CARDIFF UNIVERSITY STANDARD OPERATING PROCEDURE FOR THE USE OR STORAGE OF HUMAN TISSUE FOR THE PURPOSES OF RESEARCH TRANSPORTATION OF HUMAN TISSUE SOP Number: CU/09/HTA 05/3.0 Version Number & Date: 3.0 & Jan 2013 Superseded Version Number and Date: Effective Date: 09 Jan 2013 Review Date: 09 Jan 2014 CU/11/HTA 05/2.0 July 2011 Author: Position: Carina Hibbs HTA Governance Officer, GOVRN ____________________ Sharon Orton HTA Co-ordinator, GOVRN ____________________ Signature Approved by: Date Position: Professor Jonathan Bisson DI – Licence No 12422 ____________________ Signature Date Disclaimer When using this document, please ensure that the version you are using is the most up to date either by checking on the GOVRN/HTA website for any new versions or contact the HTA Governance Officer to confirm the current version. Out of date documents must not be relied upon and should be destroyed. CU/09/HTA 05/3.0 Page 1 of 16 Version Number 1.0 2.0 Changes to Document Changes authored by Carina Hibbs Minor changes were made including formatting and alteration of wording/definitions. Contact information updated Substantial changes: Carina Hibbs Addition of ‘Licensing’ and ‘Consent’ sections; Inclusion of detailed information about transportation of infectious substances and dangerous goods. Date Approved 14/06/2011 09/01/2013 Contact information updated Reinstated original document numbering (eg CU/09/HTA x/3.0 as opposed the incorrect CU/11/HTA x/2.0 as previously numbered) CU/09/HTA 05/3.0 Page 2 of 16 CONTENTS PAGE 1. 2. 3. 4. 5. Background Purpose Responsible Personnel Definitions Procedure 5.1 HTA Licensing 5.2 Consent 5.3 Health and Safety Issues in Transporting Human Tissues 5.4 Transportation Records and Documentation 5.5 Transport Regulations – Infectious Substances 5.6 Containment/Packaging 5.7 Containment Labelling and Documentation 5.8 Dangerous Goods and Packing Instructions 5.9 Transportation Methods 6. References 7. Referenced SOPs 8. Contacts Appendix A WHO Flowchart for the Classification of Infectious Substances and Patient Samples Acknowledgements The World Health Organization Guidance on Regulation for the Transport of Infectious Substances 2011-2012, excerpts from which appear in this SOP. CU/09/HTA 05/3.0 Page 3 of 16 1 BACKGROUND The Human Tissue Act 2004 (HT Act) came in to force fully on 1 September 2006. The aim of the HT Act is to provide a legal framework regulating the storage and use of human tissue from the living and the removal storage and use of tissue from the deceased. It introduces regulation of other activities like post mortem examinations, and the storage of human material for education, training and research. It is intended to achieve a balance between the rights and expectations of individuals and families, and broader considerations, such as the importance of research, education, training, pathology and public health surveillance to the population as a whole. The HT Act set up the Human Tissue Authority (HTA) which issues licences for a number of licensable activities under the HT Act. Cardiff University is the Licence Holder for an Anatomy, Human Application and a Research Hub and Satellite Licence. This SOP applies to the research hub and satellite licences. 2 PURPOSE The purpose of this Standard Operating Procedure (SOP) is to ensure that staff involved in research covered by the HT Act understand the procedure and mechanisms for the transportation of human tissue. 3 RESPONSIBLE PERSONNEL This SOP applies to all Cardiff University and UHB staff responsible for the transportation of human tissue for research. Chief Investigators/Research Supervisors are responsible for ensuring that this SOP is correctly applied in the conduct of research and that each researcher takes individual responsibility for applying this SOP when required to do so. Individual members of staff will be responsible for ensuring that this SOP is correctly applied when collecting, using or storing human tissue for teaching purposes. Governance and Compliance Division is responsible for ensuring that this SOP remains fit for purpose. 