Our consultant teams are observing medication rooms and other storage areas that may be accessible to unauthorized individuals. Specifically, medication rooms, which may be locked, are also accessible to EVS staff, Facilities maintenance teams, and Materials Management staff delivering non-pharmaceutical supplies.
These rooms often have medications accessible in unlocked cabinets. Organizations are not able to articulate how these medications are protected from tampering or pilfering. Per Centers for Medicare and Medicaid Services (CMS) State Operations Manual (SOM) – Hospitals, under §482.25(b)(2)(i) – All drugs and biologicalsmust be kept in a secure area, and locked when appropriate.
This means that a secure area is where drugs and biologicals are stored in a manner to prevent unmonitored access by unauthorized individuals. Drugs and biologicals must not be stored in areas that are readily accessible to unauthorized persons. All controlled medications must be locked; however, organizations are allowed a degree of flexibility with the storage of non-controlled drugs and biological agents. An area where staff are actively providing care to patients or preparing to receive patients, such as setting up for a procedure before a patient’s arrival, would generally be considered a secure area.
When a patient care area is not staffed, both controlled and non- controlled substances are expected to be locked up. Organizations should review the interpretive guidelines in the SOM under §482.25(b)(2)(i). It provides additional examples for consideration. Additionally, organizations should risk-assess their medication storage practices to identify security vulnerabilities and address them through policy and procedures.
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