ORASURE HIV-1 ORAL SPECIMEN COLLECTION DEVICE

Description of Event or Problem

COMPLAINANT (A NURSE) WAS ADMINISTERING A COLLECTION FOR AN ORAL FLUID SPECIMEN USING THE ORASURE HIV-H1 ORAL SPECIMEN COLLECTION DEVICE. THE PT WAS HIV-1 POSITIVE AND HAD VISIBLE GUM IRRITATION AND BLEEDING. AFTER SWABBING HIS GUM, THE PT INSERTED THE PAD INTO THE SPECIMEN VIAL WHICH WAS HELD BY THE COMPLAINANT. THE PT THEN SNAPPED OFF THE STICK IN THE DIRECTION OF THE COMPLAINANT, SPATTERING THE COMPLAINANT IN THE FACE AND EYES WITH RESIDUAL ORAL FLUID. NURSE WAS NOT WEARING EYE PROTECTION.

Description of Event or Problem

AT THAT TIME THE COMPLAINANT WAS SPLATTERED IN THE FACE AND EYES WITH RESIDUAL ORAL FLUID FROM THE COLLECTION DEVICE (POTENTIAL HIV-1 EXPOSURE). ACCORDING TO THE PRODUCT INSERT, THE ADMINISTRATER (COMPLAINANT) OF THE COLLECTION IS TO "OPEN THE VIAL IN AN UPRIGHT POSITION (WITH THE CAP UP, POINTED TIP DOWN) BY GENTLY ROCKING THE CAP BACK AND FORTH TO AVOID SPILLING THE CONTENTS. "NEXT, THE ADMINISTRATOR IS INSTRUCTED TO "GIVE THE OPEN VIAL TO THE TEST SUBJECT, BEING CAREFUL NOT TO SPILL THE CONTENTS." THEN THE ADMINISTRATOR INSTRUCTS THE SUBJECT TO "REMOVE THE PAD FROM THE MOUTH AND INSERT THE PAD INTO THE SPECIMEN VIAL, AND PUSH THE PAD ALL THE WAY TO THE BOTTOM OF THE VIAL." FOLLOWED NEXT BY THE ADMINISTRATOR INSTRUCTING "THE TEST SUBJECT TO BREAK THE NYLON STICK OF THE PAD BY SNAPPING IT AGAINST THE SIDE OF THE VIAL (THE STICK IS SCORED TO FACILITATE BREAKAGE) AND RETURN THE VIAL TO ADMINISTRATOR. THE ADMINISTRATOR THEN CAPS THE VIAL. THE COMPLAINANT WAS NOT WEARING EYE PROTECTION.