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Pathologist Competency

The competency of all laboratory professionals and pathologists interpreting assays must be continuously addressed. The laboratory director has the responsibility to ensure the competency of those performing the test, using established laboratory procedures that are available for review at the time of inspection.
The review of competency for pathologists should include periodic or continuous peer comparisons among reviewing pathologists for the laboratory's HER2 specimens. If variation in interpretations is encountered, remediation must be documented.