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External Quality Assurance for C&DST laboratories

External Quality Assurance (EQA) is a critical component of laboratory testing, as it ensures the accuracy and consistency of laboratory test processes throughout the examination of the specimen – from the point of collection to result reporting and database entry. The EQA of the C&DST laboratory under NTEP is through structured On-Site Evaluation (OSE), panel testing and retesting exercise.

On-Site Evaluation

A field visit is an ideal way to obtain a realistic assessment of the conditions and skills practised in the laboratory. On-site evaluation of C&DST Laboratory is therefore an essential component of a meaningful Quality Assurance (QA) programme. The visit includes a comprehensive assessment of laboratory safety, including infection control measures, conditions of equipment, adequacy of supplies, as well as the technical components of culture and DST. All the C&DST laboratories are visited at least once a year by their respective NRLs for this activity. A standard comprehensive checklist for on-site evaluation of the C&DST laboratory is available. Any significant problems identified are documented in the final report.

Panel testing: 

The National reference laboratory (NRL) sends a panel of 20 strains to the C&DST laboratory every year. This panel consists of known pan-sensitive, mono-resistant, Multi-drug resistant (MDR) and poly-resistant strains and some isolates in duplicate to check for reproducibility. The C&DST laboratories sub-culture these 20 strains and then set up Drug Susceptibility Testing (DST). The results of DST are then communicated back to the NRL. The NRL checks for concordance between the results of the C&DST laboratory and their own results. The acceptable concordance level as per the NTEP guideline, is >90%. 

Retesting:

10 randomly selected recent cultures with known sensitivity patterns from a C&DST laboratory are retested at the NRL. The results are then checked for concordance. This is generally a one-time activity conducted at the time of accreditation of the C&DST laboratory. 

 

Resources

  1. Mycobacteriology Laboratory Manual

  2. Revised National TB Control Programme Training Manual for Mycobacterium tuberculosis Culture & Drug susceptibility testing. Central TB Division, Ministry of Health and Family Welfare, GOI

Assessment

Question​

Answer 1​

Answer 2​

Answer 3

Answer 4

Correct answer​

Correct explanation​

Page id​

Part of Pre-test​

Part of Post-test​

For Retesting, 20 randomly selected recent cultures with known sensitivity patterns from a C&DST laboratory are retested at the NRL.

True

False

 

 

2

10 randomly selected recent cultures with known sensitivity patterns from a C&DST laboratory are retested at the NRL.

 

YES

YES

Why is EQA a critical component of laboratory testing?   Helps build the necessary skills for  laboratory test processes Ensures the accuracy and consistency of laboratory test processes Collects and reports accurate results Improves the speed of laboratory test processes 2 External Quality Assurance (EQA) is a critical component of laboratory testing, as it ensures the accuracy and consistency of laboratory test processes throughout the examination of the specimen – from the point of collection to result reporting and database entry.    YES YES

 

 

 

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