MANUAL ON PACKAGING AND TRANSPORT OF LABORATORY SPECIMENS FOR REFERRAL

2018 Department of Health Republic of the Philippines

2018 DEPARTMENT OF HEALTH REPUBLIC OF THE PHILIPPINES

MANUAL ON PACKAGING AND TRANSPORT OF LABORATORY SPECIMENS FOR REFERRAL

©2018 by the Department of Health. All rights reserved. Subject to the acknowledgment of the Health Facility Development Bureau (HFDB), Department of Health, the Manual may be freely abstracted, reproduced or translated in part or in whole for noncommercial purposes only. If the entire Manual or substantial portions will be translated or reproduced, permission should be requested from HFDB. Printed in the Republic of the Philippines.

Published by Department of Health San Lazaro Compound Rizal Avenue, Sta. Cruz, Manila 1003 PHILIPPINES

Development of this Manual was initiated and completed, and subsequently published through the Health Facility Development Bureau, Department of Health, Manila. Contact HFDB for inquiries: +63 2 6517800 locals 1401, 1403 and 1408.

Email address: nhln.hfdb@gmail.com / doh.hfdb.od@gmail.com

Republic of the Philippines Department of Health OFFICE OF THE SECRETARY

MESSAGE

With the President's approval of Republic Act No. 11223, or the Universal Health Care (UHC) Act, the health sector, with the Department of Health at the helm, is poised to accelerate towards the realization of health for all Filipinos. Our strategic framework to boost towards UHC is FOURmula One Plus for Health (F1 Plus), which is driven to meet our goals in better health outcomes, more responsive health system, more equitable healthcare financing, and strategized in pillars focused on governance, financing, regulations, service delivery and performance accountability.

UHC, simply put, means every Filipino gains equitable access to quality health care without the financial hardship. Thus, it serves as the health lens for our country's noble aspiration for "matatag, maginhawa, at panatag na buhay," as defined by the Philippines' long-term vision, AmBisyon Natin 2040. In UHC terms, it envisions the Filipino as one of the healthiest in Southeast Asia by 2022 and in Asia by 2040.

Much has already been achieved since we began our journey in healthcare reform. Nevertheless, now is not the time to be complacent in our efforts as stewards of a progressive healthcare system. The DOH shall ride through R.A. No. 11223's momentum and accomplish F1 Plus fueled by the energies of passionate, committed civil servants, and like-spirited people's organizations, development partners and private sector.

I commend the Health Facility Development Bureau (HFDB) for this endeavor to update the manuals of standards and operations of health facilities. With this initiative the HFDB fulfills its strategic commitments to F1 Plus; to integrate and standardize health facility operations in the context of the health provider networks; to enhance the Philippine Health Facility Development Plan; and to incentivize health facilities that institutionalize peoplecentered care and patient safety programs.

We trust that these manuals serve as standard references to guide management, service providers and support staff to instill quality in all aspects of health facility operations and service delivery. May these references, together with the Bureau's other sustained engagements with partners and stakeholders, facilitate health services that are designed according to the patient's rights, values and preferences, and delivered to their satisfaction and delight

FRANCISCO T. DUQUE III, MD, MSc

Secretary of Health

FOREWORD

In line with the thrust of the Department of Health on Service Delivery Network and Good Governance under FOURmula One Plus for Health (F1Plus), the Health Facility Development Bureau (HFDB) formulates policies and develops standards for the establishment, development, management and operations of health facilities in the country. The HFDB assumes the technical leadership and coordinates the health facility development initiatives of the government and its partners. Efforts to improve the service delivery network and determine the critical areas for continuing quality improvement that ensure patient-centered quality care have been our utmost priority.

Health workers and Health Facility/Hospital Administrators have been continuously confronted with a wide range of issues, new trends and technologies in various health care settings. The development of more relevant and responsive policies and guidelines for patient-centered quality care attunes our health systems to this dynamic environment.

For 2018, the Health Facility Development Bureau (HFDB) proudly endorses a set of Manuals for the Clinical Laboratory. These Manuals are outputs of the National Unit for Health Laboratories and the National Technical Working Groups of the National Health Laboratory Network (NHLN) Program. The authors and contributors in the conceptualization and completion of these manuals are experts in the various fields of laboratory medicine. The Manuals are in congruence with Philippine settings while maintaining consistency with international standards. Each of the following individual manuals is best used in conjunction with the other Manuals in the set:

1. Manual of Standards on Quality Management System in the Clinical Laboratory – 2nd edition
1. Manual of Standards and Criteria for Laboratory Action Plan
1. Manual of Standards on Laboratory Biosafety and Biosecurity
1. Manual on Packaging and Transport of Laboratory Specimens for Referral

The above-mentioned Manuals will serve as standard reference materials for the DOH Clinical Laboratories to aid laboratory administrators and clinical practitioners in the management and operations of various laboratory services that contribute directly and indirectly to quality patient care. These Manuals are also recommended for use in the Clinical Laboratories of Local Government Units, Military, Philippine National Police, Academe, and the Private sector.

PREFACE

The Department of Health's enactment of Administrative Order No. 2012-0021 or the "National Framework of the National Health Laboratory Network" that shall support the achievement of quality laboratory service through Service Delivery Network, as one of the strategic pillars of FOURmula 1 Plus for Health (F1 Plus). The measures to improve the quality of laboratory services are provided in the Strategic Plan for National Health Laboratory Network (NHLN). To ensure quality and take advances of economies of scale, the service capabilities of various health laboratories differ. The lower category laboratories perform the simpler and more common laboratory examinations while the higher category laboratories perform the less common and more complex laboratory procedures.

To make the more complex laboratory examinations accessible to the lower category laboratories, a referral system has been devised. Within the Regional Health Laboratory Network, referral laboratories are identified for various types of special laboratory examinations. Further, the special examinations are available from National Reference Laboratories and other tertiary category laboratories.

This Manual is designed to give proper packaging and transport of the laboratory specimens in consideration of regional health laboratory network system that aims towards time, resource and cost efficiency. The Manual will help protect the public and environment from the potential harmful effects due to improper handling of the laboratory specimens.

ACKNOWLEDGEMENT

The formulation of the Manual on Packaging and Transport of Laboratory Specimens for Referral has been made possible through the contributions of the following whose expertise is gratefully appreciated.

