Florida Senate - 2009 SB 766
By Senator Oelrich
14-00506-09 2009766__
1 A bill to be entitled
2 An act relating to anatomical gifts; amending s.
3 765.511, F.S.; providing additional definitions;
4 amending s. 765.512, F.S.; conforming terms; amending
5 s. 765.513, F.S.; revising the list of donees that may
6 accept anatomical gifts and the purposes for which
7 such gifts may be used; amending ss. 765.514, 765.515,
8 765.5155, and 765.51551, F.S.; conforming terms;
9 amending s. 765.516, F.S.; revising provisions
10 relating to a donor's amendment or revocation of an
11 anatomical gift; amending s. 765.517, F.S.; revising
12 provisions relating to a donee's use of an anatomical
13 gift at the time of the donor's death; providing
14 liability protection to the person making a gift and
15 the donor's estate; amending s. 765.521, F.S.;
16 conforming terms; amending s. 765.522, F.S.; providing
17 that the laws of this state govern the interpretation
18 of a valid document of gift, and that a document of
19 gift is presumed to be valid; amending ss. 765.541,
20 765.542, 765.543, 765.53, 765.544, and 765.545, F.S.;
21 conforming terms; creating s. 765.547, F.S.; requiring
22 medical examiners and procurement organizations to
23 cooperate and maximize opportunities for organ
24 donations; authorizing the Florida Medical Examiners
25 Commission to adopt rules; amending ss. 408.802 and
26 408.820, F.S.; conforming terms; providing an
27 effective date.
28
29 Be It Enacted by the Legislature of the State of Florida:
30
31 Section 1. Section 765.511, Florida Statutes, is amended to
32 read:
33 765.511 Definitions.—As used in this part, the term:
34 (1) “Agency” means the Agency for Health Care
35 Administration.
36 (2) “Anatomical gift” or “gift” means a donation of all or
37 part of a human body to take effect after the donor's death and
38 to be used for transplantation, therapy, research, or education.
39 (3)(1) “Bank” or “storage facility” means a facility
40 licensed, accredited, or approved under the laws of any state
41 for storage of human bodies or body parts thereof.
42 (4)(2) “Death” means the absence of life as determined, in
43 accordance with currently accepted medical standards, by the
44 irreversible cessation of all respiration and circulatory
45 function, or as determined, in accordance with s. 382.009, by
46 the irreversible cessation of the functions of the entire brain,
47 including the brain stem.
48 (5) “Decedent” means a deceased individual whose body or
49 body parts may be, or are, the source of an anatomical gift.
50 (6) “Disinterested witness” means a witness other than a
51 person listed in s. 765.512(3) or other family member.
52 (7) “Document of gift” means any of the documents or
53 mechanisms making an anatomical gift under s. 765.514.
54 (8)(3) “Donor” means an individual who makes an anatomical
55 a gift of all or part of his or her body.
56 (9) “Donor registry” means a database that contains records
57 of anatomical gifts and amendments to, or revocations of such
58 gifts.
59 (10) “Eye bank” means an entity that is accredited by the
60 Eye Bank Association of America or otherwise regulated under
61 federal or state law to engage in the retrieval, screening,
62 testing, processing, storage, or distribution of human eye
63 tissue.
64 (11) “Guardian” means a person appointed pursuant to
65 chapter 744. The term does not include a guardian ad litem.
66 (12)(4) “Hospital” means a hospital licensed, accredited,
67 or approved under the laws of any state and includes a hospital
68 operated by the United States Government or a state, or a
69 subdivision thereof, although not required to be licensed under
70 state laws.
71 (13) “Identification card” means an official identification
72 card issued by a governmental entity, state agency, or
73 subdivision thereof.
74 (14) “Organ procurement organization” means an entity that
75 is designated as an organ procurement organization by the
76 Secretary of the United States Department of Health and Human
77 Services and that engages in the retrieval, screening, testing,
78 processing, storage, or distribution of human organs.
79 (15) “Part of the body” or “body part” means an organ, eye,
80 or tissue of a human being. The term does not include the whole
81 body.
82 (16)(5) “Physician” or “surgeon” means a physician or
83 surgeon licensed to practice under chapter 458 or chapter 459 or
84 similar laws of any state. “Surgeon” includes dental or oral
85 surgeon.
86 (17) “Procurement organization” means an organ procurement
87 organization, eye bank, or tissue bank.
88 (18) “Reasonably available” means able to be contacted by a
89 procurement organization without undue effort and willing and
90 able to act in a timely manner consistent with existing medical
91 protocols necessary for the making of an anatomical gift.
