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 TWO SPECIMENS FOR THE NEWBORN. BY PROTOCOL, TWO SPECIMENS SHOULD BE SENT FOR ALL BABIES BORN IN (B)(6). THE FIRST SPECIMEN WAS RECEIVED ON (B)(6) 2014. THE CAH (CONGENITAL ADRENAL HYPERPLASIA) DISORDER WAS FOUND TO BE NORMAL. THE PATIENT REPORT PRINTED CORRECTLY AS NORMAL FOR CAH ON (B)(6) 2014. THE MARKER FOR CAH IS 17-HYDROXYPROGESTERONE (N17P). THE SECOND SPECIMEN WAS RECEIVED ON (B)(6) 2014. THE FIRST TIME THE SPECIMEN WAS TEST FOR CAH, THE LABORATORY QC REJECTED THE RESULTS DUE. THIS CREATED A REQUEST FOR THE SPECIMEN TO BE TESTED AGAIN. UPON TESTING A SECOND TIME, THE LABORATORY QC REJECTED THE RESULT AGAIN. THIS CREATED A THIRD REQUEST FOR N17P. THE LABORATORY CANCELLED THE N17P AND CAH REQUESTS ON (B)(6) 2014 AT 10:29 AM. THE SPECIMEN WAS THEN REPORTED AS NOT TESTED FOR CAH ON (B)(6) 2014 AT 11:08 AM. THE REPORT IS CORRECT, HOWEVER, PER THE LABORATORY'S PROTOCOLS THE SPECIMEN SHOULD HAVE BEEN TESTED FOR CAH. THE PATIENT REPORT RELEASED CONTAINED NO ERRONEOUS CONTENT. INTERNAL REFERENCE NUMBER: (B)(4).