Florida Senate - 2009 COMMITTEE AMENDMENT
Bill No. SB 766
Barcode 548312
LEGISLATIVE ACTION
Senate . House
Comm: FAV .
02/18/2009 .
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The Committee on Health Regulation (Sobel) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Delete everything after the enacting clause
4 and insert:
5 Section 1. Section 765.511, Florida Statutes, is amended to
6 read:
7 765.511 Definitions.—As used in this part, the term:
8 (1) “Agency” means the Agency for Health Care
9 Administration.
10 (2) “Anatomical gift” or “gift” means a donation of all or
11 part of a human body to take effect after the donor's death and
12 to be used for transplantation, therapy, research, or education.
13 (3)(1) “Bank” or “storage facility” means a facility
14 licensed, accredited, or approved under the laws of any state
15 for storage of human bodies or body parts thereof.
16 (4)(2) “Death” means the absence of life as determined, in
17 accordance with currently accepted medical standards, by the
18 irreversible cessation of all respiration and circulatory
19 function, or as determined, in accordance with s. 382.009, by
20 the irreversible cessation of the functions of the entire brain,
21 including the brain stem.
22 (5) “Decedent” means a deceased individual whose body or
23 body parts may be, or are, the source of an anatomical gift.
24 (6) “Disinterested witness” means a witness other than a
25 person listed in s. 765.512(3) or other family member.
26 (7) “Document of gift” means any of the documents or
27 mechanisms used in making an anatomical gift under s. 765.514.
28 (8)(3) “Donor” means an individual who makes an anatomical
29 a gift of all or part of his or her body.
30 (9) “Donor registry” means a database that contains records
31 of anatomical gifts and amendments to, or revocations of, such
32 gifts.
33 (10) “Eye bank” means an entity that is accredited by the
34 Eye Bank Association of America or otherwise regulated under
35 federal or state law to engage in the retrieval, screening,
36 testing, processing, storage, or distribution of human eye
37 tissue.
38 (11) “Guardian” means a person appointed pursuant to
39 chapter 744. The term does not include a guardian ad litem.
40 (12)(4) “Hospital” means a hospital licensed, accredited,
41 or approved under the laws of any state and includes a hospital
42 operated by the United States Government or a state, or a
43 subdivision thereof, although not required to be licensed under
44 state laws.
45 (13) “Identification card” means an official identification
46 card issued by a governmental entity, state agency, or
47 subdivision thereof.
48 (14) “Organ procurement organization” means an entity that
49 is designated as an organ procurement organization by the
50 Secretary of the United States Department of Health and Human
51 Services and that engages in the retrieval, screening, testing,
52 processing, storage, or distribution of human organs.
53 (15) “Part of the body” or “body part” means an organ, eye,
54 or tissue of a human being. The term does not include the whole
55 body.
56 (16)(5) “Physician” or “surgeon” means a physician or
57 surgeon licensed to practice under chapter 458 or chapter 459 or
58 similar laws of any state. “Surgeon” includes dental or oral
59 surgeon.
60 (17) “Procurement” means any retrieval, recovery,
61 processing, storage, or distribution of human organs or tissues
62 for transplantation, therapy, research, or education.
63 (18) “Procurement organization” means an organ procurement
64 organization, eye bank, or tissue bank.
65 (19) “Reasonably available” means able to be contacted by a
66 procurement organization in a timely manner without undue
67 effort, and willing and able to act in a manner consistent with
68 existing medical protocols necessary for the making of an
69 anatomical gift.
70 (20) “Record” means information that is inscribed on a
71 tangible medium or that is stored in an electronic or other
72 medium and is retrievable in perceivable form.
73 (21) “Sign” or “signed” means, with the present intent to
74 authenticate or adopt a record, to execute or adopt a tangible
75 symbol, or attach to or logically associate an electronic
76 symbol, sound, or process with the record.
77 (22) “Tissue bank” means an entity that is accredited by
78 the American Association of Tissue Banks or otherwise regulated
79 under federal or state law to engage in the retrieval,
80 screening, testing, processing, storage, or distribution of
81 human tissue.
82 Section 2. Subsections (1), (4), (5), (6), and (7) of
83 section 765.512, Florida Statutes, are amended to read:
84 765.512 Persons who may make an anatomical gift.—
85 (1) Any person who may make a will may make an anatomical
86 gift give all or part of his or her body for any purpose
87 specified in s. 765.513. The gift is effective upon the death of
88 the donor.
89 (a) If the decedent makes an anatomical gift by one of the
90 methods listed in s. 765.514(1), and in the absence of actual
91 notice of contrary indications by the decedent, the document or
92 entry in the donor organ and tissue registry is legally
93 sufficient evidence of the decedent's informed consent to donate
94 an anatomical gift.
95 (b) An anatomical gift made by a qualified donor and not
96 revoked by the donor, as provided in s. 765.516, is irrevocable
97 after the donor's death. A family member, guardian,
98 representative ad litem, or health care surrogate may not
99 modify, deny, or prevent a donor's wish or intent to make an
100 anatomical gift after the donor's death.
