Yorkhill Laboratories Policy for the Packaging and Transport of Biological Samples (sent from laboratories) H&S/Doc/07. Yorkhill Hospitals

Transcription

1 Management Procedure Packaging and Transport of This document together with Standard Operating Procedures, instruction manuals, etc, forms part of, and is representative of the Quality Management System of the Laboratories at Yorkhill Hospital as part of the Diagnostic Directorate of NHS Greater Glasgow & Clyde. It has been compiled to meet the requirements of the Clinical Pathology Accreditation (UK) Ltd (CPA) system and appropriate national and international standards and in particular standards relating to Specimen Transportation (E4). All procedures specified herein are mandatory within the Yorkhill Laboratories. EDITION No 4 DATE OF ISSUE 16/05/2008 REVIEW INTERVAL AUTHOR AUTHORISED BY MASTER DOCUMENT HELD BY LOCATION OF AUTHORISED COPIES ELECTRONIC DISSEMINATION 24 months Stuart Imrie Yorkhill Laboratories Safety Committee Stuart Imrie 1. Laboratory Safety Officer Biochemistry 2. Laboratory Safety Officer Genetics 3. Laboratory Safety Officer Haematology 4. Laboratory Safety Officer Pathology 5. Laboratory Safety Officer Microbiology Document name: Packaging and Transport of Version:4.0 Page 1 of 14

2 Contents Packaging and Transport of Introduction References Definitions Biological samples Patient (diagnostic) specimens Infectious substances Cultures (laboratory stocks) Category A pathogens Category B pathogens Substances not subject to the regulations Exemptions in the regulations for diagnostic and clinical specimens Packaging Arrangements Diagnostic samples Infectious samples Transport Arrangements Samples by Hospital Transport Road transport regulations The Laboratories Safety Committee Samples by Taxi Samples by Royal Mail Samples by Courier Companies General Advice Assignment to Category of Pathogen Research and Diagnostic Samples Dry Ice Review of this Policy Appendices... 9 Appendix Indicative Examples of Infectious Substances Included in Category A... 9 Appendix UN P650 Packaging arrangements for Diagnostic Samples General provisions Labelling For Liquids For Solids Appendix UN P620 Packaging arrangements for Infectious Samples General Provisions Labelling Appendix Packaging of Samples - Flow Chart Document name: Packaging and Transport of Version:4.0 Page 2 of 14

3 Packaging and Transport of 1.0 Introduction The Laboratories at Yorkhill as part of NHS Greater Glasgow & Clyde, aim to follow best practice and high standards of packaging and transport of samples from each of its Departments. Compliance with this policy ensures that all samples sent from laboratories are packaged in such a manner that they arrive at their destination in good condition having presented no hazard to any persons who may come in contact with or handled them during dispatch, transport or receipt at the final destination. 2.0 References Changes to Infectious Substances Transport Procedures in Department of Health UN Recommendations on the Transport of Dangerous Goods Modal Regulations, 14 th Revised Edition (2005). Transport of Infectious Substances, A guidance document produced by the department for transport, the civil aviation authority and the maritime and coastguard agency (2005) International Civil Aviation Organization: Technical Instructions for the Safe Transport of Dangerous Goods by Air Edn (Doc 9284-An/905) Transport of Infectious Substances. Best Practice Guidance for Microbiology Laboratories Department of Health Definitions 3.1 Biological samples These are defined according to the UN, Recommendations on the Transport of Dangerous Goods Modal Regulations, 14th Revised Edition. Within this document, goods are classified in Divisions and assigned UN numbers. Biological samples are classified in Division Patient (diagnostic) specimens These are materials, collected directly from humans, including, but not limited to, excreta, secreta, blood and its components, tis sue and tissue fluid swabs and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment and prevention. 3.3 Infectious substances These are substances known or reasonably expected to contain pathogens. Pathogens are defined as micro-organisms and include bacteria, viruses, rickettsiae, parasites, fungi, plasmids and other agents such as prions, that can cause disease in humans or animals. Document name: Packaging and Transport of Version:4.0 Page 3 of 14

