Bill Text: FL S0912 | 2010 | Regular Session | Introduced
Bill Title: Clinical Perfusionists [SPSC]
Spectrum: Partisan Bill (Republican 1-0)
Status: (Failed) 2010-04-30 - Died in Committee on Health Regulation [S0912 Detail]
Download: Florida-2010-S0912-Introduced.html
Florida Senate - 2010 SB 912 By Senator Peaden 2-00358A-10 2010912__ 1 A bill to be entitled 2 An act relating to clinical perfusionists; amending s. 3 456.048, F.S.; specifying financial responsibility 4 requirements for clinical perfusionists; creating s. 5 468.901, F.S.; providing definitions; requiring a 6 supervising physician to be qualified in the medical 7 area in which the clinical perfusionist performs; 8 prescribing duties of a clinical perfusionist; 9 requiring a clinical perfusionist to convey to a 10 patient that he or she is a clinical perfusionist; 11 authorizing a clinical perfusionist to perform medical 12 tasks and services within a certain protocol; 13 prohibiting a clinical perfusionist from prescribing, 14 ordering, compounding, or dispensing certain drugs or 15 medical devices; providing that a clinical 16 perfusionist may administer certain drugs, fluids, and 17 blood products under the supervision of a physician; 18 exempting a perfusionist in training from requirements 19 of a clinical perfusionist; requiring board approval 20 of training programs for clinical perfusionists; 21 providing certification requirements; providing 22 provisional certifying requirements; providing for a 23 temporary certificate as a clinical perfusionist; 24 authorizing the Board of Medicine and the Board of 25 Osteopathic Medicine to impose a penalty against a 26 clinical perfusionist found guilty of or investigated 27 for violating ch. 456, ch. 457, or ch. 458, F.S.; 28 authorizing the chairpersons of the Board of Medicine 29 and the Board of Osteopathic Medicine to appoint 30 certain persons to advise the boards regarding rules 31 for the certification of clinical perfusionists; 32 providing duties of the boards; providing for the 33 denial, suspension, or revocation of a certificate; 34 requiring the boards to adopt rules; requiring the 35 Department of Health to allocate fees collected to the 36 boards; providing exemptions from certification 37 requirements for clinical perfusionists; exempting 38 hospitals from payment of certain costs; providing 39 that the act does not prevent reimbursement of 40 employers of clinical perfusionists; providing an 41 effective date. 42 43 Be It Enacted by the Legislature of the State of Florida: 44 45 Section 1. Section 456.048, Florida Statutes, is amended to 46 read: 47 456.048 Financial responsibility requirements for certain 48 health care practitioners.— 49 (1) As a prerequisite for licensure or license renewal, the 50 Board of Acupuncture, the Board of Chiropractic Medicine, the 51 Board of Podiatric Medicine, and the Board of Dentistry shall, 52 by rule, require that all health care practitioners licensed 53 under the respective board, and the Board of Medicine and the 54 Board of Osteopathic Medicine shall, by rule, require that all 55 anesthesiologist assistants licensed pursuant to s. 458.3475 or 56 s. 459.023, and clinical perfusionists certified pursuant to s. 57 468.901, and the Board of Nursing shall, by rule, require that 58 advanced registered nurse practitioners certified under s. 59 464.012, and the department shall, by rule, require that 60 midwives maintain medical malpractice insurance or provide proof 61 of financial responsibility in an amount and in a manner 62 determined by the board or department to be sufficient to cover 63 claims arising out of the rendering of or failure to render 64 professional care and services in this state. 65 (2) The board or department may grant exemptions upon 66 application by practitioners meeting any of the following 67 criteria: 68 (a) Any person licensed under chapter 457, s. 458.3475, s. 69 459.023, chapter 460, chapter 461, s. 464.012, chapter 466, or 70 chapter 467, or certified under s. 468.901, who practices 71 exclusively as an officer, employee, or agent of the Federal 72 Government or of the state or its agencies or its subdivisions. 73 For the purposes of this subsection, an agent of the state, its 74 agencies, or its subdivisions is a person who is eligible for 75 coverage under any self-insurance or insurance program 76 authorized by the provisions of s. 768.28(16) or who is a 77 volunteer under s. 110.501(1). 78 (b) Any person whose license or certification has become 79 inactive under chapter 457, s. 458.3475, s. 459.023, chapter 80 460, chapter 461, part I of chapter 464, chapter 466,orchapter 81 467, or s. 468.901 and who is not practicing in this state. Any 82 person applying for reactivation of a license must show either 83 that such licensee maintained tail insurance coverage which 84 provided liability coverage for incidents that occurred on or 85 after October 1, 1993, or the initial date of licensure in this 86 state, whichever is later, and incidents that occurred before 87 the date on which the license became inactive; or such licensee 88 must submit an affidavit stating that such licensee has no 89 unsatisfied medical malpractice judgments or settlements at the 90 time of application for reactivation. 