ABSTRACT
Introduction : Quality control of the laboratory has gained increased importance in the present years. 70 % of the errors in the clinical laboratory occur in the pre-analytical phase. With various guidelines to gauge the quality of the laboratory, Six Sigma Metrics remains by far the most difficult benchmark that a laboratory can achieve. We aimed to quantify the performance of the quality indicators of the routine clinical Biochemistry laboratory in the pre-analytical phase in the form of sigma metrics and devise measures and identify steps to decrease the percentage of errors by defining the DMAIC approach. Materials and Methods : One year retrospective data was collected from January, 2020 to December, 2020 from the data entry register and pre-analytical variables were quantified. Defects Per Million and sigma metric were calculated for each pre-analytical indicator. DMAIC approach was applied and post intervention sigma scores for the month of Jananuary, 2021, February, 2021 and March, 2021 were calculated. Results : Postinterventional analysis was done on a month-to-month basis to monitor the trend and also to ensure corrective action can be taken without delay. Out of 5 quality indicators which were quantified, the pre versus post sigma scores (March’21) are as follows: missing location of the patient (Sigma 4 versus 3.6), missing registration number (Sigma 3.7 versus 4.3) and both registration number and location missing (Sigma 3.6 versus 4.0), Homolysed sample (4.2 versus 4.6), insufficient sample volume (sigma 3.9 versus 4.7). Encouraging results in the form of improved Sigma scores were seen in four of the quality indicators except for the fact that the patient location were still missing in the forms and hence warrants continuous monitoring.