STLS: Supply Chain Management

Supply Chain Management (SCM) is the handing of flow of goods and material from point of origin to point of consumption, with the objective to ensure that the supplies are present for utilization without any interruption. It covers everything from procurement and sourcing of raw materials to delivery of final product to the consumer, along with the related logistics. It will also include the related information systems that enable monitoring and exchange of information.

Effective SCM ensures the following:

• Continuous availability of quality-assured medicines/ products at the right time and at all healthcare levels.
• Minimizes wastage by preventing expiry of drugs at all levels, maintenance of adequate stock levels and accurate records.
• Maximizes patient care by coordination in all departments and by minimizing human errors/ medication errors.
• Economically viable by minimizing monetary loss (e.g., through pilferage) and optimizing cost via bulk purchasing or according to consumption needs.

Robust supply chain management systems have two main components:

1. Physical flow: Involved the movement and storage of supplies
2. Information flow: Allows the various stakeholders to coordinate and control the flow of supplies

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.
• NTEP Training Modules 5-9 for Programme Managers & Medical Officers, 2020.
• Guidelines for Programmatic Management of Drug-resistant TB, 2021.

Assessment

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
Which of the following statements are correct about supply chain management?	It is useful to ensure a continuous supply of good quality medicines.	It is an essential activity that must be undertaken by health programmes.	It helps reduce the cost burden on the healthcare system.	All of the above	4	Effective SCM is an essential activity that ensures a continuous supply of good quality medicines and cost optimization.	​

 

 

 

 

To ensure successful implementation, sustainability and quality services under the National TB Elimination Programme (NTEP), some guiding principles in Supply Chain Management (SCM) and drug logistics are to be ensured. These are showcased in the figure below.

 

Figure: Principles of SCM under NTEP

 

Important Points

• Timely procurement, uninterrupted supply and maintenance of stock and in-time distribution of anti-TB drugs and other consumables are essential for quality services.
• Monitoring of drug supply from the central to peripheral health institute level through web-based real-time software, Nikshay-Aushadhi, is crucial to avoid under-stocking (and delays in treatment initiation) and over-stocking (resulting in wastages).
• Maintaining appropriate storage and stacking norms i.e., different batches of drugs with different dates of manufacture and expiry are stored separately so as to facilitate First-expiry-first-out (FEFO) principles, viz., drug batches with the most recent expiry are issued first.

 

Under FEFO, the storekeeper at the drug store is responsible for:

• Installing appropriate tools to periodically monitor controls over the expiry position of drugs.
• Exercising prudence in the case of short-expiry drugs, wherein distribution is on a rational basis that considers the utilization pattern. This includes the following:
  • The storekeeper marks ‘Expiry Dates’ in Bold Letters 3” to 4” in size, on the drug cartons with a marker pen, for easy identification and control of drugs immediately on their arrival.
  • Routine monitoring of the stock position of all drugs.
  • Maintaining proper records.
  • Analyzing shelf-life analysis of drug stocks at all levels regularly.

 

 

Resources

• NTEP Training Modules 1-4 for Programme Managers & Medical Officers, 2020.
• NTEP Training Modules 5-9 for Programme Managers & Medical Officers, 2020.
• Guidelines for Programmatic Management of Drug-resistant TB, 2021.

Assessment

 

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
What is FEFO?	FEFO is the division that manages drug receipts under NTEP.	FEFO is a supply chain principle that is used to forecast consumables that are required by the programme.	FEFO means First-expiry-first-out and it is a principle to be followed when issuing drugs/ consumables.	None of the above	3	FEFO means First-expiry-first-out and it is a principle to be followed when issuing drugs/ consumables.	​

 

 

Under the National TB Elimination Programme (NTEP), the anti-TB drugs are procured at the centre level by the Central TB Division (CTD), Ministry of Health and Family Welfare (MoHFW), and supplied to the central warehouses.

From the central level warehouses, the drugs are supplied to different State Drug Stores (SDS) and further distributed to District Drug Stores (DDS) and sub-district level (TB Unit (TU) Store and Peripheral Health Institute (PHI)).

This movement of drug flow is monitored in real-time through Ni-kshay Aushadhi.

 

Figure: Flowchart Showing the Overview of Distribution of Drugs

Abbr: CMSS: Central Medical Services Society; GDF: Global Drug Facility; CTD: Central TB Division; GMSD: Government Medical Store Depot; SDS: State Drug Store; DDS: District Drug Store; TU: TB Unit; PHC: Primary Health Centre; PHI: Peripheral Health Institute.

