Assuring the quality of intravenous admixture programs.

Abstract

Several aspects of quality assurance (QA) methods in i.v. admixture programs are discussed, and a basic framework for developing QA programs for admixture services is presented. The objective of QA is to insure that admixture products: (1) are therapeutically and pharmaceutically appropriate to the patient; (2) are free from microbial and pyrogenic contaminants; (3) are free from undesirable levels of particulate or toxic contaminants; (4) contain drugs in correct amounts; and (5) are labeled, stored and distributed under principles of good drug control. Three types of QA criteria bases which may be used as indicators of quality are discussed (resources, facilities and organization; required procedures; end-products or results). Because end-product monitoring has certain limitations in the admixture setting, QA must rely heavily on procedure-centered review methods. General guidelines for developing QA programs are outlined. Adherence to procedure is the key to assuring the quality of admixture products. In developing a QA program, the highest priority should be given to the education and training of admixture personnel, particularly with respect to aseptic technique and pharmaceutical calculations.