561.1 Drugs and Biologicals
The ASF shall provide drugs and biologicals in a safe and effective
manner to meet the needs of patients, and to adequately support the organization's clinical capabilities commensurate with their licenses classification, in accordance with accepted ethical and professional practice and applicable State and Federal law, including the Pharmacy Act (63 P.S. 390-1 -390.13), 49 Pa. Code Chapter 27 (relating tot he State Board of Pharmacy), The Controlled Substance, Drug, Device and Cosmetic ACT (35 P.S. 780-101-780-144) and Chapter 25 (relating to controlled substances, drugs, devices and cosmetics).
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Observations:
Based on observation, facility documents, and interviews with staff, it was determined the facility failed to ensure pre-filled syringes were labeled utilizing acceptable standards of practice.
Findings Include:
Observation on March 12, 2025 at 12:05 PM revealed one syringe filled with 20cc of white liquid in the top drawer of the anesthesia cart, located in OR2, that was unlabeled.
Review on March 12, 2025 of facility policy, "Medication/Solution Container Labeling", last revised October 2022 revealed, "All medication, medication containers (i.e. syringes, medication cups, basins), or other solutions in the perioperative and other procedural settings should be labeled, even if only one container present ... All syringes will be labeled when not immediately injected... 2. Managing Medications on the Sterile Field ... c. Label all medication containers and delivery devices with, at minimum, the medication name, strength, concentration, if needed, date, time, and initials."
Interview on March 12, 2025 at 12:05 PM with EMP1 confirmed the filled syringe in the anesthesia cart was unlabeled and "it's probably Propofol."
| | Plan of Correction - To be completed: 03/20/2025
They survey finding was shared with the Governing Board on 3/20/2025 via ADHOC meeting. The corrective actions were approved by the Governing Board.
The survey finding will be shared with the employees during a staff meeting on 3/24/25. Staff will be encouraged to inform management of any deviation of practices stated in the policies.
Random audits will be performed by the Administrator and Director of Nursing for eight weeks until compliance is consistently met, and then quarterly on the Environment of Care/Safety Rounding to ensure sustained compliance.
Education was provided to the manager of the contracted credentialed providers of anesthesia via signed acknowledgment of the following policies.
1) Medication/Solution Container
Labeling Policy #12558436
2) Medication Administration Policy
#12571263
A copy of the signed acknowledgement will be kept in the credentialing file of each provider. This will be completed for all currently credentialed contracted anesthesia providers by 4/15/2025. Completion of the acknowledgement will be the responsibility of the Administrator and the Director of Nursing.
Ongoing compliance of acknowledgement of stated policies will be part of the initial orientation for new providers. It will be the responsibility of the Administrator and Director of Nursing to ensure completion of the policy review acknowledgment is complete and placed in the provider's file.
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