New & Improved!

Building a Compliant Pharmacy: Baptist Memorial Hospital
July 2018 - Vol. 15 No. 7 - Page #14

Baptist Memorial Hospital (BMH), a licensed 743-bed hospital in Memphis, Tennessee, focuses its services on three primary areas: cardiology, neurology, and oncology. The Baptist Health System includes a cancer center and is certified in chest pain, cardiac transplant, stem cell transplant, and stroke care. A pharmacy satellite in its Heart Institute operates from 5:30am to 11:00pm daily, servicing the cardiovascular ICU, general ICU, cardiac transplant unit, and 33 ORs. The ED is on pace to serve over 75,000 patients annually; pharmacists are present in the ED daily from 9:00am to 11:00pm.

As a highly automated health system, BMH operates two pharmacy robots, which pick twice-a-day oral medication cart-fills that supply the units’ PO needs and ADC restocks. In addition, four IV room batches, totaling 1500 to 2000 doses, are produced daily. The ADCs on the nursing units hold 150 to 200 medications, primarily fast movers and narcotics. Pharmacy technicians deliver first-dose medications and IVs to the five nursing floors every 30 minutes, and each OR is equipped with an automated anesthesia cart.

To complement the decentralized drug distribution model are unit-based pharmacists, referred to as patient care area pharmacists (PCAPs), on the floors from Monday through Friday from 7:00am to 3:00pm, along with residency-trained pharmacy specialists in specific areas: critical care, cardiac transplant, stem cell transplant, oncology, cardiology, neurology, and internal medicine. One PCAP serves approximately 60 beds and one clinical specialist is available for every 80 beds.

Goals of the New Pharmacy Build

The BMH pharmacy occupied a 5500-square-foot space, which included a robot, carousel, and IV room. Due to recent growth throughout the health system, building a larger pharmacy had been on the capital list for several years. However, the project took on a sense of urgency when the Tennessee State Board of Pharmacy enacted new pharmacy regulations in early 2014 regarding compounded sterile products, and mandated compliance by all Tennessee pharmacies within 180 days. Because it was impossible to bring the existing IV room into compliance with the new regulations—which required an ISO 7 ante-room, an ISO 5 cleanroom, and a negative pressure room for chemotherapy preparations—a new, larger pharmacy was required.

Initiating a Plan

Identifying Space

Space for the new pharmacy became available in the hospital when Baptist Corporate consolidated the business offices from several of the health system’s local hospitals. The identified space was ideal for the new pharmacy, as it was located directly across the hall from the existing hospital pharmacy. Moreover, sufficient overhead space was present, which allowed for the installation of a dedicated air handler for the IV room, which was placed on the roof.

Securing Funding

The cost of the new pharmacy was estimated at $3 million to $5 million, including all automation and the IV room. The Board of Directors approved the tentative budget, and pharmacy leaders began meeting with architects and construction companies. A team from pharmacy, including IV room pharmacists, PCAPs, and leadership, met every 1-2 weeks for several months until the pharmacy design was complete.

Choosing a Vendor

The health system had established positive relationships with many vendors over its 40-year history; these relationships were instrumental in building the new pharmacy. The vendor we chose for casework, pharmacy fixtures, and design had previously furnished and installed all the pharmacy fixtures at the health system’s new hospital in northeast Arkansas and had worked with BMH on several smaller projects; thus, we were confident they would provide excellent service in this new pharmacy build as well.

Designing the New Pharmacy

Clearly identifying the objectives of the pharmacy build at the outset is crucial to a successful project. The primary goals for the new IV room build were to become compliant with USP and state board of pharmacy regulations and to increase the available workspace. Pharmacy worked closely with the architects to outline our needs based on USP <797> standards and asked the Tennessee Board of Pharmacy inspector to review these plans. In addition, we invited the state board inspector on-site on several occasions to see the physical design and provide recommendations. Pharmacy team members also determined where the pharmacy automation should be placed to facilitate an effective workflow. After the workspace was designed, other areas were taken into account, including a pharmacy student computer area, leadership offices, a clinical specialist workspace, the pharmacy resident office, and the pharmacy buyer area.

The new space totaled about 8500 square feet; in addition, we retained the old pharmacy space for storage, overstock, and all unit-dose repackaging, including solid, oral repackaging; liquid repackaging; and overwrap machines for robot medications. In addition, the old space houses the old robot and carousel. Retaining use of this area allowed us to centralize medication storage and repackaging to a single location in the hospital, rather than utilize a variety of locations throughout the campus as we had previously done.

Ensuring Compliance

At the time of the pharmacy build, USP <800> had not yet been established, so the primary focus was on ensuring compliance with USP <797> and state board of pharmacy requirements (nonetheless, the negative pressure cleanroom
does meet USP <800> standards). Thus, we went through the text of <797>
page by page to identify the key elements for our design:

  • A comprehensive plan for facility compliance
  • Installation of electronic gauges to continually monitor room pressures
  • Space for four laminar flow hoods and a wall-mounted computer with bar code scanning
  • Coving at the ceiling and floor
  • Ceiling and wall materials that withstand regular cleaning
  • Pass-through refrigerators and two-sided fluid racks that could be restocked from outside the cleanroom
  • Pass-through windows for delivering preparations
  • A negative pressure chemotherapy room with two laminar flow chemotherapy
    hoods with exterior ventilation
  • Refrigerator storage in the chemotherapy room
  • A bio room for investigational drug products with a bio hood, freezer, and refrigeration

Identifying Expertise

Designing a compliant pharmacy required certain expertise we did not have in-house; therefore, we sought out help from a mechanical air expert. Choosing appropriate dedicated air ducts and a dedicated air handler for the IV room was critical. The air for the IV room is HEPA filtered twice: once coming out of the air handler and again through HEPA filters in the ceiling of the cleanroom; the rest of the pharmacy utilizes a separate air handler.

We also needed the expertise of the automation vendor. For example, it was necessary to determine whether the weight of the carousel, robot, and high-speed repackaging machine would require floor reinforcement. In addition, compressed air was required to prevent moisture and ensure proper use of the automation.

In addition to working closely with experts and vendors, internal collaboration was a key element of the project’s success. The team met weekly to make decisions and discuss any challenges that arose. Reminding all stakeholders that we shared one common goal ensured meaningful collaboration.

Conclusion

With hindsight, we have identified select adjustments that would have improved the pharmacy design. For example, increasing the space allotted to the IV room to accommodate the addition of extra hoods would have been prudent, as drug shortages have increased the number of products compounded in-house. Nonetheless, we are extremely pleased with the results of our pharmacy build, and staff enjoys working in the new, aesthetically pleasing, compliant pharmacy environment. Building strong relationships with vendors over the years ensured the project progressed smoothly and that our goal of USP compliance was attained.


Dennis Edward Roberts, DPh, is the director of pharmacy at Baptist Memorial Hospital (BMH) in Memphis, Tennessee. He is responsible for comprehensive pharmacy management at three hospitals in the Baptist Health System and for outpatient pharmacy, specialty pharmacy, and mail order pharmacy at BMH. Dennis is also a preceptor for pharmacy students on the mandatory advanced institutional rotation and precepts eight PGY1 practice management pharmacy residents at BMH.

  
 

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