Advancements in TB Diagnostics and Quality Assurance
T
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8
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Reduction in TB incidence rate
[as compared to 2015 levels]
9
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%
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Reduction in TB Mortality rate
[as compared to 2015 levels]
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NATIONAL REFERENCE
LABORATORY
•
Microscopy, NAAT,
LPA, Liquid
Culture, LCDST
•
Training, Quality Assurance of all
testing modalities
INTERMEDIATE REFERENCE
LABORATORY (STATE LEVEL)
C&DST LABORATORY
(IN MEDICAL COLLEGES & PRIVATE SECTOR)
Microscopy, NAAT,
LPA,
Liquid Culture, LCDST
DISTRICT & SUB-
DISTRICT LEVEL
•
Microscopy,
•
NAAT – CBNAAT &
Truenat
PERIPHERAL
LEVEL
6
34
61
3760 NAAT
22284- DMCs
LEVEL OF FACILITY IN THE HEALTH
SYSTEM
TESTING MODALITIES AVAILABLE
DMCs
NAAT
Microscopy
AB HWC – For Sample Collection and Transportation
EXPANSION OF DIAGNOSTICS UNDER NTEP
SM- Smear microscopy; CB- CBNAAT; Tru- Truenat; FL- FL LPA; SL-SL LPA; LC- Liquid
culture; LCDST- Liquid culture DST
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(
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)
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EQA is a specialized form of
assessment focused on assuring the
accuracy and reliability of examination
methods
EQA /Proficiency Testing is an effective
tool to promote continual improvement
which can identify
occurrences/nonconforming events and
offers an assessment of process output.
E
E
Q
Q
A
A
-
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By NRL team once in a year
By IRL team once in a year
•
By DTO once at least once in every month
•
By IRL team during annual visit
•
By STLS once at least once in every month
•
By DTO & MO TC team at least once a Qtr
•
By IRL team during annual visit
Under supervision of NRL team during
annual visit
Under supervision of IRL team during
annual visit
No Panel Testing as routine
No Blind checking at IRL
Review of Random blind checking records
and results by IRL team during annual visit
Blinded cross checking at the district level by
STLS of the randomly sampled slides monthly
collected from DMCs
Monthly random collection of routine slides
from DMCs. Slides transported to District
E
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Q
Q
A
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F
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O
O
R
R
N
N
A
A
A
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T
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Quality assured CBNAAT test results are essential to ensure patients are
correctly diagnosed early and initiated on an appropriate treatment
regimen.
CBNAAT EQA is conducted additionally (apart from internal quality checks
present inside the test kit) to assess the proficiency of the LT and also the
performance of the machine.
CBNAAT EQA has been extended to cover 750 Truenat sites in the first
phase.
H
o
w
?
3
W
h
y
?
1
W
h
a
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?
2
Both NAAT EQAs are coordinated by NTI, Bengaluru.
W
h
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?
4
EQA FOR CBNAAT USING
DRIED TUBE SPECIMEN (DTS)
PT panel kits
•
5 coded Dried Tube
Specimen (DTS) samples
•
well-characterized M.tb
complex and NTM
•
5 transfer pipettes
•
Instructions for testing
•
Result report form
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HR cadre (for state/ district level), educational qualifications and experience – guided by NTEP
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T
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Collection and transportation of
PTB and EPTB samples
PTE & follow up test (Hematology,
*cytology, biochemistry, and
microbiological tests available at
BPHL & IPHL) for PTB, EPTB.
Ensure Molecular Diagnostics at IPHL at
District level under PM ABHIM- NAAT
Procurement of TrueNat (Chip based Real
time micro-PCR) 15th Finance Commission
- Block level Public Health Units
Establishment of DMC, Procurement of
Microscopes, Lab Consumables for DMCs
under NHM/ 15th Finance Commission
under Support for diagnostic infrastructure
to the primary healthcare/UPHCs facilities
grant
N
N
T
T
E
E
P
P
S
S
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H
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A total of 87 tests encompassing hematology,
serology, biochemistry, clinical pathology,
microbiology, and any other test for improved public
health surveillance/clinical condition will be done at
BPHU
For diagnosis of TB, smear microscopy and NAAT will
be offered
P
P
L
L
A
A
T
T
F
F
O
O
R
R
M
M
T
T
E
E
C
C
H
H
N
N
O
O
L
L
O
O
G
G
Y
Y
Gene Xpert
Truenat
Roche/Cobas 6800
BD Max
ID NOW, Abbott
RT PCR system,
Applied biosystems
Perkin Elmer
Whole Genome
Sequencing
Additionally,
•
The process of QA of IPHL will be in accordance with QA programme
and with other specific requirements of the GoI (NQAS) in align with
Diagnostic algorithm used for diagnosis of TB
Key Actionable for the Programme Officers
Integration of services under one lab at district and block
level in terms of equipment
•
Establishment of microscopy lab at the district
hospital and SDH/CHC (if not already existing). This
could mean procurement of additional logistics for
the lab
•
Establishment of CBNAAT/TRUNAAT lab at the DH
and TrueNAT lab at the SDH/CHC. This could mean
the procurement of additional NAAT machines.
