Letterkenny General Hospital Pathology Department Prepared By HMC Dr MM

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Transport of Specimens to the Laboratory

CONTENTS

INTRODUCTION................................................................................................................ 2 1.1 1.2 1.3 1.4 1.5 SCOPE AND PURPOSE .................................................................................................. 2 RESPONSIBILITY .......................................................................................................... 2 REFERENCES .............................................................................................................. 2 DEFINITIONS................................................................................................................ 3 RELATED DOCUMENTS ................................................................................................. 3

PROCEDURE .................................................................................................................... 4 2.1 TRANSPORT OF SPECIMENS ......................................................................................... 4 2.2 PROCEDURE FOR PACKAGING, LABELLING AND DISPATCH OF LABORATORY SPECIMENS .. 5 2.3 TRANSPORT AND PACKAGING OF SPECIMENS TO THE LABORATORY FROM WITHIN THE HOSPITAL. .............................................................................................................................. 6 2.4 PACKAGING OF SPECIMENS AND INFECTIOUS SUBSTANCES GOING TO THE LABORATORY FROM OUTSIDE THE HOSPITAL ................................................................................................. 7 2.5 PROTECTION OF THE SPECIMENS FROM DETERIORATION ............................................... 8

APPENDICES.................................................................................................................... 8 3.1 3.2 3.3 3.4 3.5 3.6 APPENDIX 1 PACKING INSTRUCTIONS P650................................................................... 9 APPENDIX 2 PACKING INSTRUCTIONS P620................................................................. 10 APPENDIX 3: INDICATIVE EXAMPLES OF INFECTIOUS SUBSTANCES (CATEGORY A) ........ 13 APPENDIX 4: SAMPLE TRANSPORT DANGEROUS GOODS NOTE .................................... 15 APPENDIX 5: CLASSIFICATION FLOWCHART ................................................................. 18 APPENDIX 6: SPECIMENS EXCLUDED FROM TRANSPORT VIA THE PTTS ........................ 19

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1 INTRODUCTION 1.1 Scope and purpose

This document describes the policy on Transport of specimens to the Laboratory (from the community and within the hospital). The procedure is available to those who are responsible for specimen transportation to and within Letterkenny General Hospital. The specimen transportation system ensures the timely arrival of specimens at laboratory reception, in optimal condition, at the correct destination, in a manner that does not pose a threat to the health and safety of anyone coming in contact with the sample and is in compliance with regulations.

1.2 Responsibility
It is the responsibility of laboratory management in conjunction with hospital management to ensure that this procedure is adequate and adhered to at all times.

1.3 References
Understanding Accreditation in Laboratory Medicine by David Burnett 1996 A Practical Guide to Accreditation in Laboratory Medicine by David Burnett 2002 Health Services Advisory Committee: Safety in Health Service Laboratories, Safer Working and the Prevention of Infection in Clinical Laboratories Safe Transport of Infectious Substances by Air - Central Public Health Laboratory Agrement Dangereux Routier (ADR 2007) Carriage of Dangerous Goods Act 1998 Carriage of Dangerous Goods Amendment 2005 Advisory Committee on Dangerous Pathogens International Air Transport Association (IATA) Packaging Instruction P650 of ADR 2007 [European Agreement for the Carriage of Dangerous Goods by Road] S.I. No 29 of 2004 - Carriage of Dangerous Goods by Road Regulations, 2004. LGH Health & Safety Policies Manual of Infection Control Procedures, p 103. N. N. Damani. 2nd edition, Greenwich Medical media Limited, London, 2003.

