Spartanburg Regional Medical Center (SRMC) is a 540-bed, level-one trauma center located in Spartanburg, South Carolina. Being the only 24/7 pharmacy operation among three hospitals, SRMC’s pharmacy receives and processes after-hours CPOE orders for one of the other hospitals in our health care system. With a total of 74 FTEs, the SRMC pharmacy is staffed with 44 pharmacists, 43 technicians, seven administrative personnel, and four clinical dietitians providing nutrition support.
The SRMC pharmacy runs a hybrid distribution model, well supported with automation technology. In addition to a robot and two carousels, we employ automated dispensing cabinets with automated controlled substance storage on the units, which are supported by a 24-hour cart fill. We also have a pneumatic tube system used primarily for stat medication orders. All products dispensed from the central pharmacy are bar coded for scanning at the bedside and we are processing approximately 40% of all drug orders through CPOE. We expect this number to increase significantly throughout the entire health care system over the next year.
For an operation of this size, a modern, efficient work setting is essential. The main goals for our pharmacy renovation were to build a USP <797>-compliant IV compounding cleanroom and to expand and modernize our retail pharmacy for outpatient services.
Approaching a Pharmacy Renovation
The acquisition of automation and computerized systems is a positive step in remaining current with government regulations, patient safety initiatives, and fiscal responsibilities. However, it is important to keep in mind that these systems and the people that run them must operate within confines that are sometimes cramped, outdated, and impractical. In difficult financial times, such a capital project may appear infeasible to both hospital administration and the pharmacy department, because of cost issues, workflow disruption, and the burden of managing such a large undertaking. Despite these concerns, I doubt there is a pharmacy director out there who has not imagined the improvements and efficiencies he or she would incorporate if given the chance.
Fortunately for us, our administration approved a proposed renovation to our central pharmacy in late 2007. As our hospital expanded over the years, the pharmacy space remained in the central part of the structure, so we felt our location was suitable. However, staying in the same location presented the complex challenge of renovating while continuing to operate in the same space. We were able to subsume about 1600 square feet of space from a nearby office area that had been vacated, and in addition to the benefit of more overall space, it provided valuable empty space to work in while we were renovating. The extra area also allowed us to incorporate a new outpatient pharmacy adjacent to the inpatient department.
Gaining Approval for Capital Budget
Having undergone the last major upgrade to the pharmacy in the mid 1990s, by 2005 we began to lobby for a capital budget for renovations and upgrades due to perceived deficiencies in our existing structure, among them lack of a proper compounding cleanroom. Though we began our formal budget requests in 2005, it wasn’t until 2007 that the South Carolina Board of Pharmacy required compliance with USP <797> standards as part of its licensing and permit process. This pressure from the state board, along with pharmacy’s standing request for capital improvement funding—which included our internal justifications—swayed the administration, and in early 2008 we agreed on a strategic plan to renovate the pharmacy.
A project of this scale often requires a confluence of favorable conditions to gain approval, so perseverance is key. Even though a proposal may not gain approval on the first try, repeated requests, combined with increasingly stringent federal and state regulations, often will tilt the scale. The value from gaining the approval of and involving hospital administration throughout the project cannot be overstated. During the course of our project, we had numerous update meetings with key administrative staff that included walk-throughs of the space at various stages. Our administration kept a close eye on the project, but also gave us considerable support.
As with most large hospitals and health systems, we have an internal facilities department that handles low- and mid-level infrastructure projects for the hospital. Because this was a project that involved significant interaction with the facilities department—and one that would benefit from its expertise—the overall cost was shared between the two departments. The facilities department, which has its own construction team, handled certain construction elements on its own, whereas others were contracted out.
Our initial step in determining a cost estimate was to look at similar projects and use those cost-per-square-foot numbers to set a financial boundary within which to work. Today there are many more resources for engineering and building consulting in the areas of institutional pharmacy and cleanroom environmental controls than just a few years ago. It can be valuable to engage a cleanroom building consultant when approaching this aspect of the project.
Working with a Vendor
When it came time to address the physical makeup of the pharmacy and attendant working areas, we decided to employ a design and manufacturing company that specialized in casework and storage systems for hospital pharmacies. Again, this is an area in which it can be very helpful to have a consultant or firm that has expertise in building and retrofitting hospital pharmacies because they understand the basic needs, and can work quickly to customize a package for your specific setup.
