Designing a Contemporary Pharmacy and Cleanroom

March 2013 - Vol.10 No. 3 - Page #12

Planning, designing, and constructing an inpatient pharmacy for a large teaching hospital requires consideration of desired amenities, operational needs of staff and administrators, and compliance with USP <797> regulations. The driving forces behind the creation of a new pharmacy at Hartford Hospital were the promulgation of USP <797> guidelines and a timely Joint Commission (TJC) accreditation visit. Practice mandates in <797>, as well as the possibility of a TJC survey, have caused every institutional pharmacy in the United States to take a closer look at their methodologies for sterile product preparation and sterility assurance.

We realized that in order to continue to provide high quality pharmacy services focused on patient safety, compliance with the mandates of <797> was requisite. However, compliance proved impossible in the pharmacy’s existing location due to spatial constraints and engineering issues. Recommendations from the TJC inspection acknowledged our efforts towards compliance with USP <797>, yet recognized the incompatibility of our existing facilities with full adherence to the requirements. Their final report emphasized the need for compliance as a key element to a successful outcome in future inspections, and it was determined that a new pharmacy was necessary to meet these goals.

Layout Inefficiencies
The Hartford Hospital pharmacy department occupied six locations located in five buildings across our campus. The central pharmacy comprised 3,800 square feet on the third floor of the main patient tower. Having operated in this space for 40 years, the pharmacy was overcrowded, provided little flexibility for restructuring, and was landlocked by both the pathology and laboratory departments. The limited space available for pharmacy was delegated to order review workstations and medication storage. The parenteral preparation area was situated in a separate room within this space, with air quality controlled only through the output of its four laminar flow workbenches. The existing ventilation system provided little capacity to adhere to the environmental controls set forth in USP <797>. Pharmacy also maintained a biohazard safety cabinet, with external ventilation, located outside this rudimentary IV preparation room. Medication storage space was minimal; in fact, the bulk pharmacy stockroom was located five floors below in the basement of an adjacent building. 

Furthermore, with no available meeting space, department meetings and educational offerings required us to schedule rooms in other buildings around the hospital campus. Researching drug information questions or other project work involved staff retreating to one of the hospital’s libraries, also located in separate facilities. Our pharmacy residents were housed in yet another building, impeding easy access and interaction with pharmacy staff on a regular basis. The pharmacy management team was equally dispersed, with offices in three separate locations. These conditions prompted the determination that we needed a new space, one that would help us meet <797> requirements and pass future TJC inspections, as well as allow the pharmacy department to operate in a centralized area with an improved workflow.

Planning for a New Pharmacy
The planning process for a new pharmacy began in mid-2007 and continued until occupancy. The first building phase began in October 2009 and the final phase in January 2010. Through our initial planning we developed a list of essential components for the new pharmacy and an approximation of the required floor space based on consultant conversations, interviews with institutional pharmacies of a similar size and scope, and an extensive search of contemporary literature. 

The new pharmacy, which would accommodate all pharmacy functions under one roof, was estimated to require 12,000 square feet of space. An extensive survey by our facilities planning department examined a number of potential locations, balancing space gained through consolidation of our six existing locations with space lost through relocation of other departments. The ideal location was identified in a previously unutilized area that would require little disturbance to existing workflow.

The pharmacy, engineering, and facilities planning departments were directly involved in the planning and build process on a daily basis. Weekly progress update meetings were held to communicate information and facilitate networking with other departments to keep the project timeline on track. Design ideas were actively solicited from all pharmacy staff, which proved invaluable to the development of an efficient final design. Staff contributions ranged from simple items, such as relocation of lateral files by the pharmacy transaction window, to more complex issues, such as relocating security doors to improve access to the order review area. In addition, a consultant was engaged during the early stages of the planning process to provide an overview of current trends in pharmacy design and to validate our space projections (see Sidebar). 

Hospital administration was keenly aware of the imperative to comply with USP <797> in order to assure patient safety and to meet the standards of future TJC accreditation evaluations. As a result, funding for this project was designated through the hospital’s capital improvement fund for ongoing refurbishment and development of the institution’s infrastructure. Areas of concern included improving patient safety, meeting regulatory standards, and the rumored promulgation of new standards for parenteral product preparation under consideration by the Connecticut Commission of Pharmacy. 

Designing the Pharmacy 
Our goal was to design a pharmacy that would provide sufficient flexibility to meet our current and future needs. Initial brainstorming resulted in a proposal to utilize minimal fixed construction and liberal use of prefabricated walls in order to ensure optimum flexibility and reconfiguration options; however, national hospital fire codes, instituted in response to the tragic 1961 Hartford Hospital fire, severely limited this option. Space allocations for areas where future growth was anticipated, such as the cleanroom complex, were considered. Security issues were equally important, and considerable effort was devoted to designing a layout that would ensure the safety and security of our staff. The planning team correctly anticipated that identifying adequate storage space would be a significant challenge. In response, pharmacy undertook a detailed review of all files, supplies, and equipment located in pharmacy, and retained only vital equipment and those files that were currently in use or unavailable through archived sources.

