Will the FDA maintain the confidentiality of any patient's surgical and/or pathology results which may be seen during an inspection?
Yes. Inspectors will be checking to ensure that outcome results have been obtained by the facility and/or that there have been reasonable efforts made to obtain such results. The FDA-certified inspector will verify that a system exists to collect positive mammographic outcomes information. During typical inspections, inspectors may review patient’s surgical/pathology results or individual or aggregate physician medical outcomes audit information but will not routinely record, copy or retain this information.