42 CFR §3.408

1. (a)The nature of the violation.
2. (b)The circumstances, including the consequences, of the violation, including:
   1. (1)The time period during which the violation(s) occurred; and
   2. (2)Whether the violation caused physical or financial harm or reputational damage;
3. (c)The degree of culpability of the respondent, including:
   1. (1)Whether the violation was intentional; and
   2. (2)Whether the violation was beyond the direct control of the respondent.
4. (d)Any history of prior compliance with the Patient Safety Act, including violations, by the respondent, including:
   1. (1)Whether the current violation is the same or similar to prior violation(s);
   2. (2)Whether and to what extent the respondent has attempted to correct previous violations;
   3. (3)How the respondent has responded to technical assistance from the Secretary provided in the context of a compliance effort; and
   4. (4)How the respondent has responded to prior complaints.
5. (e)The financial condition of the respondent, including:
   1. (1)Whether the respondent had financial difficulties that affected its ability to comply;
   2. (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. (3)The size of the respondent.
6. (f)Such other matters as justice may require.