Health inspection·December 6, 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 NON-COMPLIANCE THAT WAS SUBSEQUENTLY CORRECTED PRIOR TO THIS SURVEY. Residents Affected - Some Based on record review, review of the State of Ohio Board of Pharmacy Terminal Distributor Licensure of Prescriber Practices, and staff interview, the facility failed to ensure medications administered intravenously (IV) 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 (Residents #3, #25, #37, and #42) of four residents reviewed for medications administered by a contracted ancillary provider. This affected 26 current residents (#3, #4, #10, #13, #14, #15, #18, #25, #30, #31, #34, #35, #37, #41, #42, #44, #46, #50, #56, #63, #66, #67, #69, #78, #79 and #81) and twelve discharged residents (#85, #86, #88, #89, #90, #91, #92, #93, #94, #95, and #96) identified by the facility who received IV fluids from the unlicensed source. The facility census was 80. Findings include: 1. Record review for Resident #3 revealed the resident admitted to the facility on [DATE]. Diagnoses included protein-calorie malnutrition, hypertension, and seizures. Review of the Brief Interview for Mental Status (BIMS) assessment dated [DATE] revealed Resident #3 had intact cognition. Review of the physician orders dated 06/05/23, 07/18/23, and 08/14/23 revealed Resident #3 had orders start a peripheral IV for 500 milliliter (ml) IV Micronutrient Hydration Therapy-Hydration Infusion (for overall support for multiple comorbidities) (Vitamin C, B Complex, B1, B2, B3, B4, B5, B6, B12, Magnesium Chloride, Calcium Gluconate, and Zinc) and 500 ml of Normal Saline (NS) 0.9 percent (%) for fluids. On 04/26/23 this resident received a Nutritional Infusion (for malnutrition) (Vitamin C, B Complex, B1, B2, B3, B4, B5, B12, Magnesium Oxide, Calcium Gluconate, Zinc, Amino, Glutamine, Arginine, Orthinine, Lysine, Citrulline, and BCAA.) Review of the Medication Administration Record (MAR) revealed Resident #3 received IV Micronutrient Hydration Therapy - Infection Infusion from a contracted company on 04/26/23, 06/08/23, 07/19/23, and 08/16/23. All the IV Micronutrient Hydration Therapy-Infection Infusion administrations were completed by an ancillary provider not employed at the facility. 2. Record review for Resident #25 revealed the resident was admitted to the facility on [DATE]. Diagnoses included altered mental status, dementia, psychoactive substance abuse, schizophrenia, and COVID-19. Page 1 of 12 365065 365065 12/06/2023 Harrison Pavilion Care Center 2171 Harrison Avenue Cincinnati, OH 45211

F 0694 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some Review of the Brief Interview for Mental Status (BIMS) assessment dated [DATE] revealed Resident #32 had impaired cognition. Review of the physician orders dated 04/05/23 revealed Resident #25 had an order dated 04/05/23, 05/24/23, 06/05/23,07/19/23, and 08/14/23 to start a peripheral IV for IV Micronutrient Hydration Therapy Cognition Infusion (Vitamin C, B-Complex, B-1, B2, B3, B5, B-6, Biotin, B-12, Magnesium Chloride, Calcium Gluconate, Zinc, Amino Blend, Glutamine, Arginine, Omithine, Lysine, Citrulline, Taurine, and Glycine) 1,000 ml with 1,000 ml of NS 0.9%. Review of the Medication Administration Record (MAR) revealed Resident #25 received the IV Micronutrient Hydration Therapy - Cognition Infusion with NS 0.9% on 04/26/23, 05/24/23, 06/07/23, 07/19/23, and 08/16/23. All the IV Micronutrient Hydration Therapy - Cognition Infusion administrations were completed by an ancillary provider not employed at the facility. 