House Bill 1847e1

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                                      HB 1847, First Engrossed/ntc



  1                      A bill to be entitled

  2         An act relating to regulation of health care

  3         practitioners; creating ss. 458.351 and

  4         459.026, F.S.; requiring reports to the

  5         Department of Health of adverse incidents in

  6         specified settings; providing for review of

  7         such incidents and initiation of disciplinary

  8         proceedings, where appropriate; authorizing

  9         department access to certain records and

10         preserving exemption from public access

11         thereto; providing rulemaking authority;

12         providing an effective date.

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

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16         Section 1.  Paragraph (v) of subsection (1) of section

17  458.331, Florida Statutes, 1998 Supplement, is amended to

18  read:

19         458.331  Grounds for disciplinary action; action by the

20  board and department.--

21         (1)  The following acts shall constitute grounds for

22  which the disciplinary actions specified in subsection (2) may

23  be taken:

24         (v)  Practicing or offering to practice beyond the

25  scope permitted by law or accepting and performing

26  professional responsibilities which the licensee knows or has

27  reason to know that he or she is not competent to perform. The

28  board may establish by rule standards of practice and

29  standards of care for particular practice settings, including,

30  but not limited to, education and training, equipment and

31  supplies, medications including anesthetics, assistance of and


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                                      HB 1847, First Engrossed/ntc



  1  delegation to other personnel, transfer agreements,

  2  sterilization, records, performance of complex or multiple

  3  procedures, informed consent, and policy and procedure

  4  manuals.

  5         Section 2.  Subsections (3) and (4) are added to

  6  section 458.309, Florida Statutes, 1998 Supplement, to read:

  7         458.309  Authority to make rules.--

  8         (3)  The board may establish by rule standards of

  9  practice and standards of care for particular practice

10  settings, including, but not limited to, education and

11  training, equipment and supplies, medications including

12  anesthetics, assistance of and delegation to other personnel,

13  transfer agreements, sterilization, records, performance of

14  complex or multiple procedures, informed consent, and policy

15  and procedure manuals.

16         (4)  In addition to the standards listed under

17  subsection (3), the board may establish by rule requirements

18  for the registration and inspection of settings in which Level

19  II or III office surgery, as defined by board rule, is

20  performed. Such registration and inspections shall be

21  conducted by the department for the purpose of determining

22  compliance with board rules. The board may approve appropriate

23  accreditation agencies for the purpose of conducting

24  inspections. The actual costs for registration and inspection

25  shall be paid by the person seeking to register and operate

26  the office setting in which Level II or III office surgery is

27  performed.

28         Section 3.  Section 458.351, Florida Statutes, is

29  created to read:

30         458.351  Reports of adverse incidents in office

31  practice settings.--


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                                      HB 1847, First Engrossed/ntc



  1         (1)  Any adverse incident that occurs on or after

  2  January 1, 2000, in any office maintained by a physician for

  3  the practice of medicine which is not licensed under chapter

  4  395 must be reported to the department in accordance with the

  5  provisions of this section.

  6         (2)  Any physician or other licensee under this chapter

  7  practicing in this state must notify the department if the

  8  physician or licensee was involved in an adverse incident that

  9  occurred on or after January 1, 2000, in any office maintained

10  by a physician for the practice of medicine which is not

11  licensed under chapter 395.

12         (3)  The required notification to the department must

13  be submitted in writing by certified mail and postmarked

14  within 15 days after the occurrence of the adverse incident.

15         (4)  For purposes of notification to the department

16  pursuant to this section, the term "adverse incident" means an

17  event over which the physician or licensee could exercise

18  control and which is associated in whole or in part with a

19  medical intervention, rather than the condition for which such

20  intervention occurred, and which results in the following

21  patient injuries:

22         (a)  The death of a patient.

23         (b)  Brain or spinal damage to a patient.

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

25  wrong patient.

