Transcript Uniform Anatomical Gift Act Protecting the Decision

Uniform Anatomical Gift Act
Protecting the Decision
SUZANNE A. FIDLER, M.D., J.D., CPHRM
Senior Director of Risk Management
Patient Safety
Desert Regional Medical Center
Objectives
 Understand the authority to make an
anatomical gift.
 Review legal protections for organ and
tissue donation.
 Explore how updating hospital policies and
procedures based on current law support
the donation process.
Scenarios
 If a family objects to recovery of organs and/or
tissues from a person who is listed in the donor
registry, how will providers, OPOs, and the
hospital respond?
 What if an advance directive and the decision to
donate are incongruent?
 Does the hospital have a policy providing for
administrative consent if unable to locate next of
kin?
Authorization for Organ and Tissue
Donation
 Due to the disparity between the public support and
the percentage of Americans actually donating
 Strong public policy to support organ and tissue
transplantation
 Law provides authority and protection for providers,
hospitals, and organ procurement organizations
involved in donation.
Uniform Anatomical Gift Act
(UAGA)
 Promulgated in 1968 to provide national uniformity
 Drafted by the National Conference of Commissions of
Uniform State Laws (NCCUSL)
 Amended in 1987
 Revised in 2006
 Majority of states have adopted
Revised UAGA of 2006
 Strengthens the rights of the individual and others to
make an anatomical gift
 Retains the “opt-in” system that honors the free choice
of an individual to donate
 Expands the list of persons who can make a gift
 Provides new definitions to clarify and expand the
opportunities for anatomical gifts
California Has Adopted the UAGA
 California Health & Safety Code Sections 7150-7151.40
 May be cited as the California Uniform Anatomical
Gift Act
 Based on the federal Uniform Anatomical Gift Act
which is premised on gift law, not informed consent
A Donor May Make an Anatomical Gift
 By indicating such on the donor’s driver’s license or
identification card
 Directly through the Donate Life California Organ and
Tissue Donor Registry Internet Web site
 In a will (takes effect upon donor’s death)
 During a terminal illness or injury by any form of
communication that clearly expresses the donor’s
wishes and addressed to at least 2 adults
Full Faith and Credit from State to State
 A document of gift which is valid where executed is
valid in another state.
 If the document of gift is valid based on the California
UAGA, then California law governs the interpretation
of the document of gift.
 A person may presume that a document of an
anatomical gift is valid unless that person knows
otherwise.
CA Health & Safety Code Section 7150.85;
UAGA Section 19
Purposes of the Anatomical Gift
 An anatomical gift of a donor’s body or part may be
made for the purpose of:
 Transplantation
 Therapy
 Research, or
 Education
Prioritizes Purposes of Gift
 If the purposes of the gift are not set forth in any
priority, the gift shall be used for transplantation or
therapy, if suitable; otherwise for research or
education.*
 Example: if a person is in a donor registry for “all
organs and tissues” without designation of purpose,
the gift will be used first for transplant if suitable.
*CA Health & Safety Code Section 7150.50(d);
UAGA Section 11(f)
Public Policy Favors the Making of
Anatomical Gifts
 A presumption arises that the most comprehensive
interpretation of the document of gift controls.
 There is no requirement that documents of gift be
dated; purposely omitted to avoid invalidating
documents of gift.
 Example: donor’s later-issued driver’s license is silent
regarding licensee’s prior intent to make an anatomical
gift. The gift on the prior license would still be
effective.
Others Barred from Amending or
Revoking
***Absent an express, contrary indication by the donor, a
person other than the donor is barred from making,
amending or revoking an anatomical gift of a donor’s
body or part if the donor made an anatomical gift.
CA Health & Safety Code Section 7150.35(a);
UAGA Section 8
A Donor’s Autonomous Decision Must
be Honored
 Anatomical gift that the donor does not revoke before
death is irrevocable.
 No permission from the donor’s family is warranted.
 The law firmly states that a donor’s decision to make
an anatomical gift is not subject to change by others.
 The family does not have the power, right, or authority
to consent to, amend, or revoke.
