Senate Bill sb1862c1

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    Florida Senate - 2005                           CS for SB 1862

    By the Committee on Judiciary; and Senators Dockery, Fasano,
    Villalobos, Baker, Sebesta, Atwater, Alexander, Wise,
    Constantine, Webster, Haridopolos, Pruitt, Diaz de la
    Portilla, Posey, Peaden, Clary, Campbell and Bullard


    590-2251-05

  1                      A bill to be entitled

  2         An act relating to women's health care;

  3         providing a short title; amending s. 390.012,

  4         F.S.; revising requirements for rules of the

  5         Agency for Health Care Administration relating

  6         to abortion clinics performing abortions after

  7         the first trimester of pregnancy; requiring

  8         rules that prescribe standards for physical

  9         facilities, supplies and equipment, personnel,

10         screening and evaluation, the abortion

11         procedure, recovery, followup care, and

12         incident reporting; providing that rules

13         regulating abortion clinics may not impose an

14         unconstitutional burden rather than a legally

15         significant burden on a woman's right to choose

16         to terminate her pregnancy; providing for

17         severability; providing an effective date.

18  

19         WHEREAS, abortion is an invasive surgical procedure

20  that can lead to numerous and serious medical complications,

21  including, but not limited to, bleeding, hemorrhage,

22  infection, uterine perforation, blood clots, cervical tears,

23  incomplete abortion and retained tissue, failure to actually

24  terminate the pregnancy, free fluid in the abdomen, missed

25  ectopic pregnancies, cardiac arrest, sepsis, respiratory

26  arrest, reactions to anesthesia, fertility problems, emotional

27  problems, and even death, and

28         WHEREAS, the state has a legitimate interest in

29  ensuring that abortions, like any other medical procedure, be

30  performed under circumstances that ensure maximum safety for

31  the patient, and

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    Florida Senate - 2005                           CS for SB 1862
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 1         WHEREAS, the risks for abortion are greater after the

 2  first trimester of pregnancy, and

 3         WHEREAS, the risk of hemorrhage, in particular, is

 4  greater after the first trimester of pregnancy, and the

 5  resultant complications may require a hysterectomy, other

 6  reparative surgery, or a blood transfusion, NOW, THEREFORE,

 7  

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

 9  

10         Section 1.  This act may be cited as the "Women's

11  Health and Safety Act."

12         Section 2.  Section 390.012, Florida Statutes, is

13  amended to read:

14         390.012  Powers of agency; rules; disposal of fetal

15  remains.--

16         (1)  The agency shall have the authority to develop and

17  enforce rules for the health, care, and treatment of persons

18  in abortion clinics and for the safe operation of such

19  clinics. These rules shall be comparable to rules which apply

20  to all surgical procedures requiring approximately the same

21  degree of skill and care as the performance of first trimester

22  abortions.

23         (a)  The rules shall be reasonably related to the

24  preservation of maternal health of the clients.

25         (b)  The rules shall be in accordance with s. 797.03

26  and may not impose an unconstitutional a legally significant

27  burden on a woman's freedom to decide whether to terminate her

28  pregnancy.

29         (c)  The rules shall provide for:

30         1.(a)  The performance of pregnancy termination

31  procedures only by a licensed physician.

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    Florida Senate - 2005                           CS for SB 1862
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 1         2.(b)  The making, protection, and preservation of

 2  patient records, which shall be treated as medical records

 3  under chapter 458.

 4         (2)  For clinics that perform abortions in the first

 5  trimester of pregnancy only, these rules shall be comparable

 6  to rules that apply to all surgical procedures requiring

 7  approximately the same degree of skill and care as the

 8  performance of first trimester abortions.

 9         (3)  For clinics that perform or claim to perform

10  abortions after the first trimester of pregnancy, the agency

11  shall adopt rules pursuant to ss. 120.536(1) and 120.54 to

12  implement the provisions of this chapter, including the

13  following:

14         (a)  Rules for an abortion clinic's physical

15  facilities. At a minimum, these rules shall prescribe

16  standards for:

17         1.  Adequate private space that is specifically

18  designated for interviewing, counseling, and medical

19  evaluations.

