Description of Event or Problem · 0
DURING A PLASMA DONATION VISIT (B)(6), I EXPERIENCED AN UNEXPECTED BLOOD EXPOSURE CAUSED BY STAFF ACTIONS. WHILE I WAS SEATED AND IN THE PROCESS OF DONATING, THE CLINIC STAFF WERE CLEANING A PLASMA MACHINE POSITIONED NEXT TO MY STATION. DURING THIS CLEANING PROCESS, BLOOD SUDDENLY SPEWED AND SPLASHED OUTWARD FROM THE EQUIPMENT AND CAME INTO CONTACT WITH OTHER DONORS NEARBY. THE BLOOD EXPOSURE DID NOT INVOLVE MY OWN BLOOD AND WAS NOT CAUSED BY ANY DONOR ACTION OR MISUSE. I WAS COMPLIANT WITH ALL DONOR REQUIREMENTS AND REMAINED SEATED AS INSTRUCTED. THE EXPOSURE WAS THE DIRECT RESULT OF STAFF HANDLING AND CLEANING OF EQUIPMENT IN PROXIMITY TO DONORS. FOLLOWING THE INCIDENT, I WAS PROVIDED WIPES AND ASKED IF I WANTED TO SEE A DOCTOR. TO MY KNOWLEDGE, NO FORMAL BLOODBORNE PATHOGEN EXPOSURE PROTOCOL WAS INITIATED, NO WRITTEN INCIDENT OR EXPOSURE REPORT WAS PROVIDED TO ME, AND NO DOCUMENTED MEDICAL EVALUATION WAS ARRANGED BY THE FACILITY. OPERATIONS DID NOT APPEAR TO BE STOPPED OR SECURED DESPITE MULTIPLE DONORS BEING EXPOSED. WHEN I RETURNED TO THE CLINIC AT A LATER DATE, I WAS INFORMED THAT I HAD BEEN DEFERRED FROM DONATING PLASMA FOR ONE YEAR. I WAS NOT PROVIDED WITH A CLEAR MEDICAL OR REGULATORY EXPLANATION FOR THE DEFERRAL. THE DEFERRAL APPEARS PUNITIVE, AS THE EXPOSURE WAS ENVIRONMENTAL AND CAUSED BY STAFF ACTIONS DURING EQUIPMENT CLEANING, NOT BY DONOR BLOOD, DONOR BEHAVIOR, OR DONOR RISK FACTORS. I AM CONCERNED THAT PROPER INFECTION CONTROL PROCEDURES, BIOHAZARD HANDLING, AND EXPOSURE RESPONSE PROTOCOLS WERE NOT FOLLOWED, AND THAT I WAS PENALIZED FOR AN INCIDENT RESULTING FROM CLINIC NEGLIGENCE RATHER THAN DONOR CONDUCT. I AM SUBMITTING THIS COMPLAINT FOR FDA REVIEW TO DETERMINE WHETHER THE FACILITY COMPLIED WITH APPLICABLE SAFETY, BLOOD HANDLING, AND EXPOSURE RESPONSE REGULATIONS. NO LABORATORY TESTING OR MEDICAL EVALUATION WAS PERFORMED BY THE FACILITY FOLLOWING THE BLOOD EXPOSURE INCIDENT. I WAS PROVIDED WIPES AND ASKED IF I WANTED TO SEE A DOCTOR, BUT NO TESTING, BASELINE LABS, OR DOCUMENTED EXPOSURE FOLLOW-UP WAS INITIATED OR ARRANGED BY THE FACILITY.