In clinical chemistry laboratories, quality control (QC) is the backbone of accurate, compliant, and efficient testing. Yet even the most experienced labs face hidden vulnerabilities—gaps in QC protocols that can result in regulatory risk, wasted resources, or diagnostic errors. In 2025, these risks are compounded by increasing complexity in instrumentation, staffing shortages, and evolving accreditation standards. For lab directors and quality assurance specialists alike, recognizing and resolving QC gaps has become essential to lab management.
Common Quality Control Gaps in Clinical Chemistry Workflows
Despite the critical nature of quality control in lab operations, clinical chemistry workflows frequently suffer from gaps that compromise reliability. One common issue is inconsistent QC procedures between shifts or personnel. When test protocols vary based on who’s running the analyzer, undetected errors can slip through and impact diagnostic accuracy.
Another persistent problem is the over-reliance on manual documentation or outdated standard operating procedures (SOPs). Not only does this increase the risk of transcription errors, but it also makes adapting to evolving regulatory standards far more difficult.
Proper maintenance and calibration of analyzers is equally essential. Instruments that are not serviced regularly can produce inaccurate results, leading to misdiagnoses or the need for costly re-testing.
Finally, many labs still lack real-time performance monitoring tools. Without immediate visibility into instrument behavior, QC drift or system failures may go unnoticed until patient results are affected (1).
How QC Gaps Impact Lab Accuracy and Patient Care
The downstream impact of these QC gaps is significant. Diagnostic variability across instruments or locations—often caused by inconsistent calibration, reagent lots, or environmental conditions—can lead to discrepancies that undermine diagnostic reliability.
When QC flags go unaddressed, delays in reporting or the need for retesting can cause bottlenecks in lab workflows. These delays not only strain turnaround times but also affect the quality of clinical decision-making.
Inconsistent or inaccurate results erode clinician confidence and may compromise patient safety. A lab that fails to deliver timely, reliable data risks losing credibility and affecting treatment outcomes.
Moreover, quality lapses drive financial waste. Re-running tests, addressing inspection failures, and implementing corrective action plans all contribute to increased operating costs and potential reimbursement delays (1).
Steps Labs Can Take to Identify and Resolve QC Gaps
To strengthen QC systems, clinical chemistry labs should begin by conducting regular internal audits and gap analyses. These reviews help identify process breakdowns, training deficiencies, and outdated documentation that might otherwise go unnoticed.
SOPs must also be reviewed and reassessed for compatibility with the lab’s current analyzers. When procedures don’t align with instrumentation, even well-trained staff may inadvertently introduce errors.
Standardizing practices across shifts using centralized tools such as dashboards, digital checklists, and electronic documentation systems can greatly improve consistency and traceability.
Finally, using reagents, calibrators, and quality controls validated for the specific platform in use ensures reliable results and reduces the risk of erroneous data due to incompatibility (2).
SEKISUI Diagnostics’ Commitment to Quality Control Excellence
We understand the importance of reliable quality control. That’s why we provide a broad suite of clinical chemistry reagents and controls engineered for consistency, compliance, and platform compatibility.
Laboratories can access detailed instructions for use (IFUs), safety data sheets (SDS), calibration information, and performance data directly from our product documentation. Our technical support team works closely with labs to troubleshoot complex challenges and help close persistent QC gaps.
Next Steps for Lab Leadership
Quality control gaps cannot be solved reactively; they demand proactive attention. Clinical chemistry labs that invest in regular audits, up-to-date procedures, and reliable vendor partnerships are better positioned to achieve compliance and operational excellence.
Lab leaders should promote cross-functional collaboration among QA teams, technical supervisors, and procurement staff to eliminate variability and foster a culture of accountability.
Partnering with SEKISUI Diagnostics means gaining access to QC-ready solutions—from analyzer-compatible reagents and controls to workflow-optimized support resources—that help ensure consistent, accurate testing results every time.
References
- Gruber, Lorenz, Hausch, Artur and Mueller, Thomas. Internal Quality Controls in the Medical Laboratory: A Narrative Review of the Basic Principles of an Appropriate Quality Control Plan. National Library of Medicine. [Online] National Center for Biotechnology Information, October 2024. https://pubmed.ncbi.nlm.nih.gov/39410627/.
- Westgard, Phd, James O. 2025 IFCC Recommendations for Ensuring IQC Practices in Medical Laboratories . Westgard QC. [Online] March 2025. https://westgard.com/essays/quality-requirements-and-standards/ifcc-iqc-2025.html.
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