Before engaging an outside vendor, though, we met with the managers and staff that would be working with and/or be dependent on the workflow and efficiencies gained by the new layout. These meetings included representatives from the main inpatient pharmacy, cleanroom and compounding staff, stocking and inventory, the outpatient/retail pharmacy, pharmacy administration, and facilities. It was the input from our managers and staff, along with our consultant and casework vendors’ experience, that helped us visualize the redesigned pharmacy and allowed us not only to conceptualize the most practical, cost-effective, and efficient workflow for our space, but also how we would function during the actual transition. This is probably the main difference between rebuilding a pharmacy within an existing space and starting from scratch in a totally new space. There are certain concessions that must be made if work will be continuing in the existing space during construction. While our resultant pharmacy is not perfect, by putting in extra time ahead of the project, working through possible scenarios, and finding out what was possible through our consultant and casework vendor, we achieved a very workable outcome.
For example, our consultant had initially presented three different layouts for the IV cleanroom. While they all seemed feasible on paper, we wanted a more in-depth analysis. We were able to find a large empty room in the hospital; over the course of a few weeks, we had the consultant tape off the design layouts on the floor and had our staff come in and walk around in each space. While not a concrete representation, it did reveal some interesting discoveries as to how we would interact in the space, and made the process of deciding from among the designs easier.
In addition, we made the decision up front that our existing robot and medication storage carousel would remain where they were located and that we would work the design around them. Moving them would have caused a major disruption to the workflow we had to maintain while the project was ongoing and would have exacted significant funding from the renovation budget. Due in part to those savings, we were able to add an additional pass-through storage carousel in the new cleanroom. In retrospect, this worked out well. Some of these types of automation are quite massive and often the pharmacy’s footprint is limited, so there are only so many options as to where to place them.
Building in Phases
As part of what we deemed a rotating renovation, there were five major phases to the project. The first phase was readying the outpatient pharmacy for operation. The second involved vacating the offices, the old outpatient pharmacy, and the conference area and relocating employees who work in these areas elsewhere in the hospital. The third phase was designing and building the new cleanroom. Phase four involved renovating the storage area where bulk medications and other supplies were kept, and the final phase was to incorporate the existing robot and carousel into the new prepacking area and finalize the inpatient work areas.
We tried to move through each phase in a logical fashion. Once the offices were moved out, along with the removal of the conference room and the old outpatient pharmacy, we had some empty space to work in while basic demolition took place. As an area was completed, we moved our operation into that space, and then began working on the vacated space. Thinking two steps ahead was necessary to accomplish this. We had to consider what activities we would need to be doing at that particular time—the daily activities that needed to be attended to as well as any special assignments. Planning for those conditions was something we spent a lot of time considering early on in the process.
Our compounding operation was somewhat unique in that we kept our previous space intact until the new cleanroom was finished. For this phase, we had to design the space for a new cleanroom for IV compounding that would have valuable engineering controls, such as negative pressure and proper air filtration. This was a big improvement from a situation with which many directors struggle; there is only so much a pharmacy can do to comply with USP <797> regulations without having a modern cleanroom. Previously, while we passed all our certifications, the work space was minimal and it was a daily challenge to conform to regulations.
A Work in Progress
For any long-term project, it is important to keep the end goal in mind, but also to regularly review your progress to determine improvement opportunities. For example, the addition of the dual-sided carousel came to fruition in the middle of our project. We were not aware of the product until the plan had already been set, but our designers were able to incorporate the unit into the design to replace what would have been static pass-through shelving. The carousel allows us to store many more drugs than we would have been able to otherwise, so this was an on-the-fly design change that had a big impact on our end result. Remember, just because a design is agreed upon does not mean it must be followed to the letter. Stay vigilant throughout the entirety of the project because favorable changes and additions often can present themselves over the extended process.
The additional benefits of the new carousel are a testament to automation in general. Because the carousel is dual-sided, our buyer does not have to don PPE in order to take inventory. When medications come in from our wholesaler we close the carousel down on the IV room side, allowing our buyer to stock and review inventory on the pharmacy side. Once that process is done, the pharmacy side is closed and the cleanroom side has access to the drugs without auxiliary personnel having to enter the cleanroom or cleanroom personnel having to disrobe their PPE to come out.
Leading up to a pharmacy build or remodel, it can be easy to get caught up in the specifics and logistics of casework, automation, workflow, and efficiency, but in most cases, changes also are intended to create a more appealing place to work. We certainly wanted to make our pharmacy more open, balanced, and pleasing to our staff’s sense of aesthetics. One of the main efforts we made to this end was to incorporate glass partitions to open up the space. The pharmacy now has a transparent effect, such that even when working in the cleanroom or storage areas the feeling of isolation is mitigated, which fosters a psychologically beneficial atmosphere.
A secondary consideration should be the infrequency of such projects. When fortunate enough to be able to update some or all of the pharmacy, consider the needs of the pharmacy director ten years removed. The conditions committed to today will affect staff for years to come. With this in mind, we opted for neutral tones and comfort-inducing surfaces, such as wood grain cabinetry. Try to downplay what may be currently popular when it comes to interior design and focus on trends that stand up to time. In our case, I believe we satisfied the bulk of our staff regarding aesthetic elements.