101 (4) A donee may not accept an anatomical gift if the donee
102 has actual notice of contrary indications by the donor or actual
103 notice that an anatomical a gift by a member of a class is
104 opposed by a member of a prior class.
105 (5) The person authorized by subsection (3) may make the
106 anatomical gift after the decedent's death or immediately before
107 the decedent's death.
108 (6) An anatomical A gift of all or part of a body
109 authorizes:
110 (a) Any examination necessary to assure medical
111 acceptability of the gift for the purposes intended.
112 (b) The decedent's medical provider, family, or a third
113 party to furnish medical records requested concerning the
114 decedent's medical and social history.
115 (7) Once the anatomical gift has been made, the rights of
116 the donee are paramount to the rights of others, except as
117 provided by s. 765.517.
118 Section 3. Section 765.513, Florida Statutes, is amended to
119 read:
120 765.513 Persons and entities that may become Donees;
121 purposes for which anatomical gifts may be made.—
122 (1) The following persons or entities may become donees of
123 anatomical gifts of bodies or parts of them for the purposes
124 stated:
125 (a)(1) Any procurement organization or accredited hospital,
126 surgeon, or physician for medical or dental school, college, or
127 university for education, or research, advancement of medical or
128 dental science, therapy, or transplantation.
129 (2) Any accredited medical or dental school, college, or
130 university for education, research, advancement of medical or
131 dental science, or therapy.
132 (3) Any bank or storage facility for medical or dental
133 education, research, advancement of medical or dental science,
134 therapy, or transplantation.
135 (b)(4) Any individual specified by name for therapy or
136 transplantation needed by him or her.
137 (2) If multiple purposes are set forth in the document of
138 gift but are not set forth in any priority order, the anatomical
139 gift shall be used first for transplantation or therapy, if
140 suitable. If the gift cannot be used for transplantation or
141 therapy, the gift may be used for research or education.
142 (3) However, The Legislature declares that the public
143 policy of this state prohibits restrictions on the possible
144 recipients of an anatomical gift on the basis of race, color,
145 religion, gender sex, national origin, age, physical disability
146 handicap, health status, marital status, or economic status, and
147 such restrictions are hereby declared void and unenforceable.
148 Section 4. Section 765.514, Florida Statutes, is amended to
149 read:
150 765.514 Manner of making anatomical gifts.—
151 (1) A person may make an anatomical a gift of all or part
152 of his or her body under s. 765.512(1) by:
153 (a) Signing an organ and tissue donor card.
154 (b) Registering online with the organ and tissue donor
155 registry.
156 (c) Signifying an intent to donate on his or her driver's
157 license or identification card issued by the Department of
158 Highway Safety and Motor Vehicles. Revocation, suspension,
159 expiration, or cancellation of the driver's license or
160 identification card does not invalidate the gift.
161 (d) Expressing a wish to donate in a living will or other
162 advance directive.
163 (e) Executing a will that includes a provision indicating
164 that the testator wishes to make an anatomical gift. The gift
165 becomes effective upon the death of the testator without waiting
166 for probate. If the will is not probated or if it is declared
167 invalid for testamentary purposes, the gift is nevertheless
168 valid to the extent that it has been acted upon in good faith.
169 (f) Expressing a wish to donate in a document other than a
170 will. The document must be signed by the donor in the presence
171 of two witnesses who shall sign the document in the donor's
172 presence. If the donor cannot sign, the document may be signed
173 for him or her at the donor's direction and in his or her
174 presence and the presence of two witnesses who must sign the
175 document in the donor's presence. Delivery of the document of
176 gift during the donor's lifetime is not necessary to make the
177 gift valid. The following form of written document is sufficient
178 for any person to make an anatomical gift give all or part of
179 his or her body for the purposes of this part:
180 UNIFORM DONOR CARD
181 The undersigned hereby makes this anatomical gift, if medically
182 acceptable, to take effect on death. The words and marks below
183 indicate my desires:
184 I give:
185 (a) .... any needed organs, tissues, or eyes;
186 (b) .... only the following organs, tissues, or eyes
187 ...[Specify the organs, tissues, or eyes]...
188 for the purpose of transplantation, therapy, medical research,
189 or education;
190 (c) .... my body for anatomical study if needed.
191 Limitations or special wishes, if any:
192 ...(If applicable, list specific donee;this must be arranged in
193 advance with the donee.)...
194 Signed by the donor and the following witnesses in the presence
195 of each other:
196 ...(Signature of donor)... ...(Date of birth of donor)...
197 ...(Date signed)... ...(City and State)...
198 ...(Witness)... ...(Witness)...
199 ...(Address)... ...(Address)...
200 (2) The anatomical gift may be made to a donee listed in s.
201 765.513, and the donee may be specified by name.
202 (3) Any anatomical gift by a health care surrogate
203 designated by the decedent pursuant to part II of this chapter
204 or a member of a class designated in s. 765.512(3) must be made
205 by a document signed by that person or made by that person's
206 witnessed telephonic discussion, telegraphic message, or other
207 recorded message.
