CS/CS/HB 209

1	A bill to be entitled
2	An act relating to anatomical gifts; amending s. 765.511,
3	F.S.; providing additional definitions; amending s.
4	765.512, F.S.; conforming terms; amending s. 765.513,
5	F.S.; revising the list of donees that may accept
6	anatomical gifts and the purposes for which such gifts may
7	be used; amending ss. 765.514, 765.515, 765.5155, and
8	765.51551, F.S.; conforming terms; amending s. 765.516,
9	F.S.; revising provisions relating to a donor's amendment
10	or revocation of an anatomical gift; amending s. 765.517,
11	F.S.; revising provisions relating to a donee's use of an
12	anatomical gift at the time of the donor's death;
13	providing liability protection for the person making a
14	gift and for the donor's estate; amending s. 765.521,
15	F.S.; conforming terms; amending s. 765.522, F.S.;
16	providing that the laws of this state govern the
17	interpretation of a valid document of gift and that a
18	document of gift is presumed to be valid; amending ss.
19	765.53, 765.541, 765.542, 765.543, 765.544, and 765.545,
20	F.S.; conforming terms; creating s. 765.547, F.S.;
21	requiring medical examiners and procurement organizations
22	to cooperate and maximize opportunities for organ
23	donations; authorizing the Florida Medical Examiners
24	Commission to adopt rules; amending ss. 408.802 and
25	408.820, F.S.; conforming terms; providing an effective
26	date.
27
28	Be It Enacted by the Legislature of the State of Florida:
29
30	Section 1.  Section 765.511, Florida Statutes, is amended
31	to read:
32	765.511  Definitions.--As used in this part, the term:
33	(1)  "Agency" means the Agency for Health Care
34	Administration.
35	(2)  "Anatomical gift" or "gift" means a donation of all or
36	part of a human body to take effect after the donor's death and
37	to be used for transplantation, therapy, research, or education.
38	(3)(1)  "Bank" or "storage facility" means a facility
39	licensed, accredited, or approved under the laws of any state
40	for storage of human bodies or body parts thereof.
41	(4)(2)  "Death" means the absence of life as determined, in
42	accordance with currently accepted medical standards, by the
43	irreversible cessation of all respiration and circulatory
44	function, or as determined, in accordance with s. 382.009, by
45	the irreversible cessation of the functions of the entire brain,
46	including the brain stem.
47	(5)  "Decedent" means a deceased individual whose body or
48	body parts may be, or are, the source of an anatomical gift.
49	(6)  "Department" means the Department of Highway Safety
50	and Motor Vehicles.
51	(7)  "Disinterested witness" means a witness other than a
52	person listed in s. 765.512(3) or other family member.
53	(8)  "Document of gift" means any of the documents or
54	mechanisms used in making an anatomical gift under s. 765.514.
55	(9)(3)  "Donor" means an individual who makes an anatomical
56	a gift of all or part of his or her body.
57	(10)  "Donor registry" means a database that contains
58	records of anatomical gifts and amendments to, or revocations
59	of, such gifts.
60	(11)  "Eye bank" means an entity that is accredited by the
61	Eye Bank Association of America or otherwise regulated under
62	federal or state law to engage in the retrieval, screening,
63	testing, processing, storage, or distribution of human eye
64	tissue.
65	(12)  "Guardian" means a person appointed pursuant to
66	chapter 744. The term does not include a guardian ad litem.
67	(13)(4)  "Hospital" means a hospital licensed, accredited,
68	or approved under the laws of any state and includes a hospital
69	operated by the United States Government or a state, or a
70	subdivision thereof, although not required to be licensed under
71	state laws.
72	(14)  "Identification card" means an official
73	identification card issued by a governmental entity, state
74	agency, or subdivision thereof.
75	(15)  "Organ procurement organization" means an entity that
76	is designated as an organ procurement organization by the
77	Secretary of the United States Department of Health and Human
78	Services and that engages in the retrieval, screening, testing,
79	processing, storage, or distribution of human organs.
80	(16)  "Part of the body" or "body part" means an organ,
81	eye, or tissue of a human being. The term does not include the
82	whole body.
83	(17)(5)  "Physician" or "surgeon" means a physician or
84	surgeon licensed to practice under chapter 458 or chapter 459 or
85	similar laws of any state. "Surgeon" includes dental or oral
86	surgeon.
87	(18)  "Procurement" means any retrieval, recovery,
88	processing, storage, or distribution of human organs or tissues
89	for transplantation, therapy, research, or education.
90	(19)  "Procurement organization" means an organ procurement
91	organization, eye bank, or tissue bank.
92	(20)  "Reasonably available" means able to be contacted by
93	a procurement organization in a timely manner without undue
94	effort, and willing and able to act in a manner consistent with
95	existing medical protocols necessary for the making of an
96	anatomical gift.
97	(21)  "Record" means information that is inscribed on a
98	tangible medium or that is stored in an electronic or other
99	medium and is retrievable in perceivable form.
100	(22)  "Sign" or "signed" means, with the present intent to
101	authenticate or adopt a record, to execute or adopt a tangible
102	symbol, or attach to or logically associate an electronic
103	symbol, sound, or process with the record.
