CDST_LT: Specimen transport

All efforts must be made to have decentralized local arrangements for transporting the specimens to the Designated Microscopy Centre (DMC)/ Culture Drug Susceptibility Test (CDST) and molecular Nucleic Acid Amplification Test (NAAT) and Line probe assay (LPA) labs through human volunteers/courier/speed post. The specimens collected should be carefully packed in a box to avoid any spillage or contamination. 

 

The following points must be considered for the transportation of biological specimens: 

• Samples need to be transported to DMC or CDST laboratory within 72 hours (in a cold chain if sent to CDST and molecular laboratories)
• The health care worker must inform and coordinate with the sample transportation agency to transport the sample to the necessary laboratory
• The accompanying dispatch list present along with the biological specimen must tally with the total number of sputum specimens collected, and must specify the details of the referring health facility collecting the specimen
• The Specimen Identification Number on the specimen container and the accompanying dispatch list must match
• For each patient, one biological requisition form is required and all necessary details should be filled
• All specimens transported to the laboratory must be accompanied by the request form in hard and soft copy formats 
• Triple packing system should be utilized for transportation
• The box containing the specimen samples to be transported to the National TB Elimination Program (NTEP) certified laboratory should be labelled with a “BIO-HAZARD” sticker 
• The date of dispatch must be marked by the health worker on the dispatch list and the same must be attached outside the box containing the specimen 

 

Triple Layer Packaging 

As per NTEP guidelines, the sputum specimen is packaged in triple layers for transportation to avoid spills and leakage and pose no hazard to the transporter. This includes:

 

1. Primary Container: This is a watertight, leak-proof, unbreakable tube containing the specimen. The tube is packaged with enough absorbent material to absorb all fluid in case of breakage or leakage.

Figure 1: Primary container; Source: PMDT Guidelines, 2021

 

 

2. Secondary Packaging: This is watertight, leak-proof packaging to enclose and protect the primary container. Several primary containers may be placed in one secondary packaging.

Figure 2: Secondary Packaging; Source: PMDT Guidelines, 2021

 

 

 

3. Outer Packaging: Secondary packaging is placed in rigid outer packaging to protect the contents from physical damage during transport. Gel packs should be kept inside the box to maintain temperature along with suitable absorbent/ cushioning material

 

Figure 3: Outer Packaging; Source: PMDT Guidelines, 2021

 

 

The transporter needs to ensure the following:

1. The outer packaging is not damaged and is properly sealed
2. Biohazard label is pasted on the outer packaging 
3. “From” and “To” addresses are clearly labelled
4. Contact details (name, phone no.) of the receiver is pasted
5. Upright symbol () is pasted appropriately
6. The temperature is maintained at 2-8⁰ C for the entire transportation period 
7. Transport at the earliest (to reach the destination within 72 hours)

 

Resources

 

• Technical and Operational Guidelines for TB Control in India, 2016 
• PMDT Guidelines 2021

 

Kindly provide your valuable feedback on the page to the link provided HERE
 

All efforts must be made to have decentralised local arrangements for transporting the specimens to the TB detection centre (TDC). If a proper transport mechanism for collected specimen is in place, it spares the patients from travelling to the laboratory.

The sputum sample is packaged in triple layers in such a manner that it arrives at the destination in good condition and presents no hazard to the transporter.

Transporter/ personnel transporting the sample should be sensitized by the National TB Elimination Programme (NTEP) staff prior to engagement.

• Sensitisation would be provided on Symptoms of TB disease and its transmission, precautions to be taken to prevent exposure, hand hygiene requirements and spill management.

 

The different modes of sample transport include:

1. Post: Postal department services available pan-district can be engaged to transport sputum samples. 

2. Courier: Local logistics courier companies can also be identified and hired to transport samples.

3. Volunteers/ human carriers: Community volunteers/members of NGOs can be trained as human carriers to collect and transport samples.

District TB Centre or Medical Officer TB Control (MO-TC) should ensure feasibility and financial measures required for .such arrangements for sputum transport.

 

Systems can be established for transportation of various biological samples (not only TB) from referring centre/peripheral centre to laboratories in a hub and spoke model in a integrated manner. 

 

Resources

• Specimen Transportation - A How-to Guide. 
• Health and Safety Guidelines for Staff/ Workers involved in Sputum Transportation, CTD.

 

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 can be transported through post/ courier/ human carriers.	True	False			1	Sputum can be transported through post/ courier/ human carriers.		Yes	Yes

 

Peripheral Laboratories in the NTEP need to send biological samples (such as sputum) to nearby Culture and Drug Susceptibility Testing (CDST) laboratories for advanced testing (eg Drug Resistance Testing). The samples need to be safely packaged and transported such that there is no spillage or contamination.

