Bill Text: FL S1564 | 2018 | Regular Session | Introduced


Bill Title: Advanced Birth Centers

Spectrum: Partisan Bill (Republican 1-0)

Status: (Introduced - Dead) 2018-02-27 - Withdrawn from further consideration [S1564 Detail]

Download: Florida-2018-S1564-Introduced.html
       Florida Senate - 2018                                    SB 1564
       
       
        
       By Senator Grimsley
       
       
       
       
       
       26-00936B-18                                          20181564__
    1                        A bill to be entitled                      
    2         An act relating to advanced birth centers; amending s.
    3         383.30, F.S.; revising the short title; amending s.
    4         383.301, F.S.; providing for the applicability of
    5         licensure requirements under part II of ch. 408, F.S.,
    6         to advanced birth centers; amending s. 383.302, F.S.;
    7         defining the term “advanced birth center”; revising
    8         definitions; amending s. 383.307, F.S.; providing
    9         requirements for the administration of an advanced
   10         birth center; creating s. 383.3081, F.S.; providing
   11         requirements for advanced birth center facilities and
   12         equipment; amending s. 383.309, F.S.; requiring the
   13         Agency for Health Care Administration to adopt by rule
   14         minimum standards for advanced birth centers, which
   15         must be equivalent to specified standards; authorizing
   16         the agency to enforce specified provisions of the
   17         Florida Building Code and the Florida Fire Prevention
   18         Code; requiring an advanced birth center, at a
   19         minimum, to comply with certain construction
   20         standards; amending s. 383.311, F.S.; providing for
   21         the education and orientation of advanced birth center
   22         clients and their families; amending s. 383.312, F.S.;
   23         requiring advanced birth centers to ensure that
   24         clients have adequate prenatal care; amending s.
   25         383.313, F.S.; conforming provisions to changes made
   26         by the act; creating s. 383.3131, F.S.; requiring that
   27         laboratories located in advanced birth centers be
   28         licensed as clinical laboratories; restricting the
   29         surgical procedures that may be provided at advanced
   30         birth centers; providing conditions for the
   31         administration of anesthesia and the use of specified
   32         chemical agents; amending s. 383.315, F.S.; requiring
   33         an advanced birth center to employ or maintain an
   34         agreement with an obstetrician who is available to
   35         attend and perform cesarean deliveries when necessary;
   36         amending s. 383.316, F.S.; requiring advanced birth
   37         centers to provide for the transfer and transport of
   38         emergency patients to a hospital, to identify and list
   39         certain transportation services, and to annually
   40         assess and document certain services and protocols;
   41         amending s. 383.318, F.S.; requiring that mothers and
   42         infants be discharged from an advanced birth center
   43         within specified timeframes except in unusual
   44         circumstances; requiring the filing of a certain
   45         report in such circumstances; providing protocols for
   46         postpartum care of clients and infants; providing
   47         requirements for followup care; amending s. 383.32,
   48         F.S.; specifying that clinical records must be
   49         immediately available at an advanced birth center at
   50         specified times; amending s. 383.332, F.S.; providing
   51         a criminal penalty for operating an unlicensed
   52         advanced birth center; amending s. 465.003, F.S.;
   53         revising the definition of the term “institutional
   54         pharmacy” to include pharmacies located in advanced
   55         birth centers; amending s. 465.019, F.S.; revising the
   56         definition of the term “modified Class II
   57         institutional pharmacies” to include pharmacies
   58         located in advanced birth centers; providing an
   59         effective date.
   60          
   61  Be It Enacted by the Legislature of the State of Florida:
   62  
   63         Section 1. Section 383.30, Florida Statutes, is amended to
   64  read:
   65         383.30 Birth Center and Advanced Birth Center Licensure
   66  Act; short title.—Sections 383.30-383.335 shall be known and may
   67  be cited as the “Birth Center and Advanced Birth Center
   68  Licensure Act.”
   69         Section 2. Section 383.301, Florida Statutes, is amended to
   70  read:
   71         383.301 Licensure and regulation of birth centers;
   72  legislative intent.—It is the intent of the Legislature to
   73  provide for the protection of public health and safety in the
   74  establishment, maintenance, and operation of birth centers and
   75  advanced birth centers by providing for licensure of birth
   76  centers and advanced birth centers and for the development,
