HealthSeptember 05, 2023

BayCare Health targets USP standardization and compliance accountability

Robin Colon-Moreno, PharmD, BCPS, PRS is the supervisor of pharmacy operations for Morton Plant Hospital, part of BayCare Health, an award-winning nonprofit healthcare system comprised of 15 hospitals in west central Florida.

BayCare’s mission is to improve the health of all it serves through community-owned services that set the standard for high-quality and compassionate care. Located in Clearwater, Morton Plant is licensed for 599 beds and sees more than 50,000 patients annually.

1. Describe Morton Plant's pharmacy operations.

Our pharmacy department has 81 active team members, and we are hiring more. The team includes technician trainees, technicians, pharmacists, interns, residents, and pharmacy leadership. In the main pharmacy department, we have an IV suite comprised of a wet anteroom, a dry anteroom, a non-hazardous buffer room with three vertical flow hoods, and a hazardous buffer room that has one biological safety cabinet. We also have a hazardous non-sterile room, which is located in an unclassified area and is for receiving medications for storage and compounding. In addition, at our 1500-square-foot infusion center, we have another IV suite that includes a wet anteroom, a dry anteroom, a nonhazardous buffer room with two laminar flow hoods, and a hazardous buffer room with two biological safety cabinets. This area also has a hazardous non-sterile room, for receiving and storage of hazardous medications.

2. How does Wolters Kluwer’s Simplifi 797 pharmacy compliance solution help you manage that type of pharmacy operation?

We started using Simplifi 797 in 2015, about the same time that I came on board in my current role, and it has really streamlined many of our processes. Since then, we’ve really focused on optimizing the solution for our facilities and focused on rolling out Simplifi 797 to some of our sister sites that were still using paper documentation. One of the most important changes was the way it enabled us to create digital copies of master recipes, which made reporting much easier. In addition, we use Simplifi 797 to easily track and review our compliance by using a bulletin board for monitoring daily improvements (MDI) across the health system. Each month, we track and trend where our fallout is, so it's really improved our accountability; our administration can readily see what it is that we're doing. The pre-supplied tasks are also very beneficial to us because they allow us to assign tasks to areas outside of the compounding suites, such as our eye wash station that is located in our satellite pharmacy. All of this helps us ensure we are fully compliant.

3. How has Simplifi 797 helped you address Board of Pharmacy oversight?

For the Board of Pharmacy, we keep a binder, with summary documents, created in Simplifi 797, of tests we’ve done over the past year. The binder is how the surveyor we’ve had, since at least 2015, prefers to work. When the surveyor arrives, they know they are going to sit down with a binder in our conference room, and really tear through everything that we're doing at their own pace. Usually, the surveyor can review our site fully within four hours.

4. How have ongoing improvements to Simplifi 797 enhanced the user experience for Morton Plant?

Well, we converted to the new SoleSource platform in 2021. One thing we’ve really appreciated is the email notification of out-of-limit values, as well as reminders for incubating samples. Also, it's really nice that the team can see the tasks they have due for the day, while at the same time, those of us in administration get notifications about what’s due, so if something is missed, I can easily follow up. Our team members really appreciate the single sign-on to the continuing education platform because it's one less login that they have to do to get into the competencies, and I can track each person’s last completed competencies by just clicking on a tab. There’s also a summary page of the recurring tasks, which is nice because then I can see, by area, what is assigned and what’s missing.

Another thing that’s been very helpful is the ability to upload pictures and documentation to the tasks. For example, when a team member grew something on a glove sample during a test, we could take a picture of it as proof to avoid any questioning down the road. Simplifi 797's data export has been beneficial, too, because it allows frontline team members to export information as needed instead of going into analytics and trying to manipulate that data.

5. You’ve used Simplifi 797 for more than eight years now. Why do you keep using Simplifi 797?

We reviewed the market to ensure we were doing our due diligence and looked at companies that included PharmacyKeeper, Pestle, and Compounding 360. However, after testing Compounding 360’s application for six months, we chose to stay with Simplifi 797 for several reasons beyond having an established relationship that already works well. For one, the solution’s platform is so much more advanced, so much more intuitive, and sophisticated when compared to others on the market. We also like Simplifi 797’s continuing education partner because we have many different levels of learners; the solution has helped with that, especially their responsiveness to enhancement requests.

Given those many advantages, we continued building our relationship with Wolters Kluwer. Now, in addition to 797, we have the 800 and 795 modules. We will use the analytics to help identify gaps in our compliance, and because it's a live environment, we can import information and see how everything looks in a snapshot, which is nice and speaks to the usability of Simplifi 797.

6. Any other reasons you decided to stay with Wolters Kluwer’s Simplifi 797 solution?

Another important reason is the excellent customer service; we weren’t convinced we could replicate that with the other vendors we evaluated. We were concerned that other vendors were not quite there with their technology or their support, so if we were going to convert to a whole new system, a lot of the work would fall on us. We spoke to another health system that converted to a different solution after using Simplifi 797. They said they wished they’d had better support for the conversion to that new pharmacy compliance solution.

We also like the Simplifi 797 team’s awareness of and building capabilities to address compliance with the new USP chapters. This is an area where Wolters Kluwer’s Simplifi 797 team seems particularly sophisticated, and the others seem more templated. Simplifi 797 has identified the new core skills needed and how the software can track the necessary competencies, provide all the required content, and connect the training to the actual competency to ensure that people are proficient.

7. Are there other elements of Simplifi 797 that you intend to take advantage of?

Well, we’re already taking advantage of the webinars. We’re also interested in the ability to standardize tasks, policies, procedures, and references and can push them out to our sister hospitals.

I also recently became aware of a unit inspection tool for medication storage (Simplifi+ MedStorage) that could provide oversight for all of our inspections. And we’re looking into Simplifi+ MedTrays application to help better manage things like expired drugs or drug shortages. It’s barcode scanning technology, which would be a change for us since we currently use an RFID tagging system. The advantage of the barcode scanner is that we could use it in the pharmacy, out on the floor, or wherever to speed up the process and avoid the extra cost and hassle of the tags and the oven.

8. How has your team prepared for USP chapter standards being enforced in November?

We started by forming a cross-functional subcommittee to do a gap analysis to ensure we’re ready for November. Some of the critical areas we’re focusing on include training our staff—assigning courses to ensure we meet those required competencies. We’ve also set up a 6-month glove and media sampling process for our core IV teams twice a year. Planning the cadence of review to ensure compliance in key areas is critical to sustaining compliance.

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Simplifi 797®

Take the guesswork out of USP medication compounding compliance with a customizable, mobile, evidence-based solution.

Simplifi 797 provides the latest evidence-based guidance and helps navigate the complex USP Chapters 795, 797 and 800 processes to ensure inspection confidence and keep patients and staff safe.
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