Health inspection·December 13, 2023

F 0694 Provide for the safe, appropriate administration of IV fluids for a resident when needed. Level of Harm - Minimal harm or potential for actual harm **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** THE FOLLOWING DEFICIENCY REPRESENTS AN INCIDENT OF PAST NONCOMPLIANCE THAT WAS SUBSEQUENTLY CORRECTED PRIOR TO THIS SURVEY. Residents Affected - Some Based on medical record review, review of the State of Ohio Board of Pharmacy Terminal Distributor Licensure of Prescriber Practices, review of facility policy, and interview, the facility failed to ensure a contracted entity had appropriate State of Ohio required credentials for provision of services for residents. This deficiency affected four of four Residents (#10, #62, #92, and #97) reviewed for medications administered by a contracted ancillary provider. This affected six current Residents (#5, #50, #57, #67, #74 and #77) and 13 discharged Residents (#84, #85, #87, #88, #89, #90, #91, #92, #93, #94, #95, #96 and #97). The census was 108. Findings include: 1. Record review for Resident #10 revealed he was admitted to the facility on [DATE]. His diagnoses included, osteomyelitis, paraplegia, candidiasis, anemia, and insomnia. Review of the most recent Minimum Data Set (MDS) assessment for Resident #10, dated 08/28/23, revealed he was cognitively intact. Resident #10 required extensive assistance from staff with bed mobility, toileting, personal hygiene, and dressing. He was totally dependent on staff for transfers. Resident #10 required supervision from staff with eating. Review of the plan of care dated 08/28/23 revealed the resident had potential for nutritional risk related to anemia, and infection. Review of physician orders dated 07/25/23 revealed Infection and Derma infusion protocol for Dript intravenous (IV) Nurse-Dript IV therapy infusion one time 500 milliliters (ml) normal saline (0.9%) 500 ml/hour (hr), total additive volume, 31 ml. Additive formula: Ascorbic acid five gram (gm), B complex B five (Dexpanthenol) 250 mg, B seven Biotin 20 mg, Zinc 10 mg, Glutamine 150 mg, Arginine 500 mg, Ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg, Glutathione 600 mg, three ml given intravenous push (IVP) at the end of infusion, one time only for micronutrient hydration therapy for one day one time only for hydration and nutritional wellness secondary to intake/chronic infection and frequent infections for one day infusion administration time may very based on clinic. 2. Review of the medical record for Resident #62 revealed an admission date of 03/22/23. Diagnoses included malnutrition, and paraplegia. Review of the quarterly MDS assessment dated [DATE] revealed Resident #62 had no impairments cognitive impairments. The resident was dependent for all care. Page 1 of 12 365551 365551 12/13/2023 Clovernook Health Care and Rehabilitation Center 7025 Clovernook Avenue Cincinnati, OH 45231

F 0694 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some Review of the plan of care dated 10/13/23 revealed the resident had potential for nutritional risk related to malnutrition. Interventions included honor food/fluid preferences as possible and document food/fluid intakes. Review of physician orders dated 08/21/23 revealed Infection/derma protocol-for Dript IV nurse-Dript IV therapy infusion one time (1,000 ml) 0.9% normal saline at 1,000 ml/hr. (Total additive volume, 24 ml). Additive formula: Ascorbic acid five mg, B complex B five(Dexpanthenol) 250 mg, Glutamine 150 mg, Citrulline 250 mg, and Zinc 10 mg. 3. Review of the medical record for Resident #92 revealed an admission date of 04/25/23. Diagnoses included high blood pressure, stroke, seizures, and pressure ulcer. The resident also received nutrition via a gastrostomy (g-tube) tube. Review of the significant change MDS assessment dated [DATE] revealed Resident #92 had impaired cognition. The resident was dependent for all care. Review of the plan of care dated 08/23/23 revealed the resident had potential for nutritional risk related to inability to eat by mouth. Interventions included to provide and serve supplements as ordered. Review of physician orders dated 09/21/23 revealed Nutrition Derma infusion protocol-Dript IV therapy infusion-one time 1,000 ml 0.9% normal saline at 500 ml/hr. (Total Additive volume 28.4 ml) B complex- B 1 Thiamine 200 mg, B two Riboflavin four mg, B three Niacin 200 mg, B five Dex 250 mg, Methylcobalamin two mg, Magnesium Chloride 1000 mg, Calcium Chloride 200 mg, Zinc 10 mg, glutamine 150 mg, Arginine 500 mg, Ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg, 4. Review of the medical record for Resident #97 revealed an admission date of 04/05/23. Diagnoses included chronic respiratory failure, chronic lung disease, high blood pressure and seizures. Review of the quarterly MDS assessment dated [DATE] revealed Resident #97 had no cognitive impairments however he was dependent on staff for all care. Review of the plan of care dated 11/01/23 revealed the resident had potential for nutritional risk related to recent