HB 475 — Ambulatory Surgical Centers

requiring agency enforcement;

providing administrative penalties;

creating s.

396.211, F.S.;

providing facility requirements for considering and acting upon applications for staff membership and clinical privileges at a licensed facility;

requiring a licensed facility to establish rules and procedures for consideration of such applications;

requiring a licensed facility to make available specified membership or privileges to physicians under certain circumstances;

providing construction;

requiring the governing board to set standards and procedures to be applied in considering and acting upon applications;

requiring a licensed facility to provide an applicant with reasons for denial within a specified timeframe;

providing immunity from monetary liability to certain persons;

providing that investigations, proceedings, and records produced or acquired by a review team are not subject to discovery or introduction into evidence Page 2 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 in certain proceedings under certain circumstances;

providing for the award of specified fees and costs;

creating s.

396.212, F.S.;

requiring licensed facilities to provide for peer review of certain physicians and develop procedures to conduct such reviews;

providing requirements for the procedures;

providing grounds for peer review and reporting requirements;

providing immunity from monetary liability to certain persons;

providing construction;

providing that communications, information, and records produced or acquired by a review team are not subject to discovery or introduction into evidence in certain proceedings under certain circumstances;

providing for the award of specified fees and costs;

creating s.

396.213, F.S.;

requiring licensed facilities to establish an internal risk management program;

providing requirements for such program;

requiring licensed facilities to hire a risk manager;

providing requirements for such manager;

requiring licensed facilities to annually report to the Department of Health specified information;

requiring the department and the agency to include certain statistical information in their respective annual reports;

providing for rulemaking;

providing applicability;

requiring licensed facilities to Page 3 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 annually report specified information to the agency;

authorizing the agency to grant extensions to the reporting requirement under certain circumstances;

requiring the agency to publish certain reports and summaries within certain timeframes on its website;

providing certain investigative and reporting requirements for internal risk managers;

requiring the investigation and reporting of an allegation of sexual misconduct or sexual abuse at licensed facilities;

prohibiting false allegations;

providing penalties;

providing licensure inspection review of the internal risk management program;

providing certain monetary or civil liability for licensed risk managers;

requiring the agency to report certain investigative results to the regulatory board;

prohibiting intimidation of a risk manager;

providing a penalty;

creating s.

396.214, F.S.;

requiring licensed facilities to comply with specified requirements for the transportation of biomedical waste;

creating s.

396.215, F.S.;

requiring licensed facilities to adopt a patient safety plan, appoint a patient safety officer, and conduct a patient safety culture survey at least biennially;

authorizing licensed facilities to develop an internal action plan;

creating s.

396.216, F.S.;

requiring licensed facilities to adopt protocols for the Page 4 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 treatment of victims of child abuse or neglect;

creating s.

396.217, F.S.;

providing requirements for notifying parents about adverse incidents;

providing construction;

creating s.

396.218, F.S.;

providing for rulemaking and enforcement;

authorizing the agency to impose an immediate moratorium on elective admissions to any licensed facility under certain circumstances;

creating s.

396.219, F.S.;

providing criminal and administrative penalties;

creating s.

396.311, F.S.;

providing powers and duties of the agency;

creating s.

396.312, F.S.;

requiring a licensed facility to provide timely and accurate financial information and quality of service measures to certain individuals;

providing an exemption;

requiring a licensed facility to make available on its website certain information on payments made to that facility for defined bundles of services and procedures and other information for consumers and patients;

requiring facility websites to provide specified information and notify and inform patients or prospective patients of certain information;

requiring a licensed facility to provide a written or an electronic good faith estimate of charges to a patient or prospective patient within a certain timeframe;

requiring a licensed facility to provide information regarding financial assistance Page 5 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 from the facility which may be available to a patient or a prospective patient;

providing a penalty for failing to provide an estimate of charges to a patient;

requiring that certain records be made available through electronic means that comply with a specified law;

reducing the amount of time afforded to licensed facilities to respond to certain patient requests for information;

creating s.

396.313, F.S.;

defining the term "extraordinary collection action";

prohibiting certain collection activities by a licensed facility;

creating s.

