Enhancing QC protocols through automation

July 24, 2018

Emerging technologies advance care and efficiency by streamlining QC maintenance.

The modern-day laboratory is a fast-paced environment with high demands and stretched resources. Industry-wide, laboratory managers balance fewer skilled staff and greater budgetary constraints with an upswing in testing demands. With continuing innovation and attention to better disease prevention, diagnosis, and management, the clinical laboratory is increasingly at the front and center of healthcare. Because of this, the need for fast, accurate, efficient results delivery has never been so acute, and a vigilant quality control (QC) program is essential to ensuring this need is met.

In QC management, laboratories apply various levels of rigor. Some QC procedures employ paper-based protocols, which requires storing printed documentation. This type of system necessitates extreme diligence on the part of the laboratory staff and has left laboratory managers to question QC procedural compliance. In an effort to close gaps and reduce variation in QC programs, industry innovators have posed another question: “How do we advance QC management to drive consistency and efficiency?” They have found an answer in automated middleware solutions.

Automated middleware solutions

Middleware technology takes manual laboratory QC procedures into an automated environment to ensure that processes meet defined standards 24 hours a day, seven days a week. With middleware solutions, laboratories gain increased confidence in reported results and identify instrument and control irregularities faster.

Today’s advanced middleware technology gives laboratories the ability to establish two types of QC monitoring protocols—a control protocol and a patient protocol. A control protocol—including rules-based QC management features—analyzes data from commercial control materials to ensure quality. A patient protocol performs statistical analyses—such as those based on patient moving averages—using patient results to provide insight into potential future QC failures.

An aggregate graphical display of statistical data facilitates communication in the laboratory by allowing laboratorians to readily visualize and share results and print reports. These advanced solutions offer features that promote significant advantages:

  • Streamlining QC maintenance to help laboratories monitor, manage, and act through enhanced QC; stopping autovalidation based on a single parameter, per CAP requirements
  • Ensuring all QC runs are on schedule, using a timeout feature
  • Identifying system issues proactively and ensuring quality results between QC runs through the use of exponentially weighted moving averages.

Streamlining QC maintenance

Actionable visual cues. Because laboratories are tasked with delivering excellence in patient care, while achieving operational efficiency, instrument manufacturers are continually identifying ways to elevate results quality and streamline workflow. One way to accomplish this is to give laboratorians at-a-glance information and visual parameter cues from which they can quickly take action. If QC protocols are met, tests can be run; if not, early attention can be given to gaps. Flags against individual analytes inform laboratorians about QC status and guide corrective actions, if needed, to increase confidence in results. Such flags may appear when a protocol is in error or a result is blocked.

Rules-based QC management
. Pre-programmed or user-defined rules ensure consistent performance throughout workflow processes, helping laboratories deliver quality results regardless of time of day or staff skill level. With advanced middleware solutions, laboratorians can set rules, defining QC protocols for each analyte based on QC metrics such as Westgard rules. Trained laboratory staff members can set middleware rules that inform all staff of QC issues, or automatically stop autovalidation. These system notifications ensure that necessary actions are taken based on pre-identified rules. Because rules can be defined by the user, they can be created to meet a laboratory’s individual requirements, and they can be written by laboratory staff trained in these systems, without the need for IT involvement.

Electronic audit trail
. One major benefit of an automated system is the analytics it provides for greater insight into laboratory operations. Unlike a paper-based system, automated QC management gives the user the ability to look back at QC trends. If desired, the user can research specific issues and determine what actions were taken and by whom. This assists laboratories in optimizing QC, by addressing recurring issues and confirming compliance with all protocols.

Timeout feature

New middleware solutions prevent the release of erroneous data by helping laboratories ensure QC is run within specified time frames. Using a timeout feature, data is not released if the QC is not run as indicated. This halts error reporting and promotes peace of mind for laboratory leaders and staff members, assuring them that every QC material test scheduled to run on a given day was completed.

Exponentially weighted moving averages

Minimizing release of erroneous data. Statistical analysis is at the core of QC management. A moving average is a mean calculated for a specified number of patient results. An exponentially weighted moving average (EMWA), available in newer technology, provides a moving average weighted to consider the age of the results. Depending on how the protocol is defined, EWMA can warn the laboratory to shut-off autoverification automatically to prevent the release of potentially erroneous results and eliminate the need for retesting, physician notification, and other corrective actions. It can also alert the system to stop sending test requests to a specific instrument. This round-the-clock real-time insight keeps laboratories in control of their results and provides a proactive tool to ensure results quality by monitoring portions of the laboratory that may not be normally monitored and by adding an additional level of quality assurance. It also helps to promote better patient care, as it provides early detection of system issues to reduce false high or low results.

Ensuring consistent results between QC runs
. Users of these enhanced features have reported shortened turnaround times (TATs), as specimens can be processed without waiting for the completion of QC verifications. Because reviewing laboratorians are alerted to any drifts in QC values in real time, operators can be assured that, if any QC value is not within the appropriate range, test results will be blocked from autovalidation, mitigating erroneous reporting. This allows laboratories to run specimens on the instrument sooner—reducing TATs—with a high level of confidence in diagnostic test results.

Beyond the lab: impacting patient care

Today’s tools aim to assist laboratories with the critical and often laborious task of QC management. Enhanced system features enable laboratories to move many patient samples through with accuracy and efficiency—in some cases, with shortened TATs. Advanced analytics give insight into issues that can affect results delivery—such as pre-analytical sample integrity and the order-to-collection process. The actionable data can be used to facilitate conversations with clinical partners—including Emergency Department staff members—to mitigate factors that may affect test quality or TAT.

As the demand for accurate and timely results continues to rise and as technology becomes increasingly sophisticated in all market segments, clinical diagnostics innovators will look for creative, beneficial ways to improve laboratory instrumentation. Building on already-established laboratory-enhancing technologies, these innovations will further boost efficiency through time-saving features, facilitate collaboration among all healthcare partners through actionable data, and advance patient care through quality results.