92 (19) “Record” means information that is inscribed on a
93 tangible medium or that is stored in an electronic or other
94 medium and is retrievable in perceivable form.
95 (20) “Sign” or “signed” means, with the present intent to
96 authenticate or adopt a record, to execute or adopt a tangible
97 symbol, or attach to or logically associate an electronic
98 symbol, sound, or process with the record.
99 (21) “Tissue bank” means an entity that is accredited by
100 the American Association of Tissue Banks or otherwise regulated
101 under federal or state law to engage in the retrieval,
102 screening, testing, processing, storage, or distribution of
103 human tissue.
104 Section 2. Subsections (1), (4), (5), (6), and (7) of
105 section 765.512, Florida Statutes, are amended to read:
106 765.512 Persons who may make an anatomical gift.—
107 (1) Any person who may make a will may make an anatomical
108 gift give all or part of his or her body for any purpose
109 specified in s. 765.513. The gift is effective upon the death of
110 the donor.
111 (a) If the decedent makes an anatomical gift by one of the
112 methods listed in s. 765.514(1), and in the absence of actual
113 notice of contrary indications by the decedent, the document or
114 entry in the donor organ and tissue registry is legally
115 sufficient evidence of the decedent's informed consent to donate
116 an anatomical gift.
117 (b) An anatomical gift made by a qualified donor and not
118 revoked by the donor, as provided in s. 765.516, is irrevocable
119 after the donor's death. A family member, guardian,
120 representative ad litem, or health care surrogate may not
121 modify, deny, or prevent a donor's wish or intent to make an
122 anatomical gift after the donor's death.
123 (4) A donee may not accept an anatomical gift if the donee
124 has actual notice of contrary indications by the donor or actual
125 notice that an anatomical a gift by a member of a class is
126 opposed by a member of a prior class.
127 (5) The person authorized by subsection (3) may make the
128 anatomical gift after the decedent's death or immediately before
129 the decedent's death.
130 (6) An anatomical A gift of all or part of a body
131 authorizes:
132 (a) Any examination necessary to assure medical
133 acceptability of the gift for the purposes intended.
134 (b) The decedent's medical provider, family, or a third
135 party to furnish medical records requested concerning the
136 decedent's medical and social history.
137 (7) Once the anatomical gift has been made, the rights of
138 the donee are paramount to the rights of others, except as
139 provided by s. 765.517.
140 Section 3. Section 765.513, Florida Statutes, is amended to
141 read:
142 765.513 Persons and entities that may become Donees;
143 purposes for which anatomical gifts may be made.—
144 (1) The following persons or entities may become donees of
145 anatomical gifts of bodies or parts of them for the purposes
146 stated:
147 (a)(1) Any procurement organization or accredited hospital,
148 surgeon, or physician for medical or dental school, college, or
149 university for education, or research, advancement of medical or
150 dental science, therapy, or transplantation.
151 (2) Any accredited medical or dental school, college, or
152 university for education, research, advancement of medical or
153 dental science, or therapy.
154 (3) Any bank or storage facility for medical or dental
155 education, research, advancement of medical or dental science,
156 therapy, or transplantation.
157 (b)(4) Any individual specified by name for therapy or
158 transplantation needed by him or her.
159 (2) If multiple purposes are set forth in the document of
160 gift but are not set forth in any priority order, the anatomical
161 gift shall be used first for transplantation or therapy, if
162 suitable. If the gift cannot be used for transplantation or
163 therapy, the gift may be used for research or education.
164 (3) However, The Legislature declares that the public
165 policy of this state prohibits restrictions on the possible
166 recipients of an anatomical gift on the basis of race, color,
167 religion, gender sex, national origin, age, physical disability
168 handicap, health status, marital status, or economic status, and
169 such restrictions are hereby declared void and unenforceable.
170 Section 4. Section 765.514, Florida Statutes, is amended to
171 read:
172 765.514 Manner of making anatomical gifts.—
173 (1) A person may make an anatomical a gift of all or part
174 of his or her body under s. 765.512(1) by:
175 (a) Signing an organ and tissue donor card.
176 (b) Registering online with the organ and tissue donor
177 registry.
178 (c) Signifying an intent to donate on his or her driver's
179 license or identification card issued by the Department of
180 Highway Safety and Motor Vehicles. Revocation, suspension,
181 expiration, or cancellation of the driver's license or
182 identification card does not invalidate the gift.
183 (d) Expressing a wish to donate in a living will or other
184 advance directive.
