Section R12-1-1213. Severity Levels of Violations

A.      The following violations are classified as severity level I viola- tions:

1.        Any failure, malfunction, or insufficiency of a safety sys- tem which may result in

a.         Radiation exposure to a person,

b.        A concentration of radionuclides; or

c.         A radiation level,in excess of 10 times the limits specified in 12 A.A.C.1, or 10 times the prescribed therapeutic patient dose.

2.        Any inaccurate or incomplete information that is inten- tionally provided by a licensee or registrant official, and if the information had been complete and accurate at the

time it was provided, would have likely resulted in action such as an immediate order required to protect the public health and safety.

3.        Any information that the Agency requires be kept by a licensee or  registrant that is incomplete or  inaccurate because of falsification by or with the knowledge of a licensee or registrant official, and if the information had been complete and accurate at the time it was reviewed by the Agency, would have likely resulted in action such as an immediate order required to protect the public health and safety.

4.        Any concealment or attempted concealment of a severity level I violation of the Act, 12 A.A.C. 1, or a license con- dition. This is a separate violation in addition to the origi- nal violation.

5.        Any concealment or attempted concealment of a severity level II violation of the Act, 12 A.A.C. 1, or a license condition. This violation shall increase the severity level of the original violation by one level.

6.        For the purposes of subsections (A)(2) and (3) above the term “licensee or registrant official” means the owner, a partner, a corporate officer, a radiation safety officer, the individual signing an application for a license or registra- tion, or the chairman of any radiation safety committee supervising the radiation safety program of the licensee or registrant.

B.       The following violations are classified as severity level II vio- lations:

1.        Any failure, malfunction, or insufficiency of a safety sys- tem which may result in:

a.         Radiation exposure to a person,

b.        A concentration of radionuclides, or

c.         A radiation level,in excess of two times the limits specified in 12 A.A.C. 1, or two times the prescribed therapeutic patient dose.

2.        Any attempt to prevent an Agency inspection.

3.        Any concealment or attempted concealment of a severity level III violation of the Act, 12 A.A.C. 1, or a license condition by a licensee or registrant official as defined in subsection (A)(6). This violation shall increase the sever- ity level of the original violation by one level.

4.        Significant information  provided and designated by a licensee or registrant and not previously provided to the Agency because of careless disregard on the part of a licensee official or registrant.

C.      The following violations are classified as severity level III vio- lations:

1.        Any failure, malfunction, or insufficiency of a safety sys- tem, or loss of control over a radiation source, which may result in:

a.         Radiation exposure to a person,

b.        A concentration of radionuclides, or

c.         A radiation level in excess of the limits specified in 12 A.A.C. 1, or 20% higher than the prescribed ther- apeutic patient dose.

2.        Any concealment or attempted concealment of a severity level IV or V violation of the Act, 12 A.A.C. 1, or a regis- tration or license condition. This violation shall increase the severity level of the original violation by one level.

3.        Any violation of the safety requirements for the use, stor- age, disposal, or the preparation for transportation of sources of radiation, as prescribed in the Act, 12 A.A.C. 1, or in a license or registration condition, provided the violation does not meet the criteria for a severity level I or II violation and the licensee or registrant does not main-

tain a radiation protection program meeting the require- ments of R12-1-407.

4.        Any factually incorrect statement upon which the Agency relied or would have relied in consideration of any action.

5.        Any unlawful attempt to interfere with the progress of an inspection by the Agency.

6.        The acquisition of any source of radiation without the applicable current registration or license, unless other- wise authorized by these rules; or use of the source out- side the scope of the current registration or license.

7.        The continued use of sources of radiation after April 1, if the annual fee has not been paid for the current year.

D.      The following violations are classified as severity level IV vio- lations:

1.        Any violation of R12-1-407;

2.        Any violation of the safety requirements for the use, stor- age, disposal, or preparation for transportation of sources of radiation, prescribed in the Act, 12 A.A.C. 1, or in a license or registration condition, provided the violation does not meet the criteria for a severity level I, II or III violation;

3.        Failure to maintain records of mammography quality control tests required in R12-1-614.

4.        Any failure to comply with the reporting requirements in the Act or 12 A.A.C. 1.

E.       The following violations are classified as severity level V vio- lations:

1.        Failure of a registrant or a licensee to comply with the recordkeeping requirements of:

a.         The Act;

b.        12 A.A.C. 1; or

c.         A registration or facility certification, or license con- dition, provided that  all safety  requirements pre- scribed in the Act, 12 A.A.C. 1, or in a license or registration condition are met or otherwise demon- strated.

2.        If compliance with all safety requirements cannot be demonstrated by the registrant or licensee the failure to comply with the recordkeeping requirements is classified as a level IV violation.

Historical Note

Adopted effective January 2, 1996 (Supp. 96-1).

Amended by final rulemaking at 5 A.A.R. 1817, effective May 12, 1999 (Supp. 99-2). Amended by final rulemak-

ing at 9 A.A.R. 4302, effective November 14, 2003

(Supp. 03-3).