1. A. The permit holder and the responsible pharmacist shall maintain records regarding the automated medication system in a readily retrievable manner for at least 5 years.

2. B. The records referred to in §A of this regulation shall include:

   1. (1) Maintenance records and service logs;
   2. (2) System failure reports;
   3. (3) Documentation of patient outcomes resulting from system failures;
   4. (4) Accuracy audits and system performance audits;
   5. (5) Copies of reports and analyses generated as part of the quality assurance program, including daily accuracy sampling;
   6. (6) Reports or databases related to level of access and changes in the level of access to the system;

   7. (7) Training records including:

      1. (a) Contents of the training program;
      2. (b) Dates of training completion; and
      3. (c) The identity of those attending the training program;
   8. (8) Records of destruction of medication waste removed from the system, to include an independent witness signature; and

   9. (9) Transaction information as follows:

      1. (a) Transactions involving medications stored in or removed, dispensed, or distributed from the system;

      2. (b) Medications dispensed or distributed for a patient, which shall be recorded to include the:

         1. (i) Identity of the particular automated medication system accessed;
         2. (ii) Identification of the individual accessing the system;
         3. (iii) Date of transaction;
         4. (iv) Name, strength, dosage form, and quantity of drug accessed; and
         5. (v) Name of the patient for whom the drug was accessed; and

      3. (c) Records of stocking or removal of medications from an automated medication system, which shall include the:

         1. (i) Date;
         2. (ii) Name, strength, dosage form, and quantity of drug stocked or removed; and
         3. (iii) Name, initials, or identification code of the individual stocking or removing drugs from the system.

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)