| 1 | A bill to be entitled |
| 2 | An act relating to cardiopulmonary perfusionists; amending |
| 3 | s. 456.048, F.S.; requiring the Board of Medicine and the |
| 4 | Board of Osteopathic Medicine to require medical |
| 5 | malpractice insurance or proof of financial responsibility |
| 6 | as a condition of licensure or licensure renewal for |
| 7 | licensed cardiopulmonary perfusionists; amending ss. |
| 8 | 458.331 and 459.015, F.S.; revising grounds for which a |
| 9 | physician or osteopathic physician may be disciplined for |
| 10 | failing to provide adequate supervision; providing |
| 11 | penalties; creating ss. 458.3476 and 459.024, F.S.; |
| 12 | providing definitions; providing performance standards for |
| 13 | cardiopulmonary perfusionists and supervising physicians |
| 14 | or osteopathic physicians; providing for the approval of |
| 15 | training programs and for services authorized to be |
| 16 | performed by trainees; providing licensing procedures; |
| 17 | providing for fees; providing for additional membership, |
| 18 | powers, and duties of the Board of Medicine and the Board |
| 19 | of Osteopathic Medicine; providing penalties; providing |
| 20 | for disciplinary actions; providing for the adoption of |
| 21 | rules; providing liability; providing for the allocation |
| 22 | of fees; providing an effective date. |
| 23 |
|
| 24 | Be It Enacted by the Legislature of the State of Florida: |
| 25 |
|
| 26 | Section 1. Section 456.048, Florida Statutes, is amended |
| 27 | to read: |
| 28 | 456.048 Financial responsibility requirements for certain |
| 29 | health care practitioners.-- |
| 30 | (1) As a prerequisite for licensure or license renewal, |
| 31 | the Board of Acupuncture, the Board of Chiropractic Medicine, |
| 32 | the Board of Podiatric Medicine, and the Board of Dentistry |
| 33 | shall, by rule, require that all health care practitioners |
| 34 | licensed under the respective board, and the Board of Medicine |
| 35 | and the Board of Osteopathic Medicine shall, by rule, require |
| 36 | that all anesthesiologist assistants licensed pursuant to s. |
| 37 | 458.3475 or s. 459.023 and cardiopulmonary perfusionists |
| 38 | licensed pursuant to s. 458.3476 or s. 459.024, and the Board of |
| 39 | Nursing shall, by rule, require that advanced registered nurse |
| 40 | practitioners certified under s. 464.012, and the department |
| 41 | shall, by rule, require that midwives maintain medical |
| 42 | malpractice insurance or provide proof of financial |
| 43 | responsibility in an amount and in a manner determined by the |
| 44 | board or department to be sufficient to cover claims arising out |
| 45 | of the rendering of or failure to render professional care and |
| 46 | services in this state. |
| 47 | (2) The board or department may grant exemptions upon |
| 48 | application by practitioners meeting any of the following |
| 49 | criteria: |
| 50 | (a) Any person licensed under chapter 457, s. 458.3475, s. |
| 51 | 459.023, s. 458.3476, s. 459.024, chapter 460, chapter 461, s. |
| 52 | 464.012, chapter 466, or chapter 467 who practices exclusively |
| 53 | as an officer, employee, or agent of the Federal Government or |
| 54 | of the state or its agencies or its subdivisions. For the |
| 55 | purposes of this subsection, an agent of the state, its |
| 56 | agencies, or its subdivisions is a person who is eligible for |
| 57 | coverage under any self-insurance or insurance program |
| 58 | authorized by the provisions of s. 768.28(16) or who is a |
| 59 | volunteer under s. 110.501(1). |
| 60 | (b) Any person whose license or certification has become |
| 61 | inactive under chapter 457, s. 458.3475, s. 459.023, s. |
| 62 | 458.3476, s. 459.024, chapter 460, chapter 461, part I of |
| 63 | chapter 464, chapter 466, or chapter 467 and who is not |
| 64 | practicing in this state. Any person applying for reactivation |
| 65 | of a license must show either that such licensee maintained tail |
| 66 | insurance coverage which provided liability coverage for |
| 67 | incidents that occurred on or after October 1, 1993, or the |
| 68 | initial date of licensure in this state, whichever is later, and |
| 69 | incidents that occurred before the date on which the license |
| 70 | became inactive; or such licensee must submit an affidavit |
| 71 | stating that such licensee has no unsatisfied medical |
| 72 | malpractice judgments or settlements at the time of application |
| 73 | for reactivation. |
| 74 | (c) Any person holding a limited license pursuant to s. |
| 75 | 456.015, and practicing under the scope of such limited license. |
| 76 | (d) Any person licensed or certified under chapter 457, s. |
| 77 | 458.3475, s. 459.023, s. 458.3476, s. 459.024, chapter 460, |
| 78 | chapter 461, s. 464.012, chapter 466, or chapter 467 who |
| 79 | practices only in conjunction with his or her teaching duties at |
| 80 | an accredited school or in its main teaching hospitals. Such |
| 81 | person may engage in the practice of medicine to the extent that |
| 82 | such practice is incidental to and a necessary part of duties in |
| 83 | connection with the teaching position in the school. |
| 84 | (e) Any person holding an active license or certification |
| 85 | under chapter 457, s. 458.3475, s. 459.023, s. 458.3476, s. |
| 86 | 459.024, chapter 460, chapter 461, s. 464.012, chapter 466, or |
