CMS SOM App. A, Tag A-0504

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

The hospital must assure that only authorized personnel may have access to locked areas where

drugs and biologicals are stored.

A hospital has the flexibility to define which personnel have access to locked areas, based on the

hospital’s needs as well as State and local law. For example, a hospital could include within its

definition of “authorized personnel” ancillary support personnel, such as engineering,

housekeeping staff, orderlies and security personnel as necessary to perform their assigned

duties. The hospital’s policies and procedures must specifically address how “authorized

personnel” are defined for purposes of this section. It is not necessary for the policy to name

specific authorized individuals, but the policy should be clear in describing the categories of

personnel who have authorized access, as well as whether there are different levels of access

authorized in different areas of the hospital, or at different times of day, or for different classes of

drugs and biologicals, etc.

The hospital’s policies and procedures must also address how it prevents unauthorized personnel

from gaining access to locked areas where drugs and biologicals are stored. Whenever

unauthorized personnel have access, or could gain access, to those locked areas, the hospital is

not in compliance with this requirement and is expected to re-evaluate and tighten its security

measures.

Survey Procedures §482.25(b)(2)(iii)

• Determine whether there is a hospital policy and procedure defining authorized personnel

that are permitted access to locked areas where drugs and biologicals are stored.

• Determine whether there is a hospital policy and procedure for limiting access to locked

storage areas to authorized personnel only.

• Observe whether or not access to locked storage areas is limited to personnel authorized by

the hospital’s policy.