Can the semi-annual proficiency testing challenges be used to fulfill the requirement for competency assessment of pathologists and laboratory professionals interpreting assays?
Yes. The tissue microarray slides provided in the PT challenges can be used to assess competency after PT results have been submitted to the PT provider. While the official results reported to the PT provider must reflect the method of reporting done for routine clinical cases (i.e., ordinarily a single pathologist), labs can then have all pathologists who interpret and report HER2 tests independently review the stained slides. These results can be tracked and compared with those of all Survey participants to ensure that every pathologist interpreting HER2 slides is doing so in a competent manner. The Laboratory Director will be responsible for reviewing the results of this assessment and determining when action is needed. This assessment must also be available at the time of on-site inspection.
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