Dr. Criselda G. Abesamis	Director IV	Health Facility Development Bureau
Dr. Tomas P. Maramba, Jr.	Pathologist	Victor R. Potenciano Medical Center
Dr. Marissa A. Orillaza	Pathologist	Chairman, National TWG for the Implementation of Strategies of the Strategic Plan for NHLN
Dr. Elizabeth O. Telan	Pathologist	San Lazaro Hospital-STD/AIDS Central Cooperative Laboratory NRL
Dr. Leila M. Florento	Past President	Philippine Association of Medical Technologists
Ms. Josefina Geronimo	Quality Assurance Officer	Research Institute for Tropical Medicine
Dr. Miguel Martin Moreno	President	Biological Risk Association of the Philippines
Mr. Ronaldo E. Puno	President	Philippine Association of Medical Technologists
Mr. Plebeian B. Medina	Supervising Science Research Specialist	Research Institute for Tropical Medicine
Mr. Oliver Shane Dumaoal	Associate Professor	Lyceum of the Philippines
Dr. Razel L. Kawano	Professor	Angeles University Foundation
Ms. Marieta T. Go	Medical Technologist	Health Facilities and Services Regulatory Bureau
Ms. Minda C. Quitoriano	Medical Technologist	Health Facility Development Bureau
Ms. Nenita S. Cañafranca	Medical Technologist	Lung Center of the Philippines

Ms. Angelita O. Jimenez	Developmental Management	Health Facility Development
	Officer IV	Bureau
Mr. Richard Albert J. Ramones	Medical Technologist	Health Facility Development Bureau
Mr. Henry Ryan Dominic G. Cajandig	Administrative Assistant	Health Facility Development Bureau
Mr. Glenn A. Cruz	Development Management Officer III	Health Facility Development Bureau
Ms. Camille Ann C. Ople	Senior Administrative Assistant II	Health Facility Development Bureau
National Reference Laboratory - East Avenue Medical Center
National Reference Laboratory - Lung Center of the Philippines
National Reference Laboratory - Philippine Heart Center
National Reference Laboratory - National Kidney and Transplant Institute
National Reference Laboratory - Philippine Heart Center
National Reference Laboratory - Research Institute for Tropical Medicine

LIST OF ACRONYMS

ARSRL – Antimicrobial Resistance Surveillance Reference Laboratories

EAMC – East Avenue Medical Center

ICAO – International Civil Aviation Organization IATA – International Air Transport Association

LCP – Lung Center of the Philippines

NHLN – National Health Laboratory Network NKTI – National Kidney and Transplant Institute

NRL – National Reference Laboratories

NTRL – National Tuberculosis Reference Laboratory

PHC – Philippine Heart Center

RITM – Research Institute for Tropical Medicine

SLH-SACCL – San Lazaro Hospital-STD/AIDS Central Cooperative Laboratory

VRD – Veterinary Research Department

WHO – World Health Organization

DEFINITION OF TERMS

Air waybill tracking – is a receipt issued by an international airline for goods and an evidence of the contract of carriage, but it is not a document of title to the goods.

Carrier – company that transports goods and/or people by air, land or sea, in its own or chartered vessels or equipment, and is named as the carrier in the contract of carriage.

Courier – is a person or company that delivers messages, packages and mails.

Designated Referral Laboratory – is a DOH-licensed laboratory and a member of the Regional Health Laboratory Network that is designated to receive specimens from other referring laboratories for testing.

Environmental specimen – a sample taken from the environment e.g. air, water, soil, sediments, vegetation and foods intended for laboratory examinations.

Outer shipping package – a sturdy container used to hold the secondary receptacle to protect it and its contents from outside influences such as physical damage and water while in transit.

Overpack – is an enclosure by a single shipper to contain one or more packages and to form one handling unit for convenience of handling and stowage.

Patient specimen – is a clinical sample collected directly from a human and intended for laboratory examinations.

Preservative – is a chemical substance that is used to preserve the specimen's viability (e.g. formaldehyde).

Primary receptacle – is a labelled primary leak-proof receptacle containing the specimen. The receptacle is wrapped in enough absorbent material to absorb all fluid in case of breakage.

Referring Laboratory /Sender– is a laboratory that sends specimen to a referral laboratory for testing and/or further examinations.

Regional Health Laboratory Network – is a group of laboratories that belongs to laboratory network in a designated region.

Secondary container – is a second durable, leak-proof receptacle to enclose and protect the primary receptacle. Several wrapped primary receptacles may be placed in one secondary receptacle. Sufficient additional absorbent material must be used to cushion multiple primary receptacles.

Shipper's Declaration – is a specific form prepared by sender certifying that the specimen has been packed, labelled, and declared according to IATA Dangerous Goods Regulations.

Triple packaging - a recommended packing of laboratory specimen using two (2) inner layers of leak-proof containers and one (1) sturdy outer container to prevent any spillage of its contents.

Message Foreword Preface Acknowledgement List of Acronyms	4 5 6 7 9
Definition of Terms	10
CHAPTER 1 Specimen for Referral Regulated and Unregulated Biological Materials Subject to IATA	14
Shipping Regulations Means of Specimen Transport General Steps in Handling All Specimens for Referral Procedure for Local Land and Water Transport Procedure for Air Transport Roles and Responsibilities in Specimen Packaging and Transport Spill Decontamination	14 16 17 18 25 28 29
Appendices A: Triple Packaging System B: Classification of Dangerous Goods C-1: Classification of Biological Materials for Transport C-2: Flowchart for the Classification of Infectious Substances and Patient Specimens C-3: Examples of Infectious Substances Included in Category A D: Shipper's Declaration Form E: Marking and Labelling	31 34 35 38 39 41 42
CHAPTER 2 List of National Reference Laboratories and Their Specific Requirements for Referral, Services, and Contact Information References	46 123

SPECIMEN FOR REFERRAL

The great majority of the specimens come from patients. They may be categorized into:

1. Whole Blood, Serum or Plasma
1. Urine
1. Body fluids, e.g., Pleural, Peritoneal, Cerebrospinal, or joint fluid
1. Stool or fecal smear
1. Oropharyngeal and nasopharyngeal swabs
1. Microbiological culture or smear
1. Surgical specimen for Surgical Pathology
1. Smear or fluid for Cytology
1. Water, waste and other environmental specimens

A. Regulated and Unregulated Biological Materials Subject to IATA Shipping Regulations

1. Regulated Biological Materials

The materials presented below are subject to IATA shipping regulations for infectious substances:

Infectious substances are materials regulated for shipping. These materials are known to be, or are reasonably suspected to contain, an animal or human pathogen. A pathogen is a virus, microorganism (including bacteria, plasmids, or other genetic elements), proteinaceous infectious particle (prion), or a recombinant microorganism (hybrid or mutant) that is known or reasonably expected to cause disease in humans or animals. Microorganisms that are unlikely to cause human or animal diseases are not subject to biological shipping regulations.

Category A infectious substances are materials capable of causing permanent disability, or a life-threatening or fatal disease in humans or animals when exposure to them occurs. Category A infectious substances are shipped as infectious substances affecting humans (UN2814) or infectious substances affecting animals (UN2900). Examples of Category A infectious substances are listed in Appendix C3.
Category B infectious substances are materials that do not meet Category A criteria. Category B infectious substances are shipped as UN3373.

