The Florida Senate

395.001  Legislative intent.

395.002  Definitions.

395.003  Licensure; issuance, renewal, denial, and revocation.

395.004  Application for license, disposition of fees; expenses.

395.0055  Background screening.

395.009  Minimum standards for clinical laboratory test results and diagnostic X-ray results; prerequisite for issuance or renewal of license.

395.0161  Licensure inspection.

395.0162  Inspection reports.

395.0163  Construction inspections; plan submission and approval; fees.

395.0185  Rebates prohibited; penalties.

395.0191  Staff membership and clinical privileges.

395.0193  Licensed facilities; peer review; disciplinary powers; agency or partnership with physicians.

395.0195  Access of chiropractic physicians to diagnostic reports.

395.0197  Internal risk management program.

395.0198  Notification of adverse incident; public records exemption.

395.0199  Private utilization review.

395.1011  Identification, segregation, and separation of biomedical waste.

395.1021  Treatment of sexual assault victims.

395.1023  Child abuse and neglect cases; duties.

395.1025  Infectious diseases; notification.

395.1027  Regional poison control centers.

395.1031  Emergency medical services; communication.

395.1041  Access to emergency services and care.

395.1046  Complaint investigation procedures.

395.1055  Rules and enforcement.

395.1065  Criminal and administrative penalties; injunctions; emergency orders; moratorium.

395.10971  Purpose.

395.10972  Health Care Risk Manager Advisory Council.

395.10973  Powers and duties of the agency.

395.10974  Qualifications for health care risk managers.

395.10975  Grounds for denial, suspension, or revocation of a health care risk manager's license; administrative fine.

395.2050  Routine inquiry for organ and tissue donation; certification for procurement activities.

395.301  Itemized patient bill; form and content prescribed by the agency.

395.3015  Patient records; form and content.

395.302  Patient records; penalties for alteration.

395.3025  Patient and personnel records; copies; examination.

395.3035  Confidentiality of hospital records and meetings.

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

¹395.001  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, ambulatory surgical centers, and mobile surgical facilities 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.

¹Note.--Section 10, ch. 98-303, provides that "[m]obile surgical facilities in operation pursuant to a contract with the Department of Corrections entered into prior to [May 29, 1998] shall continue to operate pursuant to such contract and shall only be subject to the provisions of this act subsequent to the effective date of any rules promulgated by the Agency for Health Care Administration relating to mobile surgical facilities."

¹395.002  Definitions.--As used in this chapter:

(1)  "Accrediting organizations" means the Joint Commission on Accreditation of Healthcare Organizations, the American Osteopathic Association, the Commission on Accreditation of Rehabilitation Facilities, and the Accreditation Association for Ambulatory Health Care, Inc.

(2)  "Agency" means the Agency for Health Care Administration.

(3)  "Ambulatory surgical center" or "mobile surgical facility" 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 the same working day and is not permitted to stay overnight, 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 shall 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. Any structure or vehicle in which a physician maintains an office and practices surgery, and which can appear to the public to be a mobile office because the structure or vehicle operates at more than one address, shall be construed to be a mobile surgical facility.

(4)  "Applicant" means an individual applicant, or any officer, director, or agent, or any partner or shareholder having an ownership interest equal to a 5-percent or greater interest in the corporation, partnership, or other business entity.

(5)  "Biomedical waste" means any solid or liquid waste as defined in s. 381.0098(2)(a).

(6)  "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.

(7)  "Department" means the Department of Health.

(8)  "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.

(9)  "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.

(10)  "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.

(11)  "General hospital" means any facility which meets the provisions of subsection (13) and which regularly makes its facilities and services available to the general population.

(12)  "Governmental unit" means the state or any county, municipality, or other political subdivision, or any department, division, board, or other agency of any of the foregoing.

(13)  "Hospital" means any establishment that:

(a)  Offers services more intensive than those required for room, board, personal services, and general nursing care, and offers facilities and beds for use beyond 24 hours by individuals requiring diagnosis, treatment, or care for illness, injury, deformity, infirmity, abnormality, disease, or pregnancy; and

(b)  Regularly makes available at least clinical laboratory services, diagnostic X-ray services, and treatment facilities for surgery or obstetrical care, or other definitive medical treatment of similar extent.

However, the provisions of this chapter do not apply to any institution conducted by or for the adherents of any well-recognized church or religious denomination that depends exclusively upon prayer or spiritual means to heal, care for, or treat any person. For purposes of local zoning matters, the term "hospital" includes a medical office building located on the same premises as a hospital facility, provided the land on which the medical office building is constructed is zoned for use as a hospital; provided the premises were zoned for hospital purposes on January 1, 1992.

(14)  "Hospital bed" means a hospital accommodation which is ready for immediate occupancy, or is capable of being made ready for occupancy within 48 hours, excluding provision of staffing, and which conforms to minimum space, equipment, and furnishings standards as specified by rule of the agency for the provision of services specified in this section to a single patient.

(15)  "Initial denial determination" means a determination by a private review agent that the health care services furnished or proposed to be furnished to a patient are inappropriate, not medically necessary, or not reasonable.

(16)  "Intensive residential treatment programs for children and adolescents" means a specialty hospital accredited by the Joint Commission on Accreditation of Healthcare Organizations 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, ambulatory surgical center, or mobile surgical facility 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)  "Mobile surgical facility" is a mobile facility in which licensed health care professionals provide elective surgical care under contract with the Department of Corrections or a private correctional facility operating pursuant to chapter 957 and in which inmate patients are admitted to and discharged from said facility within the same working day and are not permitted to stay overnight. However, mobile surgical facilities may only provide health care services to the inmate patients of the Department of Corrections, or inmate patients of a private correctional facility operating pursuant to chapter 957, and not to the general public.

(23)  "Person" means any individual, partnership, corporation, association, or governmental unit.

(24)  "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, ambulatory surgical, or mobile 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.

(25)  "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.

(26)  "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.

(27)  "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.

(28)  "Specialty bed" means a bed, other than a general bed, designated on the face of the hospital license for a dedicated use.

(29)  "Specialty hospital" means any facility which meets the provisions of subsection (13), and which regularly makes available either:

(a)  The range of medical services offered by general hospitals, but restricted to a defined age or gender group of the population;

(b)  A restricted range of services appropriate to the diagnosis, care, and treatment of patients with specific categories of medical or psychiatric illnesses or disorders; or

(c)  Intensive residential treatment programs for children and adolescents as defined in subsection (16).

(30)  "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.

(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.

¹Note.--Section 10, ch. 98-303, provides that "[m]obile surgical facilities in operation pursuant to a contract with the Department of Corrections entered into prior to [May 29, 1998] shall continue to operate pursuant to such contract and shall only be subject to the provisions of this act subsequent to the effective date of any rules promulgated by the Agency for Health Care Administration relating to mobile surgical facilities."

¹395.003  Licensure; issuance, renewal, denial, and revocation.--

(1)(a)  No person shall establish, conduct, or maintain a hospital, ambulatory surgical center, or mobile surgical facility in this state without first obtaining a license under this part.

(b)1.  It is unlawful for any person to use or advertise to the public, in any way or by any medium whatsoever, any facility as a "hospital," "ambulatory surgical center," or "mobile surgical facility" unless such facility has first secured a license under the provisions of this part.

2.  Nothing in this part applies to veterinary hospitals or to commercial business establishments using the word "hospital," "ambulatory surgical center," or "mobile surgical facility" as a part of a trade name if no treatment of human beings is performed on the premises of such establishments.

(2)(a)  Upon the receipt of an application for a license and the license fee, the agency shall issue a license if the applicant and facility have received all approvals required by law and meet the requirements established under this part and in rules.

(b)  A provisional license may be issued to a new facility or a facility that is in substantial compliance with this part and with the rules of the agency. A provisional license shall be granted for a period of no more than 1 year and shall expire automatically at the end of its term. A provisional license may not be renewed.

(c)  A license, unless sooner suspended or revoked, shall automatically expire 2 years from the date of issuance and shall be renewable biennially upon application for renewal and payment of the fee prescribed by s. 395.004(2), provided the applicant and licensed facility meet the requirements established under this part and in rules. An application for renewal of a license shall be made 90 days prior to expiration of the license, on forms provided by the agency.

(d)  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.

(e)  Intensive residential treatment programs for children and adolescents which have received accreditation from the Joint Commission on Accreditation of Healthcare Organizations 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)(a)  Each license shall be valid only for the person to whom it is issued and shall not be sold, assigned, or otherwise transferred, voluntarily or involuntarily. A license is only valid for the premises for which it was originally issued.

(b)1.  An application for a new license is required if ownership, a majority of the ownership, or controlling interest of a licensed facility is transferred or assigned and when a lessee agrees to undertake or provide services to the extent that legal liability for operation of the facility rests with the lessee. The application for a new license showing such change shall be made at least 60 days prior to the date of the sale, transfer, assignment, or lease.

2.  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. The transferee, simultaneously with the transfer of ownership, shall pay or make arrangements to pay to the agency or the department any amount owed to the agency or the department; payment assurances may be in the form of an irrevocable credit instrument or payment bond acceptable to the agency or the department provided by or on behalf of the transferor. The issuance of a license to the transferee shall be delayed pending payment or until arrangement for payment acceptable to the agency or the department is made.

(4)  The agency shall issue a license which 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. All beds which are not covered by any specialty-bed-need methodology shall be specified as general beds. 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.

(6)  No specialty hospital shall provide any service or regularly serve any population group beyond those services or groups specified in its license.

(7)  Licenses shall be posted in a conspicuous place on each of the licensed premises.

(8)  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, or 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.

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.

¹Note.--Section 10, ch. 98-303, provides that "[m]obile surgical facilities in operation pursuant to a contract with the Department of Corrections entered into prior to [May 29, 1998] shall continue to operate pursuant to such contract and shall only be subject to the provisions of this act subsequent to the effective date of any rules promulgated by the Agency for Health Care Administration relating to mobile surgical facilities."

¹395.004  Application for license, disposition of fees; expenses.--

(1)  An application for a license or renewal thereof shall be made under oath to the agency, upon forms provided by it, and shall contain such information as the agency reasonably requires, which may include affirmative evidence of ability to comply with applicable laws and rules.

(2)  Each application for a general hospital license, specialty hospital license, ambulatory surgical center license, or mobile surgical facility license, or renewal thereof, shall be accompanied by a license fee, in accordance with the following schedule:

(a)  The biennial license, provisional license, and license renewal fee required of a facility licensed under this part shall be reasonably calculated to cover the cost of regulation under this part and 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 and the total fees collected from all licensed facilities may not exceed the cost of properly carrying out the provisions of this part.

(b)  Such fees shall be paid to the agency and shall be deposited in the Planning and Regulation Trust Fund of the agency, which is hereby created, for the sole purpose of carrying out the provisions of this part.

History.--ss. 26, 30, ch. 82-182; s. 6, ch. 91-282; ss. 5, 98, ch. 92-289; s. 4, ch. 98-303.

¹Note.--Section 10, ch. 98-303, provides that "[m]obile surgical facilities in operation pursuant to a contract with the Department of Corrections entered into prior to [May 29, 1998] shall continue to operate pursuant to such contract and shall only be subject to the provisions of this act subsequent to the effective date of any rules promulgated by the Agency for Health Care Administration relating to mobile surgical facilities."

¹395.0055  Background screening.--Each applicant for licensure must comply with the following requirements:

(1)  Upon receipt of a completed, signed, and dated application, the agency shall require background screening of the managing employee in accordance with the level 2 standards for screening set forth in chapter 435, as well as the requirements of s. 435.03(3).

(2)  The agency may require background screening for a member of the board of directors of the licensee, or an officer or an individual owning 5 percent or more of the licensee, if the agency has probable cause to believe that such individual has been convicted of an offense prohibited under the level 2 standards for screening set forth in chapter 435.

(3)  Proof of compliance with the level 2 background screening requirements of chapter 435 which has been submitted within the previous 5 years in compliance with any other health care licensure requirements of this state is acceptable in fulfillment of subsection (1).

(4)  A provisional license may be granted to an applicant when each individual required by this section to undergo background screening has met the standards for the abuse registry background check and the Department of Law Enforcement background check, but the agency has not yet received background screening results from the Federal Bureau of Investigation, or a request for a disqualification exemption has been submitted to the agency as set forth in chapter 435 but a response has not yet been issued. A standard license may be granted to the applicant upon the agency's receipt of a report of the results of the Federal Bureau of Investigation background screening for each individual required by this section to undergo background screening which confirms that all standards have been met, or upon the granting of a disqualification exemption by the agency as set forth in chapter 435. Any other person who is required to undergo level 2 background screening may serve in his or her capacity pending the agency's receipt of the report from the Federal Bureau of Investigation; however, the person may not continue to serve if the report indicates any violation of background screening standards and a disqualification exemption has not been requested of and granted by the agency as set forth in chapter 435.

(5)  Each applicant must submit to the agency, with its application, a description and explanation of any exclusions, permanent suspensions, or terminations of the applicant from the Medicare or Medicaid programs. Proof of compliance with disclosure of ownership and control interest requirements of the Medicaid or Medicare programs shall be accepted in lieu of this submission.

(6)  Each applicant must submit to the agency a description and explanation of any conviction of an offense prohibited under the level 2 standards of chapter 435 by a member of the board of directors of the applicant, its officers, or any individual owning 5 percent or more of the applicant.

(7)  This section does not apply to a director of a not-for-profit corporation or organization if the director serves solely in a voluntary capacity for the corporation or organization, does not regularly take part in the day-to-day operational decisions of the corporation or organization, receives no remuneration for his or her services on the corporation or organization's board of directors, and has no financial interest and has no family members with a financial interest in the corporation or organization, provided that the director and the not-for-profit corporation or organization include in the application a statement affirming that the director's relationship to the corporation satisfies the requirements of this subsection.

(8)  A license may not be granted to an applicant if the applicant or managing employee has been found guilty of, regardless of adjudication, or has entered a plea of nolo contendere or guilty to, any offense prohibited under the level 2 standards for screening set forth in chapter 435, unless an exemption from disqualification has been granted by the agency as set forth in chapter 435.

(9)  The agency may deny or revoke licensure if the applicant:

(a)  Has falsely represented a material fact in the application required by subsection (5) or subsection (6), or has omitted any material fact from the application required by subsection (5) or subsection (6); or

(b)  Has had prior Medicaid or Medicare action taken against the applicant as set forth in subsection (5).

(10)  An application for license renewal must contain the information required under subsections (5) and (6).

History.--ss. 38, 71, ch. 98-171.

¹Note.--

A.  Section 70, ch. 98-171, provides that "[t]he provisions of this act which require an applicant for licensure, certification, or registration to undergo background screening shall apply to any individual or entity that applies, on or after July 1, 1998, for renewal of a license, certificate, or registration that is subject to the background screening required by this act."

B.  Section 71(1), ch. 98-171, provides that "[t]he provisions of this act which require an applicant for licensure, certification, or registration to undergo background screening shall stand repealed on June 30, 2001, unless reviewed and saved from repeal through reenactment by this legislature."

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 licensed under the provisions of chapter 483.

(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.

¹395.0161  Licensure inspection.--

(1)  The agency shall make or cause to be made such inspections and investigations as it deems necessary, including:

(a)  Inspections directed by the Health Care Financing Administration.

(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.

(f)  Inspections of mobile surgical facilities at each time a facility establishes a new location, prior to the admission of patients. However, such inspections shall not be required when a mobile surgical facility is moved temporarily to a location where medical treatment will not be provided.

(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)  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.

¹Note.--Section 10, ch. 98-303, provides that "[m]obile surgical facilities in operation pursuant to a contract with the Department of Corrections entered into prior to [May 29, 1998] shall continue to operate pursuant to such contract and shall only be subject to the provisions of this act subsequent to the effective date of any rules promulgated by the Agency for Health Care Administration relating to mobile surgical facilities."

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.

¹395.0163  Construction inspections; plan submission and approval; fees.--

(1)(a)  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 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)(a)  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.

(b)  Notwithstanding any other provisions of law to the contrary, all moneys received by the agency pursuant to the provisions of this section shall be deposited in the Planning and Regulation Trust Fund, as created by s. 395.004, to be held and applied solely for the operations required under this section.

(3)  The agency shall inspect a mobile surgical facility at initial licensure and at each time the facility establishes a new location, prior to admission of patients. However, such inspections shall not be required when a mobile surgical facility is moved temporarily to a location where medical treatment will not be provided.

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.

¹Note.--Section 10, ch. 98-303, provides that "[m]obile surgical facilities in operation pursuant to a contract with the Department of Corrections entered into prior to [May 29, 1998] shall continue to operate pursuant to such contract and shall only be subject to the provisions of this act subsequent to the effective date of any rules promulgated by the Agency for Health Care Administration relating to mobile surgical facilities."

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 adopt rules which assess administrative penalties for acts prohibited in subsection (1). In the case of an entity licensed by the agency, such penalties may include any disciplinary action available to the agency under the appropriate licensing laws. In the case of an entity not licensed by the agency, such 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.

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 registered nurse practitioner licensed and certified under chapter 464, in accordance with the provisions of this section. No licensed facility shall deny such application solely because the applicant is licensed under chapter 464 or because the applicant is not a participant in the Florida Birth-Related Neurological Injury Compensation Plan.

(b)  An advanced registered nurse practitioner who is certified as a registered nurse anesthetist licensed under 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.

(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 registered nurse practitioner licensed and certified under 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 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 taken in good faith and without intentional fraud in carrying out the provisions of this section.

(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.

(10)  Nothing herein shall be construed by the agency as requiring an applicant for a certificate of need to establish proof of discrimination in the granting of or denial of hospital staff membership or clinical privileges as a precondition to obtaining such certificate of need under the provisions of s. 408.043.

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.

Note.--Former s. 395.011.

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. 455.621(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. 455.621 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, 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, the agency may impose an administrative fine, not to exceed $5,000 for any violation of the reporting requirements of this section. The administrative fine for repeated nonwillful violations shall 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 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.

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 nonphysician personnel of the licensed facility working in clinical areas and providing patient care.

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.

(c)  The analysis of patient grievances that relate to patient care and the quality of medical services.

(d)  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, licensed under part IX of chapter 626, who is responsible for implementation and oversight of such facility's internal risk management program as required by this section. A risk manager must not be made responsible for more than four internal risk management programs in separate licensed facilities, unless the facilities are under one corporate ownership or the risk management programs are in rural hospitals.

(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.

