Shipment of biological samples: rules and cri6cal issues

Transcription

1 14th Meeting of the Joint Permanent Committee (JPC) of the Mediterranean Animal Health Network (REMESA) Cesare Berneri - Biosecurity Service Shipment of biological samples: rules and cri6cal issues Naples July 2017

2 MATERIAL TRANSPORTATION SAFELY TIMELY The transport of Animal specimens must be performed, minimising the risk of exposure of people involved in the transport chain, protec7ng together the environment and suscep7ble animal popula7ons from harmful exposures allowing for a rapid processing of the specimens, being the analysis results o;en cri7cal for the choice of the interven7on strategies EFFECTIVELY protec7ng the integrity of the specimens against cross-contamina7on between different samples, ensuring thus the reliability of the analy7cal response EFFICIENTLY properly se>ng up the packaging and shipping; non compliant packaging or incomplete relevant documenta7on frequently lead to the cancella7on or delay of delivery to the laboratory, making it impossible or delaying the execu7on of the analysis LEGALLY complying with the relevant local, na7onal and interna7onal regula7ons of packaging and transporta7on of biological substances

3 INTERNATIONAL REGULATION ICAO / IATA à Technical Instruc6ons for the Safe Transport of Dangerous Goods by Air Apply on all interna7onal flights. For na7onal flights, i.e. flights within one country, na7onal civil avia7on authori7es apply na7onal legisla7on. The Interna7onal Air Transport Associa7on (IATA) publishes Dangerous Goods Regula7ons (DGR) that incorporatnecessary such restric7ons e the ICAO provisions and may add further restric7ons (where are included in these guidelines) IMDG à Interna6onal Mari6me Dangerous Goods Code Of mandatory applica7on for all contrac7ng par7es to the Interna7onal Conven7on for the Safety of Life at Sea RID à Interna6onal Carriage of Dangerous Goods by Rail Apply to countries in Europe, the Middle East and North Africa ADR à European Agreement concerning the Interna2onal Carriage of Dangerous Goods by Road Apply to 48 countries. In addi7on, modified versions of the conven7on are being used by countries in South America and South-East Asia.

4 MATERIAL TRANSPORTATION - FLOW Shipping laboratory Road Train Road Train Receiving Laboratory Responsibili6es - Communica6on - Shipment prepara6on o Classifica6on o Package o Label o Documenta6on - Shipment (Courier) - No6fica6on to receiver Courier? Custom check Custom check Responsibili6es - Communica6on - Instruc6on on: o packaging o authoriza6on - Contact with custom health personnel - Receipt - No6fica6on to shipper Courier Responsibili6es Provide the consignor informa6on on the correct packaging, with necessary travel documents and instruc6ons for their compila6on / Arrange with the consignor the transport route / Keep shipping documents / Make sure that the condi6ons of the package are maintained during the journey / No6fy the consignor of possible shipping delays.

5 Category A (*) CLASSIFICATION Infec6ous substances are divided into the following An infec6ous 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 Infec7ous substances mee7ng these criteria which cause disease in humans or both in humans and animals shall be assigned to United Na6ons number UN 2814 The proper shipping name for UN 2814 is: INFECTIOUS SUBSTANCE, AFFECTING HUMANS Infec7ous substances which cause disease only in animals shall be assigned to United Na6ons number UN 2900 The proper shipping name for UN 2900 is: INFECTIOUS SUBSTANCE, AFFECTING ANIMALS only (*) WHO - Guidance on regula2ons for the Transport of Infec2ous Substances

6 CLASSIFICATION Category B (*) Infec6ous substances which do not meet the criteria for inclusion in Category A (specimens collected directly from animals/humans that are suspected or confirmed to be infected) Infec7ous substances in Category B shall be assigned to UN 3373 The proper shipping name for UN 3373 is: BIOLOGICAL SUBSTANCE, CATEGORY B Followed by the words: DIAGNOSTIC (or CLINICAL) SPECIMEN (*) WHO - Guidance on regula2ons for the Transport of Infec2ous Substances

7 CLASSIFICATION Exempt human or Animal specimen (*) Substances that do not contain infec7ous substances or that are unlikely to cause disease in humans or animals are not subject to dangerous goods regula7ons, unless they meet the criteria for inclusion in another class. Substances containing microorganisms which are non-pathogenic to humans or animals are not subject to dangerous goods regula7ons, unless they meet the criteria for inclusion in another class. Ø Human or animal specimens that have a minimal likelihood of containing pathogens must be packaged appropriately to further minimize the risk of exposure. The packaging must be marked with the words; EXEMPT HUMAN SPECIMEN or EXEMPT ANIMAL SPECIMEN, as appropriate (*) WHO - Guidance on regula2ons for the Transport of Infec2ous Substances