Patient specimens or diagnostic specimens are any human or animal materials including but not limited to excreta, secreta, blood, blood components, tissue, and tissue fluids being shipped for the purpose of diagnosis. Patient specimens that have a minimal likelihood of containing

pathogens are regulated materials, but they are also exempt from many shipping requirements. Professional judgment is used to determine if a specimen contains pathogens and should be based on the patient's medical history, symptoms, local conditions, and individual circumstances. The outer package must be marked "Exempt human specimen" or "Exempt animal specimen." If there is more than a "minimal likelihood" that a patient specimen contains pathogens, it must be shipped as a Category A or Category B infectious substance.

Biological products are materials that are derived from living organisms and manufactured for use in the prevention, diagnosis, treatment, or cure of disease in humans or animals. Examples of biological products include certain viruses, therapeutic serums, toxins, antitoxins, vaccines, blood, and blood products. Biological products transported for final packaging, distribution, or use by medical professionals is not subject to biological shipping regulations. Biological products that do not meet these criteria must be shipped as UN2814, UN2900, or UN3373 when appropriate.

2. Unregulated Biological Materials

The following materials are not subject to IATA infectious substance shipping regulations:

Substances that do not contain infectious substances or that are unlikely to cause disease in humans or animals.
Noninfectious biological materials from humans, animals, or plants. Examples include noninfectious cells, tissue culture, blood, or plasma from individuals not suspected of having an infectious disease, DNA, RNA, or other genetic elements.
Substances containing microorganisms that are nonpathogenic to humans or animals.
Substances that have been neutralized or inactivated so that they no longer pose a health risk.
Environmental samples that are not considered to pose a significant risk of infection (e.g., food and water samples).
Dried blood spots.
Fecal occult blood screening tests.
An infectious substance (other than a Category A infectious substance) contained in a patient sample being transported for research, diagnosis, investigational activities, or disease treatment and prevention; or a biological product when such materials are being transported by a private carrier in a motor vehicle used exclusively to transport such materials.
Blood or blood components that have been collected for the purpose of transfusion or the preparation of blood products to be used for transfusion or transplantation.
Tissues or organs intended for use in transplantation.
A material with a low probability of containing an infectious disease, or where the concentration of the infectious substance is at a level that naturally occurs in the environment and cannot cause disease when exposure to it occurs. Examples of these materials include foodstuffs and environmental samples (e.g., samples of water, dust, or mold).
A biological product, including an experimental or investigational product or component of a product, subject to regulations approval, permit, review, or licensing requirements.

B. MEANS OF SPECIMEN TRANSPORT

The means of transport will depend on the destination and other specific requirements of specimens to be referred (Part 2 List of National Reference Laboratories and their specific requirements for referring samples). Specimens are generally referred to:

I. Identified Laboratories in the Regional Health Laboratory Referral Network.
II. National Reference Laboratories (NRLs) located in Metro Manila (Supplemental)

The means of transport can be generally classified into personal transportation and transport by a licensed courier.

The means of transport include:

1. Personal Transportation by Land
- 1.1 Hand-carry transport between laboratories

There are specimens that are hand carried from one laboratory to another by a trained health facility staff. Hand-carry transport between laboratories generally means an employee is handcarrying the biological material in a container and walking between laboratories in the same building or buildings that are closely connected and designed for pedestrian traffic.

1.2 Personal Transportation in a Motor Vehicle

Transportation of biological material using a private or government passenger vehicle such as a car, bus taxi, motor bike tricycle, bicycle or pickup truck also required that the samples are triplepacked and transported by a trained personnel.

1.3 Transport by Boat

The laboratory specimens should be transported triple packed by a trained person.

Biological materials transported by this means are not subject to IATA regulations; however, biological materials transported by this means must at least be triple packed.

2. Delivery by courier

The courier companies that are transporting laboratory specimens are required to have undergone training and should be duly accredited in order to maintain the viability of samples and to implement the safety transport guidelines.

2.1 Transport by Land

The couriers/cargo companies that are transporting laboratory specimens via land are required to have undergone training and should be duly accredited in order to maintain the viability of samples and to implement the safety transport guidelines.

2.2 Transport by Air

Delivery by courier or carrier with airline: It is required that appropriate trainings are provided to persons and organizations processing laboratory specimens to be transported by air [2,3].

2.3 Transport by Ship

2.3.1 Transport by ship/ ship cargo

The ship/ ship cargo companies that are transporting laboratory specimens are required to have undergone training and should be duly accredited in order to maintain the viability of samples and to implement the safety transport guidelines.

C. GENERAL STEPS IN HANDLING ALL SPECIMENS FOR REFERRAL

Step 1: Determine the referral laboratory network system and their requirements:

1.1 Regional (Sub-national/Referral)

1.2 NRLs

1.3 Others

Step 2: Classify specimens to be transported.

Step 3: Plan the transport

Step 4: Pack the specimen using triple packaging system with proper

labelling in each receptacle.

Step 5: Document and label the outer container box Step 6: Transport only properly packed specimens

Step 7: Document received specimens

D. PROCEDURE FOR LOCAL LAND AND WATER TRANSPORT

Step 1: Determine the Referral Health Laboratory Network System and their requirements

1.1 Refer to the list of Referral Laboratories in the network to identify where to refer in the regional networking system and to verify the availability of the desired laboratory examination.
1.2 Check specific requirements of the identified referral laboratory for specimen referral.

Step 2: Classify Specimens to be Transported

2.1 Determine the type of the specimens to be transported (e.g. whole blood, serum, plasma, urine, body fluids, microbiological, surgical specimens, etc.) and the added chemical preservatives for anatomic specimens (e.g. alcohol or formalin).
2.2 Specify the amount of the specimen to be transported. Use plastic cryotubes (e.g. screw-capped cryovials) for the primary container or receptacle for small (1-2 ml) quantity of liquid specimens; use thick plastic (e.g. resealable plastic containers) for larger volume specimens of not more than 500 ml liquid diagnostic specimen and not more than 500g.
2.3 Determine the medical diagnosis, history and clinical symptoms of the patient source.
2.4 Determine the classification according to guidelines (refer to Appendix C1 Classification of Biological Materials for Transport)

Step 3: Plan the Transport

3.1 Coordinate specimen referral. Fill-out appropriate request forms, referral documents and specimen status monitoring form. Call up to inform the referral laboratory to inform them about the specimen referral. Document the name of the person who received the coordination call, date and time of the referral.
3.2 Choose and contact the appropriate specimen carrier (i.e. personnel, courier company or transportation vehicles). It is recommended that carriers have undergone proper training

for transport of diagnostic specimens [2,3] and to have a memorandum of agreement with couriers or transportation companies (e.g. bus, taxis, etc.) if their services are utilized in order to maintain integrity, viability security and avoid delay or theft during the transport for solid diagnostic specimen.

Step 4: Triple Pack the Sample Specimens

4.1 Pack all specimens following the basic triple packaging (Figure 1) requirement to ensure that the laboratory specimens will reach their destinations in good condition and that no risk of leakage and subsequent hazard to the public and handlers will be caused. Refer to Appendix A for further specific illustration of packaging of specimens for transport.

