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

Deficiencies in Drug Storage and Labeling

Edinboro ManorEdinboro, Pennsylvania Survey Completed on 01-31-2025

Summary

The facility failed to comply with regulations regarding the storage and labeling of drugs and biologicals. Specifically, controlled Schedule II-V medications were not stored in a separately locked, permanently affixed compartment as required. Instead, these medications were found in two separately locked containers attached to a removable shelf in the main medication room refrigerator. Additionally, an opened vial of Tubersol PPD was found without an open date, making it impossible for staff to determine the appropriate discard date. Further deficiencies were observed in the A-Wing medication cart, where an open injector pen of Humalog insulin was found with an open date indicating it was expired. The pen had been opened on 12/25/24, and according to the manufacturer's guidelines, it should have been discarded after 28 days. These findings were confirmed by LPNs during interviews, highlighting lapses in the facility's adherence to proper medication storage and labeling protocols.

Plan Of Correction

The facility immediately disposed of the medication which was not dated upon notification of the concern. The facility immediately disposed of the expired Humalog insulin upon notification of the concern. The DON and ADON have audited all medication carts and the facility medication room to ensure that there were no expired or un-dated medications present. The facilities Maintenance Director permanently attached/affixed the removable shelf on the date that it was brought to the facilities' attention. The Director of Nursing and/or designee will educate the facilities nurses on the importance of properly dating medication, disposing of expired medication, and ensuring proper storage of controlled schedule II-V medications. An audit of all medication rooms and medication carts has been conducted to ensure that there are no undated or expired medications present, as well as ensuring that controlled substances are secured and stored properly. The Assistant Director of Nursing and/or designee will conduct a weekly audit of the med room refrigerator to ensure that controlled substances are secured/stored properly and one (1) med cart a week for 4 weeks to ensure that there are no undated and/or expired medications present and that the controlled substances are secured/stored properly within the medication cart(s). The results of the audits will be reviewed at the monthly Quality Assurance and Performance Improvement meeting.

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

Below are regulatory guidelines relevant to this citation:

See other F0761 citations
Unlabeled Glucometer Strips and Expired Medications/Supplies Found in Storage Areas
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

Opened glucometer test-strip containers on multiple units were found without an open date, and staff could not verify when they had been opened. Expired medications and supplies were also found in several medication carts and a medication room, including ointment, IV sets, feeding tubes, jelly, saline bullets, and a syringe. The DON stated the containers should have been labeled and acknowledged that expired items should not be present.

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 Pills Found in Medication Cart Drawer
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

Loose pills were found in a medication cart drawer during an observation with an LVN. The pills were identified by the DON and ADON as Lisinopril/HCTZ, Oxybutynin, Eliquis, and Carvedilol. The LVN, DON, and ADM stated medications should be stored in blister packs or original manufacturer bottles, and the facility policy required drugs and biologicals to be stored in the packaging they were received in.

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 Self-Administered Medications in Resident Room
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

A resident approved for self-administration had multiple medications left unsecured in her room, including an inhaler, eye drops, nasal sprays, and nebulizer vials. The resident said her room did not lock and she did not have a lockbox, while an LPN was unsure whether room-kept meds needed to be locked and the DON confirmed the resident had not been offered a lockbox.

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 Medication and Treatment 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

Unsecured Medication and Treatment Carts: An LPN left a medication cart unlocked in the hallway with the computer screen visible and a medication cup left on top while away from the cart for about 10-15 minutes. A treatment cart with prescribed ointments and creams was also observed unattended at the nurses’ station with residents nearby, and later the 300 unit medication cart was found partially unlocked with no nurse on the unit. The DON confirmed carts should be locked when unattended, and facility policy stated medication carts are always locked when out of sight or 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.
Unauthorized Bedside 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

A resident with multiple chronic diagnoses and a BIMS of 13 had opened Neosporin and prescription miconazole 2% ointment at the bedside without a care plan, self-administration assessment, or physician order authorizing bedside storage. The resident said he used the OTC and prescribed creams on his own, while the LVN, CMA, and DON stated they were unaware the medications were in the room and confirmed residents should not keep meds at the bedside without proper authorization.

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 Storage and Labeling 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 carts and a resident room had multiple storage and labeling deficiencies. An RN left a medication cart unlocked and unattended, a narcotic drawer on another cart was unsecured, and a third cart contained unopened insulin that was not refrigerated before opening plus multiple insulin pens, inhalers, and eye drops with no open date noted. Two bedside eye drop bottles in a resident room were also unlabeled.

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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