Health inspection·November 16, 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** Based on record review, review of the State of Ohio Board of Pharmacy Terminal Distributor Licensure of Prescriber Practices, and interviews, 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 #27, #89, #85, and #30) of four reviewed for IV administration. This affected had the potential to 23 (Residents #146, #64, #38, #23, #65, #96, #70, #13, #8, #27, #89, #66, #75, #85, #30, #88, #87, #55, #61, #63, #16, #67, and #145) and 18 discharged Residents (#180, #181, #182, #183, #184, #185, #186, #187, #188, #189, #190, #191, #192, #193, #194, #195, #196, and #197) identified by the facility who received IV fluids from the unlicensed source. The census was 160. Residents Affected - Some Findings include: 1. Review of the medical record for Resident #27 revealed an admission date of 04/06/23. Diagnoses included chronic respiratory failure with hypercapnia, Chronic Obstructive Pulmonary Disease (COPD), major depressive disorder, morbid obesity, malignant neoplasm, Diabetes Mellitus Type 2 (DM2), dependence of respirator, obstructive sleep apnea, and colostomy status. Review of the quarterly Minimum Data Set (MDS) Assessment revealed Resident #27 had intact cognition. The resident required supervision setup only for bed mobility, transfers, and personal hygiene. The resident was at risk for pressure ulcers. Review of the plan of care dated 12/21/22 revealed the resident had potential for nutritional risk related to therapeutic diet, diabetes, diet as ordered, cancer, wounds, refuses weights at times, morbid obesity, and abnormal labs. Interventions included to honor food/fluid preferences as possible. At risk for nutrition or hydration problems with an intervention to provide diet as ordered and provide assistance with meals and hydration. At risk for complications related to medical conditions, medications and treatments, with interventions to document and notify physician (MD) of abnormal findings, labs as ordered, medications and treatment per physician orders. Review of physician orders dated 07/06/23 revealed Infection and Derma infusion protocol for Dript intravenous (IV) Nurse-Dript IV therapy infusion one time 1000 milliliters (ml) normal saline (0.9) at 1000 ml/hour (hr), total additive volume, 24 ml. Additive formula: Ascorbic acid 5 gram (gm), B complex {B1 Thiamine (Thia)} 100 milligram (mg), B2 Riboflavin (Ribo) 2 mg, B3 Niacin (Nia) 100 mg, B5 Dexpanthenol (Dex) 2 mg, B6 Pyridoxine (Pyr) 2 mg} B5 (Dexpanthenol) 250 mg, B7 Biotin 20 mg, Zinc 10 mg, Amino Blend?, Glutamine 150 mg, Arginine 500 mg, Ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg, Glutathione 600 mg, 3 ml given intravenous push (IVP) at the end of infusion, one time only Page 1 of 15 365209 365209 11/16/2023 Majestic Care of Middletown LLC 6898 Hamilton Middletown Road Middletown, OH 45044

F 0694 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some for micronutrient hydration therapy for one day one time only for hydration and nutritional wellness secondary to intake/falls/decline and acute/chronic infection/Urinary Tract Infection (UTI) and frequent infections for one day infusion administration time may very based on clinic. Start 07/06/23. Review of physician orders dated 09/07/23 revealed infection infusion protocol-for Dript IV nurse-Dript IV therapy infusion-one time (1000 ml) 0.9% NS at 1000ml/hr (Total additive volume, 22 ml) additive formula: Ascorbic acid 5 gm, B complex- {B1 Thia 100 mg, B2 Ribo 2 mg, B3 Nia 100 mg, B5 Dex 2 mg, B6 Pyr 2 mg} B5 (Dexpanthenol) 250 mg, Zinc 10mg-1 ml Amino Blend? Glutamine 150 mg, Arginine 500 mg, Ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg, Glutathione 600 mg, 3ml given intravenous IVP at the end of infusion one time only for infection, for one day, end date is the date of infusion Micronutrient hydration therapy. 