185 (e) Executing a will that includes a provision indicating
186 that the testator wishes to make an anatomical gift. The gift
187 becomes effective upon the death of the testator without waiting
188 for probate. If the will is not probated or if it is declared
189 invalid for testamentary purposes, the gift is nevertheless
190 valid to the extent that it has been acted upon in good faith.
191 (f) Expressing a wish to donate in a document of gift other
192 than a will. The document must be signed by the donor in the
193 presence of two witnesses who shall sign the document in the
194 donor's presence. If the donor cannot sign, the document may be
195 signed for him or her at the donor's direction and in his or her
196 presence and the presence of two witnesses who must sign the
197 document in the donor's presence. Delivery of the document of
198 gift during the donor's lifetime is not necessary to make the
199 gift valid. The following form of written document is sufficient
200 for any person to make an anatomical gift give all or part of
201 his or her body for the purposes of this part:
202 UNIFORM DONOR CARD
203 The undersigned hereby makes this anatomical gift, if medically
204 acceptable, to take effect on death. The words and marks below
205 indicate my desires:
206 I give:
207 (a) .... any needed organs, tissues, or eyes;
208 (b) .... only the following organs, tissues, or eyes
209 ...[Specify the organs, tissues, or eyes]...
210 for the purpose of transplantation, therapy, medical research,
211 or education;
212 (c) .... my body for anatomical study if needed.
213 Limitations or special wishes, if any:
214 ...(If applicable, list specific donee;this must be arranged in
215 advance with the donee.)...
216 Signed by the donor and the following witnesses in the presence
217 of each other:
218 ...(Signature of donor)... ...(Date of birth of donor)...
219 ...(Date signed)... ...(City and State)...
220 ...(Witness)... ...(Witness)...
221 ...(Address)... ...(Address)...
222 (2) The anatomical gift may be made to a donee listed in s.
223 765.513, and the donee may be specified by name.
224 (3) An anatomical Any gift by a health care surrogate
225 designated by the decedent pursuant to part II of this chapter
226 or a member of a class designated in s. 765.512(3) must be made
227 by a document signed by that person or made by that person's
228 witnessed telephonic discussion, telegraphic message, or other
229 recorded message.
230 Section 5. Section 765.515, Florida Statutes, is amended to
231 read:
232 765.515 Delivery of donor document.—
233 (1) If an anatomical a gift is made pursuant to s. 765.521,
234 the completed donor registration card shall be delivered to the
235 Department of Highway Safety and Motor Vehicles and the
236 department must communicate the donor's intent to the organ and
237 tissue donor registry, but delivery is not necessary to the
238 validity of the gift. If the donor withdraws the gift, the
239 records of the Department of Highway Safety and Motor Vehicles
240 must be updated to reflect such withdrawal and the department
241 must communicate the withdrawal to the organ and tissue donor
242 registry for the purpose of updating the registry.
243 (2) If an anatomical a gift is made by the donor to a
244 specified donee, the document of gift, other than a will, may be
245 delivered to the donee to expedite the appropriate procedures
246 immediately after death, but delivery is not necessary to the
247 validity of the gift. The Such document of gift may be deposited
248 in any hospital, bank, storage facility, or registry office that
249 accepts such documents for safekeeping or to facilitate the
250 donation of organs and tissue after death.
251 (3) At the request of any interested party upon or after
252 the donor's death, the person in possession shall produce the
253 document of gift for examination.
254 Section 6. Subsection (2), paragraph (c) of subsection (3),
255 and subsection (4) of section 765.5155, Florida Statutes, are
256 amended to read:
257 765.5155 Organ and tissue donor registry; education
258 program.—
259 (2) The agency for Health Care Administration and the
260 Department of Highway Safety and Motor Vehicles shall jointly
261 contract for the operation of an organ and tissue donor registry
262 and education program. The contractor shall be procured by
263 competitive solicitation pursuant to chapter 287,
264 notwithstanding any exemption in s. 287.057(5)(f). When awarding
265 the contract, priority shall be given to existing nonprofit
266 groups that are based within the state, have expertise working
267 with organ and tissue procurement organizations, have expertise
268 in conducting statewide organ and tissue donor public education
269 campaigns, and represent the needs of the organ and tissue
270 donation community in the state.
271 (3) The contractor shall be responsible for:
272 (c) Preparing and submitting an annual written report to
273 the agency for Health Care Administration by December 31 of each
274 year. The report must include:
275 1. The number of donors on the registry and an analysis of
276 the registration rates by location and method of donation;
277 2. The characteristics of donors as determined from
278 registry information submitted directly by the donors or by the
279 Department of Highway Safety and Motor Vehicles;
280 3. The annual dollar amount of voluntary contributions
281 received by the contractor;
282 4. A description of the educational campaigns and
283 initiatives implemented during the year and an evaluation of
284 their effectiveness in increasing enrollment on the registry;
285 and
286 5. An analysis of Florida's registry compared with other
287 states' donor registries.
