N.Y. Comp. Codes R. & Regs. tit. 10 § 405.30

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

Section 405.30 - Organ and vascularized composite allograft transplant services/programs

(a)Definitions.

For purposes of this section the following shall have the following meanings:

(1)Department shall mean the New York State Department of Health.

(2)Living donor is an individual who donates an organ or a vascularized composite allograft while alive.

(3)Organ means a human kidney, heart, liver, lung, pancreas, uterus, stomach, intestine, and/or any other tissue requiring revascularization or immunosuppression in the recipient.

(4)Organ procurement organization (OPO) means a facility or institution engaged in procuring organs and/or vascularized composite allografts for transplantation, or therapy purposes but does not include:

(i) facilities or institutions which permit procurement activities to be conducted on their premises by employees or agents of an approved organ procurement organization; or

(ii) facilities or consortia of facilities which conduct transplantation activities in accordance with article 28 of the Public Health Law when the organ is procured through an approved organ procurement organization, or from a living donor.

(5)Organ trafficking is the recruitment, transport, transfer, harboring or receipt of living or deceased persons or their organs by means of the threat or use of force or other forms of coercion, of abduction, of fraud, of deception, of the abuse of power or of a position of vulnerability, or of the giving to, or the receiving by, a third party of payments or benefits to achieve the transfer of control over the potential donor, for the purpose of exploitation by the removal of organs for transplantation.

(6)Patient means either the living donor or the recipient:

(i)adult means a patient 18 years of age or older at the time of the transplant;

(ii)pediatric patient means a patient who has not reached his or her 18th birthday at the time of the transplant.

(7)Qualified mental health professional shall mean a psychiatrist, psychologist, or qualified social worker assigned to evaluate the potential recipient and/ or living donor.

(8)Qualified social worker shall mean a person who is licensed and registered by the State Education Department to practice as a licensed master social worker (LMSW) or licensed clinical social worker (LCSW), within the scope of practice defined in article 154 of the Education Law.

(9)Recipient is an individual who receives transplanted organs, or a vascularized composite allograft.

(10)Transplant center means a unit within a hospital that performs transplants, including but not limited to activities such as qualifying patients for transplant, registering patients on the national wait list, performing transplant surgery and providing care before and after transplant. A transplant center may include one or more transplant programs.

(11)Transplant commercialism is a policy or practice in which an organ is treated as a commodity, including being bought, sold, or used for material gain.

(12)Transplant program means the persons or entity that provides organ specific transplant services within a transplant center.

(13)Transplant services means the provision of organ, living donor and or vascularized composite allograft transplants and other medical and surgical specialty services required for the care of transplant recipients and living donors.

(14)Transplant tourism is travel for transplant that involves organ trafficking and/or transplant commercialism.

(15)Travel for transplant is the movement of organs, vascularized composite allografts, donors, recipients, or transplant professionals who travel across national borders for transplant purposes.

(16)Vascularized composite allograft means a contiguous segment of mixed allogeneic tissues whose relationships have been altered only at the segment boundaries and whose transplantation requires revascularization and/or immunosuppression in the recipient. Vascularized composite allografts include, but are not limited to, hand, face, and other such contiguous segments.

(b)General requirements.

Hospitals shall not admit patients for, or otherwise provide, transplantation services unless the hospital is specifically approved by the department to provide transplant services. Transplant services for pediatric patients shall only be provided in a hospital approved by the department to provide transplant services. Hospitals that provide pediatric transplant services must comply with section 405.22(a) of this Part and must develop and adhere to written policies and procedures specific to pediatric patients.

In addition, the following standards apply to all transplant centers and programs:

(1) Transplant services, or any new Institutional Review Board (IRB) approved medical/surgical treatments which involve transplant medical/surgical care including but not limited to transplant immunology, shall be performed only in hospitals approved by the department to perform such transplant services.