 

Resources

• Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.
• Procurement, Supply Chain Management & Preventive Maintenance, Module 6, CTD, MoHFW, India.

Regular, accurate information on consumption, drug stock and supplies at the Peripheral Health Institute (PHI), Tuberculosis Units (TUs), districts and state levels are essential for timely drug stock indenting and distribution at all levels.

The anti-TB drugs are mostly procured centrally, except for very few drugs, and supplied according to a stocking norm to various level stocking units, based on indenting.

These indentings are further dependent on the certain levels of stocks predefined for each level.

The overall idea is to ensure a working and a buffer stock at each level for ensuring uninterrupted drug delivery to the beneficiaries. 

 

Drug Distribution Process

Figure: Drug Distribution Process

Abbr: CTD: Central TB Division; GMSD: Government Medical Supplies Depot; CMSS: Central Medical Services Society; SDS: State Drug Store; DDS: District Drug Store; TU: TB Unit; PHC: Public Health Centre; PHI: Peripheral Health Institute.

 

Indenting

Indenting is a process in which the requisition for stocks is submitted by the sub-store to the parent store or to the supplier in order to initiate the process of drug supply from the parent store to the sub-store. 

The stock management up to the TU level, including transfer to PHI, is handled by Ni-kshay Aushadhi software, while PHI to the patient is handled by Ni-kshay.

Offline Indenting

• The PHIs submit their drug request to the TU through offline indenting modes such as email, phone, etc.
• On receipt of the offline indent, the respective TU releases drugs to the PHI through the TU login in Ni-kshay Aushadhi using "Dispatch without drug request”  under the Issue/ Dispatch module.​

Online Indenting

• Online indenting is the term used when the indent request is placed through the Ni-kshay Aushadhi software.
• The supply of drugs from the central to the state level and further to districts and TUs is facilitated through online indenting.

 

Resources

• Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.
• Procurement, Supply Chain Management & Preventive Maintenance, Module 6, CTD, MoHFW, India.

Assessment

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
How is the online indenting process done?	Through Phone	Through e-mail	Through Physical visit	Through Ni-kshay Aushadhi	4	Online indenting is the term used when the indent request is placed through the Ni-kshay Aushadhi software.	​	Yes	Yes

 

 

 Procurement refers to the process by which governments and state-owned enterprises purchase goods and services from the private sector.

Procurement” means acquisition by way of purchase, lease, license or otherwise, either using public funds or any other source of funds (e.g. grant, loans, gifts, private investment etc.) of goods, works or services or any combination thereof.

 

 

Resources

1. Manual for procurement of goods; Ministry of Finance, GoI 2017.

 

Assessment

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
What does procurement include?	Buying and process of buying	Tendering	Acquiring goods from an external source	All of the above	4	Procurement refers to the process by which governments and state-owned enterprises purchase goods and services from the private sector.		Yes	Yes

Figure: Different types of Procurements

Figure: Procurement Process

Resources

1.  Manual for Procurement of Goods 2017

Assessment:

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
Procurement process involves	Need assessment	Bid Invitation	Bid Evaluation	Contract execution& Disposal of scrap	All of the above	Procurement process involves Need assessment Bid Invitation Bid Evaluation Contract execution& Disposal of scrap	​	Yes	Yes

 

 

 

 

 

 

z

GeM stands for Government e-Market Place. It is the digital eCommerce portal for the procurement and selling of goods and services by the Government of India.

 

Fig 1: Logo of GeM

Source:https://gem.gov.in

• Government e-Marketplace (GeM) facilitates online procurement of common-use goods & services required by various government departments/organisations / public sector units (PSUs).
• GeM aims to enhance transparency, efficiency and speed in public procurement.
• It provides the tools of e-bidding, reverses e-auction and demand aggregation to facilitate the government users to achieve the best value for their money.

Significance 

GeM is a completely paperless, cashless and system driven e-marketplace that enables procurement of common-use goods and services with minimal human interface.