Figure 1: Basic triple packing

4.2 Use primary receptacles that are leak-proof and watertight. In general, screw cap cryovials (Figure 2) are recommended for the usual clinical laboratory specimens in chemistry, serology, immunology or hematology; clean sterile conical tubes (Figure 3) for urine and thick resealable plastic containers (Figure 4) for small anatomic specimens. Label the primary container with the patient's name, type of specimen and laterality (e.g. right or left foot) when appropriate.

Figure 2: Screw cap cryovials

Figure 3: Clean sterile conical tubes

Figure 4: Resealable plastic container

4.3 Use primary containers with sturdy, leak -proof plastic containers with screw cap (Figure 5) for small anatomic or representative tissue specimens in formalin. For large anatomic specimens, place and seal in large plastic bags before putting into large sturdy, leak -proof plastic containers (Figure 6). Use of glass containers is not recommended. Microscopic slides are recommended to be individually packed in plastic slide holders (Figure 7) with outside padding to prevent breakage during transport. Pack paraffin blocks in plastic bags (Figure 8) with refrigerants to avoid melting in hot temperatures during shipment.

Figure 5 Leak -proof plastic containers with screw cap

Figure 6 Leak-proof container for large anatomic specimen

Figure 7 Plastic slide holder

Figure 8 Resealable plastic bag for paraffin blocks

4.4 Use secondary containers that are leak-proof and then place absorbent material, such as paper towels or cotton, appropriate for the size of the specimen being transported. Examples of secondary containers are screw-capped jars (Figure 9) or resealable plastic bags (Figure 10).

Figure 9 Screw-capped jars

Figure 10 Secondary containers (jar, conical tube, resealable plastic bag, lock and lock airtight container)

4.5 Secure the specimen request with identification data and monitoring record of status of specimen in a separate resealable plastic bag and place outside the secondary container.
4.6 Use solid, sturdy and durable container for the outer container/box such as thick durable carton box (Figure 11) or styrofoam box (Figure 12) or insulated cooler (Figure 13) that withstand ordinary humid environment as well as forces during regular dropping of cargo. Please refer to Appendix A for the specific packaging requirements.

Figure 11 Thick durable carton box

Figure 12 Styrofoam box

Figure 13. Insulated cooler

4.7 Securely position the specimen transport container in the transport vehicle.
4.8 Regulate the temperature for the specimen transport container that ranges from 5^oC-25^oC and/or under conditions indicated for the examination as recommended by the Referral / Receiving Laboratory.
4.9 Keep a spill kit (Figure 14) containing absorbent material, a disinfectant, a leak-proof waste disposal container and heavy duty gloves in the transport vehicle.
4.10 Transport all specimens to the laboratory for examination as quickly or as reasonably possible. It is expected that specimens will not remain in transit for longer periods than recommended by the referral laboratory.

Figure 14. Spill kit

Step 5: Document and labelling the outer container box

5.1 Secure the necessary documents required for the referral and transport of specimens inside a plastic bag and place or paste outside the secondary container. Prepare a duplicate copy of all documents for file by the sender.
5.2 Label the outer container clearly and legibly with the following information: complete address and emergency contact numbers of both referring (sender) laboratory and the referral (receiver) laboratory.
5.3 Label appropriately each specimen transport container consistent with its contents e.g. diagnostic specimens.
5.4 If used, properly label the preservative substance such as in 'Formaldehyde'.
5.5 For packages with dry ice allow the release of carbon dioxide gas to prevent pressure build-up and subsequent explosion.

Step 6: Transport only properly packed specimens.

6.1 Check and strictly follow the requirements of the referral laboratory to avoid rejection of specimens being referred.

Observe the criteria for specimen rejection and acceptance of the referral laboratory meticulously.
6.2 Comply and observe the guidelines of the regional referral system
6.3 Fill-out the specimen status monitoring form

Step 7: Document Received Specimens

7.1 For the referral laboratory: document the status of the specimen received from the referring laboratory/sender.
7.2 Indicate in the specimen monitoring form and receiving logbook the time, date and conditions of the specimens.
7.3 Fully document and file comments in case of rejection of specimen.

Note: For the receiving or referral laboratory: periodically review sample transport time periods and temperatures to verify compliance with the standard policy guidelines. Record and analyse results of these reviews/ checks.

E. PROCEDURE FOR AIR TRANSPORT

Step 1: Determine the Referral Laboratory and their requirements.

Step 2: Classify Specimens to be transported according to the UN class.

2.1 Classify specimens according to their specific class so they are properly packed and transported appropriately. Chemicals may be necessary for the preservation of the materials to be transported. It is essential to include information about the classification of both materials included in the shipment and identified in the labels and data sheets.
2.2 It is recommended that agencies and individuals involved in the transport of specimens undergo training for packaging and transport/shipping of specimens or infectious substances.

Step 3: Plan the Transport

3.1 Plan the transport following Step 3 of procedure for land and water transport.

Step 4: Pack patients' specimens according to their corresponding categories, as specified in the IATA Packaging Instructions [1,4,5]

4.1 Pack, mark and label all infectious substances using the triple packaging system (Figure 15). Although, there are slight differences in the packaging guidelines, the basic triple packaging is fundamental to all specimens. Refer to Appendix A for further illustration of triple packaging system.

Figure 15. Basic triple packaging (IATA packaging instruction)

4.2 Pack category A specimens according to IATA Packaging Instructions (PI) 620 while Category B specimens according to PI 650. Refer to Appendix A for proper packaging instructions.
4.3 Use leak-proof, screw-capped primary and secondary containers. Primary container should be individually labelled and secured for any possibility of leakage.
4.4 Use plastic bags as primary receptacle for tissue specimens with preservative. Pack paraffin blocks appropriately to avoid melting and crushing during transport.
4.5 Secure and pack microscopic slides to prevent breakage. Individual wrapping and padding should be sufficient to withstand damage during shipment.
4.6 Insert enough absorbent materials in between the primary and secondary containers. These absorbents should be able to absorb all the liquid contents in case of leakage.
4.7 Place outside the secondary container the request, monitoring status of specimens and other records which are placed in separate plastic zip lock bags.
4.8 Use rigid outer container of adequate sturdiness and strength for its expected capacity and intended purpose.
4.9 For shipping with dry ice, allow the release of carbon dioxide gas during sublimation. Place the dry ice outside the secondary container.
4.10 For overpack, several triple packages are combined into one larger package, each combined package inside the overpack are marked and labelled including hazard labels, proper shipping names and quantities (net). Indicate the mark "Overpack" in the outermost container.

Step 5: Documentation

Complete all the necessary shipping forms and make a copy for record file.

