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THE
ORCBS > Radiation
Safety
> Radiation
Safety Manual
>
 Sanctions
for Non-Compliance
Following the 1993
U.S. Nuclear Regulatory Commission inspection of MSU, the University
was directed to design and implement a plan for categorizing and responding
to instances of noncompliance with NRC regulations that are identified
in the inspections conducted by the ORCBS. This consisted of assigning
"severity levels" to violations, and levying sanctions for
laboratories found in noncompliance.
During inspections,
noncompliance with requirements may be identified. A report is sent
to the principal investigator following the survey, detailing the
results of the inspection, and explaining what corrective actions
are required within the radioisotope use area. If the problems are
corrected, no further actions will be required. If the problems
are not corrected, a Notice of Violation may be sent to the principal
investigator, and may require further corrective actions and/or
documentation.
Violations are
classified in five severity levels based on NRC definitions. The
most severe is a level I violation, which could result in a researcher
losing the privilege to use radioactive material, and the least
severe is a level V. If violations are found, actions that may be
taken are geared to these severity levels. A given instance of noncompliance
may result in multiple actions, depending on specific circumstances,
whether the incident is an isolated occurrence or is part of a repetitive
pattern, etc.
The severity
levels for violations are derived from NRC regulations and from
MSU's recent safety history. For example, proper labeling of radioisotope
work and storage areas, stock solutions and waste containers, has
been a long-running concern at the University, hence appears as
a relatively severe level III violation.
The Notice of
Violation is also intended to identify severity levels, assign sanctions
and document that instructions were given concerning violations
found. It is to be reviewed by the principal investigator, signed
and placed with the radiation safety records for the laboratory.
The sanction
system was activated during the last survey period of 1993. Due
to feed-back from researchers, changing regulatory issues and experience
gained in practice, the system may change to better reflect the
degree of severity for violations. This means that additional flexibility
may be added to some areas, while others may become more restrictive.
SEVERITY
LEVEL CATEGORIES FOR RADIATION SAFETY VIOLATIONS
Implemented
November, 1993
Severity Level
I: This is the highest severity level, and results from violations
which cause immediate risk or danger to safety, health, release to
the environment of reportable quantities, doses of substantial amounts
to humans, or place the NRC license in jeopardy (i.e., an incident
reportable to NRC).
Severity
Level II: Not as serious as Level I, but also presents any of
the above risks or threats to health, safety, the environment or
licenses.
Severity
Level III: A serious violation, but does not present immediate
risk to health, safety, the environment or the license.
Severity
Level IV: A violation, but not serious. Poses little risk to
health, safety, environment or license.
Severity
Level V: A minor violation; typically something in lesser technical
matters, such as record keeping errors of minor impact. Poses no
immediate risk to health, safety, environment or license, but is
a compliance issue which may lead to increased concerns or is a
minor technical violation.
Note: Any
violation, when seen repeatedly, may be escalated to a higher severity
level. Repeat violations can be interpreted as a disregard for safety
regulations and must be dealt with quickly and effectively to avoid
undue risks of exposure or jeopardization of the NRC broad license.
SANCTION
ACTIONS FOR NONCOMPLIANCES IN RADIATION SAFETY
Implemented
November, 1993
| Severity
Level |
Possible
Resulting Action |
| I - V |
Violations
noted on ORCBS surveys and sent to PI. All violations handled
this way. |
| I - V |
Written
corrections required of PI and maintained in laboratory record
books for review. |
| IV, V |
Health
physicist contacts principal investigator and discusses problem(s)
and correction. |
| I - V |
Require
that involved personnel attend safety class again. |
| I - V |
Increase
ORCBS surveillance. |
| I - V |
Increased
surveillance required of laboratory staff. |
| I - V |
Letter
to principal investigator from health physicist. |
| I, II |
Letter
to principal investigator from Radiation Safety Officer; response
is required in writing. |
| I-III |
Place restrictions
on individual(s) causing non-compliances. |
| I-III |
Suspend
shipments of radioactive materials to principal investigator. |
| I, II |
Require
principal investigator to appear before committee. |
| I, II |
Decrease
scope or limits of radioactive materials approval. |
| I, II |
Require
principal investigator to reapply for radioisotope use. |
| I, II |
Confiscate
radioactive materials in possession of principal investigator. |
| I |
Permanently
terminate approval to use radioactive materials. |
SEVERITY
LEVELS FOR VIOLATIONS FOUND IN
RADIATION SAFETY INSPECTIONS
November,
1993
| Severity
Level |
No. |
Compliance
Requirement |
| V |
1. |
NRC "Notice
To Employees" and "Licensing and Regulation Information"
are posted. |
| I - III |
2. |
Radioactive
materials are under the constant surveillance and immediate
control of licensee, or otherwise secured to prevent tampering
or unauthorized removal. |
| I - III |
3. |
Radiation
users are adequately trained for the functions performed. |
| I - III |
4. |
Surveyed
areas are free of contamination. |
| I - IV |
5. |
Laboratory
equipment is functional and is used correctly. |
| III - V |
6. |
Laboratory
radiation surveys are accurate and frequency is appropriate. |
| I - IV |
7. |
Food and
other consumable items are not present in the radioisotope and
chemical use/storage areas. |
| I - V |
8. |
Radioisotope
work and storage areas and equipment are labeled adequately. |
| I - IV |
9. |
Radioisotope
sources/stock solutions are labeled adequately. |
| I - III |
10. |
Radioactive
waste is manifested on both sides of the tag, secondary containment
for liquids. |
| I - V |
11. |
Shielding
is adequate (material, thickness, positioning). |
| I - V |
12. |
Dosimeters,
if assigned, and appropriate protective equipment are used during
radioisotope handling. |
| I - V |
13. |
Fume hoods
are used properly (sash setting, uncluttered, rated for radioisotope
use). |
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Safety Manual Table of Contents
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