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Open research questions in Clinical Laboratory Practices and Quality Control

139 unresolved questions extracted from the limitations and future-work sections of 786 Clinical Laboratory Practices and Quality Control papers in our library. Each links back to the study that raised it.

What the literature leaves open

  • Further studies are needed to clarify the association between treatment duration and ADS incidence, - Research should focus on putting the imperfect evidence base to good use for patients, - More studies using instrument-based approaches are needed

    Double counting, double standards · 2025 · DOI

  • The paper identifies a gap in the understanding of antidepressant discontinuation symptoms, particularly in regards to the incidence of ADS. The authors identify a gap in the methodology of meta-analyses, particularly in regards to the use of all available data. The paper identifies a gap in the consideration of the problems patients experience after antidepressant discontinuation.

    Double counting, double standards · 2025 · DOI

  • Therefore, interfaces and the unit conversion in the LIS need to be validated across the Analytical Measurement Range and should also be verified for situations where error codes are present.

    24-hour urinary total protein quantitative detection for pregnant women with unit conversion failure: a case report and laboratory administration reflection · 2026 · DOI

  • All automated calculation procedures executed within the Laboratory Information System should be thoroughly documented and validated, but comprehensive validation protocols across different LIS platforms are not well established.

    24-hour urinary total protein quantitative detection for pregnant women with unit conversion failure: a case report and laboratory administration reflection · 2026 · DOI

  • The risk of misinterpretation due to the use of different units of measurement. The hindrance of semantic interoperability in digital medicine. The need for a nationwide agreement on uniform units of measurement.

    Unity among the units – a position paper by the DGKL · 2026 · DOI

  • The lack of standardization of units of measurement in laboratory medical parameters in Germany. The need for a nationwide agreement on uniform units of measurement.

    Unity among the units – a position paper by the DGKL · 2026 · DOI

  • The current strategies to solve the problem of inappropriate prescriptions are not adequate. There is a need for a structural solution through the Health Information Technology.

    Designing Efficient Healthcare Systems: A Comparative Analysis of Decision Support Systems in Laboratory Medicine · 2026 · DOI

  • The adoption of AI in low-resource settings is hindered by constraints such as inadequate infrastructure and limited technical expertise. AI models trained on high-income population datasets may underperform in underrepresented regions. The lack of comprehensive local data and limited access to standardized laboratory procedures can reduce the accuracy and generalizability of AI outputs.

    Artificial Intelligence in Medical Laboratory Medicine: Clinical Applications, Ethical Challenges, and the Evolving Role of Laboratory Professionals in Low-Resource Settings · 2026 · DOI

  • Development of context-specific, affordable, and ethically guided AI solutions for low-resource settings. Investigation of the impact of AI adoption on laboratory workflows and patient outcomes in low-resource settings. Examination of the challenges and limitations of AI adoption in low-resource settings and development of strategies to address them.

    Artificial Intelligence in Medical Laboratory Medicine: Clinical Applications, Ethical Challenges, and the Evolving Role of Laboratory Professionals in Low-Resource Settings · 2026 · DOI

  • There is relatively little research on EQA in individual clinical laboratories. Current scientific evidence on EQA focuses primarily on the analyses carried out by EQA providers.

    Structured Error Analysis and Corrective Actions in Clinical Laboratory Practice: An Analysis of 7226 External Quality Assurance Participations · 2026 · DOI

  • The study identified that preanalytical and systemic causes played only a minor role in deviations, with predominantly analytical/quantitative deviations observed; future work should systematically characterize the specific preanalytical variables (specimen handling, transport conditions, storage duration) that do occur and their threshold effects on EQA performance across different test categories.

    Structured Error Analysis and Corrective Actions in Clinical Laboratory Practice: An Analysis of 7226 External Quality Assurance Participations · 2026 · DOI

  • The IVDR has led to substantial unintended consequences, including certification bottlenecks and diagnostic shortages. The regulation has a disproportionate impact on small and medium enterprises and healthcare institutions developing in-house diagnostic devices.

