Betsy Johnson Regional Hospital

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 26622 Based on hospital policy review, medical record review and staff interview, the nursing staff failed to ensure there was a physician order for a violent-self destructive/chemical restraint in 1 of 1 violent/chemical restraint emergency department patient records reviewed (Patient # 13). Findings include: Review on 07/22/2026 of the hospital policy titled, “Restraints, Seclusion and Safety Devices” effective May 01, 2025, revealed, “... Procedural Guidelines: ... 3. A. A LP (licensed independent practitioner) order is required. ...” Closed medical record review on 07/21/2026 for Patient #13 (Pt) revealed a 42-year-old male patient that presented via law enforcement on Involuntary Commitment (IVC) to the Emergency Department (ED) on 07/15/2026 at 2054 with a chief complaint of manic behavior. Record review revealed nursing documentation at 2100 of “new agitation.” Vital signs completed at 2119 revealed Temperature (T) 98.1 orally, Heart Rate (HR) 89, Respiratory Rate (RR) 20, Blood Pressure (BP) 136/86 and oxygen saturation (SpO2) of 98% on room air. Review of physician note documented at 0344 on 07/16/2026 revealed “Patient becoming increasingly agitated and aggressive. Required chemical restraint with intramuscular medications. Review of the physician orders revealed Haldol 5 milligrams (mg) injection once, Benadryl 50 mg injection once and Ativan 2 mg injection once was ordered on 07/16/2026 at 0344 and an order for “Therapeutic Hold” was entered electronically on 07/16/2026 at 0345 with order to obtain vital signs (T, HR, RR, BP and SpO2), prior to initial restraint order. Further review of the restraint order revealed “Reason for restraints - Imminent risk of harm to self and others.” Haldol and Benadryl were administered at 0345. Ativan was administered at 0400. Review of the record failed to revealed evidence of additional vital signs obtained prior to initiation of restraint per physician order and failed to reveal a physician order for a chemical restraint. Telephone interview on 07/23/2026 at 1546 with MD #1 revealed the therapeutic hold restraint order was an incorrect order and that the order should have been placed for chemical restraints. Interview revealed restraint ordering had been reviewed with the providers to ensure the appropriate orders were placed in the future.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 26622 Based on hospital policy review, medical record review and staff interview the nursing staff failed to monitor a chemical restraint patient per the hospital policy in 1 of 1 (Pt. #13) chemical restraint patient records reviewed. Findings include: Review on 07/22/2026 of the facility policy titled, “Restraints, Seclusion and Safety Devices” effective May 01, 2025, revealed, “... Procedural Guidelines: ... 4. Assessment-Monitoring-Documentation: ... C. Direct continuous observation of the patient by a staff member is documented every 15 minutes ... in the following circumstances: i. Initiation of Violent/Self Destructive restraints ... D. Monitoring for ... Violent/Self Destructive restraints is individualized based on patient needs but at a minimum occurs once every 2 hours. ... “ Closed medical record review on 07/21/2026 for Patient #13 (Pt) revealed a 42-year-old male patient that presented via law enforcement on Involuntary Commitment (IVC) to the Emergency Department (ED) on 07/15/2026 at 2054 with a chief complaint of manic behavior. Record review revealed nursing documentation at 2100 of “new agitation.” Vital signs completed at 2119 revealed Temperature (T) 98.1 orally, Heart Rate (HR) 89, Respiratory Rate (RR) 20, Blood Pressure (BP) 136/86 and oxygen saturation (SpO2) of 98% on room air. Review of physician note documented at 0344 on 07/16/2026 revealed “Patient becoming increasingly agitated and aggressive. Required chemical restraint with intramuscular medications. Review of the physician orders revealed Haldol 5 milligrams (mg) injection once, Benadryl 50 mg injection once and Ativan 2 mg injection once was ordered on 07/16/2026 at 0344 and an order for “Therapeutic Hold” was entered electronically on 07/16/2026 at 0345 with order to obtain vital signs (T, HR, RR, BP and SpO2), prior to initiation of restraint order. Further review of the restraint order revealed “Reason for restraints - Imminent risk of harm to self and others.” Haldol and Benadryl were administered at 0345. Ativan was administered at 0400. Review of the record failed to revealed evidence of additional vital signs obtained prior to initiation of restraint per physician order (last vital signs documented at 2119) and failed to reveal documentation of restraint monitoring per facility policy. Interview on 07/23/2026 at 1600 with RN #1 revealed there was no available documentation of vital signs completed prior to the initiation of the chemical restraint intervention on 07/16/2026 at 0345. Interview revealed there was no available documentation of restraint monitoring in the medical record. Interview confirmed the facility staff did not follow the hospital policy for assessment/monitoring after initiation of a chemical restraint. NC00236987, NC00238273”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 50111 Based on review of hospital policies, insulin instructions for use guidelines, automated medication dispensing system reports, medical record reviews and staff interviews, nursing staff failed to ensure insulin (a medication used to help regulate blood sugar levels) was not expired prior to administration for 9 of 12 sampled medical records for patients (pt) receiving insulin (Pt#3, Pt #12, Pt #14, Pt #15, Pt #18, Pt #11, Pt #13, Pt #16, Pt #17). The findings include: Review on 05/14/2025 of hospital policy “Medication Administration, General Guidelines,” effective 10/2022, revealed, “... R. Before administering a drug, read the label three (3) times: 1. When taking the drug from the medication bin. 2. When preparing the dosage. 