falls and cognitive decline. Interventions included provide and serve supplements as ordered. Review of physician orders dated 09/21/23 revealed Cognitive Infusion protocol-for Dript IV nurse-Dript IV therapy infusion-one time 500 ml. 0.9% normal saline at 500 ml/hr (total additive volume, 30.4 ml) Additive formula: ascorbic acid 5 mg, B Complex-B one Thiamine 200 mg, B two Riboflavin four mg, B three Niacin 200 mg, B five Dex 4 mg, B six Pyr four mg, glutamine 150 mg, Arginine 500 mg, ornithine 50 mg, Lysine 250 mg, Citrulline 250 mg, one time only for cognitive wellness. Interview on 11/15/23 at 9:13 A.M. with Representative #405 for the ancillary provider stated they did not have State of Ohio Terminal Distributor of Dangerous Drugs (TDDD) licensure. He stated they were a Medical Entity, with a Medical Director licensed in the State of Ohio. Every other state in which they provided services did not require a special TDDD license and about three months of providing services in the Ohio area, they learned Ohio was an exception. He stated they applied for the license and were told they could continue providing services, license approval would take days. He stated an audit was conducted, and the Board of Pharmacy reported them. Simultaneously, the group had 365551 Page 2 of 12 365551 12/13/2023 Clovernook Health Care and Rehabilitation Center 7025 Clovernook Avenue Cincinnati, OH 45231

F 0694 Level of Harm - Minimal harm or potential for actual harm decided to stop providing services in Ohio unrelated to the licensure concerns. They rescinded their application for licensure. He stated they provided five specialized infusions that could be specialized based on resident needs. The intervention was created a couple of years ago and found to be beneficial for residents with chronic urinary tract infections (UTI), residents who did not eat or drink well, and/or weight loss concerns. He stated they presented the program to facility ownership. Residents Affected - Some Interview on 11/15/23 at 11:02 A.M. General Counsel #406 stated studies had shown hydration therapy improved and reduced risk of dehydration and re hospitalization. She stated she learned of this licensing concern on 11/14/23 and had contacted the General Counsel for the ancillary provider who reported when they started the process in Ohio they had been told they did not require TDDD license for Ohio. They reported they were initially told by the Board of Pharmacy they did not require an Ohio license, there were a ton of exemptions. They reported they applied for the license. General Counsel #406 stated the provider did not explain concerns with licensure when they announced they were no longer providing services. It was explained as a decrease in services related to rate freezes. She was not involved with the initial vetting process and could not provide specific information as to the steps involved in the approval. The corporation had started a compliance investigation on this with a compliance officer specific to this incident. At 12:25 P.M. General Counsel #406 revealed the contract had been signed on 12/09/22 by their Chief Financial Officer (CFO). The General Counsel at that time would have gone through a legal review with a multi-layered vetting process before it was presented to the CFO. She was in the process of investigating everything involved in the process and was still gathering information. Interview on 12/12/23 at 9:13 A.M. with the Director of Nursing (DON) revealed the representative for the ancillary provider notified the facility either the last week of September or first week of October they would no longer provide the IV services. The DON confirmed six current Residents (#5, #50, #57, #67, #74 and #77) and 13 discharged Residents (#84, #85, #87, #88, #89, #90, #91, #92, #93, #94, #95, #96 and #97) received IV services by the ancillary provider. Interview on 12/12/23 at 9:30 A.M. with the Administrator revealed she was unaware of adverse outcomes related to the infusion of the medications. She was not aware of concerns related to TDDD licensure and stated the initial service agreement would have been initiated at the corporate level before she was employed by the facility. Review of the State of Ohio Terminal Distributor Licensure of Prescriber Practices https://www.pharmacy.ohio.gov/, dated 08/24/23, revealed a TDDD license allows a business entity to purchase, possess, and/or distribute dangerous drugs at specific locations. Terminal distributors of dangerous drugs include, but are not limited to, hospitals, pharmacies, Emergency Medical Services (EMS) organizations, laboratories, nursing homes, and prescriber practices. Distribution includes the administration of drugs on-site to patients as well as providing medications to patients to take away from the facility for later use. Dangerous drugs are defined in the Ohio Revised Code as any drug that meets any of the following: 1. Requires a subscription; 2. Bears on the label a Federal Legend (Rx Only or Caution: Federal law prohibits dispensing without a prescription); 