Specimen collection and shipment strategy Georgina Tzanakaki and Aftab Jasir European Public Health Microbiology training program (EUPHEM) • Why collection of specimens is important? • Why transportation is important? Learning objective At the end of this part of the presentation, you should be able to understand the: Procedures, preparation, processing and transport of specimens 3 Procedures • Collecting specimens • Marking and labeling • Handling • Packing • Package labeling • Necessary documents following the transporting sample Procedures • Collecting specimens • Marking and labeling • Handling • Packing • Package labeling • Necessary documents following the transporting sample Specimen collection: key issues Consider differential diagnoses Decide on test(s) to be conducted Decide on specimen/s to be collected to conduct these tests consultation between microbiologist, clinicians and epidemiologist 6 The result of any laboratory examination is only as good as the sample received in the laboratory 7 Influences the accuracy of laboratory diagnosis Sample Influences laboratory efficiency Good Management sample Influences therapeutic decisions management PH events Outbreaks Surveillance Complex Emergency situations affects patient care and outcome 8 Procedures • Collecting specimens • Marking and labeling • Handling • Packing • Package labeling • Necessary documents following the transporting sample Labeling specimens 1. Name (unique identifier) 2. Clinical specimen 3. Specimen type 4. Date, time and place of collection 5. Name/initials of the person responsible for collection 10 Criteria for rejecting samples Mismatch of information on the label and the request Inappropriate transport temperature Excessive delay in transportation Inappropriate transport medium - specimen received in a fixative - dry specimen - sample with questionable relevance Insufficient quantity Leakage 11 Case investigation form Clinicians/test requester send: Personal information – age (or date of birth), sex, complete address Clinical information – date of onset of symptoms, clinical and immunization history, risk factors or contact history where relevant, anti-microbial drugs taken prior to specimen collection Laboratory information – acute or convalescent specimen – other specimens from the same patient Line listing – if large number of patients 12 13 Procedures • Collecting specimens • Marking and labeling • Handling • Packing • Package labeling • Necessary documents following the transporting sample Biosafety Principles To protect: – the patient – yourself – the environment -------(FILM) 15 Biosafety: protect the people Use single use equipment Disinfect Work in a clean, dedicated area 16 Biosafety: protect yourself Use personal protective equipment (PPE): disposable gloves laboratory coats / gown mask protective eyewear 17 Biosafety: protect yourself Collect sharps immediately to prevent needle-stick injury Have first aid kit readily accessible Do not reuse contaminated equipment 18 Biosafety: protect others, the environment • Package samples appropriately for transport • Decontaminate spills • Disinfect working areas for future use • Soak contaminated non-disposable material • Place waste in leak-proof biohazard bags • Ensure safe final management of waste • Protect cleaning personnel with PPE 19 Sample Handling Handle all samples as if infectious 20 Procedures • Collecting specimens • Marking and labeling • Handling • Packing • Package labeling • Necessary documents following the transporting sample Transport Regulations Where do they come from? Who develops them? United Nations Economic and Social Council National transport regulations ICAO/IATA transport regulations rail, road, and sea traffic agencies postal services private couriers 22 Dangerous Goods Classes Class 2: Non-flammable non-toxic gases Liquid nitrogen (refrigeration) Class 3: Flammable liquids Ethanol (preservation) Class 6: Toxic and infectious substances Division 6.1 addresses toxic substances Division 6.2 addresses infectious substances Class 9: Miscellaneous dangerous goods Dry ice Genetically modified microorganisms and organisms (not classified under 6.2) Dangerous Goods Classes Class 2: Non-flammable non-toxic gases Liquid nitrogen (refrigeration) Class 3: Flammable liquids Ethanol (preservation) Class 6: Toxic and infectious substances Division 6.1 addresses toxic substances Division 6.2 addresses infectious substances Class 9: Miscellaneous dangerous goods Dry ice Genetically modified microorganisms and organisms (not classified under 6.2) Substance Categories (Division 6.2) Category A (Infectious Substances) – e.g. Ebola virus, Bacillus anthracis (culture only) Category B (Biological Substances) – e.g.Bacillus anthracis (patient specimen), Highly pathogenic avian influenza virus (patient specimen) Exempt – Medical assessment has determined a minimal likelihood that pathogens are present – e.g. Pregnancy test, Drug screening 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 healthy humans or animals. Category B – Biological Substances • An infectious substance which does not meet the criteria for inclusion in Category A and has not been determined by a medical professional to have a minimal likelihood that pathogens are present. e.g. serum, CSF, blood etc Exempt – Medical assessment has determined a minimal likelihood that pathogens are present e.g. Pregnancy test, Drug screening What is the difference between cultures and patient specimens? Cultures and Patient Specimens Cultures are incubated samples (with purpose of multiplying pathogens) Patient specimens are collected directly from humans/animals These differences are important for the classification of infectious substances This classification will affect the choice of packaging Categorization and Identification Categorization Proper Shipping Name Category B Biological Substance, Category B Category A Infectious Substance, Affecting Humans The Ebola virus has been found in bats and samples which have not been cultured are being shipped. Category A Infectious Substance, Affecting Humans Medical professional declares human drug test as minimal likelihood for containing pathogens. Exempt Exempt Human Specimen Situation Patient presents with suspected case of Hepatitis B virus and blood samples are sent. Sending a culture of Mycobacterium tuberculosis to a reference laboratory. 2009 World Health Organization What are the requirements for packaging Category A and B substances? Triple Packaging Triple packaging provides three layers of containment to protect the substances being shipped. These layers are primary, secondary, and outer containers. The following diagram shows the basic concept of triple packages. Primary container Absorbent and cushioning material Secondary container Outer container Procedures • Collecting specimens • Marking and labeling • Handling • Packing • Labeling packages • Necessary documents following the transporting sample Markings and Labels Infectious Substance Label Markings and Labels Orientation Labels Mandatory on opposite sides when primary container exceeds 50 ml Markings and Labels Shipper’s and Receiver's Address Markings and Labels Emergency Contact Name and Number (Cat A) Markings and Labels Proper Shipping Name and UN Number Markings and Labels UN Specification Marking (Cat A) Markings and Labels Procedures • Collecting specimens • Marking and labeling • Handling • Packing • Package labeling • Necessary documents following the transporting sample Documentation for Shipping Infectious Substances Overview Air Waybill : goes with any shipment made by air shipper or courier must complete the form Completing the Shipper’s Declaration for Dangerous Goods Take home messages For a good sample management and thus a good laboratory diagnosis you need to: Follow carefully sample collection information Label samples with all necessary information Respect biosafety principles to protect the patient, yourself and the environment Handle all samples as if infectious Use appropriate packaging according to the category of sample Respect norms and regulations for transport 45 Sources This presentation used some information of the training package „Laboratory issues for epidemiologists“ put in place by the: Department of Epidemic and Pandemic Alert and Response of the World Health Organization European Program for Public Health Microbiology (EUPHEM) 46 Thank you for your attention ? 47