The violation occurred at Costa Del Sol Healthcare, where Licensed Vocational Nurse 1 discovered an opened insulin pen for Resident 1 that bore no markings indicating when it had been accessed or when it would expire.
"The LVN who opened the insulin pen should have labelled the insulin pen with date opened and expiration date," the nurse told inspectors during an 8:05 a.m. observation on the day of the inspection.
Resident 1 was admitted to the facility with a history of diabetes mellitus and, according to medical records, had "fluctuating capacity to make medical decisions." The resident required insulin glargine, a long-acting insulin used to control blood sugar levels.
The medication error created a dangerous situation. Insulin glargine pens become unsafe to use 28 days after opening or first use when stored at room temperature, according to the manufacturer's prescribing information reviewed by the facility's pharmacist during the inspection.
"Insulin Glargine pens must be labeled with the open date and expiration date," Pharmacist 1 explained to inspectors, citing the June 2022 prescribing information that clearly states the 28-day limit.
Without proper labeling, nursing staff had no way to determine whether the insulin remained safe to administer.
"I would not know when Resident 1's Insulin Glargine pen was opened because the insulin was not labelled with date," LVN 1 told inspectors at 2:45 p.m. "It placed Resident 1 at risk of receiving expired insulin medication because the insulin pen was not labelled."
LVN 3 reinforced the severity of the oversight during a separate interview at 12:01 p.m., explaining that proper labeling prevents nurses from unknowingly administering expired medication. "All insulin pens must be labeled with the open and expiration dates so licensed nurses know when it was opened and when the expiration date would be and will not have the risk of administering an expired insulin to Resident 1."
The facility's own policies required the labeling that staff had ignored. The Director of Nursing acknowledged the policy violation during a 3:00 p.m. interview, reviewing the facility's "Medication Labeling and Storage" policy dated February 2023.
"Multi-dose vials that have been opened or accessed must be dated and discarded within 28 days," the policy states. The Director of Nursing admitted "the P&P was not followed when the licensed nurse did not label Resident 1's Insulin Glargine pen with the date when opened and the expiration date."
The policy specifically requires medication labels to include expiration dates and mandates that multi-dose vials be dated and discarded within 28 days "unless the manufacturer specifies a shorter or longer date for the open vial."
For insulin glargine pens, the manufacturer's specifications are clear. The prescribing information states that "room temperature or in-use single-resident-used prefilled pens can only be stored for 28 days."
Expired insulin poses real risks to diabetic patients. The medication can lose potency over time, potentially leading to inadequate blood sugar control. For a resident already dealing with fluctuating decision-making capacity, receiving ineffective medication could result in dangerous blood sugar spikes or other complications.
The violation represents a fundamental breakdown in medication safety protocols. Multiple nursing staff understood the labeling requirements, the facility had written policies mandating proper procedures, and the pharmacist had access to manufacturer guidelines specifying storage limits.
Yet none of these safeguards prevented Resident 1 from potentially receiving expired insulin simply because no one had written two dates on a medication pen.
The inspection classified the violation as having "minimal harm or potential for actual harm" affecting "few" residents. But for Resident 1, whose medical condition already complicated their care, the unlabeled insulin pen represented a preventable risk that nursing staff created through basic negligence.
Full Inspection Report
The details above represent a summary of key findings. View the complete inspection report for Costa Del Sol Healthcare from 2025-11-17 including all violations, facility responses, and corrective action plans.