8 CLASSIFICATION Substance for classifica6on (*) - Have any pathogens been neutralized/inac6vated? - Is it known not to contain infec6ous substances? - Are all micro-organisms present non-pathogenic for humans/animals? - Is it a blood spot/faecal occult blood? - Is it an environmental sample that is not considered to pose significant health risk? - Is it for transplant/transfusion? Yes to any No to all Yes Does it meet the defini6on of a category A substance? No No Is it a pa6ent specimen for which there is only a minimal likelihood that pathogens are present? Yes UN 2814 or UN 2900 as appropriate UN 3373 Biological substance Category B Subject to «Exempt human (or animal) specimen» provisions Subject to «Exempt human (or animal) specimen» provisions (*) WHO - Guidance on regula2ons for the Transport of Infec2ous Substances

9 CLASSIFICATION UN 2900 Infec6ous substance, affec6ng animals only O.I.E. (*) Indica6ve examples of infec6ous substances included in Category A in any form unless otherwise indicated African swine fever virus (cultures only) Avian paramyxovirus Type 1 Velogenic Newcastle disease virus (cultures only) Classical swine fever virus (cultures only) Foot and mouth disease virus (cultures only) Lumpy skin disease virus (cultures only).., for those micro-organisms listed as category A infec7ous substances (cultures only), pa6ent specimens of these pathogens do not require category A transport prac6ces. For these specimens Category B transport prac6ces should be applied. (*) O.I.E. Terrestrial Manual Chapter Transport of specimens of animal origin

10 REQUIREMENTS - PACKAGING Packaging must comply with INFECTIOUS SUBSTANCE BIOLOGICAL SUBSTANCE Packaging Instruc7on (PI) 620 à for specimens classified UN 2814 and UN 2900 Packaging Instruc7on (PI) 650 à for specimens classified as UN 3373 Shipments containing UN3373 that are compliant to the relevant IATA DGR requirements are also acceptable for road and sea transport (*) The various interna6onal modal regula6ons require the repor6ng of incidents to the relevant competent transport authori6es in addi6on to the necessary health authori6es. This applies to both categories of infec6ous substances, but par6cularly to those in Category A. (**) (*) Issued by the TNT Express Operations Dangerous Goods Department (DHO); (**) WHO_HSE_GCR_2015.2

11 REQUIREMENTS - PACKAGING Inner packaging UN 2814 UN 2900 (PI 620) (*) UN 3373 (PI 650) (*) 1 Leakproof primary receptacle(s); iden2cal 2 For liquid specimens, enough absorbent material to absorb the en7re contents If mul7ple 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 iden2cal 3 Leakproof secondary packaging; iden2cal 4 An itemized list of contents enclosed between the secondary packaging and the outer packaging Outer packaging iden2cal 5 Rigid, of adequate strength for its capacity, mass, intended use and must measure not less than 100 mm (3.9 inches) at its smallest overall external dimension See differences in the next slides (*) IATA Packing Instruc7ons (PI) 620 DOT 9CFR

12 REQUIREMENTS PACKAGING Ø Air transport regula6ons are the most restric6ve; shippers who comply with the air transport regula7ons also will meet the requirements of other transport modes (road, rail, etc.); Ø Primary receptacles must not break or leak their contents into secondary packaging; Ø An outer packaging must meet specific requirements, including being capable of passing specific test procedures based on receptacle or packaging type; at least one surface must have a minimum dimension of 100 mm X 100 mm; Ø Requirements for use of Dry Ice (carbon dioxide, solid): - If dry ice is used, it must be placed outside the secondary packaging, inside the outer packaging, or in an overpack. Also, the secondary packaging must be supported internally so that it maintains its original posi7on while the dry ice sublimates. - If dry ice is used, the packaging must allow for escape of carbon dioxide gas - The primary receptacle(s) and secondary packaging must maintain their integrity and performance at the temperatures of the refrigerant used as well as at the temperatures and pressures that could result if refrigera7on were lost.