4 Advice provided by the World Health Organisation informed the decision by the United Nations to change the method of classifying pathogens in the international transport regulation base. For transfer purposes (only), pathogens will no longer be assigned according to their risk group, but according to two new Categories, A and B. (COSHH Hazard Group classifications will continue to apply for all activities other than transfers). 3.4 Cultures (laboratory stocks) Are defined as the result of a process by which pathogens are amplified or propagated in order to generate high concentrations, thereby increasing the risk of infection when exposure to them occurs. Cultures prepared for the intentional generation of pathogens may not be transported as diagnostic specimens. 3.5 Category A pathogens 1. Category A includes the higher risk infectious micro-organisms, defined as 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. An internationally agreed indicative list will be implemented in transport regulations. The list is given in the Appendix (8.1). All other infectious micro-organisms are considered to be of less risk and are assigned to Category B. 2. Any sample from a patient that might contain micro-organisms that are listed in the Category A list, (or any laboratory culture of such a pathogen) must be sent as Category A, with the exception of pathogens on the list with the words Culture Only appearing after them. In these cases only, laboratory cultures of the pathogen need be sent as an infectious substance, the original patient samples can be sent as Category B. For example:- Bacillus anthracis (culture) must be sent as Category A Bacillus anthracis (in a body part) can be sent as Category B However Ebola virus must be sent as Category A whether the consignment is a patient sample or a lab culture 3. Infectious substances including those containing new or emerging pathogens, which do not appear in the indicative list but which meet the same criteria must be transported as a Category A infectious substance. If there is any doubt whether a pathogen falls into Category A, it must be transported as a Category A infectious substance. 4. Category A infectious substances must be transported as UN 2814 (Infectious substance, affecting humans), labelled as Infectious substance affecting humans, and packed according to Packing Instructions P620 (see appendix 8.3). Packages must be accompanied by documentation containing an itemised list of the contents. Document name: Packaging and Transport of Version:4.0 Page 4 of 14

5 3.6 Category B pathogens 1. Category B infectious substances are any that do not meet the criteria for inclusion in Category A, and include human material such as, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluids, and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment or prevention. These are assigned to UN 3373, must bear the marking Biological Substance Category B, and be packed to Packing Instructions P650. Substances packed and marked in accordance with Packing Instruction P650 are not subject to any other requirements in the regulations thus there is no requirement for documentation. 3.7 Substances not subject to the regulations Non-pathogenic micro-organisms Blood and blood components for transfusion or transplant and tissues or organs for use in transplants Samples (non-human/animal derived) where there is only a low probability of infectious substances being present eg food screening samples, environmental samples (water, soil etc) or material (including material derived from human or animal sources) that has been treated to inactivate any infectious substances Decontaminated clinical or medical waste Dried blood spots, collected by applying a drop of blood onto absorbent material, are not specifically mentioned in the transport requirements. However, expert medical advice in the United Kingdom is that such items are not realistically capable of posing a risk to health, safety, property or the environment and consequently, unless they are known or reasonably believed to contain infectious substances of Category A, need not be classified as UN3373. With exception of the samples listed above, all other specimens must be packaged for public transport to the standards of UN3373 for category B organisms unless it is known, or reasonably suspected, that they contain organisms of category A. Failure to do so may result in the inadvertent consignment of category B infectious substances not in compliance with modal regulations, for which legal penalties may result. 3.8 Exemptions in the regulations for diagnostic and clinical specimens With the regulation changes in 2005, there was a provision for the exemption for transport of certain Category A cultures intended for diagnostic and clinical purposes until the January 2007, i.e., such diagnostics and clinical cultures could be sent as Category B materials. This exemption period has now past and therefore laboratory cultures of Escherichia coli (verotoxigenic), Mycobacterium tuberculosis and Shigella dysenteriae type 1 should now be sent as Category A UN2814 (Infectious substance, affecting humans), labelled as Infectious substance affecting humans, and packed according to UN P620 Packaging arrangements for Infectious Samples. Document name: Packaging and Transport of Version:4.0 Page 5 of 14

