Compliance with Medication Storage

Over the last six months, there has been an increase in the number of deficiency citations related to medication storage in critical access hospitals (CAH). Proper medication storage is imperative to maintaining patient safety and compliance with HFAP and CMS requirements. A few examples of the citations noted expired medications, inadequate quantity of emergency medications (specifically Dantrolene), improper locking of emergency carts after use, and/or improper securing of emergency carts when a unit/department is closed. The following HFAP Standards address the safety and security of medication storage.

06.01.03 Security

Consistent with state and federal requirements, all drugs must be kept in a secure area and locked when appropriate to prevent unmonitored access by unauthorized individuals. When patient care areas are not staffed, all medications therein are expected to be secured. When a unit or service is closed due to low census or the end of the service day, the hospital may choose to lock the entire unit/suite, lock non-mobile carts, place mobile carts in a locked room, or lock mobile carts in another secured area. Hospital policies and procedures must address medication security to ensure safe storage of medications at all times.

06.01.09 Ensuring that outdated, mislabeled, or otherwise unusable drugs are not used for patient care

Hospitals must ensure safe medication management, including monitoring inventory for expired or otherwise unusable medications. Expired or unusable drugs and biologicals should never be available for patient use. The expiration date of the medication is set by the manufacturer and is based on stability testing as part of the FDA approval process.

Policies and procedures must address labeling requirements for each medication; define a process to ensure expired or “beyond-use” medications will not reach the patient; and list the types of medications and par level of medications to be available. In addition, policies and procedures should define how medications will be monitored for expiration dates and the process for disposal of expired medications.

While onsite, a Surveyor will interview department staff to see how mobile carts containing medication are secured. The Surveyor observes the process to ensure medications are secured and inaccessible to unauthorized staff, visitors, and patients both when the cart is not in use and post use. The Surveyor will look to see that the carts are checked on a daily basis for medication expiration dates and for the quantity of medication available.

Additionally, the Surveyor will review medication management policies and procedures and compare to them to observable practice. For example, following review of the malignant hyperthermia policy, the Surveyor may observe the malignant hyperthermia cart/box for medication availability, quantity, and expiration date(s) of medications. Specifically, the surveyor may want to verify that the quantity of Dantrolene vials matches nationally recognized guidelines and facility policy.

The Surveyor also may review inventory management logs for expired medications and observe the process for expired medication management.

2021 CAH manual effective June 11

As reported in the February issues of Did You Know?, HFAP Standards have been updated for 2021. New regulatory requirements for electronic notification of patient events appear in Accreditation Requirements for Critical Access Hospitals as Standard 07.01.04.

A link to the new manual has been sent to current HFAP-accredited critical access hospitals. If you did not receive yours, please contact your Account Advisor.

Want to learn more about HFAP CAH Hospital Accreditation?
Visit our Program & Services page.

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