Q:
What are the most common reasons for the citing of F761 – Storage of Drugs and Biologicals?
A:
In Appendix PP the regulatory guidance for F761 is as follows:
§483.45(g) Labeling of Drugs and Biologicals
Drugs and biologicals used in the facility must be labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions, and the expiration date when applicable.
§483.45(h) Storage of Drugs and Biologicals
§483.45(h)(1) In accordance with State and Federal laws, the facility must store all drugs and biologicals in locked compartments under proper temperature controls and permit only authorized personnel to have access to the keys.
§483.45(h)(2) The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected.
The most common deficiencies seen under this F tag involve non-compliance with labeling, storage and access to medications including:
- Medication carts or medication rooms left unlocked when not in direct supervision.
- Failure to date multi-use medications upon opening to indicate the expiration time frame.
- Temperatures in the medication storage location that are not within the required medication manufacturers recommendations, for example medication room temperatures that are too hot or medication refrigerator temperatures that are too hot or too cold.
- Controlled medications in the medication refrigerator that are not in a “permanently affixed compartment”, such as a small metal box which can be removed and carried away from the refrigerator.
- Medications found at the resident’s bedside. This could be medications that were administered but not immediately taken by the resident, or medications stored at bedside for resident use when there is no Medication Self-Administration assessment and/or no order to keep at bedside.
- Medications that are not stored separately by route, i.e., rectal medications in with oral medications or nasal sprays stored with eye drops.
- Emergency drug kit/cart supplies that have expired.
Best practices to reduce the risk of citations for F761 include:
- Using the CMS Critical Element Pathway #20089 Medication Storage or another medication storage auditing tool to inspect the med rooms/carts at a minimum of monthly.
- Frequent re-education of medication administration staff on labeling of multi-use medications and locking of the med rooms/carts when not in direct supervision.
- Observations for locking of med rooms and carts during weekly compliance rounds.
- Medication room and cart inspections performed by the pharmacy consultant staff during their visits. Daily vigilance of medication practices is essential in protecting resident safety and preventing survey deficiencies.
Take Action! Join us for the June 10th Label/Store Drugs and Biologicals Survey Smart webinar series for more insights to help reduce your risk for F761 citations.
Written By:
Janine Lehman, RN, RAC-CT, CLNC
Director of Legal Nurse Consulting
Proactive LTC Consulting
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