208 Section 5. Section 765.515, Florida Statutes, is amended to
209 read:
210 765.515 Delivery of donor document.—
211 (1) If an anatomical a gift is made pursuant to s. 765.521,
212 the completed donor registration card shall be delivered to the
213 Department of Highway Safety and Motor Vehicles and the
214 department must communicate the donor's intent to the organ and
215 tissue donor registry, but delivery is not necessary to the
216 validity of the gift. If the donor withdraws the gift, the
217 records of the Department of Highway Safety and Motor Vehicles
218 must be updated to reflect such withdrawal and the department
219 must communicate the withdrawal to the organ and tissue donor
220 registry for the purpose of updating the registry.
221 (2) If an anatomical a gift is made by the donor to a
222 specified donee, the document of gift, other than a will, may be
223 delivered to the donee to expedite the appropriate procedures
224 immediately after death, but delivery is not necessary to the
225 validity of the gift. The Such document of gift may be deposited
226 in any hospital, bank, storage facility, or registry office that
227 accepts such documents for safekeeping or to facilitate the
228 donation of organs and tissue after death.
229 (3) At the request of any interested party upon or after
230 the donor's death, the person in possession shall produce the
231 document of gift for examination.
232 Section 6. Section 765.5155, Florida Statutes, is amended
233 to read:
234 765.5155 Organ and tissue Donor registry; education
235 program.—
236 (1) The Legislature finds that:
237 (a) There is a shortage of organ and tissue donors in this
238 state willing to provide the organs and tissue that could save
239 lives or enhance the quality of life for many persons.
240 (b) There is a need to encourage the various minority
241 populations of this state to donate organs and tissue.
242 (c) A statewide organ and tissue donor registry having an
243 online donor registration process coupled with an enhanced
244 program of donor education will lead to an increase in the
245 number of organ and tissue donors registered in this state, thus
246 affording more persons who are awaiting organ or tissue
247 transplants the opportunity for a full and productive life.
248 (2) The agency for Health Care Administration and the
249 Department of Highway Safety and Motor Vehicles shall jointly
250 contract for the operation of a an organ and tissue donor
251 registry and education program. The contractor shall be procured
252 by competitive solicitation pursuant to chapter 287,
253 notwithstanding any exemption in s. 287.057(5)(f). When awarding
254 the contract, priority shall be given to existing nonprofit
255 groups that are based within the state, have expertise working
256 with organ and tissue procurement organizations, have expertise
257 in conducting statewide organ and tissue donor public education
258 campaigns, and represent the needs of the organ and tissue
259 donation community in the state.
260 (3) The contractor shall be responsible for:
261 (a) The development, implementation, and maintenance of an
262 interactive web-based organ and tissue donor registry that,
263 through electronic means, allows for online organ donor
264 registration and the recording of organ and tissue donation
265 records submitted through the driver's license identification
266 program or through other sources.
267 1. The registry must be maintained in a manner that allows,
268 through electronic and telephonic methods, immediate access to
269 organ and tissue donation records 24 hours a day, 7 days a week.
270 2. Access to the registry must be through coded and secure
271 means to protect the integrity of the data in the registry.
272 (b) A continuing program to educate and inform medical
273 professionals, law enforcement agencies and officers, other
274 state and local government employees, high school students,
275 minorities, and the public about the laws of this state relating
276 to anatomical gifts and the need for anatomical gifts.
277 1. Existing community resources, when available, must be
278 used to support the program and volunteers may assist the
279 program to the maximum extent possible.
280 2. The contractor shall coordinate with the head of a state
281 agency or other political subdivision of the state, or his or
282 her designee, to establish convenient times, dates, and
283 locations for educating that entity's employees.
284 (c) Preparing and submitting an annual written report to
285 the agency for Health Care Administration by December 31 of each
286 year. The report must include:
287 1. The number of donors on the registry and an analysis of
288 the registration rates by location and method of donation;
289 2. The characteristics of donors as determined from
290 registry information submitted directly by the donors or by the
291 Department of Highway Safety and Motor Vehicles;
292 3. The annual dollar amount of voluntary contributions
293 received by the contractor;
294 4. A description of the educational campaigns and
295 initiatives implemented during the year and an evaluation of
296 their effectiveness in increasing enrollment on the registry;
297 and
298 5. An analysis of Florida's registry compared with other
299 states' donor registries.
300 (4) Costs for the organ and tissue donor registry and
301 education program shall be paid by the agency for Health Care
302 Administration from the funds deposited into the Health Care
303 Trust Fund pursuant to ss. 320.08047 and 322.08, which are
304 designated for maintaining the organ and tissue donor registry
305 and education program. In addition, the contractor may receive
306 and use voluntary contributions to help support the registry and
307 provide education.
308 (5) The organ and tissue donor registry established by this
309 section is designated as the “Joshua Abbott Organ and Tissue
310 Registry.”
311 Section 7. Section 765.51551, Florida Statutes, is amended
312 to read
313 765.51551 Organ and tissue Donor registry; public records
314 exemption.—
315 (1) Information held in the organ and tissue donor registry
316 which identifies a donor is confidential and exempt from s.
317 119.07(1) and s. 24(a), Art. I of the State Constitution.
