Florida Senate - 2009 CS for SB 766
By the Committee on Health Regulation and Senator Oelrich
588-02137-09 2009766c1
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 for the person making a gift and
15 for 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. 765.53,
20 765.541, 765.542, 765.543, 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 used in 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” means any retrieval, recovery,
87 processing, storage, or distribution of human organs or tissues
88 for transplantation, therapy, research, or education.
89 (18) “Procurement organization” means an organ procurement
90 organization, eye bank, or tissue bank.
91 (19) “Reasonably available” means able to be contacted by a
92 procurement organization in a timely manner without undue
93 effort, and willing and able to act in a manner consistent with
94 existing medical protocols necessary for the making of an
95 anatomical gift.
96 (20) “Record” means information that is inscribed on a
97 tangible medium or that is stored in an electronic or other
98 medium and is retrievable in perceivable form.
99 (21) “Sign” or “signed” means, with the present intent to
100 authenticate or adopt a record, to execute or adopt a tangible
101 symbol, or attach to or logically associate an electronic
102 symbol, sound, or process with the record.
103 (22) “Tissue bank” means an entity that is accredited by
104 the American Association of Tissue Banks or otherwise regulated
105 under federal or state law to engage in the retrieval,
106 screening, testing, processing, storage, or distribution of
107 human tissue.
108 Section 2. Subsections (1), (4), (5), (6), and (7) of
109 section 765.512, Florida Statutes, are amended to read:
110 765.512 Persons who may make an anatomical gift.—
111 (1) Any person who may make a will may make an anatomical
112 gift give all or part of his or her body for any purpose
113 specified in s. 765.513. The gift is effective upon the death of
114 the donor.
115 (a) If the decedent makes an anatomical gift by one of the
116 methods listed in s. 765.514(1), and in the absence of actual
117 notice of contrary indications by the decedent, the document or
118 entry in the donor organ and tissue registry is legally
119 sufficient evidence of the decedent's informed consent to donate
120 an anatomical gift.
121 (b) An anatomical gift made by a qualified donor and not
122 revoked by the donor, as provided in s. 765.516, is irrevocable
123 after the donor's death. A family member, guardian,
124 representative ad litem, or health care surrogate may not
125 modify, deny, or prevent a donor's wish or intent to make an
126 anatomical gift after the donor's death.
127 (4) A donee may not accept an anatomical gift if the donee
128 has actual notice of contrary indications by the donor or actual
129 notice that an anatomical a gift by a member of a class is
130 opposed by a member of a prior class.
131 (5) The person authorized by subsection (3) may make the
132 anatomical gift after the decedent's death or immediately before
133 the decedent's death.
134 (6) An anatomical A gift of all or part of a body
135 authorizes:
136 (a) Any examination necessary to assure medical
137 acceptability of the gift for the purposes intended.
138 (b) The decedent's medical provider, family, or a third
139 party to furnish medical records requested concerning the
140 decedent's medical and social history.
141 (7) Once the anatomical gift has been made, the rights of
142 the donee are paramount to the rights of others, except as
143 provided by s. 765.517.
144 Section 3. Section 765.513, Florida Statutes, is amended to
145 read:
146 765.513 Persons and entities that may become Donees;
147 purposes for which anatomical gifts may be made.—
148 (1) The following persons or entities may become donees of
149 anatomical gifts of bodies or parts of them for the purposes
150 stated:
151 (a)(1) Any procurement organization or accredited hospital,
152 surgeon, or physician for medical or dental school, college, or
153 university for education, or research, advancement of medical or
154 dental science, therapy, or transplantation.
155 (2) Any accredited medical or dental school, college, or
156 university for education, research, advancement of medical or
157 dental science, or therapy.
158 (3) Any bank or storage facility for medical or dental
159 education, research, advancement of medical or dental science,
160 therapy, or transplantation.
161 (b)(4) Any individual specified by name for therapy or
162 transplantation needed by him or her.
163 (2) If multiple purposes are set forth in the document of
164 gift but are not set forth in any priority order, the anatomical
165 gift shall be used first for transplantation or therapy, if
166 suitable. If the gift cannot be used for transplantation or
167 therapy, the gift may be used for research or education.
168 (3) However, The Legislature declares that the public
169 policy of this state prohibits restrictions on the possible
170 recipients of an anatomical gift on the basis of race, color,
171 religion, gender sex, national origin, age, physical disability
172 handicap, health status, marital status, or economic status, and
173 such restrictions are hereby declared void and unenforceable.
