Improved prospective risk analysis for clinical laboratories compensated for the throughput in processes

Pim M.W. Janssens; Armando van der Horst

doi:10.1515/cclm-2018-0109

Article

Improved prospective risk analysis for clinical laboratories compensated for the throughput in processes

Pim M.W. Janssens and Armando van der Horst

Published/Copyright: May 5, 2018

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 56 Issue 11

Abstract

Background:

Practical application of prospective risk analysis (PRA) in clinical laboratories should reflect processes as they are carried out, while making the PRA results obtained from different processes comparable. This means that not only STAT and standard testing and testing for critical and less critical parameters should be distinguished (as published), but also that the throughput in processes and process steps should be taken into account.

Methods:

Building on our previously published PRA, a method was developed to compensate for the throughput in processes and process steps. A factor T, related to the actually observed throughput, was introduced in the risk score calculation. Introduction of this compensation factor leads to different overall risk scores. The criteria by which the risk scores are evaluated were modified accordingly.

Results:

Introduction of a factor in the PRA to compensate for throughput leads to a change in the risk score for various conceivable failures in process steps. As compared to the PRA in which no compensation for throughput is made, in a process with low throughput the risk score for various conceivable failures in process steps comes out higher after introduction of the compensation factor, while in a process with high throughput various risk scores come out lower.

Conclusions:

Introduction of a factor to account for the throughput in a process (and process steps) leads to an improved, more realistic PRA, the results of which makes the risk scores of different processes (and process steps) better comparable to each other.

Keywords: analytic error; clinical laboratory; failure mode and effect analysis (FMEA); postanalytic error; preanalytic error; prospective risk analysis; risk assessment; throughput; turnover

Corresponding author: Pim M.W. Janssens, PhD, Laboratory of Clinical Chemistry and Haematology/Semen Bank, Rijnstate Hospital, PO Box 9555, 6800 TA Arnhem, The Netherlands

Author contributions: PMWJ conceived the plan and wrote the manuscript; AvdH conceived the plan and worked it out, with existent data. Both authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Guarantor: PMWJ.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
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: 2018-01-31

Accepted: 2018-03-28

Published Online: 2018-05-05

Published in Print: 2018-10-25

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Articles in the same Issue

https://doi.org/10.1515/cclm-2018-0109

Keywords for this article

analytic error; clinical laboratory; failure mode and effect analysis (FMEA); postanalytic error; preanalytic error; prospective risk analysis; risk assessment; throughput; turnover