Sunset Regulation of Nontransplant Tissue Banks

Sunset Process - House Health and Human Services Committee. The bill implements recommendations of the department of regulatory agencies' (department) sunset review and report on the regulation of nontransplant tissue banks by continuing the regulation of nontransplant tissue banks for 9 years, to 2033. The bill grants the director of the division of professions and occupations in the department ( director ) the authority to create rules necessary for the regulation of nontransplant tissue banks. The director shall solicit input from the following groups during the rule-making process:

• Persons, including any professional organization of individuals that has signed up with the department for rule-making notification, offering services that require registration pursuant to Colorado law regulating nontransplant tissue banks; and
• Consumers or consumer representatives who advocate for consumers affected by Colorado law regulating nontransplant tissue banks and who have signed up with the department for rule-making notification.

If a nontransplant tissue bank withdraws or does not renew its registration with the director, the bill requires the nontransplant tissue bank to continue to maintain specified information on file with the director for a period of 3 years after the end of registration. The nontransplant tissue bank shall also maintain specified records and receipts for a period of 3 years after the end of registration.

In addition to standards of practice in existing law, the bill requires that a nontransplant tissue bank maintain a proper chain of custody of human remains while the human remains are in the possession of the nontransplant tissue bank. A nontransplant tissue bank is permitted to compensate a funeral establishment for transportation of human remains and other reasonable expenses, but shall not compensate a funeral establishment for human remains. The donor of human remains (donor) or the person authorized by law to consent to donation may limit the sale of the donated human remains by a nontransplant tissue bank, including prohibiting sale to foreign buyers, for nonmedical research uses, or for military uses.

A nontransplant tissue bank shall disclose the following information, in addition to required disclosures in existing law, to the donor or to the person authorized by law to consent to donation:

• That the donor or the person authorized by law to consent to donation is donating human remains to a nontransplant tissue bank;
• That the nontransplant tissue bank may sell all or any portion of the human remains;
• That the nontransplant tissue bank may compensate a funeral establishment for transportation of human remains and other reasonable expenses, but the nontransplant tissue bank shall not compensate a funeral establishment for human remains; and
• That the donor or the person authorized by law to consent to donation may limit the sale of the donated human remains by a nontransplant tissue bank, including prohibiting sale to foreign buyers, for nonmedical research uses, or for military uses.

A person owning an interest in a funeral establishment is prohibited from owning an interest in a nontransplant tissue bank. The bill excludes an approved medical college or similar educational institution that accepts human remains primarily for its own educational or research purposes from the definition of a "nontransplant tissue bank". The bill provides a private civil right of action for a person who suffers damages as a result of a violation of Colorado law regulating nontransplant tissue banks to recover damages against any person that violates the law. The bill also specifies statutory penalties for a violation of law regulating nontransplant tissue banks .

(Note: Italicized words indicate new material added to the original summary; dashes through words indicate deletions from the original summary.)

(Note: This summary applies to the reengrossed version of this bill as introduced in the second house.)