174 Section 4. Section 765.514, Florida Statutes, is amended to
175 read:
176 765.514 Manner of making anatomical gifts.—
177 (1) A person may make an anatomical a gift of all or part
178 of his or her body under s. 765.512(1) by:
179 (a) Signing an organ and tissue donor card.
180 (b) Registering online with the organ and tissue donor
181 registry.
182 (c) Signifying an intent to donate on his or her driver's
183 license or identification card issued by the Department of
184 Highway Safety and Motor Vehicles. Revocation, suspension,
185 expiration, or cancellation of the driver's license or
186 identification card does not invalidate the gift.
187 (d) Expressing a wish to donate in a living will or other
188 advance directive.
189 (e) Executing a will that includes a provision indicating
190 that the testator wishes to make an anatomical gift. The gift
191 becomes effective upon the death of the testator without waiting
192 for probate. If the will is not probated or if it is declared
193 invalid for testamentary purposes, the gift is nevertheless
194 valid to the extent that it has been acted upon in good faith.
195 (f) Expressing a wish to donate in a document other than a
196 will. The document must be signed by the donor in the presence
197 of two witnesses who shall sign the document in the donor's
198 presence. If the donor cannot sign, the document may be signed
199 for him or her at the donor's direction and in his or her
200 presence and the presence of two witnesses who must sign the
201 document in the donor's presence. Delivery of the document of
202 gift during the donor's lifetime is not necessary to make the
203 gift valid. The following form of written document is sufficient
204 for any person to make an anatomical gift give all or part of
205 his or her body for the purposes of this part:
206 UNIFORM DONOR CARD
207 The undersigned hereby makes this anatomical gift, if medically
208 acceptable, to take effect on death. The words and marks below
209 indicate my desires:
210 I give:
211 (a) .... any needed organs, tissues, or eyes;
212 (b) .... only the following organs, tissues, or eyes
213 ...[Specify the organs, tissues, or eyes]...
214 for the purpose of transplantation, therapy, medical research,
215 or education;
216 (c) .... my body for anatomical study if needed.
217 Limitations or special wishes, if any:
218 ...(If applicable, list specific donee;this must be arranged in
219 advance with the donee.)...
220 Signed by the donor and the following witnesses in the presence
221 of each other:
222 ...(Signature of donor)... ...(Date of birth of donor)...
223 ...(Date signed)... ...(City and State)...
224 ...(Witness)... ...(Witness)...
225 ...(Address)... ...(Address)...
226 (2) The anatomical gift may be made to a donee listed in s.
227 765.513, and the donee may be specified by name.
228 (3) Any anatomical gift by a health care surrogate
229 designated by the decedent pursuant to part II of this chapter
230 or a member of a class designated in s. 765.512(3) must be made
231 by a document signed by that person or made by that person's
232 witnessed telephonic discussion, telegraphic message, or other
233 recorded message.
234 Section 5. Section 765.515, Florida Statutes, is amended to
235 read:
236 765.515 Delivery of donor document.—
237 (1) If an anatomical a gift is made pursuant to s. 765.521,
238 the completed donor registration card shall be delivered to the
239 Department of Highway Safety and Motor Vehicles and the
240 department must communicate the donor's intent to the organ and
241 tissue donor registry, but delivery is not necessary to the
242 validity of the gift. If the donor withdraws the gift, the
243 records of the Department of Highway Safety and Motor Vehicles
244 must be updated to reflect such withdrawal and the department
245 must communicate the withdrawal to the organ and tissue donor
246 registry for the purpose of updating the registry.
247 (2) If an anatomical a gift is made by the donor to a
248 specified donee, the document of gift, other than a will, may be
249 delivered to the donee to expedite the appropriate procedures
250 immediately after death, but delivery is not necessary to the
251 validity of the gift. The Such document of gift may be deposited
252 in any hospital, bank, storage facility, or registry office that
253 accepts such documents for safekeeping or to facilitate the
254 donation of organs and tissue after death.
255 (3) At the request of any interested party upon or after
256 the donor's death, the person in possession shall produce the
257 document of gift for examination.
258 Section 6. Section 765.5155, Florida Statutes, is amended
259 to read:
260 765.5155 Organ and tissue Donor registry; education
261 program.—
262 (1) The Legislature finds that:
263 (a) There is a shortage of organ and tissue donors in this
264 state willing to provide the organs and tissue that could save
265 lives or enhance the quality of life for many persons.
266 (b) There is a need to encourage the various minority
267 populations of this state to donate organs and tissue.
268 (c) A statewide organ and tissue donor registry having an
269 online donor registration process coupled with an enhanced
270 program of donor education will lead to an increase in the
271 number of organ and tissue donors registered in this state, thus
272 affording more persons who are awaiting organ or tissue
273 transplants the opportunity for a full and productive life.