104	(23)  "Tissue bank" means an entity that is accredited by
105	the American Association of Tissue Banks or otherwise regulated
106	under federal or state law to engage in the retrieval,
107	screening, testing, processing, storage, or distribution of
108	human tissue.
109	Section 2.  Subsections (1), (4), (5), (6), and (7) of
110	section 765.512, Florida Statutes, are amended to read:
111	765.512  Persons who may make an anatomical gift.--
112	(1)  Any person who may make a will may make an anatomical
113	gift give all or part of his or her body for any purpose
114	specified in s. 765.513. The gift is effective upon the death of
115	the donor.
116	(a)  If the decedent makes an anatomical gift by one of the
117	methods listed in s. 765.514(1), and in the absence of actual
118	notice of contrary indications by the decedent, the document or
119	entry in the donor organ and tissue registry is legally
120	sufficient evidence of the decedent's informed consent to donate
121	an anatomical gift.
122	(b)  An anatomical gift made by a qualified donor and not
123	revoked by the donor, as provided in s. 765.516, is irrevocable
124	after the donor's death. A family member, guardian,
125	representative ad litem, or health care surrogate may not
126	modify, deny, or prevent a donor's wish or intent to make an
127	anatomical gift after the donor's death.
128	(4)  A donee may not accept an anatomical gift if the donee
129	has actual notice of contrary indications by the donor or actual
130	notice that an anatomical a gift by a member of a class is
131	opposed by a member of a prior class.
132	(5)  The person authorized by subsection (3) may make the
133	anatomical gift after the decedent's death or immediately before
134	the decedent's death.
135	(6)  An anatomical A gift of all or part of a body
136	authorizes:
137	(a)  Any examination necessary to assure medical
138	acceptability of the gift for the purposes intended.
139	(b)  The decedent's medical provider, family, or a third
140	party to furnish medical records requested concerning the
141	decedent's medical and social history.
142	(7)  Once the anatomical gift has been made, the rights of
143	the donee are paramount to the rights of others, except as
144	provided by s. 765.517.
145	Section 3.  Section 765.513, Florida Statutes, is amended
146	to read:
147	765.513  Persons and entities that may become Donees;
148	purposes for which anatomical gifts may be made.--
149	(1)  The following persons or entities may become donees of
150	anatomical gifts of bodies or parts of them for the purposes
151	stated:
152	(a)(1)  Any procurement organization or accredited
153	hospital, surgeon, or physician for medical or dental school,
154	college, or university for education, or research, advancement
155	of medical or dental science, therapy, or transplantation.
156	(2)  Any accredited medical or dental school, college, or
157	university for education, research, advancement of medical or
158	dental science, or therapy.
159	(3)  Any bank or storage facility for medical or dental
160	education, research, advancement of medical or dental science,
161	therapy, or transplantation.
162	(b)(4)  Any individual specified by name for therapy or
163	transplantation needed by him or her.
164	(2)  If multiple purposes are set forth in the document of
165	gift but are not set forth in any priority order, the anatomical
166	gift shall be used first for transplantation or therapy, if
167	suitable. If the gift cannot be used for transplantation or
168	therapy, the gift may be used for research or education.
169	(3)  However, The Legislature declares that the public
170	policy of this state prohibits restrictions on the possible
171	recipients of an anatomical gift on the basis of race, color,
172	religion, gender sex, national origin, age, physical disability
173	handicap, health status, marital status, or economic status, and
174	such restrictions are hereby declared void and unenforceable.
175	Section 4.  Section 765.514, Florida Statutes, is amended
176	to read:
177	765.514  Manner of making anatomical gifts.--
178	(1)  A person may make an anatomical a gift of all or part
179	of his or her body under s. 765.512(1) by:
180	(a)  Signing an organ and tissue donor card.
181	(b)  Registering online with the organ and tissue donor
182	registry.
183	(c)  Signifying an intent to donate on his or her driver's
184	license or identification card issued by the department of
185	Highway Safety and Motor Vehicles. Revocation, suspension,
186	expiration, or cancellation of the driver's license or
187	identification card does not invalidate the gift.
188	(d)  Expressing a wish to donate in a living will or other
189	advance directive.
190	(e)  Executing a will that includes a provision indicating
191	that the testator wishes to make an anatomical gift. The gift
192	becomes effective upon the death of the testator without waiting
193	for probate. If the will is not probated or if it is declared
194	invalid for testamentary purposes, the gift is nevertheless
195	valid to the extent that it has been acted upon in good faith.
196	(f)  Expressing a wish to donate in a document other than a
197	will. The document must be signed by the donor in the presence
198	of two witnesses who shall sign the document in the donor's
199	presence. If the donor cannot sign, the document may be signed
200	for him or her at the donor's direction and in his or her
201	presence and the presence of two witnesses who must sign the
202	document in the donor's presence. Delivery of the document of
203	gift during the donor's lifetime is not necessary to make the
204	gift valid. The following form of written document is sufficient
205	for any person to make an anatomical gift give all or part of
206	his or her body for the purposes of this part:
207
208	UNIFORM DONOR CARD
209
210	The undersigned hereby makes this anatomical gift, if medically
211	acceptable, to take effect on death. The words and marks below
212	indicate my desires:
213	I give:
214	(a)  .... any needed organs, tissues, or eyes;
215	(b)  .... only the following organs, tissues, or eyes
216	...[Specify the organs, tissues, or eyes]...
