HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: CS/HB 1009 Organ Donation and Transplantation
SPONSOR(S): Finance & Facilities Subcommittee, Latvala and others
TIED BILLS: None IDEN./SIM. BILLS: SB 1318
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY CHIEF
1) Finance & Facilities Subcommittee 14 Y, 0 N, As CS Morris Lloyd
2) Secondary Education & Career Development Fudge Sanchez
Subcommittee
3) Environment, Agriculture & Flooding
Subcommittee
4) Health & Human Services Committee
SUMMARY ANALYSIS
Organ and tissue donation is the process of surgically removing an organ or tissue from one person (the donor) and
transplanting it into another person (the recipient). Transplantation in such cases is necessary because the recipient’s
organ has failed or has been damaged by disease and injury. HB 1009 amends multiple sections of law related to organ
donation.
The bill requires The Agency for Health Care Administration (AHCA) to include minimum volume standards for organ
transplants in their rules for health care facilities.
The bill prohibits a transplant facility from charging the donor, or his or her family, any fees for services related to the
procurement or donation of his or her organs.
The bill adds a requirement to educate the public on state and federal law relating to the organ donation transplant
process to the current public education program administered by AHCA. The bill also requires Donate Life Florida to
consult with the State Board of Education to develop an instructional curriculum relating to organ donor registration for
grade 9 through 12 students which shall be taught in public schools.
The bill requires individuals who make requests to patients, living donors, or family members for a decedent’s organs to
explain the protocols of federal regulations regarding organ donation, in addition to those of the hospital and state, as
currently required.
The bill directs the Organ and Tissue Procurement and Transplantation Advisory Board to submit recommendations
relating to the regulation of organ transplants to AHCA.
The bill has a significant, negative fiscal impact on AHCA. The bill has no impact on local governments.
The bill provides an effective date of July 1, 2021.
This document does not reflect the intent or official position of the bill sponsor or House of Representatives .
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FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Background
Organ Donation
Organ and tissue donation is the process of surgically removing an organ or tissue from one person
(the donor) and transplanting it into another person (the recipient). Transplantation in such cases is
necessary because the recipient’s organ has failed or has been damaged by disease or injury.
Transplantable organs include the kidneys, liver, heart, lungs, pancreas and intestine.1 Transplantable
tissue include skin used as a temporary dressing for burns, serious abrasions and other exposed
areas; heart valves used to replace defective valves; tendons used to repair torn ligaments on knees or
other joints; veins used in cardiac by-pass surgery; corneas used to restore sight; and bone used in
orthopedic surgery to facilitate healing of fractures or prevent amputation.2
A single person can save up to eight lives through organ donation, and dozens more lives may be
improved through tissue donation.3 While most organ and tissue donations occur after the donor has
died, some organs and tissues can be donated while the donor is alive, such as a kidney or part of a
liver or lung.4 There are about as many living donors every year as there are deceased donors.5
Despite advances in medicine and technology, and increased awareness of organ donation and
transplantation, more donors are needed to meet the demand for transplants.6 As of January 2020,
there are more than 112,000 children and adults,7 including over 5,000 Floridians.8 Over 39,000 organ
transplants were performed in 2019 with organs from more than 19,000 donors.9
Organ Donation, Procurement, and Transplant Process
Established by the National Organ Transplant Act (NOTA) of 1984, the Organ Procurement and
Transplantation Network (OPTN) is a public-private partnership that links all professionals involved in
the nation’s donation and transplant system.10 The United Network for Organ Sharing (UNOS), a
private, non-profit organization based in Richmond, Virginia, serves as the OPTN under contract with
the U.S. Department of Health and Human Services.11 UNOS coordinates how donor organs are
matched and allocated to patients on the waiting list.12 Non-profit, federally designated organ
procurement organizations (OPOs) work closely with UNOS, hospitals, and transplant centers to
facilitate the organ donation and transplantation process,13 including conducting a thorough medical
1 Donate Life Florida, Frequently Asked Questions, https://www.donatelifeflorida.org/categories/donation/ (last visited March 3, 2021).
2 Id.
3 Id.
4 U.S. Government Information on Organ Donation and Transplantation, U.S. Department of Health & Human Services, How Organ
Donation Works, https://organdonor.gov/about/process.html (last visited March 3, 2021).
5 Id.
6 Organ Procurement and Transplantation Network, U.S. Department of Health & Human Services, https://optn.transplant.hrsa.gov/
(last visited March 3, 2021).
7 Id.
8 Supra, note 1.
9 Id.
10 U.S. Department of Health and Human Services, Organ Procurement and Transplantation Network – About the OPTN,
https://optn.transplant.hrsa.gov/governance/about-the-optn/ (last visited March 3, 2021).