| 87 | chapter 467 who is not practicing in this state. If such person |
| 88 | initiates or resumes practice in this state, he or she must |
| 89 | notify the department of such activity. |
| 90 | (f) Any person who can demonstrate to the board or |
| 91 | department that he or she has no malpractice exposure in the |
| 92 | state. |
| 93 | (3) Notwithstanding the provisions of this section, the |
| 94 | financial responsibility requirements of ss. 458.320 and |
| 95 | 459.0085 shall continue to apply to practitioners licensed under |
| 96 | those chapters, except for cardiopulmonary perfusionists |
| 97 | licensed pursuant to s. 458.3476 or s. 459.024 and |
| 98 | anesthesiologist assistants licensed pursuant to s. 458.3475 or |
| 99 | s. 459.023 who must meet the requirements of this section. |
| 100 | Section 2. Paragraph (dd) of subsection (1) of section |
| 101 | 458.331, Florida Statutes, is amended to read: |
| 102 | 458.331 Grounds for disciplinary action; action by the |
| 103 | board and department.-- |
| 104 | (1) The following acts constitute grounds for denial of a |
| 105 | license or disciplinary action, as specified in s. 456.072(2): |
| 106 | (dd) Failing to supervise adequately the activities of |
| 107 | those physician assistants, paramedics, emergency medical |
| 108 | technicians, advanced registered nurse practitioners, or |
| 109 | anesthesiologist assistants, or cardiopulmonary perfusionists |
| 110 | acting under the supervision of the physician. |
| 111 | Section 3. Section 458.3476, Florida Statutes, is created |
| 112 | to read: |
| 113 | 458.3476 Cardiopulmonary perfusionists.-- |
| 114 | (1) DEFINITIONS.--As used in this section, the term: |
| 115 | (a) "Approved program" means a program for the education |
| 116 | and training of cardiopulmonary perfusion which has been |
| 117 | approved by the boards as provided in subsection (5). |
| 118 | (b) "Boards" means the Board of Medicine and the Board of |
| 119 | Osteopathic Medicine. |
| 120 | (c) "Cardiopulmonary perfusionist" means a graduate of an |
| 121 | approved program who is licensed to perform medical services |
| 122 | delegated and directly supervised by a licensed physician. |
| 123 | (d) "Cardiopulmonary perfusion" means the functions |
| 124 | necessary for the support, treatment, measurement, or |
| 125 | supplementation of the cardiovascular, circulatory, and |
| 126 | respiratory systems or other organs, or a combination of those |
| 127 | activities, and to ensure the safe management of physiologic |
| 128 | functions by monitoring and analyzing the parameters of the |
| 129 | systems under an order and the supervision of a licensed |
| 130 | physician, including: |
| 131 | 1. The use of extracorporeal circulation, long-term |
| 132 | cardiopulmonary support techniques including extracorporeal |
| 133 | carbon dioxide removal and extracorporeal membrane oxygenation |
| 134 | and associated therapeutic and diagnostic technologies. |
| 135 | 2. The use of counter pulsation, ventricular assistance, |
| 136 | auto transfusion, blood conservation techniques, myocardial and |
| 137 | organ preservation, extracorporeal life support, isolated limb |
| 138 | perfusion, therapeutic aphaeresis, and platelet rich plasma |
| 139 | sequestration. |
| 140 | 3. The use of techniques involving blood management, |
| 141 | advanced life support, and other related functions. |
| 142 | 4. The performance of the following acts described in this |
| 143 | subsection: |
| 144 | a. The administration of: |
| 145 | (I) Pharmacological and therapeutic agents. |
| 146 | (II) Blood products or anesthetic agents through the |
| 147 | extracorporeal circuit or through an intravenous line as ordered |
| 148 | by a physician. |
| 149 | b. The performance and use of: |
| 150 | (I) Coagulation monitoring and analysis. |
| 151 | (II) Physiologic monitoring and analysis. |
| 152 | (III) Blood gas and chemistry monitoring and analysis. |
| 153 | (IV) Hematologic monitoring and analysis. |
| 154 | (V) Hypothermia. |
| 155 | (VI) Hyperthermia. |
| 156 | (VII) Hemoconcentration and hemodilution. |
| 157 | (VIII) Hemodialysis. |
| 158 | c. The observation of signs and symptoms related to |
| 159 | perfusion services, the determination of whether the signs and |
| 160 | symptoms exhibit abnormal characteristics and the implementation |
| 161 | of appropriate reporting, perfusion protocols, or changes in or |
| 162 | the initiation of emergency procedures. |
| 163 | (e) "Cardiopulmonary perfusionists licensing committee" |
| 164 | means the cardiopulmonary perfusion licensing committee |
| 165 | appointed by the board. |
| 166 | (f) "Continuing medical education" means courses |
| 167 | recognized and approved by the boards, the American Academy of |
| 168 | Physician Assistants, the American Medical Association, the |
| 169 | American Osteopathic Association, the American Board of |
| 170 | Cardiopulmonary Perfusion, or the Accreditation Council on |
| 171 | Continuing Medical Education. |
| 172 | (g) "Direct supervision" means the on-site, personal |
| 173 | supervision by a physician who is present in the surgical suite |
| 174 | when the procedure is being performed in that surgical suite and |
| 175 | who is in all instances immediately available to provide |
| 176 | assistance and direction to the cardiovascular perfusionist |
| 177 | while cardiac perfusion services are being performed. |
