7 lessons learned while renovating pharmacies for USP797-800 compliance
Through supporting five different regional healthcare systems with over 30 pharmacies in the rush to achieve USP797-800 compliance, we discovered that there is no simple way to update a pharmacy. It can be an incredibly complex process, with highly scrutinized performance to meet compliance. Wanting to learn from our experience and share with others, we’ve compiled our top lessons learned.
1. Communicate to Owners About the Potential Impact of Unknown Existing Conditions
Hospital pharmacies are almost always constrained deep within the confines of a hospital, meaning it’s almost impossible to get access to conditions, requiring heavy reliance on existing documentation, as well as extrapolating from what can be seen outside of the room. Typically, existing conditions are addressed during design; with pharmacies, this is often delayed until construction to limit downtime. Communicating this to owners early in the process can also help avoid questions like, “why are we changing this now?” Then, as soon as the contractor can demo walls and ceilings, it is crucial for the team to assess the conditions and immediately react.
2. Up Front Coordination is Essential
No matter the project scale, emphasis should be placed on stakeholder involvement and having all entities on board at project onset. Updating to new requirements is not just a learning process for the healthcare entity, but for everyone — owners, architects, contractors, subcontractors, commissioning agents, and staff. It is important for all parties to understand and agree on decisions, especially those that affect current policies and procedures that need to change.
We supported one client with system-wide updates to over 20 pharmacies, involving six general contractors and numerous subcontractors. Establishing standards and instituting them across the board supported efficiencies in the design and construction process as well as the ability to apply lessons learned in real-time to future projects.
3. Be Realistic with Schedule Given Certification Requirements
It's astonishing how this small space (typically only three rooms) affects the whole functionality of the hospital, especially patient care. But pharmacies have stricter regulatory requirements, where scrutiny is heightened, and the stakes are much higher. Often given the pharmacies’ small footprint along with the importance to maintaining hospital operations, there is a desire to expedite project schedules. This approach can lead to project challenges when the intricacies, regulatory requirements, and necessary padding within the schedule for unforeseen conditions are not factored in. It’s important to plan for certification taking anywhere from one week to three months in case problems arise.
If sealant joints fail in an exam room, it’s not a big deal, but if that same joint fails in a pharmacy cleanroom, it becomes a weak point where bacteria can set up shop, thus a point of failure. On one project, we struggled to maintain room pressurization. We painstakingly reviewed the entire room, and what we found was that a 6" bead of sealant was missed at the ceiling penetration of the hood exhaust duct.
4. Identify Your Temporary Pharmacy Solution
We learned early that for every pharmacy renovation, a temporary facility was needed to continue operations. Pharmacies are typically deep within the floorplate and located at the center of the building for ease of medicine distribution leaving them landlocked with little to no space to expand. Many of our projects involved renovating in place, so identifying a temporary solution was an important part of the process. This basically needs to be a full-blown pharmacy for the duration of construction; this is no small feat as it requires space, money, staffing and training. There are a few different approaches that can accomplish this:
Using Other Facilities: When it is geographically feasible, stagger the pharmacy renovations to support the facilities that are being renovated.
Temporary Pharmacies: Sometimes a local solution is needed. Use shell or under-utilized existing spaces for temporary, yet compliant pharmacies to be constructed.
Phasing Renovation: Another option is to build the new cleanrooms in a different part of the pharmacy, so the existing cleanroom(s) could stay operational - then switching and renovating the other side.
5. Importance of Decisions and Consequences of Changes
When designing a pharmacy to meet the updated USP requirements, there are many areas for consideration from material specifications to understanding the cleaning process for each specific pharmacy. Every pharmacy’s cleaning regimen is slightly different but always entails some form of physically scrubbing walls, ceilings, and floors with chemicals; the materials selected need to be able to withstand this treatment.
Typically, the finishes are based on a cleaning regimen identified at project onset. On one project, the cleaning regimen changed mid-stream, leading to significant compatibility issues causing the paint to wipe off the walls. Even details as seemingly minute as what cleaning chemicals are used can be a failure point and very costly to change down the road. Once equipment is moved in, repairs are not easy, requiring time, effort, and additional cost to fix.
6. Consider Giving the Pharmacy Its Own Mechanical System
Mechanical systems are often run based on season and space use, so it is important to understand the year-round hospital operations. Using an existing mechanical system may seem like a cost savings; however, more than likely this will turn into a major headache. Pharmacies must be constantly cooled – 24 hours a day, 7 days a week, 365 days a year. We found that many hospitals stopped their cooling cycle in the fall, shutting down the needed cooling equipment and thus requiring a separate unit to be installed to support the pharmacy.
Similarly, a pharmacy may include a hazardous exhaust, requiring special fireproofing; in many instances traveling all the way up through the building. It may seem logical at first to reuse the exhaust ductwork and just perform a switch over, but it is not that simple. When the switch is made, the pharmacy operations need to halt for days or maybe weeks while the space is balanced and certified.
If there is any question or doubt in the HVAC system’s ability to support the pharmacy, it is wise to install a standalone system as it will save many headaches and costly downtime.
7. Future Proof Everything
Technology is continuing to change at a rapid pace. Pharmacists by nature are learners and researchers, attending conferences with a desire to be on the cutting edge. The design must accommodate these future technologies, making sure there is not only additional space but also running extra data lines to support them.
While these lessons were learned supporting compliance updates, they remain relevant to any future pharmacy renovation; and remember, in this instance, it’s okay to sweat the small stuff.