Health inspection·October 11, 2023

F 0760 Ensure that residents are free from significant medication errors. Level of Harm - Actual harm **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** THE FOLLOWING DEFICIENCY REPRESENTS AN INCIDENT OF PAST NON-COMPLIANCE THAT WAS SUBSEQUENTLY CORRECTED PRIOR TO THIS SURVEY. Residents Affected - Few Based on medical record review, resident, family, and staff interview, pharmacy interview, review of pharmacy delivery manifest, review of facility policy, and review of hospital neurology notes, the facility failed to ensure Resident #01 was free of significant medication errors when Resident #01 had not received physician ordered anti-anxiety medication (Klonopin) for three days. Actual Harm occurred to Resident #01 when the facility failed to ensure medications were available for administration resulting in the resident experiencing a seizure attributed to medication withdrawal requiring hospitalization with additional testing, monitoring, and restarting of the ordered medication as a result of the medication error. This affected one (Resident #01) of three residents reviewed for medications. The facility census was 54. Findings include: Review of Resident #01's medical record revealed an admission date of 01/23/21 and a re-admission date of 02/02/21. Diagnoses included major depressive disorder, dementia, and anxiety disorder. Review of the quarterly Minimum Data Set (MDS) assessment dated [DATE] revealed Resident #01 was cognitively intact and received anti-anxiety medications seven of the seven days of the look-back period. Review of the plan of care, initiated 05/25/23, revealed Resident #01 used anti-anxiety medications. Interventions included to administer anti-anxiety medications as ordered by physician. Review of the physician orders revealed Resident #01 was prescribed Klonopin oral tablet 0.5 milligrams (mg) two times daily for anxiety. Review of the Medication Administration Record (MAR) from 09/01/23 through 09/30/23 revealed Klonopin 0.5 mg was documented as 9 on 09/08/23 evening dose, 09/09/23 morning dose, 09/10/23 evening dose, and 09/11/23 morning dose. Further review of the MAR revealed 9 indicated to see nurses notes. Review of the nursing progress notes revealed on 09/08/23, Klonopin was on order; on 09/09/23 the facility was waiting on delivery; on 09/10/23 awaiting supply; and 09/11/23, Klonopin was not available and waiting on pharmacy. Further review of the medical record from 09/08/23 through 09/11/23 revealed no evidence of communication with the physician or pharmacy regarding Klonopin being unavailable for administration to Page 1 of 4 366312 366312 10/11/2023 The Gardens of St. Francis 930 South Wynn Road Oregon, OH 43616

F 0760 Resident #01. Level of Harm - Actual harm Review of the nursing progress note dated 09/11/23 at 4:20 P.M. revealed Resident #01 was with her daughter in her room and the daughter stated she was shaking a little like she does and then all of a sudden her head went back and started shaking harder and foaming at the mouth. Daughter yelled for help and aide found writer. Resident #01 was in a safe position and was watched until it was over. Emergency 9-1-1 service was called and Resident #01 was transported to the hospital. Residents Affected - Few Review of a hospital neurology progress note, dated 09/12/23, revealed Resident #01 presented to the Emergency Department (ED) for complaints of seizure of two minutes, witnessed by family who described resident's eyes rolling back, followed by jerking, non-responsive, foaming at the mouth, while seated. Resident #01 had some facial twitching, jerking hand movements, stuttering, small seizure examined by bedside nurse that lasted five to ten seconds, and a incontinent episode. Resident #01 was brought to the hospital because of an apparent witnessed seizure. The description was of generalized convulsive activity lasting several minutes and she was confused afterwards. She had a normal Computed Tomography Scan (CT) of the brain. Per the history, she had been on Klonopin and was apparently off of this for three days. The impression was Resident #01 had a new onset seizure and given the available history, this was likely benzodiazepine (Klonopin is in this medication class) withdrawal. Anticonvulsant therapy was deferred and recommended the resident follow-up in the physician's office post-discharge. Review of a Pharmacy Delivery Manifest (PDM) revealed on 08/07/23, there were 60 - 0.5 mg clonazepam (Klonopin) tablets delivered to the facility for Resident #01. On 09/12/23, the next order of clonazepam was delivered to the facility for Resident #01. Interview on 10/11/23 at 8:15 A.M. with Resident #01 revealed she had a seizure and was in the hospital. Resident #01 stated Evidently for three days I could not get my pills and I had a seizure. That was kind of scary. Resident #01 stated she had no recollection of the seizure and had no prior history of seizures. Resident #01 confirmed she was currently receiving her medications as ordered and had no further concerns. Interview on 10/11/12 at 8:47 A.M. with Resident #01's family member revealed the facility did not have the resident's Klonopin for three days. The family member was visiting when Resident #01 had a seizure at the facility and was taken to the ED. The family member stated Resident #01 had no prior history of seizures and the hospital said the seizure was due to Klonopin withdrawal. Interview on 10/11/23 at 10:47 A.M. with the Director of Nursing (DON) verified the facility did not have Klonopin available for administration to Resident #01 from the evening dose on 09/08/23 through the morning dose on 09/11/23, for a total of six missed doses. Additionally, Resident #01 had a seizure the afternoon of 09/11/23 and was transferred to the hospital. The DON stated she investigated the incident and learned the resident's Klonopin was not delivered by the pharmacy as a new controlled substance form was needed by the pharmacy. Nursing staff had e-mailed the document to the physician on Friday, 09/08/23, but failed to follow-up with the physician to ensure he received, signed, and returned the document. Over the weekend, including 09/09/23 and 09/10/23, none of the nursing staff who worked with Resident #01 contacted the physician or the pharmacy regarding the medication. The DON confirmed Klonopin was in the facility's contingency medication box (c-box), however, since it was a controlled substance, nursing would have needed to call the pharmacy to be given an authorization code in order to pull the medication. The DON verified nursing staff did not contact the pharmacy to get authorization to pull the medication for administration to the resident. On Monday, 366312 Page 2 of 4 366312 10/11/2023 The Gardens of St. Francis 930 South Wynn Road Oregon, OH 43616

