1. The document describes the quality assurance system for sputum smear microscopy in India's Revised National Tuberculosis Control Programme (RNTCP). 2. It establishes a three level laboratory network of National Reference Laboratories, Intermediate Reference Laboratories at the state level, and Designated Microscopy Centers. 3. Quality assurance activities include internal quality control, external quality assessment including on-site evaluations, panel testing of lab staff, and random blinded rechecking of slides to evaluate performance at each level of the network.

2. 1. Introduction
2. Lab network
3. Role of different level lab in Quality Assurance
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3.  Role of sputum smear microscopy in RNTCP
 Poor quality diagnosis results in failure to detect
persons with infectious TB, who will continue to
spread infection in the community, or unnecessary
treatment of “non-TB cases.”
 An effective quality assurance (QA) system of
RNTCP sputum smear microscopy network is crucial
for reliability of data generated under RNTCP.
 QA is a total system consisting of internal quality
control (QC), external quality assessment (EQA),
and continuous quality improvement (QI).
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4. Quality Control:
› It includes all means by which lab personnel performing TB
smear microscopy control the process, including checking
of instrument, new lots of staining solutions, smear
preparation, grading, etc.
External Quality Assessment:
› A process to assess lab performance
› It includes on site evaluation of lab, panel testing and
random blinded rechecking of slides
Quality Improvement:
› It involves continued monitoring, identifying defects,
followed by remedial actions including retraining when
needed, to prevent recurrence of problems.
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5.  A nation wide network of RNTCP quality
assured designated sputum smear
microscopy laboratory has been set up.
 These laboratories carry out sputum
microscopy with External Quality Assessment.
 The laboratory network is organized
according to three levels under the RNTCP
namely:
› National level
› State level
› TB Unit level
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6.  The lab network for RNTCP in India consists of four
designated National referenced Laboratories
(NRLs):
› Tuberculosis Research Centre, Chennai;
› National Tuberculosis Institute, Bangalore;
› LRS Institute of tuberculosis and Allied science, New Delhi;
› JALMA Institute, Agra.
 RNTCP has 24 Intermediate Reference Laboratories
(IRLs) at the state level and more than 12,750
Designated Microscopic Centres (DMCs).
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7.  The State TB Training and Demonstration Centres
will be designated as IRLs, if they have a well
functioning lab.
 Otherwise, the state is to identify a Public Health
Lab or Medical College lab and designate that as
IRL after the lab is assessed by visit from the NRL.
 A DMC is established for approx. 1 Lac
population (50,000 in tribal and hilly areas).
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8.  The network for QA at each level is assessed under
three External Quality Assessment (EQA) activities
to evaluate lab performance.
› On site evaluation
› Panel Testing
› Random Blinded Rechecking
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9. NRL
By NRL team- at least once a year
IRL
By IRL team- at least once a year
District
By DTO at least once in every month
By IRL team during annual district
visit
TU
By DTO and MO - TU at least once a
By STLS at least once in every month
quarter
DMC
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10. › A NRL team headed by a Microbiologist and at least
one LT will visit the IRL for about 3 days
› IRL team will consist of IRL microbiologist, MO, Lab
supervisor or LT and the visit to DTC will be for
minimum of 2 days
› OSE includes comprehensive assessment of
 Lab safety
 Condition of binocular microscope
 Adequacy of supplies and technical component of
sputum smear microscopy including preparation,
staining and reading of smears
› On site evaluation also includes examining few
stained positive and negative smears to observe the
quality of smearing and condition of microscope
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11.  Checklists have been developed for collection
and analysis of data.
 Checklist includes following:
› General information
› Infrastructure