396.314, F.S.;

prohibiting the use of a patient's medical records for purposes of solicitation and marketing without specific written release or authorization;

providing criminal penalties;

creating s.

396.315, F.S.;

providing for confidentiality of patient records;

providing requirements for appropriate disclosure of patient records;

authorizing the department to examine certain records;

providing content and use requirements for patient records;

requiring a licensed facility to furnish, in a timely manner, a true and correct copy of all patient records to certain persons;

providing exemptions from public records requirements for specified personal information relating to employees of licensed facilities who Page 6 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 provide direct patient care or security services and their spouses and children, and for specified personal information relating to other employees of licensed facilities and their spouses and children upon their request;

amending ss.

383.145, 383.50, 385.211, 390.011, 394.4787, 395.001, 395.002, 395.003, 395.1055, 395.10973, 395.3025, 395.607, 395.701, 400.518, 400.93, 400.9935, 401.272, 408.051, 408.07, 408.802, 408.820, 409.905, 409.906, 409.975, 456.041, 456.053, 456.056, 458.3145, 458.320, 458.351, 459.0085, 459.026, 465.0125, 468.505, 627.351, 627.357, 627.6056, 627.6405, 627.64194, 627.6616, 627.736, 627.912, 765.101, 766.101, 766.110, 766.1115, 766.118, 766.202, 766.316, 812.014, 945.6041, and 985.6441, F.S.;

conforming cross-references and provisions to changes made by the act;

ChapterParagraph 396,(c) Floridaof Statutes,subsection consisting(1) of sectionssection 396.201,395.301, 396.202,Florida 396.203,Statutes, 396.204, 396.205, 396.206, 396.207, 369.208, 396.209, 396.211, 396.212, 396.213, 396.214, 396.215, 396.216, 396.217, 396.218, 396.219, 396.311, 396.312, 396.313, 396.314, and 396.315, is createdamended andto entitledread: Page 7 of 121 CODING:

Words395.301 strickenPrice aretransparency; deletions;

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 "Ambulatory Surgical Centers." Section 2.

Section 396.201, Florida Statutes, is created to read:

396.201 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 ambulatory surgical centers by providing for licensure of same and for the development, establishment, and enforcement of minimum standards with respect thereto.

Section 3.

Section 396.202, Florida Statutes, is created to read:

396.202 Definitions.—As used in this chapter, the term:

(1) "Accrediting organization" means a national accrediting organization approved by the Centers for Medicare and Medicaid Services and whose standards incorporate comparable licensure regulations required by the state.

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

(3) "Ambulatory surgical center" means a facility, the primary purpose of which is to provide elective surgical care, in which the patient is admitted to and discharged from within 24 hours, and that 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 Page 8 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 practice of dentistry may not be construed to be an ambulatory surgical center, provided that any facility or office that is certified or seeks certification as a Medicare ambulatory surgical center must be licensed as an ambulatory surgical center pursuant to this chapter.

(4) "Biomedical waste" means any solid or liquid waste as defined in s.

381.0098(2).

(5) "Clinical privileges" means the privileges granted to a physician or other licensed health care practitioner to render patient care services in an ambulatory surgical center, but does not include the privilege of admitting patients.

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

(7) "Director" means any member of the official board of directors as reported in the organization's annual corporate report to the Department of State, or, if no such report is made, any member of the operating board of directors.

The term does not include members of separate, restricted boards that serve only in an advisory capacity to the operating board.

(8) "Licensed facility" means an ambulatory surgical center licensed under this chapter.

(9) "Lifesafety" means the control and prevention of fire and other life-threatening conditions on a premises for the purpose of preserving human life.

(10) "Managing employee" means the administrator or other similarly titled individual who is responsible for the daily Page 9 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 operation of the licensed facility.

(11) "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.

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

(13) "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.

Section 4.

Section 396.203, Florida Statutes, is created to read:

396.203 Licensure;

denial, suspension, and revocation.— (1)(a) The requirements of part II of chapter 408 apply to the provision of services that require licensure pursuant to ss.

