Transport Of Infectious Substances
Transport of InfectiousSubstancesBest Practice Guidance for MicrobiologyLaboratories
Transport of Infectious Substances - Best Practice Guidance for Microbiology LaboratoriesTransport of Infectious SubstancesBest Practice Guidance for MicrobiologyLaboratoriesPrepared by: Inspector of Microbiology and Infection Control2
Transport of Infectious Substances - Best Practice Guidance for Microbiology LaboratoriesDH Information Reader ument purpose:ROCR ref:Title:Author:Publication date:Target audience:EstatesPerformanceIM & TFinancePartnership workingFor InformationGateway ref: 8334Transport of Infectious Substances - Best Practice Guidance forMicrobiology LaboratoriesInspector of Microbiology and Infection Control01 June 2007Directors of Microbiology, Directors of Pathology, Allied HealthProfessionalsCirculation list:GPs, NDPBs, Voluntary Organisations, DIPCsDescription:This document aims to offer practical advice regarding the transport ofclinical microbiology specimens from the General Practitioner’s (GP’s)surgery through to referral of cultures to reference laboratories.Cross ref:Superseded docs:N/AAction required:N/ATiming:Contact details:N/AInspector of Microbiology and Infection ControlFloor 5Wellington HouseLondonSE! 8UGFor recipient’s use: Crown copyright 2007First published 01/06/2007Published to DH website, in electronic PDF format only.http://www.dh.gov.uk/publications3
Transport of Infectious Substances - Best Practice Guidance for Microbiology LaboratoriesExecutive summary World Health Organization Guidance on regulations for the Transport of InfectiousSubstances 2005 (WHO/CDS/CSR/LYO/2005 22)1 state “it is the responsibility of theshipper i.e. the sending laboratory (consignor) to ensure the correct classification,packaging, labelling and documentation of all infectious substances destined fortransport”. This document aims to offer practical advice regarding the transport of clinicalmicrobiology specimens from the General Practitioner’s (GP’s) surgery through toreferral of cultures to reference ns/biosafety/WHO CDS CSR LYO 2005 22r%20.pdf4
Transport of Infectious Substances - Best Practice Guidance for Microbiology LaboratoriesContentsExecutive summary. 4Contents. 5Regulations 6Different packaging requirements . 7Category A and Category B classification . 7Courier Companies. . 7Royal Mail. 7Basic triple packaging system . 8Packaging (Category A Infectious Substances) . 8Packaging (Category B Infectious Substances) . 8Dangerous Goods Safety Advisers (DGSAs) . .9Driver Training. . 9Security of Specimens . 9Schedule 5 materials 9Sample Reception . 9Security Inspections by the department for Transport (DfT) 10Recording . 10Tracking .10Type of courier 10Informing receiving laboratory . 10Recipient laboratory informing sending laboratory . 10Transport of GP samples of laboratory . 10Public Transport . 11Air Passenger Provisions . 11Referral to Reference Laboratory . 11Spill clean-up procedure 12Prophylaxis . . 12Summary Sheet . 125
Transport of Infectious Substances - Best Practice Guidance for Microbiology Laboratories1. RegulationsA number of regulations govern the transport of dangerous goods, which include infectioussubstances: Transport of infectious substances to and from UK premises by road and rail is subjectto the Carriage of Dangerous Goods and Use of Transportable Pressure EquipmentRegulations 2004 as amended by the Carriage of Dangerous Goods and Use ofTransportable Pressure Equipment (Amendment Regulations 2005)2. This regulation requires consignors and carriers to use the European Agreement on thetransport of Dangerous Goods by Road (ADR) and the Regulations concerning theInternational Carriage of Dangerous Goods by Rail (RID) for the transport of alldangerous goods including infectious substances. The International Civil Aviation Organization (ICAO) issues Technical Instructions for theSafe Transport of Dangerous Goods by Air transport3. The International Air TransportAssociation (IATA) incorporates these instructions into their dangerous goodsregulations to cover air transfers4. These regulations also apply to goods sent by RoyalMail. For national flights, i.e. flights within one country, the National Civil AviationAuthorities apply national legislation, which is normally based on the ICAO provisions. Inthe UK, the Civil Aviation Authority (CAA) provides interpretation on the Safe Transportof Dangerous Goods by Air ICAO technical instructions 5 and these apply to nationalflights. The International Maritime Dangerous Goods Code published by the InternationalMaritime Association Organization (IMO) was developed as a uniform international codefor the transport of dangerous goods by sea6. In the UK, the Maritime and CoastguardAgency (MCA) are responsible for the application for the IMDG Code in the UK7. Forinfectious substances transported in road vehicles on ferry crossings, the ADRregulations are deemed to apply. There are a number of inconsistencies between road/rail and air regulations concerninginfectious substance transfers: In the definition of culture In the definition of Category B infectious substances Differences in the Category A indicative /Safety/mainframe.asp?topic id 1587http://www.mcga.gov.uk/c4mca/mcga-home36