288 (4) Costs for the organ and tissue donor registry and
289 education program shall be paid by the agency for Health Care
290 Administration from the funds deposited into the Health Care
291 Trust Fund pursuant to ss. 320.08047 and 322.08, which are
292 designated for maintaining the organ and tissue donor registry
293 and education program. In addition, the contractor may receive
294 and use voluntary contributions to help support the registry and
295 provide education.
296 Section 7. Paragraph (a) of subsection (2) of section
297 765.51551, Florida Statutes, is amended to read:
298 765.51551 Organ and tissue donor registry; public records
299 exemption.—
300 (2) Such information may be disclosed to the following:
301 (a) Organ, tissue, and eye procurement organizations that
302 have been certified by the agency for Health Care Administration
303 for the purpose of ascertaining or effectuating the existence of
304 a gift under s. 765.522.
305 Section 8. Section 765.516, Florida Statutes, is amended to
306 read:
307 765.516 Donor amendment of the terms of or the revocation
308 of anatomical the gift.—
309 (1) A donor may amend the terms of or revoke an anatomical
310 gift by:
311 (a) The execution and delivery to the donee of a signed
312 statement witnessed by at least two adults, at least one of whom
313 is a disinterested witness.
314 (b) An oral statement that is made in the presence of two
315 persons, one of whom is must not be a family member, and
316 communicated to the donor's family or attorney or to the donee.
317 An oral statement is effective only if the procurement
318 organization, transplant hospital, or physician or technician
319 knows of the amendment or revocation before an incision is made
320 to the decedent's body or an invasive procedure to prepare the
321 recipient has begun.
322 (c) A statement made during a terminal illness or injury
323 addressed to an attending physician, who must communicate the
324 revocation of the gift to the procurement organization that is
325 certified by the state.
326 (d) A signed document found on or about the donor's person.
327 (e) Removing his or her name from the organ and tissue
328 donor registry.
329 (f) A later-executed document of gift which amends or
330 revokes a previous anatomical gift or portion of an anatomical
331 gift, either expressly or by inconsistency.
332 (g) By the destruction or cancellation of the document of
333 gift or the destruction or cancellation of that portion of the
334 document of gift used to make the gift with the intent to revoke
335 the gift.
336 (2) Any anatomical gift made by a will may also be amended
337 or revoked in the manner provided for the amendment or
338 revocation of wills or as provided in subsection (1).
339 Section 9. Section 765.517, Florida Statutes, is amended to
340 read:
341 765.517 Rights and duties at death.—
342 (1) The donee, pursuant to as specified under the
343 provisions of s. 765.515(2), may accept or reject an anatomical
344 the gift. If the donee accepts a gift of the entire body or a
345 part of the body to be used for research or education scientific
346 purposes other than a transplant, the donee may authorize
347 embalming and the use of the body in funeral services, subject
348 to the terms of the gift. If the gift is of a part of the body,
349 the donee shall cause the part to be removed without unnecessary
350 mutilation upon the death of the donor and before or after
351 embalming. After removal of the body part, custody of the
352 remainder of the body vests in the surviving spouse, next of
353 kin, or other persons under obligation to dispose of the body.
354 (2) The time of death shall be determined by a physician
355 who attends the donor at the donor's death or, if there is no
356 such physician, the physician who certifies the death. After
357 death, those physicians or the patient's primary care physician
358 and in the absence of other qualified personnel, this physician
359 may participate in, but may shall not obstruct, the procedures
360 to preserve the donor's organs or tissues and may shall not be
361 paid, or reimbursed by, nor be associated with or employed by a,
362 an organ procurement organization, tissue bank, or eye bank.
363 This physician may shall not participate in the procedures for
364 removing or transplanting a part.
365 (3) The organ procurement organization, tissue bank, or eye
366 bank, or hospital medical professionals under the direction
367 thereof, may perform any and all tests to evaluate the deceased
368 as a potential donor and any invasive procedures on the deceased
369 body in order to preserve the potential donor's organs. These
370 procedures do not include the surgical removal of an organ or
371 penetrating any body cavity, specifically for the purpose of
372 donation, until:
373 (a) It has been verified that the deceased's consent to
374 donate appears in the organ and tissue donor registry or a
375 properly executed donor card or document of gift is located; or
376 (b) If a properly executed donor card or document of gift
377 cannot be located or the deceased's consent is not listed in the
378 organ and tissue donor registry, a person specified in s.
