Section: Subject Title: Transportation of Dangerous Goods ... · absorbent material, between the primary and secondary containers. Include enough absorbent to absorb the specimen

Department of Microbiology

Quality Manual

Policy # QPCMI07000

Page 1 of 13

Version: 2.0 CURRENT

Section: Process Control Subject Title: Transportation of Dangerous Goods

Procedure Prepared by QA Committee

Issued by: Laboratory Manager Revision Date: 1/3/2021

Approved by Laboratory Director:

Microbiologist-in-Chief Next Review Date:9/1/2021

Uncontrolled When Printed

UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, DEPARTMENT OF MICROBIOLOGY

NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that do not state "CONTROLLED COPY " in red print are not controlled and should be

checked against the document (titled as above) on the server prior to use. Management System\UHN_Mount Sinai Hospital Microbiology\Quality Manual Policies and Procedures\Process Control\

Purpose:

The transport of dangerous goods is regulated in Canada by the Transport of Dangerous Goods

Act and its Regulations (TDGR). The TDGR are designed to protect and promote public safety

in the transportation of dangerous goods. For air transport, International Civil Aviation

Organization (ICAO) technical instructions must be followed, which can be found in the

International Air Transport Association (IATA) Dangerous Goods Regulations.

Procedure:

In order to ship dangerous goods, a Microbiology employee must have current TDG training, or

is directly supervised by another employee who has current TDG training.

The TDGR divides dangerous goods into 9 classes as follows:

Class Type of Dangerous Goods Specific Type Handled United Nations

(UN) Number

1 Explosives

2 Gases

3 Flammable liquids

4 Flammable solids

5 Oxidizing substances

6 Toxic and infectious substances 6.2 Infectious substances

dangerous goods

Category A

UN2814

Category B

UN3373

7 Radioactive materials

8 Corrosive substances

9 Miscellaneous dangerous goods 9 Dry ice UN1845

Shipping dangerous goods by regular mail is not legal in Canada.

The Components of the TDG program


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NOTE: This document is Uncontrolled When Printed. Any documents appearing in paper form that do not state "CONTROLLED COPY” in red print are not controlled and should be


1. Classification

2. Packaging and Labeling for transport

3. Documentation for transport

4. Emergency response for incidents

Classification

Your responsibility is to determine if the specimen’s classification since Infectious substance is

packed according to their classification

Exempt patient specimens

Not TDG regulated

Which is a human or animal material including excreta, secreta, blood and its components,

tissue and tissue fluids, that is offered for transport for the purpose of diagnosis, analysis or

testing with minimal likelihood that pathogens are present. In the absence of evidence to

establish that the specimen contains regulated infectious substances, specimens transported from

health care facilities can be reasonably be believed not to contain infectious substances. These

can be mailed anywhere in Canada by Priority Post or meeting Canada Post’s minimum

packaging requirement. Phone 1-800-661-3434 to determine best way to pack the samples. Be

prepared to assume full liability.

Infectious Substance TDG regulated

An infectious substance is substance known or reasonably expected to contain viable micro

organisms that are known or reasonably expected to cause disease in humans or animals, and is

included in Risk Group 2 , 3 or 4. If you come across a Risk Group 4 specimens for transport,

contact the Microbiologist on-call for advice (these specimens require approval from the

Ministry of Transport).

Infectious substances are classified as Class 6.2, and Infectious Substances dangerous goods

Class 6.2 divides into two categories: Category A and Category B

Before transporting, you need to identify, as best you can, which microorganism is present. For

example, if a specimen is being transported to test for a microorganism (this does not include


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blood transfusion product screening), assume that the microorganism is present. Then use the

information above to determine if it is an infectious substance.

The following flowchart may be used to identify specimens:

Is the substance known to or

reasonably expected to

contain pathogens in Risk

Group 2, 3 or 4?

Yes

These substances are

Regulated Class 6.2

Dangerous Goods

Require a Shipper’s

Declaration

All Dangerous Goods

Regulations apply.