(4)  The agency shall, after consulting with the Department of Insurance, adopt rules governing the establishment of internal risk management programs to meet the needs of individual licensed facilities. Each internal risk management program shall include the use of incident reports to be filed with an individual of responsibility who is competent in risk management techniques in the employ of each licensed facility, such as an insurance coordinator, or who is retained by the licensed facility as a consultant. The individual responsible for the risk management program shall have free access to all medical records of the licensed facility. The incident reports are part of the workpapers of the attorney defending the licensed facility in litigation relating to the licensed facility and are subject to discovery, but are not admissible as evidence in court. A person filing an incident report is not subject to civil suit by virtue of such incident report. As a part of each internal risk management program, the incident reports shall be used to develop categories of incidents which identify problem areas. Once identified, procedures shall be adjusted to correct the problem areas.

(5)  For purposes of reporting to the agency pursuant to this section, the term "adverse incident" means an event over which health care personnel could exercise control and which is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred, and which:

(a)  Results in one of the following injuries:

1.  Death;

2.  Brain or spinal damage;

3.  Permanent disfigurement;

4.  Fracture or dislocation of bones or joints;

5.  A resulting limitation of neurological, physical, or sensory function which continues after discharge from the facility;

6.  Any condition that required specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent; or

7.  Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient's condition prior to the adverse incident;

(b)  Was the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient's diagnosis or medical condition;

(c)  Required the surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage was not a recognized specific risk, as disclosed to the patient and documented through the informed-consent process; or

(d)  Was a procedure to remove unplanned foreign objects remaining from a surgical procedure.

(6)(a)  Each licensed facility subject to this section shall submit an annual report to the agency summarizing the incident reports that have been filed in the facility for that year. The report shall include:

1.  The total number of adverse incidents.

2.  A listing, by category, of the types of operations, diagnostic or treatment procedures, or other actions causing the injuries, and the number of incidents occurring within each category.

3.  A listing, by category, of the types of injuries caused and the number of incidents occurring within each category.

4.  A code number using the health care professional's licensure number and a separate code number identifying all other individuals directly involved in adverse incidents to patients, the relationship of the individual to the licensed facility, and the number of incidents in which each individual has been directly involved. Each licensed facility shall maintain names of the health care professionals and individuals identified by code numbers for purposes of this section.

5.  A description of all malpractice claims filed against the licensed facility, including the total number of pending and closed claims and the nature of the incident which led to, the persons involved in, and the status and disposition of each claim. Each report shall update status and disposition for all prior reports.

(b)  The information reported to the agency pursuant to paragraph (a) which relates to persons licensed under chapter 458, chapter 459, chapter 461, or chapter 466 shall be reviewed by the agency. The agency shall determine whether any of the incidents potentially involved conduct by a health care professional who is subject to disciplinary action, in which case the provisions of s. 455.621 shall apply.

(c)  The report submitted to the agency shall also contain the name and license number of the risk manager of the licensed facility, a copy of its policy and procedures which govern the measures taken by the facility and its risk manager to reduce the risk of injuries and adverse incidents, and the results of such measures. The annual report is confidential and is not available to the public pursuant to s. 119.07(1) or any other law providing access to public records. The annual report is not discoverable or admissible in any civil or administrative action, except in disciplinary proceedings by the agency or the appropriate regulatory board. The annual report is not available to the public as part of the record of investigation for and prosecution in disciplinary proceedings made available to the public by the agency or the appropriate regulatory board. However, the agency or the appropriate regulatory board shall make available, upon written request by a health care professional against whom probable cause has been found, any such records which form the basis of the determination of probable cause.

(7)  The licensed facility shall notify the agency no later than 1 business day after the risk manager or his or her designee has received a report pursuant to paragraph (1)(d) and can determine within 1 business day that any of the following adverse incidents has occurred, whether occurring in the licensed facility or arising from health care prior to admission in the licensed facility:

(a)  The death of a patient;

(b)  Brain or spinal damage to a patient;

(c)  The performance of a surgical procedure on the wrong patient;

(d)  The performance of a wrong-site surgical procedure; or

(e)  The performance of a wrong surgical procedure.

The notification must be made in writing and be provided by facsimile device or overnight mail delivery. The notification must include information regarding the identity of the affected patient, the type of adverse incident, the initiation of an investigation by the facility, and whether the events causing or resulting in the adverse incident represent a potential risk to other patients.

(8)  Any of the following adverse incidents, whether occurring in the licensed facility or arising from health care prior to admission in the licensed facility, shall be reported by the facility to the agency within 15 calendar days after its occurrence:

(a)  The death of a patient;

(b)  Brain or spinal damage to a patient;

(c)  The performance of a surgical procedure on the wrong patient;

(d)  The performance of a wrong-site surgical procedure;

(e)  The performance of a wrong surgical procedure;

(f)  The performance of a surgical procedure that is medically unnecessary or otherwise unrelated to the patient's diagnosis or medical condition;

(g)  The surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage is not a recognized specific risk, as disclosed to the patient and documented through the informed-consent process; or

(h)  The performance of procedures to remove unplanned foreign objects remaining from a surgical procedure.

The agency may grant extensions to this reporting requirement for more than 15 days upon justification submitted in writing by the facility administrator to the agency. The agency may require an additional, final report. These reports shall not be available to the public pursuant to s. 119.07(1) or any other law providing access to public records, nor be discoverable or admissible in any civil or administrative action, except in disciplinary proceedings by the agency or the appropriate regulatory board, nor shall they be available to the public as part of the record of investigation for and prosecution in disciplinary proceedings made available to the public by the agency or the appropriate regulatory board. However, the agency or the appropriate regulatory board shall make available, upon written request by a health care professional against whom probable cause has been found, any such records which form the basis of the determination of probable cause. The agency may investigate, as it deems appropriate, any such incident and prescribe measures that must or may be taken in response to the incident. The agency shall review each incident and determine whether it potentially involved conduct by the health care professional who is subject to disciplinary action, in which case the provisions of s. 455.621 shall apply.

(9)  The internal risk manager of each licensed facility shall:

(a)  Investigate every allegation of sexual misconduct which is made against a member of the facility's personnel who has direct patient contact, when the allegation is that the sexual misconduct occurred at the facility or on the grounds of the facility; and

(b)  Report every allegation of sexual misconduct to the administrator of the licensed facility.

(c)  Notify the family or guardian of the victim, if a minor, that an allegation of sexual misconduct has been made and that an investigation is being conducted;

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

(a)  Notify the local police; and

(b)  Notify the hospital risk manager and the administrator.

For purposes of this subsection, "sexual abuse" means acts of a sexual nature committed for the sexual gratification of anyone upon, or in the presence of, a vulnerable adult, without the vulnerable adult's informed consent, or a minor. "Sexual abuse" includes, but is not limited to, the acts defined in s. 794.011(1)(h), fondling, exposure of a vulnerable adult's or minor's sexual organs, or the use of the vulnerable adult or minor to solicit for or engage in prostitution or sexual performance. "Sexual abuse" does not include any act intended for a valid medical purpose or any act which may reasonably be construed to be a normal caregiving action.

(11)  A person who, with malice or with intent to discredit or harm a licensed facility or any person, makes a false allegation of sexual misconduct against a member of a licensed facility's personnel is guilty of a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.

(12)  In addition to any penalty imposed pursuant to this section, 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, 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, the agency may impose an administrative fine, not to exceed $5,000 for any violation of the reporting requirements of this section. The administrative fine for repeated nonwillful violations shall 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 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). This subsection does not apply to the notice requirements under subsection (7).

(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 (8), 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. 455.611 be available to the public as part of the record of investigation for and prosecution in disciplinary proceedings made available to the public by the agency or the appropriate regulatory board. However, the agency or the appropriate regulatory board shall make available, upon written request by a health care professional against whom probable cause has been found, any such records which form the basis of the determination of probable cause, except that, with respect to medical review committee records, s. 766.101 controls.

(14)  The meetings of the committees and governing board of a licensed facility held solely for the purpose of achieving the objectives of risk management as provided by this section shall not be open to the public under the provisions of chapter 286. The records of such meetings are confidential and exempt from s. 119.07(1), except as provided in subsection (13).

(15)  The agency shall review, as part of its licensure inspection process, the internal risk management program at each licensed facility regulated by this section to determine whether the program meets standards established in statutes and rules, whether the program is being conducted in a manner designed to reduce adverse incidents, and whether the program is appropriately reporting incidents under subsections (5), (6), (7), and (8).

(16)  There shall be no monetary liability on the part of, and no cause of action for damages shall arise against, any risk manager, licensed under part IX of chapter 626, 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)  If the agency, through its receipt of the annual reports prescribed in subsection (6) 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.

(18)  The agency shall annually publish a report summarizing the information contained in the annual incident reports submitted by licensed facilities pursuant to subsection (6) and disciplinary actions reported to the agency pursuant to s. 395.0193. The report must, at a minimum, summarize:

(a)  Adverse incidents, by category of reported incident, and by type of professional involved.

(b)  Types of malpractice claims filed, by type of professional involved.

(c)  Disciplinary actions taken against professionals, by type of professional involved.

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.

Note.--Former ss. 395.18, 768.41; s. 395.041.

395.0198  Notification of adverse incident; public records exemption.--The information contained in the notification of an adverse incident, which is required under s. 395.0197(7) and provided to the Agency for Health Care Administration by a facility licensed under this chapter is confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution. In addition, the information is not discoverable or admissible in a civil or administrative action, unless the action is a disciplinary proceeding by the Agency for Health Care Administration or the appropriate regulatory board. The information may not be made available to the public as part of the record of investigation or prosecution in a disciplinary proceeding which is made available by the Agency for Health Care Administration or a regulatory board. This exemption is subject to the Open Government Sunset Review Act of 1995 in accordance with s. 119.15 and shall stand repealed on October 2, 2003, unless reviewed and saved from repeal through reenactment by the Legislature.

History.--s. 1, ch. 98-321.

395.0199  Private utilization review.--

(1)  The purpose of this section is to:

(a)  Promote the delivery of quality health care in a cost-effective manner.

(b)  Foster greater coordination between providers and health insurers performing utilization review.

(c)  Protect patients and insurance providers by ensuring that private review agents are qualified to perform utilization review activities and to make informed decisions on the appropriateness of medical care.

(d)  This section does not regulate the activities of private review agents, health insurers, health maintenance organizations, or hospitals, except as expressly provided herein, or authorize regulation or intervention as to the correctness of utilization review decisions of insurers or private review agents.

(2)  A private review agent conducting utilization review as to health care services performed or proposed to be performed in this state shall register with the agency in accordance with this section.

(3)  Registration shall be made annually with the agency on forms furnished by the agency and shall be accompanied by the appropriate registration fee as set by the agency. The fee shall be sufficient to pay for the administrative costs of registering the agent, but shall not exceed $250. The agency may also charge reasonable fees, reflecting actual costs, to persons requesting copies of registration.

¹(4)  Each applicant for registration must comply with the following requirements:

(a)  Upon receipt of a completed, signed, and dated application, the agency shall require background screening, in accordance with the level 2 standards for screening set forth in chapter 435, of the managing employee or other similarly titled individual who is responsible for the operation of the entity. The applicant must comply with the procedures for level 2 background screening as set forth in chapter 435, as well as the requirements of s. 435.03(3).

(b)  The agency may require background screening of any other individual who is an applicant, if the agency has probable cause to believe that he or she has been convicted of a crime or has committed any other offense prohibited under the level 2 standards for screening set forth in chapter 435.

(c)  Proof of compliance with the level 2 background screening requirements of chapter 435 which has been submitted within the previous 5 years in compliance with any other health care licensure requirements of this state is acceptable in fulfillment of the requirements of paragraph (a).

(d)  A provisional registration may be granted to an applicant when each individual required by this section to undergo background screening has met the standards for the abuse registry background check and the Department of Law Enforcement background check, but the agency has not yet received background screening results from the Federal Bureau of Investigation, or a request for a disqualification exemption has been submitted to the agency as set forth in chapter 435 but a response has not yet been issued. A standard registration may be granted to the applicant upon the agency's receipt of a report of the results of the Federal Bureau of Investigation background screening for each individual required by this section to undergo background screening which confirms that all standards have been met, or upon the granting of a disqualification exemption by the agency as set forth in chapter 435. Any other person who is required to undergo level 2 background screening may serve in his or her capacity pending the agency's receipt of the report from the Federal Bureau of Investigation. However, the person may not continue to serve if the report indicates any violation of background screening standards and a disqualification exemption has not been requested of and granted by the agency as set forth in chapter 435.

(e)  Each applicant must submit to the agency, with its application, a description and explanation of any exclusions, permanent suspensions, or terminations of the applicant from the Medicare or Medicaid programs. Proof of compliance with the requirements for disclosure of ownership and control interests under the Medicaid or Medicare programs shall be accepted in lieu of this submission.

(f)  Each applicant must submit to the agency a description and explanation of any conviction of an offense prohibited under the level 2 standards of chapter 435 by a member of the board of directors of the applicant, its officers, or any individual owning 5 percent or more of the applicant. This requirement does not apply to a director of a not-for-profit corporation or organization if the director serves solely in a voluntary capacity for the corporation or organization, does not regularly take part in the day-to-day operational decisions of the corporation or organization, receives no remuneration for his or her services on the corporation or organization's board of directors, and has no financial interest and has no family members with a financial interest in the corporation or organization, provided that the director and the not-for-profit corporation or organization include in the application a statement affirming that the director's relationship to the corporation satisfies the requirements of this paragraph.

(g)  A registration may not be granted to an applicant if the applicant or managing employee has been found guilty of, regardless of adjudication, or has entered a plea of nolo contendere or guilty to, any offense prohibited under the level 2 standards for screening set forth in chapter 435, unless an exemption from disqualification has been granted by the agency as set forth in chapter 435.

(h)  The agency may deny or revoke the registration if any applicant:

1.  Has falsely represented a material fact in the application required by paragraph (e) or paragraph (f), or has omitted any material fact from the application required by paragraph (e) or paragraph (f); or

2.  Has had prior action taken against the applicant under the Medicaid or Medicare program as set forth in paragraph (e).

(i)  An application for registration renewal must contain the information required under paragraphs (e) and (f).

(5)  Registration shall include the following:

(a)  A description of the review policies and procedures to be used in evaluating proposed or delivered hospital care.

(b)  The name, address, and telephone number of the utilization review agent performing utilization review, who shall be at least:

1.  A licensed practical nurse or licensed registered nurse, or other similarly qualified medical records or health care professionals, for performing initial review when information is necessary from the physician or hospital to determine the medical necessity or appropriateness of hospital services; or

2.  A licensed physician, or a licensed physician practicing in the field of psychiatry for review of mental health services, for an initial denial determination prior to a final denial determination by the health insurer and which shall include the written evaluation and findings of the reviewing physician.

(c)  A description of an appeal procedure for patients or health care providers whose services are under review, who may appeal an initial denial determination prior to a final determination by the health insurer with whom the private review agent has contracted. The appeal procedure shall provide for review by a licensed physician, or by a licensed physician practicing in the field of psychiatry for review of mental health services, and shall include the written evaluation and findings of the reviewing physician.

(d)  A designation of the times when the staff of the utilization review agent will be available by toll-free telephone, which shall include at least 40 hours per week during the normal business hours of the agent.

(e)  An acknowledgment and agreement that any private review agent which, as a general business practice, fails to adhere to the policies, procedures, and representations made in its application for registration shall have its registration revoked.

(f)  Disclosure of any incentive payment provision or quota provision which is contained in the agent's contract with a health insurer and is based on reduction or denial of services, reduction of length of stay, or selection of treatment setting.

(g)  Updates of any material changes to review policies or procedures.

(6)  The agency may impose fines or suspend or revoke the registration of any private review agent in violation of this section. Any private review agent failing to register or update registration as required by this section shall be deemed to be within the jurisdiction of the agency and subject to an administrative penalty not to exceed $1,000. The agency may bring actions to enjoin activities of private review agents in violation of this section.

(7)  No insurer shall knowingly contract with or utilize a private review agent which has failed to register as required by this section or which has had a registration revoked by the agency.

(8)  A private review agent which operates under contract with the federal or state government for utilization review of patients eligible for hospital or other services under Title XVIII or Title XIX of the Social Security Act is exempt from the provisions of this section for services provided under such contract. A private review agent which provides utilization review services to the federal or state government and a private insurer shall not be exempt for services provided to nonfederally funded patients. This section shall not apply to persons who perform utilization review services for medically necessary hospital services provided to injured workers pursuant to chapter 440 and shall not apply to self-insurance funds or service companies authorized pursuant to chapter 440 or part VII of chapter 626.

(9)  Facilities licensed under this chapter shall promptly comply with the requests of utilization review agents or insurers which are reasonably necessary to facilitate prompt accomplishment of utilization review activities.

(10)  The agency shall adopt rules to implement the provisions of this section.

History.--s. 1, ch. 90-187; s. 184, ch. 91-108; s. 6, ch. 91-201; ss. 17, 98, ch. 92-289; ss. 39, 71, ch. 98-171.

¹Note.--

A.  Section 70, ch. 98-171, provides that "[t]he provisions of this act which require an applicant for licensure, certification, or registration to undergo background screening shall apply to any individual or entity that applies, on or after July 1, 1998, for renewal of a license, certificate, or registration that is subject to the background screening required by this act."

B.  Section 71(1), ch. 98-171, provides that "[t]he provisions of this act which require an applicant for licensure, certification, or registration to undergo background screening shall stand repealed on June 30, 2001, unless reviewed and saved from repeal through reenactment by this legislature."

Note.--Former s. 395.0172.

395.1011  Identification, segregation, and separation of biomedical waste.--Each licensed facility shall comply with the requirements contained in s. 381.0098. Any transporter or potential transporter of such waste shall be notified of the existence and locations of such waste.

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

Note.--Former s. 395.0101.

395.1021  Treatment of sexual assault victims.--Any licensed facility which provides emergency room services shall arrange for the rendering of appropriate medical attention and treatment of victims of sexual assault through:

(1)  Such gynecological, psychological, and medical services as are needed by the victim.

(2)  The administration of medical examinations, tests, and analyses required by law enforcement personnel in the gathering of evidence required for investigation and prosecution.

(3)  The training of medical support personnel competent to provide the medical services and treatment as described in subsections (1) and (2).

Such licensed facility shall also arrange for the protection of the victim's anonymity while complying with the laws of this state and may encourage the victim to notify law enforcement personnel and to cooperate with them in apprehending the suspect.

History.--ss. 26, 30, ch. 82-182; ss. 19, 98, ch. 92-289.

Note.--Former s. 395.0201.

