Description of Event or Problem · 1
THE (B)(6) 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 TWO SPECIMENS FOR THE PATIENT. IT IS STANDARD OPERATING PROCEDURE IN NEVADA FOR THE LABORATORY TO OBTAIN AND TEST TWO SPECIMENS FOR EACH NEWBORN. THE FIRST SPECIMEN WAS RECEIVED ON (B)(6) 2014. THE INITIAL GALT RESULT WAS LOW, WHICH TRIGGERED A CONFIRMATION REQUEST FOR GALT (GALACTOSEMIA) AND GAO (TOTAL GALACTOSE). THE LABORATORY PERFORMED THE GALT TEST, WHICH WAS DEEMED AS NORMAL. THE LABORATORY CANCELLED THE REQUEST FOR GAO ON (B)(6) 2015 AT 3:23 PM AND DID NOT ANALYZE THE SPECIMEN FOR GAO. SINCE THERE WAS NO VALID RESULT FOR GAO, SPECIMEN GATE LOGIC COULD NOT DETERMINE THE RESULT FOR GALACTOSEMIA DISORDER. THE LABORATORY MANUALLY MODIFIED THE GALACTOSEMIA DISORDER RESULT TO BE NORMAL, PRIOR TO THE PATIENT REPORT BEING PRINTED. THE PATIENT REPORT WAS PRINTED AND GALACTOSEMIA DISORDER SHOWED AS NORMAL DUE TO THE MANUAL CHANGE BY THE LABORATORY EVEN THOUGH THEY DID NOT COMPLETE TESTING FOR GAO (THE REQUEST WAS CANCELLED). THE LAB HAS A PRESCRIBE TURN-AROUND-TIME FROM SAMPLE RECEIPT TO REPORTING. THE SECOND SPECIMEN WAS RECEIVED ON (B)(6) 2014, ANALYZED AND REPORTED AS NORMAL FOR GALACTOSEMIA DISORDER ON (B)(6) 2015 AT 5:59 PM. THE THE REPORT DID NOT GO OUT IN TIME DUE TO ALL TESTS NOT BEING COMPLETED AND DATA ENTRY NOT BEING COMPLETED UNTIL (B)(6) 2014. ALERTS WERE GENERATED IN SCREENING CENTER TO NOTIFY THE LABORATORY THAT TESTING, DATA ENTRY AND REPORTING WERE NOT COMPLETED IN TIME. THE ALERTS WERE CREATED ON 7/23/2014, 7/23/2014, AND 7/24/2014 RESPECTIVELY. THE PATIENT REPORT RELEASED CONTAINED NO ERRONEOUS CONTENT. (B)(4).