5.1 Properly fill -out the Shipper's Declaration Form for Dangerous Goods (for category A) with complete information provided for emergency response
5.2 Track the document which includes the name and telephone number of the person responsible for the shipment by Air Waybill tracking.

Step 6: Markings and Labelling in the Outermost Container

6.1 Mark and label the outer container with the name, address and telephone number of the shipper, as well as the name, address and telephone number of the receiver/consignee.
6.2 Write in words the UN label with the appropriate content (e.g. UN 3373 Biological Substances, Category B) next to the diamond sign (Appendix E).
6.3 Category B shipments DO NOT REQUIRE an Infectious Substance label, Shipper's Declaration form for Dangerous Goods or emergency response information.

F. ROLES AND RESPONSIBILITIES IN SPECIMEN PACKAGING AND TRANSPORT

It is the responsibility of the sender to ensure the correct designation, packaging, labelling and documentation of all diagnostic specimens for transport including the monitoring record of status of specimens. The efficient transport and transfer of diagnostic specimens requires good coordination between the sender, the carrier and the receiver (receiving laboratory), to ensure that the material is transported safely and arrives on time and in good condition. Such coordination depends upon well-established communication and a partnership among the three parties. All have specific responsibilities to carry out in order to achieve an effective and successful transport.

1. The Referring Agency/Sender

1.1 Makes advance arrangements with the receiver of the specimens. Calls the recipient to verify the shipping address and obtain the name and phone number of the contact person. Finds out when the contact person will be able to receive the shipment.
1.2 Makes advance arrangements with the carrier/courier to ensure that the shipment will be accepted for appropriate transport and that the shipment (direct transport, if possible) is undertaken by the most direct routing, avoiding arrival at weekends/holidays. Shipments should not go out on Thursdays or Fridays unless the recipient agrees that the recipient will be there to receive the package during the weekend or holiday.
1.3 Prepares necessary documentation including request forms, specimen status for specimen monitoring, permits if necessary, dispatch and shipping documents;
1.4 Notifies the receiver of transportation arrangements once these have been made, well in advance of expected arrival time.

2. The Carrier/Courier

2.1 Provides the sender with the necessary shipping documents and instructions for their completion;
2.2 Provides advice to the sender about correct packaging;
2.3 Assists the sender in arranging the most direct routing and then confirms the routing;
2.4 Maintains and archives the documentation for shipment and transport;
2.5 Monitors required holding conditions of the shipment while in transit;
2.6 Notifies the sender of any anticipated (or actual) delays in transit.
2.7 Notifies the sender of the completed or uncompleted delivery of the package.

3. The Receiver

3.1 Arranges for the timeliest and efficient collection on arrival;
3.2 Immediately acknowledges receipt and records the date and time of receipt of specimen.
3.3 Returns a copy of the monitoring record of specimen status to the sender.

Shipments should not be dispatched until:

a. Advance arrangements have been made between the sender, carrier and receiver
b. Receiver has confirmed that there will be no delay incurred in the delivery of the package to its destination.

G. SPILL DECONTAMINATION

The following general procedure shall be used as a guideline for cleanup of a damaged, or leaking package.

1. Preparation

1.1 Wear PPE such as reusable or disposable rubber gloves and safety glasses when handling decontaminant solutions or when cleaning up contaminated materials. Use double disposable gloves if possible and appropriate.

2. Clean-up

2.1 Clean the package by first pouring or soaking the package with an appropriate disinfectant such as 10% household bleach, Lysol®, or other appropriate disinfectant. Allow the disinfectant sufficient time to decontaminate the item (e.g., 10 minutes).
2.2 If possible and appropriate, pick up the decontaminated item with an impervious barrier such as a plastic bag placed over the item. Place the decontaminated item into a plastic bag, tie the bag shut, place the bag into a second bag, and tie the second bag shut.

2.3 Clean up localized gross surface contamination as needed by pouring or soaking with disinfectant and using disposable paper towels. Place waste materials in a plastic bag, remove outer contaminated disposable gloves, and double bag the waste materials.

3. Decontamination

3.1 Clean contaminated surfaces or floors as needed. Use a solution of water, detergent, and disinfectant to mop floors or wipe surfaces. Steam clean or shampoo carpets and upholstered furniture. Do not vacuum or dry sweep surfaces before wet cleaning. Pour mop or cleaning wastewater into a drain that is connected to the building's sanitary sewer system.
3.2 Remove any potentially contaminated clothing and launder with detergent and hot water separately.
3.3 Decontaminate Re-Useable Equipment
- 3.3.1 Decontaminate with the bleach solution all potentially contaminated re-useable tools or protective equipment used in the clean-up.
- 3.3.2 Autoclave the material in the laboratory before disposal.

4. Disposal

4.1 Dispose of the bags of waste in the general trash. Use an outside dumpster, as needed, to prevent odor problems.
4.2 Remove PPE, and then clean it (if reusable) or dispose of it.

5. Washing of hands

5.1 Wash hands with soap and water.
5.2 If hand-washing facilities are not available at the job site, use 70% alcohol and then wash your hands as soon as possible.

APPENDICES:

APPENDIX A: TRIPLE PACKAGING SYSTEM [5]

Packing Instruction 620 and 650 [1]

This instruction applies to substance marked as UN 2814 and UN 2900.

The following packagings are authorized provided the special packing provisions described below are met. Packagings meeting the requirements and approved accordingly consisting of:

1. Inner packagings comprised of:
- a. Leak-proof primary receptacle(s);
- b. A leak-proof secondary packaging;
- c. 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 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;
1. A rigid outer packaging:
- a. Drums (1A1, 1A2, 1B1, 1B2, 1N1, 1N2, 1H1, 1H2, 1D, 1G);
- b. Boxes (4A, 4B, 4N, 4C1, 4C2, 4D, 4F, 4G, 4H1, 4H2);
- c. Jerricans (3A1, 3A2, 3B1, 3B2, 3H1, 3H2).

The smallest external dimension shall be not less than 100 mm (4 in).

