Евалуација шест сигма коришћењем пристрасности израчунате из података интерне контроле квалитета и екстерног обезбеђења квалитета

Six Sigma Evaluation of 17 Biochemistry Parameters

  • Tülay Çevlik medical doctor
  • Goncagül Haklar medical doctor

Sažetak


Background

Six Sigma is a popular quality management system that enables continuous monitoring and improvement of analytical performance in the clinical laboratory. We aimed to calculate sigma metrics and quality goal index (QGI) for 17 biochemical analytes and compare the use of bias from internal quality control (IQC) and external quality assurance (EQA) data in the calculation of sigma metrics.

Methods

This retrospective study was conducted in Marmara University Pendik E&R Hospital Biochemistry Laboratory. Sigma metrics calculation was performed as (TEa−bias)/CV). CV was calculated from IQC data from June 2018- February 2019. EQA bias was calculated as the mean of % deviation from the peer group means in the last seven surveys, and IQC bias was calculated as [(laboratory control result mean–manufacturer control mean)/manufacturer control mean)x100]. In parameters where sigma metrics were <5; QGI=(bias/1.5CV) score of <0.8 indicated imprecision, >1.2 pointed inaccuracy, and 0.8-1.2 showed both imprecision and inaccuracy.

Results

Creatine kinase (both levels), iron and magnesium (pathologic levels) showed an ideal performance with ≥6 sigma level for both bias determinations. Eight of the 17 parameters had different sigma levels when we compared sigma values calculated from EQA and IQC derived bias% while rest of the parameters were grouped at same levels.

Conclusion

 

Sigma metrics is a good quality tool to assess a laboratory's analytical performance and facilitate the comparison of the assay performances in the same manner across multiple systems. However, we might need to design a tight internal quality control protocol for analytes showing poor assay performance.

Biografije autora

Tülay Çevlik, medical doctor

 Biochemistry Laboratory, Marmara University Pendik E&R Hospital, Istanbul, Turkey, 34899                                                                                                                                

Goncagül Haklar, medical doctor

1.Institutional affiliation: Biochemistry Laboratory, Marmara University Pendik E&R Hospital, Istanbul, Turkey, 34899                                                                                                                               

 

2.Dept. of Biochemistry, School of Medicine, Marmara University, Istanbul, Turkey, 34899                                                                                                                               

Objavljeno
2023/06/25
Rubrika
Original paper