| 178 | (h) "Extracorporeal circulation" means the diversion of a |
| 179 | patient's blood through a heart-lung machine or a similar device |
| 180 | that assumes the functions of the patient's heart, lungs, |
| 181 | kidney, liver, or other organs. |
| 182 | (i) "Trainee" means a person who is currently enrolled in |
| 183 | an approved program. |
| 184 | (j) "Perfusion protocols" means perfusion-related policies |
| 185 | and protocols developed or approved by a licensed health |
| 186 | facility or a physician through collaboration with |
| 187 | administrators, licensed cardiovascular perfusionists, and other |
| 188 | health care professionals. |
| 189 | (k) "Proficiency examination" means an entry-level |
| 190 | examination approved by the boards, including examinations |
| 191 | administered by the American Board of Cardiovascular Perfusion |
| 192 | (ABCP). |
| 193 | (l) "Provisional licensed perfusionist" means a person |
| 194 | granted a provisional license under this section. |
| 195 | (m) "Supervising physician" means an allopathic physician |
| 196 | who holds an active and unrestricted license and who has |
| 197 | successfully completed a training program approved by the |
| 198 | Accreditation Council for Graduate Medical Education or its |
| 199 | equivalent. |
| 200 | (n) "Temporary perfusionist licensee" means a person |
| 201 | granted a temporary license under this section. |
| 202 | (2) PERFORMANCE OF SUPERVISING PHYSICIAN.--A physician who |
| 203 | directly supervises a cardiopulmonary perfusionist must be |
| 204 | qualified in the medical areas in which the cardiopulmonary |
| 205 | perfusionist performs and is liable for the performance of the |
| 206 | cardiopulmonary perfusionist. A physician may only supervise two |
| 207 | cardiopulmonary perfusionists at the same time. |
| 208 | (3) PERFORMANCE OF CARDIOPULMONARY PERFUSIONISTS.-- |
| 209 | (a) A cardiopulmonary perfusionist may perform duties |
| 210 | established by rule by the board in any of the following |
| 211 | functions that are included in the cardiopulmonary |
| 212 | perfusionist's protocol while prescribed by a physician or under |
| 213 | the supervision of a physician: |
| 214 | 1. Perform extracorporeal circulation/cardiopulmonary |
| 215 | support. |
| 216 | 2. Perform or administer counter pulsation. |
| 217 | 3. Perform circulatory support and ventricular assistance. |
| 218 | 4. Perform extracorporeal membrane oxygenation (ECMO) and |
| 219 | extracorporeal life support (ECLS). |
| 220 | 5. Perform blood conservation techniques, auto |
| 221 | transfusion, and blood component sequestration. |
| 222 | 6. Perform myocardial preservation. |
| 223 | 7. Perform coagulation and hemotalogic |
| 224 | monitoring/analysis. |
| 225 | 8 . Perform physiological analysis and monitoring. |
| 226 | 9. Perform blood gas and blood chemistry analysis and |
| 227 | monitoring. |
| 228 | 10. Perform induction of hypothermia or hyperthermia with |
| 229 | reversal. |
| 230 | 11. Perform hemodilution. |
| 231 | 12. Perform hemofiltration. |
| 232 | 13. Administer blood, blood products, supportive fluids, |
| 233 | and anesthetic agents via the extracorporeal circuit. |
| 234 | 14. Documentation associated with described duties. |
| 235 | 15. Perform isolated limb and organ perfusion. |
| 236 | 16. Provide surgical assistance. |
| 237 | 17. Perform organ preservation. |
| 238 | 18. Perform dialysis while on cardiopulmonary bypass. |
| 239 | 19. Perform therapeutic aphaeresis. |
| 240 | (b) Nothing in this section or chapter prevents third- |
| 241 | party payors from reimbursing employers of cardiopulmonary |
| 242 | perfusionists for covered services rendered by such |
| 243 | cardiopulmonary perfusionists. |
| 244 | (c) A cardiopulmonary perfusionist shall clearly convey to |
| 245 | the patient that he or she is a cardiopulmonary perfusionist. |
| 246 | (d) A cardiopulmonary perfusionist may perform medical |
| 247 | tasks and services within the framework of a written practice |
| 248 | protocol developed between the supervising physician and the |
| 249 | cardiopulmonary perfusionist. |
| 250 | (e) A cardiopulmonary perfusionist may not prescribe, |
| 251 | order, or compound any controlled substance, legend drug, or |
| 252 | medical device nor may a cardiopulmonary perfusionist dispense |
| 253 | sample drugs to patients. Nothing in this paragraph prohibits a |
| 254 | cardiopulmonary perfusionist from administering legend drugs or |
| 255 | controlled substances, intravenous drugs, fluids, or blood |
| 256 | products to patients which are ordered by the supervising |
| 257 | physician and administered while under the supervision of the |
| 258 | supervising physician. |
| 259 | (4) PERFORMANCE BY TRAINEES.--The practice of a trainee |
| 260 | is exempt from the requirements of this chapter while the |
| 261 | trainee is performing assigned tasks as a trainee in conjunction |
| 262 | with an approved program. Before providing cardiopulmonary |
| 263 | perfusion services in conjunction with the requirements of an |
| 264 | approved program, the trainee must clearly convey to the patient |
| 265 | that he or she is a trainee. |
| 266 | (5) PROGRAM APPROVAL.--The boards shall approve programs |
| 267 | for the education and training of cardiopulmonary perfusionists |
| 268 | that meet standards established by board rules. The boards may |
