Current through Register Vol. 51, No. 19, September 20, 2024
A. A pharmacy permit holder shall establish
and maintain an ongoing quality assurance program to:
(1) Identify, investigate, and promote the
prevention of medication errors; and
(2) Establish protocols and procedures to
minimize the potential for medication errors.
B. The ongoing quality assurance program
shall include the records, proceedings, files, and any other documents of the
ongoing quality assurance program, including for each medication error:
(1) The date of the error;
(2) A brief description of the
error;
(3) The results of the
evaluation by the ongoing quality assurance program's investigation;
and
(4) Remedial action taken or
recommendations.
C.
Periodic Review.
(1) A pharmacy permit holder
shall analyze the records, proceedings, files, and any other documents of the
ongoing quality assurance program required under §B of this regulation,
including any medication errors relating to automated medication systems or
unlicensed personnel, at least every 3 months as part of the periodic review
that is required to maintain an ongoing quality assurance program.
(2) Each pharmacy permit holder shall conduct
an analysis of its medication delivery system at least every 6 months to
determine which medications in the prescription area of the pharmacy are
high-alert medications, as part of the pharmacy's ongoing quality assurance
program.
D.
Documentation of Periodic Review. The records, proceedings, files, and any
other documents of the ongoing quality assurance program shall include for
each:
(1) Periodic review required under
§C(1) of this regulation:
(a)
Documentation of the periodic review;
(b) A description of the system's weaknesses
found during the periodic review; and
(c) A description of the actions taken to
remedy any weaknesses identified in the medication system; and
(2) Analysis of a pharmacy's
medication delivery system to identify high-alert medications required under
§C(2) of this regulation:
(a) A list of
high-alert medications present in the prescription area of the
pharmacy;
(b) The date that a
high-alert medication was added to or removed from the list of high-alert
medications;
(c) Dates that the
list was reviewed by the pharmacy permit holder; and
(d) Remedial actions taken based on the
review of the list of high-alert medications and any medication errors relating
to the high-alert medications.
E. Unless otherwise specified in law, the
permit holder shall maintain the ongoing quality assurance program records
referred to in this regulation for 2 years.
F. The proceedings, records, and files of an
ongoing quality assurance program that meets the requirements of Health
Occupations Article, §1-401, Annotated
Code of Maryland, and this chapter, are not discoverable and are not admissible
in evidence in any civil action, as provided in Health Occupations Article,
§1-401, Annotated
Code of Maryland.
