By James L. Neff, MS, RPh

HOLY CROSS HOSPITAL IN FORT LAUDERDALE, FLORIDA, IS A 587-BED hospital that dispenses over 300 IVs a day, and compounds approximately 60 non-hazardous IVs and an estimated 30 chemo preparations on a daily basis. Concerned about USP <797> regulations, the pharmacy started looking into cleanrooms. We soon discovered that our 40-year-old facility would require extensive upgrades to its electrical and plumbing systems, and the tiled walls, grout, and acoustic ceiling tiles would also need to be addressed. We would also have been required to bring the facility up to current building codes if we did any remodeling. The estimated price tag for a project of this size was between $250,000 and $300,000.

Product Selection
For the purposes of cost control, I began to investigate other options. In August of 2005, at the Florida Society of Health-System Pharmacists (FSHP) annual show, I visited the Germfree exhibit to try out their compounding aseptic isolator, the LFGIUSP. I found Germfree’s equipment to be designed with both safety and user comfort in mind. In addition to being cost-effective, the LGFI also eliminated the need for remodeling our existing pharmacy and the associated business disruption.
Soon after the FSHP show, I contacted Germfree and received specialized one-on-one service to help me determine the needs of our facility. During our JCAHO inspection, we were asked how we intended to handle USP <797>. When I showed the inspector the 6-foot LFGI-USP we were using, the JCAHO inspector stated we had a viable, working solution for meeting the sterility requirements of USP <797>. I told them we were planning to install our purchased Germfree 3-foot LFGI-USP for chemo preparations shortly. Again the inspector was satisfied that we were well on our way to meeting the intent of .

Next, I talked to my cleanroom certifier, who told me that, based on his experience in certifying various brands of hoods, Germfree was a very reputable company. He had found that Germfree products consistently exhibit quality construction and are reliable and easy to certify. Finally, I spoke with several of my peers and confirmed that Germfree has a great reputation for manufacturing equipment built for longevity and reliability.

Several features made the Germfree isolators stand out. The durable, all stainlesssteel product will still look good in 30 years. Also, the available option for electric height adjustment enables users to accommodate their height with the touch of a finger. I was also pleased that the pharmacy staff would be able to continue using their current gloves, with which they were already comfortable, with the LFGI. In addition, I felt that the design of the airlock on the Germfree isolator made it almost foolproof for the user.

The small footprint of the LFGI was also a consideration, because space was an issue in our pharmacy. In addition, I appreciated Germfree’s “Continuous Quality Improvement” cycle; I was impressed with the idea that Germfree continually strives to improve their products to meet the needs of their customers. Another deciding factor in the purchase decision was the opportunity I received at the FSHP show to actually try out the LFGI and see for myself what it was like to work in a Germfree isolator. In my opinion, the Germfree LFGI is the best value in assuring the safety of my people, product, and patients, and I am certain the LGFIs are the last isolators I will have to buy in my career as a pharmacy director.

Our Germfree consultants provided exceptional customer service and worked with us to assess our needs and provide us with the knowledge and expertise we needed to choose the optimum equipment for our facility. Due to that satisfying relationship, we plan to add another LFGI to our oncology unit at Holy Cross.

Implementation
Three to four weeks after placing the order for an LFGI-3USP and a LFGI-6USP, the units arrived at Holy Cross Hospital. We arranged for our certifier to be at the facility the day the units arrived to ensure minimal disruption to our patients and staff. The units easily rolled to their destination because the LFGI comes standard with cleanroom-grade castors. Once the units were rolled into place and certified, and the proper training was complete, our pharmacy staff began using the isolators. The only real change they had to make was to pre-plan their work; because compounding materials must be introduced via the isolators’ airlocks, the compounding personnel have to carefully collect all of the materials needed before beginning the process. By following this procedure, the work becomes seamless and we have increased our compounding accuracy, improved patient and worker safety, and reduced spills. It has been easier for us to do things the right way in an isolator.

It took two to four weeks for the staff to acclimate to the changes in their compounding process, but it has now become standard operating procedure, and our compounding time has not increased at all. One staff member even said he felt much safer knowing that everything was contained in the isolator. Staff members also appreciate the isolators’ user-friendly gloveports, which have 3-inch-deep armrests, and its ergonomic height-adjustment features.
After all was said and done, using the isolators was far more economically feasible than going the cleanroom route, and the devices were easy to implement and incorporate into our pharmacy’s compounding workflow.

James L. Neff, MS, RPh is the director of pharmacy services at Holy Cross Hospital in Fort Lauderdale, Florida. Neff graduated from the University of Florida with a BS in pharmacy and from St. Thomas University with a master’s degree in health management.