396.201-396.315 and part II of chapter 408 and to entities licensed by or applying for such licensure from the Agency for Health Care Administration pursuant to ss.

396.201-396.315.

A license issued by the agency is required in order to operate an ambulatory surgical center in this state.

(b)1.

It is unlawful for a person to use or advertise to the public, in any way or by any medium whatsoever, any facility as an "ambulatory surgical center" unless such facility has Page 10 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 first secured a license under this chapter.

2.

This chapter does not apply to veterinary hospitals or to commercial business establishments using the word "hospital" as a part of a trade name if no treatment of human beings is performed on the premises of such establishments.

(2) In addition to the requirements in part II of chapter 408, the agency shall, at the request of a licensee, issue a single license to a licensee for facilities located on separate premises.

Such a license shall specifically state the location of the facilities, the services, and the licensed beds available on each separate premises.

If a licensee requests a single license, the licensee shall designate which facility or office is responsible for receipt of information, payment of fees, service of process, and all other activities necessary for the agency to carry out this chapter.

(3) In addition to the requirements of s.

408.807, after a change of ownership has been approved by the agency, the transferee shall be liable for any liability to the state, regardless of when identified, resulting from changes to allowable costs affecting provider reimbursement for Medicaid participation or Public Medical Assistance Trust Fund Assessments, and related administrative fines.

(4) An ambulatory surgical center shall comply with ss.

627.64194 and 641.513 as a condition of licensure.

(5) In addition to the requirements of part II of chapter Page 11 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 408, whenever the agency finds that there has been a substantial failure to comply with the requirements established under this chapter or in rules, the agency is authorized to deny, modify, suspend, and revoke:

(a) A license;

(b) That part of a license that 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.

Section 5.

Section 396.204, Florida Statutes, is created to read:

396.204 Application for license;

fees.—In accordance with s.

408.805, an applicant or a licensee shall pay a fee for each license application submitted under this chapter, part II of chapter 408, and applicable rules.

The amount of the fee shall be established by rule.

The license fee required of a facility licensed under this chapter shall be established by rule, except that the minimum license fee shall be $1,500.

Section 6.

Section 396.205, Florida Statutes, is created to read:

396.205 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 Page 12 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 laboratory tests performed by or for the licensed facility be performed by a clinical laboratory appropriately certified by the Centers for Medicare and Medicaid Services under the federal Clinical Laboratory Improvement Amendments and the federal rules adopted thereunder.

(2) Each licensed facility, as a requirement for issuance or renewal of its license, shall establish minimum standards for acceptance of results of diagnostic X rays performed by or for the licensed facility.

Such standards shall require licensure or registration of the source of ionizing radiation under chapter 404.

(3) The results of clinical laboratory tests and diagnostic X rays performed before 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.

Section 7.

Section 396.206, Florida Statutes, is created to read:

396.206 Licensure inspection.— (1) In addition to the requirement of s.

408.811, the agency shall make or cause to be made such inspections and investigations as it deems necessary, including all of the following:

(a) Inspections directed by the Centers for Medicare and Page 13 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 Medicaid Services.

(b) Validation inspections.

(c) Lifesafety inspections.

(d) Licensure complaint investigations, including full licensure investigations with a review of all licensure standards as outlined in the administrative rules.

Complaints received by the agency from individuals, organizations, or other sources are subject to review and investigation by the agency.

(e) Emergency access complaint investigations.

(2) The agency shall accept, in lieu of its own periodic inspections for licensure, the survey or inspection of an accrediting organization, provided that the accreditation of the licensed facility is not provisional and provided that the licensed facility authorizes release of, and the agency receives the report of, the accrediting organization.

The agency shall develop, and adopt by rule, criteria for accepting survey reports of accrediting organizations in lieu of conducting a state licensure inspection.

(3) In accordance with s.

408.805, an applicant or licensee shall pay a fee for each license application submitted under this chapter, part II of chapter 408, and applicable rules.

