How to Pack Specimens Correctly

Transcription

1 English translation of Folkhälsomyndighetens guide Packa provet rätt - by Karolinska Institutet How to Pack Specimens Correctly Specimens for chemical or microbiological analyses are often transported by car and/or mail to the laboratory. International and national provisions regulate what you are allowed to send and how the contents should be packaged and labeled. This booklet is a practical guide on how to transport specimens within Sweden. 1(7) It is always the sender s obligation to ensure that specimens are correctly classified, packaged and labeled and that complete transport documentation is enclosed. Contact your local safety adviser if you have concerns regarding specimen classification and transport. Why is Packaging Important? For the Patient Each taking of a specimen is an intrusion on the patient. Taking the specimen can be experienced as unpleasant and it is common to wait anxiously for the result of an analysis. Correct packaging is necessary in order for the specimen to reach the laboratory without delay and undamaged, which is one of the requirements for a reliable test result. For the Transport Staff Post Office and transport staff experience anxiety when coming across poorly packaged specimens. They fear that leaking containers could infect them with dangerous diseases and that the specimens will contaminate other mail. For the Laboratory Staff Laboratory staff should be able to open the package without risk of coming into direct contact with the sample material. Contact Folkhälsomyndigheten (the Public Health Agency of Sweden) Telephone number: , opening hours Rules for Transport of Dangerous Goods Address: Folkhälsomyndigheten, Tomtebodavägen 12B, Solna

2 2(7) Rules for transport of dangerous goods Transport Rules The transport rules for dangerous goods are based on international agreements and regulated by provisions issued for the four types of transport; road (ADR-S 1 ), railway (RID-S 1 ), air (ICAO-TI 2 ) and sea (the IMDG code). These frameworks are revised every second year and it is therefore important to have access to the latest edition. Local rules apply for transport within hospitals or health care facilities. Safety adviser Access to a safety adviser is a requirement when transporting dangerous goods, although there are certain exceptions. Good to know Before Posting a Specimen Classification Transport of dangerous goods entails dangers of different types and substances are classified into different classes depending on their properties. Classification is important since it governs the type of packaging, labelling and documentation. The substance is also allotted a 4-digit UN number. Infectious substances in class 6.2 comprise substances and products that contain infectants in the form of bacteria, viruses or parasites that can spread disease to humans and animals. Class 6.2 is divided into category A and B. Substances that may cause permanent, life-threatening or deadly diseases for humans and animals belong to category A. Infectious substances that affect humans are divided into UNnumber UN2814 whereas substances that affect animals are allotted UN-number UN2900. There will be no further instructions for transport of UN2900 substances in this document. Infectious substances that do not meet the criteria for category A belongs to category B. Substances in category B have UN-number UN3373. Specimens from humans or animals where the probability of pathogens being present is minimal are not regulated by the rules, provided that the specimens are packaged in a leakproof receptacle and that it is marked with UNDANTAGET MEDICINSKT PROV (excluded medical sample). There are exemptions from the rules for transport of infectious substances with low or very low probability to cause disease. For a complete description of these exemptions, see the respective provisions. On pages 4-5 there is a summarized description of the transport rules for category A and B substances and for exempt medical sample. Dry ice is also classified as dangerous goods and regulated by transport rules when used for cooling of speciments, see page 6. 1 Provisions of the Swedish Civil Contingencies Agency (MSB) MSBFS : Transport of Dangerous Goods by Road and on Terrain (ADR-S), in Swedish 2 International Civil Air Organization. Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO TI).

3 3(7) The Packaging All specimens must be packaged and transported safely in order to prevent any substances from leaking during normal transport conditions. The same principle applies to all specimen packages, regardless of specimen type and transport method. The specimen packaging shall always contain the following: a leak-proof primary receptacle, e.g. a glass or plastic tube tightly sealed by a rubber stopper or screw-cap, an absorbent material capable of absorbing the full specimen volume; a leak-proof and protective secondary receptacle, a protective outer packaging. The requirement for type-approved packaging and labelling differs depending on the classification of the sample. If several tubes are placed in the same secondary receptacle, they must be separate from each other. Labelling Each package that contains dangerous goods must be clearly labelled and tagged in order to provide information regarding the dangerous properties of the substance. The outer packaging must be clearly labelled with the UN number(s), including the letters UN, and tagged with the warning diamond required by the frameworks and provisions. Fasten the label so that it is fully visible and stays in place during the entire transport. Documentation The sender must issue the required transport documents for each transport of dangerous goods. Depending on the type of transport, this may be a goods declaration, referral or shipper s declaration.

