CFR > Title 42 - Public Health > CHAPTER I—PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER A—GENERAL PROVISIONS (parts 1 to 9) > PART 3—PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT > SUBPART D—Enforcement Program (§3.304 to §3.552) > 3.408—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.