Transport of Infectious Substances. Best Practice Guidance for Microbiology Laboratories

Transcription

1 Transport of Infectious Substances Best Practice Guidance for Microbiology Laboratories

2 Transport of Infectious Substances Best Practice Guidance for Microbiology Laboratories Prepared by: Inspector of Microbiology and Infection Control 2

3 DH Information Reader Box Policy HR/Workforce Management Planning Clinical Document purpose: Estates Performance IM & T Finance Partnership working For Information ROCR ref: Gateway ref: 8334 Title: Transport of Infectious Substances - Best Practice Guidance for Microbiology Laboratories Author: Inspector of Microbiology and Infection Control Publication date: 01 June 2007 Target audience: Directors of Microbiology, Directors of Pathology, Allied Health Professionals Circulation list: GPs, NDPBs, Voluntary Organisations, DIPCs Description: Cross ref: Superseded docs: This document aims to offer practical advice regarding the transport of clinical microbiology specimens from the General Practitioner s (GP s) surgery through to referral of cultures to reference laboratories. N/A Action required: N/A Timing: Contact details: N/A Inspector of Microbiology and Infection Control Floor 5 Wellington House London SE! 8UG For recipient s use: Crown copyright 2007 First published 01/06/2007 Published to DH website, in electronic PDF format only. 3

4 Executive summary World Health Organization Guidance on regulations for the Transport of Infectious Substances 2005 (WHO/CDS/CSR/LYO/ ) 1 state it is the responsibility of the shipper i.e. the sending laboratory (consignor) to ensure the correct classification, packaging, labelling and documentation of all infectious substances destined for transport. This document aims to offer practical advice regarding the transport of clinical microbiology specimens from the General Practitioner s (GP s) surgery through to referral of cultures to reference laboratories

5 Contents Executive summary... 4 Contents... 5 Regulations 6 Different packaging requirements.. 7 Category A and Category B classification. 7 Courier Companies... 7 Royal Mail.. 7 Basic triple packaging system. 8 Packaging (Category A Infectious Substances).. 8 Packaging (Category B Infectious Substances).. 8 Dangerous Goods Safety Advisers (DGSAs)...9 Driver Training... 9 Security of Specimens. 9 Schedule 5 materials 9 Sample Reception. 9 Security Inspections by the department for Transport (DfT) 10 Recording. 10 Tracking..10 Type of courier 10 Informing receiving laboratory.. 10 Recipient laboratory informing sending laboratory Transport of GP samples of laboratory Public Transport.. 11 Air Passenger Provisions. 11 Referral to Reference Laboratory. 11 Spill clean-up procedure 12 Prophylaxis Summary Sheet

6 1. Regulations A number of regulations govern the transport of dangerous goods, which include infectious substances: Transport of infectious substances to and from UK premises by road and rail is subject to the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2004 as amended by the Carriage of Dangerous Goods and Use of Transportable Pressure Equipment (Amendment Regulations 2005)2. This regulation requires consignors and carriers to use the European Agreement on the transport of Dangerous Goods by Road (ADR) and the Regulations concerning the International Carriage of Dangerous Goods by Rail (RID) for the transport of all dangerous goods including infectious substances. The International Civil Aviation Organization (ICAO) issues Technical Instructions for the Safe Transport of Dangerous Goods by Air transport3. The International Air Transport Association (IATA) incorporates these instructions into their dangerous goods regulations to cover air transfers4. These regulations also apply to goods sent by Royal Mail. For national flights, i.e. flights within one country, the National Civil Aviation Authorities apply national legislation, which is normally based on the ICAO provisions. In the UK, the Civil Aviation Authority (CAA) provides interpretation on the Safe Transport of Dangerous Goods by Air ICAO technical instructions 5 and these apply to national flights. The International Maritime Dangerous Goods Code published by the International Maritime Association Organization (IMO) was developed as a uniform international code for the transport of dangerous goods by sea6. In the UK, the Maritime and Coastguard Agency (MCA) are responsible for the application for the IMDG Code in the UK7. For infectious substances transported in road vehicles on ferry crossings, the ADR regulations are deemed to apply. There are a number of inconsistencies between road/rail and air regulations concerning infectious substance transfers: In the definition of culture In the definition of Category B infectious substances Differences in the Category A indicative list

7 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 of Health (DH) publication Changes to Infectious Substances Transport Procedures in This is available on the DH website8. Clinical Pathology Accreditation (UK) Ltd (CPA), Standards for the Medical Laboratory advise that the transport of specimens meet the necessary UK/International regulations9. 3. Category A and Category B classification The United Nations changed the method of classifying pathogens in the international transport regulation base. For transfer purposes only, pathogens will no longer be assigned according 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 all categories are given in Changes to Infectious Substances Transport Procedures in Courier Companies Some courier companies will accept only Category B infectious substances; laboratories should review their own local arrangements. It is advisable that individual laboratories identify, in advance, the courier company they would use should there be a need to courier a Category A infectious substance at short notice. 5. Royal Mail Royal Mail Group plc will not accept a package that contains UN2814 or UN2900 infectious substances as classified at 6.2 of the Technical Instructions for the Safe Transport of Dangerous Goods by Air published by ICAO i.e. they are not prepared to carry Category A infectious substances. It will accept Category B diagnostic specimens provided they are packaged to P650 requirements. Full details may be accessed on the Royal Mail website10. In 2005 DH published a document Changes to Infectious Substances Transport Procedures in This document recommended that an exemption for transport by road/rail of Category A cultures intended for diagnostic and clinical purposes be applied to Escherichia coli (verotoxigenic), Mycobacterium tuberculosis and Shigella dysenteriae type 1. This has been adopted in transport legislation w.e.f. 1 July However, DH advise that these &chk=8ziaOg & &chk=8ziaOg 7