With the exception of state-operated licensed facilities, each facility licensed under this chapter shall pay to the agency, at the time of inspection, the following fees:

(a) Inspection for licensure.—A fee shall be paid which is Page 14 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 at least $400 per facility.

(b) Inspection for lifesafety only.—A fee shall be paid which is at least $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.

Section 8.

Section 396.207, Florida Statutes, is created to read:

396.207 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 at least 5 years after the date the reports are filed and issued.

(2) Any records, reports, or documents which are confidential and exempt from s.

119.07(1) may 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 Page 15 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 to the licensed facility, as provided in subsection (1), provided that the person requesting such report agrees to pay a reasonable charge to cover copying costs, not to exceed $1 per page.

Section 9.

Section 396.208, Florida Statutes, is created to read:

396.208 Construction inspections;

plan submission and approval;

fees.— (1)(a) The design, construction, erection, alteration, modification, repair, and demolition of all licensed facilities are governed by the Florida Building Code and the Florida Fire Prevention Code under ss.

553.73 and 633.206.

In addition to the requirements of ss.

553.79 and 553.80, the agency shall review facility plans and survey the construction of any facility licensed under this chapter.

The agency shall make, or cause to be made, such construction inspections and investigations as it deems necessary.

The agency may prescribe by rule that any licensee or applicant desiring to make specified types of alterations or additions to its facilities or to construct new facilities shall, before commencing such alteration, addition, or new construction, submit plans and specifications therefor to the agency for preliminary inspection and approval or recommendation with respect to compliance with applicable provisions of the Florida Building Code or agency rules and standards.

The agency shall approve or disapprove the plans and Page 16 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 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 licensed facilities shall submit plans and specifications to the agency for review under this section.

(2) The agency is authorized to charge an initial fee of $2,000 for review of plans and construction on all projects, no part of which is refundable.

The agency may also collect a fee, not to exceed 1 percent of the estimated construction cost or the actual cost of review, whichever is less, for the portion of the review which encompasses initial review through the initial revised construction document review.

The agency is further authorized to collect its actual costs on all subsequent portions of the review and construction inspections.

The initial fee payment shall accompany the initial submission of plans and specifications.

Any subsequent payment that is due is payable upon receipt of the invoice from the agency.

Section 10.

Section 396.209, Florida Statutes, is created to read:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 396.209 Rebates prohibited;

penalties.— (1) It is unlawful for any person to pay or receive any commission, bonus, kickback, or rebate or engage in any split- fee arrangement, in any form whatsoever, with any physician, surgeon, organization, or person, either directly or indirectly, for patients referred to a licensed facility.

(2) The agency shall enforce subsection (1).

In the case of an entity not licensed by the agency, administrative penalties may include:

(a) A fine not to exceed $1,000.

(b) If applicable, a recommendation by the agency to the appropriate licensing board that disciplinary action be taken.

Section 11.

Section 396.211, Florida Statutes, is created to read:

396.211 Staff membership and clinical privileges.— (1) A licensed facility, in considering and acting upon an application for staff membership or clinical privileges, may not 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.

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 (2)(a) Each licensed facility shall establish rules and procedures for consideration of an application for clinical privileges submitted by an advanced practice registered nurse licensed under part I of chapter 464, in accordance with this section.

A licensed facility may not deny such application solely because the applicant is licensed under part I of chapter 464 or because the applicant is not a participant in the Florida Birth-Related Neurological Injury Compensation Plan.

(b) An advanced practice registered nurse who is certified as a registered nurse anesthetist licensed under part I of chapter 464 shall administer anesthesia under the onsite medical direction of a professional licensed under chapter 458, chapter 459, or chapter 466, and in accordance with an established protocol approved by the medical staff.

The medical direction shall specifically address the needs of the individual patient.

(c) Each licensed facility shall establish rules and procedures for consideration of an application for clinical privileges submitted by a physician assistant licensed pursuant to s.

458.347 or s.

459.022.

Clinical privileges granted to a physician assistant pursuant to this subsection shall automatically terminate upon termination of staff membership of the physician assistant's supervising physician.

