Standard Operating Procedure (SOP) For Shipping An Outbound Package
Standard Operating Procedure (SOP) For Shipping An Outbound Package
C. Ambient Temperature
C.1. Slides
C.2. FFPE Blocks
C.3. FedEx for FFPE Blocks and Slides
C.4. Miscellaneous Ambient
D. Dry Ice
E. Cryoports
E.2. Charging Cryoports
E.4. Data Loggers
E.5. Returning Specimens to Sites
E.6. FedEx for Cryoports
E.7. Cryoport Shipment Preparation
F. Documentation and Tracking
II. PROCEDURE
A. Safety Precautions
1. Liquid Nitrogen (LN2) and dry ice can cause asphyxiation and severe burns. Always
wear the appropriate personal protective equipment (PPE) required when working with
these substances, including an impermeable lab coat, goggles, closed toe shoes, nitrile
gloves, and thermal insulated gloves. A full face shield is required in lieu of goggles
when working with LN2.
a. Refer to BPC-SAF-004 “Compressed Gases Hazards and Safety” for additional
handling precautions.
2. Assume all samples are infectious. Refer to the following documents for guidance:
a. BPC-SAF-011 “Microbiological Hazards and Safety”
b. BPC-SAF-010 “Laboratory Exposure Plan”
c. NCH IC-VII-1 “Exposure Control Plan for OSHA Blood-borne Pathogen”
3. If disposable items (such as packing material, shipping documents, or dry ice) become
contaminated during this process, then they must be discarded in a biohazard bin.
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B. Quality Control
1. For quality control purposes use BCR-FRM-016 “Outbound Shipment Verification and
Quality Control Form” to document all outgoing shipments.
2. All BCR personnel responsible for shipping must complete IATA/Saf-T-Pak
Compliance Training before they can prepare, create, or handle a shipment. Trained
employees must maintain this certification to continue to ship specimens.
3. Shipping addresses should be located using the calendar located on BCR SharePoint. A
representative from Clinical Outreach or MGL will confirm this address as correct, or
will provide the corrected shipping information. The address will be verified for
typographical errors by an additional Logistics Tech, after an airbill has been generated,
during the QC process.
4. Several monitors are in place to ensure adequate shipment tracking:
a. The technician assigned to the shipping rotation is responsible for tracking packages
to ensure timely delivery and to correct any issues or delays as quickly as possible.
The technician checks the designated courier’s website (e.g. FedEx) at the end of
the work day in which they are shipped, and throughout the following work day(s)
until a confirmation of delivery is received (via email or status on the website). Any
shipment that is experiencing unexpected delays requires immediate action
from Logistics, including involving the Logistics Supervisor. The courier
should be contacted for resolution and Clinical Outreach, as well as BCR
leadership, should be notified.
b. When packages have been delivered to the recipient, they are proxy received in
LabVantage (BCR-SOP-A001). A custom data audit tracks packages that have been
created or shipped in LabVantage that have not been proxy received. These data
audits are sent to the Program Director, Project Manager, Logistics Manager, and
Logistics Supervisor.
c. In the W230 Logistics Lab, a shipping whiteboard is used to track outstanding
cryoports; this is updated daily. If a cryoport is not returned in an appropriate time
frame (typically within 7 days), then Clinical Outreach should be notified to contact
the site.
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i. The manifest should contain the following information: site contact name and
address, tracking number (once generated), total number of slides in the
package, and the specimen/barcode information for all slides being shipped.
(a) Note: When applicable, the BCR must act as an honest broker when
distributing slides. No TSS identifiers can be present or viewable on
slides or manifest distributed from the BCR to a different site.
ii. A copy of this manifest is emailed to the designated Clinical Outreach (CO)
representative and shipment confirmation is requested.
iii. Once shipping address confirmation is received, an airbill can be created (see
II.C.3. below). The tracking number is added to the shipping manifest, which is
then saved on the BCR SharePoint (Shared documents > Logistics > Shipping
Logs > Return of Slides) and an updated copy is emailed back to the CO
Representative.
iv. A hard copy of the manifest is used by Logistics for QC purposes and will also
be included in the outbound package.
c. Create a FedEx airbill (refer to section C.3. below)
d. A second Logistics technician must verify that the physical slides being shipped
match those listed on the manifest created in II.C.1.b. Once verified, the technician
signs and dates BCR-FRM-016 “Outbound Shipment Verification and QC”.