395.1023  Child abuse and neglect cases; duties.--Each licensed facility shall adopt a protocol that, at a minimum, requires the facility to:

(1)  Incorporate a facility policy that every staff member has an affirmative duty to report, pursuant to chapter 39, any actual or suspected case of child abuse, abandonment, or neglect; and

(2)  In any case involving suspected child abuse, abandonment, or neglect, designate, at the request of the department, a staff physician to act as a liaison between the hospital and the Department of Children and Family Services office which is investigating the suspected abuse, abandonment, or neglect, and the child protection team, as defined in s. 39.01, when the case is referred to such a team.

Each general hospital and appropriate specialty hospital shall comply with the provisions of this section and shall notify the agency and the department of its compliance by sending a copy of its policy to the agency and the department as required by rule. The failure by a general hospital or appropriate specialty hospital to comply shall be punished by a fine not exceeding $1,000, to be fixed, imposed, and collected by the agency. Each day in violation is considered a separate offense.

History.--s. 4, ch. 84-226; s. 1, ch. 85-65; s. 36, ch. 92-78; ss. 20, 98, ch. 92-289; s. 2, ch. 97-237; s. 141, ch. 98-403.

Note.--Former s. 395.0205.

395.1025  Infectious diseases; notification.--Notwithstanding the provisions in s. 381.004, if, while treating or transporting an ill or injured patient to a licensed facility, an emergency medical technician, paramedic, or other person comes into direct contact with the patient who is subsequently diagnosed as having an infectious disease, it shall be the duty of the licensed facility receiving the patient to notify the emergency medical technician, paramedic, or his or her emergency medical transportation service employer, or other person of the individual's exposure to the patient within 48 hours, or sooner, of confirmation of the patient's diagnosis and to advise him or her of the appropriate treatment, if any. Notification made pursuant to this section shall be done in a manner which will protect the confidentiality of such patient information and shall not include any patient's name.

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

Note.--Former s. 395.0147.

395.1027  Regional poison control centers.--

(1)  There shall be created three accredited regional poison control centers, one each in the north, central, and southern regions of the state. Each regional poison control center shall be affiliated with and physically located in a certified Level I trauma center. Each regional poison control center shall be affiliated with an accredited medical school or college of pharmacy. The regional poison control centers shall be coordinated under the aegis of the Division of Children's Medical Services in the department.

(2)  Each regional poison control center shall provide the following services:

(a)  Toll-free access by the public for poison information.

(b)  Case management of poison cases.

(c)  Professional consultation to health care practitioners.

(d)  Prevention education to the public.

(e)  Data collection and reporting.

(3)  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 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.

(4)  By October 1, 1999, each regional poison control center shall develop a prehospital emergency dispatch protocol with each licensee defined by s. 401.23(13) in the geographic area covered by the regional poison control center. The prehospital emergency dispatch protocol shall be developed by each licensee's medical director in conjunction with the designated regional poison control center responsible for the geographic area in which the licensee operates. The protocol shall define toxic substances and describe the procedure by which the designated regional poison control center may be consulted by the licensee. If a call is transferred to the designated regional poison control center in accordance with the protocol established under this section and s. 401.268, the designated regional poison control center shall assume responsibility and liability for the call.

History.--s. 18, ch. 89-283; s. 1, ch. 90-192; ss. 22, 98, ch. 92-289; s. 1, ch. 94-147; s. 97, ch. 95-143; s. 1, ch. 98-7; s. 103, ch. 99-8.

Note.--Former s. 395.038.

395.1031  Emergency medical services; communication.--Each licensed hospital with an emergency department must be capable of communicating by two-way radio with all ground-based basic life support service vehicles and advanced life support service vehicles that operate within the hospital's service area under a state permit and with all rotocraft air ambulances that operate under a state permit. The hospital's radio system must be capable of interfacing with municipal mutual aid channels designated by the Department of Management Services and the Federal Communications Commission.

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

395.1041  Access to emergency services and care.--

(1)  LEGISLATIVE INTENT.--The Legislature finds and declares it to be of vital importance that emergency services and care be provided by hospitals and physicians to every person in need of such care. The Legislature finds that persons have been denied emergency services and care by hospitals. It is the intent of the Legislature that the agency vigorously enforce the ability of persons to receive all necessary and appropriate emergency services and care and that the agency act in a thorough and timely manner against hospitals and physicians which deny persons emergency services and care. It is further the intent of the Legislature that hospitals, emergency medical services providers, and other health care providers work together in their local communities to enter into agreements or arrangements to ensure access to emergency services and care. The Legislature further recognizes that appropriate emergency services and care often require followup consultation and treatment in order to effectively care for emergency medical conditions.

(2)  INVENTORY OF HOSPITAL EMERGENCY SERVICES.--The agency shall establish and maintain an inventory of hospitals with emergency services. The inventory shall list all services within the service capability of the hospital, and such services shall appear on the face of the hospital license. Each hospital having emergency services shall notify the agency of its service capability in the manner and form prescribed by the agency. The agency shall use the inventory to assist emergency medical services providers and others in locating appropriate emergency medical care. The inventory shall also be made available to the general public. On or before August 1, 1992, the agency shall request that each hospital identify the services which are within its service capability. On or before November 1, 1992, the agency shall notify each hospital of the service capability to be included in the inventory. The hospital has 15 days from the date of receipt to respond to the notice. By December 1, 1992, the agency shall publish a final inventory. Each hospital shall reaffirm its service capability when its license is renewed and shall notify the agency of the addition of a new service or the termination of a service prior to a change in its service capability.

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

(a)  Every general hospital which has an emergency department shall provide emergency services and care for any emergency medical condition when:

1.  Any person requests emergency services and care; or

2.  Emergency services and care are requested on behalf of a person by:

a.  An emergency medical services provider who is rendering care to or transporting the person; or

b.  Another hospital, when such hospital is seeking a medically necessary transfer, except as otherwise provided in this section.

(b)  Arrangements for transfers must be made between hospital emergency services personnel for each hospital, unless other arrangements between the hospitals exist.

(c)  A patient, whether stabilized or not, may be transferred to another hospital which has the requisite service capability or is not at service capacity, if:

1.  The patient, or a person who is legally responsible for the patient and acting on the patient's behalf, after being informed of the hospital's obligation under this section and of the risk of transfer, requests that the transfer be effected;

2.  A physician has signed a certification that, based upon the reasonable risks and benefits to the patient, and based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another hospital outweigh the increased risks to the individual's medical condition from effecting the transfer; or

3.  A physician is not physically present in the emergency services area at the time an individual is transferred and a qualified medical person signs a certification that a physician, in consultation with personnel, has determined that the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual's medical condition from effecting the transfer. The consulting physician must countersign the certification;

provided that this paragraph shall not be construed to require acceptance of a transfer that is not medically necessary.

(d)1.  Every hospital shall ensure the provision of services within the service capability of the hospital, at all times, either directly or indirectly through an arrangement with another hospital, through an arrangement with one or more physicians, or as otherwise made through prior arrangements. A hospital may enter into an agreement with another hospital for purposes of meeting its service capability requirement, and appropriate compensation or other reasonable conditions may be negotiated for these backup services.

2.  If any arrangement requires the provision of emergency medical transportation, such arrangement must be made in consultation with the applicable provider and may not require the emergency medical service provider to provide transportation that is outside the routine service area of that provider or in a manner that impairs the ability of the emergency medical service provider to timely respond to prehospital emergency calls.

3.  A hospital shall not be required to ensure service capability at all times as required in subparagraph 1. if, prior to the receiving of any patient needing such service capability, such hospital has demonstrated to the agency that it lacks the ability to ensure such capability and it has exhausted all reasonable efforts to ensure such capability through backup arrangements. In reviewing a hospital's demonstration of lack of ability to ensure service capability, the agency shall consider factors relevant to the particular case, including the following:

a.  Number and proximity of hospitals with the same service capability.

b.  Number, type, credentials, and privileges of specialists.

c.  Frequency of procedures.

d.  Size of hospital.

4.  The agency shall publish proposed rules implementing a reasonable exemption procedure by November 1, 1992. Subparagraph 1. shall become effective upon the effective date of said rules or January 31, 1993, whichever is earlier. For a period not to exceed 1 year from the effective date of subparagraph 1., a hospital requesting an exemption shall be deemed to be exempt from offering the service until the agency initially acts to deny or grant the original request. The agency has 45 days from the date of receipt of the request to approve or deny the request. After the first year from the effective date of subparagraph 1., if the agency fails to initially act within the time period, the hospital is deemed to be exempt from offering the service until the agency initially acts to deny the request.

(e)  Except as otherwise provided by law, all medically necessary transfers shall be made to the geographically closest hospital with the service capability, unless another prior arrangement is in place or the geographically closest hospital is at service capacity. When the condition of a medically necessary transferred patient improves so that the service capability of the receiving hospital is no longer required, the receiving hospital may transfer the patient back to the transferring hospital and the transferring hospital shall receive the patient within its service capability.

(f)  In no event shall the provision of emergency services and care, the acceptance of a medically necessary transfer, or the return of a patient pursuant to paragraph (e) be based upon, or affected by, the person's race, ethnicity, religion, national origin, citizenship, age, sex, preexisting medical condition, physical or mental handicap, insurance status, economic status, or ability to pay for medical services, except to the extent that a circumstance such as age, sex, preexisting medical condition, or physical or mental handicap is medically significant to the provision of appropriate medical care to the patient.

(g)  Neither the hospital nor its employees, nor any physician, dentist, or podiatric physician shall be liable in any action arising out of a refusal to render emergency services or care if the refusal is made after screening, examining, and evaluating the patient, and is based on the determination, exercising reasonable care, that the person is not suffering from an emergency medical condition or a determination, exercising reasonable care, that the hospital does not have the service capability or is at service capacity to render those services.

(h)  A hospital may request and collect insurance information and other financial information from a patient, in accordance with federal law, if emergency services and care are not delayed. No hospital to which another hospital is transferring a person in need of emergency services and care may require the transferring hospital or any person or entity to guarantee payment for the person as a condition of receiving the transfer. In addition, a hospital may not require any contractual agreement, any type of preplanned transfer agreement, or any other arrangement to be made prior to or at the time of transfer as a condition of receiving an individual patient being transferred. However, the patient or the patient's legally responsible relative or guardian shall execute an agreement to pay for emergency services or care or otherwise supply insurance or credit information promptly after the services and care are rendered.

(i)  Each hospital offering emergency services shall post, in a conspicuous place in the emergency service area, a sign clearly stating a patient's right to emergency services and care and the service capability of the hospital.

(j)  If a hospital subject to the provisions of this chapter does not maintain an emergency department, its employees shall nevertheless exercise reasonable care to determine whether an emergency medical condition exists and shall direct the persons seeking emergency care to a nearby facility which can render the needed services and shall assist the persons seeking emergency care in obtaining the services, including transportation services, in every way reasonable under the circumstances.

(k)1.  Emergency medical services providers may not condition the prehospital transport of any person in need of emergency services and care on the person's ability to pay. Nor may emergency medical services providers condition a transfer on the person's ability to pay when the transfer is made necessary because the patient is in immediate need of treatment for an emergency medical condition for which the hospital lacks service capability or when the hospital is at service capacity. However, the patient or the patient's legally responsible relative or guardian shall execute an agreement to pay for the transport or otherwise supply insurance or credit information promptly after the transport is rendered.

2.  A hospital may enter into an agreement with an emergency medical services provider for purposes of meeting its service capability requirements, and appropriate compensation and other reasonable conditions may be negotiated for these services.

(l)  Hospital emergency services personnel may withhold or withdraw cardiopulmonary resuscitation if presented with an order not to resuscitate executed pursuant to s. 401.45. Facility staff and facilities shall not be subject to criminal prosecution or civil liability, nor be considered to have engaged in negligent or unprofessional conduct, for withholding or withdrawing cardiopulmonary resuscitation pursuant to such an order.

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

(a)1.  Each hospital shall maintain records of each transfer made or received for a period of 5 years. These records of transfers shall be included in a transfer log, as well as in the permanent medical record of any patient being transferred or received.

2.  Each hospital shall maintain records of all patients who request emergency care and services, or persons on whose behalf emergency care and services are requested, for a period of 5 years. These records shall be included in a log, as well as in the permanent medical record of any patient or person for whom emergency services and care is requested.

(b)  Any hospital employee, physician, other licensed emergency room health care personnel, or certified prehospital emergency personnel who knows of an apparent violation of this section or the rules adopted under this section shall report the apparent violation to the agency within 30 days following its occurrence.

(c)  A hospital, government agency, or person shall not retaliate against, penalize, institute a civil action against, or recover monetary relief from, or otherwise cause any injury to:

1.  A physician or other person for reporting in good faith an apparent violation of this section or the rules adopted under this section to the agency, hospital, medical staff, or any other interested party or government agency;

2.  A physician who refuses to transfer a patient if the physician determines, within reasonable medical probability, that the transfer or delay caused by the transfer will create a medical hazard to the patient; or

3.  A physician who effectuates the transfer of a patient if the physician determines, within a reasonable medical probability, that failing to transfer the patient will create a medical hazard to the patient.

(5)  PENALTIES.--

(a)  The agency may deny, revoke, or suspend a license or impose an administrative fine, not to exceed $10,000 per violation, for the violation of any provision of this section or rules adopted under this section.

(b)  Any person who suffers personal harm as a result of a violation of this section or the rules adopted hereunder may recover, in a civil action against the responsible hospital administrative or medical staff or personnel, damages, reasonable attorney's fees, and other appropriate relief. However, this paragraph shall not be construed to create a cause of action beyond that recognized by this section and rules adopted under this section as they existed on April 1, 1992.

(c)  Any hospital administrative or medical staff or personnel who knowingly or intentionally violates any provision of this section commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.

(d)1.  Any hospital, or any physician licensed under chapter 458 or chapter 459, who suffers a financial loss as a direct result of a violation by a physician or a hospital of a requirement of this section may, in a civil action against the physician or the hospital, obtain damages for financial loss of charges and such equitable relief as is appropriate, including reasonable attorney's fees and costs.

2.  If the defendant prevails in an action brought by the hospital or physician pursuant to this paragraph, the court may award reasonable attorney's fees and costs to the defendant.

(e)  A physician licensed under chapter 458 or chapter 459 who negligently or knowingly violates any requirement of this section relating to the provision of emergency services and care shall be deemed in violation of the provisions of such chapters for any of the following violations:

1.  Failure or refusal to respond within a reasonable time after notification when on call.

2.  Failure or refusal to sign a certificate of transfer as required by this section.

3.  Signing a certificate of transfer stating that the medical benefits to be reasonably expected from a transfer to another facility outweigh the risks associated with the transfer, when the physician knew or should have known that the benefits did not outweigh the risks as required by this section.

4.  Misrepresentation of an individual's condition or other information when requesting a transfer.

Any fine collected for a violation of this section, including any fine collected from a physician licensed under chapter 458 or chapter 459, shall be deposited into the Public Medical Assistance Trust Fund.

(f)  In determining whether a licensee is deemed in violation of this section and in assessing any penalties for violation, the agency shall consider, and the licensee may offer as an affirmative defense or in mitigation, whether the licensee has established that the alleged violation arose from the unanticipated changes in service capability or other factors beyond the licensee's control.

(6)  RIGHTS OF PERSONS BEING TREATED.--A hospital providing emergency services and care to a person who is being involuntarily examined under the provisions of s. 394.463 shall adhere to the rights of patients specified in part I of chapter 394 and the involuntary examination procedures provided in s. 394.463, regardless of whether the hospital, or any part thereof, is designated as a receiving or treatment facility under part I of chapter 394 and regardless of whether the person is admitted to the hospital.

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.

Note.--Former s. 395.0142.

395.1046  Complaint investigation procedures.--

(1)  The agency shall investigate any complaint against a hospital for any violation of s. 395.1041 that the agency reasonably believes to be legally sufficient. A complaint is legally sufficient if it contains ultimate facts which show that a violation of this chapter, or any rule adopted under this chapter by the agency, has occurred. The agency may investigate, or continue to investigate, and may take appropriate final action on a complaint, even though the original complainant withdraws his or her complaint or otherwise indicates his or her desire not to cause it to be investigated to completion. When an investigation of any person or facility is undertaken, the agency shall notify such person in writing of the investigation and inform the person or facility in writing of the substance, the facts which show that a violation has occurred, and the source of any complaint filed against him or her. The agency may conduct an investigation without notification to any person if the act under investigation is a criminal offense. The agency shall have access to all records necessary for the investigation of the complaint.

(2)  The agency or its agent shall expeditiously investigate each complaint against a hospital for a violation of s. 395.1041. When its investigation is complete, the agency shall prepare an investigative report. The report shall contain the investigative findings and the recommendations of the agency concerning the existence of probable cause.

(3)  The complaint and all information obtained by the agency during an investigation conducted pursuant to this section are exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution until 10 days after probable cause has been found to exist by the agency, or until the person who is the subject of the investigation waives his or her privilege of confidentiality, whichever occurs first. In cases where the agency finds that the complaint is not legally sufficient or when the agency determines that no probable cause exists, all records pertaining thereto are confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution. However, the complaint and a summary of the agency's findings shall be available, although information therein identifying an individual shall not be disclosed.

History.--s. 3, ch. 89-275; s. 4, ch. 89-283; s. 1, ch. 90-192; ss. 26, 98, ch. 92-289; s. 728, ch. 95-148; s. 2, ch. 95-387; s. 215, ch. 96-406.

Note.--Former s. 395.0175.

¹395.1055  Rules and enforcement.--

(1)  The agency shall adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this part, which shall include reasonable and fair minimum standards for ensuring that:

(a)  Sufficient numbers and qualified types of personnel and occupational disciplines are on duty and available at all times to provide necessary and adequate patient care and safety.

(b)  Infection control, housekeeping, sanitary conditions, and medical record procedures that will adequately protect patient care and safety are established and implemented.

(c)  A comprehensive emergency management plan is prepared and updated annually. Such standards must be included in the rules adopted by the agency after consulting with the Department of Community Affairs. At a minimum, the rules must provide for plan components that address emergency evacuation transportation; adequate sheltering arrangements; postdisaster activities, including emergency power, food, and water; postdisaster transportation; supplies; staffing; emergency equipment; individual identification of residents and transfer of records, and responding to family inquiries. The comprehensive emergency management plan is subject to review and approval by the local emergency management agency. During its review, the local emergency management agency shall ensure that the following agencies, at a minimum, are given the opportunity to review the plan: the Department of Elderly Affairs, the Department of Health, the Agency for Health Care Administration, and the Department of Community Affairs. Also, appropriate volunteer organizations must be given the opportunity to review the plan. The local emergency management agency shall complete its review within 60 days and either approve the plan or advise the facility of necessary revisions.