91 (c) Any person holding a limited license pursuant to s. 92 456.015, and practicing under the scope of such limited license. 93 (d) Any person licensed or certified under chapter 457, s. 94 458.3475, s. 459.023, chapter 460, chapter 461, s. 464.012, 95 chapter 466,orchapter 467, or s. 468.901 who practices only in 96 conjunction with his or her teaching duties at an accredited 97 school or in its main teaching hospitals. Such person may engage 98 in the practice of medicine to the extent that such practice is 99 incidental to and a necessary part of duties in connection with 100 the teaching position in the school. 101 (e) Any person holding an active license or certification 102 under chapter 457, s. 458.3475, s. 459.023, chapter 460, chapter 103 461, s. 464.012, chapter 466,orchapter 467, or s. 468.901 who 104 is not practicing in this state. If such person initiates or 105 resumes practice in this state, he or she must notify the 106 department of such activity. 107 (f) Any person who can demonstrate to the board or 108 department that he or she has no malpractice exposure in the 109 state. 110 (3) Notwithstanding the provisions of this section, the 111 financial responsibility requirements of ss. 458.320 and 112 459.0085 shall continue to apply to practitioners licensed under 113 those chapters, except for anesthesiologist assistants licensed 114 pursuant to s. 458.3475 or s. 459.023 who must meet the 115 requirements of this section. 116 Section 2. Section 468.901, Florida Statutes, is created to 117 read: 118 468.901 Clinical perfusionists.— 119 (1) DEFINITIONS.—As used in this section, the term: 120 (a) “Approved program” means a program for the education 121 and training of clinical perfusion which is approved by the 122 boards as provided in subsection (5). 123 (b) “Boards” means the Board of Medicine and the Board of 124 Osteopathic Medicine. 125 (c) “Clinical perfusionist” means a person who has 126 graduated from an approved program, who is certified pursuant to 127 this section to perform medical services, and who is prescribed, 128 delegated, or supervised by a licensed physician. 129 (d) “Clinical perfusion” means the functions necessary for 130 the support, treatment, measurement, or supplementation of the 131 cardiovascular, circulatory, or respiratory systems or other 132 organs, or a combination of those activities, and the safe 133 management of physiologic functions by monitoring and analyzing 134 the parameters of the systems, under an order and the 135 supervision of a physician licensed under chapter 458 or chapter 136 459, through extracorporeal circulation, long-term clinical 137 support techniques, including extracorporeal carbon-dioxide 138 removal and extracorporeal membrane oxygenation, and associated 139 therapeutic and diagnostic technologies, such as counter 140 pulsation, ventricular assistance, auto transfusion, blood 141 conservation techniques, myocardial and organ preservation, 142 extracorporeal life support, isolated limb perfusion, 143 therapeutic aphaeresis, and platelet rich plasma sequestration. 144 (e) “Clinical perfusionist’s protocol” means perfusion 145 related policies and protocols developed or approved by a 146 licensed health facility or a physician through collaboration 147 with administrators, certified clinical perfusionists, and other 148 health care professionals. 149 (f) “Continuing medical education” means courses recognized 150 and approved by the boards, the American Academy of Physician 151 Assistants, the American Medical Association, the American 152 Osteopathic Association, the American Board of Cardiovascular 153 Perfusion, or the Accreditation Council on Continuing Medical 154 Education. 155 (g) “Department” means the Department of Health. 156 (h) “Direct supervision” means the onsite, personal 157 supervision by a clinical perfusionist who is present when a 158 procedure is being performed and who is in all instances 159 immediately available to provide assistance and direction while 160 clinical perfusion services are being performed. 161 (i) “Extracorporeal circulation” means the diversion of a 162 patient’s blood through a heart-lung machine or a similar device 163 that assumes the functions of the patient’s heart, lungs, 164 kidney, liver, or other organs. 165 (j) “Perfusionist in training” means a student enrolled in 166 an approved program who has not yet passed the proficiency 167 examination and works under the direct supervision of a clinical 168 perfusionist. 