Current through Register Vol. 46, No. 39, September 25, 2024
(a)
Definitions.
For the purposes of this section, the following terms
shall have the following meanings:
(1)
designated requestor shall mean a person selected by the
hospital to discharge the responsibilities of requesting the spouse, next of
kin or guardian of the decedent to consent to an anatomical gift. The
designated requestor shall be a trained hospital employee, or an employee of an
organ procurement organization, eye bank or other tissue bank. Designated
requestors, at a minimum, must complete a course, that meets the criteria set
forth in subdivision (e) of this section, provided or approved by an organ
procurement organization and designed in consultation with the eye bank or
other tissue bank community, whichever is applicable, on how to approach
potential donor families and request organ, eye or other tissue donation. The
hospital administrator may select more than one designated requestor;
(2)
suitability for organ, eye and
other tissue donation shall mean that the organ procurement
organization, eye bank or other tissue bank in consultation with the hospital,
after appropriate medical screening (which may include serological testing if
applicable) determines that the patient meets the medical criteria for
donation;
(3)
organ
procurement organization (OPO) shall mean an organization which is
designated by the Secretary, U.S. Department of Health and Human Services, to
perform or coordinate the performance of retrieving, preserving and
transporting organs and to maintain a system of locating prospective recipients
for available organs; and
(4)
tissue bank shall mean a tissue bank licensed under Part 52,
which includes eye banks.
(b) The hospital shall assure that written
policies and procedures are established, implemented and maintained for
notifying an organ procurement organization and/or appropriate tissue banks
including eye banks, licensed pursuant to Part 52 when death of a patient has
occurred or is imminent, designating the requestor(s) to approach the family,
selecting eye bank(s) and other applicable tissue bank(s) for referrals,
causing a timely request to be made by the designated requestor and monitoring
the implementation of these functions. These policies and procedures shall be
developed in consultation with organ procurement organizations and licensed eye
banks and other tissue banks selected by the hospital. Written policies and
procedures to be established shall include:
(1) protocol for notification of the organ
procurement organization, eye bank or other tissue bank upon the death or
imminent death of every patient, including provisions specifying that for
ventilator patients declared brain dead, the organ procurement provider must be
notified and able to determine suitability for donation prior to removal of
such patients from the ventilator;
(2) procedures for seeking consent by the
designated requestor so that requests are made only when the candidate meets
the medical criteria for screening potential donors, and that no requests are
made when the conditions listed in paragraph (d)(1), (2) or (3) of this section
are present;
(3) a procedure for
documenting in the patient's medical record notification of the organ
procurement organization, eye bank or other applicable tissue bank(s), and the
results of such notification and requests for consent or absence of a
request;
(4) an ongoing system for
monitoring compliance with routine referral of potential donors including the
outcomes of such referrals and any resulting requests. When a hospital
contracts with an outside organization to review hospital policies, procedures,
patient records and outcomes to assess compliance with this section, the
contract shall be written and executed in accordance with section
400.4 of this Title and shall
require the contractor to be held to the same standards of patient
confidentiality as the hospital; and
(5) a method for hospitals to select at least
one eye bank(s) and all applicable tissue bank(s) for the procurement of tissue
and any policies and procedures the hospital has adopted concerning the
rotation of referrals.
(c)
(1)
Where a patient is a suitable candidate for organ, eye or other tissue donation
and where the patient has not properly executed an organ donor card, or other
authorization for organ, eye or other tissue donation, the designated requestor
shall, in a timely manner, at the time of death of a hospital patient, request
the persons listed below, in the order of priority stated, to consent to the
gift of all useful organs, tissues and/or other body parts of the decedent's
body:
(i) the spouse;
(ii) a son or daughter 18 years of age or
older;
(iii) either
parent;
(iv) a brother or sister 18
years of age or older; or
(v) a
guardian of the person of the decedent at the time of his/her death.
(2) Consent or refusal need only
be obtained from any person in the highest priority class available when
persons in prior classes have been sought with due diligence and are not
available at the time of death. Any consent to an anatomical gift by a person
designated in this subdivision shall be given by a document signed by him/her
or given by his/her telegraphic, recorded telephonic or other recorded
message.
(3) A designated requestor
may also request consent to an anatomical gift from any other person who is
authorized or under the obligation to dispose of the body including, but not
limited to, a person named in a decedent's will, a commissioner of a social
services district, a coroner, a medical examiner, or a hospital
administrator.
(d)
Anatomical donations shall not be requested when any one of the following
conditions are present:
(1) actual notice of
contrary intentions by the decedent;
(2) actual notice of opposition by a member
of the highest priority class available specified in subparagraphs
(c)(1)(i)-(v) of this section; or
(3) other reason to believe that an
anatomical gift is contrary to the decedent's religious or moral beliefs. The
medical record shall document the evidence that served as the basis for the
"reason to believe."
(e)
The designated requestor shall be selected by the hospital based on his/her
ability to relate to families in a sensitive and caring manner and shall
complete a course provided by a tissue bank and approved by the organ
procurement organization, or provided by the organ procurement organization and
designed in consultation with community eye bank or other tissue bank,
whichever is applicable, to have demonstrated proficiency in the following
areas:
(1) psychological and emotional
considerations when dealing with bereaved families and particularly with
individuals with diminished mental capacity;
(2) social, cultural, ethical and religious
factors affecting attitudes toward organ donation;
(3) general medical concepts involved in
organ and tissue transplantation and the use of organs and tissues in research
and education;
(4) procedures for
declaring death, and collecting and preserving organs, tissues and/or other
body parts and how these procedures are most appropriately explained to the
decedent's family;
(5) the cost
implications to the family for organ and tissue donation, if any;
(6) the existing networks for the procurement
of organs and the systems for allocating donated organs, tissues and other body
parts to suitable recipients; and
(7) the routine referral law and the
hospital's policies and procedures regarding requests for consent to anatomical
gifts.
