Standardized Compounding
HealthJuly 01, 2021

Optum Infusion: Standardizing through rapid growth with Simplifi 797

As one of the leading home infusion companies in the country with coverage coast to coast, Optum Infusion Services prides itself on delivering high-quality, cost-effective exceptional care to patients.

Challenge: rapid growth leading to lack of standardization

Optum Infusion has undergone several major transitions in the last six years with multiple entities coming together. Over the course of two years (2019 to 2021), Optum Infusion has grown from 40 to 52 infusion branches. Because of the rapid growth, there was lack of standardization with respect to cleanroom certifications, policies, or competencies. Additionally, all compliance documentation had been created manually on paper, so there was no visibility from the corporate level as to what was happening at the local sites.  As a home infusion company that has broad regional coverage, that posed risks related to patient safety and regulatory compliance.  

Solution: a standardized, scalable compliance system

To solve these problems, Optum Infusion sought a compliance solution to help ensure the same standards at every location. They wanted an electronic system that would help standardize competencies and streamline data collection, as well as provide clear visibility from corporate down to the site level. While they considered multiple vendors, Optum Infusion selected Wolters Kluwer's Simplifi 797 closed-loop compliance solution to help meet their goals. “We were already familiar with CriticalPoint education and look to them as an industry leader. Engaging with Simplifi 797 as an extension of that expertise, as well as the centralized records management, really made our choice clear,” said Jeff Arquiette, VP of Clinical Pharmacy Services at Optum Infusion.  

As the corporate and regional leaders met to begin standardizing expectations across the nation, a few key areas emerged: competencies, documentation of core tasks, and centralized management of reports. “Simplifi 797 has really helped to standardize our documentation and competencies across our sites. This has been huge and one of the biggest drivers of our success,” says Mr. Arquiette.

Compliance training and competencies

Optum Infusion continues to utilize the CriticalPoint training modules. Staff at all locations are expected to complete selected courses, assigned based on non-hazardous and hazardous drug compounding functions, between January and August each year. With the USP 797 standards in flux, they are already moving towards the best practices for semi-annual core competencies such as hand hygiene and garbing, gloved fingertip, and media fill. These are assigned in Simplifi 797 for completion in January-February and July-August, allowing adequate time for all requirements to be completed at each site. Competency completion status is then monitored by each regional leader and reported as a key performance indicator on the corporate compliance dashboard.

Another major improvement is that they have eliminated manual competency forms that they had been tracking on an alternate database. Mr. Arquiette is pleased his team does not have to update documents in two places; he explains: “We’ve been able to eliminate the redundancy by focusing on updating Simplifi 797, which then quickly disseminates the updates across all the sites.”

Documentation and centralized management

Simplifi 797 not only makes documenting the core tasks for USP compliance easy, it also serves as a centralized location for document management. Optum Infusion utilizes the References section to store supporting documents such as certification reports and corrective action forms so all compliance records are easy to access at the site and system level.     

Because the regional pharmacy leaders have visibility into individual sites, they can review the data in near real time and help sites get back on track. “Before Simplifi 797, we did onsite audits of each branch once a year. We had to manually review all the documentation when we got there. If a site was lagging behind, we wouldn’t have a chance to remediate the issue in a timely manner.” A central repository for documentation also helps with inspection readiness because they have easy access to their results, can more quickly make a course correction, and can store the documentation in Simplifi 797. When a surveyor asks for a document, they can pull it from their central references or run a quick report in Analytics.  

As an example of centralized management, a corrective action-preventive action (CAPA) form is completed for any remediation activity related to sterile compounding. These are then categorized into air issues, surface excursions, or mechanical issues. The goal is to initiate remediation within three days of an issue being identified and to resolve the issue within three weeks. Again, all the CAPA forms are centrally stored within the Simplifi 797 platform enhancing visibility so regional leaders can step in and support site leaders even from a distance. 

System standards and site customization

Even with the value of system standardization, there are occasionally times sites need to customize documentation at the local level.  Simplifi 797 supports this and Optum Infusion has implemented a new process for review of custom tasks to ensure they are still aligned with the policies and standards of the organization.  Each site will reach out to their Regional Clinical Pharmacist to make sure the new task aligns with company policy and is appropriate for the site.

Ability to scale

Optum Infusion has grown quickly, especially over the last two years. When a new infusion branch comes online, the Optum Infusion executive leadership team is very engaged in the Simplifi 797 implementation process, both with the new site and with the Wolters Kluwer team. The Wolters Kluwer implementation team builds out the new site and applies system standard tasks. This collaborative process helps streamline adoption of Optum Infusion standards and sets the new infusion branch up for success from day one. Regional pharmacy leaders are better able to support new sites with clear visibility into completion and compliance.

Outcomes: pharmacy compliance oversight and analytics for sustainable growth

Optum Infusion’s regional pharmacy leadership provides oversight to their specific region to monitor key performance indicators and help drive compliance. Simplifi 797’s Analytics platform gives them visibility into all sites’ activity, something they only dreamed of before. The leadership team has set a benchmark of 100% compliance with competencies and 100% task completion. Site leaders are evaluated on performance to these targets.

With Simplifi 797’s Analytics engine, the team can quickly assess targets at the company, regional, and individual site level. The reports make it easy to see where the outliers are and to further drill down to determine which task or competency a site may be struggling with. Regional pharmacy directors then follow up with the site leader to make adjustments and bring documentation back to target levels. 

For example, one site was meeting task documentation goals, but the tasks were only being completed on time 55% of the time. Upon further review of task set up for that site, due times were set at 8:00 am, and documentation was occurring at 8:30-9:00 am daily. But the pharmacy opens at 8:00 am, and it was unrealistic to expect staff to document immediately upon opening. By adjusting to due times to later in the day, pharmacy staff now have a wider window to document their work, increasing their on-time performance goal. Because of Simplifi 797’s Analytics platform, all the data and documentation is updated daily, providing transparency and visibility into multiple locations at the click of a mouse. This enhances oversight and enables a more rapid process improvement cycle.   

Giving the Optum Infusion leadership team clear oversight into the activities of each of their facilities, as well as an opportunity to identify and manage system-level trends, has been integral to standardizing best practices as they continue to expand their operations. The centralized management capabilities and industry-leading analytics offered by Simplifi 797 have been key to their successful growth tactics.  

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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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