Health inspection·December 7, 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 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 #13, #22, #72, and #80) out of four residents reviewed for IV medication administration. This also affected 11 current residents (Residents #1, #3, #4, #8, #14, #37, #71, #75, #76, #87, and #90) and 16 discharged residents (Residents #100, #101, #102, #103, #104, #105, #106, #107, #108, #109, #110, #111, #112, #113, #114, and #115) that were identified by the facility as having received IV medication from the unlicensed source. The census was 90. Findings include: 1. Review of the medical record for Resident #13 revealed he was admitted to the facility on [DATE]. Diagnoses included chronic obstructive pulmonary disease, major depressive disorder, hyperlipidemia, obesity, and diabetes mellitus due to underlying condition with diabetic neuropathy. Review of the quarterly Minimum Data Set (MDS) 3.0 assessment, dated 05/17/23, revealed Resident #13 had moderately impaired cognition evidenced by a Brief Interview for Mental Status (BIMS) score of 15. The resident was assessed to require limited assistance for bed mobility, transfers, dressing, and toilet use as well as supervision for personal hygiene and eating. Review of the plan of care revised on 08/17/23 revealed the resident was at nutritional risk related to diagnoses of diabetes mellitus, chronic obstructive pulmonary disease, hyperlipidemia, and depression. The resident was also at risk for dehydration related to diuretic use. Interventions included monitoring intakes, labs, weights and skin assessments, and observing signs/symptoms of dehydration. Review of the physician orders dated 06/05/23, 07/18/23, 08/15/23, and 09/19/23 revealed orders for nutrition Agency #700 IV therapy infusion one time (500 milliliters (ml)) 0.9 % normal saline at 500 ml/hour (total additive volume 27.4 ml) with vitamin c 5 grams (gm), B complex, {[NAME] 200 milligrams (mg), Rib 4 mg, Nia 200 mg, Dex 4 mg, Pyr 4 mg, B5 250 mg, Methyl 2 mg, Magnesium Chloride 1000 mg, Calcium Chloride 200 mg, Zinc 10 mg, Glutamine 150 mg, Arg 500 mg, [NAME] 150 mg, [NAME] 250 mg, Cit 250 mg, and BCAA 2 ml}. Page 1 of 12 366156 366156 12/07/2023 Lincoln Crawford Care Center 1346 Lincoln Avenue Cincinnati, OH 45206

F 0694 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some 2. Review of the medical record for Resident #22 revealed she was admitted to the facility on [DATE]. Diagnoses included renovascular hypertension, other cerebral infarction, psychotic disorder with delusions due to known physiological condition, major depressive disorder, vascular dementia unspecified severity with other behavioral disturbance, anorexia, generalized anxiety disorder, nutritional anemia, chronic kidney disease stage three, atherosclerosis of renal artery, mixed hyperlipidemia, renal osteodystrophy, and unspecified severe protein-calorie malnutrition. Review of the quarterly Minimum Data Set (MDS) 3.0 assessment, dated 04/03/23, revealed Resident #22 had moderately impaired cognition evidenced by a Brief Interview for Mental Status (BIMS) score of 11. The resident was assessed to require extensive assistance for bed mobility, transfer, dressing, and toilet use, limited assistance for personal hygiene, and supervision for eating. Review of the plan of care revised on 08/29/23 revealed the resident was at risk for decline in nutritional status due to diagnoses of protein-calorie malnutrition, chronic kidney disease stage three, hyperlipidemia, anemia, and metabolic encephalopathy. Interventions included house supplements, monitoring intakes, labs, weights and skin assessments, vitamins and minerals as ordered, and observe for signs/symptoms of dehydration. Review of the physician orders dated 06/05/23, 07/18/23, 08/15/23, and 09/19/23 revealed orders for nutrition Agency #700 IV therapy infusion one time (500 milliliters (ml)) 0.9 % normal saline at 500 ml/hour (total additive volume 27.4 ml) with vitamin c 5 grams (gm), B complex, {[NAME] 200 milligrams (mg), Rib 4 mg, Nia 200 mg, Dex 4 mg, Pyr 4 mg, B5 250 mg, Methyl 2 mg, Magnesium Chloride 1000 mg, Calcium Chloride 200 mg, Zinc 10 mg, Glutamine 150 mg, Arg 500 mg, [NAME] 150 mg, [NAME] 250 mg, Cit 250 mg, and BCAA 2 ml}. 