transport & disposal of specimen containers & specimens policy

TRANSPORT & DISPOSAL OFSPECIMEN CONTAINERS &SPECIMENS POLICYJANUARY 2009Author:D. Johnston – Health andSafety Manager (Acute)Responsible Director:Ian Reid – Director of HRApproved by:Health and Safety ForumDate approved: January 2009Date for Review: January 2010Version: GGC Version 1Replaces previous version: N/A[if applicable]Specimen Transport Page 1 of 29

TRANSPORT & DISPOSAL OF SPECIMEN CONTAINERS & SPECIMENS POLICY............................................................................................................................................. 11 INTRODUCTION ...................................................................................................... 31.1 Location of copies:.............................................................................................. 31.2 References:.......................................................................................................... 31.3 Review ................................................................................................................ 41.4 Communication and Implementation Plan.......................................................... 41.5 Monitoring .......................................................................................................... 41.6 Impact Assessment.............................................................................................. 41.7 Definitions........................................................................................................... 42 SCOPE ........................................................................................................................ 53 ROLES AND RESPONSIBILITIES .......................................................................... 64 FLOW CHART OF PROCESSES COVERED BY THIS POLICY.......................... 85 CONSUMABLES IDENTIFIED AND SOURCED: ................................................. 96 HEALTH & SAFETY .............................................................................................. 106.1 Courier .............................................................................................................. 106.2 General Public................................................................................................... 116.3 Receiving Laboratory........................................................................................ 117 DISTRIBUTION OF SPECIMEN CONTAINERS ................................................. 128 PNEUMATIC AIR TUBE SYSTEMS..................................................................... 128.1 Breakdown of pneumatic system...................................................................... 128.2 Spillages............................................................................................................ 129 TRANSPORT OF BIOLOGICAL MATERIAL AND/OR SPECIMENSBETWEEN LABORATORIES........................................................................................ 1210 COURIERS........................................................................................................... 1311.1 Model Rules for Laboratory Porters ................................................................ 1311.2 Model Rules for Laboratory Couriers.............................................................. 1411.3 Model Rules For Pathology Laboratory Couriers............................................. 1511.4 Model Rules for Uplift of Specimens .............................................................. 1611.5 MODEL RULES FOR VISITORS OR OTHERS DELIVERINGDIRECTLY TO LABORATORIES............................................................................. 1712 PACKAGING, LABELLING AND DESPATCH ............................................... 1813 SPECIMEN INTEGRITY .................................................................................... 1914 INCIDENT REPORTING .................................................................................... 1915 REGULATORY REQUIREMENTS.................................................................... 2016 CLASSIFICATION OF INFECTIOUS MATERIAL.......................................... 2017 DISPOSAL OF WASTE SPECIMENS AND OTHER BIOLOGICALMATERIALS.................................................................................................................... 2018 Appendices............................................................................................................ 2218.1 Appendix 1 - Pathology .................................................................................... 22Specimen Transport Page 2 of 29

1 INTRODUCTIONThis policy describes the minimum standard to which operators should aim whentransporting specimens within and between hospital premises, to and fromcommunity sources and to outside (non NHSGG&C) agencies.It is recognized that the large and varied area and practices covered cannot beserved by a prescriptive policy document. The policy, therefore, does notprescribe the mechanisms or precise means of transport of specimens in thevarious areas and activities covered. It seeks, rather, to encourage localmanagers to design and document their own safe working procedures, remindsthem of their statutory legal obligation to assess and document any risk involvedand audit/police the success of their standard operating procedures.Several sets of “Model Rules” are provided in this document and should be usedwhere general staff functions are discharged in a manner that is not determinedby geographic peculiarities.The Policy aims to provide a uniform structure and define standards, for all ofNHSGG&C, to transport and receive biological specimens in a legally compliantand safe manner.1.1 Location of copies:Placement at each laboratory reception area and at each specimen collectionpoint. Available for each manager/quality officer involved with specimencollection/transfer/disposal. Procurement/Laboratories Directorate ExecutiveOfficers/ Transport Managers. Copies may be downloaded through StaffNet.1.2 References:1. CPA standards C5 and E42. Transport of Infectious Substances, 2004, Department of CommunicableDisease, Surveillance and Response, World Health Organisation.3. Chemicals (Hazard Information and Packaging for Supply) Regulations2002 as amended4. A Code of Practice for the Prevention of Infection in Clinical Laboratories –Howie report 1979 – Appendix 2 Model Rules for Laboratory Porters andMessengers, Prevention of Infection5. A Code of Practice for the Prevention of Infection in Clinical Laboratories –Howie Report 1979 Appendix 2 Model Rules for Laboratory6. The Approved List of Biological Agents, for the purposes of Control ofSubstances Hazardous to Health Regulations 2002, 20047. Safe Working and the Prevention of Infection in Clinical Laboratories andsimilar facilities, Health Services Advisory Committee, 20038. Safe Working and the Prevention of Infection in the Mortuary and PostMortem Room, Health Services Advisory Committee, 2003Specimen Transport Page 3 of 29