274 (2) The agency for Health Care Administration and the
275 Department of Highway Safety and Motor Vehicles shall jointly
276 contract for the operation of a an organ and tissue donor
277 registry and education program. The contractor shall be procured
278 by competitive solicitation pursuant to chapter 287,
279 notwithstanding any exemption in s. 287.057(5)(f). When awarding
280 the contract, priority shall be given to existing nonprofit
281 groups that are based within the state, have expertise working
282 with organ and tissue procurement organizations, have expertise
283 in conducting statewide organ and tissue donor public education
284 campaigns, and represent the needs of the organ and tissue
285 donation community in the state.
286 (3) The contractor shall be responsible for:
287 (a) The development, implementation, and maintenance of an
288 interactive web-based organ and tissue donor registry that,
289 through electronic means, allows for online organ donor
290 registration and the recording of organ and tissue donation
291 records submitted through the driver's license identification
292 program or through other sources.
293 1. The registry must be maintained in a manner that allows,
294 through electronic and telephonic methods, immediate access to
295 organ and tissue donation records 24 hours a day, 7 days a week.
296 2. Access to the registry must be through coded and secure
297 means to protect the integrity of the data in the registry.
298 (b) A continuing program to educate and inform medical
299 professionals, law enforcement agencies and officers, other
300 state and local government employees, high school students,
301 minorities, and the public about the laws of this state relating
302 to anatomical gifts and the need for anatomical gifts.
303 1. Existing community resources, when available, must be
304 used to support the program and volunteers may assist the
305 program to the maximum extent possible.
306 2. The contractor shall coordinate with the head of a state
307 agency or other political subdivision of the state, or his or
308 her designee, to establish convenient times, dates, and
309 locations for educating that entity's employees.
310 (c) Preparing and submitting an annual written report to
311 the agency for Health Care Administration by December 31 of each
312 year. The report must include:
313 1. The number of donors on the registry and an analysis of
314 the registration rates by location and method of donation;
315 2. The characteristics of donors as determined from
316 registry information submitted directly by the donors or by the
317 Department of Highway Safety and Motor Vehicles;
318 3. The annual dollar amount of voluntary contributions
319 received by the contractor;
320 4. A description of the educational campaigns and
321 initiatives implemented during the year and an evaluation of
322 their effectiveness in increasing enrollment on the registry;
323 and
324 5. An analysis of Florida's registry compared with other
325 states' donor registries.
326 (4) Costs for the organ and tissue donor registry and
327 education program shall be paid by the agency for Health Care
328 Administration from the funds deposited into the Health Care
329 Trust Fund pursuant to ss. 320.08047 and 322.08, which are
330 designated for maintaining the organ and tissue donor registry
331 and education program. In addition, the contractor may receive
332 and use voluntary contributions to help support the registry and
333 provide education.
334 (5) The organ and tissue donor registry established by this
335 section is designated as the “Joshua Abbott Organ and Tissue
336 Registry.”
337 Section 7. Section 765.51551, Florida Statutes, is amended
338 to read
339 765.51551 Organ and tissue Donor registry; public records
340 exemption.—
341 (1) Information held in the organ and tissue donor registry
342 which identifies a donor is confidential and exempt from s.
343 119.07(1) and s. 24(a), Art. I of the State Constitution.
344 (2) Such information may be disclosed to the following:
345 (a) Organ, tissue, and eye Procurement organizations that
346 have been certified by the agency for Health Care Administration
347 for the purpose of ascertaining or effectuating the existence of
348 a gift under s. 765.522.
349 (b) Persons engaged in bona fide research if the person
350 agrees to:
351 1. Submit a research plan to the agency that specifies the
352 exact nature of the information requested and the intended use
353 of the information;
354 2. Maintain the confidentiality of the records or
355 information if personal identifying information is made
356 available to the researcher;
357 3. Destroy any confidential records or information obtained
358 after the research is concluded; and
359 4. Not directly or indirectly contact, for any purpose, any
360 donor or donee.
361 (3) This section is subject to the Open Government Sunset
362 Review Act in accordance with s. 119.15 and shall stand repealed
363 on October 2, 2013, unless reviewed and saved from repeal
364 through reenactment by the Legislature.
365 Section 8. Section 765.516, Florida Statutes, is amended to
366 read:
367 765.516 Donor amendment of the terms of or the revocation
368 of anatomical the gift.—
369 (1) A donor may amend the terms of or revoke an anatomical
370 gift by:
371 (a) The execution and delivery to the donee of a signed
372 statement witnessed by at least two adults, at least one of whom
373 is a disinterested witness.