217	for the purpose of transplantation, therapy, medical research,
218	or education;
219	(c)  .... my body for anatomical study if needed.
220	Limitations or special wishes, if any:
221	...(If applicable, list specific donee; this must be arranged in
222	advance with the donee.)...
223
224	Signed by the donor and the following witnesses in the presence
225	of each other:
226
227	...(Signature of donor)...     ...(Date of birth of donor)...
228	...(Date signed)...     ...(City and State)...
229
230	...(Witness)...     ...(Witness)...
231	...(Address)...     ...(Address)...
232
233	(2)  The anatomical gift may be made to a donee listed in
234	s. 765.513, and the donee may be specified by name.
235	(3)  Any anatomical gift by a health care surrogate
236	designated by the decedent pursuant to part II of this chapter
237	or a member of a class designated in s. 765.512(3) must be made
238	by a document signed by that person or made by that person's
239	witnessed telephonic discussion, telegraphic message, or other
240	recorded message.
241	Section 5.  Section 765.515, Florida Statutes, is amended
242	to read:
243	765.515  Delivery of donor document.--
244	(1)  If an anatomical a gift is made pursuant to s.
245	765.521, the completed donor registration card shall be
246	delivered to the department of Highway Safety and Motor Vehicles
247	and the department must communicate the donor's intent to the
248	organ and tissue donor registry, but delivery is not necessary
249	to the validity of the gift. If the donor withdraws the gift,
250	the records of the department of Highway Safety and Motor
251	Vehicles must be updated to reflect such withdrawal and the
252	department must communicate the withdrawal to the organ and
253	tissue donor registry for the purpose of updating the registry.
254	(2)  If an anatomical a gift is made by the donor to a
255	specified donee, the document of gift, other than a will, may be
256	delivered to the donee to expedite the appropriate procedures
257	immediately after death, but delivery is not necessary to the
258	validity of the gift. The Such document of gift may be deposited
259	in any hospital, bank, storage facility, or registry office that
260	accepts such documents for safekeeping or to facilitate the
261	donation of organs and tissue after death.
262	(3)  At the request of any interested party upon or after
263	the donor's death, the person in possession shall produce the
264	document of gift for examination.
265	Section 6.  Section 765.5155, Florida Statutes, is amended
266	to read:
267	765.5155  Organ and tissue Donor registry; education
268	program.--
269	(1)  The Legislature finds that:
270	(a)  There is a shortage of organ and tissue donors in this
271	state willing to provide the organs and tissue that could save
272	lives or enhance the quality of life for many persons.
273	(b)  There is a need to encourage the various minority
274	populations of this state to donate organs and tissue.
275	(c)  A statewide organ and tissue donor registry having an
276	online donor registration process coupled with an enhanced
277	program of donor education will lead to an increase in the
278	number of organ and tissue donors registered in this state, thus
279	affording more persons who are awaiting organ or tissue
280	transplants the opportunity for a full and productive life.
281	(2)  The agency for Health Care Administration and the
282	department of Highway Safety and Motor Vehicles shall jointly
283	contract for the operation of a an organ and tissue donor
284	registry and education program. The contractor shall be procured
285	by competitive solicitation pursuant to chapter 287,
286	notwithstanding any exemption in s. 287.057(5)(f). When awarding
287	the contract, priority shall be given to existing nonprofit
288	groups that are based within the state, have expertise working
289	with organ and tissue procurement organizations, have expertise
290	in conducting statewide organ and tissue donor public education
291	campaigns, and represent the needs of the organ and tissue
292	donation community in the state.
293	(3)  The contractor shall be responsible for:
294	(a)  The development, implementation, and maintenance of an
295	interactive web-based organ and tissue donor registry that,
296	through electronic means, allows for online organ donor
297	registration and the recording of organ and tissue donation
298	records submitted through the driver's license identification
299	program or through other sources.
300	1.  The registry must be maintained in a manner that
301	allows, through electronic and telephonic methods, immediate
302	access to organ and tissue donation records 24 hours a day, 7
303	days a week.
304	2.  Access to the registry must be through coded and secure
305	means to protect the integrity of the data in the registry.
306	(b)  A continuing program to educate and inform medical
307	professionals, law enforcement agencies and officers, other
308	state and local government employees, high school students,
309	minorities, and the public about the laws of this state relating
310	to anatomical gifts and the need for anatomical gifts.
311	1.  Existing community resources, when available, must be
312	used to support the program and volunteers may assist the
313	program to the maximum extent possible.
314	2.  The contractor shall coordinate with the head of a
315	state agency or other political subdivision of the state, or his
316	or her designee, to establish convenient times, dates, and
317	locations for educating that entity's employees.
