STAGO STA COMPACT MAX

Description of Event or Problem

AT ONE OF OUR CLINICAL LABORATORIES, IT WAS IDENTIFIED THAT AN ERRONEOUS ISI VALUE WAS ENTERED DURING A REAGENT LOT CHANGE THAT TOOK PLACE ON (B)(6) 2024, CAUSING INTERNATIONAL NORMALIZED RATIO (INR) RESULTS TO BE INACCURATE UNTIL THE ERROR WAS DISCOVERED IN (B)(6) 2025 FOLLOWING PROFICIENCY TESTING IN (B)(6) 2025. OUR ANTICOAGULATION PHARMACY REVIEWED ALL CORRECTED INTERNATIONAL NORMALIZED RATIOS (INR)? 1.5 FOR ANY POTENTIAL ADVERSE EVENTS AND NEED FOR RETESTING. ONE CASE OF SERIOUS INJURY POTENTIALLY RELATED TO THE ISI VALUE WAS IDENTIFIED ¿ THIS PATIENT WITH HISTORY OF ATRIAL FIBRILLATION (AFIB), CHRONIC HEART FAILURE (CHF) AND MECHANICAL AORTIC HEART VALVE ON COUMADIN WAS ADMITTED ON (B)(6) 2025 WITH NON-TRAUMATIC TRACE BILATERAL SDH (THE DAY PRIOR TO ADMISSION, THE CORRECTED INR WAS 3.7 (THOUGHT TO HAVE BEEN 2.7 TO A TARGET OF 2.5 ¿ 3.5). ADMISSION INTERNATIONAL NORMALIZED RATIO (INR) WAS 3.1. VITAMIN K WAS GIVEN, NEUROSURGERY WAS CONSULTED AND THE PATIENT WAS ADMITTED FOR CLOSE OBSERVATION AND SERIAL IMAGING. NO OTHER INTERVENTION WAS NEEDED. OF NOTE, THE PATIENT HAD A COUGH IN THE DAYS PRIOR FROM A SUSPECTED UPPER RESPIRATORY/VIRAL INFECTION. PER NEUROSURGICAL EVALUATION OF THE CASE, THE ANTECEDENT COUGH AS WELL AS THE PATIENT'S AGE MAY HAVE BEEN CONTRIBUTING FACTORS TOWARDS THE DEVELOPMENT OF THE SMALL SDH SEEN. SHE WAS ALSO FOUND TO HAVE ACUTE ON CHRONIC HEART FAILURE (CHF) AND ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE WHICH WERE MEDICALLY MANAGED THROUGH DISCHARGE ON (B)(6) 2025. (B)(6) 2025 CORRECTED VALUE WAS 2.5 UPON DISCOVERY OF ISI ERROR (B)(6) 2025 CORRECTED VALUE WAS 2.3 (B)(6) 2025 CORRECTED VALUE WAS 3.7 (B)(6) 2025 CORRECTED VALUE WAS 4.0 (B)(6) 2025 CORRECTED VALUE WAS 3.9 (B)(6) 2025 CORRECTED VALUE WAS 3.7 (B)(6) 2025 CORRECTED VALUE WAS 3.7.