# COMAR Title 10 — Maryland Department of Health

## Subtitle 34 — Board of Pharmacy

### Chapter 28 — Automated Medication Systems

#### Regulation .10 Quality Assurance Program.

*COMAR 10.34.28.10*

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.