   77  establishment, and enforcement of minimum standards with respect
   78  to birth centers and advanced birth centers. The requirements of
   79  part II of chapter 408 shall apply to the provision of services
   80  that require licensure pursuant to ss. 383.30-383.335 and part
   81  II of chapter 408 and to entities licensed by or applying for
   82  such licensure from the Agency for Health Care Administration
   83  pursuant to ss. 383.30-383.335. A license issued by the agency
   84  is required in order to operate a birth center or an advanced
   85  birth center in this state.
   86         Section 3. Present subsections (1) through (10) of section
   87  383.302, Florida Statutes, are redesignated as subsections (2)
   88  through (11), respectively, present subsections (3), (4), and
   89  (5) are amended, and a new subsection (1) is added to that
   90  section, to read:
   91         383.302 Definitions of terms used in ss. 383.30-383.335.—As
   92  used in ss. 383.30-383.335, the term:
   93         (1)“Advanced birth center” means a birth center that is
   94  authorized to perform trials of labor after cesarean deliveries
   95  for qualified and screened patients, planned low-risk cesarean
   96  deliveries, and anticipated vaginal deliveries for laboring
   97  patients after the completion of a patient’s 36th week of
   98  gestation but prior to the 42nd week of gestation.
   99         (4)(3) “Clinical staff” means individuals employed full
  100  time or part time by a birth center or an advanced birth center
  101  who are licensed or certified to provide care at childbirth.
  102         (5)(4) “Consultant” means a physician licensed pursuant to
  103  chapter 458 or chapter 459 who agrees to provide advice and
  104  services to a birth center or an advanced birth center and who
  105  either:
  106         (a) Is certified or eligible for certification by the
  107  American Board of Obstetrics and Gynecology;, or
  108         (b) Has hospital obstetrical privileges.
  109         (6)(5) “Governing body” means any individual, group,
  110  corporation, or institution which is responsible for the overall
  111  operation and maintenance of a birth center or an advanced birth
  112  center.
  113         Section 4. Section 383.307, Florida Statutes, is amended to
  114  read:
  115         383.307 Administration of birth center or advanced birth
  116  center.—
  117         (1) Each birth center and advanced birth center shall have
  118  a governing body which is responsible for the overall operation
  119  and maintenance of the birth center.
  120         (a) The governing body shall develop and display a table of
  121  organization which shows the structure of the birth center or
  122  advanced birth center and identifies the governing body, the
  123  birth center director, the clinical director, the clinical
  124  staff, and the medical consultant.
  125         (b) The governing body shall develop and make available to
  126  staff, clinicians, consultants, and licensing authorities a
  127  manual which documents policies, procedures, and protocols,
  128  including the roles and responsibilities of all personnel.
  129         (2) There shall be an adequate number of licensed personnel
  130  to provide clinical services needed by mothers and newborns and
  131  a sufficient number of qualified personnel to provide services
  132  for families and to maintain the birth center or the advanced
  133  birth center.
  134         (3) All clinical staff members and consultants shall hold
  135  current licenses from this state to practice their respective
  136  disciplines.
  137         (4) Clinical staff members and consultants shall adopt
  138  bylaws which are subject to the approval of the governing body
  139  and which shall include recommendations for clinical staff or
  140  consultation appointments, delineation of clinical privileges,
  141  and the organization of the clinical staff.
  142         Section 5. Section 383.3081, Florida Statutes, is created
  143  to read:
  144         383.3081Advanced birth center facility and equipment;
  145  requirements.—
  146         (1)An advanced birth center shall meet all of the
  147  requirements of s. 383.308.
  148         (2)An advanced birth center shall be operated and staffed
  149  24 hours a day, 7 days a week.
  150         (3)Each advanced birth center shall have at least one
  151  properly equipped, dedicated surgical suite for the performance
  152  of cesarean deliveries.
  153         Section 6. Section 383.309, Florida Statutes, is amended to
  154  read:
  155         383.309 Minimum standards for birth centers and advanced
  156  birth centers; rules and enforcement.—
  157         (1) The agency shall adopt and enforce rules to administer
  158  ss. 383.30-383.335 and part II of chapter 408, which rules shall
  159  include, but are not limited to, reasonable and fair minimum
  160  standards for ensuring that:
  161         (a) Sufficient numbers and qualified types of personnel and
  162  occupational disciplines are available at all times to provide
  163  necessary and adequate patient care and safety.
  164         (b) Infection control, housekeeping, sanitary conditions,
