Health inspection·January 10, 2024

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** Based on record review, review of psychotropic medication information, facility policy review and interview, the facility failed to prevent a significant medication error for Resident #26 when the resident's psychotropic medication, for reducing risk of recurrent suicidal behavior with schizophrenia was not administered as ordered by the physician from 11/20/23 until 12/06/23. The facility also failed to ensure the physician was notified timely that the medication was unavailable for administration. Residents Affected - Few Actual Harm occurred on 12/07/23 when Resident #26 was admitted to the hospital with psychosis (having increased behaviors and hallucinations), suicidal ideations, threatening to kill herself and slit her throat with a knife as a result of the missed doses of the psychotropic medication, Clozapine. This affected one resident (#26) of four residents reviewed for medication administration. The facility census was 52. Findings Include: Review of the medical record for Resident #26 revealed an initial admission date of 09/21/23 with a hospital stays from 10/13/23 to 11/20/23 and from 12/07/23 to 12/29/23. Diagnoses included schizoaffective disorder bipolar type, dementia, anxiety disorder, drug induced akathisia (inability to remain still), and insomnia. Resident #26 had a court appointed guardian. Review of the admission Minimum Data Set (MDS) assessment, dated 12/03/23, revealed Resident #26 had no cognitive impairment and received antipsychotic medications. Review of physician's orders revealed Resident #26 had a re-admission order dated 11/20/23 for Clozapine (antipsychotic) 300 milligrams (mg) daily for seven days then give 350 mg daily for seven days followed by 400 mg daily for 14 days. On 12/04/23, the Clozapine order was changed to 100 mg for one day as a titrating dose, then give 150 mg on 12/05/23, 200 mg on 12/06/23, 250 mg on 12/07/23, 350 mg on 12/08/23, 350 mg on 12/09/23, 400 mg on 12/10/23, then 400 mg daily at bedtime thereafter. Review of the progress notes revealed Resident #26 was admitted to the hospital on [DATE] due to increasing behaviors and was refusing medications. On 11/20/23, Resident #26 was re-admitted . Clozapine 300 mg was documented as not available to administer, being on order, awaiting pharmacy delivery from 11/20/23 through 11/26/23. On 11/25/23, laboratory tests were re-faxed to the pharmacy. On 11/26/23, pharmacy requested Physician #240 to submit required information to dispense the Clozapine. The request to complete the required information was faxed to Physician #240's office. On 11/28/23, Clozapine 350 mg was documented as not available to administer, being on order, awaiting pharmacy delivery. On 11/29/23, Physician #240 examined Resident #26 via telehealth. Staff reported to Physician #240 of Resident #26 being more agitated for the past seven days. Physician #240 ordered Page 1 of 4 366270 366270 01/10/2024 Eagle Pointe Skilled Nursing & Rehab 87 Staley Road Orwell, OH 44076

F 0760 Level of Harm - Actual harm Residents Affected - Few fluphenazine (antipsychotic) to be administered at 25 mg for one dose, then 10 mg daily for seven days due to Resident #26's behaviors. There was no evidence the staff informed Physician #240 of the multiple missed doses of Clozapine. On 12/01/23, Clozapine 350 mg was documented as being not found in the medication cart or medication room and was awaiting on pharmacy. On 12/03/23 Clozapine 350 mg was documented as not administered due to waiting on pharmacy required information. Review of the Medication Administration Record (MAR) for November 2023 to December 2023 revealed Resident #26 did not receive the physician ordered Clozapine 300 mg daily from 11/20/23 to 11/26/23. Clozapine 350 mg daily was not administered on 11/27/23, 11/28/23, 11/30/23, 12/01/23 and 12/03/23. The nursing staff signed the MAR record to indicate Clozapine 350 mg was administered on 11/29/23 and 12/02/23. On 12/04/23, Clozapine 100 mg for one dose was not administered. On 12/05/23, Clozapine 150 mg for one dose was documented as administered. On 12/06/23, Clozapine 200 mg was documented as not administered. Review of an email from Director of Nursing (DON) to Physician #240 dated 12/04/23 at 9:33 A.M. reported Resident #26 needed required information for pharmacy to deliver Clozapine, and Resident #26 was out of the medication for a few days. Review of an email from Physician #240 to the DON dated 12/04/23 at 9:44 A.M. questioned DON on how many days Resident #26 had not received Clozapine as it would need re-titrated if more than three days. Review of an email from Physician #240 dated 12/04/23 at 9:46 A.M. revealed the required information was completed. Review of an email from the DON to Physician #240 dated 12/04/23 at 10:27 A.M. reported Resident #26 had missed three days of Clozapine. Review of an email from Physician #240 to the DON dated 12/04/23 at 10:42 A.M. indicated Resident #26's Clozapine would need re-titrated due to missing three days and could be more aggressive since it had only been three days. Physician #240 ordered to give Clozaril 100 mg on 12/04/23, 150 mg on 12/05/23, 200 mg on 12/06/23, 250 mg on 12/07/23, 300 mg on 12/08/23, 350 mg on 12/09/23 then 400 mg thereafter. Additional directions were provided to the DON regarding adverse effects including orthostatic hypotension or over-sedation. Physician #240 indicated follow-up with Resident #26 at a telehealth appointment on 12/06/23. Review of progress notes revealed on 12/05/23, Clozaril 100 mg was not available and waiting on pharmacy to deliver. On 12/07/23, Resident #26 was agitated throughout the day with multiple occasions of hallucinations with redirection having little to no effect. Resident #26 had refused all medications in the morning. A message was left with Physician #240 to contact the facility to be informed of missed medications. Physician #240 responded and indicated Resident #26 would benefit from hospitalization to evaluate medications. Resident #26 was transferred to the hospital with Assistant Director of Nursing (ADON) #220 in accompaniment to assist with behaviors, and Resident #26 was admitted . On 12/29/23, Resident #26 was returned from the hospital. Review of hospital documentation from 12/07/23 to 12/29/23 revealed Resident #26 was admitted for psychosis and suicidal ideation. On 12/08/23, Physician #240 documented the facility reported Resident #26 missed doses of Clozapine from 12/01/23 to 12/03/23 due to a pharmacy error and required re-titration. The last reported dose received was on 12/06/23. ADON #220 reported Resident #26 had 366270 Page 2 of 4 366270 01/10/2024 Eagle Pointe Skilled Nursing & Rehab 87 Staley Road Orwell, OH 44076