The items required for safe packaging biological specimens are: 

1. Falcon tubes
2. Three-layer packing materials like thermocol box
3. Ice gel pack (pre-frozen at -20^oC for 48 hours)
4. Request for CDST forms
5. Polythene bags
6. Tissue paper roll for absorbent packing
7. Parafilm tapes
8. Brown tape for packing the thermocol box
9. Permanent marker pen
10. Labels with 'To' and 'From' address and blank labels for sample details 
11. Biohazard sticker
12. Scissors
13. Spirit swab 

Figure: Items needed for packaging of biological specimens for CDST laboratory; Source: Guidelines for Programmatic Management of Drug Resistant TB in India, 2021

Resources

• Training Module (1-4) for Program Managers and Medical Officer, NTEP, MoHFW, 2020.
• Guidelines for Programmatic Management of Drug Resistant TB in India, 2021.

Standard Operating Procedure (SOP) for Packaging Specimen during the transportation of biological specimens for TB diagnosis, also known as Triple Layer Packaging, is as follows:

The Lab Technicians (LTs) at the Designated Microscopy Centres (DMCs) should be trained to carefully pack the sputum samples in the cold box to avoid spillage of the samples. Before packing, personal protection measures such as wearing hand gloves (double gloves preferred), goggles and masks are to be followed by the LTs to prevent contracting the infection.

 

Table: Steps in Standard Operating Procedure (SOP) for Packaging Specimen during Transportation for TB Diagnosis

	Step 1. Make sure that the specimen collection tube is tightly closed after the sample has been collected from the patient.
	Step 2. Wipe the outer surface of the 50 ml conical tube with 5% phenol followed by absorbent tissues and allow it to air dry.
	Step 3. Write the patient details on the opaque area (white area) of the specimen collection tube using a permanent marker pen, clearly in capital letters.
	Step 4. Cut the parafilm strip and wrap one of the strips at the joint between the cap and the neck of the specimen collection tube such that a secured seal is formed. (Primary receptacle/ package
	Step 5. Open the absorbent cotton roll and spread it out on the workbench; separate the cotton into two equal layers. Roll the specimen collection tube containing the sample tightly in the absorbent cotton such that the tube is covered completely.
	Step 6. Put this roll containing the specimen collection tube into the ziplock pouch. Roll the whole into a tight bundle, ensuring that there is no air in the pouch. This bundle should be secured with rubber bands. (Secondary receptacle/ package)
	Step 7. Repeat steps 5–7 for the second sample of the patient.
	Step 8. Insert the Test Request form printed from Nikshay into the ziplock pouch after ensuring that the details on the form and the sample tubes match, with the writing facing outside (details visible through the package). Seal the ziplock on the pouch.
	Step 9. Place the cooled gel packs into the thermocol box, place the sample tubes packed in ziplock pouches on the frozen gel packs (frozen for 48 hours at -40°C) and also keep the pouch containing the Test Request form printed from Nikshay on top. Stick the BIOHAZARD sign over the lid and “To and From” stickers on the exterior of the thermocol box or box used to pack the specimen. Close the lid of the box and wrap it tightly with brown duct tape. (Tertiary receptacle/ package)
	Step 10. Complete the ‘From’ and ‘To’ addresses on the stickers, using a permanent marker pen.

 

The LT of the DMC should promptly inform the sample transport agency like a courier/ speed post service, or a human carrier to collect and transport the samples.

Resources

 

• Training Module (1-4) for Program Managers and Medical Officers, NTEP, MoHFW, 2020.
• Guidelines for Programmatic Management of Drug-resistant TB in India, 2021.

 

Kindly provide your valuable feedback on the page to the link provided HERE
 

Technical specifications for TB diagnosis specimen carriers are as follows:

 

Thermocol Box:

• Thickness of box - 2.5 cm
• Outer dimensions: Length - 18.5 cm, breadth - 13 cm, height - 12 cm (without lid), height - 14 cm (with lid); Inner dimensions: Length - 14.5 cm, breadth - 8 cm, height - 12 cm (without lid), height - 13 cm (with inner part of lid).

 

Gel Pack:

• Number of gel packs required: 2
• Weight of fully packed consignment box: 400 grams
• Gel packs maintain a temperature between 12-20ºC for up to approximately 48 hours in tightly packed thermocol boxes (average outside temperature 35ºC)
• Conditioning in the deep freezer (temperature between -20 to -15ºC) for a minimum 48 hours to a maximum 72 hours before use, is required. 

This is a one-time use carrier since the thermocol boxes and the gel packs are not reused.

 

Figure: TB Diagnostic Specimen Carrier - Thermocol Box with Gel Packs; Source: NTEP Guidelines for Programmatic Management of Drug Resistant TB in India, 2021

 

 

 

Resources

 

• Training Module (1-4) for Program Managers and Medical Officer, NTEP, MoHFW, 2020.
• Guidelines for Programmatic Management of Drug Resistant TB in India, 2021.