| 269 | recommend only those cardiopulmonary perfusionist training |
| 270 | programs that hold full accreditation or provisional |
| 271 | accreditation from the Commission on Accreditation of Allied |
| 272 | Health Education Programs. |
| 273 | (6) CARDIOPULMONARY PERFUSIONIST LICENSURE.-- |
| 274 | (a) Any person desiring to be licensed as a |
| 275 | cardiopulmonary perfusionist shall apply to the department. The |
| 276 | department shall issue a license to any person certified by the |
| 277 | board to: |
| 278 | 1. Be 18 years of age or older. |
| 279 | 2. Have satisfactorily passed proficiency examination with |
| 280 | a score established by the American Board of Cardiovascular |
| 281 | Perfusion (ABCP). The board, on receipt of an application and |
| 282 | application fee, shall waive the examination requirement for an |
| 283 | applicant who at the time of application: |
| 284 | a. Is appropriately licensed or certified by another |
| 285 | state, territory, or possession of the United States if the |
| 286 | requirements of that state, territory, or possession for the |
| 287 | license or certificate are the substantial equivalent of the |
| 288 | requirements of this section as determined by the board; or |
| 289 | b. Holds a current certificate as a certified clinical |
| 290 | perfusionist issued by the American Board of Cardiovascular |
| 291 | Perfusion (ABCP) or its successor prior to July 1, 2005. |
| 292 | 3. Be certified in basic cardiac life support. |
| 293 | 4. Have completed the application form and remitted an |
| 294 | application fee, not to exceed $1,000, as set by the boards. An |
| 295 | application must include: |
| 296 | a. A certificate of completion of an approved program. |
| 297 | b. A sworn statement of any prior felony convictions. |
| 298 | c. A sworn statement of any prior discipline or denial of |
| 299 | licensure or certification in any state. |
| 300 | d. One letter of recommendation from a physician and one |
| 301 | letter of recommendation from a cardiopulmonary perfusionist. |
| 302 | (b) A license must be renewed biennially. Each renewal |
| 303 | must include: |
| 304 | 1. A renewal fee, not to exceed $1,000, as set by the |
| 305 | boards. |
| 306 | 2. A sworn statement of no felony convictions in the |
| 307 | immediately preceding 2 years. |
| 308 | (c) Each licensed cardiopulmonary perfusionist must |
| 309 | biennially complete 40 hours of continuing medical education or |
| 310 | hold a current certificate issued by the American Board of |
| 311 | Cardiovascular Perfusion or its successor. |
| 312 | 1. A provisional license may be issued by the board to a |
| 313 | person who has successfully completed an approved perfusion |
| 314 | education program and the filing of an application, payment of |
| 315 | an application fee, and the submission of evidence satisfactory |
| 316 | to the board of the successful completion of the education |
| 317 | requirement set forth in this section. A provisional licensee |
| 318 | shall be under the supervision and direction of a licensed |
| 319 | perfusionist at all times during which the provisional licensee |
| 320 | performs perfusion. Rules adopted by the board governing such |
| 321 | supervision and direction may not require the immediate physical |
| 322 | presence of the supervising licensed perfusionist. A provisional |
| 323 | license is valid for 2 years from the date it is issued and may |
| 324 | be extended subject to rule by the board. The application for |
| 325 | extension must be signed by a supervising licensed perfusionist. |
| 326 | Upon notification by the approved testing service or the board |
| 327 | that any portion of the licensing examination has been failed |
| 328 | after the 2-year provisional license term, the provisional |
| 329 | license will be surrendered to the board. |
| 330 | 2. A temporary license may be issued by the department to |
| 331 | a person who has successfully completed the perfusion licensure |
| 332 | application. |
| 333 | (d) The board may impose upon a cardiopulmonary |
| 334 | perfusionist any penalty specified in s. 456.072 or s. |
| 335 | 458.331(2) if the cardiopulmonary perfusionist or the |
| 336 | supervising physician is found guilty of or is investigated for |
| 337 | an act that constitutes a violation of this chapter or chapter |
| 338 | 456. |
| 339 | (7) CARDIOVASCULAR SURGEON AND CARDIOPULMONARY |
| 340 | PERFUSIONIST TO ADVISE THE BOARD.-- |
| 341 | (a) The chairperson of the board may appoint a |
| 342 | cardiovascular surgeon and a cardiopulmonary perfusionist to |
| 343 | advise the board as to the adoption of rules for the licensure |
| 344 | of cardiopulmonary perfusionists. The board may use a committee |
| 345 | structure that is most practicable in order to receive any |
| 346 | recommendations to the board regarding rules and all matters |
| 347 | relating to cardiopulmonary perfusionists, including, but not |
| 348 | limited to, recommendations to improve safety in the clinical |
| 349 | practices of licensed cardiopulmonary perfusionists. |
| 350 | (b) In addition to its other duties and responsibilities |
| 351 | as prescribed by law, the board shall: |
| 352 | 1. Recommend to the department the licensure of |
| 353 | cardiopulmonary perfusionists. |
| 354 | 2. Develop all rules regulating the use of cardiopulmonary |