    EFLM position statement on the proposed 2025/0404(COD) IVDR Amendment of Article 5.5 · 2026 · DOI

  • Finally, the data analysis requires complex bioinformatic pipelines for which no standards exist, and which are also often developed in a non-commercial environment of specialty laboratories. This includes the lack of standardized DNA/ RNA extraction methods allowing each laboratory to adopt different protocols for nucleic acid isolation, lack/difference in Conclusion The above examples relate to the lack of complete standardization in NGS pipelines (3–7).

    EFLM position statement on the proposed 2025/0404(COD) IVDR Amendment of Article 5.5 · 2026 · DOI

  • The study only tested equilibration times of 1, 2, 4, 6, and 8 hours. The study used a limited number of serum samples (40).

    Determination of optimal equilibration time for sodium measurement using Johnson Vitros dry chemistry analyzer · 2026 · DOI

  • The manufacturer's recommended 2-hour equilibration time may be insufficient for sodium measurement. Clinical observations suggest that sodium results may be sensitive to equilibration time.

    Determination of optimal equilibration time for sodium measurement using Johnson Vitros dry chemistry analyzer · 2026 · DOI

  • Analytical errors can lead to inaccurate test results, - Certain analytes are prone to high error rates, - Quality control measures are needed to improve test result accuracy

    Factors associated with analytical errors in blood chemistry tests · 2026 · DOI

  • There is a need to consider the limitations of Milan model 1b when setting APS. The current approach to setting APS may not fully account for the complexities of clinical decision-making.

    Limitations to the development of Milan model 1b analytical performance specifications · 2026 · DOI

  • Insufficient rigor of study designs - Limited attention to test selection, critical value management, and interprofessional communication in laboratory medicine education - Lack of long-term longitudinal follow-up data

    Educational strategies for enhancing medical students’ competency in laboratory medicine practice: a scoping review · 2026 · DOI

  • The primary weakness of the current body of evidence lies in the insufficient rigor of study designs, with most interventional studies employing non-randomized designs. The review did not include a formal quality assessment of the studies or a meta-analysis. The studies assessed only immediate or short-term effects, lacking long-term longitudinal follow-up data.

    Educational strategies for enhancing medical students’ competency in laboratory medicine practice: a scoping review · 2026 · DOI

  • There is a need for a more efficient approach to reduce unnecessary dilutions in clinical chemistry tests. Prior work has focused on automating laboratory processes, but there is a lack of studies on revising validation rules to report results above predefined thresholds.

    A model to increase automation and support reliable interpretation of clinical chemistry tests · 2026 · DOI

  • The lack of harmonization in laboratory medicine, particularly in CBC testing. The need for standardized reporting and personalized reference intervals.

    The complete blood count: data or clinical information? · 2026 · DOI

  • The study identifies a gap in the understanding of the impact of spontaneous haemolysis on routine haemostasis assays. The study addresses the need to characterise the analyser's haemolysis flagging behaviour.

    Re-evaluating haemolysis rejection criteria for PT, aPTT, and D-dimer testing: evidence from paired clinical samples on the CN-3000 analyser · 2026 · DOI

  • Further evaluation of the performance of molecular POCT assays and AI-based digital microscopy POCT systems for various applications. Development of more compact and reliable POC devices for different diagnostic testing applications. Investigation of the clinical impact of improved analytical accuracy and reliability of POCT results on patient care and outcomes.

    5 th National Point-Of-Care Testing Symposium · 2026 · DOI

  • Significant concerns persist regarding the analytical accuracy and reliability of POCT results. The alignment of POCT analytical performance specifications with current scientific recommendations and clinical requirements is crucial.

    5 th National Point-Of-Care Testing Symposium · 2026 · DOI

  • Hemolysis, icterus, and lipemia can interfere with routine test results and lead to misinterpretation. The interactions between these indices are complex and not well understood. There is a need for a reliable and standardized method for assessing HIL indices.

    Cross-interference of hemolysis, icterus and lipemia: A study with real patient samples · 2026 · DOI

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139 open questions have been extracted from the limitations and future-work passages of 786 Clinical Laboratory Practices and Quality Control papers in our library. Each one below links back to the study that raised it, so you can read the original claim in context.

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