Current through Register Vol. 39, No. 6, September 16, 2024
(a) The potential
donor must be free to make an informed independent decision, which has been
termed informed choice. Informed choice addresses the decision process of the
potential donor as he or she determines whether or not to donate. Informed
choice has several aspects. First, the potential donor must know he or she has
a choice, meaning he or she can freely decide either to donate or not to donate
an organ. Second, the potential donor must be aware of both the risks and
benefits of donation. The potential donor must be able to weigh the positive
aspects of the donation as well as take into account the technical aspects such
as the surgery, recovery, financial impact and any unexpected but potential
consequences that may result such as a change in the patient's life, health,
insurability, employment or emotional stability.
(b) The person who consents to be a live
organ donor shall be:
(1) Legally
competent;
(2) Willing to
donate;
(3) Free from coercion,
including financial coercion, actual or implied;
(4) Medically suitable;
(5) Informed and able to express
understanding of the risks and benefits of donation; and
(6) Informed of the risks, benefits and
alternative treatment regimens available to the recipient.
(c) A statement signed by the potential donor
that his or her participation is completely voluntary and may be withdrawn at
any time shall be placed in the medical record.
(d) Understanding
(1) The potential donor shall be able to
demonstrate that he or she understands the essential elements of the donation
process with emphasis on the risks associated with the procedure;
(2) With the potential donor's permission,
the donor's designee, family or next of kin shall be given the opportunity to
openly discuss the donor's concerns in a safe and non-threatening environment;
and
(3) The potential donor shall
understand, agree to, and commit to postoperative follow-up and testing by the
facility performing the surgical removal of the organ and subsequent organ
transplant.
(e)
Disclosure
(1) The donor surgical team and
the IDAT shall disclose any facility affiliations to the potential
donor;
(2) The potential donor
shall have a period of reflection appropriate to the acuity of the clinical
condition of the recipient and reaffirmation of the decision to donate
subsequent to the completion of the medical work-up and final approval to
proceed by the IDAT. After the period of reflection the potential donor may
sign the consent for the donation procedure;
(3) Non-English speaking candidates and
hearing impaired candidates must be provided with a non-family interpreter who
understands the donor's language and culture;
(4) A member of the IDAT shall witness the
potential donor signing the consent documents for removal of the donor organ;
and
(5) The overall donation
process and experience shall be explained to the potential donor and shall be
provided in writing to include:
(A) Donor
evaluation procedure;
(B) Surgical
procedure;
(C) Recuperative
period;
(D) Short-term and long
term follow-up care;
(E)
Alternative donation and transplant procedure;
(F) Potential psychological benefits to
donor;
(G) Transplant facility and
surgeon-specific statistics of donor and recipient outcomes;
(H) Confidentiality of the donor's
information and decisions;
(I)
Donor's ability to opt out at any point in the process;
(J) Information about how the facility
performing the transplant will attempt to follow the health of the donor;
and
(K) Need for the donor to
review potential personal insurability for future insurance coverage.
(f) The IDAT shall make
the potential donor aware of the following risk factors:
(1) Physical
(A) Potential for surgical complications
including risk of donor death;
(B)
Potential for organ failure and the need for future organ transplant for the
donor;
(C) Potential for other
medical complications including long-term complications and complications
currently unforeseen;
(D)
Scars;
(E) Pain;
(F) Fatigue; and
(G) Abdominal or bowel symptoms such as
bloating and nausea.
(2)
Psychosocial
(A) Potential for problems with
body image;
(B) Possibility of
transplant recipient death;
(C)
Possibility of transplant recipient rejection and need for
re-transplantation;
(D) Possibility
of recurrent disease in a transplant recipient;
(E) Possibility of post surgery adjustment
problems;
(F) Impact on the donor's
family or next of kin;
(G) Impact
on the transplant recipient's family or next of kin; and
(H) Potential impact of donation on the
donor's lifestyle.
(3)
Financial
(A) Out of pocket
expenses;
(B) Child care
costs;
(C) Possible loss of
employment;
(D) Potential impact on
the ability to obtain future employment; and
(E) Potential impact on the ability to obtain
or afford health and life insurance.
(g) The potential donor shall provide
assurance and consent that the following areas have been addressed:
(1) That there is no monetary profit to the
potential donor. Coverage for expenses incurred as a result of the organ
donation is not considered monetary profit;
(2) That family members or others did not
coerce the potential donor into making his or her decision;
(3) That the potential donor has been
provided with a general statement of unsuitability for donation if requested.
Medical information regarding the potential donor shall not be falsified to
provide the donor with an excuse to decline donation;
(4) That the potential donor is
intellectually and emotionally capable of participation in a discussion of
potential risks and benefits;
(5)
That the potential donor has been provided adequate information to ensure his
or her understanding regarding the risks of the donation;
(6) That the potential donor has been
educated regarding the recipient's options for organs from deceased persons,
including risks and outcomes; and
(7) That the potential donor understands that
he or she may decline to donate at any time.
(h) Documentation
(1) A medical record, separate and distinct
from the transplant recipient's record, shall be maintained to protect donor
confidentiality; and
(2) The
informed choice process and evaluation protocol shall be documented and placed
in the potential donor's medical record.
(i) Decision to Donate. Once the IDAT
determines the suitability of the potential donor the IDAT shall discuss with
the potential donor's surgical team and transplant team its decision prior to
its presentation to the potential donor. If the potential donor wishes to
donate, but the IDAT does not agree, the IDAT's opposition shall be so noted in
a report to the donor surgeon, who shall document reasons for proceeding
against the IDAT advice. The reason why the IDAT has objections shall be
explained to the potential donor. For example, the potential donor may not have
the ability to understand the information provided to him or her or the donor
may be unable to integrate the degree of risk pertinent to his or her situation
or there may be a lack of balance between the risks to the potential donor and
potential benefits to the transplant recipient. Even if the potential donor is
willing to donate his or her organ, the final review and decision whether or
not to proceed with the donation rests with the donor surgical team and
transplant team.
(j) In cases
involving living liver donation, prior to reaching a decision to donate the
potential donor shall be provided in writing the U.S. Department of Health and
Human Services Advisory Committee on Organ Transplantation (ACOT)
recommendations entitled "Living Liver Donor Initial Consent for Evaluation"
which is hereby incorporated by reference with all subsequent amendments. The
ACOT recommendations can be obtained free of charge via the internet at:
http://www.organdonor.gov/acotrecs.html. The items contained in the ACOT
recommendations must be explained to the potential donor in language and terms
which he or she can understand and then be signed by the donor and the
signature witnessed. Subsequent to this, if all the facts show that the
potential donor is, in fact, in all respects a viable potential donor, then he
or she shall execute the ACOT recommended form entitled "Living Liver Donor
Informed Consent for Surgery" which is hereby incorporated by reference with
all subsequent amendments. In addition, this form shall comply with
G.S.
90-21.13 Informed Consent which is hereby
incorporated by reference with all subsequent amendments.
Authority
G.S.
131E-75;
131E-79;
143B-165;
Eff. May
1, 2006;
Pursuant to
G.S.
150B-21.3A, rule is necessary without
substantive public interest Eff. July 22,
2017.