3. Is intended for injection into the human body; or 4. Any drug that is a biological product as defined in section 3715.01 of the Revised Code. Ohio Revised Code (ORC) 4729.51 states that no licensed manufacturer, outsourcing facility, third-party logistics provider, repackage, or wholesale distributor shall sell dangerous drugs to anyone other than the following: (1) a licensed terminal distributor of dangerous drugs; (2) Any person exempt from licensure as a terminal distributor of dangerous drugs under section 4729.541 of the Revised Code (3) a licensed manufacturer, outsourcing facility, third-party logistics provider, repackage, or wholesale distributor; or (4) A terminal distributor, manufacturer, outsourcing facility, 365551 Page 3 of 12 365551 12/13/2023 Clovernook Health Care and Rehabilitation Center 7025 Clovernook Avenue Cincinnati, OH 45231

F 0694 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some third-party logistics provider, repackage, or wholesale distributor that is located in another state, is not engaged in the sale of dangerous drugs within this state, and is actively licensed to engage in the sale of dangerous drugs by the state in which the distributor conducts business. In general, the exemptions to Ohio's TDDD licensure requirements do not apply if the prescriber practice is engaged in drug compounding. Compounding is defined as the preparation, mixing, assembling, packaging, and labeling of one or more drugs. Compounding includes the combining, admixing, diluting, reconstituting, or otherwise altering of a drug or bulk drug substance. Review of facility policy titled, Governing Body, dated 07/13/23, revealed the facility will have a governing body, or designated persons functioning as a governing body, that is legally responsible for establishing and implementing policies regarding the management and operation of the facility. The governing body refers to individuals such as facility owner(s), Chief Executive Officer(s), or other individuals who are legally responsible to establish and implement policies regarding the management and operations of the facility. As a result of the incident, the facility took the following actions to correct the deficient practice by 11/22/23: • On 11/20/23, Director of Clinical Operations #12 provided an education to the corporate leadership team on ways to ensure proper licensure for any company that provides medications to the facility. • All residents that received services from DriptIV were assessed by the DON/Designee on or before 11/22/23 to ensure there were no adverse effects from DriptIV services. No adverse effects were noted. • An audit of all contracts that involve providing medication were reviewed to ensure the proper TDDD licensure is in place was completed 11/22/23. • Going forward, the Administrator/designee will complete an audit of any company providing any pharmacy services to ensure that the appropriate TDDD license is effective in the state of Ohio. Audits will be completed weekly for one month and then monthly times three. Audit will be taken to Quality Assurance and Performance Improvement (QAPI) for review. This deficiency represents non-compliance investigated under Complaint Number OH00148181. 365551 Page 4 of 12 365551 12/13/2023 Clovernook Health Care and Rehabilitation Center 7025 Clovernook Avenue Cincinnati, OH 45231

F 0755 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some Provide pharmaceutical services to meet the needs of each resident and employ or obtain the services of a licensed pharmacist. **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** THE FOLLOWING DEFICIENCY REPRESENTS AN INCIDENT OF PAST NONCOMPLIANCE THAT WAS SUBSEQUENTLY CORRECTED PRIOR TO THIS SURVEY. Based on medical record review, review of the State of Ohio Board of Pharmacy Terminal Distributor Licensure of Prescriber Practices, review of facility policy, and interview, the facility failed to ensure medications were obtained from a source with a Terminal Distributor of Dangerous Drugs (TDDD) license (which allows a business entity to purchase, possess, and/or distribute dangerous drugs at a specific location) specific to the State of Ohio. This deficiency affected four of four Residents (#10, #62, #92, and #97) reviewed for medications administered by a contracted ancillary provider. This affected six current Residents (#5, #50, #57, #67, #74 and #77) and 13 discharged Residents (#84, #85, #87, #88, #89, #90, #91, #92, #93, #94, #95, #96 and #97). The census was 108. Findings include: 1. Record review for Resident #10 revealed he was admitted to the facility on [DATE]. His diagnoses included, osteomyelitis, paraplegia, candidiasis, anemia, and insomnia. Review of the most recent Minimum Data Set (MDS) assessment for Resident #10, dated 08/28/23, revealed he was cognitively intact. Resident #10 required extensive assistance from staff with bed mobility, toileting, personal hygiene, and dressing. He was totally dependent on staff for transfers. Resident #10 required supervision from staff with eating. Review of the