Aseptic Technique Breach During a Hazardous Drug Transfer
A technician is compounding 5-fluorouracil 500 mg in 250 mL of 0.9% sodium chloride for a patient in an oncology infusion center. While transferring from a vial to the bag using a closed system transfer device (CSTD), the technician notices a small droplet on the outside of the vial adapter and a visible wet spot on the sterile drape. The technician has already wiped the vial with 70% isopropyl alcohol and allowed it to dry. The hood is a Class II biological safety cabinet (BSC) that was certified 5 months ago. The technician has been compounding for 45 minutes without a break, and the airflow alarm has not sounded. The pharmacist is at the verification window and asks the technician to continue, citing the small volume.
1. Should the technician continue compounding this CSP? Justify your answer using aseptic technique and hazardous drug handling principles.
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No - stop and remediate. A visible droplet on the vial adapter and a wet spot on the drape indicate a breach of the closed system and a potential contamination pathway.
Reasoning:
- Aseptic technique: Once a sterile surface is compromised (wet drape, droplet on a critical site), the CSP cannot be assumed sterile. The correct action is to discard the affected components, decontaminate the work surface, and start over with new supplies.
- Hazardous drug handling: 5-FU is a hazardous drug. A droplet on the adapter is a potential occupational exposure and a sign the CSTD may not be seated correctly. The technician should don fresh chemotherapy gloves (and double gloves if not already), use a spill kit for the droplet, and document the event.
- Fatigue: 45 minutes of continuous compounding increases error risk; a break and re-verification of technique is appropriate.
- Pharmacist's request: The pharmacist's instruction to continue does not override the contamination finding. The pharmacist should be informed and the CSP remade.
Model answer: Stop, discard, decontaminate, don appropriate PPE, restart with a new CSTD and new supplies, and document the breach and corrective action.
2. What documentation and follow-up should occur after this event, and who should be notified?
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Documentation and follow-up:
- Event report: Record the time, drug, volume, CSTD lot, hood certification date, and the nature of the breach. Note the wet drape and droplet location.
- Exposure assessment: Determine whether the technician had skin contact; if so, follow the facility's hazardous drug exposure protocol (wash area, report to employee health).
- Notification: Inform the pharmacist-in-charge, the oncology nurse manager, and the safety officer. If a patient dose was delayed, notify the prescriber.
- CSTD investigation: Check whether the adapter was properly primed and seated; inspect the lot for defects.
- Environmental: Verify BSC certification is current (it is, at 5 months) and that airflow is unobstructed.
- Quality improvement: Add a second-person check for CSTD seating and a fatigue break policy.
Model answer: Complete an event report, assess and report any exposure, notify the pharmacist-in-charge and safety officer, investigate the CSTD, and implement a corrective action.