374 (b) An oral statement that is made in the presence of two
375 persons, one of whom is must not be a family member, and
376 communicated to the donor's family or attorney or to the donee.
377 An oral statement is effective only if the procurement
378 organization, transplant hospital, or physician or technician
379 has actual notice of the oral amendment or revocation before an
380 incision is made to the decedent's body or an invasive procedure
381 to prepare the recipient has begun.
382 (c) A statement made during a terminal illness or injury
383 addressed to an attending physician, who must communicate the
384 revocation of the gift to the procurement organization that is
385 certified by the state.
386 (d) A signed document found on or about the donor's person.
387 (e) Removing his or her name from the organ and tissue
388 donor registry.
389 (f) A later-executed document of gift which amends or
390 revokes a previous anatomical gift or portion of an anatomical
391 gift, either expressly or by inconsistency.
392 (g) By the destruction or cancellation of the document of
393 gift or the destruction or cancellation of that portion of the
394 document of gift used to make the gift with the intent to revoke
395 the gift.
396 (2) Any anatomical gift made by a will may also be amended
397 or revoked in the manner provided for the amendment or
398 revocation of wills or as provided in paragraph (1)(a)
399 subsection (1).
400 Section 9. Section 765.517, Florida Statutes, is amended to
401 read:
402 765.517 Rights and duties at death.—
403 (1) The donee, pursuant to as specified under the
404 provisions of s. 765.515(2), may accept or reject an anatomical
405 the gift. If the donee accepts a gift of the entire body or a
406 part of the body to be used for research or education scientific
407 purposes other than a transplant, the donee may authorize
408 embalming and the use of the body in funeral services, subject
409 to the terms of the gift. If the gift is of a part of the body,
410 the donee shall cause the part to be removed without unnecessary
411 mutilation upon the death of the donor and before or after
412 embalming. After removal of the body part, custody of the
413 remainder of the body vests in the surviving spouse, next of
414 kin, or other persons under obligation to dispose of the body.
415 (2) The time of death shall be determined by a physician
416 who attends the donor at the donor's death or, if there is no
417 such physician, the physician who certifies the death. After
418 death, those physicians or the donor's primary care and in the
419 absence of other qualified personnel, this physician may
420 participate in, but may shall not obstruct, the procedures to
421 preserve the donor's organs or tissues and may shall not be paid
422 or reimbursed for such participation by, nor be associated with
423 or employed by, a, an organ procurement organization, tissue
424 bank, or eye bank. These physicians may This physician shall not
425 participate in the procedures for removing or transplanting a
426 part. However, this subsection does not prevent a physician from
427 serving in a voluntary capacity on the board of directors of a
428 procurement organization or participating on any board, council,
429 commission, or similar body related to the organ and tissue
430 procurement system.
431 (3) The organ procurement organizations organization,
432 tissue bank, or eye bank, or hospital medical professionals
433 under the direction thereof, may perform any and all tests to
434 evaluate the deceased as a potential donor and any invasive
435 procedures on the deceased body in order to preserve the
436 potential donor's organs. These procedures do not include the
437 surgical removal of an organ or penetrating any body cavity,
438 specifically for the purpose of donation, until:
439 (a) It has been verified that the deceased's consent to
440 donate appears in the organ and tissue donor registry or a
441 properly executed donor card or document of gift is located; or
442 (b) If a properly executed donor card or document of gift
443 cannot be located or the deceased's consent is not listed in the
444 organ and tissue donor registry, a person specified in s.
445 765.512(2) or (3) has been located, has been notified of the
446 death, and has granted legal permission for the donation.
447 (4) All reasonable additional expenses incurred in the
448 procedures to preserve the donor's organs or tissues shall be
449 reimbursed by the organ procurement organization, tissue bank,
450 or eye bank.
451 (5) A person who acts in good faith and without negligence
452 in accord with the terms of this part or under the anatomical
453 gift laws of another state or a foreign country, or attempts in
454 good faith to do so, is not liable for damages in any civil
455 action, is not or subject to prosecution for his or her acts in
456 any criminal proceeding, and is not subject to discipline,
457 penalty, or liability in any administrative proceeding.
458 (6) The provisions of this part are subject to the laws of
459 this state prescribing powers and duties with respect to
460 autopsies.
461 (7) The person making an anatomical gift and the donor's
462 estate are not liable for any injury or damages that result from
463 the making or use of the gift.