Maintaining Pharmacy Operations
As department managers, we made the effort to maintain a presence in the pharmacy as much as possible during the course of this project, but due to the scattering of offices during construction, our overall teamwork and communication suffered. From start to finish, this project lasted about 13 months, which is a long time to be in a temporary state. Staff members who were used to working together in close quarters were thrown off by having to communicate with people on different floors and wide-ranging areas of the hospital. While emails and phone calls are helpful, there is no substitute for face-to-face interaction with staff. Thus, it is essential to put significant effort into maintaining a managerial presence in the operational area, and focusing on communication during this critical time will make it easier to transition back to working together again after the renovation is complete.
The idea of continuing operations during construction in a pharmacy is generally not a preferable situation, but there is a silver lining. Staff members working in these conditions will have unique insight into the process and can provide valuable feedback that can positively affect the end result. This is where empowering staff can really pay off, because they have a vested interest in the ultimate operation. During the course of the renovation, there were obvious challenges for staff working in even more cramped conditions than before and having to negotiate a constantly changing space, but those same staff members reaped the immediate reward of moving directly into the new spaces as they were completed instead of having to wait for the entire project to be finished. If we had moved to an entirely new space, likely there would have been fewer opportunities, if any, to make changes on the fly based on the immersed experience. The project probably could have been completed in less time in such a case, but every project is going to have negatives and positives; in our case, we were able to turn the perceived negative of operating in the construction site into a positive.
Looking Back at the Project
Ultimately, our process worked well overall, but there were occasional setbacks. Among them, the trickiest was fine-tuning the conditions within the cleanroom, such as proper air pressure and filtration, which took some time to work out among the engineers, our facilities staff, and the contractors. We had to take something of a trial and error approach to this, to tweak certain things and then test the results. We did run somewhat overbudget on creating precise environment controls, as the ideal environmental settings in a new cleanroom can be difficult to predict, and it took a few tries to attain proper airflow and pressure.
In the end, there are always going to be issues that cannot be precisely planned for up front. An issue we had some back and forth on was flooring material. Ultimately we decided on a type of seamless flooring that is not only conducive to cleaning, but facilitates easy movement of carts and endures less strain than the tiles we had previously. This surface will last a lot longer than other materials.
For the most part we were able to work within our budget, but with a project this large, there are many opportunities for mistakes or errors that require time and money to remedy. As mentioned previously, keeping our administration up-to-date ensured that there were no big surprises. At the time of our project, there were fewer companies and consultants with vast experience designing and building for <797> compliance. Today, there are many design and engineering consultants who have specific USP <797> design experience, and bringing this expertise on board early can make the transition much smoother.
Work with the State Board
From early planning through to the end of the project, we maintained a good working relationship with the state board of pharmacy, such that an inspector made several visits to the site and provided valuable insight during critical phases. The state board clearly supported the project as part of ensuring compliance, and we viewed them as an ally whose goal was to help us achieve regulatory compliance. Due to the complexity of this kind of project, it is only logical to include compliance arbiters as much and as often as possible. Completing the project and then having the board representative come in and make observations that require significant revisions should be avoided. Our particular state board inspector had worked with one of the individuals who was extensively involved in drafting USP <797>, and so had a good grasp on what was necessary for compliance. Her input during the process was invaluable as we were able to stay within the requirements throughout the process.
Ultimately, the state board is going to come and inspect at some point, so it is better to take advantage of their input during the process rather than being forced to make changes after the fact.
The project was completed in February of 2010 and in the time since we have been able to adjust to the new space and work out any bugs in the system. All our staff is either satisfied or very satisfied with the way the space turned out and workflow quality and efficiency have benefited because of it. The cleanroom staff also is a lot happier and enjoys working in their new space. As with any process improvement, a better model should always be sought, and even with our new space, there are areas where we can make gains—there are no perfect processes. Ultimately, ongoing communication with staff, administration, and regulatory bodies, as well as planning ahead, are key to the success of such a project. Get your staff involved as much as possible throughout the process and listen to their advice.
George P. Reid, PharmD, has been the director of pharmacy services at Spartanburg Regional Healthcare System for the past 16 years. He received his BS in pharmacy and his PharmD from the Medical University of South Carolina. George is currently serving on the South Carolina College of Pharmacy Leadership Advisory Council and his professional interests include pharmacy administrative practice, medication use safety, and pharmacy technology.
Michael Ferguson, PharmD, is the manager of IV services at Spartanburg Regional Medical Center. He received his BS in Pharmacy from the Medical University of South Carolina and has been with Spartanburg Regional Healthcare System for 29 years.
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