4 DEFINITIONS Category A Infectious Substance – 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 Infectious Substance – An infectious substance that does not meet the criteria for inclusion in Category A. Chief Investigator (CI) – is the appropriately qualified individual who has responsibility for the conduct of the study. Exempt Human Specimen – Human specimens for which there is minimal likelihood that pathogens are present. CU/09/HTA 05/3.0 Page 4 of 16 Human Tissue – Any and all constituent parts of the human body formed by cells. The Human Tissue Authority has issued a Supplementary List of Materials which contains additional information. Human Tissue Authority (HTA) – The governing body set up to regulate activities that come under the HT Act. The HTA is a watchdog that supports public confidence by licensing organisations that store and use human tissue for purposes such as research, patient treatment, post-mortem examination, teaching, and public exhibitions. Material Transfer Agreement (MTA) – a contract that governs the transfer of research materials between two organisations when the recipient intends to use the material for their own research. National Research Ethics Service (NRES) – NRES is the core function of the Health Research Authority (HRA) which was established on 01 December 2011. It provides an efficient and robust ethics review service and has a dual mission: to protect the rights, safety, dignity and well-being of research participants, to facilitate and promote ethical research that is of potential benefit to participants, science and society. Person Designate (PD) – A person to whom the licence applies and to whom the authority conferred by the licence extends. Each School/Institute operating under an HTA Licence should have at least one Person Designate. Relevant Material – Any material, other than gametes, removed from the body which consists of or includes human cells. In the HT Act references to relevant material from a human body do not include: embryos outside the human body, hair and nail from the body of a living person, cell lines or any other human material created outside the human body, serum, DNA and RNA. See Cardiff University HTA Standard Operating Procedure for Obtaining Informed Consent for the HTA Supplementary List of Materials. Standard Operating Procedure (SOP) – Detailed, written instructions to achieve uniformity of performance of a specific function. CU/09/HTA 05/3.0 Page 5 of 16 5 PROCEDURE 5.1 HTA Licensing 5.1.1 In order to transport relevant material legally between two establishments within England, Wales and Northern Ireland both must have an HTA Licence, unless one of the following exemptions applies: a) Transportation of the tissue is covered by project specific NRES approval; b) The distributing establishment sends the tissue off site within 7 days and the receiving establishment has an HTA Licence or one of the exemptions applies; c) The receiving establishment renders the tissue acellular as a result of processing within 7 days and the distributing establishment has an HTA Licence or one of the exemptions applies; d) The tissue is distributed for use in a specific research project from a Research Tissue Bank (RTB) with generic NRES approval and the RTB is held on HTA Licensed premises; e) The tissue is not relevant material, e.g. the tissue is acellular; f) The relevant material is more than 100 years old. 5.1.2 Evidence of an HTA Licence or the exemption must be provided before the tissue is transported. 5.1.3 Relevant material must not be sent to an establishment within England, Wales or Northern Ireland that does not have an HTA Licence unless one of the exemptions above applies. Doing so could seriously jeopardise Cardiff University’s HTA Licence(s) and may have legal implications. 5.1.4 For information on the export of human tissue to establishments outside England, Wales and Northern Ireland, see the Cardiff University HTA Standard Operating Procedure for the Import and Export of Human Tissue. 5.2 Consent 5.2.1 Consent from the donor to transport the tissue must be in place prior to transportation, whether this is to establishments within England, Wales and Northern Ireland or exported to establishments outside England, Wales and Northern Ireland. 5.2.2 If consent was not in place to transport the tissue, and it was not feasible to approach the donors for consent, the tissue could be transported providing it was from the living, anonymised and NRES approval to transport the samples had been obtained. 5.2.3 NRES approval could be sought to transport tissue even if the original project did not require NRES approval. 5.2.4 If the tissue was from the deceased consent must be in place to transport the samples; it is not an option to obtain NRES approval to transport tissue from the deceased in place of obtaining consent. 5.3 Health and Safety Issues in Transporting Human Tissue 5.3.1 Cardiff University policies and procedures from the Occupational Safety, Health and Environment Unit must be followed when handling or transporting human tissue and refrigerants. CU/09/HTA 05/3.0 Page 6 of 16 5.3.2 All processes involving the handling and transportation of human tissues must be subject to risk assessment and made available to everyone involved. Risk assessments must cover risks to the tissue in addition to the individual. For further information on risk assessments see Cardiff University HTA Standard Operating Procedure for Risk Management and Contingency Planning. 