Florida Senate - 2019                                     SB 448
       
       
        
       By Senator Harrell
       
       
       
       
       
       25-00587-19                                            2019448__
    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 applicability of licensure
    5         requirements under part II of ch. 408, F.S., to
    6         advanced birth centers; amending s. 383.302, F.S.;
    7         defining the terms “advanced birth center” and
    8         “medical director”; revising definitions; amending s.
    9         383.305, F.S.; providing applicability of licensure
   10         fee requirements to advanced birth centers; amending
   11         s. 383.307, F.S.; providing for administration of
   12         advanced birth centers; creating s. 383.3081, F.S.;
   13         providing requirements for advanced birth center
   14         facilities and equipment; requiring the employment of
   15         specified personnel at an advanced birth center;
   16         requiring an advanced birth center to enter into a
   17         written agreement with a blood bank for emergency
   18         blood bank services; requiring that a patient who
   19         receives an emergency blood transfusion at an advanced
   20         birth center be immediately transferred to a hospital
   21         for further care; amending s. 383.309, F.S.; providing
   22         minimum standards for advanced birth centers;
   23         authorizing the Agency for Health Care Administration
   24         to enforce specified provisions of the Florida
   25         Building Code and the Florida Fire Prevention Code;
   26         amending s. 383.3105, F.S.; providing applicability of
   27         adoption protocols for staff of an advanced birth
   28         center; amending s. 383.311, F.S.; providing for the
   29         education and orientation of advanced birth center
   30         clients and their families; amending s. 383.312, F.S.;
   31         requiring that an advanced birth center ensure that
   32         clients have adequate prenatal care and that certain
   33         required tests are administered; amending s. 383.313,
   34         F.S.; providing for laboratory and surgical services
   35         at a birth center; creating s. 383.3131, F.S.;
   36         providing requirements for laboratory and surgical
   37         services at an advanced birth center; providing
   38         conditions for administration of anesthesia;
   39         authorizing the intrapartal use of chemical agents;
   40         amending s. 383.315, F.S.; requiring an advanced birth
   41         center to employ or maintain an agreement with an
   42         obstetrician under certain circumstances; amending s.
   43         383.316, F.S.; requiring an advanced birth center to
   44         provide for the transport of emergency patients to a
   45         hospital; requiring each center to enter into a
   46         written transfer agreement with a local hospital or an
   47         obstetrician for such transfers under certain
   48         conditions; amending s. 383.318, F.S.; providing
   49         protocols for postpartum care of clients and infants;
   50         providing requirements for followup care; amending s.
   51         383.32, F.S.; specifying when clinical records must be
   52         made immediately available at an advanced birth
   53         center; amending s. 383.324, F.S.; requiring an
   54         advanced birth center to pay an inspection fee to the
   55         agency; amending s. 383.325, F.S.; requiring an
   56         advanced birth center to maintain and make available
   57         inspection reports; amending s. 383.327, F.S.;
   58         requiring an advanced birth center to provide reports
   59         of all births and deaths occurring at the center;
   60         requiring an advanced birth center to annually submit
   61         a report to the agency; amending s. 383.33, F.S.;
   62         authorizing the agency to impose a specified
   63         administrative fine for certain violations;
   64         authorizing the agency to impose a moratorium on
   65         elective admissions to any birth center or advanced
   66         birth center upon making a certain determination;
   67         amending s. 383.332, F.S.; providing a criminal
   68         penalty for operating an unlicensed advanced birth
   69         center; amending s. 408.033, F.S.; providing
   70         applicability of an assessment to advanced birth
   71         centers; amending s. 408.07, F.S.; defining the term
   72         “advanced birth center”; revising the definition of
   73         the term “health care facility”; amending s. 408.802,
   74         F.S.; providing applicability of licensure
   75         requirements under part II of ch. 408, F.S., to
   76         advanced birth centers; amending s. 408.820, F.S.;
   77         exempting advanced birth centers from certain
   78         licensure requirements under part II of ch. 408, F.S.;
   79         amending s. 465.003, F.S.; revising the definition of
   80         the term “institutional pharmacy” to include
   81         pharmacies located in advanced birth centers; amending
   82         s. 465.019, F.S.; revising the definition of the term
   83         “modified Class II institutional pharmacies” to
   84         include pharmacies located in advanced birth centers;
   85         providing an effective date.
