Page 1 of 3 Charles R. Drew University of Medicine and Science Institutional Biosafety Committee (IBC) Pioneering in Health and Education Incident Report Form Please complete this Incident Report Form and immediately send to Biosafety-IBC@cdrewu.edu . Initial Report Follow-up Report Final Report Date Report Submitted: CDU IBC #: Project Title: Name of Principal Investigator: Name and Title of Person Who Completed the Form: Date and Time of Incident: Location of Incident: How many people were involved? Provide position titles of personnel involved. The incident/event involved the following. Check all that applies. Spills and accidents involving recombinant or synthetic nucleic acid molecules, biohazardous material, microorganisms, or genetically modified organisms and resulting in Personal injury (e.g., cuts, bites, needlestick) Overt exposure (e.g., inhalation, ingestion, injection, skin contact, eye exposure) Illness (e.g., salmonellosis, shigellosis, brucellosis, HBV, HCV, HIV, zoonotic disease) Missing or improper disposition of a transgenic animal or genetically modified animal Breach of containment or release of genetic material, microorganisms, or biohazardous material from primary containment device (e.g., biological safety cabinet, centrifuge) Failure to follow approved IBC protocol, Institutional or laboratory standard operating procedures (SOPs), applicable regulations and policies, IBC requirements Failure to follow containment and biosafety practices described in the NIH Guidelines Description of the Incident/Event Describe the incident/event in detail. Provide candid discussion on the root cause of the incident/event. Created November 2013 Version 1.0 Page 2 of 3 Describe the recombinant DNA molecules/materials or gene products involved in the incident. Exposure Information What is the nature of the organism to which the personnel were exposed? (strain name and history, complete drug-resistance/susceptibility profile, other information pertinent to treatment) Describe route(s) of possible exposure (e.g., percutaneous injuries, inhalation of aerosols, mucous membrane exposures, and accidental ingestion) Describe the Personal Protective Equipment (PPE) used at the time of incident. Environmental Release Describe any biological materials spilled and/or splashed on environmental surfaces (contamination) that occurred in the laboratory. Describe any untreated biological material released from the laboratory. Are there any missing transgenic or genetically modified animal? Actions taken after the incident or exposure Describe the actions taken immediately to limit any potential health or environmental consequences from the incident. If applicable, describe the following: o Steps taken to evaluate the health of the exposed personnel o Whether personnel received first aid and/or professional medical treatment and if so, how many hours/days after the exposure o Describe the clean-up procedure (who, how, when, and what) and the PPE used. o Describe any security and safety measure enacted to prevent secondary exposure to other personnel. Corrective and Preventive Action (CAPA) Plan Action taken or planned to prevent recurrence of a similar incident or event Who will implement CAPA and monitor to make sure that CAPA is effective? Who will be affected by CAPA (e.g., PI and the entire laboratory personnel, research laboratories)? Created November 2013 Version 1.0 Page 3 of 3 Reporting Requirement Did you notify this incident to any other CDU office, officers or external agencies (federal, state, local)? If yes, who was notified and when the report was submitted, if any. Certification I certify that the information contained in this form is complete and accurate to the best of my knowledge. __________________________________________________ Name of Principal Investigator __________________________________________________ Signature Date _____________________________________________ Name of Person Submitting the Incident Report (if not the Principal Investigator) _____________________________________________ Signature Date Created November 2013 Version 1.0 __________________________________ Relationship to the study (e.g., Co-investigator, lab manager, etc.)