3. Record review for Resident #37 revealed the resident was admitted to the facility on [DATE]. Diagnoses included multiple sclerosis, protein-calorie malnutrition, hyperkalemia, and cirrhosis of the liver. Review of the Brief Interview for Mental Status (BIMS) assessment dated [DATE] revealed Resident #37 had intact cognition. Review of the physician orders dated 04/05/23, 06/05/23, and 07/18/23 revealed Resident #37 had an order to start a peripheral IV for IV Micronutrient Hydration Therapy - Derma and Infection Infusion (Vitamin C, B-Complex, B1, B2, B3, B5, B6, B12, Magnesium Chloride, Calcium Gluconate, Zinc, Amino Blend, Glutamine, Arginine, Ornthine, Lysine, Citrulline, BCAAA, B7 Biotin, and Glutathione) 500 milliliters (ml) per hour with 500 ml of Normal Saline (NS) 0.9% due to wound management and infections. On 08/14/23, a Hydration Infusion for hydration (Vitamin C, B Complex, B1, B2, B3, B4, B5, B6, B12, Magnesium Chloride, Calcium Gluconate, and Zinc) 250 ml at 250 ml per hour. Review of the Medication Administration Record (MAR) revealed Resident #37 received the IV Micronutrient Hydration Therapy -with NS 0.9% on 04/26/23, 06/07/23, 07/19/23, and 08/16/23 All the IV Micronutrient Hydration Therapy - Nutrition Infusion administrations were completed by an ancillary provider not employed at the facility. 4. Record review for Resident #42 revealed the resident was admitted to the facility on [DATE]. Diagnoses included hypertension, Alzheimer's disease, edema, dermatitis, and other infectious or parasitic diseases. Review of the Brief Interview for Mental Status (BIMS) assessment dated [DATE] revealed Resident #42 had intact cognition. Review of the physician orders dated 04/05/23, 05/24/23, 06/07/23, 07/19/23 and 0814/23 revealed Resident #42 had an order to start a peripheral IV for IV Micronutrient Hydration Therapy -Cognition Infusion (Vitamin C, B-Complex, B-1, B2, B3, B5, B-6, Biotin, B-12, Magnesium Chloride, Calcium Gluconate, Zinc, Amino Blend, Glutamine, Arginine, Omithine, Lysine, Citrulline, Taurine, and Glycine) 1,000 ml with 1,000 ml of NS 0.9%. Review of the Medication Administration Record (MAR) revealed Resident #42 received the IV Micronutrient Hydration Therapy - Nutrition Infusion with NS 0.9% on 05/11/23, 06/08/23, and 07/13/23. All 365065 Page 2 of 12 365065 12/06/2023 Harrison Pavilion Care Center 2171 Harrison Avenue Cincinnati, OH 45211

F 0694 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some the IV Micronutrient Hydration Therapy - Cognition Infusion administrations All the IV Micronutrient Hydration Therapy - Cognitive Infusion administrations were completed by an ancillary provider not employed at the facility. Interview with the Corporate [NAME] President of Operations (CVOP) #60 on 12/06/23 at 9:54 A.M. confirmed she was never provided with the company's Ohio Terminal Distributor of Dangerous Drugs (TDDD) license. CVOP #60 confirmed Residents #3, #25, #37, and #42) received IV infusions of medications supplied by an unlicensed ancillary provider. All infusions ceased in September 2023 due to state licensure issues. Interview with Medical Director (MD) #70 on 12/06/23 could not be completed after several calls that went unreturned. Interview with a representative for the ancillary provider on 12/06/23 at 9:55 A.M. confirmed his company did not have and had never had an Ohio TDDD license to provide medications in the state of Ohio, and he did not understand the specific Ohio laws. 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, repackager, 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, repackager, or wholesale distributor; or (4) A terminal distributor, manufacturer, outsourcing facility, third-party logistics provider, repackager, 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. The deficient practice was corrected on 11/21/23 when the facility implemented the following corrective actions: • The company no longer serves the facility with cessation of services effective on 09/22/23. • 365065 Page 3 of 12 365065 12/06/2023 Harrison Pavilion Care Center 2171 Harrison Avenue Cincinnati, OH 45211

