Quality assurance studies in eight State tuberculosis laboratories in India

Int J Tuberc Lung Dis. 2003 Jun;7(6):522-7.

Abstract

Setting: Tuberculosis Research Centre, Chennai, India.

Objective: To undertake quality assurance studies in sputum smear microscopy at eight State-level laboratories in India using a panel of stained smears.

Design: Coded panels of stained smears (100 slides in rounds I-IV and 50 slides in Round V), comprising different grades of positivity, were sent to each centre at 6-monthly intervals. The results obtained were analysed for consistency of positive and negative results and overall agreement, as well as discordance.

Results: Consistency of positives ranged from 38% to 100%, indicating under-reading at some sites. The negative consistency was better, however, with only five of the total of 95 readers in all rounds yielding a consistency of less than 100%. Considering overall agreement, seven of the eight centres showed an agreement of over 90%. Four of the eight centres gave no false-positive result. For the remaining centres the false positivity rate varied from 2% to 7%. A wide variation was also observed in the proportion of false-negatives (3%-52%).

Conclusions: This study helped in the evaluation of the performance of individual laboratories and in identifying the drawbacks of this system of proficiency testing.

Publication types

  • Evaluation Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Competence
  • Clinical Laboratory Techniques*
  • Diagnostic Errors
  • Government Programs*
  • Humans
  • India
  • Microscopy*
  • Mycobacterium tuberculosis / isolation & purification
  • Program Evaluation
  • Quality Assurance, Health Care*
  • Reproducibility of Results
  • Sputum / cytology
  • Sputum / microbiology
  • Systems Analysis
  • Tuberculosis, Pulmonary / microbiology*
  • Tuberculosis, Pulmonary / pathology*