5.3.3 Workers handling the tissues must have training and health screening as appropriate. 5.3.4 Care must be taken when handling heavy or bulky containers, personnel involved in their transport should be trained in handling techniques. 5.3.5 Suitable labelling including biohazard warnings must be affixed to each container. 5.3.6 Reagents used in preserving and fixing tissues are harmful and consideration must be given to the safe handling of these reagents. 5.4 Transportation Records and Documentation 5.4.1 A Material Transfer Agreement (MTA) needs to be in place for any outgoing or incoming tissue. The MTA should define how the human tissue will be preserved, any potential contamination risks associated with it and who will be responsible for disposal. The MTA must be signed on behalf of the University/UHB not by an individual researcher. All University MTAs need to go through Research and Commercial Division before being used. 5.4.2 Evidence of an HTA Licence or the exemption must be provided before the tissue is transported to establishments within England, Wales or Northern Ireland. 5.4.3 Human tissue samples must be tracked and recorded from collection to disposal. A record must be kept of all tissue that is transported, including where it went, how much, when it was transported and who was responsible for the transport and receipt of the tissue. 5.4.4 A risk assessment for the transportation of the tissue from the perspective of the tissue would need to be written and read by all involved in the tissue transportation. 5.4.5 Appropriate modes of transport, suitable routes and arrangements with people involved must be planned and arranged in advance, and considered when preparing risk assessments. A record should be kept of all transportation arrangements, including contracts with third parties. 5.5 Transport Regulations – Infectious Substances 5.5.1 The World Health Organization (WHO) document ‘Guidance on Regulations for the Transport of Infectious Substances 2011-2012’, is based on the 16th revised edition of the United Nations Recommendations on the Transport of Dangerous Goods. 5.5.2 The WHO guidance describes the hazard classification, appropriate labelling and handling of such substances; a flowchart included in the guidance for the classification of infectious substances and patient specimens can be found in Appendix A. CU/09/HTA 05/3.0 Page 7 of 16 5.5.3 The WHO guidance has been incorporated into this document and must be followed when transporting human tissue, both nationally and internationally; Sections 5.5 and 5.8 of this SOP contain extracts from the guidance. The full document can be accessed via the following link: http://www.who.int/ihr/publications/who_hse_ihr_20100801/en/ 5.5.4 Category A Infectious Substances: 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 health humans or animals. Examples of such substances can be found in the WHO Guidance on Regulation for the Transport of Infectious Substances 2011-2012. 5.5.5 5.5.6 .1 Infectious substances that cause disease in humans or both human and animals should be assigned to United Nations number UN 2814. Infectious substances that cause disease only in animals should be assigned to UN 2900. These numbers must be clearly displayed on the external outer surface of the package. .2 The proper shipping name for UN2814 is INFECTIOUS SUBSTANCE, AFFECTING HUMANS. The proper shipping name for UN 2900 is INFECTIOUS SUBSTANCE, AFFECTING ANIMALS only. .3 Assignment to UN 2814 or UN 2900 should be based on the known medical history and symptoms of the source human, endemic local conditions, or professional judgement concerning individual circumstances of the source human. .4 Infectious substances in Category A must be transported in packaging that meets the United Nations class 6.2 specifications and complies with Packing Instruction P620. Full details of the packaging required for Category A substances can be found in the WHO Guidance on Regulation for the Transport of Infectious Substances 2011-2012. Category B Infectious Substances: An infectious substance that does not meet the criteria for inclusion in Category A. .1 Infectious substances in Category B should be assigned to UN 3373 using the proper shipping name BIOLOGICAL SUBSTANCE, CATEGORY B. This information must be clearly visible on the external surface of the outer packaging. .2 Infectious substances in Category B must be transported in packaging which complies with Packing Instruction P650. Full details of the packaging required for Category B substances can be found in the WHO Guidance on Regulation for the Transport of Infectious Substances. Exempt Human Specimen: Human specimens for which there is minimal likelihood that pathogens are present. .1 Exempt human specimens are not subject to the WHO regulations if the specimen is transported in a