Appendix A – Severity Categories

The following examples of severity levels 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) Health Physics. (a) Single exposure of a worker in excess of 25 rems of radiation to the whole body, 150 rems to the skin of the whole body, or 375 rems to the feet, ankles, hands or forearms; (b) Annual whole body exposure of a member of the public in excess of 2.5 rems of radiation; (c) Release of radioactive material to an unrestricted area in excess of ten times the limits of 105 CMR 120.253; (d) Disposal of licensed material in quantities or concentrations in excess of ten times the limits of 105 CMR 120.253; (e) Exposure of a worker in restricted areas of ten times the limits of 105 CMR 120.212. (2) Transportation. (a) Annual whole body radiation exposure of a member of the public in excess of 0.5 rems of radiation; or (b) Breach of package integrity resulting in surface contamination or external radiation levels in excess of ten times the Agency limits. (3) Materials Operations. (a) Radiation levels, contamination levels, or releases that exceed ten times the limits specified in the license; (b) A system designed to prevent or mitigate a serious safety event not being operable when actually required to perform its design function. (4) Miscellaneous Matters. (a) A Material False Statement (MFS) in which the statement made was deliberately false; (b) Falsification of records which the Agency requires be kept of significant information in which the records were deliberately falsified by or with the knowledge of management; or, (c) A knowing and intentional failure to provide any notice required by 105 CMR 120.000. (d) Possession of licensable quantities of radioactive material without a license, or loss of control of a source of radiation. (e) Refusing authorized Agency personnel access to facilities, records and/or equipment to conduct inspections or investigations. (5) Emergency Preparedness. In an emergency, licensee failure to promptly: (a) correctly identify the event; (b) make required notifications to responsible Federal, State, and local agencies; or (c) respond to the event (e.g., assess actual or potential offsite consequences, activate emergency response facilities, and augment shift staff). (B) Severity Level II -- Very Significant Violations. (1) Health Physics. (a) Single exposure of a worker in excess of 10 rems total effective dose equivalent, 30 rems to the lens of the eye or 100 rems to the skin of the whole body, or to the feet, ankles, hands or forearms or to any other organ or tissue; (b) Annual whole body exposure of a member of the public in excess of 0.5 rems of radiation; (c) Release of radioactive material to an unrestricted area in excess of five times the limits of 105 CMR 120.222; (d) Failure to make an immediate notification as required by 105 CMR 120.282(A), and (B); (e) Disposal of license material in quantities or concentrations in excess of five times the limits of 105 CMR 120.253; (f) Exposure of a worker in restricted areas in excess of five times the limits of 105 CMR 120.212. (g) 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. (h) A fluoroscopic x-ray system with a tabletop entrance exposure rate of greater than or equal to 25 R/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. (i) A fluoroscopic system such that the entire x-ray beam is not intercepted by the primary protective barrier; or, (j) Therapy systems which exhibit excessive leakage and/or inoperable door interlocks, shutters, timers, etc. (k) Therapy system, with improper operator/patient communication/observation. S))))))))))))))))))))))))))))Q In 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 severity 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 or deliberateness). The relative weight given to each of these factors will be dependent on the circumstances of the violation. (2) Transportation. (a) Breach of package integrity resulting in surface contamination or external radiation levels in excess of Agency requirements; (b) Surface contamination or external radiation levels in excess of five times Agency limits that did not result from a breach of package integrity; or, (c) Failure to make required initial notifications associated with Severity Level I or II violations. (3) Material Operations. (a) Radiation levels, contamination levels, or releases that exceed five times the limits specified in the license; or, (b) A system designed to prevent or mitigate a serious safety event being inoperable. (4) Miscellaneous Matters. (a) 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; (b) A MFS in which the false statement was made with careless disregard. (c) Deliberate falsification of records which the Agency requires be kept involving significant information; or, (d) A failure to provide the notice required. (e) Failure to register sources of radiation or services as required by 105 CMR 120.000. (f) Action by management to discriminate against an employee for attempting to communicate or for actually communicating with the Agency. (5) Emergency Preparedness. Licensee failure to meet or implement more than one emergency planning standard involving assessment or notification. (C) Severity Level III --- Significant Violations. (1) Health Physics. (a) A radiation exposure during any year of a worker in excess of 5 rems total effective dose