USP <800>: 1500 Square Feet Provides Giant Leap for Pediatrics Hospital’s Pharmacy

When the U.S. Pharmacopeial Convention (USP) adopted Chapter <800> in 2015 setting new standards for the handling of hazardous drugs in health care settings, like most hospital pharmacies Gillette Children’s Specialty Healthcare needed to modify current operations for the new Chapter <800>. With an initial deadline to achieve compliance set for July 2018, Gillette proceeded to identify a pathway to the new compliance standard.

In searching for the best design solution, staff discovered a need for more than space that logistically and technically fit the new guidelines for compounding hazardous drugs. The hospital discovered new work processes, and, as important, a new working relationship between facilities, pharmacy, and environmental services that would make Gillette’s pharmacy space a success in its first months of operation.

“Our new pharmacy represents a combination of clinical knowledge with facilities knowledge,” said Laura Hay, PharmD, Gillette pharmacy manager.

“We couldn’t have achieved the pharmacy that we did if we hadn’t worked as one entire team,” said Kraig Quamme, Gillette environment of care project manager.

A year-and-a-half ahead of the current December 2019 deadline to meet USP <800> guidelines, the specialty children’s hospital has a pharmacy that expands what it does for patients and what it offers staff in workplace performance.

Seizing the Opportunity

Rather than seeing this as a safety-improvement exercise, Gillette went a step further, leveraging USP <800> as a workplace improvement opportunity. By aligning the day-to-day operational needs of the staff with the safety protocols designed to protect the staff, Gillette focused on performance and safety with compliance as the foundation.

“This was a great opportunity to evaluate Gillette’s whole pharmacy system, from the way it receives and processes it drugs to how the drugs are delivered by staff throughout the hospital,” said Chan Scholz, AIA, BWBR’s architect and project manager on this pharmacy project. “USP <800> is forcing many hospitals to redesign their pharmacies to comply with the safety guidelines. Working with Gillette, we discovered a design that elevated Gillette’s work environment.”

For Gillette – a recognized national leader in pediatrics treating some of the most complex and statistically uncommon musculoskeletal and neurological conditions – USP <800> was more than a technical challenge. Previously, the hospital did not have the ability to compound their own hazardous drugs within their own pharmacy, and, notably, did not have a contiguous space for its pharmacy.

The first step was to address the continuous space, and Gillette found the appropriate space by repurposing former administrative offices. Fortunately, abandoned duct work gave the organization the needed ventilation route needed to make the space operable.

The first-floor location also gave the pharmacy an opportunity for space to provide an appropriately sized receiving room from which the rest of the 1,500-square-foot space could then come together. In linear fashion, receiving opens to hazardous storage. A pass-through window connects hazardous storage to the negative-pressured chemo prep cleanroom, and then an anteroom sits between chemo prep and sterile prep. The pharmacy picking area, at nearly one-third of the entire space, spans the length of the preparation, ante, and storage rooms.

“We’re in a better position to be adaptable to whatever comes up on that NIOSH list,” Quamme said, referencing the National Institute for Occupational Safety and Health’s frequently updated list of hazardous drugs in health care.

Technical and Workflow Challenge

Creating a space for Gillette to handle and compound hazardous and nonhazardous sterile and nonsterile drugs required new equipment and protocols for the organization. While the ventilation to the space accommodated the appropriate number of air exchanges per hour, the organization now needs to document those exchanges.

Additionally, pressure in the positive and negative airflow spaces, temperature control, and humidity control are monitored and documented. Cleaning schedules also are documented in order to monitor and maintain a pharmacy space that operates closer to pharmacy manufacturing facility standards in terms of sterility and cleanroom demands.

“This is a totally different space than we’ve worked in before,” Hay said. “USP <800> is to protect our employees. Staff appreciate that. To make sure the pharmacy works properly, though, engaging staff at the start of operations in the new space and continuing the engagement on the space’s performance has been key to our early success.

“The guidelines gave us a map to where we needed to go, but the space itself is a tool. Making sure our staff understand how the tool works and its role in our operations has been key to our early success.”