› Inquiry regarding stock and supply
› Condition of binocular microscope
› Training status
 When poor performance is identified through any
of the above-mentioned activities, additional visits
by trained laboratory personnel from the higher
level laboratory is mandatory.
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12. NRL
Under supervision of NRL team
during annual visit
IRL (Microbiologist and all LTs )
Under supervision of IRL team
during annual visit
District (All STLS)
No panel testing as routine
DMC
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13.  It is used to determine whether a LT can
adequately perform AFB smear microscopy.
 This method evaluates individual performance in
staining and reading.
 It is considered to be less effective than random
blinded re-checking of routine slides because it
does not monitor routine performance.
 A panel consists of a batch of unstained smears for
processing, reading, and reporting of results.
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14.  The test panel includes slides with different grades
in order to evaluate ability of LT to properly grade
positive slides.
 An approximate time of 25 to 35 minutes for 5 slides
is given.
 Standardized forms for recording and reporting
results are provided.
 Poor performance always results in investigation to
identify the reason.
 Investigation includes evaluating overall
performance by all participating labs to determine
if the problem was poor slide preparation at NRL.
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15. Classification of errors:
Result of controller
Result of
technician Negative 1-9 1+ 2+ 3+
AFB/100
fields
Negative Correct LFN HFN HFN HFN
1-9 AFB/100 LFP Correct Correct QE QE
fields
1+ HFP Correct Correct Correct QE
2+ HFP QE Correct Correct Correct
3+ HFP QE QE Correct Correct
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16. NRL
No random blinded cross
checking at IRL
IRL
Review of random blinded cross
checking by IRL team during
annual visit
District
Blinded cross checking at district
level by the STLS of randomly
sampled slides collected from DMCs
TU
Monthly random collection of
routine slides from the DMCs. Slides
transported to district
DMC
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17.  It is a process of rereading a sample of slides from a
laboratory to assess whether that laboratory has an
acceptable level of performance.
 Random blinded rechecking involves selection of a
small sample of slides, which is representative of all
slides of a DMC (both positive and negative).
 The results of the slides are blinded and read by a
STLS not belonging to the same TU to prevent bias.
 The discrepant results are resolved by reading of the
slides by another STLS (umpire reader).
 A timely feedback is provided every month to LTs and
MOs of DMCs for improvement in the quality of
microscopy.
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18. Recommended annual sample size:
No. of Slide positivity rate (SPR%)
negative
slides in the
DMC in a 2.5-4.9 5.0-7.49 7.5-9.9 10.0-14.9 >= 15
year
301-500 243 (21) 154 (13) 114 (10) 89 (8) 62 (6)
501-1000 318 (27) 180 (15) 128 (11) 96 (8) 66 (6)
>1000 456 (38) 216 (18) 144 (12) 104 (9) 69 (6)
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19. 1. The activities of NRL:
a. On-site evaluation of STDC/ IRL Labs
b. Manufacture of Panel testing slides and
panel testing of STDC/ IRL Lab staff
c. Training of STDC supervisory staff in:
i. On site evaluation of STLS
ii. Manufacture of panel slides
iii. Assessment of blinded re-checking of DMC
slides at DTC
iv. Facilitating the training of STLS for External
Quality Assessment (EQA)
d. Re-training of STDC/ IRL supervisory staff, if
required.
e. Prompt reporting the results of activities to
STO/ DDG TB.

20. 2. The activities of STDC/ IRL:
a. Training of STLS, DTO, MO-TC for EQA.
b. On-site evaluation of DTC Labs.
c. Manufacture of Panel testing slides and panel
testing of DTC Lab supervisors including all STLS
of the district.
d. Assessment of blinded re-checking of DMC
slides at DTC.
e. Re-training of DTC LT/ STLS, if required.
f. Prompt reporting the results of activities by
Director STDC/ IRL to STO, CTD & NRL.

21. 3. The activities of DTC/ TU:
a. On-site evaluation of DMC Labs
b. Unblinded re-checking of DMC slides at DMC
c. Blinded re-checking of DMC slides at DTC
d. Prompt reporting of the results of activities to LT
and MO of DMC as well as STDC/ IRL.

22. THANK YOU
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