20         2.  Dressing rooms for staff and patients.

21         3.  Appropriate lavatory areas.

22         4.  Areas for preprocedure hand washing.

23         5.  Private procedure rooms.

24         6.  Adequate lighting and ventilation for abortion

25  procedures.

26         7.  Surgical or gynecological examination tables and

27  other fixed equipment.

28         8.  Postprocedure recovery rooms that are equipped to

29  meet the patients' needs.

30         9.  Emergency exits to accommodate a stretcher or

31  gurney.

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    Florida Senate - 2005                           CS for SB 1862
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 1         10.  Areas for cleaning and sterilizing instruments.

 2         11.  Adequate areas for the secure storage of medical

 3  records and necessary equipment and supplies.

 4         12.  The display in the abortion clinic, in a place

 5  that is conspicuous to all patients, of the clinic's current

 6  license issued by the agency.

 7         (b)  Rules to prescribe abortion clinic supplies and

 8  equipment standards, including supplies and equipment that are

 9  required to be immediately available for use or in an

10  emergency. At a minimum, these rules shall:

11         1.  Prescribe required clean and sterilized equipment

12  and supplies, including medications, required for the conduct,

13  in an appropriate fashion, of any abortion procedure that the

14  medical staff of the clinic anticipates performing and for

15  monitoring the progress of each patient throughout the

16  procedure and recovery period.

17         2.  Prescribe required equipment, supplies, and

18  medications that shall be available and ready for immediate

19  use in an emergency and requirements for written protocols and

20  procedures to be followed by staff in an emergency, such as

21  the loss of electrical power.

22         3.  Prescribe equipment and supplies for required

23  laboratory tests and requirements for protocols to calibrate

24  and maintain laboratory equipment or equipment operated by

25  clinic staff at the abortion clinic.

26         4.  Require ultrasound equipment.

27         5.  Require that all equipment is safe for the patient

28  and the staff, meets applicable federal standards, and is

29  checked annually to ensure safety and appropriate calibration.

30         (c)  Rules relating to abortion clinic personnel. At a

31  minimum, these rules shall require that:

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    Florida Senate - 2005                           CS for SB 1862
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 1         1.  The abortion clinic designate a medical director

 2  who is licensed to practice medicine and surgery in the state

 3  and who has admitting privileges at an accredited hospital in

 4  the state which is within 50 miles of the abortion clinic.

 5         2.  If a physician is not present after an abortion is

 6  performed, a registered nurse, licensed practical nurse,

 7  advanced registered nurse practitioner, or physician assistant

 8  shall be present and remain at the clinic to provide

 9  postoperative monitoring and care until the patient is

10  discharged.

11         3.  Surgical assistants receive training in counseling,

12  patient advocacy, and the specific responsibilities associated

13  with the services the surgical assistants provide.

14         4.  Volunteers receive training in the specific

15  responsibilities associated with the services the volunteers

16  provide, including counseling and patient advocacy as provided

17  in the rules adopted by the director for different types of

18  volunteers based on their responsibilities.

19         (d)  Rules relating to the medical screening and

20  evaluation of each abortion clinic patient. At a minimum,

21  these rules shall require:

22         1.  A medical history, including reported allergies to

23  medications, antiseptic solutions, or latex; past surgeries;

24  and an obstetric and gynecological history.

25         2.  A physical examination, including a bimanual

26  examination estimating uterine size and palpation of the

27  adnexa.

28         3.  The appropriate laboratory tests, including:

29         a.  For an abortion in which an ultrasound examination

30  is not performed before the abortion procedure, urine or blood

31  tests for pregnancy performed before the abortion procedure.

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    Florida Senate - 2005                           CS for SB 1862
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 1         b.  A test for anemia.