26         (d)1.  The performance of a wrong-site surgical

27  procedure;

28         2.  The performance of a wrong surgical procedure; or

29         3.  The surgical repair of damage to a patient

30  resulting from a planned surgical procedure where the damage

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                                      HB 1847, First Engrossed/ntc



  1  is not a recognized specific risk as disclosed to the patient

  2  and documented through the informed-consent process

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  4  if it results in: death; brain or spinal damage; permanent

  5  disfigurement not to include the incision scar; fracture or

  6  dislocation of bones or joints; a limitation of neurological,

  7  physical or sensory function; or any condition that required

  8  the transfer of the patient.

  9         (e)  A procedure to remove unplanned foreign objects

10  remaining from a surgical procedure.

11         (f)  Any condition that required the transfer of a

12  patient to a hospital licensed under chapter 395 from an

13  ambulatory surgical center licensed under chapter 395 or any

14  facility or any office maintained by a physician for the

15  practice of medicine which is not licensed under chapter 395.

16         (5)  The department shall review each incident and

17  determine whether it potentially involved conduct by a health

18  care professional who is subject to disciplinary action, in

19  which case s. 455.621 applies. Disciplinary action, if any,

20  shall be taken by the board under which the health care

21  professional is licensed.

22         (6)  The board may adopt rules to administer this

23  section.

24         Section 4.  Section 459.026, Florida Statutes, is

25  created to read:

26         459.026  Reports of adverse incidents in office

27  practice settings.--

28         (1)  Any adverse incident that occurs on or after

29  January 1, 2000, in any office maintained by an osteopathic

30  physician for the practice of osteopathic medicine which is

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                                      HB 1847, First Engrossed/ntc



  1  not licensed under chapter 395 must be reported to the

  2  department in accordance with the provisions of this section.

  3         (2)  Any osteopathic physician or other licensee under

  4  this chapter practicing in this state must notify the

  5  department if the osteopathic physician or licensee was

  6  involved in an adverse incident that occurred on or after

  7  January 1, 2000, in any office maintained by an osteopathic

  8  physician for the practice of osteopathic medicine which is

  9  not licensed under chapter 395.

10         (3)  The required notification to the department must

11  be submitted in writing by certified mail and postmarked

12  within 15 days after the occurrence of the adverse incident.

13         (4)  For purposes of notification to the department

14  pursuant to this section, the term "adverse incident" means an

15  event over which the physician or licensee could exercise

16  control and which is associated in whole or in part with a

17  medical intervention, rather than the condition for which such

18  intervention occurred, and which results in the following

19  patient injuries:

20         (a)  The death of a patient.

21         (b)  Brain or spinal damage to a patient.

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

23  wrong patient.

24         (d)1.  The performance of a wrong-site surgical

25  procedure;

26         2.  The performance of a wrong surgical procedure; or

27         3.  The surgical repair of damage to a patient

28  resulting from a planned surgical procedure where the damage

29  is not a recognized specific risk as disclosed to the patient

30  and documented through the informed-consent process

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






                                      HB 1847, First Engrossed/ntc



  1  if it results in: death; brain or spinal damage; permanent

  2  disfigurement not to include the incision scar; fracture or

  3  dislocation of bones or joints; a limitation of neurological,

  4  physical or sensory function; or any condition that required

  5  the transfer of the patient.

  6         (e)  A procedure to remove unplanned foreign objects

  7  remaining from a surgical procedure.

  8         (f)  Any condition that required the transfer of a

  9  patient to a hospital licensed under chapter 395 from an

10  ambulatory surgical center licensed under chapter 395 or any

11  facility or any office maintained by a physician for the

12  practice of medicine which is not licensed under chapter 395.

13         (5)  The department shall review each incident and

14  determine whether it potentially involved conduct by a health

15  care professional who is subject to disciplinary action, in

16  which case s. 455.621 applies. Disciplinary action, if any,

17  shall be taken by the board under which the health care

18  professional is licensed.

19         (6)  The board may adopt rules to administer this

20  section.

21         Section 5.  This act shall take effect upon becoming a

22  law.

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