The redesign of the pharmacy covered every aspect of pharmacy operations, including an order review area, pharmacy purchasing area, repackaging room, anteroom, cleanroom, chemotherapy preparation room, and a controlled substances vault, as well as storage areas for oral solids, liquids, injectables, and parenteral solutions. It also provided an administrative suite where, for the first time in 40 years, all of the pharmacy management team would be located in the same area. A resource center, affording a quiet location for research and projects, as well as a conference room designed for multimedia presentations and meetings, also were included. Other key areas were a staff break room, offices for the clinical specialists and pharmacy residents, and an area for staff lockers. 

Several project areas were designed with future growth in mind. The cleanroom was intentionally overbuilt to accommodate possible future robotic installations for the preparation of commonly used parenteral preparations, and the chemotherapy preparation area was constructed with an additional biohazard safety cabinet in anticipation of the growth of the hospital’s outpatient infusion center. Adjustable storage shelving and wire rack carts, as well as duplicative electrical outlets and data ports integrated to the emergency power backup system, were installed. 

Planning and designing a USP <797>-compliant cleanroom was the product of close collaboration between the project architect and the pharmacy cleanroom champions. The architectural firm we selected had considerable experience in hospital construction, but little familiarity with the requirements of USP <797>. Nevertheless, through ongoing meetings and detailed discussions we were able to collaboratively develop a compliant facility. A crucial element to our success was a general contractor with extensive experience in hospital construction, a flexible attitude, and willingness to incorporate our suggestions. Our thorough planning helped design an efficient cleanroom that has repeatedly passed airflow and sterility testing. 

Moving all pharmacy operations to a completely new location was much less of a problem than we had originally anticipated. Careful planning allowed us to continue operations in the old locations until the new space was ready for occupancy. At that point, half of a given function (eg, distribution, parenteral preparation, etc) would move to the new location; once the first group was in place and operational, the remainder would commence relocation. 

Unexpected Challenges
Despite careful planning, several unexpected challenges were identified during the build process. The structure housing the new pharmacy was originally constructed in 1949, and since that time had been home to a number of departments and services. During the demolition phase, steam and gas piping, ventilation shafts, and electrical conduits were discovered, many of which did not appear on blueprints. This resulted in the need to adjust our original design during the build process. 

Construction of a controlled substance vault also presented a challenge. The original vault plans called for wall construction with the same materials as those used in high-security prisons; however, those materials were unavailable at the time of construction. Vault specifications detailed in Connecticut pharmacy laws are conducive to ground slab construction as used in retail pharmacies, but applying those requirements to our new pharmacy, which would be located on the building’s 13th floor, created an untenable floor load. Agents from the Connecticut Division of Drug Control (DDC) proved invaluable collaborators in identifying an acceptable alternative. After consideration of numerous options, a firm specializing in prefabricated security vaults was located and approval for use of their product was subsequently obtained from the DDC. 

In retrospect, despite the success of this venture, our experience taught us that several changes might have yielded improved workflow and efficiency. Locating the cleanroom closer to the pharmacy transaction window would facilitate communication and improve the efficiency of parenteral product dispensing. Additionally, our focus on added cleanroom space for future growth resulted in the shortchanging of anteroom space, which has caused some congestion in this area. Additional space in the vault area also would have been prudent to provide additional controlled substance storage. Although the new vault at 240 square feet represents a 50% increase in floor space, in retrospect, allocating 400 square feet would have provided more flexibility in layout and function. 

Renovation Results 
Staff response to the new pharmacy has been overwhelmingly positive. Not only does the new facility provide a brighter and more cheerful environment, but seeing their ideas and contributions incorporated in the result conveys a sense of ownership in the project. 

The most satisfying innovations were those made to improve pharmacy security, drug safety, and quality of the cleanroom complex. Our security system requires both card swipe access and individualized code keypad entry to access the pharmacy. Incorporation of intruder-resistant materials and systems, along with extensive deployment of security cameras throughout the department, ensure that staff is protected to the fullest extent. Hospital security and pharmacy staff are able to monitor all areas of the pharmacy from a single, multiscreen display. 

Ultimately, the impetus for the creation of our modern, efficient pharmacy was driven by our need to meet <797> standards. Early planning and encouraging staff contributions were crucial elements of our successful pharmacy construction. Planning for the future by leaving space for eventual growth and practice changes are the best guarantees of long-term success for a pharmacy renovation. 

Ralph J. Frank Jr, RPh, MPH, has served as the pharmacy manager at Hartford Hospital since 2005. He received his RPh from the University of Connecticut School of Pharmacy in 1975 and his Masters of Public Health from UConn in 1990. Ralph maintains a professional interest in substance abuse trends as well as epidemiological trends of poisoning and overdose events. He is a past president of the Connecticut Society of Health System Pharmacists and is active in both the Connecticut and American Societies of Health Systems Pharmacists.

Choosing Pharmacy Renovation Partners
Consultants can provide valuable external viewpoints, unclouded by the internal constraints and political issues of a facility. Ideally, a consultant should have experience with pharmacy practice, administration, and contemporary design, and should be able to readily provide references from recently completed projects. The consultant’s history with other clients provides an overview of their experience and a relative framework for what others have experienced during the renovation process. It is critical to use a consultant with a solid understanding of contemporary pharmacy practice issues, such as USP <797> compliance, automated inventory systems, and workflow parameters specific to your needs. 

In addition, choose your architect wisely, making site visits to their prior projects whenever possible and speaking to former customers to determine their level of expertise and customer attentiveness.


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