   86          
   87  Be It Enacted by the Legislature of the State of Florida:
   88  
   89         Section 1. Section 383.30, Florida Statutes, is amended to
   90  read:
   91         383.30 Birth Center and Advanced Birth Center Licensure
   92  Act; short title.—Sections 383.30-383.332 shall be known and may
   93  be cited as the “Birth Center and Advanced Birth Center
   94  Licensure Act.”
   95         Section 2. Section 383.301, Florida Statutes, is amended to
   96  read:
   97         383.301 Licensure and regulation of birth centers and
   98  advanced birth centers; legislative intent.—It is the intent of
   99  the Legislature to provide for the protection of public health
  100  and safety in the establishment, maintenance, and operation of
  101  birth centers and advanced birth centers by providing for
  102  licensure of birth centers and advanced birth centers and for
  103  the development, establishment, and enforcement of minimum
  104  standards with respect to birth centers and advanced birth
  105  centers. The requirements of part II of chapter 408 shall apply
  106  to the provision of services that require licensure pursuant to
  107  ss. 383.30-383.332 and part II of chapter 408 and to entities
  108  licensed by or applying for such licensure from the Agency for
  109  Health Care Administration pursuant to ss. 383.30-383.332. A
  110  license issued by the agency is required in order to operate a
  111  birth center or an advanced birth center in this state.
  112         Section 3. Subsections (1) through (8) of section 383.302,
  113  Florida Statutes, are renumbered as subsections (2) through (9),
  114  respectively, subsections (9) and (10) are renumbered as
  115  subsections (11) and (12), present subsections (3), (4), and (5)
  116  are amended, and new subsections (1) and (10) are added to that
  117  section, to read:
  118         383.302 Definitions of terms used in ss. 383.30-383.332.—As
  119  used in ss. 383.30-383.332, the term:
  120         (1)“Advanced birth center” means a birth center that may
  121  perform trial of labor after cesarean deliveries for screened
  122  patients who qualify, planned low-risk cesarean deliveries, and
  123  anticipated vaginal deliveries for laboring patients from the
  124  beginning of the 37th week of gestation through the end of the
  125  41st week of gestation.
  126         (4)(3) “Clinical staff” means individuals employed full
  127  time or part time by a birth center or an advanced birth center
  128  who are licensed or certified to provide care at childbirth.
  129         (5)(4) “Consultant” means a physician licensed pursuant to
  130  chapter 458 or chapter 459 who agrees to provide advice and
  131  services to a birth center or an advanced birth center and who
  132  either:
  133         (a) Is certified or eligible for certification by the
  134  American Board of Obstetrics and Gynecology or the American
  135  Osteopathic Board of Obstetrics and Gynecology, or
  136         (b) Has hospital obstetrical privileges.
  137         (6)(5) “Governing body” means any individual, group,
  138  corporation, or institution that which is responsible for the
  139  overall operation and maintenance of a birth center or an
  140  advanced birth center.
  141         (10)“Medical director” means a person who holds an active
  142  unrestricted license as an allopathic physician under chapter
  143  458 or osteopathic physician under chapter 459.
  144         Section 4. Section 383.305, Florida Statutes, is amended to
  145  read:
  146         383.305 Licensure; fees.—
  147         (1) In accordance with s. 408.805, an applicant for
  148  licensure as a birth center or an advanced birth center or a
  149  licensee shall pay a fee for each license application submitted
  150  under ss. 383.30-383.332 and part II of chapter 408. The amount
  151  of the fee shall be established by rule.
  152         (2) Each applicant for licensure and each licensee must
  153  comply with the requirements of this chapter and part II of
  154  chapter 408.
  155         Section 5. Section 383.307, Florida Statutes, is amended to
  156  read:
  157         383.307 Administration of birth center and advanced birth
  158  center.—
  159         (1) Each birth center and advanced birth center shall have
  160  a governing body that which is responsible for the overall
  161  operation and maintenance of the birth center.
  162         (a) The governing body shall develop and display a table of
  163  organization which shows the structure of the birth center or
  164  advanced birth center and identifies the governing body, the
  165  medical directors birth center director, the clinical director,
  166  the clinical staff, and the medical consultant.
  167         (b) The governing body shall develop and make available to
  168  staff, clinicians, consultants, and licensing authorities a
  169  manual that which documents policies, procedures, and protocols,
  170  including the roles and responsibilities of all personnel.
  171         (2) There shall be an adequate number of licensed personnel
  172  to provide clinical services needed by mothers and newborns and
  173  a sufficient number of qualified personnel to provide services
  174  for families and to maintain the birth center or advanced birth
  175  center.
