N.Y. Comp. Codes R. & Regs. tit. 10 § 405.31

Current through Register Vol. 46, No. 50, December 11, 2024

Section 405.31 - Living donor transplantation services

Hospitals performing living donor transplants shall comply with the requirements of this section, section 405.30 and with section 405.22(a) of this Part. In addition, the following standards apply to all living donor transplant services:

(a)Definition.

(1)Donor advocate is a person or a team responsible for ensuring that the rights and interests of the living donor and the prospective living donor are protected.

(b) Donor advocate responsibilities.

A donor advocate shall be established for any living donor transplantation program. The transplant program shall, as appropriate, consult with an ethicist, and a psychiatrist or other qualified mental health professional, as defined in section 405.30(a)(6) of this Part. The donor advocate's primary responsibility is to support the donor, beginning with the donor evaluation process and continuing through donation, the postoperative period, and discharge, and to ensure that there are appropriate referrals for post discharge care. The advocate shall assist the donor in making informed decisions and balancing external/family pressures to donate. The advocate must evaluate the donor and make a recommendation concerning donor suitability and ensure that the needs of the donor are fulfilled promptly and in accordance with best medical practice. The advocate shall:

(1) advocate for the interests and well-being of the donor;

(2) explain the evaluation process, what to expect, what it means to be a donor;

(3) verify that such living donor is at least 18 years of age at the time of such donor's initial evaluation related to the transplant procedure or is a parent donating to his or her child;

(4) ensure all decisions made by the donor are informed and not coerced by:

(i) evaluating whether there is monetary or property enrichment for the donor, and ensuring the donor signs an attestation as specified in paragraph (4) of this subdivision;

(ii) evaluating whether there is overt coercion to donate by family or others;

(iii) assessing the donor's intellectual and emotional capability of participating in a balanced discussion of potential risks and benefits;

(iv) providing information to the donor about the medical, psychosocial, and financial implications of the living donation for the potential donor and about the recipient's options for deceased donation transplant, including risks and outcomes;

(v) ensuring the donor understands that he or she may decline to donate at any time prior to his or her surgery; and

(vi) if requested by the donor, assisting the donor in the preparation of a general, medically accurate statement of unsuitability for donation.

(5) consult with the surgical team regarding donor suitability before issuing a formal recommendation;

(6) transmit donor advocate findings in writing to the surgical team. The transmittal shall include the reasons for the donor advocate's recommendation. The final determination of donor suitability rests with the attending surgeons of the surgical team;

(7) the potential donor will be advised of the donor advocate's recommendation. At least one attending surgeon and the donor advocate shall make themselves available to the potential donor upon his or her request to discuss the donor advocate's recommendation; and

(8) assure there is continuity of care during hospitalization and assure that there are appropriate referrals for post-discharge care.

(c)Donor advocate requirements.

(1) Such donor advocate or, in the case of multiple members of a donor advocate team at least one member of such team, must not participate in the care of transplant recipients. The advocate's interests shall be centered on the well-being of the living donor.

(2) The donor advocate shall not receive any direct or indirect benefit from recommending continuation of the donor's participation.

(3) The status of the donor advocate at the transplant center may not be affected by recommending for or against donation.

(4) The donor advocate shall be medically sophisticated in transplantation and aware of relevant statistics such as center volume and outcome data, and be able to explain such information to the potential donor.

(5) The donor advocate shall have sufficient preparation in his or her role to recommend that a specific donor is or is not a candidate for living donation.

(6) The donor advocate shall have a comprehensive working knowledge of living donor transplantation.

(d)Education of the donor.

In order to ensure that the potential donor has the knowledge and capacity to exercise informed consent, the advocate shall do the following:

(1) consider the intellectual and emotional capacity of the potential donor to exercise legally and ethically adequate informed consent as described in subdivision (e) of this section;

(2) inform him or her orally and in writing about the risks and benefits of medical interventions;

(3) evaluate whether there is a thorough understanding of the elements of the decision;

(4) evaluate whether the potential donor's decision is voluntary;

(5) inform the potential donor that the donor advocate may recommend against donation and that the advocate's recommendation will be given significant consideration in the surgical team's decision. The reasons for the advocate's decision shall be explained to the donor; and

(6) advise the potential donor of the opportunity to discuss donation with others who have donated in the past and assist in making arrangements to do so, if requested by the donor.

(e)Informed consent.

