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Licensed Unlicensed Requires Authentication Published by De Gruyter October 17, 2017

Validation of the Six Sigma Z-score for the quality assessment of clinical laboratory timeliness

  • Cristiano Ialongo EMAIL logo and Sergio Bernardini

Abstract

Background:

The International Federation of Clinical Chemistry and Laboratory Medicine has introduced in recent times the turnaround time (TAT) as mandatory quality indicator for the postanalytical phase. Classic TAT indicators, namely, average, median, 90th percentile and proportion of acceptable test (PAT), are in use since almost 40 years and to date represent the mainstay for gauging the laboratory timeliness. In this study, we investigated the performance of the Six Sigma Z-score, which was previously introduced as a device for the quantitative assessment of timeliness.

Methods:

A numerical simulation was obtained modeling the actual TAT data set using the log-logistic probability density function. Five thousand replicates for each size of the artificial TAT random sample (n=20, 50, 250 and 1000) were generated, and different laboratory conditions were simulated manipulating the PDF in order to generate more or less variable data. The Z-score and the classic TAT indicators were assessed for precision (%CV), robustness toward right-tailing (precision at different sample variability), sensitivity and specificity.

Results:

Z-score showed sensitivity and specificity comparable to PAT (≈80% with n≥250), but superior precision that ranged within 20% by moderately small sized samples (n≥50); furthermore, Z-score was less affected by the value of the cutoff used for setting the acceptable TAT, as well as by the sample variability that reflected into the magnitude of right-tailing.

Conclusions:

The Z-score was a valid indicator of laboratory timeliness and a suitable device to improve as well as to maintain the achieved quality level.


Corresponding author: Dr. Med. Cristiano Ialongo, PhD, Department of Physiology and Pharmacology, Sapienza University of Rome, Piazzale Aldo Moro 5, 00185 Rome (RM), Italy, Phone: +3906-4991-2987

  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.

Appendix

If x is the continuous random variable representing the TAT:

(1)f(x)=(β/α)[(xγ)/α]β1[1+[(xγ)/α]β]2,α>0,x>c;β1

Eq. (1) is the generalized log-logistic PDF with scale α, shape β, and threshold γ.

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Supplemental Material:

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2017-0642).


Received: 2017-7-21
Accepted: 2017-9-13
Published Online: 2017-10-17
Published in Print: 2018-3-28

©2018 Walter de Gruyter GmbH, Berlin/Boston

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