  176         (3) All clinical staff members and consultants shall hold
  177  current licenses from this state to practice their respective
  178  disciplines.
  179         (4) Clinical staff members and consultants shall adopt
  180  bylaws that which are subject to the approval of the governing
  181  body and which shall include recommendations for clinical staff
  182  or consultation appointments, delineation of clinical
  183  privileges, and the organization of the clinical staff.
  184         Section 6. Section 383.3081, Florida Statutes, is created
  185  to read:
  186         383.3081Advanced birth center facility and equipment;
  187  requirements.—
  188         (1)An advanced birth center shall meet all of the
  189  requirements of s. 383.308.
  190         (2)An advanced birth center shall be operated and staffed
  191  24 hours per day, 7 days per week.
  192         (3)An advanced birth center shall employ two medical
  193  directors to oversee the activities of the center, one of whom
  194  must be a board-certified obstetrician and one of whom must be a
  195  board-certified anesthesiologist.
  196         (4)An advanced birth center shall have at least one
  197  properly equipped, dedicated surgical suite for the performance
  198  of cesarean deliveries.
  199         (5)At a minimum, an advanced birth center must employ a
  200  registered nurse who is present in the center at all times and
  201  has the ability to stabilize and facilitate the transfer of
  202  patients and newborn infants when appropriate.
  203         (6)Each advanced birth center must enter into a written
  204  agreement with a blood bank for emergency blood bank services
  205  and must have written protocols for the management of
  206  obstetrical hemorrhage that include provisions for emergency
  207  blood transfusions. If a patient admitted to an advanced birth
  208  center receives an emergency blood transfusion at the center,
  209  the patient must immediately thereafter be transferred to a
  210  hospital for further care.
  211         Section 7. Section 383.309, Florida Statutes, is amended to
  212  read:
  213         383.309 Minimum standards for birth centers and advanced
  214  birth centers; rules and enforcement.—
  215         (1) The agency shall adopt and enforce rules to administer
  216  ss. 383.30-383.332 and part II of chapter 408, which rules shall
  217  include, but are not limited to, reasonable and fair minimum
  218  standards for ensuring that:
  219         (a) Sufficient numbers and qualified types of personnel and
  220  occupational disciplines are available at all times to provide
  221  necessary and adequate patient care and safety.
  222         (b) Infection control, housekeeping, sanitary conditions,
  223  disaster plan, and medical record procedures that will
  224  adequately protect patient care and provide safety are
  225  established and implemented.
  226         (c) Licensed facilities are established, organized, and
  227  operated consistent with established programmatic standards.
  228         (2)The standards adopted by rule for advanced birth
  229  centers must, at a minimum, be equivalent to the minimum
  230  standards adopted for ambulatory surgical centers pursuant to s.
  231  395.1055 and must include standards for quality of care, blood
  232  transfusions, and sanitary conditions for food handling and food
  233  service.
  234         (3)(2) The agency may not establish any rule governing the
  235  design, construction, erection, alteration, modification,
  236  repair, or demolition of birth centers or advanced birth
  237  centers. It is the intent of the Legislature to preempt that
  238  function to the Florida Building Commission and the State Fire
  239  Marshal through adoption and maintenance of the Florida Building
  240  Code and the Florida Fire Prevention Code. However, the agency
  241  shall provide technical assistance to the commission and the
  242  State Fire Marshal in updating the construction standards of the
  243  Florida Building Code and the Florida Fire Prevention Code which
  244  govern birth centers and advanced birth centers. In addition,
  245  the agency may enforce the special-occupancy provisions of the
  246  Florida Building Code and the Florida Fire Prevention Code which
  247  apply to birth centers and advanced birth centers in conducting
  248  any inspection authorized under this chapter or part II of
  249  chapter 408. At a minimum, advanced birth centers must comply
  250  with the Florida Building Code and Florida Fire Prevention Code
  251  standards for ambulatory surgical centers.
  252         Section 8. Section 383.3105, Florida Statutes, is amended
  253  to read:
  254         383.3105 Patients consenting to adoptions; protocols.—
  255         (1) Each licensed birth center and advanced birth center
  256  facility shall adopt a protocol that at a minimum provides for
  257  birth center and advanced birth center facility staff to be
  258  knowledgeable of the waiting periods, revocation, and the
  259  contents of the consent to adoption as contained in s.