9. Biological Agents: Managing the Risks in Laboratories and HealthcarePremises, Advisory Committee on Dangerous Pathogens, 200510. Management of Health and Safety at Work Regulations 199911. Control of Substances Hazardous to Health Regulations 2002 (asamended)1.3 ReviewThis policy will be reviewed at least every two years or when circumstancesdictate1.4 Communication and Implementation PlanThe following will be included for awareness of the policy and dissemination tostaff:Procurement,Ward Managers,Laboratory Managers,Portering and Domestic Services,Quality Managers,Directorate Executive Managers,Human Resources (Health and Safety Advisers.)Transport Departments1.5 MonitoringProgress and implementation of the policy will be subject to a rolling auditprocedure. Health and Safety Advisers will be responsible for administration andexecution of audits. At least one full audit report will be presented to LaboratoryAnnual Management Review meetings.1.6 Impact AssessmentTo be completed upon agreement of Policy, prior to final distribution.1.7 DefinitionsCategory A Pathogens: the higher risk infectious micro-organisms, defined as“an infectious substance, which is transported in a form that, when exposure to itoccurs, is capable of causing permanent disability, life-threatening or fataldisease in otherwise healthy humans or animals”. Any specimen that mightreasonably be considered to harbour such organisms should also be treated asCategory ASpecimen Transport Page 4 of 29

W.H.O. Risk groups classifications may found at:www.who.int/csr/resources/publications/WHO_CDS_LYO_2004_9/En/Infectious substances including those containing new or emerging pathogens,which do not appear in the lists defined above, but that meet the same criteria ascategory A pathogens, should be treated as Category A pathogens. These mustbe transported as UN2814 (Infectious substance affecting humans) and labeledas “Infectious substance affecting humans” Pack according to PackingInstructions P620THE DEPARTMENT OF HEALTH HAS PROHIBITED SENDING OF ANYCATEGORY A SUBSTANCES BY POST.Category B Pathogens: any micro-organism that does not meet the criteria forcategory A. It includes human material such as, but not limited to, excreta,secreta, blood and its components, tissue and tissue fluids, and body parts beingtransported for purposes such as research, diagnosis, investigational activities,disease treatment or prevention. These are assigned to UN3373 and must bearthe marking “Biological Substance – Category B” and be packed to PackingInstructions P650Substances not subject to the regulations: Non-pathogenic organisms Blood and blood components for transfusion or transplant andtissues or organs for use in transplants Samples (non-human/animal derived) where there is only a lowprobability of infectious substances being present Decontaminated clinical or medical waste2 SCOPEThis policy describes the requirements for methods of transport of specimensand containers to and from laboratories within the NHSGG&C area and tolaboratories outwith that area. Specifications according to various disciplines maybe accessed in the Appendices as requiredDeliberate Exclusions:1. Techniques of specimen collection: physical collection of specimens, frompatients, must be determined on geographical, individual and clinical basisto suit the circumstances of collection. It is therefore outwith the scope ofthis policy to prescribe methods of collecting specimens.2. Biological material, e.g. organs or tissue (solid or liquid), and theirproducts, that are harvested for therapeutic purposes, from eithercadaveric or living donors, require special modes of preservation andtransport and are therefore not included in this policy.Specimen Transport Page 5 of 29