package which will prevent any leakage and which is marked with the words “Exempt Human Specimen”. .2 The packaging for Exempt Human Specimens should meet the following conditions: CU/09/HTA 05/3.0 Page 8 of 16 (a) The packaging should consist of three components (see section 5.6 for more detail): 1) leak-proof primary receptacle(s) 2) leak-proof secondary packaging; and 3) an outer packaging of adequate strength for its capacity, mass and intended use, and with at least one surface having minimum dimensions of 100mm x 100mm; (b) For liquids, absorbent material in sufficient quantity to absorb the entire contents should be placed between the primary receptacle(s) and the secondary packaging so that, during transport, any release or leak of a liquid substance will not reach the outer packaging and will not compromise the integrity of the cushioning material; (C) When multiple fragile primary receptacles are placed in single secondary packaging, they should either be individually wrapped or separated to prevent contact between them. .3 An element of professional judgement is required to determine if a substance is exempt under this paragraph. That judgement should be based on the known medical history and symptoms of the source human or animal and endemic local conditions. 5.6 Containment/Packaging 5.6.1 Details of the containment requirements for transporting Category A and Category B infectious substances can be found in the WHO Guidance on Regulation for the Transport of Infectious Substances 2011-2012. 5.6.2 There are three levels of basic containment required when transporting all other human tissue samples: primary containment, secondary containment and outer packaging. Below are the minimum precautions necessary for each level. 5.6.3 Primary Containment 5.6.4 .1 Tissues must be held in suitable containment able to withstand the planned mode of transport and possible accidents, in conjunction with secondary containment or further packaging. .2 Primary containers must be break resistant and leak proof. The nature of the tissue and the project will largely determine the optimum choice of container. .3 The primary container must bear appropriate labelling. Secondary Containment .1 Secondary containers must be able to hold the primary containers securely and be able to withstand the planned mode of transport. .2 Secondary containers must also be suitable for the containment of any refrigerants being used, e.g. liquid nitrogen, dry ice, water ice. CU/09/HTA 05/3.0 Page 9 of 16 5.6.5 .3 The container must bear appropriate labelling, including hazard information and emergency contact details. .4 Secondary containers must be leak proof and have adequate locks, seals or catches, able to prevent the accidental release of contents during transport. .5 There should be sufficient absorbent material to absorb the fluid form all the primary containers in the case of breakage. .6 Processes must be in place to ensure that there is no contamination to any external surfaces of secondary containment. Outer Packaging .1 Outer packaging must be sufficiently robust to withstand the planned mode of transport. .2 The outer packaging must bear appropriate labelling, including hazard information and emergency contact details. 5.7 Containment Labelling and Documentation 5.7.1 Each level of containment must be labelled sufficiently and correctly. Specific labels are required for Category A and Category B Infectious Substances, for further information see the WHO Guidance on Regulations for the Transport of Infectious Substances 2011-2012. 5.7.2 Below are the minimum labels necessary for each level of containment for substances not considered to be Category A or Category B: 5.7.3 Labelling on Primary Containment All labelling must be sufficiently robust to withstand the planned storage method and transport while remaining fully legible. If a sample has already been assigned a sample ID, this should be affixed to the primary container for transportation; the sample ID should be unique and should not contain any donor identifiers. If an anonymous sample is being transported prior to allocating a sample ID, e.g. following collection from a source hospital, and no other relevant information is associated with the sample that would render the sample useless if it became dissociated, transportation without a sample ID on the primary container is permitted. However all labelling and information on the secondary and outer packaging must be in full. 5.7.4 Labelling on Secondary Containment .1 All labelling must be able to withstand the planned mode of transport. .2 The container should be clearly labelled with any relevant hazard signage. Where necessary this should include a warning sign, e.g. ”Do Not Open, please observe emergency procedures“. CU/09/HTA 05/3.0 Page 10 of 16 5.7.5 .3 