10.50.01.07

.07 Accredited Tissue Bank and Accrediting Organization.

A. Accredited Tissue Bank — Determination. The Secretary may accept as compliance with the inspection requirements of this chapter a tissue bank accredited by an organization approved by the Secretary, as set forth in §C of this regulation, if the OHCQ determines that the standards of the tissue bank accrediting organization are equivalent to those under this chapter.

B. Accredited Tissue Bank — Requirements. In addition to meeting the requirements for accreditation, as set forth by a tissue bank's accrediting organization, an accredited tissue bank shall:

(1) Obtain and maintain a valid permit issued by the Secretary; and

(2) Be subject to inspection by the OHCQ to:

(a) Determine if the tissue bank is operating in a manner that does not constitute an imminent and serious risk to public health;

(b) Investigate complaints;

(c) Determine whether a permittee is operating a tissue bank beyond the scope of the permit; and

(d) Validate findings of a tissue bank's accrediting organization.

C. Accrediting Organization.

(1) A private, nonprofit tissue-bank accrediting organization may inspect and accredit tissue banks in the State for the purpose of a State permit only after applying for and receiving approval of the OHCQ.

(2) The OHCQ may approve a tissue bank accrediting organization based on a review of that organization, if the review includes (but need not be limited to) an evaluation of:

(a) Accreditation policies and standards;

(b) Copies of inspection forms and guidelines;

(c) Inspection and deficiency writing policies;

(d) Inspector qualifications; and

(e) Complaint investigation policies.

(3) In addition to other requirements set forth in this chapter, an accrediting organization shall provide to the OHCQ:

(a) Annually, an updated list containing the names, addresses, and accreditation expiration dates of all tissue banks in the State accredited by the accrediting organization;

(b) Within 30 days after conducting an inspection, a certified written or electronic copy of each inspection report covering each tissue bank applying for or maintaining accreditation in the State;

(c) At least 30 days before the effective date of the change, written notice of any proposed change to requirements for tissue bank accreditation;

(d) Within 30 days after a tissue bank's accreditation expires, written or electronic notice if the tissue bank does not renew its accreditation;

(e) Documentation of a complaint and complaint investigation; and

(f) On request, a copy of:

(i) Inspector qualifications; and

(ii) Other information the Secretary may require relating to the regulation of a tissue bank.

(4) When the Secretary denies accreditation to a tissue-bank accrediting organization, the Secretary shall inform the accrediting agency in writing that it has an opportunity for a hearing under State Government Article, §10-226, Annotated Code of Maryland.