§483.45(g) Labeling of Drugs and Biologicals
Drugs and biologicals used in the facility must be labeled in accordance with currently accepted professional principles, and include the appropriate accessory and cautionary instructions, and the expiration date when applicable.
§483.45(h) Storage of Drugs and Biologicals
§483.45(h)(1) In accordance with State and Federal laws, the facility must store all drugs and biologicals in locked compartments under proper temperature controls, and permit only authorized personnel to have access to the keys.
§483.45(h)(2) The facility must provide separately locked, permanently affixed compartments for storage of controlled drugs listed in Schedule II of the Comprehensive Drug Abuse Prevention and Control Act of 1976 and other drugs subject to abuse, except when the facility uses single unit package drug distribution systems in which the quantity stored is minimal and a missing dose can be readily detected.
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Observations:
Based on observation, staff interview, and clinical record review, it was determined that the facility failed to ensure that a medication label was accurate for one of (Resident R3).
Findings include:
Review of Resident R3's April 2026 physican orders revealed an order dated March 19, 2025, for Potassium Chloride Liquid 20 MEQ/15ML (10%), Give 20 mEq via PEG-Tube one time a day for Hypokalemia (low Potassium Levels)
Observation conducted of the label on the medication for Potassium Chloride revealed Potassium Chloride Liquid 20 MEQ/7.5 ML.
On April 28, 2025, at 10:31 a.m., interview with the Director of Nursing revealed that the Pharmacy wrongly labelled the dose of Potassium Chloride Liquid 20 MEQ/15ML (10%), for R3 as to administer 7.5 ML, instead of 15 ML.
28 Pa. Code 211.9(a)(1) Pharmacy services
| | Plan of Correction - To be completed: 05/19/2025
Preparation and/or execution of this plan of correction does not constitute admission or agreement by this provider of the facts alleged, or conclusion set forth in the statement of deficiencies. The plan of correction is prepared and/or executed solely because it is required by the provisions of federal and/or state law. The plan of correction constitutes our credible allegation of compliance.
1. On 4/28/2025 the Nurse Unit Manager immediately assessed Resident R3 and identified no adverse complications related to the medication discrepancy. The physician was notified by the Nurse Unit Manager and orders for follow up labs obtained. Resident's lab results were at a therapeutic level and there were no negative outcomes. The attending Physician changed the order to 7.5 ML. The DON verified that the physician's order matches the label on the medication.
2. On 4/28/2025 the nurse management team reviewed resident's receiving liquid Potassium Chloride to verify that the physician's order in the electronic medical record matched the label on the medication.
3. On 4/28/2025 the DON, ADON and/or designee started education for licensed nursing staff on administering liquid Potassium Chloride based on physicians orders and verifying that medication labels match physician orders in the electronic medical record. Education will be completed by 5/14/2025.
4. During the morning clinical meeting, the IDT team will review all medication changes for liquid Potassium Chloride to verify that order matches the medication label.
5. The DON and/or Designee will conduct random audits on accuracy of medication labels weekly for 4 weeks and monthly for 3 months. The audits will be forwarded to the monthly Quality Assurance Meeting.
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