Violations of Safety Policies

Safety Policy Infractions and Incidents

1. Statement of intent.  The IRC takes MRI safety very seriously.  However, it generally must be understood that operating procedures in a research facility are fundamentally different from those established for clinical or clinical research facilities. Specifically, the continual infusion of new and experimental hardware and software can require continual modification of operating procedures and safety guidelines.  It is recognized that unexpected undesirable consequences can occur in such an environment.  While the present procedures attempt to minimize the possibility of such consequences, it is recognized that MRI-trained operators and staff may encounter such situations despite their best intentions. 

2. Definition of infraction and incident.  An infraction is any action that violates University of Texas, IRC, IRB, or IACUC policy, or an approved research protocol.  An incident is any occurrence or condition that results in an unsafe environment (regardless of outcome), damage to equipment, or injury to a human or animal.  “Close calls” and “near misses” qualify as incidents, and are to be treated accordingly.  Incidents may or may not be a direct result of an infraction, nevertheless, all incidents should be treated the same.

3. Responsibility to report.  In order to foster a safer and more effective research environment, the IRC requires all staff members and users who encounter unexpectedly unsafe conditions to report these to the IRC Operations Administrator, Medical Director, or Director so that remedial action can be implemented. 

4. Required action.  When infractions or incidents are observed or otherwise noted, it is the duty of all users to immediately stop experiments or procedures.  Such events must be reported to the IRC Operations Administrator and Medical Director using the IRC incident report form.

5.  Reporting and corrective action.  The Medical Director, Operations Administrator, or other designed person will immediately report incidents to the Director of the IRC.  Infractions shall be reported to the same within 48 hours.  Safety incidents will be evaluated by one or more members of the senior staff, the Director, the Medical Director, or the Safety Committee.  Generally, the response to infractions and incidents will be remedial – some action that reduces the likelihood of a recurrence.  However, if a safety violation is found to have occurred through willful action or negligence, punitive actions will be taken (e.g. the withdrawal of scanning privileges for a period of time).  Particularly egregious or multiple violations will lead to permanent loss of scanning privileges.  Safety incidents will be reported to the MR magnet manufacturer and FDA within the required time by the Operations Administrator or Director of the IRC facility, as called for by statutory and contractual requirements.