Objective

The intent of this policy is to describe the process for reporting research-related incidents. Effective incident reporting is necessary to ensure that staff members receive appropriate care, to promote the effective mitigation of hazards, to protect institutional liability, and to comply with regulatory requirements and institutional policies.

Scope

This procedure shall apply to students, visitors, staff, and faculty involved in research at the University of Tennessee Health Science Center or on university property. It shall also apply to students, visitors, staff, and faculty engaged in off-site, university-sponsored research activities.

Definitions

Accident: An incident resulting in damage or injury.

Biological Agent: Living organism or its product, capable of causing or treating a disease. IBC: Institutional Biosafety Committee

Illness: Any abnormal condition or disorder, other than one resulting from an occupational injury, caused by exposure to factors associated with employment. Some of the common types of occupational illnesses include asthma and other respiratory problems, pesticide poisoning, Hepatitis B among workers handling human blood and body fluids, and influenza and other communicable diseases among healthcare workers.

IRB: Institutional Review Board

Incident: An event or occurrence that is problematic in nature. Examples include accidents, exposure events, spills, protocol non-compliance, etc.

Hazardous Agent: Chemical, biological, or radiological materials or energy with hazards identified in the Safety Data Sheet or known cause harm to living organisms or the environment.

Near-miss: A narrowly avoided accident, also known as a close call or non-injury accident. Such incidents may alert workers to hazardous conditions or unacceptable risks.

NIH Guidelines: The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.

Procedure

1. Employees that are injured, exposed to a hazardous material, or who experience symptoms of a potential research-related illness must notify their supervisor immediately. They must contact the Corvel 24/7 nurse line at 1-866-245-8588 after moving to a safe environment and obtaining the necessary first aid. Corvel must be called within 48 hours of the incident and before seeking follow-up medical treatment. Employees must then notify UT Risk Management by completing the On-the-job Injury form accessible through the UT Incident Report website.
2. Students or visitors that are injured, exposed to a hazardous material or who experience symptoms of a potential research-related illness must notify their supervisor or UTHSC liaison. The supervisor or UTHSC liaison must complete they must then notify UT Risk Management by visiting the UT Incident Report website, selecting General Liability and completing the online form.
3. Employees are encouraged to immediately address safety or health concerns, including those resulting in near misses, where feasible. Any individual can report safety and health concerns, including near misses, to their immediate supervisor or the Office of Research Safety Affairs by emailing safety@uthsc.edu.
4. Any individual may report unsafe or potentially hazardous conditions directly to the Office of Research Safety Affairs and request anonymity. Concerns may be reported by emailing safety@uthsc.edu.
5. The reporting of such conditions by an employee shall in no way result in disciplinary action or reprisal against the employee.
6. Supervisors or the campus Safety Officer are authorized to issue a stop work order in cases in where imminent danger is present.
7. The office of Research Safety Affairs will investigate the concern, act upon, and respond within 15 working days to any person who registers a concern, complaint or report of unsafe conditions.
8. Specific types of incidents must be reported within 48-hours as detailed below:
   1. Incidents involving Biological Agents: The Principal Investigator must notify the department chair, the chairperson of the IBC and University Health Services of the development of any symptoms consistent with agents used in the laboratory. The PI must also report to their department chair and the IBC Chair any of the following:
      1. Significant problems (any spill or accident involving recombinant DNA research or that otherwise leads to personal injury or illness or to a breach of containment is considered significant and must be reported. Minor spills of low-risk agents that do not involve recombinant DNA and do not involve a breach of containment, that were properly cleaned and decontaminated generally do not need to be reported.)
      2. Research-related accidents,
      3. Illnesses and exposures involving recombinant DNA,
      4. Violations of the NIH Guidelines,
      5. The escape of a transgenic animal.
   2. Incidents involving animal research: Non-compliance with IACUC policies and protocols, concerns about animal care and use at UTHSC – including animal treatment – must be reported to the IACUC Chair or LACU Director. Alternatively, such issues can be reported by calling the Research Compliance Office.
   3. Incidents involving radioactive materials or radiation: The Radiation Safety Officer must be notified of incidents involving radioactive materials or other modalities of radiation (e.g., lasers, x-rays, etc.). Such incidents will be reported to and reviewed by the Radiation Safety Committee.
   4. Incidents involving select agents: The theft, loss or release of select agents must immediately be reported to the Regional Biocontainment Lab (RBL) Responsible Official (RO). RBL incidents resulting in the activation of an occupational health protocol must also be reported to the Responsible Official. Other safety-related incidents or incidents involving work that is not consistent with RBL standard operating procedures must be reported to the RO or RBL Biosafety Officer at 901-448-3904. Additional details about reporting requirements and procedures are provided in the IACUC policy Review of Non- Compliance and Animal Welfare Concern.
   5. Incidents involving ionizing or non-Ionizing radiation: Radioactive material spills must be reported to the Radiation Safety Officer (RSO) immediately. Concerns about exposure to ionizing (e.g. radioactive material or x-ray) or non-ionizing radiation [e.g. laser radiation, radio frequency (RF) radiation] should also be reported to the (RSO). Personnel exposures identified through dosimetry are reported directly to the state by the vendor of dosimetry service and are investigated by the RSO. Suspected exposures via inhalation, ingestion, injection, or other means must also be reported to the RSO.
   6. Incidents human subjects’ research: For information about reporting Unanticipated Problems such as reportable adverse events, protocol deviations, or waivers, consult the UTHSC IRB standard operating procedures located at http://www.uthsc.edu/research/compliance/irb/researchers/standard-operating- procedures.php.

