.09 Tissue Bank Standards — Inspection.

A. General.

(1) A permittee shall allow an on-site inspection by the OHCQ, at any time during the tissue bank's regular hours of operation, to evaluate the tissue bank's compliance with the applicable requirements, conditions, and standards of this chapter.

(2) An inspection may include, but is not limited to, observation and examination of:

(a) Tissue bank facilities and physical security;

(b) Equipment;

(c) Quality assurance and quality control policies and records;

(d) Operating procedures, policies, and records;

(e) Personnel and personnel records;

(f) Donor documentation and records; and

(g) Other records and files pertinent to this chapter.

(3) Tissue bank employees shall make data and records accessible within a reasonable time during an on-site inspection.

B. Permitted Tissue Bank. A permittee operating a tissue bank under a provisional permit or a permit shall:

(1) Be subject to an initial inspection conducted by OHCQ; and

(2) Undergo an annual inspection conducted by the OHCQ.

C. Accredited Tissue Bank.

(1) Initial Inspection. An accredited tissue bank is subject to an initial inspection by the OHCQ.

(2) Annual Inspection. Except as provided in §C(3) of this regulation, an accredited tissue bank undergoing an annual, on-site inspection by an accrediting organization approved by the Secretary is not subject to annual inspection by the OHCQ.

(3) Complaint and Validation Inspections. At any time during a tissue bank's normal hours of operation, the OHCQ may conduct:

(a) A validation inspection to determine both the tissue bank's and accrediting organization's compliance with this chapter; and

(b) A complaint inspection on receiving a complaint related to the standards or requirements of this chapter.