CMS Manual System - Louisiana Department of Health and Hospitals

The identification of any irregularities;
Reporting irregularities to the attending physician and the director of nursing; and
Action in response to irregularities reported.
Criteria for compliance
Compliance with 42 CFR 483.60(c)(1) and (2), F428, Medication Regimen Review
The facility is in compliance with this requirement if:
The pharmacist has performed a medication regimen review on each resident at least
once a month or more frequently depending upon the resident‘s condition and/or risks or
adverse consequence associated with the medication regimen;
The pharmacist has identified any existing irregularities;
The pharmacist has reported any identified irregularities to the director of nursing and
attending physician; and
The report of any irregularities has been acted upon.
If not, cite F428.
Noncompliance for F428
After completing the Investigative Protocol, analyze the data in order to determine whether or
not compliance with F428 exists. A determination of noncompliance with F428 does not require
a finding of harm to the resident. Noncompliance may include (but is not limited to) one or more
of the following:
The pharmacist failed to conduct an MRR at least monthly (or more frequently, as
indicated).
The pharmacist failed to identify or report the absence of or inadequate indications for
use of a medication, or a medication or medication combination with significant potential
for adverse consequences or medication interactions.
The pharmacist failed to identify or report medications in a resident‘s regimen that could
(as of the review date) be causing or associated with new, worsening, or progressive signs
and symptoms.
The pharmacist failed to identify and report the absence of any explanation as to why or
how the benefit of a medication(s) with potential for clinically significant adverse
consequences outweighs the risk.