Florida Senate - 2008 SB 2646

By Senator Jones

13-03837-08 20082646__

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A bill to be entitled

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An act relating to medical quality assurance; amending s.

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395.0193, F.S.; requiring that disciplinary actions at a

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licensed health care facility be reported to the Division

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of Medical Quality Assurance within the Department of

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Health rather than to the Division of Health Quality

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Assurance of the Agency for Health Care Administration;

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amending s. 395.0197, F.S.; requiring the Agency for

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Health Care Administration to forward a copy of a licensed

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facility's adverse incident report related to certain

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health care practitioners to the Division of Medical

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Quality Assurance; deleting the requirement of the agency

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or the appropriate regulatory board to make records

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available to a health care professional against whom

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probable cause has been found; deleting the agency's

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requirement to review an adverse incident and determine

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whether it involved conduct by a health care professional

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who is subject to disciplinary action; amending s.

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395.3025, F.S.; authorizing the disclosure of patient

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medical records without consent to the department for its

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investigation, prosecution, and appeal of disciplinary

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proceedings; requiring an administrator or custodian of

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records of a licensed facility to certify that a copy of

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records requested has been provided to the department;

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requiring the licensed facility to charge a reasonable fee

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for copies of records requested by the department;

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prohibiting the department from making the records

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available to the public; requiring the department to make

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the records available to a health care practitioner

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against whom probable cause has been found; amending s.

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400.141, F.S.; requiring a facility licensed under ch.

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400, F.S., to provide a certified copy of records upon

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subpoena to the department; amending s. 400.145, F.S.;

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requiring the administrator or records custodian at a

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facility licensed under ch. 400, F.S., to certify that a

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copy of records subpoenaed or requested by patient release

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has been provided to the department; amending s. 400.147,

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F.S.; providing that notification of an adverse incident

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at a facility licensed under ch. 400, F.S., is not

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discoverable or admissible in any civil or administrative

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action except in disciplinary proceedings by the

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department; requiring the department to review each

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adverse incident and determine whether it involved conduct

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by a health care professional who is subject to

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disciplinary action; requiring a copy of an adverse

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incident report be forwarded to the division for review;

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requiring the department to determine whether any of the

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adverse incidents involved conduct by a health care

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professional who is subject to disciplinary action;

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amending s. 456.057, F.S.; providing that the employer or

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clinic is the responsible records owner of abandoned

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medical records following abandonment of records or

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closure of a clinic or facility; authorizing the

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department or the appropriate probable cause panel to find

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reasonable cause to subpoena patient's records without

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patient authorization under certain conditions; amending

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ss. 458.309 and 459.005, F.S.; deleting an exception to

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the department's requirement to annually inspect a

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physician's office or an osteopathic physician's office

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where certain medical procedures are performed; providing

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an effective date.

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Be It Enacted by the Legislature of the State of Florida:

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     Section 1.  Subsection (4) of section 395.0193, Florida

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Statutes, is amended to read:

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     395.0193  Licensed facilities; peer review; disciplinary

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powers; agency or partnership with physicians.--

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     (4)  Pursuant to ss. 458.337 and 459.016, any disciplinary

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actions taken under subsection (3) shall be reported in writing

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to the Division of Medical Health Quality Assurance of the

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department agency within 30 working days after its initial

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occurrence, regardless of the pendency of appeals to the

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governing board of the hospital. The notification shall identify

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the disciplined practitioner, the action taken, and the reason

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for such action. All final disciplinary actions taken under

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subsection (3), if different from those that which were reported

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to the division agency within 30 days after the initial

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occurrence, shall be reported within 10 working days to the

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Division of Medical Health Quality Assurance of the department

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agency in writing and shall specify the disciplinary action taken

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and the specific grounds therefor. The division shall review each

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report and determine whether it potentially involved conduct by

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the licensee that is subject to disciplinary action, in which

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case s. 456.073 applies shall apply. The reports are not subject

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to inspection under s. 119.07(1) even if the division's

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investigation results in a finding of probable cause.

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     Section 2.  Paragraphs (b) and (c) of subsection (6) and

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subsections (7) and (13) of section 395.0197, Florida Statutes,

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are amended to read:

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     395.0197  Internal risk management program.--

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     (6)

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     (b)  The information reported to the agency pursuant to

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paragraph (a) which relates to health care practitioners as

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defined in s. 456.001 persons licensed under chapter 458, chapter

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459, chapter 461, or chapter 466 shall be reviewed by the agency.