plan of care dated 08/28/23 revealed the resident had potential for nutritional risk related to anemia, and infection. Review of physician orders dated 07/25/23 revealed Infection and Derma infusion protocol for Dript intravenous (IV) Nurse-Dript IV therapy infusion one time 500 milliliters (ml) normal saline (0.9%) 500 ml/hour (hr), total additive volume, 31 ml. Additive formula: Ascorbic acid five gram (gm), B complex B five (Dexpanthenol) 250 mg, B seven Biotin 20 mg, Zinc 10 mg, Glutamine 150 mg, Arginine 500 mg, Ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg, Glutathione 600 mg, three ml given intravenous push (IVP) at the end of infusion, one time only for micronutrient hydration therapy for one day one time only for hydration and nutritional wellness secondary to intake/chronic infection and frequent infections for one day infusion administration time may very based on clinic. 2. Review of the medical record for Resident #62 revealed an admission date of 03/22/23. Diagnoses included malnutrition, and paraplegia. Review of the quarterly MDS assessment dated [DATE] revealed Resident #62 had no impairments cognitive impairments. The resident was dependent for all care. Review of the plan of care dated 10/13/23 revealed the resident had potential for nutritional risk related to malnutrition. Interventions included honor food/fluid preferences as possible and document food/fluid intakes. Review of physician orders dated 08/21/23 revealed Infection/derma protocol-for Dript IV nurse-Dript IV therapy infusion one time (1,000 ml) 0.9% normal saline at 1,000 ml/hr. (Total additive volume, 365551 Page 5 of 12 365551 12/13/2023 Clovernook Health Care and Rehabilitation Center 7025 Clovernook Avenue Cincinnati, OH 45231

F 0755 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some 24 ml). Additive formula: Ascorbic acid five mg, B complex B five(Dexpanthenol) 250 mg, Glutamine 150 mg, Citrulline 250 mg, and Zinc 10 mg. 3. Review of the medical record for Resident #92 revealed an admission date of 04/25/23. Diagnoses included high blood pressure, stroke, seizures, and pressure ulcer. The resident also received nutrition via a gastrostomy (g-tube) tube. Review of the significant change MDS assessment dated [DATE] revealed Resident #92 had impaired cognition. The resident was dependent for all care. Review of the plan of care dated 08/23/23 revealed the resident had potential for nutritional risk related to inability to eat by mouth. Interventions included to provide and serve supplements as ordered. Review of physician orders dated 09/21/23 revealed Nutrition Derma infusion protocol-Dript IV therapy infusion-one time 1,000 ml 0.9% normal saline at 500 ml/hr. (Total Additive volume 28.4 ml) B complex- B 1 Thiamine 200 mg, B two Riboflavin four mg, B three Niacin 200 mg, B five Dex 250 mg, Methylcobalamin two mg, Magnesium Chloride 1000 mg, Calcium Chloride 200 mg, Zinc 10 mg, glutamine 150 mg, Arginine 500 mg, Ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg, 4. Review of the medical record for Resident #97 revealed an admission date of 04/05/23. Diagnoses included chronic respiratory failure, chronic lung disease, high blood pressure and seizures. Review of the quarterly MDS assessment dated [DATE] revealed Resident #97 had no cognitive impairments however he was dependent on staff for all care. Review of the plan of care dated 11/01/23 revealed the resident had potential for nutritional risk related to recent falls and cognitive decline. Interventions included provide and serve supplements as ordered. Review of physician orders dated 09/21/23 revealed Cognitive Infusion protocol-for Dript IV nurse-Dript IV therapy infusion-one time 500 ml. 0.9% normal saline at 500 ml/hr (total additive volume, 30.4 ml) Additive formula: ascorbic acid 5 mg, B Complex-B one Thiamine 200 mg, B two Riboflavin four mg, B three Niacin 200 mg, B five Dex 4 mg, B six Pyr four mg, glutamine 150 mg, Arginine 500 mg, ornithine 50 mg, Lysine 250 mg, Citrulline 250 mg, one time only for cognitive wellness. Interview on 11/15/23 at 9:13 A.M. with Representative #405 for the ancillary provider stated they did not have State of Ohio TDDD licensure. He stated they were a Medical Entity, with a Medical Director licensed in the State of Ohio. Every other state in which they provided services did not require a special TDDD license and about three months of providing services in the Ohio area, they learned Ohio was an exception. He stated they applied for the license and were told they could continue providing services, license approval would take days. He stated an audit was conducted, and the Board of Pharmacy reported them. Simultaneously, the group had decided to stop providing services in Ohio unrelated to the licensure concerns. They rescinded their application for licensure. He stated they provided five specialized infusions that could be specialized based on resident needs. The intervention was created a couple of years ago and found to be beneficial for residents with chronic urinary tract infections (UTI), residents who did not eat or drink well, and/or weight loss concerns. He stated they presented the program to facility ownership. 365551 Page 6 of 12 365551 12/13/2023 Clovernook Health Care and Rehabilitation Center 7025 Clovernook Avenue Cincinnati, OH 45231