F 0694 Level of Harm - Minimal harm or potential for actual harm All residents that received services from the company have been properly assessed by the Director of Nursing (DON)/designee and do not have any signs or symptoms of adverse effects related to IVF/medications received on or before 11/21/23. • Residents Affected - Some All residents with prior services from the company are at risk of this alleged deficient practice. • This service from the company is no longer being offered effective 09/22/23. • All contracts that involve providing medication were reviewed to ensure the proper TDDD licensure is in place, completed on or before 11/21/23. • Education was provided to the governing body to ensure that TDDD licensure for Ohio is effective before accepting medication into the facility or completion of administration was completed on or before 11/21/23. This was completed by the Director of Clinical Services #99. • Administrator/designee will complete audits 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 for three months. All audits will be provided to the Quality Assurance Performance Improvement (QAPI) committee for review effective 11/21/23. This deficiency represents non-compliance investigated under Complaint Number OH00148108. 365065 Page 4 of 12 365065 12/06/2023 Harrison Pavilion Care Center 2171 Harrison Avenue Cincinnati, OH 45211

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 NON-COMPLIANCE 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, and staff 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 (Residents #3, #25, #37, and #42) of four residents reviewed for medications administered by a contracted ancillary provider. This affected 26 current residents (#3, #4, #10, #13, #14, #15, #18, #25, #30, #31, #34, #35, #37, #41, #42, #44, #46, #50, #56, #63, #66, #67, #69, #78, #79 and #81) and twelve discharged residents (#85, #86, #88, #89, #90, #91, #92, #93, #94, #95, and #96) identified by the facility who received IV fluids from the unlicensed source. The facility census was 80. Findings include: 1. Record review for Resident #3 revealed the resident admitted to the facility on [DATE]. Diagnoses included protein-calorie malnutrition, hypertension, and seizures. Review of the Brief Interview for Mental Status (BIMS) assessment dated [DATE] revealed Resident #3 had intact cognition. Review of the physician orders dated 06/05/23, 07/18/23, and 08/14/23 revealed Resident #3 had orders start a peripheral IV for 500 milliliter (ml) IV Micronutrient Hydration Therapy-Hydration Infusion (for overall support for multiple comorbidities) (Vitamin C, B Complex, B1, B2, B3, B4, B5, B6, B12, Magnesium Chloride, Calcium Gluconate, and Zinc) and 500 ml of Normal Saline (NS) 0.9 percent (%) for fluids. On 04/26/23 this resident received a Nutritional Infusion (for malnutrition) (Vitamin C, B Complex, B1, B2, B3, B4, B5, B12, Magnesium Oxide, Calcium Gluconate, Zinc, Amino, Glutamine, Arginine, Orthinine, Lysine, Citrulline, and BCAA.) Review of the Medication Administration Record (MAR) revealed Resident #3 received IV Micronutrient Hydration Therapy - Infection Infusion from a contracted company on 04/26/23, 06/08/23, 07/19/23, and 08/16/23. All the IV Micronutrient Hydration Therapy-Infection Infusion administrations were completed by an ancillary provider not employed at the facility. 2. Record review for Resident #25 revealed the resident was admitted to the facility on [DATE]. Diagnoses included altered mental status, dementia, psychoactive substance abuse, schizophrenia, and COVID-19. Review of the Brief Interview for Mental Status (BIMS) assessment dated [DATE] revealed Resident #32 had impaired cognition. Review of the physician orders dated 04/05/23 revealed Resident #25 had an order dated 04/05/23, 05/24/23, 06/05/23,07/19/23, and 08/14/23 to start a peripheral IV for IV Micronutrient Hydration Therapy Cognition Infusion (Vitamin C, B-Complex, B-1, B2, B3, B5, B-6, Biotin, B-12, Magnesium Chloride, Calcium Gluconate, Zinc, Amino Blend, Glutamine, Arginine, Omithine, Lysine, Citrulline, 365065 Page 5 of 12 365065 12/06/2023 Harrison Pavilion Care Center 2171 Harrison Avenue Cincinnati, OH 45211

