Regulation .10 Quality Assurance Program.
Regulation .10 Quality Assurance Program.LinkCopy Citation
A.
The responsible pharmacist, in consultation with the health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19.713.6, Annotated Code of Maryland, shall develop, maintain, and review annually a quality assurance program regarding the automated medication system that addresses, at minimum:
(1)
A testing program which includes daily accuracy sampling that verifies the integrity of the system;
(2)
Investigation of medication errors related to the automated medication system, and remedial actions taken;
(3)
Review of discrepancies and transaction reports to identify patterns of inappropriate use and access;
(4)
Review of the overall functioning of the system2;
(5)
Security and access:
(6)
Preventative maintenance;
(7)
Sanitation;
(8)
Storage conditions;
(9)
Inventory of drugs;
(10)
Drug procurement, delivery, and receipt;
(11)
Record keeping;
(12)
Proper labeling procedures; and
(13)
Protocols in the event of a power outage or other situation in which the services of the system are interrupted, that include:
(a)
A plan for insuring continuity of pharmacy services to patients; and
(b)
A plan for system recovery.
B.
The responsible pharmacist, in consultation with the health care facility, a related institution as defined in Health-General Article, §19-301, Annotated Code of Maryland, or a medical facility owned and operated by a group model health maintenance organization as defined in Health-General Article, §19.713.6, Annotated Code of Maryland, shall develop, maintain, and review annually a quality assurance program regarding the remote or decentralized automated medication system that addresses, at a minimum, system override management to include:
(1)
A list of medications that can be overridden which is limited to starter doses; and
(2)
Review of system overrides to ensure appropriate utilization.