MAN - Packaging and Transport Manual As of 2019June06-Edited - CCO
MAN - Packaging and Transport Manual As of 2019June06-Edited - CCO
MAN - Packaging and Transport Manual As of 2019June06-Edited - CCO
2018
DEPARTMENT OF HEALTH
REPUBLIC OF THE PHILIPPINES
1
MANUAL ONPACKAGINGANDTRANSPORTOFLABORATORY SPECIMENS FORREFERRAL
2018
DEPARTMENT OF HEALTH
REPUBLIC OF THE PHILIPPINES
2
MANUAL ON PACKAGING AND TRANSPORT OF LABORATORY
SPECIMENS FOR REFERRAL
ISBN
Published by
Department of Health
San Lazaro Compound
Rizal Avenue, Sta. Cruz, Manila
1003 PHILIPPINES
3
Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
MESSAGE
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.
MANUAL ONPACKAGINGANDTRANSPORTOFLABORATORY SPECIMENS FORREFERRAL
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 people-
centered 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
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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.
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
MANUAL ONPACKAGINGANDTRANSPORTOFLABORATORY SPECIMENS FORREFERRAL
manuals is best used in conjunction with the other Manuals in the set:
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PREFACE
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ACKNOWLEDGEMENT
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Developmental
Health Facility Development
Ms. Angelita O. Jimenez Management
Bureau
Officer IV
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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
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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.
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.
Patient specimen – is a clinical sample collected directly from a human and intended
for laboratory examinations.
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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.
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TABLE OF CONTENTS
Message …………………………………………………………………… 4
Foreword …………………………………………………………………… 5
Preface …………………………………………………………… 6
Acknowledgement ……………………………………………………………. 7
List of Acronyms ……………………………………………………………. 9
Definition of Terms ……………………………………………………………. 10
CHAPTER 1
Specimen for Referral …………………………………………………… 14
Regulated and Unregulated Biological Materials Subject to IATA
Shipping Regulations …………………………………...……… 14
Means of Specimen Transport …………………………………………… 16
General Steps in Handling All Specimens for Referral ………………… 17
Procedure for Local Land and Water Transport …………………………... 18
Procedure for Air Transport …………………………………………… 25
Roles and Responsibilities in Specimen Packaging and Transport …... 28
Spill Decontamination …………………………………………………… 29
Appendices
A: Triple Packaging System …………………………………………… 31
B: Classification of Dangerous Goods ……………………………….…… 34
C-1: Classification of Biological Materials for Transport …………… 35
C-2: Flowchart for the Classification of Infectious Substances and Patient
MANUAL ONPACKAGINGANDTRANSPORTOFLABORATORY SPECIMENS FORREFERRAL
Specimens ………………………………………………..…………. 38
C-3: Examples of Infectious Substances Included in Category A ….... 39
D: Shipper’s Declaration Form …………………………………… 41
E: Marking and Labelling …………………………………………………... 42
CHAPTER 2
List of National Reference Laboratories and Their Specific Requirements
for Referral, Services, and Contact Information …………………………... 46
References …………………………………………………………… 123
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MANUAL ONPACKAGINGANDTRANSPORTOFLABORATORY SPECIMENS FORREFERRAL
CHAPTER 1
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SPECIMEN FOR REFERRAL
The great majority of the specimens come from patients. They may be
categorized into:
1. Whole Blood, Serum or Plasma
2. Urine
3. Body fluids, e.g., Pleural, Peritoneal, Cerebrospinal, or joint fluid
4. Stool or fecal smear
5. Oropharyngeal and nasopharyngeal swabs
6. Microbiological culture or smear
7. Surgical specimen for Surgical Pathology
8. Smear or fluid for Cytology
9. Water, waste and other environmental specimens
The materials presented below are subject to IATA shipping regulations for
infectious substances:
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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.
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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.
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:
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 hand-
carrying 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.
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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
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Step 7: Document received specimens
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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.
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Figure 3: Clean sterile conical tubes
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Figure 6 Leak-proof container for large anatomic specimen
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).
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Figure 9 Screw-capped jars
MANUAL ONPACKAGINGANDTRANSPORTOFLABORATORY SPECIMENS FORREFERRAL
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.
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Figure 11 Thick durable carton box
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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.
5.1 Secure the necessary documents required for the referral and
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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.
5.5 For packages with dry ice allow the release of carbon dioxide
gas to prevent pressure build-up and subsequent explosion.
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Observe the criteria for specimen rejection and acceptance of
the referral laboratory meticulously.
3.1 Plan the transport following Step 3 of procedure for land and
water transport.
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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.
MANUAL ONPACKAGINGANDTRANSPORTOFLABORATORY SPECIMENS FORREFERRAL
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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.
4.9 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.
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5.2 Track the document which includes the name and telephone
number of the person responsible for the shipment by Air
Waybill tracking.
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).
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F. ROLES AND RESPONSIBILITIES IN SPECIMEN PACKAGING AND
TRANSPORT
2. The Carrier/Courier
2.1 Provides the sender with the necessary shipping documents and
instructions for their completion;
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;
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2.6 Notifies the sender of any anticipated (or actual) delays in transit.
3. The Receiver
3.2 Immediately acknowledges receipt and records the date and time of
receipt of specimen.
G. SPILL DECONTAMINATION
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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).
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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
4. Disposal
MANUAL ONPACKAGINGANDTRANSPORTOFLABORATORY SPECIMENS FORREFERRAL
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
5.2 If hand-washing facilities are not available at the job site, use 70%
alcohol and then wash your hands as soon as possible.
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APPENDICES:
APPENDIX A: TRIPLE PACKAGING SYSTEM [5]
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The following packagings are authorized provided the special packing provisions
described below are met. Packagings meeting the requirements and approved
accordingly consisting of:
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:
2. Other than for exceptional consignments, e.g. whole organs that require special
packaging, the following additional requirements shall apply:
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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.
4. 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
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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
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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.
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.
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.
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.
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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:
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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:
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APPENDIX C-2: FLOWCHART FOR THE CLASSIFICATION OF INFECTIOUS
SUBSTANCES AND PATIENT SPECIMENS [1]
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APPENDIX C-3: EXAMPLES OF INFECTIOUS SUBSTANCES INCLUDED IN
CATEGORY A [1, 10]
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APPENDIX E: MARKING AND LABELLING [1, 10]
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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.
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.
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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
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infectious substances.
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References
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