| 355 | perfusionists under this chapter and chapter 459, except for |
| 356 | rules relating to the formulary developed under s. |
| 357 | 458.347(4)(f). The board shall also develop rules to ensure that |
| 358 | the continuity of supervision is maintained in each practice |
| 359 | setting. The boards shall consider adopting a proposed rule at |
| 360 | the regularly scheduled meeting immediately following the |
| 361 | submission of the proposed rule. A proposed rule may not be |
| 362 | adopted by either board unless both boards have accepted and |
| 363 | approved the identical language contained in the proposed rule. |
| 364 | The language of all proposed rules must be approved by both |
| 365 | boards pursuant to each respective board's guidelines and |
| 366 | standards regarding the adoption of proposed rules. |
| 367 | 3. Address concerns and problems of practicing |
| 368 | cardiopulmonary perfusionists to improve safety in the clinical |
| 369 | practices of licensed cardiopulmonary perfusionists. |
| 370 | (c) When the board finds that an applicant for licensure |
| 371 | has failed to meet, to the board's satisfaction, each of the |
| 372 | requirements for licensure set forth in this section, the board |
| 373 | may enter an order to: |
| 374 | 1. Refuse to certify the applicant for licensure; |
| 375 | 2. Approve the applicant for licensure with restrictions |
| 376 | on the scope of practice or license; or |
| 377 | 3. Approve the applicant for conditional licensure. Such |
| 378 | conditions may include placement of the licensee on probation |
| 379 | for a period of time and subject to such conditions as the board |
| 380 | specifies, including, but not limited to, requiring the licensee |
| 381 | to undergo treatment, to attend continuing education courses, or |
| 382 | to take corrective action. |
| 383 | (8) PENALTY.--A person who falsely holds himself or |
| 384 | herself out as a cardiopulmonary perfusionist commits a felony |
| 385 | of the third degree, punishable as provided in s. 775.082, s. |
| 386 | 775.083, or s. 775.084. |
| 387 | (9) DENIAL, SUSPENSION, OR REVOCATION OF LICENSURE.--The |
| 388 | boards may deny, suspend, or revoke the license of a |
| 389 | cardiopulmonary perfusionist who the board determines has |
| 390 | violated any provision of this section or chapter or any rule |
| 391 | adopted pursuant thereto. |
| 392 | (10) RULES.--The boards shall adopt rules to administer |
| 393 | this section. |
| 394 | (11) LIABILITY.--A supervising physician is liable for any |
| 395 | act or omission of a cardiopulmonary perfusionist acting under |
| 396 | the physician's supervision and control and shall comply with |
| 397 | the financial responsibility requirements of this chapter and |
| 398 | chapter 456, as applicable. |
| 399 | (12) FEES.--The department shall allocate the fees |
| 400 | collected under this section to the board. |
| 401 | Section 4. Paragraph (hh) of subsection (1) of section |
| 402 | 459.015, Florida Statutes, is amended to read: |
| 403 | 459.015 Grounds for disciplinary action; action by the |
| 404 | board and department.-- |
| 405 | (1) The following acts constitute grounds for denial of a |
| 406 | license or disciplinary action, as specified in s. 456.072(2): |
| 407 | (hh) Failing to supervise adequately the activities of |
| 408 | those physician assistants, paramedics, emergency medical |
| 409 | technicians, advanced registered nurse practitioners, |
| 410 | anesthesiologist assistants, cardiopulmonary perfusionists, or |
| 411 | other persons acting under the supervision of the osteopathic |
| 412 | physician. |
| 413 | Section 5. Section 459.025, Florida Statutes, is created |
| 414 | to read: |
| 415 | 459.025 Cardiopulmonary perfusionists.-- |
| 416 | (1) DEFINITIONS.--As used in this section, the term: |
| 417 | (a) "Approved program" means a program for the education |
| 418 | and training of cardiopulmonary perfusion which has been |
| 419 | approved by the boards as provided in subsection (5). |
| 420 | (b) "Boards" means the Board of Medicine and the Board of |
| 421 | Osteopathic Medicine. |
| 422 | (c) "Cardiopulmonary perfusionist" means a graduate of an |
| 423 | approved program who is licensed to perform medical services |
| 424 | delegated and directly supervised by a licensed osteopathic |
| 425 | physician. |
| 426 | (d) "Cardiopulmonary perfusion" means the functions |
| 427 | necessary for the support, treatment, measurement, or |
| 428 | supplementation of the cardiovascular, circulatory, and |
| 429 | respiratory systems or other organs, or a combination of those |
| 430 | activities, and to ensure the safe management of physiologic |
| 431 | functions by monitoring and analyzing the parameters of the |
| 432 | systems under an order and the supervision of a licensed |
| 433 | osteopathic physician, including: |
| 434 | 1. The use of extracorporeal circulation, long-term |
| 435 | cardiopulmonary support techniques including extracorporeal |
| 436 | carbon dioxide removal and extracorporeal membrane oxygenation, |
| 437 | and associated therapeutic and diagnostic technologies. |
| 438 | 2. The use of counter pulsation, ventricular assistance, |
| 439 | auto transfusion, blood conservation techniques, myocardial and |
| 440 | organ preservation, extracorporeal life support, isolated limb |