8 three organisms should not be sent via Royal Mail, rather a recognised courier company should be utilised. 6. Basic triple packaging system The World Health Organization describe a basic triple packaging system12, which is reproduced here. This system of packaging shall be used for all infectious substances. It consists of three layers 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 of breakage. Secondary packaging. A second durable, watertight, leak-proof packaging to enclose and protect the primary receptacle(s). Several cushioned primary receptacles may be placed in one secondary packaging, but sufficient additional absorbent material shall be used to absorb all fluid in case of breakage. Outer packaging. Secondary packaging are placed in outer shipping packaging with suitable cushioning material Outer packaging protect their contents from outside influences, such as physical damage, while in transit. The smallest overall external dimension shall be 10x10 cm. Each completed package is normally required to be marked, labelled and accompanied with appropriate shipping documents (as applicable). 7. Packaging (Category A Infectious substances) Samples classed as Category A should be packed according to Packing Instructions P620 for transport by road or rail. The packing, marking, labelling and documentation requirements for Category A infectious substances are available from the World Health Organization Guidance on regulations for the Transport of Infectious Substances 2005 (WHO/CDS/CSR/LYO/ )13. It is recommended that the packaging used in the transport of Category A samples should not be re-used. A number of commercial companies supply packaging for Category A infectious substances. 8. Packaging (Category B Infectious substances) Category B infectious substances are assigned to UN 3373 (Diagnostic or Clinical Specimens) and must be packed to Packing Instructions P650. The packaging in which Category B samples have been transported may be re-used provided it is not contaminated or soiled and is in good condition. A number of commercial companies supply packaging for Category B infectious substances. There are different packaging requirements for Packing Instruction P650 depending on which mode of transport is used. These are detailed in a

9 guidance document produced by the Department for Transport, the Civil Aviation Authority and the Maritime and Coastguard Agency Dangerous Goods Safety Advisers (DGSAs) The Carriage of Dangerous Goods regulations state that all those (ie consignor, carrier and consignee) involved in the transfer of dangerous goods, which includes Category A infectious substances, must have access to a Dangerous Goods Safety Adviser. The DGSA does not have to be a member of staff, the role can be contracted out. A number of hospitals, for example, share a DGSA. Standards for DGSAs are laid down by the Department for Transport and training and examination is operated under contract by the Scottish Qualifications Authority. 10. Driver Training All drivers who carry Category A material are required to undergo 4-5 days training approved by Department for Transport and pass formal exams. Drivers of vehicles not exceeding 3.5 metric tonnes were exempt from these requirements until 1st January Security of Specimens There is the potential that infectious substances being transferred from one site to another might be misappropriated for use in bioterrorism activities, so should be kept secure and not handled by anyone that has not been appropriately identified. Further advice is detailed in the DH document Security and Safety in Microbiology Laboratories. 12. Schedule 5 materials Laboratories that have notified their holdings of Schedule 5 pathogens/toxins under Part 7 of the Anti Terrorism Crime and Security Act 2001 are not required under the Act to notify transfers of Schedule 5 materials. Further advice regarding the holding of Schedule 5 pathogens/toxins may be obtained from the National Counter Terrorism Security Office (NaCTSO) (nactso@btconnect.com). However the Control of Substances Hazardous to Health Regulations (2002) (COSHH) do require advance notification to the Health and Safety Executive (HSE) regarding a proposed transfer of human pathogens in Hazard Group 4. COSHH regulation 7(10) Schedule 3 paragraph 6. Further details are given at the HSE website Sample Reception Sample reception is detailed in the CPA Standards for Medical Laboratories: a laboratory should have space for specimen reception (C1.2(b)) and laboratory management shall establish a health and safety procedure(s) that includes specimen collection and handling, transport, reception and referral to other laboratories (C5.3(j))