2. Review of the medical record for Resident #89 revealed an admission date of 12/31/19. Diagnoses included COPD, hemiplegia and hemiparesis, cognitive communication deficit, acute and chronic respiratory failure, hypertension, and gastroesophageal reflux disease (GERD). Review of the quarterly MDS assessment dated [DATE] revealed Resident #89 had impaired cognition. The resident required extensive assistance of two persons for bed mobility, and personal hygiene. The resident required extensive assistance of one person for transfers. The resident had impairment to both sides of upper and lower extremities. Review of the plan of care dated 12/31/23 revealed the resident had potential for nutritional risk related to history of dementia, depression, obese, no significant changes in weight, and diet as ordered. Interventions included honor food/fluid preferences as possible and document food/fluid intakes. Review of physician orders dated 07/05/23 and 08/04/23 revealed hydration infusion protocol-for Dript IV nurse-Dript IV therapy infusion one time (1000ml) 0.9% normal saline at 1000 ml/hr. (Total additive volume, 19.4 ml) Additive formula: Ascorbic acid 5 mg, B complex- {B1 Thia 100 mg, B2 Ribo 2 mg, B3 Nia 100 mg, B5 Dex 2 mg, B6 Pyr 2 mg} 1ml, B5 (Dexpanthenol) 250 mg, Methylcobalamin 2 mg, Magnesium Chloride 900 mg, Calcium Gluconate 200 mg, Zinc 10 mg. 3. Review of the medical record for Resident #85 revealed an admission date of 10/19/17. Diagnoses included DM2 with diabetic polyneuropathy, aphasia, acquired absence of right leg below knee, COPD, acquired absence of left leg above the knee, hemiplegia and hemiparesis following cerebral infarction affecting right dominant side, cutaneous abscess of right and left foot, and vitamin deficiency. Review of the quarterly MDS assessment dated [DATE] revealed Resident #85 had impaired cognition. The resident required substantial/maximal assistance for bed mobility, was dependent for chair to bed transfer and personal hygiene. Review of the plan of care dated 10/18/23 revealed the resident had potential for nutritional risk related to diabetes, renal disease, dysphasia, diet as ordered, and weight loss due to amputation. Intervention included to provide and serve supplements as ordered. Review of physician orders dated 07/06/23, 08/04/23, and 09/07/23 revealed Nutrition infusion protocol-Dript IV therapy infusion-one time-1000ml 0.9% normal saline at 1000ml/hr. (Total Additive volume 27.4ml) Ascorbic Acid 5 mg, B complex- {B1 [NAME] 100 mg, B2 Ribo 2 mg, B3 Nia 100 mg, B5 Dex 2 365209 Page 2 of 15 365209 11/16/2023 Majestic Care of Middletown LLC 6898 Hamilton Middletown Road Middletown, OH 45044

F 0694 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some mg, B6 Pyr 2 mg} B5 (Dexpanthenol) 250 mg, Methylcobalamin 2 mg, Magnesium Chloride 900 mg, Calcium Chloride 200 mg, Zinc 10 mg, Amino Blend?, glutamine 150 mg, Arginine 500 mg, Ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg- branched-chain amino acid (BCAA), essential nutrients that help support muscle metabolism and are important for building muscle tissue protein, {Leucine (Leu) 20 mg/ISO 30 mg/[NAME] 80mg}. One time only for nutrition for one day. End date is date of infusion Micronutrient hydration therapy. 4. Review of the medical record for Resident #30 revealed an admission date of 04/20/23. Diagnoses included anoxic brain damage, acute and chronic respiratory failure, COPD, and gastrostomy status. Review of the admission MDS assessment dated [DATE] revealed Resident #30 was non-responsive with memory problem. The resident had impairment to both sides of upper and lower extremities and required extensive assistance of two persons for bed mobility. The resident required total assistance of two persons for hygiene. Resident #30 was at risk for pressure ulcers, and required invasive mechanical ventilation and tube feeds. Review of the plan of care dated 04/21/23 revealed the resident had potential for nutritional risk related to enteral feeding, nothing by mouth (NPO), brain injury, trach collar and vent support, tube feed dependent, supplement and tube feed as ordered, abnormal labs, and multiple pressure wounds with goal to not exhibit significant weight change. Interventions included provide and serve supplements as ordered. The resident had impaired skin integrity related to anoxic brain injury and tracheostomy status with an intervention for supplements as ordered. Review of physician orders dated 07/06/23, 08/04/23, and 09/07/23 revealed Derma Infusion protocol-for Dript IV nurse-Dript IV therapy infusion-one time-1000ml 0.9% normal saline at 1000ml/hr (total additive volume, 20 ml) Additive formula: ascorbic acid 5 mg, B Complex-{B1 Thia 100 mg, B2 Ribo 2 mg, B3 Nia 100 mg, B5 Dex 2 mg, B6 Pyr 2 mg}B7 Biotin 20 mg, Amino Blend?, glutamine 150 mg, Arginine 500 mg, ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg, zinc 10 mg one time only for Derma for one day end date is date of infusion, micronutrient hydration therapy. Interview on 11/14/23 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 stated the representative did not inform the facility of concerns related to TDDD Ohio licensure. Interview on 11/14/23 at 10:16 A.M. with the Administrator revealed he was unaware of adverse outcomes related to the infusion of the medications. He was not aware of concerns related to TDDD licensure and stated the initial service agreement would have been initiated at the corporate level. Interview on 11/14/23 at 3:53 P.M. the DON confirmed the above listed residents received IV infusions of medications supplied by an unlicensed ancillary provider. 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 365209 Page 3 of 15 365209 11/16/2023 Majestic Care of Middletown LLC 6898 Hamilton Middletown Road Middletown, OH 45044

F 0694 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some 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. This deficiency represents non-compliance investigated under Complaint Number OH00148164. 365209 Page 4 of 15 365209 11/16/2023 Majestic Care of Middletown LLC 6898 Hamilton Middletown Road Middletown, OH 45044

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** 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 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 (#27, #89, #85, and #30) reviewed for medications administered by a contracted ancillary provider. This affected 23 current Residents (#146, #64, #38, #23, #65, #96, #70, #13, #8, #27, #89, #66, #75, #85, #30, #88, #87, #55, #61, #63, #16, #67, and #145) and 18 discharged Residents (#180, #181, #182, #183, #184, #185, #186, #187, #188, #189, #190, #191, #192, #193, #194, #195, #196, and #197). The census was 160. Findings include: 1. Review of the medical record for Resident #27 revealed an admission date of 04/06/23. Diagnoses included chronic respiratory failure with hypercapnia, Chronic Obstructive Pulmonary Disease (COPD), major depressive disorder, morbid obesity, malignant neoplasm, Diabetes Mellitus Type 2 (DM2), dependence of respirator, obstructive sleep apnea, and colostomy status. Review of the quarterly Minimum Data Set (MDS) Assessment revealed Resident #27 had intact cognition. The resident required supervision setup only for bed mobility, transfers, and personal hygiene. The resident was at risk for pressure ulcers. Review of the plan of care dated 12/21/22 revealed the resident had potential for nutritional risk related to therapeutic diet, diabetes, diet as ordered, cancer, wounds, refuses weights at times, morbid obesity, and abnormal labs. Interventions included to honor food/fluid preferences as possible. At risk for nutrition or hydration problems with an intervention to provide diet as ordered and provide assistance with meals and hydration. At risk for complications related to medical conditions, medications and treatments, with interventions to document and notify physician (MD) of abnormal findings, labs as ordered, medications and treatment per physician orders. Review of physician orders dated 07/06/23 revealed Infection and Derma infusion protocol for Dript intravenous (IV) Nurse-Dript IV therapy infusion one time 1000 milliliters (ml) normal saline (0.9) at 1000 ml/hour (hr), total additive volume, 24 ml. Additive formula: Ascorbic acid 5 gram (gm), B complex {B1 Thiamine (Thia)} 100 milligram (mg), B2 Riboflavin (Ribo) 2 mg, B3 Niacin (Nia) 100 mg, B5 Dexpanthenol (Dex) 2 mg, B6 Pyridoxine (Pyr) 2 mg} B5 (Dexpanthenol) 250 mg, B7 Biotin 20 mg, Zinc 10 mg, Amino Blend?, Glutamine 150 mg, Arginine 500 mg, Ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg, Glutathione 600 mg, 3 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/falls/decline and acute/chronic infection/Urinary Tract Infection (UTI) and frequent infections for one day infusion administration time may very based on clinic. Start 07/06/23. Review of physician orders dated 09/07/23 revealed infection infusion protocol-for Dript IV nurse-Dript IV therapy infusion-one time (1000 ml) 0.9% NS at 1000ml/hr (Total additive volume, 22 ml) additive formula: Ascorbic acid 5 gm, B complex- {B1 Thia 100 mg, B2 Ribo 2 mg, B3 Nia 100 mg, B5 Dex 2 mg, B6 Pyr 2 mg} B5 (Dexpanthenol) 250 mg, Zinc 10mg-1 ml Amino Blend? Glutamine 150 mg, Arginine 365209 Page 5 of 15 365209 11/16/2023 Majestic Care of Middletown LLC 6898 Hamilton Middletown Road Middletown, OH 45044

