Broken Ampule in a Negative Pressure IV Room
You are the technician working alone in a small hospital's USP <797> sterile compounding area at 2:00 AM. The room is an ISO Class 7 buffer area with a primary engineering control (a Class II biological safety cabinet). While reaching for a glass ampule of a hazardous antineoplastic drug, you knock it off the counter; it shatters on the floor inside the buffer area. You are wearing a gown, chemo-rated gloves, and a respirator, but no shoe covers. Glass fragments and a small amount of liquid are now on the floor and counter. The next scheduled cleaning is not until 6:00 AM, and a dose for a patient is due at 7:00 AM. The room's pressure gauge reads -0.03 inches of water column relative to the adjacent ante room.
1. What is the correct immediate sequence of actions, and why does the negative pressure reading matter here?
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First, stop work and do not attempt to clean up with bare hands or a broom. Because the drug is hazardous and the spill is inside the primary and secondary engineering controls, you should contain the spill: cover liquids with absorbent pads to limit aerosolization, and keep the room's negative pressure intact by NOT propping doors open. The -0.03 in. w.c. reading confirms the buffer is at negative pressure relative to the ante room, which means air flows inward and contaminated aerosols are less likely to escape into the ante room. You should alert the designated person, follow the facility's hazardous drug spill kit procedure, and document the event. The 7:00 AM dose cannot be compounded in a contaminated environment; the buffer must be cleaned and, if required, re-certified or at minimum allowed to recover air quality before use.
2. You have no shoe covers on. Does that change your decontamination plan, and what PPE step do you take before re-entering?
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Yes. Without shoe covers, your shoes may have contacted contaminated floor. You should not walk out of the buffer into the ante room in contaminated shoes. Don shoe covers (or dedicated cleanroom shoes) before moving, or have a second person bring them to the buffer door. Then remove contaminated outer PPE in the correct order at the ante room boundary, and wash hands. This prevents tracking hazardous residue into clean areas.