6 The Royal Mail has announced that it will be prepared to accept infectious substances assigned to UN3373, but not to UN2814. However the Department of Health recommends that no cultures likely to contain substances on the Category A indicative list, or suspected to fit the criteria for Category A, should be sent by post. 4.0 Packaging Arrangements A simplified flow diagram summarising the decision process to determine the correct specimen packaging is provided in appendix Diagnostic samples Diagnostic samples (classified as UN3373) must be packaged in a container that meets the requirements of UN packaging instruction P650. (See appendix 8.2) Such packaging may be specially purchased for this purpose or constructed from suitable components. 4.2 Infectious samples Infectious samples (classified as UN2814) i.e. those that appear on the Category A list (see appendix 7.1) must be packaged in containers compliant with UN packaging instruction P620. (See appendix 8.3). These containers must be purchased specifically for this purpose. 5.0 Transport Arrangements Consignors of diagnostic or infectious substances shall ensure that packages are prepared in such a manner that they arrive at their destination in good condition and present no hazard to any persons during transport. In particular consignors must consider the mode of transport used and apply the following specific criteria:- 5.1 Samples by Hospital Transport Road transport regulations Packaging must be secure and strong enough to protect the sample in general handling, taking account of the size and weight of the package as well as the material from which the primary container is made. External packaging must be marked with appropriate labelling to identify diagnostic or infectious specimens so as to alert those handling the samples of special precautions in the event of accidental spillage. In the case of infectious samples i.e. in Category A (UN2814), the packaging must comply with UN packaging instruction P620 (See appendix 8.3) including the labelling. Document name: Packaging and Transport of Version:4.0 Page 6 of 14

7 5.1.2 The Laboratories Safety Committee shall work with the Hospital General Services Manager to ensure that:- All Hospital vehicles used for the transport of biological samples have a rigid box or container for holding samples in transit. Vehicle transport containers are marked with an appropriate Biohazard sticker. Vehicles carry a Biohazard Spill Kit and staff members receive training in their correct use. Written procedures are in place for the transport of biological samples including accident procedures and regular cleaning/decontamination of the vehicle transport container(s) 5.2 Samples by Taxi Packaging arrangements P650 or P620 (see appendices 8.2 & 8.3) must be applied. In addition to these standards, a label identifying an emergency contact number in the event of accidental damage or spillage must be visible to the carrier. 5.3 Samples by Royal Mail Under no circumstances should ANY samples be placed in normal envelopes in the general mail system. Samples must be packaged according to UN packaging arrangements P650 (see appendix 8.2), for diagnostic samples. As detailed above (3.8), the Royal Mail has announced that it is not prepared to accept infectious substances on the Category A list i.e. assigned to UN2814 (Infectious substance, affecting humans) even when packed as P620. The use of a rigid secondary container (cardboard or similar) placed within a padded jiffy bag (as tertiary packaging) is acceptable, providing the construction complies with the requirements of UN (P650) packaging arrangements for Diagnostic Samples. 5.4 Samples by Courier Companies Samples must be packaged according to UN packaging arrangements P650 or P620 (see appendices 8.2 & 8.3), for diagnostic or infectious samples. 6.0 General Advice 6.1 Assignment to Category of Pathogen Laboratory Safety Officers will be happy to advise on assignment of samples which might contain a pathogen, appropriate packaging and method of transport for samples sent from the site (where they are being dispatched from source) however the consignor will be responsible for the correct implementation of this advice. Document name: Packaging and Transport of Version:4.0 Page 7 of 14

