Cleanrooms Renovation for USP <797> and USP <800> Compliance

Saint Francis Hospital and Medical Center Case Study

In the summer of 2014, with USP <797> standards becoming state law and USP <800> requirements on the horizon, Saint Francis Hospital undertook compliance as a key initiative.

Historical Overview

Saint Francis Hospital and Medical Center was founded in 1897. From the beginning, stakeholders recognized that improving health required innovation, affiliation, and strategic partnerships.

A corporate merger between Saint Francis and Mount Sinai Hospital was formalized in 1995. Today, groundbreaking technology helps Smilow Cancer Hospital Yale-New Haven at Saint Francis treat a wide variety of cancers.

A 2015 partnership between Saint Francis and Yale-New Haven Hospital greatly expanded access to outpatient medical oncology services and hematology at state, regional, and national levels.

The Challenges

Growth in the organization’s oncology services, as well as more rigorous compliance demands at both national and state levels, made it challenging to maintain a consistently high quality of CSPs in the existing cancer center pharmacy. Finding contiguous space large enough to house the pharmacy in close proximity to patients and clinicians, as well as optimizing the flow of products and people, was an early challenge. Exploration of where that space would be found involved additions to the team.

An additional challenge was finding a modular cleanrooms supplier to help the team meet regulatory requirements with expertise and products that they were confident would deliver a return on the hospital’s financial investment and minimize disruption during installation.

Saint Francis Hospital and Medical Center pharmacy cleanroom design map

The Solution

A Saint Francis team that included pharmacy leadership and staff began by identifying gaps, researching options for filling them, and planning a new cleanrooms design. Because of the company’s experience in design, engineering, and sterile manufacturing, Grifols was also brought into the process in its early stages.

Using knowledge of what is required by USP and the state of Connecticut for compliance, the cross- functional team performed a gap analysis of existing space, compounding activities, and activities to determine changes needed to policies, space, workflow, airflow, and equipment.

Following the gap analysis, Grifols worked in concert with TRO and the internal Saint Francis team to perform a thorough evaluation of the oncology pharmacy workflow of people and product, space, and existing infrastructure. Several layouts were proposed for review and consideration by facilities and clinical decision-makers and influencers.

Once final floor plans and specifications were defined, a request for proposal (RFP) was issued in the May 2015 timeframe.

The Results

The new modular cleanrooms offers proximity to care providers and has nearly tripled the space for better workflow, greater productivity, and an environment conducive to training. The large anteroom facilitates good workflow and meets USP <797> and USP <800> requirements.

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