F 0755 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some 500 mg, Ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg, Glutathione 600 mg, 3ml given intravenous IVP at the end of infusion one time only for infection, for one day, end date is the date of infusion Micronutrient hydration therapy. 2. Review of the medical record for Resident #89 revealed an admission date of 12/31/19. Diagnoses included COPD, hemiplegia and hemiparesis, cognitive communication deficit, acute and chronic respiratory failure, hypertension, and gastroesophageal reflux disease (GERD). Review of the quarterly MDS assessment dated [DATE] revealed Resident #89 had impaired cognition. The resident required extensive assistance of two persons for bed mobility, and personal hygiene. The resident required extensive assistance of one person for transfers. The resident had impairment to both sides of upper and lower extremities. Review of the plan of care dated 12/31/23 revealed the resident had potential for nutritional risk related to history of dementia, depression, obese, no significant changes in weight, and diet as ordered. Interventions included honor food/fluid preferences as possible and document food/fluid intakes. Review of physician orders dated 07/05/23 and 08/04/23 revealed hydration infusion protocol-for Dript IV nurse-Dript IV therapy infusion one time (1000ml) 0.9% normal saline at 1000 ml/hr. (Total additive volume, 19.4 ml) Additive formula: Ascorbic acid 5 mg, B complex- {B1 Thia 100 mg, B2 Ribo 2 mg, B3 Nia 100 mg, B5 Dex 2 mg, B6 Pyr 2 mg} 1ml, B5 (Dexpanthenol) 250 mg, Methylcobalamin 2 mg, Magnesium Chloride 900 mg, Calcium Gluconate 200 mg, Zinc 10 mg. 3. Review of the medical record for Resident #85 revealed an admission date of 10/19/17. Diagnoses included DM2 with diabetic polyneuropathy, aphasia, acquired absence of right leg below knee, COPD, acquired absence of left leg above the knee, hemiplegia and hemiparesis following cerebral infarction affecting right dominant side, cutaneous abscess of right and left foot, and vitamin deficiency. Review of the quarterly MDS assessment dated [DATE] revealed Resident #85 had impaired cognition. The resident required substantial/maximal assistance for bed mobility, was dependent for chair to bed transfer and personal hygiene. Review of the plan of care dated 10/18/23 revealed the resident had potential for nutritional risk related to diabetes, renal disease, dysphasia, diet as ordered, and weight loss due to amputation. Intervention included to provide and serve supplements as ordered. Review of physician orders dated 07/06/23, 08/04/23, and 09/07/23 revealed Nutrition infusion protocol-Dript IV therapy infusion-one time-1000ml 0.9% normal saline at 1000ml/hr. (Total Additive volume 27.4ml) Ascorbic Acid 5 mg, B complex- {B1 [NAME] 100 mg, B2 Ribo 2 mg, B3 Nia 100 mg, B5 Dex 2 mg, B6 Pyr 2 mg} B5 (Dexpanthenol) 250 mg, Methylcobalamin 2 mg, Magnesium Chloride 900 mg, Calcium Chloride 200 mg, Zinc 10 mg, Amino Blend?, glutamine 150 mg, Arginine 500 mg, Ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg- branched-chain amino acid (BCAA), essential nutrients that help support muscle metabolism and are important for building muscle tissue protein, {Leucine (Leu) 20 mg/ISO 30 mg/[NAME] 80mg}. One time only for nutrition for one day. End date is date of infusion Micronutrient hydration therapy. 4. Review of the medical record for Resident #30 revealed an admission date of 04/20/23. Diagnoses included anoxic brain damage, acute and chronic respiratory failure, COPD, and gastrostomy status. 365209 Page 6 of 15 365209 11/16/2023 Majestic Care of Middletown LLC 6898 Hamilton Middletown Road Middletown, OH 45044

