Wisconsin Administrative Code › Department of Health Services › DHS 110-199 - Health › Chapter DHS 157 - Radiation Protection › Appendix R

Current through June 24, 2024
Examples of Severity Levels
The following examples of severity levels apply to licensees
				  or registrants and are neither exhaustive nor controlling. They reflect only
				  the seriousness of the violation and not the intent of the violator, the
				  history of the violator, the amount necessary to deter future violations, or
				  efforts to correct the violation.
A. Severity Level 1 - Most Significant Violations.
1. Exposure of a worker in excess of 250 mSv (25 rems) of
				  radiation to the whole body, or 1.50 Sv (150 rems) to the skin of the whole
				  body, or 3.75 Sv (375 rems) to the feet, ankles, hands, or forearms.
2. Annual whole body exposure in excess of 25 mSv (2.5 rems)
				  of radiation to a non-radiation worker or a radiation worker who is a
				  minor.
3. Release of radioactive material to an unrestricted area in
				  excess of 10 times the limits specified in this chapter.
4. Radiation levels, contamination levels, or releases that
				  exceed 10 times the limits specified in this chapter or the license.
5. Disposal of licensed material into a sanitary sewerage
				  system in quantities or concentrations which exceed 10 times the limits of s.
				  DHS
				  157.30(3).
6. Exposure of a worker in a restricted area to 10 times the
				  limits of s.
				  DHS
				  157.22(1).
7. A required system or equipment designed to prevent or
				  mitigate a serious safety event not being operable when actually required to
				  perform its designed function.
8. A material false statement in which the statement made is
				  deliberately false.
9. Action by management to discriminate against an employee
				  for attempting to communicate or for actually communicating with the department
				  to report a real or suspected violation of this chapter or license
				  condition.
10. Deliberate exposure of an individual except by or under
				  the supervision of an individual licensed to engage in the healing arts.
11. Refusing authorized department personnel access to
				  facilities, equipment or records necessary to conduct inspections or
				  investigations.
12. Possession of licensable quantities of radioactive
				  material without a license or loss of control of a source of radiation.
13. Falsification of records required by this chapter in
				  which the records were deliberately falsified by or with the knowledge of the
				  licensee or registrant.
14. Licensee or registrant failure to promptly respond to an
				  emergency that has actual or potential offsite consequences.
15. Operating a mammography facility without proper
				  certification.
B. Severity Level 2 - Very Significant Violations.
1. Single exposure of a worker in excess of 50 mSv of
				  radiation to the whole body, 300 mSv to the skin of the whole body, or 750 mSv
				  to the feet, ankles, hands or forearms.
2. Annual whole body exposure in excess of 50 mSv of
				  radiation to a non-radiation worker or radiation worker who is a minor.
3. Release of radioactive material to an unrestricted area in
				  excess of 5 times the limits of s.
				  DHS
				  157.23(2).
4. Radiation levels, contamination levels, or releases that
				  exceed 5 times the limits specified in this chapter.
5. Failure to immediately notify the department as required
				  by s.
				  DHS
				  157.32(1) and s.
				  DHS
				  157.32(2) (a) and (b).
6. Unauthorized disposal of licensed material in quantities
				  or concentrations in excess of 5 times the limits of s.
				  DHS
				  157.30(3).
7. Exposure of a worker in a restricted area in excess of 5
				  times the limits specified in s.
				  DHS
				  157.22.
8. A required system designed to prevent or mitigate a
				  serious safety event or unnecessary exposure is absent or inoperable.
9. Failure to obtain appropriate department approval before
				  moving to a new use or storage location.
10. A material false statement or a reporting failure
				  involving information which, had it been available to the department and
				  accurate at the time the information should have been submitted, would have
				  resulted in regulatory action or would likely have resulted in the department
				  seeking further information.
11. Radiation output on fluoroscopic devices which exceed 200
				  mGy per minute in high rate mode.
12. Failure to register sources of radiation as required by
				  this chapter.
13. Operating a mammography facility without qualified
				  personnel, under 21 CFR Part 900.
C. Severity Level 3 - Significant Violations.
1. Single exposure of a worker in excess of 30 mSv (3 rem) of
				  radiation to the whole body, or 75 mSv (7.5 rem) to the skin of the whole body,
				  or 187.5 mSv (18.75 rem) to the feet, ankles, hands or forearms.