A person who gives consent to be a living donor shall be competent, willing to donate, free from coercion, medically and psychosocially suitable, fully informed of the risks and benefits as a donor, fully informed of the risks, benefits and any alternative treatments available to the recipient, at least 18 years of age at the time of the donor's initial evaluation related to the transplant procedure unless the person is a parent seeking to donate to their own child, and be likely to benefit in a way not involving the transfer of money or property in connection with the donation, other than reimbursement of donation-related expenses as allowed by law. The informed consent process must include:

(1) informed understanding:

(i) presentation of all information to the potential donor in a language or manner understandable to him or her, consistent with his or her education level;

(ii) the potential donor shall be given the opportunity and adequate time to assimilate the information provided, ask questions and have questions answered;

(iii) the donor shall identify the family and loved ones who shall be given the opportunity to discuss openly with the donor advocate and the surgical team their concerns in a safe and non-threatening environment; and

(iv) the potential donor shall be informed with regard to the need for postoperative, long-term follow-up and testing by the transplant center. The donor shall also be provided with information regarding the need and importance for long term follow-up and annual primary care.

(f)Disclosure requirements.

(1) The donation process shall be explained to the potential donor. This explanation shall address, at a minimum:

(i) donor evaluation procedure;

(ii) surgical procedure;

(iii) recuperative period;

(iv) short and long term follow-up care;

(v) alternative donation and transplant procedures;

(vi) potential psychological benefits and detriments to the donor;

(vii) transplant center and surgeon specific statistics of donor and recipient outcomes;

(viii) confidentiality of the donor's information and decision;

(ix) donor's ability to opt out at any point in the process up to the time of surgery; and

(x) information about how the transplant center will follow the health of the donor for at least two years post donation.

(2) The transplant team and the donor advocate shall disclose their institutional affiliations to the potential donor.

(g)Risks.

Risks shall be fully explained to the potential donor. The explanation shall include:

(1) physical:

(i) potential for surgical complications including risk of donor death;

(ii) potential for organ failure and the need for transplantation;

(iii) potential for other medical complications including long-term complications;

(iv) scars;

(v) pain;

(vi) fatigue;

(vii) abdominal and/or bowel symptoms such as bloating and nausea;

(2) psychosocial:

(i) potential for problems with body image;

(ii) possibility of recipient death;

(iii) possibility of recipient rejection and need for retransplantation;

(iv) possibility of recurrent disease in the recipient;

(v) possibility of adjustment disorder post-surgery;

(vi) possible impact on donor's family;

(vii) possible impact on recipient's family; and

(viii) potential impact of donation on the donor's lifestyle.

(3) Financial:

(i) out of pocket expenses;

(ii) possible loss of employment;

(iii) potential impact on ability to obtain future employment;

(iv) potential for disability benefits and need for assistance completing relevant paperwork; and

(v) possible impact on ability to obtain health and life insurance.

(h)Documentation.

The entire disclosure and consent process, including the attestation required by section 405.30(b)(8) of this Part shall be documented in the donor's medical record, which shall be maintained separate and distinct from the recipient's medical record.

(i)Primary medical evaluation.

A medical evaluation of the potential donor shall be made by an appropriate medical physician. Appropriate laboratory and imaging studies shall be done. Additionally, the following shall also be assessed:

(1) compatibility of the potential donor to the recipient;

(2) general health of, and surgical risk for, the potential donor;

(3) co-morbidities and significant medical conditions that impact the potential donor's suitability;

(4) the potential donor's vulnerability to infection, blood loss, or delayed wound healing; and the potential donor's personal and family medical history.

(j)Psychosocial.

(1) A psychosocial evaluation of the potential donor shall be made by the qualified mental health professional, as defined in section 405.30(a)(6) of this Title. The evaluation shall include, but not be limited to: consideration of the donor's current and past history of: any psychiatric illness, physical abuse, sexual abuse, alcohol abuse, and substance abuse.

(2) Social services shall be provided in accordance with section 405.28 of this Part as well as any additional requirements established in this Part.

(k)Recipient criteria.

The transplant center must establish written policies and procedures governing recipient eligibility for living donation. At a minimum, such policies and procedures shall:

(1) ensure the patient meets the center's written eligibility criteria as specified in section 405.30(b)(5) and (e) of this Part;

(2) ensure the recipient has received information regarding specific risks and benefits, alternative treatments and expected outcome of the transplantation;

(3) establish conditions which require recipient exclusion; and

(4) ensure that the benefits to both the donor and the recipient outweigh the risks before any living transplant is performed.

(l)Donor management.

(1) The donor surgeon shall have the primary responsibility for the donor's care and welfare throughout his or her hospital stay.

