Errors within the total laboratory testing process, from test selection to medical decision-making – A review of causes, consequences, surveillance and solutions

Mrazek, Cornelia; Lippi, Giuseppe; Keppel, Martin H.; Felder, Thomas K.; Oberkofler, Hannes; Haschke-Becher, Elisabeth; Cadamuro, Janne

doi:10.11613/bm.2020.020502

Cited by 49 publications

(31 citation statements)

References 95 publications

(234 reference statements)

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“… 15 Laboratory personnel should control the whole TTP using QIs and focus on improving extra-laboratory procedures, in particular test selection and interpretation in coordination with other medical staff. 16 …”

Section: Introductionmentioning

confidence: 99%

Total Clinical Chemistry Laboratory Errors and Evaluation of the Analytical Quality Control Using Sigma Metric for Routine Clinical Chemistry Tests

Teshome¹,

Worede²,

Asmelash³

2021

JMDH

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Section: Introductionmentioning

confidence: 99%

Total Clinical Chemistry Laboratory Errors and Evaluation of the Analytical Quality Control Using Sigma Metric for Routine Clinical Chemistry Tests

Teshome¹,

Worede²,

Asmelash³

2021

JMDH

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“…Recently, Makary et al reported that after cardiopulmonary and malignant diseases, medical errors were the third leading cause of death in the US ( 11 ). Most laboratory-related medical errors originate from physicians who order and interpret test results ( i.e ., the initial and final steps of TTP) ( 1 - 3 , 12 , 13 ). To achieve efficiency and quality in the laboratory processes, errors should be identified and subsequently reduced to a negligible level.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, safe and valid interpretations of test results are essential for the cor-rect diagnosis, monitoring, and treatment of patients. However, it has been shown that the rate of errors related to the interpretation of test results is high and ranked second among the five phases of the total testing process (TTP) (1)(2)(3). To interpret test results correctly, it is imperative for clinicians to understand the factors that affect these results.…”

Section: Introductionmentioning

confidence: 99%

Utilization of biological variation data in the interpretation of laboratory test results – survey about clinicians’ opinion and knowledge

Emre

Karpuzoğlu

Coşkun

et al. 2021

Biochem. med. (Online)

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Introduction To interpret test results correctly, understanding of the variations that affect test results is essential. The aim of this study is: 1) to evaluate the clinicians’ knowledge and opinion concerning biological variation (BV), and 2) to investigate if clinicians use BV in the interpretation of test results. Materials and methods This study uses a questionnaire comprising open-ended and close-ended questions. Questions were selected from the real-life numerical examples of interpretation of test results, the knowledge about main sources of variations in laboratories and the opinion of clinicians on BV. A total of 399 clinicians were interviewed, and the answers were evaluated using a scoring system ranked from A (clinician has the highest level of knowledge and the ability of using BV data) to D (clinician has no knowledge about variations in laboratory). The results were presented as number (N) and percentage (%). Results Altogether, 60.4% of clinicians have knowledge of pre-analytical and analytical variations; but only 3.5% of them have knowledge related to BV. The number of clinicians using BV data or reference change value (RCV) to interpret measurements results was zero, while 79.4% of clinicians accepted that the difference between two measurements results located within the reference interval may be significant. Conclusions Clinicians do not use BV data or tools derived from BV such as RCV to interpret test results. It is recommended that BV should be included in the medical school curriculum, and clinicians should be encouraged to use BV data for safe and valid interpretation of test results.

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“…Investigation of erroneous results should include interrogation of the total testing process, from ensuring the correct test was ordered to the correct interpretation of test results ( 14 ). Simple paraprotein-related effects, such as failed aspiration of sample on the automated chemistry analyser due to hyperviscosity, should be excluded.…”

Section: Discussionmentioning

confidence: 99%

Pre-analytical mysteries: A case of severe hypervitaminosis D and mild hypercalcaemia

Whittle

Waal

Huynh

et al. 2021

Biochem. med. (Online)

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We describe a case of severe hypervitaminosis D and mild hypercalcaemia in a 68-year-old woman who presented with fatigue and weight loss. Her 25-hydroxy vitamin D (25OHD) was > 400 nmol/L (50-150) and corrected serum calcium was 2.83 mmol/L (2.1-2.6). Her intact parathyroid hormone (PTH) was 4.9 pmol/L (2.0-9.5). Further investigation revealed an IgM kappa paraprotein, and a bone marrow aspirate confirmed a diagnosis of lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia (LPL/WM). As the vitamin D level was discordant with the patient’s other results and presentation, the presence of an assay interferent was suspected. A 1-in-2 dilution of the sample returned a 25OHD result of 84 nmol/L in keeping with the presence of an interferent. Testing for rheumatoid factor was negative. The sample was treated with an antibody blocking reagent (Scantibodies) and results were not consistent with heterophile antibody interference. The sample was then analysed using liquid chromatography tandem mass spectrometry (LC-MS/MS), which returned a 25OHD result of 82 nmol/L. Testing on an alternative immunoassay platform produced a 25OHD result of 75 nmol/L. Reapeted testing on the original platform following reduction of the monoclonal paraprotein with chemotherapy, returned a result of 64 nmol/L. The patient’s mild hypercalcaemia persisted following resolution of the monoclonal paraprotein, in keeping with a diagnosis of primary hyperparathyroidism. This case highlights the potential for paraproteins to cause assay interference, and the importance of considering interference when results are incongruous with the clinical presentation.

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Errors within the total laboratory testing process, from test selection to medical decision-making – A review of causes, consequences, surveillance and solutions

Cited by 49 publications

References 95 publications

Total Clinical Chemistry Laboratory Errors and Evaluation of the Analytical Quality Control Using Sigma Metric for Routine Clinical Chemistry Tests

Total Clinical Chemistry Laboratory Errors and Evaluation of the Analytical Quality Control Using Sigma Metric for Routine Clinical Chemistry Tests

Utilization of biological variation data in the interpretation of laboratory test results – survey about clinicians’ opinion and knowledge

Pre-analytical mysteries: A case of severe hypervitaminosis D and mild hypercalcaemia

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