health care risk management. (b) Applicable federal, state, and local health and safety laws and rules. (c) General risk management administration. (d) Patient care. (e) Medical care. (f) Personal and social care. (g) Accident prevention. (h) Departmental organization and management. (i) Community interrelationships. (j) Medical terminology. (3) In addition to the programs mandated by this section, other innovative approaches intended to reduce the frequency and severity of medical malpractice and patient injury claims shall be encouraged and their implementation and operation facilitated. Such additional approaches may include extending internal risk management programs to health care providers’ offices and the assuming of provider liability by a licensed health care facility for acts or omissions occurring within the licensed facility. Each licensed facility shall annually report to the agency and the Department of Health the name and judgments entered against each health care practitioner for which it assumes liability. The agency and Department of Health, in their respective annual reports, shall include statistics that report the number of licensed facilities that assume such liability and the number of health care practitioners, by profession, for whom they assume liability. (4) The agency shall adopt rules governing the establishment of internal risk management programs to meet the needs of individual licensed facilities. Each internal risk management program shall include the use of incident reports to be filed with an individual of responsibility who is competent in risk management techniques in the employ of each licensed facility, such as an insurance coordinator, or who is retained by the licensed facility as a consultant. The individual responsible for the risk management program shall have free access to all medical records of the licensed facility. The incident reports are part of the workpapers of the attorney defending the licensed facility in litigation relating to the licensed facility and are subject to discovery, but are not admissible as evidence in court. A person filing an incident report is not subject to civil suit by virtue of such incident report. As a part of each internal risk management program, the incident reports shall be used to develop categories of incidents which identify problem areas. Once identified, procedures shall be adjusted to correct the problem areas. (5) For purposes of reporting to the agency pursuant to this section, the term “adverse incident” means an event over which health care personnel could exercise control and which is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred, and which: (a) Results in one of the following injuries: 1. Death; 2. Brain or spinal damage; 3. Permanent disfigurement; 4. Fracture or dislocation of bones or joints; 5. A resulting limitation of neurological, physical, or sensory function which continues after discharge from the facility; 6. Any condition that required specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent; or 7. Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient’s condition prior to the adverse incident; (b) Was the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient’s diagnosis or medical condition; (c) Required the surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage was not a recognized specific risk, as disclosed to the patient and documented through the informed-consent process; or (d) W