N.Y. Comp. Codes R. & Regs. tit. 10 § 405.25

Current through Register Vol. 46, No. 45, November 2, 2024

Section 405.25 - Organ and tissue donation (anatomical gifts)

(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.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 405.25

Amended New York State Register November 13, 2019/Volume XLI, Issue 46, eff. 11/13/2019