8 6.2 Research and Diagnostic Samples Where samples are to be sent from the Yorkhill site, the Laboratories advise that these come via laboratory services. In the case of research samples, arrangements for dispatch of samples must be agreed with one of the laboratories in advance of the research being undertaken and the cost of appropriate packaging must be covered by research funds. 6.3 Dry Ice Samples may require to be consigned refrigerated or frozen, using ice or dry ice If ice is used, the outer packaging or overpack must be leakproof. If dry ice is used, the outer packaging or overpack must permit the release of carbon dioxide gas. The primary receptacle and the secondary packaging shall maintain their integrity at the temperature of the refrigerant used Where samples are packed in dry ice, the outer packaging must clearly indicate this. If samples packaged in refrigerants are to be handled by Royal Mail, courier companies or are to be sent overseas, it is advisable to contact the handlers for specific packaging instructions in advance of sampling. 7.0 Review of this Policy The will review this policy every two years to coincide with the cycle of review and publication of the UN Recommendations on the Transport of Dangerous Goods Modal Regulations. Document name: Packaging and Transport of Version:4.0 Page 8 of 14

9 8.0 Appendices Appendix 8.1 Indicative Examples of Infectious Substances Included in Category A UNLESS OTHERWISE INDICATED THE SUBSTANCE IS INCLUDED AS CATEGORY A IN ANY FORM UN Number and name UN No Infectious substances affecting humans Micro-organism Bacillus anthracis (cultures only) Brucella abortus (cultures only) Brucella melitensis (cultures only) Brucella suis (cultures only) Burkholderia mallei Pseudomonas mallei Glanders (cultures only) Burkholderia pseudomallei Pseudomonas pseudomallei (cultures only) Chlamydia psittaci avian strains (cultures only) Clostridium botulinum (cultures only) Coccidioides immitis (cultures only) Coxiella burnetii (cultures only) Crimean-Congo hemorrhagic fever virus Dengue virus (cultures only) Eastern equine encephalitis virus (cultures only) Escherichia coli, verotoxigenic (cultures only) Ebola virus Flexal virus Francisella tularensis (cultures only) Guanarito virus Hantaan virus Hantaviruses causing hantavirus pulmonary syndrome Hendra virus Hepatitis B virus (cultures only) Herpes B virus (cultures only) Human immunodeficiency virus (cultures only) Highly pathogenic avian influenza virus (cultures only) Japanese Encephalitis virus (cultures only) Junin virus Kyasanur Forest disease virus Lassa virus Machupo virus Marburg virus Monkeypox virus Mycobacterium tuberculosis (cultures only) Nipah virus Rift Valley fever virus Russian spring-summer encephalitis virus (cultures only) Sabia virus Shigella dysenteriae type 1 (cultures only) Tick-borne encephalitis virus (cultures only) Variola virus Venezuelan equine encephalitis virus West Nile virus (cultures only) Yellow fever virus (cultures only) Yersinia pestis (cultures only) Document name: Packaging and Transport of Version:4.0 Page 9 of 14

10 Appendix 8.2 UN P650 Packaging arrangements for Diagnostic Samples Adapter from UN Recommendations on the Transport of Dangerous Goods Modal Regulations, 14th Revised Edition. Diagnostic samples must be packaged in containers compliant with UN packaging instruction P650, as follows:- General provisions 1. Diagnostic specimens shall be packed in good quality packaging, which shall be strong enough to withstand the shocks and loadings normally encountered during transport, including manual or mechanical handling. 2. Packaging shall be constructed and closed so as to prevent any loss of contents when prepared for transport, which might be caused under normal conditions of transport, by vibration, or by changes in temperature, humidity or pressure. 3. Primary receptacles (i.e. sample containers) shall be packed in secondary packaging in such a way that, under normal conditions of transport, they cannot break, be punctured or leak their contents into the secondary packaging. 4. Secondary packaging shall be secured in outer packaging with suitable cushioning material. Any leakage of the contents shall not substantially impair the protective properties of the cushioning material or of the outer packaging. Labelling All packages will require to be marked with a diamond containing UN number UN3373 and the words BIOLOGICAL SUBSTANCE CATEGORY B (see figure 1 below). Labels are available from Laboratory Safety Officers. Biological Substance Category B Figure 1 Document name: Packaging and Transport of Version:4.0 Page 10 of 14