It aims at:

• Instituting a unified procurement policy to encourage behavioural change and drive reform
• Establishing a lean, dynamic organisation capable of continuous innovation and market-driven decision making
• Building an easy-to-use, fully automated platform to ensure transparency and efficiency in procurement
• Demonstrating commitment to delivering value by ensuring the right quality at the right price
• Creating a sustainable ecosystem covering all stakeholders and driving inclusive development in India

Resources

1. GeM web portal  

Assessment:

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
What are the advantages of GeM?	Paperless procurement processes	Cashless procurement processes	1& 2	None	3	GeM is a completely paperless, cashless and system-driven eMarketplace that enables procurement of common-use goods and services with minimal human interface.	​	Yes	Yes

Depending upon the total value of procurement, the GeM platform provides three primary buying modes:

Direct purchase:

Direct purchase enables buyers to buy products of value up to INR 25,000 that meet the requisite quality, specifications, and delivery period without comparison (except automobiles) through any available sellers on GeM.

Direct purchase with L1

The Direct Purchase with L1 is used for mid-value (INR 25,000 to 50,000) transactions and allows the buyer to directly procure from the L1 seller after comparing all available sellers on the platform that meet the requisite quality, specification and delivery period as specified by the buyer. The comparison must be made between goods/services of at least three different manufacturers/Original Equipment Manufacturers (OEMs) and three different sellers.

E-Bid/ Reverse Auction

The E-bid/Reverse Auction mode allows buyers to conduct an electronic bid for the goods and services on the platform. The creation of bid documents as well as system-driven evaluation, are driven through well-defined and standardized technical parameters. The GeM platform shall provide buyers with the option to customize the bid, as per their requirements by way of objective selections.

Proprietary Article Certificate (PAC) Buying

The GeM platform allows buyers to procure on a proprietary basis by using the PAC filter provided on the GeM platform, which allows the selection of a specific model/makes from a particular seller that is available on the platform.

Resources

GeM training modules

 

Assessment

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
Who hosts the GeM portal	Ministry of Health and Family welfare	Central TB Division	Directorate General of Supplies and Goods	Ministry of commerce	3	GeM portal is hosted by the Directorate General of Supplies and Goods.		YES	YES

 

 

Direct purchase enables a buyer to buy services of value up to Rs. 25,000, which meets the requisite quality, specifications and delivery period without comparison(except automobiles), through any of the available sellers on the Government e-Marketplace (GeM) portal.

Steps include:

 1.Login to the GeM portal as a buyer

 

2. Click on Market--> Services

 

3. Select the service required

 

 

 

4. Check 'Service Level Agreement'

 

5. Select consignee location and number of resources. Fill in contract dates.

 

 

6. Fill in delivery details

 

 

7. Can view different service providers

 

8. Apply filters

 

9.'Add to Cart' the required one

10. Review cart and proceed

11. Preview Formula

 

12. 

13. Click on 'Direct Purchase' to proceed

14. Click 'Confirm'

 

15. Enter the 'Reason for Choosing the Seller'

 

 

16.

 

17. Enter 'Financial Details'

18.

 

 

19.

 

20.

 

 

21.

 

 

22.

 

Resources

1. GeM Portal.

Assessment

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
Which service/s are eligible for direct procurement through GeM?	Services of value above Rs 1 lakh	Services of value up to Rs. 25,000	None of the above	All of the above	2	Direct Purchase enables a buyer to buy services of value up to Rs. 25,000 (except automobiles) through any of the available sellers on GeM.

A tender is an invitation to bid for a project or accept a formal offer. Tender is a process on its own; bidding is just a step towards applying for the tender and getting it. 

The process of floating a tender through the Government e-Marketplace (GeM) portal has the following steps:

Step 1: Login to the GeM portal using your credentials

Figure 1: Logging into GeM portal

Source: GeM portal

 

Step 2: Search for the desired product

On logging in, a “Search” option is available at the top section of the same. Click on the “Categories” section of the site and select the product or click on the “search” option and enter the product's name.

Figure 2: Options to search for the desired product

Source: GeM portal

Step 3: Choose the desired product

After searching, product/products will come under the L1 category. If you want to buy items which are made in India, click on the “Made in India” section. However, before you can bid on something, you will need to compare the same with others. This enables you to find the best offering available under the amount of money you are willing to spend. 

For this, click on the “Compare” option first. Various other similar options come up on the screen. Compare them side by side.

Figure 3: Comparing products and selecting the desired one

Source: GeM portal

 

Step 4: Bid on the product

Once the comparison procedure is done, tap on the “Add to Cart” option available under the product. A new window will open; tap on the “Proceed to Checkout” option. Select the “Bidding” option.

Figure 4: Proceed to checkout

Source: GeM portal

Figure 5: Select the‘ Bidding’ option

Source: GeM portal

 

Step 5: Entering bid details and finalizing

On selecting the “Bidding" option, the bid details page opens. Fill in all details and create the bid.