318 (2) Such information may be disclosed to the following:
319 (a) Organ, tissue, and eye Procurement organizations that
320 have been certified by the agency for Health Care Administration
321 for the purpose of ascertaining or effectuating the existence of
322 a gift under s. 765.522.
323 (b) Persons engaged in bona fide research if the person
324 agrees to:
325 1. Submit a research plan to the agency that specifies the
326 exact nature of the information requested and the intended use
327 of the information;
328 2. Maintain the confidentiality of the records or
329 information if personal identifying information is made
330 available to the researcher;
331 3. Destroy any confidential records or information obtained
332 after the research is concluded; and
333 4. Not directly or indirectly contact, for any purpose, any
334 donor or donee.
335 (3) This section is subject to the Open Government Sunset
336 Review Act in accordance with s. 119.15 and shall stand repealed
337 on October 2, 2013, unless reviewed and saved from repeal
338 through reenactment by the Legislature.
339 Section 8. Section 765.516, Florida Statutes, is amended to
340 read:
341 765.516 Donor amendment of the terms of or the revocation
342 of anatomical the gift.—
343 (1) A donor may amend the terms of or revoke an anatomical
344 gift by:
345 (a) The execution and delivery to the donee of a signed
346 statement witnessed by at least two adults, at least one of whom
347 is a disinterested witness.
348 (b) An oral statement that is made in the presence of two
349 persons, one of whom is must not be a family member, and
350 communicated to the donor's family or attorney or to the donee.
351 An oral statement is effective only if the procurement
352 organization, transplant hospital, or physician or technician
353 has actual notice of the oral amendment or revocation before an
354 incision is made to the decedent's body or an invasive procedure
355 to prepare the recipient has begun.
356 (c) A statement made during a terminal illness or injury
357 addressed to an attending physician, who must communicate the
358 revocation of the gift to the procurement organization that is
359 certified by the state.
360 (d) A signed document found on or about the donor's person.
361 (e) Removing his or her name from the organ and tissue
362 donor registry.
363 (f) A later-executed document of gift which amends or
364 revokes a previous anatomical gift or portion of an anatomical
365 gift, either expressly or by inconsistency.
366 (g) By the destruction or cancellation of the document of
367 gift or the destruction or cancellation of that portion of the
368 document of gift used to make the gift with the intent to revoke
369 the gift.
370 (2) Any anatomical gift made by a will may also be amended
371 or revoked in the manner provided for the amendment or
372 revocation of wills or as provided in paragraph (1)(a)
373 subsection (1).
374 Section 9. Section 765.517, Florida Statutes, is amended to
375 read:
376 765.517 Rights and duties at death.—
377 (1) The donee, pursuant to as specified under the
378 provisions of s. 765.515(2), may accept or reject an anatomical
379 the gift. If the donee accepts a gift of the entire body or a
380 part of the body to be used for research or education scientific
381 purposes other than a transplant, the donee may authorize
382 embalming and the use of the body in funeral services, subject
383 to the terms of the gift. If the gift is of a part of the body,
384 the donee shall cause the part to be removed without unnecessary
385 mutilation upon the death of the donor and before or after
386 embalming. After removal of the body part, custody of the
387 remainder of the body vests in the surviving spouse, next of
388 kin, or other persons under obligation to dispose of the body.
389 (2) The time of death shall be determined by a physician
390 who attends the donor at the donor's death or, if there is no
391 such physician, the physician who certifies the death. After
392 death, those physicians or the donor's primary care and in the
393 absence of other qualified personnel, this physician may
394 participate in, but may shall not obstruct, the procedures to
395 preserve the donor's organs or tissues and may shall not be paid
396 or reimbursed for such participation by, nor be associated with
397 or employed by, a, an organ procurement organization, tissue
398 bank, or eye bank. These physicians may This physician shall not
399 participate in the procedures for removing or transplanting a
400 part. However, this subsection does not prevent a physician from
401 serving in a voluntary capacity on the board of directors of a
402 procurement organization or participating on any board, council,
403 commission, or similar body related to the organ and tissue
404 procurement system.
405 (3) The organ procurement organizations organization,
406 tissue bank, or eye bank, or hospital medical professionals
407 under the direction thereof, may perform any and all tests to
408 evaluate the deceased as a potential donor and any invasive
409 procedures on the deceased body in order to preserve the
410 potential donor's organs. These procedures do not include the
411 surgical removal of an organ or penetrating any body cavity,
412 specifically for the purpose of donation, until:
413 (a) It has been verified that the deceased's consent to
414 donate appears in the organ and tissue donor registry or a
415 properly executed donor card or document of gift is located; or
416 (b) If a properly executed donor card or document of gift
417 cannot be located or the deceased's consent is not listed in the
418 organ and tissue donor registry, a person specified in s.
419 765.512(2) or (3) has been located, has been notified of the
420 death, and has granted legal permission for the donation.
421 (4) All reasonable additional expenses incurred in the
422 procedures to preserve the donor's organs or tissues shall be
423 reimbursed by the organ procurement organization, tissue bank,
424 or eye bank.
