Need for Quality Testing and Control

Quality Assurance (QA) is a systematic process used to determine the quality standards of TB laboratories.

Poor quality diagnosis may results in failure to diagnose TB or unnecessary treatment of non-TB case. Thus an effective QA mechanism is important for reliability of laboratory diagnosis.

QA in National Tuberculosis Elimination Programme (NTEP) consists of:

• Internal Quality Control (QC)
• External Quality Assessment (EQA)
• Continuous Quality Improvement (QI)

QC or Internal Quality Assurance is a systematic internal monitoring of working practices, technical procedures, checking equipment, new lot of reagents, smear preparation, grading etc

EQA is a process to assess laboratory performance by comparing laboratory results with a laboratory in higher tier i.e.Intermediate Reference Laboratory (IRL)/ National Reference Laboratory (NRL) through on-site evaluation, panel testing and random blinded rechecking of slides. Figure 1 depicts an eg of on-site evaluation with roles of various stakeholders and frequency of this activity. 

Figure 1: On-site evaluation (RNTCP Laboratory Network Guidelines)

QI is continuous monitoring of laboratory performance, finding non compliance and taking remedial measures to prevent recurrence of problems

Resources

• RNTCP Laboratory Network Guidelines.

Assessment