11 For Liquids The primary receptacle(s) shall be leakproof and shall not contain more than 500 ml. There shall be absorbent material placed between the primary receptacle and the secondary packaging; if several fragile primary receptacles are placed in a single secondary packaging, they shall be either individually wrapped or separated so as to prevent contact between them. The absorbent material, such as cotton wool, shall be in sufficient quantity to absorb the entire contents of the primary receptacles and there shall be a secondary packaging, which shall be leakproof. The primary receptacle or the secondary packaging shall be capable of withstanding without leakage an internal pressure producing a pressure differential of not less than 95 kpa (0.95 bar). The outer packaging shall not contain more than 4 litres. For Solids The primary receptacle(s) shall not contain more than 500 g. If several fragile primary receptacles are placed in a single secondary packaging, they shall be either individually wrapped or separated so as to prevent contact between them and there shall be a secondary packaging, which shall be leakproof. The total weight of any such secondary packaging shall not exceed 4 kg. Document name: Packaging and Transport of Version:4.0 Page 11 of 14

12 Appendix 8.3 UN P620 Packaging arrangements for Infectious Samples Adapted from UN Recommendations on the Transport of Dangerous Goods Modal Regulations, 14 th Revised Edition. Infectious samples (classified as UN2814) must be packaged in containers compliant with UN packaging instruction P620, as follows:- General Provisions Packaging consists of: 1. An inner packaging comprising a watertight primary receptacle(s) (sample container); 2. a watertight secondary packaging; 3. other than for solid infectious substances, an absorbent material in sufficient quantity to absorb the entire contents placed between the primary receptacle(s) and the secondary packaging; if multiple primary receptacles are placed in a single secondary packaging, they shall be individually wrapped so as to prevent contact between them; 4. An outer packaging of adequate strength for its capacity, mass and intended use. The smallest external dimension shall be at least 100 mm. Labelling 1. Packaging that meets the requirements for the transport of infectious samples is pre-marked with the United Nations packaging symbol (figure 2) and codes designating the type of packaging, class of substance, year and country of manufacture. Such a marking would appear on the packaging similar to figure 3 2. Packages containing infectious samples must display specimen label for Class 6.2 infectious samples, (figure 4). Figure 2. Figure 3. Figure 4 Document name: Packaging and Transport of Version:4.0 Page 12 of 14

13 Inner packaging containing infectious substances shall not be consolidated with inner packaging containing unrelated types of goods. Complete packages may be overpacked with ice or dry ice using an approved container, designed to maintain its integrity at the temperature of the refrigerant used. Where samples are packed in dry ice, the outer packaging must clearly indicate this. If samples packaged in refrigerants are to be handled by Royal Mail, courier companies or are to be sent overseas, it is advisable to contact the handlers for specific packaging instructions. An itemized list of contents must be enclosed between the secondary packaging and the outer packaging. Before an empty packaging is returned to the consignor, or sent elsewhere, it must be thoroughly disinfected or sterilized and any label or marking indicating that it had contained an infectious substance shall be removed or obliterated. Document name: Packaging and Transport of Version:4.0 Page 13 of 14

14 Appendix 8.4 Packaging of Samples - Flow Chart Is this sample a patient (diagnostic) specimen No [i.e. collected directly from humans, including, but not limited to, excreta, secreta, blood and its components, tissue and tissue fluid swabs and body parts being transported for purposes such as research, diagnosis, investigational activities, disease treatment and prevention] Yes Is this sample exempt from the packaging regulations Yes [i.e. Blood and blood components for transfusion or transplant and tissues or organs for use in transplants, samples that have been treated to inactivate any infectious substances, or dried blood spots collected by applying a drop of blood onto absorbent material ] No Is this sample known or reasonably expected to contain a pathogen (including bacteria, viruses, rickettsiae, parasites, fungi, plasmids and other agents such as prions), or laboratory cultures of these pathogens, which appears on the categoy A list of pathogens (see appendix 8.1) No Yes Packaging regulations do not apply Diagnostic Specimen (UN3373) Package according to UN 650 regulations See Appendix 8.2 Infectious Substance (UN2814) Package according to UN 620 regulations See Appendix 8.3 Document name: Packaging and Transport of Version:4.0 Page 14 of 14