(d)  New facilities and a new wing or floor added to an existing facility after July 1, 1999, are structurally capable of serving as shelters only for patients, staff, and families of staff and patients, and equipped to be self-supporting during and immediately following disasters.

(e)  Construction, maintenance, repair, lifesafety, and renovation of licensed facilities are governed by the most recently adopted, nationally recognized lifesafety code, except as may be specifically modified by rule.

(f)  Licensed facilities are established, organized, and operated consistent with established standards and rules.

(g)  Licensed facility beds conform to minimum space, equipment, and furnishings standards as specified by the department.

(h)  All hospitals submit such data as necessary to conduct certificate-of-need reviews required under ss. 408.031-408.045. Such data shall include, but shall not be limited to, patient origin data, hospital utilization data, type of service reporting, and facility staffing data. The agency shall not collect data that identifies or could disclose the identity of individual patients. The agency shall utilize existing uniform statewide data sources when available and shall minimize reporting costs to hospitals.

(i)  Each hospital has a quality improvement program designed according to standards established by their current accrediting organization. This program will enhance quality of care and emphasize quality patient outcomes, corrective action for problems, governing board review, and reporting to the agency of standardized data elements necessary to analyze quality of care outcomes. The agency shall use existing data, when available, and shall not duplicate the efforts of other state agencies in order to obtain such data.

(2)  Separate standards may be provided for general and specialty hospitals, ambulatory surgical centers, mobile surgical facilities, and statutory rural hospitals as defined in s. 395.602.

(3)  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.

(4)  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.

(5)  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.

(6)  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.

(7)  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.

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.

¹Note.--Section 10, ch. 98-303, provides that "[m]obile surgical facilities in operation pursuant to a contract with the Department of Corrections entered into prior to [May 29, 1998] shall continue to operate pursuant to such contract and shall only be subject to the provisions of this act subsequent to the effective date of any rules promulgated by the Agency for Health Care Administration relating to mobile surgical facilities."

Note.--Former s. 395.005.

395.1065  Criminal and administrative penalties; injunctions; emergency orders; moratorium.--

(1)  Any person establishing, conducting, managing, or operating any facility without a license under this part is guilty of 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 deny, revoke, or suspend a license or impose an administrative fine, not to exceed $1,000 per violation, per day, for the violation of any provision of this part or rules promulgated hereunder. Each day of violation constitutes a separate violation and is subject to a separate fine.

(b)  In determining the amount of fine to be levied for a violation, as provided in paragraph (a), the following factors shall be considered:

1.  The severity of the violation, including the probability that death or serious harm to the health or safety of any person will result or has resulted, the severity of the actual or potential harm, and the extent to which the provisions of this part were violated.

2.  Actions taken by the licensee to correct the violations or to remedy complaints.

3.  Any previous violations of the licensee.

(c)  All amounts collected pursuant to this section shall be deposited into the Planning and Regulation Trust Fund, as created by s. 395.004.

(3)  Notwithstanding the existence or pursuit of any other remedy, the agency may maintain an action in the name of the state for injunction or other process to enforce the provisions of this part and rules promulgated hereunder.

(4)  The agency may issue an emergency order immediately suspending or revoking a license when it determines that any condition in the licensed facility presents a clear and present danger to public health and safety.

(5)  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.

(6)  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.

History.--ss. 26, 30, ch. 82-182; ss. 28, 98, ch. 92-289; s. 32, ch. 96-169; s. 105, ch. 99-8.

Note.--Former s. 395.018.

395.10971  Purpose.--The Legislature finds that control and prevention of medical accidents and injuries is a significant public health and safety concern. An essential method of controlling medical injuries is a comprehensive program of risk management, as required by s. 395.0197. The key to such a program is a competent and qualified health care risk manager. It is the intent of the Legislature to establish certain minimum standards for health care risk managers to ensure the public welfare.

History.--ss. 38, 53, ch. 85-175; s. 4, ch. 91-429; s. 87, ch. 92-289; s. 26, ch. 98-89.

Note.--Former s. 626.941.

395.10972  Health Care Risk Manager Advisory Council.--The Director of Health Care Administration may appoint a five-member advisory council to advise the agency on matters pertaining to health care risk managers. The members of the council shall serve at the pleasure of the director. The council shall designate a chair. The council shall meet at the call of the director or at those times as may be required by rule of the agency. The members of the advisory council shall receive no compensation for their services, but shall be reimbursed for travel expenses as provided in s. 112.061. The council shall consist of individuals representing the following areas:

(1)  Two shall be active health care risk managers.

(2)  One shall be an active hospital administrator.

(3)  One shall be an employee of an insurer or self-insurer of medical malpractice coverage.

(4)  One shall be a representative of the health-care-consuming public.

History.--ss. 38, 53, ch. 85-175; s. 4, ch. 91-429; s. 312, ch. 97-102; s. 27, ch. 98-89.

Note.--Former s. 626.942.

395.10973  Powers and duties of the agency.--It is the function of the agency to:

(1)  Adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this part conferring duties upon it.

(2)  Develop, impose, and enforce specific standards within the scope of the general qualifications established by this part which must be met by individuals in order to receive licenses as health care risk managers. These standards shall be designed to ensure that health care risk managers are individuals of good character and otherwise suitable and, by training or experience in the field of health care risk management, qualified in accordance with the provisions of this part to serve as health care risk managers, within statutory requirements.

(3)  Develop a method for determining whether an individual meets the standards set forth in s. 395.10974.

(4)  Issue licenses to qualified individuals meeting the standards set forth in s. 395.10974.

(5)  Receive, investigate, and take appropriate action with respect to any charge or complaint filed with the agency to the effect that a certified health care risk manager has failed to comply with the requirements or standards adopted by rule by the agency or to comply with the provisions of this part.

(6)  Establish procedures for providing periodic reports on persons certified or disciplined by the agency under this part.

(7)  Develop a model risk management program for health care facilities which will satisfy the requirements of s. 395.0197.

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.

Note.--Former s. 626.943.

395.10974  Qualifications for health care risk managers.--

(1)  Any person desiring to be licensed as a health care risk manager shall submit an application on a form provided by the agency. In order to qualify, the applicant shall submit evidence satisfactory to the agency which demonstrates the applicant's competence, by education or experience, in 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.

The agency may require such additional information, from the applicant or any other person, as may be reasonably required to verify the information contained in the application.

(2)  The agency shall not grant or issue a license as a health care risk manager to any individual unless from the application it affirmatively appears that the applicant:

(a)  Is 18 years of age or over;

(b)  Is a high school graduate or equivalent; and

(c)1.  Has fulfilled the requirements of a 1-year program or its equivalent in health care risk management training which may be developed or approved by the agency;

2.  Has completed 2 years of college-level studies which would prepare the applicant for health care risk management, to be further defined by rule; or

3.  Has obtained 1 year of practical experience in health care risk management.

(3)  The agency shall issue a ¹license to practice health care risk management to any applicant who qualifies under this section and submits an application fee of not more than $75, a fingerprinting fee of not more than $75, and a license fee of not more than $100. The agency shall by rule establish fees and procedures for the issuance and cancellation of licenses.

(4)  The agency shall renew a health care risk manager ²license upon receipt of a biennial renewal application and fees. The agency shall by rule establish a procedure for the biennial renewal of licenses.

History.--ss. 38, 53, ch. 85-175; s. 4, ch. 86-287; s. 33, ch. 88-166; s. 184, ch. 90-363; s. 4, ch. 91-429; s. 29, ch. 98-89; s. 75, ch. 98-199.

¹Note.--As amended and transferred to its present location by s. 29, ch. 98-89. The amendment by s. 75, ch. 98-199, added the words "and an appointment" following the word "license."

²Note.--As amended and transferred to its present location by s. 29, ch. 98-89. The amendment by s. 75, ch. 98-199, substituted the word "appointment" for the word "license."

Note.--Former s. 626.944.

395.10975  Grounds for denial, suspension, or revocation of a health care risk manager's license; administrative fine.--

(1)  The agency may, in its discretion, deny, suspend, revoke, or refuse to renew or continue the license of any health care risk manager or applicant, if it finds that as to such applicant or licensee any one or more of the following grounds exist:

(a)  Any cause for which issuance of the license could have been refused had it then existed and been known to the agency.

(b)  Giving false or forged evidence to the agency for the purpose of obtaining a license.

(c)  Having been found guilty of, or having pleaded guilty or nolo contendere to, a crime in this state or any other state relating to the practice of risk management or the ability to practice risk management, whether or not a judgment or conviction has been entered.

(d)  Having been found guilty of, or having pleaded guilty or nolo contendere to, a felony, or a crime involving moral turpitude punishable by imprisonment of 1 year or more under the law of the United States, under the law of any state, or under the law of any other country, without regard to whether a judgment of conviction has been entered by the court having jurisdiction of such cases.

(e)  Making or filing a report or record which the licensee knows to be false; or intentionally failing to file a report or record required by state or federal law; or willfully impeding or obstructing, or inducing another person to impede or obstruct, the filing of a report or record required by state or federal law. Such reports or records shall include only those which are signed in the capacity of a licensed health care risk manager.

(f)  Fraud or deceit, negligence, incompetence, or misconduct in the practice of health care risk management.

(g)  Violation of any provision of this part or any other law applicable to the business of health care risk management.

(h)  Violation of any lawful order or rule of the agency or failure to comply with a lawful subpoena issued by the department.

(i)  Practicing with a revoked or suspended health care risk manager license.

(j)  Repeatedly acting in a manner inconsistent with the health and safety of the patients of the licensed facility in which the licensee is the health care risk manager.

(k)  Being unable to practice health care risk management with reasonable skill and safety to patients by reason of illness; drunkenness; or use of drugs, narcotics, chemicals, or any other material or substance or as a result of any mental or physical condition. Any person affected under this paragraph shall have the opportunity, at reasonable intervals, to demonstrate that he or she can resume the competent practices of health care risk manager with reasonable skill and safety to patients.

(l)  Willfully permitting unauthorized disclosure of information relating to a patient or a patient's records.

(m)  Discriminating in respect to patients, employees, or staff on account of race, religion, color, sex, or national origin.

(2)  If the agency finds that one or more of the grounds set forth in subsection (1) exist, it may, in lieu of or in addition to suspension or revocation, enter an order imposing one or more of the following penalties:

(a)  Imposition of an administrative fine not to exceed $2,500 for each count or separate offense.

(b)  Issuance of a reprimand.

(c)  Placement of the licensee on probation for a period of time and subject to such conditions as the agency may specify, including requiring the licensee to attend continuing education courses or to work under the supervision of another licensee.

(3)  The agency may reissue the license of a disciplined licensee in accordance with the provisions of this part.

History.--ss. 38, 53, ch. 85-175; s. 26, ch. 87-226; s. 185, ch. 90-363; s. 4, ch. 91-429; s. 313, ch. 97-102; s. 30, ch. 98-89.

Note.--Former s. 626.945.

395.2050  Routine inquiry for organ and tissue donation; certification for procurement activities.--

(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. 732.922 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. 381.6021-381.6026.

(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.

395.301  Itemized patient bill; form and content prescribed by the agency.--

(1)  A licensed facility not operated by the state shall notify each patient during admission and at discharge of his or her right to receive an itemized bill upon request. Within 7 days following discharge or release from a licensed facility not operated by the state, or within 7 days after the earliest date at which the loss or expense from the service may be determined, the licensed facility providing the service shall, upon request, submit to the patient, or to the patient's survivor or legal guardian as may be appropriate, an itemized statement detailing in language comprehensible to an ordinary layperson the specific nature of charges or expenses incurred by the patient, which in the initial billing shall contain a statement of specific services received and expenses incurred for such items of service, enumerating in detail the constituent components of the services received within each department of the licensed facility and including unit price data on rates charged by the licensed facility, as prescribed by the agency.

(2)  Each such statement:

(a)  May not include charges of hospital-based physicians if billed separately.

(b)  May not include any generalized category of expenses such as "other" or "miscellaneous" or similar categories.

(c)  Shall list drugs by brand or generic name and not refer to drug code numbers when referring to drugs of any sort.

(d)  Shall specifically identify therapy treatment as to the date, type, and length of treatment when therapy treatment is a part of the statement. Any person receiving a statement pursuant to this section shall be fully and accurately informed as to each charge and service provided by the institution preparing the statement.

(3)  On each such itemized statement there shall appear the words "A FOR-PROFIT (or NOT-FOR-PROFIT or PUBLIC) HOSPITAL (or AMBULATORY SURGICAL CENTER) LICENSED BY THE STATE OF FLORIDA" or substantially similar words sufficient to identify clearly and plainly the ownership status of the licensed facility. Each itemized statement must prominently display the phone number of the medical facility's patient liaison who is responsible for expediting the resolution of any billing dispute between the patient, or his or her representative, and the billing department.

(4)  An itemized bill shall be provided once to the patient's physician at the physician's request, at no charge.

(5)  In any billing for services subsequent to the initial billing for such services, the patient, or the patient's survivor or legal guardian, may elect, at his or her option, to receive a copy of the detailed statement of specific services received and expenses incurred for each such item of service as provided in subsection (1).

(6)  No physician, dentist, podiatric physician, or licensed facility may add to the price charged by any third party except for a service or handling charge representing a cost actually incurred as an item of expense; however, the physician, dentist, podiatric physician, or licensed facility is entitled to fair compensation for all professional services rendered. The amount of the service or handling charge, if any, shall be set forth clearly in the bill to the patient.

History.--ss. 26, 30, ch. 82-182; ss. 29, 98, ch. 92-289; s. 729, ch. 95-148; s. 183, ch. 98-166.

Note.--Former s. 395.015.

395.3015  Patient records; form and content.--Each hospital operated by the agency or by the Department of Corrections shall require the use of a system of problem-oriented medical records for its patients, which system shall include the following elements: basic client data collection; a listing of the patient's problems; the initial plan with diagnostic and therapeutic orders as appropriate for each problem identified; and progress notes, including a discharge summary. The agency shall, by rule, establish criteria for such problem-oriented medical record systems in order to ensure comparability among facilities and to facilitate the compilation of statewide statistics.

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

Note.--Former s. 395.016.

395.302  Patient records; penalties for alteration.--

(1)  Any person who fraudulently alters, defaces, or falsifies any medical record, or causes or procures any of these offenses to be committed, commits a misdemeanor of the second degree, punishable as provided in s. 775.082 or s. 775.083.

(2)  A conviction under subsection (1) is also grounds for restriction, suspension, or termination of license privileges.

History.--ss. 25, 52, ch. 85-175; s. 69, ch. 91-224; ss. 31, 98, ch. 92-289.

Note.--Former s. 395.0165.

395.3025  Patient and personnel records; copies; examination.--

(1)  Any licensed facility shall, upon written request, and only after discharge of the patient, furnish, in a timely manner, without delays for legal review, to any person admitted therein for care and treatment or treated thereat, or to any such person's guardian, curator, or personal representative, or in the absence of one of those persons, to the next of kin of a decedent or the parent of a minor, or to anyone designated by such person in writing, a true and correct copy of all patient records, including X rays, and insurance information concerning such person, which records are in the possession of the licensed facility, provided the person requesting such records agrees to pay a charge. The exclusive charge for copies of patient records may include sales tax and actual postage, and, except for nonpaper records which are subject to a charge not to exceed $2 as provided in s. 28.24(9)(c), may not exceed $1 per page, as provided in s. 28.24(8)(a). 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 person to whom they pertain, but appropriate disclosure may be made without such consent to:

(a)  Licensed facility personnel and attending physicians for use in connection with the treatment of the patient.

(b)  Licensed facility personnel only for administrative purposes or risk management and quality assurance functions.

(c)  The agency, for purposes of health care cost containment.

(d)  In any civil or criminal action, unless otherwise prohibited by law, upon the issuance of a subpoena from a court of competent jurisdiction and proper notice by the party seeking such records to the patient or his or her legal representative.

(e)  The agency upon subpoena issued pursuant to s. 455.611, but the records obtained thereby must be used solely for the purpose of the agency and the appropriate professional board in its investigation, prosecution, and appeal of disciplinary proceedings. If the agency requests copies of the records, the facility shall charge no more than its actual copying costs, including reasonable staff time. The records must be sealed and must not be available to the public pursuant to s. 119.07(1) or any other statute providing access to records, nor may they be available to the public as part of the record of investigation for and prosecution in disciplinary proceedings made available to the public by the agency or the appropriate regulatory board. However, the agency must make available, upon written request by a practitioner against whom probable cause has been found, any such records that form the basis of the determination of probable cause.

(f)  The Department of Health or its agent, for the purpose of establishing and maintaining a trauma registry and for the purpose of ensuring that hospitals and trauma centers are in compliance with the standards and rules established under ss. 395.401, 395.4015, 395.4025, 395.404, 395.4045, and 395.405, and for the purpose of monitoring patient outcome at hospitals and trauma centers that provide trauma care services.

(g)  The Department of Children and Family Services or its agent, for the purpose of investigations of cases of abuse, neglect, or exploitation of children or disabled adults or elderly persons.

(h)  The State Long-Term Care Ombudsman Council and the district long-term care ombudsman councils, with respect to the records of a patient who has been admitted from a nursing home or long-term care facility, when the councils are conducting an investigation involving the patient as authorized under part II of chapter 400, upon presentation of identification as a council member by the person making the request. Disclosure under this paragraph shall only be made after a competent patient or the patient's representative has been advised that disclosure may be made and the patient has not objected.

(i)  A local trauma agency or a regional trauma agency that performs quality assurance activities, or a panel or committee assembled to assist a local trauma agency or a regional trauma agency in performing quality assurance activities. Patient records obtained under this paragraph are confidential and exempt from s. 119.07(1) and s. 24(a), Art. I of the State Constitution.

(j)  Organ procurement organizations, tissue banks, and eye banks required to conduct death records reviews pursuant to s. 395.2050.

(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)  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, social security numbers, and photographs of employees of any licensed facility who provide direct patient care or security services; the home addresses, telephone numbers, social security numbers, photographs, 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. This subsection is subject to the Open Government Sunset Review Act of 1995 in accordance with s. 119.15, and shall stand repealed on October 2, 2004, unless reviewed and saved from repeal through reenactment by the Legislature.

(11)  The home addresses, telephone numbers, social security numbers, and photographs of employees of any licensed facility who have a reasonable belief 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, social security numbers, photographs, 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. This subsection is subject to the Open Government Sunset Review Act of 1995 in accordance with s. 119.15, and shall stand repealed on October 2, 2004, unless reviewed and saved from repeal through reenactment by the Legislature.

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.

Note.--Former s. 395.017.

