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Quality performance of laboratory testing in pharmacies: a collaborative evaluation

  • Martina Zaninotto EMAIL logo , Giorgia Miolo , Adriano Guiotto , Silvia Marton and Mario Plebani ORCID logo
Published/Copyright: May 19, 2016
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 54 Issue 11

Abstract

Background:

The quality performance and the comparability between results of pharmacies point-of-care-testing (POCT) and institutional laboratories have been evaluated.

Methods:

Eight pharmacies participated in the project: a capillary specimen collected by the pharmacist and, simultaneously, a lithium-heparin sample drawn by a physician of laboratory medicine for the pharmacy customers (n=106) were analyzed in the pharmacy and in the laboratory, respectively. Glucose, cholesterol, HDL-cholesterol, triglycerides, creatinine, uric acid, aspartate aminotransferase, alanine aminotransferase, were measured using: Reflotron, n=5; Samsung, n=1; Cardiocheck PA, n=1; Cholestech LDX, n=1 and Cobas 8000. The POCT analytical performance only (phase 2) were evaluated testing, in pharmacies and in the laboratory, the lithium heparin samples from a female drawn fasting daily in a week, and a control sample containing high concentrations of glucose, cholesterol and triglycerides.

Results:

For all parameters, except triglycerides, the slopes showed a satisfactory correlation. For triglycerides, a median value higher in POCT in comparison to the laboratory (1.627 mmol/L vs. 0.950 mmol/L) has been observed. The agreement in the subjects classification, demonstrates that for glucose, 70% of the subjects show concentrations below the POCT recommended level (5.8–6.1 mmol/L), while 56% are according to the laboratory limit (<5.6 mmol/L). Total cholesterol exhibits a similar trend while POCT triglycerides show a greater percentage of increased values (21% vs. 9%). The reduction in triglycerides bias (phase 2) suggests that differences between POCT and central laboratory is attributable to a pre-analytical problem.

Conclusions:

The results confirm the acceptable analytical performance of POCT pharmacies and specific criticisms in the pre- and post-analytical phases.

Keywords: point-of-care-testing; post-analytical phase; pre-analytical phase; quality performance

Acknowledgments:

This study has been carried out thanks to skillful cooperation of the following authors: Carrara Franco, Farmacia S. Domenico; Finato Matteo, Farmacia Cappellini; Manni Maria Daniela, Farmacia S. Croce; Lazzarin Angelo, Farmacia Lazzarin; Vaccato Bagilotto Alessandro, Farmacia Moderna; Vignes Nadia, Farmacia all’Angelo; Visco Laura, Farmacia San Giovanni; Ciato Sebastiano, Farmacia Ciato.

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2016-2-10
Accepted: 2016-3-30
Published Online: 2016-5-19
Published in Print: 2016-11-1

©2016 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2016-0104
Keywords for this article
point-of-care-testing; post-analytical phase; pre-analytical phase; quality performance

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. CCLM Award for the Most Cited Paper Recently Published
  4. Laboratory economics. Risk or opportunity?
  5. Reviews
  6. Molecular diagnosis and precision medicine in allergy management
  7. The insulin autoimmune syndrome (IAS) as a cause of hypoglycaemia: an update on the pathophysiology, biochemical investigations and diagnosis
  8. Opinion Paper
  9. Role of microsatellite instability, immunohistochemistry and mismatch repair germline aberrations in immunosuppressed transplant patients: a phenocopy dilemma in Muir-Torre syndrome
  10. Genetics and Molecular Diagnostics
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  12. False low holotranscobalamin levels in a patient with a novel TCN2 mutation
  13. General Clinical Chemistry and Laboratory Medicine
  14. Quality performance of laboratory testing in pharmacies: a collaborative evaluation
  15. Cost evaluation of clinical laboratory in Taiwan’s National Health System by using activity-based costing
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  17. HbA1c: EQA in Germany, Belgium and the Netherlands using fresh whole blood samples with target values assigned with the IFCC reference system
  18. Iohexol clearance in unstable critically ill patients: a tool to assess glomerular filtration rate
  19. Characteristics of Chinese patients with antiphospholipid syndrome and the ability of lupus anticoagulant assays to identify them
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  23. Evaluation of Mindray BC-6800 body fluid mode for automated cerebrospinal fluid cell counting
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  26. Cardiovascular Diseases
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