Md. Code Regs. 10.34.28.11

Current through Register Vol. 51, No. 24, December 2, 2024

Section 10.34.28.11 - Record Keeping

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.

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

(1) Maintenance records and service logs;

(2) System failure reports;

(3) Documentation of patient outcomes resulting from system failures;

(4) Accuracy audits and system performance audits;

(5) Copies of reports and analyses generated as part of the quality assurance program, including daily accuracy sampling;

(6) Reports or databases related to level of access and changes in the level of access to the system;

(7) Training records including:

(a) Contents of the training program;

(b) Dates of training completion; and

(c) The identity of those attending the training program;

(8) Records of destruction of medication waste removed from the system, to include an independent witness signature; and

(9) Transaction information as follows:

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

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

(i) Identity of the particular automated medication system accessed;

(ii) Identification of the individual accessing the system;

(iii) Date of transaction;

(iv) Name, strength, dosage form, and quantity of drug accessed; and

(v) Name of the patient for whom the drug was accessed; and

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

(i) Date;

(ii) Name, strength, dosage form, and quantity of drug stocked or removed; and

(iii) Name, initials, or identification code of the individual stocking or removing drugs from the system.

Md. Code Regs. 10.34.28.11