  165  disaster plan, and medical record procedures that will
  166  adequately protect patient care and provide safety are
  167  established and implemented.
  168         (c) Licensed facilities are established, organized, and
  169  operated consistent with established programmatic standards.
  170         (2) The agency shall adopt by rule minimum standards for
  171  advanced birth centers which are equivalent to the minimum
  172  standards for ambulatory surgical centers adopted under s.
  173  395.1055. Such standards must include sanitary conditions for
  174  food handling and food service.
  175         (3)(2) The agency may not establish any rule governing the
  176  design, construction, erection, alteration, modification,
  177  repair, or demolition of birth centers or advanced birth
  178  centers. It is the intent of the Legislature to preempt that
  179  function to the Florida Building Commission and the State Fire
  180  Marshal through adoption and maintenance of the Florida Building
  181  Code and the Florida Fire Prevention Code. However, the agency
  182  shall provide technical assistance to the commission and the
  183  State Fire Marshal in updating the construction standards of the
  184  Florida Building Code and the Florida Fire Prevention Code which
  185  govern birth centers and advanced birth centers. In addition,
  186  the agency may enforce the special-occupancy provisions of the
  187  Florida Building Code and the Florida Fire Prevention Code which
  188  apply to birth centers or advanced birth centers in conducting
  189  any inspection authorized under this chapter or part II of
  190  chapter 408. At a minimum, an advanced birth center must comply
  191  with the Florida Building Code and the Florida Fire Prevention
  192  Code construction standards for ambulatory surgical centers.
  193         Section 7. Section 383.311, Florida Statutes, is amended to
  194  read:
  195         383.311 Education and orientation for birth center and
  196  advanced birth center clients and their families.—
  197         (1) The clients and their families shall be fully informed
  198  of the policies and procedures of the birth center or advanced
  199  birth center, including, but not limited to, policies and
  200  procedures on:
  201         (a) The selection of clients.
  202         (b) The expectation of self-help and family/client
  203  relationships.
  204         (c) The qualifications of the clinical staff.
  205         (d) The transfer to secondary or tertiary care.
  206         (e) The philosophy of childbirth care and the scope of
  207  services.
  208         (f) The customary length of stay after delivery.
  209         (2) The clients shall be prepared for childbirth and
  210  childbearing by education in:
  211         (a) The course of pregnancy and normal changes occurring
  212  during pregnancy.
  213         (b) The need for prenatal care.
  214         (c) Nutrition, including encouragement of breastfeeding.
  215         (d) The effects of smoking and substance abuse.
  216         (e) Labor and delivery.
  217         (f) The care of the newborn to include safe sleep practices
  218  and the possible causes of Sudden Unexpected Infant Death.
  219         Section 8. Section 383.312, Florida Statutes, is amended to
  220  read:
  221         383.312 Prenatal care of birth center and advanced birth
  222  center clients.—
  223         (1) A birth center and an advanced birth center shall
  224  ensure that their its clients have adequate prenatal care, as
  225  defined by the agency, and shall ensure that serological tests
  226  are administered as required by this chapter.
  227         (2) Records of prenatal care shall be maintained for each
  228  client and shall be available during labor and delivery.
  229         Section 9. Section 383.313, Florida Statutes, is amended to
  230  read:
  231         383.313 Birth center performance of laboratory and surgical
  232  services; use of anesthetic and chemical agents.—
  233         (1) LABORATORY SERVICES.—A birth center may collect
  234  specimens for those tests that are requested under protocol. A
  235  birth center may perform simple laboratory tests, as defined by
  236  rule of the agency, and is exempt from the requirements of
  237  chapter 483, provided no more than five physicians are employed
  238  by the birth center and testing is conducted exclusively in
  239  connection with the diagnosis and treatment of clients of the
  240  birth center.
  241         (2) SURGICAL SERVICES.—Surgical procedures are shall be
  242  limited to those normally performed during uncomplicated
  243  childbirths, such as episiotomies and repairs and may shall not
  244  include operative obstetrics or caesarean sections.
  245         (3) ADMINISTRATION OF ANALGESIA AND ANESTHESIA.—General and
  246  conduction anesthesia may not be administered at a birth center.
  247  Systemic analgesia may be administered, and local anesthesia for
  248  pudendal block and episiotomy repair may be performed if
  249  procedures are outlined by the clinical staff and performed by
  250  personnel with statutory authority to do so.
