ACCELERATE PHENO SYSTEM

Description of Event or Problem

IN SUMMARY, WE ARE REPORTING THIS EVENT BECAUSE WE ARE CONCERNED ABOUT THE HIGH ERROR RATES WHEN COMPARING PHENO RESULTS TO THOSE OF SENSITITRE AND OTHER STANDARD METHODS IN OUR CLINICAL MICROBIOLOGY LABORATORY. WE SUSPECT WE ARE ACUTELY AWARE OF THESE ISSUES BECAUSE OUR ANTIMICROBIAL STEWARDSHIP TEAM IS HEAVILY INVOLVED IN THE DAY-TO-DAY FUNCTIONS OF THE CLINICAL MICROBIOLOGY LABORATORY. WE BELIEVE OUR PRACTICE OF ROUTINELY PERFORMING ADDITIONAL SUSCEPTIBILITY TESTING IS LIKELY PROVIDING RESOLUTION AT A LEVEL NOT TYPICALLY PRESENT IN A CLINICAL MICROBIOLOGY SETTING. WE WANTED TO VOICE OUR CONCERN, AS THERE MAY BE LABORATORIES THAT DO NOT UTILIZE THESE ADDITIONAL METHODS, AND PATIENTS MAY BE RECEIVING INCORRECT THERAPY OR SPECTRUM AS A RESULT. WE ARE MOST CONCERNED ABOUT THE PSEUDOMONAS AERUGINOSA ERRORS AND, WHILE MOSTLY MINOR AND DUE TO OVERCALLING OF RESISTANCE, THIS OFTEN LEAVES VERY FEW ACTUAL TREATMENT OPTIONS AND RESULTS IN THE ADDITION OF UNNECESSARY THERAPY. WE ALSO WANT TO HIGHLIGHT THAT IMPLEMENTATION OF OUR HOSPITAL'S-SPECIFIC RULES FOR DELAYED REPORTING OF AMPICILLIN/SULBACTAM, CEFAZOLIN AND PIPERACILLIN/TAZOBACTAM WHEN NONSUSCEPTIBLE, PREVENTED AN ADDITIONAL 162 INSTANCES OF OVERCALLING RESISTANCE. WHILE THESE ERRORS HAVE NOT RESULTED IN OBVIOUS PATIENT HARM WITHIN OUR SYSTEM, THERE HAS BEEN A SIGNIFICANT IMPACT ON PATIENT CARE OVERALL THAT WE CONSIDERED SUFFICIENT FOR REPORTING TO THE FDA.