| 441 | perfusion, therapeutic aphaeresis, and platelet rich plasma |
| 442 | sequestration. |
| 443 | 3. The use of techniques involving blood management, |
| 444 | advanced life support, and other related functions. |
| 445 | 4. The performance of the following acts described in this |
| 446 | subsection: |
| 447 | a. The administration of: |
| 448 | (I) Pharmacological and therapeutic agents. |
| 449 | (II) Blood products or anesthetic agents through the |
| 450 | extracorporeal circuit or through an intravenous line as ordered |
| 451 | by an osteopathic physician. |
| 452 | b. The performance and use of: |
| 453 | (I) Coagulation monitoring and analysis. |
| 454 | (II) Physiologic monitoring and analysis. |
| 455 | (III) Blood gas and chemistry monitoring and analysis. |
| 456 | (IV) Hematologic monitoring and analysis. |
| 457 | (V) Hypothermia. |
| 458 | (VI) Hyperthermia. |
| 459 | (VII) Hemoconcentration and hemodilution. |
| 460 | (VIII) Hemodialysis. |
| 461 | c. The observation of signs and symptoms related to |
| 462 | perfusion services, the determination of whether the signs and |
| 463 | symptoms exhibit abnormal characteristics, and the |
| 464 | implementation of appropriate reporting, perfusion protocols, or |
| 465 | changes in or the initiation of emergency procedures. |
| 466 | (e) "Cardiopulmonary perfusionists licensing committee" |
| 467 | means the cardiopulmonary perfusion licensing committee |
| 468 | appointed by the board. |
| 469 | (f) "Continuing medical education" means courses |
| 470 | recognized and approved by the boards, the American Academy of |
| 471 | Physician Assistants, the American Medical Association, the |
| 472 | American Osteopathic Association, the American Board of |
| 473 | Cardiopulmonary Perfusion, or the Accreditation Council on |
| 474 | Continuing Medical Education. |
| 475 | (g) "Direct supervision" means the on-site, personal |
| 476 | supervision by an osteopathic physician who is present in the |
| 477 | surgical suite when the procedure is being performed in that |
| 478 | surgical suite and who is in all instances immediately available |
| 479 | to provide assistance and direction to the cardiovascular |
| 480 | perfusionist while cardiac perfusion services are being |
| 481 | performed. |
| 482 | (h) "Extracorporeal circulation" means the diversion of a |
| 483 | patient's blood through a heart-lung machine or a similar device |
| 484 | that assumes the functions of the patient's heart, lungs, |
| 485 | kidney, liver, or other organs. |
| 486 | (i) "Trainee" means a person who is currently enrolled in |
| 487 | an approved program. |
| 488 | (j) "Perfusion protocols" means perfusion-related policies |
| 489 | and protocols developed or approved by a licensed health |
| 490 | facility or an osteopathic physician through collaboration with |
| 491 | administrators, licensed cardiovascular perfusionists, and other |
| 492 | health care professionals. |
| 493 | (k) "Proficiency examination" means an entry-level |
| 494 | examination approved by the boards, including examinations |
| 495 | administered by the American Board of Cardiovascular Perfusion |
| 496 | (ABCP). |
| 497 | (l) "Provisional licensed perfusionist" means a person |
| 498 | granted a provisional license under this section. |
| 499 | (m) "Supervising osteopathic physician" means an |
| 500 | osteopathic physician who holds an active and unrestricted |
| 501 | license and who has successfully completed a training program |
| 502 | approved by the Accreditation Council for Graduate Medical |
| 503 | Education or its equivalent. |
| 504 | (n) "Temporary perfusionist licensee" means a person |
| 505 | granted a temporary license under this section. |
| 506 | (2) PERFORMANCE OF SUPERVISING OSTEOPATHIC PHYSICIAN.--An |
| 507 | osteopathic physician who directly supervises a cardiopulmonary |
| 508 | perfusionist must be qualified in the medical areas in which the |
| 509 | cardiopulmonary perfusionist performs and is liable for the |
| 510 | performance of the cardiopulmonary perfusionist. An osteopathic |
| 511 | physician may only supervise two cardiopulmonary perfusionists |
| 512 | at the same time. |
| 513 | (3) PERFORMANCE OF CARDIOPULMONARY PERFUSIONISTS.-- |
| 514 | (a) A cardiopulmonary perfusionist may perform duties |
| 515 | established by rule by the board in any of the following |
| 516 | functions that are included in the cardiopulmonary |
| 517 | perfusionist's protocol while prescribed by an osteopathic |
| 518 | physician or under the supervision of an osteopathic physician: |
| 519 | 1. Perform extracorporeal circulation/cardiopulmonary |
| 520 | support. |
| 521 | 2. Perform or administer counter pulsation. |
| 522 | 3. Perform circulatory support and ventricular assistance. |
| 523 | 4. Perform extracorporeal membrane oxygenation (ECMO) and |
| 524 | extracorporeal life support (ECLS). |
| 525 | 5. Perform blood conservation techniques, auto |
| 526 | transfusion, and blood component sequestration. |
| 527 | 6. Perform myocardial preservation. |
| 528 | 7. Perform anticoagulation and hemotalogic |
| 529 | monitoring/analysis. |
| 530 | 8. Perform physiological analysis and monitoring. |
| 531 | 9. Perform blood gas and blood chemistry analysis and |
| 532 | monitoring. |
| 533 | 10. Perform induction of hypothermia or hyperthermia with |
| 534 | reversal. |
| 535 | 11. Perform hemodilution. |