F 0760 Level of Harm - Actual harm Residents Affected - Few 09/11/23, the physician was contacted and the controlled substance form was signed and returned to the pharmacy in order for the medication to be delivered to the facility. The DON verified Resident #01 had seizure-like activity that afternoon, was sent to the ED, and the treating neurologist at the hospital believed the seizure was likely the result of benzodiazepine withdrawal. The DON stated every licensed nurse who worked with Resident #01 from 09/08/23 through 09/11/23 was disciplined and all licensed nursing staff were re-educated on the process for ordering medications, follow-up with the physician and pharmacy, and accurate and complete documentation related to medication administration. Telephone interview on 10/11/23 at 12:39 P.M. with Quality Assurance Pharmacist (QAP) #200 confirmed the pharmacy had filled Resident #01's Klonopin order on 08/07/23 and stated it made sense the facility did not have any medication to administer to the resident from 09/08/23 through 09/11/23. QAP #200 stated the pharmacy did not have a valid controlled substance form for Resident #01 and a new one was needed before any additional medication could be delivered. QAP #200 verified the facility was responsible for obtaining the controlled substance form. QAP #200 verified the facility had Klonopin in their c-box and, had the facility contacted the pharmacy indicating a need for the medication, the pharmacy would have paged the physician to obtain a verbal order and provided an authorization code for the facility to pull the medication for Resident #01. QAP #200 confirmed there was no record anyone from the facility had contacted the pharmacy regarding Resident #01's Klonopin from 09/08/23 through 09/11/23. Interview on 10/11/23 at 1:50 P.M. with the Administrator verified Resident #01 did not have Klonopin available for administration from 09/08/23 through 09/11/23. The Administrator stated when administration learned of the medication error on 09/11/23, a plan of correction was developed and implemented to prevent any further significant medication errors. Review of the facility policy titled Administering Medications, revised April 2019, revealed medications are administered in accordance with prescriber orders. The deficient practice was corrected on 09/30/23 when the facility implemented the following corrective actions: • On 09/11/23, the DON followed-up with the physician and received the controlled substance form in order to obtain Resident #01's medication. • On 09/11/23, Resident #01 was transferred to the ED for assessment following a seizure. Resident #01 was restarted on her medication. • On 09/12/23, the DON completed an audit of all residents on benzodiazepine medications and found no other concerns related to medications being available or administered per physician orders. • 366312 Page 3 of 4 366312 10/11/2023 The Gardens of St. Francis 930 South Wynn Road Oregon, OH 43616

F 0760 On 09/12/23, the pharmacy delivered Resident #01's medication to the facility. Level of Harm - Actual harm • Residents Affected - Few From 09/13/23 through 09/21/23, the DON met with each of the four licensed nursing staff (Licensed Practical Nurses (LPN) #100, #105, #110, and #115) who were responsible for medication administration during the time Resident #01 did not receive her medication and provided re-education and disciplinary action related to the medication not being available, administered, and lack of follow-up with the physician and/or pharmacy. • From 09/13/23 through 09/30/23, the DON re-educated all licensed nursing staff on re-ordering medications, medication administration, follow-up with the physician and/or pharmacy, and complete and accurate documentation. • On 09/13/23, the Administrator provided education to the Medical Director on the process of ordering medications, signing controlled substance forms timely, and being in compliance with timely ordering of medications. • On 09/13/23, Assistant Director of Nursing (ADON) #150 audited all residents to ensure all ordered medications were available for administration, were administered as ordered, and accurately documented in the medical record. Additional audits conducted on 09/19/23, 10/02/23, and 10/10/23 revealed no additional concerns related to medications administration and documentation. Audits will continue for a total of six weeks and any additional concerns will be presented to the Quality Assurance and Performance Improvement (QAPI) team members. • On 09/28/23, an ad hoc QAPI meeting was held to review the audits that had been completed to ensure medications were administered correctly and free of error. This deficiency represents non-compliance investigated under Complaint Number OH00146724. 366312 Page 4 of 4