3. Review of the medical record for Resident #72 revealed he was admitted to the facility on [DATE]. Diagnoses included hemiplegia and hemiparesis following cerebral infarction affecting right dominant side, other sequelae of cerebral infarction, major depressive disorder, morbid (severe) obesity due to excess calories, cardiomyopathy, anemia, hyperlipidemia, vitamin d deficiency, and congestive heart failure. Review of the quarterly Minimum Data Set (MDS) 3.0 assessment, dated 04/07/23, revealed Resident #72 had moderately impaired cognition evidenced by a Brief Interview for Mental Status (BIMS) score of 11. This resident was assessed to require extensive assistance for bed mobility, transfer, dressing, and toilet use as well as supervision for personal hygiene and eating. Review of the plan of care revised on 10/17/23 revealed the resident was at risk for decline in nutritional status due to congestive heart failure, anemia, obesity, vitamin d deficiency, and prediabetes. The resident was also at risk for dehydration related to diuretic therapy. Interventions included house supplements, monitoring intakes, labs, weights and skin assessments, and observing for signs/symptoms of dehydration. Review of the physician orders dated 06/05/23, 07/18/23, 08/15/23, and 09/19/23 revealed orders for Agency #700 IV therapy infusion one time 500 ml 0.9% normal saline at 500 ml/hour (total additive volume 30.4 ml) with vitamin c 5 gm, B complex, {{[NAME] 200 milligrams (mg), Rib 4 mg, Nia 200 mg, Dex 4 mg, Pyr 4 mg, B5 250 mg, Methyl 2 mg, Biotin 20 mg, Magnesium Chloride 1000 mg, Calcium Glutamine 200 mg, Zinc 10 mg, Glutamine 150 mg, Arg 500 mg, [NAME] 50 mg, [NAME] 250 mg, Cit 250 mg, [NAME] 100 mg, and Gly 100 mg}. 366156 Page 2 of 12 366156 12/07/2023 Lincoln Crawford Care Center 1346 Lincoln Avenue Cincinnati, OH 45206

F 0694 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some 4. Review of the medical record for Resident #80 revealed she was admitted to the facility on [DATE]. Diagnoses included hemiplegia and hemiparesis following cerebral infarction affecting left non-dominant side, major depressive disorder, unspecified convulsions, other specified anemias, mixed hyperlipidemia, and chronic obstructive pulmonary disease. Review of the annual Minimum Data Set (MDS) 3.0 assessment, dated 05/25/23, revealed Resident #80 had severely impaired cognition evidenced by a Brief Interview for Mental Status (BIMS) score of 04. This resident was assessed to require extensive assistance for bed mobility, transfer, dressing, and eating, and was totally dependent on staff for toilet use and personal hygiene. Review of the plan of care revised on 09/19/23 revealed the resident was at nutritional/hydration risk due to diagnoses of hypertension, hyperlipidemia, cerebrovascular accident, and anemia. Interventions included monitoring intakes, labs, skin assessments and weights, and observing for signs/symptoms of dehydration. Review of the physician order dated 06/05/23 revealed an order for Agency #700 IV therapy infusion one time 500 ml 0.9% normal saline at 500 ml/hour (total additive volume 30.4 ml) with vitamin c 5 gm, B complex, {{[NAME] 200 milligrams (mg), Rib 4 mg, Nia 200 mg, Dex 4 mg, Pyr 4 mg, B5 250 mg, Methyl 2 mg, Biotin 20 mg, Magnesium Chloride 1000 mg, Calcium Glutamine 200 mg, Zinc 10 mg, Glutamine 150 mg, Arg 500 mg, [NAME] 50 mg, [NAME] 250 mg, Cit 250 mg, [NAME] 100 mg, and Gly 100 mg}. Interview with Representative #405 for the ancillary provider (Agency #700) stated they did not have a 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 after 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 12/06/23 at 11:45 A.M. with the Administrator revealed the facility's corporate staff arranged the services with Agency #700. The Administrator stated he was unaware the provider lacked a TDDD license for the State of Ohio. Interview on 12/06/23 at 11:48 A.M. with the Director of Nursing (DON) revealed corporate notified the facility that services from Agency #700 would no longer be utilized but provided no further information. The DON stated she was unaware the provider lacked a TDDD license for the State of Ohio. The DON verified the above listed residents received the IV medications and denied any residents experienced any adverse outcomes. 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 366156 Page 3 of 12 366156 12/07/2023 Lincoln Crawford Care Center 1346 Lincoln Avenue Cincinnati, OH 45206

