| (C) violation of, or failure to observe any of the terms and conditions of the Act, this chapter, or of the license, certificate of registration, or industrial radiographer certification or order of the agency; or (D) existing conditions that constitute a substantial threat to the public health or safety or the environment. (4) If another state or federal entity takes an action such as modification, revocation, or suspension of the license, certificate of registration, or industrial radiographer certification, the agency may take a similar action against the licensee, registrant, or certified industrial radiographer. (5) When the agency determines that the action provided for in paragraph (8) of this subsection or subsection (j) of this section is not to be taken immediately, the agency may offer the licensee, registrant, or certified industrial radiographer an opportunity to attend an informal conference to discuss the following with the agency: (A) methods and schedules for correcting the violation(s); or (B) methods and schedules for showing compliance with applicable provisions of the Act, the rules, license or registration conditions, or any orders of the agency. (6) Notice of any informal conference shall be delivered by personal service, or certified mail, addressed to the last known address. An informal conference is not a prerequisite for the action to be taken in accordance with paragraph (8) of this subsection or subsection (j) of this section. (7) Except in cases in which the occupational and public health, or safety requires otherwise, no license, certificate of registration, or industrial radiographer certification shall be modified, suspended, or revoked unless, prior to the institution of proceedings therefore, facts or conduct that may warrant such action shall have been called to the attention of the licensee, registrant, or certified industrial radiographer in writing, and the licensee, registrant, or certified industrial radiographer shall have been afforded an opportunity to demonstrate compliance with all lawful requirements. (8) When the agency contemplates modification, suspension, or revocation of the license, certificate of registration, or industrial radiographer certification, the licensee, registrant, or certified industrial radiographer shall be afforded the opportunity for a hearing. Notice of the contemplated action, along with a complaint, shall be given to the licensee, registrant, or certified industrial radiographer by personal service or certified mail, addressed to the last known address. (9) Any applicant, licensee, registrant, or certified industrial radiographer against whom the agency contemplates an action described in paragraph (8) of this subsection may request a hearing by submitting a written request to the director within 30 days of service of the notice. (A) The written request for a hearing must contain the following: (i) statement requesting a hearing; (ii) name, address, and identification number of the licensee, registrant, or certified industrial radiographer against whom the action is being taken. (B) Failure to submit a written request for a hearing within 30 days will render the agency action final. (j) Assessment of administrative penalties. (1) When the agency determines that monetary penalties are appropriate, proposals for assessment of and hearings on administrative penalties shall be made in accordance with the Act, §401.384, and applicable sections of the Formal Hearing Procedures, §§1.21, 1.23, 1.25, and 1.27 of this title. (2) Assessment of administrative penalties shall be based on the following criteria: (A) the seriousness of the violation(s); (B) previous compliance history; (C) the amount necessary to deter future violations; (D) efforts to correct the violation; and (E) any other mitigating or enhancing factors. (3) Application of administrative penalties. The agency may impose differing levels of penalties for different severity level violations and different classes of users as follows. (A) Administrative penalties may be imposed for severity level I and II violations. Administrative penalties may be imposed for severity level III, IV, and V violations when they are combined with those of higher severity level(s) or for repeated violations. (B) The following Tables IA and IB show the base administrative penalties. Attached Graphic (C) Adjustments to the percentages of base amounts in Table IB may be made for the presence or absence of the following factors: (i) prompt identification and reporting; (ii) corrective action to prevent recurrence; (iii) compliance history; (iv) prior notice of similar event; (v) multiple occurrences; and (vi) negligence that resulted in or increased adverse effects. (D) The penalty for each violation may be in an amount not to exceed $10,000 a day for a person who violates the Act or a rule, order, license or registration issued in accordance with the Act. Each day a violation continues may be considered a separate violation for purposes of penalty assessment. (4) The department may conduct settlement negotiations. (k) Severity levels of violations for licensees, registrants, certified industrial radiographers, or other persons. (1) Violations for licensees, registrants, certified industrial radiographers, or other persons shall be categorized by one of the following severity levels. (A) Severity level I are violations that are most significant and may have a significant negative impact on occupational and/or public health and safety or on the environment. Severity level I violations are most significant and may have a significant negative impact by increasing the risk of unauthorized use of radioactive material that would be detrimental to public health and safety. (B) Severity level II are violations that are very significant and may have a negative impact on occupational and/or public health and safety or on the environment. Severity level II violations are very significant and may have a negative impact by increasing the risk of unauthorized use of radioactive material that would be detrimental to public health and safety. (C) Severity level III are violations that are significant and which, if not corrected, could threaten occupational and/or public health and safety or the environment. Severity level III are significant and, if not corrected, could increase the risk of unauthorized use of radioactive material that would be detrimental to public health and safety. (D) Severity level IV are violations that are of more than minor significance, but if left uncorrected, could lead to more serious circumstances. (E) Severity level V are violations that are of minor safety or environmental significance. (2) Additional violations for mammography registrants. Violations for mammography registrants shall be categorized by one of the following severity levels. (A) Severity level I violations indicate a serious noncompliance that may adversely affect image quality or that may compromise the quality of mammography services. (B) Severity level II violations indicate key quality system requirements are being met, but there is a failure to meet one or more quality standards that may lead to a compromise of the quality of mammography services. (C) Severity level III violations indicate that the quality system requirements are being met, but minor corrective actions are required for compliance with the quality standards. (D) Severity level IV violations indicate that the quality system requirements and standards are being met, but minor corrective actions are required for compliance. (3) Criteria to elevate or reduce severity levels. (A) Severity levels may be elevated to a higher severity level for the following reasons: (i) more than one violation resulted from the same underlying cause; (ii) a violation contributed to or was the consequence of the underlying cause, such as a management breakdown or breakdown in the control of licensed or registered activities; (iii) a violation occurred multiple times between inspections; (iv) a violation was willful or grossly negligent; (v) compliance history; or (vi) other mitigating factors. (B) Severity levels may be reduced to a lower level for the following reasons: (i) the licensee/registrant identified and corrected the violation prior to the agency inspection; Cont'd... |
