Description of Event or Problem · 1
BIO-RAD LABORATORIES TECHNICAL SUPPORT RECEIVED A CALL IN 10/27/07, INQUIRING ABOUT THE KIND OF PRECAUTIONS THAT SHOULD BE TAKEN FOR THE GENETIC SYSTEMS TEST KIT. THE CUSTOMER STATED THAT WHILE DISCUSSING AN ISSUE REGARDING A PLATE RUN WITH THE SUPERVISOR, THE TECH BROUGHT THE PLATE INTO HER OFFICE. THE SUPERVISOR DID NOT REALIZE THAT IT WAS A PROCESSED PLATE OR THAT THERE WAS LIQUID IN THE PLATE. THE LIQUID SPILLED ONTO HER HANDS. SHE WAS NOT WEARING ANY PPE AND CALLED WITH CONCERNS ABOUT WHAT TYPE OF PRECAUTIONS SHOULD BE TAKEN, AS WELL AS HOW INFECTIOUS THE CONTROLS ARE FOR THE GENETIC SYSTEM. TECHNICAL SUPPORT INFORMED HER THAT THE CONTROLS IS INACTIVATED BY HEAT TREATMENT, HOWEVER, THE PT SAMPLES SHOULD BE EVALUATED TO SEE IF ANY OF THOSE SAMPLES, FROM THE SPILLED PLATE, ARE REACTIVE. TECHNICAL SUPPORT ALSO INFORMED THE CUSTOMER THAT THE PACKAGE INSERT STATES THE ASSAY SHOULD BE CONSIDERED INFECTIOUS THROUGHOUT THE PROCESS. THE CUSTOMER STATED THAT THE PT SAMPLES ON THE SPILLED PLATE WERE RE-RUN AND TWO PT SAMPLES WERE REACTIVE. TECHNICAL SUPPORT SENT THE MSDS AND INSTRUCTED HER TO TAKE THE MSDS AND THE PACKAGE INSERT TO THE MEDICAL DIRECTOR FOR ADVICE REGARDING APPROPRIATE TREATMENT. TECHNICAL SUPPORT CONTACTED THE CUSTOMER ON TWO DAYS LATER, TO INQUIRE ABOUT WHAT ADVICE SHE RECEIVED FROM THE MEDICAL DIRECTOR. THE CUSTOMER SAID THAT THE MEDICAL DIRECTOR ADVISED HER NOT TO SEEK MEDICAL ATTENTION, DUE TO THE FACT THAT THE SPILL OCCURRED ON THE PALM OF HER HAND, WHICH DID NOT HAVE ANY CUTS. IN ADDITION, SHE HAD WASHED HER HAND WITH SOAP, PUT BLEACH ON HER HAND, AND THEN POURED ISOPROPYL ALCOHOL ON HER HAND. THE MEDICAL DIRECTOR INSTRUCTED HER TO HAVE HER BLOOD DRAWN THAT DAY AND HAVE IT TESTED, AND THEN ANOTHER DRAW IN 6-8 WEEKS FOR RETESTING. THE GENETIC SYSTEMS PACKAGE INSERT, SECTION 5, PAGE 8, #4 STATES "THIS TEST KIT SHOULD BE HANDLED ONLY BY QUALIFIED PERSONNEL TRAINED IN LAB PROCEDURES AND FAMILIAR WITH THEIR POTENTIAL HAZARDS. WEAR APPROPRIATED PROTECTIVE CLOTHING, GLOVES AND EYE/FACE PROTECTION AND HANDLE APPROPRIATELY WITH THE REQUISITE GOOD LAB PRACTICES". SECTION 5, PAGE 9, #5 STATES "THE CONTAINS HUMAN BLOOD COMPONENTS. NO KNOWN TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT INFECTIOUS AGENTS ARE ABSENT. THEREFORE, ALL HUMAN BLOOD DERIVATIVES, REAGENTS AND HUMAN SPECIMENS SHOULD BE HANDLED AS IF CAPABLE OF TRANSMITTING INFECTIOUS DISEASE, FOLLOWING RECOMMENDED UNIVERSAL PRECAUTIONS FOR BLOOD BORNE PATHOGENS AS DEFINED BY OSHA, THE GUIDELINES FROM THE CURRENT CDC-NIH BIOSAFETY IN MICROBIOLOGICAL AND BIOMEDICAL LAB AND/OR LOCAL, REGIONAL AND NATIONAL REGULATIONS".