(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 Page 19 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 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) This section does not restrict in any way the authority of the medical staff of a licensed facility to review for approval or disapproval all applications for appointment and reappointment to all categories of staff and to make recommendations on each applicant to the governing board, including the delineation of privileges to be granted in each case.

In making such recommendations and in the delineation of privileges, each applicant shall be considered individually pursuant to criteria for a doctor licensed under chapter 458, chapter 459, chapter 461, or chapter 466, or for an advanced practice registered nurse licensed under part I of chapter 464, or for a psychologist licensed under chapter 490, as applicable.

The applicant's eligibility for staff membership or clinical privileges shall be determined by the applicant's background, experience, health, training, and demonstrated competency;

the applicant's adherence to applicable professional ethics;

the applicant's reputation;

and the applicant's ability to work with others and by such other elements as determined by the governing Page 20 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 board, consistent with this chapter.

(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 after 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 is no monetary liability on the part of, and no cause of action for injunctive relief or damages shall arise against, any licensed facility, its governing board or governing board members, medical staff, or disciplinary board or against its agents, investigators, witnesses, or employees, or against any other person, for any action arising out of or related to carrying out this section, absent intentional fraud.

(8) The investigations, proceedings, and records of the board, or its agent with whom there is a specific written contract for the purposes of this section, as described in this Page 21 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 section are not 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 any person who was in attendance at a meeting of such board or its agent is not 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 fees and costs to the defendant.

(b) As a condition of any applicant bringing any action Page 22 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 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 fees.

Section 12.

Section 396.212, Florida Statutes, is created to read:

396.212 Licensed facilities;

peer review;

disciplinary powers;

agency or partnership with physicians.— (1) It is the intent of the Legislature that good faith participants in the process of investigating and disciplining physicians pursuant to the state-mandated peer review process shall, in addition to receiving immunity from retaliatory tort suits pursuant to s.

456.073(12), be protected from federal antitrust suits filed under the Sherman AntiTrust 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 all of the following:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 (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 Page 24 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 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 ambulatory surgical center.

The notification shall identify the disciplined Page 25 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 practitioner, the action taken, and the reason for such action.

All final disciplinary actions taken under subsection (3), if different from those which were reported to the agency within 30 days after the initial occurrence, shall be reported within 10 working days to the Division of Health Quality Assurance of the agency in writing and shall specify the disciplinary action taken and the specific grounds therefor.

The division shall review each report and determine whether it potentially involved conduct by the licensee that is subject to disciplinary action, in which case s.

456.073 shall apply.

The reports are not subject to inspection under s.

119.07(1) even if the division's investigation results in a finding of probable cause.

(5) There is 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 an ambulatory surgical center;

or any other person for any action taken without intentional fraud in carrying out this section.

(6) For a single incident or series of isolated incidents that are nonwillful violations of the reporting requirements of this section or part II of chapter 408, the agency shall first seek to obtain corrective action by the licensed facility.

If correction is not demonstrated within the timeframe established by the agency or if there is a pattern of nonwillful violations Page 26 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 of this section or part II of chapter 408, the agency may impose an administrative fine, not to exceed $5,000 for any violation of the reporting requirements of this section or part II of chapter 408.

The administrative fine for repeated nonwillful violations may not exceed $10,000 for any violation.

The administrative fine for each intentional and willful violation may not exceed $25,000 per violation, per day.

The fine for an intentional and willful violation of this section or part II of chapter 408 may not exceed $250,000.

In determining the amount of fine to be levied, the agency shall be guided by s.

395.1065(2)(b).

(7) The proceedings and records of peer review panels, committees, and governing boards or agents 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 or agents thereof are not open to the public under chapter 286.

(8) The investigations, proceedings, and records of the peer review panel, a disciplinary board, or a governing board, or any agent thereof with whom there is a specific written contract for that purpose, as described in this section may 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 Page 27 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 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 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, Page 28 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 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 fees.

Section 13.

Section 396.213, Florida Statutes, is created to read:

396.213 Internal risk management program.— (1) Every licensed facility shall, as a part of its administrative functions, establish an internal risk management program that includes all of the following components:

(a) The investigation and analysis of the frequency and causes of general categories and specific types of adverse incidents to patients.

