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Open research questions in Clinical Laboratory Practices and Quality Control

44 unresolved questions extracted from the limitations and future-work sections of 725 Clinical Laboratory Practices and Quality Control papers in our library. Each links back to the study that raised it.

What the literature leaves open

  • Whilst information on the ordering of tests and the resulting continuous test values are available, their optimal integration into data-driven confounding control strategies like the high-dimensional propensity score (HDPS) remains unclear.

    Methods for incorporating test result information within the high-dimensional propensity score framework: application in UK electronic health record data · 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 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

  • While staff training emerged as a recurring corrective measure, the study did not assess training effectiveness, content standardization, or long-term retention of corrective actions; targeted investigation of which specific training modalities (theoretical vs. hands-on) and competency assessments best prevent recurrence of EQA deviations in clinical chemistry and immunodiagnostics is needed.

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

  • The study relied on quality and completeness of EQA reports documented in the laboratory's quality management system; validation against raw analytical data and investigation of potential underreporting or documentation bias in the QMS records is necessary to confirm the accuracy of the reported <2% error rate and corrective action classifications.

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

  • The study documents that inter-assay variability and method heterogeneity in immunoassay-based biomarkers and autoimmune diagnostics concentrated deviations in specific departments; systematic comparison of EQA performance across different immunoassay platforms and autoimmune diagnostic methodologies is needed to identify which specific assay techniques drive method-related differences.

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

  • Patient-specific clinical outcomes were not analyzed in this retrospective EQA study; future research should correlate clinically irrelevant analytical deviations identified through EQA with actual downstream patient safety impacts and clinical decision-making errors to quantify the relationship between laboratory analytical performance and patient harm.

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

  • Only 6 of 13 commonly employed urinary albumin measurement methods included dilution protocols for analytes with concentrations exceeding the Analytical Measurement Range, indicating incomplete standardization across detection systems.

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

  • The main objectives of greater standardisation in the presentation of laboratory medical measurements are to increase patient safety, simplify semantic interoperability and enable the effective use of the ePA. Process optimisations in clinical care, the consolidation and networking of laboratories, and a high degree of transparency also contribute to the desire for greater standardisation, including the harmonisation of units. Standardisation in medicine is a lengthy process that requires many individual steps. Radical changes that take a long time to implement have little chance of success. Actions that are left to voluntary participation also carry the risk of failing due to habitual processes, even if selective nationwide standardisation of measurement units has been published, for example in the case of immunoassays, where a voluntary “bottom-up” approach was essentially implemented. The main expectation was that laboratories and their senders would agree on a suitable procedure themselves. The authors therefore suggest that the standardisation and mandatory use of laboratory medical units of measurement is one of the next steps towards increased patient safety, simplified semantic interoperability and the effective use of electronic patient records. This is also to support the standardisation of remaining differences at international level, which were most recently reported in the field of haematology. In addition to the question of whether the measured values should be reported in “SI” or “conventional units”, this also includes a recommendation on the appropriate form of representation in the decimal system [8, 20, 21]. Concrete efforts towards standardisation are already being made in this regard in diabetology [22, 23]. Approaches to dealing with method- or collectiverelated differences in reference ranges are not considered in this position paper, nor are standardisations at the level of test design and test implementation. Approaches to reporting laboratory results, e.g. in the form of dimensionless relative values instead of specific substance quantities, volumes or activity data, are also not considered here [25–27].

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

  • After investigation, we detected that the criterion to classify a DBS as scant was not consolidated, and also a lack of consensus on whether or not to report Bart's haemoglobin depending on its percentage.

    Inter-rater reliability assessment for the new-born screening quality assurance · 2022 · DOI

  • INTRODUCTION: It is often quoted that 70% of clinical decisions are based on laboratory results, but the evidence to substantiate this claim is lacking.

    Using clinical guidelines to assess the potential value of laboratory medicine in clinical decision-making · 2020 · DOI

  • Introduction: No guideline currently exists on how to detect or document haemolysis, icterus or lipemia (HIL) in blood samples, nor on subsequent use of this information.

    European survey on preanalytical sample handling – Part 2: Practices of European laboratories on monitoring and processing haemolytic, icteric and lipemic samples. On behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EF · 2019 · DOI

  • The impact of the information obtained on the lack of standardization is to recommend abandoning methods such as ALT, AST without exogenous pyridoxal phosphate, Jaffe method for creatinine, and do not use non-commutable calibrators, such as aqueous solutions for calcium and sodium.

    Standardization in laboratory medicine: Two years’ experience from category 1 EQA programs in Spain · 2018 · DOI

  • CONCLUSIONS: The two years of category 1 EQA program experience in Spain have manifested a lack of standardization of 17 most frequent biochemistry tests used in our laboratories.

    Standardization in laboratory medicine: Two years’ experience from category 1 EQA programs in Spain · 2018 · DOI

  • BACKGROUND: Patients with coagulation disorders may present to a variety of physician specialties; however, accurate and efficient diagnosis can be challenging for physicians not specialized in hematology, due to identified gaps in knowledge around appropriate laboratory assays and interpretation of test results.

    The Coags Uncomplicated App: Fulfilling Educational Gaps Around Diagnosis and Laboratory Testing of Coagulation Disorders · 2017 · DOI

  • The leading aspects which contribute to enhance the vulnerability of this part of the total testing process include the lack of standardization of different practices for collecting, managing, transporting and processing biological specimens, the insufficient compliance with available guidelines and the still considerable number of preventable human errors.

    Novel Opportunities for Improving the Quality of Preanalytical Phase. A Glimpse to the Future? · 2017 · DOI

  • Many contradictory data on K- ethylenediaminetetra acetic acid (K-EDTA) contamination of samples as consequence of non- compliance to order of draw are published.

    Data analysis of surrogate markers for detection of K-EDTA contamination · 2015

  • CONCLUSION: Confidence level at last venipuncture among both profiles of healthcare staff was very high, but they showed insufficient knowledge about possible factors affecting hemolysis due to materials used in venipuncture compared with factors due to venipuncture technique and handling of blood sample.

    Confidence level in venipuncture and knowledge on causes of in vitro hemolysis among healthcare professionals · 2015 · DOI

  • Although the dried blood spot-based CRP assay protocol has been validated in the United States, it remains unclear whether laboratories in other less-developed countries can generate CRP results of similar quality.

    External Quality Control for Dried Blood Spot-Based C-Reactive Protein Assay: Experience from the Indonesia Family Life Survey and the Longitudinal Aging Study in India · 2015 · DOI

  • Although nucleic acid amplification tests (NAATs) are widely used for pertussis diagnosis, their real‐world performance in routine clinical laboratories has not been systematically evaluated.

    A Small‐Scale Regional External Quality Assessment of Nucleic Acid Amplification Tests for <scp> <i>Bordetella pertussis</i> </scp> in China · 2026 · DOI

  • While the Roche cobas pro platform is increasingly adopted in clinical laboratories, pediatric-specific RIs for routine chemistry analytes on this system have not yet been established.

    Pediatric reference intervals for 27 routine chemistry analytes in healthy children and adolescents on the Roche cobas pro platform · 2026 · DOI

  • Given the high judicial regard for medical assessments over police observations, this lack of standardization undermines the principle of equal treatment.

    Observer bias in medical evaluations: a critical pre-analytical factor impacting the quality of judicial evidence in forensic-toxicological casework · 2026 · DOI

  • Taken together, these observations highlight that harmonization should not be limited to analytical standardization alone but must also address the appropriateness of test requesting and the clinical interpretation of laboratory results.

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

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44 open questions have been extracted from the limitations and future-work passages of 725 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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