Figure 6: Bid details page

Source: GeM portal

Figure 7: Create a bid

Source: GeM portal

 

Review the terms and conditions and click “Finalize Bid”.

Figure 8: Finalizing bid

Source: GeM portal

 

The bid is generated and details are displayed.

Figure 9: Successful bid creation

Source: GeM portal

On clicking the bid number, you can anytime review the bid- cancel or extend it.

Figure 10: Review of bid

Source: GeM portal

 

Resources

GeM portal https://gem.gov.in/

Assessment

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
GeM portal has the option to select ‘Made in India’ products.	True	False			1	If you want to buy items which are made in India, click on the “Made in India” section.		Yes	Yes

 

To preserve the quality of medicines, good storage practices should be in place at all levels, which requires that staff are appropriately trained and storage conditions adequate.

 

General Guidelines on Storage of Drugs

 

Mechanisms to improve TB stock management in central or peripheral drug stores are:

1. Stock rotation follows a First-expiry, First-out (FEFO) approach.
2. The cleanliness of the area is ensured.
3. The environment of the warehouse protects medicines from factors that could inhibit their effectiveness or use, such as sunlight, heat, cold, moisture, pests and theft.
4. The stock area is divided into zones for easy location of different products.
5. There is a designated area for second-line TB medicines.

 

Storage Guidelines under the National TB Elimination Programme (NTEP)

 

Under NTEP, space requirements change at the state, district and peripheral levels according to the NTEP stocking norms, but all other requirements remain the same as shown in the table below. The State TB Officer (STO)/ District TB Officer (DTO) must ensure that the pharmacist/ storekeeper adheres to the following guidelines on the proper storage of drugs.

 

Table: Guidelines for the Storage of Anti-TB Drugs in NTEP Drug Stores

Space Requirements at the State Drog Store (SDS)

For every ten lakh population, provision should be made for the storage of about 45 cartons (of 20 boxes each), of Patient-wise Boxes (PWBs) for new cases (PC-1) and PWBs for retreatment cases (PC-2) taken together. This is approximately equivalent to 6 months requirement of drugs. For this volume of drugs, the minimum space requirement may be approximated as 50 cubic feet. For loose drugs, space provision would be 10% of space allocated to PC-1 and PC-2 PWB cartons. These could alternatively be stored in cupboards/ almirahs where volumes are low and should be kept under lock and key. Do not stack drug cartons on the floor or on top of one another.

Room Requirements

The store should preferably comprise one large room. Where multiple rooms exist, these should be contiguous or proximate to each other. The ceiling must have a height of at least 5 metres. There should be a lockable door and at least one window with a grill and wire meshing. Properly lit with extra light points for plugging in the required office equipment. An even-level, ‘pukka’ floor.

Stacking Requirements

Ensure that different drug/ consumable items are clearly segregated and stacked on separate racks. Different batches of drugs with different dates of manufacture and expiry are stored separately to facilitate FEFO principles (drug batches with the most recent expiry are issued first) Mark ‘Expiry Dates’ in Bold Letters 3” to 4” in size, on the drug cartons with a marker pen, for easy identification and control of drugs immediately on their arrival. Separate and dispose of damaged or expired products without delay as soon as approval of the same has been received, according to the biomedical waste guidelines.

Temperature and Humidity Control

To keep humidity levels below the maximum 60% recommended for storage of drugs ensure appropriate ventilation and air circulation, and do not open cartons/ drug boxes unless necessary. Hydro thermometers are to be installed up to TB Unit (TU) drug store levels to monitor humidity and temperature regularly. Overhead exhaust fan required. Plastered walls and ceiling with whitewash without any kind of seepage in the room. The store should be clean, dry and well-ventilated. Ceiling and sidewalls should preferably be insulated, ensuring that the ambient temperature during peak summer does not result in damage to anti-TB drugs. The ambient temperature may be taken as 15-25°C or depending on climatic conditions, up to 30°C. PWBs/ cartons should be placed on shelves ensuring that there is sufficient space between shelves and walls of the storeroom. A regular power supply should be available for air conditioning.

Protection from Sunlight

Shade the windows or use curtains if they are in direct sunlight. Keep products in cartons/ drug boxes. Do not store or pack products in sunlight. Maintain trees around the premises of the drug store to help provide shade and cooling. Check their condition regularly to prevent any untoward incidents.

