Donna Kitchen has written to request an amendment to her PHI from Waldo Hospital. She states that incorrect information is present on the document in question. The document is an incident report from Waldo Hospital, which was erroneously placed in Mrs$.$ Kitchen's health record. The covered entity declines to grant her request based on which privacy rule provision?

It was not created by the covered entity.

It is not part of the deslgnated record set.

Both a and is

None. The covered entity must grant her request.