(i) The donor surgeon is responsible for making the final determination regarding a donor's suitability after reviewing and considering the donor's medical, psychological, and social history; the donor's current medical, psychological and social status; the recommendation of the donor advocate, all consultative reports; and the standards set forth in this subdivision.

(ii) If the donor surgeon decides to proceed with a donation after receiving an adverse recommendation from the donor advocate, the surgeon shall document the reasons for doing so in the patient's medical record.

(m)Imaging service requirements.

Hospitals performing living donor transplantation shall have adequate imaging services and staff support appropriate to evaluate recipients and living donors. Radiologists with experience in interventional procedures (angiography) and ultrasound imaging studies in the living donor and recipient, must be available at all times including weekends and holidays. If there is an emergent complication requiring imaging services, these patients should be prioritized for access to such imaging services by the hospital.

(n) Discharge planning requirements.

The hospital shall comply with the discharge planning requirements contained in section 405.9 of this Part as well as the following:

(1) The donor advocate shall be available to the donor from pre-admission to post-discharge.

(2) A detailed, written discharge plan shall be developed, given to the donor and provided to all health care professionals involved in the donor's care, including the donor's primary care physician.

(3) This plan shall be reviewed with the donor by a health care professional such as a registered professional nurse, qualified social worker or transplant coordinator.

(4) The plan shall include, at a minimum, instructions on:

(i) activities;

(ii) diet;

(iii) medication for pain; and

(iv) wound care.

(5) The patient shall be provided with a 24-hour contact number that he/she can call with questions. The responder shall be available when needed and knowledgeable about living donation.

(6) Information shall include the name, address and telephone number of the surgeon and instructions for the follow-up visit.

(7) Instructions for family members or caregivers shall be provided.

(o)Post-discharge requirements.

(1) Medical follow-up shall meet generally accepted standards for someone who has undergone a major transplant procedure. This follow-up shall include:

(i) postoperative visits with the donor's surgeon(s);

(ii) follow-up coordinated with the donor's primary care physician to assess wound healing and to monitor for signs/symptoms of infection;

(iii) laboratory studies as appropriate; and

(iv) a written summary of the donor's condition, which shall be provided to the donor and his or her primary care physician upon the donor's discharge from the hospital.

(2) The hospital shall provide or arrange for follow-up social/psychological supports directly related to the donation as needed, which may include measures such as:

(i) visits with a social worker familiar with organ transplantation issues;

(ii) visits with a psychologist or psychiatrist familiar with organ transplantation issues;

(iii) participation in a professionally run support group;

(iv) participation in a center sponsored computer donor listserve or bulletin board to share patient concerns; and

(v) invitation to a donor recognition event, such as an annual recognition ceremony or presentation of a donor medal.

(3) Donors shall be informed of the option to discuss financial/insurance concerns with the transplant center's financial coordinator.

(4) Hospitals shall report to the department such information as the department shall require to assist the department in assessing the quality of care provided; determining routine or unusual complications or outcomes, and identifying potential improvements to donor education, screening, consent, preoperative, surgical and postoperative care and follow-up. Such information shall include, but not be limited to:

(i) donor demographics;

(ii) preoperative medical and psychosocial information;

(iii) surgical information and complications;

(iv) hospital staff training and experience;

(v) recipient outcome; and

(vi) immediate and long-term postoperative care, complications, and impact on quality of life.

(5) Hospitals shall track the donor and his or her condition for at least two years post donation in accordance with the provisions set forth in section 405.30(b)(9) of this Part.

(p)Living adult donor to adult recipient liver transplantation services.

(1) Surgical team requirements:

(i) At least two liver transplant attending surgeons with experience as established in subparagraph (v) of this paragraph shall participate in the surgery of the donor. These two surgeons shall be present for the critical parts of the surgery including the live parenchymal transection. They both shall be available and scrubbed if needed for complications, however, only one surgeon need be present for the remainder of the donor operation.

(ii) A third liver transplant attending surgeon shall be present in the recipient operating room. This surgeon must have experience in deceased liver transplantation.

(iii) All three surgeons shall be board certified or board admissible in general surgery or have foreign certification determined to be equivalent by the New York State Department of Health.

(iv) All three surgeons shall have demonstrated experience in liver transplant surgery.

(v) One of the two surgeons must demonstrate experience as the primary surgeon or first assistant in 20 major hepatic surgeries (to include living donor hepatectomies or major hepatic resections), seven of which must have been live donor hepatectomies within the prior five year period. The other of the two surgeons must be either a liver transplant surgeon or hepatobiliary surgeon practicing at a transplant hospital and must have performed at least 20 major liver resections within the prior five year period. Both of the surgeons must be available during the donor hepatic resection.

