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Licensed Unlicensed Requires Authentication Published by De Gruyter December 5, 2019

Use of clinical data and acceleration profiles to validate pneumatic transportation systems

Charlotte Gils EMAIL logo , Franziska Broell , Pernille J. Vinholt , Christian Nielsen and Mads Nybo

Abstract

Background

Modern pneumatic transportation systems (PTSs) are widely used in hospitals for rapid blood sample transportation. The use of PTS may affect sample integrity. Impact on sample integrity in relation to hemolysis and platelet assays was investigated and also, we wish to outline a process-based and outcome-based validation model for this preanalytical component.

Methods

The effect of PTS was evaluated by drawing duplicate blood samples from healthy volunteers, one sent by PTS and the other transported manually to the core laboratory. Markers of hemolysis (potassium, lactate dehydrogenase [LD] and hemolysis index [HI]) and platelet function and activation were assessed. Historic laboratory test results of hemolysis markers measured before and after implementation of PTS were compared. Furthermore, acceleration profiles during PTS and manual transportation were obtained from a mini g logger in a sample tube.

Results

Hand-carried samples experienced a maximum peak acceleration of 5 g, while peaks at almost 15 g were observed for PTS. No differences were detected in results of potassium, LD, platelet function and activation between PTS and manual transport. Using past laboratory data, differences in potassium and LD significantly differed before and after PTS installation for all three lines evaluated. However, these estimated differences were not clinically significant.

Conclusions

In this study, we found no evidence of PTS-induced hemolysis or impact on platelet function or activation assays. Further, we did not find any clinically significant changes indicating an acceleration-dependent impact on blood sample quality. Quality assurance of PTS can be performed by surveilling outcome markers such as HI, potassium and LD.


Corresponding author: Charlotte Gils, MD, Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, J.B. Winsløwsvej 4, 5000 Odense C, Denmark; and Clinical Institute, University of Southern Denmark, Odense, Denmark, Phone: +45 2729 0409

Acknowledgments

Assistance provided by Esben Hansen, electrical technician, is greatly appreciated.

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

  2. Research funding: This work was supported by the Region of Southern Denmark [grant number 17/15099] and the Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.

  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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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2019-0881).


Received: 2019-08-20
Accepted: 2019-11-03
Published Online: 2019-12-05
Published in Print: 2020-03-26

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