Recombinant DNA and Synthetic Nucleic Acid Incident Reporting Template

To comply with NIH regulations, the University of Utah Biosafety Office facilitates reporting of potential laboratory exposures, spills, or other incidents (1) to the NIH Office of Biotechnology Activities (OBA). If an incident (sharps injury, splash, spill, unauthorized work, etc) occurs, the following steps must be taken by the PI:

  1. Report incident within 24 hours by phone (801-581-6590) or email (biosafety@ehs.utah.edu) to University of Utah Biosafety.
  2. Submit additional information to Biosafety using this form; this information MUST be submitted to Biosafety within 10 working days after the initial incident.

A final report will be compiled based on the provided information and submitted to NIH by Biosafety.

(1)The NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) states that “…any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses” must be reported to NIH OBA within 30 days. Certain types of incidents must be reported on a more expedited basis. Spills or accidents in BL2 laboratories resulting in an overt exposure must be immediately reported to NIH OBA. Spills or accidents occurring in high containment (BL3 or BL4) laboratories resulting in an overt or potential exposure must be immediately reported to NIH OBA.

Recombinant DNA and Synthetic Nucleic Acid Incident Reporting Template
(possible issues include level of training communications, awareness of hazards, etc.)
Please provide a narrative of the incident including a timeline of events. The incident should be described in sufficient detail to all for an understanding of the nature and consequences of the incident. Include the following information as applicable.

A description of:

  1. The recombinant agent or material involved.
  2. The incident/violation location (e.g. laboratory biosafety level, vivarium, non-laboratory space).
  3. Who was involved in the incident/violation, including others present at the incident location? Note: please do not identify individuals by name; provide only position titles.
  4. Actions taken immediately following the incident/violation, and by whom, to limit any health or environmental consequences of the event.
  5. The training received by the individual(s) involved and the date(s) the training was conducted.
  6. The institutional or laboratory standard operating procedures (SOPs) for the research and whether there was any deviation from these SOPs at the time of the incident/violation.
  7. Any deviation from the IBC approved containment level or other IBC approval conditions at the time of the incident/violation.
  8. The personal protective equipment in use at the time of the incident/violation.
  9. The occupational health requirements for laboratory personnel involved in the research.
  10. Any medical advice/treatment/surveillance provided or recommended after the incident.
  11. Any injury or illness associated with the incident.
  12. Medical surveillance results (if not available at the time of the initial report please indicate when the results will be available).
  13. Equipment failures.
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