Risk analysis and assessment based on Sigma metrics and intended use

Biochemia Medica
Yong XiaLing Ji

Abstract

In order to ensure the quality in clinical laboratories and meet the low risk requirements of patients and clinicians, a risk analysis and assessment model based on Sigma metrics and intended use was constructed, based on which differential sigma performance (σ) expectations of 42 analytes were developed. Failure mode and effects analysis was applied to produce an analytic risk rating based on three factors, each test of which was graded as follows: 1) Sigma metrics; 2) the severity of harm; 3) intended use. By multiplying the score of Sigma metrics by the score of severity of harm by the score of intended use, each was assigned a typical risk priority number (RPN), with RPN ≤ 25 rated as low risk. Low risk was defined as acceptable standards; the sigma performance expectations were calculated. Among the 42 analytes, tests with σ ≥ 6, 5 ≤ σ < 6, 4 ≤ σ < 5, 3 ≤ σ < 4, σ < 3 were 21, 5, 5, 6, and 5, respectively; there were 7 high-risk tests, 8 of them medium risk tests. According to the risk assessment conclusion, 13 tests had sigma performance expectations ≥ 6; 15 test items had sigma performance expectations ≥ 5, while 3 test items had sigma performance expectations ≥ 4; 11 test items had sigma performance expectations ≥ 3. Co...Continue Reading

References

Mar 24, 2009·Clinica Chimica Acta; International Journal of Clinical Chemistry·Maurice O'Kane
Jan 18, 2011·Clinical Chemistry and Laboratory Medicine : CCLM·Bedrich FriedeckyMarek Budina
Oct 5, 2011·Journal of Health Services Research & Policy·Nada SheblAnam Parand
Dec 7, 2011·Biochemia Medica·Lidija Bilić-Zulle
Mar 27, 2012·BMJ Quality & Safety·Bryony Dean FranklinNick Barber
Jan 22, 2013·Clinics in Laboratory Medicine·James O Westgard
Jan 22, 2013·Clinics in Laboratory Medicine·Sten Westgard
Jan 16, 2014·Indian Journal of Clinical Biochemistry : IJCB·Rachna Agarwal
Mar 13, 2014·Clinical Chemistry and Laboratory Medicine : CCLM·Koen HensSten Westgard
May 23, 2015·Clinical Chemistry and Laboratory Medicine : CCLM·Andrea Rita HorvathUNKNOWN Test Evaluation Working Group of the European Federation of Clinical Chemistry and Laboratory Medicine
Jul 8, 2015·Annals of Clinical Biochemistry·James O Westgard, Sten A Westgard
Feb 6, 2017·Clinics in Laboratory Medicine·James O Westgard, Sten A Westgard
Nov 4, 2017·Clinical Chemistry·James O WestgardSten A Westgard

❮ Previous
Next ❯

Citations

Mar 9, 2020·Clinical Chemistry and Laboratory Medicine : CCLM·Yong XiaLing Ji
Jun 2, 2020·Scandinavian Journal of Clinical and Laboratory Investigation·Claudio IlardoJoel Barthes
Jul 20, 2018·Biochemia Medica·Sten WestgardJames O Westgard
Dec 15, 2020·Journal of Clinical Laboratory Analysis·Yong XiaLing Ji

❮ Previous
Next ❯

Methods Mentioned

BETA
electrophoresis

Software Mentioned

Excel

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.