395.3035  Confidentiality of hospital records and meetings.--

(1)  All meetings of a governing board of a public hospital and all public hospital records shall be open and available to the public in accordance with s. 286.011 and s. 24(b), Art. I of the State Constitution and chapter 119 and s. 24(a), Art. I of the State Constitution, respectively, unless made confidential or exempt by law.

(2)  The following records and information of any hospital that is subject to chapter 119 and s. 24(a), Art. I of the State Constitution are confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution:

(a)  Contracts for managed care arrangements, as managed care is defined in s. 408.701, under which the public hospital provides health care services, including preferred provider organization contracts, health maintenance organization contracts, exclusive provider organization contracts, and alliance network arrangements, and any documents directly relating to the negotiation, performance, and implementation of any such contracts for managed care or alliance network arrangements.

(b)  A strategic plan the disclosure of which would be reasonably likely to be used by a competitor to frustrate, circumvent, or exploit the purpose of the plan before it is implemented and which is not otherwise known or cannot otherwise be legally obtained by the competitor. However, documents that are submitted to the hospital's governing board as part of the board's approval of the hospital's budget, and the budget itself, are not confidential and exempt.

(c)  Trade secrets, as defined in s. 688.002, including reimbursement methodologies and rates.

(d)  Documents, offers, and contracts, not including contracts for managed care, that are the product of negotiations with nongovernmental entities for the payment for services when such negotiations concern services that are or may reasonably be expected by the hospital's governing board to be provided by competitors of the hospital. If the governing board is required to vote on the documents, offers, or contracts, this exemption expires 30 days prior to the date of the meeting at which the hospital's governing board is scheduled to take the vote.

(3)  Those portions of a governing board meeting at which negotiations for contracts with nongovernmental entities occur or are reported on when such negotiations or reports concern services that are or may reasonably be expected by the hospital's governing board to be provided by competitors of the hospital are exempt from the provisions of s. 286.011 and s. 24(b), Art. I of the State Constitution. All governing board meetings at which the board is scheduled to vote to accept, reject, or amend contracts, except managed care contracts, shall be open to the public. All portions of any board meeting which are closed to the public shall be recorded by a certified court reporter. The reporter shall record the times of commencement and termination of the meeting, all discussion and proceedings, the names of all persons present at any time, and the names of all persons speaking. No portion of the meeting shall be off the record. The court reporter's notes shall be fully transcribed and maintained by the hospital records custodian within a reasonable time after the meeting. The transcript shall become public 1 year after the termination or completion of the term of the contract to which such negotiations relate or, if no contract was executed, 1 year after termination of the negotiations.

(4)(a)  Those portions of a board meeting at which one or more written strategic plans that are confidential pursuant to subsection (2) are discussed, reported on, modified, or approved by the governing board are exempt from the provisions of s. 286.011 and s. 24(b), Art. I of the State Constitution. This paragraph is subject to the Open Government Sunset Review Act of 1995 in accordance with s. 119.15 and shall stand repealed on October 2, 2004, unless reviewed and saved from repeal through reenactment by the Legislature.

(b)  All portions of any board meeting which are closed to the public pursuant to this subsection shall be recorded by a certified court reporter. The reporter shall record the times of commencement and termination of the meeting, all discussion and proceedings, the names of all persons present at any time, and the names of all persons speaking. No portion of the meeting shall be off the record. The court reporter's notes shall be fully transcribed and maintained by the hospital records custodian within a reasonable time after the meeting. The closed meeting shall be restricted to discussion, reports, modification, or approval of a written strategic plan. The transcript shall become public 3 years after the date of the board meeting or at an earlier date if the strategic plan discussed, reported on, modified, or approved at the meeting has been publicly disclosed by the hospital or implemented to the extent that confidentiality of the strategic plan is no longer necessary. If a discrete part of a strategic plan has been publicly disclosed by the hospital or has been implemented to the extent that confidentiality of that portion of the plan is no longer necessary, then the hospital shall redact the transcript and release only that part which records discussion of the nonconfidential part of the strategic plan, unless such disclosure would divulge any part of the strategic plan that remains confidential.

(c)  This subsection does not allow the boards of two separate public entities to meet together in a closed meeting to discuss, report on, modify, or approve the implementation of a strategic plan that affects both public entities.

(5)  Any public records, such as tape recordings, minutes, and notes, generated at any governing board meeting or portion of a governing board meeting which is closed to the public pursuant to this section are confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution. All such records shall be retained and shall cease to be exempt at the same time as the transcript of the meeting becomes available to the public.

(6)  For purposes of this section, the term "strategic plan" means any record which describes actions or activities to:

(a)  Initiate or acquire a new health service;

(b)  Materially expand an existing health service;

(c)  Acquire additional facilities by purchase or by lease;

(d)  Materially expand existing facilities;

(e)  Change all or a material part of the use of an existing facility or a newly acquired facility;

(f)  Acquire another health care facility or health care provider;

(g)  Merge or consolidate with another health care facility when the surviving entity is an entity that is subject to s. 24, Art. I of the State Constitution;

(h)  Enter into a shared service arrangement with another health care provider; or

(i)  Any combination of paragraphs (a)-(h).

The term "strategic plan" does not include records that describe the existing operations of a hospital or other health care facility which implement or execute the provisions of a strategic plan, unless disclosure of any such document would divulge any part of a strategic plan which has not been fully implemented or is a record that is otherwise exempt from the public records laws. Such existing operations include, without limitation, the hiring of employees, the purchase of equipment, the placement of advertisements, and the entering into contracts with physicians to perform medical services. Records that describe operations are not exempt, except as specifically provided in this section.

(7)  If the governing board of the hospital closes a portion of any board meeting pursuant to subsection (4) before placing the strategic plan or any separate component of the strategic plan into operation, the governing board must give notice of an open meeting in accordance with s. 286.011, and conduct the meeting to inform the public, in general terms, of the business activity that is to be implemented. If a strategic plan involves a substantial reduction in the level of medical services provided to the public, the meeting notice must be given at least 30 days prior to the meeting at which the governing board considers the decision to implement the strategic plan.

(8)  A hospital may not approve a binding agreement to implement a strategic plan at any closed meeting of the board. Any such approval must be made at a meeting open to the public and noticed in accordance with s. 286.011.

(9)(a)  No less than once every 3 months, the hospital shall report in writing to the governing board on the number of records for which a public records request has been made and the records have been declared to be confidential under the provisions of this section. For each such record, the hospital shall provide the governing board with a general description of the record, the date on which the record became confidential, whether the public will have access to the record at a future time, and, if so, on what date the public will be granted access to such record. The hospital shall also report in writing to the governing board each record that had been confidential to which the public has been granted access since the hospital's last report to the board. For each such record to which the public now has access, the hospital shall give a general description of the record and the date on which the record became confidential. The governing board of the hospital shall retain copies of these reports for 5 years from the date on which the report was made to the governing board of the hospital. If the governing board of a public hospital is comprised of members who are appointed, the board shall transmit each report to the official or authority that appoints the members to the governing board within 10 working days after the date on which the governing board received the report from the hospital.

(b)  The governing board of the hospital shall maintain a written list of the meetings or portions of meetings that were closed under the provisions of this section. For each such meeting or portion of meeting, the governing board shall list the date on which the meeting was closed, the approximate length of time the meeting was closed, a general description of the subject of the meeting, the titles of the meeting participants, and a description of the format of the meeting. The governing board may purge information about a meeting from this list 5 years after the date on which the meeting was closed. If the governing board of a public hospital is comprised of members who are appointed, the board shall transmit the list required by this paragraph to the official or authority that appoints the members to the governing board no less than once every 3 months.

History.--s. 3, ch. 91-219; s. 2, ch. 93-87; s. 1, ch. 95-199; s. 217, ch. 96-406; s. 1, ch. 99-346.

Note.--Former s. 119.16.

¹395.3036  Confidentiality of records and meetings of corporations that lease public hospitals or other public health care facilities.--The records of a private corporation that leases a public hospital or other public health care facility are confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution, and the meetings of the governing board of a private corporation are exempt from s. 286.011 and s. 24(b), Art. I of the State Constitution when the public lessor complies with the public finance accountability provisions of s. 155.40(5) with respect to the transfer of any public funds to the private lessee and when the private lessee meets at least three of the five following criteria:

(1)  The public lessor that owns the public hospital or other public health care facility was not the incorporator of the private corporation 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 ²subsection (2).

(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 the requirements of 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.

¹Note.--

A.  Section 3, ch. 98-330, provides that "[t]his act does not change existing law relating to discovery of records and information that are otherwise discoverable under the Florida Rules of Civil Procedure or any statutory provision allowing discovery or pre-suit disclosure of such records and information for the purpose of civil actions."

B.  Section 4, ch. 98-330, provides that "[t]his act shall take effect [May 30, 1998] and shall apply to existing leases and future leases of public hospitals and other health care facilities."

²Note.--The reference appears to be incorrect.

395.40  Legislative findings and intent.

395.401  Trauma services system plans; verification of trauma centers and pediatric trauma referral centers; procedures; renewal.

395.4015  State regional trauma planning; trauma regions.

395.402  Trauma service areas; number and location of trauma centers.

395.4025  Selection of state-approved trauma centers.

395.403  Reimbursement of state-sponsored trauma centers.

395.4035  Trauma Services Trust Fund.

395.404  Review of trauma registry data; confidentiality and limited release.

395.4045  Emergency medical service providers; transport of trauma victims to trauma centers.

395.405  Rulemaking authority.

395.50  Quality assurance activities of trauma agencies.

395.51  Confidentiality and quality assurance activities of trauma agencies.

395.40  Legislative findings and intent.--

(1)  The Legislature finds that there has been a lack of timely access to trauma care due to the state's fragmented trauma system. This finding is based on the 1999 Trauma System Report on Timely Access to Trauma Care submitted by the department in response to the request of the Legislature.

(2)  The Legislature finds that it is necessary to plan for and to establish an inclusive trauma system to meet the needs of trauma victims. An "inclusive trauma system" means a system designed to meet the needs of all injured trauma victims who require care in an acute-care setting and into which every health care provider or facility with resources to care for the injured trauma victim is incorporated. The Legislature deems the benefits of trauma care provided within an inclusive trauma system to be of vital significance to the outcome of a trauma victim.

(3)  It is the intent of the Legislature to place primary responsibility for the planning and establishment of a statewide inclusive trauma system with the department. The department shall undertake the implementation of a statewide inclusive trauma system as funding is available.

(4)  The Legislature finds that significant benefits are to be obtained by directing the coordination of activities by several state agencies, relative to access to trauma care and the provision of trauma care to all trauma victims. It is the intent of the Legislature that the department, the Agency for Health Care Administration, the Board of Medicine, and the Board of Nursing establish interagency teams and agreements for the development of guidelines, standards, and rules for those portions of the inclusive state trauma system within the statutory authority of each agency. This coordinated approach will provide the necessary continuum of care for the trauma victim from injury to final hospital discharge. The department has the leadership responsibility for this activity.

(5)  In addition, the agencies listed in subsection (4) should undertake to:

(a)  Establish a coordinated methodology for monitoring, evaluating, and enforcing the requirements of the state's inclusive trauma system which recognizes the interests of each agency.

(b)  Develop appropriate roles for trauma agencies, to assist in furthering the operation of trauma systems at the regional level. This should include issues of system evaluation as well as managed care.

(c)  Develop and submit appropriate requests for waivers of federal requirements which will facilitate the delivery of trauma care.

(d)  Develop criteria that will become the future basis for mandatory consultation on the care of trauma victims and mandatory transfer of appropriate trauma victims to trauma centers.

(e)  Develop a coordinated approach to the care of the trauma victim. This shall include the movement of the trauma victim through the system of care and the identification of medical responsibility for each phase of care for out-of-hospital and in-hospital trauma care.

(f)  Require the medical director of an emergency medical services provider to have medical accountability for a trauma victim during interfacility transfer.

(6)  Furthermore, the Legislature encourages the department to actively foster the provision of trauma care and serve as a catalyst for improvements in the process and outcome of the provision of trauma care in an inclusive trauma system. Among other considerations, the department is encouraged to:

(a)  Promote the development of at least one trauma center in every trauma service area.

(b)  Promote the development of a trauma agency for each trauma region.

(c)  Update the state trauma system plan by December 2000 and at least every 5th year thereafter.

History.--s. 193, ch. 99-397.

395.401  Trauma services system plans; verification of trauma centers and pediatric trauma referral centers; procedures; renewal.--

(1)  As used in this part, the term:

(a)  "Agency" means the Agency for Health Care Administration.

(b)  "Charity care" or "uncompensated charity care" means that portion of hospital charges reported to the agency for which there is no compensation for care provided to a patient whose family income for the 12 months preceding the determination is less than or equal to 150 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.

(c)  "Department" means the Department of Health.

(d)  "Level I trauma center" means a hospital that is determined by the department to be in substantial compliance with trauma center and pediatric trauma referral center verification standards as established by rule of the department, and which:

1.  Has formal research and education programs for the enhancement of trauma care.

2.  Serves as a resource facility to Level II trauma centers, pediatric trauma referral centers, and community hospitals.

3.  Ensures an organized system of trauma care.

(e)  "Level II trauma center" means a hospital that is determined by the department to be in substantial compliance with trauma center verification standards as established by rule of the department, and which:

1.  Serves as a resource facility to community hospitals.

2.  Ensures an organized system of trauma care.

(f)  "Pediatric trauma referral center" means a hospital that is determined to be in substantial compliance with pediatric trauma referral center standards as established by rule of the department.

(g)  "State-approved trauma center" means a hospital that has successfully completed the state-approved selection process pursuant to s. 395.4025 and has been approved by the department to operate as a trauma center in the state.

(h)  "State-sponsored trauma center" means a state-approved trauma center that receives state funding for trauma care services.

(i)  "Trauma agency" means an agency established and operated by one or more counties, or an entity with which one or more counties contract, for the purpose of administering an inclusive regional trauma system.

(j)  "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.

(k)  "Trauma center" means any hospital that has been determined by the department to be in substantial compliance with trauma center verification standards.

(l)  "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.

(m)  "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.

(2)(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.

(b)  The local and regional trauma agencies shall develop and submit to the department plans for local and regional trauma services systems. The plans must include, at a minimum, the following components:

1.  The organizational structure of the trauma system.

2.  Prehospital care management guidelines for triage and transportation of trauma cases.

3.  Flow patterns of trauma cases and transportation system design and resources, including air transportation services, and provision for interfacility transfer.

4.  The number and location of needed state-approved trauma centers based on local needs, population, and location and distribution of resources.

5.  Data collection regarding system operation and patient outcome.

6.  Periodic performance evaluation of the trauma system and its components.

7.  The use of air transport services within the jurisdiction of the local trauma agency.

8.  Public information and education about the trauma system.

9.  Emergency medical services communication system usage and dispatching.

10.  The coordination and integration between the verified trauma care facility and the nonverified health care facilities.

11.  Medical control and accountability.

12.  Quality control and system evaluation.

(c)  The department shall receive plans for the implementation of inclusive trauma systems from trauma agencies. The department may approve or not approve trauma agency plans based on the conformance of the plan with this section and ss. 395.4015, 395.404, and 395.4045 and the rules adopted by the department pursuant to those sections. The department shall approve or disapprove the plans within 120 days after the date the plans are submitted to the department.

(d)  A trauma agency shall not operate unless the department has approved the local or regional trauma services system plan of the agency.

(e)  The department may grant an exception to a portion of the rules adopted pursuant to this section or s. 395.4015 if the local or regional trauma agency proves that, as defined in the rules, compliance with that requirement would not be in the best interest of the persons served within the affected local or regional trauma area.

(f)  A local or regional trauma agency may implement a trauma care system only if the system meets the minimum standards set forth in the rules for implementation established by the department and if the plan has been submitted to, and approved by, the department. At least 60 days before the local or regional trauma agency submits the plan for the trauma care system to the department, the local or regional trauma agency shall hold a public hearing and give adequate notice of the public hearing to all hospitals and other interested parties in the area to be included in the proposed system.

(g)  Local or regional trauma agencies may enter into contracts for the purpose of implementing the local or regional plan. If local or regional agencies contract with hospitals for trauma services, such agencies must contract only with hospitals which are verified trauma centers.

(h)  Local or regional trauma agencies providing service for more than one county shall, as part of their formation, establish interlocal agreements between or among the several counties in the regional system.

(i)  This section does not restrict the authority of a health care facility to provide service for which it has received a license pursuant to this chapter.

(j)  Any hospital which is verified as a trauma center shall accept all trauma victims that are appropriate for the facility regardless of race, sex, creed, or ability to pay.

(k)  It is unlawful for any hospital or other facility to hold itself out as a trauma center unless it has been so verified.

(l)  A county, upon the recommendations of the local or regional trauma agency, may adopt ordinances governing the transport of a patient who is receiving care in the field from prehospital emergency medical personnel when the patient meets specific criteria for trauma, burn, or pediatric centers adopted by the local or regional trauma agency. These ordinances must be consistent with s. 395.4045, ordinances adopted under s. 401.25(6), and the local or regional trauma system plan and, to the furthest possible extent, must ensure that individual patients receive appropriate medical care while protecting the interests of the community at large by making maximum use of available emergency medical care resources.

(m)  The local or regional trauma agency shall, consistent with the regional trauma system plan, coordinate and otherwise facilitate arrangements necessary to develop a trauma services system.

(n)  After the submission of the initial trauma system plan, each trauma agency shall, every 5th year, submit to the department for approval an updated plan that identifies the changes, if any, to be made in the regional trauma system.

(o)  This section does not preclude a local or regional trauma agency from adopting trauma care system standards.

(3)  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.

(4)  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.

Note.--Former s. 395.031.

395.4015  State regional trauma planning; trauma regions.--

(1)  The department shall establish a state trauma system plan. As part of the state trauma system plan, the department shall establish trauma regions which cover all geographical areas of the state. These regions may serve as the basis for the development of department-approved local or regional trauma plans. The department shall base its definition of the regions upon:

(a)  Geographical considerations so as to ensure rapid access to trauma care by patients;

(b)  Historical patterns of patient referral and transfer in an area;

(c)  Inventories of available trauma care resources;

(d)  Predicted population growth characteristics;

(e)  Transportation capabilities, including ground and air transport;

(f)  Medically appropriate ground and air travel times; and

(g)  Other appropriate criteria.

(2)  The department shall develop trauma systems plans for the department-defined trauma regions which include at a minimum the following components:

(a)  An assessment of current and future trauma care needs of the population, based upon incidence rates and acuity indicators developed by the department, as well as other relevant characteristics of the region.

(b)  The organizational structure of the regional trauma system, including the identification of local trauma agency service areas within the region.