Reporting Procedure

1. Accidents/injuries and hazardous agent exposures must be reported to a supervisor immediately.
2. In a medical emergency that is life-threatening or results in serious bodily injury, employees must call 911 or go to the nearest hospital emergency room. The employee’s supervisor or a family member should call the CorVel 24-hour nurse line at 1-866-245-8588 to report the incident.
3. For non-emergency injuries, employees and their supervisor must call the CorVel 24-hour nurse line at 1-866-245-8588. A nurse will determine if your injury requires self-care, or urgent care and provide you with the nearest authorized medical provider.
   1. If the injury only requires self-care, this would be an incident only claim and no further action would be needed with CorVel.
   2. When medical treatment is needed, supervisors must make a follow-up phone call to CorVel. Failure of the supervisor to call CorVel and complete the First Notice of Loss will result in the department being fined by the State.
   3. On the University of Tennessee Risk Management website, there are links to the “Incident Report,” “Lost Time/Return to Work Calendar,” and “Employee and Supervisor Instructions” forms. When warranted by the nature of the incident or injury completed by employee’s and their supervisor. Once completed, form must be forwarded to your campus HR/WC representative.
   4. Every attempt must be made to report the incident within 48-hours of becoming aware of the incident.
   5. Concerns related to health, safety and compliance in research may be reported by contacting the Office of Research Safety at 448-6114 or emailing labsafety@uthsc.edu.

Contact Information

Corvel: 1-866-245-8588

Human Resources (901) 448-8481

IBC Chairperson: Dr. Mark Miller ibc@uthsc.edu

IACUC Chairperson: Jeff Steketee, PhD. jstekete@uthsc.edu

IRB Reporting: Cameron Barclay, IRB Director cbarclay@uthsc.edu

Occupational Health: Evelyn Wright-Lewis, eohs@uthsc.edu

Office of Research Safety Affairs: (901) 448-6114

labsafety@uthsc.edu

Responsible Official & Additional Contacts

Subject Matter	Office Name	Telephone Number (xxx) xxx-xxxx	Email/Web Address
Policy Clarification and Interpretation	Campus Safety and Emergency Management	901-448-6114	labsafety@uthsc.edu
Policy Training	Campus Safety and Emergency Management	901-448-6114	labsafety@uthsc.edu
Incident Reporting	Campus Safety and Emergency Management	901-448-6114	labsafety@uthsc.edu

Related Policies/Guidance Documents

• University of Tennessee Policy on Accident and incident reporting