N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-2.2

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

Section 52-2.2 - Provisional licensure

(a) The department may issue a provisional license which shall be valid for a period determined by the department to be sufficient to enable the department to assess the compliance of the tissue bank or nontransplant anatomic bank with this Part. The provisional license may be renewed pending issuance or denial of a license.

(b) Except for a limited tissue procurement service, a tissue bank initially applying for a license may be issued a provisional license provided it meets the following conditions:

(1) a valid and complete license application has been filed;

(2) unless the site is a tissue transplantation facility or insemination/implantation site or a tissue storage facility whose tissue storage activity is limited to virally inactivated tissue, a medical advisory committee, consisting of at least five individuals with experience in tissue banking and/or transplantation medicine, including at least one member with expertise in infectious diseases, has been designated;

(3) if the tissue bank has been inspected by the department, the tissue bank has provided satisfactory evidence of correction of any deficiencies found; and

(4) the owners and/or persons with a controlling interest, tissue bank director, medical director, tissue bank compliance officer and transplantation service director, as required, meet the requirements of this Part and possess the education and experience necessary to ensure that the tissue bank is operated in substantial compliance with this Part.

(c) A nontransplant anatomic bank or a limited tissue procurement service initially applying for a license may be issued a provisional license provided it submits a complete application.

(d) A provisional license may be withheld if the director, medical director, tissue bank compliance officer, any owner, or any person with a controlling interest applying for a provisional license has ever directed, owned or controlled a health care facility, laboratory, tissue bank, funeral directing firm, or nontransplant anatomic bank which has had its permit or license denied, revoked, suspended, limited or annulled, or which has an enforcement proceeding against it pending at the time of application for a provisional license.

(e) A provisional license may be denied or terminated, without a hearing, if the department finds that the tissue bank or nontransplant anatomic bank is not operated in substantial compliance with the applicable provision of section 52- 2.5 of this Subpart.

(f) The valid provisional license shall be conspicuously posted within the facility.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 52-2.2