(c)  Prehospital care management guidelines for triage and transportation of trauma cases.

(d)  Flow patterns of trauma cases and transportation system design and resources, including air transportation services, and provision for interfacility transfer.

(e)  The current and projected number, acuity level, and geographic location of trauma cases expected so as to assure that the assessed current and future trauma care needs of the population are adequately met and that state-sponsored trauma centers will maintain the volume of cases sufficient to provide quality care to trauma cases referred to them.

(f)  The availability of qualified health professionals, including physicians and surgeons, capable of staffing trauma centers to the level of current and future assessed needs.

(g)  Data collection regarding system operation and patient outcome, as well as the number, type, and generalized locations of state-sponsored trauma centers needed to meet the needs of the population.

(h)  Periodic performance evaluation of the trauma system and its components.

(i)  The type and extent of air transport services available and needed in each region.

(j)  Public information and education about the trauma system.

(k)  Emergency medical services communication system usage and dispatching.

(l)  The coordination and integration between the state-sponsored trauma centers, verified trauma centers, and other health care facilities which may provide services to trauma victims.

(m)  Medical control and accountability.

(n)  Quality control and system evaluation.

(3)  The department shall consider the advice and recommendations of any affected local or regional trauma agency in developing the state trauma systems plan. The department may, in lieu of specific regional components of its own plan, accept components developed by local or regional trauma agencies.

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.

Note.--Former s. 395.032.

395.402  Trauma service areas; number and location of trauma centers.--

(1)  The Legislature recognizes that Level I and Level II trauma centers should each be capable of annually treating a minimum of 1,000 and 500 patients, respectively, with an injury severity score (ISS) of 9 or greater. Further, the Legislature finds that, based on the numbers and locations of trauma victims with these injury severity scores, there should be 19 trauma service areas in the state, and, at a minimum, there should be at least one trauma center in each service area.

(2)  It is the intent of the Legislature that, as a planning guideline, Level I and Level II trauma centers should generally each provide care annually to a minimum of 1,000 and 500 patients, respectively. Level II trauma centers in counties of more than 500,000 population are expected to be able to care for 1,000 patients per year, as a planning guideline.

(3)  Trauma service areas are to be used. The department shall periodically review the assignment of the 67 counties to trauma service areas. These assignments are made for the purpose of developing a system of trauma centers. Revisions made by the department should take into consideration the recommendations made as part of the regional trauma system plans approved by the department, as well as the recommendations made as part of the state trauma system plan. These areas must, at a minimum, be reviewed in the year 2000 and every 5 years thereafter. Until the department completes its initial review, the assignment of counties shall remain as established pursuant to chapter 90-284, Laws of Florida.

(a)  The following trauma service areas are hereby established:

1.  Trauma service area 1 shall consist of Escambia, Okaloosa, Santa Rosa, and Walton Counties.

2.  Trauma service area 2 shall consist of Bay, Gulf, Holmes, and Washington Counties.

3.  Trauma service area 3 shall consist of Calhoun, Franklin, Gadsden, Jackson, Jefferson, Leon, Liberty, Madison, Taylor, and Wakulla Counties.

4.  Trauma service area 4 shall consist of Alachua, Bradford, Columbia, Dixie, Gilchrist, Hamilton, Lafayette, Levy, Putnam, Suwannee, and Union Counties.

5.  Trauma service area 5 shall consist of Baker, Clay, Duval, Nassau, and St. Johns Counties.

6.  Trauma service area 6 shall consist of Citrus, Hernando, and Marion Counties.

7.  Trauma service area 7 shall consist of Flagler and Volusia Counties.

8.  Trauma service area 8 shall consist of Lake, Orange, Osceola, Seminole, and Sumter Counties.

9.  Trauma service area 9 shall consist of Pasco and Pinellas Counties.

10.  Trauma service area 10 shall consist of Hillsborough County.

11.  Trauma service area 11 shall consist of Hardee, Highlands, and Polk Counties.

12.  Trauma service area 12 shall consist of Brevard and Indian River Counties.

13.  Trauma service area 13 shall consist of DeSoto, Manatee, and Sarasota Counties.

14.  Trauma service area 14 shall consist of Martin, Okeechobee, and St. Lucie Counties.

15.  Trauma service area 15 shall consist of Charlotte, Glades, Hendry, and Lee Counties.

16.  Trauma service area 16 shall consist of Palm Beach County.

17.  Trauma service area 17 shall consist of Collier County.

18.  Trauma service area 18 shall consist of Broward County.

19.  Trauma service area 19 shall consist of Dade and Monroe Counties.

(b)  Each trauma service area should have at least one Level I or Level II trauma center.

(c)  There shall be no more than a total of 44 state-sponsored trauma centers in the state.

History.--ss. 5, 15, ch. 90-284; ss. 37, 98, ch. 92-289; s. 195, ch. 99-397.

Note.--Former s. 395.033.

395.4025  Selection of state-approved trauma centers.--

(1)  For purposes of developing a system of state-approved trauma centers, the department shall use the 19 trauma service areas established in s. 395.402. Within each service area and based on the state trauma system plan, the local or regional trauma services system plan, recommendations of the local or regional trauma agency, and the 1990 Report and Proposal for Funding State-Sponsored Trauma Centers, the department shall establish the approximate number of state-approved trauma centers needed to ensure reasonable access to high-quality trauma services. Using the guidelines and procedures outlined in the 1990 report, except when in conflict with those prescribed in this section, the department shall select those hospitals that are to be recognized as state-approved trauma centers and shall include all trauma centers verified as of October 1, 1990, and subsequently, subject to specific programmatic and quality of care standards.

(2)(a)  The department shall annually notify each acute care general hospital and each local and each regional trauma agency in the state that the department is accepting letters of intent from hospitals that are interested in becoming state-approved trauma centers. In order to be considered by the department, a hospital that operates within the geographic area of a local or regional trauma agency must certify that its intent to operate as a state-approved trauma center is consistent with the trauma services plan of the local or regional trauma agency, as approved by the department, if such agency exists. Letters of intent must be postmarked no later than midnight October 1. This paragraph does not apply to any hospital that is a provisional or verified trauma center on January 1, 1992.

(b)  By October 15, the department shall send to all hospitals that submitted a letter of intent an application package that will provide the hospitals with instructions for submitting information to the department for selection as a state-approved trauma center. The standards for verification of trauma centers and pediatric trauma referral centers provided for in s. 395.401(3), as adopted by rule of the department, shall serve as the basis for these instructions.

(c)  In order to be considered by the department, applications from those hospitals seeking selection as state-approved trauma centers, including those current verified trauma centers that seek to be state-approved trauma centers, must be received by the department no later than the close of business on April 1. The department shall conduct a provisional review of each application for the purpose of determining that the hospital's application is complete and that the hospital has the critical elements required for a state-approved trauma center. This critical review will be based on trauma center verification standards and shall include, but not be limited to, a review of whether the hospital has:

1.  Equipment and physical facilities necessary to provide trauma services.

2.  Personnel in sufficient numbers and with proper qualifications to provide trauma services.

3.  An effective quality assurance process.

4.  Submitted written confirmation by the local or regional trauma agency that the verification of the hospital as a state-approved trauma center is consistent with the plan of the local or regional trauma agency, as approved by the department, if such agency exists. This subparagraph applies to any hospital that is not a provisional or verified trauma center on January 1, 1992.

(d)1.  Notwithstanding other provisions in this section, the department may grant up to an additional 18 months to a hospital applicant that is unable to meet all requirements as provided in paragraph (c) at the time of application if the number of applicants in the service area in which the applicant is located is equal to or less than the service area allocation, as provided by rule of the department. An applicant that is granted additional time pursuant to this paragraph shall submit a plan for departmental approval which includes timelines and activities that the applicant proposes to complete in order to meet application requirements. Any applicant that demonstrates an ongoing effort to complete the activities within the timelines outlined in the plan shall be included in the number of state-approved trauma centers at such time that the department has conducted a provisional review of the application and has determined that the application is complete and that the hospital has the critical elements required for a state-approved trauma center.

2.  Timeframes provided in subsections (1)-(8) shall be stayed until the department determines that the application is complete and that the hospital has the critical elements required for a state-approved trauma center.

(3)  After April 30, any hospital that submitted an application found acceptable by the department based on provisional review, including all trauma centers verified as of December 1, 1989, shall be eligible to operate as a provisional state-approved trauma center.

(4)  Between May 1 and October 1 of each year, the department shall conduct an in-depth evaluation of all applications found acceptable in the provisional review. The applications shall be evaluated against criteria enumerated in the application packages as provided to the hospitals by the department.

(5)  Beginning October 1 of each year and ending no later than June 1 of the following year, a review team of out-of-state experts assembled by the department shall make onsite visits to all provisional state-approved trauma centers. The department shall develop a survey instrument to be used by the expert team of reviewers. The instrument shall include objective criteria and guidelines for reviewers based on existing trauma center and pediatric trauma referral center verification standards such that all trauma centers and pediatric trauma referral centers are assessed equally. The survey instrument shall also include a uniform rating system that will be used by reviewers to indicate the degree of compliance of each center with specific standards, and to indicate the quality of care provided by each center as determined through an audit of patient charts. In addition, hospitals being considered as provisional state-approved trauma centers shall meet all the requirements of a verified trauma center or pediatric trauma referral center, and shall be located in a trauma service area that has a need for such a center.

(6)  Based on recommendations from the review team, the department shall select state-approved trauma centers by July 1. An applicant for designation as a state-approved trauma center or a state-approved pediatric trauma referral center may request an extension of its provisional status if it submits a corrective action plan to the department. The corrective action plan must demonstrate the ability of the applicant to correct deficiencies noted during the applicant's onsite review conducted by the department between the previous October 1 and June 1. The department may extend the provisional status of an applicant for designation as a state-approved trauma center or a state-approved pediatric trauma referral center through December 31 if the applicant provides a corrective action plan acceptable to the department. The department or a team of out-of-state experts assembled by the department shall conduct an onsite visit on or before November 1 to confirm that the deficiencies have been corrected. The provisional state-approved trauma center or the provisional state-approved pediatric trauma referral center is responsible for all costs associated with the onsite visit in a manner prescribed by rule of the department. By January 1, the department must approve or deny the application of any provisional applicant granted an extension. Each state-approved trauma center shall be granted a 7-year verification period during which time it must continue to maintain trauma center verification standards and acceptable patient outcomes as determined by department rule. A verification, 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. After July 1, 1992, only those hospitals selected as state-approved trauma centers may operate as trauma centers.

(7)  Any hospital that wishes to protest a decision made by the department based on the department's preliminary or in-depth review of applications or on the recommendations of the site visit review team pursuant to this section shall proceed as provided in chapter 120. 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.

(8)  Notwithstanding any provision of chapter 381, a hospital licensed under ss. 395.001-395.3025 that operates a state-approved trauma center may not terminate or substantially reduce the availability of trauma service without providing at least 6 months' notice of its intent to terminate such service. Such notice shall be given to the Department of Health, to all affected local or regional trauma agencies, and to all state-approved trauma centers, hospitals, and emergency medical service providers in the trauma service area.

(9)  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, pediatric trauma referral 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 of verification, and monitoring patient outcomes. A trauma center, pediatric trauma referral 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, pediatric trauma referral center, hospital, emergency medical service provider, medical examiner, or an individual who provides trauma services is not disclosed.

(10)  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.

(11)  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, pediatric trauma referral centers, hospitals, emergency medical service providers, local or regional trauma agencies, or medical examiners regarding the care, transport, treatment, or examination of trauma patients.

(12)  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.

(13)  The department may adopt, by rule, the procedures and process by which it will select state-approved trauma centers. Such procedures and process must be used in annually selecting state-approved trauma centers and must be consistent with subsections (1)-(8) 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.

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.

Note.--Former s. 395.0335.

395.403  Reimbursement of state-sponsored trauma centers.--

(1)  The Legislature finds that many hospitals which provide services to trauma victims are not adequately compensated for such treatment. The Legislature also recognizes that the current verified trauma centers are providing such services without adequate reimbursement. Therefore, it is the intent of the Legislature to provide financial support to the current verified trauma centers and to establish a system of state-sponsored trauma centers as soon as feasibly possible. It is also the intent of the Legislature that this system of state-sponsored trauma centers be assisted financially based on the volume and acuity of uncompensated trauma care provided.

(2)  All provisional and state-approved trauma centers shall be considered state-sponsored trauma centers when state funds are specifically appropriated for state-sponsored trauma centers in the General Appropriations Act.

(3)  To receive state funding, a state-sponsored trauma center shall submit a claim electronically via the Trauma Claims Processing System, designed, developed, implemented, and operated by the department's Medicaid program, to the department's Medicaid program upon discharge of a trauma patient. When a hospital stay spans a state fiscal year, a separate hospital claim shall be submitted for the hospital days incurred in each fiscal year.

(4)(a)  State-sponsored trauma centers shall determine each trauma patient's eligibility for state funding prior to the submission of a claim.

(b)  A trauma patient treated must meet the definition of charity care, have been designated as having an ISS score of 9 or greater, and have received services that are medically necessary from a state-sponsored trauma center in order for the state-sponsored trauma center to receive state funding for that patient.

(c)  Each state-sponsored trauma center shall retain appropriate documentation showing a trauma patient's eligibility for state funding. Documentation recognized by the department as appropriate shall be limited to one of the following:

1.  W-2 withholding forms.

2.  Payroll stubs.

3.  Income tax returns.

4.  Forms approving or denying unemployment compensation or workers' compensation.

5.  Written verification of wages from employer.

6.  Written verification from public welfare agencies or any other governmental agency which can attest to the patient's income status for the past 12 months.

7.  A witnessed statement signed by the patient or responsible party, as provided for in Pub. L. No. 79-725, as amended, known as the Hill-Burton Act, except that such statement need not be obtained within 48 hours of the patient's admission to the hospital as required by the Hill-Burton Act. The statement shall include acknowledgment that, in accordance with s. 817.50, providing false information to defraud a hospital for the purposes of obtaining goods or services is a misdemeanor of the second degree.

(d)  The department shall conduct an audit or shall contract with an independent party to conduct an audit of each state-sponsored trauma center's claims to ensure that state funding was only provided for eligible trauma patients and medically necessary services.

(e)  The department's Medicaid program office shall check each claim to confirm that the patient is not covered under the Medicaid program and shall pay the claim out of the Trauma Services Trust Fund. Trauma patients who are eligible for the Medicaid program shall not be considered eligible for the state-sponsored trauma center program except for Medicaid noncovered services. If a claim is denied by the Trauma Claims Processing System as a result of Medicaid eligibility for Medicaid covered services, the hospital shall submit a claim to the Medicaid fiscal agent for payment.

(5)  State funding shall be at a per diem rate equal to $860 to provisional state-approved and state-approved trauma centers. This rate shall be effective for the first 12 months of funding, after which time payment to provisional state-approved and state-approved trauma centers shall be based on a trauma cost-based reimbursement methodology developed by the department. The department shall consult with representatives from the hospital industry including the Florida Hospital Association, the Association of Voluntary Hospitals of Florida, and the Florida League of Hospitals in the development of the reimbursement methodology.

(6)(a)  To ensure a fair distribution of funds appropriated for state-sponsored trauma centers and to ensure that no state-sponsored trauma center gains an unfair advantage due solely to its ability to bill more quickly than another state-sponsored trauma center, the total amount of state funds appropriated in the General Appropriations Act for this section shall be divided into 19 trauma fund accounts with an account for each service area established in s. 395.402(3). The amount of funds distributed to a service area shall be based on the following formula:

SAAA = service area appropriation amount.

SATD = uncompensated service area trauma days with ISS score of 9 or greater.

TTD = uncompensated total trauma days with ISS score of 9 or greater for all 19 service areas.

TA = total dollars appropriated for state-sponsored trauma centers.

(b)  The database to be used for this calculation shall be the detailed patient discharge data of the most recently completed calendar year for which the board possesses data. Out-of-state days that are included in the database shall be allocated to the service area where the treating hospital is located.

(c)  Fifty percent of the funds allocated to those service areas which had one or more trauma centers as of December 1, 1989, shall be distributed to those verified trauma centers proportionately based on volume and acuity of uncompensated trauma care provided during the most recently completed calendar year for which the board possesses data in a lump-sum payment on the date funding becomes available. These trauma centers shall submit claims pursuant to subsection (3) in order to justify this funding. Effective 9 months after funding becomes available, any trauma center which fails to submit claims for reimbursement equal to or greater than the amount the trauma center received under the initial allocation shall return any unearned funds to the department for distribution pursuant to paragraph (e). Once this 50-percent lump sum is depleted, a trauma center will be reimbursed from the remaining 50 percent of the service area's original allocation.

(d)  The department shall pay trauma claims on a monthly basis. In a given month when the outstanding claims will exceed the unexpended funds allocated to a service area, the department shall pay all of the submitted claims for the service area on a pro rata basis.

(e)  At the end of the fiscal year, the unexpended funds for each service area shall be placed in one large state trauma account from which all remaining claims are paid without regard to service area on a pro rata basis until such funds are depleted.

(f)  For any state fiscal year, reimbursement for any patient residing outside the trauma service area of the state-sponsored trauma center where the patient is treated shall be paid out of the funds allocated for the trauma service area where the patient resides. Out-of-state days shall be paid from the service area where the treating hospital is located.

(7)  In order to receive payments under this section, a hospital shall be a state-sponsored trauma center and shall:

(a)  Agree to conform to all departmental requirements as provided by rule to assure high-quality trauma services.

(b)  Agree to provide information concerning the provision of trauma services to the department, in a form and manner prescribed by rule of the department.

(c)  Agree to accept all trauma patients, regardless of ability to pay, on a functional space-available basis.

(8)  A state-sponsored trauma center which fails to comply with any of the conditions listed in subsection (7) or the applicable rules of the department shall not receive payments under this section for the period in which it was not in compliance.

History.--ss. 7, 15, ch. 90-284; s. 79, ch. 91-282; s. 92, ch. 92-33; ss. 39, 98, ch. 92-289; s. 19, ch. 98-89.

Note.--Former s. 395.034.

395.4035  Trauma Services Trust Fund.--

(1)  There is hereby created the Trauma Services Trust Fund in the State Treasury, which shall be used exclusively for the development and support of a system of state-sponsored trauma centers. Trust fund revenue shall be used for the purpose of funding trauma patient care in a provisional state-sponsored trauma center, or a state-sponsored trauma center as provided for in this act; for funding the associated trauma claims processing costs, including the costs for the design, development, implementation, and operation of a payment system; and for administration of this act.