Fire Safety

Ensure that the fire safety equipment is available and accessible, and that personnel are trained to use it.

Others

Store medical supplies separately, away from rodents, insecticides, chemicals, old files, office supplies and other materials. Stores should not have any odour or indications of contamination and should be sanitised periodically including pest control measures.

 

Resources

• NTEP Training Modules (5-9) for Programme Managers & Medical Officers, 2020.
• Standard Operating Procedures Manual for State Drug Stores, NTEP, 2012.

 

Assessment

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
Concerning storage of anti-TB drugs, which of the following is correct?	Stock rotation follows a First-expiry, First-out (FEFO) approach.	Store drugs away from direct sunlight.	Hydro thermometers are to be installed up to TU drug store levels to monitor humidity and temperature regularly.	All of the above	4	Appropriate anti-TB drug storage conditions include keeping drugs away from direct sunlight, maintaining appropriate temperature and humidity and following a FEFO approach.		Yes	Yes

 

 

Ni-kshay Aushadhi is a web-based portal that deals with the management of stocks (anti-TB drugs, consumables and other commodities) across all the stocking points across the National TB Elimination Programme (NTEP), i.e., Government Medical Store Depot (GMSD), Central Medical Services Society (CMSS) warehouses, State Drug Stores (SDS), District Drug Stores (DDS), TB Units (TUs) including Peripheral Health Institutes (PHIs).

Ni-kshay Aushadhi also helps in real-time management of stock position, providing expiry details of commodities, routine/ Additional Drug Request (ADR) Requirements, and patient-wise consumption of drugs at all levels.

Table 1: Nikshay Aushadhi Stakeholders

User	Services
Central TB Division (CTD)	1. Quantification 2. Purchase Order (PO) generation 3. Quality control 4. State warehouse Drug Transfer Advice (DTA) 5. Monitoring of nation-wide stock & expiry
CMSS warehouse	1. Quantification 2. Purchase request generation 3. Advance shipment details 4. Supplier delivery details 5. Release Order (RO) to SDS 6. Acknowledge desk 7. Transfer of drugs to other warehouses
GMSD	1. Quantification 2. Acknowledge desk 3. Advance shipment details 4. Transfer of drugs to other warehouses
Supplier	1. View Purchase Order (PO) and delivery schedule 2. Enter dispatch details 3. View receipt 4. Demand vs issue
SDS/ DDS/ Drug-resistant TB Centre (DR-TBC)/ TU	1. Routine/ ADR & dispatch to sub-stores 2. Acknowledge desk 3. Transfer of drugs to other warehouses 4. Issue voucher DTA 5. Box preparation, box modification, unpacking and box completion 6. Local purchase
PHI	1. Routine/ ADR  2. Acknowledge the receipt of drugs 3. Issue to patient 4. Return from patient

 

The Ni-kshay Aushadhi can be used for the following purposes:

• Quantification and forecasting
• Monitoring and distribution
• Data management and analysis
• Recording and reporting of the drugs related data
• Training and capacity building
• Quantification of drugs
• Issue/ dispatch
• Return of drugs
• Drug request management - Routine/ ADR
• Stock management (like drug inventory, Physical Stock Verification (PSV))
• Packaging/ repackaging
• Receive from store/ Acknowledge desk
• Quality control management

 

Figure: Supply chain management in NTEP through Ni-kshay Aushadhi; Source: Ni-kshay Aushadhi Manual

 

Resources

• Ni-kshay Aushadhi Portal.

 

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct Answer	Correct Explanation	Page ID	Part of Pre-Test	Part of Post-Test
Ni-kshay Aushadhi can be used for the quantification and forecasting of drug stocks.	True	False			1	The Ni-kshay Aushadhi can be used for the following purposes: Quantification and forecasting Monitoring and distribution Data management and analysis Recording and reporting of the drugs-related data Training and capacity building Quantification of drugs Issue/ dispatch Return of drugs Drug request management - Routine/ ADR Stock management (like drug inventory, PSV) Packaging/ Repackaging Receive from store/ Acknowledge desk Quality control management Miscellaneous		Yes	Yes

 

The process of receipt of drugs is completed through the Ni-kshay Aushadhi application. Once a consignment is dispatched to the receiving unit, the system will display following three options:

1. Acknowledge Desk - For acknowledgment of drugs received against CTD-RO/ Issue Voucher
2. DTA Receipt - For acknowledgment of drugs received against CTD-DTA: This process is to be used to record receipt of drugs which are received against DTAs issued by CTD/ issued by parent store to correct stock imbalances in sub-stores.
3. Received from Third Party :This process is to be used when a store receives any drug or commodity from third party as donation.

