What action should be taken if contamination is suspected in a compounded sterile preparation?

When contamination is suspected in a compounded sterile preparation, the most appropriate action is to report the issue and quarantine the affected preparation. This step is critical in preventing potential harm to patients who may receive a contaminated product. Quarantine ensures that the preparation is isolated from other products, preventing its unintentional use and allowing for an assessment and investigation into the source of the contamination.

Additionally, reporting the issue allows the relevant personnel or team to initiate an appropriate response, including determining the extent of the contamination, evaluating whether any products have already been dispensed, and implementing corrective actions to prevent recurrence. This procedure aligns with the principles of patient safety and quality assurance in sterile compounding practices outlined in the USP 797 standards.

Continuing to use the product could lead to serious consequences for patients due to the risk of infection. Ignoring the issue and waiting to dispose of the product is also negligent and can compromise patient care. While cleaning equipment and starting over may seem like a proactive step, it does not address the immediate need to contain and assess the suspected contamination, making quarantine and reporting the paramount action.