3. Storage and transport of cadavers is not included in this policy.4. Transfer of specimens, in a working situation and wholly within laboratorypremises, is excluded.5. Couriers who are contracted by NHSGG&C, who stipulate specialconditions for specimen uplift and transfer, and who provide allconsumables required, are excluded from this policy.6. Cultures prepared for the intentional generation of pathogens may not betransported as diagnostic specimens. Special instructions (P620) apply tothese materials.3 ROLES AND RESPONSIBILITIESResponsibility:All those involved in specimen collection are responsible for ensuring the safetransport of the specimens to their intended destination.All health care workers who handle or transfer specimens are responsible fordoing so in a safe, appropriate and confidential manner.Procedures designed during the process, for transfer of specimens, must be riskassessed formally by appropriate managers and recorded.The policy document has been designed and edited by groups from theLaboratory Directorate, Infection Control, Domestic and Portering Services andTransport Services.Applicability:The policy applies to collection of specimens within ward or community clinicalareas, their transport to laboratories, and their final disposal after analysis.While it is expected that everyone dealing with specimens will observe the policyit is also recognised that, from time to time, circumstances or geographicrestrictions or peculiarities may make certain parts of the policy unworkable.There may also be methods of transfer of specimens, e.g. involving cryogenicmaterials, which will require special containers, heightened levels of difficulty ortransfer conditions. Senior managers, in conjunction with H&S Officers andadvisers must assess risk of alternative procedures and make suitable, sufficientand safe adjustments to the policy at a local level. Such alterations must berecorded and lodged with the Clinical Director for Laboratories, with QualityManagers for the areas concerned, with the senior Site Facilities Manager for thearea and, if relevant, with the senior Manager of Transport Services.Traceability:On occasion, where exceptionally invasive or uncomfortable techniques havebeen used, e.g. biopsy specimens, or where there is a legal requirement for“chain of custody” a system of traceability is required. This will involve a detailedmethod of tracking the history of specimen transfer from place to place and fromperson to person. Most of the manual transfer of specimens within Healthcarepremises and to and from delivery/collection points is expected to be performedby porters who are under direct control of Facilities Managers. The organisationSpecimen Transport Page 6 of 29

and delivery of the means of delivering this function will therefore be theresponsibility of the (Lead) Site Facilities Managers who will co-operate withTransport Managers serving their areas. The process may be carried out usingeither paper or electronic means or a combination of both and must takecognisance of the principal consignor, transfer and recipient parties concerned.The success of such an operating procedure is dependent on the inclusion andco-operation of all of these parties.Specimen Transport Page 7 of 29

5 CONSUMABLES IDENTIFIED AND SOURCED:CEDAR numbers vary according to site of request: contact helpdesk at local suppliesDepartment for CEDAR numbers and codes.A level of standardisation may be required. At present different request forms and differentrequesting techniques are used.The items and suppliers described here may alter, from time to time, according to general servicerequirements.Item description: Manufacturer’s Part Number FunctionNot RequiredComputergeneratedrequestsHISS type request form (blank andprinted on requesting site)Twin pocket polythene bag “ResealableSpecimen Bags)Request form integral with sealablebagOpaque blue polythene bag for(manual) ward to lab transferBox for courier/van transport or softsided pack Gusset Style EnvopakEnvopak pouch, flat style, long edgezipGriff BinSharp SafesAutoclave boxesShelved trolley at each specimencollection/delivery point.May also be used for ward to lab(manual) transfers.Henley’s MedicalHB-55Jones & BrooksBiochemistry,HaematologyMicrobiology/VirologyPathology: Supplier to becontacted with specificationsonce unitary forms havebeen agreedFast-Aid Products LtdB402839BUDaniels, Industrial Estate,Kidlington, Oxon. OX5 1JQPart No.: DD851Part number required1G412, 457x356x102 mm1F7 483 x 381mmGriffiths and Neilson.Stane StreetSlinfoldHorshamWest SussexRH13 OTWUKMail Room TrolleyHC Slingsby PLC, OtleyRoad, Baildon,Shipley,BD17 7LWPathopak (for GPO) DGP Pathoshield 4,Compliance@dgpgroup.comwww.dgpgroup.comFor HISS formand tubesFor handwrittenrequestsWard to labportering withmultiplecollections onmultiple floorsGP to LabtransfersAlternative GPto lab or wardto lab transfersDisposal ofanalysedspecimensFor bulktransfer ofspecimens(Van to Lab,Ward to Lab)For sending byGPO or nonNHS courier.Specimen Transport Page 9 of 29

6 HEALTH & SAFETYSpecimens must be transported in such a way as to ensure the safety of thecourier, the general public and the receiving laboratory.6.1 CourierPrimary and secondary specimen containers are ordered through GeneralStores/Supplies Department using the CEDAR system.Specimens must be packed for transport in a way that prevents crosscontamination of forms or other specimens when a specimen leaks. As far as ispossible, all specimens should be kept within a leakproof container and beseparate to their own request form. Reasonable care should be taken that thespecimen is closed properly, that its primary transport container is sealedproperly and can contain any leaks or spills, and that all documentationaccompanying the specimen is clean and unlikely to be contaminated. Theseprinciples should also be applied to secondary and tertiary containers that maybe required for onward transport. Do not put more than one set of patientspecimens in one bag.ENVOPAK sealable bags are used to transfer emergency specimens(http://www.envopak.com/) on occasions when use of taxis or other publicservice transport cannot be avoided.Model Rules for Laboratory Couriers are detailed in Management Instructionsand are published as a separate controlled document and within this document(Refer to local document control system).Instructions in case of accident or incident, where the Laboratory Courier isunable to communicate, are detailed in Management Instructions and within thisdocument. (Refer to local document control system)Instructions for use of Pneumatic Air Tube Systems is detailed in ManagementInstructions (Refer to local document control system)Specimen Transport Page 10 of 29