F 0694 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some 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 11/20/23 when the facility implemented the following corrective actions: • By 09/19/23, Agency #700 infusions were no longer being utilized. • By 11/20/23, all residents that received Agency #700's infusions were assessed with no negative outcomes noted. • By 11/20/23, education was provided to Corporate Staff, the Administrator, DON, and Medical Director related to utilizing providers with proper credentials. • By 11/20/23, all contracted suppliers were reviewed for appropriate credentials and will be reviewed annually moving forward. • Interview on 12/06/23 at 1:33 P.M. with the Administrator and DON confirmed education was received regarding TDDD licenses and only using providers with appropriate credentials. This deficiency represents non-compliance investigated under Complaint Number OH00148171. 366156 Page 4 of 12 366156 12/07/2023 Lincoln Crawford Care Center 1346 Lincoln Avenue Cincinnati, OH 45206

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 record review, review of the State of Ohio Board of Pharmacy Terminal Distributor Licensure of Prescriber Practices, and staff interviews, 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 #13, #22, #72, and #80) out of four residents that were reviewed for medications administered by a contracted ancillary provider. This also affected 11 current residents (Residents #1, #3, #4, #8, #14, #37, #71, #75, #76, #87, and #90) and 16 discharged residents (Residents #100, #101, #102, #103, #104, #105, #106, #107, #108, #109, #110, #111, #112, #113, #114, and #115) that were identified by the facility as having received medication from the unlicensed source. The census was 90. Findings include: 1. Review of the medical record for Resident #13 revealed he was admitted to the facility on [DATE]. Diagnoses included chronic obstructive pulmonary disease, major depressive disorder, hyperlipidemia, obesity, and diabetes mellitus due to underlying condition with diabetic neuropathy. Review of the quarterly Minimum Data Set (MDS) 3.0 assessment, dated 05/17/23, revealed Resident #13 had moderately impaired cognition evidenced by a Brief Interview for Mental Status (BIMS) score of 15. This resident was assessed to require limited assistance for bed mobility, transfer, dressing, and toilet use as well as supervision for personal hygiene and eating. Review of the plan of care revised on 08/17/23 revealed the resident was at nutritional risk related to diagnoses of diabetes mellitus, chronic obstructive pulmonary disease, hyperlipidemia, and depression. The resident was also at risk for dehydration related to diuretic use. Interventions included monitoring intakes, labs, weights and skin assessments, and observing signs/symptoms of dehydration. Review of the physician orders dated 06/05/23, 07/18/23, 08/15/23, and 09/19/23 revealed orders for nutrition Agency #700 IV therapy infusion one time (500 milliliters (ml)) 0.9 % normal saline at 500 ml/hour (total additive volume 27.4 ml) with vitamin c 5 grams (gm), B complex, {[NAME] 200 milligrams (mg), Rib 4 mg, Nia 200 mg, Dex 4 mg, Pyr 4 mg, B5 250 mg, Methyl 2 mg, Magnesium Chloride 1000 mg, Calcium Chloride 200 mg, Zinc 10 mg, Glutamine 150 mg, Arg 500 mg, [NAME] 150 mg, [NAME] 250 mg, Cit 250 mg, and BCAA 2 ml}. 2. Review of the medical record for Resident #22 revealed she was admitted to the facility on [DATE]. Diagnoses included renovascular hypertension, other cerebral infarction, psychotic disorder with delusions due to known physiological condition, major depressive disorder, vascular dementia unspecified severity with other behavioral disturbance, anorexia, generalized anxiety disorder, nutritional anemia, chronic kidney disease stage three, atherosclerosis of renal artery, mixed hyperlipidemia, renal osteodystrophy, and unspecified severe protein-calorie malnutrition. Review of the quarterly Minimum Data Set (MDS) 3.0 assessment, dated 04/03/23, revealed Resident 366156 Page 5 of 12 366156 12/07/2023 Lincoln Crawford Care Center 1346 Lincoln Avenue Cincinnati, OH 45206

