Description of Event or Problem · 1
THE (B)(6) STATE PUBLIC HEALTH NEWBORN SCREENING LABORATORY USES THE PERKINELMER SCREENING CENTER MODULE OF SPECIMEN GATE (SGSC) SOFTWARE (A CLASS I MEDICAL DEVICE) TO STORE, RETRIEVE, AND PROCESS THE DATA ASSOCIATED WITH SPECIMEN TESTING INCLUDING BUT NOT LIMITED TO PATIENT DEMOGRAPHICS, TESTS ORDERED, TEST RESULTS, TEST RESULT INTERPRETATION, QUALITY CONTROL RESULTS, AND RESULT CODES (FLAGS) THAT MAY BE ASSOCIATED WITH THE SPECIMEN FROM ITS ENTRY INTO THE LABORATORY WORKFLOW UNTIL PATIENT REPORT IS GENERATED AND RELEASED. WHEN SGSC SOFTWARE IS INSTALLED, CONFIGURABLE SETTINGS ARE PROGRAMMED BASED ON THE CUSTOMER PREFERENCES. FOR INSTANCE, EACH LABORATORY ENTERS THEIR SPECIFIC POPULATION BASED REFERENCE RANGES THAT ARE USED TO EVALUATE IF A PATIENT'S TEST RESULTS ARE NORMAL, BELOW OR ABOVE THE REFERENCE RANGE AND REQUIRE FURTHER ACTION SUCH AS REPEAT TESTING. THIS LABORATORY SPECIFIC LOGIC AUTOMATES THE FLOW OF THE SPECIMEN THROUGH THE LABORATORY. THE CUSTOMER DEFINES THE NOMENCLATURE USED FOR THEIR RESULT CODES (FLAGS), AND WHEN THE SOFTWARE ENCOUNTERS THE PREDEFINED RESULT CODE THE SOFTWARE PROCESSES THE SPECIMEN ACCORDING TO THE LOGIC ASSOCIATED WITH THE RESULT CODE. THE NEWBORN SCREENING LABORATORY RECEIVED 3 SPECIMENS FOR THE PATIENT. BY PROTOCOL, TWO SPECIMENS SHOULD BE SENT FOR ALL BABIES BORN IN (B)(6). THE FIRST SPECIMEN WAS RECEIVED ON (B)(6) 2015. THE INITIAL MSUD (MAPLE SYRUP URINE DISEASE) AND HCY (HOMOCYSTINURIA) WERE ELEVATED, TRIGGERING A CONFIRMATION REQUEST. THE CONFIRMATION WAS NOT TESTED BY THE LABORATORY, BUT THE CONFIRMATION RECORD WAS ATTACHED TO A SEPARATE ASSAY THAT THE SPECIMEN WAS NOT PUNCHED TO, CAUSING INCOMPLETE RESULTS FOR THE CONFIRMATION MSUD AND HCY DISORDERS SO THE LABORATORY WAS UNABLE TO PRINT THE REPORT AND CONTACTED PERKINELMER FOR ASSISTANCE. PERKINELMER CANCELLED AND UNATTACHED THE RECORDS THAT WERE INCORRECTLY ASSOCIATED WITH THE SEPARATE ASSAY. A REVIEW ITEM WAS CREATED FOR THIS SPECIMEN ON (B)(6) 2015 AT 10:45 AM PREVENTING THE REPORT FROM BEING PRINTED. THE LABORATORY CLOSED THE REVIEW ITEM ON (B)(6) 2015 AT 11:37 AM ALLOWING THE REPORT TO BE PRINTED, DISPLAYING NORMAL FOR THE MSUD AND HCY DISORDERS EVEN THOUGH TESTING NEEDED TO BE CONFIRMED. THE SECOND SPECIMEN WAS RECEIVED ON (B)(6) 2015, ANALYZED AND REPORTED AS NORMAL FOR MSUD AND HCY DISORDERS ON (B)(6) 2015. THE THIRD SPECIMEN WAS RECEIVED ON (B)(6) 2015, ANALYZED AND REPORTED AS NORMAL FOR MSUD AND HCY DISORDERS ON (B)(6) 2015. SUMMARY: PROCEDURAL ANOMALY OCCURRED. FOR SAMPLE 1 THERE WERE ANALYTES THAT WERE ELEVATED REQUIRING REPEAT TESTING. THE REPORT WAS ISSUED WITH NORMAL INTERPRETATION ALTHOUGH SAMPLE 1, WHICH WAS FLAGGED TO BE REPEATED, HAD NOT YET BEEN REPEATED. WHEN SAMPLE 2 AND 3 WERE TESTED, THE ANALYTICAL VALUES WERE WITHIN NORMAL RANGE FOR THE ANALYTES ELEVATED WITH SAMPLE 1. IT WAS AT THIS POINT THE LABORATORY FOUND THE SAMPLE 1 REPORT HAD BEEN ISSUED ALTHOUGH IT WAS CODED FOR REPEAT TESTING. AS THE SAMPLE 1 PATIENT REPORT RESULTS WERE NORMAL, THE LABORATORY DECIDED TO NOT REISSUE THE FIRST REPORT AS THE INTERPRETATION WAS CORROBORATED BY SAMPLE 2 AND 3. (B)(4).