F 0760 decompensated since 12/06/23 after being without Clozapine from 12/01/23 to 12/03/23 and requiring re-titration. Resident #26 was now paranoid, threatening to kill herself, and to cut her throat with a knife. Level of Harm - Actual harm Residents Affected - Few Interview on 01/09/24 at 1:41 P.M. with Registered Nurse (RN) #234 indicated Resident #26 had baseline schizophrenic behaviors such as agitation and rocking. RN #234 confirmed there was an issue with getting the Clozapine from pharmacy, and it probably aided the agitation. RN #234 stated the nurses followed-up with pharmacy to find out why a medication was not available and contact the physician for directions. Interview on 01/09/24 at 2:36 P.M. with the DON and ADON #220 verified Resident #26 was re-admitted on [DATE] and the ordered Clozapine was not administered from 11/20/23 to 11/26/23. On 11/27/23 the physician was notified of the pharmacy need for REMS (Risk Evaluation and Mitigation Strategy) documentation to be completed to dispense Clozapine. At the time, the physician was not made aware of the missed Clozapine doses. On 11/27/23, 11/28/23, 11/30/23, 12/01/23 and 12/03/23, the ordered Clozapine was also not administered due to the medication not being available. On 12/04/23, the physician was contacted, and new orders were received for re-titration. Clozapine was not administered on 12/04/23 and 12/06/23, then Resident #26 went to the hospital on [DATE]. Interview on 01/09/24 at 3:58 P.M. with DON and ADON #220 confirmed Resident #26's physician was not notified of the missed doses of Clozapine until 12/04/23. ADON #220 indicated contacting the physician and reported increased agitation and Resident #26 was deteriorating due to the change in medication. On 12/07/23, Resident #26 was sent to the hospital due to increased behaviors, starting to refuse medications, and being suicidal. With a medication that requires REMS, laboratory results are sent to the pharmacy, and the pharmacy will notify the physician of the required documentation needed. If the physician does not complete it, then the pharmacy will notify the facility. The DON and ADON #220 verified it was the nurse's responsibility to contact the physician to obtain required documentation for the pharmacy. Interview on 01/10/24 at 9:29 A.M. with Physician #240 indicated being unaware Resident #26 missed more than three days of Clozapine. It was not until 12/04/23 when an email was received from the facility which reported a need for REMS documentation for the Clozapine and missed doses from 12/01/23 to 12/03/23. The facility had access to both Physician #240's phone number and email to contact at any time each day. It was the DON who provided information when anything was needed for medication dispensing. Physician #240 confirmed Resident #26's hospitalization on 12/07/24 for suicidal tendencies, paranoia, and agitation was a direct result from the lack of administration of Clozapine. Interview on 01/10/24 at 9:41 A.M. with Pharmacist #241 confirmed Resident #26's Clozapine was not delivered to the facility for administration between 11/20/23 and 12/04/23. Communication for REMS documentation was between the facility and the physician with the facility faxing laboratory values to the pharmacy. Pharmacist #241 verified the abrupt stopping of Clozapine had possible adverse effects including increased agitation and psychosis. Review of drug information on Clozapine retrieved from Medscape on 01/10/24 at https://reference.medscape.com/drug/clozaril-versacloz-clozapine-342972 revealed Clozapine was indicated for reducing risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder, and in patients who are judged to be at chronic risk to re-experience suicidal behavior. Reduce doses gradually over a period of one to two weeks and taper gradually to avoid withdrawal symptoms and minimize risk of relapse for schizophrenia. Guidelines recommend gradual taper over six to 24 months. The 366270 Page 3 of 4 366270 01/10/2024 Eagle Pointe Skilled Nursing & Rehab 87 Staley Road Orwell, OH 44076

F 0760 American Psychiatric Association guidelines recommend reducing dose by 10 percent each month. Level of Harm - Actual harm Review of the facility policy titled Administering Medications, revised April 2019, revealed medications were administered in accordance with prescriber orders, including any required time frame. If a medication was suspected of being associated with adverse consequences, the physician would be contacted to discuss the concerns. Residents Affected - Few This deficiency represents non-compliance investigated under Complaint Number OH00149534. 366270 Page 4 of 4