1. 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. (1) A testing program which includes daily accuracy sampling that verifies the integrity of the system;
   2. (2) Investigation of medication errors related to the automated medication system, and remedial actions taken;
   3. (3) Review of discrepancies and transaction reports to identify patterns of inappropriate use and access;
   4. (4) Review of the overall functioning of the system2;
   5. (5) Security and access:
   6. (6) Preventative maintenance;
   7. (7) Sanitation;
   8. (8) Storage conditions;
   9. (9) Inventory of drugs;
   10. (10) Drug procurement, delivery, and receipt;
   11. (11) Record keeping;
   12. (12) Proper labeling procedures; and

   13. (13) Protocols in the event of a power outage or other situation in which the services of the system are interrupted, that include:

       1. (a) A plan for insuring continuity of pharmacy services to patients; and
       2. (b) A plan for system recovery.

2. 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. (1) A list of medications that can be overridden which is limited to starter doses; and
   2. (2) Review of system overrides to ensure appropriate utilization.

Authority: Health Occupations Article, §§12-205(a) and 12-605, Annotated Code of Maryland

Effective date: August 5, 2002 (29:15 Md. R. 1142)

Chapter revised effective October 1, 2012 (39:7 Md. R. 493)