379 765.512(2) or (3) has been located, has been notified of the
380 death, and has granted legal permission for the donation.
381 (4) All reasonable additional expenses incurred in the
382 procedures to preserve the donor's organs or tissues shall be
383 reimbursed by the organ procurement organization, tissue bank,
384 or eye bank.
385 (5) A person who acts in good faith and without negligence
386 in accord with the terms of this part or under the anatomical
387 gift laws of another state or a foreign country, or attempts in
388 good faith to do so, is not liable for damages in any civil
389 action, or subject to prosecution for his or her acts in any
390 criminal proceeding, or liable in any administrative proceeding.
391 (6) The provisions of this part are subject to the laws of
392 this state prescribing powers and duties with respect to
393 autopsies.
394 (7) The person making an anatomical gift and the donor's
395 estate are not liable for any injury or damages that result from
396 the making or use of the gift.
397 (8) In determining whether an anatomical gift has been
398 made, amended, or revoked under this part, a person may rely
399 upon representation of an individual listed in s. 765.512,
400 relating to the individual's relationship to the donor or
401 prospective donor, unless the person knows that the
402 representation is untrue.
403 Section 10. Section 765.521, Florida Statutes, is amended
404 to read:
405 765.521 Donations as part of driver license or
406 identification card process.—
407 (1) The agency for Health Care Administration and the
408 Department of Highway Safety and Motor Vehicles shall develop
409 and implement a program encouraging and allowing persons to make
410 anatomical gifts as a part of the process of issuing
411 identification cards and issuing and renewing driver licenses.
412 The donor registration card distributed by the Department of
413 Highway Safety and Motor Vehicles shall include the information
414 required by the uniform donor card under s. 765.514 and such
415 additional information as determined necessary by the
416 department. The department shall also develop and implement a
417 program to identify donors, which includes notations on
418 identification cards, driver licenses, and driver records or
419 such other methods as the department develops to clearly
420 indicate the individual's intent to make an anatomical gift
421 donate the individual's organs, tissues, or eyes. A notation on
422 an individual's driver license or identification card that the
423 individual intends to make a gift donate organs, tissues, or
424 eyes satisfies all requirements for consent to organ or tissue
425 donation. The agency for Health Care Administration shall
426 provide the necessary supplies and forms from funds appropriated
427 from general revenue or contributions from interested voluntary,
428 nonprofit organizations. The department shall provide the
429 necessary recordkeeping system from funds appropriated from
430 general revenue. The Department of Highway Safety and Motor
431 Vehicles and the agency for Health Care Administration shall
432 incur no liability in connection with the performance of any
433 acts authorized herein.
434 (2) The Department of Highway Safety and Motor Vehicles,
435 after consultation with and concurrence by the agency for Health
436 Care Administration, shall adopt rules to implement the
437 provisions of this section according to the provisions of
438 chapter 120.
439 (3) Funds expended by the agency for Health Care
440 Administration to carry out the intent of this section may shall
441 not be taken from any funds appropriated for patient care.
442 Section 11. Section 765.522, Florida Statutes, is amended
443 to read:
444 765.522 Duty of certain hospital administrators; liability
445 of hospital administrators and, organ procurement organizations,
446 eye banks, and tissue banks.—
447 (1) When used in this section, “hospital” means any
448 establishment licensed under chapter 395 except psychiatric and
449 rehabilitation hospitals.
450 (1)(2) If Where, based on accepted medical standards, a
451 hospital patient is a suitable candidate for organ or tissue
452 donation, the hospital administrator or the hospital
453 administrator's designee shall, at or near the time of death,
454 notify the appropriate procurement organization organ, eye, or
455 tissue recovery program, which shall access the organ and tissue
456 donor registry created by s. 765.5155 or any other donor
457 registry to ascertain the existence of an entry in the registry
458 which that has not been revoked, a donor card, or a document of
459 gift executed by the decedent. In the absence of an entry in the
460 donor registry or a document of gift, donor card, organ donation
461 sticker or organ donation imprint on a driver's license, or
462 other properly executed document, the organ, eye, or tissue
463 recovery program shall request:
464 (a) The patient's health care surrogate, as authorized in
465 s. 765.512(2); or
466 (b) If the patient does not have a surrogate, or the
467 surrogate is not reasonably available, any of the persons
468 specified in s. 765.512(3), in the order and manner listed,
469 to consent to the gift of all or any part of the decedent's body
470 for any purpose specified in this part. Except as provided in s.
471 765.512, in the absence of actual notice of opposition, consent
472 need only be obtained from the person or persons in the highest
473 priority class reasonably available.
