When you qualify (or re-qualify) compounders, the competency isn’t just one test. It’s 4!
1. Media-fill to prove aseptic technique under realistic manipulations.
2. Post–media-fill gloved fingertip & thumb sampling to verify low bioburden on gloves after performing manipulations.
3. Surface sampling of the direct compounding area (DCA) to confirm the individual’s ability to maintain the work deck.
4. Direct observation of technique.
A failure of any one of these results in an overall failure, requiring an investigation and appropriate remediation based on organizational SOPs. Verify that your SOP defines the actions to take, even if it is just having the Designated Person evaluate the situation.