Persons Authorized to Make an
Anatomical Gift on Behalf of Decedent
 In the following order of priority for those persons
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reasonably available:
(1) an agent of the decedent
(2) the spouse or domestic partner
(3) adult children
(4) parents
(5) adult siblings
(6) adult grandchildren
(7) grandparents
Persons Authorized to Make an
Anatomical Gift on Behalf of Decedent
 (8) An adult who exhibited special care and concern
for the decedent
 (9) The persons who were acting as the guardians or
conservators
 (10) Any other person having the authority to dispose
of the decedent’s body, including but not limited to, a
coroner, medical examiner, or hospital administrator ,
provided that reasonable effort has been made to
locate and inform persons listed above.
CA Health & Safety Code Section 7150.40(a);
UAGA Section 9
Administrative Consent
 Supports hospital administration as a donation
decision-maker in the event that no one is reasonably
available to decide on behalf of the potential donor
 For these cases, hospitals have developed policies
incorporating administrative consent where the
hospital may be in a position to step in to potentially
permit the gift of life.
Person Authorizing the Donation May
Expand the Gift
 A donor’s gift of a part for one purpose does not
preclude another person from expanding the gift to
include another purpose or part.
 Example: A donor signs a document of gift stating, “I
give my liver for transplantation.” Following the
donor’s death, an individual listed above may expand
to include research or include the donor’s heart, unless
the donor restricted the purposes of the gift or the
part.
Objection Based on Majority Rule
 Previous versions of UAGA provided that one person
in a class could veto a gift (e.g., a single dissenting
person has disrupted the donation process).
 Currently, if an objection is known, the gift can only be
made by a majority of the members of the same class
who are reasonably available.
CA Health & Safety Code Section 7150.40(b);
UAGA Section 9(b)
“Reasonably Available”
 Known objections by persons not reasonably available
do not bar persons who are reasonably available from
making an anatomical gift.
 Defined as “able to be contacted by a procurement
agency without undue efforts and willing and able to
act in a timely manner consistent with existing medical
criteria necessary for making anatomical gifts” *
*CA Health & Safety Code Section 7150.10(a)(23);
UAGA Section 2(23)
“Reasonably Available”
 “Reasonably available” is not synonymous with
physically present.
 Provides guidance to hospitals and OPOs in time
sensitive situations.
 If a member in a higher class is unwilling to make a
decision, that person is not reasonably available; this
permits the ability to move down the priority list.
Reasonable Search
 A reasonable search shall be conducted to locate a document of
gift or other information identifying the individual as a donor or
as an individual who made a refusal
 A reasonable effort shall be deemed to have been made when a
search of the persons has been underway for at least 12 hours.
 The search shall include a check of local police missing persons
records, examination of personal effects, and the questioning of
any persons visiting the decedent before his or her death.*
 A person is not subject to criminal or civil liability for failing to
discharge these duties but may be subject to administrative
sanctions. **
* CA Health & Safety Code Section 7150.40(a)(10)(B); UAGA Section 12
** CA Health & Safety Code Section 7050.55; UAGA Section 12
Karen Jacobsen and Hardy Jacobsen v.
Marin General Hospital
 California case sent on appeal to the U.S. Court of
Appeals for the Ninth Circuit, 1999.
 Martin Jacobsen, a Danish citizen, was visiting the U.S.
and found by CHP unconscious along Highway 101.
 He had no identification, was presumed homeless,
and no next of kin were identified.
 The OPO contacted the Marin County Coroner’s
Office and requested donation.
Jacobsen Case
 The coroner denied the request and initiated a 40-
hour search for next of kin that included the FBI.
 No next of kin identified and Martin was declared
brain dead.
 Coroner released the body for organ donation (kidney,
liver, pancreas and heart were harvested).
Jacobsen Case
 Martin’s parents, living in Denmark, were later located
and they sued the hospital, network and coroner.
 The district court dismissed the case stating that the
search was reasonable and that the defendants acted
in compliance with the Gift Act.
 The Appeals Court upheld the ruling: (1) there was no
duty for the hospital or network to also search for next
of kin and (2) acted in good faith
Medical Suitability
 The OPO may conduct any reasonable examination
necessary to ensure the medical suitability.
 During the examination period, measures necessary to
ensure the medical suitability of the part may not be
withdrawn.
