Md. Code Regs. 10.34.28.10

Current through Register Vol. 51, No. 12, June 14, 2024

Section 10.34.28.10 - Quality Assurance Program

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.

Md. Code Regs. 10.34.28.10