  251         (4) INTRAPARTAL USE OF CHEMICAL AGENTS.—Labor may not be
  252  inhibited, stimulated, or augmented with chemical agents during
  253  the first or second stage of labor unless prescribed by
  254  personnel with statutory authority to do so and unless in
  255  connection with and prior to emergency transport.
  256         Section 10. Section 383.3131, Florida Statutes, is created
  257  to read:
  258         383.3131Advanced birth center performance of laboratory
  259  and surgical services; use of anesthetic and chemical agents.—
  260         (1)LABORATORY SERVICES.—A laboratory located in an
  261  advanced birth center must be licensed as a clinical laboratory
  262  under chapter 483.
  263         (2)SURGICAL SERVICES.—In addition to surgical procedures
  264  authorized pursuant to s. 383.312(2), an advanced birth center
  265  may only provide surgical procedures related to uncomplicated
  266  cesarean deliveries and the management of immediate
  267  complications. Postpartum sterilization may be performed on a
  268  mother, and circumcision may be performed on an infant, before
  269  discharge.
  270         (3)ADMINISTRATION OF ANESTHESIA.—General, conduction, and
  271  local anesthesia may be administered at an advanced birth center
  272  by personnel with statutory authority to do so. All general
  273  anesthesia must be administered by an anesthesiologist or a
  274  certified registered nurse anesthetist in accordance with s.
  275  464.012, and such practitioner must be present in the advanced
  276  birth center at all times during the administration of
  277  anesthesia and during the postanesthesia recovery period until
  278  the patient is fully alert. A board-certified anesthesiologist
  279  must be on call and readily available at all times when
  280  anesthesia services are performed by a certified registered
  281  nurse anesthetist.
  282         (4)INTRAPARTAL USE OF CHEMICAL AGENTS.—Labor may be
  283  inhibited, stimulated, or augmented with chemical agents during
  284  the first or second stage of labor if such agents are prescribed
  285  by personnel with statutory authority to do so. Labor may be
  286  induced at 39 or more weeks of gestation if the patient has a
  287  documented Bishop score of 8 or greater.
  288         Section 11. Section 383.315, Florida Statutes, is amended
  289  to read:
  290         383.315 Agreements with consultants for advice or services;
  291  maintenance.—
  292         (1) A birth center and an advanced birth center shall
  293  maintain in writing a consultation agreement, signed within the
  294  current license period, with each consultant who has agreed to
  295  provide advice and services to the birth center or the advanced
  296  birth center as requested.
  297         (2) Consultation may be provided onsite or by telephone, as
  298  required by clinical and geographic conditions.
  299         (3)An advanced birth center shall employ or maintain an
  300  agreement with an obstetrician who is available to attend and
  301  perform cesarean deliveries when necessary.
  302         Section 12. Section 383.316, Florida Statutes, is amended
  303  to read:
  304         383.316 Transfer and transport of clients to hospitals.—
  305         (1) If unforeseen complications arise during labor,
  306  delivery, or postpartum the client shall be transferred to a
  307  hospital.
  308         (2) Each licensed birth center and advanced birth center
  309  facility shall make arrangements with a local ambulance service
  310  licensed under chapter 401 for the transport of emergency
  311  patients to a hospital. Such arrangements shall be documented in
  312  the center’s policy and procedures manual of the facility if the
  313  birth center or advanced birth center does not own or operate a
  314  licensed ambulance. The policy and procedures manual shall also
  315  contain specific protocols for the transfer of any patient to a
  316  licensed hospital.
  317         (3) A licensed birth center and advanced birth center
  318  facility shall identify neonatal-specific transportation
  319  services, including ground and air ambulances; list their
  320  particular qualifications; and have the telephone numbers for
  321  access to these services clearly listed and immediately
  322  available.
  323         (4) The birth center or advanced birth center shall
  324  annually assess and document Annual assessments of the
  325  transportation services and transfer protocols shall be made and
  326  documented.
  327         Section 13. Section 383.318, Florida Statutes, is amended
  328  to read:
  329         383.318 Postpartum care for birth center and advanced birth
  330  center clients and infants.—
  331         (1) A mother and her infant must shall be discharged
  332  dismissed from a the birth center within 24 hours after the
  333  birth of the infant, except in unusual circumstances as defined
  334  by rule of the agency. If a mother or an infant is retained at
  335  the birth center for more than 24 hours after the birth, a
  336  report shall be filed with the agency within 48 hours of the
  337  birth describing the circumstances and the reasons for the
