§3.408. Factors considered in determining the amount of a civil money penalty.
42 C.F.R. § 3.408
In determining the amount of any civil money penalty, the Secretary may consider as aggravating or mitigating factors, as appropriate, any of the following:
The nature of the violation.
The circumstances, including the consequences, of the violation, including—
The time period during which the violation(s) occurred; and
Whether the violation caused physical or financial harm or reputational damage;
The degree of culpability of the respondent, including—
Whether the violation was intentional; and
Whether the violation was beyond the direct control of the respondent.
Any history of prior compliance with the Patient Safety Act, including violations, by the respondent, including:
Whether the current violation is the same or similar to prior violation(s);
Whether and to what extent the respondent has attempted to correct previous violations;
How the respondent has responded to technical assistance from the Secretary provided in the context of a compliance effort; and
How the respondent has responded to prior complaints.
The financial condition of the respondent, including—
Whether the respondent had financial difficulties that affected its ability to comply;
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
The size of the respondent.
Such other matters as justice may require.
Notes, amendments, and revision history
Authority
Authority: 42 U.S.C. 216, 299b-21 through 299b-26; 42 U.S.C. 299c-6.
Source
Source: 73 FR 70796, Nov. 21, 2008, unless otherwise noted.