(2)  Any funds appropriated in the General Appropriations Act for the implementation of this act, and any other funds that become available for the implementation of this act, may be deposited in the Trauma Services Trust Fund.

History.--s. 9, ch. 90-284; s. 80, ch. 91-282; s. 40, ch. 92-289.

Note.--Former s. 395.0345.

395.404  Review of trauma registry data; confidentiality and limited release.--

(1)  Each trauma center shall furnish, and all acute care hospitals shall furnish for department review, trauma registry data as prescribed by rule of the department for the purpose of monitoring patient outcome and ensuring compliance with the standards of approval.

(2)  Notwithstanding the provisions of ¹s. 413.48, each trauma center and acute care hospital shall submit severe disability and head-injury registry data to the department as provided by rule in lieu of submitting such registry information to the Department of Labor and Employment Security. Each trauma center and acute care hospital shall continue to provide initial notification of persons who have severe disabilities and head injuries to the Department of Labor and Employment Security within timeframes provided in chapter 413. Such initial notification shall be made in the manner prescribed by the Department of Labor and Employment Security for the purpose of providing timely vocational rehabilitation services to the severely disabled or head-injured person.

(3)  Trauma registry data obtained 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. However, the department may provide such trauma registry data to the person, trauma center, pediatric trauma referral center, hospital, emergency medical service provider, local or regional trauma agency, medical examiner, or other entity from which the data were obtained. The department may also use or provide trauma registry data for purposes of research in accordance with the provisions of chapter 405.

History.--s. 7, ch. 87-399; s. 3, ch. 88-186; s. 1, ch. 88-303; s. 10, ch. 90-344; ss. 41, 98, ch. 92-289; s. 3, ch. 94-324; s. 4, ch. 95-387; s. 28, ch. 95-398; s. 219, ch. 96-406.

¹Note.--Transferred to s. 381.74 by s. 18, ch. 99-240.

Note.--Former s. 395.035.

395.4045  Emergency medical service providers; transport of trauma victims to trauma centers.--

(1)  Each emergency medical services provider licensed under chapter 401 shall transport trauma alert victims to hospitals approved as trauma centers, except as may be provided for either in department-approved local or regional trauma transport protocol or, if no local or regional trauma transport protocol is in effect, as provided for in a department-approved provider's trauma transport protocol. Development of regional trauma protocols shall be through consultation with interested parties, including, but not limited to, each approved trauma center; physicians specializing in trauma care, emergency care, and surgery in the region; each trauma system administrator in the region; and each emergency medical service provider in the region licensed under chapter 401. Trauma alert victims shall be identified through the use of a trauma scoring system. The department shall specify by rule the subjects to be included in an emergency medical service provider's trauma transport protocol and shall approve or disapprove each such protocol.

(2)  If an air ambulance service is available in the trauma service area in which an emergency medical service provider is located, trauma transport protocols shall not provide for transport outside of the trauma service area unless otherwise provided for by written mutual agreement. If air ambulance service is not available and there is no agreement for interagency transport of trauma patients between two adjacent local or regional trauma agencies, both of which include at least one approved trauma center, then the transport of a trauma patient with an immediately life-threatening condition shall be to the most appropriate trauma center as defined pursuant to trauma transport protocols approved by the department. The provisions of this subsection shall apply only to those counties with a population in excess of 1 million residents.

History.--s. 6, ch. 87-399; s. 1, ch. 88-303; ss. 42, 98, ch. 92-289; s. 196, ch. 99-397.

Note.--Former s. 395.036.

395.405  Rulemaking authority.--The department shall adopt rules to implement ss. 395.0199, 395.401, 395.4015, 395.402, 395.4025, 395.403, 395.404, and 395.4045.

History.--s. 7, ch. 89-275; s. 17, ch. 89-283; s. 2, ch. 90-187; s. 1, ch. 90-192; s. 8, ch. 90-284; ss. 43, 98, ch. 92-289.

Note.--Former s. 395.037.

395.50  Quality assurance activities of trauma agencies.--

(1)  As used in this section, the term "entity" means a local trauma agency or a regional trauma agency that performs quality assurance activities, or a panel or committee assembled to assist a local trauma agency or a regional trauma agency in performing quality assurance activities in accordance with a plan approved under s. 395.401.

(2)  A hospital or an emergency medical services provider shall disclose records and reports of patient care, transport, and treatment to an entity, and a hospital or an emergency medical services provider may disclose to an entity and to one another its own quality assurance proceedings, records, or reports. However, this section does not require a hospital or an emergency medical services provider to disclose to an entity its own quality assurance proceedings, records, or reports prepared under s. 395.0191, s. 395.0193, s. 401.265, s. 401.30, s. 401.425, or s. 766.101.

(3)  A local trauma agency or regional trauma agency may assemble a panel or committee to assist in performing the tasks authorized by an approved plan under s. 395.401.

(4)  The investigations, proceedings, records, and reports obtained or made by any entity under this section are not subject to discovery or introduction into evidence in a civil or administrative action that arises out of a matter that is the subject of evaluation and review by the entity, and a person who attends a meeting of the entity may not testify in any such civil or administrative action as to any evidence or other matter produced or presented during the proceedings of the entity or as to any findings, recommendations, evaluations, opinions, or other actions of the entity or any members thereof. However, information, documents, or records provided to the entity from a source external to the entity are not immune from discovery or use in a civil or administrative action, and a person who is a member of the entity may testify in such action as to matters within his or her knowledge, but may not be asked about his or her testimony before the entity or about information obtained from or opinions formed by him or her as a result of participating in activities conducted by the entity.

(5)(a)  There is no monetary liability on the part of, and no cause of action arises against, any person, including a person who acts as a witness, incident reporter to, or investigator for an entity for any act or proceeding undertaken or performed within the scope of the functions of the entity if the action is taken without intentional fraud or malice.

(b)  The provisions of this section do not supersede the provisions of s. 768.28.

(6)  Except as provided in subsection (4), this section does not confer immunity from liability on a person for services performed outside his or her capacity as a member of an entity or upon a person who acts as a witness for, incident reporter to, or investigator for the entity for any act or proceeding undertaken or performed outside the scope of the functions of the entity.

(7)  If the defendant prevails in an action brought by a person against a person who initiated, participated in, was a witness in, or conducted any review as authorized by this section, the court shall award reasonable attorney's fees and costs to the defendant.

(8)  Nothing in this section, ss. 395.401-395.405, or s. 395.51 prohibits admitting into evidence patient care, transport, or treatment records or reports, or records or reports of the department in any civil or administrative action brought by or involving the department, excluding the name, residence or business address, telephone number, social security or other identifying number, or photograph of any person or the spouse, relative, or guardian of such person or other patient-specific information that otherwise identifies the patient, either directly or indirectly.

History.--s. 2, ch. 94-129; s. 1053, ch. 95-148.

395.51  Confidentiality and quality assurance activities of trauma agencies.--

(1)  All information which is confidential by operation of law and which is obtained by a local or regional trauma agency or a panel or committee assembled by a local or regional trauma agency pursuant to s. 395.50, shall retain its confidential status and be exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution.

(2)  All information which is confidential by operation of law and which is obtained by a hospital or emergency medical services provider from a local or regional trauma agency or a panel or committee assembled by a local or regional trauma agency pursuant to s. 395.50, shall retain its confidential status and shall be exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution.

(3)  Portions of meetings, proceedings, reports, and records of a local or regional trauma agency, or a panel or committee assembled by a local or regional trauma agency pursuant to this chapter, which relate solely to patient care quality assurance are confidential and exempt from the provisions of s. 286.011, and s. 24(b), Art. I of the State Constitution and are confidential and exempt from the provisions of s. 119.07(1) and s. 24(a), Art. I of the State Constitution, respectively. Patient care quality assurance, for the purpose of this section, shall include consideration of specific persons, cases, incidents relevant to the performance of quality control, and system evaluation.

History.--s. 4, ch. 94-260; s. 220, ch. 96-406.

395.602  Rural hospitals.

395.603  Rules; rural hospital impact statement.

395.604  Other rural hospital programs.

395.605  Emergency care hospitals.

395.6061  Rural hospital capital improvement.

395.602  Rural hospitals.--

(1)  LEGISLATIVE FINDINGS AND INTENT.--

(a)  The Legislature finds that rural hospitals are the nucleus or "backbone" of rural health care systems. Public health programs and physicians depend on rural hospitals to meet many of their medical needs. Rural hospitals are usually the only source of emergency medical care in rural areas for life-threatening situations and play a crucial role in attracting physicians to rural areas. The Legislature deems the benefits derived from these features to be truly significant as rural counties with hospitals have lower accidental death rates and lower incidence of low birth weight than rural counties without hospitals. In addition, rural hospitals enhance their communities beyond the scope of health care as they are among the largest employers in rural areas and substantially foster economic development and growth. For these reasons, the Legislature finds that rural hospitals are widely viewed as integral to the welfare of rural communities. However, the rural health care system is experiencing significant instability as the financial viability of many of these hospitals is threatened. The Legislature finds that sharply declining occupancy rates, increasing dependence on Medicaid and Medicare reimbursements, liability concerns, frequent changes in ownership, high levels of bad debt, greater competition on more sophisticated levels with urban hospitals, and physician and personnel staffing problems threaten the existence of some rural hospitals.

(b)  It is the intent of the Legislature to ease the burdens experienced by rural hospitals in personnel staffing by:

1.  Providing financial incentives under the Medical Education Tuition Reimbursement Program in order to increase the number of primary care physicians and nurses in rural areas; and

2.  Requiring a study of problems unique to rural hospitals generated by existing licensure and certification requirements for allied health care practitioners in the state.

(c)  In addition, it is the intent of the Legislature to ease the severe financial constraints being experienced by some rural hospitals by extending Medicaid reimbursements to rural hospital swing-beds and establishing the full utilization, when feasible, of rural hospital services by departmental primary care programs and programs serving the elderly citizens of the state.

(d)  Furthermore, the Legislature encourages the department to actively foster the provision of health care services in rural areas and serve as a catalyst for improved health services to citizens in rural areas of the state. Among other considerations, the department is encouraged to:

1.  Promote the location and relocation of health care practitioners in rural areas.

2.  Further analyze the financial viability of rural hospitals and their continued existence in rural counties.

3.  Integrate policies related to physician workforce, hospitals, primary care, and state regulatory functions.

4.  Collect relevant data on rural health care issues for use in departmental policy development.

5.  Propose solutions for problems affecting health care delivery in rural areas.

(2)  DEFINITIONS.--As used in this part:

(a)  "Emergency care hospital" means a medical facility which provides:

1.  Emergency medical treatment; and

2.  Inpatient care to ill or injured persons prior to their transportation to another hospital or provides inpatient medical care to persons needing care for a period of up to 96 hours. The 96-hour limitation on inpatient care does not apply to respite, skilled nursing, hospice, or other nonacute care patients.

(b)  "Essential access community hospital" means any facility which:

1.  Has at least 100 beds;

2.  Is located more than 35 miles from any other essential access community hospital, rural referral center, or urban hospital meeting criteria for classification as a regional referral center;

3.  Is part of a network that includes rural primary care hospitals;

4.  Provides emergency and medical backup services to rural primary care hospitals in its rural health network;

5.  Extends staff privileges to rural primary care hospital physicians in its network; and

6.  Accepts patients transferred from rural primary care hospitals in its network.

(c)  "Inactive rural hospital bed" means a licensed acute care hospital bed, as defined in ¹s. 395.002(12), that is inactive in that it cannot be occupied by acute care inpatients.

(d)  "Rural area health education center" means an area health education center (AHEC), as authorized by Pub. L. No. 94-484, which provides services in a county with a population density of no greater than 100 persons per square mile.

(e)  "Rural hospital" means an acute care hospital licensed under this chapter, having 100 or fewer licensed beds and an emergency room, located in an area defined as rural by the United States Census, and which is:

1.  The sole provider within a county with a population density of no greater than 100 persons per square mile; or

2.  An acute care hospital, in a county with a population density of no greater than 100 persons per square mile, which is at least 30 minutes of travel time, on normally traveled roads under normal traffic conditions, from any other acute care hospital within the same county; or

3.  A hospital supported by a tax district or subdistrict whose boundaries encompass a population of 100 persons or fewer per square mile; or

4.  A hospital in a constitutional charter county with a population of over 1 million persons that has imposed a local option health service tax pursuant to law and in an area that was directly impacted by a catastrophic event on August 24, 1992, for which the Governor of Florida declared a state of emergency pursuant to chapter 125, and has 120 beds or less that serves an agricultural community with an emergency room utilization of no less than 20,000 visits and a Medicaid in-patient utilization rate greater than 15 percent.

Population densities used in this paragraph must be based upon the most recently completed United States census.

(f)  "Rural primary care hospital" means any facility meeting the criteria in paragraph (e) or s. 395.605 which provides:

1.  Twenty-four-hour emergency medical care;

2.  Temporary inpatient care for periods of 72 hours or less to patients requiring stabilization before discharge or transfer to another hospital. The 72-hour limitation does not apply to respite, skilled nursing, hospice, or other nonacute care patients; and

3.  Has no more than six licensed acute care inpatient beds.

(g)  "Swing-bed" means a bed which can be used interchangeably as either a hospital, skilled nursing facility (SNF), or intermediate care facility (ICF) bed pursuant to the ²Code of Federal Regulations, parts 405, 435, 440, 442, and 447.

(3)  USE OF FUNDS.--It is the intent of the Legislature that funds as appropriated shall be utilized by the department for the purpose of increasing the number of primary care physicians, physician assistants, certified nurse midwives, nurse practitioners, and nurses in rural areas, either through the Medical Education Reimbursement and Loan Repayment Program as defined by s. 240.4067 or through a federal loan repayment program which requires state matching funds. The department may use funds appropriated for the Medical Education Reimbursement and Loan Repayment Program as matching funds for federal loan repayment programs for health care personnel, such as that authorized in Pub. L. No. 100-177, s. 203. If the department receives federal matching funds, the department shall only implement the federal program. Reimbursement through either program shall be limited to:

(a)  Primary care physicians, physician assistants, certified nurse midwives, nurse practitioners, and nurses employed by or affiliated with rural hospitals, as defined in this act; and

(b)  Primary care physicians, physician assistants, certified nurse midwives, nurse practitioners, and nurses employed by or affiliated with rural area health education centers, as defined in this section. These personnel shall practice:

1.  In a county with a population density of no greater than 100 persons per square mile; or

2.  Within the boundaries of a hospital tax district which encompasses a population of no greater than 100 persons per square mile.

If the department administers a federal loan repayment program, priority shall be given to obligating state and federal matching funds pursuant to paragraphs (a) and (b). The department may use federal matching funds in other health workforce shortage areas and medically underserved areas in the state for loan repayment programs for primary care physicians, physician assistants, certified nurse midwives, nurse practitioners, and nurses who are employed by publicly financed health care programs that serve medically indigent persons.

(4)  RULEMAKING AUTHORITY.--The department may adopt all necessary rules pertaining to the standards of care applicable to rural hospital swing-beds and the criteria whereby swing-bed stays of longer than 30 days shall be authorized. The latter length-of-stay criteria shall include, but not be limited to, the medical needs of the patient, the county of residence of the patient and patient's family, patient preference, proximity to relatives and friends, and distance to available nursing home beds, if any.

History.--ss. 32, 33, 35, 39, ch. 88-294; s. 1, ch. 89-296; s. 9, ch. 89-527; s. 14, ch. 90-295; ss. 45, 98, ch. 92-289; s. 731, ch. 95-148; s. 1, ch. 98-14; s. 1, ch. 98-21; s. 33, ch. 98-89; s. 2, ch. 99-209.

¹Note.--Redesignated as s. 395.002(14) by the reviser incident to the compilation of the 1998 Supplement to the Florida Statutes 1997.

²Note.--The reference is to 42 C.F.R. parts 405, 435, 440, 442, and 447.

Note.--Former s. 395.102.

395.603  Rules; rural hospital impact statement.--

(1)  The agency shall establish, by rule, a process by which a rural hospital, as defined in s. 395.602, that seeks licensure as a rural primary care hospital or as an emergency care hospital, or becomes a certified rural health clinic as defined in Pub. L. No. 95-210, or becomes a primary care program such as a county health department, community health center, or other similar outpatient program that provides preventive and curative services, may deactivate general hospital beds. Rural primary care hospitals and emergency care hospitals shall maintain the number of actively licensed general hospital beds necessary for the facility to be certified for Medicare reimbursement. Hospitals that discontinue inpatient care to become rural health care clinics or primary care programs shall deactivate all licensed general hospital beds. All hospitals, clinics, and programs with inactive beds shall provide 24-hour emergency medical care by staffing an emergency room. Providers with inactive beds shall be subject to the criteria in s. 395.1041. The agency shall specify in rule requirements for making 24-hour emergency care available. Inactive general hospital beds shall be included in the acute care bed inventory, maintained by the agency for certificate-of-need purposes, for 10 years from the date of deactivation of the beds. After 10 years have elapsed, inactive beds shall be excluded from the inventory. The agency shall, at the request of the licensee, reactivate the inactive general beds upon a showing by the licensee that licensure requirements for the inactive general beds are met.

(2)  In formulating and implementing policies and rules that may have significant impact on the ability of rural hospitals to continue to provide health care services in rural communities, the agency, the department, or the respective regulatory board adopting policies or rules regarding the licensure or certification of health care professionals shall provide a rural hospital impact statement. The rural hospital impact statement shall assess the proposed action in light of the following questions:

(a)  Do the health personnel affected by the proposed action currently practice in rural hospitals or are they likely to in the near future?

(b)  What are the current numbers of the affected health personnel in this state, their geographic distribution, and the number practicing in rural hospitals?

(c)  What are the functions presently performed by the affected health personnel, and are such functions presently performed in rural hospitals?

(d)  What impact will the proposed action have on the ability of rural hospitals to recruit the affected personnel to practice in their facilities?

(e)  What impact will the proposed action have on the limited financial resources of rural hospitals through increased salaries and benefits necessary to recruit or retain such health personnel?

(f)  Is there a less stringent requirement which could apply to practice in rural hospitals?

(g)  Will this action create staffing shortages, which could result in a loss to the public of health care services in rural hospitals or result in closure of any rural hospitals?

History.--s. 8, ch. 89-527; s. 1, ch. 90-192; ss. 46, 47, 98, ch. 92-289; s. 98, ch. 97-101.

Note.--Former s. 395.103.

395.604  Other rural hospital programs.--

(1)  The agency may license rural primary care hospitals subject to federal approval for participation in the Medicare and Medicaid programs. Rural primary care hospitals shall be treated in the same manner as emergency care hospitals and rural hospitals with respect to ss. 395.605(2)-(8)(a), 408.033(2)(b)3., and 408.038.