F 0755 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some #22 had moderately impaired cognition evidenced by a Brief Interview for Mental Status (BIMS) score of 11. This resident was assessed to require extensive assistance for bed mobility, transfer, dressing, and toilet use, limited assistance for personal hygiene, and supervision for eating. Review of the plan of care revised on 08/29/23 revealed the resident was at risk for decline in nutritional status due to diagnoses of protein-calorie malnutrition, chronic kidney disease stage three, hyperlipidemia, anemia, and metabolic encephalopathy. Interventions included house supplements, monitoring intakes, labs, weights and skin assessments, vitamins and minerals as ordered, and observe for signs/symptoms of dehydration. Review of the physician orders dated 06/05/23, 07/18/23, 08/15/23, and 09/19/23 revealed orders for nutrition Agency #700 IV therapy infusion one time (500 milliliters (ml)) 0.9 % normal saline at 500 ml/hour (total additive volume 27.4 ml) with vitamin c 5 grams (gm), B complex, {[NAME] 200 milligrams (mg), Rib 4 mg, Nia 200 mg, Dex 4 mg, Pyr 4 mg, B5 250 mg, Methyl 2 mg, Magnesium Chloride 1000 mg, Calcium Chloride 200 mg, Zinc 10 mg, Glutamine 150 mg, Arg 500 mg, [NAME] 150 mg, [NAME] 250 mg, Cit 250 mg, and BCAA 2 ml}. 3. Review of the medical record for Resident #72 revealed he was admitted to the facility on [DATE]. Diagnoses included hemiplegia and hemiparesis following cerebral infarction affecting right dominant side, other sequelae of cerebral infarction, major depressive disorder, morbid (severe) obesity due to excess calories, cardiomyopathy, anemia, hyperlipidemia, vitamin d deficiency, and congestive heart failure. Review of the quarterly Minimum Data Set (MDS) 3.0 assessment, dated 04/07/23, revealed Resident #72 had moderately impaired cognition evidenced by a Brief Interview for Mental Status (BIMS) score of 11. This resident was assessed to require extensive assistance for bed mobility, transfer, dressing, and toilet use as well as supervision for personal hygiene and eating. Review of the plan of care revised on 10/17/23 revealed the resident was at risk for decline in nutritional status due to congestive heart failure, anemia, obesity, vitamin d deficiency, and prediabetes. The resident was also at risk for dehydration related to diuretic therapy. Interventions included house supplements, monitoring intakes, labs, weights and skin assessments, and observing for signs/symptoms of dehydration. Review of the physician orders dated 06/05/23, 07/18/23, 08/15/23, and 09/19/23 revealed orders for Agency #700 IV therapy infusion one time 500 ml 0.9% normal saline at 500 ml/hour (total additive volume 30.4 ml) with vitamin c 5 gm, B complex, {{[NAME] 200 milligrams (mg), Rib 4 mg, Nia 200 mg, Dex 4 mg, Pyr 4 mg, B5 250 mg, Methyl 2 mg, Biotin 20 mg, Magnesium Chloride 1000 mg, Calcium Glutamine 200 mg, Zinc 10 mg, Glutamine 150 mg, Arg 500 mg, [NAME] 50 mg, [NAME] 250 mg, Cit 250 mg, [NAME] 100 mg, and Gly 100 mg}. 4. Review of the medical record for Resident #80 revealed she was admitted to the facility on [DATE]. Diagnoses included hemiplegia and hemiparesis following cerebral infarction affecting left non-dominant side, major depressive disorder, unspecified convulsions, other specified anemias, mixed hyperlipidemia, and chronic obstructive pulmonary disease. Review of the annual Minimum Data Set (MDS) 3.0 assessment, dated 05/25/23, revealed Resident #80 had severely impaired cognition evidenced by a Brief Interview for Mental Status (BIMS) score of 04. This resident was assessed to require extensive assistance for bed mobility, transfer, dressing, and 366156 Page 6 of 12 366156 12/07/2023 Lincoln Crawford Care Center 1346 Lincoln Avenue Cincinnati, OH 45206