Integration of services under one lab at district and
block level in terms of infrastructure
•
Find a spot in the DH/SDH/CHC premises to set
up or integrate the NTEP lab services
•
Provide linkages for timely collection of samples
and transportation to the labs from
OPD/IPD/spokes
Integration of services under one lab at district and block level in terms of Human Resources
•
Utilization of already existing lab HR to ensure continued services under NTEP
•
Capacity building of the HR on diagnostic techniques, Ni-Kshay, sample packaging etc
•
Involvement of HR especially Medical Officers in -monitoring and regular reviews.
•
Storage and dispensation of Anti TB drugs and drugs for TB preventive therapy from DH/SDH/CHC pharmacist
Integration of laboratory services under IPHL will increase the preparedness for future epidemics, and also facilitate the
achievement of our end TB strategy
Thank You
The integration of lab services under NTEP with IPHL aims to improve TB diagnosis and treatment. The National TB Elimination Mission 2025 focuses on reducing TB incidence and mortality rates while preventing catastrophic expenditure. Diagnostic algorithms, existing lab networks, and testing facilities are being enhanced to achieve these goals. The expansion of diagnostics under NTEP includes scaling up lab networks and tests. External Quality Assurance plays a vital role in ensuring the accuracy and reliability of TB examination methods.
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Presentation Transcript
INTEGRATION OF LAB SERVICES INTEGRATION OF LAB SERVICES UNDER NTEP WITH IPHL UNDER NTEP WITH IPHL
TB ELIMINATION THE VISION National TB Elimination Mission 2025 has taken up key priorities along with reduction in incidence rate 80% TB INCIDENCE RATE Reduction in TB incidence rate [as compared to 2015 levels] 90% TB MORTALITY RATE Reduction in TB Mortality rate [as compared to 2015 levels] INR 0 CATASTROPHIC EXPENDITURE Due to TB
EXISTING NETWORK OF LABORATORIES UNDER NTEP
LEVEL OF FACILITY IN THE HEALTH SYSTEM TESTING MODALITIES AVAILABLE NATIONAL REFERENCE LABORATORY Microscopy, NAAT, LPA, Liquid Culture, LCDST Training, Quality Assurance of all testing modalities 6 INTERMEDIATE REFERENCE LABORATORY (STATE LEVEL) Microscopy, NAAT, LPA, Liquid Culture, LCDST C&DST LABORATORY (IN MEDICAL COLLEGES & PRIVATE SECTOR) Microscopy, NAAT CBNAAT & Truenat DISTRICT & SUB- DISTRICT LEVEL PERIPHERAL Microscopy LEVEL AB HWC For Sample Collection and Transportation
EXPANSION OF DIAGNOSTICS UNDER NTEP Network of laboratories 25000 Scale up of diagnostic tests (in lakhs) 140 20000 2017 2018 2019 2020 2021 120 2017 2018 2019 2020 2021 100 15000 80 10000 60 40 5000 20 0 0 LC DST 0.26 CBNAA T 651 1180 1180 1268 1303 SM CB Tru FL SL LC DMC NAAT Truenat LPA LC DST 2017 2018 16000 2019 20356 2020 21717 2021 22284 0 651 1180 1547 3147 3760 0 0 56 62 64 64 70 45 48 51 81 81 2017 103.9 10.77 2018 121.6 24.07 2019 111.8 35.3 2020 75.63 28.58 12.59 2.5 2021 88.9 14.34 21.97 3.2 0 0 2 0.93 2 3.5 0 1.5 0.59 2.45 0.18 0.72 3.53 0.19 0.58 2.85 0.11 0.58 3 367 1879 2457 0.14 SM- Smear microscopy; CB- CBNAAT; Tru- Truenat; FL- FL LPA; SL-SL LPA; LC- Liquid culture; LCDST- Liquid culture DST
EXTERNAL QUALITY ASSURANCE (EQA) EQA EQA is a specialized form of assessment focused on assuring the accuracy and reliability of examination methods EQA /Proficiency Testing is an effective tool to promote continual improvement which can occurrences/nonconforming events and offers an assessment of process output. identify
EQA- SMEAR MICROSCOPY Random Blinded Crosschecking Onsite Supervision Panel Testing NRL NRL NRL No Blind checking at IRL By NRL team once in a year Under supervision of NRL team during annual visit IRL IRL IRL (Microbiologist & LTs of IRL) Review of Random blind checking records and results by IRL team during annual visit By IRL team once in a year District District Under supervision of IRL team during annual visit Blinded cross checking at the district level by STLS of the randomly sampled slides monthly collected from DMCs By DTO once at least once in every month By IRL team during annual visit District (All STLS) Tuberculosis unit Tuberculosis Unit No Panel Testing as routine By STLS once at least once in every month By DTO & MO TC team at least once a Qtr By IRL team during annual visit Monthly random collection of routine slides from DMCs. Slides transported to District DMC DMC DMC
EQA FOR NAAT Quality assured CBNAAT test results are essential to ensure patients are correctly diagnosed early and initiated on an appropriate treatment regimen. 1 Why? CBNAAT EQA is conducted additionally (apart from internal quality checks present inside the test kit) to assess the proficiency of the LT and also the performance of the machine. 2 What? 3 CBNAAT EQA has been extended to cover 750 Truenat sites in the first phase. How? 4 Both NAAT EQAs are coordinated by NTI, Bengaluru. Where?