F 0755 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some Interview on 11/15/23 at 11:02 A.M. General Counsel #406 stated studies had shown hydration therapy improved and reduced risk of dehydration and re hospitalization. She stated she learned of this licensing concern on 11/14/23 and had contacted the General Counsel for the ancillary provider who reported when they started the process in Ohio they had been told they did not require TDDD license for Ohio. They reported they were initially told by the Board of Pharmacy they did not require an Ohio license, there were a ton of exemptions. They reported they applied for the license. General Counsel #406 stated the provider did not explain concerns with licensure when they announced they were no longer providing services. It was explained as a decrease in services related to rate freezes. She was not involved with the initial vetting process and could not provide specific information as to the steps involved in the approval. The corporation had started a compliance investigation on this with a compliance officer specific to this incident. At 12:25 P.M. General Counsel #406 revealed the contract had been signed on 12/09/22 by their Chief Financial Officer (CFO). The General Counsel at that time would have gone through a legal review with a multi-layered vetting process before it was presented to the CFO. She was in the process of investigating everything involved in the process and was still gathering information. Interview on 12/12/23 at 9:13 A.M. with the Director of Nursing (DON) revealed the representative for the ancillary provider notified the facility either the last week of September or first week of October they would no longer provide the IV services. The DON confirmed six current Residents (#5, #50, #57, #67, #74 and #77) and 13 discharged Residents (#84, #85, #87, #88, #89, #90, #91, #92, #93, #94, #95, #96 and #97) received IV services by the ancillary provider. Interview on 12/12/23 at 9:30 A.M. with the Administrator revealed she was unaware of adverse outcomes related to the infusion of the medications. She was not aware of concerns related to TDDD licensure and stated the initial service agreement would have been initiated at the corporate level before she was employed by the facility. Review of the State of Ohio Terminal Distributor Licensure of Prescriber Practices https://www.pharmacy.ohio.gov/, dated 08/24/23, revealed a TDDD license allows a business entity to purchase, possess, and/or distribute dangerous drugs at specific locations. Terminal distributors of dangerous drugs include, but are not limited to, hospitals, pharmacies, Emergency Medical Services (EMS) organizations, laboratories, nursing homes, and prescriber practices. Distribution includes the administration of drugs on-site to patients as well as providing medications to patients to take away from the facility for later use. Dangerous drugs are defined in the Ohio Revised Code as any drug that meets any of the following: 1. Requires a subscription; 2. Bears on the label a Federal Legend (Rx Only or Caution: Federal law prohibits dispensing without a prescription); 3. Is intended for injection into the human body; or 4. Any drug that is a biological product as defined in section 3715.01 of the Revised Code. Ohio Revised Code (ORC) 4729.51 states that no licensed manufacturer, outsourcing facility, third-party logistics provider, repackage, or wholesale distributor shall sell dangerous drugs to anyone other than the following: (1) a licensed terminal distributor of dangerous drugs; (2) Any person exempt from licensure as a terminal distributor of dangerous drugs under section 4729.541 of the Revised Code (3) a licensed manufacturer, outsourcing facility, third-party logistics provider, repackage, or wholesale distributor; or (4) A terminal distributor, manufacturer, outsourcing facility, third-party logistics provider, repackage, or wholesale distributor that is located in another state, is not engaged in the sale of dangerous drugs within this state, and is actively licensed to engage in the sale of dangerous drugs by the state in which the distributor conducts business. In general, the exemptions to Ohio's TDDD licensure requirements do not apply if the prescriber practice is engaged in drug compounding. Compounding is defined as the preparation, mixing, assembling, packaging, and labeling of one or more drugs. Compounding 365551 Page 7 of 12 365551 12/13/2023 Clovernook Health Care and Rehabilitation Center 7025 Clovernook Avenue Cincinnati, OH 45231