 

Kindly provide your valuable feedback on the page to the link provided HERE
 

These are the technical specifications for labelling specimen transport carriers:

 

• Specimen containers need to be labelled legibly with details such as the patients’ name, date and time of specimen collection, TB detection centre/ District Tuberculosis Centre (DTC), lab no., specimen A or B.

​

Figure: Details to be filled on the specimen containers

 

• Dispatch list with details of each specimen transported and the request form for examination of biological specimen for each specimen should be put in an envelope and attached to the outside box.
• As per the national guidelines for biomedical waste management, the containers used for transporting specimen samples to the National TB Elimination Programme (NTEP) - certified laboratory should be labelled with a “BIOHAZARD” sticker.

 

• Other than the Biohazard sticker it is mandatory to add 'To' and 'From' stickers on the specimen transportation carrier and fill in the necessary details.
• Specimen transport carriers should be labelled legibly with all the necessary details as listed above.
• A specimen may be rejected at the receiving laboratory if the specimen transport carriers are unlabelled or mislabelled.

 

Resources

 

• Guidelines for Programmatic Management of Drug-resistant Tuberculosis in India, 2021.

 

Kindly provide your valuable feedback on the page to the link provided HERE

A cold chain is a system of transporting and storing TB specimens at optimum temperature while being transported from the peripheral health institutions to the diagnostic labs to reduce the growth of contaminating endogenous respiratory organisms.

 

Cold chain requirements for transportation of TB diagnostic specimens are (Figure 1):

• A thick thermocol box (one-time use box), which has a thickness of about 2.5 cm. Outer dimensions of the box - Length: 18.5 cm, Breadth: 13 cm, Height: 12 cm. Inner dimensions of the box - Length: 14.5 cm, Breadth: 8 cm, Height: 10 cm.
• Two gel packs to maintain a temperature between 12-20°C for up to approximately 48 hours in tightly packed thermocol boxes (average outside temperature 35°C). Gel packs to be conditioned in the deep freezer (temperature between -20 to -15°C) for a minimum of 48-72 hours before use.

Figure 1: Technical specifications of transport box for sputum specimen transportation in cold chain

 

   

Specimen Transport  Steps - Cold Chain (Figure 2)

 

1. Place the gel pack into the thermocol box. 
2. Place the sample tubes (in zip-lock pouches) on the frozen gel packs.
3. Keep the pouch containing the Test Request form on top before placing another gel pack on top. 
4. Close the lid of the box and wrap tightly with brown duct tape to maintain the cold chain.

Figure 2: Steps for specimen transportation in cold chain

 

 

Resources

 

• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India, March 2021.

 

Kindly provide your valuable feedback on the page to the link provided HERE

For presumptive Drug-resistant TB (DR-TB) patients’, the health facility staff arranges for specimen collection from patient, packs samples as per the Standard  Operating Procedure (SOP) for triple layer packaging and dispatches it for transportation in cool chain to the linked Culture and Drug Susceptibility Testing (C&DST) laboratory.

All necessary materials for specimen collection and modality for transportation need to be made available/ arranged at the Designated Microscopy Centre (DMC)/ Peripheral Health Institute (PHI) by the District TB Officer (DTO).

 

Steps in sample dispatch include:

• Add test details in Nikshay (Figure) to generate test requests (Test ID) for the patient’s episode ID in Nikshay.
  • This will enable instant online intimation about the upcoming specimen to the C&DST laboratory.
• Complete test request form for biological specimen by adding:
  • Patient information
  • Details on name and type of referring facility
  • Health establishment ID
  • Reason for testing and test requested
  • Patient ID and Test ID
• Put the appropriate address of receiving C&DST laboratory and address of health facility form where samples are dispatched on the transportation box.
• Lab Technician (LT) of the health facility should promptly inform the transport agency (courier/ speed post service) or human volunteers to collect and transport the samples.

Figure: Adding Test Details in Nikshay for Diagnosis of DR-TB; Source: Nikshay Diagnostics Training Content.

 

Resources

• Training Modules (1-4) for Programme Managers and Medical Officers, NTEP, 2020.
• Guidelines for PMDT in India, 2021.
• Nikshay Zendesk, Nikshay Knowledge Base, Diagnostics.

 

Assessment

Question​	Answer 1​	Answer 2​	Answer 3​	Answer 4​	Correct answer​	Correct explanation​	Page id​	Part of Pre-test​	Part of Post-test​
Test details are added in Nikshay to generate test requests (Test ID) for the patient’s episode ID in Nikshay.	True	False			1	Test details are added in Nikshay to generate test requests (Test ID) for the patient’s episode ID in Nikshay.	​	Yes	Yes