425 (5) A person who acts in good faith and without negligence
426 in accord with the terms of this part or under the anatomical
427 gift laws of another state or a foreign country, or attempts in
428 good faith to do so, is not liable for damages in any civil
429 action, is not or subject to prosecution for his or her acts in
430 any criminal proceeding, and is not subject to discipline,
431 penalty, or liability in any administrative proceeding.
432 (6) The provisions of this part are subject to the laws of
433 this state prescribing powers and duties with respect to
434 autopsies.
435 (7) The person making an anatomical gift and the donor's
436 estate are not liable for any injury or damages that result from
437 the making or use of the gift.
438 (8) In determining whether an anatomical gift has been
439 made, amended, or revoked under this part, a person may rely
440 upon the representation of an individual listed in s. 765.512,
441 relating to the individual's relationship to the donor or
442 prospective donor, unless the person knows that the
443 representation is untrue.
444 Section 10. Section 765.521, Florida Statutes, is amended
445 to read:
446 765.521 Donations as part of driver license or
447 identification card process.—
448 (1) The agency for Health Care Administration and the
449 Department of Highway Safety and Motor Vehicles shall develop
450 and implement a program encouraging and allowing persons to make
451 anatomical gifts as a part of the process of issuing
452 identification cards and issuing and renewing driver licenses.
453 The donor registration card distributed by the Department of
454 Highway Safety and Motor Vehicles shall include the information
455 required by the uniform donor card under s. 765.514 and such
456 additional information as determined necessary by the
457 department. The department shall also develop and implement a
458 program to identify donors, which includes notations on
459 identification cards, driver licenses, and driver records or
460 such other methods as the department develops to clearly
461 indicate the individual's intent to make an anatomical gift
462 donate the individual's organs, tissues, or eyes. A notation on
463 an individual's driver license or identification card that the
464 individual intends to make an anatomical gift donate organs,
465 tissues, or eyes satisfies all requirements for consent to organ
466 or tissue donation. The agency for Health Care Administration
467 shall provide the necessary supplies and forms from funds
468 appropriated from general revenue or contributions from
469 interested voluntary, nonprofit organizations. The department
470 shall provide the necessary recordkeeping system from funds
471 appropriated from general revenue. The Department of Highway
472 Safety and Motor Vehicles and the agency for Health Care
473 Administration shall incur no liability in connection with the
474 performance of any acts authorized herein.
475 (2) The Department of Highway Safety and Motor Vehicles,
476 after consultation with and concurrence by the agency for Health
477 Care Administration, shall adopt rules to implement the
478 provisions of this section according to the provisions of
479 chapter 120.
480 (3) Funds expended by the agency for Health Care
481 Administration to carry out the intent of this section may shall
482 not be taken from any funds appropriated for patient care.
483 Section 11. Section 765.522, Florida Statutes, is amended
484 to read:
485 765.522 Duty of certain hospital administrators; liability
486 of hospital administrators and, organ procurement organizations,
487 eye banks, and tissue banks.—
488 (1) When used in this section, “hospital” means any
489 establishment licensed under chapter 395 except psychiatric and
490 rehabilitation hospitals.
491 (1)(2) If Where, based on accepted medical standards, a
492 hospital patient is a suitable candidate for organ or tissue
493 donation, the hospital administrator or the hospital
494 administrator's designee shall, at or near the time of death,
495 notify the appropriate procurement organization organ, eye, or
496 tissue recovery program, which shall access the organ and tissue
497 donor registry created by s. 765.5155 or any other donor
498 registry to ascertain the existence of an entry in the registry
499 which that has not been revoked, a donor card, or a document of
500 gift executed by the decedent. In the absence of an entry in the
501 donor registry, a document of gift donor card, organ donation
502 sticker or organ donation imprint on a driver's license, or
503 other properly executed document, the procurement organization
504 organ, eye, or tissue recovery program shall request:
505 (a) The patient's health care surrogate, as authorized in
506 s. 765.512(2); or
507 (b) If the patient does not have a surrogate, or the
508 surrogate is not reasonably available, any of the persons
509 specified in s. 765.512(3), in the order and manner listed,
510 to consent to the anatomical gift of all or any part of the
511 decedent's body for any purpose specified in this part. Except
512 as provided in s. 765.512, in the absence of actual notice of
513 opposition, consent need only be obtained from the person or
514 persons in the highest priority class reasonably available.
515 (3) A document of gift is valid if made pursuant to a
516 request required by this section shall be executed in accordance
517 with this part or the laws of the state or country where it was
518 executed and where the person making the anatomical gift was
519 domiciled, has a place of residence, or was a citizen at the
520 time the document of gift was executed pursuant to s. 765.514.
521 (4) The agency for Health Care Administration shall
522 establish rules and guidelines concerning the education of
523 individuals who may be designated to perform the request and the
524 procedures to be used in making the request. The agency is
525 authorized to adopt rules concerning the documentation of the
526 request, where such request is made.
527 (5) If a document of gift is valid under this section, the
528 laws of this state govern the interpretation of the document of
529 gift.
530 (6) A document of gift or amendment of an anatomical gift
531 is presumed to be valid unless it was not validly executed or
532 was revoked.