Information giving full destination details including the name of the Principal Investigator must be clearly displayed. .4 Documentation must be attached to the container providing a description and identification details of the tissue (if relevant), the address of both source and destination establishments, details of any hazardous contents, and emergency procedures, including at least 3 contact numbers and addresses. This may be in a sealed envelope, which may be opened in an emergency. Labelling on Outer packaging .1 Any outer packaging should have similar information to secondary containment. .2 If transport is undertaken by a third party (e.g. special courier), the guidelines supplied by the third party must also be followed. .3 If transporting material in dry ice or liquid nitrogen, specific signage is required to comply with legislation (see Section 5.8 for more information). 5.8 Dangerous Goods and Packing Instructions 5.8.1 Aside from infectious substances there are a number of other substances that may be used for transporting human tissue that could be considered ‘Dangerous Goods’. 5.8.2 The Air Navigation (Dangerous Goods) Regulations 2002 make detailed requirements for the carriage of ‘Dangerous Goods’ which means any article or substance identified as such in the Technical Instructions approved and published by the International Civil Aviation Organization, such as an infectious substances or dry ice packaging. 5.8.3 If a Category A substance is packed in dry ice, the dry ice needs to be included alongside the Infectious Substance on the ‘Declaration of Dangerous Goods’ and the outer packaging needs to contain the UN1845 hazard label. The packing instruction P003 (ICAO/IATA P1954) should be followed. 5.8.4 If a Category B or Exempt substance is packed in dry ice, the package should be marked “Carbon dioxide, solid” or “Dry ice”. The packing instruction P003 (ICAO/IATA P1954) should be followed. 5.8.5 If liquid nitrogen is used as a refrigerant, special arrangements should be made in advance with the carrier. The hazard label for liquid nitrogen should be attached to the outer packaging and, if carried by air, the handling label for cryogenic liquids should also be affixed. 5.8.6 Dry Shippers do not contain free liquid nitrogen and are not a regulated dangerous good; the hazard label is therefore not required. However the classification of infectious substance must be properly marked on the outer packaging and included in the Dangerous Goods Declaration for Category A substances or contained on the Air Waybill for Category B or Exempt Packages. CU/09/HTA 05/3.0 Page 11 of 16 5.9 Transportation Methods 5.9.1 A specialist courier would always be the preferred option for transporting human tissue. The courier would ease the burden of sending tissue samples as they should arrange and/or ensure the correct paperwork and labelling were in pace. 5.9.2 There are a number of methods for transporting human tissue. Below are the minimum precautions necessary for each method. 5.9.3 Transport by Sea and Air 5.9.4 5.9.5 .1 Where possible, the use of a professional courier service is recommended, especially when transporting internationally. .2 The precise nature of the material being transported will determine appropriate procedures to be followed, advice will need to be obtained from the transport operator. .3 Hand carriage, including hand luggage, checked in baggage or upon the person, of Category A or Category B infectious substances is strictly prohibited by international air carriers. .4 Regulations relating to the use of human tissue in the destination country must be consulted when planning transportation. .5 The transport operator and HM Revenue and Customs should be contacted prior to transport to determine the appropriate conditions for transport. .6 HTA guidelines on the import and export of human tissues should be observed, see HTA Code of Practice 8: Import and Export of Human Bodies, Body Parts and Tissue and the Cardiff University HTA Standard Operating Procedure for the Import and Export of Human Tissue. Transport by Post .1 Postal transport of Category A infectious substances is strictly prohibited. .2 Postal transport of Category B infectious substances are prohibited in the international post, but may be carried within the UK provided strict conditions are met. Samples must be packaged in accordance with Packing Instruction P650. .3 There are several commercially available packing systems that are fully compliant with Packing Instructions P650 and the requirements of Category B infectious substances, including the Royal Mail ‘Safebox’. .4 Postal transport of dry ice is prohibited. Transporting by Hand or Road .1 Secondary/outer packaging must be suitably labelled. .2 Secondary/outer packaging must be sufficiently robust to contain