1. Introduction2. Lab network3. Role of different level lab in Quality Assurance QA in RNTCP 12/30/2011 2
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). QA in RNTCP 12/30/2011 3
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 slidesQuality Improvement: › It involves continued monitoring, identifying defects, followed by remedial actions including retraining when needed, to prevent recurrence of problems. QA in RNTCP 12/30/2011 4
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 QA in RNTCP 12/30/2011 5
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). QA in RNTCP 12/30/2011 6
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). QA in RNTCP 12/30/2011 7
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 QA in RNTCP 12/30/2011 8
NRL By NRL team- at least once a year IRL By IRL team- at least once a year DistrictBy DTO at least once in every month By IRL team during annual district visit TU By DTO and MO - TU at least once aBy STLS at least once in every month quarter DMC QA in RNTCP 12/30/2011 9
› 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 QA in RNTCP 12/30/2011 10
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. QA in RNTCP 12/30/2011 11
NRLUnder 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 QA in RNTCP 12/30/2011 12
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. QA in RNTCP 12/30/2011 13
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. QA in RNTCP 12/30/2011 14
Classification of errors: Result of controller Result of technician Negative 1-9 1+ 2+ 3+ AFB/100 fields Negative Correct LFN HFN HFN HFN1-9 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 QA in RNTCP 12/30/2011 15
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 randomlysampled slides collected from DMCs TU Monthly random collection ofroutine slides from the DMCs. Slides transported to district DMC QA in RNTCP 12/30/2011 16
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. QA in RNTCP 12/30/2011 17
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) QA in RNTCP 12/30/2011 18
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.
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.
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.