F 0755 Taurine, and Glycine) 1,000 ml with 1,000 ml of NS 0.9%. Level of Harm - Minimal harm or potential for actual harm Review of the Medication Administration Record (MAR) revealed Resident #25 received the IV Micronutrient Hydration Therapy - Cognition Infusion with NS 0.9% on 04/26/23, 05/24/23, 06/07/23, 07/19/23, and 08/16/23. All the IV Micronutrient Hydration Therapy - Cognition Infusion administrations were completed by an ancillary provider not employed at the facility. Residents Affected - Some 3. Record review for Resident #37 revealed the resident was admitted to the facility on [DATE]. Diagnoses included multiple sclerosis, protein-calorie malnutrition, hyperkalemia, and cirrhosis of the liver. Review of the Brief Interview for Mental Status (BIMS) assessment dated [DATE] revealed Resident #37 had intact cognition. Review of the physician orders dated 04/05/23, 06/05/23, and 07/18/23 revealed Resident #37 had an order to start a peripheral IV for IV Micronutrient Hydration Therapy - Derma and Infection Infusion (Vitamin C, B-Complex, B1, B2, B3, B5, B6, B12, Magnesium Chloride, Calcium Gluconate, Zinc, Amino Blend, Glutamine, Arginine, Ornthine, Lysine, Citrulline, BCAAA, B7 Biotin, and Glutathione) 500 milliliters (ml) per hour with 500 ml of Normal Saline (NS) 0.9% due to wound management and infections. On 08/14/23, a Hydration Infusion for hydration (Vitamin C, B Complex, B1, B2, B3, B4, B5, B6, B12, Magnesium Chloride, Calcium Gluconate, and Zinc) 250 ml at 250 ml per hour. Review of the Medication Administration Record (MAR) revealed Resident #37 received the IV Micronutrient Hydration Therapy -with NS 0.9% on 04/26/23, 06/07/23, 07/19/23, and 08/16/23 All the IV Micronutrient Hydration Therapy - Nutrition Infusion administrations were completed by an ancillary provider not employed at the facility. 4. Record review for Resident #42 revealed the resident was admitted to the facility on [DATE]. Diagnoses included hypertension, Alzheimer's disease, edema, dermatitis, and other infectious or parasitic diseases. Review of the Brief Interview for Mental Status (BIMS) assessment dated [DATE] revealed Resident #42 had intact cognition. Review of the physician orders dated 04/05/23, 05/24/23, 06/07/23, 07/19/23 and 0814/23 revealed Resident #42 had an order to start a peripheral IV for IV Micronutrient Hydration Therapy -Cognition Infusion (Vitamin C, B-Complex, B-1, B2, B3, B5, B-6, Biotin, B-12, Magnesium Chloride, Calcium Gluconate, Zinc, Amino Blend, Glutamine, Arginine, Omithine, Lysine, Citrulline, Taurine, and Glycine) 1,000 ml with 1,000 ml of NS 0.9%. Review of the Medication Administration Record (MAR) revealed Resident #42 received the IV Micronutrient Hydration Therapy - Nutrition Infusion with NS 0.9% on 05/11/23, 06/08/23, and 07/13/23. All the IV Micronutrient Hydration Therapy - Cognition Infusion administrations All the IV Micronutrient Hydration Therapy - Cognitive Infusion administrations were completed by an ancillary provider not employed at the facility. Review of the facility's contract with the ancillary provider revealed the contract was entered into agreement on 01/24/23. This provided for a monthly clinic to be provided to residents with various deficiencies. The type of therapy was administered per physician orders by contracted staff through 365065 Page 6 of 12 365065 12/06/2023 Harrison Pavilion Care Center 2171 Harrison Avenue Cincinnati, OH 45211

F 0755 the ancillary provider. Level of Harm - Minimal harm or potential for actual harm Interview with the Corporate [NAME] President of Operations (CVOP) #60 on 12/06/23 at 9:50 A.M. confirmed the facilities entered into the contract with the ancillary provider on 01/24/23 and began treatment clinics in March 2023. CVOP #60 verified the ancillary provider brought their own supplies and IV products to the facility. CVOP #60 verified the ancillary provider was based out of Illinois and used their own staff for IV administration. CVOP #60 verified she was never provided with the company's Ohio Terminal Distributor of Dangerous Drugs (TDDD) license. CVOP #60 verified the above listed residents received IV infusions of medications supplied by an unlicensed