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1.4 Definitions
ADR: Agrement Dangereux Routier (UN/ECE European Agreement Concerning the International Carriage of Dangerous Goods by Road) Patient specimens: Human material including but are not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs, and body parts being carried for purposes such as research, diagnosis, investigational activities, disease treatment and prevention. Cultures: The result of a process by which pathogens are intentionally propagated. IATA: International Air Transport Association Infectious Substance: Category A: An infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in otherwise healthy humans or animals. Category B: An infectious substance which does not meet the criteria for inclusion in Category A. LIS: Laboratory Information System UN: United Nations PTTS: Pneumatic Tube Transport System

1.5 Related documents

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2 PROCEDURE
This procedure is in place to ensure specimen integrity and the safety of all those coming in contact with the specimen during transportation. It takes account of ADR Regulations 2007, IATA Regulations 1994 and 1998, the Safety, Health & Welfare at Work Act 2005, Biological Agents Regulations,1994 and 1998 and all other relevant health & safety regulations.

2.1 Transport of Specimens

Specimens are transported to the Laboratory as follows: To the Laboratory by: Authorised hospital staff General Practitioners Patients Courier Taxi Pneumatic Tube Transport System

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2.2 Procedure for Packaging, Labelling and Dispatch of Laboratory Specimens

All laboratory specimens have the potential to contain substances that are infectious. Sometimes this potential is unknown but equally there are times when it may be known. The main principle of safety in this regard is to package and label all specimens in such a manner so that they present no threat to those sending, transporting or receiving them. However, when it is known that a specimen contains a serious hazard in the form of an infectious agent then it is prudent that a higher than normal standard of packaging, labelling and transport be applied. For these reasons specimens are categorised as belong to one of two categories, with each category having its own labelling and packaging instructions. CATEGORY A: An infectious substance which is transported in a form that, when exposure to it occurs, is capable of causing permanent disability, life-threatening or fatal disease in humans or animals. An exposure occurs when an infectious substance is released outside of the protective packaging, resulting in physical contact with humans or animals. An indicative list of infectious agents in Category A is given is Appendix No. 3. Contact the laboratory or refer to Appendix 3 if transporting specimens thought to contain agents in Category A. CATEGORY B: An infectious substance that does not meet the criteria for inclusion in Category A. The majority of laboratory specimens fit into Category B. Ref.: Appendix No. 3: Indicative Examples Of Infectious Substances (Category A) A BIOHAZARD sticker (fig1) should be placed on the sample container and request form of any specimen from a patient who is known to have or is being investigated for any of the following: Undiagnosed jaundice HIV Hepatitis B or C Tuberculosis Viral Haemorrhagic Fever History of I.V. drug abuse Severe Acute Respiratory Syndrome (SARS) New variant Creutzfeldt-Jacob Disease (nvCJD)

Biohazard

Fig1

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2.3 Transport and Packaging of Specimens to the Laboratory from within the Hospital.
These regulations are in place to ensure the safety of all those coming in contact with pathology specimens during transportation. All patient specimens should be treated as potentially hazardous and handled accordingly. Should there be a suspicion that a specimen contains a Category A infectious substance, please contact the laboratory for information on packing instructions or refer to Appendix No. 2. Specimens are transported to the laboratory via the pneumatic transport system or are brought directly to the laboratory by members of the hospital staff. 1. Primary specimen containers, e.g. blood collection tube or an MSU container, must be placed in an appropriate biohazard plastic bag with the request form (if any) in a separate plastic bag. 2. For PTTS transport the bagged specimen is placed inside the carrier pod and sent to the required destination in the laboratory. Specimens excluded from transport via the PTTS are listed in Appendix No. 6 3. Those specimens brought to the laboratory should be packed and transported in a carrier bag in such a way as to avoid damage in transit. 4. The carrier bag must be capable of retaining any liquid in the event of sample leakage. 5. If a specimen leaks or is damaged in transit an appropriate laboratory or portering supervisor should be contacted immediately. 6. All tissue (excluding bone marrow) from a patient with known or suspected nvCJD or any TSE must be packaged according to Packaging instruction P650, Appendix No. 1,and brought directly to the histopathology department. The Histopathology Department must be notified in advance of any such tissue being sampled. Ref.: H&S-0003 Staff Health & Safety Manual. Ref.: Appendix No. 1: Packaging Instruction P650 Ref.: Appendix No. 2: Packaging Instruction P620 Ref.: Appendix No. 3: Indicative Examples Of Infectious Substances (Category A) Ref.: Appendix No. 6: Specimens Excluded from Transport via the PTTS