533 (7)(5) There shall be no civil or criminal liability
534 against any organ procurement organization, eye bank, or tissue
535 bank certified under s. 765.542, or against any hospital or
536 hospital administrator or designee who complies, when complying
537 with the provisions of this part and agency the rules of the
538 agency for Health Care Administration or if when, in the
539 exercise of reasonable care, a request for organ donation is
540 inappropriate and the gift is not made according to this part
541 and agency the rules of the agency for Health Care
542 Administration.
543 (8)(6) The hospital administrator or a designee shall, at
544 or near the time of death of a potential organ donor, directly
545 notify the affiliated organ procurement organization designated
546 by the United States Department of Health and Human Services of
547 the potential organ donor. The This organ procurement
548 organization must offer any organ from such a donor first to
549 patients on a Florida-based local or state organ sharing
550 transplant list. For the purpose of this subsection, the term
551 “transplant list” includes certain categories of national or
552 regional organ sharing for patients of exceptional need or
553 exceptional match, as approved or mandated by the Organ
554 Procurement and Transplantation Network, or its agent. This
555 notification may not be made to a tissue bank or eye bank in
556 lieu of the organ procurement organization unless the tissue
557 bank or eye bank is also designated as an organ procurement
558 organization by the United States Department of Health and Human
559 Services.
560 Section 12. Subsections (1), (5), and (6) of section
561 765.53, Florida Statutes, are amended to read:
562 765.53 Organ Transplant Advisory Council; membership;
563 responsibilities.—
564 (1) There is hereby created within the agency for Health
565 Care Administration A statewide technical Organ Transplant
566 Advisory Council is created within the agency, consisting of
567 twelve members who are physicians licensed under chapter 458 or
568 chapter 459, to represent the interests of the public and the
569 clients of the Department of Health or the agency. The members
570 shall be physicians licensed according to chapter 458 or chapter
571 459. A person employed by the agency may not be appointed as a
572 member of the council.
573 (5) Members of the council shall receive no compensation,
574 but shall be reimbursed for per diem and travel expenses by the
575 agency for Health Care Administration in accordance with the
576 provisions of s. 112.061 while engaged in the performance of
577 their duties.
578 (6) The responsibilities of the council shall be to
579 recommend to the agency for Health Care Administration
580 indications for adult and pediatric organ transplants. The
581 council shall also formulate guidelines and standards for organ
582 transplants and for the development of End Stage Organ Disease
583 and Tissue/Organ Transplant programs. The recommendations,
584 guidelines, and standards developed by the council are
585 applicable only to those health programs funded through the
586 agency for Health Care Administration.
587 Section 13. Section 765.541, Florida Statutes, is amended
588 to read:
589 765.541 Certification of procurement organizations engaged
590 in the practice of cadaveric organ and tissue procurement.—The
591 agency for Health Care Administration shall:
592 (1) Establish a program for the certification of
593 organizations, corporations agencies, or other entities engaged
594 in the procurement of organs, tissues, and eyes for
595 transplantation.;
596 (2) Adopt rules that set forth appropriate standards and
597 guidelines for the program in accordance with ss. 765.541
598 765.546 and part II of chapter 408. These standards and
599 guidelines must be substantially based on the existing laws of
600 the Federal Government and this state and the existing standards
601 and guidelines of the United Network for Organ Sharing (UNOS),
602 the American Association of Tissue Banks (AATB), the South
603 Eastern Organ Procurement Foundation (SEOPF), the North American
604 Transplant Coordinators Organization (NATCO), and the Eye Bank
605 Association of America (EBAA). In addition, the agency for
606 Health Care Administration shall, before adopting these
607 standards and guidelines, seek input from all organ procurement
608 organizations, tissue banks, and eye banks based in this state.;
609 (3) Collect, keep, and make available to the Governor and
610 the Legislature information regarding the numbers and
611 disposition of organs, and tissues, and eyes procured by each
612 certified procurement organization. entity;
613 (4) Monitor procurement organizations participating
614 facilities and agencies for program compliance.; and
615 (5) Provide for the administration of the Organ and Tissue
616 Procurement and Transplantation Advisory Board.
617 Section 14. Section 765.542, Florida Statutes, is amended
618 to read:
619 765.542 Certification of organ procurement organizations,
620 tissue banks, and eye banks.—
621 (1) The requirements of part II of chapter 408 apply to the
622 provision of services that require licensure pursuant to ss.
623 765.541-765.546 and part II of chapter 408 and to entities
624 licensed or certified by or applying for such licensure or
625 certification from the agency for Health Care Administration
626 pursuant to ss. 765.541-765.546. A person An organization,
627 agency, or other entity may not engage in the practice of organ
628 procurement in this state without being designated as an organ
629 procurement organization by the secretary of the United States
630 Department of Health and Human Services and being appropriately
631 certified by the agency for Health Care Administration. As used
632 in this subsection, the term “procurement” includes the
633 retrieval, processing, or distribution of human organs. A
634 physician or organ procurement organization based outside this
635 state is exempt from these certification requirements if:
636 (a) The organs are procured for an out-of-state patient who
637 is listed on, or referred through, the United Network for Organ
638 Sharing System; and
639 (b) The organs are procured through an agreement of an
640 organ procurement organization certified by the state.
