F0761 F761: Ensure drugs and biologicals used in the facility are labeled in accordance with currently accepted professional principles; and all drugs and biologicals must be stored in locked compartments, separately locked, compartments for controlled drugs.
D

Failure to Label Insulin Vial and Secure Self-Administered Medications

Penn Highlands Jefferson ManorBrookville, Pennsylvania Survey Completed on 01-09-2025

Summary

The facility failed to properly label a multi-dose insulin vial and ensure the secure storage of medications for self-administration. During an observation, it was noted that a medication cart contained an opened, undated multi-dose Lantus insulin vial, which should have been labeled with the date it was opened to ensure timely disposal according to the manufacturer's instructions. A Licensed Practical Nurse (LPN) confirmed that the vials should be dated upon opening to prevent usage past expiration. Additionally, the facility did not secure medications for a resident who was permitted to self-administer. The resident's room contained a plastic storage bin with multiple medications left unsecured on a bedside tray table throughout the day. Interviews with LPNs revealed that the medications were left in the resident's room from morning until evening, contrary to the facility's policy that requires medications to be stored securely when not in use.

Plan Of Correction

Facility has done a full sweep to identify if any other residents have been impacted by the concern. No other residents were impacted. All other medication carts in the facility were reviewed by director of nursing or RN supervisor to determine no other inappropriate labeling or lack thereof had occurred. Inter-disciplinary team (IDT) reviewed the patient's care plan as well as physician orders with resident. Resident R22 understands there is a safety risk for other residents for leaving meds unattended in the room and is agreeable to keeping medications secured in the medication cart outside of medication administration times. Resident requests at the time of the medication needing given that medications be brought to bed-side, then R22 will prepare medications and take them supervised with nurse. The medications will be locked again and secured in med cart. R22 expresses the safety factor and is willing to participate. Nursing Staff have been educated on the new process in regard to this resident. Care plan and orders have been updated. Education was also provided to nursing staff on labeling vials. DON or designee will audit that this new process is happening 3 times a week for 4 weeks and then weekly for 6 weeks. Audits will be completed on multi-dose labeling and audited 3 times weekly for 6 weeks and once weekly for one month. Facility has identified this as a performance improvement program for their Quality Assurance Performance Improvement (QAPI) Program. We will review quarterly with QAPI and track progress.

Penalty

No penalty information released
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The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.

Resources

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See other F0761 citations
Medication Labeling and Storage Deficiencies
E
F0761 F761: Ensure drugs and biologicals used in the facility are labeled in accordance with currently accepted professional principles; and all drugs and biologicals must be stored in locked compartments, separately locked, compartments for controlled drugs.
Short Summary

Medication labeling and storage deficiencies were observed during med pass and cart/room checks. An LPN prepared hydrocodone-acetaminophen for a resident from blister packs whose labels did not match the EMR orders, another cart contained a loose pill in an unlabeled state, and a rehab unit med room had a controlled-medication lock box that was not affixed to the refrigerator. The DON and Administrator stated labels should match orders, carts should not contain loose pills, and controlled meds should be securely locked.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Unattended RT Medication Cart Left Unlocked
D
F0761 F761: Ensure drugs and biologicals used in the facility are labeled in accordance with currently accepted professional principles; and all drugs and biologicals must be stored in locked compartments, separately locked, compartments for controlled drugs.
Short Summary

Unattended RT Medication Cart Left Unlocked: RT Medication/Treatment Cart A was observed unlocked and unattended in the 200 Hall with the keys hanging from the opened lock while no staff or residents were within eyesight. RT F stated she had stepped away briefly to check on a resident and acknowledged she should have locked the cart. Medications and supplies were visible in the cart, and RT F said she did not know when she was last trained on keeping the cart locked when unattended. The DON and ADM stated staff were expected to keep carts locked when not with them.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Unlabeled Medications Left at Bedside
D
F0761 F761: Ensure drugs and biologicals used in the facility are labeled in accordance with currently accepted professional principles; and all drugs and biologicals must be stored in locked compartments, separately locked, compartments for controlled drugs.
Short Summary

Unlabeled medication cups and supplies were left unattended at the bedside of two residents. A CNA stated cream was left in one resident’s room and later applied, while another resident had a clear cup with a spoon and cream on the nightstand. Staff confirmed neither resident had an order to self-administer medications, and an LPN and the DON stated the residents did not have self-administration orders. The facility policy required medications and biologicals to be stored in locked compartments.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Medications Missing Opened-On Dates
D
F0761 F761: Ensure drugs and biologicals used in the facility are labeled in accordance with currently accepted professional principles; and all drugs and biologicals must be stored in locked compartments, separately locked, compartments for controlled drugs.
Short Summary

Medications in two med carts and one med room were found without opened-on dates, including eyedrops, creams, gels, ointments, and an insulin pen. RN-A and RN-B stated these items should be dated when opened, and the DON confirmed staff were expected to affix and complete date-opened stickers for these medications. Facility policy required containers or vials to be dated when the original seal was broken.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Missing Medication Refrigerator Temperature Monitoring
F
F0761 F761: Ensure drugs and biologicals used in the facility are labeled in accordance with currently accepted professional principles; and all drugs and biologicals must be stored in locked compartments, separately locked, compartments for controlled drugs.
Short Summary

Missing Medication Refrigerator Temperature Monitoring: The facility failed to monitor temperatures in 3 of 3 medication refrigerators. Temperature logs for Station 1, Station 2, and Station 3 showed multiple missing daily entries, and the Administrator confirmed staff were expected to check the refrigerators daily but there was no back-up temperature monitoring system on the days with blank temperatures.

Inspection fine: $17,665
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
Expired and Discontinued Medications Left in Medication Carts
E
F0761 F761: Ensure drugs and biologicals used in the facility are labeled in accordance with currently accepted professional principles; and all drugs and biologicals must be stored in locked compartments, separately locked, compartments for controlled drugs.
Short Summary

Expired and discontinued medications were left available in multiple medication carts, including Pantoprazole, ABH Gel syringes, and Propranolol. The DON, an LPN, and a medication aide stated the medications should have been removed from the carts and placed in the return-to-pharmacy bin, but they remained on the 100-hall cart and both 200-hall carts.

No penalty information released
tooltip icon
The penalty, as released by CMS, applies to the entire inspection this citation is part of, covering all citations and f-tags issued, not just this specific f-tag. For the complete original report, please refer to the 'Details' section.
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