3. At the bedside prior to administering the medication to the patient ...” Review on 05/14/2025 of hospital policy “Pharmaceutical Compounding-Sterile Preparations,” effective 10/2023 and last revised on 11/2024 with no changes, revealed, “... Insulin vials are labeled with a 28-day expiration date by pharmacy personnel when they are loaded into the automated dispensing cabinets and discarded when the expiration date is reached ...” Review on 05/14/2025 of hospital policy “Expired Medications,” effective on 11/2021 and last revised on 11/2024 with no changes, revealed, “... A. Expired medications are pulled from general inventory on a monthly basis ... C. When expired medications are found in the Pharmacy, one of the Nursing Units, or ancillary storage area, the medications shall be immediately pulled from stock ...” Review on 05/14/2025 of the Lantus Instructions for Use Guidelines, last revised 11/2018, revealed, “... 16.2 Storage ... Storage conditions are summarized in the following table ... 10 mL (milliliter) vial ... Not in-use (unopened) Room Temperature ... 28 days ... In-use (opened) ... 28 days Refrigerated or room temperature ...” Review on 05/14/2025 of ADS (automated dispensing system) Report for ADS A, with a timeframe of 08/01/2024 through 03/14/2025, revealed Lantus was refilled by the pharmacy on 08/04/2024 at 1031. Review revealed inventory was verified by the pharmacy on 03/14/2025 at 0913 and refilled at 0915 (7 months and 10 days after the last refill). According to the refill date, the vial of Lantus in ADS A was scheduled to expire on 09/01/2024 (28 days after being placed in ADS A). Review failed to reveal evidence that Lantus was inventoried or refilled between 08/04/2024 and 03/14/2025 by the pharmacy (for 6 months and 13 days after the 28 day expiration date). 1. Closed medical record review on 05/12/2025 for Pt #3 revealed a 56-year-old female that admitted to Floor A on 03/11/2025 at 1646 with a history of diabetes (a condition that results in elevated levels of sugar in the bloodstream) and presented with a right foot ulcer (sore). Review of the Medication Administration Record (MAR) revealed Pt #3 received 50 units of Lantus insulin subcutaneously (injected under the skin) on 03/12/2025 at 0908 and on 03/13/2025 at 1023. Review revealed Lantus was not given on 03/14/2025 at 0930. Review of the Nursing Note at 0930 revealed Pt #3 had refused the Lantus. Further review revealed Pt #3 received Lantus daily per provider orders. The patient received further care and was discharged home on 03/21/2025 at 1528. Review of the All Transactions Activity Report for ADS A, with a timeframe of 09/01/2024 through 03/14/2025, revealed Lantus was removed from ADS A for Pt #3 on 03/12/2025 at 0858 and on 03/13/2025 at 1013 (twice during the timeframe that Lantus was expired). Interview on 05/13/2025 at 1540 with Registered Nurse (RN #1) revealed RN #1 performed a medication verification at the ADS with RN #2. The verification process consisted of verifying the patient, route, dose, looking at the medication vial, and checking the expiration date on the vial. RN #1 recalled going by the manufacturer expiration date when the Lantus was verified. RN #1 recalled the vial was open at the time it was removed from the ADS. Interview revealed RN #1 did not know Lantus expired within 28 days from the time it was opened when it was administered to Pt #3. RN #1 was notified that the vial of Lantus expired in September 2024 the following day. Interview on 05/13/2025 at 1000 with RN #2 revealed RN #2 recalled verifying the manufacturer expiration date on the Lantus vial when pulling the Lantus vial from the ADS with RN #1. RN #2 did not recall seeing a 28 day expiration on the vial. Interview revealed only one vial of Lantus was stored in the ADS at a time. RN #2 stated insulin was not regularly administered on Floor A and RN #2 was not aware that all insulin vials expired 28 days after being placed in the ADS at the time it was administered to Pt #3. Interview on 05/13/2025 at 1350 with Manager #8 revealed RN #9 found a vial of Lantus that expired in September 2024 in the ADS on 03/14/2025. RN #9 notified Manager #8 and the pharmacy prior to administration of Lantus on that day. Manager #8 inspected the vial and noted the orange expiration label had a date of September 2024 written on the label. There were no other vials of Lantus in ADS A at the time the expired vial of Lantus was discovered. Manager #8 was not sure that a patient had received the expired medication at the time the expired vial was discovered. Interview revealed nursing staff should check the 28 day expiration date and the manufacturer expiration date prior to administration. Interview on 05/14/2025 at 1120, while on tour of Floor A, with Pharmacist #3 revealed the following process for labeling insulin vials and removal of expired medications. Orange labels with a 28 day expiration date were placed on all insulin vials in the pharmacy when the vials were removed from the refrigerator. The labeled vials were then taken to the floor and stocked in the ADS. The pharmacist or pharmacy technician entered the 28 day expiration date or the manufacturer expiration date, whichever expired the soonest, into the ADS system. Interview revealed a daily report was generated in the pharmacy with a list of expiring medications and those medications were removed and replaced in the ADS by the pharmacy each day. Interview revealed the process had been in place as long as Pharmacist #3 could remember. Interview of 05/14/2025 at 1245 with Manager #4, Staff #5, Director #6, Pharmacist #7, and Manager #8 revealed hospital leadership was not aware that 9 patients received expired Lantus prior to 5/14/2025. Interview revealed that according to the ADS A report, Lantus was filled on 08/04/2024 and not filled again until 03/14/2025. Interview revealed the 09/01/2024 expiration date was correct as it was 28 days after the vial was placed in ADS A. Pharmacist #7 was notified of the expired vial but was not aware patients had received the medication. Pharmacist #7 revealed the manufacturer expiration date, not the 28 day expiration date, was