4 4(7) Transport of Infectious Substances UN 2814, Infectious Substances that affects humans Specimens suspected to contain risk group 4 microorganisms, patient samples as well as cultures, belong to UN2814 infectious substances that affect humans see, appendix 1. Some viruses that belong to risk group 2-3 are also included in this group as are certain bacterial cultures. If there are uncertainties to whether a substance meets the criteria or not, the specimen shall be included in category A. Specimens in category A are sent to the Public Health Agency of Sweden for analysis. For further reading about procedures, see Transport av höginfektiöst prov till Folkhälsomyndigheten (Swedish only). Both sender and transporter must have access to a safety adviser when transporting infectious substances, category A. Furthermore, the sender and transporter must meet the requirements for transport protection in chapter 1.10, that is, they shall work to minimize theft and unauthorized access. The driver must have a valid ADR license. Packaging The packaging must meet the requirements in packaging instruction P620 and be type-tested by an accredited test laboratory and granted a type-approved label (e.g. 4G/class 6.2/09/S/...). Label and tag For transport by road, label the outer packaging with: UN2814 Warning diamond class 6.2 Sender and receiver (clearly written) For transport by air, label the outer packaging with infectious substance affecting humans, UN2814 tag class 6.2 the net weight or net volume of the specimen name and address of sender name and address of receiver name and telephone number to the liable person Documentation The shipment must be accompanied by a goods declaration with the following information: UN 2814, INFECTIOUS SUBSTANCE THAT AFFECTS HUMANS (the complete biological name of the infectious substance) or (suspicion of infectious substance, category A), 6.2, (E) number and type of packages and total weight (tubes and contents) if required, the transport temperature name and address of sender name and address of receiver name and telephone number to the liable person, See appendix 2 for an example of a goods declaration. A detailed table of contents (referral) is placed in between the secondary receptacle and the outer packaging. In addition to a goods declaration, transport by air also requires a shipper declaration in two copies, written in English.

5 5(7) UN 3373, Biological substance, category B Included here are specimens from humans or animals, such as secretions, blood and blood components, tissue and tissue fluids, that are transported for research or diagnostic purposes, analysis, treatment or prophylaxis and that are likely to contain micro-organisms. Also included are clinical isolates in transport media sent for verification and typing, and panels for quality control. Packaging The packaging must meet the requirements in packaging instruction P650. There is no requirement for type-approval, but the packaging must be sturdy enough to withstand the contents. For transport by road, either the secondary or outer packaging must be rigid. For transport by air, the outer packaging must be rigid. Label and tag For transport by road, label the outer packaging with: BIOLOGISKT ÄMNE, KATEGORI B (Biological substance, category B) warning diamond, to the right preferably write the name of the sender and the receiver (not required in the framework) For transport by air, label the outer packaging with Biological substance, Category B UN3373 warning diamond, to the right the net weight or net volume of the specimen name and address of sender name and address of receiver Documentation There is no requirement for a goods declaration or shipper s declaration for transport of Biological substances, category B. Exempt Medical Specimen Included here are specimens where the risk of pathogens being present is minimal, for example blood or urine for chemical analysis. Note that specimens from patients with suspected/known infection must be classified as UN3373 Biological Substance Category B or UN2814 Infectious Substance Category A Packaging Exempt medical specimens are not regulated by ADR-S provided that the specimen is transported in a package that prevents leakage and that the specimen is correctly labelled. Furthermore, the packaging must adhere to the basic principles for a package (see above) and one side of the outer package must be at least 100 mm x 100 mm. It is appropriate to use the same packaging material as for biological specimens, category B. Label and tag Label with the text EXEMPT MEDICAL SPECIMEN. Sender and receiver shall be clearly marked on the packaging. Documentation There is no requirement for a goods declaration or shipper s declaration for transport of exempt medical specimen.

6 Frozen or cooled specimens Packaging When common ice is used to cool samples, it should be placed outside the secondary receptacle and in the outer package, which can be placed in an overpack 3. The secondary receptacle must be secured inwardly so that it does not move after the ice has melted. The outer package or the overpack must be leak-proof. Dry ice is classified as dangerous goods. Dry ice transforms into gas, which must be able to escape the package. 6(7) Label and tag For transport on road, label the package with the text: KOLDIOXID FAST (TORRIS) SOM KYLMEDEL In addition to that, dry ice is not affected by the regulations in ADR-S when used for cooling purposes. For air transport, label the package with: UN2814 Dry ice or Carbon dioxide (solid), net weight of the dry ice (kg) per package and the warning diamond to the right When several packages are placed in an overpack, the total weight of the dry ice must be indicated on the outside. Documentation A shipper s declaration is only a requirement when the dry ice is used to cool samples in another class of dangerous goods that do require a shipper s declaration, for example UN2814 Infectious substance that affects humans. 3 An overpack is a surrounding package, which is used for one or more packages in order to create one unit that is easier to handle.