Additional requirements:

1. Inner packagings containing infectious substances shall not be consolidated with inner packagings containing unrelated types of goods. Complete packages may be overpacked in accordance with the provisions of 1.2.1 and 5.1.2; such an overpack may contain dry ice.
1. Other than for exceptional consignments, e.g. whole organs that require special packaging, the following additional requirements shall apply:
- a. Substances consigned at ambient temperatures or at a higher temperature. Primary receptacles shall be of glass, metal or plastics. Positive means of ensuring a leak-proof seal shall be provided, e.g. a heat seal, a skirted stopper or a metal crimp seal. If screw caps are used, they shall be secured by positive means, e.g., tape, paraffin sealing tape or manufactured locking closure;
- b. Substances consigned refrigerated or frozen. Ice, dry ice or other refrigerant shall be placed around the secondary packaging(s) or alternatively in an overpack with one or more complete packages marked. Interior supports shall be provided to secure secondary packaging(s) or packages in position after the ice or dry ice has dissipated. If ice is used, the outer packaging or overpack shall be leak-proof. If dry ice is used, the outer packaging or overpack shall 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;
c. Substances consigned in liquid nitrogen. Plastics primary receptacles capable of withstanding very low temperature shall be used. The secondary packaging shall also be capable of withstanding very low temperatures, and in most cases will need to be fitted over the primary receptacle individually. Provisions for the consignment of liquid nitrogen shall also be fulfilled. The primary receptacle and the secondary packaging shall maintain their integrity at the temperature of the liquid nitrogen;
d. Lyophilized substances may also be transported in primary receptacles that are flame-sealed glass ampoules or rubber-stoppered glass vials fitted with metal seals.
1. Whatever the intended temperature of the consignment, 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 and temperatures in the range -40 °C to +55 °C (-40 °F to +130 °F).
1. Other dangerous goods shall not be packed in the same packaging as Division 6.2 infectious substances unless they are necessary for maintaining the viability, stabilizing or preventing degradation or neutralizing the hazards of the infectious substances. A quantity of 30 ml or less of dangerous goods included in Classes 3 (flammable liquids), 8 (corrosive substances) or 9 (miscellaneous dangerous substances and articles, including environmentally hazardous substances) may be packed in each primary receptacle containing infectious substances. These small quantities of dangerous goods of Classes 3, 8 or 9 are not subject to any additional requirements of these Regulations when packed in accordance with this packing instruction.
1. Alternative packagings for the transport of animal material may be authorized by the competent authority.

APPENDIX B: CLASSIFICATION LIST OF DANGEROUS GOODS [1, 2, 4, 5]

Class 1 - Explosives

Class 2 - Gases

Class 3 - Flammable Liquids

Class 4 - Flammable Solids

Class 5 - Oxidizing Agents and Organic Peroxides

Class 6 - Toxic and Infectious Substances

6.1 Toxic Agents

6.2 Biohazard substances (Category A or B)

Class 7 - Radioactive Materials

Class 8 - Corrosive Agents

Class 9 - Miscellaneous

								]	Passenger and o	cargo aire	raft	Cargo	aircraft only
								Limite	d quantity
Proper Shipping Name	UN No.	Class or Div	Sub Risk	Hazard Labels	State Var	SP	UN Pkg Grp	Pkg Inst	Max net Qty/ Pkg	Pkg Inst	Max net Qty/ Pkg	Pkg Inst	Max net Qty/ Pkg
1	2	3	4	5	6	7	8	9	10	11	12	13	14
Aviation regulated liquid, n.o.s.	3334	9		Mise.		A27		Y964	30 kg G	964	450 L	964	450 L
Biological substance, Category B	3373	6.2		None	CA 5; GB 5					see 650		see 650
(Bio) medical waste	3291	6.2		Inf.		A117	п			622	No limit	622	No limit
Carbon dioxide, solid Dry ice	1845	9		Mise.		A48 A151				954	200 kg	954	200 kg
Clinical waste, unspecified, n.o.s.	3291	6.2		Inf.		A117	п			622	No limit	622	No limit
Ethanol Ethanol solution	1170	3		Flamm		A3 A58	п	Y341	l litre	353	5 litres	364	60 litres
Ethyl alcohol Ethyl alcohol solution	11/0	3		Liq		A180	ш	Y344	10 litres	355	60 litres	366	220 litres
Formaldehyde solution, with not less than 25% formaldehyde	2209	8		Corrsv	US 4		ш	Y841	l litre	852	5 litres	856	60 litres
Formaldehyde solution, flammable	1198	3	8	Flam m Liq &		A180	ш	Y342	1 litre	354	5 litres	365	60 litres
Genetically modified micro- organisms Genetically modified organisms	3245	9		Mise.		A47				959	No limit	959	No limit
Infectious substance, affecting animals only	2900	6.2		Inf.	AU 3; CA 8; VU 2	A81 A140				620	50 ml or 50 g	620	4 litres ro 4 kg
Infectious substance, affecting humans	2814	6.2		Inf.	AU 3; CA 8; VU 2	A81 A140				620	50 ml or 50 g	620	4 litres or 4 kg
Medical waste, n.o.s.	3291	6.2		Inf.		A117	п			622	No limit	622	No limit
Methanol	1230	3	6.1	Flamm liquid		A104 A113	п	Y341	l litre	352	1 litre	364	60 litres
Nitrogen, refrigerated liquid	1977	2.2		Non- flamm gas		A152				202	50 kg	202	500 kg
Regulated medical waste, n.o.s.	3291	6.2		Inf.		A117	п			622	No limit	622	No limit

APPENDIX C-1: CLASSIFICATION OF BIOLOGICAL MATERIALS FOR TRANSPORT [5]

Dangerous goods are assigned UN numbers and proper shipping names according to their hazard classification and their composition. Proper shipping names are used to clearly identify the dangerous article or substance.

Infectious substances are classified in Division 6.2 and assigned to UN 2814, UN 2900, UN 3291 or UN 3373, as appropriate. Infectious substances are divided into the following categories:

CATEGORY A:

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.

NOTE: An exposure occurs when an infectious substance is released outside of the protective packaging, resulting in physical contact with humans or animals.

1. Infectious substances meeting these criteria which cause disease in humans or both in humans and animals shall be assigned to United Nations number UN 2814. Infectious substances which cause disease only in animals shall be assigned to UN 2900.
1. Assignment to UN 2814 or UN 2900 shall be based on the known medical history and symptoms of the source human or animal, endemic local conditions, or professional judgement concerning individual circumstances of the source human or animal.

CATEGORY B:

An infectious substance which does not meet the criteria for inclusion in Category A Infectious substances in Category B shall be assigned to UN 3373.

NOTE: The proper shipping name of UN 3373 is "BIOLOGICAL SUBSTANCE, CATEGORY B".

Exemptions:

Substances that do not contain infectious substances or that are unlikely to cause disease in humans or animals are not subject to dangerous goods regulations, unless they meet the criteria for inclusion in another class.

Substances containing microorganisms that are non-pathogenic to humans or animals are not subject to dangerous goods regulations, unless they meet the criteria for inclusion in another class.[7] WHO/WHE/CPI/2017.[8] Guidance on regulations for the transport of infectious substances 2017–2018 Substances in a form that any present pathogens have been neutralized or inactivated such that they no longer pose a health risk are not subject to dangerous goods regulations, unless they meet the criteria for inclusion in another class.

NOTE: Medical equipment that has been drained free of liquid is deemed to meet the requirements of this paragraph and is not subject to dangerous goods regulations.

Environmental samples (including food and water samples) which are not considered to pose a significant risk of infection are not subject to dangerous goods regulations, unless they meet the criteria for inclusion in another class.

Dried blood spots, collected by applying a drop of blood onto absorbent material are not subject to dangerous goods regulations.

Fecal occult blood screening samples are not subject to dangerous goods regulations.

