CMS SOM App. A, Tag A-0503

Abuse Prevention and Control Act of 1970 must be kept locked within a secure area.

Interpretive Guidelines §482.25(b)(2)(ii)

All Schedule II, III, IV, and V drugs must be kept locked within a secure area. A secure area

means the drugs and biologicals are stored in a manner to prevent unmonitored access by

unauthorized individuals. Medication automated distribution units with logon and

password/biometric identification are considered to be locked, since they can only be accessed

by authorized personnel who are permitted access to Schedule II – V medications.

Mobile nursing medication carts, anesthesia carts, epidural carts and other medication carts

containing Schedule II, III, IV, and V drugs must be locked within a secure area.

Survey Procedures §482.25(b)(2)(ii)

• Determine whether there is a hospital policy and procedure that requires Schedule II, III,

IV, and V drugs to be kept in a locked storage area.

• Observe in various parts of the hospital whether Schedule II, III, IV and V drugs are

locked and stored in a secure area..

• Determine whether security features in automated medication distribution units are

implemented and actively maintained, e.g., that access authorizations are regularly

updated to reflect changes in personnel, assignments, etc.

• Interview staff to determine whether policies and procedures to restrict access to

authorized personnel are implemented and effective.