10 14. Security Inspections by the Department for Transport (DfT) The DfT is responsible for the security inspections of premises that are responsible for the transfer of infectious substances. Laboratories moving Category A substances must have a security plan in place under provisions of ADR chapter Recording A laboratory should hold a record of all samples referred to other laboratories. CPA Standards for the Medical Laboratory advise that laboratory management establish procedures for the referral to other laboratories. This should include maintaining a record of all specimens referred, dispatch dates and monitoring the return reports Tracking Some courier companies use tracking systems to trace all packages going through their care. It is recommended that sending laboratories ensure that their courier company does have such a system in place. A tracking system should be used for all Category A infectious substances 17. Type of courier The courier should be chosen according to the category of samples to be sent. The onus is on the sending laboratory to ensure samples are sent in a proper manner. Some courier companies will accept only Category B infectious samples, it may be necessary to use a different company for Category A infectious samples. 18. Informing receiving laboratory For all Category A infectious substances, it is necessary for the sending laboratory to inform the recipient laboratory that samples are being sent and provide information on which tests are required. 19. Recipient laboratory informing sending laboratory The receiving laboratory should inform consignees of receipt of Category A infectious substances within 24hours of them being received. This also applies to the deregulated E coli (verocytotoxigenic), M tuberculosis and S dysenteriae type O1. However if a result is sent to the consignee within the 24 hours of the infectious substance being dispatched, it is not necessary to send a confirmation of receipt. 20. Transport of GP samples to laboratory Clinical samples transferred from General Practitioner (GP) surgeries to hospital laboratories should be packaged to Packing Instruction P650. However It may be

11 impracticable to package each specimen individually. The primary container holding the clinical sample should be placed into a sealed transport bag this is usually attached to the specimen request form. Some commercial companies do sell specimen transport bags with a small pad of absorbent material in the sample bag. If multiple specimens are placed in the same transport bag, they should be cushioned to prevent breakage. The transport bags are then placed into one large bag which contains sufficient absorbent material to contain the liquid in all of the primary containers. This second bag is sealed and placed into a rigid outer container with a sealable lid for transport purposes. Ensuring that this outer container may be autoclaved is a sensible precaution should a spillage occur. The outer container should be labelled as detailed in Packing Instruction P650. (Note: The current labelling requirements will changed in air transport from 1st January 2007 and will change in land transport from 1st July The regulations will require, in addition to the current mark, the words BIOLOGICAL SUBSTANCE, CATEGORY A/ CATEGORY B. Anyone ordering packaging now may apply this information, as it does not contravene the current provisions.) 21. Public Transport Category A or B infectious substances must not be carried by a member of staff on the person on public transport. A patient may take a sample to a GPs surgery via public transport because this is outside the ADR regulations. A member of staff transporting clinical samples as part of their work would be expected to comply with the ADR regulations. 22. Air Passenger Provisions Infectious substances in Category A or B are not permitted for transport in carry-on or checked baggage and must not be carried on the person. (taken from Guidance on Regulations for the Transport of Infectious Substances) Referral to Reference Laboratory Do not mix Category A and Category B samples in the same packaging (samples boxes are opened in different containment areas befitting the contents). Some couriers will not transport Category A samples Do not mix ACDP category 2 and 3 in the same Category B packaging (samples are processed under different ACDP containment conditions) Indicate preliminary identification of the organism on the sample form to ensure appropriate containment level processing of the sample in the reference laboratory Include all relevant clinical information and preliminary identification of the infectious substance on the referral form

12 24. Spill clean-up procedure A guideline for the appropriate response in the event of an exposure to any infectious substance is included in the Wold Health Organization document, Guidance on Regulations for the Transport of Infectious Substances In the event of an exposure, the primary response is to wash or disinfect the affected area as soon as possible, regardless of the agent. Even if an infectious substance comes into contact with non-intact skin, washing of the affected area with soap and water or with an antiseptic solution can reduce the risk of infection. Medical advice should be sought anytime there is a suspected exposure to infectious substances resulting from a damaged package. The following procedure for clean-up can be used for spills of all infectious substances including blood: 1. Wear gloves and protective clothing, including face and eye protection if indicated 2. Cover the spill with a cloth or paper towels to contain it 3. Pour an appropriate disinfectant over the cloth or paper towels and the immediately surrounding area (5% bleach solutions are generally appropriate, but for spills on aircraft, quaternary ammonium disinfectants should be used. 4. Apply the disinfectant concentrically beginning at the outer margin of the spill area, working towards the centre 5. After about 30 min, clear away the materials. If there is broken glass or other sharps are involved, use a dustpan or a piece of stiff cardboard to collect the materials and deposit them into a puncture-resistant container for disposal 6. Clean and disinfect the area of the spillage (if necessary, repeat steps 2-5) 7. Dispose of contaminated materials into a leak-proof, puncture-resistant waste disposal container 8. After successful disinfection, report the incident to the competent authority and inform them that the site has been decontaminated 25. Prophylaxis The Health Protection Agency will provide advice regarding prophylaxis, upon request. or telephone and ask for the duty doctor. 12

13 26. Summary Sheet Category A Packaging P620 Category A specialist courier company Inform recipient laboratory prior to sending Expect confirmation of receipt (or results within 24 hours) from recipient laboratory Do not use Royal Mail Category B Package as Category B Send by courier or Royal Mail E. coli (verocytotoxigenic), Mycobacterium tuberculosis, Shigella dysenteriae type O1 Package as Category B Send by Category B courier company not Royal Mail Inform recipient laboratory prior to sending Expect confirmation of receipt (or results within 24 hours) from recipient laboratory 13