Institutional Biosafety Committee (IBC) – Reporting Exposures, Injuries, Releases and Other Incidents

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Policy Number:
UW-6075
Old Policy Number:
IBC-POL-005
Responsible Office:
Environment, Health and Safety

University Policy

Rationale/​Purpose:

The purpose of this Institutional Biosafety Committee (IBC) policy is to define the institutional process for reporting exposures, injuries, releases or other incidents involving biological materials.

Definitions:
Exposure
Skin, eye, mucous membrane, or parenteral contact with potentially biohazardous or recombinant materials. Examples of exposures include (not limited to): Needle sticks, animal bites or scratches, aerosol exposures, exposures to pathogenic organisms, exposures to recombinant non pathogenic organisms, other incidents potentially resulting in disease, spills outside primary containment
First report of biological exposure or release event form
A report used for any potential exposure to, or release of, recombinant materials or biohazardous materials. When submitted, this report form provides the Office of Biological Safety and the Occupational Health Program with information to assist in following up with the laboratory.
Incident
Spills, exposures, potential exposures, injuries, releases, or other unplanned events involving biological materials, potential releases to the environment, and unauthorized releases of transgenic animals or plants.
Release
A discharge of recombinant or biohazardous material, including plants and animals outside the primary containment barrier due to failure in the containment system, an accidental spill, or occupational exposure. Examples of release of materials include (not limited to): escape or release of a recombinant vertebrate or invertebrate animal, unauthorized release of plants, spill or release of recombinant seeds, disposal of materials prior to disinfection or inactivation, tube breaking during centrifugation.
Policy:

Policy Details

Principal investigators (PIs) are responsible for ensuring fulfillment of reporting requirements specified in their approved biosafety protocol. Exposures, potential exposures, injuries, releases, or other incidents involving biological materials must be reported using the First Report of Biological Exposure or Release Event form or other approved reporting mechanism. Reporting should be done as soon as possible but must be completed within 24 hours of the incident unless a different timeline is specified in the biosafety protocol.

The Biological Safety Officer (BSO) or designee will determine whether the incident should be reported to the NIH/OSP and in what timeframe according to the NIH Guidelines. If the incident involves recombinant materials, including recombinant or synthetic nucleic acids, recombinant microbes, transgenic animals, or transgenic plants, the BSO or designee will fulfill this reporting obligation as required by the NIH Guidelines.  Reportable incidents may include injuries, spills, exposures or potential exposures, and violations of the NIH Guidelines. All incidents that are reported to the NIH/OSP will also be reported to the IBC at the next convened meeting. In cases where incidents are reported to the NIH/OSP in an expedited fashion and the next convened IBC meeting does not occur within that timeframe, the IBC Chair will be notified.

Roles and Responsibilities

  • UW–Madison Principal Investigator (PI), designee, or lab personnel: Report any release or exposure using the UW–Madison First Report of Biological Exposure or Release Event form or other approved reporting mechanism. Provide training at least annually and whenever there is a change in procedure for reporting mechanisms.
  • BSO or designee: Ensure that appropriate follow-up is taken according to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, current version. Assess incident to determine whether it needs to be reported to the NIH/OSP and in what timeframe. Communicate with Occupational Medicine if necessary. Follow up with personnel involved in incident and determine what actions should be taken, if any, to help prevent a similar situation from occurring in the future. BSO will assist with actions needed following the event in accordance with communication from the IBC and NIH/OSP as applicable. The BSO will also communicate potential exposures and releases of recombinant material to the IBC Chair prior to the next convened IBC meeting, as applicable.
Related UW–Madison Documents, Web Pages, or Other Resources:
External References:

Policy Administration

Approval Authority:
Institutional Biosafety Committee
Policy Manager:
Director of Biological Safety - Biological Safety Officer
Contact:
Director of Biological Safety - Biological Safety Officer -- Andrea Ladd, andrea.ladd@wisc.edu, (608) 263-9013
Associate Biological Safety Officer -- Stephanie Kutz, stephanie.kutz@wisc.edu, (608) 622-9764
Effective Date:
05-05-2010
Revised Dates:

09-02-2020

Retrieved:
09-29-2023 16:58:52