Section 3.408 - Factors considered in determining the amount of a civil money penaltyIn 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.