Originally published by our sister publication Specialty Pharmacy Continuum
By Gina Shaw
The increased air and surface sampling requirements for sterile pharmaceutical compounding found in USP General Chapter <797> translate to an enormous increase in environmental sampling data for hospital pharmacies to collect, review and act on. At The Johns Hopkins Hospital (JHH), in Baltimore, a new dashboard is helping staff maintain control of all that data and identify trends.
As the flagship hospital of Johns Hopkins Health System, JHH has approximately 1,100 beds and includes 10 cleanroom suites, with eight containing hazardous drug compounding buffer rooms. Nonhazardous sterile compounding facilities include 22 laminar airflow workbenches, two compounding aseptic isolators and one compounding robot, while containment primary engineering controls for hazardous compounding include 10 biological safety cabinets, four compounding aseptic containment isolators and two compounding robots. Approximately 210 surface areas within these facilities are sampled monthly, while approximately 100 air samples are collected over each six-month period. (About 10 samples per area are collected with one to two areas sampled each month.)
“We sample what’s required in the standards, as well as use a risk-based approach to also sample other frequently touched surfaces,” said Dorela Priftanji, PharmD, MBA, BCPS, the health system’s assistant director of pharmacy compounding services, in a session at the ASHP Midyear 2024 Clinical Meeting & Exhibition, in New Orleans. “We also didn’t want to just sample all of these areas without being able to collate, understand and act on the data. There is value in reviewing trends from the additional sampling.”
In February 2024, JHH transitioned to a new certifier, and at the same time, they implemented the new dashboard, which is populated with data received from the certifier using a business analytics tool called Tableau. “Each month, we receive PDF reports emailed from the certifier for each pharmacy that is sampled,” said John D. Hill, PharmD, BCPS, BCSCP, CPEL, the director of medication use systems and automation. “We get results on specific organisms that speciate for all growth, regardless of whether or not USP’s CFU [colony-forming unit] threshold is exceeded, so we can see patterns for organisms.”
Thoroughly reviewing the wealth of data contained in these reports is a daunting task, he said. However, the dashboard provides a five-minute monthly update that includes an easy-to-follow visual representation of findings and trends.
Dr. Priftanji meets with the infection control team monthly to review the results for all the pharmacy areas. “We then highlight one or two items for each pharmacy to look at based on trends we notice. The dashboard helps the team focus on the biggest risks,” she said.
For example, Dr. Priftanji continued, “for a couple of months we had a shaker with a few CFUs. Although it did not always exceed the CFU threshold, we could see a trend. Shakers can sometimes be very hard to clean because they have crevices, so we highlighted that to the pharmacy area and they dedicated time to reeducating their staff on improving shaker cleaning. Then the next two months, we saw no growth at all there.”
The dashboard has also helped JHH identify areas where there is little value in sampling. “In some areas, we expect there will always be growth,” Dr. Priftanji said. “One example was the anteroom bench. If you’re going to sit on it before you’re donning your PPE [personal protective equipment], it most likely will be dirty. By looking at a large volume of data at one time across the compounding areas, we were able to identify [bench] samples to remove and standardize.”
Drs. Priftanji and Hill would ultimately like to deploy the dashboard at other hospitals within the health system, but maintaining the underlying spreadsheet is a manual data process that would require staff capability at each hospital. “At other hospitals within our system, the volume of sampling is not as high as at JHH, so the dashboard may not be as valuable or worthwhile, given the data spreadsheet maintenance step,” Dr. Priftanji said. “For now, we have been working with our certifier to get their reports and data up on their website, in hopes that this could be the data source for the dashboard without having to maintain a spreadsheet.”
The sources reported no relevant financial disclosures.