ancillary provider. Residents Affected - Some Interview with Chief Executive Officer #80 from the ancillary provider on 12/06/23 at 9:55 P.M. verified his company did not have and did not ever have an Ohio TDDD license to provide drugs in the State of Ohio, as he did not understand the specific Ohio laws. He verified a Cease-and-Desist order was given in September 2023, and no further infusions had taken place after this order. He verified two of his nurses would come in the facility and provide services, one with an Ohio license and the other with a reciprocal license from the state of Indiana to practice in Ohio. 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, repackager, 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, repackager, or wholesale distributor; or (4) A terminal distributor, manufacturer, outsourcing facility, third-party logistics provider, repackager, 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. The deficient practice was corrected on 11/21/23 when the facility implemented the following corrective actions: • The company no longer serves the facility with cessation of services effective on 09/22/23. • 365065 Page 7 of 12 365065 12/06/2023 Harrison Pavilion Care Center 2171 Harrison Avenue Cincinnati, OH 45211

F 0755 Level of Harm - Minimal harm or potential for actual harm All residents that receidved services from the company have been properly assessed by the DON/designee and do not have any signs or symptoms of adverse effects related to IVF/medications received on or before 11/21/23. • Residents Affected - Some All residents with prior services from the company are at risk of this alleged deficient practice. • This service from the company is no longer being offered effective 09/22/23. • All contracts that involve providing medication were reviewed to ensure the proper TDDD licensure is in place, completed on or before 11/21/23. • Education was provided to the governing body to ensure that TDDD licensure for Ohio is effective before accepting medication into the facility or completion of administration was completed on or before 11/21/23. This was completed by the Director of Clinical Services #99. • Administrator/designee will complete audits 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 for three months. All audits will be provided to QAPI for review, effective 11/21/23. This deficiency represents non-compliance investigated under Complaint Number OH00148108. 365065 Page 8 of 12 365065 12/06/2023 Harrison Pavilion Care Center 2171 Harrison Avenue Cincinnati, OH 45211

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 NON-COMPLIANCE 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,, 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 (Residents #3, #25, #37, and #42) of four residents reviewed for medications administered by a contracted ancillary provider. This affected 26 current residents ( #3, #4, #10, #13, #14 #15, #18, #25, #30, #31, #34, #35, #37, #41, #42, #44, #46, #50, #56, #63, #66, #67, #69, #78, #79 and #81) and twelve discharged residents (#85, #86, #88, #89, #90, #91, #92, #93, #94, #95, and #96) identified by the facility who received IV fluids from the unlicensed source. The facility census was 80. Findings include: 1. Record review for Resident #3 revealed the resident admitted to the facility on [DATE]. Diagnoses included protein-calorie malnutrition, hypertension, and seizures. Review of the Brief Interview for Mental Status (BIMS) assessment dated [DATE] revealed Resident #3 had intact cognition. Review of the physician orders dated 06/05/23, 07/18/23, and 08/14/23 revealed Resident #3 had orders start a peripheral IV for 500 milliliter (ml) IV Micronutrient Hydration Therapy - Hydration Infusion (for overall support for multiple comorbidities) (Vitamin C, B Complex, B1, B2, B3, B4, B5, B6, B12, Magnesium Chloride, Calcium Gluconate, and Zinc) and 500 ml of Normal Saline (NS) 0.9% for fluids. On 04/26/23 this resident received a Nutritional Infusion (for malnutrition) (Vitamin C, B Complex, B1, B2, B3, B4, B5, B12, Magnesium Oxide, Calcium Gluconate, Zinc, Amino, Glutamine, Arginine, Orthinine, Lysine, Citrulline, and BCAA.) Review of the Medication Administration Record (MAR) revealed Resident #3 received IV Micronutrient Hydration Therapy - Infection Infusion from a contracted company on 04/26/23, 06/08/23, 07/19/23, and 08/16/23. All the IV Micronutrient Hydration Therapy - Infection Infusion administrations were completed by an ancillary provider not employed at the facility. 