318	(c)  Preparing and submitting an annual written report to
319	the agency for Health Care Administration by December 31 of each
320	year. The report must include:
321	1.  The number of donors on the registry and an analysis of
322	the registration rates by location and method of donation;
323	2.  The characteristics of donors as determined from
324	registry information submitted directly by the donors or by the
325	department of Highway Safety and Motor Vehicles;
326	3.  The annual dollar amount of voluntary contributions
327	received by the contractor;
328	4.  A description of the educational campaigns and
329	initiatives implemented during the year and an evaluation of
330	their effectiveness in increasing enrollment on the registry;
331	and
332	5.  An analysis of Florida's registry compared with other
333	states' donor registries.
334	(4)  Costs for the organ and tissue donor registry and
335	education program shall be paid by the agency for Health Care
336	Administration from the funds deposited into the Health Care
337	Trust Fund pursuant to ss. 320.08047 and 322.08, which are
338	designated for maintaining the organ and tissue donor registry
339	and education program. In addition, the contractor may receive
340	and use voluntary contributions to help support the registry and
341	provide education.
342	(5)  The organ and tissue donor registry established by
343	this section is designated as the "Joshua Abbott Organ and
344	Tissue Registry."
345	Section 7.  Section 765.51551, Florida Statutes, is amended
346	to read
347	765.51551  Organ and tissue Donor registry; public records
348	exemption.--
349	(1)  Information held in the organ and tissue donor
350	registry which identifies a donor is confidential and exempt
351	from s. 119.07(1) and s. 24(a), Art. I of the State
352	Constitution.
353	(2)  Such information may be disclosed to the following:
354	(a)  Organ, tissue, and eye Procurement organizations that
355	have been certified by the agency for Health Care Administration
356	for the purpose of ascertaining or effectuating the existence of
357	a gift under s. 765.522.
358	(b)  Persons engaged in bona fide research if the person
359	agrees to:
360	1.  Submit a research plan to the agency that specifies the
361	exact nature of the information requested and the intended use
362	of the information;
363	2.  Maintain the confidentiality of the records or
364	information if personal identifying information is made
365	available to the researcher;
366	3.  Destroy any confidential records or information
367	obtained after the research is concluded; and
368	4.  Not directly or indirectly contact, for any purpose,
369	any donor or donee.
370	(3)  This section is subject to the Open Government Sunset
371	Review Act in accordance with s. 119.15 and shall stand repealed
372	on October 2, 2013, unless reviewed and saved from repeal
373	through reenactment by the Legislature.
374	Section 8.  Section 765.516, Florida Statutes, is amended
375	to read:
376	765.516  Donor amendment of the terms of or the revocation
377	of anatomical the gift.--
378	(1)  A donor may amend the terms of or revoke an anatomical
379	gift by:
380	(a)  The execution and delivery to the donee of a signed
381	statement witnessed by at least two adults, at least one of whom
382	is a disinterested witness.
383	(b)  An oral statement that is made in the presence of two
384	persons, one of whom is must not be a family member, and
385	communicated to the donor's family or attorney or to the donee.
386	An oral statement is effective only if the procurement
387	organization, transplant hospital, or physician or technician
388	has actual notice of the oral amendment or revocation before an
389	incision is made to the decedent's body or an invasive procedure
390	to prepare the recipient has begun.
391	(c)  A statement made during a terminal illness or injury
392	addressed to an attending physician, who must communicate the
393	revocation of the gift to the procurement organization that is
394	certified by the state.
395	(d)  A signed document found on or about the donor's
396	person.
397	(e)  Removing his or her name from the organ and tissue
398	donor registry.
399	(f)  A later-executed document of gift which amends or
400	revokes a previous anatomical gift or portion of an anatomical
401	gift, either expressly or by inconsistency.
402	(g)  The destruction or cancellation of the document of
403	gift or the destruction or cancellation of that portion of the
404	document of gift used to make the gift with the intent to revoke
405	the gift.
406	(2)  Any anatomical gift made by a will may also be amended
407	or revoked in the manner provided for the amendment or
408	revocation of wills or as provided in paragraph (1)(a)
409	subsection (1).
410	Section 9.  Section 765.517, Florida Statutes, is amended
411	to read:
412	765.517  Rights and duties at death.--
413	(1)  The donee, pursuant to as specified under the
414	provisions of s. 765.515(2), may accept or reject an anatomical
415	the gift. If the donee accepts a gift of the entire body or a
416	part of the body to be used for research or education scientific
417	purposes other than a transplant, the donee may authorize
418	embalming and the use of the body in funeral services, subject
419	to the terms of the gift. If the gift is of a part of the body,
420	the donee shall cause the part to be removed without unnecessary
421	mutilation upon the death of the donor and before or after
422	embalming. After removal of the body part, custody of the
423	remainder of the body vests in the surviving spouse, next of
424	kin, or other persons under obligation to dispose of the body.
425	(2)  The time of death shall be determined by a physician
426	who attends the donor at the donor's death or, if there is no
427	such physician, the physician who certifies the death. After
428	death, those physicians or the donor's primary care and in the
429	absence of other qualified personnel, this physician may
430	participate in, but may shall not obstruct, the procedures to
431	preserve the donor's organs or tissues and may shall not be paid
432	or reimbursed for such participation by, nor be associated with
433	or employed by, a an organ procurement organization, tissue
434	bank, or eye bank. These physicians may This physician shall not
435	participate in the procedures for removing or transplanting a
436	part. However, this subsection does not prevent a physician from
437	serving in a voluntary capacity on the board of directors of a
438	procurement organization or participating on any board, council,
439	commission, or similar body related to the organ and tissue
440	procurement system.