e. Once verified, the glass slides can be placed into an appropriate slide case which is
then taped shut and bubble wrapped to ensure safety during transit.
f. If size allows, place the shipping manifest and protected slides into a padded FedEx
Pak, then close and seal it following the instructions on the outside of the Pak. Place
the airbill pouch on the designated area on the front of the Pak. For larger packages,
use an appropriately-sized cardboard box.
g. Complete the following in LabVantage (BCR-SOP-A005):
i. Receive CDT and take custody of the slides.
ii. Create a package for the shipment.
iii. Place virtual slides into the LabVantage package.
iv. “Ship” the package.
h. Physically take the package to the designated FedEx pick-up location for shipment.
Track the package as specified in section II.B.4 above.
2. Shipping Formalin-Fixed Paraffin-Embedded (FFPE) Blocks
a. If the blocks to be shipped are not currently in Logistics’ custody then Histology
will be notified. Histology will pull the blocks from storage and send them to
Logistics, accompanied by a Custodial Domain Transfer (CDT) report that reflects
this physical transfer in LabVantage (BCR-SOP-A001). Logistics will then verify
that the blocks they received against this report before accepting custody of them in
LabVantage.
b. Create a shipping manifest as outlined above in II.C.1.b.
c. Create a FedEx airbill for FFPE blocks (refer to section C.3 below).
d. A second Logistics technician must verify, and initial BCR-FRM-016, that the
physical blocks being shipped match those listed on the shipping manifest.
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e. Once verified the blocks can be placed into an appropriate container. During
warmer months the blocks may be packaged with an ice pack to prevent melting of
the paraffin.
f. If size allows, place the shipping manifest and blocks into a padded FedEx Pak,
then close and seal it following the instructions on the outside of the Pak. Place the
appropriate airbill pouch on the designated area on the front of the Pak. For larger
packages use an appropriately sized cardboard box. For shipments requiring use of
an ice pack during warmer months, use an appropriately sized insulated box.
g. Complete the following in LabVantage (BCR-SOP-A005):
i. Receive CDT and take custody of the blocks.
ii. Create a package for the shipment.
iii. Place virtual blocks into the LabVantage package.
iv. “Ship” the package.
h. Physically take the package to the designated FedEx pick-up location for shipment.
Track the package as specified in section II.B.4 above.
3. Creating FedEx Airbills for slides or FFPE blocks
a. Log in to the FedEx website. Under the “Ship” header, select “Create a Shipment”.
b. In the “To” section, enter the confirmed address and contact information.
c. In the “Package & Shipment Details” section, enter the following:
i. Service Type: Standard or 2 Day shipping.
ii. Package Type: Your Packaging or FedEx Pak (as applicable)
iii. No. of Packages: 1
iv. Weight: Weight of package (scale located in W230)
v. Declared value:
(a) Domestic shipments have a declared value of 0 USD
(b) International shipments have a declared value of 10 USD
d. In the “Billing Details” section, enter the following:
i. Bill transportation to: BCR-662
ii. Your reference: Project, Receiving Site, and Sample Type.
e. In the “E-mail Notifications” section, expand the “Edit” link. Enter an email
address for both the shipper and the receiver; then select “Tendered”, “Exception”
and “Delivery” in the “Notification type” column.
f. In the “Complete your Shipment” section, click “Ship”.
g. Print the FedEx generated airbill.
h. For International Shipments:
i. In the “Commodity Information” section select “Add new commodity”. In the
drop down menu under “Commodity”, enter the following:
(a) Commodity description
(i) Slides: “This package contains # glass slides used for pathology. The
slides are non-hazardous and are for research/analysis purposes only.”
(ii) Blocks: “This package contains # fixed blocks used for pathology. The
samples are non-hazardous and are for research/analysis purposes
only.”
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d. A hard copy of the manifest is used by Logistics for QC purposes and will also be
included in the outbound package.
4. A second Logistics technician must verify, and initial BCR-FRM-016 “Outbound
Shipment Verification and QC”, that the physical samples being shipped match those
listed on the shipping manifest.
5. Place sample(s) in a Saf-T-Pak Biohazard bag with an absorbent sheet and seal
completely. Place the sealed bag inside an insulated foam shipping container, working
quickly to avoid thawing the sample(s). Using the shipping station scale, weigh and
record the package weight prior to dry ice. Remove the sealed biohazard bag containing
the samples and return to the cryocart or dry ice chest.
