561.25 Distressed drugs, devices and cosmetics
Drugs, devices and cosmetics which are outdated, visibly deteriorated, unlabeled or inadequately labeled, recalled, discontinued or obsolete shall be identified by the licensed pharmacist or responsible practitioner and shall be disposed of in compliance with applicable Commonwealth and Federal regulations.
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Observations:
Based on observation, review of facility policy, and interview with staff (EMP) it was determined the facility failed to ensure expired equipment was removed from crash carts.
Findings include:
Observation on April 29, 2025, at 10:27 AM of the Post Anesthesia Care Unit (PACU) code cart revealed the following expired equipment: Laryngeal Mask Airway (LMA) size 3 expired in 2023, five (5) Intravenous (IV) sets expired in 2024, two (2) suture sets for Central Venous Cather kit expired in 2024.
Observation on April 29, 2025, at approximately 11:08 AM of the Operating Room (OR) hallway code cart revealed the following expire equipment: Laryngeal Mask Airway (LMA) size 5 expired in 2024, Lung Expansion kit expired in 2024, two (2) surgical needles expired in 2024.
Review on May 8, 2025, of facility policy " Emergency Medications/Cart", effective April 15th, 2015, revealed " This policy establishes a process for maintaining the necessary medications, supplies and equipment required for emergency situations that may occur at the Center ...An emergency medication cart is prepared and maintained by Center's nursing staff ...They are kept in the PACU and OR hallway ...The emergency cart and related equipment are checked each day the Center is open by the nursing staff to assure that the cart has not been opened or that there are not any medications due to expire within the cart ... "
Interview on April 29, 2025, with EMP1 confirmed the location of the equipment and confirmed all the equipment observed was expired during the observation tour of the facility.
| | Plan of Correction - To be completed: 06/13/2025
1.The Preoperative and Post-Anesthesia Care Unit Manager will re-educate all nursing staff members who are responsible for monitoring the code carts that every item located in the emergency code cart — including medications, medical supplies, and equipment — must be checked for expiration dates during every cart inspection. Any expired item must be immediately removed and replaced.
2.All emergency cart items, including medications, medical supplies, and equipment with expiration dates, will be logged into the facility's compliance tracking software system. This system is configured to generate an alert 30 days before an item reaches its expiration date. These alerts will be sent via email to the Director of Nursing, who will ensure that necessary replacements are made before expiration.
3.Policy Number 115, "Emergency Medications/Cart," has been revised by the Administrator to include all emergency cart items (not limited to medications) must be inspected for expiration. The revised policy will be submitted to the Board of Directors for their review and approval within 14 days.
4.The Director of Nursing will manage monthly audits of emergency cart logs and cross-check them against the compliance tracking software to ensure no expired items remain in circulation. A quarterly report will be submitted to the Administrator detailing compliance status and any identified issues.
5.The Administrator is responsible for ensuring overall compliance and timely completion of the outlined steps.
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