Health inspection·October 15, 2020

F 0761 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Few Ensure drugs and biologicals used in the facility are labeled in accordance with currently accepted professional principles; and all drugs and biologicals must be stored in locked compartments, separately locked, compartments for controlled drugs. Based on observations, record review, and interviews the facility did not ensure that controlled substances schedule II-V were stored in permanently affixed compartments in one of two medication rooms sampled during the performance of the facility task of Medication Storage and Labeling. Findings included: On 10/14/2020 at 2:35 p.m., the unit manager (UM) for 100 and 200 hall accommodated the observation of the locked medication storage room located behind the nurse's station. The UM unlocked a drawer that contained an Emergency Drug Kit (EDK) that contained controlled substances scheduled II-V. Medications were in a small plastic box closed with plastic tie wraps. The plastic box was not permanently affixed and could be easily removed from the drawer. The UM then unlocked the refrigerator which contained an EDK that contained refrigerated medications not limited to Ativan 2 mg/ml (Lorazepam) (quantity 4) a schedule IV medication, and Lorazepam Intensol (quantity 1), a schedule IV medication. Medications were in a small plastic box closed with tie wraps that were not permanently affixed and could easily be removed from the refrigerator. The UM was not aware that schedule II-V medications must be stored in a permanently affixed compartment. On 10/14/2020 at 3:10 p.m., the Director of Nursing (DON) revealed that she also was unaware of the requirement for storage in a permanently affixed compartment for schedule II-V medications. She stated that she thought that if schedule II-V medications were stored behind two locks that was enough. A review of the facility policy titled Medication Storage In The Facility ID2: Controlled Substance Storage with a revised date of August 2014 revealed: B. Schedule [II-V] medications and other medications subject to abuse or diversion are stored in a permanently affixed, [double locked] compartment separate from all other medications or per state regulation C. Controlled-substances that require refrigeration are stored within a locked box within the refrigerator. This box must be attached to the inside of the refrigerator. On 10/15/2020 at 9:30 a.m., a telephone interview with the Consultant Pharmacist revealed that his opinion was that if the controlled substances were stored behind two locks in a separate container that was enough. When asked about refrigerated controlled substances, he stated that it has also been an issue and very difficult to comply with. He stated that traditionally what the facility was doing has been an accepted practice. He continued on to state, the way that facility is doing it meets the intent of the regulation. Page 1 of 2 105385 105385 10/15/2020 Royal Oak Nursing Center 37300 Royal Oak Lane Dade City, FL 33525

F 0761 Photographic evidence was obtained. Level of Harm - Minimal harm or potential for actual harm Residents Affected - Few 105385 Page 2 of 2