Florida Administrative Code
59 - AGENCY FOR HEALTH CARE ADMINISTRATION
59A - Health Facility and Agency Licensing
Chapter 59A-3 - HOSPITAL LICENSURE
Section 59A-3.274 - Anatomical Gifts, Routine Inquiry
Universal Citation: FL Admin Code R 59A-3.274
Current through Reg. 50, No. 187; September 24, 2024
(1) Each Class I and Class II hospital shall establish a mechanism whereby the next of kin of all patients who are deemed medically acceptable and who die in Florida hospitals are given the opportunity to consider the donation of organs, tissues and eyes for transplantation and research.
(2) Education and Training of Designee. The hospital administrator or designee making the request of the next of kin for organ, tissue and eye donations shall be trained in the request procedures used in organ and tissue donation. The Organ Procurement Organization (OPO), tissue bank and eye bank shall, in conjunction with their affiliated hospitals, develop a requester training curriculum that will meet the individual needs of each affiliated hospital. The Agency shall assist, if requested, in the implementation of the requester training curriculum in conjunction with an OPO, tissue bank and eye bank where the OPO, tissue bank and eye bank do not have adequate resources for the implementation of the requester training curriculum within their affiliated hospitals. This training shall include the following minimum basic curriculum:
(a) The criteria used by the affiliated OPO,
tissue bank, and eye bank for determining the acceptability of patients as
organ, tissue, or eye donors;
(b)
The requirements of Florida law to be met in order for a donation to be allowed
to proceed including:
1. Explanatory
information regarding the family's rights to allow or refuse a donation, to
donate specific organs, tissues or eyes and to designate the organs, tissues or
eyes for the purpose of transplantation, medical research or instruction,
and,
2. The criteria for
determining whether a particular death falls within the scope of section
406.11, F.S., necessitating
close communication with the Medical Examiner's office, and permission from the
Medical Examiner when required;
(c) Necessary basic information regarding the
process and procedures related to organ, tissue, and eye donation and
transplantation including the following:
1.
The procedures and techniques used in the recovery and preservation of organs,
tissues and eyes;
2. The success
rates of currently accepted transplant procedures;
3. The numbers of patients presently awaiting
these procedures; and,
4. The
financial procedures and arrangements applicable to the donation of organs,
tissues and eyes.
(d) The
various approaches which can be used in dealing with a family in a grief
situation and offering them the opportunity of organ, tissue, or eye donation.
These approaches shall be based on the criteria of the affiliated OPO, tissue
bank, and eye bank, which shall not be inconsistent with these
guidelines;
(e) Notification of the
affiliated OPO, tissue bank and eye bank; and,
(f) Training regarding the administrative
rules and guidelines promulgated by the Agency for the purpose of implementing
the Routine Inquiry provisions of the Anatomical Gift Act, in accordance with
section 765.522,
F.S.
(3) Each Class I and Class II hospital or its designee shall, using the criteria of the affiliated OPO, tissue bank, and eye bank, implement the following procedures:
(a) Establish and publish a formal written
policy and procedure for the identification and referral of organ, tissue, and
eye donors. This policy shall include the procedure to be followed for the
determination of brain death.
(b)
Identify and designate the personnel or organization which will make the
request for organ, tissue, or eye donation. These personnel shall be trained as
required in subsection (2), above, and shall be available on a 24-hour "on
call" basis to make the initial evaluations of donor suitability, request, and
referrals.
(c) The Hospital
Administrator or designee shall ensure that the District Medical Examiner is
contacted in all medical examiners' cases regarding the wishes of the family as
to organ, tissue, and eye donation and to determine whether or not the medical
examiner has released such organs, tissues or eyes for transplantation, medical
research or instruction. This contact shall be recorded on the Routine Inquiry
Form and placed in the patient's medical record. When completion of the Routine
Inquiry Form is designated by the hospital administrator and accepted by the
affiliated procurement agency, the contact shall be noted in the records of the
affiliated procurement agency. This notation shall indicate that request for
donation of organs, tissue or eyes was made.
(d) The hospital administrator or designee
shall ensure that all identified potential organ, tissue, or eye donors meeting
the criteria of brain death as defined in section
382.009, F.S., or
cardiorespiratory death as defined in subsection
59A-3.065(9),
F.A.C., shall be referred to the affiliated OPO, tissue bank, or eye bank for
evaluation and recovery of the organs, tissues, or eyes to be donated according
to the medical standards of the affiliated OPO, tissue bank and eye bank. This
referral shall be recorded on the Routine Inquiry Form and placed in the
patient's medical record. When completion of the Routine Inquiry Form is
designated by the hospital administrator and accepted by the affiliated
procurement agency, the referral shall be noted in the records of the
affiliated procurement agency.
