Factors considered in determining the amount of a civil money penalty.

§ 3.408 Factors considered in determining the amount of a civil money penalty. In determining the amount of any civil money penalty, the Secretary may consider as aggravating or mitigating factors, as appropriate, any of the following: (a) The nature of the violation. (b) The circumstances, including the consequences, of the violation, including: (1) The time period during which the violation(s) occurred; and (2) Whether the violation caused physical or financial harm or reputational damage; (c) The degree of culpability of the respondent, including: (1) Whether the violation was intentional; and (2) Whether the violation was beyond the direct control of the respondent. (d) Any history of prior compliance with the Patient Safety Act, including violations, by the respondent, including: (1) Whether the current violation is the same or similar to prior violation(s); (2) Whether and to what extent the respondent has attempted to correct previous violations; (3) How the respondent has responded to technical assistance from the Secretary provided in the context of a compliance effort; and (4) How the respondent has responded to prior complaints. (e) The financial condition of the respondent, including: (1) Whether the respondent had financial difficulties that affected its ability to comply; (2) Whether the imposition of a civil money penalty would jeopardize the ability of the respondent to continue to provide health care or patient safety activities; and (3) The size of the respondent. (f) Such other matters as justice may require.