Impact of NABL on Quality Indicators of Pre-Analytical Phase of Testing in Tertiary Care Hospital

  • Margit Ghanshyambhai Gajjar GMERS Medical College Kharvad Ground, Sipor Road, Vadnagar, Mehsana, Gujarat- India
  • Dipti Rameshbhai Gajjar GMERS Medical College Kharvad Ground, Sipor Road, Vadnagar, Mehsana, Gujarat- India
Keywords: NABL, The International Federation of Clinical Chemistry (IFCC), Quality indicators, Defect per million, Six sigma


Introduction: The laboratory’s compliance to requirements of the standard and its technical competence are assessed by NABL for accreditation. QIs should be part of a coherent and integrated quality improvement strategy implemented according to the specifically developed International Standard for Medical Laboratories Accreditation (ISO 15189: 2012). Pre-analytical errors account for more than 70% of the total number of laboratory errors. The International Federation of Clinical Chemistry (IFCC) and Laboratory Medicine Working Group on Laboratory Errors and Patient Safety (WG-LEPS) has made an important contribution to developing QIs for the preanalytical phase and specifications for those indicators. We selected following QIs pertaining to the key activities of the pre-analytical phase. These were: Hemolyzed samples (in biochemistry; QI-10b); Samples with inadequate quantity (QI-12).   Material and Method: QI-10b and 12 were recorded from ‘Sample rejection register’ and ‘Sample transport register’. We calculated the sigma metric for these QIs. First, we calculated the Defect Per Million (DPM) then the DPM rate was converted to a sigma value.   Result After NABL accreditation improvement in six sigma values of QI-10b is 4.0-5.0, suggests ‘Good’ level of performance and for QI-12 shows between 3.0-4.0, no significant improvement.   Conclusion NABL accreditation does not make any statement about the technical competence of the laboratory. As continual improvement is necessary for the good laboratory practice, we continue to collect data regarding errors to monitor this critical phase of laboratory testing to ensure ongoing satisfactory performance.

Author Biographies

Margit Ghanshyambhai Gajjar, GMERS Medical College Kharvad Ground, Sipor Road, Vadnagar, Mehsana, Gujarat- India
Department of Biochemistry
Dipti Rameshbhai Gajjar, GMERS Medical College Kharvad Ground, Sipor Road, Vadnagar, Mehsana, Gujarat- India
Department of Biochemistry


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Original Article