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Drugs, devices and cosmetics which are outdated, visibly deteriorated, unlabeled or inadequately labeled, recalled, discontinued or obsolete shall be identified by the licensed pharmacist or responsible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 review of facility documents, observation, and staff interview (EMP) it was determined the facility failed to identify, document and dispose of expired medications and supplies.
Finding included:
On March 27, 2025 review of facility policy "SUPPLIES/EQUIPMENT - STOCK" last reviewed March 20, 2025, revealed "Policy -The Administrator's designee has the responsibility for monitoring and maintaining adequate supply of stock. A 'just in time' inventory of all items is kept on hand. Objective - To maintain equipment and levels of supplies necessary to provide optimal patient care. Procedure- B. Items with expiration dates (medications, sterilized supplies) will be checked monthly. Those with short expiration dates will be utilized first, those items which can be resterilized will be done so at least two weeks prior to their expiration date. Other items will be returned to the supplier (if acceptable) or discarded and replaced. The replacements will be obtained prior to the expiration date of already stocked items."
Observation on March 27, 2025, Operating Room (OR) two (2) in the anesthesia cart were two (2) expired PVC Nasopharyngeal Airway (NPA). (1) 18Fr expired January 28, 2023; (2) 16 Fr expired February 28, 2023.
Observation on March 27, 2025, OR four (4) in the anesthesia cart were two (2) expired NPA (1) 28Fr expired October 21, 2023; (2) 34 Fr expired February 28, 2023. Seven (7) expired Laryngeal Mask Airway (LMA) (1) 1.5Fr expired April 23, 2015; (2) 2Fr expired May 28, 2021; (3) 2Fr expired June 28, 2023; (4) 2Fr expired August 28, 2024; (5) 3Fr expired April 28, 2023; (6) 5Fr expired March 28, 2023; (7) 5Fr expired February 26, 2025.
Observation on March 27, 2025, OR six (6) in the anesthesia cart were three (3) expired NPA (1) 16Fr expired April 28, 2023; (2) 18Fr expired January 28, 2023; (3) 20Fr expired April 28, 2023. Three (3) expired LMA (1) 2Fr expired August 28, 2024; (2) 3Fr expired April 28, 2023; (3) 5Fr expired December 28, 2024.
Interview with EMP1 on March 27, 2025, EMP1 confirmed the information above is accurate and does not follow facility policy.
| | Plan of Correction - To be completed: 04/21/2025
The current policy, "SUPPLIES/EQUIPMENT – STOCK" was reviewed by Anesthesia Staff. An item list was created for the Anesthesia Cart and Anesthesia Medication/Supply Cart in each OR. A new process was put in place on April 7, 2025, whereby designated staff will complete a monthly inventory check for outdated supplies in these carts. Any expired supplies will be immediately discarded and replaced. Confirmation of this check will be documented on the newly created form, and the form will be kept in a plastic sleeve on each corresponding anesthesia cart. All anesthesia personnel will receive training on this new process which will be completed by April 21, 2025, and will go into effect immediately.
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