474 (3) A document of gift is valid if made pursuant to a
475 request required by this section shall be executed in accordance
476 with this part or the laws of the state or country where it was
477 executed and where the person making the anatomical gift was
478 domiciled, has a place of residence, or was a citizen at the
479 time the document of gift was executed pursuant to s. 765.514.
480 (4) The agency for Health Care Administration shall
481 establish rules and guidelines concerning the education of
482 individuals who may be designated to perform the request and the
483 procedures to be used in making the request. The agency is
484 authorized to adopt rules concerning the documentation of the
485 request, where such request is made.
486 (5) If a document of gift is valid under this section, the
487 laws of this state govern the interpretation of the document of
488 gift.
489 (6) A document of gift or amendment of an anatomical gift
490 is presumed to be valid unless it was not validly executed or
491 was revoked.
492 (7)(5) There shall be no civil or criminal liability
493 against any organ procurement organization, eye bank, or tissue
494 bank certified under s. 765.542, or against any hospital or
495 hospital administrator or designee who complies, when complying
496 with the provisions of this part and agency the rules of the
497 agency for Health Care Administration or if when, in the
498 exercise of reasonable care, a request for organ donation is
499 inappropriate and the gift is not made according to this part
500 and agency the rules of the agency for Health Care
501 Administration.
502 (8)(6) The hospital administrator or a designee shall, at
503 or near the time of death of a potential organ donor, directly
504 notify the affiliated organ procurement organization designated
505 by the United States Department of Health and Human Services of
506 the potential organ donor. The This organ procurement
507 organization must offer any organ from such a donor first to
508 patients on a Florida-based local or state organ sharing
509 transplant list. For the purpose of this subsection, the term
510 “transplant list” includes certain categories of national or
511 regional organ sharing for patients of exceptional need or
512 exceptional match, as approved or mandated by the Organ
513 Procurement and Transplantation Network, or its agent. This
514 notification may not be made to a tissue bank or eye bank in
515 lieu of the organ procurement organization unless the tissue
516 bank or eye bank is also designated as an organ procurement
517 organization by the United States Department of Health and Human
518 Services.
519 Section 12. Section 765.541, Florida Statutes, is amended
520 to read:
521 765.541 Certification of procurement organizations engaged
522 in the practice of cadaveric organ and tissue procurement.—The
523 agency for Health Care Administration shall:
524 (1) Establish a program for the certification of
525 organizations, corporations agencies, or other entities engaged
526 in the procurement of organs, tissues, and eyes for
527 transplantation.;
528 (2) Adopt rules that set forth appropriate standards and
529 guidelines for the program in accordance with ss. 765.541
530 765.546 and part II of chapter 408. These standards and
531 guidelines must be substantially based on the existing laws of
532 the Federal Government and this state and the existing standards
533 and guidelines of the United Network for Organ Sharing (UNOS),
534 the American Association of Tissue Banks (AATB), the South
535 Eastern Organ Procurement Foundation (SEOPF), the North American
536 Transplant Coordinators Organization (NATCO), and the Eye Bank
537 Association of America (EBAA). In addition, the agency for
538 Health Care Administration shall, before adopting these
539 standards and guidelines, seek input from all organ procurement
540 organizations, tissue banks, and eye banks based in this state.;
541 (3) Collect, keep, and make available to the Governor and
542 the Legislature information regarding the numbers and
543 disposition of organs, and tissues, and eyes procured by each
544 certified procurement organization. entity;
545 (4) Monitor certified procurement organizations
546 participating facilities and agencies for program compliance.;
547 and
548 (5) Provide for the administration of the Organ and Tissue
549 Procurement and Transplantation Advisory Board.
550 Section 13. Section 765.542, Florida Statutes, is amended
551 to read:
552 765.542 Certification of organ procurement organizations,
553 tissue banks, and eye banks.—
554 (1) The requirements of part II of chapter 408 apply to the
555 provision of services that require licensure pursuant to ss.
556 765.541-765.546 and part II of chapter 408 and to entities
557 licensed or certified by or applying for such licensure or
558 certification from the agency for Health Care Administration
559 pursuant to ss. 765.541-765.546. An organization, agency, or
560 other entity may not engage in the practice of organ procurement
561 in this state without being designated as an organ procurement
562 organization by the secretary of the United States Department of
563 Health and Human Services and being appropriately certified by
564 the agency for Health Care Administration. As used in this
565 subsection, the term “procurement” includes the retrieval,
566 processing, or distribution of human organs. A physician or
567 organ procurement organization based outside this state is
568 exempt from these certification requirements if:
569 (a) The organs are procured for an out-of-state patient who
570 is listed on, or referred through, the United Network for Organ
571 Sharing System; and
572 (b) The organs are procured through an agreement of an
573 organ procurement organization certified by the state.
