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:
144 383.3081 Advanced 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:
258 383.3131 Advanced 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.