Risk assessment of the total testing process based on quality indicators with the Sigma metrics.

Clinical Chemistry and Laboratory Medicine : CCLM
Yong XiaLing Ji

Abstract

Background Evidence-based evaluation of laboratory performances including pre-analytical, analytical and post-analytical stages of the total testing process (TTP) is crucial to ensure patients receiving safe, efficient and effective care. To conduct risk assessment, quality management tools such as Failure Mode and Effect Analysis (FMEA) and the Failure Reporting and Corrective Action System (FRACAS) were constantly used for proactive or reactive analysis, respectively. However, FMEA and FRACAS faced big challenges in determining the scoring scales and failure prioritization in the assessment of real-world cases. Here, we developed a novel strategy, by incorporating Sigma metrics into risk assessment based on quality indicators (QIs) data, to provide a more objective assessment of risks in TTP. Methods QI data was collected for 1 year and FRACAS was applied to produce the risk rating based on three variables: (1) Sigma metrics for the frequency of defects; (2) possible consequence; (3) detection method. The risk priority number (RPN) of each QI was calculated by a 5-point scale score, where a value of RPN > 50 was rated as high-risk. Results The RPNs of two QIs in post-analytical phase (TAT of Stat biochemistry analyte and Time...Continue Reading

References

May 26, 2007·Clinical Chemistry·Paolo Carraro, Mario Plebani
Jun 21, 2007·Clinical Chemistry and Laboratory Medicine : CCLM·Michael Laposata, Anand Dighe
Mar 21, 2009·Clinica Chimica Acta; International Journal of Clinical Chemistry·Maria Laura Chiozza, Clemente Ponzetti
Jul 31, 2009·Journal of Pharmaceutical and Biomedical Analysis·J F van LeeuwenD M Barends
Jun 15, 2011·Clinical Chemistry and Laboratory Medicine : CCLM·Mario Plebani, Giuseppe Lippi
Dec 14, 2011·Clinical Chemistry and Laboratory Medicine : CCLM·Laura SciacovelliMario Plebani
Dec 12, 2012·Clinical Biochemistry·Mario PlebaniMaria Laura Chiozza
Aug 30, 2014·Archives of Pathology & Laboratory Medicine·Peter J HowanitzDonald S Karcher
Aug 30, 2014·Archives of Pathology & Laboratory Medicine·Raouf E NakhlehPeter J Howanitz
Jul 15, 2015·BMJ Quality & Safety·Lisa M McElroyJane L Holl
Dec 15, 2015·Clinical Chemistry and Laboratory Medicine : CCLM·Laura SciacovelliMario Plebani
Jan 12, 2016·Clinical Chemistry and Laboratory Medicine : CCLM·Yang FeiWenxiang Chen
Sep 1, 2016·Clinical Chemistry and Laboratory Medicine : CCLM·Zlata Flegar-MeštrićAna Devčić-Jeras
Feb 6, 2017·Clinics in Laboratory Medicine·Mario PlebaniAda Aita
Feb 9, 2017·Clinical Biochemistry·Mario Plebani, UNKNOWN EFLM Task Force on Performance Specifications for the extra-analytical phases
Aug 5, 2017·Clinical Chemistry and Laboratory Medicine : CCLM·Tony BadrickKen Sikaris
Jul 18, 2018·Clinical Chemistry and Laboratory Medicine : CCLM·Min DuanZongjiu Zhang
Jul 20, 2018·Biochemia Medica·Sten WestgardJames O Westgard
Jul 20, 2018·Biochemia Medica·Yong XiaLing Ji
May 6, 2019·Clinical Chemistry and Laboratory Medicine : CCLM·Canan Karadağ, Nafi Nevrez Demirel

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Clinical Chemistry and Laboratory Medicine : CCLM
Zlata Flegar-MeštrićAna Devčić-Jeras
Clinical Chemistry and Laboratory Medicine : CCLM
Laura SciacovelliMario Plebani
IEEE Computer Graphics and Applications
Gary Singh
© 2021 Meta ULC. All rights reserved