N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-2.3

Current through Register Vol. 46, No. 45, November 2, 2024

Section 52-2.3 - Ownership or controlling interest reporting requirements

(a) Except for a tissue bank owned and operated by a facility established pursuant to Public Health Law, article 28, any change in the direct or indirect ownership status of five percent or more or in a controlling interest in a tissue bank or nontransplant anatomic bank, shall be reported to the department on a new application within 30 days of the change. Such application shall be reviewed in accordance with section 52-2.5 of this Subpart. Any change in the direct or indirect ownership status or of a person with a controlling interest which requires Public Health Council approval pursuant to Public Health Law, article 28, shall be reported to the department within 30 days of the change.

(b) All changes in tissue bank director, medical director, nontransplant anatomic bank director, or tissue bank compliance officer shall be reported to the department in writing within five days of the change, and a new application reflecting all changes since the prior application must be submitted within 30 days of the change. Such application shall be reviewed in accordance with section 52-2.5 of this Subpart.

(c) If any person or corporation with an ownership or controlling interest in a tissue bank or nontransplant anatomic bank of five percent or more has been convicted of a criminal offense related to the operation of such a bank, a laboratory or of any programs established by title XVIII, XIX or XX of the Federal Social Security Act, such conviction shall be disclosed within 30 days of its occurrence. Conviction does not necessarily bar ownership; the department shall review the conviction under the requirements of the Public Health Law to determine whether the conviction may affect the ability of the bank to operate in compliance with Public Health Law, article 5, title V and article 43-B, and applicable State and Federal regulations regarding the operation of tissue banks.

(d) Ownership of or controlling interest in any other tissue bank, nontransplant anatomic bank, laboratory or health care facility holding a New York State or New York City license shall be disclosed within 30 days of any change in such status.

(e) Failure to comply with the reporting and application requirements of this section shall result in termination of the license.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-2.3