equivalent, 15 rems to the lens of the eye, or 50 rems to the skin of the whole body or to the feet, ankles, hands or forearms, or to any other organ or tissue; (b) A radiation level in an unrestricted area such that an individual could receive greater than 100 millirem in a one hour period or 500 millirem in a seven consecutive days; (c) Failure to make a 24-hour notification as required by 105 CMR 120.281 or an immediate notification required by 105 CMR 120.282; (d) Substantial potential for an exposure or release in excess of 105 CMR 120.200, 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); (e) Release of radioactive material to an unrestricted area in excess of the limits of 105 CMR 120.222; (f) Improper disposal of licensed material not covered in Severity Level I or II; (g) Exposure of worker in restricted areas in excess of the limits of 105 CMR 120.212; (h) 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; (i) Cumulative worker exposure above regulatory limits when such cumulative exposure reflects a programmatic, rather than an isolated weakness in radiation protection; (j) Conduct of licensee activities by a technically unqualified person; (k) Significant failure to control licensed material; (l) Failure to use exposure reduction devices properly (e.g., collimators, filtration); (m) For a fluoroscopic system where the maximum allowable tabletop exposure rate is 5 R/min., test values of greater than or equal to 7 R/min. (uncorrected), but less than 25 R/min. Correspondingly, for a maximum allowable rate of 10 R/min., test values of greater than or equal to 14 R/min. (uncorrected) but less than 25 R/min. are included. (n) 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% of the SID when the equipment indicates that the beam axis is perpendicular to the plane of the image receptor. (o) 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 nine centimeters or which exhibit a minimum SSD less than 16 centimeters. (p) Dental radiographic systems in which it is possible to produce x-rays with the timer in the zero or off position. (q) Mammographic x-ray systems in which the edge of the x-ray field at the chest wall extends beyond the edges of the image receptor by more than 5% of the source to image receptor distance. (r) Therapy systems which fail to maintain proper surveys, calibrations, spot checks or operating procedures. (2) Transportation. (a) Breach of package integrity; (b) 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; (c) 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, (d) Failure to make required initial notification associated with Severity Level III violations. (3) Materials Operations. (a) Failure to control access to licensed materials for radiation purposes as specified by Agency requirements; (b) Possession or use of unauthorized equipment or materials in the conduct of licensee activities which degrades safety; (c) Use of radioactive material on humans where such use is not authorized; (d) Conduct of licensed activities by a technically unqualified person; (e) Radiation levels, contamination levels, or releases that exceed the limits specified in the license; or, (f) Medical therapeutic misadministrations. (g) Failure to obtain appropriate Agency approval before moving to a new use and/or storage location. (4) Miscellaneous Matters. (a) An MFS not amounting to a Severity Level I or II violation; or, (b) 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. (5) Emergency Preparedness. Violations of lesser severity than Severity Level II violations. (D) Severity Level IV -- Violations. (1) Health Physics. (a) Exposures in excess of the limits of 105 CMR 120.211 not constituting Severity Level I, II, or III violations; (b) A radiation level in an unrestricted area such that an individual could receive greater than two millirem in a one-hour period or 50 millirem in a year; (c) Failure to make a 30-day notification required by 105 CMR 120.283; (d) Failure to make a follow-up written report as required by 105 CMR 120.281, 120.287 and 120.750; or, (e) Any other matter that has more than minor safety or environmental significance. (f) A capacitor storage radiographic system such that the standby radiation is greater than 3.0 mR/hr, but less than 25 mR/hr. (g) Systems equipped with positive beam limiting devices which do not allow the field size to be reduced to a size less than that of the image receptor. (h) Systems equipped with positive beam limiting devices which do not provide for an automatic return to PBL from a reduced field size. (i) Mobile radiographic systems for which the minimum source to skin distance is less than 27.5 centimeters. (j) 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% of the SID. (2) Transportation. (a) Package selection of 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, (b) Other violations that have more than minor safety or environmental significance. (3) Material Operations. (a) 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; (b) Other violations that have more than minor safety or environmental significance; or, (c) Failure to report medical diagnostic misadministrations. (4) Miscellaneous Matters. (a) 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. (b) 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, (5) Emergency Preparedness. Violations of lesser severity than Severity Level III violations.