While the protocols come with the new compliance regulations, Gillette went further to increase its security level, monitoring and mitigating any diversions through the use of electronic key door access and cameras. Beyond monitoring for diversions, the security measures create a more collegial atmosphere among the care team since non-pharmacy personnel are able to be in the adjacent ancillary spaces.

In addition to these changes, there is now a space that is more welcoming to complement the new measures. This includes a staff reception area along with an adjoining supervisor’s office and drop-in workstations.

Workplace, Not Just Workspace

Understanding the intent of USP <800>, Gillette saw something more. In creating a technical space to comply with the guidelines, the pediatric specialty hospital went a step further to examine the ergonomics and functionality of the entire space.

In working with Gillette pharmacy team, the designers tested a number of ideas for layout and traffic. Through these studies, they identified a floor plan to create the optimum flow.

From there, the team and designers focused on the details that improved the work environment. Those included a 6-inch rise to the existing ceiling height to provide a more user-friendly and open workspace; cushion-back flooring to eliminate anti-fatigue mats that were harder to clean; appropriate task chairs specified for cleanrooms; sit-to-stand workstations; and abundant countertop spaces that are easy to maintain and provide ample area to handle multiple tasks without disruptions to the workflow.

Patterns in the floor also make the space highly intuitive, marking areas with sterile gowning requirements. An intercom system facilitates staff communication by connecting the technicians working in the clean rooms with the pharmacists on the outside.

Making Clean a Performance Goal

As much as the pharmacy and facilities staff examined efficiency and technical operations to determine the new space’s performance goals, ease of cleaning also ranked high, recognizing the strategic role the environmental services staff plays in infection control and employee safety.

Minimizing dust collection was a key goal for these measures. Staff focused on improving day-to-day maintenance, including easy-to-clean casters on tables and equipment and a hard ceiling with curved corners that are easier to clean than ceilings with corners. The hospital also minimized supplies and storage in the compounding space that could act as dust-collecting surfaces. To reduce particle collection, the team avoided wood doors, and wall paint was chosen for ease of maintenance.

In addition to creating an environment that supports the environmental services staff, the hospital provides training, including spill training, for the environmental services members who work in the pharmacy and in out-of-pharmacy locations.

“Preventing infections in our patients is paramount to the care that we provide, and the EVS is central to that goal,” Hay said. “The USP guidelines are designed to provide a safe, sterile product, and EVS staff are helping us do just that.”

Beyond the day-to-day cleaning operations, staff log their actions, which allows the hospital to monitor the space’s performance in relation to the other operational aspects such as air exchanges and humidity controls.

“We’re getting our results back and trying to interpret why we’re seeing what we’re seeing, both in terms of what’s working and where we might be seeing variances,” Quamme said.

While a small space compared to large hospital system pharmacies, Hay and Quamme say the anxiety to meet the new USP <800> guidelines was as high for the smaller Gillette Children’s Specialty Healthcare. The goals were the same – to create both a compliant and much improved pharmacy for staff and patients. Through deliberate coordination, engagement, and attention to workplace details, they said they attained their goals, affirmed by comments received during the pharmacy’s inspection.

“The space is so clean and the flow is so right,” Hay said. “We’re looking at a design that works.”


SIDEBARTwo Hoods Better than One

In planning for the space, Gillette Children’s Specialty Healthcare considered all scenarios that could influence operations for the new pharmacy. For a small pharmacy like that of Gillette’s, multiple hoods in the hazardous cleanroom may seem too much for an overall space measuring 1,500 square feet; yet, with redundancy hood venting, a second hood guaranteed that if there was a mechanical breakdown or issue with one hood, the staff at the 24-hour facility would be able to continue to serve patients.

“The consequences of one hood could mean we redirect compounding to a different area, and that comes with its own costs and risks,” said Laura Hay, PharmD, pharmacy manager.

Additionally, Gillette utilizes a back-up hood location in an operating room satellite where the space has ISO classification. While only accommodating a maximum 12-hour “beyond use” dating, the location allows the pharmacy to continue operations, even if the hospital must waste medication or change out continuous products more frequently while troubleshooting the new space.