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2.4 Packaging of Specimens and Infectious Substances Going to the Laboratory from Outside the Hospital
It is the responsibility of all persons sending samples to the laboratory to adhere to this policy and to national regulations and to ensure that specimens sent to the laboratory do not present a risk to anyone coming in contact with it during transportation or on receipt in the laboratory. The principle of safe transport by this means is the same as for air or international transport the material should not have any possibility of escaping from the package under normal conditions of transport. The following practices should be observed: 1. Specimen containers should be watertight and leak-proof; e.g. blood collection tube, MSU container 2. If the specimen container is a tube, it must be tightly capped and placed in a rack to maintain it in an upright position; NB: Urine containers must be individually packaged to absorb the entire contents of the primary receptacle 3. Specimen containers and racks should be placed in robust, leak-proof plastic or metal transport boxes with secure, tight fitting covers; 4. The transport box should be secured in the transport vehicle; 5. Each transport box should be labelled appropriately consistent with its contents; the mark illustrated below shall be displayed on the external surface of the outer package.

The proper shipping name "BIOLOGICAL SUBSTANCE, CATEGORY B must be marked on the outer packaging adjacent to the diamond-shaped mark. 6. Specimen data forms and identification data should accompany each transport box; 7. A spill kit containing absorbent material, a chlorine disinfectant, a leak-proof waste disposal container and heavy duty reusable gloves should be kept in the transport vehicle. Note: The practices 1 7 described above are not intended to supersede local or national requirements.
Packaging of Specimens Assigned to Category A Specimens assigned to category A are packaged and labelled in accordance with packaging instruction P620. Contact the laboratory.

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2.5 Protection of the Specimens from Deterioration

All specimens must be transported to the laboratory for examination as quickly as is reasonably practicable. Specimens are maintained at the correct temperature and under conditions recommended for examination as per the Primary Sample Collection Manual

3 APPENDICES
1. Appendix No. 1: Packaging Instruction P650 2. Appendix No. 2: Packaging Instruction P620 3. Appendix No. 3: Indicative Examples Of Infectious Substances (Category A) 4. Appendix No. 4: Sample Transport Dangerous Goods Note 5. Appendix No. 5: Classification flowchart 6. Appendix No. 6: Specimens Excluded from Transport via the PTTS

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3.1 Appendix 1 Packing Instructions P650

Packagings shall be of good quality and strong enough to withstand normal shocks and loadings normally encountered during carriage. Packagings shall be constructed and closed so as to prevent any loss of contents, which might be caused under normal conditions of transport, by vibrations or by changes in temperature, or humidity. Packaging requirements: Inner packaging containing: -One or several powder-proof primary containers. Secondary packaging: -Hermetically sealed; -Absorbent material must be included in sufficient quantity to absorb the whole package contents. Primary containers shall be packed in secondary packagings in such a way that they cannot break [...], be punctured or leak and that they contain all liquid material within the package without leakage to the outside. Outer packaging -Constructed and closed; -Strong enough to withstand the free-fall drop tests 1 Please note that infectious substances relating to N UN 3373 which have been packaged and marked according to the P650 packaging instruction are not subjected to any other ADR requirements.

