Located in South Central Montana, St. Vincent Healthcare is a 210-bed hospital with specialties in cardiovascular care, neurosciences, orthopedics, women’s and pediatric services, surgical services, and oncology. St. Vincent Healthcare also has a Level III NICU and a Level II trauma center and serves a geographic region of 125,000 square miles with a population of over 900,000. The pharmacy department employs 42 FTEs, comprising 25 pharmacists and 17 technicians. Decentralized pharmacy services compliment a centralized IV compounding service, as well as a bedside point-of-care bar code scanning and documentation system supported by clinical pharmacy services.

For many years, IV services were provided using a dedicated IV room that housed an eight-foot compounding hood, a TPN compounding hood, and a biological safety cabinet (BSC). During that time, hazardous and non-hazardous compounding occurred literally inches from each other. Product and supply storage, refrigerated storage, and paperwork processing—which included labeling of premixed IV solutions—were common activities that took place throughout each day and often involved numerous accesses, by multiple personnel, into the IV room. In order to become compliant with USP Chapter , we knew it would be necessary to make changes to both the facility and our workflow.

Choosing a Cleanroom Vendor
Foremost among the deficiencies we identified was a lack of space. Without acquiring additional space, building a new cleanroom would be a significant challenge. Despite appropriating about 250 additional square feet, our consulting architect indicated that the necessary space requirements and costly remodeling projections associated with a permanent IV cleanroom would render the project unfeasible. Knowing this, we began researching our options for a modular cleanroom. To accommodate this alternative, we reorganized our stockroom and came up with a set location that would ultimately compliment workflow and provide an effective IV cleanroom space.

In performing our due diligence on possible modular cleanroom vendors, we decided that prior experience in designing and building modular cleanrooms would be the governing selection criterion. As we had never gone through a modern cleanroom build, we determined we could not rely on literature alone; rather, expertise and advice from experienced builders would be vital. We ultimately chose Lasco Services based on their years of experience with building modular cleanrooms. Additionally, partnering with our own Facilities department for demolition of the chosen location, and ultimately, HVAC installation, proved critical in keeping our tight budget under control. Once the modular cleanroom was installed, all external finish work was also completed through our Facilities department, and go-live occurred on January 28th of this year.

Justifying Budget Requirements
The implementation of a USP -compliant cleanroom had been in the planning stages for over five years prior to actually attaining approval from administration. Although capital budgeting was attempted numerous times, other projects managed to take priority. We now credit the persistence of our dedicated management team—which consisted of our pharmacy director, clinical coordinator, and two pharmacy supervisors—with eventually convincing administrators that the improved quality and patient safety standards concomitant to a proper cleanroom would justify the cost. Even though our pharmacy is experiencing on-going scaling back of budget dollars, and despite future plans to relocate the entire pharmacy, our new modular cleanroom is meeting our current needs.

Our Facilities department continues to play an important role through monitoring of both airflow and temperature in the cleanroom. With a natural increase in compounding times due to gowning and garbing processes and general adjustment to the new environment, coupled with the need for scheduled and delineated cleaning of a -compliant modular cleanroom, we have also partnered with our Environmental Services department for on-going maintenance. They have provided guidance on the selection of cleaning and bactericidal solutions and wipes. An apparent benefit of the clear, see-through walls of the cleanroom is that it allows for easy surveillance of cleanroom operations as well as opportunities to show off our operations to other areas and departments in the hospital.

Workflow Changes
With the completion of the build, we have continued to adjust our workflow processes in an ongoing manner. In order to streamline workflow, minimize wasted motion, and limit cleanroom pass-throughs, we have altered batch preparation times, moved work stations and inventory storage areas, and shifted IV inventory pull/setup areas. We have also been able to reallocate staff to other processes and bring on-board a dedicated IV technician. This position subsumed the tasks of pulling and setting up products and supplies for batching and on-demand compounding projects. Pharmacist responsibilities also shifted to allow for more efficient review of compounded products, as well as provision of assistance to the technician when necessary. We also brought on a second staff technician to focus on chemotherapy compounding. We continue to refine responsibilities and apply lean principles to our processes to stay ahead of the curve.

Activities in the modular cleanroom are limited to actual compounding tasks only. This includes syringe and piggyback preparation, large-volume parenterals, and total parenteral nutrition preparation. Chemotherapy preparation is completed in a separate, negative-pressure room under the BSC, isolating the product, supplies, and technician. The design of a functional, temperature-controlled work area dedicated to our patients was crucial. In the modular cleanroom, the addition of two small pass-through chambers and a roll-up door pass-through, coupled with efficient external product and supply workflows, have provided the ability to keep the cleanroom and anteroom free of non-essential items. No workstations, phones, and only minimal paperwork (i.e., labels and documentation materials) are allowed in the IV room, anteroom, or chemotherapy room. Throughout the training and implementation phases, staff developed a heightened awareness of Patient First initiatives, including quality and safety protocols. We have improved education and training starting from the external task-preparation phase through the cleaning phases within the cleanroom.

Conclusion
When considering a similar capital project, it is essential to involve your staff in conceptualizing a cleanroom that promotes optimal workflows, minimizes waste (of both time and product), and provides safe compounded products. You should plan to communicate with and educate not only your own staff, but also any department staff that you work with regularly. We provided additional education to staff from the cath lab, OR, ICU, as well as the general nursing units explaining our goal of patient safety. Allow for ample planning time, as changes made after construction begins are often costly and can add significant delays to the project. Ultimately, our vendor was able to provide a functional cleanroom design that fit within our space requirements, and delivered excellent workmanship. By reviewing our vendor’s previous projects, interviewing their clients, and presenting them with a detailed list of requirements—prior to the design phase—we ended up with a -compliant cleanroom that the hospital and pharmacy administration and pharmacy staff are pleased with.

Todd Koepp, RPh, graduated from the University of Montana School of Pharmacy in 1977 and completed a pharmacy internship at St. Peter’s hospital in Helena, Montana, before joining St. Vincent Healthcare, in Billings, Montana, full time in 1978. Todd has served as pharmacy supervisor at St. Vincent since 1996. Todd has eight years experience in home IV therapy services outside of St. Vincent and is currently seeking certification in Lean Training to identify and eliminate wasteful activities from all pharmacy processes.