(2) Anesthesia requirements:

(i) there shall be two separate attending anesthesiologists; one each for the living adult liver transplantation donor and recipient operations. These anesthesiologists shall be present for the critical anesthetic and surgical portions of the procedures and immediately available at all other times. As one case is completed, either anesthesiologist may take responsibility for the ongoing case. The anesthesiologists shall have experience in liver transplant anesthesia and/or major hepatic resection surgery and/or cardiac surgery anesthesia;

(ii) there shall be two separate anesthesia teams in two operating rooms (one for the donor, one for the recipient); and

(iii) these teams shall each be directed by a separate attending anesthesiologist for the living donor and the recipient procedure. In addition to the attending anesthesiologist who shall be present as specified in subparagraph (i) of this paragraph, at least one member of the anesthesia team who is an anesthesiologist, chief resident, fellow (postgraduate year 3, 4, or 5), or qualified certified registered nurse anesthetist shall be present and responsible, under the direction of the attending anesthesiologist, for the evaluation and care of the patient through all phases of the procedure pertaining to the administration of, and recovery from, anesthesia. All team members shall have ongoing education and training in liver and/or cardiac surgery and have had anesthesia responsibility for major liver resections.

(3) Postoperative care requirements. Donors shall receive postoperative care consistent with the following:

(i) day 0-1. Living adult liver donors shall receive intensive care (ICU or PACU) for at least 24 hours, at a minimum;

(ii) day 2. If stable and cleared for transfer by the transplant team after the first 24 hour period, donors shall be cared for in a hospital unit that is dedicated to the care of transplant recipients or a hospital unit in which patients who undergo major hepatobiliary resectional surgery are cared for. Living liver donors may be cared for on another unit if a specific medical condition of the donor warrants such a transfer and the transfer is documented in the donor's medical record;

(iii) the donor shall be evaluated at least daily by one of the qualified liver transplant attending physicians with documentation in the medical record;

(iv) the transplant team shall be responsible for the pain management of the donor. In institutions where a pain management team is available, the transplant team may delegate its responsibility to this team. However, there shall be a written protocol in place for assessment and management of donor pain;

(v) the patient care staff shall be familiar with the common complications associated with the donor and recipient operations and have appropriate monitoring in place to detect these problems should they arise; and

(vi) if there is an emergent complication requiring reoperation, these patients shall be prioritized by the hospital for access to the operating room by the institution.

(4) Minimum Medical Staffing Requirements.

(i) There shall be 24-hour, seven day-a-week continuous coverage of the transplant service by general surgery residents at the postgraduate year two level or higher, transplant fellows, nurse practitioners or physician assistants. Between the hours of 6 p.m. and 8 a.m. on weekdays and at all times on the weekends and holidays, the covering residents, fellows, nurse practitioners, or physician assistants should be dedicated to the transplant service and not covering other surgical or nonsurgical patients. An attending transplant surgeon shall be available immediately as a resource for the residents, fellows, nurse practitioners or physician assistants at all times.

(ii) Any patient with abnormal vital signs or unusual symptoms shall be evaluated immediately. Notification to the appropriate senior medical staff member (fellow, chief resident, attending) shall be made in accordance with written hospital policy and procedures and in no case no more than 30 minutes after abnormal vital signs or unusual symptoms were first observed.

(5) Nursing Minimum Staffing Requirements. Nurse staffing shall be in accordance with the annual clinical staffing plan established under paragraph (8) of subdivision (a) of section 405.5 of this Title. In addition:

(i) Nursing staff shall have ongoing education and training in live donor liver transplantation nursing care (donor and recipient). This shall include education in the pain management issues particular to the donor. The registered professional nursing ratio shall be at least one registered professional nurse for every two patients (1:2) in the ICU/PACU level setting, increased as appropriate for the acuity level of the patients.

(ii) After the donor is transferred from the ICU/PACU, the registered professional nursing ratio shall be at least 1:4 on all shifts, increased as appropriate for the acuity level of the patients

(iii) The same registered professional nurse shall not take care of both the donor and the recipient.

(iv) The nursing service shall verify that the potential donor received appropriate pre-surgical information.

(v) The names and contact numbers of the transplant team shall be posted on all units receiving transplant donors.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 405.31

Amended by New York State Register September 10, 2014/Volume XXXVI, Issue 36, eff. 9/10/2014.

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

Amended New York State Register July 19, 2023/Volume XLV, Issue 29, eff. 7/19/2023