464 (8) In determining whether an anatomical gift has been
465 made, amended, or revoked under this part, a person may rely
466 upon the representation of an individual listed in s. 765.512,
467 relating to the individual's relationship to the donor or
468 prospective donor, unless the person knows that the
469 representation is untrue.
470 Section 10. Section 765.521, Florida Statutes, is amended
471 to read:
472 765.521 Donations as part of driver license or
473 identification card process.—
474 (1) The agency for Health Care Administration and the
475 Department of Highway Safety and Motor Vehicles shall develop
476 and implement a program encouraging and allowing persons to make
477 anatomical gifts as a part of the process of issuing
478 identification cards and issuing and renewing driver licenses.
479 The donor registration card distributed by the Department of
480 Highway Safety and Motor Vehicles shall include the information
481 required by the uniform donor card under s. 765.514 and such
482 additional information as determined necessary by the
483 department. The department shall also develop and implement a
484 program to identify donors, which includes notations on
485 identification cards, driver licenses, and driver records or
486 such other methods as the department develops to clearly
487 indicate the individual's intent to make an anatomical gift
488 donate the individual's organs, tissues, or eyes. A notation on
489 an individual's driver license or identification card that the
490 individual intends to make an anatomical gift donate organs,
491 tissues, or eyes satisfies all requirements for consent to organ
492 or tissue donation. The agency for Health Care Administration
493 shall provide the necessary supplies and forms from funds
494 appropriated from general revenue or contributions from
495 interested voluntary, nonprofit organizations. The department
496 shall provide the necessary recordkeeping system from funds
497 appropriated from general revenue. The Department of Highway
498 Safety and Motor Vehicles and the agency for Health Care
499 Administration shall incur no liability in connection with the
500 performance of any acts authorized herein.
501 (2) The Department of Highway Safety and Motor Vehicles,
502 after consultation with and concurrence by the agency for Health
503 Care Administration, shall adopt rules to implement the
504 provisions of this section according to the provisions of
505 chapter 120.
506 (3) Funds expended by the agency for Health Care
507 Administration to carry out the intent of this section may shall
508 not be taken from any funds appropriated for patient care.
509 Section 11. Section 765.522, Florida Statutes, is amended
510 to read:
511 765.522 Duty of certain hospital administrators; liability
512 of hospital administrators and, organ procurement organizations,
513 eye banks, and tissue banks.—
514 (1) When used in this section, “hospital” means any
515 establishment licensed under chapter 395 except psychiatric and
516 rehabilitation hospitals.
517 (1)(2) If Where, based on accepted medical standards, a
518 hospital patient is a suitable candidate for organ or tissue
519 donation, the hospital administrator or the hospital
520 administrator's designee shall, at or near the time of death,
521 notify the appropriate procurement organization organ, eye, or
522 tissue recovery program, which shall access the organ and tissue
523 donor registry created by s. 765.5155 or any other donor
524 registry to ascertain the existence of an entry in the registry
525 which that has not been revoked, a donor card, or a document of
526 gift executed by the decedent. In the absence of an entry in the
527 donor registry, a document of gift donor card, organ donation
528 sticker or organ donation imprint on a driver's license, or
529 other properly executed document, the procurement organization
530 organ, eye, or tissue recovery program shall request:
531 (a) The patient's health care surrogate, as authorized in
532 s. 765.512(2); or
533 (b) If the patient does not have a surrogate, or the
534 surrogate is not reasonably available, any of the persons
535 specified in s. 765.512(3), in the order and manner listed,
536 to consent to the anatomical gift of all or any part of the
537 decedent's body for any purpose specified in this part. Except
538 as provided in s. 765.512, in the absence of actual notice of
539 opposition, consent need only be obtained from the person or
540 persons in the highest priority class reasonably available.
541 (3) A document of gift is valid if made pursuant to a
542 request required by this section shall be executed in accordance
543 with this part or the laws of the state or country where it was
544 executed and where the person making the anatomical gift was
545 domiciled, has a place of residence, or was a citizen at the
546 time the document of gift was executed pursuant to s. 765.514.
547 (4) The agency for Health Care Administration shall
548 establish rules and guidelines concerning the education of
549 individuals who may be designated to perform the request and the
550 procedures to be used in making the request. The agency is
551 authorized to adopt rules concerning the documentation of the
552 request, where such request is made.
553 (5) If a document of gift is valid under this section, the
554 laws of this state govern the interpretation of the document of
555 gift.
556 (6) A document of gift or amendment of an anatomical gift
557 is presumed to be valid unless it was not validly executed or
558 was revoked.