  260  63.082(4), and that describes the supportive and unbiased manner
  261  in which facility staff will interact with birth parents and
  262  prospective adoptive parents regarding the adoption, in
  263  particular during the waiting period required in s. 63.082(4)(b)
  264  before consenting to an adoption.
  265         (2) The protocol must shall be in writing and be provided
  266  upon request to any birth parent or prospective adoptive parent
  267  of a child born in the birth center or advanced birth center
  268  facility.
  269         Section 9. Section 383.311, Florida Statutes, is amended to
  270  read:
  271         383.311 Education and orientation for birth center and
  272  advanced birth center clients and their families.—
  273         (1) The clients and their families shall be fully informed
  274  of the policies and procedures of the birth center or advanced
  275  birth center, including, but not limited to, policies and
  276  procedures on:
  277         (a) The selection of clients.
  278         (b) The expectation of self-help and family/client
  279  relationships.
  280         (c) The qualifications of the clinical staff.
  281         (d) The transfer to secondary or tertiary care.
  282         (e) The philosophy of childbirth care and the scope of
  283  services.
  284         (f) The customary length of stay after delivery.
  285         (2) The clients shall be prepared for childbirth and
  286  childbearing by education in:
  287         (a) The course of pregnancy and normal changes occurring
  288  during pregnancy.
  289         (b) The need for prenatal care.
  290         (c) Nutrition, including encouragement of breastfeeding.
  291         (d) The effects of smoking and substance abuse.
  292         (e) Labor and delivery.
  293         (f) The care of the newborn to include safe sleep practices
  294  and the possible causes of Sudden Unexpected Infant Death.
  295         Section 10. Section 383.312, Florida Statutes, is amended
  296  to read:
  297         383.312 Prenatal care of birth center and advanced birth
  298  center clients.—
  299         (1) A birth center and an advanced birth center shall
  300  ensure that their its clients have adequate prenatal care, as
  301  defined by the agency, and shall ensure that serological tests
  302  are administered as required by this chapter.
  303         (2) Records of prenatal care shall be maintained for each
  304  client and shall be available during labor and delivery.
  305         Section 11. Section 383.313, Florida Statutes, is amended
  306  to read:
  307         383.313 Birth center performance of laboratory and surgical
  308  services; use of anesthetic and chemical agents.—
  309         (1) LABORATORY SERVICES.—A birth center may collect
  310  specimens for those tests that are requested under protocol. A
  311  birth center must obtain and continuously maintain certification
  312  by the Centers for Medicare and Medicaid Services under the
  313  federal Clinical Laboratory Improvement Amendments and the
  314  federal rules adopted thereunder in order to perform laboratory
  315  tests specified by rule of the agency, and which are appropriate
  316  to meet the needs of the patient.
  317         (2) SURGICAL SERVICES.—Surgical procedures shall be limited
  318  to those normally performed during uncomplicated childbirths,
  319  such as episiotomies and repairs and may shall not include
  320  operative obstetrics or caesarean sections.
  321         (3) ADMINISTRATION OF ANALGESIA AND ANESTHESIA.—General and
  322  conduction anesthesia may not be administered at a birth center.
  323  Systemic analgesia may be administered, and local anesthesia for
  324  pudendal block and episiotomy repair may be performed if
  325  procedures are outlined by the clinical staff and performed by
  326  personnel who have the with statutory authority to do so.
  327         (4) INTRAPARTAL USE OF CHEMICAL AGENTS.—Labor may not be
  328  inhibited, stimulated, or augmented with chemical agents during
  329  the first or second stage of labor unless prescribed by
  330  personnel who have the with statutory authority to do so and
  331  unless in connection with and before prior to emergency
  332  transport.
  333         Section 12. Section 383.3131, Florida Statutes, is created
  334  to read:
  335         383.3131Advanced birth center performance of laboratory
  336  and surgical services; use of anesthetic and chemical agents.—
  337         (1)LABORATORY SERVICES.—An advanced birth center must have
  338  a clinical laboratory on site. The clinical laboratory must, at
  339  a minimum, be capable of providing laboratory testing for
  340  hematology, metabolic screening, liver function, and coagulation
  341  studies. An advanced birth center may collect specimens for
  342  those tests that are requested under protocol. An advanced birth
  343  center may perform laboratory tests as defined by rule of the
  344  agency. Laboratories located in advanced birth centers must be
  345  appropriately certified by the Centers for Medicare and Medicaid
  346  Services under the federal Clinical Laboratory Improvement
  347  Amendments and the federal rules adopted thereunder.
  348         (2)SURGICAL SERVICES.—In addition to surgical procedures
  349  authorized pursuant to s. 383.313(2), surgical procedures are
  350  limited to low-risk cesarean deliveries and surgical management
  351  of immediate complications. Postpartum sterilization may be
  352  performed before discharge of the patient who has given birth
  353  during that admission. Circumcisions may be performed before
  354  discharge of the newborn infant.