441	(3)  The organ procurement organizations organization,
442	tissue bank, or eye bank, or hospital medical professionals
443	under the direction thereof, may perform any and all tests to
444	evaluate the deceased as a potential donor and any invasive
445	procedures on the deceased body in order to preserve the
446	potential donor's organs. These procedures do not include the
447	surgical removal of an organ or penetrating any body cavity,
448	specifically for the purpose of donation, until:
449	(a)  It has been verified that the deceased's consent to
450	donate appears in the organ and tissue donor registry or a
451	properly executed donor card or document of gift is located; or
452	(b)  If a properly executed donor card or document of gift
453	cannot be located or the deceased's consent is not listed in the
454	organ and tissue donor registry, a person specified in s.
455	765.512(2) or (3) has been located, has been notified of the
456	death, and has granted legal permission for the donation.
457	(4)  All reasonable additional expenses incurred in the
458	procedures to preserve the donor's organs or tissues shall be
459	reimbursed by the organ procurement organization, tissue bank,
460	or eye bank.
461	(5)  A person who acts in good faith and without negligence
462	in accord with the terms of this part or under the anatomical
463	gift laws of another state or a foreign country, or attempts to
464	do so, may not be subject to any civil action for damages, may
465	not be subject to any criminal proceeding, and may not be
466	subject to discipline, penalty, or liability in any
467	administrative proceeding is not liable for damages in any civil
468	action or subject to prosecution for his or her acts in any
469	criminal proceeding.
470	(6)  The provisions of this part are subject to the laws of
471	this state prescribing powers and duties with respect to
472	autopsies.
473	(7)  The person making an anatomical gift and the donor's
474	estate are not liable for any injury or damages that result from
475	the making or use of the gift.
476	(8)  In determining whether an anatomical gift has been
477	made, amended, or revoked under this part, a person may rely
478	upon the representation of an individual listed in s. 765.512,
479	relating to the individual's relationship to the donor or
480	prospective donor, unless the person knows that the
481	representation is untrue.
482	Section 10.  Section 765.521, Florida Statutes, is amended
483	to read:
484	765.521  Donations as part of driver license or
485	identification card process.--
486	(1)  The agency for Health Care Administration and the
487	department of Highway Safety and Motor Vehicles shall develop
488	and implement a program encouraging and allowing persons to make
489	anatomical gifts as a part of the process of issuing
490	identification cards and issuing and renewing driver licenses.
491	The donor registration card distributed by the department of
492	Highway Safety and Motor Vehicles shall include the information
493	required by the uniform donor card under s. 765.514 and such
494	additional information as determined necessary by the
495	department. The department shall also develop and implement a
496	program to identify donors, which includes notations on
497	identification cards, driver licenses, and driver records or
498	such other methods as the department develops to clearly
499	indicate the individual's intent to make an anatomical gift
500	donate the individual's organs, tissues, or eyes. A notation on
501	an individual's driver license or identification card that the
502	individual intends to make an anatomical gift donate organs,
503	tissues, or eyes satisfies all requirements for consent to organ
504	or tissue donation. The agency for Health Care Administration
505	shall provide the necessary supplies and forms from funds
506	appropriated from general revenue or contributions from
507	interested voluntary, nonprofit organizations. The department
508	shall provide the necessary recordkeeping system from funds
509	appropriated from general revenue. The department of Highway
510	Safety and Motor Vehicles and the agency for Health Care
511	Administration shall incur no liability in connection with the
512	performance of any acts authorized herein.
513	(2)  The department of Highway Safety and Motor Vehicles,
514	after consultation with and concurrence by the agency for Health
515	Care Administration, shall adopt rules to implement the
516	provisions of this section according to the provisions of
517	chapter 120.
518	(3)  Funds expended by the agency for Health Care
519	Administration to carry out the intent of this section may shall
520	not be taken from any funds appropriated for patient care.
521	Section 11.  Section 765.522, Florida Statutes, is amended
522	to read:
523	765.522  Duty of certain hospital administrators; liability
524	of hospital administrators and, organ procurement organizations,
525	eye banks, and tissue banks.--
526	(1)  When used in this section, "hospital" means any
527	establishment licensed under chapter 395 except psychiatric and
528	rehabilitation hospitals.
