SEC-031: Required Reporting of "Events" Involving Radiation Exposure or Radioactive Material

Date: 10/25/2010 Status: Final
Policy Type: University
Oversight Executive: Vice President for Research
Applies To: Academic Division, the Medical Center, and the College at Wise.
Table of Contents:

Policy Statement
Procedures

Reason for Policy:

The University’s radioactive materials license and the Commonwealth of Virginia’s Radiation Protection Regulations require that certain events be reported to the University’s Radiation Safety Officer and the Radiological Health Program of the Virginia Department of Health.

Definition of Terms in Statement:
  • Event:

    Any incident that is not consistent with the ordinary course or expected outcomes of operations involving the use of radioactive materials or radiation producing equipment.  An injury does not have to occur.  Events include, but are not limited to:

    • A medical event or misadministration as defined by the Virginia Radiation Protection and Nuclear Regulatory Commission regulations;
    • Events in which a dose is delivered to the patient that is not in accordance with the prescribed treatment plan (plan as prescribed prior to start of treatment);
    • Physical harm to patients or third parties such as visitors;
    • Equipment malfunctions that could potentially cause unexpected radiation exposures to patients or employees;
    • Unsafe radiological situations or working conditions;
    • Violations of the license or registration terms and conditions; or
    • Loss of radioactive material.
       
Policy Statement:

Individuals authorized to use radioactive material and/or radiation producing equipment must immediately report to the University’s Radiation Safety Officer (RSO) any event (as defined above) that involves a patient or staff. The RSO will evaluate the report and take appropriate action if necessary.

The RSO must make the determination as to whether a medical event or mis-administration may have occurred in accordance with the State regulations regarding such events and must report such to the Radiological Health Program of the Virginia Department of Health within time frames specified in the regulations. The RSO will investigate the event through consultation with individuals involved in the event in order to make a determination. The RSO will notify the Medical Center’s representative or other appropriate member of the Radiation Safety Committee, as well as the appropriate department chair about any events in their respective areas that are being investigated and any subsequent decisions made about reporting to the regulators.

In an effort to further assist the RSO in notification of all relevant events involving radiation exposure or devices that occur in the Medical Center, Environmental Health and Safety (EHS) shall have access to and receive all Medical Center quality reports (QR) that involve radiation producing machines or radioactive materials. QRs shall be completed in accordance with Medical Center Policy #0132 – The Quality Reporting Process.

Procedures:

Notification of any event shall be made directly by phone (434-982-4911) to the RSO in EHS.

Related Information:

Virginia Department of Health “Notice to Employees”
EHS Radiation Safety Program
Medical Center document entitled “QR Track General Event Types”
Commonwealth of Virginia Radiation Protection Regulations
U.S. Nuclear Regulatory Commission Regulations:
            Reports
            Report and Notification of a dose to an embryo/fetus or nursing child
Medical Center Policy #0076 – Management of New Medical Devices Used in Patient Care
SEC-009, Utilization of Radioactive Materials
SEC-010, Radiation Protection during Pregnancy

Major Category: Safety, Security and Environmental Quality
Approved by, Date: Executive Vice President and Chief Operating Officer, 10/25/2010
Revision History: This is the first version of this policy.