Method for testing aseptic technique of intravenous admixture personnel

A method of checking the aseptic technique of personnel that prepare i.v. admixtures is described. The following sterile dosage forms of trypticase soy broth (TSB) were prepared: (1) single-strength ampuls 5 ml, (2) six-times (6X) concentrated broth ampuls 10 ml, (3) lyophilized broth sufficient to make 5 ml single-strength broth in 10-ml vials, and lyophilized broth sufficient to make 10.6 ml 6X concentrated broth in 20-ml vials. Admixture personnel were told these were investigational products, and they were given simulated orders to prepare syringes and 50-ml piggyback admixtures of the products. The specimens containing the broth were intercepted by an investigator, incubated for seven days at 37 degree C, and observed for turbidity on days 2 and 7. To verify that the broth supported the growth of bacteria, two common contaminants were inoculated into the broth in the syringes and admixtures to serve as positive controls. At least 100 samples from each of four procedures were processed during the three-month study period. A total of 405 samples prepared by 13 individuals were tested. None of the samples became turbid; hence, the bacterial contamination rate was 0%. Among the positive controls, 98% inoculated with one species and 100% inoculated with the other became turbid. This method is now used for monitoring the aseptic technique of new admixture personnel. This unique method of checking the aseptic technique of personnel is accurate and cost effective, and it avoids the risk of adventitious contamination.