Bill Text: FL S0448 | 2019 | Regular Session | Introduced
Bill Title: Advanced Birth Centers
Spectrum: Partisan Bill (Republican 1-0)
Status: (Failed) 2019-05-03 - Died in Children, Families, and Elder Affairs [S0448 Detail]
Download: Florida-2019-S0448-Introduced.html
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 thatwhichis 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 thatwhichis responsible for the overall 161 operation and maintenance of thebirthcenter. 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 directorsbirth 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 thatwhichdocuments 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 thatwhichare subject to the approval of the governing 181 body andwhich shallinclude 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; 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 256facilityshall adopt a protocol that at a minimum provides for 257 birth center and advanced birth centerfacilitystaff 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 whichfacilitystaff 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 mustshallbe 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 268facility. 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 theiritsclients 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 mayshallnot 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 thewithstatutory 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 thewithstatutory authority to do so and 331 unless in connection with and beforeprior toemergency 332 transport. 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; 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 396facilityshall 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 manualof the facilityif 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 412facilityshall 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 documentAnnual assessments ofthe transportation 419 services and transfer protocols annuallyshall be made and420documented. 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 athe426 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 afterofthe 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 fromthe provisions ofs. 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 centerfacilitylicensed 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 centerfacilityof 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 514facilityshall maintain as public information, available upon 515 request, records of all inspection reports pertaining to the 516 centerthat facilitywhich 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 centerfacilityfor no less than 5 years afterfromthe 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 fromthe provisions ofs. 119.07(1) and mayshallnot 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 528facilityshall, upon the request of any person who has completed 529 a written application with intent to be admitted to such center 530facilityor any person who is a patient of such centerfacility, 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 centerfacility, 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 birthshall be filed543 with the local registrar within 5 days afterofeach birth in 544 accordance with chapter 382. 545 (2) Immediately report each maternal death, newborn death, 546 and stillbirthshall be reported immediatelyto the medical 547 examiner. 548 (3)The licensee shallComply with all requirements of this 549 chapter and rules promulgated hereunder. 550 (4) Annually submit a reportshall be submitted annuallyto 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 centerfacility, 576 building or portion thereof, or service when the agency 577 determines that any condition in the centerfacilitypresents 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 centerfacilitywithout 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 ofThis part applies 626applyto 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 676shallnot 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 whichthatmeet 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.