Description of Event or Problem · 1
DURING 2010, THE LABORATORY DEPARTMENT EXPERIENCED PROBLEMS WITH CONSISTENTLY LOW RESULTS ON THE CO2 ASSAY PERFORMED ON THE ABBOTT ARCHITECT ANALYZER. THE QUALITY CONTROL VALUES WERE IN RANGE, BUT WITH A NEGATIVE BIAS, YET ALL THE PT RESULTS WERE VERY LOW. IT BEGAN AS AN INTERMITTENT PROBLEM AROUND THE MIDDLE OF (B)(6) 2010 WHEN A NEW CALIBRATOR AND REAGENT APPEARED TO SOLVE THE PROBLEM. BUT BY (B)(6) 2010, THE PROBLEM RETURNED, THE ABBOTT REP SUGGESTED CHECKING THE PH OF THE WATER WHICH WAS FOUND TO BE ACCEPTABLE. IN (B)(6) 2010, THE RESULTS WERE STILL REMAINING LOW, AND IT WAS SUGGESTED BY ABBOTT REPS THAT THE BOTTLED WATER USED FOR RECONSTITUTING THE Q.C. WAS THE PROBLEM, THIS WAS INCORRECT AND NOT THE REASON FOR THE LOW RESULTS. ON (B)(6), THE ABBOTT CO2 ASSAY WAS DISCONTINUED. DURING (B)(6), A NEW LOT NUMBER OF REAGENT WAS DELIVERED WHICH GAVE BETTER PERFORMANCE, THE BAD LOT NUMBER OF REAGENTS WAS RETURNED TO THE COMPANY AND IT WAS THOUGHT THAT THE PROBLEM HAD BEEN SOLVED. HOWEVER, BY (B)(6) 2010., THE CO2 RESULTS BECAME LOW AGAIN AND IT WAS AT FIRST BELIEVED THAT THERE MAY HAVE BEEN A MILLIPORE WATER PROBLEM CAUSING THE ERRORS. THIS PROVED NOT TO BE THE CASE. THE RESULTS CONTINUED TO DECLINE IN RELIABILITY AND BY (B)(6) 2011 WE HAD TO STOP PERFORMING THE ASSAY FOR TWO MONTHS. ABBOTT SUPPLIED US WITH A NEW REAGENT LOT # AND NEW CALIBRATOR LOT# AS WELL AS CHANGING THE MILLIPORE FILTERS. TESTING WAS RESUMED IN (B)(6) 2011 AND VERY CLOSE ATTENTION WAS PAID TO THE RESULTS. THE QUALITY CONTROL VALUES WERE ON THE MEAN COMPARED TO THE PEER GROUP, BUT AGAIN IT WAS NOTED THAT THE PTS' CO2 RESULTS WERE CONTINUALLY LOWER THAN THEY SHOULD HAVE BEEN. EXTENSIVE TROUBLESHOOTING BY BOTH OUR STAFF AND THE ABBOTT ENGINEERS COULD NOT FIND A SOLUTION TO THE INACCURATE ASSAY. ABBOTT ENGINEERS WERE ASSUMING IT WAS A POOR QUALITY WATER PROBLEM AND NOT THEIR REAGENTS. IT WAS NECESSARY FOR US TO STOP OFFERING THE CO2 ASSAY TO THE PHYSICIANS ONCE MORE. (B)(6) 2011. UNFORTUNATELY THE PHYSICIANS, AND IN PARTICULAR THE NEPHROLOGIST, RELY VERY HEAVILY ON THE RESULTS OF THIS CO2 ASSAY IN ORDER TO ADMINISTER BICARBONATE TO THEIR PTS. IT WAS VERY IMPORTANT THAT THE RESULTS OF THIS WERE AVAILABLE TO THE MEDICAL STAFF AND THEY NEEDED US TO FIND A WAY TO PERFORM THIS ASSAY RELIABLY AND ACCURATELY. IN AN ATTEMPT TO DO THIS, WE CORRELATED AND FACTORIZED THE ABBOTT ARCHITECT CO2 ASSAY RESULTS AGAINST THE ROCHE MODULAR CO2 ASSAY RESULTS FROM ANOTHER HOSPITAL. THIS ALLOWED US TO REPORT A CALCULATED CO2 FIGURE AND THE ASSAY WAS RESUMED ON THE (B)(6) 2011. THESE CALCULATED FIGURES WERE ACCEPTABLE TO OUR NEPHROLOGISTS. THIS CORRELATION ACTION WAS TAKEN BECAUSE ABBOTT WERE UNABLE TO FURNISH US WITH A CORRECTIVE ACTION TO RESOLVE THE MAJOR PROBLEM THAT WE WERE EXPERIENCING WITH THEIR CO2 ASSAY AT THIS TIME. ABBOTT REPS OFFERED US RANDOX CO2 REAGENT AS A THIRD PARTY REAGENT, WHICH CAN BE USED ON THE ABBOTT ARCHITECT ANALYZER. IN ORDER FOR US TO USE THIS NEW REAGENT, EVAL BEGAN IN (B)(4) 2011. ABBOTT HAVE SUPPLIED US WITH SUFFICIENT QUANTITIES OF THIS NEW REAGENT AND FOLLOWING FURTHER METHOD VALIDATION, WE HOPE TO BE IN A POSITION TO RESUME THE ASSAY USING THE RANDOX CO2 REAGENT NO LATER THAN THE MIDDLE OF (B)(6) 2012. THERE HAVE NOT BEEN ANY ADVERSE EFFECTS REPORTED ON PTS DURING THE TIME OF THIS PROBLEM. AT THE TIME OF THE WRITING OF THIS REPORT, THE PROBLEM WITH THE ABBOTT ARCHITECT CO2 REAGENT STILL HAS NOT BEEN RESOLVED BY ABBOTT. WE ARE ANXIOUS TO KNOW WHAT CAUSED THE PROBLEM, HOW IT CAN OVERCOME AND HOW REPETITION CAN BE AVOIDED. TO DATE, WE HAVE NOT HEARD FROM ABBOTT, MUCH TO OUR CHAGRIN. OUR RESPONSIBILITY IS TO PROVIDE TIMELY AND ACCURATE RESULTS FROM THE PT SAMPLES TO OUR MEDICAL STAFF. HAVING RELIABLE ASSAYS IS A MAJOR PART OF THIS PROCESS. WE NEED THIS PROBLEM SOLVING, A REASON FOR ITS OCCURRENCE GIVEN AND AN ASSURANCE THAT THE FUTURE WILL BE AS NEAR PROBLEM FREE AS IS PRACTICABLY POSSIBLE.