529	(1)(2)  If Where, based on accepted medical standards, a
530	hospital patient is a suitable candidate for organ or tissue
531	donation, the hospital administrator or the hospital
532	administrator's designee shall, at or near the time of death,
533	notify the appropriate procurement organization organ, eye, or
534	tissue recovery program, which shall access the organ and tissue
535	donor registry created by s. 765.5155 or any other donor
536	registry to ascertain the existence of an entry in the registry
537	which that has not been revoked, a donor card, or a document of
538	gift executed by the decedent. In the absence of an entry in the
539	donor registry, a document of gift donor card, organ donation
540	sticker or organ donation imprint on a driver's license, or
541	other properly executed document, the procurement organization
542	organ, eye, or tissue recovery program shall request:
543	(a)  The patient's health care surrogate, as authorized in
544	s. 765.512(2); or
545	(b)  If the patient does not have a surrogate, or the
546	surrogate is not reasonably available, any of the persons
547	specified in s. 765.512(3), in the order and manner listed,
548
549	to consent to the anatomical gift of all or any part of the
550	decedent's body for any purpose specified in this part. Except
551	as provided in s. 765.512, in the absence of actual notice of
552	opposition, consent need only be obtained from the person or
553	persons in the highest priority class reasonably available.
554	(3)  A document of gift is valid if made pursuant to a
555	request required by this section shall be executed in accordance
556	with this part or the laws of the state or country where it was
557	executed and where the person making the anatomical gift was
558	domiciled, has a place of residence, or was a citizen at the
559	time the document of gift was executed pursuant to s. 765.514.
560	(4)  The agency for Health Care Administration shall
561	establish rules and guidelines concerning the education of
562	individuals who may be designated to perform the request and the
563	procedures to be used in making the request. The agency is
564	authorized to adopt rules concerning the documentation of the
565	request, where such request is made.
566	(5)  If a document of gift is valid under this section, the
567	laws of this state govern the interpretation of the document of
568	gift.
569	(6)  A document of gift or amendment of an anatomical gift
570	is presumed to be valid unless it was not validly executed or
571	was revoked.
572	(7)(5)  There shall be no civil or criminal liability
573	against any organ procurement organization, eye bank, or tissue
574	bank certified under s. 765.542, or against any hospital or
575	hospital administrator or designee who complies, when complying
576	with the provisions of this part and agency the rules of the
577	agency for Health Care Administration or if when, in the
578	exercise of reasonable care, a request for organ donation is
579	inappropriate and the gift is not made according to this part
580	and agency the rules of the agency for Health Care
581	Administration.
582	(8)(6)  The hospital administrator or a designee shall, at
583	or near the time of death of a potential organ donor, directly
584	notify the affiliated organ procurement organization designated
585	by the United States Department of Health and Human Services of
586	the potential organ donor. The This organ procurement
587	organization must offer any organ from such a donor first to
588	patients on a Florida-based local or state organ sharing
589	transplant list. For the purpose of this subsection, the term
590	"transplant list" includes certain categories of national or
591	regional organ sharing for patients of exceptional need or
592	exceptional match, as approved or mandated by the Organ
593	Procurement and Transplantation Network, or its agent. This
594	notification may not be made to a tissue bank or eye bank in
595	lieu of the organ procurement organization unless the tissue
596	bank or eye bank is also designated as an organ procurement
597	organization by the United States Department of Health and Human
598	Services.
599	Section 12.  Subsections (1), (5), and (6) of section
600	765.53, Florida Statutes, are amended to read:
601	765.53  Organ Transplant Advisory Council; membership;
602	responsibilities.--
603	(1)  There is hereby created within the agency for Health
604	Care Administration A statewide technical Organ Transplant
605	Advisory Council is created within the agency, consisting of 12
606	twelve members who are physicians licensed under chapter 458 or
607	chapter 459, to represent the interests of the public and the
608	clients of the Department of Health or the agency. The members
609	shall be physicians licensed according to chapter 458 or chapter
610	459. A person employed by the agency may not be appointed as a
611	member of the council.
612	(5)  Members of the council shall receive no compensation,
613	but shall be reimbursed for per diem and travel expenses by the
614	agency for Health Care Administration in accordance with the
615	provisions of s. 112.061 while engaged in the performance of
616	their duties.
617	(6)  The responsibilities of the council shall be to
618	recommend to the agency for Health Care Administration
619	indications for adult and pediatric organ transplants. The
620	council shall also formulate guidelines and standards for organ
621	transplants and for the development of End Stage Organ Disease
622	and Tissue/Organ Transplant programs. The recommendations,
623	guidelines, and standards developed by the council are
624	applicable only to those health programs funded through the
625	agency for Health Care Administration.
626	Section 13.  Section 765.541, Florida Statutes, is amended
627	to read:
628	765.541  Certification of procurement organizations; agency
629	responsibilities engaged in the practice of cadaveric organ and
630	tissue procurement.--The agency for Health Care Administration
631	shall:
632	(1)  Establish a program for the certification of
633	organizations, corporations agencies, or other entities engaged
634	in the procurement of organs, tissues, and eyes for
635	transplantation.;
636	(2)  Adopt rules that set forth appropriate standards and
637	guidelines for the program in accordance with ss. 765.541-
638	765.546 and part II of chapter 408. These standards and
639	guidelines must be substantially based on the existing laws of
640	the Federal Government and this state and the existing standards
641	and guidelines of the United Network for Organ Sharing (UNOS),
642	the American Association of Tissue Banks (AATB), the South-
643	Eastern Organ Procurement Foundation (SEOPF), the North American
644	Transplant Coordinators Organization (NATCO), and the Eye Bank
645	Association of America (EBAA). In addition, the agency for
646	Health Care Administration shall, before adopting these
647	standards and guidelines, seek input from all organ procurement
648	organizations, tissue banks, and eye banks based in this state.;
649	(3)  Collect, keep, and make available to the Governor and
650	the Legislature information regarding the numbers and
651	disposition of organs, and tissues, and eyes procured by each
652	certified procurement organization. entity;