• Receipt of  'complete' or 'partial' quantity of drugs can be acknowledged in Ni-kshay Aushadhi, as the case may be. When the user selects a particular consignment and clicks on the ‘Acknowledge’ option, the system shows a list of issued drugs/ items with the following details: Drug Name, Batch Number, Expiry Date, Requested Quantity, Issued Quantity, To be Acknowledged Quantity, Received Quantity, Damaged Quantity, Shortage Quantity.
• In instances where the quantity received is lesser than the issued quantity, the user should enter the same in the ‘Received qty’ column. As the request is partially acknowledged, the system will display it in the orange/ pink colour on the ‘acknowledge desk’. As and when the remaining quantity is received,  the user can acknowledge the same by selecting the previous partially acknowledged record and entering the remaining quantity that has been received.     

 

Resources

• Standard Operating Procedure Manual-Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.

• Procurement, Supply Chain Management & Preventive Maintenance, Module 6, CTD, MoHFW, India.

• Receive and Acknowledge, Ni-kshay Aushadhi User Manual, CTD, MoHFW, India.

 

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
The partially acknowledged ‘receipt’ will be shown in which colour in the ‘acknowledge desk’ on Ni-kshay Aushadhi?	Yellow/ Blue	Orange/ Pink	Black/ White	Green/ Red	2	The partially acknowledged ‘receipt’ will be shown in orange/ pink colour in the ‘acknowledge desk’ on Ni-kshay Aushadhi.		Yes	Yes

The National TB Elimination Programme (NTEP) laboratory network is composed of National Reference Laboratories (NRLs) at the national level, at the state level Intermediate Reference Laboratories (IRLs) and Culture & Drug Susceptibility Testing (C&DST) laboratories and at the peripheral level Designated Microscopy Centres (DMCs).

Each of these laboratories is responsible for performing various functions at its own levels.

 

Figure: Flowchart of Laboratory Consumables

 

Table: Laboratory Consumables

Laboratory Consumables	Description
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.
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.
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.
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.

Resources

• Training Module (1-4) for Programme Managers and Medical Officers, NTEP, MoHFW, 2020.
• Procurement, Supply Chain Management & Preventive Maintenance, Module 6, CTD.
• Module for Laboratory Technicians, CTD, MoHFW, India, 2005.
• Standard Operating Procedure Manual Procurement & Supply Chain Management, CTD, MoHFW, India, 2018.

 

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	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

• Designated Microscopy Centres (DMCs) are the most peripheral laboratory under the National TB Elimination Programme (NTEP) network.
• Any person identified to be a presumptive TB patient is first referred to the nearest DMC for sputum examination or their sputum specimens are collected and transported to the DMC. Therefore, it is very important for the DMCs to maintain an adequate stock of reagents and other consumables.
• The Medical Officer (MO) of DMC is responsible for determining the number of reagents and other materials the DMC needs every month.
• The Senior Tuberculosis Laboratory Supervisor (STLS) ensures these supplies are distributed in a timely manner, as and when required.
• The Lab Technician (LT) is responsible for exhausting the old supplies before the new ones.

 

The consumables required at the DMC can be broadly categorised as:

1. Consumables required for sputum collection
2. Consumables required for slide preparation
3. Consumables required for smear examination
4. Consumables stationery
5. Other

