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