Introduction and Aim: Accreditation of medical laboratories by National Accreditation Board for Testing and Calibration Laboratories (NABL) ISO 15189 is needed to improve quality and safety in healthcare. It is a rigorous third-party external evaluation process that encompasses assessment against a given set of standards. The aim is to narrate the process of accreditation of a diagnostic laboratory affiliated to a newly established teaching medical institute and elaborate various facets which were worked upon from initialization till the culmination of the assessment.
 
Methods: Bulk of data is the author’s first-hand experience as all worked hands-on in getting the NABL accreditation from July 2022 to January 2023. For standards and technical information guidelines of NABL & ISO 15189:2012 was referred. Input from peers working in accredited labs was taken. Entire process of preparation and applying for accreditation aspects was compiled and presented.
 
Results: With interdepartmental coordination and changes in workflow process complemented by document control procedures culminated in the laboratory successfully getting accredited.
 
Conclusion: The entire process of getting accreditation was challenging but nevertheless gratifying. For medical laboratories affiliated to teaching institutes accreditation needs extra time and effort but is nonetheless achievable.

Chronicle of getting the diagnostic laboratory NABL accredited in a teaching medical institute: An overview of our experience

INTRODUCTION
Clinical laboratories serve a critical role in increasing the efficiency of patient care. Choosing the right test, getting trustworthy results and appropriate interpretation are of utmost importance in improving the patient's well-being. Quality management strategies should be applied in routine patient care because laboratory errors have a major impact on the quality of patient care. In sigma metrics, errors identified are quantified as percentage errors or defects per million (DPM). It aims at improving the quality control (QC) process by forming an appropriate strategy.


AIM AND OBJECTIVES
To analyze the internal quality control (IQC) of hematology analytes using the sigma metrics method and to devise the frequency of IQC by the results of six sigma metric analysis.


MATERIALS AND METHODS
This study was conducted in a tertiary care center of western India. Internal quality control (IQC) data sets of five analytes- Red Blood Cell count (RBC), Hemoglobin (Hb), Hematocrit (Hct), White blood cell count (WBC), and Platelet count (PLT) were analyzed retrospectively of six months using Beckman Coulter DXH 800 hematology analyzers.


RESULTS
The observed sigma value was >6 for Hb, TLC, and PLT, indicating excellent results and requiring no modification in IQC. The Sigma value was between 3 and 4 for RBC and Hct suggested the need for improvement in quality control (QC) processes. No analytes showed a Sigma value of <3.


CONCLUSION
Sigma metrics provide a quantitative framework that helps to assess analytic methodologies and can serve as an important self-assessment tool for quality assurance in the clinical laboratory.

Analysis of hematology quality control using six sigma metrics.

Introduction and Aim: Sigma represents Standard Deviation (SD) which indicates the degree of variation in a process, where the higher sigma value implies that less likely the laboratory reports false test results. Using a newer parameter called Quality Goal Index (QGI) we can find the reason behind the lower sigma value. Our study aimed to compare the six-sigma metric and QGI ratio 3 months prior to first lockdown due to COVID-19 pandemic and 3 months during the first lockdown.
 
Methodology: A retrospective study was used to compare the six-sigma metric and QGI ratio 3 months prior to first lockdown due to COVID-19 pandemic and 3 months during the first lockdown for the selected ten analytes from 1st of January 2020 to 30th of June 2020 from the clinical biochemistry section of Yenepoya Medical College Hospital, Deralakatte, Mangalore.
 
Results: The sigma metrics from January to March (level 1) indicated that urea, TSH, beta-HCG fell short of meeting Six Sigma quality performance and from April to June, glucose, creatinine, urea and ALT had metrics less than 3 at both the Internal Quality Control levels. QGI ratio indicated that from January to March, the problem was imprecision for urea, TSH and beta-HCG (QGI < 0.8). From April to June, urea and creatinine showed imprecision, glucose and ALT showed inaccuracy, urea and ALT showed both imprecision and inaccuracy.
 
Conclusion: This study highlights the necessity for stringent Internal Quality Control and External Quality Assurance monitoring even during the lockdown period of the pandemic. By implementing six sigma and finding QGI ratio, quality of laboratory services can be improved immensely.

A comparative evaluation of six sigma metrics and quality goal index ratio 3 months prior to first lockdown due to COVID-19 pandemic and 3 months during lockdown in a NABL accredited central laboratory

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A comparative evaluation of six sigma metrics and quality goal index ratio 3 months prior to first lockdown due to COVID-19 pandemic and 3 months during lockdown in a NABL accredited central laboratory