New York Codes, Rules and Regulations
Title 10 - DEPARTMENT OF HEALTH
Chapter V - Medical Facilities
Subchapter A - Medical Facilities-minimum Standards
Article 2 - Hospitals
Part 405 - Hospitals-Minimum Standards
Section 405.30 - Organ and vascularized composite allograft transplant services/programs
Universal Citation: 10 NY Comp Codes Rules and Regs ยง 405.30
Current through Register Vol. 46, No. 39, September 25, 2024
(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.
Disclaimer: These regulations may not be the most recent version. New York may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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