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3.2 Appendix 2 Packing Instructions P620

Packaging Infectious substances in Category A may only be transported in packaging that meets the United Nations class 6.2 specifications and complies with Packing Instruction P620. This ensures that strict performance criteria are met; tests for compliance with these criteria include a 9-metre drop test, a puncture test and a pressure test. The outer packaging shall bear the United Nations packaging specification marking), which indicates that the packaging has passed the performance tests to the satisfaction of the competent authority. The primary receptacle or the secondary packaging shall be capable of withstanding a pressure differential of not less than 95 kPa. The United Nations packaging specification marking alone does not indicate that a test for this has been undertaken, and packaging users should ask their suppliers whether the completed package meets this requirement. For surface transport there is no maximum quantity per package. For air transport the limits per package are as follows: 50 ml or 50 g for passenger aircraft 4 l or 4 kg for cargo aircraft. Any primary receptacle with a capacity of more than 50 ml shall be oriented in the outer packaging so that the closures are upwards. Orientation labels (UP arrows) shall be affixed to two opposite sides of the outer packaging. Marking Packages are marked to provide information about the contents of the package, the nature of the hazard, and the packaging standards applied. All markings on packages or overpacks shall be placed in such a way that they are clearly visible and not covered by any other label or marking. Each package shall display the following information on the outer packaging or the overpack. the shippers (senders, consignors) name and address the telephone number of a responsible person, knowledgeable about the shipment the receivers (consignees) name and address the United Nations number followed by the proper shipping name (UN 2814 INFECTIOUS SUBSTANCES AFFECTING HUMANS or UN 2900 INFECTIOUS SUBSTANCES AFFECTING ANIMALS, as appropriate). Technical names need not be shown on the package. temperature storage requirements (optional) when dry ice or liquid nitrogen is used: the technical name of the refrigerant, the appropriate United Nations number, and the net quantity

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Letterkenny General Hospital Pathology Department Prepared By HMC Dr MM Labelling There are two types of labels:

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(a) hazard labels in the form of a square set at an angle of 45 (diamondshaped) are required for most dangerous goods in all classes; (b) handling labels in various shapes are required, either alone or in addition to hazard labels, for some dangerous goods. Specific hazard label(s) shall be affixed to the outside of each package for all dangerous goods to be shipped (unless specifically exempted). The hazard labels shown below are of importance for infectious substances in Category A:

Label name: Infectious substance Minimum dimensions: 100 100 mm (for small packages: 50 50 mm) No. of labels per package: 1 Colour: Black and white The words INFECTIOUS SUBSTANCE shall be shown. The statement In case of damage or leakage immediately notify a Public Health Authority is required in some countries.

Hazard label for Category A infectious substances and for genetically modified microorganisms and organisms that meet the definition of an infectious substance, Category A Label name: Miscellaneous dangerous substances Minimum dimensions: 100 100 mm (for small packages: 50 50 mm) No. of labels per package: 1 Colour: Black and white

Hazard label for certain noninfectious genetically modified microorganisms and organisms (UN 3245) and for carbon dioxide, solid (dry ice) (UN 1845);

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Letterkenny General Hospital Pathology Department Prepared By HMC Dr MM Documentation The following shipping documents are required.

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To be prepared and signed by the shipper: for air: the shippers Declaration for Dangerous Goods (Figure 8 shows one example) a packing list/proforma invoice that includes the receivers address, the number of packages, detail of contents, weight, value (Note: for international transport, a minimal value shall be indicated, for customs purposes, if the items are supplied free of charge) an import and/or export permit and/or declaration if required. To be prepared by the shipper or the shippers agent: an air waybill for air transport or equivalent documents for road, rail and sea journeys. For UN 2814 and UN 2900, an itemized list of contents shall be enclosed between the secondary ackaging and the outer packaging. When the infectious substance to be transported is unknown, but suspected of meeting the criteria for inclusion in category A and assignment to UN 2814 or UN 2900, the words suspected Category A infectious substance shall be shown,

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3.3 Appendix 3: Indicative Examples Of Infectious Substances (Category A)

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3.4 Appendix 4: Sample Transport Dangerous Goods Note