(2) The hospital shall be a member in good standing of the Organ and Procurement and Transplantation Network (OPTN) approved by the Secretary of the U.S. Department of Health and Human Services (HHS) and shall abide by its rules and requirements.

(3) When fully operational, to ensure quality of care, the hospital shall perform at least 10 liver transplants per year if it is to continue as an approved liver transplant program; or at least 10 human heart transplants per year if it is to continue as an approved heart transplant program; or at least 10 kidney transplants a year if it is to continue as an approved kidney transplant program; or at least 10 lung transplants per year if it is to continue as an approved lung transplant program. The department will monitor outcomes for graft and patient survival.

(4) The hospital shall participate in a patient registry program with an organ procurement organization designated by the Secretary of the U. S. Department of Health and Human Services. Before arranging for the placement of the patient on the waiting list, each facility shall inform a patient awaiting transplantation of the prohibition against being placed on multiple facility waiting lists within New York State before arranging for the placement of the patient on the waiting list.

(5) Every hospital performing transplant services shall maintain written criteria for the selection of patients for such services which shall be consistent with professional standards of practice, applied consistently, and made available to the public.

(6) The hospital shall maintain a record of:

(i) all patients who are referred for transplantation and the date of their referral;

(ii) the results of the evaluation of all candidates for transplantation which documents the reasons a candidate is determined to be either suitable or unsuitable for transplantation;

(iii) the psychosocial evaluation;

(iv) the date a suitable candidate is selected for transplantation;

(v) the reasons for, and date of, any declination of a matching organ or vascularized composite allograft offered to a potential recipient;

(vi) the date the transplantation surgery occurred;

(vii) documentation of donor and recipient blood type;

(viii) the donor's United Network for Organ Sharing (UNOS) identification number; and

(ix) the organs or vascularized composite allografts utilized.

(7) The hospital will ensure that appropriate informed consent is obtained from both the recipient and if applicable, the living donor. The process for obtaining such consent shall include the provision of information, at a minimum of the following:

(i) the evaluation process used to determine suitability for transplant;

(ii) the surgical procedure including the post-operative period;

(iii) the availability of alternative treatments;

(iv) organ donor risk factors that could affect the success of the graft or the health of the patient, including, but not limited to, the donor's history, condition or age of the organs or vascularized composite allografts used, and the recipient's potential risk of contracting the human immunodeficiency virus (HIV) and other infectious diseases if the disease cannot be detected in an infected donor;

(v) if applicable, providing adequate information to the recipient to ensure his or her understanding regarding the risks to the living donor;

(vi) potential medical and psychosocial risks;

(vii) the national and transplant center outcomes for recipients;

(viii) the patient's right to refuse transplantation, or the donor's right to refuse to be a donor; and

(ix) the effect that provision of transplant services provided in a facility not approved as a Medicare-approved transplant center could have on the recipient's ability to have his or her immunosuppressive drugs paid for under Medicare Part B.

(8) For procedures involving a living donor, the hospital must obtain a written attestation from the living donor attesting that the donor has not received anything of value in exchange for the donation, aside from reimbursement for expenses associated with the donation to the extent allowed by New York State and Federal law. The recipient must also attest in writing that he or she has not offered and is not aware of any offers of valuable consideration to the donor for their donation, except as allowed by New York State or Federal law.

(9) The hospital must utilize an organized system for follow-up of patients after discharge, including maintenance of records on the long-term survival of persons who have received a transplant or who have made a living donation. Transplant centers must follow the health of each donor for at least two years post-donation.

(10) The hospital shall ensure that written procedures are maintained and implemented for the receipt, identification, and verification of all organs and vascularized composite allografts for transplantation.

(11) The hospital shall develop, maintain and implement written infection control policies and procedures specific to the transplant services, as an integral part of the hospital's infection control program.