13 REQUIREMENTS - PACKAGING Feature PI 650 (*) PI 620 (*) Primary Container Required Required Secondary Container Required Required Outer Container Required Required Absorbent Material for En6re Contents Required Required United Na6ons design type tes6ng* (performance requirements) 1.2 m drop test Must Pass Must Pass 9 m drop test Not Required Must Pass Puncture test Not Required Must Pass Water immersion test Not Required Must Pass Test Reports Should be available Must be available UN Specifica6on Mark Not Required Required Minimum dimensions Not Defined Defined Volume and Weight Restric6ons Not Defined Defined Packaging Size Restric6ons Not Defined Defined (*) IATA Packing Instruc7ons (PI) 620 DOT 9CFR

14 REQUIREMENTS UN 2900 PACKAGING (PI 620) ATTENTION If the package is inside an overpack, labeling must also be reported on the overpack. This packaging mode must be specified in the relevant documentation

15 UN Images (Labels and marking) FROM: (Shipper) Name of laboratory Address.. Responsible. Phone:. 1 MANDATORY 1- Shipper data 5 - Air Waybill number 2 - Receiver data 6 - Orienta7on, x2 3 - Contact for emergencies 7 - UN code (marking) 4 - Proper shipp. name & UN number 8 - Biological hazard TO: (Consignee) Name of laboratory Address.. Responsible. Phone: x 2 In caseof emergencies: Responsible (receiver)... Phone number. 3 8 Note: Diamond shaped labels have fixed measures, of 50 mm each side for small package, or 100 mm for bigger one INFECTIOUS SUBSTANCE AFFECTING ANIMALS only UN 2900 AWB Note: Labels needed only if dry ice is used DRY ICE UN kg (net weight)

16 REQUIREMENTS UN 3373 PACKAGING ATTENTION If the outer container is inside an overpack, labeling must also be reported on the overpack. This packaging mode must be specified in the relevant documentation

17 UN Images (Labels and marking) FROM: (shipper) Name of laboratory. Address (complete).. Contact. Phone: MANDATORY 1- Shipper data 4 - Kind of specimen 2 - Receiver data 5 - UN number 3 - Air Waybill number 6 - Proper shipping name 5 TO: (consignee) Name of the laboratory. Address.... Contact person.... Phone: BIOLOGICAL SUBSTANCE CATEGORY B 6 Note: Diamond shaped labels have fixed measures, of 50 mm each side for small package, or 100 mm for bigger one AWB.. 3 DIAGNOSTIC SPECIMEN 4 Note: Labels needed only if dry ice is used DRY ICE UN kg (net weight)

18 SHIPPING INFORMATION Shipment Type Proper Shipping Name UN Number Hazard Class Packing Group (PG) Packing Instruc6on (PI) Max. Net qty/pkg for Passenger Aircrap Max. Net qty/pkg for Cargo Aircrap Cat. A Infec7ous substance, affec7ng humans Infec7ous substance, affec7ng humans (technical name) UN n.a ml or 50 g 4 L (for liquids) or 4 kg (for solids) Cat. A infec7ous substance, affec7ng animals Infec7ous substance, affec7ng animals (technical name) UN n.a ml or 50 g 4 L (for liquids) or 4 kg (for solids) Cat. B Infec7ous Substance Biological substance, Category B UN n.a L (for liquids) or 4 kg (for solids) 4 L (for liquids) or 4 kg (for solids) (*) IATA Packing Instruc7ons (PI) 620 DOT 9CFR n.a. = not applicable

19 REQUIREMENTS PACKAGING «EXEMPT» Human or animal specimens that have a minimal likelihood of containing pathogens must be packaged appropriately to further minimize the risk of exposure. Note: In determining whether a pa2ent specimen has a minimal likelihood that pathogens are present, an element of professional judgment is required to determine if a substance is exempt. It should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local condi2ons. e.g. specimens for an2body detec2on in humans or animals in the absence of any concern for infec2on The packaging must be marked with the words Exempt human specimen or Exempt animal specimen, as appropriate (*) IATA - Guidance document Infec7ous substances

20 REQUIREMENTS PACKAGING «EXEMPT» (a) The packaging must consist of three components: 1. A leak-proof primary receptacle(s); 2. A 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 100 mm x 100 mm; (b) For liquids, absorbent material in sufficient quan7ty to absorb the en7re contents must 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 mul7ple fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them. (*) IATA Guidance document Infec7ous substances

21 DOCUMENTATION The documenta6on must be fixed to the outer package and/or to the overpack, if used. - Itemized list of contents (*) Note: The list must be put either between the secondary and the outer package and into the documenta7on affixed to the outer package. The list must indicate the commercial value (pro-forma) - Air waybill - Temperature store requirements, where appropriate, together with relevant labelling on the outer package (UN number of the refrigerant, if listed as dangerous) (*) I. Monne IZSVE- Transport of biological materials September 2015 Tunis

