How well-managed labs prioritize quality control practices to safeguard patient health

Quality control (QC) in clinical laboratories is not just a regulatory requirement – it is essential for ensuring accurate test results and, ultimately, patient safety. In an era of increasing testing demands, staffing shortages, and ever-advancing technology, maintaining high standards of QC is more complex than ever.

To address these challenges, SelectScience^® hosted an immersive webinar: Best Practices in Quality Control in the Clinical Lab, featuring a virtual tour of the Marien Hospital’s Institute of Laboratory Medicine in Stuttgart, Germany. The session included expert insights from Dr. Matthias Orth, Chief Physician and Medical Director of the institute, and Oswald Sonntag, Independent Consultant and QC expert. The discussion covered key aspects of modern laboratory QC, including proficiency testing, accreditation, reagent shortages, calibration, and troubleshooting.

Minimizing errors and increasing confidence in patient results

Clinical laboratories perform millions of tests annually, providing critical information that influences patient care. At Marien Hospital, Dr. Orth and his team conduct over three million tests per year, serving both inpatients and outpatients. The sheer volume of testing means even small QC inefficiencies can lead to significant consequences.

“The aim of our quality control is to deliver reliable results for patient care so that physicians and patients can have confidence in laboratory test reports,” says Dr. Orth. He emphasizes that QC procedures must be simple, efficient, and closely resemble patient samples to minimize errors.

Sonntag reinforces this point, stating that accurate QC materials are crucial. “The most significant challenge is to find a proper quality control material, which should be close to the medical decision limit where clinical decisions are made,” he explains. Without reliable QC materials, errors could go undetected, potentially leading to incorrect test reporting.

Challenges and solutions in laboratory QC

Ensuring accuracy with high testing volumes and resource challenges

With increasing testing demands, laboratories must ensure accurate results while managing resources including staff workload. Sonntag emphasizes the importance of using QC materials with known target values to monitor performance in real time. He also highlights the role of proficiency testing, an external QC measure where labs analyze unknown samples and compare results with peers.

“Proficiency testing should help you to figure out where you are compared with other laboratories using similar or the same tests and instrumentation,” Sonntag says. He notes that while proficiency testing is essential, labs must also use internal QC measures for immediate accuracy checks.

Dr. Orth adds that maintaining supplier relationships is another key strategy for avoiding reagent shortages, which can disrupt testing. “I would choose a reliable supplier rather than saving a few cents on a test and risking bigger problems,” he says. “You really have to be in a relationship with your vendor, and both parties are invested to stay in this relationship for a longer period.”

The role of accreditation in QC management

Accreditation is often viewed as a benchmark for laboratory quality, but the speakers emphasize that true QC success depends on more than just certification. Sonntag explains that ISO 15189, a common accreditation standard, “is just proving if you have the competency to run a medical laboratory.”

Dr. Orth took a more practical view, stating that while accreditation can be beneficial, “the accreditation alone doesn’t help to improve the quality, but the quality management system does.” In his experience, national regulations can be just as effective as international standards, provided they include robust QC protocols.

Troubleshooting QC failures

When QC issues arise, labs must quickly determine whether they stem from reagent problems, instrument malfunctions, or procedural errors. Sonntag explains that Peer group data — comparing a lab’s QC results to similar labs — can be a useful troubleshooting tool. “You can see if you’re with the peers or if you’re not. If you’re not with the peers, then it could be an isolated problem in your laboratory.”

Dr. Orth emphasizes the importance of using quality control materials, with target values, to detect shifts early. “We are using such quality materials so you can really know from the first day that the new lot of QC material or the reagent lot is out of order or whether it’s performing well.”

Best practices in calibration and measurement uncertainty

Calibration is another critical component of QC, ensuring that instruments produce accurate results over time. Sonntag cautions against over-reliance on calibration as a fix-all solution. “As soon as the quality control material may show a shift or drift, you have to consider that something happened to your instrument or reagent,” he says. “But if you have a problem find out why you have an issue.”

Dr. Orth echoes this sentiment, noting that modern instruments and reagents have improved significantly, reducing the need for frequent recalibration. He also warns that recalibrating too often can introduce errors, “You need reliable quality material for the internal quality control to detect these shifts.”

Regarding measurement uncertainty, Dr. Orth is pragmatic, “We know that we have a measurement uncertainty, but it’s nice to know this in the lab. We have to supply attending physicians with reliable results, so I do not care about the measurement uncertainty – I have to run QC on all tests I do.”

The importance of independent QC materials

Both experts advocate for the use of independent QC materials rather than relying solely on manufacturer-provided controls. “If I have a quality material which is adapted to the reagent lot and adapted to calibrate a lot, then this is not independent material,” Dr. Orth explains. “We are trying to use as much independent material as possible for patient safety.” Sonntag agrees, stating that independent QC materials allow labs to detect potential issues more effectively.

Strategies to ensure accuracy, efficiency, and patient safety

The webinar provides valuable insights into the complexities of QC in modern clinical laboratories. Some key takeaways include:

• Accuracy depends on strong QC materials: Labs must use high-quality, independent QC materials that closely resemble patient samples.
• Proficiency testing is essential but not enough: While external QC is useful, internal daily checks are crucial for real-time accuracy.
• Calibration should be approached carefully: Labs should avoid unnecessary recalibration and focus on identifying underlying issues when shifts occur.
• Supplier relationships matter: Working with reliable vendors helps prevent reagent shortages and ensures continuity of operations.
• Accreditation is a tool, not a guarantee: Labs must actively maintain QC standards beyond just meeting certification requirements.

Ultimately, the webinar discussion underscores that a well-managed lab prioritizes simplicity, efficiency, and rigorous QC practices to safeguard patient health. As Sonntag explains, “patient safety is what matters most — because anyone, including yourself, could be a patient, and you'd want accurate results”.

If you missed the live session, you can watch the webinar on demand.