F 0755 Level of Harm - Minimal harm or potential for actual harm Review of the admission MDS assessment dated [DATE] revealed Resident #30 was non-responsive with memory problem. The resident had impairment to both sides of upper and lower extremities and required extensive assistance of two persons for bed mobility. The resident required total assistance of two persons for hygiene. Resident #30 was at risk for pressure ulcers, and required invasive mechanical ventilation and tube feeds. Residents Affected - Some Review of the plan of care dated 04/21/23 revealed the resident had potential for nutritional risk related to enteral feeding, nothing by mouth (NPO), brain injury, trach collar and vent support, tube feed dependent, supplement and tube feed as ordered, abnormal labs, and multiple pressure wounds with goal to not exhibit significant weight change. Interventions included provide and serve supplements as ordered. The resident had impaired skin integrity related to anoxic brain injury and tracheostomy status with an intervention for supplements as ordered. Review of physician orders dated 07/06/23, 08/04/23, and 09/07/23 revealed Derma Infusion protocol-for Dript IV nurse-Dript IV therapy infusion-one time-1000ml 0.9% normal saline at 1000ml/hr (total additive volume, 20 ml) Additive formula: ascorbic acid 5 mg, B Complex-{B1 Thia 100 mg, B2 Ribo 2 mg, B3 Nia 100 mg, B5 Dex 2 mg, B6 Pyr 2 mg}B7 Biotin 20 mg, Amino Blend?, glutamine 150 mg, Arginine 500 mg, ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg, zinc 10 mg one time only for Derma for one day end date is date of infusion, micronutrient hydration therapy. Interview on 11/14/23 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 stated the representative did not inform the facility of concerns related to TDDD Ohio licensure. Interview on 11/14/23 at 10:16 A.M. with the Administrator revealed he was unaware of adverse outcomes related to the infusion of the medications. He was not aware of concerns related to TDDD licensure and stated the initial service agreement would have been initiated at the corporate level. Interview on 11/14/23 at 3:53 P.M. the DON confirmed the above listed residents received IV infusions of medications supplied by an unlicensed ancillary provider. 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. Interview on 11/15/23 at 12:44 P.M. the Medical Director stated the company was introduced as an ancillary service. She stated they welcomed the idea as it would benefit residents with wounds and risks for dehydration. The intravenous infusion contained vitamins, minerals, and zinc additives. She stated the therapy was introduced from corporate, it was not experimental, and a service not 365209 Page 7 of 15 365209 11/16/2023 Majestic Care of Middletown LLC 6898 Hamilton Middletown Road Middletown, OH 45044

F 0755 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some typically provided through the contracted pharmacy. She stated she was not involved in the provider agreement, it was auxiliary, and a flyer was presented that informed of potential benefits. She stated when a service was brought on board, she assumed it had been reviewed. She stated the facility had several ancillary providers, dental, wound, and podiatry. 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. This deficiency represents non-compliance investigated under Complaint Number OH00148164. 365209 Page 8 of 15 365209 11/16/2023 Majestic Care of Middletown LLC 6898 Hamilton Middletown Road Middletown, OH 45044

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** 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 (#27, #89, #85, and #30) reviewed for medications administered by a contracted ancillary provider. This affected 23 current Residents (#146, #64, #38, #23, #65, #96, #70, #13, #8, #27, #89, #66, #75, #85, #30, #88, #87, #55, #61, #63, #16, #67, and #145) and 18 discharged Residents (#180, #181, #182, #183, #184, #185, #186, #187, #188, #189, #190, #191, #192, #193, #194, #195, #196, and #197). The census was 160. Findings include: 1. Review of the medical record for Resident #27 revealed an admission date of 04/06/23. Diagnoses included chronic respiratory failure with hypercapnia, Chronic Obstructive Pulmonary Disease (COPD), major depressive disorder, morbid obesity, malignant neoplasm, Diabetes Mellitus Type 2 (DM2), dependence of respirator, obstructive sleep apnea, and colostomy status. Review of the quarterly Minimum Data Set (MDS) Assessment revealed Resident #27 had intact cognition. The resident required supervision setup only for bed mobility, transfers, and personal hygiene. The resident was at risk for pressure ulcers. Review of the plan of care dated 12/21/22 revealed the resident had potential for nutritional risk related to therapeutic diet, diabetes, diet as ordered, cancer, wounds, refuses weights