10-144-220 Me. Code R. § B-A-3

Current through 2024-51, December 18, 2024

Section 144-220-B-A-3 - Severity Level III - Significant violations

A. Health Physics

1. Single exposure of a worker in excess of 3 rems (0.3 Sv) of radiation to the whole body, 7.5 rems (0.075 Sv) to the skin of the whole body, or 18.75 rems (0.1875 Sv) to the feet, ankles, hands or forearms;

2. A radiation level in an unrestricted area such that an individual could receive greater than 100 millirem (1 mSv) in a one hour period or 500 millirem (5 mSv) in any seven consecutive days;

3. Failure to make a 24-hour notification or an immediate notification as required by Part D.2202;

4. Substantial potential for an exposure or release in excess of Part D of these rules, whether or not such exposure or release occurs (e.g., entry into high radiation areas, such as under reactor vessels or in the vicinity of exposed radiographic sources, without having performed an adequate survey, operation of a radiation facility with a nonfunctioning interlock system);

5. Release of radioactive material to an unrestricted area in excess of the limits of Part D.1302;

6. Improper disposal of licensed material not covered in Severity Level I or II;

7. Exposure of worker in restricted areas in excess of the limits of Part D.1201.;

8. Release for unrestricted use of contaminated or radioactive material or equipment which poses a realistic potential for significant exposure to members of the public, or which reflects a programmatic (rather than isolated) weakness in the radiation control program;

9. Cumulative worker exposure above regulatory limits when such cumulative exposure reflects a programmatic, rather than an isolated weakness in radiation protection;

10. Conduct of licensee activities by a technically unqualified person;

11. Significant failure to control licensed material;

12. Failure to use exposure reduction devices properly (e.g., collimators, filtration);

13. For a fluoroscopic system where the maximum allowable tabletop exposure rate is 5 R/min (0.05 Gy/min), test values of greater than or equal to 7 R/min. (0.07 Gy/min) (uncorrected), but less than 25 R/min (0.25 Gy/min). Correspondingly, for a maximum allowable rate of 10 R/min (0.10 Gy/min) , test values of greater than or equal to 14 R/min (0.14 Gy/min) (uncorrected) but less than 25 R/min (0.25 Gy/min) are included;

14. A radiographic x-ray system having positive beam limitation where the x-ray field size in the plane of the image receptor, whether automatically or manually adjusted, is such that either the length or the width of the x-ray field differs from that of the image receptor by greater than 10 percent of the SID when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor.

15. Intraoral dental systems capable of operations in the above 50 kVp range for which the field size at the cone tip is greater than or equal to 9 centimeters or which exhibit a minimum SSD less than 16 centimeters.

16. Dental radiographic systems in which it is possible to produce x-rays with the timer in the zero or off position.

17. Mammographic x-ray systems in which the edge of the x-ray field at the chestwall extends beyond the edges of the image receptor by more than 5 percent of the source to image receptor distance.

18. Therapy systems which fail to maintain proper surveys, calibrations, spot checks or operating procedures.

B. Transportation

1. Breach of package integrity

2. Surface contamination or external radiation levels in excess of, but less than a factor of five above Agency requirements that did not result from a breach of package integrity;

3. Any noncompliance with labeling, placarding, shipping paper, packaging loading, or other requirements that could reasonably 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; or

(c) Substantial potential for personnel exposure or contamination, or improper transfer of material; or

4. Failure to make required initial notification associated with Severity Level III violations.

C. Materials Operations

1. Failure to control access to licensed materials for radiation purposes as specified by Agency requirements;

2. Possession or use of unauthorized equipment or materials in the conduct of licensee activities which degrades safety;

3. Use of radioactive material on humans where such use is not authorized;

4. Conduct of licensed activities by a technically unqualified person;

5. Radiation levels, contamination levels, or releases that exceed the limits specified in the license; or

6. Therapeutic medical event.

7. Failure to obtain appropriate Agency approval before moving to a new use and/or storage location.

D. Miscellaneous Matters

1. An MFS not amounting to a Severity Level I or II violation; or

2. Deliberate falsification, or falsification by or with the knowledge of management of records which the Agency requires be kept that did not involve signification information.

E. Emergency Preparedness.

1. Violations of lesser severity than Severity Level II violations.

10-144 C.M.R. ch. 220, § B-A-3