559 (7)(5) There shall be no civil or criminal liability
560 against any organ procurement organization, eye bank, or tissue
561 bank certified under s. 765.542, or against any hospital or
562 hospital administrator or designee who complies, when complying
563 with the provisions of this part and agency the rules of the
564 agency for Health Care Administration or if when, in the
565 exercise of reasonable care, a request for organ donation is
566 inappropriate and the gift is not made according to this part
567 and agency the rules of the agency for Health Care
568 Administration.
569 (8)(6) The hospital administrator or a designee shall, at
570 or near the time of death of a potential organ donor, directly
571 notify the affiliated organ procurement organization designated
572 by the United States Department of Health and Human Services of
573 the potential organ donor. The This organ procurement
574 organization must offer any organ from such a donor first to
575 patients on a Florida-based local or state organ sharing
576 transplant list. For the purpose of this subsection, the term
577 “transplant list” includes certain categories of national or
578 regional organ sharing for patients of exceptional need or
579 exceptional match, as approved or mandated by the Organ
580 Procurement and Transplantation Network, or its agent. This
581 notification may not be made to a tissue bank or eye bank in
582 lieu of the organ procurement organization unless the tissue
583 bank or eye bank is also designated as an organ procurement
584 organization by the United States Department of Health and Human
585 Services.
586 Section 12. Subsections (1), (5), and (6) of section
587 765.53, Florida Statutes, are amended to read:
588 765.53 Organ Transplant Advisory Council; membership;
589 responsibilities.—
590 (1) There is hereby created within the agency for Health
591 Care Administration A statewide technical Organ Transplant
592 Advisory Council is created within the agency, consisting of
593 twelve members who are physicians licensed under chapter 458 or
594 chapter 459, to represent the interests of the public and the
595 clients of the Department of Health or the agency. The members
596 shall be physicians licensed according to chapter 458 or chapter
597 459. A person employed by the agency may not be appointed as a
598 member of the council.
599 (5) Members of the council shall receive no compensation,
600 but shall be reimbursed for per diem and travel expenses by the
601 agency for Health Care Administration in accordance with the
602 provisions of s. 112.061 while engaged in the performance of
603 their duties.
604 (6) The responsibilities of the council shall be to
605 recommend to the agency for Health Care Administration
606 indications for adult and pediatric organ transplants. The
607 council shall also formulate guidelines and standards for organ
608 transplants and for the development of End Stage Organ Disease
609 and Tissue/Organ Transplant programs. The recommendations,
610 guidelines, and standards developed by the council are
611 applicable only to those health programs funded through the
612 agency for Health Care Administration.
613 Section 13. Section 765.541, Florida Statutes, is amended
614 to read:
615 765.541 Certification of procurement organizations engaged
616 in the practice of cadaveric organ and tissue procurement.—The
617 agency for Health Care Administration shall:
618 (1) Establish a program for the certification of
619 organizations, corporations agencies, or other entities engaged
620 in the procurement of organs, tissues, and eyes for
621 transplantation.;
622 (2) Adopt rules that set forth appropriate standards and
623 guidelines for the program in accordance with ss. 765.541
624 765.546 and part II of chapter 408. These standards and
625 guidelines must be substantially based on the existing laws of
626 the Federal Government and this state and the existing standards
627 and guidelines of the United Network for Organ Sharing (UNOS),
628 the American Association of Tissue Banks (AATB), the South
629 Eastern Organ Procurement Foundation (SEOPF), the North American
630 Transplant Coordinators Organization (NATCO), and the Eye Bank
631 Association of America (EBAA). In addition, the agency for
632 Health Care Administration shall, before adopting these
633 standards and guidelines, seek input from all organ procurement
634 organizations, tissue banks, and eye banks based in this state.;
635 (3) Collect, keep, and make available to the Governor and
636 the Legislature information regarding the numbers and
637 disposition of organs, and tissues, and eyes procured by each
638 certified procurement organization. entity;
639 (4) Monitor procurement organizations participating
640 facilities and agencies for program compliance.; and
641 (5) Provide for the administration of the Organ and Tissue
642 Procurement and Transplantation Advisory Board.
643 Section 14. Section 765.542, Florida Statutes, is amended
644 to read:
645 765.542 Certification of organ procurement organizations,
646 tissue banks, and eye banks.—
647 (1) The requirements of part II of chapter 408 apply to the
648 provision of services that require licensure pursuant to ss.