at times, morbid obesity, and abnormal labs. Interventions included to honor food/fluid preferences as possible. At risk for nutrition or hydration problems with an intervention to provide diet as ordered and provide assistance with meals and hydration. At risk for complications related to medical conditions, medications and treatments, with interventions to document and notify physician (MD) of abnormal findings, labs as ordered, medications and treatment per physician orders. Review of physician orders dated 07/06/23 revealed Infection and Derma infusion protocol for Dript intravenous (IV) Nurse-Dript IV therapy infusion one time 1000 milliliters (ml) normal saline (0.9) at 1000 ml/hour (hr), total additive volume, 24 ml. Additive formula: Ascorbic acid 5 gram (gm), B complex {B1 Thiamine (Thia)} 100 milligram (mg), B2 Riboflavin (Ribo) 2 mg, B3 Niacin (Nia) 100 mg, B5 Dexpanthenol (Dex) 2 mg, B6 Pyridoxine (Pyr) 2 mg} B5 (Dexpanthenol) 250 mg, B7 Biotin 20 mg, Zinc 10 mg, Amino Blend?, Glutamine 150 mg, Arginine 500 mg, Ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg, Glutathione 600 mg, 3 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/falls/decline and acute/chronic infection/Urinary Tract Infection (UTI) and frequent infections for one day infusion administration time may very based on clinic. Start 07/06/23. Review of physician orders dated 09/07/23 revealed infection infusion protocol-for Dript IV nurse-Dript IV therapy infusion-one time (1000 ml) 0.9% NS at 1000ml/hr (Total additive volume, 22 ml) additive formula: Ascorbic acid 5 gm, B complex- {B1 Thia 100 mg, B2 Ribo 2 mg, B3 Nia 100 mg, B5 Dex 2 mg, B6 Pyr 2 mg} B5 (Dexpanthenol) 250 mg, Zinc 10mg-1 ml Amino Blend? Glutamine 150 mg, Arginine 365209 Page 9 of 15 365209 11/16/2023 Majestic Care of Middletown LLC 6898 Hamilton Middletown Road Middletown, OH 45044

F 0837 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some 500 mg, Ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg, Glutathione 600 mg, 3ml given intravenous IVP at the end of infusion one time only for infection, for one day, end date is the date of infusion Micronutrient hydration therapy. 2. Review of the medical record for Resident #89 revealed an admission date of 12/31/19. Diagnoses included COPD, hemiplegia and hemiparesis, cognitive communication deficit, acute and chronic respiratory failure, hypertension, and gastroesophageal reflux disease (GERD). Review of the quarterly MDS assessment dated [DATE] revealed Resident #89 had impaired cognition. The resident required extensive assistance of two persons for bed mobility, and personal hygiene. The resident required extensive assistance of one person for transfers. The resident had impairment to both sides of upper and lower extremities. Review of the plan of care dated 12/31/23 revealed the resident had potential for nutritional risk related to history of dementia, depression, obese, no significant changes in weight, and diet as ordered. Interventions included honor food/fluid preferences as possible and document food/fluid intakes. Review of physician orders dated 07/05/23 and 08/04/23 revealed hydration infusion protocol-for Dript IV nurse-Dript IV therapy infusion one time (1000ml) 0.9% normal saline at 1000 ml/hr. (Total additive volume, 19.4 ml) Additive formula: Ascorbic acid 5 mg, B complex- {B1 Thia 100 mg, B2 Ribo 2 mg, B3 Nia 100 mg, B5 Dex 2 mg, B6 Pyr 2 mg} 1ml, B5 (Dexpanthenol) 250 mg, Methylcobalamin 2 mg, Magnesium Chloride 900 mg, Calcium Gluconate 200 mg, Zinc 10 mg. 3. Review of the medical record for Resident #85 revealed an admission date of 10/19/17. Diagnoses included DM2 with diabetic polyneuropathy, aphasia, acquired absence of right leg below knee, COPD, acquired absence of left leg above the knee, hemiplegia and hemiparesis following cerebral infarction affecting right dominant side, cutaneous abscess of right and left foot, and vitamin deficiency. Review of the quarterly MDS assessment dated [DATE] revealed Resident #85 had impaired cognition. The resident required substantial/maximal assistance for bed mobility, was dependent for chair to bed transfer and personal hygiene. Review of the plan of care dated 10/18/23 revealed the resident had potential for nutritional risk related to diabetes, renal disease, dysphasia, diet as ordered, and weight loss due to amputation. Intervention