Qaulity-control plan for intravenous admixture programs. II: Validation of operator technique

A plan for the validation of aseptic-operator technique in i.v. admixture programs and two test methods for evaluating the plan are proposed. After a new operator has been trained, the plan involves qualification of the operator through the preparation of statistically valid samples, to be followed by the random selection of samples for in-process monitoring. To test the plan, trypticase soy broth transfers were used in one hospital and Addi-Chek (Millipore Corp.) filtrations were used in another. The participants, all trained operators, initially prepared 40 test samples as a validation step. The finding of no microbial growth in these test samples permitted continuation into the monitoring phase, during which test samples were prepared randomly, one test sample out of every 25 i.v. admixtures prepared for patient use. All samples were negative for microbial growth, indicating that the operators maintained aseptic technique. These findings give evidence that the proposed testing plan is valid. The authors propose the plan as a phase of a quality control program, based on valid statistical principles, to give assurance that i.v. room operators are qualified to prepare sterile parenteral medications.