649 765.541-765.546 and part II of chapter 408 and to entities
650 licensed or certified by or applying for such licensure or
651 certification from the agency for Health Care Administration
652 pursuant to ss. 765.541-765.546. A person An organization,
653 agency, or other entity may not engage in the practice of organ
654 procurement in this state without being designated as an organ
655 procurement organization by the secretary of the United States
656 Department of Health and Human Services and being appropriately
657 certified by the agency for Health Care Administration. As used
658 in this subsection, the term “procurement” includes the
659 retrieval, processing, or distribution of human organs. A
660 physician or organ procurement organization based outside this
661 state is exempt from these certification requirements if:
662 (a) The organs are procured for an out-of-state patient who
663 is listed on, or referred through, the United Network for Organ
664 Sharing System; and
665 (b) The organs are procured through an agreement of an
666 organ procurement organization certified by the state.
667 (2) A person An organization, agency, or other entity may
668 not engage in tissue procurement in this state unless it is
669 appropriately certified as a tissue bank by the agency for
670 Health Care Administration. As used in this subsection, the term
671 “procurement” includes any retrieval, processing, storage, or
672 distribution of human tissue for transplantation.
673 (3) A person An organization, agency, or other entity may
674 not engage in the practice of eye procurement in this state
675 without being appropriately certified as an eye bank by the
676 agency for Health Care Administration. As used in this
677 subsection, the term “procurement” includes the retrieval,
678 processing, or distribution of human eye tissue. Funeral
679 directors or direct disposers who that retrieve eye tissue for
680 an eye bank certified under this subsection are exempt from the
681 certification requirements under this subsection.
682 (4) A limited certificate may be issued to a tissue bank or
683 eye bank, certifying only those components of procurement which
684 the bank has chosen to perform. The agency for Health Care
685 Administration may issue a limited certificate if it determines
686 that the tissue bank or eye bank is adequately staffed and
687 equipped to operate in conformity with the rules adopted under
688 this section.
689 Section 15. Subsection (3) of section 765.543, Florida
690 Statutes, is amended to read:
691 765.543 Organ and Tissue Procurement and Transplantation
692 Advisory Board; creation; duties.—
693 (3) The board shall:
694 (a) Assist the agency for Health Care Administration in the
695 development of necessary professional qualifications, including,
696 but not limited to, the education, training, and performance of
697 persons engaged in the various facets of organ and tissue
698 procurement, processing, preservation, and distribution for
699 transplantation;
700 (b) Assist the agency for Health Care Administration in
701 monitoring the appropriate and legitimate expenses associated
702 with organ and tissue procurement, processing, and distribution
703 for transplantation and developing methodologies to assure the
704 uniform statewide reporting of data to facilitate the accurate
705 and timely evaluation of the organ and tissue procurement and
706 transplantation system;
707 (c) Provide assistance to the Florida Medical Examiners
708 Commission in the development of appropriate procedures and
709 protocols to ensure the assure continued improvement in the
710 approval and release of potential organ and tissue donors by the
711 district medical examiners and associate medical examiners;
712 (d) Develop with and recommend to the agency for Health
713 Care Administration the necessary procedures and protocols
714 required to assure that all residents of this state have
715 reasonable access to available organ and tissue transplantation
716 therapy and that residents of this state can be reasonably
717 assured that the statewide procurement transplantation system is
718 will be able to fulfill their organ and tissue requirements
719 within the limits of the available supply and according to the
720 severity of their medical condition and need; and
721 (e) Develop with and recommend to the agency for Health
722 Care Administration any changes to the laws of this state or
723 administrative rules or procedures required to ensure assure
724 that the statewide organ and tissue procurement and
725 transplantation system is will be able to function smoothly,
726 effectively, and efficiently, in accordance with the Federal
727 Anatomical Gift Act and in a manner that assures the residents
728 of this state that no person or entity profits from the
729 altruistic voluntary donation of organs or tissues.
730 Section 16. Section 765.544, Florida Statutes, is amended
731 to read
732 765.544 Fees; organ and tissue donor education and
733 procurement.—
734 (1) In accordance with s. 408.805, an applicant or a
735 certificateholder shall pay a fee for each application submitted
736 under this part, part II of chapter 408, and applicable rules.
737 The amount of the fee shall be as follows:
738 (a) An initial application fee of $1,000 from organ
739 procurement organizations and tissue banks and $500 from eye
740 banks.
741 (b) Annual fees to be used, in the following order of
742 priority, for the certification program, the advisory board,
743 maintenance of the organ and tissue donor registry, and the
744 organ and tissue donor education program in the following
745 amounts, which may not exceed $35,000 per organization:
746 1. Each general organ procurement organization shall pay
747 the greater of $1,000 or 0.25 percent of its total revenues
748 produced from procurement activity in this state by the
749 certificateholder during its most recently completed fiscal year
750 or operational year.