641 (2) A person An organization, agency, or other entity may
642 not engage in tissue procurement in this state unless it is
643 appropriately certified as a tissue bank by the agency for
644 Health Care Administration. As used in this subsection, the term
645 “procurement” includes any retrieval, processing, storage, or
646 distribution of human tissue for transplantation.
647 (3) A person An organization, agency, or other entity may
648 not engage in the practice of eye procurement in this state
649 without being appropriately certified as an eye bank by the
650 agency for Health Care Administration. As used in this
651 subsection, the term “procurement” includes the retrieval,
652 processing, or distribution of human eye tissue. Funeral
653 directors or direct disposers who that retrieve eye tissue for
654 an eye bank certified under this subsection are exempt from the
655 certification requirements under this subsection.
656 (4) A limited certificate may be issued to a tissue bank or
657 eye bank, certifying only those components of procurement which
658 the bank has chosen to perform. The agency for Health Care
659 Administration may issue a limited certificate if it determines
660 that the tissue bank or eye bank is adequately staffed and
661 equipped to operate in conformity with the rules adopted under
662 this section.
663 Section 15. Subsection (3) of section 765.543, Florida
664 Statutes, is amended to read:
665 765.543 Organ and Tissue Procurement and Transplantation
666 Advisory Board; creation; duties.—
667 (3) The board shall:
668 (a) Assist the agency for Health Care Administration in the
669 development of necessary professional qualifications, including,
670 but not limited to, the education, training, and performance of
671 persons engaged in the various facets of organ and tissue
672 procurement, processing, preservation, and distribution for
673 transplantation;
674 (b) Assist the agency for Health Care Administration in
675 monitoring the appropriate and legitimate expenses associated
676 with organ and tissue procurement, processing, and distribution
677 for transplantation and developing methodologies to assure the
678 uniform statewide reporting of data to facilitate the accurate
679 and timely evaluation of the organ and tissue procurement and
680 transplantation system;
681 (c) Provide assistance to the Florida Medical Examiners
682 Commission in the development of appropriate procedures and
683 protocols to ensure the assure continued improvement in the
684 approval and release of potential organ and tissue donors by the
685 district medical examiners and associate medical examiners;
686 (d) Develop with and recommend to the agency for Health
687 Care Administration the necessary procedures and protocols
688 required to assure that all residents of this state have
689 reasonable access to available organ and tissue transplantation
690 therapy and that residents of this state can be reasonably
691 assured that the statewide procurement transplantation system is
692 will be able to fulfill their organ and tissue requirements
693 within the limits of the available supply and according to the
694 severity of their medical condition and need; and
695 (e) Develop with and recommend to the agency for Health
696 Care Administration any changes to the laws of this state or
697 administrative rules or procedures required to ensure assure
698 that the statewide organ and tissue procurement and
699 transplantation system is will be able to function smoothly,
700 effectively, and efficiently, in accordance with the Federal
701 Anatomical Gift Act and in a manner that assures the residents
702 of this state that no person or entity profits from the
703 altruistic voluntary donation of organs or tissues.
704 Section 16. Section 765.544, Florida Statutes, is amended
705 to read
706 765.544 Fees; organ and tissue donor education and
707 procurement.—
708 (1) In accordance with s. 408.805, an applicant or a
709 certificateholder shall pay a fee for each application submitted
710 under this part, part II of chapter 408, and applicable rules.
711 The amount of the fee shall be as follows:
712 (a) An initial application fee of $1,000 from organ
713 procurement organizations and tissue banks and $500 from eye
714 banks.
715 (b) Annual fees to be used, in the following order of
716 priority, for the certification program, the advisory board,
717 maintenance of the organ and tissue donor registry, and the
718 organ and tissue donor education program in the following
719 amounts, which may not exceed $35,000 per organization:
720 1. Each general organ procurement organization shall pay
721 the greater of $1,000 or 0.25 percent of its total revenues
722 produced from procurement activity in this state by the
723 certificateholder during its most recently completed fiscal year
724 or operational year.
725 2. Each bone and tissue procurement organization agency or
726 bone and tissue bank shall pay the greater of $1,000 or 0.25
727 percent of its total revenues from procurement and processing
728 activity in this state by the certificateholder during its most
729 recently completed fiscal year or operational year.
730 3. Each eye bank shall pay the greater of $500 or 0.25
731 percent of its total revenues produced from procurement activity
732 in this state by the certificateholder during its most recently
733 completed fiscal year or operational year.
734 (2) The agency for Health Care Administration shall specify
735 by rule the administrative penalties for the purpose of ensuring
736 adherence to the standards of quality and practice required by
737 this chapter, part II of chapter 408, and applicable rules of
738 the agency for continued certification.
739 (3)(a) Proceeds from fees, administrative penalties, and
740 surcharges collected pursuant to this section must be deposited
741 into the Health Care Trust Fund.
