Creates a state-wide database of all donations of tissue or non-transplant organs procured by an organ procurement organization or a procurement organization

Subdivision (2) states that the information required to be kept in this database shall not preempt the recording requirements described in the New York Code and Regulations 52-2.9. Furthermore, any identifying information, such as a donor's name and address, shall not be disclosed or released by the Department of Health to any person or entity, except upon the written consent of the donor, the person authorized by law to make such a donation, authorized employees of the department, or as permitted by law.

Subdivision (3) grants the Department of Health the authority to promulgate any rules and regulations necessary for the implementation of this database.

Subdivision (4) requires the Department of Health to develop a protocol to provide notice to tissue or organ recipients, if it is determined that such tissue or organs have been procured from a donor who has or had an infectious, contagious or communicable disease or cancer.

Section 2. Effective Date.

Existing law

None.

Justification

In response to major medical breakthroughs in healing burn victims, fixing athletic knee injuries and easing back pain, the tissue bank industry has boomed in recent years. According to the Food Drug Administration (FDA), the number of musculosketal tissue transplants done in the United States has more than doubled over the past dozen years - from 350,000 in 1990 to 800,000 in 2002.

Although the proper harvesting of tissue makes medical miracles possible to achieve, there is a certain risk of disease transmission associated with tissue transplantation. The risk is believed to be low, but when the transmission of a disease has occurred the results have been tragic. In 2001, for example, a 23-year-old Minnesota man died four days after receiving a transplant of bone and cartilage to reconstruct his knee. He had acquired a deadly infection from toxic bacteria in the tissue. In 2002, five tissue recipients in the United States were believed to be infected by hepatitis C from a single donor's tissues. And in 2003, contaminated corneas resulted in infections and vision loss in two people.

While it is essential to mitigate the probability of obtaining a dangerous disease through a tissue transplantation by extensively testing tissue, it also crucial to establish a comprehensive statewide database of all donations of tissue. Tissue safety depends on the cooperative and collaborative efforts of many entities, including the FDA, the CDC, the NYS Department of Health, and the tissue industry. A statewide database would ensure the efficient inspection and monitoring of all donor tissue and would help the Department of Health better communicate with procurement facilities and donees when specific tissue or organs have been procured from a donor who has or had an infectious, contagious or communicable disease or cancer. By consolidating all the information of tissue and organ donors into one searchable statewide database, it would significantly improve the Department of Health's response time to recipients of disease tissue or organs, potentially saving their lives.

As legislators, it is our responsibility to take all the necessary steps to ensure the well-being of New York State residents. Therefore, this legislation establishes a statewide database of all donation tissue or non-transplant organs procured by an organ procurement or a procurement organization and enumerates the type of information that must be included in this database.

Legislative history

2005-2006: S.7331 - Health; 2007-2008 - Health.

Fiscal implications

None.

Effective date

This act shall take effect immediately; provided, however, that within one year of the effective date of this act, the addition, amendment and/or repeal of any rule or regulation necessary for the implementation of this act are authorized and directed to be made and completed.