Packaging of Diagnostic Samples
Diagnostic samples include blood, urine, faecal and other clinico-pathological samples sent for laboratory analysis and diagnosis. Since January 1st 2007, the packaging of these samples has been governed by new EC guidelines (ADR 2007).
These samples should be packaged in the manner prescribed below:
- The material should be placed in a leak-proof primary container. Faecal samples should be placed in screw-top containers to counter the effects of gas production in the container.
- The primary container should then be placed in a leak-proof secondary container. This can be achieved by placing the primary container into a leakproof bag. Ensure that either the secondary container or the outercontainer is rigid, for example, do not place a sample with a secondary plastic baginside a jiffy envelope- it must be in a box.
- Absorbent material should be placed between the primary container and the secondary and should be capable of absorbing the entire contents of the primary container.
- The words `BIOLOGICAL SUBSTANCES, CATEGORY B' should be clearly printed on the outside of the package.
Details of both the consignor and recipient, including contact names and numbers, should be printed on the outside of the package, along with the words 'BIOLOGICAL SUBSTANCES, CATEGORY B' and the following hazard symbol:
Provided that these conditions are met, the package may be sent by courier or post without any of the other conditions of the regulations applying
Diagnostic specimens sent in any other way to that prescribed above do not meet the requirements of the ADR and may not sufficiently protect the samples. Leakages of this material in transit may present serious health risks to those transporting the material and to the laboratory staff who receive it.
The term 'diagnostic specimen' (UN3373) applies to human or animal material - including but not limited to - excreta, secreta, blood and its components, tissue and tissue fluids, and body parts, being transported for purposes such as research, diagnosis, investigational activities, disease treatment, or prevention. This includes specimens likely to contain pathogens in World Health Organisation (WHO) Risk Groups 2 and 3 (see http://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf )
Samples that are known to contain, or have a very strong possibility of containing, an infectious micro-organism classified as belonging to World Health Organization (WHO) risk group 4* , or animal Class A diseases (Diseases of Animals Acts, 1966 to 2001), should be regarded as infectious substance and packaged as such. The full requirements of the ADR regulations apply. Further details may be obtained from the relevant legislation: Carriage of Dangerous Goods Act, 1998; S.I. No. 248 of 1998: Safety, Health, And Welfare At Work (Biological Agents) (Amendment) Regulations, 1998 - Fourth Schedule; Diseases of Animals Acts, 1966 to 2001.
*WHO Risk Group 4 pathogens are defined as pathogens that usually cause serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly, and for which, effective treatment and preventative measures are usually not available (i.e. high individual and community risk).
The following lists some of the companies that provide regulation compliant diagnostic specimen packaging systems:
Unit 5 Westpoint Trade Centre
Phone 021 4849082
16 Highfield Green,
21 Clover Hill,