Florida Senate - 2019 SB 448
By Senator Harrell
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.
87 Be It Enacted by the Legislature of the State of Florida:
89 Section 1. Section 383.30, Florida Statutes, is amended to
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
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.
(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
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
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
157 383.307 Administration of birth center and advanced birth
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
176 (3) All clinical staff members and consultants shall hold
177 current licenses from this state to practice their respective
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:
186 383.3081 Advanced birth center facility and equipment;
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
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
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
269 Section 9. Section 383.311, Florida Statutes, is amended to
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
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
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
333 Section 12. Section 383.3131, Florida Statutes, is created
334 to read:
335 383.3131 Advanced 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;
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
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
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
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.
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
462 383.32 Birth center and advanced birth center clinical
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
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
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
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
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
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
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
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
694 Section 28. This act shall take effect July 1, 2019.