  355         (3)ADMINISTRATION OF ANALGESIA AND ANESTHESIA.—General,
  356  conduction, and local anesthesia may be administered at an
  357  advanced birth center if administered by personnel who have the
  358  statutory authority to do so. All general anesthesia shall be
  359  administered by an anesthesiologist or a certified registered
  360  nurse anesthetist in accordance with s. 464.012. When general
  361  anesthesia is administered, a physician or a certified
  362  registered nurse anesthetist shall be present in the advanced
  363  birth center during the anesthesia and postanesthesia recovery
  364  period until the patient is fully alert. Each advanced birth
  365  center shall comply with s. 395.0191(2)(b).
  366         (4)INTRAPARTAL USE OF CHEMICAL AGENTS.—Labor may be
  367  inhibited, stimulated, or augmented with chemical agents during
  368  the first or second stage of labor at an advanced birth center
  369  if prescribed by personnel who have the statutory authority to
  370  do so. Labor may be electively induced beginning at the 39th
  371  week of gestation for a patient with a documented Bishop score
  372  of 8 or greater.
  373         Section 13. Section 383.315, Florida Statutes, is amended
  374  to read:
  375         383.315 Agreements with consultants for advice or services;
  376  maintenance.—
  377         (1) A birth center and an advanced birth center shall
  378  maintain in writing a consultation agreement, signed within the
  379  current license period, with each consultant who has agreed to
  380  provide advice and services to the birth center and advanced
  381  birth center as requested.
  382         (2) Consultation may be provided onsite or by telephone, as
  383  required by clinical and geographic conditions.
  384         (3)An advanced birth center shall employ or maintain an
  385  agreement with an obstetrician who must be present in the center
  386  at all times during which a patient is in active labor in the
  387  center to attend deliveries, respond to emergencies, and, when
  388  necessary, be available to perform cesarean deliveries.
  389         Section 14. Section 383.316, Florida Statutes, is amended
  390  to read:
  391         383.316 Transfer and transport of clients to hospitals.—
  392         (1) If unforeseen complications arise during labor,
  393  delivery, or postpartum recovery, the client shall be
  394  transferred to a hospital.
  395         (2) Each licensed birth center or advanced birth center
  396  facility shall make arrangements with a local ambulance service
  397  licensed under chapter 401 for the transport of emergency
  398  patients to a hospital. Such arrangements shall be documented in
  399  the center’s policy and procedures manual of the facility if the
  400  birth center or advanced birth center does not own or operate a
  401  licensed ambulance. The policy and procedures manual shall also
  402  contain specific protocols for the transfer of any patient to a
  403  licensed hospital.
  404         (3)Each licensed advanced birth center shall enter into a
  405  written transfer agreement with a local hospital licensed under
  406  chapter 395 for the transfer and admission of emergency patients
  407  to the hospital or a written agreement with an obstetrician who
  408  has hospital privileges to provide coverage at all times and who
  409  has agreed to accept the transfer of the advanced birth center’s
  410  patients.
  411         (4)(3) A licensed birth center or advanced birth center
  412  facility shall identify neonatal-specific transportation
  413  services, including ground and air ambulances; list their
  414  particular qualifications; and have the telephone numbers for
  415  access to these services clearly listed and immediately
  416  available.
  417         (5)(4)The birth center or advanced birth center shall
  418  assess and document Annual assessments of the transportation
  419  services and transfer protocols annually shall be made and
  420  documented.
  421         Section 15. Section 383.318, Florida Statutes, is amended
  422  to read:
  423         383.318 Postpartum care for birth center and advanced birth
  424  center clients and infants.—
  425         (1) A mother and her infant shall be dismissed from a the
  426  birth center within 24 hours after the birth of the infant,
  427  except in unusual circumstances as defined by rule of the
  428  agency. If a mother or an infant is retained at the birth center
  429  for more than 24 hours after the birth, a report shall be filed
  430  with the agency within 48 hours after of the birth describing
  431  the circumstances and the reasons for the decision.
