Description of Event or Problem · 0
FROM JUNE THROUGH OCTOBER 2023, OUR LAB BEGAN TO NOTICE A SHARP INCREASE IN THE SPECIMEN REJECTION RATE FOR SPECIMENS COLLECTED ON THE CEPHEID 900-0370 COLLECTION AND TRANSPORT DEVICE. THESE SWABS ARE MANUFACTURED FOR CEPHEID BY COPAN ITALIA S.P.A. THE MAJORITY OF THESE SPECIMENS WERE COLLECTED TO RUN ON THE CEPHEID GENEXPERT CARBA-R ASSAY, AN FDA APPROVED ASSAY WHICH REQUIRES COLLECTION USING THE 900-0370 IN ITS PACKAGE INSERT. BEGINNING IN MAY 2023, THE ALL-CAUSE SPECIMEN REJECTION RATE FOR THIS ASSAY WAS <1%. THIS RATE INCREASED STEADILY, WITH 6% IN JUNE. 9% IN JULY. 13% IN AUGUST, WITH REJECTIONS OCCURRING ALMOST EXCLUSIVELY BECAUSE OF SWABS LEAKING IN TRANSIT. ALL LEAKING SWABS EXHIBITED THE SAME LEAKING PATTERN, WITH LIQUID SEEPING DOWN THE TUBE LABEL NEAR THE RED CAP. TUBE LABELS ARE VISIBLY WET WITH TRANSPORT LIQUID AND OCCASIONALLY STOOL AND THE LEAKAGE EXTENDS UP TO A HALF INCH DOWN THE LABEL FROM THE CAP. WHILE OUR SPECIMEN REJECTION RATE DROPPED BACK DOWN TO 4% IN SEPT, THE REJECTION RATE IN OCTOBER JUMPED TO AN ALARMING 31% -- ALL DUE TO LEAKING. SPECIMEN REJECTION RATES IN NOVEMBER WERE 26%. OVERALL, APPROXIMATELY 265 SWABS WERE REJECTED DURING THIS TIME PERIOD FOR LEAKING. LEAKING WAS CONFIRMED BY AN ADDITIONAL (B)(6) SCIENTIST AND SUPERVISOR, AND MANY WERE PHOTOGRAPHED. WE CAN PROVIDE ADDITIONAL PHOTOGRAPHS UPON REQUEST. RECTAL SWABS WERE COLLECTED USING CEPHEID 900-0370 SWABS, CLOSED, WRAPPED IN PARAFILM, PLACED IN INDIVIDUAL BIOHAZARD BAGS WITH ABSORBENT PAPER, AND SHIPPED AT AMBIENT TEMPERATURE VIA COURIER, FEDEX PRIORITY OVERNIGHT (GROUND OR AIR) TRANSPORTATION. LEAKING SPECIMENS CAME FROM (B)(6) AND WERE COLLECTED IN AT LEAST 30 DIFFERENT HEALTHCARE FACILITIES RANGING FROM NURSING HOMES TO LARGE ACUTE CARE HOSPITALS. (B)(6) REQUESTED RE-COLLECTION ON LEAKING SPECIMENS, A NUMBER OF WHICH LEAKED FOR A SECOND TIME. PRIOR TO SPECIMEN COLLECTION, SWABS WERE STORED AT AMBIENT TEMPERATURE AND CHECKED OVER FOR POSSIBLE DEFECTS. LEAKAGE SEEMED TO ONLY OCCUR AFTER SPECIMEN COLLECTION AND DURING TRANSPORT, AND WAS OBSERVED REGARDLESS OF WHETHER SPECIMENS WERE WRAPPED IN PARAFILM OR NOT. SCIENTISTS AT (B)(6) WERE ABLE TO REPLICATE THIS LEAKING PATTERN USING UNINOCULATED SWABS. THEY REMOVED THE WHITE CAP COVERING THE TUBE, PLACED THE RED CAP WITH ATTACHED SWABS INTO THE TUBE AND TIGHTLY PLACED PARAFILM ON EACH TUBE ENCLOSING THE RED CAP AND THE TOP OF THE TUBE. SWABS WERE LEFT OVERNIGHT IN VARIOUS ORIENTATIONS IN AN OFFICE AT AMBIENT TEMPERATURE AND FOUND TO BE LEAKING THE FOLLOWING DAY. A COMPARISON OF AN OLDER LOT (210236100, EXP 06/30/2022) WITH THE NEWER, DEFECTIVE LOTS SHOWS THE TUBE LABEL APPEARS TO ENCROACH HIGHER