CDST_LT: Specimen receipt

There is a specific procedure prescribed under the National TB Elimination Program (NTEP) during receipt of the specimen for NTEP Laboratory.

At the laboratory, all specimens need to be received in the registration area.

To minimize the risk of infection, the following procedures should be applied:

1. The specimen box received needs to be opened only in a biosafety cabinet inside the laboratory. (Do not open on an open bench at the lab reception). 
2. Before opening the package, one should inspect the delivery box for signs of breakage or leakage; if there is gross leakage evident, one needs to discard the package following biomedical waste management.
3. If on gross inspection there is no leakage, one needs to proceed with opening the sample.
4. One needs to open the package carefully and re-check for any leakage. In case of leakage, again it should be discarded (the entire contents) following biosafety precautions. The laboratory needs to inform about rejection/ leakage of samples to the respective District TB Officers immediately to enable re-collection of specimens.
5. Laboratory needs to check the labelling of specimens in the specimen container and the test request form.
6. It should register the samples in Laboratory Information Management System (LIMS) and proceed for processing by the appropriate method.
7. Each laboratory needs to document the date of the receipt of the specimen, patient name, age, sex and address, the name of the referring health centre, the reason for testing and volume of the specimen in the Culture & Drug Susceptibility Testing lab register.

Resources

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

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

The criteria for acceptance and rejection of TB specimens at TB Diagnostic Laboratories are listed below:

Acceptance Criteria:

• Sample received in triple layer with no leakage
• Sample is without any blood and food particles
• Sample is received within 48 hours expected timeline after collection in a cool chain
• Adequate label and information about the specimen
• Identical name on the specimen and in the test request
• Sample is in adequate quantity

Rejection Criteria:

• Unlabeled or mislabeled specimens
• Specimen sent without the test request ID in Nikshay
• Mismatch in the name on the specimen and the test request in Nikshay
• If the container is full up to the lid with the specimen
• Sample is not collected in an appropriate container
• Specimen container is broken
• Leakage of specimen
• Sample received after two days of collection

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
 

All healthcare workers need to take the following precautions while undertaking the TB diagnostic specimen collection, transportation and receipt of samples as TB is an airborne infection:

1. There is the risk of transmission of tuberculosis infection occurring in health care facilities, including the laboratory when patients remain undiagnosed and untreated for tuberculosis.
2. The specimen needs to be collected in an aseptic environment, preferably in open space.
3. The collection area should be well-ventilated with adequate air exchanges (>12 per hour).
4. The Information, Education and Communication (IEC) material related with cough etiquette needs to be displayed in all TB related setting including Designated Microscopy Centres/ Nucleic Acid Amplification Testing Centres/ Culture Drug Susceptibility Testing laboratories.
5. Use of closed room, toilet and Outpatient Department area should be avoided while collection of sputum sample by a patient.
6. The slides once used should not be reused; same is applicable for thermocol boxes.
7. The contaminated materials should be safely disposed off.
8. The Triple Layer Packaging needs to be monitored at all levels; at point of exit and point of reception.
9. Leakage and broken thermocol boxes should be avoided and samples should be discarded in case of leakage.
10. While transportation, cold chain needs to be maintained.
11. The sample handlers should use proper personal protection equipment, including gloves, masks and gowns.
12. Use of mask, preferably N95, while receipt of samples and during processing in laboratories.
13. Healthcare workers should be provided with adequate waste disposal bins as per Biomedical Waste Guidelines and it should be utilized on regular basis.
14. Soap, sanitizer and handwash should be available to all dealing with collection, transportation and receipt of samples.
15. Those with symptoms suggestive of TB should not be involved in these key activities and should undergo a complete diagnostic workout.

Resources

• Training Module (1-4) for Program Managers and Medical Officer, NTEP, MoHFW, 2020.

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

Biological specimen/ samples collected on reaching a TB testing laboratory needs to be formally received. The sample may be handed over by agents(couriers, health staff/ volunteers, patient representatives) or by patients themselves. The formal receipt of sample enables further processes such as testing and communication of results back to the patient. If the sample is successfully received, the appropriate testing process is initiated using the sample, else it is rejected and a fresh sample requested. 

The designated Lab Technician (LT) at the Laboratory is responsible for receiving the sample. To initiate the receipt, the sample along with the patient, or the sample along with accompanying test request is required. If it is available, following are the steps to complete sample receipt:

1. Compare patient information (Patient Name and Patient ID / Sample ID/ Test ID) to the test request that has been made.
   • This is performed by searching the patient ID in Nikshay under the Diagnostics menu and comparing and matching the patient details and the label on the sample.
   • If a physical form (Request for examination of Biological specimen for TB) is available, the details on the sample label and form needs to be compared and matched as well.
2. If the details are matched the LT then checks the quality (mucopurulent, non-blood stained), quantity (adequate to perform the requested test) of the sample and ensures that there is no leakage.
3. If the above checks are passed, then the LT Accepts sample. If not the LT rejects sample with a request to get a new sample. The rejection of the sample and request to obtain a new sample is recorded on Nikshay and is communicated to the patient and the person who requested the test.  
4. To register the receipt by accepting/Check in the sample for testing in Nikshay. The relevant information may also be captured in the TB Laboratory Register.  Ensure that the Test ID (if not already present) / Lab serial number from the Lab register is labelled on the sample container.

Sample receiving in Nikshay

Figure: Sample Journey Tracking in Nikshay; Source: Nikshay Diagnostic Training Content.

Resources

1. Training Modules (1-4) for Programme Managers and Medical Officers, NTEP, 2020.
2. Nikshay Zendesk, Nikshay Knowledge Base, FAQs.
3. Nikshay Zendesk, Nikshay Knowledge Base, Diagnostics.

Assessment

Storage conditions of sputum sample can effect the test results.

• Sputum samples should be transported to the laboratory as soon as possible after collection.
• It is the responsibility of Laboratory Technician (LT) and Senior TB Laboratory Supervisor (STLS) to ensure proper storage and transport of sputum specimens.
• Sputum is stored to preserve the specimen quality.
• The stored sputum samples should not be frozen.

Storage of Sputum Samples

For microscopy

• For smear microscopy, sputum specimens should be examined on the same day and not later than 2 days after collection.
• If delay is unavoidable, the sputum collected should be stored in a cool place/ refrigerated at 4°C to inhibit the growth of unwanted microorganisms.
• Stored sputum samples should be protected from light and heat to prevent liquefaction of the sample, else it makes the selection of mucopurulent part of the sample difficult.
• Samples received over holidays/weekends should be stored in a cool place/ refrigerated at 4°C.

For liquid culture

• Sputum should be stored in a cool place/ refrigerated at 4°C to inhibit the growth of unwanted microorganisms; not later than 3 days after collection.

For molecular tests - Nucleic Acid Amplification Test (NAAT) and Line Probe Assay (LPA)

• Sputum must be stored by refrigerating at 4°C to inhibit the growth of unwanted microorganisms and transported in cool chain to the nearest molecular laboratory. It should not be stored beyond one week at 4°C.

Resources

Technical and Operational Guidelines; Chapter 3: Case finding and diagnosis strategy

PMDT Guidelines 2021

Assessment