Description of Event or Problem · 0
BACKGROUND- EMERGENCY DEPARTMENT CLINICIANS OBSERVED THAT EPOC POINT-OF-CARE ANALYZER RESULTS WERE FREQUENTLY INCONSISTENT WITH RESULTS FROM THE MAIN CLINICAL LABORATORY. IN RESPONSE, SEVERAL EMERGENCY DEPARTMENT PHYSICIANS CONDUCTED A QUALITY IMPROVEMENT (QI) STUDY TO FORMALLY INVESTIGATE THESE DISCREPANCIES. THE STUDY COMPARED EPOC RESULTS TO CLOSELY TIMED CLINICAL LABORATORY RESULTS (COLLECTED WITHIN 14 MINUTES OF EACH OTHER) OVER THE PERIOD OF DECEMBER 29, 2017 TO OCTOBER 21, 2025, USING MD CLONE. THE ANALYSIS CONFIRMED THAT EPOC RESULTS DIFFERED SIGNIFICANTLY FROM MAIN LAB RESULTS FOR SEVERAL ANALYTES, WITH THE MOST PRONOUNCED DISCREPANCIES SEEN IN POTASSIUM AND HEMATOCRIT. CONFIRMING ANALYSIS BY DR. (B)(6) DR. (B)(6) INDEPENDENTLY ANALYZED THE LAST SIX MONTHS OF BEAKER DATA, FOCUSING ON CASES WHERE BOTH A MAIN LAB AND AN EPOC TEST WERE COLLECTED WITHIN FIVE MINUTES OF EACH OTHER. HER FINDINGS CORROBORATED THE EMERGENCY DEPARTMENT PHYSICIANS' OBSERVATIONS, IDENTIFYING SIGNIFICANT DISCREPANCIES IN HEMATOCRIT AND POTASSIUM RESULTS: HEMATOCRIT: APPROXIMATELY 38% OF EPOC HEMATOCRIT RESULTS WERE HIGHER THAN EXPECTED COMPARED TO THE MAIN LAB. POTASSIUM: APPROXIMATELY 5% OF EPOC POTASSIUM RESULTS WERE HIGHER THAN EXPECTED COMPARED TO THE MAIN LAB. RELATED OR INVESTIGATION CONCURRENTLY, DR. (B)(6) WAS INVESTIGATING A SEPARATE COMPLAINT FROM THE OPERATING ROOM (OR) INVOLVING SPURIOUSLY ELEVATED HEMATOCRIT RESULTS FOUND ACROSS TWO PATIENTS OVER MULTIPLE SAMPLINGS AND INSTRUMENTS. A REVIEW OF MEDICATIONS ADMINISTERED DURING SURGERY DID NOT FULLY EXPLAIN THE ELEVATIONS, THOUGH SOME OF THE DISCREPANCY APPEARS ATTRIBUTABLE TO DRUG INTERFERENCE. REFERENCE RANGE CORRELATION STUDY DURING THIS SAME PERIOD, THE POC SERVICE AND CLINICAL CHEMISTRY SECTION WERE CONDUCTING A REFERENCE RANGE CORRELATION STUDY TO COMPARE SODIUM REFERENCE RANGES ACROSS THREE PLATFORMS: MAIN CHEMISTRY ANALYZERS (PLASMA, RUN AS A BASIC METABOLIC PROFILE), GEM LABORATORY WHOLE BLOOD ANALYZER, EPOC POINT-OF-CARE ANALYZERS SAMPLES WERE OBTAINED FROM NORMAL BLOOD DONORS. GIVEN THE FINDINGS ABOVE, DR. (B)(6) EXTENDED THE ANALYSIS TO INCLUDE HEMATOCRIT/HEMOGLOBIN AND POTASSIUM RESULTS FROM THESE ANALYZERS. THIS EVALUATION IDENTIFIED ERRONEOUS EPOC RESULTS IN: POTASSIUM: APPROXIMATELY 3% OF RESULTS WERE SPURIOUS VERY HIGH. HEMATOCRIT/HEMOGLOBIN: APPROXIMATELY 5% OF RESULTS WERE HIGHER THAN THE ACCEPTABLE ANALYTICAL ERROR. SUMMARY AND CONCLUSION THE EMERGENCY DEPARTMENT PHYSICIANS' PERCEPTION OF SIGNIFICANT INACCURACIES IN EPOC MEASUREMENTS IS SUBSTANTIATED BY THIS INVESTIGATION. THE ERRONEOUS RESULTS APPEAR TO BE ATTRIBUTABLE TO A COMBINATION OF TWO FACTORS: PREANALYTICAL ERROR: ISSUES OCCURRING PRIOR TO ANALYSIS, SUCH AS SAMPLE COLLECTION OR HANDLING PROBLEMS. EPOC REAGENT CARTRIDGE ERROR: SOME DEGREE OF ERROR ATTRIBUTABLE TO THE EPOC REAGENT CARTRIDGES THEMSELVES. A MEETING WITH THE VENDOR OCCURRED ON (B)(6) 2026 WITH FINDINGS. PT: 4582. DEVICE: 1535, 2457, 3005. REF: MW5186851.