(12) The hospital shall ensure that the infection control program utilizes sufficient professional and laboratory resources to address transplant-related transmissible infections, including discovery, identification and management of complications from organisms associated with transplants whether commonly or uncommonly encountered.

(13) Each transplant center shall develop and implement a policy for a formalized process of communication with OPOs, the center's clinical staff, the department and as appropriate, local/city departments of health with regard to suspected and confirmed donor disease transmission. This policy shall include:

(i) identification of a patient safety contact, with coverage so that there is a person available on a 24 hour, 7 days a week, 365 days a year basis, to be the primary contact for possible disease transmission events;

(ii) a procedure to promptly contact the OPO that recovered the organ whenever a suspected disease transmission has occurred;

(iii) prompt communication and documentation when made aware of the suspected transmission;

(iv) identification of an infectious disease resource available to assist in the evaluation of a potential disease transmission; and

(v) the documentation of and notification to the transplant program director or his or her designee of the potential disease transmission, and the implementation of mechanisms to ensure that the information is acted upon in a timely manner.

(14) Every transplant center shall develop and implement a policy on travel for transplant including, transplant tourism, transplant commercialism and organ trafficking. Such policy may include:

(i) notice to all potential donors and recipients of the legal prohibitions against the sale of organs or vascularized composite allografts;

(ii) information about the medical risks of receiving an organ or vascularized composite allografts in a foreign country, in particular, the risk of infectious disease transmission to and from the recipient, the possible difficulties in obtaining recipient records related to the surgical procedure and post-operative treatment, and in cases of living donation the records regarding the donor's social/medical history;

(iii) notice that participation in transplant commercialism and or organ trafficking may violate the laws of the countries involved as well as international treaties or conventions.

(15) Transplant centers that provide liver transplant services must join and be a member in good standing of a recognized consortium organization providing quality assurance, peer review, data sharing, and best practices collaboration activities for liver transplant services. If such a consortium(s) exists for other transplant services, such as heart or kidney, transplant centers must join the appropriate organization relevant to the transplants it performs and be a member in good standing.

(16) Review. Facilities shall allow the department, or its designee, to conduct site visits to and/or survey data and patient record reviews from existing and prospective new transplant centers.

(17) Closure.

(i) Failure to meet one or more statutory or regulatory requirements or inactivity in a program for a period of 12 months may result in actions up to and including withdrawal of approval as a transplant center.

(ii) Voluntary closure. The hospital must provide a closure plan and written notification of potential closure to the department at least 60 days prior to planned discontinuance of transplant services. Such closure plan must address and provide a means of implementation with regard to, at minimum, the following: the means by which the program's patients (including those being evaluated for transplant, wait-listed patients, transplant recipients and living donors currently being treated by the program) will be provided with written notice of the planned closure and the means by which such persons may transfer to another transplant program; the means by which the Organ Procurement and Transplant Network, operated under contract with the U.S. Department of Health and Human Services by the United Network for Organ Sharing, the Federal Centers for Medicare and Medicaid Services and the hospital's transplant program's referral networks will be notified of the planned closure; and the means by which the program's patients (including those being evaluated for transplant, wait-listed patients, transplant recipients and living donors currently being treated by the program) will be assisted in transferring to another transplant program. No transplant service shall discontinue operation without prior written approval from the department.

(18) Notification of significant changes. A hospital must notify the department in writing within seven days of any significant changes in its transplantation services including, but not limited to:

(i) any temporary or permanent suspension of services;

(ii) departure of or change in the physician program director;

(iii) unavailability of the transplant surgeon or physician of more than 15 days, if a program is without a physician credentialed to perform one or more of the procedures or services of the transplant service as a result of such unavailability; or

(iv) inability to meet workload requirements.

(19) Data collection and reporting. Data and governmental and accrediting body reports shall be maintained for a period at least as long as that required for the retention of patient medical records under this Part, and made available to the department upon request.

(c)Organization and staffing.