keyed into ADS A when the Lantus was stocked; therefore, the expired Lantus did not appear on the daily expiration date report. The report only generated medications expiring that day and did not show future expirations. Manager # 8 revealed there were 6 nurses involved in the administration of expired medications. Manager #8 was not sure how 6 RNs missed the orange expiration label on the vial. Nursing staff on Floor A were not aware that expired Lantus was given to patients. Interview revealed there was not an incident report for the expired Lantus vial. Director #6 revealed an incident report would have triggered further investigation. Follow-up interview on 05/14/2025 at 1638 with Manager #8 revealed Manager #8 did not have access to reports that would show which patients received insulin from the ADS A drawer. Manager #8 was not concerned that patients had received expired Lantus at the time because Lantus was not frequently given on Floor A. Follow-up interview on 05/14/2025 at 1630 with Pharmacist #7 revealed that when Pharmacist #7 received the expired vial, it was visually inspected for signs of contamination. Interview revealed the vial did not appear to be contaminated. Manager #7 did not feel there was a risk to patient safety; therefore, Manager #7 did not check to see if any patients had received the expired Lantus. RN # 9 was not available for interview. 2. Closed medical record review on 05/14/2025 for Pt #12 revealed a 49-year-old female that arrived in the Emergency Department (ED) on 01/28/2025 at 1330 with a chief complaint of hyperglycemia (elevated blood sugar levels) and a history of diabetes. Record review revealed Pt #12 was admitted to Floor A on 01/29/2025 at 1630. Review of the MAR revealed Pt #12 received 10 units of Lantus insulin subcutaneously on 01/29/2025 at 2006 and on 01/30/2025 at 2141. The patient was transferred to Floor C on 01/31/2025 at 2151. Pt #12 received further care and was discharged home on 02/02/2025 at 1220. Review of the All Transactions Activity Report for ADS A, with a timeframe of 09/01/2024 through 03/14/2025, revealed Lantus was removed from ADS A for Pt #12 on 01/29/2025 at 1950 and on 01/30/2025 at 2113 (twice during the timeframe that Lantus was expired). Interview on 05/13/2025 at 1350 with Manager #8 revealed RN #9 found a vial of Lantus that expired in September 2024 in the ADS on 03/14/2025. RN #9 notified Manager #8 and the pharmacy prior to administration of Lantus on that day. Manager #8 inspected the vial and noted the orange expiration label had a date of September 2024 written on the label. There were no other vials of Lantus in ADS A at the time the expired vial of Lantus was discovered. Manager #8 was not sure that a patient had received the expired medication at the time the expired vial was discovered. Interview revealed nursing staff should check the 28 day expiration date and the manufacturer expiration date prior to administration. Interview on 05/14/2025 at 1120, while on tour of Floor A, with Pharmacist #3 revealed the following process for labeling insulin vials and removal of expired medications. Orange labels with a 28 day expiration date were placed on all insulin vials in the pharmacy when the vials were removed from the refrigerator. The labeled vials were then taken to the floor and stocked in the ADS. The pharmacist or pharmacy technician entered the 28 day expiration date or the manufacturer expiration date, whichever expired the soonest, into the ADS system. Interview revealed a daily report was generated in the pharmacy with a list of expiring medications and those medications were removed and replaced in the ADS by the pharmacy each day. Interview revealed the process had been in place as long as Pharmacist #3 could remember. Interview of 05/14/2025 at 1245 with Manager #4, Staff #5, Director #6, Pharmacist #7, and Manager #8 revealed hospital leadership was not aware that 9 patients received expired Lantus prior to 5/14/2025. Interview revealed that according to the ADS A report, Lantus was filled on 08/04/2024 and not filled again until 03/14/2025. Interview revealed the 09/01/2024 expiration date was correct as it was 28 days after the vial was placed in ADS A. Pharmacist #7 was notified of the expired vial but was not aware patients had received the medication. Pharmacist #7 revealed the manufacturer expiration date, not the 28 day expiration date, was keyed into ADS A when the Lantus was stocked; therefore, the expired Lantus did not appear on the daily expiration date report. The report only generated medications expiring that day and did not show future expirations. Manager # 8 revealed there were 6 nurses involved in the administration of expired medications. Manager #8 was not sure how 6 RNs missed the orange expiration label on the vial. Nursing staff on Floor A were not aware that expired Lantus was given to patients. Interview revealed there was not an incident report for the expired Lantus vial. Director #6 revealed an incident report would have triggered further investigation. Follow-up interview on 05/14/2025 at 1638 with Manager #8 revealed Manager #8 did not have access to reports that would show which patients received insulin from the ADS A drawer. Manager #8 was not concerned that patients had received expired Lantus at the time because Lantus was not frequently given on Floor A. Follow-up interview on 05/14/2025 at 1630 with Pharmacist #7 revealed that when Pharmacist #7 received the expired vial, it was visually inspected for signs of contamination. Interview revealed the vial did not appear to be contaminated. Manager #7 did not feel there was a risk to patient safety; therefore, Manager #7 did not check to see if any patients had received the expired Lantus. 