CMS SOM App. A, Tag A-0502

locked when appropriate.

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

A secure area means that 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. For example, if medications are kept in a private

office, or other area where patients and visitors are not allowed without the supervision or

presence of a health care professional (for example, ambulatory infusion), they are considered

secure. Areas restricted to authorized personnel only would generally be considered “secure

areas.” If there is evidence of tampering or diversion, or if medication security otherwise

becomes a problem, the hospital is expected to evaluate its current medication control policies

and procedures, and implement the necessary systems and processes to ensure that the problem is

corrected, and that patient health and safety are maintained. (71 FR 68689)

All controlled substances must be locked. Hospitals are permitted flexibility in the storage of

non-controlled drugs and biologicals when delivering care to patients, and in the safeguarding of

drugs and biologicals to prevent tampering or diversion. An area in which staff are actively

providing care to patients or preparing to receive patients, i.e., setting up for procedures before

the arrival of a patient, 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.

Generally labor and delivery suites and critical care units are staffed and actively providing

patient care around the clock, and, therefore, considered secure. However, hospital policies and

procedures are expected to ensure that these areas are secure, with entry and exit limited to

appropriate staff, patients and visitors.

The operating room suite is considered secure when the suite is staffed and staff are actively

providing patient care. When the suite is not in use (e.g., weekends, holidays and after hours), it

would not be considered secure. A hospital may choose to lock the entire suite, lock non-mobile

carts containing drugs and biologicals, place mobile carts in a locked room, or otherwise lock

drugs and biologicals in a secure area. If an individual operating room is not in use, the hospital

is expected to lock non-mobile carts, and ensure mobile carts are in a locked room. (71 FR

68689)

This regulation gives hospitals the flexibility to integrate patient self-administration of non-controlled drugs and biologicals into their practices as appropriate. When a hospital allows a

patient to self-administer selected drugs and biologicals, the hospital authorizes the patient to

have access to these medications. This regulation is consistent with the current practice of

giving patients access at the bedside to urgently needed medications, such as nitroglycerine

tablets and inhalers. It supports the current practice of placing selected nonprescription

medications at the bedside for the patient’s use, such as lotions and creams, and rewetting eye

drops. Hospitals are expected to address patient self-administration of non-controlled drugs and

biologicals in their policies and procedures (see self-administration discussion at

§§482.23(c)(6)(i) and 482.23(c)(6)(ii)). This regulation supports hospital development, in

collaboration with the medical staff and the nursing and pharmacy departments, of formal patient

medication self-administration programs for select populations of patients, including hospital

policies and procedures necessary to ensure patient safety and security of medications. The

policies and procedures are expected to include measures to ensure the security of bedside drugs

and biologicals. They are also expected to address both the competence of the patient to self-administer drugs and biologicals as well as patient education regarding self-administration of

drugs and biologicals. (71 FR 68689)

Due to their mobility, mobile nursing medication carts, anesthesia carts, epidural carts and other

medication carts containing drugs or biologicals (hereafter, all referred to as “carts”) must be

locked in a secure area when not in use. Hospital policies and procedures are expected to

address the security and monitoring of carts, locked or unlocked, containing drugs and

biologicals in all patient care areas to ensure their safe storage and to ensure patient safety. (71

FR 68689)

Medication automated distribution units with security features, such as logon and password or

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

authorized personnel who are permitted access to the medications. Such units must be stored in

a secure area.

Survey Procedures §482.25(b)(2)(i)

• Review hospital policies and procedures governing the security of drugs and biologicals

to determine whether they provide for securing and locking as appropriate;

• Review hospital policies and procedures governing patient self-administration of drugs

and biologicals;

• Observe whether medications in various areas of the hospital are stored in a secure area,

and locked when appropriate. Are medication storage areas periodically inspected by

pharmacy staff to make sure medications are properly stored?

• Determine that 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;

• If patient self-administration of drugs and biologicals is permitted, interview patients and

staff to determine whether policies and procedures are implemented and effective.