QC Monitoring Case Study

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At A Glance

The company is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally.
They needed a web-based quality control monitoring application to replace their existing paper-based system.
It was important that the system accept data from thousands of instruments, analyzers and LIS’s worldwide.

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The Solution

Primero developed a web-based quality control system to allow the company the ability to abandon their more error-prone and less efficient paper-based system.

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Benefits

Improved efficiencies due to less reliance on manual data entry via paper.
Higher customer satisfaction due to the multiple data entry modes available, including manual entry via the website, batch entry, and auto-upload directly from the laboratory information system (LIS) and/or analyzers.
Immediate reporting instead of waiting for faxed or mailed reports.
Instant peer comparison to allow users to instantly see how their data sets compare to their peers.

Background

Around ten years ago, this partner needed a web-based quality control (QC) monitoring application to replace their existing paper-based systems. The cost to scale their existing process didn’t make financial or operational business sense for continued investment.

The Primero Solution

Primero Systems has designed and deployed (and is actively developing, enhancing and maintaining) a system for this partner, which processes thousands of quality control statistics in real time. Some of the world’s most respected hospitals and companies trust our system to check and track their data.

Laboratories around the globe submit QC test results from their instruments to this platform, which stores the data and provides peer statistics back to the laboratories. In turn, this helps the labs to detect suspicious results that can identify an issue with an instrument, a trend, or just confirm acceptable values.

Currently using a heavily modified “off-the-shelf” LIMS that would regularly crash and was hitting maximum capacity, this drug testing lab found that their makeshift LIMS wasn’t able to grow with the business. As a rapidly growing company, they needed a solution that was custom-built to their specific needs. It was time for the company’s LIMS to start helping to drive business forward – instead of impeding its progress.

GDS systems are huge applications and typically built on legacy technology – making integrations difficult. They are also constantly changing, so the system needed to be agile enough to adapt to these changes.

With change being one of the only constants in this world – when industries experience any kind of change in the way that things have typically been executed – technology is needed to embrace this disruption. The competitive and consultative advantage that Primero provides allows its clients to differentiate themselves and enhance their offerings to their customer base. In this case, Primero has been there and guided the company through software product development and proprietary third-party integrations – over the course of several years. According to their CEO, “The Primero team has been able to handle any challenge that we have thrown their way. They are able to mold our platform in any way that we need.”

The Primero Prescription

One of the key features is real-time peer data comparison, significantly expediting troubleshooting efforts and peer statistic review; it can compare QC data with other labs around the globe instantaneously or just within the lab’s affiliated network.

Submissions can be done manually by the lab users on the website, although automatic data entry is encouraged, providing faster input and eliminating manual errors.

Every data point added to the system is exposed to different validation algorithms, ensuring that outliers are excluded from the process. Some algorithms are based on fixed ranges, others on auto-calculated ranges obtained from statistics. There are also “violation rules algorithms” integrated into the system; Westgard Rules and Rilibak among others. Additionally, Review and Approval workflows are integral to the system’s design – allowing each data point to be reviewed and approved/declined by lab personnel where required or appropriate.

The system provides more than twenty types of PDF reports for the labs to review, including standard graph analysis like Levey Jennings and Youden. In addition to static reporting, the system offers interactive chart visualizations, allowing users to set time ranges, compare with other instruments and include comments.

More than up for the challenge, Primero developed a complete LIMS for the company’s urine and oral fluid drug testing operations that supports over 15,000 specimens daily – with 100% uptime. From the moment a specimen enters the door through its entire lifecycle and related customer reports, the company’s new, custom-built LIMS deftly handles every touchpoint.

The new system can accommodate new orders to fit the preference of any of the lab’s clients. For clients opting to order by paper requisition, the Primero system provides a robust order entry screen that allows for remarkably fast input and high throughput. For those clients preferring to go paperless, the system’s web-based functionality allows users to place their orders using an intuitive online ordering system from the browser and device of their choice. This same online interface also allows the user to track work-in-progress as well as current and archived result reports. Additionally, clients in institutions with Electronic Medical Record (EMR) systems also can place orders through the robust HL7 interface to the LIMS.

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