Transport of Infectious Substances - Best Practice Guidance for Microbiology Laboratories2. Different packaging requirementsHowever, for practical purposes, most infectious substance transfers involve some roadtransport and road regulations would then apply.In 2005 these transport regulations were amended. Changes are detailed in a Departmentof Health (DH) publication “Changes to Infectious Substances Transport Procedures in2005”. This is available on the DH website8.Clinical Pathology Accreditation (UK) Ltd (CPA), Standards for the Medical Laboratoryadvise that the transport of specimens meet the necessary UK/International regulations9.3. Category A and Category B classificationThe United Nations changed the method of classifying pathogens in the internationaltransport regulation base. For transfer purposes only, pathogens will no longer be assignedaccording to their ACDP Hazard Group, but according to two new Categories, A and B.(ACDP Hazard Group classifications continue to apply for all activities other than transport).Some substances however, are not subject to this classification. Further details for allcategories are given in “Changes to Infectious Substances Transport Procedures in 2005.”4. Courier CompaniesSome courier companies will accept only Category B infectious substances; laboratoriesshould review their own local arrangements.It is advisable that individual laboratories identify, in advance, the courier company theywould use should there be a need to courier a Category A infectious substance at shortnotice.5. Royal MailRoyal Mail Group plc will not accept a package that contains UN2814 or UN2900 infectioussubstances as classified at 6.2 of the Technical Instructions for the Safe Transport ofDangerous Goods by Air published by ICAO i.e. they are not prepared to carry Category Ainfectious substances. It will accept Category B diagnostic specimens provided they arepackaged to P650 requirements. Full details may be accessed on the Royal Mailwebsite10.In 2005 DH published a document Changes to Infectious Substances Transport Proceduresin 200511. This document recommended that an exemption for transport by road/rail ofCategory A cultures intended for diagnostic and clinical purposes be applied to Escherichiacoli (verotoxigenic), Mycobacterium tuberculosis and Shigella dysenteriae type 1. This hasbeen adopted in transport legislation w.e.f. 1 July 2007. However, DH advise that nsLegislationArticle/fs/en?CONTENT ID 4114809&chk uk/portal/po/content1?catId 19100182&mediaId 19100261 &http://www.royalmail.com/portal/rm/content1?catId 400044&mediaId ionsLegislationArticle/fs/en?CONTENT ID 4114809&chk 8ziaOg7
Transport of Infectious Substances - Best Practice Guidance for Microbiology Laboratoriesthree organisms should not be sent via Royal Mail, rather a recognised courier companyshould be utilised.6. Basic triple packaging systemThe World Health Organization describe a basic triple packaging system12, which isreproduced here.This system of packaging shall be used for all infectious substances. It consists of threelayers as follows. Primary receptacle. A primary watertight leak-proof receptacle containing the specimen.The receptacle is packaged with enough absorbent material to absorb all fluid in case ofbreakage. Secondary packaging. A second durable, watertight, leak-proof packaging to encloseand protect the primary receptacle(s). Several cushioned primary receptacles may beplaced in one secondary packaging, but sufficient additional absorbent material shall beused to absorb all fluid in case of breakage. Outer packaging. Secondary packaging are placed in outer shipping packaging withsuitable cushioning material Outer packaging protect their contents from outsideinfluences, such as physical damage, while in transit. The smallest overall externaldimension shall be 10x10 cm.Each completed package is normally required to be marked, labelled and accompaniedwith appropriate shipping documents (as applicable).7. Packaging (Category A Infectious substances)Samples classed as Category A should be packed according to Packing Instructions