SECTION 1. Subsection (c) of section 15 of chapter 17 of the General Laws, as appearing in the 2010 Official Edition, is hereby amended by adding the following clause:-
(8) study what the term “reasonable amount” as found in section 16 of chapter 113A currently means in the tissue donation community and make recommendations as to what the limit on said “reasonable amount” should be to ensure that corruption is not incentivized within the industry.
SECTION 2. Chapter 113A of the General Laws, as inserted by section 2 of chapter 39 of the acts of 2012, is hereby amended by inserting, after section 14, the following 4 sections:-
Section 14A. The department of public health shall create a model code for tissue banks as defined by section 2 and procurement organizations that deal with tissue as defined by section 2. Included in this model code shall be rules and regulations that ensure that said banks and organizations procure tissue legally and that said tissue is only taken from eligible donors. Tissue banks and procurement organizations covered by this section shall ensure the eligibility of donors based on medical history interviews and records.
The department shall also promulgate rules and regulations in order to perform annual audits on tissue banks and procurement organizations. During the audit, the department shall have access to the medical and financial records kept by the banks or organizations.
Section 14B. Any tissue bank or procurement organization that deals with tissue as defined by section 2 shall register with the department of public health. Said bank or organization shall also provide upon request to the potential donor, or the legally authorized representative of a potential donor, a description of the process for recovery of human cells, tissues, or cellular or tissue based products and what the cells, tissue, or cellular or tissue based products will be used for. Said tissue bank or procurement organization shall inform such donor or representative of the right to receive such a description. Additionally, the bank or organization shall inform the donor or representative of whether the establishment is accredited under regulations promulgated by the department of public health.
Section 14C. An establishment that fails to comply with the rules and regulations promulgated by the department of public safety shall be subject to a civil fine of $5,000.
Section 14D. An establishment, or an individual employed by an establishment, that knowingly uses fraudulent information for, or fraudulent means of, obtaining the consent of a donor or knowingly uses tissue from a donor who is not eligible as described under the section 14A shall be:
(a)fined not more than $10,000, or imprisoned for not more than 6 months, or both, for the first such violation; and
(b) fined not more than $250,000, or imprisoned for not more than 10 years, or both, for the second and any subsequent such violation.
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