Initial Comments:
This report is the result of a State Re-licensure survey conducted onsite on March 7, 2024 and completed offsite on March 21, 2024, at Main Line Surgery Center. It was determined the facility was not in compliance with the requirements of the Pennsylvania Department of Health's Rules and Regulations for Ambulatory Care Facilities, Annex A, Title 28, Part IV, Subparts A and F, Chapters 551-573, November 1999.
Plan of Correction:
561.25 LICENSURE
Distressed drugs, devices and cosmetics
Name - Component - 00
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Drugs, devices and cosmetics which are outdated, visibly deteriorated, unlabeled or inadequately labeled, recalled, discontinued or obsolete shall be identified by the licensed pharmacist or responsible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.
Observations:
Based on observation, review of facility policy, and interview with staff (EMP), it was determined the facility failed to properly discard and waste Propofol.
Findings include:
Observation on March 7, 2024 at 12:20 PM of the facility's Endoscopy Suite revealed, a bottle of propofol containing approximatley 3/4th's of propofol remaining, discarded in a red bin.
A request was made to EMP1 on March 7, 2024 for a policy addressing disposal of Propofol. None provided.
An interview conducted on March 7, 2024 at 12:20 PM with EMP1 confirmed propofol should be wasted in a drug destroyer.
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Based on observations, and employee interviews (EMP), it was determined the facility failed to ensure drugs and devices intended for single-use remained in sterilized packaging, adequately labeled and dated until time of patient use.
Findings include:
Request made to EMP1 on March 7, 2024 for a policy addressing pre-filled medication syringes. None provided.
Observation on March 7, 2024 at approximatley 10:45 AM of the facility's eye room revealed a pre-filled syringe containing an unknown substance lacking initials of the individual preparing the medication and/or expirations dates associated with the prepared medication.
EMP1 was present at the time of observation and confirmed the above findings.
Observation on March 7, 2024 of the pre-op area at approximately 10:55 AM, revealed two (2) pre-filled tubes marked as Sodium Chloride, lacking initials of the individual preparing the medication and/or expiration dates associated with the prepared medication.
Interview with EMP1 on March 7, 2024 confirmed the facility does not support staff pre-filling syringes or medications.
Plan of Correction:Our policy 2.28 Disposal of Partial Doses of Control Substances has been updated to include Propofol. This policy was reviewed and signed by our anesthesia department. All RXDestroyer containers will be labeled with propofol must go here. A QI study will be conducted by our anesthesia department next quarter to ensure compliance. It will be overseen by the clinical director and reported at our next QI meeting. Our clinical director will monitor compliance weekly and report continual compliance to the QI committee.
The medication Policy 2.14 has been updated to include all immediate use 0.9% sodium chloride syringes will be open at the bedside. This policy will be reviewed by the pre-op staff and signed. A QI study will be conducted by a pre-op nurse and overseen by the clinical director. This will be reported at our next QI meeting. Our clinical director will monitor compliance weekly and report continual compliance to the QI committee.
Investigation of the syringe that was discovered with unknow substance lacking initials and expiration date, was a fellow who drew up saline for immediate use to insert into a patient eye. She has been counseled. During orientation all cornea fellows will review and sign our policy, 2.14 Medication Administration and Safety. Compliance will be monitored during orientation day by the Clinical Director.
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