Assessing Patient and Reporter Identifiability

Patient and reporter identifiability is necessary to avoid case duplication, detect fraud, and facilitate follow-up of appropriate cases. The term identifiable in this context refers to the verification of the existence of a patient and a reporter.

One or more of the following automatically qualifies a patient as identifiable: age (or age category, e.g., adolescent, adult, elderly), gender, initials, date of birth, name, or patient identification number. Additionally, in the event of second-hand reports, every effort should be made to verify the report source. All parties supplying case information (or approached for case information) are subject to the notion of identifiability: not only the initial reporter (the initial contact for the case), but also others supplying information.

In the absence of qualifying descriptors, a report referring to a definite number of patients should not be regarded as a case until the minimum four criteria for case reporting are met. For example, "Two patients experienced." or " a few patients experienced" should be followed up for patient-identifiable information before regulatory reporting.