F 0755 eating, and was totally dependent on staff for toilet use and personal hygiene. Level of Harm - Minimal harm or potential for actual harm Review of the plan of care revised on 09/19/23 revealed the resident was at nutritional/hydration risk due to diagnoses of hypertension, hyperlipidemia, cerebrovascular accident, and anemia. Interventions included monitoring intakes, labs, skin assessments and weights, and observing for signs/symptoms of dehydration. Residents Affected - Some Review of the physician order dated 06/05/23 revealed an order for Agency #700 IV therapy infusion one time 500 ml 0.9% normal saline at 500 ml/hour (total additive volume 30.4 ml) with vitamin c 5 gm, B complex, {{[NAME] 200 milligrams (mg), Rib 4 mg, Nia 200 mg, Dex 4 mg, Pyr 4 mg, B5 250 mg, Methyl 2 mg, Biotin 20 mg, Magnesium Chloride 1000 mg, Calcium Glutamine 200 mg, Zinc 10 mg, Glutamine 150 mg, Arg 500 mg, [NAME] 50 mg, [NAME] 250 mg, Cit 250 mg, [NAME] 100 mg, and Gly 100 mg}. Interview with Representative #405 for the ancillary provider (Agency #700) 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 after 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 12/06/23 at 11:45 A.M. with the Administrator revealed the facility's corporate staff arranged the services with Agency #700. The Administrator stated he was unaware the provider lacked a TDDD license for the State of Ohio to provide medications. Interview on 12/06/23 at 11:48 A.M. with the Director of Nursing (DON) revealed corporate notified the facility that services from Agency #700 would no longer be utilized but provided no further information. The DON stated she was unaware the provider lacked a TDDD license for the State of Ohio to supply medications. The DON verified the above listed residents received the medications and denied any residents experienced any adverse outcomes. 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 366156 Page 7 of 12 366156 12/07/2023 Lincoln Crawford Care Center 1346 Lincoln Avenue Cincinnati, OH 45206

F 0755 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some 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 11/20/23 when the facility implemented the following corrective actions: • By 09/19/23, Agency #700 infusions were no longer being utilized. • By 11/20/23, all residents that received Agency #700's infusions were assessed with no negative outcomes noted. • By 11/20/23, education was provided to Corporate Staff, the Administrator, DON, and Medical Director related to utilizing providers with proper credentials. • By 11/20/23, all contracted suppliers were reviewed for appropriate credentials and will be reviewed annually moving forward. • Interview on 12/06/23 at 1:33 P.M. with the Administrator and DON confirmed education was received regarding TDDD licenses and only using providers with appropriate credentials. This deficiency represents non-compliance investigated under Complaint Number OH00148171. 366156 Page 8 of 12 366156 12/07/2023 Lincoln Crawford Care Center 1346 Lincoln Avenue Cincinnati, OH 45206

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 record review, review of the State of Ohio Board of Pharmacy Terminal Distributor Licensure of Prescriber Practices, staff interviews, and review of the facility policy, 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 #13, #22, #72, and #80) out of four residents that were reviewed for medications administered by a contracted ancillary provider. This also affected 11 current residents (Residents #1, #3, #4, #8, #14, #37, #71, #75, #76, #87, and #90) and 16 discharged residents (Residents #100, #101, #102, #103, #104, #105, #106, #107, #108, #109, #110, #111, #112, #113, #114, and #115) that were identified by the facility as having received medication from the unlicensed source. The census was 90. Findings include: 1. Review of the medical record for Resident #13 revealed he was admitted to the facility on [DATE]. Diagnoses included chronic obstructive pulmonary disease, major depressive disorder, hyperlipidemia, obesity, and diabetes mellitus due to underlying condition with diabetic neuropathy. Review of the quarterly Minimum Data Set (MDS) 3.0 assessment, dated 05/17/23, revealed Resident #13 had moderately impaired cognition evidenced by a Brief Interview for Mental Status (BIMS) score of 15. This resident was assessed to require limited assistance for bed mobility, transfer, dressing, and toilet use as well as supervision for personal hygiene and eating. Review of the plan of care revised on 08/17/23 revealed the resident was at nutritional risk related to diagnoses of diabetes mellitus, chronic obstructive pulmonary disease, hyperlipidemia, and