Pay especial note to restrictions in type of specimen (governed by pathology oranalysis) that can be transferred using this type of system. Note that localcircumstances will dictate precise use of these tools.Model Rules for porters are detailed in Management Instructions and within thisdocument. (Refer to local document control system)6.2 General PublicMembers of the General Public are issued with guidelines on the collection andtransport of specimens as required. This includes the use of urine collectionbottles containing acid preservatives. Safety Data Sheets should be issued witheach specimen container. These should include instructions, for patients andothers, on how to collect a 24h specimen of urine and how to use the bottles.Patients should be encouraged to use Hospital or Health Centre facilities fortransport of specimens to laboratories. They should be discouraged from bringingspecimens to the laboratories by their own means of transport.Model Rules for visitors to the laboratory are detailed in a separate controlleddocument and at the end of this document. (Refer to local document controlsystem)6.3 Receiving LaboratoryClinical laboratories’ reception staff are trained in the proper method of openingthe sealed specimen transport boxes. Boxes contain wadding, which is changedwhen the box is cleaned and/or in the event of a spillage.Specimen containers that are visibly soiled will be dealt with as per departmentalprocedure. The source of origin will be notified should action be required.Biohazard Spill kits are located within laboratory reception areas. All staff aretrained to use these kits. Laboratory staff will not clean spills outside of thelaboratory area unless a formal agreement has been made for them to do so.Model Rules for Laboratory Reception Staff are detailed in a separate controlleddocument . These rules may vary according to local conditions and requirements.(Refer to local document control system)Specimen Transport Page 11 of 29

7 DISTRIBUTION OF SPECIMEN CONTAINERSSpecimen Containers: Specimen containers should be ordered via general storesand used for transport of specimens to the laboratory. The outer containersshould be labelled with originating source.Specimen Uplift:Collection times and points must be agreed at local managerial level andregistered with the local Quality Managers, the Director of transport, Director andlocal manager of laboratories. It should be understood that all times agreed aredependent on traffic and weather conditions8 PNEUMATIC AIR TUBE SYSTEMSAll specimens should be placed in sealed specimen bags and placed in apneumatic tube carrier (pod) as described in local policy.8.1 Breakdown of pneumatic systemIn the event of breakdown contact the appropriate persons as described by localpolicy and with reference to the installation company.8.2 SpillagesIf a spillage is suspected in a carrier pod do not open the pod unless within thelaboratory environment and under the instruction of a qualified and experiencedperson.9 TRANSPORT OF BIOLOGICAL MATERIAL AND/ORSPECIMENS BETWEEN LABORATORIES.Royal MailTransport of W.H.O. Risk group 3 and 4 specimens/materials, by public mailsystems, is prohibited. These materials must be transported, followingappropriate packaging, by specialist courier/transport companies.W.H.O. Risk Group 1 and 2 materials/specimens can be sent by public postalsystems provided they are wrapped properly and are labelled according to theinstructions (following) in this policy.Specialist couriers may have different requirements and a standard operatingprocedure, for making materials/specimens safe for transport, should be agreedwith the courier before sending.W.H.O. Risk groups classifications may found at:Specimen Transport Page 12 of 29

www.who.int/csr/resources/publications/WHO_CDS_LYO_2004_9/En/10 COURIERSWhere possible, use couriers already contracted to NHSGG&C. These couriercompanies will help with advice about methods and materials for packaging. Thecourier also has the right to refuse collection of materials considered unsafe evenif properly packaged.11 MODEL RULESThese may differ by location. Local rules will not form part of the policy but willhave to be agreed both at local level and with partnership input.11.1 Model Rules for Laboratory PortersThe Model Rules, given below, are published as a separate controlled documentwhich is displayed within the Porters Office, Laboratory Reception and in eachdepartment of the laboratory. (Refer to local document control system)1. Carry all specimens in opaque plastic bags (blue bags are sourced in thepreceding table) or the boxes provided - large boxes for ward collection,small boxes for collection of emergency specimens. Pathology specimensare transported directly to the Pathology Department in specialised, sealedboxes. Theatre and Day Surgery Unit boxes must be transported flat onthe trolley provided. At the Pathology Department, the boxes areexchanged on a one for one basis.Sealed boxes must not be opened by unauthorised staff2. Any cuts or grazes on your hands should be covered with a waterproofdressing at all times3. Touch specimens as little as possible4. If you do touch any specimens wash your hands as soon as possibleafterwards5. Wash your hands often - before meal breaks, and at the end of a spell ofduty6. If a specimen leaks into the box, tell laboratory reception staff who willtake steps to make the spillage safe7. If you drop or break a specimen, do not touch it or clear up the mess.Quarantine the area and call for assistance in having the spillage cleanedby people trained for that task.8. Handle specimens carefully at all times9. Never eat, drink or smoke when carrying specimens, or when in thelaboratorySpecimen Transport Page 13 of 29

