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Patient 1
IN [DATE REDACTED] 2019 THE HOSPITAL LABORATORY BEGAN TESTING FOR (B)(6) USING THE BIORAD BIOPLEX RPR AND TREPONEMAL AUTOMATED IMMUNOASSAYS. TESTING WAS ADOPTED UTILIZING THE FORWARD SCREENING ALGORITHM ((B)(6) RPR'S CONFIRMED VIA TREPONEMAL ANTIBODY TESTING). IN [DATE REDACTED] 2019 THE LABORATORY HAD NOTICED AN INCREASE IN THE AMOUNT OF (B)(6) RPR RESULTS ((B)(6) RPR RESULTS THAT DID NOT CONFIRM AS (B)(6) BY TREPONEMAL ANTIBODY TESTING). THE NUMBER OF (B)(6) RPR RESULTS INCREASED FROM 4 PER MONTH (PRE- BIOPLEX IMPLEMENTATION) TO 103 PER MONTH (POST- BIOPLEX IMPLEMENTATION). THIS CORRELATED TO A CHANGE FROM A 75% (B)(6) PREDICTIVE VALUE (PRE GO LIVE) TO A 31% (B)(6) PREDICTIVE VALUE (POST GO LIVE). THIS ALSO DIFFERED FROM THE 71% (B)(6) PREDICTIVE VALUE WE OBSERVED IN OUR INITIAL PRE-IMPLEMENTATION VALIDATION STUDY. THE HIGH LEVEL OF (B)(6) PROMPTED NUMEROUS PHONE CALLS FROM OUR PROVIDERS. THOUGH PATIENTS WERE STILL RECEIVING CONFIRMATORY TESTING VIA TREPONEMAL ANTIBODY TESTING, THE LARGE AMOUNTS OF (B)(6) RESULTS (OCCURRING DAILY) WERE PROMPTING PHYSICIAN CONFUSION AND UNNECESSARY ADDITIONAL WORKUP. THEY WERE ALSO LEADING TO CONCERN REGARDING THE MONITORING OF PATIENTS WITH KNOWN (B)(6) (IN WHOM RPR (B)(6) IS USED TO MAKE TREATMENT DECISIONS WITHOUT TREPONEMAL CONFIRMATORY TESTING). GIVEN THESE CONCERNS OUR LABORATORY ADOPTED A TEMPORARY TEST WORK AROUND, REQUIRING CONFIRMATION OF EACH (B)(6) BIOPLEX RPR WITH THE PREVIOUSLY IN USE CARD RPR METHOD. WE ALSO CONTACTED BIORAD REGARDING OUR CONCERNS. IN [DATE REDACTED] 2019 WE RECEIVED AN UPDATED REAGENT LOT WHICH WE WERE INITIALLY TOLD BY BIORAD CONTAINED CHANGES MEANT TO ADDRESS THE PROBLEM. HOWEVER, WE NOTED SIMILAR PROBLEMS WITH THE NEW LOT.