P620for transport by road or rail. The packing, marking, labelling and documentationrequirements for Category A infectious substances are available from the World HealthOrganization Guidance on regulations for the Transport of Infectious Substances 2005(WHO/CDS/CSR/LYO/2005 22)13.It is recommended that the packaging used in the transport of Category A samples shouldnot be re-used. A number of commercial companies supply packaging for Category Ainfectious substances.8. Packaging (Category B Infectious substances)Category B infectious substances are assigned to UN 3373 (Diagnostic or ClinicalSpecimens) and must be packed to Packing Instructions P650. The packaging in whichCategory B samples have been transported may be re-used provided it is not contaminatedor soiled and is in good condition. A number of commercial companies supply packaging forCategory B infectious substances. There are different packaging requirements for PackingInstruction P650 depending on which mode of transport is used. These are detailed in y/WHO CDS CSR LYO 2005 iosafety/WHO CDS CSR LYO 2005 22r%20.pdf138
Transport of Infectious Substances - Best Practice Guidance for Microbiology Laboratoriesguidance document produced by the Department for Transport, the Civil Aviation Authorityand the Maritime and Coastguard Agency14.9. Dangerous Goods Safety Advisers (DGSAs)The Carriage of Dangerous Goods regulations state that all those (ie consignor, carrier andconsignee) involved in the transfer of dangerous goods, which includes Category Ainfectious substances, must have access to a Dangerous Goods Safety Adviser. TheDGSA does not have to be a member of staff, the role can be contracted out. A number ofhospitals, for example, share a DGSA. Standards for DGSAs are laid down by theDepartment for Transport and training and examination is operated under contract by theScottish Qualifications Authority.10. Driver TrainingAll drivers who carry Category A material are required to undergo 4-5 days trainingapproved by Department for Transport and pass formal exams. Drivers of vehicles notexceeding 3.5 metric tonnes were exempt from these requirements until 1st January 2007.11. Security of SpecimensThere is the potential that infectious substances being transferred from one site to anothermight be misappropriated for use in bioterrorism activities, so should be kept secure andnot handled by anyone that has not been appropriately identified. Further advice is detailedin the DH document Security and Safety in Microbiology Laboratories.12. Schedule 5 materialsLaboratories that have notified their holdings of Schedule 5 pathogens/toxins under Part 7of the Anti Terrorism Crime and Security Act 2001 are not required under the Act to notifytransfers of Schedule 5 materials.Further advice regarding the holding of Schedule 5 pathogens/toxins may be obtained fromthe National Counter Terrorism Security Office (NaCTSO) (nactso@btconnect.com).However the Control of Substances Hazardous to Health Regulations (2002) (COSHH) dorequire advance notification to the Health and Safety Executive (HSE) regarding aproposed transfer of human pathogens in Hazard Group 4. COSHH regulation 7(10)Schedule 3 paragraph 6. Further details are given at the HSE website15.13. Sample ReceptionSample reception is detailed in the CPA Standards for Medical Laboratories: a laboratoryshould have space for specimen reception (C1.2(b)) and laboratory management shallestablish a health and safety procedure(s) that includes specimen collection and handling,transport, reception and referral to other laboratories s/dft freight/documents/page/dft freight tes.htm16 www.cpa-uk.co.uk159
Transport of Infectious Substances - Best Practice Guidance for Microbiology Laboratories14. Security Inspections by the Department for Transport (DfT)The DfT is responsible for the security inspections of premises that are responsible for thetransfer of infectious substances. Laboratories moving Category A substances must have asecurity plan in place under provisions of ADR chapter 1.1017.15. RecordingA laboratory should hold a record of all samples referred to other laboratories. CPAStandards for the Medical Laboratory advise that laboratory management establishprocedures for the referral to other laboratories. This should include maintaining a record ofall specimens referred, dispatch dates and monitoring the return reports 18.16. TrackingSome courier companies use tracking systems to trace all packages going through theircare. It is recommended that sending laboratories ensure that their courier company doeshave such a system in place. A tracking system should be used for all Category Ainfectious substances17. Type