Health inspection·July 29, 2021

F 0761 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Many 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. **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview and record review, the facility failed to monitor medication storage refrigerators on a daily bases and maintain the refrigerator temperature at the recommended temperature of 36 to 46 degree Fahrenheit (F). The facility also failed to monitor and expose of 13 expired Insyte Autoguards (used to start intravenous lines) that were located in the Intravenous (IV) cart. This had the potential to affect 13 residents (Resident #1, #2, #5, #20, #25, #32, #42, #45, #47, #50, #207, #258, and #261) of 13 residents reviewed for medication storage, with the potential to affect all 53 residents in the facility. Findings include: 1. Observation on [DATE] at 8:30 A.M. of the medication storage room with the Director of Nursing (DON) revealed one medication storage refrigerator was located in the medication storage room. The forms titled, Temperature log for [DATE], [DATE], [DATE] and [DATE] were located on the door of the refrigerator. Interview with the DON at this time verified the temperature log had documentation of the internal temperature of the refrigerator. The DON revealed the nurses should monitor the internal temperature of the refrigerator daily to assure the medications are stored within the recommended range. Record Review of the Temperature Log for [DATE] revealed the temperature was monitored for only two dates. Record review of the Temperature Log for [DATE], revealed the temperature was monitored for 17 dates. The temperature ranged 35 to 40 degrees F. Record review revealed on [DATE], [DATE], and [DATE] the refrigerator temperature was 35 degrees F. Record review of the Temperature Log for [DATE], revealed the temperature was monitored for 11 dates. The temperature ranged 35 to 40 degrees F. On [DATE] and [DATE], the temperature was 35 degrees F. Record review of the Temperature Log from [DATE] through [DATE] revealed nine temperatures were documented for the internal temperature of the refrigerator which ranged 35 to 40 degrees F. The last temperature documented was [DATE]. On [DATE], the temperature was documented to be 35 degrees F. Observation on [DATE] at 8:15 A.M. with the DON revealed the medication storage refrigerator was 30 to 31 degrees F. Medications stored in the medication storage refrigerator included: Page 1 of 2 365428 365428 07/29/2021 Sanctuary Wadsworth 365 Johnson Rd Wadsworth, OH 44281

F 0761 1. One locked narcotic box. Level of Harm - Minimal harm or potential for actual harm 2. 46 insulin vials of insulin (NovoLog, Lantus, Novolin 70/30, Novolin R, and Lispro) belonging to 10 Residents (Resident #1, #2, #5, #20, #32, #42, #47, #50, #207, and #261). Residents Affected - Many 3. One vial of Tuberculin solution titled house stock. 4. One Avanox pen (used in treatment of multiple sclerosis) for Resident #45. 5. Gabapentin solution for Resident #258. 6. Granix injection (a leukocyte growth factor for the reduction in the duration of severe neutropenia), eight boxes, for Resident #25. Observation on [DATE] at 9:05 A.M. with the DON confirmed the internal temperature of the medication storage refrigerator was 30 to 31 degrees F. DON confirmed the lack of temperature monitoring through April, May, June, and [DATE]. Record review of the medication inserts, located under storage for NovoLog, Lantus, Novolin 70/30, Novolin R, Lispro, Tuberculin solution, Avanox pen, Gabapentin solution, and Granix injection revealed medications were to be stored between 36 and 46 degrees F, do not freeze. Interview on [DATE] at 10:35 A.M. with the facility Pharmacy Director #401 revealed he had spoke with the DON in the past and told her the medication refrigerator temperatures must be monitored daily. Interview on [DATE] at 2:15 P.M. with the facility Pharmacy Consultant revealed if the stated medications, NovoLog, Lantus, Novolin 70/30, Novolin R, Lispro, Tuberculin solution, Avanox pen, Gabapentin solution, and Granix injections, are stored below the recommended storage temperature, the potency of the medication may deteriorate or be less effective. Interview on [DATE] at 3:30 P.M. with DON confirmed she received a Pharmacy Recommendation form the Facility Pharmacy on [DATE] stating refrigerator temperatures were to be monitored daily. Record review titled, Medication Storage dated 2007 revealed medications requiring refrigeration or temperatures between 36 F and 46 F are kept in a refrigerator with a thermometer to allow temperature monitoring. 2. Observation on [DATE] at 8:50 A.M. with DON revealed the Intravenous (IV) cart was located in the medication storage room. DON revealed there was only one IV cart for the facility, and all IV supplies were stored in the IV cart. Observation revealed, in the top drawer of the IV cart was 34 Insyte Autoguard BC 22 gauge. Observation revealed, and DON confirmed 13 of the 34 Insyte Autoguard BC 22 gauge expired on [DATE]. Interview ON [DATE] at 9:00 A.M. with DON revealed the pharmacy consultant audits the IV cart monthly and the expired items should have been removed. 365428 Page 2 of 2