7 Brief guidelines 7(7) Access to safety advisor required UN2814 Infectious substance that affects humans UN3373 Biological substance, Category B Yes No No Postal transit No Yes Yes ADR-driver Yes No No Packaging Type-approved for class 6.2 with preprinted label Primary receptacle Tube/container with leakproof stopper/lid Meet the criteria of packaging instruction P650, with adequate integrity Tube/container with leak-proof stopper/lid Absorbent material Yes Yes Yes Secondary receptacle Referral Outer packaging Leak-proof Packed on the outside of the secondary receptacle Rigid packaging, not smaller than 100 mm Secondary or outer packaging must be rigid when transported on road. Packed on the outside of the secondary receptacle Rigid packaging or padded envelope for transport by road, rigid packaging for transport by air. Minimal size is 100 mmx 100 mm Exempt Medical Specimen Leak-proof packaging Tube/container with leak-proof stopper/lid Leak-proof Packed on the outside of the secondary receptacle Rigid packaging or padded envelope, with adequate integrity Label See page 4 See page 5 See page 5 Tag No Goods declaration Yes No No Shipper s Declaration Max allowed volume for air transport 2 copies for air transport, in English Primary receptacle: 50 ml (g), Outer packaging: 4 l (kg), excluding dry ice No Primary receptacle: 1 l (kg), Outer packaging: 4 l (kg), excluding dry ice No -

8 Appendix 1. UN 2814 Infectious substances that affects humans 8(7) Biological agents that can cause infections in humans are defined according to 3 AFS 2005:1 as infectious and are classified according to the criteria in appendix 2 A to risk group 2, 3 or 4. When transported, patient samples or cultures that are suspected to contain infectious substances from risk group 4, fall into the classification UN2814 Infectious substances that affect humans. Some viruses from risk groups 2-3 are also included in this category as well as cultures of some bacteria, se below or section in ADR-S 2015:1. Examples of infectious substances in UN2814: Viruses in risk group 4 Strains / cultures and patient samples: All viruses in risk group 4 (according to classification in AFS 2005:1), Hendravirus (Paramyxoviridae), earlier Equine morbillivirus (not included in AFS 2005:1) Niphavirus (Paramyxovidirae) (not included in AFS 2005:1) Viruses in risk group 3 Strains / cultures and patient samples: Flexal virus (Arenaviridae) Hantaan virus (Bunyaviridae) Omsk Hemorragic Fever virus (Flaviviridae) Kuanasur Forest dis. virus (Flaviviridae) Monkeypox (Poxviridae) Seoul virus (Bunyaviridae) Viruses in risk group 2 or 3 Only applicable for strains/cultures (not patient samples) Dengue virus MERS-CoV (not in AFS 2005:1) Eastern Equine Encephalomyelitis virus Polio virus (EEE) Rabies virus Yellow Fever virus Rift Valley Fever virus Hepatitis B virus Russian Spring Summer Encephalitis virus Herpes B virus Sars-Corona virus (not in AFS 2005:1) HIV virus TBE Influenza A (H5N1) (not in AFS 2005:1) Venezuelan Equine Encephalomyelitis (VEE) Influenza A (H7N9) (not in AFS 2005:1) West Nile Fever virus Japanese Encephalitis virus Bacteria in risk group 3 bacteria Only applicable for strains/cultures Bacillus anthracis Chlamydia psittaci Brucella abortus Clostridium botulinum Brucella melitensis Coccidioides immitis Brucella suis Coxiella burnetii Burkholderia mallei Escherichia coli, verotoxigen a Burkholderia pseudomallei Francisella tularensis Mycobacterium tuberculosis a Rickettsia prowazekii Rickettsia rickettsia Shigella dysenteriae type 1 a Yersinia pestis a Cultures for diagnostic or clinical purposes are allowed to be transported as Category B, UN3373 Note that this table is not complete. Infectious agents, including new or newly discovered pathogens, that are not on the lists but that meet the criteria according to MSBFS 2015:1, shall be classified as UN2814. If it is unclear whether a substance meets the criteria or not, it shall be included in category A, UN2814.

9 Appendix 2. Example of a goods declaration 9(7) Content UN2814 Infectious substance that affects humans (suspicion of infectious substance, category A), 6.2, (E) Number of packages (förpackningar) Total weight (kg or l) Sender Unit/company Receiver Unit/company Liable sender Liable receiver Address Address Telephone Telephone

10 10( 7) Updates from previous version ( ) The format of the document has been changed since the earlier version. Information concerning packaging, labelling and documentation of specimens classified as UN2814, UN3373 and Exempt medical specimen are presented in this version with the purpose to simplify for senders of specimen. The section on frozen samples have been extended and an example of a goods declaration has been added. The changes in this version has been prepared together with Myndigheten för samhällsskydd och beredskap (MSB) and Stena Recycling AB. Translation into English by the Security and Environment Unit, Facilities Office, Karolinska Institutet.

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