Description of Event or Problem · 0
SITUATION: ACTIVATED CLOTTING TIME (ACT) PATIENT TESTING PERFORMED WITHOUT PROPER OR ACCURATE PATIENT IDENTIFICATION. BACKGROUND: HEMOCHRON SIGNATURE ELITE DEVICES ARE CONFIGURED IN RALS TO REQUIRE PATIENT IDENTIFICATION BEFORE PERFORMING PATIENT TESTING. THE PREFERRED METHOD IS TO SCAN THE PATIENT ARMBAND. MANUAL ENTRY IS PERMITTED, USERS ARE REQUIRED TO MANUALLY ENTER THE PATIENT MEDICAL RECORD NUMBER (MRN) TWICE FOR CONFIRMATION. ASSESSMENT: -ACT PERFORMED ON (B)(6) 2025 WITH NO PATIENT ID, ON THE ANALYZER THE RESULT SHOWED WITH NO PATIENT IDENTIFICATION. (B)(6) 2025 POINT OF CARE (POC) CREATED AN INCIDENT TICKET WITH WERFEN TO RESEARCH THE ISSUE (B)(6) 2025 POC FOUND ANOTHER 2 RESULTS WITH NO PATIENT ID PERFORMED ON (B)(6) 2025, TESTING WAS PERFORMED IN OPERATION ROON. CASE IDENTIFIED: ACT DOCUMENTED ON INCORRECT PATIENT ON (B)(6) 2025 IN OR AFTER USER BYPASSED EQC AND RAN PATIENT TESTING WITHOUT PATIENT ID. GAPS IDENTIFIED: IF A USER ENTERS LIQUID QC MODE AND THEN SELECTS "CANCEL" THE DEVICE ALLOWS THE USER TO PERFORM PATIENT TESTING WITH NO PATIENT ID, EVEN IF DEVICE IS CONFIGURED TO REQUIRE PATIENT ID. USER CAN INTERRUPT ELECTRONIC QC MODE BY LOADING CUVETTE INTO ANALYZER, THIS ALLOWS USER TO PROCEED WITH TESTING WITHOUT ENTERING PATIENT ID. WHEN EQC IS INTERRUPTED, IT BYPASSES THE 8-HOUR EQC REQUIREMENT AND ALLOWS PATIENT TESTING TO BE PERFORMED WITHOUT PATIENT ID OR EQC BEING PERFORMED AT THE PROPER TIME, EVEN IF DEVICE IS CONFIGURED TO REQUIRE PATIENT ID. IN SOME INSTANCES THE MOST RECENT PATIENT ID STORED ON THE DEVICE IS ATTACHED TO RESULTS RAN WITHOUT PATIENT ID, CAUSING PATIENT RESULTS TO FILE UNDER THE WRONG PATIENT MEDICAL RECORD. THERE IS NO WAY TO CLEARLY OR EASILY IDENTIFY WHEN THIS HAS HAPPENED IN THE ANALYZER OR IN RALS, IT APPEARS AS A NORMAL PATIENT RUN -ALL INFORMATION DISCOVERED INCLUDING VIDEOS HAVE BEEN SHARED WITH WERFEN AND ESCALATED TO THEIR QA DEPARTMENT.