| 536 | 12. Perform hemofiltration. |
| 537 | 13. Administer blood, blood products, supportive fluids, |
| 538 | and anesthetic agents via the extracorporeal circuit. |
| 539 | 14. Documentation associated with described duties. |
| 540 | 15. Perform isolated limb and organ perfusion. |
| 541 | 16. Provide surgical assistance. |
| 542 | 17. Perform organ preservation. |
| 543 | 18. Perform dialysis while on cardiopulmonary bypass. |
| 544 | 19. Perform therapeutic aphaeresis. |
| 545 | (b) Nothing in this section or chapter prevents third- |
| 546 | party payors from reimbursing employers of cardiopulmonary |
| 547 | perfusionists for covered services rendered by such |
| 548 | cardiopulmonary perfusionists. |
| 549 | (c) A cardiopulmonary perfusionist shall clearly convey to |
| 550 | the patient that he or she is a cardiopulmonary perfusionist. |
| 551 | (d) A cardiopulmonary perfusionist may perform medical |
| 552 | tasks and services within the framework of a written practice |
| 553 | protocol developed between the supervising osteopathic physician |
| 554 | and the cardiopulmonary perfusionist. |
| 555 | (e) A cardiopulmonary perfusionist may not prescribe, |
| 556 | order, or compound any controlled substance, legend drug, or |
| 557 | medical device, nor may a cardiopulmonary perfusionist dispense |
| 558 | sample drugs to patients. Nothing in this paragraph prohibits a |
| 559 | cardiopulmonary perfusionist from administering legend drugs or |
| 560 | controlled substances, intravenous drugs, fluids, or blood |
| 561 | products to patients which are ordered by the supervising |
| 562 | osteopathic physician and administered while under the |
| 563 | supervision of the supervising osteopathic physician. |
| 564 | (4) PERFORMANCE BY TRAINEES.--The practice of a trainee is |
| 565 | exempt from the requirements of this chapter while the trainee |
| 566 | is performing assigned tasks as a trainee in conjunction with an |
| 567 | approved program. Before providing cardiopulmonary perfusion |
| 568 | services in conjunction with the requirements of an approved |
| 569 | program, the trainee must clearly convey to the patient that he |
| 570 | or she is a trainee. |
| 571 | (5) PROGRAM APPROVAL.--The boards shall approve programs |
| 572 | for the education and training of cardiopulmonary perfusionists, |
| 573 | which meet standards established by board rules. The boards may |
| 574 | recommend only those cardiopulmonary perfusionist training |
| 575 | programs that hold full accreditation or provisional |
| 576 | accreditation from the Commission on Accreditation of Allied |
| 577 | Health Education Programs. |
| 578 | (6) CARDIOPULMONARY PERFUSIONIST LICENSURE.-- |
| 579 | (a) Any person desiring to be licensed as a |
| 580 | cardiopulmonary perfusionist shall apply to the department. The |
| 581 | department shall issue a license to any person certified by the |
| 582 | board to: |
| 583 | 1. Be 18 years of age or older. |
| 584 | 2. Have satisfactorily passed proficiency examination with |
| 585 | a score established by the American Board of Cardiovascular |
| 586 | Perfusion (ABCP). The board, on receipt of an application and |
| 587 | application fee, shall waive the examination requirement for an |
| 588 | applicant who at the time of application: |
| 589 | a. Is appropriately licensed or certified by another |
| 590 | state, territory, or possession of the United States if the |
| 591 | requirements of that state, territory, or possession for the |
| 592 | license or certificate are the substantial equivalent of the |
| 593 | requirements of this section as determined by the board; or |
| 594 | b. Holds a current certificate as a certified clinical |
| 595 | perfusionist issued by the American Board of Cardiovascular |
| 596 | Perfusion (ABCP) or its successor prior to July 1, 2005. |
| 597 | 3. Be certified in basic cardiac life support. |
| 598 | 4. Have completed the application form and remitted an |
| 599 | application fee, not to exceed $1,000, as set by the boards. An |
| 600 | application must include: |
| 601 | a. A certificate of completion of an approved program. |
| 602 | b. A sworn statement of any prior felony convictions. |
| 603 | c. A sworn statement of any prior discipline or denial of |
| 604 | licensure or certification in any state. |
| 605 | d. One letter of recommendation from an osteopathic |
| 606 | physician and one letter of recommendation from a |
| 607 | cardiopulmonary perfusionist. |
| 608 | (b) A license must be renewed biennially. Each renewal |
| 609 | must include: |
| 610 | 1. A renewal fee, not to exceed $1,000, as set by the |
| 611 | boards. |
| 612 | 2. A sworn statement of no felony convictions in the |
| 613 | immediately preceding 2 years. |
| 614 | (c) Each licensed cardiopulmonary perfusionist must |
| 615 | biennially complete 40 hours of continuing medical education or |
| 616 | hold a current certificate issued by the American Board of |
| 617 | Cardiovascular Perfusion or its successor. |
| 618 | 1. A provisional license may be issued by the board to a |
| 619 | person who has successfully completed an approved perfusion |
| 620 | education program and the filing of an application, payment of |
| 621 | an application fee, and the submission of evidence satisfactory |
| 622 | to the board of the successful completion of the education |
| 623 | requirement set forth in this section. A provisional licensee |