12. If you cut yourself or have an accident, however small, tell your linemanager and if required go to the Accident & Emergency Department.Also tell the Health & Safety Officer and see that an incident report iscompleted11.3 Model Rules For Pathology Laboratory Couriers1. The Model Rules, given below, are published as a separate controlleddocument which is displayed within the Transport Office, PathologyLaboratory Van and Pathology Reception. (Refer to local documentcontrol system)2. In the event of an accident or incident, vacate vehicle, cordon offimmediate area, telephone the Hospital switchboard who will contact asenior member of the Pathology Department for advice.3. If you have a breakdown or accident do not let anyone touch thespecimens unless they are an authorised hospital employee4. Always ensure specimens are not subjected to extreme heat, cold or left indirect sunlight. Report all incidents that may affect the quality of thespecimens or the safety of personnel to the laboratory representative, whowill liaise with the sample source and destination5. Uplift sufficient empty specimen boxes for each run from the laboratory6. Boxes are sealed at source using plastic ties, uplift box and leave empty,replacement box7. Deliver sealed boxes to Pathology reception8. Carry gloves and some absorbent wadding (cotton wool or wypalls) inyour vehicle. The standard operating procedure, for dealing with leakingspecimens, should be followed.9. Any cuts or grazes on your hands should be covered with a waterproofdressing at all times10. Do NOT touch specimens at any time11. Wash your hands often - before meal breaks, and at the end of a spell ofdutySpecimen Transport Page 15 of 29

12. Never eat, drink or smoke when carrying specimens, within hospitaltransport or when in the laboratory13. If you cut yourself or have an accident, however small, tell your linemanager and if required go to the Accident & Emergency Department.Also tell the Health & Safety Officer and see that an incident report iscompleted11.4 Model Rules for Uplift of SpecimensThe Model Rules, given below, are published as a separate controlled documentwhich is displayed within each specimen collection area, at porters’ stations,within laboratory reception areas and in the Transport Manager’s office. (Referto local document control system)1. Patient confidentiality, privacy and dignity must be maintained at all times.2. Specimens must be kept in a stable and suitable manner especiallyhaving regard to requirements of temperature and exposure to bright light.3. Equipment and materials must be on hand, readily, to deal with breakageof or spillage from specimen containers.4. Specimen collection points must be easily recognisable and, as far as isreasonably possible, must be in a constant position within the area.5. Design of the collection point, and its position, will be the responsibility ofthe area manager but must be agreed with those, e.g. porters, couriers,etc., who will collect specimens from it.6. A timetable for collection of specimens should be agreed with thoseresponsible for collecting the specimens and should be published adjacentto the specimen collection point.7. The specimen collection point must be sited so as not to be accessible tocasual passers by or other unauthorised persons.8. Staff in charge of collection points are encouraged to demanddocumentary identification details from those coming to collect specimensat the collection point.9. All materials kept at the collection point must be stored in a way that doesnot allow casual observation of identification or clinical details on individualspecimens.Specimen Transport Page 16 of 29

10. Persons leaving specimens at collection points must ensure, by carefulvisual examination, that the specimens containers, wrappers, bags andrequest forms are clean and free of visible contamination.11. Persons collecting specimens should examine them to ensure that thespecimens containers, wrappers, bags and request forms are clean andfree of visible contamination. The specimen must not be uplifted from thespecimen collection point if there is any obvious contamination or soilingon it or its associated wrapper and documentation.12. Any deviation from any of these rules should be reported, immediately, tothe manager in charge of the area in which the collection point is placed.11.5 MODEL RULES FOR VISITORS OR OTHERSDELIVERING DIRECTLY TO LABORATORIESAll visitors should report to reception on arrivalEngineers or workers from out-with the department must obtain approvalfrom the section manager before commencing workChildren are not allowed in the laboratory working area and must besupervised closely at all times if present in other areasAll visitors should:o Avoid eating, drinking, chewing, smoking or running in anylaboratory working areao Wear appropriate protective clothing in the laboratory working areabut not in the common room or hospital dining areaso Avoid hanging protective clothing beside coats, jackets etc. (pegsare provided for protective clothing)o Wash hands after removing protective clothing or handlingspecimens.o Keep all areas clean and unclutteredo Not obstruct exits or floorso Remain under supervision. If required to do so a senior member oflaboratory staff and/or security should be informed when the visitorenters and leaves the work areaSpecimen Transport Page 17 of 29

