Regulation .11 Record Keeping.
Regulation .11 Record Keeping.LinkCopy Citation
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.