10-144-220 Me. Code R. § B-A-4

Current through 2024-51, December 18, 2024
Section 144-220-B-A-4 - Severity Level IV - Violations
A. Health Physics
1. Exposures in excess of the limits of Part D. not constituting Severity Level I, II, or III violations;
2. A radiation level in an unrestricted area such that an individual could receive greater than 2 millirem (20 µSv) in a one-hour period or 100 millirem (1 mSv) in any seven consecutive days;
3. Failure to make a 30-day notification required by Part D.2202;
4. Failure to make a follow-up written report as required by Parts D.2201, D.2203, and J.4; or
5. Any other matter that has more than minor safety or environmental significance.
6. A capacitor storage radiographic system such that the standby radiation is greater than 3.0 mR/hr (30 µGy/hr), but less than 25 mR/hr (250 µGy/hr).
7. Systems equipped with positive beam limitation devices which do not allow the field size to be reduced to a size less than that of the image receptor.
8. Systems equipped with positive beam limiting devices which do not provide for an automatic return to PBL from a reduced field size.
9. Mobile radiographic systems for which the minimum source to skin distance is less than 27.5 centimeters.
10. Mammographic systems manufactured after October 1977 for which the edges of the x-ray field on the right or left sides extend beyond the edges of the image receptor. If manufactured prior to November 1977 and the edges of the x-ray field on either side extend beyond the edge of the image receptor by more than 5 percent of the SID.
B. Transportation
1. Package selection or preparation requirements which do not result in a breach of package integrity or surface contamination or external radiation levels in excess of Agency requirements; or
2. Other violations that have more than minor safety or environmental significance.
C. Material Operations
1. Failure to maintain patients hospitalized who have cobalt-60, cesium-137, or iridium-192 implants or to conduct required leakage or contamination tests, or to use properly calibrated equipment;
2. Other violations that have more than minor safety or environmental significance; or
3. Failure to report diagnostic medical event.
D. Miscellaneous Matters
1. A false statement caused by an inadvertent clerical or similar error involving information which, had it been available to the Agency and accurate at the time the information should have been submitted, would probably not have resulted in regulatory action or the Agency seeking additional information.
2. Unless specified in a more severe category, changes in procedures or other conditions of a license or certificate of registration of which the Agency was not informed (e.g., change of address, expiration of certificate of registration); or
E. Emergency Preparedness
1. Violations of lesser severity than Severity Level III violations.

10-144 C.M.R. ch. 220, § B-A-4