169 (k) “Proficiency examination” means an entry-level 170 examination administered by the American Board of Cardiovascular 171 Perfusion. 172 (l) “Provisional certified clinical perfusionist” means a 173 person provisionally certified under this section. 174 (m) “Supervising physician” means a physician licensed 175 under chapter 458 or chapter 459 who holds an active license. 176 (n) “Temporary clinical perfusionist” means a person 177 granted a temporary certificate under this section. 178 (2) PERFORMANCE OF A SUPERVISING PHYSICIAN.—A physician who 179 supervises a clinical perfusionist must be qualified in the 180 medical areas in which the clinical perfusionist performs. 181 (3)(a) PERFORMANCE OF CLINICAL PERFUSIONISTS.—A clinical 182 perfusionist may perform duties established by rule by the 183 boards, including the following duties that are included in the 184 clinical perfusionist’s protocol, if prescribed by a physician 185 or under the supervision of a physician: 186 1. Perform extracorporeal circulation and its clinical 187 support; 188 2. Perform or administer counter pulsation; 189 3. Perform circulatory support and ventricular assistance; 190 4. Perform extracorporeal membrane oxygenation and 191 extracorporeal life support; 192 5. Perform blood conservation techniques, autotransfusion, 193 and blood component sequestration; 194 6. Perform myocardial preservation; 195 7. Perform coagulation and hematologic monitoring; 196 8. Perform physiological monitoring; 197 9. Perform blood gas and blood chemistry monitoring; 198 10. Perform induction of hypothermia or hyperthermia with 199 reversal; 200 11. Perform hemodilution; 201 12. Perform hemofiltration; 202 13. Administer blood, blood products, supportive fluids, 203 and anesthetic agents via the extracorporeal circuit; 204 14. Perform isolated limb and organ perfusion; 205 15. Provide surgical assistance; 206 16. Perform organ preservation; 207 17. Perform dialysis while on clinical bypass; 208 18. Perform therapeutic apheresis; 209 19. Administer blood, blood products, and supportive fluids 210 via the therapeutic apheresis circuit; and 211 20. Perform pacemaker lead and battery analysis. 212 (b) A clinical perfusionist shall clearly convey to a 213 patient that he or she is a clinical perfusionist. 214 (c) A clinical perfusionist may perform medical tasks and 215 services within the framework of a written practice protocol 216 developed between the supervising physician and the clinical 217 perfusionist. 218 (d) A clinical perfusionist may not prescribe, order, 219 compound, or dispense any controlled substance, legend drug, or 220 medical device to any patient. This paragraph does not prohibit 221 a clinical perfusionist from administering legend drugs, 222 controlled substances, intravenous drugs, fluids, or blood 223 products that are ordered by the physician and administered to a 224 patient while under the orders of such physician. 225 (4) PERFORMANCE BY PERFUSIONISTS IN TRAINING.—The practice 226 of a perfusionist in training is exempt from the requirements of 227 this section while the perfusionist in training is performing 228 assigned tasks in conjunction with an approved program. Before 229 providing clinical perfusion in conjunction with the 230 requirements of an approved program, the perfusionist in 231 training shall clearly convey to the patient that he or she is a 232 perfusionist in training and is under direct supervision. 233 (5) PROGRAM APPROVAL.—The boards shall approve programs for 234 the education and training of clinical perfusionists which hold 235 full accreditation or provisional accreditation from the 236 Commission on Accreditation of Allied Health Education Programs 237 or a successor organization, as approved by the boards. 238 (6) CLINICAL PERFUSIONIST CERTIFICATION.— 239 (a) Any person seeking to be certified as a clinical 240 perfusionist must apply to the department. The department shall 241 issue a certificate to any person certified by the boards to: 242 1. Be at least 21 years of age. 243 2. Have satisfactorily passed a proficiency examination 244 approved by the boards. The boards, on receipt of an application 245 and application fee, shall waive the examination requirement for 246 an applicant who at the time of application holds a current 247 certificate issued by a certifying agency approved by the 248 boards. 249 3. Be certified in basic cardiac life support. 250 4. Have completed the application form and remitted an 251 application fee, not to exceed $1,000, as set by the department. 