2. A radiation level in an unrestricted area such that an
				  individual could receive greater than 1.0 mSv (100 millirem) in a one-hour
				  period or 5.0 mSv (500 millirem) in any 7 consecutive days.
3. Failure to notify the department immediately as required
				  by s.
				  DHS
				  157.32(2) (a) or failure to notify
				  the department within 24 hours as required by s.
				  DHS
				  157.32(2) (b).
4. Substantial potential for an exposure or release in excess
				  of the limits of this chapter, such as entry into high radiation areas without
				  performing an adequate survey or operation of a radiation device with a
				  nonfunctioning interlock system, if one is required.
5. Release of radioactive material to an unrestricted area in
				  excess of the limits of s.
				  DHS
				  157.23(2).
6. Unauthorized disposal of licensed material not covered in
				  severity levels I or II.
7. Exposure of a worker in restricted areas in excess of the
				  limits of s.
				  DHS
				  157.22(1).
8. Release for unrestricted use of radioactive material or
				  contaminated equipment which poses a potential for significant exposure to
				  members of the public, or which reflects a programmatic rather than isolated
				  weakness in the radiation safety program.
9. Cumulative worker exposure in excess of the regulatory
				  limits in this chapter when such exposure reflects a programmatic rather than
				  an isolated weakness in radiation protection.
10. Any noncompliance with posting, labeling, placarding,
				  shipping papers, packaging, loading, or other transportation requirements that
				  could result in the following:
a. Improper identification of the type, quantity, or form of
				  material.
b. Failure of the carrier or recipient to exercise adequate
				  controls.
c. Substantial potential for personnel exposure or
				  contamination.
d. Improper transfer of material.
11. Failure to control access to licensed materials as
				  specified by this chapter.
12. Possession or use by a licensee or registrant of a
				  unauthorized radiation machine or radioactive material in conducting registrant
				  or licensee activities.
13. Radiation levels, contamination levels or releases that
				  exceed the limits specified in the license.
14. Failure to use exposure reduction devices properly, such
				  as collimators, filtration or patient shielding.
15. Failure to hospitalize patients who have sealed source
				  implants or therapeutic quantities of radioactive material in accordance with
				  the license or license conditions.
D. Severity Level 4 - Violations.
1. Exposure in excess of the limits of s.
				  DHS
				  157.22(1) not constituting severity
				  I, II, or III violations.
2. A radiation level in an unrestricted area such that an
				  individual could receive greater than 0.02 mSv (2 millirems) in any one hour
				  period or 1.0 mSv (100 millirems) in any 7 consecutive days.
3. Failure to notify the department within 30 days as
				  required by s.
				  DHS
				  157.32(3).
4. Failure to make a follow-up written report to the
				  department as required by s.
				  DHS
				  157.32(1) (b) or s.
				  DHS
				  157.32(6).
5. Failure to conduct required leakage or contamination tests
				  or to use properly calibrated equipment.
6. Unless specified in a more severe category, changes in
				  procedures or other conditions of a license or certificate of registration of
				  which the department was not informed, such as change of address, change of
				  person in control or changes in the use of registered or licensed
				  devices.
7. Failure to maintain complete records and forms required by
				  this chapter.
8. Failure to report medical events as required in s.
				  DHS
				  157.72.
9. Failure to report a dose to a embryo, fetus or nursing
				  child as required by s.
				  DHS
				  157.72(2).
10. Fluoroscopic systems where the maximum table top skin
				  entrance exposure rate is 100 mGy (11.5 R) per minute having test values
				  greater than 140 mGy (16.1 R) per minute but less than 200 mGy (23 R) per
				  minute.
11. Radiographic systems in which it is possible to produce
				  x-rays with the timer in the zero or off position.
12. Radiation therapy systems in which the registrant fails
				  to maintain proper surveys, calibrations, spot checks or operating
				  procedures.
E. Severity Level 5 - Minor Violations.
1. Failure to maintain a current copy of this chapter and
				  current copies of active licenses or certificates of registration.
2. Failure to post notices required by this chapter.
3. Failure to report leaking sources as required by s.
				  DHS
				  157.72(3).
4. Other violations that have minor safety or environmental
				  significance.