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
Loose Medications Found on Two Medication Carts
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

Surveyors found loose pills in drawers on two medication carts, indicating medications were not stored in their original packaging or assigned resident-specific areas as required by facility policy. On one cart, two loose tablets later identified as Carbidopa-Levodopa and Zofran were discovered with a medication aide who stated she was responsible for checking the cart at the start of her shift. On the second cart, four loose tablets identified as Allopurinol, Metoprolol, Lasix, and Amlodipine were found with another medication aide, who also reported routinely checking the cart for cleanliness and loose medications. The DON and ADM both reported they were unaware of the loose medications and stated that medication aides, nurses, and charge nurses were responsible for proper medication storage, monitored through administrative and pharmacy cart audits.

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.
Unsecured Medicated Ointments and Solutions Left in Resident Rooms
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

Surveyors found that the facility failed to follow its own medication storage policy when medicated ointments and solutions were left unsecured in several resident rooms. A resident with heart failure had Diclofenac ointment on the sink, another resident with bladder cancer had Ciclopirox topical solution on the nightstand, and a severely cognitively impaired resident with a history of cerebral infarction had hydrophilic wound dressing stored in a bedside basket on multiple observations. Staff, including an LPN, a wound care nurse, and the ADON, stated that medications and ointments were supposed to be kept on locked carts and not at the bedside, and that residents were not permitted to keep medications in their rooms, demonstrating noncompliance with the facility’s written storage policy and federal requirements.

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.
Medication Cart Left Unlocked and Unattended
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

Medication cart security was not maintained for Cart 700. Facility policy required the cart to be locked when out of the medication nurse’s sight, but an RN walked away from the cart and later entered a resident room while leaving it unlocked and unattended. The RN confirmed the cart should have been locked, and the President of Clinical Operations confirmed carts should be locked when unattended.

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.
Insulin Storage and Labeling Deficiency
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

Insulin Storage and Labeling Deficiency: The short hall med cart contained multiple insulin items that were not properly dated, including an open Lantus vial, an unopened Novolin vial, a Lantus pen, and a Novolog pen. The ADON said insulin containers should be dated for 28 days when removed from refrigeration and opened, but she was unsure when the items were taken out. The DON also confirmed insulin should be labeled with the expiration date when removed from the refrigerator, and the facility policy required pens to be dated when placed into use.

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.
Loose medications and missing open date 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

Loose medications were found in 2 of 8 observed med carts, including five loose pills in one cart, one loose pill in another, and one loose blue pill in a third cart. A bottle of Active Liquid Protein also lacked an open date. Staff interviews confirmed that carts are checked by nurses, unit managers, DON, and pharmacy, and the facility policy requires the date opened to be recorded on multi-dose containers.

Fine: $27,378
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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.
Unlocked Treatment Cart and Improper Medication Storage
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

Unlocked treatment cart and improper medication storage were observed in multiple areas. An unlocked, unattended treatment cart was found in a hallway, and the East Medication Room contained personal items mixed with medication supplies. Opened Tubersol vials in two refrigerators and multiple opened meds in the A Hall and C Hall medication carts were not dated, and an LPN confirmed several of the findings.

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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