OVER THE LIP OF THE TUBE ON THE NEWER LOTS. WHEN PLACING THE RED CAP ON THE TUBE, OFTEN THE LABEL APPEARS TO BUNCH UP UNDER THE CAP, POSSIBLY PREVENTING A TIGHT SEAL. WE ATTEMPTED MULTIPLE REMEDIATION EFFORTS, INCLUDING PACKAGING SPECIMENS UPRIGHT, EXPERIMENTING WITH MULTIPLE WAYS TO SEAL TUBES, AND NONE OF THE INVESTIGATED METHODS WERE ABLE TO SUBSTANTIALLY IMPROVE THE LEAKING RATE. THESE LEAKING COLLECTION DEVICES REPRESENT A LABORATORY SAFETY HAZARD TO ACCESSIONING AND TESTING STAFF AS WELL AS A CROSS-CONTAMINATION RISK WHEN PERFORMING THE HIGHLY SENSITIVE NUCLEIC ACID AMPLIFICATION TEST. HIGH SPECIMEN REJECTION RATES FROM LEAKING TUBES ALSO PRESENT A PATIENT SAFETY RISK, AS FACILITIES ARE UNABLE TO ASCERTAIN COLONIZATION WITH CARBAPENEM RESISTANT ORGANISM AND APPROPRIATELY COHORT PATIENTS TO REDUCE TRANSMISSION OF CARBAPENEMASE PRODUCING ORGANISMS IN THE HIGHLY VULNERABLE POPULATIONS WE SERVE. A SIMILAR LEAKING PATTERN WAS OBSERVED IN AN EQUIVALENT SWAB MANUFACTURED BY COPAN AND DISTRIBUTED BY (B)(4), HEALTHLINK TRANSPORTER SYSTEM ITEM NUMBER 8139CQ/4019BX, LOT NUMBER 230627100. WE RECEIVED 81 SWABS FROM THIS LOT NUMBER AND 34 WERE FOUND TO BE LEAKING. AS SUCH, WE FEAR THAT ADDITIONAL EQUIVALENT SWABS BY COPAN MAY HAVE THE SAME ISSUE, THOUGH WE ARE STILL EVALUATING THE OTHER EQUIVALENT SWABS. TO DATE, THIS PROBLEM HAS THUS FAR BEEN OBSERVED ACROSS 6 PRODUCT LOTS AT (B)(6): 230397900, EXP 2024-JUL-03; 221973300, EXP 2024-MAR-31; 22122200, EXP 2023-DEC-31; 221122800, EXP 2023-DEC-31; 230065900, EXP 2024-JUN-13; 230627500, EXP 2024-AUG-04; THE EXPIRATION DATE IN THE BELOW FORM HAS THE LATEST AVAILABLE EXPIRATION DATE. ON AUGUST 4, 2022, (B)(6) MADE A COMPLAINT TO CEPHEID ABOUT TWO LOTS EXPERIENCING LEAKAGE. THE COMPANY REPLACED THE DEFECTIVE SWABS WITH A NEW LOT, THOUGH THE NEW LOT EXPERIENCED SIMILAR ISSUES. WE REOPENED OUR COMPLAINT WITH CEPHEID IN OCTOBER AND OPENED A COMPLAINT WITH COPAN DIRECTLY IN NOVEMBER. COPAN REQUESTED UNINOCULATED SWABS FOR TESTING, WHICH WERE SHIPPED TO COPAN ON 11/21/2023. CEPHEID HAS ALSO INDICATED THAT THEY WISHED TO RECEIVE THE PRODUCT FOR TESTING BUT HAVE DELAYED IN PROVIDING A MECHANISM WITH WHICH TO SHIP THE DEFECTIVE PRODUCT BACK TO THEM. ON NOV 27, COPAN INDICATED THEY WISHED TO DELIVER ALL UPDATES THROUGH CEPHEID. HOWEVER, TO DATE UPDATES FROM CEPHEID REGARDING THIS MATTER HAVE BEEN SPARSE. THEY HAVE INDICATED THAT THEY ARE IN "INTERNAL CONVERSATIONS" AT CEPHEID AND WITH COPAN ABOUT THE ISSUE, BUT HAVE NOT PROVIDED SUBSTANTIVE UPDATES BEYOND THAT. THE LACK OF APPROPRIATE ACTION AND A SUITABLE SOLUTION HAS FORCED US TO DRAMATICALLY SLOW DOWN TESTING UNTIL THE ISSUE IS RESOLVED. MW5149173, MW5149174, MW5149176, MW5149177, MW5149178.