(1) The director of the transplant center, in addition to the requirements in section 405.22(a)(1) of this Part, shall be a qualified specialist with previous experience and demonstrated competence in the transplant service. The director is responsible for planning, organizing, conducting, and directing the transplant center and must devote sufficient time to carry out these responsibilities including, but not limited to overseeing the transplant center's quality assurance and performance improvement (QAPI) program.

(2) Each transplant center shall have on-site a qualified transplant physician and another person who is a qualified transplant surgeon who may also fulfill the requirement as director of the service.

(3) The hospital shall provide a clinical transplant coordinator and sufficient staff to coordinate the activities of the transplant center, including patient follow-up after discharge. The clinical transplant coordinator shall be a physician, registered professional nurse, registered physician assistant, or nurse practitioner, licensed and currently registered or certified to practice in New York State.

(4) The hospital shall ensure that all staff members providing transplant services are prepared for their responsibilities through ongoing education, experience, demonstrated competence and completion of in-service education programs as needed.

(5) From admission to discharge, including post discharge follow-up, patient care evaluation, planning and management shall be performed by a multidisciplinary care team involved with the care of the patient; (which includes, at a minimum physicians, surgeons, nurses, qualified social workers, clinical transplant coordinators, nutritional services as needed and pharmacy as needed). The patient and, as appropriate, the patient's family shall be involved and have input into the patient's care plan.

(6) The transplant center shall make available nutritional assessments and diet counseling services to all transplant recipients and donors.

(7) The transplant center shall make psychiatric and social services available, directly or via referrals, to patients to assist with psychosocial problems of the patients, as related to the donation. Such professionals shall be skilled in individual and family counseling, shall understand the entire donation and transplantation process, and be able to provide information on financial issues and community resources.

(d) Quality assessment and performance improvement (QAPI) programs.

(1) The transplant center must develop, implement and maintain a written, comprehensive, data driven QAPI program to monitor and evaluate performance of all transplantation services, including services provided under contract or arrangement.

(2) The transplant center's QAPI program must use objective measures to evaluate the center's performance with regard to transplantation activities and outcomes. Outcome measures may include, but are not limited to: patient and donor selection criteria, accuracy of the waiting list in accordance with the Organ Procurement Transplantation Network (OPTN) waiting list requirements, accuracy of donor and recipient matching, patient and donor management, techniques for organ and vascularized composite allograft recovery, consent practices, patient education, patient satisfaction, and patient rights.

(3) The transplant center must take actions that result in ongoing performance improvements and track performance to ensure that improvements are sustained.

(4) A transplant center must establish and implement written policies to identify, analyze, report, address and document adverse events that occur during any phase of an organ or vascularized composite allograft transplantation case, and utilize such efforts to prevent future adverse events.

(e)Organ and vascularized composite allograft acceptance criteria.

(1) In consultation with an organ procurement organization, the hospital shall develop and uniformly apply organ and vascularized composite allograft acceptance criteria and establish written policies and procedures to ensure the medical suitability of organs and vascularized composite allografts to be transplanted. Hospitals shall also develop and uniformly apply acceptance criteria for living donors. Such acceptance criteria shall be consistent with professional standards of practice, and shall ensure that the living donor is at least 18 years of age at the time of the initial living donor evaluation. Specific medical conditions of the donor shall be determined by the transplant surgeon through the donor's medical history, appropriate clinical laboratory testing and other confirmation methods and must be documented in the recipient's medical record. A parent may consent to a living donation to the parent's own child, regardless of the parent's age.

(2) Written organ and vascularized composite allograft acceptance criteria shall be:

(i) specific for each type of organ or vascularized composite allograft;

(ii) shall describe those medical conditions and circumstances which would make the potential donor ineligible; and

(iii) shall describe those medical conditions for which medical discretion may be exercised.

(3) The potential recipient will be fully informed of the risks and benefits of the particular solid organ or vascularized composite allograft.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 405.30

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