105 CMR, § 120.019 - 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)1 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.
1 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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.