§1270.33 Records, general requirements.

The CFR section most relevant to this litigation reads as follows:

(a) Records shall be maintained concurrently with the performance of each significant step required in this part in the performance of infectious disease screening and testing of donors of human tissue. All records shall be accurate, indelible, and legible. The records shall identify the person performing the work, the dates of the various entries, and shall be as detailed as necessary to provide a complete history of the work performed and to relate the records to the particular tissue involved.

(b) The frequency of inspection will be at the agency’s discretion.

That is shocking. There is no standard for how often to inspect. It is no wonder that we now have a huge problem with unscreened body parts.