Ariz. Admin. Code § 9-7-1213

Current through Register Vol. 30, No. 50, December 13, 2024

Section R9-7-1213 - Severity Levels of Violations

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

1. Any failure, malfunction, or insufficiency of a safety system 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 9 A.A.C. 7, or 10 times the prescribed therapeutic patient dose.

2. Any inaccurate or incomplete information that is intentionally 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 Department 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 Department, 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, 9 A.A.C. 7, or a license condition. This is a separate violation in addition to the original violation.

5. Any concealment or attempted concealment of a severity level II violation of the Act, 9 A.A.C. 7, 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 registration, 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 violations:

1. Any failure, malfunction, or insufficiency of a safety system 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 9 A.A.C. 7, or two times the prescribed therapeutic patient dose.

2. Any attempt to prevent a Department inspection.

3. Any concealment or attempted concealment of a severity level III violation of the Act, 9 A.A.C. 7, or a license condition by a licensee or registrant official as defined in subsection (A)(6). This violation shall increase the severity 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 Department because of careless disregard on the part of a licensee official or registrant.

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

1. Any failure, malfunction, or insufficiency of a safety system, 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 9 A.A.C. 7, or 20% higher than the prescribed therapeutic patient dose.

2. Any concealment or attempted concealment of a severity level IV or V violation of the Act, 9 A.A.C. 7, or a registration 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, storage, disposal, or the preparation for transportation of sources of radiation, as prescribed in the Act, 9 A.A.C. 7, 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 maintain a radiation protection program meeting the requirements of R9-7-407.

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

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

6. The acquisition of any source of radiation without the applicable current registration or license, unless otherwise authorized by these rules; or use of the source outside 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 violations:

1. Any violation of R9-7-407;

2. Any violation of the safety requirements for the use, storage, disposal, or preparation for transportation of sources of radiation, prescribed in the Act, 9 A.A.C. 7, 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 R9-7-614.

4. Any failure to comply with the reporting requirements in the Act or 9 A.A.C. 7.

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

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

a. The Act;

b. 9 A.A.C. 7; or

c. A registration or facility certification, or license condition, provided that all safety requirements prescribed in the Act, 9 A.A.C. 7, or in a license or registration condition are met or otherwise demonstrated.

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.

Ariz. Admin. Code § R9-7-1213

New Section R9-7-1213 recodified from R12-1-1213 at 24 A.A.R. 813, effective March 22, 2018 (Supp. 18-1).