742 (b) Moneys deposited in the trust fund pursuant to this
743 section must be used exclusively for the implementation,
744 administration, and operation of the certification program and
745 the advisory board, for maintaining the organ and tissue donor
746 registry, and for organ and tissue donor education.
747 (4) As used in this section, the term “procurement activity
748 in this state” includes the bringing into this state for
749 processing, storage, distribution, or transplantation of organs
750 or tissues that are initially procured in another state or
751 country.
752 Section 17. Section 765.545, Florida Statutes, is amended
753 to read:
754 765.545 Physician supervision of cadaveric organ and tissue
755 procurement coordinators.—Organ Procurement organizations,
756 tissue banks, and eye banks may employ coordinators, who are
757 registered nurses, physician's assistants, or other medically
758 trained personnel who meet the relevant standards for organ
759 procurement organizations, tissue banks, or eye banks as adopted
760 by the agency for Health Care Administration under s. 765.541,
761 to assist in the medical management of organ donors or in the
762 surgical procurement of cadaveric organs, tissues, or eyes for
763 transplantation or research. A coordinator who assists in the
764 medical management of organ donors or in the surgical
765 procurement of cadaveric organs, tissues, or eyes for
766 transplantation or research must do so under the direction and
767 supervision of a licensed physician medical director pursuant to
768 rules and guidelines to be adopted by the agency for Health Care
769 Administration. With the exception of organ procurement surgery,
770 this supervision may be indirect supervision. For purposes of
771 this section, the term “indirect supervision” means that the
772 medical director is responsible for the medical actions of the
773 coordinator, that the coordinator is operating under protocols
774 expressly approved by the medical director, and that the medical
775 director or his or her physician designee is always available,
776 in person or by telephone, to provide medical direction,
777 consultation, and advice in cases of organ, tissue, and eye
778 donation and procurement. Although indirect supervision is
779 authorized under this section, direct physician supervision is
780 to be encouraged when appropriate.
781 Section 18. Section 765.547, Florida Statutes, is created
782 to read:
783 765.547 Cooperation between medical examiner and
784 procurement organization.—
785 (1) A medical examiner and procurement organization shall
786 cooperate with each other in order to maximize opportunities to
787 recover anatomical gifts for the purpose of transplantation,
788 therapy, research, or education.
789 (2) The Florida Medical Examiners Commission shall adopt
790 rules establishing cooperative responsibilities between medical
791 examiners and procurement organizations to facilitate and
792 expedite completion of the medical examiner's responsibilities
793 under chapter 406 in a manner that will maximize opportunities
794 to recover anatomical gifts.
795 (3) This part does not supersede any part of chapter 406
796 relating to medical examiners and the disposition of dead
797 bodies.
798 Section 19. Subsection (30) of section 408.802, Florida
799 Statutes, is amended to read:
800 408.802 Applicability.—The provisions of this part apply to
801 the provision of services that require licensure as defined in
802 this part and to the following entities licensed, registered, or
803 certified by the agency, as described in chapters 112, 383, 390,
804 394, 395, 400, 429, 440, 483, and 765:
805 (30) Organ, and tissue, and eye procurement organizations
806 agencies, as provided under part V of chapter 765.
807 Section 20. Subsection (29) of section 408.820, Florida
808 Statutes, is amended to read:
809 408.820 Exemptions.—Except as prescribed in authorizing
810 statutes, the following exemptions shall apply to specified
811 requirements of this part:
812 (29) Organ, and tissue, and eye procurement organizations
813 agencies, as provided under part V of chapter 765, are exempt
814 from s. 408.810(5)-(10).
815 Section 21. This act shall take effect July 1, 2009.
816
817 ================= T I T L E A M E N D M E N T ================
818 And the title is amended as follows:
819 Delete everything before the enacting clause
820 and insert:
821 A bill to be entitled
822 An act relating to anatomical gifts; amending s. 765.511, F.S.;
823 providing additional definitions; amending s. 765.512, F.S.;
824 conforming terms; amending s. 765.513, F.S.; revising the list
825 of donees that may accept anatomical gifts and the purposes for
826 which such gifts may be used; amending ss. 765.514, 765.515,
827 765.5155, and 765.51551, F.S.; conforming terms; amending s.
828 765.516, F.S.; revising provisions relating to a donor's
829 amendment or revocation of an anatomical gift; amending s.
830 765.517, F.S.; revising provisions relating to a donee's use of
831 an anatomical gift at the time of the donor's death; providing
832 liability protection for the person making a gift and for the
833 donor's estate; amending s. 765.521, F.S.; conforming terms;
834 amending s. 765.522, F.S.; providing that the laws of this state
835 govern the interpretation of a valid document of gift, and that
836 a document of gift is presumed to be valid; amending ss. 765.53,
837 765.541, 765.542, 765.543, 765.544, and 765.545, F.S.;
838 conforming terms; creating s. 765.547, F.S.; requiring medical
839 examiners and procurement organizations to cooperate and
840 maximize opportunities for organ donations; authorizing the
841 Florida Medical Examiners Commission to adopt rules; amending
842 ss. 408.802 and 408.820, F.S.; conforming terms; providing an
843 effective date.