 2         c.  Rh typing, unless reliable written documentation of

 3  blood type is available.

 4         d.  Other tests as indicated from the physical

 5  examination.

 6         4.  An ultrasound evaluation for all patients who elect

 7  to have an abortion after the first trimester. The rules shall

 8  require that if a person who is not a physician performs an

 9  ultrasound examination, that person shall have documented

10  evidence that he or she has completed a course in the

11  operation of ultrasound equipment as prescribed in rule. The

12  physician, registered nurse, licensed practical nurse,

13  advanced registered nurse practitioner, or physician assistant

14  shall review, at the request of the patient, the ultrasound

15  evaluation results, including an estimate of the probable

16  gestational age of the fetus, with the patient before the

17  abortion procedure is performed.

18         5.  That the physician is responsible for estimating

19  the gestational age of the fetus based on the ultrasound

20  examination and obstetric standards in keeping with

21  established standards of care regarding the estimation of

22  fetal age as defined in rule and shall write the estimate in

23  the patient's medical history. The physician shall keep

24  original prints of each ultrasound examination of a patient in

25  the patient's medical history file.

26         (e)  Rules relating to the abortion procedure. At a

27  minimum, these rules shall require:

28         1.  That a physician, registered nurse, licensed

29  practical nurse, advanced registered nurse practitioner, or

30  physician assistant is available to all patients throughout

31  the abortion procedure.

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    Florida Senate - 2005                           CS for SB 1862
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 1         2.  Standards for the safe conduct of abortion

 2  procedures that conform to obstetric standards in keeping with

 3  established standards of care regarding the estimation of

 4  fetal age as defined in rule.

 5         3.  Appropriate use of general and local anesthesia,

 6  analgesia, and sedation if ordered by the physician.

 7         4.  Appropriate precautions, such as the establishment

 8  of intravenous access, at least for patients undergoing

 9  post-first trimester abortions.

10         5.  Appropriate monitoring of the vital signs and other

11  defined signs and markers of the patient's status throughout

12  the abortion procedure and during the recovery period until

13  the patient's condition is deemed to be stable in the recovery

14  room.

15         (f)  Rules that prescribe minimum recovery room

16  standards. At a minimum, these rules shall require that:

17         1.  Postprocedure recovery rooms are supervised and

18  staffed to meet the patients' needs.

19         2.  Immediate postprocedure care consists of

20  observation in a supervised recovery room for as long as the

21  patient's condition warrants.

22         3.  The clinic arranges hospitalization if any

23  complication beyond the medical capability of the staff occurs

24  or is suspected.

25         4.  A registered nurse, licensed practical nurse,

26  advanced registered nurse practitioner, or physician assistant

27  who is trained in the management of the recovery area and is

28  capable of providing basic cardiopulmonary resuscitation and

29  related emergency procedures remains on the premises of the

30  abortion clinic until all patients are discharged.

31  

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    Florida Senate - 2005                           CS for SB 1862
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 1         5.  A physician shall sign the discharge order and be

 2  readily accessible and available until the last patient is

 3  discharged to facilitate the transfer of emergency cases if

 4  hospitalization of the patient or viable fetus is necessary.

 5         6.  A physician discusses Rho(D) immune globulin with

 6  each patient for whom it is indicated and ensures that it is

 7  offered to the patient in the immediate postoperative period

 8  or that it will be available to her within 72 hours after

 9  completion of the abortion procedure. If the patient refuses

10  the Rho(D) immune globulin, a refusal form approved by the

11  agency shall be signed by the patient and a witness and

12  included in the medical record.

13         7.  Written instructions with regard to postabortion

14  coitus, signs of possible problems, and general aftercare are

15  given to each patient. Each patient shall have specific

16  written instructions regarding access to medical care for

17  complications, including a telephone number to call for

18  medical emergencies.

19         8.  There is a specified minimum length of time that a

20  patient remains in the recovery room by type of abortion

21  procedure and duration of gestation.