| 624 | shall be under the supervision and direction of a licensed |
| 625 | perfusionist at all times during which the provisional licensee |
| 626 | performs perfusion. Rules adopted by the board governing such |
| 627 | supervision and direction may not require the immediate physical |
| 628 | presence of the supervising licensed perfusionist. A provisional |
| 629 | license is valid for 2 years from the date it is issued and may |
| 630 | be extended subject to rule by the board. The application for |
| 631 | extension must be signed by a supervising licensed perfusionist. |
| 632 | Upon notification by the approved testing service or the board |
| 633 | that any portion of the licensing examination has been failed |
| 634 | after the 2-year provisional license term, the provisional |
| 635 | license will be surrendered to the board. |
| 636 | 2. A temporary license may be issued by the department to |
| 637 | a person who has successfully completed the perfusion licensure |
| 638 | application. |
| 639 | (d) The board may impose upon a cardiopulmonary |
| 640 | perfusionist any penalty specified in s. 456.072 or s. |
| 641 | 459.015(2) if the cardiopulmonary perfusionist or the |
| 642 | supervising osteopathic physician is found guilty of or is |
| 643 | investigated for an act that constitutes a violation of this |
| 644 | chapter or chapter 456. |
| 645 | (7) CARDIOVASCULAR SURGEON AND CARDIOPULMONARY |
| 646 | PERFUSIONIST TO ADVISE THE BOARD.-- |
| 647 | (a) The chairperson of the board may appoint a |
| 648 | cardiovascular surgeon and a cardiopulmonary perfusionist to |
| 649 | advise the board as to the adoption of rules for the licensure |
| 650 | of cardiopulmonary perfusionists. The board may use a committee |
| 651 | structure that is most practicable in order to receive any |
| 652 | recommendations to the board regarding rules and all matters |
| 653 | relating to cardiopulmonary perfusionists, including, but not |
| 654 | limited to, recommendations to improve safety in the clinical |
| 655 | practices of licensed cardiopulmonary perfusionists. |
| 656 | (b) In addition to its other duties and responsibilities |
| 657 | as prescribed by law, the board shall: |
| 658 | 1. Recommend to the department the licensure of |
| 659 | cardiopulmonary perfusionists. |
| 660 | 2. Develop all rules regulating the use of cardiopulmonary |
| 661 | perfusionists under this chapter and chapter 458, except for |
| 662 | rules relating to the formulary developed under s. |
| 663 | 458.347(4)(f). The board shall also develop rules to ensure that |
| 664 | the continuity of supervision is maintained in each practice |
| 665 | setting. The boards shall consider adopting a proposed rule at |
| 666 | the regularly scheduled meeting immediately following the |
| 667 | submission of the proposed rule. A proposed rule may not be |
| 668 | adopted by either board unless both boards have accepted and |
| 669 | approved the identical language contained in the proposed rule. |
| 670 | The language of all proposed rules must be approved by both |
| 671 | boards pursuant to each respective board's guidelines and |
| 672 | standards regarding the adoption of proposed rules. |
| 673 | 3. Address concerns and problems of practicing |
| 674 | cardiopulmonary perfusionists to improve safety in the clinical |
| 675 | practices of licensed cardiopulmonary perfusionists. |
| 676 | (c) When the board finds that an applicant for licensure |
| 677 | has failed to meet, to the board's satisfaction, each of the |
| 678 | requirements for licensure set forth in this section, the board |
| 679 | may enter an order to: |
| 680 | 1. Refuse to certify the applicant for licensure; |
| 681 | 2. Approve the applicant for licensure with restrictions |
| 682 | on the scope of practice or license; or |
| 683 | 3. Approve the applicant for conditional licensure. Such |
| 684 | conditions may include placement of the licensee on probation |
| 685 | for a period of time and subject to such conditions as the board |
| 686 | specifies, including, but not limited to, requiring the licensee |
| 687 | to undergo treatment, to attend continuing education courses, or |
| 688 | to take corrective action. |
| 689 | (8) PENALTY.--A person who falsely holds himself or |
| 690 | herself out as a cardiopulmonary perfusionist commits a felony |
| 691 | of the third degree, punishable as provided in s. 775.082, s. |
| 692 | 775.083, or s. 775.084. |
| 693 | (9) DENIAL, SUSPENSION, OR REVOCATION OF LICENSURE.--The |
| 694 | boards may deny, suspend, or revoke the license of a |
| 695 | cardiopulmonary perfusionist who the board determines has |
| 696 | violated any provision of this section or chapter or any rule |
| 697 | adopted pursuant thereto. |
| 698 | (10) RULES.--The boards shall adopt rules to administer |
| 699 | this section. |
| 700 | (11) LIABILITY.--A supervising osteopathic physician is |
| 701 | liable for any act or omission of a cardiopulmonary perfusionist |
| 702 | acting under the physician's supervision and control and shall |
| 703 | comply with the financial responsibility requirements of this |
| 704 | chapter and chapter 456, as applicable. |
| 705 | (12) FEES.--The department shall allocate the fees |
| 706 | collected under this section to the board. |
| 707 | Section 6. This act shall take effect July 1, 2005. |