F 0755 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some includes the combining, admixing, diluting, reconstituting, or otherwise altering of a drug or bulk drug substance. Review of facility policy titled, Governing Body, dated 07/13/23, revealed the facility will have a governing body, or designated persons functioning as a governing body, that is legally responsible for establishing and implementing policies regarding the management and operation of the facility. The governing body refers to individuals such as facility owner(s), Chief Executive Officer(s), or other individuals who are legally responsible to establish and implement policies regarding the management and operations of the facility. As a result of the incident, the facility took the following actions to correct the deficient practice by 11/22/23: • On 11/20/23, Director of Clinical Operations #12 provided an education to the corporate leadership team on ways to ensure proper licensure for any company that provides medications to the facility. • All residents that received services from DriptIV were assessed by the DON/Designee on or before 11/22/23 to ensure there were no adverse effects from DriptIV services. No adverse effects were noted. • An audit of all contracts that involve providing medication were reviewed to ensure the proper TDDD licensure is in place was completed 11/22/23. • Going forward, the Administrator/designee will complete an audit of any company providing any pharmacy services to ensure that the appropriate TDDD license is effective in the state of Ohio. Audits will be completed weekly for one month and then monthly times three. Audit will be taken to Quality Assurance and Performance Improvement (QAPI) for review. This deficiency represents non-compliance investigated under Complaint Number OH00148181. 365551 Page 8 of 12 365551 12/13/2023 Clovernook Health Care and Rehabilitation Center 7025 Clovernook Avenue Cincinnati, OH 45231

F 0837 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some Establish a governing body that is legally responsible for establishing and implementing policies for managing and operating the facility and appoints a properly licensed administrator responsible for managing the facility. **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** THE FOLLOWING DEFICIENCY REPRESENTS AN INCIDENT OF PAST NONCOMPLIANCE THAT WAS SUBSEQUENTLY CORRECTED PRIOR TO THIS SURVEY. Based on medical record review, review of the State of Ohio Board of Pharmacy Terminal Distributor Licensure of Prescriber Practices, review of facility policy, and interview, the facility failed to ensure a contracted entity had appropriate State of Ohio required credentials for provision of services for residents. This deficiency affected four of four Residents (#10, #62, #92, and #97) reviewed for medications administered by a contracted ancillary provider. This affected six current Residents (#5, #50, #57, #67, #74 and #77) and 13 discharged Residents (#84, #85, #87, #88, #89, #90, #91, #92, #93, #94, #95, #96 and #97). The census was 108. Findings include: 1. Record review for Resident #10 revealed he was admitted to the facility on [DATE]. His diagnoses included, osteomyelitis, paraplegia, candidiasis, anemia, and insomnia. Review of the most recent Minimum Data Set (MDS) assessment for Resident #10, dated 08/28/23, revealed he was cognitively intact. Resident #10 required extensive assistance from staff with bed mobility, toileting, personal hygiene, and dressing. He was totally dependent on staff for transfers. Resident #10 required supervision from staff with eating. Review of the plan of care dated 08/28/23 revealed the resident had potential for nutritional risk related to anemia, and infection. Review of physician orders dated 07/25/23 revealed Infection and Derma infusion protocol for Dript intravenous (IV) Nurse-Dript IV therapy infusion one time 500 milliliters (ml) normal saline (0.9%) 500 ml/hour (hr), total additive volume, 31 ml. Additive formula: Ascorbic acid five gram (gm), B complex B five (Dexpanthenol) 250 mg, B seven Biotin 20 mg, Zinc 10 mg, Glutamine 150 mg, Arginine 500 mg, Ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg, Glutathione 600 mg, three ml given intravenous push (IVP) at the end of infusion, one time only for micronutrient hydration therapy for one day one time only for hydration and nutritional wellness secondary to intake/chronic infection and frequent infections for one day infusion administration time may very based on clinic. 2. Review of the medical record for Resident #62 revealed an admission date of 03/22/23. Diagnoses included malnutrition, and paraplegia. Review of the quarterly MDS assessment dated [DATE] revealed Resident #62 had no impairments cognitive impairments. The resident was dependent for all care. Review of the plan of care dated 10/13/23 revealed the resident had potential for nutritional risk related to malnutrition. Interventions included honor food/fluid preferences as possible and document food/fluid intakes. Review of physician orders dated 08/21/23 revealed Infection/derma protocol-for Dript IV nurse-Dript IV therapy infusion one time (1,000 ml) 0.9% normal saline at 1,000 ml/hr. (Total additive volume, 365551 Page 9 of 12 365551 12/13/2023 Clovernook Health Care and Rehabilitation Center 7025 Clovernook Avenue Cincinnati, OH 45231

