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.
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). 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.