3. Closed medical record review on 05/14/2025 for Pt #14 revealed a 63-year-old male that was transferred from Hospital B to Hospital A, Floor A on 12/2/2024 at 1429 for acute (sudden or severe onset) cystitis (urinary tract infection) and encephalopathy (disease process that alters brain function) secondary to infection. The patient had a history of diabetes. Review of the MAR revealed Pt #14 received 10 units of Lantus insulin subcutaneously on 12/06/2024 at 2140. Record review revealed additional doses of Lantus insulin were pulled from another ADS on Floor A. The patient received further care and was discharged to a long term care facility on 12/17/2024. Pt #14 returned to Hospital A’s ED on 12/20/2024 at 1852 with a chief complaint of chest pain. The patient was admitted to Floor A at 2247. Review of the MAR revealed Pt #14 received 10 units of Lantus insulin subcutaneously on 12/20/2024 at 2308. Record review revealed additional doses of Lantus insulin were pulled from another ADS on Floor A. Pt #14 was transferred to Hospital B on 12/22/2024 at 1852 for a cardiac catheterization (a procedure where a thin tube is inserted into the heart via a blood vessel for diagnosis and treatment of heart conditions). Review of the All Transactions Activity Report for ADS A, with a timeframe of 09/01/2024 through 03/14/2025, revealed Lantus was removed from ADS A for Pt #14 on 12/06/2024 at 2117 and on 12/20/24 at 2258 (twice during the timeframe that Lantus was expired). Interview on 05/13/2025 at 1350 with Manager #8 revealed RN #9 found a vial of Lantus that expired in September 2024 in the ADS on 03/14/2025. RN #9 notified Manager #8 and the pharmacy prior to administration of Lantus on that day. Manager #8 inspected the vial and noted the orange expiration label had a date of September 2024 written on the label. There were no other vials of Lantus in ADS A at the time the expired vial of Lantus was discovered. Manager #8 was not sure that a patient had received the expired medication at the time the expired vial was discovered. Interview revealed nursing staff should check the 28 day expiration date and the manufacturer expiration date prior to administration. Interview on 05/14/2025 at 1120, while on tour of Floor A, with Pharmacist #3 revealed the following process for labeling insulin vials and removal of expired medications. Orange labels with a 28 day expiration date were placed on all insulin vials in the pharmacy when the vials were removed from the refrigerator. The labeled vials were then taken to the floor and stocked in the ADS. The pharmacist or pharmacy technician entered the 28 day expiration date or the manufacturer expiration date, whichever expired the soonest, into the ADS system. Interview revealed a daily report was generated in the pharmacy with a list of expiring medications and those medications were removed and replaced in the ADS by the pharmacy each day. Interview revealed the process had been in place as long as Pharmacist #3 could remember. Interview of 05/14/2025 at 1245 with Manager #4, Staff #5, Director #6, Pharmacist #7, and Manager #8 revealed hospital leadership was not aware that 9 patients received expired Lantus prior to 5/14/2025. Interview revealed that according to the ADS A report, Lantus was filled on 08/04/2024 and not filled again until 03/14/2025. Interview revealed the 09/01/2024 expiration date was correct as it was 28 days after the vial was placed in ADS A. Pharmacist #7 was notified of the expired vial but was not aware patients had received the medication. Pharmacist #7 revealed the manufacturer expiration date, not the 28 day expiration date, was keyed into ADS A when the Lantus was stocked; therefore, the expired Lantus did not appear on the daily expiration date report. The report only generated medications expiring that day and did not show future expirations. Manager # 8 revealed there were 6 nurses involved in the administration of expired medications. Manager #8 was not sure how 6 RNs missed the orange expiration label on the vial. Nursing staff on Floor A were not aware that expired Lantus was given to patients. Interview revealed there was not an incident report for the expired Lantus vial. Director #6 revealed an incident report would have triggered further investigation. Follow-up interview on 05/14/2025 at 1638 with Manager #8 revealed Manager #8 did not have access to reports that would show which patients received insulin from the ADS A drawer. Manager #8 was not concerned that patients had received expired Lantus at the time because Lantus was not frequently given on Floor A. Follow-up interview on 05/14/2025 at 1630 with Pharmacist #7 revealed that when Pharmacist #7 received the expired vial, it was visually inspected for signs of contamination. Interview revealed the vial did not appear to be contaminated. Manager #7 did not feel there was a risk to patient safety; therefore, Manager #7 did not check to see if any patients had received the expired Lantus. 4. Closed medical record review on 05/14/2025 for Pt #15 revealed a 74-year-old male that arrived to Hospital A on 11/19/2024 at 0808 for image guided sinus surgery and a history of diabetes. Pt #15 was admitted to Floor A for postoperative care at 1231. Review of the MAR revealed Pt #15 received 5 units of Lantus insulin subcutaneously on 11/19/2024 at 2116. The patient received 10 units of Lantus insulin subcutaneously on 11/20/2024 at 0833. Pt #15 was discharged home on 11/20/2024 at 1210. Review of the All Transactions Activity Report for ADS A, with a timeframe of 09/01/2024 through 03/14/2025, revealed Lantus was removed from ADS A for Pt #15 on 11/19/2024 at 2101 and on 11/20/2024 at 0821 (twice during the timeframe that Lantus was expired). Interview on 05/13/2025 at 1350 with Manager #8 revealed RN #9 found a vial of Lantus that expired in September 2024 in the ADS on 03/14/2025. RN #9 notified Manager #8 and the pharmacy prior to administration of Lantus on that day. Manager #8 inspected the vial and noted the orange expiration label had a date of September 2024 written on the label. There were no other vials of Lantus in ADS A at the time the expired vial of Lantus was discovered. Manager #8 was not sure that a patient had received the expired medication at the time the expired vial was discovered. Interview revealed nursing staff should check the 28 day expiration date and the manufacturer expiration date prior to