F 0837 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some 24 ml). Additive formula: Ascorbic acid five mg, B complex B five(Dexpanthenol) 250 mg, Glutamine 150 mg, Citrulline 250 mg, and Zinc 10 mg. 3. Review of the medical record for Resident #92 revealed an admission date of 04/25/23. Diagnoses included high blood pressure, stroke, seizures, and pressure ulcer. The resident also received nutrition via a gastrostomy (g-tube) tube. Review of the significant change MDS assessment dated [DATE] revealed Resident #92 had impaired cognition. The resident was dependent for all care. Review of the plan of care dated 08/23/23 revealed the resident had potential for nutritional risk related to inability to eat by mouth. Interventions included to provide and serve supplements as ordered. Review of physician orders dated 09/21/23 revealed Nutrition Derma infusion protocol-Dript IV therapy infusion-one time 1,000 ml 0.9% normal saline at 500 ml/hr. (Total Additive volume 28.4 ml) B complex- B 1 Thiamine 200 mg, B two Riboflavin four mg, B three Niacin 200 mg, B five Dex 250 mg, Methylcobalamin two mg, Magnesium Chloride 1000 mg, Calcium Chloride 200 mg, Zinc 10 mg, glutamine 150 mg, Arginine 500 mg, Ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg, 4. Review of the medical record for Resident #97 revealed an admission date of 04/05/23. Diagnoses included chronic respiratory failure, chronic lung disease, high blood pressure and seizures. Review of the quarterly MDS assessment dated [DATE] revealed Resident #97 had no cognitive impairments however he was dependent on staff for all care. Review of the plan of care dated 11/01/23 revealed the resident had potential for nutritional risk related to recent falls and cognitive decline. Interventions included provide and serve supplements as ordered. Review of physician orders dated 09/21/23 revealed Cognitive Infusion protocol-for Dript IV nurse-Dript IV therapy infusion-one time 500 ml. 0.9% normal saline at 500 ml/hr (total additive volume, 30.4 ml) Additive formula: ascorbic acid 5 mg, B Complex-B one Thiamine 200 mg, B two Riboflavin four mg, B three Niacin 200 mg, B five Dex 4 mg, B six Pyr four mg, glutamine 150 mg, Arginine 500 mg, ornithine 50 mg, Lysine 250 mg, Citrulline 250 mg, one time only for cognitive wellness. Interview on 11/15/23 at 9:13 A.M. with Representative #405 for the ancillary provider stated they did not have State of Ohio Terminal Distributor of Dangerous Drugs (TDDD) licensure. He stated they were a Medical Entity, with a Medical Director licensed in the State of Ohio. Every other state in which they provided services did not require a special TDDD license and about three months of providing services in the Ohio area, they learned Ohio was an exception. He stated they applied for the license and were told they could continue providing services, license approval would take days. He stated an audit was conducted, and the Board of Pharmacy reported them. Simultaneously, the group had decided to stop providing services in Ohio unrelated to the licensure concerns. They rescinded their application for licensure. He stated they provided five specialized infusions that could be specialized based on resident needs. The intervention was created a couple of years ago and found to be beneficial for residents with chronic urinary tract infections (UTI), residents who did not eat or drink well, and/or weight loss concerns. He stated they presented the program to facility ownership. 365551 Page 10 of 12 365551 12/13/2023 Clovernook Health Care and Rehabilitation Center 7025 Clovernook Avenue Cincinnati, OH 45231

F 0837 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some Interview on 11/15/23 at 11:02 A.M. General Counsel #406 stated studies had shown hydration therapy improved and reduced risk of dehydration and re hospitalization. She stated she learned of this licensing concern on 11/14/23 and had contacted the General Counsel for the ancillary provider who reported when they started the process in Ohio they had been told they did not require TDDD license for Ohio. They reported they were initially told by the Board of Pharmacy they did not require an Ohio license, there were a ton of exemptions. They reported they applied for the license. General Counsel #406 stated the provider did not explain concerns with licensure when they announced they were no longer providing services. It was explained as a decrease in services related to rate freezes. She was not involved with the initial vetting process and could not provide specific information as to the steps involved in the approval. The corporation had started a compliance investigation on this with a compliance officer specific to this incident. At 12:25 P.M. General Counsel #406 revealed the contract had been signed on 12/09/22 by their Chief Financial Officer (CFO). The General Counsel at that time would have gone through a legal review with a multi-layered vetting process before it was presented to the CFO. She was in the process of investigating