Use Packing Type 620

No

Is the material being shipped

to be tested for pathogens?

Yes

No

Is the sample being shipped

for any other reason?

Yes These samples are not

Dangerous Goods

Shipper’s Declaration is NOT

required

Use Packing Type 650

No

Is the sample known not to

contain pathogens? (There

must be no reason to suspect)

Yes


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2. Packaging and Labeling

See Appendix I: Shipping Checklist

All regulated biological substances shipments require triple packaging which includes:

1. Leak-proof primary packaging

2. Absorbent materials & material to separate fragile contents

3. Secondary packaging

4. Outer packaging

Category B

The packaging of Category B specimens is described in IATA packing Type 650. Package type

1B (TC-125-1B) is used and consists of the following:

1. Primary container – this is the blood tube, urine or specimen container. Wrap with bubble

wrap.

2. Secondary container – use a leak-proof zip-lock bag.

3. Absorbent material – include an absorbent material such as paper towel or commercial

absorbent material, between the primary and secondary containers. Include enough

absorbent to absorb the specimen completely should the primary container leak.

4. Place the secondary container into a cardboard box of adequate strength, if shipping at

room temperature. If shipping with a freeze pack or dry ice, use a Styrofoam box inside a

cardboard box.

You do need to include the following labels:

A label indicating “BIOLOGICAL SUBSTANCE, CATEGORY B, UN3373” 1. If you included dry ice in the package, a label indicating “ DRY ICE, UN1845, __ kg net

weight”.

2. Shipper’s name, address and telephone number.

3. Consignee’s (who the specimen is being sent to) name, address and telephone number.

4. Ensure that irrelevant marks are removed.

Category A

The packaging of infectious substances is described in IATA packing Type 620. Package type

1A (TC-125-1A) is used and consists of the following:


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1. Primary container – this is the blood tube, urine or specimen container. Wrap with bubble

wrap.

2. Secondary container – use a leak-proof zip-lock bag.

3. Absorbent material – include an absorbent material such as paper towel or commercial

absorbent material, between the primary and secondary containers. Include enough

absorbent to absorb the specimen completely should the primary container leak. Place the

secondary container into a Saf-T-Pak STP-100 shipper or other commercial shipper -

made up of a Styrofoam box contained with a cardboard box. (A rigid Standardized outer

packaging)

Label the package as follows:

1. Affix a TDG 4x4 inch “Infectious Substance – Class “6” label

2. Affix UN2814 , Infectious substance, affecting humans

3. Shipper’s name and address.

4. Name and telephone number of the person responsible for the shipment.

5. Consignee’s name, address and telephone number.

6. If you included dry ice in the package, affix a TDG 4x4 inch “Dry Ice – Class 9” label.

As well, label indicating “ DRY ICE, UN1845, __ kg net weight”.

7. Ensure that irrelevant marks are removed.

See Appendix II: SHIPPER’S DOCUMENT CHECKLIST

Shipping with Dry Ice

Include with the secondary container, an adequate amount of dry ice to keep the infectious

substance container frozen. Because dry ice continuously evaporates into CO2 gas, you must

include an opening, such as a seam without packing tape, in the package for the CO2 gas to

escape. If you do not include an opening, the package may explode.

Quantity Limits When Shipping by Air Transport:

Passenger (Max) Cargo (max)

Category A 50ml or 50g 4L or 4Kg

Category B 4L or 4Kg 4L or 4Kg

3. Documentation for Transport


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Unless you have made arrangements with consignee, do not ship a refrigerated or frozen

specimen on a Friday, to avoid the package sitting at the destination without refrigeration

through a weekend.

A shipper’s declaration form is not required for Exempt patient specimens, even when the

package contains dry ice.

When shipping an infectious substance, obtain access to your lab’s electronic version of the Saf-

T-Pak Shipper’s Declaration form (contact the departmental Safety Officer if you cannot locate

this). Use the procedure below to copy over the existing information on the Saf-T-Pak form.

