The University of Wisconsin–Madison Office of Radiation Safety (ORS) conducts routine, quarterly, semiannual, or annual inspections of laboratories and clinics which use radioactive material (RAM) and radiation producing devices. Additionally, the ORS interacts with these laboratory groups and clinics on a frequent basis, aside from routine inspections (e.g., RAM delivery, radioactive waste management). When non-compliance issues are observed and documented during these interactions, enforcement actions are taken to ensure compliance with federal and state regulations as well as University policies. These enforcement actions are described and defined in the categories below. Failure to correct the issues of non-compliance will result in an escalation of enforcement actions as explained through the three levels below.
A Level One – Notice of Non-Compliance may be issued when a repeat issue of non-compliance (repeat violation) or an egregious violation by a group or individual permitted to use RAM or radiation producing devices is identified. This issue may be identified during a scheduled or unscheduled inspection, regular permit review, the office’s verification of reported unsafe practices reported by others, or any other touchpoint with the group. This notice will be sent to the Permit Holder and their Radiation Safety Supervisor (RSS) and/or Lab Manager informing them of the non-compliance issue(s) and of the potential for suspension of the permit or lock-out from the device.
The notice will indicate the item(s) of non-compliance and require a response from the Permit Holder indicating the corrective action(s) to be implemented. Failure to respond within the stated time period (30 days from the date of issue) may escalate the notice level to a Level Two. The Radiation Safety Officer (RSO) and the group’s assigned Health Physicist shall review the adequacy of the response and offer guidance, as appropriate. The ORS will bring the non-compliance issues and the issuance of the notice to the attention of the affiliated committees depending upon their areas of oversight as listed below:
The Level One – Notice of Non-Compliance will also be reported to Executive Radiation Safety Committee (ERSC).
Documentation of the recurrence of the same non-compliance issue(s) or any other egregious violation within 12 months of the issuance of a Level One - Notice of Non-Compliance may result in the issuance of a Level Two - Notice of Non-Compliance. This notice will be sent to the Permit Holder, their RSS and/or Lab Manager and their Department Chair informing them of the non-compliance issue(s) and of the potential for suspension of the permit or lock-out from the device.
The Chair of the appropriate affiliated committee, in consultation with the ERSC, will review the circumstances requiring the issuance of the Level Two Notice of Non-Compliance and may assign a member of the appropriate affiliated committee, or another appropriate designee, to meet with the Permit Holder to further assess the situation and to provide assistance to the Permit Holder in returning their group to full compliance.
The Permit Holder must provide a written response to the Chair of the appropriate affiliated committee in addition to the RSO, as to the reasons why the previous corrective action(s) was/were ineffective and what further corrective action(s) will be implemented to prevent recurrence. Documented retraining of all affected staff members may be required. Failure to respond within the stated time period (15 days from the date of issue) may escalate the notice to a Level Three.
The RSO will provide the Permit Holder’s formal response to the Chair of the appropriate affiliated committee, the ERSC, and the appointed designee (when applicable) for review. The details of the Level Two Notice of Non-Compliance will also be presented to the next appropriate affiliated committee and ERSC meetings. ERSC and appropriate affiliated committee meetings.
Documentation of the recurrence of the same non-compliance issue(s) or any other egregious violation within 12 months of the issuance of a Level Two Notice of Non-Compliance may result in the issuance of a Level Three Notice of Non-Compliance. This notice will be sent to the Permit Holder, RSS and/or Lab Manager, Department Chairperson, Associate Dean, and Dean of the respective school informing them of the continuing non-compliance issues. The Permit Holder’s permit may be suspended, or device locked-out, pending concurrence by the RSO and/or the ERSC and appropriate affiliated committee. During the suspension period, the Permit Holder will be instructed to appear before the ERSC to explain what corrective changes have been taken to enable the ORS to reactivate the permit.
In the event of significant disregard for safety by a Permit Holder or the Permit Holder’s associated group, the Permit Holder’s radiation use permit may be suspended, or device locked-out, immediately by the RSO. The resulting Notice of Non-Compliance Level will be commensurate with the observed issue of non-compliance. Should this occur, the Permit Holder will be required to appear before the appropriate affiliated committee and the ERSC before radiation use may resume.
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07-01-2018