included to provide and serve supplements as ordered. Review of physician orders dated 07/06/23, 08/04/23, and 09/07/23 revealed Nutrition infusion protocol-Dript IV therapy infusion-one time-1000ml 0.9% normal saline at 1000ml/hr. (Total Additive volume 27.4ml) Ascorbic Acid 5 mg, B complex- {B1 [NAME] 100 mg, B2 Ribo 2 mg, B3 Nia 100 mg, B5 Dex 2 mg, B6 Pyr 2 mg} B5 (Dexpanthenol) 250 mg, Methylcobalamin 2 mg, Magnesium Chloride 900 mg, Calcium Chloride 200 mg, Zinc 10 mg, Amino Blend?, glutamine 150 mg, Arginine 500 mg, Ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg- branched-chain amino acid (BCAA), essential nutrients that help support muscle metabolism and are important for building muscle tissue protein, {Leucine (Leu) 20 mg/ISO 30 mg/[NAME] 80mg}. One time only for nutrition for one day. End date is date of infusion Micronutrient hydration therapy. 4. Review of the medical record for Resident #30 revealed an admission date of 04/20/23. Diagnoses included anoxic brain damage, acute and chronic respiratory failure, COPD, and gastrostomy status. 365209 Page 10 of 15 365209 11/16/2023 Majestic Care of Middletown LLC 6898 Hamilton Middletown Road Middletown, OH 45044

F 0837 Level of Harm - Minimal harm or potential for actual harm Review of the admission MDS assessment dated [DATE] revealed Resident #30 was non-responsive with memory problem. The resident had impairment to both sides of upper and lower extremities and required extensive assistance of two persons for bed mobility. The resident required total assistance of two persons for hygiene. Resident #30 was at risk for pressure ulcers, and required invasive mechanical ventilation and tube feeds. Residents Affected - Some Review of the plan of care dated 04/21/23 revealed the resident had potential for nutritional risk related to enteral feeding, nothing by mouth (NPO), brain injury, trach collar and vent support, tube feed dependent, supplement and tube feed as ordered, abnormal labs, and multiple pressure wounds with goal to not exhibit significant weight change. Interventions included provide and serve supplements as ordered. The resident had impaired skin integrity related to anoxic brain injury and tracheostomy status with an intervention for supplements as ordered. Review of physician orders dated 07/06/23, 08/04/23, and 09/07/23 revealed Derma Infusion protocol-for Dript IV nurse-Dript IV therapy infusion-one time-1000ml 0.9% normal saline at 1000ml/hr (total additive volume, 20 ml) Additive formula: ascorbic acid 5 mg, B Complex-{B1 Thia 100 mg, B2 Ribo 2 mg, B3 Nia 100 mg, B5 Dex 2 mg, B6 Pyr 2 mg}B7 Biotin 20 mg, Amino Blend?, glutamine 150 mg, Arginine 500 mg, ornithine 150 mg, Lysine 250 mg, Citrulline 250 mg, zinc 10 mg one time only for Derma for one day end date is date of infusion, micronutrient hydration therapy. Interview on 11/14/23 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 stated the representative did not inform the facility of concerns related to TDDD Ohio licensure. Interview on 11/14/23 at 10:16 A.M. with the Administrator revealed he was unaware of adverse outcomes related to the infusion of the medications. He was not aware of concerns related to TDDD licensure and stated the initial service agreement would have been initiated at the corporate level. Interview on 11/14/23 at 3:53 P.M. the DON confirmed the above listed residents received IV infusions of medications supplied by an unlicensed ancillary provider. 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. 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 rehospitalization. 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 365209 Page 11 of 15 365209 11/16/2023 Majestic Care of Middletown LLC 6898 Hamilton Middletown Road Middletown, OH 45044

F 0837 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some 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 11/15/23 at 12:44 P.M. the Medical Director stated the company was introduced as an ancillary service. She stated they welcomed the idea as it would benefit residents with wounds and risks for dehydration. The intravenous infusion contained vitamins, minerals, and zinc additives. She stated the therapy was introduced from corporate, it was not experimental, and a service not typically provided through the contracted pharmacy. She stated she was not involved in the provider agreement, it was auxiliary, and a flyer was presented that informed of potential benefits. She stated when a service was brought on board, she assumed it had been reviewed. She stated the facility had several ancillary providers, dental, wound, and podiatry. 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. 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 365209 Page 12 of 15 365209 11/16/2023 Majestic Care of Middletown LLC 6898 Hamilton Middletown Road Middletown, OH 45044