574 (2) An organization, corporation agency, or other entity
575 may not engage in tissue procurement in this state unless it is
576 appropriately certified as a tissue bank by the agency for
577 Health Care Administration. As used in this subsection, the term
578 “procurement” includes any retrieval, processing, storage, or
579 distribution of human tissue for transplantation.
580 (3) An organization, corporation agency, or other entity
581 may not engage in the practice of eye procurement in this state
582 without being appropriately certified as an eye bank by the
583 agency for Health Care Administration. As used in this
584 subsection, the term “procurement” includes the retrieval,
585 processing, or distribution of human eye tissue. Funeral
586 directors or direct disposers who that retrieve eye tissue for
587 an eye bank certified under this subsection are exempt from the
588 certification requirements under this subsection.
589 (4) A limited certificate may be issued to a tissue bank or
590 eye bank, certifying only those components of procurement which
591 the bank has chosen to perform. The agency for Health Care
592 Administration may issue a limited certificate if it determines
593 that the tissue bank or eye bank is adequately staffed and
594 equipped to operate in conformity with the rules adopted under
595 this section.
596 Section 14. Subsection (3) of section 765.543, Florida
597 Statutes, is amended to read:
598 765.543 Organ and Tissue Procurement and Transplantation
599 Advisory Board; creation; duties.—
600 (3) The board shall:
601 (a) Assist the agency for Health Care Administration in the
602 development of necessary professional qualifications, including,
603 but not limited to, the education, training, and performance of
604 persons engaged in the various facets of organ and tissue
605 procurement, processing, preservation, and distribution for
606 transplantation;
607 (b) Assist the agency for Health Care Administration in
608 monitoring the appropriate and legitimate expenses associated
609 with organ and tissue procurement, processing, and distribution
610 for transplantation and developing methodologies to assure the
611 uniform statewide reporting of data to facilitate the accurate
612 and timely evaluation of the organ and tissue procurement and
613 transplantation system;
614 (c) Provide assistance to the Florida Medical Examiners
615 Commission in the development of appropriate procedures and
616 protocols to ensure the assure continued improvement in the
617 approval and release of potential organ and tissue donors by the
618 district medical examiners and associate medical examiners;
619 (d) Develop with and recommend to the agency for Health
620 Care Administration the necessary procedures and protocols
621 required to assure that all residents of this state have
622 reasonable access to available organ and tissue transplantation
623 therapy and that residents of this state can be reasonably
624 assured that the statewide procurement transplantation system is
625 will be able to fulfill their organ and tissue requirements
626 within the limits of the available supply and according to the
627 severity of their medical condition and need; and
628 (e) Develop with and recommend to the agency for Health
629 Care Administration any changes to the laws of this state or
630 administrative rules or procedures required to ensure assure
631 that the statewide organ and tissue procurement and
632 transplantation system is will be able to function smoothly,
633 effectively, and efficiently, in accordance with the Federal
634 Anatomical Gift Act and in a manner that assures the residents
635 of this state that no person or entity profits from the
636 altruistic voluntary donation of organs or tissues.
637 Section 15. Subsections (1), (5), and (6) of section
638 765.53, Florida Statutes, are amended to read:
639 765.53 Organ Transplant Advisory Council; membership;
640 responsibilities.—
641 (1) There is hereby created within the agency for Health
642 Care Administration A statewide technical Organ Transplant
643 Advisory Council is created within the agency, consisting of
644 twelve members, who are physicians, to represent the interests
645 of the public and the clients of the Department of Health or the
646 agency. The members shall be physicians licensed according to
647 chapter 458 or chapter 459. A person employed by the agency may
648 not be appointed as a member of the council.
649 (5) Members of the council shall receive no compensation,
650 but shall be reimbursed for per diem and travel expenses by the
651 agency for Health Care Administration in accordance with the
652 provisions of s. 112.061 while engaged in the performance of
653 their duties.
654 (6) The responsibilities of the council shall be to
655 recommend to the agency for Health Care Administration
656 indications for adult and pediatric organ transplants. The
657 council shall also formulate guidelines and standards for organ
658 transplants and for the development of End Stage Organ Disease
659 and Tissue/Organ Transplant programs. The recommendations,
660 guidelines, and standards developed by the council are
661 applicable only to those health programs funded through the
662 agency for Health Care Administration.
