Assessment of quality control system by sigma metrics and quality goal index ratio: A roadmap towards preparation for NABL.

Abstract

Aim: To study sigma metrics and quality goal index ratio (QGI).

Methods: The retrospective study was conducted at the Clinical Biochemistry Laboratory, PGIMS, Rohtak, which recently became a National Accreditation Board for Testing and Calibration of Laboratories accredited lab as per the International Organization for Standardization 15189:2012 and provides service to a > 1700-bed tertiary care hospital. Data of 16 analytes was extracted over a period of one year from January 2017 to December 2017 for calculation of precision, accuracy, sigma metrics, total error, and QGI.

Results: The average coefficient of variation ranged from 2.12% (albumin) to 5.42% (creatinine) for level 2 internal quality control and 2% (albumin) to 3.62% (high density lipoprotein-cholesterol) for level 3 internal quality control. Average coefficient of variation of all the parameters was below 5%, reflecting very good precision. The sigma metrics for level 2 indicated that 11 (68.5%) of the 16 parameters fall short of meeting Six Sigma quality performance. Of these, five failed to meet minimum sigma quality performance with metrics less than 3, and another six just met minimal acceptable performance with sigma metrics between 3 and 6. For level 3, the data collected indicated eight (50%) of the parameters did not achieve Six Sigma quality performance, out of which three had metrics less than 3, and five had metrics between 3 and 6. QGI ratio indicated that the main problem was inaccuracy in the case of total cholesterol, aspartate transaminase, and alanine transaminase (QGI > 1.2), imprecision in the case of urea (QGI < 0.8), and both imprecision and inaccuracy for glucose.

Conclusion: On the basis of sigma metrics and QGI, it may be concluded that the Clinical Biochemistry Laboratory, PGIMS, Rohtak was able to achieve satisfactory results with world class performance for many analytes one year preceding the accreditation by the National Accreditation Board for Testing and Calibration of Laboratories. Aspartate transaminase and alanine transaminase required strict external quality assurance scheme monitoring and modification in quality control procedure as their QGI ratio showed inaccuracy.