  432         (2)(a)A mother and her infant shall be dismissed from an
  433  advanced birth center within 48 hours after a vaginal delivery
  434  of the infant or within 72 hours after a delivery by cesarean
  435  section, except in unusual circumstances as defined by rule of
  436  the agency.
  437         (b)If a mother or an infant is retained at the advanced
  438  birth center for more than the timeframes set forth in paragraph
  439  (a), a report shall be filed with the agency within 48 hours
  440  after the scheduled discharge time describing the circumstances
  441  and the reasons for the decision.
  442         (3)(2) A prophylactic shall be instilled in the eyes of
  443  each newborn in accordance with s. 383.04.
  444         (4)(3) The birth center or advanced birth center shall
  445  provide a postpartum evaluation and followup care that includes
  446  all of the following:
  447         (a) Physical examination of the infant.
  448         (b) Metabolic screening tests required by s. 383.14.
  449         (c) Referral to sources for pediatric care.
  450         (d) Maternal postpartum assessment that incorporates mental
  451  health screening.
  452         (e) Information on postpartum depression and the telephone
  453  number of the Family Health Line operated pursuant to s.
  454  383.011.
  455         (f) Instruction in child care, including immunization,
  456  breastfeeding, safe sleep practices, and possible causes of
  457  Sudden Unexpected Infant Death.
  458         (g) Family planning services.
  459         (h) Referral to secondary or tertiary care, as indicated.
  460         Section 16. Section 383.32, Florida Statutes, is amended to
  461  read:
  462         383.32 Birth center and advanced birth center clinical
  463  records.—
  464         (1) Clinical records shall contain information prescribed
  465  by rule, including, but not limited to:
  466         (a) Identifying information.
  467         (b) Risk assessments.
  468         (c) Information relating to prenatal visits.
  469         (d) Information relating to the course of labor and
  470  intrapartum care.
  471         (e) Information relating to consultation, referral, and
  472  transport to a hospital.
  473         (f) Newborn assessment, APGAR score, treatments as
  474  required, and followup.
  475         (g) Postpartum followup.
  476         (2) Clinical records shall be immediately available at the
  477  birth center or advanced birth center:
  478         (a) At the time of admission.
  479         (b) When transfer of care is necessary.
  480         (c) For audit by licensure personnel.
  481         (3) Clinical records shall be kept confidential in
  482  accordance with s. 456.057 and exempt from the provisions of s.
  483  119.07(1). A client’s clinical records shall be open to
  484  inspection only under the following conditions:
  485         (a) A consent to release information has been signed by the
  486  client; or
  487         (b) The review is made by the agency for a licensure survey
  488  or complaint investigation.
  489         (4)(a) Clinical records shall be audited periodically, but
  490  no less frequently than every 3 months, to evaluate the process
  491  and outcome of care.
  492         (b) Statistics on maternal and perinatal morbidity and
  493  mortality, maternal risk, consultant referrals, and transfers of
  494  care shall be analyzed at least semiannually.
  495         (c) The governing body shall examine the results of the
  496  record audits and statistical analyses and shall make such
  497  reports available for inspection by the public and licensing
  498  authorities.
  499         Section 17. Section 383.324, Florida Statutes, is amended
  500  to read:
  501         383.324 Inspections and investigations; inspection fees.
  502  Each birth center and advanced birth center facility licensed
  503  under s. 383.305 shall pay to the agency an inspection fee
  504  established by rule of the agency. In addition to the
  505  requirements of part II of chapter 408, the agency shall
  506  coordinate all periodic inspections for licensure made by the
  507  agency to ensure that the cost to the birth center or advanced
  508  birth center facility of such inspections and the disruption of
  509  services by such inspections is minimized.
  510         Section 18. Section 383.325, Florida Statutes, is amended
  511  to read:
  512         383.325 Inspection reports.—
  513         (1) Each licensed birth center and advanced birth center
  514  facility shall maintain as public information, available upon
  515  request, records of all inspection reports pertaining to the
  516  center that facility which have been filed with, or issued by,
  517  any governmental agency. Copies of such reports shall be
  518  retained in the records of the birth center or advanced birth
  519  center facility for no less than 5 years after from the date the
  520  reports are filed and issued.
  521         (2) Any record, report, or document which, by state or
  522  federal law or regulation, is deemed confidential shall be
  523  exempt from the provisions of s. 119.07(1) and may shall not be
  524  distributed or made available for purposes of compliance with
  525  this section unless or until such confidential status expires,
  526  except as described in s. 383.32(2)(c).