2. Record review for Resident #25 revealed the resident was admitted to the facility on [DATE]. Diagnoses included altered mental status, dementia, psychoactive substance abuse, schizophrenia, and COVID-19. Review of the Brief Interview for Mental Status (BIMS) assessment dated [DATE] revealed Resident #32 had impaired cognition. Review of the physician orders dated 04/05/23 revealed Resident #25 had an order dated 04/05/23, 05/24/23, 06/05/23,07/19/23, and 08/14/23 to start a peripheral IV for IV Micronutrient Hydration Therapy Cognition Infusion (Vitamin C, B-Complex, B-1, B2, B3, B5, B-6, Biotin, B-12, Magnesium Chloride, Calcium Gluconate, Zinc, Amino Blend, Glutamine, Arginine, Omithine, Lysine, Citrulline, 365065 Page 9 of 12 365065 12/06/2023 Harrison Pavilion Care Center 2171 Harrison Avenue Cincinnati, OH 45211

F 0837 Taurine, and Glycine) 1,000 ml with 1,000 ml of NS 0.9 percent (%). Level of Harm - Minimal harm or potential for actual harm Review of the Medication Administration Record (MAR) revealed Resident #25 received the IV Micronutrient Hydration Therapy - Cognition Infusion with NS 0.9% on 04/26/23, 05/24/23, 06/07/23, 07/19/23, and 08/16/23. All the IV Micronutrient Hydration Therapy - Cognition Infusion administrations were completed by an ancillary provider not employed at the facility. Residents Affected - Some 3. Record review for Resident #37 revealed the resident was admitted to the facility on [DATE]. Diagnoses included multiple sclerosis, protein-calorie malnutrition, hyperkalemia, and cirrhosis of the liver. Review of the Brief Interview for Mental Status (BIMS) assessment dated [DATE] revealed Resident #37 had intact cognition. Review of the physician orders dated 04/05/23, 06/05/23, and 07/18/23 revealed Resident #37 had an order to start a peripheral IV for IV Micronutrient Hydration Therapy - Derma and Infection Infusion (Vitamin C, B-Complex, B1, B2, B3, B5, B6, B12, Magnesium Chloride, Calcium Gluconate, Zinc, Amino Blend, Glutamine, Arginine, Ornthine, Lysine, Citrulline, BCAAA, B7 Biotin, and Glutathione) 500 milliliters (ml) per hour with 500 ml of Normal Saline (NS) 0.9% due to wound management and infections. On 08/14/23, a Hydration Infusion for hydration (Vitamin C, B Complex, B1, B2, B3, B4, B5, B6, B12, Magnesium Chloride, Calcium Gluconate, and Zinc) 250 ml at 250 ml per hour Review of the Medication Administration Record (MAR) revealed Resident #37 received the IV Micronutrient Hydration Therapy - with NS 0.9% on 04/26/23, 06/07/23, 07/19/23, and 08/16/23 All the IV Micronutrient Hydration Therapy - Nutrition Infusion administrations were completed by an ancillary provider not employed at the facility. 4. Record review for Resident #42 revealed the resident was admitted to the facility on [DATE]. Diagnoses included hypertension, Alzheimer's disease, edema, dermatitis, and other infectous or parasitic diseases Review of the Brief Interview for Mental Status (BIMS) assessment dated [DATE] revealed Resident #42 had intact cognition. Review of the physician orders dated 04/05/23, 05/24/23, 06/07/23, 07/19/23 and 0814/23 revealed Resident #42 had an order to start a peripheral IV for IV Micronutrient Hydration Therapy -Cognition Infusion (Vitamin C, B-Complex, B-1, B2, B3, B5, B-6, Biotin, B-12, Magnesium Chloride, Calcium Gluconate, Zinc, Amino Blend, Glutamine, Arginine, Omithine, Lysine, Citrulline, Taurine, and Glycine) 1,000 ml with 1,000 ml of NS 0.9%. Review of the Medication Administration Record (MAR) revealed