Description of Event or Problem · 1
MIXING OF REAGENT IN TISSUE PROCESSOR. THE UNIT IS SUBJECT OF PREVENTIVE MAINTENANCE AS PLAN (MARCH 30, 2016). DURING THE ANNUAL P.M. (MARCH 30, 2016), THE SERVICE ENGINEER DID NOT TORQUED CORRECTLY THE ELECTRO-VALVES, SO THAT REAGENTS SLOWLY MIXED THEMSELVES RUN AFTER RUN. AFTER THE P.M., THE FINAL USER, USED THE TISSUE PROCESSOR, AS DONE UP TO THE P.M. DAY. THE USE OF THE UNIT CONTINUED FROM THE DAY OF THE P.M. ((B)(6) 2016), BUT THE MIXING OF THE REAGENTS MADE THE SPECIMENS CRUNCHY (DAY OF EVENT (B)(6) 2016). IN THE EVENING RUN OF (B)(6) 2016, THE CROSS CONTAMINATION OF REAGENTS WAS SIGNIFICANT ENOUGH TO DAMAGE APPROXIMATELY ONE-THIRD OF THE PATIENT SPECIMENS PROCESSED THAT EVENING, ROUGHLY 47 OUT OF 140 TOTAL PATIENT SPECIMENS. THIS PROBLEM WAS NOTICED ON THE MORNING OF (B)(6) 2016 DURING TISSUE EMBEDDING AND MICROTOMY WHEN TISSUE WAS DISCOVERED TO BE BRITTLE. THE PATHOLOGISTS HAD DIFFICULTY INTERPRETING SOME OF THE H&E PREPARED SLIDES AND REQUIRED STEPS TO BE TAKEN TO TRY AND SALVAGE THE SPECIMENS IN ORDER TO RENDER A DIAGNOSIS. AS A RESULT OF THIS INSTRUMENT MALFUNCTION THE PATHOLOGISTS WERE UNABLE TO PROVIDE A DIAGNOSIS ON TWO PATIENTS, BOTH OF WHICH UNDERWENT EXTREME PROCEDURES TO OBTAIN THE SPECIMENS FOR DIAGNOSIS. TO REITERATE: APPROXIMATELY 47 PATIENT SPECIMENS HAD SUBOPTIMAL TISSUE PROCESSING; ATTEMPTS TO SALVAGE THE SPECIMENS WERE NOT SUCCESSFUL; TWO PATIENT CASES HAD SPECIMENS PROCESSED SO POORLY THAT NO DIAGNOSIS COULD BE MADE. SURGICAL PROCEDURES MAY NEED TO BE REPEATED ON THESE TWO PATIENTS. THE SERVICE DPT. WAS INFORMED OF THE EVENT, AND WENT TO THE FACILITY SIDE (APRIL 26, 2016), AND THE SERVICE INSPECTED THE LOGOS TISSUE PROCESSOR: THE VALVES THOSE SELECT THE REAGENT(S), WERE OPEN DURING THE PREVENTIVE MAINTENANCE ACTIVITY TO SUBSTITUTE THE MEMBRANE, ARE NOT CLOSED WITH PROPER TORQUE.