When you have finished, print the form using a color printer so that the hashed border is a red

color. Complete the following information on the shipper’s declaration form:

1. Shipper’s name, address and telephone number.

2. Consignee’s name, address and telephone number.

3. The shipper’s reference number (i.e. Fedex number) in the top right corner of the form.

4. Name and phone number of the person responsible for the shipment.

5. If shipping by air, identify the type of aircraft to be used, and the airports of departure

and destination.

6. Indicate that the shipment is not radioactive, by crossing out that box.

7. Under the “Nature and Quantity of Dangerous Goods” complete the following:

a) under Shipping name: enter “Infectious substance, affecting humans”, then the

technical name of the substance in brackets. For example (Hepatitis B virus). As

well, if shipping with dry ice, enter “Dry ice” on the next line.

b) under Class: enter “6.2” for infectious substance, and “9” for driy ice.

c) under UN number enter “UN2814” for infectious substance, and “UN1845” for

dry ice. The UN number refers to a number assigned by a United Nations

Committee of Experts on Transport of Dangerous Goods.

d) under Packing Group – this does not apply to infectious substances. If using dry

ice, enter III.under Quantity and Type of Packaging – enter number grams or mLs

of infectious

e) substance. Enter number of kg of dry ice. Then describe how it is packed, i.e. “All

packed in one cardboard box”.

f) Under Packing Instruction – enter 620 for infectious substance. Enter 904 for dry

ice.

8. In the bottom right corner: enter your name and title, place and date.


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9. Print out 4 copies of the form (one copy for the lab’s records), and sign the bottom right

hand corner.

10. Finally, complete the courier’s waybill, and arrange for the courier pickup.


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“Nature and Quantity of Dangerous Goods” Documentation Summary

Item Being

Shipped

Class of

Dangerous

Goods

UN

Number

Quantity

and Type

of Packing

Packing

Type

Category B 6.2 UN3373 Weight in

grams or

volume in

mLs

650

Category A 6.2 UN2814 Weight in

grams or

volume in

mLs

620

Dry Ice 9 UN1845 Weight in

kg

904

4. Emergency Response

“CANUTEC (613) 996-6666” is noted on our shipper’s declaration form as an emergency

response contact. This is a service provided by Transport Canada to assist emergency personnel

in handling dangerous goods emergencies. CANUTEC offers 24 hour telephone advice. If our

shipment’s courier were involved in an accident and the shipment leaked outside the package,

police could call CANUTEC for advice on how to handle the spill.

Local Police

A 24 hour monitored phone number is required on the “Shipper’s Declaration” when

Shipping to the USA (check operator variations for each country)

Shipping risk group 4 organisms

Use Mircobiologist-on-call phone number. Shipper must notify the Microbiologist on-call what

they are shipping and the destination.

In Case of a Spill or Leak


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If a spill or leak occurs will you are handling or delivering the specimen, refer to our Biological

Spill Control procedure QFS01704.01 in the Lab Safety Manual.

5. Training

Each person who offers for transport must be properly trained and hold a current

training certificate.

The certificates are filed with management and held for 2 years past expiry.

Certification is valid for 2 years for air and 3 years for ground transport.

A shipper must be able to classify dangerous goods, package them accordingly

and prepare appropriate documentation.

They must be prepared to assume full liability.

Transport Canada has the authority to inspect, seize and in cases of non-compliance,

administer fees

Additional information:

When shipping an infectious substance, you can also refer to the Compliance Reference Manual-

the safe Transport of Division 6.2 Infectious Substances, Biological Specimens, Dry Ice &

Related Materials from SAFTPAK (contact the departmental Safety Officer if you cannot locate

this)

UHN/MSH Microbiology department Transport of dangerous goods power-point

Refer to TDG website for the list of Category A & Category B bacteria, viruses and fungi

https://www.tc.gc.ca/eng/tdg/clear-part2-339.htm see Appendix 3.