everything involved in the process and was still gathering information. Interview on 12/12/23 at 9:13 A.M. with the Director of Nursing (DON) revealed the representative for the ancillary provider notified the facility either the last week of September or first week of October they would no longer provide the IV services. The DON confirmed six current Residents (#5, #50, #57, #67, #74 and #77) and 13 discharged Residents (#84, #85, #87, #88, #89, #90, #91, #92, #93, #94, #95, #96 and #97) received IV services by the ancillary provider. Interview on 12/12/23 at 9:30 A.M. with the Administrator revealed she was unaware of adverse outcomes related to the infusion of the medications. She was not aware of concerns related to TDDD licensure and stated the initial service agreement would have been initiated at the corporate level before she was employed by the facility. Review of the State of Ohio Terminal Distributor Licensure of Prescriber Practices https://www.pharmacy.ohio.gov/, dated 08/24/23, revealed a TDDD license allows a business entity to purchase, possess, and/or distribute dangerous drugs at specific locations. Terminal distributors of dangerous drugs include, but are not limited to, hospitals, pharmacies, Emergency Medical Services (EMS) organizations, laboratories, nursing homes, and prescriber practices. Distribution includes the administration of drugs on-site to patients as well as providing medications to patients to take away from the facility for later use. Dangerous drugs are defined in the Ohio Revised Code as any drug that meets any of the following: 1. Requires a subscription; 2. Bears on the label a Federal Legend (Rx Only or Caution: Federal law prohibits dispensing without a prescription); 3. Is intended for injection into the human body; or 4. Any drug that is a biological product as defined in section 3715.01 of the Revised Code. Ohio Revised Code (ORC) 4729.51 states that no licensed manufacturer, outsourcing facility, third-party logistics provider, repackage, or wholesale distributor shall sell dangerous drugs to anyone other than the following: (1) a licensed terminal distributor of dangerous drugs; (2) Any person exempt from licensure as a terminal distributor of dangerous drugs under section 4729.541 of the Revised Code (3) a licensed manufacturer, outsourcing facility, third-party logistics provider, repackage, or wholesale distributor; or (4) A terminal distributor, manufacturer, outsourcing facility, third-party logistics provider, repackage, or wholesale distributor that is located in another state, is not engaged in the sale of dangerous drugs within this state, and is actively licensed to engage in the sale of dangerous drugs by the state in which the distributor conducts business. In general, the exemptions to Ohio's TDDD licensure requirements do not apply if the prescriber practice is engaged in drug compounding. Compounding is defined as the preparation, mixing, assembling, packaging, and labeling of one or more drugs. Compounding 365551 Page 11 of 12 365551 12/13/2023 Clovernook Health Care and Rehabilitation Center 7025 Clovernook Avenue Cincinnati, OH 45231

F 0837 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some includes the combining, admixing, diluting, reconstituting, or otherwise altering of a drug or bulk drug substance. Review of facility policy titled, Governing Body, dated 07/13/23, revealed the facility will have a governing body, or designated persons functioning as a governing body, that is legally responsible for establishing and implementing policies regarding the management and operation of the facility. The governing body refers to individuals such as facility owner(s), Chief Executive Officer(s), or other individuals who are legally responsible to establish and implement policies regarding the management and operations of the facility. As of 09/22/23, DriptIV stopped providing services to CCH Healthcare facilities. As a result of the incident, the facility took the following actions to correct the deficient practice by 11/22/23: • On 11/20/23, Director of Clinical Operations #12 provided an education to the corporate leadership team on ways to ensure proper licensure for any company that provides medications to the facility. • All residents that received services from DriptIV were assessed by the DON/Designee on or before 11/22/23 to ensure there were no adverse effects from DriptIV services. No adverse effects were noted. • An audit of all contracts that involve providing medication were reviewed to ensure the proper TDDD licensure is in place was completed 11/22/23. • Going forward, the Administrator/designee will complete an audit of any company providing any pharmacy services to ensure that the appropriate TDDD license is effective in the state of Ohio. Audits will be completed weekly for one month and then monthly times three. Audit will be taken to Quality Assurance and Performance Improvement (QAPI) for review. This deficiency represents non-compliance investigated under Complaint Number OH00148181. 365551 Page 12 of 12