653	(4)  Monitor procurement organizations participating
654	facilities and agencies for program compliance.; and
655	(5)  Provide for the administration of the Organ and Tissue
656	Procurement and Transplantation Advisory Board.
657	Section 14.  Section 765.542, Florida Statutes, is amended
658	to read:
659	765.542  Requirements to engage in organ, tissue, or eye
660	Certification of organ procurement organizations, tissue banks,
661	and eye banks.--
662	(1)  The requirements of part II of chapter 408 apply to
663	the provision of services that require licensure pursuant to ss.
664	765.541-765.546 and part II of chapter 408 and to entities
665	licensed or certified by or applying for such licensure or
666	certification from the agency for Health Care Administration
667	pursuant to ss. 765.541-765.546. A person An organization,
668	agency, or other entity may not engage in the practice of organ
669	procurement in this state without being designated as an organ
670	procurement organization by the secretary of the United States
671	Department of Health and Human Services and being appropriately
672	certified by the agency for Health Care Administration. As used
673	in this subsection, the term "procurement" includes the
674	retrieval, processing, or distribution of human organs. A
675	physician or organ procurement organization based outside this
676	state is exempt from these certification requirements if:
677	(a)  The organs are procured for an out-of-state patient
678	who is listed on, or referred through, the United Network for
679	Organ Sharing System; and
680	(b)  The organs are procured through an agreement of an
681	organ procurement organization certified by the state.
682	(2)  A person An organization, agency, or other entity may
683	not engage in tissue procurement in this state unless it is
684	appropriately certified as a tissue bank by the agency for
685	Health Care Administration. As used in this subsection, the term
686	"procurement" includes any retrieval, processing, storage, or
687	distribution of human tissue for transplantation.
688	(3)  A person An organization, agency, or other entity may
689	not engage in the practice of eye procurement in this state
690	without being appropriately certified as an eye bank by the
691	agency for Health Care Administration. As used in this
692	subsection, the term "procurement" includes the retrieval,
693	processing, or distribution of human eye tissue. Funeral
694	directors or direct disposers who that retrieve eye tissue for
695	an eye bank certified under this subsection are exempt from the
696	certification requirements under this subsection.
697	(4)  A limited certificate may be issued to a tissue bank
698	or eye bank, certifying only those components of procurement
699	which the bank has chosen to perform. The agency for Health Care
700	Administration may issue a limited certificate if it determines
701	that the tissue bank or eye bank is adequately staffed and
702	equipped to operate in conformity with the rules adopted under
703	this section.
704	Section 15.  Subsection (3) of section 765.543, Florida
705	Statutes, is amended to read:
706	765.543  Organ and Tissue Procurement and Transplantation
707	Advisory Board; creation; duties.--
708	(3)  The board shall:
709	(a)  Assist the agency for Health Care Administration in
710	the development of necessary professional qualifications,
711	including, but not limited to, the education, training, and
712	performance of persons engaged in the various facets of organ
713	and tissue procurement, processing, preservation, and
714	distribution for transplantation;
715	(b)  Assist the agency for Health Care Administration in
716	monitoring the appropriate and legitimate expenses associated
717	with organ and tissue procurement, processing, and distribution
718	for transplantation and developing methodologies to ensure
719	assure the uniform statewide reporting of data to facilitate the
720	accurate and timely evaluation of the organ and tissue
721	procurement and transplantation system;
722	(c)  Provide assistance to the Florida Medical Examiners
723	Commission in the development of appropriate procedures and
724	protocols to ensure assure continued improvement in the approval
725	and release of potential organ and tissue donors by the district
726	medical examiners and associate medical examiners;
727	(d)  Develop with and recommend to the agency for Health
728	Care Administration the necessary procedures and protocols
729	required to assure that all residents of this state have
730	reasonable access to available organ and tissue transplantation
731	therapy and that residents of this state can be reasonably
732	assured that the statewide procurement transplantation system is
733	will be able to fulfill their organ and tissue requirements
734	within the limits of the available supply and according to the
735	severity of their medical condition and need; and
736	(e)  Develop with and recommend to the agency for Health
737	Care Administration any changes to the laws of this state or
738	administrative rules or procedures required to ensure assure
739	that the statewide organ and tissue procurement and
740	transplantation system is will be able to function smoothly,
741	effectively, and efficiently, in accordance with the Federal
742	Anatomical Gift Act and in a manner that assures the residents
743	of this state that no person or entity profits from the
744	altruistic voluntary donation of organs or tissues.
745	Section 16.  Section 765.544, Florida Statutes, is amended
746	to read
747	765.544  Fees; organ and tissue donor education and
748	procurement.--
749	(1)  In accordance with s. 408.805, an applicant or a
750	certificateholder shall pay a fee for each application submitted
751	under this part, part II of chapter 408, and applicable rules.
