Description of Event or Problem · 0
ON THE AFTERNOON OF (B)(6) 2022, IT WAS DISCOVERED THAT 19 PATIENTS RECEIVED INCORRECT RESULTS FOR THEIR COVID-19 RT-PCR TEST AFTER SUBMITTING THEIR SAMPLES TO VERILY CLIA (VCLIA) LAB. 15 POSITIVE REPORTS WERE INCORRECTLY RELEASED AS NEGATIVE AND 4 NEGATIVE REPORTS WERE INCORRECTLY RELEASED AS POSITIVE. ON (B)(6) 2022, A PCR LEAD CONTACTED THE SUPERVISORS TO DISCUSS DISCREPANCIES IN POOLING AND UNPOOLED RESULTS. THE SAMPLES IN QUESTION HAD TESTED POSITIVE FOR ALL THREE GENES (N GENE, S GENE, AND ORF1AB) IN POOLED SAMPLES, HOWEVER, UPON UNPOOLED TESTING OF SAMPLES CONTAINED WITHIN THE POOLS, THE UNPOOLED SAMPLES TESTED POSITIVE FOR ONLY TWO GENES (N GENE AND ORF1AB). POOLED SAMPLES WERE RAN ON RT-PCR PLATE 2 QUADRANT 2 ON (B)(6) 2022. UNPOOLED SAMPLES WERE RETESTED ON RT-PCR PLATE 1 QUADRANT 2 ON (B)(6) 2022. THERE WERE DISCREPANCIES BETWEEN POOLING AND UNPOOLED RESULTS, AND THEREFORE ANY INCONCLUSIVES AND POSITIVES WERE RETESTED AGAIN ON RT-PCR PLATE 2 QUADRANT 3 ON (B)(6) 2022. EXPECTED POSITIVE RESULTS FROM RT-PCR PLATE 2 QUADRANT 3 WERE NEGATIVE. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT EXTRACTION PLATES CONTAINED ON RT-PCR PLATE 1 QUADRANTS 1 AND 2 ON (B)(6) 2022 WERE SWAPPED. UNFORTUNATELY, ALL RESULTS FROM RT-PCR PLATE 1 QUADRANT 1 AND ALL NEGATIVE RESULTS FROM RT-PCR PLATE 1 QUADRANT 2 ON (B)(6) 2022 WERE RELEASED ERRONEOUSLY BEFORE THE TEAM BECAME AWARE OF THE DISCREPANCY. AFTER RETESTING THE QUADRANTS IN QUESTION, ALL AFFECTED PATIENTS WERE NOTIFIED OF THE ERROR AND CORRECTED REPORTS WERE ISSUED. THE ISSUE OF INCORRECT REPORTS WAS PURELY DUE TO AN OPERATOR ERROR AND IS NOT RELATED TO ANY PERFORMANCE ISSUE OF THE VERILY COVID-19 RT-PCR TEST. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO AVOID SIMILAR ISSUES.