22         9.  The physician ensures that a registered nurse,

23  licensed practical nurse, advanced registered nurse

24  practitioner, or physician assistant from the abortion clinic

25  makes a good-faith effort to contact the patient by telephone,

26  with the patient's consent, within 24 hours after surgery to

27  assess the patient's recovery.

28         10.  Equipment and services are readily accessible to

29  provide appropriate emergency resuscitative and life support

30  procedures pending the transfer of the patient or viable fetus

31  to the hospital.

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    Florida Senate - 2005                           CS for SB 1862
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 1         (g)  Rules that prescribe standards for followup care.

 2  At a minimum, these rules shall require that:

 3         1.  A postabortion medical visit that includes a

 4  medical examination and a review of the results of all

 5  laboratory tests is offered.

 6         2.  A urine pregnancy test is obtained at the time of

 7  the followup visit to rule out continuing pregnancy.

 8         3.  If a continuing pregnancy is suspected, the patient

 9  shall be evaluated and a physician who performs abortions

10  shall be consulted.

11         (h)  Rules to prescribe minimum abortion clinic

12  incident reporting. At a minimum, these rules shall require

13  that:

14         1.  The abortion clinic records each incident that

15  results in serious injury to a patient or a viable fetus at an

16  abortion clinic and shall report an incident in writing to the

17  agency within 10 days after the incident occurs. For the

18  purposes of this paragraph, the term "serious injury" means an

19  injury that occurs at an abortion clinic and that creates a

20  serious risk of substantial impairment of a major bodily

21  organ.

22         2.  If a patient's death occurs, other than a fetal

23  death properly reported pursuant to law, the abortion clinic

24  reports it to the department not later than the next

25  department workday.

26         (4)  The rules adopted pursuant to this section shall

27  not limit the ability of a physician to advise a patient on

28  any health issue.

29         (5)  The provisions of this section and the rules

30  adopted pursuant to this section shall be in addition to any

31  

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    Florida Senate - 2005                           CS for SB 1862
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 1  other laws, rules, and regulations that are applicable to

 2  facilities defined as abortion clinics under this section.

 3         (6)(2)  The agency may adopt and enforce rules, in the

 4  interest of protecting the public health, to ensure the prompt

 5  and proper disposal of fetal remains and tissue resulting from

 6  pregnancy termination.

 7         (7)(3)  If any owner, operator, or employee of an

 8  abortion clinic fails to dispose of fetal remains and tissue

 9  in a manner consistent with the disposal of other human tissue

10  in a competent professional manner, the license of such clinic

11  may be suspended or revoked, and such person is guilty of a

12  misdemeanor of the first degree, punishable as provided in s.

13  775.082 or s. 775.083.

14         Section 3.  If any provision of this act or the

15  application thereof to any person or circumstance is held

16  invalid, the invalidity shall not affect other provisions or

17  applications of the act which can be given effect without the

18  invalid provision or application. To this end, the provisions

19  of this act are declared severable.

20         Section 4.  This act shall take effect July 1, 2005.

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    Florida Senate - 2005                           CS for SB 1862
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 1          STATEMENT OF SUBSTANTIAL CHANGES CONTAINED IN
                       COMMITTEE SUBSTITUTE FOR
 2                         Senate Bill 1862

 3                                 

 4  This committee substitute:

 5  --   Requires ultrasound equipment for all facilities, not
         just those providing abortions after 12 weeks gestation;
 6  
    --   Requires rules to be adopted to include an ultrasound for
 7       all abortions after the first trimester, rather than
         after 12 weeks gestation;
 8  
    --   Changes references from "Department" to "Agency"
 9       regarding the entity required to approve a refusal form
         relating to Rho(D) immune globulin and the entity
10       receiving reports of serious injuries;

11  --   Changes the requirement that equipment and services be
         physically located in the recovery room to requiring that
12       they be "readily accessible"; and

13  --   Removes the confidentiality provision relating to
         personally identifiable patient and physician information
14       provided to the Department of Health.

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