USP 797: Aseptic work practice evaluation and manipulation skill assessment in a clinical nuclear medicine department

Objectives Recently, the nuclear medicine pharmacy at Northwestern Memorial Hospital has achieved full compliance to USP 797 guidelines. The fingertip sampling and media-fill tests are among the most complex USP 797 requirement. Our department incorporated these tests into the clinical nuclear medicine program.

Methods Gloved fingertip sampling was used to access sterile hand hygiene and consisted of pressing fingers and thumb of each hand into a nutrient agar Petri dish. The procedure was performed three times over the course of a workday. Petri dishes were then incubated at 30° to 35°C for 48 to 72 hours, and the number of colony forming units (cfu) counted. More than three cfus per hand indicated test failure. Personal aseptic technique was measured using the media-fill test procedure under the most challenging compounding conditions. The test required employees to transfer a soybean digest media from one vial, to six syringes, and finally to two new vials. The vials were incubated at 30° to 35°C for a minimum of 14 days. Test failure was indicated by a visible turbidity in the media test vial.

Results Twenty-three nuclear medicine technologists and students were tested using the gloved fingertip and media-fill challenge testing procedures as outlined. No technologist or student exceeded one cfu per hand when performing the gloved fingertip sampling. Results of the media-fill challenge test for both technologists and students came back negative at fourteen days post incubation.

Conclusions Northwestern Memorial Hospital’s nuclear pharmacy has achieved compliance to USP 797 guidelines. Complex testing procedures, including gloved fingertip sampling and the media-fill challenge test, have been incorporated into the routine use