Box Completion Instructions 1 Exporter (Shipper, Consignor, Sender) Name and address including postcode. Customs reference/status This box should be used by the exporter to declare the Unique Consignment Reference (UCR) for the export movement. The construction of the declaration UCR (DUCR) should follow the format required by HM Revenue & Customs, including the use of alpha, numeric characters and spaces and hyphens - see HM Revenue & Customs. Tariff and Public Notice No. 275. Exporters should NOT use this box for the purpose of quoting just the commercial reference of the consignment (see Box 4 below). This box should NOT be used for declaring the Master UCR (MUCR) - see Box 12 below - or consignments in FREE CIRCULATION moving solely within the EU. Booking number Booking reference number of carrier (shipping line, combined transport operator). Exporter's reference Consignment reference designated by the exporter - optional if already quoted as part of the DUCR in Box 2. Forwarder's reference Consignment reference designated by the forwarder (if any). Consignee Should be used for name and address including post code of the consignee/importer. DSHA Notification (in accordance with DSHA regulations (as amended) given by There is a requirement under DSHA (Dangerous Substances in Harbour Areas) regulations to pre-notify the movement of dangerous goods into harbour areas to the Harbour Master. A cross ("X") should be placed in the box of the person responsible for pre-notification. Prior notice must be given to the port before the dangerous goods arrive. The period is usually a minimum of 24 hours but is often less for ro/ro ports. The DGN may be accepted as pre-notification. Freight Forwarder Name, address of freight forwarder (if any), including postcode. International Carrier Name of shipping line or combined transport operator. Not required by sea for short sea roll on/roll off consignments. Other UK transport details Information required in this box will differ depending on the consignment in question and the specific information and procedural requirements of receiving authorities and shipping lines e.g. delivery address, ICD terminal, vehicle booking reference, receiving dates, name of receiving authority, haulier's collection instructions. Vessel and port of loading. Vessel name and the port of loading e.g. MV Canadian Explorer, Liverpool. Port of discharge and destination. Name of the port of discharge and the ultimate destination (if inland carriage is included) e.g. Casablanca, Marrakech.

3 4 5 6

6A

7 8

10 11

12

Consignment Information the UN Number preceded by the letters "UN". the Proper Shipping Name (supplemented when applicable with the technical name). Trade names alone are not acceptable. the Class, or when assigned the division of the goods, including for Class 1 the compatibility group letter followed by any subsidiary hazard class which should be shown in brackets; the Packing Group, where assigned, for the substance which may be preceded with the letters "PG" (e.g.PG II) the Sequence of the Information a, b, c, d Examples "UN 1098 ALLYL ALCOHOL, 6.1 (3), I" or "UN 1098 (3), PG I" Laboratory ALLYL ALCOHOL, 6.1 CORROSIVE, N.O.S (Potassium hydroxide solution in alcohol)on (8), PGII paper only Policy Controlled documents , 3 BLUE "UN 2924 FLAMMABLE LIQUID, Additional Information required by modal regulations following a-e For ADR The tunnel Code unless you are certain the goods will not pass through a tunnel For IMDG Code The flashpoint, marine pollutant, limited quantity etc

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This is not a comprehensive list of additional information Particular attention should be paid to the following: Requirements for Specific Classes, including infectious and radioactive material. Salvage Packaging, Waste, Elevated Temperatures. Empty Uncleaned Packagings and Tanks. There are some differences between the road, rail and sea regulations. The Number and Kind of Packages e.g. 2 x 250 L steel drums; 3 x fibreboard boxes each containing 48 kg. (There is no need to specify details of inner receptacles or inner packagings). Note: UN Packaging codes (1A1, 4G, etc) may only be used to supplement a package description. E.g. "steel drum (1A1)". They must not be used on their own Overpacks Where a number of boxes or drums, for example, are consolidated onto pallets or into larger boxes for ease of handling then the description on the DGN should state that the packages are overpacked. NOTE a pallet is not a package Variations in requirements between the Dangerous Goods Regulations In a few circumstances the requirements for a particular substance or article may be significantly different between the IMDG Code and RID/ADR. In such cases the provisions of Chapter 1.1.4.2 of the ADR Agreement and RID Regulations (consignments that fully meet the requirements of the IMDG Code for packing, mixed packing, marking and labelling shall be accepted for carriage under ADR/RID in a transport chain including maritime transport), a statement shall be included in the transport document as follows; "Carriage in accordance with 1.1.4.2.1" h. Customs - Where a consignment forms part of a consolidation or groupage movement this box should also be used to declare the Master UCR (MUCR). The consolidator or groupage operator should construct the MUCR in accordance with the format prescribed by HM Revenue & Customs, including the use of alpha, numeric characters and spaces, hypens and forward slashes - see HM Revenue & Customs Tariff and Public Notice No. 275. The consolidator or groupage operator should normally add the MUCR to a Standard Shipping Note already completed by the Exporter. 13 Net weight (kg) of goods The net weight (kg) for each separate dangerous goods description. Note only required for explosives (Class 1)