Resident #42 received the IV Micronutrient Hydration Therapy - Nutrition Infusion with NS 0.9% on 05/11/23, 06/08/23, and 07/13/23. All the IV Micronutrient Hydration Therapy - Cognition Infusion administrations All the IV Micronutrient Hydration Therapy - Cognitive Infusion administrations were completed by an ancillary provider not employed at the facility. Review of the facility's contract with the ancillary provider revealed the contract was entered into agreement on 01/24/23. This provided for a monthly clinic to be provided to residents with various deficiencies. The type of therapy was administered per physician orders by contracted staff through 365065 Page 10 of 12 365065 12/06/2023 Harrison Pavilion Care Center 2171 Harrison Avenue Cincinnati, OH 45211

F 0837 the ancillary provider. Level of Harm - Minimal harm or potential for actual harm Interview with the Corporate [NAME] President of Operations (CVOP) #60 on 12/06/23 at 9:50 A.M. revealed the facilities entered into the contract with the ancillary provider on 01/24/23 and began treatment clinics in March 2023. CVOP #60 verified the ancillary provider brought their own supplies and IV products to the facility. CVOP #60 verified the ancillary provider was based out of Illinois and used their own staff for IV administration. CVOP #60 verified she was never provided with the company's Ohio Terminal Distributor of Dangerous Drugs (TDDD) license. CVOP #60 verified the above listed residents received IV infusions of medications supplied by an unlicensed ancillary provider. Residents Affected - Some Interview with Chief Executive Officer #80 from the ancillary provider on 12/06/23 at 9:55 A.M. verified his company does not have and did not ever have an Ohio TDDD license to provide drugs in the State of Ohio, as he did not understand the specific Ohio laws. He verified a Cease and Desist order was given in September 2023, and no further infusions had taken place after this order. He verified two of his nurses would come in the facility and provide services, which one had an Ohio license and the other has a reciprocal license from the state of Indiana to practice in Ohio. 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, repackager, 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, repackager, or wholesale distributor; or (4) A terminal distributor, manufacturer, outsourcing facility, third-party logistics provider, repackager, 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. The deficient practice was corrected on 11/21/23 when the facility implemented the following corrective actions: • The company no longer serves the facility with cessation of services effective on 09/22/23. • 365065 Page 11 of 12 365065 12/06/2023 Harrison Pavilion Care Center 2171 Harrison Avenue Cincinnati, OH 45211

F 0837 Level of Harm - Minimal harm or potential for actual harm All residents that received services from the company have been properly assessed by the Director of Nursing (DON)/designee and do not have any signs or symptoms of adverse effects related to IVF/medications received on or before 11/21/23. • Residents Affected - Some All residents with prior services from the company are at risk of this alleged deficient practice. • This service from the company is no longer being offered effective 09/22/23. • All contracts that involve providing medication were reviewed to ensure the proper TDDD licensure is in place, completed on or before 11/21/23. • Education was provided to the governing body to ensure that TDDD licensure for Ohio is effective before accepting medication into the facility or completion of administration was completed on or before 11/21/23. This was completed by the Director of Clinical Services #99. • Administrator/designee will complete audits 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 for three months. All audits will be provided to QAPI for review, effective 11/21/23. This deficiency represents non-compliance investigated under Complaint Number OH00148108. 365065 Page 12 of 12