of courierThe courier should be chosen according to the category of samples to be sent. The onus ison the sending laboratory to ensure samples are sent in a proper manner.Some courier companies will accept only Category B infectious samples, it may benecessary to use a different company for Category A infectious samples.18. Informing receiving laboratoryFor all Category A infectious substances, it is necessary for the sending laboratory toinform the recipient laboratory that samples are being sent and provide information onwhich tests are required.19. Recipient laboratory informing sending laboratoryThe receiving laboratory should inform consignees of receipt of Category A infectioussubstances within 24hours of them being received. This also applies to the deregulated Ecoli (verocytotoxigenic), M tuberculosis and S dysenteriae type O1. However if a result issent to the consignee within the 24 hours of the infectious substance being dispatched, it isnot necessary to send a confirmation of receipt.20. Transport of GP samples to laboratoryClinical samples transferred from General Practitioner (GP) surgeries to hospitallaboratories should be packaged to Packing Instruction P650. However It may be17 http://www.dft.gov.uk/stellent/groups/dft transsec/documents/divisionhomepage/030867.hcsp18 www.cpa-uk.co.uk10
Transport of Infectious Substances - Best Practice Guidance for Microbiology Laboratoriesimpracticable to package each specimen individually. The primary container holding theclinical sample should be placed into a sealed transport bag – this is usually attached to thespecimen request form. Some commercial companies do sell specimen transport bags witha small pad of absorbent material in the sample bag. If multiple specimens are placed in thesame transport bag, they should be cushioned to prevent breakage. The transport bags arethen placed into one large bag which contains sufficient absorbent material to contain theliquid in all of the primary containers. This second bag is sealed and placed into a rigidouter container with a sealable lid for transport purposes. Ensuring that this outer containermay be autoclaved is a sensible precaution should a spillage occur. The outer containershould be labelled as detailed in Packing Instruction P650. (Note: The current labellingrequirements will changed in air transport from 1st January 2007 and will change in landtransport from 1st July 2007. The regulations will require, in addition to the current mark,the words “BIOLOGICAL SUBSTANCE, CATEGORY A/ CATEGORY B”. Anyone orderingpackaging now may apply this information, as it does not contravene the currentprovisions.)21. Public TransportCategory A or B infectious substances must not be carried by a member of staff on theperson on public transport. A patient may take a sample to a GPs surgery via publictransport because this is outside the ADR regulations. A member of staff transportingclinical samples as part of their work would be expected to comply with the ADRregulations.22. Air Passenger ProvisionsInfectious substances in Category A or B are not permitted for transport in carry-on orchecked baggage and must not be carried on the person. (taken from Guidance onRegulations for the Transport of Infectious Substances)1923. Referral to Reference Laboratory19 Do not mix Category A and Category B samples in the same packaging (samples boxesare opened in different containment areas befitting the contents). Some couriers will nottransport Category A samples Do not mix ACDP category 2 and 3 in the same Category B packaging (samples areprocessed under different ACDP containment conditions) Indicate preliminary identification of the organism on the sample form to ensureappropriate containment level processing of the sample in the reference laboratory Include all relevant clinical information and preliminary identification of the infectioussubstance on the referral formhttp://www.dft.gov.uk/stellent/groups/dft freight/documents/page/dft freight 611600.pdf11
Transport of Infectious Substances - Best Practice Guidance for Microbiology Laboratories24. Spill clean-up procedureA guideline for the appropriate response in the event of an exposure to any infectioussubstance is included in the Wold Health Organization document, Guidanc
Transport of Infectious Substances - Best Practice Guidance for Microbiology Laboratories 2. Different packaging requirements However, for practical purposes, most infectious substance transfers involve some road transport and road regulations would then apply. In 2005 these transport regulations were amended. Changes are detailed in a Department
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