(b) The development of appropriate measures to minimize the risk of adverse incidents to patients, including, but not limited to:

1.

Risk management and risk prevention education and training of all nonphysician personnel as follows:

a.

Such education and training of all nonphysician personnel as part of their initial orientation;

and b.

At least 1 hour of such education and training annually for all personnel of the licensed facility working in clinical areas and providing patient care, except those persons licensed as health care practitioners who are required to complete Page 29 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 continuing education coursework pursuant to chapter 456 or the respective practice act.

2.

A prohibition, except when emergency circumstances require otherwise, against a staff member of the licensed facility attending a patient in the recovery room, unless the staff member is authorized to attend the patient in the recovery room and is in the company of at least one other person.

However, a licensed facility is exempt from the two-person requirement if it has:

a.

Live visual observation;

b.

Electronic observation;

or c.

Any other reasonable measure taken to ensure patient protection and privacy.

3.

A prohibition against an unlicensed person from assisting or participating in any surgical procedure unless the licensed facility has authorized the person to do so following a competency assessment, and such assistance or participation is done under the direct and immediate supervision of a licensed physician and is not otherwise an activity that may only be performed by a licensed health care practitioner.

4.

Development, implementation, and ongoing evaluation of procedures, protocols, and systems to accurately identify patients, planned procedures, and the correct site of the planned procedure so as to minimize the performance of a surgical procedure on the wrong patient, a wrong surgical Page 30 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 procedure, a wrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient's diagnosis or medical condition.

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

(d) A system for informing a patient or an individual identified pursuant to s.

765.401(1) that the patient was the subject of an adverse incident, as defined in subsection (5).

Such notice shall be given by an appropriately trained person designated by the licensed facility as soon as practicable to allow the patient an opportunity to minimize damage or injury.

(e) The development and implementation of an incident reporting system based upon the affirmative duty of all health care providers and all agents and employees of the licensed 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 licensed facility.

Each licensed facility shall hire a risk manager who is responsible for implementation and oversight of the facility's internal risk management program and who demonstrates competence, through education or experience, in all of the following areas:

(a) Applicable standards of health care risk management.

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 (b) Applicable federal, state, and local health and safety laws and rules.

(c) General risk management administration.

(d) Patient care.

(e) Medical care.

(f) Personal and social care.

(g) Accident prevention.

(h) Departmental organization and management.

(i) Community interrelationships.

(j) Medical terminology.

(3) In addition to the programs mandated by this section, other innovative approaches intended to reduce the frequency and severity of medical malpractice and patient injury claims are 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 facility for acts or omissions occurring within the licensed facility.

Each licensed facility shall annually report to the agency and the Department of Health the name and judgments entered against each health care practitioner for which it assumes liability.

The agency and Department of Health, in their respective annual reports, shall include statistics that report the number of licensed facilities that assume such liability and the number of health care practitioners, by profession, for whom they assume Page 32 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 liability.

(4) The agency shall adopt rules governing the establishment of internal risk management programs to meet the needs of individual licensed facilities.

Each internal risk management program shall include the use of incident reports to be filed with an individual of responsibility who is competent in risk management techniques in the employ of each licensed facility, such as an insurance coordinator, or who is retained by the licensed facility as a consultant.

The individual responsible for the risk management program shall have free access to all medical records of the licensed facility.

The incident reports are part of the workpapers of the attorney defending the licensed facility in litigation relating to the licensed facility and are subject to discovery, but are not admissible as evidence in court.

A person filing an incident report is not subject to civil suit by virtue of such incident report.

As a part of each internal risk management program, the incident reports shall be used to develop categories of incidents which identify problem areas.

Once identified, procedures shall be adjusted to correct the problem areas.

(5) For purposes of reporting to the agency pursuant to this section, the term "adverse incident" means an event over which health care personnel could exercise control and which is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred, and Page 33 of 121 CODING:

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hb475-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 475 2025 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 licensed 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 licensed facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient's condition before 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 Page 34 of 121 CODING:

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