depression. The resident was also at risk for dehydration related to diuretic use. Interventions included monitoring intakes, labs, weights and skin assessments, and observing signs/symptoms of dehydration. Review of the physician orders dated 06/05/23, 07/18/23, 08/15/23, and 09/19/23 revealed orders for nutrition Agency #700 IV therapy infusion one time (500 milliliters (ml)) 0.9 % normal saline at 500 ml/hour (total additive volume 27.4 ml) with vitamin c 5 grams (gm), B complex, {[NAME] 200 milligrams (mg), Rib 4 mg, Nia 200 mg, Dex 4 mg, Pyr 4 mg, B5 250 mg, Methyl 2 mg, Magnesium Chloride 1000 mg, Calcium Chloride 200 mg, Zinc 10 mg, Glutamine 150 mg, Arg 500 mg, [NAME] 150 mg, [NAME] 250 mg, Cit 250 mg, and BCAA 2 ml}. 2. Review of the medical record for Resident #22 revealed she was admitted to the facility on [DATE]. Diagnoses included renovascular hypertension, other cerebral infarction, psychotic disorder with delusions due to known physiological condition, major depressive disorder, vascular dementia unspecified severity with other behavioral disturbance, anorexia, generalized anxiety disorder, nutritional anemia, chronic kidney disease stage three, atherosclerosis of renal artery, mixed hyperlipidemia, renal osteodystrophy, and unspecified severe protein-calorie malnutrition. Review of the quarterly Minimum Data Set (MDS) 3.0 assessment, dated 04/03/23, revealed Resident 366156 Page 9 of 12 366156 12/07/2023 Lincoln Crawford Care Center 1346 Lincoln Avenue Cincinnati, OH 45206

F 0837 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some #22 had moderately impaired cognition evidenced by a Brief Interview for Mental Status (BIMS) score of 11. This resident was assessed to require extensive assistance for bed mobility, transfer, dressing, and toilet use, limited assistance for personal hygiene, and supervision for eating. Review of the plan of care revised on 08/29/23 revealed the resident was at risk for decline in nutritional status due to diagnoses of protein-calorie malnutrition, chronic kidney disease stage three, hyperlipidemia, anemia, and metabolic encephalopathy. Interventions included house supplements, monitoring intakes, labs, weights and skin assessments, vitamins and minerals as ordered, and observe for signs/symptoms of dehydration. Review of the physician orders dated 06/05/23, 07/18/23, 08/15/23, and 09/19/23 revealed orders for nutrition Agency #700 IV therapy infusion one time (500 milliliters (ml)) 0.9 % normal saline at 500 ml/hour (total additive volume 27.4 ml) with vitamin c 5 grams (gm), B complex, {[NAME] 200 milligrams (mg), Rib 4 mg, Nia 200 mg, Dex 4 mg, Pyr 4 mg, B5 250 mg, Methyl 2 mg, Magnesium Chloride 1000 mg, Calcium Chloride 200 mg, Zinc 10 mg, Glutamine 150 mg, Arg 500 mg, [NAME] 150 mg, [NAME] 250 mg, Cit 250 mg, and BCAA 2 ml}. 3. Review of the medical record for Resident #72 revealed he was admitted to the facility on [DATE]. Diagnoses included hemiplegia and hemiparesis following cerebral infarction affecting right dominant side, other sequelae of cerebral infarction, major depressive disorder, morbid (severe) obesity due to excess calories, cardiomyopathy, anemia, hyperlipidemia, vitamin d deficiency, and congestive heart failure. Review of the quarterly Minimum Data Set (MDS) 3.0 assessment, dated 04/07/23, revealed Resident #72 had moderately impaired cognition evidenced by a Brief Interview for Mental Status (BIMS) score of 11. This resident was assessed to require extensive assistance for bed mobility, transfer, dressing, and toilet use as well as supervision for personal hygiene and eating. Review of the plan of care revised on 10/17/23 revealed the resident was at risk for decline in nutritional status due to congestive heart failure, anemia, obesity, vitamin d deficiency, and prediabetes. The resident was also at risk for dehydration related to diuretic therapy. Interventions included house supplements, monitoring intakes, labs, weights and skin assessments, and observing for signs/symptoms of dehydration. Review of the physician orders dated 06/05/23, 07/18/23, 08/15/23, and 09/19/23 revealed orders for Agency #700 IV therapy infusion one time 500 ml 0.9% normal saline at 500 ml/hour (total additive volume 30.4 ml) with vitamin c 5 gm, B complex, {{[NAME] 200 milligrams (mg), Rib 4 mg, Nia 200 mg, Dex 4 mg, Pyr 4 mg, B5 250 mg, Methyl 2 mg, Biotin 20 mg, Magnesium Chloride 1000 mg, Calcium Glutamine 200 mg, Zinc 10 mg, Glutamine 150 mg, Arg 500 mg, [NAME] 50 mg, [NAME] 250 mg, Cit 250 mg, [NAME] 100 mg, and Gly 100 mg}. 