  527         (3) A licensed birth center or advanced birth center
  528  facility shall, upon the request of any person who has completed
  529  a written application with intent to be admitted to such center
  530  facility or any person who is a patient of such center facility,
  531  or any relative, spouse, or guardian of any such person, furnish
  532  to the requester a copy of the last inspection report issued by
  533  the agency or an accrediting organization, whichever is most
  534  recent, pertaining to the licensed birth center or advanced
  535  birth center facility, as provided in subsection (1), provided
  536  the person requesting such report agrees to pay a reasonable
  537  charge to cover copying costs.
  538         Section 19. Section 383.327, Florida Statutes, is amended
  539  to read:
  540         383.327 Birth and death records; reports.—Each licensed
  541  birth center and advanced birth center shall:
  542         (1) File a completed certificate of birth shall be filed
  543  with the local registrar within 5 days after of each birth in
  544  accordance with chapter 382.
  545         (2) Immediately report each maternal death, newborn death,
  546  and stillbirth shall be reported immediately to the medical
  547  examiner.
  548         (3) The licensee shall Comply with all requirements of this
  549  chapter and rules promulgated hereunder.
  550         (4) Annually submit a report shall be submitted annually to
  551  the agency. The contents of the report shall be prescribed by
  552  rule of the agency.
  553         Section 20. Subsection (3) of section 383.33, Florida
  554  Statutes, is amended, and subsections (1) and (2) of that
  555  section are republished, to read:
  556         383.33 Administrative penalties; moratorium on admissions.—
  557         (1) In addition to the requirements of part II of chapter
  558  408, the agency may impose an administrative fine not to exceed
  559  $500 per violation per day for the violation of any provision of
  560  ss. 383.30-383.332, part II of chapter 408, or applicable rules.
  561         (2) In determining the amount of the fine to be levied for
  562  a violation, as provided in this section, the following factors
  563  shall be considered:
  564         (a) The severity of the violation, including the
  565  probability that death or serious harm to the health or safety
  566  of any person will result or has resulted; the severity of the
  567  actual or potential harm; and the extent to which ss. 383.30
  568  383.332, part II of chapter 408, or applicable rules were
  569  violated.
  570         (b) Actions taken by the licensee to correct the violations
  571  or to remedy complaints.
  572         (c) Any previous violations by the licensee.
  573         (3) In accordance with part II of chapter 408, the agency
  574  may impose an immediate moratorium on elective admissions to any
  575  licensed birth center or advanced birth center facility,
  576  building or portion thereof, or service when the agency
  577  determines that any condition in the center facility presents a
  578  threat to the public health or safety.
  579         Section 21. Section 383.332, Florida Statutes, is amended
  580  to read:
  581         383.332 Establishing, managing, or operating a birth center
  582  or an advanced birth center without a license; penalty.—Any
  583  person who establishes, conducts, manages, or operates any birth
  584  center or advanced birth center facility without a license
  585  issued under s. 383.305 and part II of chapter 408 commits a
  586  misdemeanor and, upon conviction, shall be fined not more than
  587  $100 for the first offense and not more than $500 for each
  588  subsequent offense; and each day of continuing violation after
  589  conviction shall be considered a separate offense.
  590         Section 22. Paragraph (a) of subsection (2) of section
  591  408.033, Florida Statutes, is amended to read:
  592         408.033 Local and state health planning.—
  593         (2) FUNDING.—
  594         (a) The Legislature intends that the cost of local health
  595  councils be borne by assessments on selected health care
  596  facilities subject to facility licensure by the Agency for
  597  Health Care Administration, including abortion clinics, assisted
  598  living facilities, ambulatory surgical centers, birth centers,
  599  advanced birth centers, home health agencies, hospices,
  600  hospitals, intermediate care facilities for the developmentally
  601  disabled, nursing homes, health care clinics, and multiphasic
  602  testing centers and by assessments on organizations subject to
  603  certification by the agency pursuant to chapter 641, part III,
  604  including health maintenance organizations and prepaid health
  605  clinics. Fees assessed may be collected prospectively at the
  606  time of licensure renewal and prorated for the licensure period.
  607         Section 23. Subsections (8) and (23) of section 408.07,
  608  Florida Statutes, are amended to read:
  609         408.07 Definitions.—As used in this chapter, with the
  610  exception of ss. 408.031-408.045, the term:
  611         (8) “Birth center” or “advanced birth center” means an
  612  organization licensed under s. 383.305.
