Hospital pharmacies — large and small — find ways to make new software work
Hospital pharmacies — large and small — find ways to make new software work
Software helps meet USP 797 rules
Hospital pharmacies have had to scramble to meet the tough revised requirements of the U.S. Pharmacopeia (USP) chapter 797 standards for pharmaceutical compounding and sterile preparations, which were made official on June 1, 2008.
For mid-sized and large hospital systems, adherence to the new standards would be very difficult without help from an electronic system that provides an efficient way to track real-time compliance and eliminates paper documentation.
Drug Formulary Review has interviewed several hospital pharmacy supervisors from hospitals around the country about how they've implemented an electronic documentation and process that simplifies USP 797 compliance.
"USP 797 came up with new standards for monitoring and quality assurance for IV preparations," says Jim Roe, RPh, a pharmacy supervisor at the Greenville Hospital System University Medical Center in Greenville, SC. The hospital system has more than 100 pharmacy rotations, 60 pharmacists, and 60 technicians serving a facility that has 900 beds and seven sterile compounding areas.
The original changes for the USP 797 were done a couple of years ago, and then the final version came out this summer.
"USP 797 was looking at all sterile products given in the health care system," Roe explains. "You might not see a problem immediately, so how do you know someone didn't receive a contaminated IV product?"
The answer is to put in place processes that make certain the facility is preparing the best sterile product it can, Roe says.
"USP chapter 797 outlines a series of quality improvement processes, process control steps that you're required to do to make sure your compounding technique and facilities and staff adhere to these rules," says David Musa, MBA, RPh, assistant director in the department of pharmacy at the University of Wisconsin Hospitals and Clinics in Madison, WI.
The biggest outcome since the pharmacy switched to the electronic system has been a better organization of compliance documentation, Musa says.
"We all have limited amounts of time, so if you spend time following up to make sure documentation is complete, then you can't spend that time doing other tasks," Musa adds.
Also, the software enables Musa to have a global view of the hospital system's multiple compounding sites throughout the city.
For others, the elimination of paperwork is a big plus.
"In the past we used paper logs and individual notebooks for each compounding area," Roe explains.
The hospital system eliminated the time-consuming paper documentation process by implementing an electronic system that tracks compliance and streamlines quality assurance measures, Roe says.
Called Simplifi 797, the software is sold by Pharmacy OneSource Inc. of Bellevue, WA.
"Simplifi 797 also e-mails a monthly report to pharmacy managers that gives us a grade on how well we're performing," Roe says. "This provides documentation for the board of pharmacy."
Saving paper is a big plus, he adds.
"We had seven notebooks with probably six pages of entries per day, 365 days a year, because of what USP 797 says," Roe says. "And the board of pharmacy says that if you're not documenting it, you're not doing it."
The electronic system eliminates the need for those notebooks.
Since switching to the electronic system, Advocate Lutheran General Hospital of Park Ridge, IL, has saved staff time and improved compliance, says Geri Anderson, CPhT, BSBM, pharmacy technical services manager.
"I guess it's saving me a good day's work in a week," Anderson says. "It lets me get out on the floor into the pharmacy to make sure everything is running well, and it allows me to help them in the pharmacy if they're getting behind and need help."
Martha Jefferson Hospital in Charlottesville, VA, which is using the software for its third year, used to have four to six papers hanging on every isolator for documenting controls, and now all paper logs, including paper refrigeration logs, are gone, says Peggy L. Toms, CPhT, RPhT, pharmacy regulatory and quality analyst.
"It's made a huge, huge difference," Toms says.
"It didn't change staffing needs within the IV room, but it expedited and saved time for the staff," Toms says. "And for me personally as the one who oversees the IV area as far as environmental monitoring, I can't even begin to explain how much difference it made in that part of my job."
Toms uses her extra time now to perform more audits and oversee or even staff the IV room, as needed.
"They were very busy this morning, and I was in there helping them," she says. "It absolutely improves job quality."
The software also provides standard templates for various procedures, including clean room procedures, and there's a web page with links to necessary references and documents, Musa says.
"We have the whole policy and procedure module on-line and USP 797 continuing education programs to access," Musa says.
An electronic USP 797 program gives the pharmacy flexibility in monitoring compliance, Toms notes.
"I can go to 'tasks' in the software, and I can change the tasks," Toms says.
For example, Toms recently changed the tasks to include sterile gloves, which are required in the latest USP 797 revision.
"I can change, delete, and change the schedule on tasks," she explains. "And anytime the schedule prompts us to do something different, we can go into the program and adjust it at that time."
Also, new stations can be added to the program as regulations change.
Implementing the new software involved working with the software company to tailor it to the pharmacy's specific needs, Anderson says.
"It didn't take an extraordinary amount of time," Anderson says. "A woman from the software company had a couple of sessions with us on the phone, and then we downloaded the competencies, templates, tasks, and anything else our pharmacy manager wanted."
There also was a web-based training program for management and supervisors, Roe says.
"They helped us set up all competencies and processes that have to be monitored," Roe explains. "Then they helped assign pharmacy personnel to the program with log-on information."
Roe trained each employee handling sterile products individually on how to log-on and how the system works.
Basically, they need to get to know the dashboard, which shows at log-on the various daily tasks, including daily cleaning, temperature logs, pressure differential, Roe explains.
"The technician only has to click the task, complete the task that needs to be done, and then hit a check box that says it's done, and it will go into the column for tasks completed," Roe says.
"I can teach someone how to log-on and how to complete scheduled tasks in about 30 minutes," Roe says.
It wasn't difficult achieving staff buy-in, Musa says.
"Our organization is very efficient, and the staff are coming to expect electronic documentation," he says.
Employees enjoy the electronic system because they no longer have to keep the paper logs, which were more time-consuming than the electronic check boxes, Roe says.
Finally, the electronic system provides internal benchmarking reports.
"The monthly report we receive from Simplifi gives us a number grade and shows us how we're performing as an institution compared to our previous months or years," Roe says. "Basically, it started out kind of low, about 60% compliance in tasks performed, when we first implemented the software, and now we're running almost 100% compliance."
Hospital pharmacies have had to scramble to meet the tough revised requirements of the U.S. Pharmacopeia (USP) chapter 797 standards for pharmaceutical compounding and sterile preparations, which were made official on June 1, 2008.Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.