F 0837 Level of Harm - Minimal harm or potential for actual harm 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. This deficiency represents non-compliance investigated under Complaint Number OH00148164. Residents Affected - Some 365209 Page 13 of 15 365209 11/16/2023 Majestic Care of Middletown LLC 6898 Hamilton Middletown Road Middletown, OH 45044

F 0842 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Few Safeguard resident-identifiable information and/or maintain medical records on each resident that are in accordance with accepted professional standards. Based on record review, staff interviews, and review of facility policy, the facility failed to ensure medication administration was signed off by appropriate staff. This affected two (Residents #27 and #85) of four reviewed for Intravenous (IV) administration of medications. The census was 160. Findings include: 1. Review of the medical record for Resident #27 revealed an admission date 04/06/23. Diagnoses included chronic respiratory failure with hypercapnia, chronic obstructive pulmonary disease (COPD), major depressive disorder, morbid obesity, malignant neoplasm, Diabetes Mellitus Type 2 (DM2), dependence of respirator, obstructive sleep apnea, and colostomy status. Review of the Medication Administration Record (MAR) for July 2023 revealed facility Licensed Practical Nurse (LPN) #313 signed off an IV medication on 07/06/23. The medication was to have been infused by a contracted Registered Nurse (RN) from the ancillary provider. Interview on 11/15/23 at 4:02 P.M. with the Director of Nursing (DON) verified she spoke with LPN #313 on 11/15/23 at 10:00 A.M. by phone and the LPN reported she did not administer the medication and admitted to signing off. The DON stated she provided education. 2. Review of the medical record for Resident #85 revealed admission date 10/19/17. Diagnoses included DM2 with diabetic polyneuropathy, aphasia, acquired absence of right leg below knee, COPD, acquired absence of left leg above the knee, hemiplegia and hemiparesis following cerebral infarction affecting right dominant side, cutaneous abscess of right and left foot, and vitamin deficiency. Review of the MAR for August 2023 revealed facility LPN #411 signed off on an IV medication on 08/04/23. The medication was to have been infused by a contracted Registered Nurse (RN) from the ancillary provider. Interview on 11/15/23 at 4:02 P.M. with the Director of Nursing (DON) verified LPN #411 no longer worked for the facility. Interview on 11/16/23 at 11:48 A.M. contracted Registered Nurse (RN) #409 revealed facility staff did not administer the IV medications contracted to be administered by the ancillary provider. She provided education to facility nurses and with one time orders, the order dropped off the MAR with no ability for them to sign the order. Interview on 11/16/23 at 11:59 A.M. with contracted RN #410 stated facility staff did not administer the IV medications ordered to be administered by the contracted staff. She stated once the order was signed there was no opportunity to strike out the sign off. She stated she educated facility nurses. Review of the facility policy titled, Medication Administration, dated 10/20/20, revealed medications are administered by licensed nurses, or other staff who are legally authorized to do so in this state, as ordered by the physician and in accordance with professional standards of practice, in a manner to prevent contamination or infection. 17. Sign MAR after administered. For those medications requiring vital signs, record the vital signs onto the MAR. 19. Report and document any adverse side 365209 Page 14 of 15 365209 11/16/2023 Majestic Care of Middletown LLC 6898 Hamilton Middletown Road Middletown, OH 45044

F 0842 effects or refusals. Level of Harm - Minimal harm or potential for actual harm Residents Affected - Few 365209 Page 15 of 15