663 Section 16. Paragraph (b) of subsection (1) and subsection
664 (2) of section 765.544, Florida Statutes, is amended to read:
665 765.544 Fees; organ and tissue donor education and
666 procurement.—
667 (1) In accordance with s. 408.805, an applicant or a
668 certificateholder shall pay a fee for each application submitted
669 under this part, part II of chapter 408, and applicable rules.
670 The amount of the fee shall be as follows:
671 (b) Annual fees to be used, in the following order of
672 priority, for the certification program, the advisory board,
673 maintenance of the organ and tissue donor registry, and the
674 organ and tissue donor education program in the following
675 amounts, which may not exceed $35,000 per organization:
676 1. Each general organ procurement organization shall pay
677 the greater of $1,000 or 0.25 percent of its total revenues
678 produced from procurement activity in this state by the
679 certificateholder during its most recently completed fiscal year
680 or operational year.
681 2. Each bone and tissue procurement organization agency or
682 bone and tissue bank shall pay the greater of $1,000 or 0.25
683 percent of its total revenues from procurement and processing
684 activity in this state by the certificateholder during its most
685 recently completed fiscal year or operational year.
686 3. Each eye bank shall pay the greater of $500 or 0.25
687 percent of its total revenues produced from procurement activity
688 in this state by the certificateholder during its most recently
689 completed fiscal year or operational year.
690 (2) The agency for Health Care Administration shall specify
691 by rule the administrative penalties for the purpose of ensuring
692 adherence to the standards of quality and practice required by
693 this chapter, part II of chapter 408, and applicable rules of
694 the agency for continued certification.
695 Section 17. Section 765.545, Florida Statutes, is amended
696 to read:
697 765.545 Physician supervision of cadaveric organ and tissue
698 procurement coordinators.—Organ Procurement organizations,
699 tissue banks, and eye banks may employ coordinators, who are
700 registered nurses, physician's assistants, or other medically
701 trained personnel who meet the relevant standards for organ
702 procurement organizations, tissue banks, or eye banks as adopted
703 by the agency for Health Care Administration under s. 765.541,
704 to assist in the medical management of organ donors or in the
705 surgical procurement of cadaveric organs, tissues, or eyes for
706 transplantation or research. A coordinator who assists in the
707 medical management of organ donors or in the surgical
708 procurement of cadaveric organs, tissues, or eyes for
709 transplantation or research must do so under the direction and
710 supervision of a licensed physician medical director pursuant to
711 rules and guidelines to be adopted by the agency for Health Care
712 Administration. With the exception of organ procurement surgery,
713 this supervision may be indirect supervision. For purposes of
714 this section, the term “indirect supervision” means that the
715 medical director is responsible for the medical actions of the
716 coordinator, that the coordinator is operating under protocols
717 expressly approved by the medical director, and that the medical
718 director or his or her physician designee is always available,
719 in person or by telephone, to provide medical direction,
720 consultation, and advice in cases of organ, tissue, and eye
721 donation and procurement. Although indirect supervision is
722 authorized under this section, direct physician supervision is
723 to be encouraged when appropriate.
724 Section 18. Section 765.547, Florida Statutes, is created
725 to read:
726 765.547 Cooperation between medical examiner and
727 procurement organization.—
728 (1) A medical examiner and procurement organization shall
729 cooperate with each other in order to maximize opportunities to
730 recover anatomical gifts for the purpose of transplantation,
731 therapy, research, or education.
732 (2) The Florida Medical Examiners Commission shall adopt
733 rules to govern the working relationships of medical examiners
734 and procurement organizations in order to facilitate organ
735 donation.
736 (3) This part does not supersede any part of chapter 406
737 relating to medical examiners and the disposition of dead
738 bodies.
739 Section 19. Subsection (30) of section 408.802, Florida
740 Statutes, is amended to read:
741 408.802 Applicability.—The provisions of this part apply to
742 the provision of services that require licensure as defined in
743 this part and to the following entities licensed, registered, or
744 certified by the agency, as described in chapters 112, 383, 390,
745 394, 395, 400, 429, 440, 483, and 765:
746 (30) Organ, and tissue, and eye procurement organizations
747 agencies, as provided under part V of chapter 765.
748 Section 20. Subsection (29) of section 408.820, Florida
749 Statutes, is amended to read:
750 408.820 Exemptions.—Except as prescribed in authorizing
751 statutes, the following exemptions shall apply to specified
752 requirements of this part:
753 (29) Organ, and tissue, and eye procurement organizations
754 agencies, as provided under part V of chapter 765, are exempt
755 from s. 408.810(5)-(10).
756 Section 21. This act shall take effect July 1, 2009.