752	The amount of the fee shall be as follows:
753	(a)  An initial application fee of $1,000 from organ
754	procurement organizations and tissue banks and $500 from eye
755	banks.
756	(b)  Annual fees to be used, in the following order of
757	priority, for the certification program, the advisory board,
758	maintenance of the organ and tissue donor registry, and the
759	organ and tissue donor education program in the following
760	amounts, which may not exceed $35,000 per organization:
761	1.  Each general organ procurement organization shall pay
762	the greater of $1,000 or 0.25 percent of its total revenues
763	produced from procurement activity in this state by the
764	certificateholder during its most recently completed fiscal year
765	or operational year.
766	2.  Each bone and tissue procurement organization agency or
767	bone and tissue bank shall pay the greater of $1,000 or 0.25
768	percent of its total revenues from procurement and processing
769	activity in this state by the certificateholder during its most
770	recently completed fiscal year or operational year.
771	3.  Each eye bank shall pay the greater of $500 or 0.25
772	percent of its total revenues produced from procurement activity
773	in this state by the certificateholder during its most recently
774	completed fiscal year or operational year.
775	(2)  The agency for Health Care Administration shall
776	specify by rule the administrative penalties for the purpose of
777	ensuring adherence to the standards of quality and practice
778	required by this chapter, part II of chapter 408, and applicable
779	rules of the agency for continued certification.
780	(3)(a)  Proceeds from fees, administrative penalties, and
781	surcharges collected pursuant to this section must be deposited
782	into the Health Care Trust Fund.
783	(b)  Moneys deposited in the trust fund pursuant to this
784	section must be used exclusively for the implementation,
785	administration, and operation of the certification program and
786	the advisory board, for maintaining the organ and tissue donor
787	registry, and for organ and tissue donor education.
788	(4)  As used in this section, the term "procurement
789	activity in this state" includes the bringing into this state
790	for processing, storage, distribution, or transplantation of
791	organs or tissues that are initially procured in another state
792	or country.
793	Section 17.  Section 765.545, Florida Statutes, is amended
794	to read:
795	765.545  Physician supervision of cadaveric organ and
796	tissue procurement coordinators.--Organ Procurement
797	organizations, tissue banks, and eye banks may employ
798	coordinators, who are registered nurses, physician's assistants,
799	or other medically trained personnel who meet the relevant
800	standards for organ procurement organizations, tissue banks, or
801	eye banks as adopted by the agency for Health Care
802	Administration under s. 765.541, to assist in the medical
803	management of organ donors or in the surgical procurement of
804	cadaveric organs, tissues, or eyes for transplantation or
805	research. A coordinator who assists in the medical management of
806	organ donors or in the surgical procurement of cadaveric organs,
807	tissues, or eyes for transplantation or research must do so
808	under the direction and supervision of a licensed physician
809	medical director pursuant to rules and guidelines to be adopted
810	by the agency for Health Care Administration. With the exception
811	of organ procurement surgery, this supervision may be indirect
812	supervision. For purposes of this section, the term "indirect
813	supervision" means that the medical director is responsible for
814	the medical actions of the coordinator, that the coordinator is
815	operating under protocols expressly approved by the medical
816	director, and that the medical director or his or her physician
817	designee is always available, in person or by telephone, to
818	provide medical direction, consultation, and advice in cases of
819	organ, tissue, and eye donation and procurement. Although
820	indirect supervision is authorized under this section, direct
821	physician supervision is to be encouraged when appropriate.
822	Section 18.  Section 765.547, Florida Statutes, is created
823	to read:
824	765.547  Cooperation between medical examiner and
825	procurement organization.--
826	(1)  A medical examiner and procurement organization shall
827	cooperate with each other in order to maximize opportunities to
828	recover anatomical gifts for the purpose of transplantation,
829	therapy, research, or education.
830	(2)  The Florida Medical Examiners Commission shall adopt
831	rules establishing cooperative responsibilities between medical
832	examiners and procurement organizations to facilitate and
833	expedite completion of the medical examiner's responsibilities
834	under chapter 406 in a manner that will maximize opportunities
835	to recover anatomical gifts.
836	(3)  This part does not supersede any part of chapter 406
837	relating to medical examiners and the disposition of dead
838	bodies.
839	Section 19.  Subsection (30) of section 408.802, Florida
840	Statutes, is amended to read:
841	408.802  Applicability.--The provisions of this part apply
842	to the provision of services that require licensure as defined
843	in this part and to the following entities licensed, registered,
844	or certified by the agency, as described in chapters 112, 383,
845	390, 394, 395, 400, 429, 440, 483, and 765:
846	(30)  Organ, and tissue, and eye procurement organizations
847	agencies, as provided under part V of chapter 765.
848	Section 20.  Subsection (29) of section 408.820, Florida
849	Statutes, is amended to read:
850	408.820  Exemptions.--Except as prescribed in authorizing
851	statutes, the following exemptions shall apply to specified
852	requirements of this part:
853	(29)  Organ, and tissue, and eye procurement organizations
854	agencies, as provided under part V of chapter 765, are exempt
855	from s. 408.810(5)-(10).
856	Section 21.  This act shall take effect July 1, 2009.

CODING: Words stricken are deletions; words underlined are additions.