(e)
The hospital shall work with the affiliated OPO, tissue bank, and eye bank to
evaluate the patient as a potential organ, tissue, or eye donor in accordance
with section 765.522, F.S. The medical
acceptability of such organs, tissues, and eyes shall be determined according
to the medical standards of the affiliated procurement agency. The hospital
administrator may designate personnel of the affiliated OPO, tissue bank, or
eye bank who shall make the request for donation. Where non-hospital personnel
are designated to make the request for organ, tissue or eye donation, the
affiliated OPO, tissue bank, or eye bank shall be given the opportunity to
approach the next of kin about donation and shall utilize the following
procedure when approaching the next of kin:
1.
The affiliated OPO shall be given the opportunity to approach the next of kin
about donation of organs in all suitable vascular organ donor cases when the
potential donor meets the medical standards of the affiliated OPO. Where the
suitable vascular organ donor also meets the medical standards of the
affiliated tissue bank or eye bank, and in the absence of a contrary agreement
between the affiliated OPO, tissue bank, and eye bank, the affiliated OPO may
represent the affiliated tissue bank and eye bank and approach the next of kin
about donation in all suitable tissue and eye donor cases.
2. The affiliated tissue bank shall be given
the opportunity to approach the next of kin about donation in all suitable
tissue donor cases where the potential donor meets the medical standards of the
affiliated tissue bank and where the affiliated OPO has not already approached
the next of kin for donation of tissues and eyes in all non-suitable vascular
organ donor cases. Where the suitable tissue donor also meets the medical
standards of the affiliated eye bank, and in the absence of a contrary
agreement between the affiliated tissue bank and eye bank, the affiliated
tissue bank may represent the affiliated eye bank and approach the next of kin
about donation in all suitable eye donor cases.
3. The affiliated eye bank shall be given the
opportunity to approach the next of kin about donation in all suitable eye
donor cases where the potential donor meets the medical standards of the
affiliated eye bank, and where the affiliated OPO or tissue bank has not
already approached the next of kin for donation of eyes. Where the suitable eye
donor also meets the medical standards of the affiliated tissue bank, and in
the absence of a contrary agreement between the affiliated eye bank and tissue
bank, the affiliated eye bank may represent the affiliated tissue bank and
approach the next of kin about donation in all suitable tissue donor
cases.
(f) The request
for organ, tissue, or eye donation shall be made at or near the time of death,
and in a manner which is conducive to the discussion of organ, tissue, and eye
donation with the grieving next of kin according to the priority specified in
section 765.512, F.S.
(g) A Routine Inquiry Form shall be completed
upon every patient death occurring within the hospital and shall become a part
of each patient's medical record.
1. The form
shall document whether the patient was deemed medically suitable for donation
of organs, tissues and eyes, and if the patient is not medically suitable for
donation, the form shall document the specific reason according to the criteria
of the affiliated procurement agency.
2. If the patient is deemed medically
acceptable for donation, the form shall document that the patient's appropriate
next of kin was approached, as well as the outcome of the patient's expressed
wishes, if known, regarding the donation of organs, tissues, and eyes. If the
family allows donation, a specific consent form shall be signed or completed by
means of telegraphic, recorded telephonic, or other recorded message by the
appropriate next of kin as specified in section
765.512, F.S.
3. If a request for donation is deemed to be
exempted according to subsection (4) of this section, or the medical standards
of the affiliated OPO, tissue bank, and eye bank, the form shall document the
specific reason for the lack of a request.
(h) The lack of request and a complete
written explanation shall be noted on the Routine Inquiry Form and made a part
of the patient's medical record or if designated by the hospital administrator,
and accepted by the affiliated procurement agency, in the affiliated
procurement agency's records. If the affiliated procurement agency has been
designated, the patient's medical record shall document the referral of the
potential donor to the affiliated procurement agency. All Routine Inquiry Forms
maintained by the affiliated procurement agency shall be complete and include
the patient's name and medical record number. These records shall be made
available to the hospital during normal working hours. The referral of the
affiliated procurement agency shall be documented in the patient's medical
record. This documentation shall include the name of the procurement agency and
time and date of the referral. This referral shall be documented in the
patient's death record.
(4) Request Exemptions.
(a) The appropriate next of kin as defined by
section 765.512, F.S., of patients
deemed medically acceptable by the medical standards of the affiliated OPO,
tissue bank and eye bank, and dying in the hospital shall be asked about organ,
tissue, and eye donation except as follows:
1.
There is on record notification of prior objection by the individual, or the
appropriate next of kin as defined by section
765.512, F.S., or
2. The appropriate next of kin cannot be
found after a reasonable search; or
3. No positive identification of the
potential donor has been found; or
4. The medical examiner has denied
permission; or
5. The hospital or
designee, in accordance with a request for the affiliated procurement agency,
has agreed to delay the request until the family has left the
hospital.
Rulemaking Authority 765.522, 873.01(3)(a) FS. Law Implemented 765.522 FS.
New 9-4-95, Formerly 59A-3.219, Amended 10-16-14.
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