  338  decision.
  339         (2)A mother and her infant must be discharged from an
  340  advanced birth center within 48 hours after a vaginal delivery
  341  and within 72 hours after a delivery by cesarean section, except
  342  in unusual circumstances as defined by agency rule. If a mother
  343  or an infant is kept at the advanced birth center for a longer
  344  period of time, a report must be filed with the agency within 48
  345  hours after the scheduled discharge time describing the
  346  circumstances and the reasons for the extended stay.
  347         (3)(2) A prophylactic shall be instilled in the eyes of
  348  each newborn in accordance with s. 383.04.
  349         (4)(3) Postpartum evaluation and followup care shall be
  350  provided, which must shall include:
  351         (a) Physical examination of the infant.
  352         (b) Metabolic screening tests required by s. 383.14.
  353         (c) Referral to sources for pediatric care.
  354         (d) Maternal postpartum assessment.
  355         (e) Instruction in child care, including immunization,
  356  breastfeeding, safe sleep practices, and possible causes of
  357  Sudden Unexpected Infant Death.
  358         (f) Family planning services.
  359         (g) Referral to secondary or tertiary care, as indicated.
  360         Section 14. Subsection (2) of section 383.32, Florida
  361  Statutes, is amended to read:
  362         383.32 Clinical records.—
  363         (2) Clinical records must shall be immediately available at
  364  the birth center or advanced birth center:
  365         (a) At the time of admission.
  366         (b) When transfer of care is necessary.
  367         (c) For audit by licensure personnel.
  368         Section 15. Section 383.332, Florida Statutes, is amended
  369  to read:
  370         383.332 Establishing, managing, or operating a birth center
  371  or an advanced birth center without a license; penalty.—Any
  372  person who establishes, conducts, manages, or operates any birth
  373  center or advanced birth center facility without a license
  374  issued under s. 383.305 and part II of chapter 408 commits a
  375  misdemeanor and, upon conviction, shall be fined not more than
  376  $100 for the first offense and not more than $500 for each
  377  subsequent offense; and each day of continuing violation after
  378  conviction shall be considered a separate offense.
  379         Section 16. Paragraph (a) of subsection (11) of section
  380  465.003, Florida Statutes, is amended to read:
  381         465.003 Definitions.—As used in this chapter, the term:
  382         (11)(a) “Pharmacy” includes a community pharmacy, an
  383  institutional pharmacy, a nuclear pharmacy, a special pharmacy,
  384  and an Internet pharmacy.
  385         1. The term “community pharmacy” includes every location
  386  where medicinal drugs are compounded, dispensed, stored, or sold
  387  or where prescriptions are filled or dispensed on an outpatient
  388  basis.
  389         2. The term “institutional pharmacy” includes every
  390  location in a hospital, clinic, advanced birth center, nursing
  391  home, dispensary, sanitarium, extended care facility, or other
  392  facility, hereinafter referred to as “health care institutions,”
  393  where medicinal drugs are compounded, dispensed, stored, or
  394  sold.
  395         3. The term “nuclear pharmacy” includes every location
  396  where radioactive drugs and chemicals within the classification
  397  of medicinal drugs are compounded, dispensed, stored, or sold.
  398  The term “nuclear pharmacy” does not include hospitals licensed
  399  under chapter 395 or the nuclear medicine facilities of such
  400  hospitals.
  401         4. The term “special pharmacy” includes every location
  402  where medicinal drugs are compounded, dispensed, stored, or sold
  403  if such locations are not otherwise defined in this subsection.
  404         5. The term “Internet pharmacy” includes locations not
  405  otherwise licensed or issued a permit under this chapter, within
  406  or outside this state, which use the Internet to communicate
  407  with or obtain information from consumers in this state and use
  408  such communication or information to fill or refill
  409  prescriptions or to dispense, distribute, or otherwise engage in
  410  the practice of pharmacy in this state. Any act described in
  411  this definition constitutes the practice of pharmacy as defined
  412  in subsection (13).
  413         Section 17. Paragraph (c) of subsection (2) of section
  414  465.019, Florida Statutes, is amended to read:
  415         465.019 Institutional pharmacies; permits.—
  416         (2) The following classes of institutional pharmacies are
  417  established:
  418         (c) “Modified Class II institutional pharmacies” are those
  419  institutional pharmacies in short-term, primary care treatment
  420  centers and advanced birth centers which that meet all the
  421  requirements for a Class II permit, except space and equipment
  422  requirements.
  423         Section 18. This act shall take effect July 1, 2018.

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