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





                                                  SENATE AMENDMENT

    Bill No. CS for SB 2220

    Amendment No.    

                            CHAMBER ACTION
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11  Senator Campbell moved the following amendment:

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13         Senate Amendment (with title amendment) 

14         On page 69, between lines 9 and 10,

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16  insert:

17         Section 56.  Paragraph (v) of subsection (1) of section

18  458.331, Florida Statutes, 1998 Supplement, is amended to

19  read:

20         458.331  Grounds for disciplinary action; action by the

21  board and department.--

22         (1)  The following acts shall constitute grounds for

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

24  be taken:

25         (v)  Practicing or offering to practice beyond the

26  scope permitted by law or accepting and performing

27  professional responsibilities which the licensee knows or has

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

29  board may establish by rule standards of practice and

30  standards of care for particular practice settings, including,

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

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2220

    Amendment No.    





 1  supplies, medications including anesthetics, assistance of and

 2  delegation to other personnel, transfer agreements,

 3  sterilization, records, performance of complex or multiple

 4  procedures, informed consent, and policy and procedure

 5  manuals.

 6         Section 57.  Subsections (3) and (4) are added to

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

 8         458.309  Authority to make rules.--

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

10  practice and standards of care for particular practice

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

12  training, equipment and supplies, medications including

13  anesthetics, assistance of and delegation to other personnel,

14  transfer agreements, sterilization, records, performance of

15  complex or multiple procedures, informed consent, and policy

16  and procedure manuals.

17         (4)  In addition to the standards listed under

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

19  for the registration and inspection of settings in which Level

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

21  performed. Such registration and inspections shall be

22  conducted by the department for the purpose of determining

23  compliance with board rules. The board may approve appropriate

24  accreditation agencies for the purpose of conducting

25  inspections. The actual costs for registration and inspection

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

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

28  performed.

29         Section 58.  Section 458.351, Florida Statutes, is

30  created to read:

31         458.351  Reports of adverse incidents in office

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2220

    Amendment No.    





 1  practice settings.--

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

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

 4  the practice of medicine which is not licensed under chapter

 5  395 must be reported to the department in accordance with the

 6  provisions of this section.

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

 8  practicing in this state must notify the department if the

 9  physician or licensee was involved in an adverse incident that

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

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

12  licensed under chapter 395.

13         (3)  The required notification to the department must

14  be submitted in writing by certified mail and postmarked

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

16         (4)  For purposes of notification to the department

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

18  event over which the physician or licensee could exercise

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

20  medical intervention, rather than the condition for which such

21  intervention occurred, and which results in the following

22  patient injuries:

23         (a)  The death of a patient.

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

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

26  wrong patient.

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

28  procedure;

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

30         3.  The surgical repair of damage to a patient

31  resulting from a planned surgical procedure where the damage

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2220

    Amendment No.    





 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 59.  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

31  not licensed under chapter 395 must be reported to the

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2220

    Amendment No.    





 1  department in accordance with the provisions of this section.

 2         (2)  Any osteopathic physician or other licensee under

 3  this chapter practicing in this state must notify the

 4  department if the osteopathic physician or licensee was

 5  involved in an adverse incident that occurred on or after

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

 7  physician for the practice of osteopathic medicine which is

 8  not licensed under chapter 395.

 9         (3)  The required notification to the department must

10  be submitted in writing by certified mail and postmarked

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

12         (4)  For purposes of notification to the department

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

14  event over which the physician or licensee could exercise

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

16  medical intervention, rather than the condition for which such

17  intervention occurred, and which results in the following

18  patient injuries:

19         (a)  The death of a patient.

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

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

22  wrong patient.

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

24  procedure;

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

26         3.  The surgical repair of damage to a patient

27  resulting from a planned surgical procedure where the damage

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

29  and documented through the informed-consent process

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

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2220

    Amendment No.    





 1  disfigurement not to include the incision scar; fracture or

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

 3  physical or sensory function; or any condition that required

 4  the transfer of the patient.

 5         (e)  A procedure to remove unplanned foreign objects

 6  remaining from a surgical procedure.

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

 8  patient to a hospital licensed under chapter 395 from an

 9  ambulatory surgical center licensed under chapter 395 or any

10  facility or any office maintained by a physician for the

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

12         (5)  The department shall review each incident and

13  determine whether it potentially involved conduct by a health

14  care professional who is subject to disciplinary action, in

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

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

17  professional is licensed.

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

19  section.

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21  (Redesignate subsequent sections.)

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24  ================ T I T L E   A M E N D M E N T ===============

25  And the title is amended as follows:

26         On page 1, line 2, delete that line

27

28  and insert:

29         An act relating to health; creating ss. 458.351

30         and 459.026, F.S.; requiring reports to the

31         Department of Health of adverse incidents in

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                                                  SENATE AMENDMENT

    Bill No. CS for SB 2220

    Amendment No.    





 1         specified settings; providing for review of

 2         such incidents and initiation of disciplinary

 3         proceedings, where appropriate; authorizing

 4         department access to certain records and

 5         preserving exemption from public access

 6         thereto; providing rulemaking authority;

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