Blood or blood components which have been collected for the purposes of transfusion or for the preparation of blood products to be used for transfusion or transplantation and any tissues or organs intended for use in transplantation as well as samples drawn in connection with such purposes are not subject to dangerous goods regulations.

Human or animal specimens (patient specimens) for which there is minimal likelihood that pathogens are present are not subject to dangerous goods regulations if the specimen is transported in a packaging which will prevent any leakage and which is marked with the words "Exempt human specimen" or "Exempt animal specimen", as appropriate. The packaging should meet the following conditions:

1. The packaging should consist of three components:
- a. a leak-proof primary receptacle(s);
- b. a leak-proof secondary packaging; and
- c. 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 × 100 mm;
1. 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;
1. When multiple fragile primary receptacles are placed in a single secondary packaging, they should be either individually wrapped or separated to prevent contact between them.

NOTE 1: An element of professional judgment is required to determine if a substance is exempt under this paragraph. That judgment should be based on the known medical history, symptoms and individual circumstances of the source, human or animal, and endemic local conditions. Examples of specimens which may be transported under this paragraph include the blood or urine tests to monitor cholesterol levels, blood glucose levels, hormone levels, or prostate specific antigen (PSA); those required to monitor organ function such as heart, liver or kidney function for humans or animals with non-infectious diseases, or therapeutic drug monitoring; those conducted for insurance or employment purposes and are intended to determine the presence of drugs or alcohol; pregnancy test; biopsies to detect cancer; and antibody detection in humans or animals in the absence of any concern for infection (e.g. evaluation of vaccine induced immunity, diagnosis of autoimmune disease, etc.).

NOTE 2: For air transport, packaging for specimens exempted under this paragraph shall meet the conditions in (a) to (c). 8 WHO/WHE/CPI/2017.8 Guidance on regulations for the transport of infectious substances 2017–2018

Except for:

a. Medical waste (UN 3291);
b. Medical devices or equipment contaminated with or containing infectious substances in Category A (UN 2814 or UN 2900); and
c. Medical devices or equipment contaminated with or containing other dangerous goods that meet the definition of another hazard class, medical devices or equipment potentially contaminated with or containing infectious substances which are being transported for disinfection, cleaning, sterilization, repair, or equipment evaluation are not subject to the provisions of dangerous goods regulations if packed in packagings designed and constructed in such a way that, under normal conditions of transport, they cannot break, be punctured or leak their contents. Packaging shall be designed to meet specific construction requirements – this is not considered further in these guidelines.

These packaging shall meet general packaging requirements not considered further in these guidelines, and be capable of retaining the medical devices and equipment when dropped from a height of 1.2 m. For air transport, additional requirements may apply.

The packaging shall be marked "USED MEDICAL DEVICE" or "USED MEDICAL EQUIPMENT". When using overpacks, these shall be marked in the same way, except when the inscription remains visible.

APPENDIX C-2: FLOWCHART FOR THE CLASSIFICATION OF INFECTIOUS SUBSTANCES AND PATIENT SPECIMENS [1]

APPENDIX C-3: EXAMPLES OF INFECTIOUS SUBSTANCES INCLUDED IN CATEGORY A [1, 10]

or rungi.
INDICATIVE EXAMPLES OF INFECTIOUS SUBSTANCES INCLUDED IN CATEGORY A IN ANY FORM UNLESS OTHERWISE INDICATED

UN Number and	16
Proper Shipping	Microorganism
Name UN 2814
	Bacillus anthracis (cultures only)
Infectious	Brucella abortus (cultures only)
substance,	Brucella melitensis (cultures only)
affecting humans
	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 haemorrhagic fever virus
	Dengue virus (cultures only)
	Eastern equine encephalitis virus (cultures only)
	Escherichia coli, verotoxigenic (cultures only) ^T
	Ebola virus
	Flexal virus
	Francisella tularensis (cultures only)
	Guanarito virus
	Hantaan virus
	Hantaviruses causing haemorrhagic fever with renal 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
	Kyasamır Forest disease virus
	Lassa virus
	Machupo virus
	Marburg virus
	Monkeypox virus
	Mycobacterium tuberculosis (cultures only) ¹
	Nipah virus

INDICATIVE E	XAMPLES OF INFECTIOUS SUBSTANCES INCLUDED IN CATEGORY A IN ANY FORM UNLESS OTHERWISE INDICATED
	Omsk haemorrhagic fever virus
	Poliovirus (cultures only)
	Rabies virus (cultures only)
	Rickettsia prowazekii (cultures only)
	Rickettsia rickettsii (cultures only)
	Rift Valley fever virus (cultures only)
ĵ	Russian spring-summer encephalitis virus (cultures only)
	Sabia virus
	Shigella dysenteriae type 1 (cultures only) ¹
	Tick-borne encephalitis virus (cultures only)
ĵ	Variola virus
ĺ.	Venezuelan equine encephalitis virus (cultures only)
	West Nile virus (cultures only)
ĵ	Yellow fever virus (cultures only)
	Yersinia pestis (cultures only)
UN 2900	African swine fever virus (cultures only)
Infectious	Avian paramyxovirus Type 1 – Velogenic Newcastle disease virus (cultures only)
substance,	Classical swine fever virus (cultures only)
affecting animals	Foot and mouth disease virus (cultures only)
only	Lumpy skin disease virus (cultures only)
	Mycoplasma mycoides - contagious bovine pleuropneumonia (cultures only)
) (	Peste des petits ruminants virus (cultures only)
	Rinderpest virus (cultures only)
	Sheep-pox virus (cultures only)
	Goatpox virus (cultures only)
	Swine vesicular disease virus (cultures only)
	Vesicular stomatitis virus (cultures only)

APPENDIX D: SHIPPER'S DECLARATION FORM [1, 10]

Chinner	SHIPP	ER'S DECLARAT	ION F	OR DA	ANGER	OUS GOODS
Shipper Dr XY	Orange, tel 0789 456 123			Air l	Waybill	No. 543 7654 987	6
Childrens' hospital 4. Splendid Street 12345 Boauticity Nicecountry				Page 1 of 1 Pages Shipper's Reference Number

Dr AB	Normal, tel 03210 987 4568 actiung Laboratories
6, Mar	ny Way Myplace
98765 Hereo	Myplace untry
Two completed and signed copies of this declaration must be handed to the operator.
TRANSPORT DETAILS				WARNING
This shipment is within the limitations presonbed for: (Delete non-applicable) Amilgoving				Failure to comply in all aspects with the applicable Dangerous Goods Regulations may be in breach of the applicable law, subject to legal penalties.

