Description of Event or Problem · 1
TO WHOM IT MAY CONCERN, MY NAME IS (B) (6) AND I AM THE LABORATORY MANAGER AT (B) (6). I FEEL COMPELLED TO SEND THIS E-MAIL. IN (B) (6) 2009 THIS HOSPITAL AGREED TO PURCHASE FROM ORTHO CLINICAL DIAGNOSTICS A JOHNSON & JOHNSON COMPANY, A NEW CHEMISTRY ANALYZER. (VITROS 5600). THE ANALYZER WAS INSTALLED IN (B) (6) 2009. DURING THE NEXT TWO MONTHS TRAINING AND CERTIFICATION TOOK PLACE. ON (B) (6) 2009, THE INSTRUMENT WAS PUT ON LINE. FROM (B) (6) 2009 THROUGH (B) (6) 2009, THERE WERE 19 SERVICE CALLS ON THE INSTRUMENT. IN (B) (6) 2010, ORTHO SENT A SENIOR ENGINEER TO OUR LOCATION IN AN ATTEMPT TO RESOLVE SOME OF OUR OPERATIONAL PROBLEMS. THE UNIT HAS STILL REQUIRED 4 SERVICE CALLS WITH AN ADDITIONAL ONE TODAY (B) (6) 2010. WE HAVE HAD WEEKLY CONFERENCE CALLS WITH ORTHO SINCE (B) (6). WE HAVE REPORTED NUMEROUS PROBLEMS TO THEM REGARDING QUALITY CONTROL, PRODUCT PROBLEMS, PATIENT REPEATABILITY, ETC. ONLY TO BE TALKED DOWN TO, WHICH ONE OF MY STAFF TOOK VERY PERSONAL! BASED ON OUR COMPLAINTS AND FINDINGS ORTHO HAS FOUND PROBLEMS WITH THEIR PRODUCTS AS WELL AS OUR MACHINE BUT STILL REMAINS SET IN THEIR MIND THAT NOTHING IS WRONG AND CONTINUES TO OFFER NO REPLACEMENTS. OUR DOCTORS HAVE QUESTIONED NUMEROUS TEST RESULTS THAT HAVE BEEN CORRELATED WITH OUR REFERENCE LAB AND MANY HAVE NOT MATCHED LEAVING THEM SKEPTICAL AND DISTRUSTFUL OF ANY CHEMISTRY WE REPORT. JUST A COUPLE OF QUICK EXAMPLES; A TOTAL PROTEIN OF 8.9 G/DL WHICH WAS REPEATED OK, HOWEVER WHEN THE DOCTOR ORDERED SERUM PROTEIN ELECTROPHORESIS BE SENT TO THE REFERENCE LAB NOT ONLY WAS THE SELP NORMAL BUT THE TOTAL PROTEIN WAS NORMAL. NUMEROUS MEMBERS OF OUR MEDICAL STAFF BROUGHT TO OUR ATTENTION ALL OF THE NEGATIVE RUBELLA SCREENS THEY HAVE BEEN SEEING SO WE OPTED TO CHECK SOME NEGATIVE RUBELLA RESULTS OUT WITH OUR REFERENCE LAB. ONCE AGAIN THE COMPARISON RESULTS DID NOT MATCH AT RATE BETTER THAN 50%. WE REPORTED THIS; THEY HAD A TECH SPECIALIST COME OUT TO CHECK OUT THE PROBLEM. THE TECH SPECIALIST WORKED ON THIS ISSUE ONLY TO GET THE SAME RESULTS; THE ANSWER/SOLUTION WAS THAT IS JUST HOW ARE METHODOLOGY WORKS AND SO IF WE ERROR WE DO SO ON THE SIDE OF CAUTION. AS RECENT AS YESTERDAY ((B) (6) 2010) WE WERE ASKED ABOUT A POTASSIUM RESULT THAT HAD BEEN REPORTED OUT ON (B) (6) 2010 AS 2.6 MEQ/L WHY WOULD IT BE 3.7 MEQ/L A WEEK LATER WHEN THERE WAS NO CHANGE IN TREATMENT. THE ORIGINAL REPORT OF 2.6 RECHECKED OK ON THE DAY OF TESTING. HOWEVER, THE SAMPLE WAS PULLED FROM STORAGE RERAN FIVE TIMES AND THE ANSWERS WERE 3.4/3.4/3.4/3.5 AND 3.4. IT IS OF NO VALUE TO HAVE ANSWERS REPEAT WHEN YOU CANNOT BE SURE THEY ARE CORRECT. WE HAVE HAD PROBLEMS WITH ALL ASPECTS OF THE ANALYZER DRY SLIDE, MICRO TIP AND MICRO WELL. WHAT ORTHO REFERS TO AS COMPETITIVE ASSAYS DOES NOT HOLD CALIBRATION BECAUSE OF A PACK DESIGN FLAW THAT ALLOWS REAGENT TO EVAPORATE ONCE THEY HAVE BEEN OPENED FOR THE FIRST TIME. WHAT WAS ADVERTISED AS TESTS THAT WILL HOLD THEIR CALIBRATION FOR 30 DAYS BARELY HOLDS A WEEK FOR US! SURE ORTHO IS WILLING TO REPLACE PRODUCT BUT THEY TELL US THEY WILL NOT HAVE A FIX FOR US UNTIL THE END OF 2010. THEREFORE, WE ARE WASTING TECH TIME CALIBRATING EVERY WEEK. QUALITY CONTROL ON MANY TESTS IS POOR AT BEST. LOT OR GENERATION CHANGES OF PRODUCT AFFECT SOME ANALYTES BY AS MUCH AS 40 OR MORE POINTS. THEY DO NOT SEEM TO UNDERSTAND THAT ANY CHANGE THAT TAKES A NORMAL TEST RESULT AND TURNS IT INTO AN ABNORMAL RESULT CAN BE ACCEPTABLE. THE RESPONSE THAT THIS IS HOW THIS ANALYZER WORKS JUST SIMPLY DOES NOT CUT IT IN THE MINDS OF OUR MEDICAL STAFF! IF THIS PRODUCT WAS NOT DESIGNED TO WORK IN A SMALL MARKET WHY WERE THEY ALLOWED TO MARKET IT AS SUCH? WE HAVE ASKED THEM; WHY WOULD YOU WANT AN UNHAPPY CUSTOMER OUT IN THE MARKET PLACE, WHY WON'T YOU SIMPLY TAKE THIS INSTRUMENT BACK AND LET US PURCHASE SOMETHING ELSE, WHY WON'T YOU SIMPLY LET US OUT OF OUR LEASE? THE RESPONSE WE GET IS LEGAL WOULD NOT ALLOW THAT. THE FEELING THAT WE GET (PERCEIVE) FROM ORTHO DIAGNOSTICS IS OUR HOSPITAL IS NO GIANT CORPORATION SO OUR PATIENTS AND OUR DOCTORS AREN'T AS IMPORTANT. IT'S OK IF OUR LAB DOESN'T KNOW IF WHAT THEIR REPORT IS CORRECT OR NOT. SO WHO CARES IF OUR DOCTOR TREATS A PATIENT INCORRECTLY BECAUSE THIS LAB SENT OUT A RESULT WITH A MEMO ATTACHED TO IT (THIS IS JUST THE WAY OUR ANALYZER WORKS)! A RESPONSE ON THE ISSUES SURROUNDING OUR ORTHO VITROS 5600 ANALYZER WOULD BE GREATLY APPRECIATED. THANK YOU AND WE WILL BE LOOKING FORWARD TO HEARING FROM YOU.