Section 144-220-B-A-2 - Severity Level II - Very Significant ViolationsA. Health Physics 1. Single exposure of a worker in excess of 5 rems (0.05 Sv) of radiation to the whole body, 30 rems (0.3 Sv) to the skin of the whole body or 75 rems (0.75 Sv) to the feet, ankles, hands or forearms;2. Annual whole body exposure of a member of the public in excess of 0.5 rems (0.005 Sv) of radiation;3. Release of radioactive material to an unrestricted area in excess of five times the limits of Part D.1302.;4. Failure to make an immediate notification as required by Parts D.2201 and D.2202;5. Disposal of license material in quantities or concentrations in excess of five times the limits of Part D.2001;6. Exposure of a worker in restricted areas in excess of five times the limits of Part D.1201;7. An x-ray system having a malfunction such that inadvertent exposures could occur e.g., a system such that when the exposure switch is activated, not one but repeated exposures occur, or the timer fails to terminate exposure, or exposure initiated without utilizing the exposure switch.8. A fluoroscopic x-ray system with a tabletop entrance exposure rate of greater than or equal to 25 R/min (0.25 Gy/min) at the point where the center of the useful beam enters the patient, except: (a) During recording of fluoroscopic images, or(b) When an optional high level control is activated.9. A fluoroscopic system such that the entire x-ray beam is not intercepted by the primary protective barrier, or10. Therapy systems which exhibit excessive leakage and/or inoperable door interlocks, shutters, timers, etc.11. Therapy system, with improper operator/patient communication/observation.B. Transportation 1. Breach of package integrity resulting in surface contamination or external radiation levels in excess of Agency requirements;2. Surface contamination or external radiation levels in excess of five times Agency limits that did not result from a breach of package integrity; or3. Failure to make required initial notifications associated with Severity Level I or II violations.C. Material Operations 1. Radiation levels, contamination levels, or releases that exceed five times the limits specified in the license; or2. A system designed to prevent or mitigate a serious safety event being inoperable.D. Miscellaneous Matters 1. A MFS or a reporting failure, involving information which, had it been available to the Agency and accurate at the time the information should have been submitted, would have resulted in regulatory action or would likely have resulted in the Agency seeking further information;2. A MFS made with careless disregard;3. Deliberate falsification of records which the Agency requires be kept involving significant information; or4. A failure to provide the notice required.5. Failure to register sources of radiation or services as required by these rules.6. Action by management to discriminate against an employee for attempting to communicate or for actually communicating with the Agency.E. Emergency Preparedness 1. Licensee failure to meet or implement more than one emergency planning standard involving assessment or notification.2In essence, a material false statement is a statement that is false by omission or commission and is relevant to the regulatory process. As can be seen in the examples, in determining the specific level of a violation involving material false statements or falsification of records, consideration will be given to such factors as the position of the person involved in the violation (e.g., first line supervisor or senior manager), the significance of the information involved, and the intent of the violator (i.e., negligence not amounting to careless disregard, careless disregard, or deliberateness. The relative weight given to each of these factors in arriving at the appropriate severity level will be dependent on the circumstances of the violation.
10-144 C.M.R. ch. 220, § B-A-2