STLS: Maintaining Supplies of Lab consumables at TDC

Laboratory Consumables

Description

1. Cartridge-based Nucleic Acid Amplification Tests (CBNAAT) machines and Cartridges

• The CBNAAT machines and cartridges are procured by Central TB Division (CTD) and supplied to state/ district/ CBNAAT sites based on their requirement.
• Cartridges are supplied based on the stock availability, consumption and expected case load.
• Recording, reporting and monitoring of cartridges are done through Ni-kshay Aushadhi.

2. Binocular Microscope (BM) and LED Fluorescence microscopy (LED-FM)

• The procurement of both items is undertaken by CTD and then delivered to the states/ districts.
• All LED-FM/ BMs should be covered by annual maintenance contracts by states/districts, at the end of their warranty periods.
• NTEP guideline recommends 1 BM for every Designated Microscopy Centre (DMC) and LED FMs only for the high case load facilities with >25 slides per day.
• Along with public sector DMCs, NTEP may also supply BMs to DMCs established in other sectors like ESIS, Public Sector Undertakings, Medical College, etc., if required.

3. Sputum containers

Calculation of requirement of sputum containers:

For diagnosis:

• During the first week of each quarter, the number of new pulmonary smear-positive cases registered and treated during the last quarter in the district should be determined and this number should be multiplied by 10.
• 10 is the average number of symptomatic required to be examined for detecting one case of new pulmonary smear-positive tuberculosis and it includes all types of patients.
• Since two sputum specimens are taken for each symptomatic patient, further multiply the number obtained above by 2.
• The final number derived would be the required no. of slides for diagnosis.

For follow-up:

• Two follow-up specimens are taken for the majority of patients (one at the end of the intensive phase and the other at the end of treatment), therefore one sputum container is needed for each follow-up.
• On the last working day of the quarter, count the number of sputum containers in stock and subtract from the required number as calculated above.
• Allow sufficient reserve stock for three months, add 10% to account for wastage of sputum containers, and account for the sputum containers in stock.

4. Slides

• One slide is used to examine one specimen in a sputum container. Therefore, order a slightly higher number of slides, than the required no. of sputum containers to account for unavoidable breakage of slides.
• Order for both sputum containers and slides should be placed during the first week of the quarter.
• The supplies will be procured by the state/ district and supplied to all the peripheral health institutions in the district.

Question​

Answer 1​

Answer 2​

Answer 3​

Answer 4​

Correct answer​

Correct explanation​

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Part of Pre-test​

Part of Post-test​

Identify the correct statement from the options given below.

The CBNAAT machines and cartridges are procured at the district level as per the requirement.

The CBNAAT machines and cartridges are procured centrally and supplied to state/ district/ CBNAAT sites based on their requirement.

The CBNAAT machines and cartridges are procured at the Designated Microscopy Centre level as per the requirement.

The CBNAAT machines and cartridges are procured at the Tuberculosis Unit level as per the requirement.

2

The CBNAAT machines and cartridges are procured centrally and supplied to state/ district/ CBNAAT sites based on their requirement.

​

Yes

Yes

1. For Sputum collection

2. For slide preparation

The Senior Tuberculosis Laboratory Supervisor (STLS) ensures these supplies are distributed in a timely manner, as and when required.

Trueprep AUTO MTB Sample Pre-treatment Pack for sample processing

1. Liquefaction buffer
2. Lysis buffer
3. Disposable transfer pipette (graduated) - 1ml

Trueprep AUTO v2 Universal Cartridge Based Sample Prep Kit for DNA extraction

1. The Reagent Pack contains the following reagents
   1. Wash Buffer A
   2. Wash Buffer B
   3. Elution Buffer
   4. Priming Waste
2. The Cartridge Pack contains the following
   • Cartridge
   1. Elute collection tube
   2. Elute collection tube label
   3. Disposable transfer pipette
3. Disposable Transfer Pipettes (graduated) - 3 ml
4. Reagent Reset Card

Truenat MTB Chip-based Real-Time PCR test for Mycobacterium tuberculosis

1. Truenat MTB micro-PCR chip
2. Microtube with freeze-dried PCR reagents
3. DNase & RNase free pipette tip

Truenat MTB-RIF Dx Chip-based Real-Time PCR Test for Rifampicin Resistant Mycobacterium tuberculosis

1. Truenat MTB-RIF Dx micro-PCR chip
2. Microtube with freeze-dried PCR reagents
3. DNase & RNase free pipette tip

Other Consumables

1. Gloves
2. Masks
3. Sodium hypochlorite

For diagnosis:

• During the first week of each quarter, the number of new smear-positive cases registered and treated during the last quarter should be determined and this number should be multiplied by 10.
• Ten is the average number of symptomatic required to be examined for detecting one case of new pulmonary smear-positive tuberculosis.
• Since two sputum specimens are taken for each symptomatic patient, further multiply the number obtained above by 2.

