F-Tag in focus: F-431

Sonja Quale
Sonja Quale

In today's environment, long-term care providers face growing regulatory demands designed to improve the quality of care. In order to become preferred facilities, they must demonstrate their commitment to ensuring compliance, optimizing survey results and reducing risk.

To help, in this six-part series, I'll review some of the more challenging pharmacy-related F-Tags for centers and offer specific advice on how to avoid them. To start, we'll look at F-431.

F-431 requires that facilities:

  1. Establish a system for recording the receipt and disposition of all controlled drugs, and maintain and routinely reconcile an accounting of all controlled drugs.

  2. Label all drugs and biologicals according to currently accepted professional principles, and include appropriate accessory and cautionary instruction as well as the expiration date, when applicable.

  3. Store and lock all drugs and biologicals in compartments under proper temperature controls to which only authorized personnel have access

While F-431 is one of the simplest tags to avoid during a survey, it remains one of the most commonly cites. In fact, 21.9% of facilities in the last standard health survey were cited, according to CASPER.

To avoid being cited, facilities and their staffs can take several steps:

  • Instruct nurses to inspect labeling when receiving medications from the pharmacy to ensure proper storage. Remember: medications for internal use should be stored separately from those designated for topical or external use.

  • Store medications requiring refrigeration at a temperature of 36° F to 46° F. Be sure to check the thermometer in each refrigerator regularly and document the temperature in a log.

  • Report any damaged packaging or labeling to the pharmacy.

  • Train nursing staff to perform daily inspections of medication storage areas and to thoroughly inspect each medication prior to its administration to each resident. Nurses should also verify expiration dates when comparing the MAR to the product label during med pass to ensure patient safety.

  • Keep medication cards and rooms clean, organized and secured/locked when unattended by nursing.

  • Inspect the exterior labeling of emergency kits for the earliest expiration of kit contents. When items are removed, the label should be verified to include the expiration date prior to use and the kit re-secured.

  • Remove and properly discard discontinued or expired medications or return them, depending on pharmacy procedure.

  • Upon arrival of surveyors, nurses should conduct vigilant and immediate checks of storage areas and continue the checks every shift during the survey.

For additional assistance, PharMerica provides a number of resources to assist with medication storage compliance, including inspection forms, in-servicing and routine inspections by our team of nurse consultants to complement your internal QAPI process.

In my next post, I'll address F-428 and how best to avoid citations so you can better prepare today to succeed tomorrow.

Sonja Quale, Pharm.D., is the vice president and chief clinical officer at PharMerica Corporation.

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