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The agency shall forward a copy of the report of each incident to

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the Division of Medical Quality Assurance in the department to

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determine whether it determine whether any of the incidents

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potentially involved conduct by a health care professional who is

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subject to disciplinary action, in which case the provisions of

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s. 456.073 shall apply.

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     (c)  The report submitted to the agency shall also contain

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the name and license number of the risk manager of the licensed

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facility, a copy of its policy and procedures which govern the

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measures taken by the facility and its risk manager to reduce the

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risk of injuries and adverse incidents, and the results of such

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measures. The annual report is confidential and is not available

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to the public pursuant to s. 119.07(1) or any other law providing

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access to public records. The annual report is not discoverable

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or admissible in any civil or administrative action, except in

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disciplinary proceedings by the agency or the appropriate

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regulatory board. The annual report is not available to the

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public as part of the record of investigation for and prosecution

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in disciplinary proceedings made available to the public by the

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agency or the appropriate regulatory board. However, the agency

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or the appropriate regulatory board shall make available, upon

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written request by a health care professional against whom

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probable cause has been found, any such records which form the

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basis of the determination of probable cause.

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     (7)  Any of the following adverse incidents, whether

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occurring in the licensed facility or arising from health care

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prior to admission in the licensed facility, shall be reported by

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the facility to the agency within 15 calendar days after its

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occurrence:

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     (a)  The death of a patient;

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     (b)  Brain or spinal damage to a patient;

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

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patient;

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

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     (e)  The performance of a wrong surgical procedure;

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     (f)  The performance of a surgical procedure that is

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medically unnecessary or otherwise unrelated to the patient's

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diagnosis or medical condition;

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     (g)  The surgical repair of damage resulting to a patient

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from a planned surgical procedure, where the damage is not a

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recognized specific risk, as disclosed to the patient and

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documented through the informed-consent process; or

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     (h)  The performance of procedures to remove unplanned

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foreign objects remaining from a surgical procedure.

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The agency may grant extensions to this reporting requirement for

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more than 15 days upon justification submitted in writing by the

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facility administrator to the agency. The agency may require an

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additional, final report. These reports shall not be available to

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the public pursuant to s. 119.07(1) or any other law providing

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access to public records, nor be discoverable or admissible in

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any civil or administrative action, except in disciplinary

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proceedings by the agency or the appropriate regulatory board,

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nor shall they be available to the public as part of the record

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of investigation for and prosecution in disciplinary proceedings

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made available to the public by the agency or the appropriate

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regulatory board. However, the agency or the appropriate

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regulatory board shall make available, upon written request by a

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health care professional against whom probable cause has been

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found, any such records which form the basis of the determination

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of probable cause. The agency may investigate, as it deems

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appropriate, any such incident and prescribe measures that must

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or may be taken in response to the incident. The agency shall

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review each incident and determine whether it potentially

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involved conduct by the health care professional who is subject

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to disciplinary action, in which case the provisions of s.

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456.073 shall apply.

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     (13)  The agency shall have access to all licensed facility

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records necessary to carry out the provisions of this section.

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The records obtained by the agency under subsection (6),

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subsection (7), or subsection (9) are not available to the public

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under s. 119.07(1), nor shall they be discoverable or admissible

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in any civil or administrative action, except in disciplinary

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proceedings by the agency or the appropriate regulatory board,

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nor shall records obtained pursuant to s. 456.071 be available to

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the public as part of the record of investigation for and

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prosecution in disciplinary proceedings made available to the

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public by the agency or the appropriate regulatory board.

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However, the agency or the appropriate regulatory board shall

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make available, upon written request by a health care

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professional against whom probable cause has been found, any such

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records which form the basis of the determination of probable

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cause, except that, with respect to medical review committee

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records, s. 766.101 controls.

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     Section 3.  Paragraph (e) of subsection (4) of section

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395.3025, Florida Statutes, is amended to read:

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     395.3025  Patient and personnel records; copies;

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examination.--

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     (4)  Patient records are confidential and must not be

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disclosed without the consent of the person to whom they pertain,

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but appropriate disclosure may be made without such consent to:

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     (e) The department agency upon subpoena issued pursuant to

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s. 456.071, but the records obtained thereby must be used solely

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for the purpose of the department agency and the appropriate

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professional board in its investigation, prosecution, and appeal

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of disciplinary proceedings. The administrator or records

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custodian in a facility licensed under this chapter shall certify

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that a true and complete copy of the records requested pursuant

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to a subpoena or patient release has been provided to the

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department or shall otherwise identify those documents that have

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not been provided. If the department agency requests copies of

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the records, the facility shall charge a reasonable fee as

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determined by rule of the department no more than its actual

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copying costs, including reasonable staff time. The records must

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be sealed and must not be available to the public pursuant to s.