4. Review of the medical record for Resident #80 revealed she was admitted to the facility on [DATE]. Diagnoses included hemiplegia and hemiparesis following cerebral infarction affecting left non-dominant side, major depressive disorder, unspecified convulsions, other specified anemias, mixed hyperlipidemia, and chronic obstructive pulmonary disease. Review of the annual Minimum Data Set (MDS) 3.0 assessment, dated 05/25/23, revealed Resident #80 had severely impaired cognition evidenced by a Brief Interview for Mental Status (BIMS) score of 04. This resident was assessed to require extensive assistance for bed mobility, transfer, dressing, and 366156 Page 10 of 12 366156 12/07/2023 Lincoln Crawford Care Center 1346 Lincoln Avenue Cincinnati, OH 45206

F 0837 eating, and was totally dependent on staff for toilet use and personal hygiene. Level of Harm - Minimal harm or potential for actual harm Review of the plan of care revised on 09/19/23 revealed the resident was at nutritional/hydration risk due to diagnoses of hypertension, hyperlipidemia, cerebrovascular accident, and anemia. Interventions included monitoring intakes, labs, skin assessments and weights, and observing for signs/symptoms of dehydration. Residents Affected - Some Review of the physician order dated 06/05/23 revealed an order for Agency #700 IV therapy infusion one time 500 ml 0.9% normal saline at 500 ml/hour (total additive volume 30.4 ml) with vitamin c 5 gm, B complex, {{[NAME] 200 milligrams (mg), Rib 4 mg, Nia 200 mg, Dex 4 mg, Pyr 4 mg, B5 250 mg, Methyl 2 mg, Biotin 20 mg, Magnesium Chloride 1000 mg, Calcium Glutamine 200 mg, Zinc 10 mg, Glutamine 150 mg, Arg 500 mg, [NAME] 50 mg, [NAME] 250 mg, Cit 250 mg, [NAME] 100 mg, and Gly 100 mg}. Interview with Representative #405 for the ancillary provider (Agency #700) 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 after 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 12/06/23 at 11:45 A.M. with the Administrator revealed the facility's corporate staff arranged the services with Agency #700. The Administrator stated he was unaware the provider lacked a TDDD license for the State of Ohio to provide medications. Interview on 12/06/23 at 11:48 A.M. with the Director of Nursing (DON) revealed corporate notified the facility that services from Agency #700 IV would no longer be utilized but provided no further information. The DON stated she was unaware the provider lacked a TDDD license for the State of Ohio to supply medications. The DON verified the above listed residents received the medications and denied any residents experienced any adverse outcomes. 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 366156 Page 11 of 12 366156 12/07/2023 Lincoln Crawford Care Center 1346 Lincoln Avenue Cincinnati, OH 45206

F 0837 Level of Harm - Minimal harm or potential for actual harm Residents Affected - Some 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 the facility policy titled Administrative Management (Governing Board), revised 04/2011, revealed the governing board was responsible for the management and operation of the facility. The deficient practice was corrected on 11/20/23 when the facility implemented the following corrective actions: • By 09/19/23, Agency #700 IV infusions were no longer being utilized. • By 11/20/23, all residents that received Agency #700's IV infusions were assessed with no negative outcomes noted. • By 11/20/23, education was provided to Corporate Staff, the Administrator, DON, and Medical Director related to utilizing providers with proper credentials. • By 11/20/23, all contracted suppliers were reviewed for appropriate credentials and will be reviewed annually moving forward. • Interview on 12/06/23 at 1:33 P.M. with the Administrator and DON confirmed education was received regarding TDDD licenses and only using providers with appropriate credentials. This deficiency represents non-compliance investigated under Complaint Number OH00148171. 366156 Page 12 of 12