Senate Bill 1348

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    Florida Senate - 1999                                  SB 1348

    By Senator Campbell





    33-1001-99

  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; providing an effective

21         date.

22

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

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25         Section 1.  Section 458.351, Florida Statutes, is

26  created to read:

27         458.351  Reports of adverse incidents in specified

28  settings.--

29         (1)  Effective January 1, 2000, any adverse incident

30  that occurs in any setting that is not licensed under chapter

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    Florida Senate - 1999                                  SB 1348
    33-1001-99




  1  395 must be reported to the department in accordance with this

  2  section.

  3         (2)  Any physician or other person licensed under this

  4  chapter who practices in this state must notify the department

  5  of any adverse incident that involved the physician or

  6  licensee and occurred in a setting that is not licensed under

  7  chapter 395, or of any patient whom the physician or licensee

  8  accepted for care or treatment due to an injury that was the

  9  result of an adverse incident that occurred in a setting that

10  is not licensed under chapter 395.

11         (3)  The physician or licensee must notify the

12  department in writing and by certified mail of the adverse

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

14  the adverse incident occurred.

15         (4)  As used in this section, the term "adverse

16  incident" means an event over which the physician or licensee

17  could exercise control and which is associated in whole or in

18  part with a medical intervention, rather than the condition

19  for which such intervention occurred, and which results in the

20  following patient injuries:

21         (a)  The death of a patient.

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

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

24  wrong patient.

25         (d)  The performance of a wrong-site surgical

26  procedure.

27         (e)  The performance of a wrong surgical procedure.

28         (f)  The performance of a surgical procedure that is

29  medically unnecessary or otherwise unrelated to the patient's

30  diagnosis or medical condition.

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    Florida Senate - 1999                                  SB 1348
    33-1001-99




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

  2  patient from a planned surgical procedure, where the damage

  3  was not a recognized specific risk, as disclosed to the

  4  patient and documented through the informed-consent process.

  5         (h)  A procedure to remove unplanned foreign objects

  6  remaining from a surgical procedure.

  7         (5)  The department shall review each adverse incident

  8  and determine whether the incident potentially involved

  9  conduct by a health care professional who is subject to

10  disciplinary action, in which case s. 455.621 applies. The

11  department shall have access to all medical records necessary

12  to administer this section.

13         (6)  The department or the appropriate regulatory board

14  shall make available, upon written request by a health care

15  professional against whom probable cause has been found, any

16  such records that form the basis of the determination of

17  probable cause, except that s. 766.101 applies with respect to

18  records of a medical review committee.

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

20  section.

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

22  458.331, Florida Statutes, 1998 Supplement, is amended to

23  read:

24         458.331  Grounds for disciplinary action; action by the

25  board and department.--

26         (1)  The following acts shall constitute grounds for

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

28  be taken:

29         (v)  Practicing or offering to practice beyond the

30  scope permitted by law or accepting and performing

31  professional responsibilities which the licensee knows or has

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    Florida Senate - 1999                                  SB 1348
    33-1001-99




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

  2  board may establish by rule standards of practice and

  3  standards of care for particular practice settings, including,

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

  5  supplies, medications including anesthetics, assistance of and

  6  delegation to other personnel, transfer agreements,

  7  sterilization, records, performance of complex or multiple

  8  procedures, informed consent, and policy and procedure

  9  manuals.

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

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

12         458.309  Authority to make rules.--

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

14  practice and standards of care for particular practice

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

16  training, equipment and supplies, medications including

17  anesthetics, assistance of and delegation to other personnel,

18  transfer agreements, sterilization, records, performance of

19  complex or multiple procedures, informed consent, and policy

20  and procedure manuals.

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

22  practice and standards of care for the conduct of surgery in

23  office settings other than a hospital, including an ambulatory

24  surgical center, abortion clinic, or other facility licensed

25  by the Department of Health, the Agency for Health Care

26  Administration, or a successor agency. In addition to the

27  standards listed under subsection (3), the board may establish

28  by rule requirements for the registration and inspection of

29  settings in which office surgery is performed. Such

30  registration and inspections shall be conducted by the

31  department for the purpose of determining compliance with

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    Florida Senate - 1999                                  SB 1348
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  1  board rules. However, the board may approve appropriate

  2  accreditation agencies for the purpose of conducting required

  3  inspections. The actual costs for registration and inspection

  4  shall be paid by the person or entity seeking to register or

  5  operate the office setting at which surgery is performed.

  6         Section 4.  This act shall take effect July 1, 1999.

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  9                          SENATE SUMMARY

10    Requires that a physician or person licensed under ch.
      458, F.S., notify the Department of Health of any adverse
11    incident that occurs in a setting other than a hospital.
      Specifies the events that constitute an adverse incident.
12    Requires that the Department of Health review reported
      adverse incidents. Provides rulemaking authority for the
13    Board of Medicine with respect to reports of adverse
      incidents. (See bill for details.)
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