  613         (23) “Health care facility” means an ambulatory surgical
  614  center, a hospice, a nursing home, a hospital, a diagnostic
  615  imaging center, a freestanding or hospital-based therapy center,
  616  a clinical laboratory, a home health agency, a cardiac
  617  catheterization laboratory, a medical equipment supplier, an
  618  alcohol or chemical dependency treatment center, a physical
  619  rehabilitation center, a lithotripsy center, an ambulatory care
  620  center, a birth center, an advanced birth center, or a nursing
  621  home component licensed under chapter 400 within a continuing
  622  care facility licensed under chapter 651.
  623         Section 24. Subsection (2) of section 408.802, Florida
  624  Statutes, is amended to read:
  625         408.802 Applicability.—The provisions of This part applies
  626  apply to the provision of services that require licensure as
  627  defined in this part and to the following entities licensed,
  628  registered, or certified by the agency, as described in chapters
  629  112, 383, 390, 394, 395, 400, 429, 440, 483, and 765:
  630         (2) Birth centers and advanced birth centers, as provided
  631  under chapter 383.
  632         Section 25. Subsection (2) of section 408.820, Florida
  633  Statutes, is amended to read:
  634         408.820 Exemptions.—Except as prescribed in authorizing
  635  statutes, the following exemptions shall apply to specified
  636  requirements of this part:
  637         (2) Birth centers and advanced birth centers, as provided
  638  under chapter 383, are exempt from s. 408.810(7)-(10).
  639         Section 26. Subsection (11) of section 465.003, Florida
  640  Statutes, is amended to read:
  641         465.003 Definitions.—As used in this chapter, the term:
  642         (11)(a) “Pharmacy” includes a community pharmacy, an
  643  institutional pharmacy, a nuclear pharmacy, a special pharmacy,
  644  and an Internet pharmacy.
  645         1. The term “community pharmacy” includes every location
  646  where medicinal drugs are compounded, dispensed, stored, or sold
  647  or where prescriptions are filled or dispensed on an outpatient
  648  basis.
  649         2. The term “institutional pharmacy” includes every
  650  location in a hospital, clinic, advanced birth center, nursing
  651  home, dispensary, sanitarium, extended care facility, or other
  652  facility, hereinafter referred to as “health care institutions,”
  653  where medicinal drugs are compounded, dispensed, stored, or
  654  sold.
  655         3. The term “nuclear pharmacy” includes every location
  656  where radioactive drugs and chemicals within the classification
  657  of medicinal drugs are compounded, dispensed, stored, or sold.
  658  The term “nuclear pharmacy” does not include hospitals licensed
  659  under chapter 395 or the nuclear medicine facilities of such
  660  hospitals.
  661         4. The term “special pharmacy” includes every location
  662  where medicinal drugs are compounded, dispensed, stored, or sold
  663  if such locations are not otherwise defined in this subsection.
  664         5. The term “Internet pharmacy” includes locations not
  665  otherwise licensed or issued a permit under this chapter, within
  666  or outside this state, which use the Internet to communicate
  667  with or obtain information from consumers in this state and use
  668  such communication or information to fill or refill
  669  prescriptions or to dispense, distribute, or otherwise engage in
  670  the practice of pharmacy in this state. Any act described in
  671  this definition constitutes the practice of pharmacy as defined
  672  in subsection (13).
  673         (b) The pharmacy department of any permittee shall be
  674  considered closed whenever a Florida licensed pharmacist is not
  675  present and on duty. The term “not present and on duty” may
  676  shall not be construed to prevent a pharmacist from exiting the
  677  prescription department for the purposes of consulting or
  678  responding to inquiries or providing assistance to patients or
  679  customers, attending to personal hygiene needs, or performing
  680  any other function for which the pharmacist is responsible,
  681  provided that such activities are conducted in a manner
  682  consistent with the pharmacist’s responsibility to provide
  683  pharmacy services.
  684         Section 27. Paragraph (c) of subsection (2) of section
  685  465.019, Florida Statutes, is amended to read:
  686         465.019 Institutional pharmacies; permits.—
  687         (2) The following classes of institutional pharmacies are
  688  established:
  689         (c) “Modified Class II institutional pharmacies” are those
  690  institutional pharmacies in short-term, primary care treatment
  691  centers and advanced birth centers which that meet all the
  692  requirements for a Class II permit, except space and equipment
  693  requirements.
  694         Section 28. This act shall take effect July 1, 2019.