Gross weight (kg) of goods The weight of the merchandise in its export packaging in kilograms for each separate goods description included on the DGN NOTE: DG rules require the total quantity they do not specify whether it should be mass (KG) or volume (L) but it 13A must be shown for each Proper Shipping Name Total gross weight of goods The total gross weight in kilograms of the goods should be entered. For containerised goods this excludes the weight of the container. Cube (m3) of goods Measurement of goods in cubic metres for each separate goods description indicating whether pallet measurements are included Total cube of goods The total cubic measurement of the goods. Package dimensions of abnormal loads. Not required by sea for short sea roll on/roll off consignments Container/vehicle packing certificate and declaration (CVPC) Note: the CVPC is at present required only for sea transport, including combined journeys. For container/vehicle loads - name of company, name/status of declarant, place and date (where and when signed), signature of person responsible for the packing/loading of the dangerous goods into the container/vehicle. NB: The container/vehicle packing certificate and declaration serves a separate function to the dangerous goods declaration, and the two are very often signed by different people. However, for the sake of convenience the two declarations are included in the same document. The consignor (exporter) of the goods is responsible for signing the dangerous goods declaration (box 17), but the declaration under the container/vehicle packing certificate (box 15) must be signed by whoever is responsible for packing/loading the dangerous goods into the container/vehicle. It is clearly inappropriate for the consignor to sign the packing certificate (box 15), if the packing/loading of the container/vehicle is undertaken elsewhere - e.g. at a groupage or consolidation depot, or at an outside warehouse. (Further guidance can be found in the introduction to this note) Container identification number/vehicle registration number e.g. ACLU 269687/4. Seal Number(s) The number as shown on exporter's and/or Customs' seals used to secure the container/trailer. Container/vehicle size and type e.g. 40ft GP. The ISO code for container size/type may also be used (although this is not mandatory). Tare (kg) The tare weight as marked on the container safety convention (CSC) plate. Total gross weight (including tare) (kg) Total weight of boxes 13A and 16C.

14

15

16 16A 16B 16C 16D

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NOTE: Boxes 16-16D will normally need to be completed by the haulier or carrier Name and telephone number of shipper preparing this note Name/status of declarant - name and position within the company of the person preparing the DGN. Place and date - place and date of signature Signature of declarant - signature of a responsible person who is familiar with the nature of the danger(s) of the goods and with the legal requirements and liabilities which apply to the shipment of dangerous goods (see box 10A of the DGN - the Dangerous Goods Declaration). NOTE: This box only need be completed when there is a sea journey . Declarations and signatures are not required for road or rail journeys

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3.5 Appendix 5: Classification Flowchart

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3.6 Appendix 6: Specimens Excluded from Transport via the PTTS

Precious/irreplaceable specimens e.g. CSF, frozen sections. Blood and blood components for transfusion. Samples from patients known to be infected with biohazardous organisms e.g. HIV, Hepatitis B, Hepatitis C etc. (see blood borne hazards policy

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