Initial Comments:
This report is the result of a State Relicensure survey conducted onsite on January 10, 2024 and completed offsite on January 12, 2024, at Ambulatory Surgery Center of Bala Cynwyd. 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Drugs, devices and cosmetics which are outdated, visibly deteriorated, unlabeled or inadequately labeled, recalled, discontinued or obsolete shall be identified by the licensed pharmacist or responsible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 review of facility policy, observation and interview with staff (EMP), it was determined the facility failed to properly discard and waste a controlled substance.
Findings include:
Observation on January 10, 2024 at 10:55 AM of Operating Room 1 revealed, a 200 mL bottle of propofol containing an ample amount of propofol remaining, discarded in a red bin.
A review on January 10, 2024 of facility policy "Controlled Substance wastage: . a. Controlled substances remaining in partial vials or syringes after administration to a patient will be treated as "wastage"..."
An interview conducted on January 10, 2024 at 10:56 AM with EMP2 confirmed, propofol should be wasted in a drug destroyer and the empty bottle can be discarded in a unretrievable red bin.
Plan of Correction:a. On January 24, 2024 an emergency Governing Board meeting was held to address the need for staff and provider re-education regarding proper physical narcotic medication wastage. Staff and clinicians were re-educated to policy 914- Controlled Substance Tracking and Accountability, 914a- Controlled Substance Tracking and Accountability- Amendment A, and 914b Controlled Substance Tracking and Accountability- Amendment B via in-service and/or electronic review. Sign in sheets and/or electronic receipts of understanding completed for reference.
b. On January 24, 2024 an emergency Governing Board meeting was held to address the need for monitored compliance of physical wastage of Propofol (aka "Diprivan") wherein the facility has implemented daily monitoring for improper Propofol disposal. The audit is being conducted daily at the end of each shift by direct observation of the disposal of all Propofol medication and subsequent container as empty prior to placement in the assigned disposal container. The Director of Nursing is responsible to ensure all audits and subsequent documentation is completed and accurate.
c. The data collected is being recorded in a log at the end of each day and promulgated into a formula where the denominator is the number of Propofol vials/bottles needing to be wasted and the numerator is the number of Propofol vials/bottles wasted according to the organizations policies. The result of the data collection will be presented to the Governing Board at each quarterly meeting. The organization's compliance goal remains at 100%. After six months of consistent compliance at 100%, the facility will continue with a minimum of weekly audits until deemed 100% compliant by the Governing Board for a minimum of twelve (12) month review.
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