HR REQUIREMENTS DMC NAAT C&DST 1- Lab Technician 1- Lab Technician 2- Microbiologists 5- Senior LTs 1- Lab Attendant & 1 DEO Provided under NHM PIP HR cadre (for state/ district level), educational qualifications and experience guided by NTEP
TRAINING SCHEDULE Duration (days) Category of personnel trained Coordinated with Name of the training Program Curriculum Comprehensive Training Course for lab personnel (LPA, LC DST, NAAT & Ni- kshay) Module reading, presentation, Demonstration, Hands on training 12 NRL/ IRL Microbiologist Technical Officer/Sr LTs/ LTs Presentation, Demonstration & Hands-on training Presentation, Demonstration & Hands on training 5 NRL/ IRL LPA First line & second line Liquid culture and DST (First line and Second line) 5 NRL/ IRL Module reading, slide preparation, observation, grading, recording and reporting Hand on training 10 LT of DMC/STLS State/ District LT Modular and NIKSHAY training NIKSHAY 1 STLS Presentation Presentation, Demonstration of sample processing State CBNAAT LT, STLS CBNAAT and NIKSHAY Training 2 State
NTEP SERVICES UNDER IPHL AT THE DISTRICT LEVEL Clinical Clinical Pathology Pathology Ensure Molecular Diagnostics at IPHL at District level under PM ABHIM- NAAT Microbiology Microbiology Hematology Hematology Procurement of TrueNat (Chip based Real time micro-PCR) 15th Finance Commission - Block level Public Health Units PTE & follow up test (Hematology, *cytology, biochemistry, and microbiological tests available at BPHL & IPHL) for PTB, EPTB. Services Services Establishment of DMC, Procurement of Microscopes, Lab Consumables for DMCs under NHM/ 15th Finance Commission under Support for diagnostic infrastructure to the primary healthcare/UPHCs facilities grant Cytology Cytology Biochemistry Biochemistry Sample Sample collection collection from from OPD/IPD/spo OPD/IPD/spo kes and kes and Reporting Reporting area area Collection and transportation of PTB and EPTB samples
NTEP Services in Block Public Health Unit A total of 87 tests encompassing hematology, serology, biochemistry, clinical pathology, microbiology, and any other test for improved public health surveillance/clinical condition will be done at BPHU For diagnosis of TB, smear microscopy and NAAT will be offered
PLATFORM TECHNOLOGY Gene Xpert Truenat Roche/Cobas 6800 BD Max ID NOW, Abbott RT PCR system, Applied biosystems Perkin Elmer Whole Genome Sequencing
Additionally, The process of QA of IPHL will be in accordance with QA programme and with other specific requirements of the GoI (NQAS) in align with Diagnostic algorithm used for diagnosis of TB
Key Actionable for the Programme Officers Integration of services under one lab at district and block level in terms of equipment Establishment of microscopy lab at the district hospital and SDH/CHC (if not already existing). This could mean procurement of additional logistics for the lab Establishment of CBNAAT/TRUNAAT lab at the DH and TrueNAT lab at the SDH/CHC. This could mean the procurement of additional NAAT machines. Integration of services under one lab at district and block level in terms of infrastructure Find a spot in the DH/SDH/CHC premises to set up or integrate the NTEP lab services Provide linkages for timely collection of samples and transportation to the labs from OPD/IPD/spokes Integration of services under one lab at district and block level in terms of Human Resources Utilization of already existing lab HR to ensure continued services under NTEP Capacity building of the HR on diagnostic techniques, Ni-Kshay, sample packaging etc Involvement of HR especially Medical Officers in -monitoring and regular reviews. Storage and dispensation of Anti TB drugs and drugs for TB preventive therapy from DH/SDH/CHC pharmacist Integration of laboratory services under IPHL will increase the preparedness for future epidemics, and also facilitate the achievement of our end TB strategy