Table: List of Items with Technical Specifications of Laboratory Consumables Required for DMCs
Sl. No.	Name of the item	Technical Specifications
For Sputum collection
Sputum containers		Cups made of Special Medical Grade Polypropylene, thin plastic, translucent, diameter - 4 cm, capacity - 30 ml, the screwable cap should also be made of Special Medical Grade Polypropylene and should be airtight and leak-proof.
Absorbent cotton		500 gms/roll
Phenolic compound		5% phenol/ 40% phenolic compound (proprietary Phenyl) diluted to 5%
Adhesive labels for sputum containers
Sputum specimen transport box		Insulated box, made of plastic 10” x 10” x 10”, thickness 1” with lid, handle and nylon belt 1” width 2.5 feet length, nylon strap of 1” width 2 feet length with velcro to strap the lid of the box from side to side.
For slide preparation
Slides for Microscopes		Glass slides plain, size = 76mm x 26mm x 1.3mm, clean, scratch-free with smooth edges, uniform refractive index, pack of 50.
Broomstick		10 cms in length and thick enough to make good smears.
Diamond marker pencil		6" (15.24 cm.) holder with artificial diamond (hard stone) embedded at one end with a screw cap, to mark on microscope glass slides.
Grease marking pencil		Marking pencil MPS, blue or red coloured, 8" length, to write on glassware/ metal surfaces.
Staining racks		For drying the slides.
Slide boxes for storing slides
Glass (or metal) rods		For holding slides during the staining process.
Forceps, Chitel forceps		Stainless steel for slides, 15 cm.
Scissors		25 cm, stainless steel
Ziehl Neelsen stain
Auramine O fluorescent dye for Fluorescence Microscopy (FM)		Wherever FM is being done
Whatman filter paper No 1
3 ) For smear examination
Binocular Microscope		With 10x, 40x and oil immersion objective (100x) eyepieces (10x) and spare bulbs and fuses.
Immersion oil
Filter paper		To drain the oil from the slides.
Fine Silk and Lint cloth
Lens paper		For wiping the oil immersion lens after examination of each slide
4) Consumables - Stationery
Request form for examination of biological specimen for sputum examination
TB Laboratory Register
Referral/ Transfer form for treatment
Stock register – laboratory
Marker pen
5 ) Other
Plastic tumblers/ mugs
Time (stop-watch)
Spirit lamp or Bunsen burner
Silica gel		Hygroscopic agent to maintain the microscope in a moisture-free environment (to be placed in the cabinet for Binocular Microscope).
Alcohol (absolute)		Ethanol
Cotton, full sleeves Aprons
Disposable gloves		6 and 8 inches
Methylated spirit

 

Resources

• Training Module (1-4) for Program Managers and Medical Officers, NTEP, MoHFW, 2020. 
• Guidelines for Quality Assurance of Smear Microscopy for Diagnosing Tuberculosis, RNTCP Lab Network, CTD, MoHFW, India, 2005. 
• Module for Laboratory Technicians, CTD, MoHFW, India, 2005.

 

Assessment

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
Sputum containers and their screwable cap used for sputum collection at the DMC should be made of Special Medical Grade Polypropylene and should be air-tight.	True	False			1	Sputum containers and their screwable cap used for sputum collection at the DMC should be made of Special Medical Grade Polypropylene and should be air-tight and leakproof.	​	Yes	Yes
Who ensures that supplies are distributed in a timely manner at DMCs?	Treatment Supporter	Medical Officer	Senior Tuberculosis Laboratory Supervisor (STLS)	Lab Technician (LT)	3	The Senior Tuberculosis Laboratory Supervisor (STLS) ensures these supplies are distributed in a timely manner, as and when required.		Yes	Yes

The consumables required at a Cartridge-based Nucleic Acid Amplification Testing (CBNAAT) laboratory include the following:

CBNAAT/ GeneXpert Dx System consisting of CBNAAT machine preloaded with assay software, Computer and the Barcode reader

• CBNAAT assay kit (Figure) consisting of:
  • CBNAAT cartridges: Kit contains 10 or 50 individually packed cartridges.
  • CBNAAT reagent: 8 ml volume pack per cartridge. The sample reagent solution is clear but may range from colourless to golden yellow.
  • Sterile pipette: Individually packed, disposable transfer pipettes, one per each test, with a single mark for the minimum volume of sample transfer to each cartridge.
  • CD containing the Assay Definition File.

Figure: Contents of CBNAAT Assay Kit; Source: GLI Training Package for CBNAAT.

• Sputum containers 

 

• Personal protective equipment:
  • Laboratory coats
  • Disposable gloves
     
• Disinfectants
  • 1% Sodium hypochlorite solution 
  • 5% Phenol
  • 70% Ethanol 
     

• Power stabiliser (UPS) for uninterrupted power supply to perform CBNAAT assay.

   

Resources

• GLI Training Package for CBNAAT.  
• FIND Diagnosis for All, CBNAAT SOP.

