Microbiologic quality assurance for intravenous admixtures in a small hospital

Area of Science:

• Microbiology
• Pharmaceutical Science
• Quality Control

Background:

• Microbial contamination of intravenous (IV) admixtures poses a significant risk to patient safety.
• Existing methods for end-product testing can be costly and complex.
• Hospital pharmacists require simple, reliable methods for quality assurance.

Purpose of the Study:

• To develop and validate a simple, inexpensive method for end-product testing of IV admixtures for microbial contamination.
• To assess the accuracy and cost-effectiveness of the developed method.
• To provide hospital pharmacists with a practical quality assurance tool.

Main Methods:

• A 16-step total-sample membrane filtration procedure using a 0.2-micrometer filter unit was established.
• Intravenous admixtures were deliberately contaminated with low concentrations of Klebsiella pneumoniae and Pseudomonas aeruginosa.
• Filtration was performed on a laboratory bench, and filters were incubated on sheep-blood agar.
• Control groups included sterile saline inoculations and uninoculated solutions.

Main Results:

• The membrane filtration method successfully isolated a mean of 82% of deliberately inoculated organisms.
• Five instances of adventitious contamination were observed across all 288 samples.
• The cost per sample was determined to be between $4 and $5.

Conclusions:

• The developed membrane filtration method is a simple, accurate, and cost-effective approach for end-product testing of IV admixtures.
• This method provides hospital pharmacists with a viable tool for quality assurance and documentation.
• The system effectively detects low levels of microbial contamination, enhancing patient safety.