administration. Interview on 05/14/2025 at 1120, while on tour of Floor A, with Pharmacist #3 revealed the following process for labeling insulin vials and removal of expired medications. Orange labels with a 28 day expiration date were placed on all insulin vials in the pharmacy when the vials were removed from the refrigerator. The labeled vials were then taken to the floor and stocked in the ADS. The pharmacist or pharmacy technician entered the 28 day expiration date or the manufacturer expiration date, whichever expired the soonest, into the ADS system. Interview revealed a daily report was generated in the pharmacy with a list of expiring medications and those medications were removed and replaced in the ADS by the pharmacy each day. Interview revealed the process had been in place as long as Pharmacist #3 could remember. Interview of 05/14/2025 at 1245 with Manager #4, Staff #5, Director #6, Pharmacist #7, and Manager #8 revealed hospital leadership was not aware that 9 patients received expired Lantus prior to 5/14/2025. Interview revealed that according to the ADS A report, Lantus was filled on 08/04/2024 and not filled again until 03/14/2025. Interview revealed the 09/01/2024 expiration date was correct as it was 28 days after the vial was placed in ADS A. Pharmacist #7 was notified of the expired vial but was not aware patients had received the medication. Pharmacist #7 revealed the manufacturer expiration date, not the 28 day expiration date, was keyed into ADS A when the Lantus was stocked; therefore, the expired Lantus did not appear on the daily expiration date report. The report only generated medications expiring that day and did not show future expirations. Manager # 8 revealed there were 6 nurses involved in the administration of expired medications. Manager #8 was not sure how 6 RNs missed the orange expiration label on the vial. Nursing staff on Floor A were not aware that expired Lantus was given to patients. Interview revealed there was not an incident report for the expired Lantus vial. Director #6 revealed an incident report would have triggered further investigation. Follow-up interview on 05/14/2025 at 1638 with Manager #8 revealed Manager #8 did not have access to reports that would show which patients received insulin from the ADS A drawer. Manager #8 was not concerned that patients had received expired Lantus at the time because Lantus was not frequently given on Floor A. Follow-up interview on 05/14/2025 at 1630 with Pharmacist #7 revealed that when Pharmacist #7 received the expired vial, it was visually inspected for signs of contamination. Interview revealed the vial did not appear to be contaminated. Manager #7 did not feel there was a risk to patient safety; therefore, Manager #7 did not check to see if any patients had received the expired Lantus. 5. Closed medical record review on 05/14/2025 for Pt #18 revealed a 26-year-old female that arrived in the ED on 09/03/2024 at 1817 with a chief complaint of a right foot ulcer and a history of diabetes. Pt #18 was admitted to Floor A at 2219. Review of the MAR revealed Pt #18 received 5 units of Lantus insulin subcutaneously on 09/04/2024 at 2059 and on 09/05/2024 at 2040. The patient received further care and was discharged home on 09/06/2024 at 1555. Review of the All Transactions Activity Report for ADS A, with a timeframe of 09/01/2024 through 03/14/2025, revealed Lantus was removed from ADS A for Pt #18 on 09/04/2024 at 2019 and on 09/05/2024 at 2036 (twice during the timeframe that Lantus was expired). Interview on 05/13/2025 at 1350 with Manager #8 revealed RN #9 found a vial of Lantus that expired in September 2024 in the ADS on 03/14/2025. RN #9 notified Manager #8 and the pharmacy prior to administration of Lantus on that day. Manager #8 inspected the vial and noted the orange expiration label had a date of September 2024 written on the label. There were no other vials of Lantus in ADS A at the time the expired vial of Lantus was discovered. Manager #8 was not sure that a patient had received the expired medication at the time the expired vial was discovered. Interview revealed nursing staff should check the 28 day expiration date and the manufacturer expiration date prior to administration. Interview on 05/14/2025 at 1120, while on tour of Floor A, with Pharmacist #3 revealed the following process for labeling insulin vials and removal of expired medications. Orange labels with a 28 day expiration date were placed on all insulin vials in the pharmacy when the vials were removed from the refrigerator. The labeled vials were then taken to the floor and stocked in the ADS. The pharmacist or pharmacy technician entered the 28 day expiration date or the manufacturer expiration date, whichever expired the soonest, into the ADS system. Interview revealed a daily report was generated in the pharmacy with a list of expiring medications and those medications were removed and replaced in the ADS by the pharmacy each day. Interview revealed the process had been in place as long as Pharmacist #3 could remember. Interview of 05/14/2025 at 1245 with Manager #4, Staff #5, Director #6, Pharmacist #7, and Manager #8 revealed hospital leadership was not aware that 9 patients received expired Lantus prior to 5/14/2025. Interview revealed that according to the ADS A report, Lantus was filled on 08/04/2024 and not filled again until 03/14/2025. Interview revealed the 09/01/2024 expiration date was correct as it was 28 days after the vial was placed in ADS A. Pharmacist #7 was notified of the expired vial but was not aware patients had received the medication. Pharmacist #7 revealed the manufacturer expiration date, not the 28 day expiration date, was keyed into ADS A when the Lantus was stocked; therefore, the expired Lantus did not appear on the daily expiration date report. The report only generated medications expiring that day and did not show future expirations. Manager # 8 revealed there were 6 nurses involved in the administration of expired medications. Manager #8 was not sure how 6 RNs missed the orange expiration label on the vial. Nursing