For follow-up:

• Two follow-up specimens are taken for the majority of patients - one at the end of the intensive phase and the other at the end of treatment. One sputum container is needed for each follow-up.
• Once the number of sputum containers required has been calculated, allow sufficient reserve stock for three months, add 10% to account for wastage of sputum containers, and account for the sputum containers in stock.
• On the last working day of the quarter, count the number of sputum containers in stock and subtract from that needed for diagnosis and follow-up examinations as calculated above.

• Once the number of sputum containers needed for the next quarter is determined, order a slightly higher number of slides than the required no. of sputum containers to account for unavoidable breakage of slides. 

• Reagents are supplied to the DMCs on monthly basis by the District TB Centre (DTC).
• The stock register should have the mention of expiry dates of the reagents and the first expiring reagents must be exhausted first based on the First Expiry First Out (FEFO) principle.
• The reagents should not be used beyond three months from the date of preparation.

CBNAAT/ Truenat Machines and Cartridges/ Chips

• These are procured centrally and supplied to state/ district/ sites based on their requirement.
• Recording, reporting and monitoring of cartridges/ chips is done through Nikshay-Aushadhi and they are supplied based on the stock availability, consumption and expected case load.

• 1 BM is required for every DMC.
• The no. of BM in place and no. of BM in working condition should be reported in the stock register.
• LED FM is supplied to the high case load facilities where the workload is more than 25 slides per day.

• Each TB lab register allows for the registration of at least 2000 patients.
• For each lakh population, 75 smear-positive patients are projected, requiring the examination of 750 patients (thrice each). Additional follow-up examinations will bring the number of registers needed to approximately one lab register/ lakh.
• If there are blank pages in the register at the end of a year, it can be used the following year. However, every year should be started on a new page.

• For diagnosis, approximately 10 laboratory forms for sputum examination are needed. (10 is the average number of symptomatic for each case of pulmonary smear-positive tuberculosis identified).
• For follow-up, approximately 0.2 laboratory forms for sputum examination are needed for each pulmonary tuberculosis case. (1 out of 10 examined will be smear-positive, each needs two forms for follow-up. When calculated, out of 10 it will be 0.2)

For follow-up, approximately 0.2 laboratory forms for sputum examination are needed for each pulmonary tuberculosis case.

For diagnosis, approximately 10 laboratory forms for sputum examination are needed. 10 is the average number of symptomatic for each case of pulmonary smear-positive tuberculosis identified. 1 out of 10 examined will be smear-positive, each needs two forms for follow-up. When calculated, out of 10 it will be 0.2

Yes

Yes

Sl. No

Items

Item Adequate/ Acceptable

Problems Identified

Adequate stock and supply of: 

2.

Lens tissue

Y / N

3.

Filter paper

Y / N

4.

Spirit lamp or bunsen burner

Y / N

5.

Immersion oil

Y / N

6.

Disinfectants

Y / N

7.

Smearing/ staining equipment (staining racks, loops, sticks, etc.)

Y / N

8.

Slide boxes

Y / N

9.

External Quality Assurance (EQA) forms

Y / N

Staining reagents/ equipment:

Within expiry date

1.

1% Carbol fuchsin

Y / N

2.

0.1% Methylene Blue

Y / N

3.

25% Sulphuric acid

Y / N

4.

Distilled water

Y / N

5

Equipment for preparation of stains/ reagents such as balance (for weighing reagents) and measuring cylinder, etc.

Y / N

Question​

Answer 1​

Answer 2​

Answer 3​

Answer 4​

Correct answer​

Correct explanation​

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Part of Pre-test​

Part of Post-test​

Who does the assessment of stock at DMC?

National Reference Laboratory during their annual EQA OSE visit

Intermediate Reference Laboratory during their annual EQA OSE visit

Central Internal Evaluation team

STLS during their monthly OSE visit

All of the above

Assessment of stock at DMC done by NRL, IRL, CIE Team and also by STLS.