When USP 800 was released in 2016, the goal was straightforward: to protect hospital staff from the dangers that potent chemicals in chemotherapy and other hazardous drugs present when compounded. While previous guidance focused on sterile compounding of hazardous and nonhazardous drugs, it lacked direction on the handling of these drugs. USP 800 fills in that gap, addressing safety concerns through requirements for staff, handling, personal protective equipment, medical surveillance, receiving, storage, and air exchanges.
At face value, USP 800 presents itself as a mechanical-engineering initiative because of the requirements demanding new protocols for air exchanges and sterile environments. A closer look, though, reveals other opportunities, including workplace quality and performance improvement, for hospital-based pharmacies.
Functional space planning
For Saint Paul, Minn.-based Gillette Children’s Specialty Healthcare, a national leader in pediatrics treating some of the most complex and statistically uncommon musculoskeletal and neurological conditions, renovating its existing pharmacy to be USP 800 compliant was more than a technical challenge. Previously, the hospital didn’t have the ability to compound hazardous drugs within its own pharmacy and, notably, didn’t have a contiguous space for its pharmacy, with various functions divided among separate floors.
Solving for the latter was key to creating a functional space for the hospital and its staff. As USP 800 directly addresses how spaces facilitate the way hazardous drugs are received, stored, compounded, and contained with appropriate air flow and sterile separation between the activities, any pharmacy space must accommodate access and flow, with a floor plan that facilitates movement into and throughout the pharmacy. Additionally, the mechanical work is designed for negative air flow to create a safe environment in areas where the drugs are to be handled, received, and unpacked.
Gillette Children’s pharmacy measures 1,500 square feet and was carved from existing office space. In updating to USP 800, the first-floor location provided the opportunity to designate an appropriately sized receiving room from which the rest of the renovated pharmacy space could flow. In linear fashion, the receiving room opens to hazardous storage; a pass-through window connects hazardous storage to the negative-pressured chemotherapy prep cleanroom; and then an anteroom sits between chemotherapy prep and sterile prep. Adjacent to these spaces is the main pharmacy picking area, where prescribed medications are filled and prepared for distribution to patients.
Improving staff workspace
Partitions and windows become a key architectural element in a pharmacy’s compliance with USP 800, driven by the air pressure demands that differ between the various rooms in the space, such as the receiving, sterile prep room, and picking area. Required air pressure demands run the risk of a design that isolates staff. For example, whereas staff may have free access in and out of the receiving room, working in the negative-pressure environment of a sterile prep room is often solitary, requiring staff to be gowned, which makes casual or quick trips out of the space inconvenient. To temper that, Gillette Children’s approached the project by looking at maintaining connections in the space and then utilizing large windows coupled with an intercom system to facilitate staff communication between technicians working in the clean rooms and the pharmacists on the outside. While this corrected an issue from Gillette’s previous sterile prep room, it’s also an issue that designers need to be aware of when meeting the USP 800 guidelines.
The space is also designed to be more intuitive for staff. Areas of the pharmacy carry higher sterile requirements, necessitating gowning requirements for those areas. Patterns in the floor help to delineate these zones, making them clearer to pharmacy staff as well as environmental services staff cleaning the areas.
Recognizing the role the environmental services staff plays in infection control and safety, the hospital ranked ease of cleaning as a key performance goal for its renovated pharmacy. Minimizing dust is a key measure for this goal. Hard ceilings with coved corners instead of typical acute corners were installed in the cleanroom preparation areas to make cleaning easier. Stainless-steel work tables and equipment feature easy-to-clean casters. To reduce particle collection, the pharmacy uses fiberglass-reinforced polymer doors in lieu of wood doors, allowing for a smooth, nonporous, easy-to-clean surface. Through procurement planning, the hospital also minimizes supplies and storage in the compounding space that could act as dust-collecting surfaces.
Planning for continuous operations
Gillette considered all scenarios, including prior periods of unscheduled downtime due to mechanical issues. This led to a noteworthy decision for a small pharmacy: install a second exhaust hood within the pharmacy that would allow staff to continue serving patients even if a mechanical breakdown or issue occurs with the primary exhaust hood.
Prioritizing space to accommodate an additional hood comes with both risk and cost benefit, as the expense of a second hood is offset by any risk posed by redirecting compounding activities to a different area of the hospital or off campus because of a hood going offline. Furthermore, Gillette also utilizes a back-up hood location in a satellite operating room where the space has ISO classification, which defines cleanroom standards. This redundancy in equipment will allow the pharmacy to continue operations for 12 hours, even if the hospital must waste medication or change out continuous products more frequently, while troubleshooting issues in the new pharmacy.
Embracing change
Although driven by safety protections for those who handle and distribute life-saving drugs, USP 800 opens doors to a holistic evaluation of a pharmacy system, from the way it receives hazardous drugs to how the drugs are delivered by staff throughout a hospital. If approached from the right angle, rather than forcing a redesign, USP 800 can help an organization elevate the pharmacy work environment and better position the hospital to adapt to future changes in pharmacy and drug handling regulations driven by air quality, sterility, and staff safety mandates.
Kraig Quamme is project manager of environment of care for Gillette Children’s Specialty Healthcare (Saint Paul, Minn.). He can be reached at kraigaquamme@gillettechildrens.com. Chan Scholz, AIA, is a senior project architect at BWBR (Saint Paul, Minn.) He can be reached at cscholz@bwbr.com.