staff on Floor A were not aware that expired Lantus was given to patients. Interview revealed there was not an incident report for the expired Lantus vial. Director #6 revealed an incident report would have triggered further investigation. Follow-up interview on 05/14/2025 at 1638 with Manager #8 revealed Manager #8 did not have access to reports that would show which patients received insulin from the ADS A drawer. Manager #8 was not concerned that patients had received expired Lantus at the time because Lantus was not frequently given on Floor A. Follow-up interview on 05/14/2025 at 1630 with Pharmacist #7 revealed that when Pharmacist #7 received the expired vial, it was visually inspected for signs of contamination. Interview revealed the vial did not appear to be contaminated. Manager #7 did not feel there was a risk to patient safety; therefore, Manager #7 did not check to see if any patients had received the expired Lantus. 6. Closed medical record review on 05/14/2025 for Pt #11 revealed a 66-year-old female that arrived to Hospital A on 02/03/2025 at 0919 for surgery to correct a closed displaced fracture of the upper end of the right humorous bone (when the upper part of the arm bone that connects to the shoulder joint breaks but does not pierce the skin) and a history of diabetes. Record review revealed the patient was admitted to Floor A for postoperative care at 1448. Review of the MAR revealed Pt #11 received 24 units of Lantus insulin subcutaneously on 02/03/2025 at 2150. The patient received further care and was discharged home on 02/04/2025 at 1237. Review of the All Transactions Activity Report for ADS A, with a timeframe of 09/01/2024 through 03/14/2025, revealed Lantus was removed from ADS A for Pt #11 on 02/03/2025 at 2146 (once during the timeframe that Lantus was expired). Interview on 05/13/2025 at 1350 with Manager #8 revealed RN #9 found a vial of Lantus that expired in September 2024 in the ADS on 03/14/2025. RN #9 notified Manager #8 and the pharmacy prior to administration of Lantus on that day. Manager #8 inspected the vial and noted the orange expiration label had a date of September 2024 written on the label. There were no other vials of Lantus in ADS A at the time the expired vial of Lantus was discovered. Manager #8 was not sure that a patient had received the expired medication at the time the expired vial was discovered. Interview revealed nursing staff should check the 28 day expiration date and the manufacturer expiration date prior to administration. Interview on 05/14/2025 at 1120, while on tour of Floor A, with Pharmacist #3 revealed the following process for labeling insulin vials and removal of expired medications. Orange labels with a 28 day expiration date were placed on all insulin vials in the pharmacy when the vials were removed from the refrigerator. The labeled vials were then taken to the floor and stocked in the ADS. The pharmacist or pharmacy technician entered the 28 day expiration date or the manufacturer expiration date, whichever expired the soonest, into the ADS system. Interview revealed a daily report was generated in the pharmacy with a list of expiring medications and those medications were removed and replaced in the ADS by the pharmacy each day. Interview revealed the process had been in place as long as Pharmacist #3 could remember. Interview of 05/14/2025 at 1245 with Manager #4, Staff #5, Director #6, Pharmacist #7, and Manager #8 revealed hospital leadership was not aware that 9 patients received expired Lantus prior to 5/14/2025. Interview revealed that according to the ADS A report, Lantus was filled on 08/04/2024 and not filled again until 03/14/2025. Interview revealed the 09/01/2024 expiration date was correct as it was 28 days after the vial was placed in ADS A. Pharmacist #7 was notified of the expired vial but was not aware patients had received the medication. Pharmacist #7 revealed the manufacturer expiration date, not the 28 day expiration date, was keyed into ADS A when the Lantus was stocked; therefore, the expired Lantus did not appear on the daily expiration date report. The report only generated medications expiring that day and did not show future expirations. Manager # 8 revealed there were 6 nurses involved in the administration of expired medications. Manager #8 was not sure how 6 RNs missed the orange expiration label on the vial. Nursing staff on Floor A were not aware that expired Lantus was given to patients. Interview revealed there was not an incident report for the expired Lantus vial. Director #6 revealed an incident report would have triggered further investigation. Follow-up interview on 05/14/2025 at 1638 with Manager #8 revealed Manager #8 did not have access to reports that would show which patients received insulin from the ADS A drawer. Manager #8 was not concerned that patients had received expired Lantus at the time because Lantus was not frequently given on Floor A. Follow-up interview on 05/14/2025 at 1630 with Pharmacist #7 revealed that when Pharmacist #7 received the expired vial, it was visually inspected for signs of contamination. Interview revealed the vial did not appear to be contaminated. Manager #7 did not feel there was a risk to patient safety; therefore, Manager #7 did not check to see if any patients had received the expired Lantus. 