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Tag No.: A0385
Based on observation, interview and record review, the facility failed to ensure nursing staff adhered to the policies and procedures of the facility, failed to provide adequate evaluation of contracted nursing personnel, and failed to ensure standards of practice for medication administration, resulting in administration of an overdose of medication to 1 (P-1) of 10 patients reviewed. See tags:
A0398 - Supervision of Nursing Personnel
A0405 - Administration of Drugs
Tag No.: A0398
Based on record review and interview, the facility failed to ensure nursing staff adhered to the policies and procedures of the facility and failed to provide adequate evaluation of contracted nursing personnel, resulting in a medication administration error for 1 (P-1) of 10 records reviewed, where the patient received an overdose which required transfer to an acute care facility. Findings include:
P-1: This 8-year-old female was admitted to the facility on 10/9/25 with diagnoses of disruptive mood dysregulation disorder, attention-deficit hyperactivity disorder, and post-traumatic stress disorder.
During medical record review, it was noted on the medication administration record on 10/20/25 at 2021, Trileptal 37.5mg was given by RN (Staff I). Staff I documented on a nursing progress note, dated 10/20/25 at 2244, "patient was given 1800mg oxcarbazepine (Trileptal) when the prescribed dose was 37.5mg." The progress note indicated that poison control, the psychiatrist, primary care physician, and P-1's family were notified. However, there was no evidence of documentation indicating the communication or recommendations from the primary care physician or any evidence of orders for frequency for observation/vital signs or what symptoms to monitor for potential medication toxicity. It was also noted that nursing failed to document vital signs or progress notes on 10/21/25 between 0001 and 0554.
During personnel file review, it was noted that Staff I's Pharmacology Competency, provided by the employment agency, was dated 7/10/24. There was no evidence of current competency.
These findings were reviewed and acknowledged by the Chief Nursing Officer (Staff C) during an interview on 11/4/25 at 1317.
Policy PHR-159, Medication Administration and Records (Reviewed 5/2025) states, "The correct medication will be located in the automated medication machine. The nurse will compare the final dosage form of the drug and the entry on the medication administration record to confirm that the drug, dose, and route of administration are correct."
Policy 2.25.00, Medical Facility Transfer (Revised 07/2024) states, in non-life-threatening conditions, the RN will contact the Medical Doctor and report his/her assessment of the patient's current medical condition. The Medical Doctor advises the RN of the immediate action to be taken.
Tag No.: A0405
Based on interview and record review, the facility failed to ensure standards of practice for medication administration for 1 (P-1) of 10 patients reviewed, resulting in overdose and transfer to an acute care facility. Findings include:
P-1: This 8-year-old female was admitted to the facility on 10/9/25 with diagnoses of disruptive mood dysregulation disorder, attention-deficit hyperactivity disorder, and post-traumatic stress disorder.
P-1 was ordered Trileptal 300mg/5ml, 37.5mg by mouth twice daily on 10/16/25.
During medical record review, it was noted on the medication administration record on 10/20/25 at 2021, Trileptal 37.5mg was given by RN (Staff I). Staff I documented on a nursing progress note, dated 10/20/24 at 2244, "patient was given 1800mg oxcarbazepine (Trileptal) when the prescribed dose was 37.5mg."
On 10/21/25 at 0800, P-1 vomited, had diarrhea, and was observed to be lethargic, pale, shaking, and unsteady on her feet. P-1 was transported via ambulance to an acute care hospital on 10/21/25 at 0930.
This finding was reviewed and acknowledged by the Chief Nursing Officer (Staff C) during an interview on 11/3/25 at 1345.
Policy PHR-159, Medication Administration and Records (Reviewed 5/2025) states, "The correct medication will be located in the automated medication machine. The nurse will compare the final dosage form of the drug and the entry on the medication administration record to confirm that the drug, dose, and route of administration are correct."
Tag No.: A0501
Based on interview, observation, and record review, the pharmacy failed to ensure that medications were dispensed in a manner to minimize potential adverse events in 1 (P-1) of 10 records reviewed, resulting in overdose and transfer to acute care hospital. Findings include:
P-1: This 8-year-old female was admitted to the facility on 10/9/25 with diagnoses of disruptive mood dysregulation disorder, attention-deficit hyperactivity disorder, and post-traumatic stress disorder.
During medical record review, it was noted on a nursing progress note, completed by RN (Staff I), dated 10/20/25 at 2244 stated, "patient was given 1800mg oxcarbazepine (Trileptal) when the prescribed dose was 37.5mg."
The pharmacist (Staff L) stated that when a pediatric patient was on Trileptal suspension, a 60ml vial would be sent to the unit (containing 3600mg) during an interview on 11/3/25 at 1500. P-1 was ordered 75mg per day, and one 60ml vial contained dosing for 48 days was sent to the unit.
A tour of the pharmacy was conducted on 11/4/25 at 0930. One stock bottle (containing 250ml) was noted on the pharmacy shelves as well as multiple sleeves of 300mg/5ml medication cups. Staff L stated the 300mg/5ml doses were ordered and delivered to the nursing units on 10/29/25. Staff L stated the stock bottle will be discarded when it expires.
The facility failed to follow pharmacy minimum standard guidelines.
American Society of Health-System Pharmacists. ASHP guidelines: minimum standard for pharmacies in hospitals. Am J Health-Syst Pharm. 2013; 70:1619-30. Standard V. Preparing, packaging, and labeling medications: Unit dose packaging. "Whenever possible, medications shall be available for inpatient use in single-unit packages and in a ready-to-administer form. Manipulation of medications before administration (e.g., withdrawal of doses from containers, reconstitution of powdered drug products, labeling of containers, and splitting of tablets) by final users should be minimized."