Refer to TDG Bulletin Shipping Infectious Substances

https://www.tc.gc.ca/media/documents/tdg-eng/BULLETIN_-

_SHIPPING_INFECTIOUS_SUBSTANCES.pdf

Consult Biosafety Officer or Safety officers

https://www.tc.gc.ca/eng/tdg/clear-part2-339.htm%20see%20Appendix%203

https://www.tc.gc.ca/media/documents/tdg-eng/BULLETIN_-_SHIPPING_INFECTIOUS_SUBSTANCES.pdf

https://www.tc.gc.ca/media/documents/tdg-eng/BULLETIN_-_SHIPPING_INFECTIOUS_SUBSTANCES.pdf


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Appendix I: SHIPPING’S CHECKLIST

Use this checklist to ensure that your package AND waybill has been properly marked and

labelled. Category A - 620

Category B - 650 Dry ice - 904 Exempt patient

specimen

Address of consignor AND consignee

□ □ □ □

Hazard label/ mark affixed

□ □ □

N/A

Orientation labels on opposing sides of package

□ □ □ □

UN number □ UN 2814 or 2900 N/A (already on mark)

□ UN 1845 N/A

Proper shipping name or other designation

□ Infectious substance affecting humans or Infectious substance affecting animals

□ Biological substance, Category B

□ Dry ice, or Carbon dioxide, solid

□ Exempt human specimen or Exempt animal specimen

Technical name □ (optional on package) N/A N/A N/A

Quantity of dangerous good

N/A** N/A □ (kilograms or pounds

N/A

Name and telephone number of a person responsible

□ □ (optional if on waybill)

N/A N/A

Tech 1 Initials:

□ Package □ Waybill




Tech 2 Initials:





Tech 2 Initials:

Add properly labeled specimen into specimen shipping container and seal container.

Put sealed container in Styrofoam over pack box.

** The quantity of a Category A Substance needs to be marked on the package when it is shipped with dry ice.


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Appendix II: SHIPPER’S DOCUMENT CHECKLIST

Document YES

Name, address and phone number of shipper

Name, address and phone number of consignee

Name and phone number of Person Responsible

Page of page

Airport of departure (if known)

Airport of destination (if known)

DELETE radioactive box

DELETE aircraft limitation box

Proper shipping Name (Infectious substance, affecting humans)

Technical name (in brackets)

Class (6.2, 9)

UN Number ( UN 2814, UN 2900)

Packing Group (Dry Ice only PG III)

Quantity (ml ,g, kg)

Type and number of packages

Packing Instruction (620, 904)

Authorization (NA)

“Prior arrangements…” statement

24 hour emergency contact number

“ If package damaged….phone Canutec (613- 996- 6666)’’ statement

Name and title of signatory

Place and date

Shipper’s signature

“Prepared according to…” statement

Related Documents

Document Title Document Number

Transport of Dangerous Goods Regulations http://www.tc.gc.ca/tdg.

International Air Transport Association http://www.iata.org

Saf-T-Pak Shipper’s Declaration form (electronic) Transportation form

http://www.tc.gc.ca/tdg

http://www.iata.org/

../Live%20Manual/Quality%20Manual/Process%20Control/Transportation%20form.doc


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Record of Edited Revisions

Manual Section Name: Transportation of Dangerous Goods Procedure

Page Number / Item Date of Revision Signature of

Approval

Annual Review May 1, 2004 Dr. T. Mazzulli


Annual Review July 23, 2006 Dr. T. Mazzulli

Annual Review August 13, 2007 Dr. T. Mazzulli

Annual Review June 16, 2008 Dr. T. Mazzulli

Annual Review June 16, 2009 Dr. T. Mazzulli







Annual Review

Added New appendix checklists

Merged TGD section on lab safety manual

here.

May 09, 2017 Dr. T. Mazzulli


Minor formatting September 14, 2018 Dr. T. Mazzulli

Annual Review

Addition of Category A and Category B

Addition of Exempt patient specimens

Removed Diagnostic specimens

December 22, 2020 Dr. T. Mazzulli


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