Steady state errors and risk of a QC strategy.
Assay capability
Assay stability
Error budget
FMEA
Frequency of QC challenge
Steady state error
Journal
Clinical biochemistry
ISSN: 1873-2933
Titre abrégé: Clin Biochem
Pays: United States
ID NLM: 0133660
Informations de publication
Date de publication:
Feb 2019
Feb 2019
Historique:
received:
16
10
2018
revised:
08
12
2018
accepted:
11
12
2018
pubmed:
16
12
2018
medline:
16
3
2019
entrez:
16
12
2018
Statut:
ppublish
Résumé
To minimise the risk of patient harm from results, laboratories should establish QC strategies and monitor the performance of assays in line with the analytical and clinical risk. Steady state errors were calculated from a distribution normalized for an Analytical Performance Specification expressed as Assay Capability (imprecision) minus Assay Stability (drift). Inverting this error rate gave QC run length containing one error. Multiplying by error detection of a critical shift gave a QC functional run length for stable and unstable situations. Suitability of this technique was examined using laboratory EQA imprecision and drift data against various analytical and clinical performance specifications. Steady state errors and error detection, and hence QC functional run length, were dramatically affected by worsening imprecision, drift or changing performance specifications. For a single analyser type, laboratory steady state errors against RCPAQAP performance specification ranged over five orders of magnitude, with contributions from Assay Capability and Assay Stability varying by laboratory. Steady state errors accumulate for all assays. Our functional QC run length based on steady state error rate adjusted for error detection of the QC algorithm, amounts to a risk approach using the first two elements of FMEA-like calculation and allows laboratories to examine the suitability of their combinations of QC run length, algorithm, workload and timing of QC challenges. An appropriate common performance specification is critical when assessing and comparing risk.
Sections du résumé
BACKGROUND
BACKGROUND
To minimise the risk of patient harm from results, laboratories should establish QC strategies and monitor the performance of assays in line with the analytical and clinical risk.
METHODS
METHODS
Steady state errors were calculated from a distribution normalized for an Analytical Performance Specification expressed as Assay Capability (imprecision) minus Assay Stability (drift). Inverting this error rate gave QC run length containing one error. Multiplying by error detection of a critical shift gave a QC functional run length for stable and unstable situations. Suitability of this technique was examined using laboratory EQA imprecision and drift data against various analytical and clinical performance specifications.
RESULTS
RESULTS
Steady state errors and error detection, and hence QC functional run length, were dramatically affected by worsening imprecision, drift or changing performance specifications. For a single analyser type, laboratory steady state errors against RCPAQAP performance specification ranged over five orders of magnitude, with contributions from Assay Capability and Assay Stability varying by laboratory.
CONCLUSIONS
CONCLUSIONS
Steady state errors accumulate for all assays. Our functional QC run length based on steady state error rate adjusted for error detection of the QC algorithm, amounts to a risk approach using the first two elements of FMEA-like calculation and allows laboratories to examine the suitability of their combinations of QC run length, algorithm, workload and timing of QC challenges. An appropriate common performance specification is critical when assessing and comparing risk.
Identifiants
pubmed: 30552866
pii: S0009-9120(18)31137-8
doi: 10.1016/j.clinbiochem.2018.12.005
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
37-43Informations de copyright
Copyright © 2018 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.