Organ and Tissue Donation is one of the most regulated areas in health care. State and federal legislation is in place to provide the safest and most equality based system for allocation, distribution, and transplantation. NJ Sharing Network operates in accordance with the regulations, laws and guidelines of federal, state and industry governing bodies.
Federal & State Legislations
Centers for Medicare and Medicaid Services (CMS)
The Centers for Medicare and Medicaid Services (CMS) issued Conditions of Participation on organ procurement designed to increase organ donation. The regulations imposed several requirements a hospital must meet which became effective August 21, 1998. These requirements apply to all Medicare and Medicaid participating hospitals. The CMS organ procurement regulations and hospital requirements are codified in 42 C.F.R., Section 482, Conditions of Participation: organ, tissue, and eye procurement.
Health Insurance Portability & Accountability Act (HIPAA)
The HIPAA Privacy Rule Section §164.512 (h) allows hospitals to disclose protected health information to organ procurement organizations (OPOs) or other entities engaged in the procurement, banking or transplantation of cadaveric organs, eyes or tissues. OPOs are specifically permitted to perform their core function, with stringent confidentiality, but outside the scope of HIPAA. No additional consent, authorization or opportunity to agree or object is required.
National Association of Attorney Generals
The National Association of Attorneys Generals recently passed a resolution “in support of respecting and upholding the decisions made by persons who elect to be organ, eye, and tissue donors."
NJ Hero Act
New Jersey has become the first state in the union to advocate that its residents have the fundamental responsibility to choose whether to help save another person’s life. The state’s public policy toward organ and tissue donation has moved from a position of general support to a position of advocacy that encourages positive donation decisions as imperative to saving more lives. The Hero Act was designed to create a more dynamic and comprehensive public policy regarding organ and tissue donation and includes mandated decisional and educational components.
Uniform Anatomical Gift Act (UAGA) - New Jersey Revised
The Uniform Anatomical Gift Act (UAGA) was originally enacted in 1968, and was the first law governing organ and tissue donation in the United States. This law has been adopted by all 50 states. The 2006 UAGA was revised to provide uniformity in state laws regarding organ and tissue donation.
Conditions of Participation Q&A
Department of Health Regulations Pertaining to Organ and Tissue Donation
Organ and Tissue Governing Organizations
American Association of Tissue Banks (AATB)
Association of Organ Procurement Organizations (AOPO)
Eye Bank Association of America (EBAA)
Food and Drug Administration (FDA)
The Joint Commission Organ Donation Standards
JOINT COMMISSION STANDARDS RELATING TO ORGAN DONATION
Revisions to Standards
United Network for Organ Services (UNOS)