59A-3.274. Anatomical Gifts, Routine Inquiry

(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. History–New 9-4-95, Formerly 59A-3.219, Amended 10-16-14.