o Report any incidents including any personal injury to the Health &Safety Officer and documented (IR1 form)o Refer to the local fire safety procedure12 PACKAGING, LABELLING AND DESPATCHAll specimen boxes have an identifying yellow label containing the biohazardsymbol: -and stating: -BIOHAZARDPATHOLOGICAL SPECIMENSIN THE EVENT OF ANACCIDENT OR INCIDENTPLEASE CONTACT: -Local Contact details to be inserted.Instructions in case of accident or incident are published as a separate controlleddocument. (Refer to local document control system)Leakproof secure containers (Part number/Cedar Number supplied) must beused when specimens are transported outside of hospital bounds.All hazardous specimen containers are identified with appropriate hazardwarning labels e.g. corrosive symbol for acid.24-hour urine bottles are transported in individual carrier boxes containingsufficient packaging material to soak up any liquid spillage. Formalin bottles aretransported in leak proof containers capable of containing the effects of aspillage.Specimen Transport Page 18 of 29

COSHH Risk assessments are available for all hazardous specimencontainer materials eg - 10% Buffered FormaldehydeSpecimens in FormaldehydeEXEMPT HUMAN SPECIMENSPI 650The specimen containers and specimens are transported via the appropriateHospital Transport DepartmentA more detailed description of requirements for specimens preserved inFormaldehyde, especially concerning Pathology Departmentalrequirements, is given in Appendix 1.13 SPECIMEN INTEGRITYSpecimens are transported to the laboratory with minimum delay. All specimensare kept out of direct sunlight to preserve sample integrity.14 INCIDENT REPORTINGIncidents and accidents are reported to the appropriate Line Manager, and theHealth & Safety department, if an IR1 form is required.Specimen Transport Page 19 of 29

Incidents and accidents involving the Pathology van are also reported to thePathology Department.All incidents and accidents are investigated.15 REGULATORY REQUIREMENTSSpecimen transport complies with the Transport of Infectious Substances, 2004,Department of Communicable Disease, Surveillance and Response, WorldHealth Organisation. Specimen containers are packaged to comply withChemicals (Hazard Information and Packaging for Supply) Regulations 2002,asamended16 CLASSIFICATION OF INFECTIOUS MATERIALThe classification UN3373 “Biological Specimens – Category B” covers allspecimens, which are sent to laboratories except those which might containGroup 4 biological agents. As such they must be packaged under packaginginstructions P650. This requires a leak proof primary receptacle (universal, bloodvial, etc) and leak proof secondary packaging such as a self-sealing plastic bag.Liquid specimens must have absorbent material between the primary andsecondary containers sufficient to absorb the entire contents.The classification UN3373 is based on the small quantity of infectious materiallikely to be present in a diagnostic specimen. Bacterial cultures sent from onelaboratory to another contain much more hazardous material and should beclassified as UN2814 “Infectious substance affecting humans” and must bepackaged under packaging instructions P620.Packaging instructions P650 and P620 are outlined in annex 1 and annex 2Transport of Infectious Substances, 2004, Department of CommunicableDisease, Surveillance and Response, World Health Organisation.Note additional requirement for labelling of specimens in formaldehyde. (Section 12above and Appendix 1 below.)17 DISPOSAL OF WASTE SPECIMENS AND OTHERBIOLOGICAL MATERIALSA local standard operating procedure for disposal of waste specimens should beagreed between laboratory managers, theatre managers and the local Director ofFacilities.Essential requirements are:1. All materials should be kept secure until disposal.2. Weight and size restrictions, as required by Manual Handling OperationsRegulations, must be obeyed.Specimen Transport Page 20 of 29

3. All waste material must be packaged in water and gas tight packaging4. All marks that might lead to identification of patients providing thespecimens/tissue must be obliterated in the disposal procedure. Thedisposal agents may have to take responsibility for this and providesatisfactory evidence of the process.5. All waste material must be destroyed in such a way that any residue,particularly if going to landfill, is microbiologically sterile and chemicallystable as befits disposal by landfill.6. Any material that is not suitable for incineration should be clearly markedas such.Specimen Transport Page 21 of 29