7. Closed medical record review on 05/14/2025 for Pt #13 revealed a 74-year-old female that arrived in the ED on 11/27/2024 at 0110 with complaints of polysubstance (multiple substances) abuse and elder abuse with a history of diabetes. Pt #13 was admitted to Floor B at 0447. The patient received treatment and was transferred to Floor A on 12/11/2024 at 1753. Review of the MAR revealed Pt #13 received 15 unites of Lantus insulin subcutaneously on 12/20/2024 at 2004. Record review revealed additional doses of Lantus insulin were pulled from another ADS on Floor A. The patient received further care and was discharged to a long term care facility on 01/07/2025 at 1027. Review of the All Transactions Activity Report for ADS A, with a timeframe of 09/01/2024 through 03/14/2025, revealed Lantus was removed from ADS A for Pt #13 on 12/20/2024 at 1958 (once during the timeframe that Lantus was expired). Interview on 05/13/2025 at 1350 with Manager #8 revealed RN #9 found a vial of Lantus that expired in September 2024 in the ADS on 03/14/2025. RN #9 notified Manager #8 and the pharmacy prior to administration of Lantus on that day. Manager #8 inspected the vial and noted the orange expiration label had a date of September 2024 written on the label. There were no other vials of Lantus in ADS A at the time the expired vial of Lantus was discovered. Manager #8 was not sure that a patient had received the expired medication at the time the expired vial was discovered. Interview revealed nursing staff should check the 28 day expiration date and the manufacturer expiration date prior to administration. Interview on 05/14/2025 at 1120, while on tour of Floor A, with Pharmacist #3 revealed the following process for labeling insulin vials and removal of expired medications. Orange labels with a 28 day expiration date were placed on all insulin vials in the pharmacy when the vials were removed from the refrigerator. The labeled vials were then taken to the floor and stocked in the ADS. The pharmacist or pharmacy technician entered the 28 day expiration date or the manufacturer expiration date, whichever expired the soonest, into the ADS system. Interview revealed a daily report was generated in the pharmacy with a list of expiring medications and those medications were removed and replaced in the ADS by the pharmacy each day. Interview revealed the process had been in place as long as Pharmacist #3 could remember. Interview of 05/14/2025 at 1245 with Manager #4, Staff #5, Director #6, Pharmacist #7, and Manager #8 revealed hospital leadership was not aware that 9 patients received expired Lantus prior to 5/14/2025. Interview revealed that according to the ADS A report, Lantus was filled on 08/04/2024 and not filled again until 03/14/2025. Interview revealed the 09/01/2024 expiration date was correct as it was 28 days after the vial was placed in ADS A. Pharmacist #7 was notified of the expired vial but was not aware patients had received the medication. Pharmacist #7 revealed the manufacturer expiration date, not the 28 day expiration date, was keyed into ADS A when the Lantus was stocked; therefore, the expired Lantus did not appear on the daily expiration date report. The report only generated medications expiring that day and did not show future expirations. Manager # 8 revealed there were 6 nurses involved in the administration of expired medications. Manager #8 was not sure how 6 RNs missed the orange expiration label on the vial. Nursing staff on Floor A were not aware that expired Lantus was given to patients. Interview revealed there was not an incident report for the expired Lantus vial. Director #6 revealed an incident report would have triggered further investigation. Follow-up interview on 05/14/2025 at 1638 with Manager #8 revealed Manager #8 did not have access to reports that would show which patients received insulin from the ADS A drawer. Manager #8 was not concerned that patients had received expired Lantus at the time because Lantus was not frequently given on Floor A. Follow-up interview on 05/14/2025 at 1630 with Pharmacist #7 revealed that when Pharmacist #7 received the expired vial, it was visually inspected for signs of contamination. Interview revealed the vial did not appear to be contaminated. Manager #7 did not feel there was a risk to patient safety; therefore, Manager #7 did not check to see if any patients had received the expired Lantus. 8. Closed medical record review on 05/14/2025 for Pt #16 revealed a 60-year-old that arrived to Hospital A on 10/16/2024 at 0627 for a total knee arthroplasty (a surgical procedure that replaces damaged cartilage and bone in the knee joint with artificial implants) with a history of diabetes. Pt #16 was admitted to Floor A for postoperative care at 1048. Review of the MAR revealed Pt #16 received 25 units of Lantus insulin subcutaneously on 10/16/2024 at 2034. The patient received further care and was discharged home on 10/17/2024 at 1645. Review of the All Transactions Activity Report for ADS A, with a timeframe of 09/01/2024 through 03/14/2025, revealed Lantus was removed from ADS A for Pt #16 on 10/16/2024 at 2028 (once during the timeframe that Lantus was expired). Interview on 05/13/2025 at 1350 with Manager #8 revealed RN #9 found a vial of Lantus that expired in September 2024 in the ADS on 03/14/2025. RN #9 notified Manager #8 and the pharmacy prior to administration of Lantus on that day. Manager #8 inspected the vial and noted the orange expiration label had a date of September 2024 written on the label. There were no other vials of Lantus in ADS A at the time the expired vial of Lantus was discovered. Manager #8 was not sure that a patient had received the expired medication at the time the expired vial was discovered. Interview revealed nursing staff should check the 28 day expiration date and the manufacturer expiration date prior to administration. Interview on 05/14/2025 at 1120, while on tour of Floor A, with Pharmacist #3 revealed the following process for labeling insulin vials and removal of expired medications. Orange labels with a 28 day expiration date were placed on all insulin vials in the pharmacy when the vials were removed from the refrigerator. The labeled vials were then taken to the floor and stocked in the ADS. The pharmacist or pharmacy technician entered the 28 day expiration date or the manufacturer expiration date, whichever expired the soonest, into the ADS system. Interview revealed a daily report was generated in the pharmacy with a list of expiring medications and those medications were removed and replaced in the ADS by the pharmacy each day. Interview revealed the process had been in place as long as Pharmacist #3 could remember. Interview of 05/14/2025 at 1245 with Manager #4, Staff #5, Director #6, Pharmacist #7, and Manager #8 revealed hospital leadership was not aware that 9 