AIRCRAF	NRCRAFT ONLY				Shipment Type (Delete non-applicable)
Willgetthere				г	NOM	RADIOACTIVE	PABIOAG	TRAC
NATURE	AND QUANTITY OF DANGEROUS	G0005			HON	- Latorio III E	Biono
one	Dangerous Goods Identi			Т				I
UN or			Parel			Quantity and	Parking	Authorization
UN or ID No.	Proper 8 hipping Name	Giose or Division (Bubcidlary Rick)	Gree	•	Guantity and Type of Packing		Positing inet
UN 2814	Infectious substance, affecting humans (Ebola virus)	6.2			1 fibro	eboard box x 50mi	626












	Handling Information mergency contact: Dr Orai	nge tel. +41 78	945	612	3
l hereby	declare that the contents of t	his consignme	nt are	fully	y and	Name/Title of Sig	natory Dr X	Y Orange
aecurate classifie	ly described above by the pr d, packaged, marked and lab	roper shipping elled/placarded	name , and	, and	d are in all	•	Goo	ds Dispatch
respects in proper condition for transport according to a international and national governmental regulations. I de- all of the applicable air transport requirements have been a					sable	Place and Date: Beauticity 2 January 2015
					that		2 January 2	2015

APPENDIX E: MARKING AND LABELLING [1, 10]

W/HO/W/HE/CDI/2017 8

Guidance on regulations for the transport of infectious substances 2017-2018

Marking

Packages are marked to provide information about the contents of the package, the nature of the hazard, and the packaging standards applied. All marks on packages or overpacks shall be placed in such a way that they are clearly visible and not covered by any other label or mark. Each package shall display the following information on the outer packaging or the overpack.

the shipper's (sender's, consignor's) name and address
the name and telephone number of a responsible person, knowledgeable about the shipment
· the receiver's (consignee's) name and address
the United Nations number followed by the proper shipping name (UN 2814 "INFECTIOUS SUBSTANCE, AFFECTING HUMANS" or UN 2900 "INFECTIOUS SUBSTANCE, AFFECTING ANIMALS only", as appropriate). Technical names need not be shown on the package.
temperature storage requirements (optional)
when dry ice or liquid nitrogen is used: the technical name of the refrigerant, the appropriate United Nations number, and the net quantity.

Labelling

There are two types of labels: (a) hazard labels in the form of a square set at an angle of 45° (diamond-shaped) are required for most dangerous goods in all classes; (b) handling labels in various shapes are required, either alone or in addition to hazard labels, for some dangerous goods. Specific hazard label(s) shall be affixed to the outside of each package for all dangerous goods to be shipped (unless specifically exempted). The hazard labels shown in Figures 3–5 and handling labels shown in figures 6-8 are of importance for infectious substances in Category A:

Label name: Infectious substance Minimum

dimensions: 100 × 100 mm (for small packages: 50 × 50 mm) No. of labels per package: 1 Colour: Black and white

The words "INFECTIOUS SUBSTANCE" should be shown. The statement "In case of damage or leakage immediately notify a Public Health Authority" is required in some countries.

Appendix E Figure 1. Hazard label for Category A infectious substances and for genetically modified microorganisms and organisms that meet the definition of an infectious substance. Category A.

Label name: Miscellaneous dangerous substances Minimum

dimensions: 100 × 100 mm (for small packages: 50 × 50 mm) No. of labels per package: 1 Colour: Black and white

Appendix E Figure 2. Hazard label for certain non-infectious genetically modified microorganisms and organisms (UN 3245) and for carbon dioxide, solid (dry ice) (UN 1845); substances packed in dry ice shall bear this label in addition to the primary risk label.

Appendix E Figure 3. Hazard label for liquid nitrogen; substances packed using liquid nitrogen shall bear this label in addition to the primary risk label (for Category A infectious substances, and for Category B infectious substances)

Appendix E Figure 4. Handling label for cryogenic liquids; for transport by air, where cryogenic liquids (deeply refrigerated liquefied gases) are used, this label shall be affixed to insulated vessels or flasks used as outer packaging in addition to other labels, as appropriate.

Appendix E Figure 5. Orientation label to indicate position of closures on the primary receptacles; for the air transport of quantities of liquid infectious substances in Category A that exceed 50 ml per primary receptacle, this label shall be affixed to two opposite sides of the package with the arrows pointing in the right direction, in addition to other labels.

Appendix E Figure 6. Cargo Aircraft Only (CAO) label; to be used on packages that may only be transported on a cargo aircraft. For example: for the air transport of quantities of liquid or solid infectious substances in Category A (UN2814 or UN2900) that exceed 50 ml or 50 grams respectively, per package, (excluding overpacks).

Appendix E Figure 7. The mark shown below is used for shipments of Category B infectious substances.

References

Civil Aviation Authority of the Philippines. (2011). Advisory Circular AC 18-002. Guidance for Development of Dangerous Goods Manuals.
Civil Aviation Authority of the Philippines. (2014). Memorandum Circular MC 02-14. All AOC Holders, Shippers, Cargo Agencies, Freight Forwarders, Ground Handling Service Providers, AMOs and ATOs.
International Air Transport Association. (2012). IATA Dangerous Goods Regulations (53rd ed.).
International Air Transport Association. (2017). Packing Instruction 650. Retrieved April 25, 2019, from International Air Transport Association: https://www.iata.org/whatwedo/cargo/dgr/Documents/packing-instruction-650-DGR56-en.pdf
International Civil Aviation Organization. (2005). Technical Instructions for the Safe Transport of Dangerous Goods by Air, 2005-2006. Retrieved April 25, 2019, from International Civil Aviation Organization: https://www.icao.int/publications/Documents/guidance\_doc\_infectious\_substa nces.pdf
Research Institute for Tropical Medicine & Department of Health. (2014). Guidelines for Specimen Collection, Transport and Referral during Infectious Disease Outbreak: Manual for Clinical Specimens. Manila, Philippines.
United Nations. (2011). Recommendations on the Transport od Dangerous Goods, Model Regulations, 17th Edition. Retrieved April 25, 2019, from United Nations Economic Commission for Europe: https://www.unece.org/fileadmin/DAM/trans/danger/publi/unrec/rev17/Englis h/Rev17_Volume1.pdf
World Health Organization. (2004). Laboratory Biosafety Manual, Third Edition. Retrieved April 25, 2019, from World Health Organization: https://www.who.int/csr/resources/publications/biosafety/Biosafety7.pdf
World Health Organization. (2010, June). A Guide for Shipping Infectious Substances.
World Health Organization. (2011). Guidance on Regulations for the Transport of Infectious Substances 2011-2012. Retrieved April 24, 2019, from World Health Organization: http
- ://www.who.int/ihr/publications/who_hse_ihr_20100801_en.pdf
World Health Organization. (2012). Guidance on regulations for the Transport of Infectious Substances 2011-2012. Retrieved from https://www.who.int/ihr/publications/who\_hse\_ihr\_20100801\_en.pdf

DOH Manual: Packaging and Transport of Laboratory Specimen for Referral

Document Info

MANUAL ON PACKAGING AND TRANSPORT OF LABORATORY SPECIMENS FOR REFERRAL