11 Id.
12 U.S. Government Information on Organ Donation and Transplantation, U.S. Department of Health & Human Services, The Organ
Transplant Process, https://organdonor.gov/about/process/transplant-process.html (last visited March 3, 2021).
13 Donate Life Florida, Organ Procurement Organizations and Transplant Centers, https://www.donatelifeflorida.org/local-
resources/transplant-centers/ (last visited March 3, 2021).
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and social history of the potential donor to help determine the suitability of his or her organs for
transplantation.14
The donation process begins when a person, or their family if the person was not already a registered
donor before brain death, decides to become an organ donor. After brain death is declared, the donor’s
body is kept functioning by artificial means, such as a ventilator support.15 Specially-trained medical
practitioners from the OPO evaluates the patient to determine if they are medically suitable to donate
their organs.16 If the patient is suitable, their organs are surgically removed and sent to the transplant
hospitals where transplant candidates are waiting.17 The deceased donor’s blood type, height, weight,
the hospital zip code, and other data are entered into UNOS’ national database to begin the organ
allocation process.18
Transplant candidates are patients on the transplant waiting list. A patient is usually referred to a
transplant center by their physician for placement on the waiting list.19 The transplant center’s
transplant teams, composed of transplant physicians, surgeons and other practitioners, perform a
medical evaluation of the patient.20 Each transplant center sets its own criteria to help determine if a
patient is a good or bad candidate.21 Typical criteria includes weight, age, and health history. If the
patient is a bad candidate, the patient is not placed on the waiting list, but can try to get placed on the
waiting list at another transplant center or be reconsidered by the same transplant center if their
condition improves (for example, losing weight as directed).22 If a patient is determined to be a good
candidate for an organ transplant, they are placed on the waiting list by the transplant center and wait
for an organ to become available. Candidates are able to be placed on the waiting list at more than one
transplant center.23
When an organ becomes available, the OPO will query the national database for a match based on a
variety of factors, including relative location of the recipient to the organ, blood type, weight, and age.24
If a match is found, the transplant surgeon will evaluate the potential recipient of the organ transplant
and make a determination on whether the potential recipient is medically suitable.25 The transplant
team only has one hour to make this determination.26 If suitable, the organ is transported to the
transplant center where the recipient is waiting and the transplant surgery is performed, otherwise the
potential recipient remains on the waiting list.
Regulation of Organ Donation, Procurement, and Transplantation in Florida
14 Organ Procurement and Transplantation Network, U.S. Department of Health & Human Services, The Basic Path of Donation,
https://optn.transplant.hrsa.gov/learn/about-donation/the-basic-path-of-donation/ (last visited March 3, 2021).
15 Donate Life Florida, Frequently Asked Questions - Donation, https://www.donatelifeflorida.org/categories/donation/ (last visited March
3, 2021).
16 UNOS, Deceased Donation, https://unos.org/transplant/deceased-donation/ (last visited March 3, 2021).
17 Id.
18 Id.
19 Health Resources & Services Administration, The Organ Transplant Process, https://www.organdonor.gov/about/process/transplant-
process.html#list (last visited March 3, 2021).
20 U.S. Department of Health and Human Services, The Transplant Team, https://optn.transplant.hrsa.gov/learn/about-
transplantation/the-transplant-team/ (last visited March 3, 2021).
21 UNOS, Frequently Asked Questions – What do I need to do to be considered for a transplant?, https://unos.org/transplant/frequently-
asked-questions/ (last visited March 3, 2021).
22 UNOS Transplant Living, Frequently Asked Questions – Are there age limits or medical conditions that rule out organ
transplantation?, https://transplantliving.org/before-the-transplant/frequently-asked-questions/ (last visited March 3, 2021).
23 UNOS, What Every Patient Needs to Know (2019), https://unos.org/wp-content/uploads/unos/WEPNTK.pdf (last visited March 3,
2021).
24 Heath Resources & Services Administration, Matching Donors and Recipients,
https://www.organdonor.gov/about/process/matching.html#criteria (last visited March 3, 2021). See also Health Resources & Services
Administration, Find Your Local Organ Procurement Organization, https://www.organdonor.gov/awareness/organizations/local-opo.html
(last visited March 3, 2021).
25 UNOS Transplant Living, Frequently Asked Questions – How does the matching process work? https://transplantliving.org/before-
the-transplant/frequently-asked-questions/ (last visited March 3, 2021).