22 DOCUMENTATION - Customs invoice (proforma) and export cer6ficate, if needed - Import Permit The parcel must ever be accompanied by the copy of the «Import Permit» released by the Health Authority of the recipient country. The permission: is released for the import of specific types of samples and pathogens May have an expiry date and may establish specific condi7ons concerning transport, storage, use and disposal of samples and pathogens Arrival Airport(s) are only those defined into the permission. In Italy, Border Inspec7on Posts are responsible for import checks on samples and pathogens - Other informa6on: Sample details (leser addressed to the recipient laboratory)

23 DOCUMENTATION - SHIPPER DECLARATION FOR UN 2900 ONLY ü Mandatory for the shipping of Category A infec7ous substances ü A standard format is provided by relevant Regula7ons ü All the parts into the format must be compiled, or cancelled, if not relevant

24 SHIPPER DECLARATION - UPPER PART OF THE FORM Complete address of the Shipper and the Consignee, with the name of the responsible persons Airport of Departure Air Waybill number Number of pages Airport of Des6na6on Delete with XXXX the non-applicable

25 SHIPPER DECLARATION - LOWER PART OF THE FORM UN number of dangerous material in the package Risk Class for dangerous materials Packing Group Number of items and quan6ty Packing Instruc6on Note: For Class 6.2 Packing Group is not expected x. xxx Name and phone number of the Responsible for emergencies Name of Shipment Responsible, date and Signature

26 CRITICAL ISSUES Poor contact between laboratories (sender - consignee) Lack of awareness of the regula7ons Lack of package suppliers Lack of training opportuni7es Shipments too expensive Shipment delayed with samples that have lost their viability Box refused by the courier with no other alterna7ve or by the pilot Package destroyed by customs or border agencies (*) A. Ripani O.I.E. - Transport of biological materials September 2015 Tunis

27 MATERIAL TRANSPORTATION - FLOW Shipping laboratory Road Train Road Train Receiving Laboratory Responsibili6es - Communica6on - Shipment prepara6on o Classifica6on o Package o Label o Documenta6on - Shipment (Courier) - No6fica6on to receiver Courier? Custom check Custom check Responsibili6es - Communica6on - Instruc6on on: o packaging o authoriza6on - Contact with custom health personnel - Receipt - No6fica6on to shipper Courier Responsibili6es Provide the consignor informa6on on the correct packaging, with necessary travel documents and instruc6ons for their compila6on / Arrange with the consignor the transport route / Keep shipping documents / Make sure that the condi6ons of the package are maintained during the journey / No6fy the consignor of possible shipping delays.

28 CRITICAL ISSUES REPACKING BY THE COURIER The pictures are of the same parcel. The repacking opera7ons had covered all the labels, except that with the UN number and the proper shipping name

29 CRITICAL ISSUES REPACKING BY THE COURIER In another case (see above pictures), no labels were visible. At the opening of the package, however, the packaging was conform, with 4 different containers! INCOMPLETE OR WRONG TRAVEL DOCUMENTS On another occasion, an invalid shipping account was used. The shipment was blocked at a German airport by Courier s Deutch branch and, a;er several vicissitudes, the courier itself decided for parcel destroying.

30 RECOMMENDATIONS Develop a working rela6onship between those involved the sender, the carrier and the receiver - in order to provide for safe and expedi6ous transport of materials Ensure the correct classifica6on of the shipping material (UN) Design the Packaging of infec6ous substances for transport in order to fully comply the local, Na6onal and Interna6onal Regula6ons Make sure that the documenta6on is clear and complete, consistent with the chosen UN code; Always check the consistency between the material to be sent and the restric6ons imposed by the import authoriza6on before shipment Con6ngency planning for the availability of containers (with labels and marking), courier, refrigerants etc. Preferably rely on Interna6onal courier company(es) specialized in infec6ous substances transport (trained personnel)

31 ABOUT THE COSTS.. UN 3373 between 200 and 400 (Depending on the distances, weight and presence/absence of dry ice) Couriers: Interna6onal couriers like DHL, TNT, etc. (Trained personnel) UN 2900 between 1000 and 2000 Couriers: World Courier, DGI (Dangerous Goods Interna7onal), etc. These couriers offer a complete service (packaging and labeling included)

32 THANK YOU, MERCI, شكر, GRAZIE SECURITY AND SAFETY ARE COSTS THAT REPRESENT A SAVING Thanks to Dr. E. Brocchi and Dr. S. Grazioli for their valuable collabora6on and prac6cal advice.