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Based on observation, interview, and review of the United States Pharmacopoeia (USP) Chapter 797 and Chapter 795, when the hospital failed to provide an admixture log for sterile compounding to ensure correct beyond use dates (BUD). These failures had the potential to affect the quality of the medications administered to patients and the ability to track them for potential recalls for patients that received care at the hospital. The hospital census was one Acute Care Patient, five Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patients and zero Observation (Observation - outpatient services provided to a patient while the patient ' s physician decides whether to admit the patient to Acute Care services or to discharge the patient) patients for a total census of six.

Findings included:

Observation on 04/25/24 at 9:30 AM, in Sterile Compounding Room #1, showed Staff B, Pharmacy Technician, mixed 2 milliliter (ml, system of measurement for one thousandth of a liter) of thiamine with 100 cubic centimeter (cc, a system of measurement equal to ml) of normal saline (NS) without documenting the admixture on a log.

During an interview on 04/25/24 at 10:00 AM, Staff A, Pharmacist, stated they did not have a way to track the time of the admixtures and never logged the mixing times for immediate use compounding.

Review of the United States Pharmacopoeia (USP) Chapter 797 and Chapter 795 showed beyond-use date (BUD) is the date or time after which administration of a CSP shall not be initiated. As described in previous ASHP guidelines and in USP chapter 797, the BUD is determined from the date or time the preparation is compounded, its chemical stability, and the sterility limits described later in these guidelines. Both the stability of the components and the sterility limits described above must be taken into consideration when determining BUDs. Information regarding stability dating procedures and defaults can be found in USP chapter 795, Pharmaceutical Compounding. USP chapter 795 requirements for documentation showed all CSPs must have a compounding record to permit traceability of all components in case of recall or quality issues.