26 Id.
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The Agency for Health Care Administration (AHCA) oversees the various organizations and facilities
involved in the organ procurement and transplant process in this state. AHCA licenses transplant
facilities, contracts with an organization to educate the public on organ donation, sets requirements for
training individuals who engage with families whose deceased relatives may be a good candidate for
organ donation, and supports the Organ Transplant Advisory Council and the Organ and Tissue
Procurement and Transplantation Advisory Board.
Organ Donor Registry
In 2008,27 Florida’s Legislature found that a shortage of organ and tissue donors existed in Florida.
Findings included a need for:
 A statewide donor registry with online donor registration capability; and
 Enhanced donor education, to increase the number of organ and tissue donors.
The online registry would afford more persons who are awaiting organ or tissue transplants the
opportunity for a full and productive life.28 As directed by the legislature, AHCA and the Department of
Highway Safety and Motor Vehicles (DHSMV) jointly contracted for the operation of Florida’s interactive
web-based donor registry that allows for online donor registration and the recording of organ and tissue
donation records submitted through the driver license identification program or through other sources.
AHCA and the DHSMV selected Donate Life Florida, which is a coalition of Florida’s organ, tissue, and
eye donor programs, to run the donor registry and maintain donor records.
Floridians who are age 18 or older can join the donor registry either online, at the DHSMV (or their local
driver license office), or by contacting Donate Life Florida for a paper application.29 Children ages 13 to
17 may join the registry, but the final decision on any organ donation of a minor rests with the parent or
guardian. The registry collects personal information from each donor including, but not limited to, his or
her name, address, date and place of birth, race, ethnicity, and driver’s license number.
As of March 3, 2021, there were 11,468,537 people registered in the donor registry.30
A person may make an anatomical gift of all or part of his or her body by:31
 Signing an organ and tissue donor card;
 Registering online with the donor registry;
 Signifying an intent to donate on his or her driver license or identification card issued by the
DHSMV;32
 Expressing a wish to donate in a living will or other advance directive;
 Executing a will that includes a provision indicating that the testator wishes to make an
anatomical gift;33 or
 Expressing a wish to donate in a document other than a will.34
Donor Education
When a patient dies in a hospital and is not a registered organ donor, but is determined to be a good
candidate by the hospital’s medical staff and the OPO, a representative of the OPO or a member of the
27 Ch. 2008-223, Laws of Fla.
28 S. 765.5155(1), F.S.
29 Donate Life Florida, Welcome to the Joshua Abbott Organ and Tissue Donor Registry, http://www.donatelifeflorida.org/ (last visited
March 3, 2021)
30 Id.
31 S. 765.514(1), F.S.
32 Revocation, suspension, expiration, or cancellation of the driver license or identification card does not invalidate the gift.
33 The gift becomes effective upon the death of the testator without waiting for probate. If the will is not probated or if it is declared
invalid for testamentary purposes, the gift is nevertheless valid to the extent that it has been acted upon in good faith.
34 The document must be signed by the donor in the presence of two witnesses who shall sign the document in the donor’s presence. If
the donor cannot sign, the document may be signed for him or her at the donor’s direction and in his or her presence and the presence
of two witnesses who must sign the document in the donor’s presence. Delivery of the document of gift during the donor’s lifetime is not
necessary to make the gift valid.
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hospital’s staff may approach the patient’s family about organ donation.35 AHCA has developed rules
for training and guidelines for the person making the request for organ donation.36 The requestor is
trained in explaining the process of organ donation to the patient’s family, including their right to allow
or refuse donation and for what purpose the organs would be donated (transplantation, research, or
education).37 The requestor is also specifically trained in the different types of approaches to deal with
a family’s grief and offering them the opportunity for organ donation.38 The current rules require the
requestor to explain the requirements needed to be met under Florida law in order for a donation to be
allowed, but not federal regulations relating to organ donation.
Organ Donation Fees
Generally, an organ donor and their family are not charged by a transplant facility for the medical care
required to donate an organ.39 Families pay for medical care and funeral costs, but costs related to
living or deceased donation are paid by the recipient, usually through insurance, Medicare, or
Medicaid.40 Typically, any cost that falls outside of the transplant center’s donor evaluation or actual
surgery, such as travel, lodging, lost wages, and other non-medical expenses, is borne by the living
donor or recipient.41
Organ and Tissue Procurement and Transplantation Advisory Board
Created by the Legislature in 1991, the Organ and Tissue Procurement and Transplantation Advisory
Board (board) is housed at AHCA. Current law requires the board to assist AHCA in the development of
professional qualifications of people involved in the organ donation and transplant process. The board
is also tasked with helping AHCA monitor expenses associated with organ and tissue procurement,
processing, and distribution for transplantation. Current law requires the board to provide assistance to
the Florida Medical Examiners Commission in the development of ap