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119.07(1) or any other statute providing access to records, nor

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may they be available to the public as part of the record of

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investigation for and prosecution in disciplinary proceedings

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made available to the public by the department agency or the

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appropriate regulatory board. However, the department agency must

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make available, upon written request by a practitioner against

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whom probable cause has been found, any such records that form

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the basis of the determination of probable cause.

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     Section 4.  Subsection (10) of section 400.141, Florida

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Statutes, is amended to read:

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     400.141  Administration and management of nursing home

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facilities.--Every licensed facility shall comply with all

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applicable standards and rules of the agency and shall:

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     (10)  Keep full records of resident admissions and

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discharges; medical and general health status, including medical

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records, personal and social history, and identity and address of

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next of kin or other persons who may have responsibility for the

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affairs of the residents; and individual resident care plans

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including, but not limited to, prescribed services, service

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frequency and duration, and service goals. The records shall be

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open to inspection by the agency. A certified true and complete

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copy of the records shall be provided to the Department of Health

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upon subpoena issued pursuant to ss. 456.057 and 456.071. Chapter

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456 applies to the records obtained pursuant to this section.

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Facilities that have been awarded a Gold Seal under the program

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established in s. 400.235 may develop a plan to provide certified

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nursing assistant training as prescribed by federal regulations

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and state rules and may apply to the agency for approval of their

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program.

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     Section 5.  Subsection (3) is added to section 400.145,

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Florida Statutes, to read:

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     400.145  Records of care and treatment of resident; copies

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to be furnished.--

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     (3) The administrator or records custodian in a facility

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licensed under this chapter shall certify that a true and

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complete copy of records subpoenaed pursuant to ss. 456.057 and

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456.071 or requested by patient release have been provided to the

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Department of Health or shall otherwise identify those documents

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that have not been provided.

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     Section 6.  Subsection (7) and paragraph (b) of subsection

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(8) of section 400.147, Florida Statutes, are amended to read:

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     400.147  Internal risk management and quality assurance

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program.--

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     (7)  The facility shall initiate an investigation and shall

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notify the agency within 1 business day after the risk manager or

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his or her designee has received a report pursuant to paragraph

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(1)(d). The notification must be made in writing and be provided

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electronically, by facsimile device or overnight mail delivery.

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The notification must include information regarding the identity

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of the affected resident, the type of adverse incident, the

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initiation of an investigation by the facility, and whether the

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events causing or resulting in the adverse incident represent a

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potential risk to any other resident. The notification is

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confidential as provided by law and is not discoverable or

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admissible in any civil or administrative action, except in

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disciplinary proceedings by the Department of Health agency or

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the appropriate regulatory board. The agency may investigate, as

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it deems appropriate, any such incident and prescribe measures

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that must or may be taken in response to the incident. The

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Department of Health agency shall review each incident and

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determine whether it potentially involved conduct by the health

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care professional who is subject to disciplinary action, in which

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case the provisions of s. 456.073 shall apply.

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     (8)

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     (b) A copy of the report submitted The information reported

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to the agency pursuant to paragraph (a) which relates to health

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care practitioners as defined in s. 456.001 shall be forwarded to

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the Division of Medical Quality Assurance within the Department

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of Health for review persons licensed under chapter 458, chapter

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459, chapter 461, or chapter 466 shall be reviewed by the agency.

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The Department of Health agency shall determine whether any of

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the incidents potentially involved conduct by a health care

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professional who is subject to disciplinary action, in which case

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the provisions of s. 456.073 shall apply.

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     Section 7.  Subsection (1) and paragraph (a) of subsection

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(9) of section 456.057, Florida Statutes, are amended to read:

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     456.057  Ownership and control of patient records; report or

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copies of records to be furnished.--

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     (1)  As used in this section, the term "records owner" means

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any health care practitioner who generates a medical record after

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making a physical or mental examination of, or administering

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treatment or dispensing legend drugs to, any person; any health

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care practitioner to whom records are transferred by a previous

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records owner; or any health care practitioner's employer,

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including, but not limited to, group practices and staff-model

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health maintenance organizations, provided the employment

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contract or agreement between the employer and the health care

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practitioner designates the employer as the records owner.