(2)  The agency may designate essential access community hospitals.

(3)  The agency may adopt licensure rules for rural primary care hospitals and essential access community hospitals. Such rules must conform to s. 395.1055.

(4)  The department may seek federal recognition of emergency care hospitals authorized by s. 395.605 under the essential access community hospital program authorized by the Omnibus Budget Reconciliation Act of 1989.

History.--s. 15, ch. 90-295; s. 6, ch. 91-201; ss. 48, 98, ch. 92-289; s. 16, ch. 97-79.

Note.--Former s. 395.104.

395.605  Emergency care hospitals.--

(1)  Only rural hospitals meeting the criteria in s. 395.602(2)(e) may be licensed as emergency care hospitals.

(2)  For the purpose of Medicaid swing-bed reimbursement pursuant to the Medicaid program, the department shall treat emergency care hospitals in the same manner as rural hospitals.

(3)  For the purpose of participation in the Medical Education Reimbursement and Loan Repayment Program as defined in s. 240.4067 or other loan repayment or incentive programs designed to relieve medical workforce shortages, the department shall treat emergency care hospitals in the same manner as rural hospitals.

(4)  For the purpose of coordinating primary care services described in s. 154.011(1)(c)10., the department shall treat emergency care hospitals in the same manner as rural hospitals.

(5)  Rural hospitals that make application under the certificate-of-need program to be licensed as emergency care hospitals shall receive expedited review as defined in s. 408.032. Emergency care hospitals seeking relicensure as acute care general hospitals shall also receive expedited review.

(6)  The board shall treat emergency care hospitals in the same manner as hospitals defined in s. 408.07.

(7)  Emergency care hospitals are exempt from certificate-of-need requirements for home health and hospice services and for swing beds in a number that does not exceed one-half of the facility's licensed beds.

(8)  The agency shall adopt rules for facility licensure that conform to s. 395.1055. Rules shall include the following provisions:

(a)  Emergency care hospitals shall have agreements with other hospitals, skilled nursing facilities, home health agencies, and with providers of diagnostic-imaging and laboratory services that are not provided on site but are needed by patients.

(b)  All patients shall be under the care of a physician or under the care of a nurse practitioner or physician assistant supervised by a physician.

(c)  A physician, nurse practitioner, or physician assistant shall be on duty at all times, or a physician shall be on call and available within 30 minutes at all times.

(d)  All compounding, packaging, and dispensing of drugs and biologicals shall be under the supervision of a pharmacist.

(e)  Diagnostic radiologic services and clinical laboratory services shall be maintained at the facility or shall be available to meet the needs of its patients.

(f)  Clinical laboratory services provided by the facility shall, at a minimum, include:

1.  Chemical examinations of urine by stick or tablet methods, or both (including urine ketones).

2.  Microscopic examinations of urine sediment.

3.  Hemoglobin or hematocrit.

4.  Blood sugar.

5.  Gram stain.

6.  Examination of stool specimens for occult blood.

7.  Pregnancy tests.

8.  Primary culturing for transmittal to a certified laboratory.

9.  Sediment rate, CBC.

(9)  The agency may use specific diagnosis-related groups, ICD-9 codes, or similar patient illness-severity classification schemes to define the scope of inpatient care in emergency care hospitals in lieu of the 96-hour inpatient care limitation. The methodology used for determining the scope of inpatient care permitted in emergency care hospitals shall be included in rule.

History.--s. 5, ch. 89-527; s. 1, ch. 90-192; s. 13, ch. 90-295; s. 56, ch. 91-282; s. 91, ch. 92-33; ss. 49, 98, ch. 92-289; s. 732, ch. 95-148; s. 207, ch. 99-13.

Note.--Former s. 395.01465.

395.6061  Rural hospital capital improvement.--There is established a rural hospital capital improvement grant program.

(1)  A rural hospital as defined in s. 395.602 may apply to the department for a grant. The grant application must provide information that includes:

(a)  A statement indicating the problem the rural hospital proposes to solve with the grant funds;

(b)  The strategy proposed to resolve the problem;

(c)  The organizational structure, financial system, and facilities that are essential to the proposed solution;

(d)  The projected longevity of the proposed solution after the grant funds are expended;

(e)  Evidence of participation in a rural health network as defined in s. 381.0406;

(f)  Evidence that the rural hospital has difficulty in obtaining funding or that funds available for the proposed solution are inadequate;

(g)  Evidence that the grant funds will assist in maintaining or returning the hospital to an economically stable condition or that any plan for closure or realignment of services will involve development of innovative alternatives for the discontinued services;

(h)  Evidence of a satisfactory record-keeping system to account for grant fund expenditures within the rural county;

(i)  A rural health network plan that includes a description of how the plan was developed, the goals of the plan, the links with existing health care providers under the plan, indicators quantifying the hospital's financial well-being, measurable outcome targets, and the current physical and operational condition of the hospital.

(2)  Each rural hospital as defined in s. 395.602 shall receive a minimum of $100,000 annually, subject to legislative appropriation, upon application to the Department of Health, for projects to acquire, repair, improve, or upgrade systems, facilities, or equipment.

(3)  Any remaining funds shall annually be disbursed to rural hospitals in accordance with this section. The Department of Health shall establish, by rule, criteria for awarding grants for any remaining funds, which must be used exclusively for the support and assistance of rural hospitals as defined in s. 395.602, including criteria relating to the level of uncompensated care rendered by the hospital, the participation in a rural health network as defined in s. 381.0406, and the proposed use of the grant by the rural hospital to resolve a specific problem. The department must consider any information submitted in an application for the grants in accordance with subsection (1) in determining eligibility for and the amount of the grant, and none of the individual items of information by itself may be used to deny grant eligibility.

(4)  The department shall ensure that the funds are used solely for the purposes specified in this section. The total grants awarded pursuant to this section shall not exceed the amount appropriated for this program.

History.--s. 1, ch. 99-209.

395.701  Annual assessments on net operating revenues to fund public medical assistance; administrative fines for failure to pay assessments when due; exemption.

395.7015  Annual assessment on health care entities.

¹395.701  Annual assessments on net operating revenues to fund public medical assistance; administrative fines for failure to pay assessments when due; exemption.--

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

(a)  "Agency" means the Agency for Health Care Administration.

(b)  "Gross operating revenue" or "gross revenue" means the sum of daily hospital service charges, ambulatory service charges, ancillary service charges, and other operating revenue.

(c)  "Hospital" means a health care institution as defined in ²s. 395.002(11), but does not include any hospital operated by the agency or the Department of Corrections.

(d)  "Net operating revenue" or "net revenue" means gross revenue less deductions from revenue.

(e)  "Total deductions from gross revenue" or "deductions from revenue" means reductions from gross revenue resulting from inability to collect payment of charges. Such reductions include bad debts; contractual adjustments; uncompensated care; administrative, courtesy, and policy discounts and adjustments; and other such revenue deductions, but also includes the offset of restricted donations and grants for indigent care.

(2)  There is imposed upon each hospital an assessment in an amount equal to 1.5 percent of the annual net operating revenue for each hospital, such revenue to be determined by the agency, based on the actual experience of the hospital as reported to the agency. Within 6 months after the end of each hospital fiscal year, the agency shall certify the amount of the assessment for each hospital. The assessment shall be payable to and collected by the agency in equal quarterly amounts, on or before the first day of each calendar quarter, beginning with the first full calendar quarter that occurs after the agency certifies the amount of the assessment for each hospital. All moneys collected pursuant to this subsection shall be deposited into the Public Medical Assistance Trust Fund.

(3)  The agency shall impose an administrative fine, not to exceed $500 per day, for failure of any hospital to pay its assessment by the first day of the calendar quarter on which it is due. The failure of a hospital to pay its assessment within 30 days after the assessment is due is ground for the agency to impose an administrative fine not to exceed $5,000 per day.

(4)  The purchaser, successor, or assignee of a facility subject to the agency's jurisdiction shall assume full liability for any assessments, fines, or penalties of the facility or its employees, regardless of when identified. Such assessments, fines, or penalties shall be paid by the employee, owner, or licensee who incurred them, within 15 days of the sale, transfer, or assignment. However, the purchaser, successor, or assignee of the facility may withhold such assessments, fines, or penalties from purchase moneys or payment due to the seller, transferor, or employee, and shall make such payment on behalf of the seller, transferor, or employee. Any employer, purchaser, successor, or assignee who fails to withhold sufficient funds to pay assessments, fines, or penalties arising under the provisions of chapter 408 shall make such payments within 15 days of the date of the transfer, purchase, or assignment. Failure by the transferee to make payments as provided in this subsection shall subject such transferee to the penalties and assessments provided in chapter 408. Further, in the event of sale, transfer, or assignment of any facility under the agency's jurisdiction, future assessments shall be based upon the most recently available prior year report or audited actual experience for the facility. It shall be the responsibility of the new owner or licensee to require the production of the audited financial data for the period of operation of the prior owner. If the transferee fails to obtain current audited financial data from the previous owner or licensee, the new owner shall be assessed based upon the most recent year of operation for which 12 months of audited actual experience are available or upon a reasonable estimate of 12 months of full operation as calculated by the agency.

(5)  A statutory teaching hospital that had 100,000 or more Medicaid covered days during the most recent fiscal year may elect to have its assessment imposed pursuant to subsection (2) deducted from any Medicaid disproportionate share payment due to such hospital for the quarter ending 6 months after the assessment due date. If the assessment is greater than the disproportionate share payment, or if no disproportionate share payment is due the hospital, the difference, or full amount of the assessment in cases in which no payment is due, shall be paid on or before the date the disproportionate share payment is made or would have been made.

(6)  Outpatient radiation therapy services provided by a hospital subject to this section are exempt from the provisions of this section.

History.--ss. 6, 7, ch. 84-35; s. 1, ch. 85-65; s. 3, ch. 91-48; s. 61, ch. 91-221; s. 93, ch. 92-33; s. 36, ch. 92-78; ss. 51, 98, ch. 92-289; s. 9, ch. 98-89; s. 1, ch. 98-192.

¹Note.--Section 4, ch. 98-192, as amended by s. 3, ch. 99-356, provides that "[t]his act shall take effect July 1, 1998. However, if the Agency for Health Care Administration between April 15, 1999 and November 15, 1999 receives written certification from the federal Health Care Financing Administration that the amendments enacted herein to s. 395.701, F.S. or s. 395.7015, F.S., violate federal regulations regarding permissible state health care taxes which would cause the state to be denied federal Medicaid funds, then the amendment to the individual section contained herein and so identified by the Health Care Financing Administration as violating federal law hereby stands repealed. Upon receipt of written certification from the Health Care Financing Administration, the Agency for Health Care Administration shall forward such certification to the Secretary of State, the President of the Senate and the Speaker of the House of Representatives with a letter identifying the section or sections which stand repealed consistent with this section. The Secretary of State shall delete the amendment to the section so identified in the official records of the Florida Statutes consistent with this section. The effective date of the repeal of the section contained in the federal certification shall be the date that the notice is received by the Secretary of State."

²Note.--Redesignated as s. 395.002(13) by the reviser incident to the compilation of the 1998 Supplement to the Florida Statutes 1997.

Note.--Former s. 395.101.

¹395.7015  Annual assessment on health care entities.--

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

(a)  "Net operating revenue" means gross revenue less deductions from revenue.

(b)  "Gross revenue" means the sum of daily service charges, ambulatory service charges, ancillary service charges, and other operating revenue, except revenues received for testing or analysis of samples received from outside the state or from product sales outside the state.

(c)  "Deductions from revenue" means reductions from gross revenue resulting from inability to collect payment of charges. Such reductions include bad debts; contractual adjustments; uncompensated care; administrative, courtesy, and policy discounts and adjustments; and other such revenue deductions, and includes the offset of restricted donations and grants for indigent care.

²(2)  There is imposed an annual assessment against certain health care entities as described in this section:

(a)  The assessment shall be equal to 1.5 percent of the annual net operating revenues of health care entities. The assessment shall be payable to and collected by the agency. Assessments shall be based on annual net operating revenues for the entity's most recently completed fiscal year as provided in subsection (3).

(b)  For the purpose of this section, "health care entities" include the following:

1.  Ambulatory surgical centers and mobile surgical facilities licensed under s. 395.003. This subsection shall only apply to mobile surgical facilities operating under contracts entered into on or after July 1, 1998.

2.  Clinical laboratories licensed under s. 483.091, excluding any hospital laboratory defined under s. 483.041(5), any clinical laboratory operated by the state or a political subdivision of the state, any clinical laboratory which qualifies as an exempt organization under s. 501(c)(3) of the Internal Revenue Code of 1986, as amended, and which receives 70 percent or more of its gross revenues from services to charity patients or Medicaid patients, and any blood, plasma, or tissue bank procuring, storing, or distributing blood, plasma, or tissue either for future manufacture or research or distributed on a nonprofit basis, and further excluding any clinical laboratory which is wholly owned and operated by 6 or fewer physicians who are licensed pursuant to chapter 458 or chapter 459 and who practice in the same group practice, and at which no clinical laboratory work is performed for patients referred by any health care provider who is not a member of the same group.

3.  Diagnostic-imaging centers that are freestanding outpatient facilities that provide specialized services for the identification or determination of a disease through examination and also provide sophisticated radiological services, and in which services are rendered by a physician licensed by the Board of Medicine under s. 458.311, s. 458.313, or s. 458.317, or by an osteopathic physician licensed by the Board of Osteopathic Medicine under s. 459.006, s. 459.007, or s. 459.0075. For purposes of this paragraph, "sophisticated radiological services" means the following: magnetic resonance imaging; nuclear medicine; angiography; arteriography; computed tomography; positron emission tomography; digital vascular imaging; bronchography; lymphangiography; splenography; ultrasound, excluding ultrasound providers that are part of a private physician's office practice or when ultrasound is provided by two or more physicians licensed under chapter 458 or chapter 459 who are members of the same professional association and who practice in the same medical specialties; and such other sophisticated radiological services, excluding mammography, as adopted in rule by the board.

(3)(a)  Beginning July 1, 1993, the assessment shall be on the actual experience of the entity as reported to the agency within 120 days after the end of its fiscal year in the preceding calendar year based upon reports developed by the board in a rule after consultation with appropriate professional and governmental advisory bodies.

(b)  Within 6 months after the end of each entity's fiscal year, the agency shall certify the amount of the assessment to each entity. The assessment shall be payable to and collected by the agency in equal quarterly amounts on or before the first day of each calendar quarter, beginning with the first full calendar quarter.

(4)  All moneys collected pursuant to this section shall be deposited into the Public Medical Assistance Trust Fund.

(5)  The agency may use its authority under chapter 408 in administering this section.

History.--s. 177, ch. 91-112; s. 94, ch. 92-33; s. 33, ch. 92-58; s. 74, ch. 92-149; s. 52, ch. 92-289; s. 73, ch. 95-143; s. 2, ch. 98-192; s. 9, ch. 98-303.

¹Note.--Section 10, ch. 98-303, provides that "[m]obile surgical facilities in operation pursuant to a contract with the Department of Corrections entered into prior to [May 29, 1998] shall continue to operate pursuant to such contract and shall only be subject to the provisions of this act subsequent to the effective date of any rules promulgated by the Agency for Health Care Administration relating to mobile surgical facilities."

²Note.--Section 4, ch. 98-192, as amended by s. 3, ch. 99-356, provides that "[t]his act shall take effect July 1, 1998. However, if the Agency for Health Care Administration between April 15, 1999 and November 15, 1999 receives written certification from the federal Health Care Financing Administration that the amendments enacted herein to s. 395.701, F.S. or s. 395.7015, F.S., violate federal regulations regarding permissible state health care taxes which would cause the state to be denied federal Medicaid funds, then the amendment to the individual section contained herein and so identified by the Health Care Financing Administration as violating federal law hereby stands repealed. Upon receipt of written certification from the Health Care Financing Administration, the Agency for Health Care Administration shall forward such certification to the Secretary of State, the President of the Senate and the Speaker of the House of Representatives with a letter identifying the section or sections which stand repealed consistent with this section. The Secretary of State shall delete the amendment to the section so identified in the official records of the Florida Statutes consistent with this section. The effective date of the repeal of the section contained in the federal certification shall be the date that the notice is received by the Secretary of State."

Note.--Former s. 395.1015.

395.805  Definitions.

395.806  Designation of family practice teaching hospitals.

395.807  Retention of family practice residents.

395.805  Definitions.--As used in this act, the term:

(1)  "Agency" means the Agency for Health Care Administration.

(2)  "Family practice teaching hospital" means a freestanding, community-based hospital licensed under this chapter that offers a 3-year family practice residency program accredited through the Residency Review Committee of the Accreditation Council of Graduate Medical Education or the Council on Postdoctoral Training of the American Osteopathic Association.

History.--s. 2, ch. 94-182.

395.806  Designation of family practice teaching hospitals.--

(1)(a)  A hospital that offers a family practice residency program of at least 18 positions for resident family practice physicians is eligible for designation as a family practice teaching hospital.

(b)  A hospital seeking designation as a family practice teaching hospital must submit documentation and an application to the Agency for Health Care Administration in the manner the agency determines.

(c)  To maintain the designation as a family practice teaching hospital, a hospital must offer a residency program of at least 24 positions for resident family practice physicians within 5 years after the initial designation. The agency shall terminate the designation of a hospital that does not meet the requirements of this paragraph.

(2)(a)  A family practice teaching hospital must fill at least 90 percent of its positions for resident family practice physicians.

(b)  A family practice teaching hospital that has residency programs other than family practice must maintain at least 60 percent of its total residents in family practice.

History.--s. 3, ch. 94-182; s. 34, ch. 95-146; s. 19, ch. 98-89.

395.807  Retention of family practice residents.--

(1)  A family practice teaching hospital must have a documented plan for retaining family practice residents in the state.

(2)(a)  The director of the agency shall appoint a seven-member family practice physician retention advisory committee, consisting of a faculty member of a family practice teaching hospital, an active family practice resident, a member of the Florida Academy of Family Physicians, a member of the Florida Society of the American College of Osteopathic Family Physicians, a family practice physician who practices in an urban area, a family practice physician who practices in a rural area, and the residency director of a family practice residency program.

(b)  The committee shall develop a program for recruiting minority physicians into family practice residency programs and shall promote further efforts to retain and place minority physicians into local communities.

(c)  The committee shall report to the Legislature annually, beginning October 1, 1995, on the retention of family practice residents in the state by family practice teaching hospitals. The committee shall also track and report on the placement of family practice physicians in medically underserved areas.

History.--s. 4, ch. 94-182.