CA Health & Safety Code Section 7150.65(c);
UAGA Section 14
Advance Directives and Donation
 Situation where there is an advance directive
instructing the withdrawal or withholding of lifesupport and consent for donation
 Requires that parties look toward the patient’s intent
rather than assume an advanced directive to withdraw
support automatically overrides the decision to
donate.
Potential Conflict
 Before resolution of the conflict, measures necessary
to ensure the medical suitability of the part may not be
withheld or withdrawn as long as not contraindicated
by appropriate end-of-life care.
 When possible, the prospective donor (or agent) and
attending shall confer to resolve the conflict.
 The conflict should be resolved as expeditiously as
possible and collaborate with OPO.
CA Health & Safety Code Section 7151.10(b);
UAGA Section 21(b)
Revocation and Amendments
 A donor may revoke or amend an anatomical gift by signing
a record or directing another individual to do so.
 A donor’s revocation of an anatomical gift does not bar
another authorized person from making an anatomical gift
before or after the donor’s death; a donor who wishes to
bind others to a revocation must sign a refusal.
 Refusal: a record that expressly states an intent to bar other
persons from making an anatomical gift of an individual’s
body or part.
CA Health & Safety Code Section 7150.35(b);
UAGA Section 6
Family Consent Practices
 The UAGA has always authorized an adult to “gift”
organs and tissues without requiring family consent or
permitting family to override that gift.
 However, fear of litigation and negative publicity have
driven the practice of obtaining family consent.
 No reported cases of a family successfully suing
healthcare or donation professionals where an
individual had made a valid donation.
Legal Immunity
 Professionals who act in good faith
 Not liable in a civil action, criminal prosecution, or
administrative proceeding*
 Courts have upheld this protection
 Kelly-Nevils v. Detroit Receiving Hosp. (Mich. 1995)
 Nicoletta v. Rochester Eye & Human Parts Bank, Inc. (New York 1987)
 Carey v. New England Organ Bank (Mass. 2006)
*CA Health & Safety Code Section 7150.80
UAGA Section 18
Kelly-Nevils v. Detroit Receiving Hospital
 Unidentified man with a gunshot wound to the head
was admitted to the hospital.
 The hospital solicited an organ donation consent from
a young man identifying himself as the brother and
only living relative but did not verify the man’s
identity.
 Police located the mother 3 days after the patient’s
death; he had no brother.
Kelly-Nevils Court Ruling
 There was no duty on the hospital to conduct an
independent investigation to determine whether the
young man had authority.
 No one had notified the hospital of any opposition to
the organ donation.
 The court concluded that to impose any duty of
investigation would frustrate the purpose of the UAGA
since “time is of the essence.”
Nicoletta v. Rochester Eye and Human
Parts Bank
 Peter Nicoletta was injured in a motorcycle accident
and a woman identified herself as the wife and signed
the chart as “Judy Shufelt” with “wife” in parenthesis.
 Several hours later she signed paperwork to donate the
organs as “Judy Nicoletta” (wife).
 The father sued the hospital and eye bank because
“Judy” did not have authority to authorize donation.
Nicoletta Court Ruling
 The Court upheld the “good faith” immunity
protection conferred by the UAGA.
 The Court ruled that the hospital and eye bank had
acted in “good faith” (“honest belief, the absence of
malice and the absence of design to defraud or to seek
an unconscionable act”).
Maintain Clearly Defined Roles
 Neither the physician who attends the decedent at
death nor the physician who determines the time of
death may participate in the procedures for removing
or transplanting a part.
 This section addresses potential public misperceptions
and avoids the appearance of a conflict of interest.
CA Health & Safety Code Section 7150.65(i)
UAGA Section 14(j)
Summary
 Strong public policy supports the transplantation
community.
 UAGA upholds the rights of the individual and others
to make an anatomical gift.
 A donor’s autonomous decision to donate must be
honored.
 Continue to update policies and procedures in
collaboration with providers, hospitals, and the OPO
incorporating the evolving legal protections developed
for donation.
Call to Action
To request a policy review, please call your
Donation Development Coordinator directly or contact:
Clinique Burrell
Executive Assistant
OneLegacy Donation Development Department
213-229-5634 / [email protected]