Standard Operating Procedure- SOP
Name of institution
Sample Transport
ID Code:
Ap 10
Topic & Purpose:
Review Period:
Explains how to perform safe transport of
sample
1 year
Location:
Distribution:
Version number:
Annex:
V 1.0
None
Written by:
Name(s), Date(s) and Signature(s) of the Author(s)
Reviewed by:
Name(s), Date(s) and Signature(s)
Authorized by:
Name, Date and Signature
Replaces the version:
Not applicable (1st version)
Changes to the last authorized version:
Not applicable (1st version)
Institution:
Version: 1.0
Date:
ID Code: Ap10
Number of pages: Name of
3
procedure:
Sample Transport QM chapter: 7
Procedure
Sample Transport Procedure
Application ....................................................................................................... 2
Objective .......................................................................................................... 2
Definitions ........................................................................................................ 2
References....................................................................................................... 2
Responsibilities ................................................................................................ 2
Operating mode ............................................................................................... 2
Related documents .......................................................................................... 3
Application
This procedure ensures that no materials are inappropriately released to the
environment during transportation and that service employees are not
needlessly exposed to potentially hazardous materials.
Objective
This procedure explains the measures to be followed to safely and properly
pack and send samples.
Definitions
IATA: International Air Transport Association
References
WHO. Guidance on regulations for the Transport of Infectious Substances
2013–2014. Geneva, World Health Organization, 2012
(http://www.who.int/ihr/publications/who_hse_ihr_20100801/en/, accessed 30
August 2013).
Responsibilities
To be defined
Operating mode
Safe transportation procedures are universal for local or international ground /
air transportation – in normal circumstances materials should not leak out of a
container. After preparing the sample into appropriate transport media (refer
to SOP XXX), sample transportation rules must be followed to protect the
sample, the transporters, the environment and the recipient.
The following rules should be followed:
1. The sample container should be airtight and impermeable to water.
2. If the sample is contained in a tube, the tube should be firmly closed and
placed vertically for transportation.
3. The primary sample container should be placed for transportation into a
metal or plastic, firm, hermetically sealed transport container.
4. The transport container should be handled with care during transportation.
5. Each transport container should be labelled describing its contents.
6. Each transport container should be accompanied with forms indicating
sample details and patient identification data.
2
Institution:
Version: 1.0
Date:
ID Code: Ap10
Number of pages: Name of
3
procedure:
Sample Transport QM chapter: 7
Procedure
7. The transport device should be equipped with an emergency spill kit
consisting of absorbent material, disinfectant, waste container and gloves.
International rules for dangerous goods transportation
A. The main rules are structured by the “triple package” concept: three
different layers will be used to package the sample for transport.
1. Primary layer*: leak-proof sample container. The primary container
must be wrapped in sufficient absorbent material to absorb its entire
contents.
2. Secondary layer*: leak-proof secondary container, usually plastic or
metal. The primary or secondary container must withstand, without
leakage, a pressure differential of 95 kPa at temperatures between 40°C and +55°C.
3. Third layer*: an outer shipping container. The smallest overall external
dimension shall be 100 x 100 mm.
Infectious substance entering in United Nations Category A (infectious
substance which is transported in a form that is capable of causing permanent
disability, life-threatening or fatal disease in otherwise healthy humans or
animals)*: use IATA Packing Instruction P620
Infectious substance entering in United Nations Category B (infectious
substance which does not meet the criteria for inclusion in Category A)*: use
IATA Packing Instruction P650
* Please refer to current shipping guidelines for more details about definitions,
packaging requirements, markings and labels, accompanying documentation,
and refrigerants.
B. Packaging details
1. Do not contaminate the primary container (tube, transport media or
other).
2. The secondary container must have an adequate seal and be breakresistant. Tape the secondary container lid to prevent loosening during
transport.
3. All labels must be legible, indelible, and completely visible (do not
overlap). Label all material following labeling rules (refer to SOP
Sample Labelling).
4. Make sure the patient's name and date of birth on the accompanying
form(s) exactly match what is written on the transport tubes.
5. Place the absorbent material between the primary and secondary
containers to absorb the entire contents of the primary container in the
event of breakage or leakage.
6. Include the names, addresses, and telephone numbers of the sender
and recipient laboratories on both the containers and the
accompanying documents.
Related documents
SOP Sample Labelling Ref XXX, provided in this QM template as Ap 8
3