Assessment

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
What are the components of the CBNAAT assay kit?	CBNAAT cartridges	CBNAAT reagent	Sterile pipette	All the 3	4	CBNAAT assay kit includes CBNAAT cartridges, CBNAAT reagent and sterile pipette.	​	Yes	Yes

Consumables required for Truenat test provided by the manufacturer include:

 

Trueprep AUTO MTB Sample Pre-treatment Pack for sample processing Liquefaction buffer Lysis buffer Disposable transfer pipette (graduated) - 1ml
Trueprep AUTO v2 Universal Cartridge Based Sample Prep Kit for DNA extraction The Reagent Pack contains the following reagents Wash Buffer A Wash Buffer B Elution Buffer Priming Waste The Cartridge Pack contains the following Cartridge Elute collection tube Elute collection tube label Disposable transfer pipette Disposable Transfer Pipettes (graduated) - 3 ml Reagent Reset Card
Truenat MTB Chip-based Real-Time PCR test for Mycobacterium tuberculosis Truenat MTB micro-PCR chip Microtube with freeze-dried PCR reagents DNase & RNase free pipette tip
Truenat MTB-RIF Dx Chip-based Real-Time PCR Test for Rifampicin Resistant Mycobacterium tuberculosis Truenat MTB-RIF Dx micro-PCR chip Microtube with freeze-dried PCR reagents DNase & RNase free pipette tip
Other Consumables Gloves Masks Sodium hypochlorite

 

 

Resources

 

• MolBio Diagnostics Product Details
• Practical Guide to Implementation of Truenat™ Tests for the Detection of TB and Rifampicin Resistance

 

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• Designated Microscopy Centres (DMCs) are the most peripheral laboratory under the National TB Elimination Programme (NTEP) network. Therefore, it is very important for the DMCs to maintain an adequate stock of all consumables.
• A paper-based stock register is maintained at the DMC and submitted as a part of the ‘Monthly report on programme management, logistics and microscopy’.
• All the DMCs as well as Peripheral Health Institute (PHI) that are a DMC need to fill the second part of this monthly report format for reporting the status of laboratory consumables and equipment (Figure below).

Figure: Monthly report format for reporting status of laboratory consumables and equipment, to be filled by PHI that is DMC.

 

• The stock register for consumables at the DMC has the provision to enter the information about the stock of consumables that are available at the DMC on the first day of the month, stock received and consumed during the month and stock remaining on the last day of the month along with the requested quantity of new stock.
• The Lab Technician (LT) of the DMC is responsible for exhausting the old supplies before the new ones.
• The Medical Officer (MO) of the DMC is responsible for determining the stocks and the Senior Tuberculosis Lab Supervisor (STLS) should ensure these supplies are distributed in a timely manner, as and when required.

 

Table: Calculation of Stocks Required at the DMC

Sputum containers	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.
Slides	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	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.
Binocular Microscopes (BM) and LED Fluorescence Microscopes (FM)	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.
Tuberculosis Laboratory Register	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.
Laboratory Form for Sputum Examination	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)

 

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, CTD, MoHFW, GoI, 2020.
• Module for STS Part 2: Ensuring Proper Registration and Reporting. CTD, MoHFW, India.

 

Assessment

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
How many TB Laboratory Register/s is/are required in one year for each DMC?	1	2	3	4	1	Each Tuberculosis Laboratory Register allows for the registration of at least 2000 patients. For each lakh, 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/ DMC.	​	Yes	Yes
For follow-up, approximately 0.2 laboratory forms for sputum examination are needed for each pulmonary tuberculosis case.	True	False			1	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

 

Stock is critical in assuring that the network of Designated Microscopy Centres (DMC) has all of the necessary supplies, equipment, and commodities to conduct testing. It assures that TB control and patient management are not interrupted by stockouts.

Assessment of stocks at DMC is carried out by estimating the number of presumptive TB cases diagnosed and treated during the last quarter.

There is a standard checklist for the assessment of stock at DMC with the help of this checklist assessment is carried out.

 

Sl. No	Items	Item Adequate/ Acceptable	Problems Identified
	Adequate stock and supply of:
1.	Slides	Y / N
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

 

Assessment is carried out by National Reference Laboratory (NRL)/ Intermediate Reference Laboratory (IRL)/ Central Internal Evaluation (CIE) team yearly once during their Onsite Evaluation (OSE) External Quality Assurance (EQA) visit by the Senior TB Laboratory Supervisor (STLS).

The DMC laboratory technician and the concerned Medical Officer (MO) in charge of the institution have to take adequate measures to address the problems identified. 

 

Resources

• Guidelines for Quality Assurance of Smear Microscopy for Diagnosing Tuberculosis, CTD, DGHS, MoHFW, 2005.

 

Assessment

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	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.