Table 22. Impact assessment strategy.

Recommended practice	Complete list of affected samples. Evaluation of analytical variations. Clinical impact study (in case of analytical discrepancy). If warranted, provide updated reports to prescribers and patients. Extensive traceability of all stages of the impact study in the event of non-compliance.
Acceptable practice	No distinction between analytical and clinical discrepancies and excessive patient recall. Non-systematic traceability of all steps of the impact study, but at least traceability of recovery calculations and report modifications.
Unacceptable practice	Missing some potentially impacted files. The inability to identify analytical and especially clinical discrepancies. No transmission of modified laboratory test reports and no argumentation
IQC – internal quality control.