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Patient 1
THE FOLLOWING INFORMATION WAS DOCUMENTED FOR ONSITE REVIEW OF THE SLIDE FROM THE BREAST CORE BIOPSY SAMPLE STAINED FOR ER IN THE RUN 3469 COMMENCING ON (B)(6) 2018, USING THE AUTOMATED SLIDE STAINER BOND-III SERIAL NUMBER (B)(4): "ESTROGEN SLIDE HAS STRONG INTENSITY AND PERCENTAGE (80%), NORMAL DUCTS WERE PRESENT AND STAINED, EXTERNAL POSITIVE AND NEGATIVE CONTROL TISSUES WERE PLACED ON THE SLIDE AND STAINED AS EXPECTED." THE FOLLOWING INFORMATION WAS DOCUMENTED FOR ONSITE REVIEW OF THE SLIDE FROM THE BREAST CORE BIOPSY SAMPLE, CUT AT THE SAME TIME WITH THE (B)(6) STAINING, STAINED FOR ER IN THE RUN 4616 COMMENCING ON (B)(6) 2018, USING THE AUTOMATED SLIDE STAINER BOND-III SERIAL NUMBER (B)(4): "ESTROGEN IS NEGATIVE, NORMAL DUCTS POSITIVE STAINING AS EXPECTED." THE CUSTOMER DECIDED TO RE-CUT SLIDES TO "AVOID AGING ARTIFACTS". THE FOLLOWING INFORMATION WAS DOCUMENTED FOR ONSITE REVIEW OF THE SLIDE FROM THE BREAST CORE BIOPSY SAMPLE, ON A SLIDE PREPARED JUST FOR OESTROGEN STAINING FROM THE SAME BIOPSY, STAINED FOR ER IN THE RUN 4645 COMMENCING ON (B)(6) 2018, USING THE AUTOMATED SLIDE STAINER BOND-III SERIAL NUMBER (B)(4): "ESTROGEN NEGATIVE, NORMAL DUCT POSITIVE, EXTERNAL POSITIVE AND NEGATIVE CONTROL TISSUES (ON THE SAME SLIDE) STAINED AS EXPECTED." THE ROOT CAUSE OF THE ER STAINING DISCREPANCY BETWEEN SLIDES PREPARED FROM A BREAST CORE BIOPSY AND STAINED IN RUNS COMMENCING ON BOTH (B)(6) 2018 USING BOND-III AUTOMATED SLIDE STAINER SERIAL NUMBER (B)(4), AS REPORTED BY THE COMPLAINANT, COULD NOT BE ATTRIBUTED TO THE INSTRUMENT FROM THE INFORMATION AVAILABLE. AN ADDITIONAL ER STAINING RUN, PERFORMED ON (B)(6) 2018 ON BOND-III AUTOMATED SLIDE STAINER SERIAL NUMBER (B)(4) USING SLIDE(S) RE-CUT FROM THE ORIGINAL BIOPSY SAMPLE, SHOWED THE SAME STAINING AS OBTAINED FROM THE RUN OF (B)(6) 2018.