Senate Bill 1348c1

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



    Florida Senate - 1999                           CS for SB 1348

    By the Committee on Health, Aging and Long-Term Care; and
    Senator Campbell




    317-1883-99

  1                      A bill to be entitled

  2         An act relating to the practice of medicine;

  3         creating s. 458.351, F.S.; requiring that a

  4         physician or person licensed under ch. 458,

  5         F.S., notify the Department of Health of any

  6         adverse incident occurring in a setting that is

  7         not licensed under ch. 395, F.S.; defining the

  8         term "adverse incident"; requiring that the

  9         department review adverse incidents;

10         authorizing the Board of Medicine to adopt

11         rules; amending s. 458.331, F.S., relating to

12         grounds for disciplinary action by the board;

13         deleting provisions made obsolete by the act;

14         amending s. 458.309, F.S.; authorizing the

15         board to adopt standards of practice and care

16         for particular practice settings; authorizing

17         the board to adopt standards for conducting

18         surgery in settings other than a hospital;

19         authorizing the board to approve other agencies

20         to conduct inspections; creating s. 459.026,

21         F.S.; requiring that an osteopathic physician

22         or person licensed under ch. 459, F.S., notify

23         the Department of Health of any adverse

24         incident occurring in a setting that is not

25         licensed under ch. 395, F.S.; defining the term

26         "adverse incident"; requiring that the

27         department review adverse incidents;

28         authorizing the Board of Osteopathic Medicine

29         to adopt rules; providing an effective date.

30

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

                                  1

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






    Florida Senate - 1999                           CS for SB 1348
    317-1883-99




  1         Section 1.  Section 458.351, Florida Statutes, is

  2  created to read:

  3         458.351  Reports of adverse incidents in specified

  4  settings.--

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

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

  7  the practice of medicine which is not licensed under chapter

  8  395 must be reported to the department in accordance with this

  9  section.

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

11  practicing in this state must notify the department if the

12  physician or licensee was involved in an adverse incident that

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

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

15  licensed under chapter 395.

16         (3)  The required notification to the department must

17  be submitted in writing by certified mail of the adverse

18  incident, which notice must be postmarked within 15 days after

19  the occurrence of the adverse incident.

20         (4)  For purposes of notification to the department

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

22  event over which the physician or licensee could exercise

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

24  medical intervention, rather than the condition for which such

25  intervention occurred, and which results in the following

26  patient injuries:

27         (a)  The death of a patient.

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

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

30  wrong patient.

31

                                  2

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






    Florida Senate - 1999                           CS for SB 1348
    317-1883-99




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

  2  procedure;

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

  4         3.  The surgical repair of damage to a patient

  5  resulting from a planned surgical procedure where the damage

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

  7  and documented through the informed-consent process

  8

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

10  disfigurement not to include the incision scar; fracture or

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

12  physical, or sensory function; or any condition that required

13  the transfer of the patient.

14         (e)  A procedure to remove unplanned foreign objects

15  remaining from a surgical procedure.

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

17  patient to a hospital licensed under chapter 395 from an

18  ambulatory surgical center licensed under chapter 395 or any

19  facility or any office maintained by a physician for the

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

21         (5)  The department shall review each incident and

22  determine whether it potentially involved conduct by a health

23  care professional who is subject to disciplinary action, in

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

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

26  professional is licensed.

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

28  section.

29         Section 2.  Paragraph (v) of subsection (1) of section

30  458.331, Florida Statutes, 1998 Supplement, is amended to

31  read:

                                  3

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






    Florida Senate - 1999                           CS for SB 1348
    317-1883-99




  1         458.331  Grounds for disciplinary action; action by the

  2  board and department.--

  3         (1)  The following acts shall constitute grounds for

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

  5  be taken:

  6         (v)  Practicing or offering to practice beyond the

  7  scope permitted by law or accepting and performing

  8  professional responsibilities which the licensee knows or has

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

10  board may establish by rule standards of practice and

11  standards of care for particular practice settings, including,

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

13  supplies, medications including anesthetics, assistance of and

14  delegation to other personnel, transfer agreements,

15  sterilization, records, performance of complex or multiple

16  procedures, informed consent, and policy and procedure

17  manuals.