751 2. Each bone and tissue procurement organization agency or
752 bone and tissue bank shall pay the greater of $1,000 or 0.25
753 percent of its total revenues from procurement and processing
754 activity in this state by the certificateholder during its most
755 recently completed fiscal year or operational year.
756 3. Each eye bank shall pay the greater of $500 or 0.25
757 percent of its total revenues produced from procurement activity
758 in this state by the certificateholder during its most recently
759 completed fiscal year or operational year.
760 (2) The agency for Health Care Administration shall specify
761 by rule the administrative penalties for the purpose of ensuring
762 adherence to the standards of quality and practice required by
763 this chapter, part II of chapter 408, and applicable rules of
764 the agency for continued certification.
765 (3)(a) Proceeds from fees, administrative penalties, and
766 surcharges collected pursuant to this section must be deposited
767 into the Health Care Trust Fund.
768 (b) Moneys deposited in the trust fund pursuant to this
769 section must be used exclusively for the implementation,
770 administration, and operation of the certification program and
771 the advisory board, for maintaining the organ and tissue donor
772 registry, and for organ and tissue donor education.
773 (4) As used in this section, the term “procurement activity
774 in this state” includes the bringing into this state for
775 processing, storage, distribution, or transplantation of organs
776 or tissues that are initially procured in another state or
777 country.
778 Section 17. Section 765.545, Florida Statutes, is amended
779 to read:
780 765.545 Physician supervision of cadaveric organ and tissue
781 procurement coordinators.—Organ Procurement organizations,
782 tissue banks, and eye banks may employ coordinators, who are
783 registered nurses, physician's assistants, or other medically
784 trained personnel who meet the relevant standards for organ
785 procurement organizations, tissue banks, or eye banks as adopted
786 by the agency for Health Care Administration under s. 765.541,
787 to assist in the medical management of organ donors or in the
788 surgical procurement of cadaveric organs, tissues, or eyes for
789 transplantation or research. A coordinator who assists in the
790 medical management of organ donors or in the surgical
791 procurement of cadaveric organs, tissues, or eyes for
792 transplantation or research must do so under the direction and
793 supervision of a licensed physician medical director pursuant to
794 rules and guidelines to be adopted by the agency for Health Care
795 Administration. With the exception of organ procurement surgery,
796 this supervision may be indirect supervision. For purposes of
797 this section, the term “indirect supervision” means that the
798 medical director is responsible for the medical actions of the
799 coordinator, that the coordinator is operating under protocols
800 expressly approved by the medical director, and that the medical
801 director or his or her physician designee is always available,
802 in person or by telephone, to provide medical direction,
803 consultation, and advice in cases of organ, tissue, and eye
804 donation and procurement. Although indirect supervision is
805 authorized under this section, direct physician supervision is
806 to be encouraged when appropriate.
807 Section 18. Section 765.547, Florida Statutes, is created
808 to read:
809 765.547 Cooperation between medical examiner and
810 procurement organization.—
811 (1) A medical examiner and procurement organization shall
812 cooperate with each other in order to maximize opportunities to
813 recover anatomical gifts for the purpose of transplantation,
814 therapy, research, or education.
815 (2) The Florida Medical Examiners Commission shall adopt
816 rules establishing cooperative responsibilities between medical
817 examiners and procurement organizations to facilitate and
818 expedite completion of the medical examiner's responsibilities
819 under chapter 406 in a manner that will maximize opportunities
820 to recover anatomical gifts.
821 (3) This part does not supersede any part of chapter 406
822 relating to medical examiners and the disposition of dead
823 bodies.
824 Section 19. Subsection (30) of section 408.802, Florida
825 Statutes, is amended to read:
826 408.802 Applicability.—The provisions of this part apply to
827 the provision of services that require licensure as defined in
828 this part and to the following entities licensed, registered, or
829 certified by the agency, as described in chapters 112, 383, 390,
830 394, 395, 400, 429, 440, 483, and 765:
831 (30) Organ, and tissue, and eye procurement organizations
832 agencies, as provided under part V of chapter 765.
833 Section 20. Subsection (29) of section 408.820, Florida
834 Statutes, is amended to read:
835 408.820 Exemptions.—Except as prescribed in authorizing
836 statutes, the following exemptions shall apply to specified
837 requirements of this part:
838 (29) Organ, and tissue, and eye procurement organizations
839 agencies, as provided under part V of chapter 765, are exempt
840 from s. 408.810(5)-(10).
841 Section 21. This act shall take effect July 1, 2009.
842