Institution
Laboratory name
Location
Head/Responsible person / Biosafety Manual
Sputum Collection and Packaging / Code:
Version: no.
Date: of release
Page: 1of 3

1. Sputum Collection and Packaging
2. Objectives and scope

The objective of this SOP is to describe proper, safe collection and packaging of sputum samples from patients in the clinic and field prior to transportation to the laboratory. This applies to all health workers involved in specimen collection and packaging.

This SOP is applicable to all employees of the laboratory and to all health workers involved in specimen collection and packaging.

3. Abbreviations, definitions and terms

•BO Biosafety Officer

•QMQuality Manual

•SOP Standard Operating Procedure

•TB Tuberculosis

•UN United Nations

•WHOWorld Health Organization

4. Tasks, responsibilities and accountabilities

Task / Responsible / Accountable
Proper collection of samples / Clinicians / Lab manager

5. Safety and environment

N.A.

6. Procedure

  1. The sputum container must be plastic, wide-mouthed, screw-capped and leak-proof. A 50 ml polypropylene tube is thus ideal.
  2. Tell the patient to move to an outdoor area exposed to sunshine.
  3. Tell the patient to cough 3-5 ml of sputum into the sputum container (primary receptacle).
  4. The patient should take care not to spit on the outer walls of the container.
  5. The patient tightens the lid of the container and returns it to the health worker.
  6. The health worker labels the container with the patient name, age and sex.
  7. The health worker fills in the patient’s details in a laboratory request form.
  8. The health worker wraps the container in cotton wool in sufficient quantity to absorb the entire contents in case of leakage.
  1. Secondary packaging – the cotton-wrapped sputum container is placed inside the ziplock bag and the bag zipped up.
  1. Tertiary packaging: The Ziplock bag and its contents are placed in another container.

The sputum is now considered safe to move from one laboratory to another.

A.Safety warnings to be written on the tertiary container

•Sputum and other specimens suspected to contain infectious Mycobacteria or other infectious agents are classified as “Infectious substance, Category B’’.

•The shipping name labeled on containers with such specimens is “BIOLOGICAL SUBSTANCE, CATEGORY B”.

•Infectious substances in Category B are assigned to a specific UN number: UN 3373.

•Label the safety box with the words “BIOLOGICAL SUBSTANCE, CATEGORY B” and the UN number: UN 3373


B. Maximum and minimum shipping quantity rules

For surface transport (road, rail or water) there is no maximum quantity per package.

For air transport:

•No primary receptacle shall exceed 1 L (for liquids) or 1 kg (for solids).

•The volume shipped per package shall not exceed 4L or 4 kg.

Detailed instructions are given in packing instruction P650 (reference 1)

7. Related documents

Quality Manual

8. Related forms

9. References

WHO/CDS/CSR/LYO/2005.22. Guidance on regulations for the Transport of Infectious Substances.

10. Attachments / Annexes

N.A.

Source: GLI Stepwise Process towards TB Laboratory Accreditation