252 An application must include: 253 a. A certificate of completion of an approved program or 254 its equivalent; 255 b. A sworn statement of any prior felony convictions; 256 c. A sworn statement of any prior discipline or denial of 257 certification or license in any state; 258 d. Two letters of recommendation, one from a physician and 259 one from a certified clinical perfusionist; and 260 e. A set of fingerprints on a form and under procedures 261 specified by the department, along with payment in an amount 262 equal to the costs incurred by the department for a national 263 criminal history check of the applicant. 264 265 Before January 1, 2011, a person is eligible to apply to the 266 boards and receive a certification notwithstanding the 267 requirements of this subsection if the person was actively 268 engaged in the practice of perfusion consistent with applicable 269 law, and if the person was operating cardiopulmonary bypass 270 systems during cardiac surgical cases in a licensed health care 271 facility in this state as the person’s primary function and had 272 been operating the system for at least 9 of the 10 years 273 preceding application for certification. 274 (b) Between July 1, 2010, and June 30, 2011, an applicant 275 who was not a graduate of an accredited program before 1981, but 276 met the then-current eligibility requirements for certification 277 as a certified clinical perfusionist and subsequently was 278 certified, shall be certified as a perfusionist if the 279 application otherwise complies with this section. 280 (c) A certificate must be renewed biennially. Each renewal 281 must include: 282 1. A renewal fee, not to exceed $1,000, as set by the 283 department; and 284 2. A sworn statement of no felony convictions in the 285 immediately preceding 2 years. 286 (d) Each certified clinical perfusionist shall biennially 287 complete continuing medical education as required by the boards. 288 (e)1. A certificate as a provisional certified clinical 289 perfusionist may be issued by the boards to a person who has 290 successfully completed an approved perfusion education program, 291 completed an application and remitted an application fee, and 292 submitted evidence satisfactory to the boards of the successful 293 completion of the requisite education requirements. 294 2. A provisional certified clinical perfusionist must be 295 under the supervision and direction of a certified clinical 296 perfusionist at all times during which the provisional certified 297 clinical perfusionist performs the prescribed duties. 298 3. A provisional certificate is valid for 2 years following 299 the date it is issued and may be extended subject to rule by the 300 boards. The application for extension must be signed by a 301 supervising certified clinical perfusionist. Upon notification 302 by the approved testing service, or the boards, that any portion 303 of the certifying examination has been failed after the 2-year 304 provisional certificate term, the provisional certificate must 305 be surrendered to the boards. 306 (f) A certificate as a temporary clinical perfusionist may 307 be issued by the department to a person who has successfully 308 completed the application for perfusion certification and met 309 other requirements as established by the boards. 310 (g) The boards shall adopt rules governing supervisory 311 requirements between clinical perfusionists and provisional 312 certified clinical perfusionists, temporary clinical 313 perfusionists, and clinical perfusionists in training. 314 (h) The Board of Medicine may impose upon a clinical 315 perfusionist any penalty specified in s. 456.072 or s. 316 458.331(2) if the clinical perfusionist is found guilty of or is 317 investigated for an act that constitutes a violation of chapter 318 456, chapter 457, or chapter 458. 319 (7) CARDIOVASCULAR SURGEON AND CLINICAL PERFUSIONIST TO 320 ADVISE THE BOARDS.— 321 (a) The chairpersons of the Board of Medicine and the Board 322 of Osteopathic Medicine may appoint a cardiovascular surgeon and 323 a certified clinical perfusionist to advise the boards as to the 324 adoption of rules for the certification of clinical 325 perfusionists. The boards may use a committee structure that is 326 most practicable in order to receive any recommendations to the 327 boards regarding rules and all matters relating to clinical 328 perfusionists, including, but not limited to, recommendations to 329 improve safety in the clinical practices of certified clinical 330 perfusionists. 331 (b) In addition to its other duties and responsibilities as 332 prescribed by law, the boards shall: 333 1. Recommend to the department the certification of 334 clinical perfusionists. 335 2. Develop rules regulating the use of clinical 336 perfusionists under chapter 458 or chapter 459, except for rules 337 relating to the formulary developed under s. 458.347(4). The 338 boards shall also develop rules to ensure that the continuity of 339 supervision is maintained in each practice setting. The boards 340 shall consider adopting a proposed rule at the regularly 341 scheduled meeting immediately following the submission of the 342 proposed rule. A proposed rule may not be adopted by either 343 board unless both boards have accepted and approved the 344 identical language contained in the proposed rule. The 345 provisions of all the proposed rules must be approved by both 346 boards pursuant to each respective board’s guidelines and 347 standards regarding the adoption of proposed rules. 