material in the event of an accident. CU/09/HTA 05/3.0 Page 12 of 16 5.9.6 6 .3 The material must never be left unattended. .4 Instructions for action in an emergency must be clearly indicated. .5 The University’s policy relating to the use of personal and hire vehicles must be observed, for further information see Cardiff University Occupational Health, Safety and Environment Unit. .6 Cryogenic gases, such as dry ice, must be kept separate from the driver and passengers. Vehicles with a separate cab (e.g. pick-up truck) or vehicles with a separate trailer are essential. Cryogenic gases should never be transported in cars. .7 Cardiff University policies and procedures from the Occupational Safety, Health and Environment Unit must be followed when handling or transporting human tissue and refrigerants. .8 Transportation of human tissue using public transport is not recommended. Use of Third Parties for Transport .1 Only specialist couriers with established procedures for transporting human material should be used for transporting fresh unfixed material. .2 Embedded blocks, slides etc may be transported by secure courier services. .3 A secure tracking system must be in place from sender to a specified recipient. .4 The recipient must either be: a) compliant with HTA legislation and authorised to receive the tissue under an individual licence, satellite licence or under NRES ethical approval, unless otherwise exempt from HTA licensing, or b) compliant with the regulations in force in the destination country. These regulations must be determined in advance of transport arrangements. REFERENCES Cardiff University Occupational Safety, Health and Environment Unit: http://www.cardiff.ac.uk/osheu/safety/index.html HTA Codes of Practice: http://www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.c fm International Civil Aviation Organization, Technical Instructions for the Safe Transport of Dangerous Good by Air: http://www.icao.int/safety/DangerousGoods/Pages/technical-instructions.aspx The Air Navigation (Dangerous Goods) Regulations 2002: http://www.legislation.gov.uk/uksi/2002/2786/contents/made CU/09/HTA 05/3.0 Page 13 of 16 7 UN Recommendations on the Transport of Dangerous Goods - Model Regulations Sixteenth revised edition: http://www.unece.org/trans/danger/publi/unrec/rev16/16files_e.html WHO Guidance on Regulations for the Transport of Infectious Substances: http://www.who.int/ihr/publications/who_hse_ihr_20100801/en/ REFERENCED SOPs Cardiff University HTA SOP Obtaining Informed Consent [CU/09/ HTA 02/3.0] Cardiff University HTA SOP Management of Records [CU/09/ HTA 06/3.0] Cardiff University HTA SOP Risk Management and Contingency Planning [CU/11/ HTA 10/3.0] Cardiff University HTA SOP Import and Export of Human Tissue [CU/13/ HTA 13/1.0] CU/09/HTA 05/3.0 Page 14 of 16 8 CONTACTS 8.1 DI and PDs Name School/ UHB Coverage Email Tel Prof Jonathan Bisson DI CU/UHB All areas BissonJI@cf.ac.uk (207)43742 ARUK BBC BIOSI LongmanAJ1@cf.ac.uk EdwardsWD@cf.ac.uk (208)75419 (208)75136 DENTL DENTL DENTL DENTL StephensP@cf.ac.uk ChadwickBL@cf.ac.uk WhiteFS@cf.ac.uk Gilmour@cf.ac.uk (207)42529 (207)46569 (207)42546 (207)42617 PATHY AML and HAEMY Jasani@cf.ac.uk (207)42700 WhitePC@cf.ac.uk (207)44524 PowellNG@cf.ac.uk (207)44742 IdziaszczykSA1@cf.ac.uk (206)87859 Bowden@cf.ac.uk GregoryC1@cf.ac.uk MantripragadaKK@cf.ac.uk Topley@cf.ac.uk (206)87302 (206)87221 (206)87063 (207)43770 ITIME MOLEX HanzelK@cf.ac.uk DayanCM@cf.ac.uk (207)42050 (207)42182 MOLEX SURGY Tenovus Building OPTOM PHRMY Med Gen PowellW1@cf.ac.uk MartinTA1@cf.ac.uk (207)48497 (207)46536 WangEC@cf.ac.uk AlbonJ@cf.ac.uk BirchallJC@cf.ac.uk Ian.Frayling@wales.nhs.uk (206)87318 (208)75427 (208)75815 (207) 44203 Dr Andrea Longman Mr Bill Edwards Prof Bharat Jasani BIOSI PD BIOSI PD DENTL Lead PD DENTL PD DENTL PD DENTL PD MEDIC Lead PD Dr Paul White MEDIC PD Dr Ned Powell MEDIC PD Prof Phil Stephens Prof Barbara Chadwick Dr Fiona Gagg Dr Alan Gilmour Mrs Shelley Idziaszczyk MEDIC PD Dr Paul Bowden Dr Clive Gregory Dr Kiran Mantripragada Prof Nick Topley Dr Wendy Powell Dr Tracey Martin MEDIC PD MEDIC PD MEDIC PD MEDIC PD MEDIC PD (assistant) MEDIC PD MEDIC PD (assistant) MEDIC Dr Eddie Wang Dr Julie Albon Dr James Birchall Dr Ian Frayling MEDIC PD OPTOM PD PHRMY PD UHB Mr Karl Hanzel Prof Colin Dayan 8.2 ICAGE/ GYNON ICAGE/ MGENE INIIM in HWB IPCPH IPMCN ITIME HT Act Compliance Team Name Division Position Email Tel Mrs Sharon Orton GOVRN HTA Co-ordinator HTA@cf.ac.uk (208)74888 Dr Carina Hibbs GOVRN Governance Officer HTA@cf.ac.uk (208)70231 Mrs Pat Tamplin UHB Governance Officer Pat.Tamplin@wales.nhs.uk (207)45879 CU/09/HTA 05/3.0 Page 15 of 16 APPENDIX A WHO Flowchart for the Classification of Infectious Substances and Patient Samples © World Health Organization 2010 CU/09/HTA 05/3.0 Page 16 of 16