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.
E

Failure to Properly Label and Remove Expired Insulin

Bayshore Residence And Rehabilitation CenterDuluth, Minnesota Survey Completed on 04-17-2025

Summary

Surveyors found that the facility failed to ensure biologic medications, specifically insulin aspart, were properly labeled with a pharmacy label indicating the resident's name and prescription information. During an observation of a medication cart in the Harbor Light community, an LPN confirmed the presence of an insulin aspart mix pen in the top drawer without knowledge of its owner. The LPN also acknowledged that the cart was checked regularly for expired or beyond-use medications, but the insulin pen was not labeled with the required information and had not been removed after its beyond-use date (BUD). Further interviews revealed that the DON expected insulin to be labeled with the resident's name, the date it was opened, and to be removed from use after reaching its BUD. The facility's policy on labeling medication containers required all medications to be properly labeled with specific information, including the resident's name, prescriber's name, pharmacy details, drug information, prescription number, dispensing date, cautionary statements, expiration date, and directions for use. The policy also required checking the expiration or BUD prior to medication administration. These requirements were not met for the insulin aspart pen found in the medication cart.

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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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
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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.
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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