348 3. Address concerns and problems of clinical perfusionists 349 to improve safety in the clinical practices of certified 350 clinical perfusionists. 351 (c) When the boards find that an applicant for 352 certification has failed to meet, to the boards’ satisfaction, 353 any of the requirements for certification set forth in this 354 section, the boards may enter an order to: 355 1. Refuse to certify the applicant; 356 2. Approve the applicant for certification with 357 restrictions on the scope of practice; or 358 3. Approve the applicant for provisional or temporary 359 certification. Such conditions may include placement of the 360 applicant on probation for a period of time and subject to such 361 conditions as the boards specify, including, but not limited to, 362 requiring the applicant to undergo treatment, to attend 363 continuing medical education courses, or to take corrective 364 action. 365 (8) DENIAL, SUSPENSION, OR REVOCATION OF CERTIFICATION.—The 366 boards may deny, suspend, or revoke the certification of a 367 clinical perfusionist whom the boards determine have violated 368 any provision of this section, chapter 456, chapter 458, or 369 chapter 459 or any rule adopted pursuant thereto. 370 (9) RULES.—The boards shall adopt rules to administer this 371 section. 372 (10) FEES.—The department shall allocate the fees collected 373 under this section to the boards for the sole purpose of 374 administering the provisions of this section. 375 (11) EXEMPTIONS.— 376 (a) This section does not limit the practice of a physician 377 licensed under chapter 458 or chapter 459 or a respiratory 378 therapist licensed under chapter 468, so long as that person 379 does not hold himself or herself out to the public as possessing 380 a certificate or provisional certificate issued under this 381 section or use a professional title protected by this section. 382 (b) This section does not limit the practice of nursing or 383 prevent qualified members of other regulated health professions 384 from doing work of a nature consistent with the state laws and 385 rules that govern their respective health professions, so long 386 as those persons do not hold themselves out to the public as 387 possessing a certificate or provisional certificate issued under 388 this section or use a professional title protected by this 389 section. 390 (c) A person need not be certified under this section who: 391 1. Is a qualified person in this state or another state or 392 territory who is employed by the United States Government or an 393 agency thereof while discharging his or her official duties. 394 2. Is a student providing services regulated under this 395 chapter who is: 396 a. Pursuing a course of study that leads to a degree in a 397 profession regulated by this chapter; 398 b. Providing services in a training setting, as long as 399 such services and associated activities constitute part of a 400 supervised course of study; and 401 c. Designated by the title “perfusionist in training.” 402 (d) The boards shall establish by rule the qualifications 403 necessary for a clinical perfusionist who is not a resident of 404 this state and is licensed or certified by any other state or 405 territory of the United States. Such clinical perfusionist may 406 not offer services in this state for more than 30 days in any 407 calendar year. 408 (e) Except as stipulated by the boards, the exemptions in 409 this subsection do not apply to any person certified under this 410 section whose certificate has been revoked or suspended by 411 either of the boards or whose license or certification in 412 another jurisdiction has been revoked or suspended by the 413 licensing or certifying authority in that jurisdiction. 414 (f) This subsection does not exempt a person from meeting 415 the minimum standards of performance in professional activities 416 when measured against generally prevailing peer performance, 417 including the undertaking of activities for which the person is 418 not qualified by training or experience. 419 (12) PAYMENTS AND REIMBURSEMENTS.— 420 (a) A hospital is not required to pay for, or reimburse any 421 person for, the costs of compliance with any requirement of this 422 section, including costs of continuing medical education. 423 (b) This section does not prevent third-party payors from 424 reimbursing employers of clinical perfusionists for covered 425 services rendered by such clinical perfusionists. 426 Section 3. This act shall take effect July 1, 2010.
