OBJECTIVE To evaluate spill contamination and sterile operations during hazardous drug dispensing in pharmacy intravenous admixture services(PIVAS), and to explore a media-fill test combined with fluorescein(MFT-F) for training and assessment of negative pressure dispensing technology for hazardous drugs.

METHODS Sixty preparation personnel were selected to participate in the test, including 20 untrained interns/trainees as the control group, 20 trained personnel as the observation group A, and 20 experienced pharmacists as the observation group B. In an ISO Class 5 environment, the MFT-F method was performed to simulate hazardous drug compounding. All operators prepared a tryptone soy broth containing 0.01% fluorescein, from which both C and T samples were generated. Sterile operation was verified by detecting fluorescein spill contamination under ultraviolet light(365 nm) and microbial samples cultured(30 ℃ incubator, 14 d).

RESULTS The sterile operation pass rate was 20% in the control group, 65% in observation group A, and 100% in observation group B(P<0.001). All fluorescence contamination in the control group were unacceptablewith a mean score of (22.45±2.35), while 10 participants in observation group A passed the fluorescence contaminationwith a mean score of (26.50±1.28), and all participants in observation group B passedwith a mean score of (28.40±1.05)(P<0.001). Fluorescence contamination was mainly concentrated in gloves, treatment pads, and sterile bottles. For quality control, 2 participants in the control group passedwith a mean score of (25.60±1.14), 17 in observation group A passedwith a mean score of (27.60±1.14), and all individuals in the observation group B passedwith a mean score of (29.55±0.76)(P<0.001). All MFT-F results in the control group were unacceptable, 9 results in observation group A were acceptable, and all results in observation group B were qualified(P<0.001).

CONCLUSION MFT-F can be used to assess hazardous drug contamination and sterile operation. It verifies the negative pressure dispensing technology of hazardous drugs by the preparation personnel, and provides scientific basis for the training and quality control of PIVAS hazardous drug spill preparation personnel.