18 Appendices18.1 Appendix 1 - PathologyTransportation of Laboratory (Pathology) SpecimensBecause of the distinction of risks between infectious substances and diagnosticspecimens, there are variations to the packaging, labelling and documentationrequirements.The packaging requirements are determined by the United Nations (UN) and arecontained in ICAO (International Civil Aviation Authority) and IATA (International AirTransport Authority) regulations in the form of Packaging Instructions PI 602 and PI 650There are 4 steps involved in the transportation of laboratory specimens1. Classification & Categorisation2. Packaging3. Labelling4. Transporting1) ClassificationInfectious substances are classified according to their risk/danger to humans. Theycome under Class 6 –(Toxic Poisonous and Infectious substances), Division sub class 6.2 (Infectioussubstance)CategorisationWithin Division 6.2, infectious substances are categorised as follows - Category A – an infectious substance which is transported in a form that, whenexposure to it occurs, is capable of causing permanent disability, life threateningor fatal disease to humans or animalsAssigned shipping classification – Humans UN 2814. Animals only Assignedclassification – UN 2900Packaging instruction – P620Hazard Group Classification i.e. - UN 6 (infectious)Category B – any infectious substance that does not meet the criteria forinclusion in Category AAssigned shipping classification – UN 3373.Packaging instruction – P650Hazard Group Classification i.e. - UN 6 (infectious)The only exception to this is CULTURES, which are assigned UN 2814 or 2900Specimen Transport Page 22 of 29

2) PackagingThe Packaging Instruction is determined depending on the infectious categorisation orrisk category as followsCategory A substances - Packaging Instruction PI 620Packaging should be UN type approved and consist of –1. Leak proof primary receptacle either glass, metal or plastic2. Leak proof secondary receptacle either metal or plastic – If screw caps are used,they should be secured by positive means e.g. tape3. Other than solid infectious substances, absorbent material in sufficient quantity toabsorb the entire contents placed between the primary receptacle and thesecondary packaging4. An itemised list of contents shall be enclosed between the secondary packagingand the outer packaging5. Specimens of unknown infectious risk but suspected of meeting the criteria forinclusion in Category A, the words ( suspected Category A infectioussubstance) must be shown on the outer packagingEmpty containers showing signs of contamination must be destroyed rather thanbeing returned to the original consignor.Category B substances – Packaging Instruction PI 650The packaging shall consist of 3 components –1. A primary receptacle of suitable material appropriate to the specimen2. A secondary packaging to contain the primary packaging in such a way that undernormal handling the primary packaging will not break or leak. Absorbent materialshould be placed between the Primary and the Secondary as a precaution toleaking fluid.3. An outer packaging to contain the secondary packaging and suitable cushioningmaterial to secure the secondary packaging. This should not be compromised bybreakage or leakage of the primary packagingFormaldehyde content - Packaging Instruction PI 650The packaging for pathological specimens containing formaldehyde is as for CategoryB substancesRefrigerants (dry ice) - Packaging Instruction PI 904When specimens are being transported in dry ice (solid carbon dioxide) it ismandatory that the packaging isdesigned and constructed to permit the release of carbon dioxide gas and prevent abuild up of pressure thatcould rupture the package. The dry ice must be placed outside the secondaryreceptacle. If wet ice is used,all packaging must be leak proof.Specimen Transport Page 23 of 29

If dry ice is used for infectious substances, the details must appear on the packaging,the word“MISCELLANEOUS” and Hazard Group classification UN 9 (Dry Ice)3) LabellingBasically when specimens are being transported, the following information should beevident on the outsideof the transport container (the tertiary packaging)1. United Nations risk of infection shipping classification (the level of risk) – UNnumber2. How the specimen was packaged – Packaging Instruction Classification – PInumber3. Identification of the hazard type – UN Hazard Class number4. Orientation Arrows – Keep specimen upright – not required if fluid is less that120ml and absorbent material will completely absorb the liquid. Class 6 infectioussubstances – 50ml (January 2007 edition of RID) page 591. ExamplePathological Sample in Formaldehyde11111111EXEMPT HUMANPI 650Specimen Transport Page 24 of 29