patients received expired Lantus prior to 5/14/2025. Interview revealed that according to the ADS A report, Lantus was filled on 08/04/2024 and not filled again until 03/14/2025. Interview revealed the 09/01/2024 expiration date was correct as it was 28 days after the vial was placed in ADS A. Pharmacist #7 was notified of the expired vial but was not aware patients had received the medication. Pharmacist #7 revealed the manufacturer expiration date, not the 28 day expiration date, was keyed into ADS A when the Lantus was stocked; therefore, the expired Lantus did not appear on the daily expiration date report. The report only generated medications expiring that day and did not show future expirations. Manager # 8 revealed there were 6 nurses involved in the administration of expired medications. Manager #8 was not sure how 6 RNs missed the orange expiration label on the vial. Nursing staff on Floor A were not aware that expired Lantus was given to patients. Interview revealed there was not an incident report for the expired Lantus vial. Director #6 revealed an incident report would have triggered further investigation. Follow-up interview on 05/14/2025 at 1638 with Manager #8 revealed Manager #8 did not have access to reports that would show which patients received insulin from the ADS A drawer. Manager #8 was not concerned that patients had received expired Lantus at the time because Lantus was not frequently given on Floor A. Follow-up interview on 05/14/2025 at 1630 with Pharmacist #7 revealed that when Pharmacist #7 received the expired vial, it was visually inspected for signs of contamination. Interview revealed the vial did not appear to be contaminated. Manager #7 did not feel there was a risk to patient safety; therefore, Manager #7 did not check to see if any patients had received the expired Lantus. 9. Closed medical record review on 05/14/2025 for Pt #17 revealed a 54-year-old female that arrived to Hospital A on 10/15/2024 at 0633 for a thyroidectomy (a surgical procedure involving removal of all or part of the thyroid gland) with a history of diabetes. Pt #17 was admitted to Floor A for postoperative care at 1249. Review of the MAR revealed Pt #17 received 26 units of Lantus insulin subcutaneously on 10/15/2024 at 2129. The patient received further care and was discharged home on 10/16/2024 at 1447. Review of the All Transactions Activity Report for ADS A, with a timeframe of 09/01/2024 through 03/14/2025, revealed Lantus was removed from ADS A for Pt #17 on 10/15/2024 at 2124 (once during the timeframe that Lantus was expired). Interview on 05/13/2025 at 1350 with Manager #8 revealed RN #9 found a vial of Lantus that expired in September 2024 in the ADS on 03/14/2025. RN #9 notified Manager #8 and the pharmacy prior to administration of Lantus on that day. Manager #8 inspected the vial and noted the orange expiration label had a date of September 2024 written on the label. There were no other vials of Lantus in ADS A at the time the expired vial of Lantus was discovered. Manager #8 was not sure that a patient had received the expired medication at the time the expired vial was discovered. Interview revealed nursing staff should check the 28 day expiration date and the manufacturer expiration date prior to administration. Interview on 05/14/2025 at 1120, while on tour of Floor A, with Pharmacist #3 revealed the following process for labeling insulin vials and removal of expired medications. Orange labels with a 28 day expiration date were placed on all insulin vials in the pharmacy when the vials were removed from the refrigerator. The labeled vials were then taken to the floor and stocked in the ADS. The pharmacist or pharmacy technician entered the 28 day expiration date or the manufacturer expiration date, whichever expired the soonest, into the ADS system. Interview revealed a daily report was generated in the pharmacy with a list of expiring medications and those medications were removed and replaced in the ADS by the pharmacy each day. Interview revealed the process had been in place as long as Pharmacist #3 could remember. Interview of 05/14/2025 at 1245 with Manager #4, Staff #5, Director #6, Pharmacist #7, and Manager #8 revealed hospital leadership was not aware that 9 patients received expired Lantus prior to 5/14/2025. Interview revealed that according to the ADS A report, Lantus was filled on 08/04/2024 and not filled again until 03/14/2025. Interview revealed the 09/01/2024 expiration date was correct as it was 28 days after the vial was placed in ADS A. Pharmacist #7 was notified of the expired vial but was not aware patients had received the medication. Pharmacist #7 revealed the manufacturer expiration date, not the 28 day expiration date, was keyed into ADS A when the Lantus was stocked; therefore, the expired Lantus did not appear on the daily expiration date report. The report only generated medications expiring that day and did not show future expirations. Manager # 8 revealed there were 6 nurses involved in the administration of expired medications. Manager #8 was not sure how 6 RNs missed the orange expiration label on the vial. Nursing staff on Floor A were not aware that expired Lantus was given to patients. Interview revealed there was not an incident report for the expired Lantus vial. Director #6 revealed an incident report would have triggered further investigation. Follow-up interview on 05/14/2025 at 1638 with Manager #8 revealed Manager #8 did not have access to reports that would show which patients received insulin from the ADS A drawer. Manager #8 was not concerned that patients had received expired Lantus at the time because Lantus was not frequently given on Floor A. Follow-up interview on 05/14/2025 at 1630 with Pharmacist #7 revealed that when Pharmacist #7 received the expired vial, it was visually inspected for signs of contamination. Interview revealed the vial did not appear to be contaminated. Manager #7 did not feel there was a risk to patient safety; therefore, Manager #7 did not check to see if any patients had received the expired Lantus. NC00228855”