18         Section 3.  Subsections (3) and (4) are added to

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

20         458.309  Authority to make rules.--

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

22  practice and standards of care for particular practice

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

24  training, equipment and supplies, medications including

25  anesthetics, assistance of and delegation to other personnel,

26  transfer agreements, sterilization, records, performance of

27  complex or multiple procedures, informed consent, and policy

28  and procedure manuals.

29         (4)  In addition to the standards listed under

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

31  for the registration and inspection of settings in which Level

                                  4

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






    Florida Senate - 1999                           CS for SB 1348
    317-1883-99




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

  2  performed. Such registration and inspections shall be

  3  conducted by the department for the purpose of determining

  4  compliance with board rules. The board may approve appropriate

  5  accreditation agencies for the purpose of conducting

  6  inspections. The actual costs for registration and inspection

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

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

  9  performed.

10         Section 4.  Section 459.026, Florida Statutes, is

11  created to read:

12         459.026  Reports of adverse incidents in office

13  practice settings.--

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

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

16  physician for the practice of osteopathic medicine which is

17  not licensed under chapter 395 must be reported to the

18  department in accordance with the provisions of this section.

19         (2)  Any osteopathic physician or other licensee under

20  this chapter practicing in this state must notify the

21  department if the osteopathic physician or licensee was

22  involved in an adverse incident that occurred on or after

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

24  physician for the practice of osteopathic medicine which is

25  not licensed under chapter 395.

26         (3)  The required notification to the department must

27  be submitted in writing by certified mail and postmarked

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

29         (4)  For purposes of notification to the department

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

31  event over which the osteopathic physician or licensee could

                                  5

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






    Florida Senate - 1999                           CS for SB 1348
    317-1883-99




  1  exercise control and which is associated in whole or in part

  2  with medical intervention, rather than the condition for which

  3  such intervention occurred, and which results in any of the

  4  following patient injuries:

  5         (a)  The death of a patient;

  6         (b)  Brain or spinal damage to a patient;

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

  8  wrong patient;

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

10  procedure;

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

12         3.  The surgical repair of damage to a patient

13  resulting from a planned surgical procedure where the damage

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

15  and documented through the informed-consent process

16

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

18  disfigurement not to include the incision scar; fracture or

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

20  physical, or sensory function; or any condition that required

21  the transfer of the patient.

22         (e)  The performance of procedures to remove foreign

23  objects left unintentionally during a previous surgical

24  procedure.

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

26  patient to a hospital licensed under chapter 395 from an

27  ambulatory surgical center licensed under chapter 395 or any

28  facility or any office maintained by a physician for the

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

30         (5)  The department shall review each incident and

31  determine whether it potentially involved conduct by a health

                                  6

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






    Florida Senate - 1999                           CS for SB 1348
    317-1883-99




  1  care professional who is subject to disciplinary action, in

  2  which case the provisions of s. 455.621 shall apply; and

  3  disciplinary action, if any, shall be taken by the board under

  4  which the health care professional is licensed.

  5         (6)  The board may adopt rules to implement this

  6  section.

  7         Section 5.  This act shall take effect July 1, 1999.

  8

  9          STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
                       COMMITTEE SUBSTITUTE FOR
10                         Senate Bill 1348

11

12  Requires any medical physician, osteopathic physician, or
    physician assistant to notify the Department of Health of any
13  adverse incident that involved the physician or physician
    assistant which occurred on or after January 1, 2000, in any
14  office maintained by the physician for the practice of
    medicine that is not licensed under chapter 395, F.S.,
15  relating to licensure for hospitals and ambulatory surgical
    centers. Revises the definition of adverse incident. Limits
16  the Board of Medicine's authority to establish by rule
    requirements for the registration and inspection of settings
17  in which Level II or Level III office surgery, as defined by
    the board rule, is performed rather than all office surgery
18

19

20

21

22

23

24

25

26

27

28

29

30

31

                                  7