Additional Labelling common to all P.I.5) Sender address6) Receiver address7) Contact details (telephone number of sender)8) Biological Hazard Sticker4) TransportingThere are several reasons why specimens require to be transported – Doctor’s surgery to laboratory From hospital to diagnostic laboratory From one laboratory to anotherThe principles for safe transport are the same as for air or international transport – thematerial should not have any possibility of escaping from the package under normalconditions of transportGeneral Principles Specimens should be packaged appropriately according to their risk Where indicated, specimens should be transported upright secure Specimens should be secured within a watertight and leak proof transport boxwith a “secure tag” type lid Specimen boxes should be secured in a suitable dedicated laboratory vehicle Each transport box should be labelled appropriately consistent with itscontents Specimen data, forms and identification data should accompany each transportbox (audit sheet) A Spill Kit containing appropriate materials should be carried in eachlaboratory transport vehicle (not in the specimen compartment) Laboratory transport vehicle drivers should carry a mobile phone and be fullyaware of all SOPs relating to their activityTransport planningThe efficient transport and transfer of specimens and infectious material dependsupon good communications and a partnership between all partiesThere are 3 parties involved in specimen transportation and all have a specificresponsibility to carry out the transport effortSpecimen Transport Page 25 of 29

The sender Make advance arrangements with receiver where appropriate Make advance arrangements with courier (if not a routine service) Prepare appropriate documentation (tracker sheets) Notify receiver if appropriate of expected time of arrivalThe carrier Provide sender with shipping documentation if appropriate (privatecourier) Is familiar with the contents of the shipment (external markings onpackages) Is familiar with SOPs appropriate to the task ( full set of instructionsrelative to specimen transportation) Carries a Spill Kit and is trained in its use Notifies sender of any problems with specimens or delays in deliveryThe receiver Informs sender ( telephone, FAX) if there is any discrepancy where thecontents are not in accordance with the accompanying documentationPathology ExampleDiagnostic Pathological Specimen being sent by road in a container of formaldehydesolution1. UN 2209 – Formaldehyde2. PI 650 – Packing Instruction3. UN 8 – Hazard Classification – Corrosive4. Additional labelling common to allEXEMPTIONS from Category B - UN 3373 (January 2007 edition of RID) page 23/24Exemption applies to substances in a form that any present pathogens have beenneutralised or inactivated (formaldehyde fixation, example above) such that they nolonger pose a health risk. Such substances are not subject to RID.Diagnostic pathological specimens where there is a minimal likelihood that pathogens arepresent and provided that the specimen is carried in a packaging, which will prevent anyleakage and which is also marked with the words “EXEMPT HUMAN SPECIMEN”,would fall into the exemption category.Specimen Transport Page 26 of 29

In the case of the example above, the UN 2209 (formaldehyde) has been substituted forUN 3373 as the risk is not one of infection but that of formaldehyde i.e. UN 2209 and istransported under “Dangerous Goods”Where non-fixed pathological material is being transported, an element of professionaljudgement is required to determine if a substance is exempt. This judgement should bebased on known medical history, symptoms and individual circumstances of the sourceand endemic local conditions.Non Pathology ExampleCategory ADiagnostic Specimen meeting the criteria for inclusion in Category A being sent byroad1. UN 2814 – Infectious Category A2. PI 620 – Packing Instruction3. UN 6 – Hazard Classification – Infectious4. Additional labelling common to allNon Pathology ExampleCategory BDiagnostic Specimen not meeting the criteria of Category A1. UN 3373 – Infectious Category B2. PI 650 – Packing Instruction3. UN 6 – Hazard Classification – Infectious4. Additional labelling common to allSpecimen Transport Page 27 of 29

18.3 Appendix 2 Example of Tracker Form for Traceability (Internal)Clyde Pathology ServicesTracker SheetComplete all sections in Block CapitalsDispatchedFrom………………………………………..DispatchedTo…………….……..………………………Discrepancy ContactNo……....…..….…….…………..Extension…………………….Date Dispatched………………Time Dispatched….…….…..…Courier/NHS/Other…………….Dispatched by…………………………………Date Theatre Patient's Name D.O.B. No. of Pots Specimen DescriptionSpec takenClinicDate Received…………………….Time Received…………………….Received By…………………………Checked By…………………………Specimen Transport Page 28 of 29

18.4 Appendix 3 Example of Tracker Form (External Transport)LF-RPAT-SR002V1.0Issue Date: 1 st February 2008Clyde Division Histopathology ServiceDepartment of Laboratory MedicineRoyal Alexandra HospitalCorsebar RoadPaisley PA2 9PNTEL: 0141 314 6647Fax: 0141 314 6913External Transport Delivery Tracker FormIn order to comply with CPA and the Royal College of Pathologists Guidelines, please acknowledge byFAX receipt of the following materialDatePatient Name + DOBSpecimen DescriptionDestination DepartmentDestination HospitalPackaged ByCourier / Taxi FirmDriver: Print Full NameCompany Contact No.I acknowledge receipt of the above material:Please print your name in CAPITAL LETTERS:……………………………………………………………………………………………..Signed:Date:Please complete and fax this form to the number above as soon as possible to confirm receipt ofrequested materialSpecimen Transport Page 29 of 29