Chemical Hygiene Plan and Safety Manual - LP3050.3 Bloodborne Pathogen Exposure Control Plan

5.0 Responsibility

5.1 CLIA Supervisor: the supervisor is responsible for overseeing all clinical laboratory personnel and practices The supervisor is responsible for compliance of clinical testing to standard operating procedures created by Purity as well as regulatory standards

5 2 CLIA Laboratory Director: the director is responsible for overall operation and administration of the laboratory as well as employing competent personnel The director is responsible for ensuring that all CLIA regulations are met and are being implemented correctly

5.3 Personnel: clinical laboratory personnel are required to follow all procedures set in place by the CLIA supervisor and follow all regulatory standards for a clinical laboratory. Personnel are required to wear proper personal protection equipment (PPE) at all times within the laboratory setting. This includes but is not limited to: lab coats, eye protection, long pants, closed-toe shoes and gloves.

5.3.1 Other PPE will be available to all personnel who might need extra protection against various hazards. This includes aprons, full coverage eye protection, heavy-duty gloves, and respirators.

6.0 Biosafety Levels

6.1 Biosafety Levels: This category is for microbiological hazards such as positive control standards. The range of BSL is 1-4 with 4 being the most hazardous.

6.1.1 Strains of microorganisms not known to cause disease in healthy human adults. Normal safety procedures apply.

6.1.2 Moderate risk microorganisms that are associated with less serious human diseases. Extra precautions are necessary such as PPE and limited lab access.

6.1.3 High risk microorganisms with a true potential for infection via inhalation. PPE required such as respirators, double gloves and gowns Work only to be conducted in an isolated laboratory

6 1 4 Easily transmitted very high risk microorganisms which cause life threatening diseases for which there is no treatment Hazmat suits required as well as chemical showers

6 2 With the exception of extraordinary circumstances in which the samples are suspected to contain extremely contagious pathogenic material, clinical laboratory samples are to be handled under BSL-2 Level 2 is the level for which HIV, HBV and HCV are handled and are the most likely pathogens a clinical laboratory employee will encounter.

6.3 The focus of BSL-2 is the prevention of exposure to pathogenic material via mucosal membranes and percutaneous injuries.

6.4 BSL-2 requires the laboratory to use primary barriers such as PPE, universal precautions and a biosafety cabinet to prevent splashing and spraying of droplets of potentially pathogenic material.