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However, with regard to abandoned medical records, the employer

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or clinic is deemed the responsible records owner following

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abandonment of records or closure of a clinic or facility

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regardless of the contract.

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     (9)(a)1.  The department may obtain patient records pursuant

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to a subpoena without written authorization from the patient if

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the department and the probable cause panel of the appropriate

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board, if any, find reasonable cause to believe that a health

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care practitioner has excessively or inappropriately prescribed

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any controlled substance specified in chapter 893 in violation of

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this chapter or any professional practice act or that a health

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care practitioner has practiced his or her profession below that

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level of care, skill, and treatment required as defined by this

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chapter or any professional practice act and also find that

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appropriate, reasonable attempts were made to obtain a patient

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release. The department or the appropriate probable cause panel

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may find reasonable cause to subpoena patient records without

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written authorization from the patient if the patient refuses to

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cooperate or if, in the department's discretion, any attempt to

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obtain a patient release would be detrimental to completing the

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investigation.

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     2.  The department may obtain patient records and insurance

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information pursuant to a subpoena without written authorization

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from the patient if the department and the probable cause panel

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of the appropriate board, if any, find reasonable cause to

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believe that a health care practitioner has provided inadequate

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medical care based on termination of insurance and also find that

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appropriate, reasonable attempts were made to obtain a patient

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release.

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     3.  The department may obtain patient records, billing

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records, insurance information, provider contracts, and all

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attachments thereto pursuant to a subpoena without written

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authorization from the patient if the department and probable

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cause panel of the appropriate board, if any, find reasonable

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cause to believe that a health care practitioner has submitted a

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claim, statement, or bill using a billing code that would result

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in payment greater in amount than would be paid using a billing

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code that accurately describes the services performed, requested

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payment for services that were not performed by that health care

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practitioner, used information derived from a written report of

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an automobile accident generated pursuant to chapter 316 to

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solicit or obtain patients personally or through an agent

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regardless of whether the information is derived directly from

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the report or a summary of that report or from another person,

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solicited patients fraudulently, received a kickback as defined

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in s. 456.054, violated the patient brokering provisions of s.

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817.505, or presented or caused to be presented a false or

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fraudulent insurance claim within the meaning of s.

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817.234(1)(a), and also find that, within the meaning of s.

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817.234(1)(a), patient authorization cannot be obtained because

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the patient cannot be located or is deceased, incapacitated, or

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suspected of being a participant in the fraud or scheme, and if

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the subpoena is issued for specific and relevant records.

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     4.  Notwithstanding subparagraphs 1.-3., when the department

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investigates a professional liability claim or undertakes action

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pursuant to s. 456.049 or s. 627.912, the department may obtain

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patient records pursuant to a subpoena without written

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authorization from the patient if the patient refuses to

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cooperate or if the department attempts to obtain a patient

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release and the failure to obtain the patient records would be

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detrimental to the investigation.

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     Section 8.  Subsection (3) of section 458.309, Florida

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Statutes, is amended to read:

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     458.309  Rulemaking authority.--

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     (3)  All physicians who perform level 2 procedures lasting

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more than 5 minutes and all level 3 surgical procedures in an

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office setting must register the office with the department

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unless that office is licensed as a facility pursuant to chapter

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395. The department shall inspect the physician's office annually

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unless the office is accredited by a nationally recognized

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accrediting agency or an accrediting organization subsequently

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approved by the Board of Medicine. The actual costs for

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registration and inspection or accreditation shall be paid by the

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person seeking to register and operate the office setting in

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which office surgery is performed.

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     Section 9.  Subsection (2) of section 459.005, Florida

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Statutes, is amended to read:

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     459.005  Rulemaking authority.--

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     (2)  All physicians who perform level 2 procedures lasting

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more than 5 minutes and all level 3 surgical procedures in an

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office setting must register the office with the department

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unless that office is licensed as a facility pursuant to chapter

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395. The department shall inspect the physician's office annually

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unless the office is accredited by a nationally recognized

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accrediting agency or an accrediting organization subsequently

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approved by the Board of Osteopathic Medicine. The actual costs

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for registration and inspection or accreditation shall be paid by

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the person seeking to register and operate the office setting in

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which office surgery is performed.

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     Section 10.  This act shall take effect upon becoming a law.

CODING: Words stricken are deletions; words underlined are additions.