6. Fill the insulated container with enough dry ice to cover the bottom of the package.
Place the sealed biohazard bag on top of this dry ice layer, then fill the rest of the box
with dry ice.
a. **Note: To ensure that samples remain frozen at all times, specimens must be
completely buried in enough dry ice to still be covered upon arrival at the
destination.
b. A minimum of 4 pounds of dry ice must be used per package.
7. Weigh the full insulated container and subtract the weight of the insulated container and
samples to calculate the weight of dry ice used.
8. Never use tape to close the inner insulated container; dry ice must be allowed to
ventilate as it evaporates to prevent an explosion.
9. Place the insulated foam container into a secondary shipping cardboard box.
10. Place the shipping manifest in a plastic bag on the outside of the inner insulated foam
shipping container, but inside the outer cardboard box.
11. Tape the secondary shipping cardboard box shut.
12. Fill out and attach a Dry Ice UN 1845 label to the package.
a. **Note: Dry Ice UN 1845 labels require the shipper and recipient address to be
durably marked on the package (in addition to the FedEx shipping label). The
recipient address should be clearly marked and placed directly next to the dry ice
label.
13. Create a FedEx Priority Overnight dry ice shipping label and air bill.
a. Log in to the FedEx website, www.FedEx.com with assigned user name and
password and go to “Create Shipment”.
b. In the “To” section, enter the confirmed address and contact information.
c. In the “Package & Shipment Details” section, enter the following:
i. Weight: Total weight of package (including the dry ice)
ii. Declared value: 0 U.S. Dollars
iii. Service Type: Priority Overnight
iv. Package Type: Your Packaging
d. In the “Billing Details” section, enter the following:
i. Bill transportation to: BCR-662, FedEx Account # 491048662
ii. Your reference: Project, Receiving Site, Dry Ice
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e. In the “Special Services” section, expand the “Edit” link. Select “Dry Ice” and
enter the weight of the dry ice only in the “Total dry ice weight” field.
f. In the “E-mail Notifications” section, expand the “Edit” link. Enter an email
address for the shipper and the receiver. For both, select “Tendered”, “Exception”
and “Delivery” in the “Notification type” column.
g. In the “Complete your Shipment” section, click “Ship”.
14. Print the FedEx shipping label and place inside an airbill pouch attached to the package.
15. Complete the following in LabVantage (BCR-SOP-A005):
a. Create a package for the shipment.
b. Place virtual samples into the LabVantage package.
c. “Ship” the package.
16. Physically take the package to the designated FedEx pick-up location for shipment.
Track the package as specified in section II.B.4 above.
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iii. Replace the data logger lid and label the cryoport shell with initials and the
charge date.
iv. Allow the cryoport to properly charge (i.e. allow liquid nitrogen to fully
saturate the absorbent material in the outer walls of the cryoport):
(a) If the cryoport is newly filled, the LN2 must absorb for a minimum of 4 or
up to 24 hours. The cryoport must then be refilled and the LN2 absorbed
for an additional 1-3 days.
(b) For all subsequent uses (i.e. when the cryoports is -80°C or colder from a
previous use) of the cryoport, the LN2 must absorb for 1-3 days to fully
charge.
(c) Any deviations are noted on BCR-FRM-016 “Outbound Shipment
Verification and QC”.
3. Charged cryoports are prepared for shipment by pouring off the excess liquid nitrogen
into an empty cryocart.
a. Use the dated label on the cryoport shell to verify that an adequate charge time has
elapsed (24 – 72 hours) and remove the data logger lid.
b. With at least 2 technicians present, position the cryocart near the air vent and
remove the lids. CAUTION – The cryocart must be positioned near the air vent
during pour off. Do not prepare the cryoports when in close proximity to the O2
monitors as this may cause a centralized pocket of gaseous nitrogen to trigger a
false low oxygen level alarm.
c. Lift the cryoport using the top metal handle on the inner dewar, and position it over
the cryocart until the flow of liquid nitrogen stops.
d. Lower the cryoport to the ground, check for appropriate temperature probe length,
and then replace the data logger lid.
4. Cryoports must maintain a temperature of -185°C or below to be shipped from the
BCR. A one-hour temperature log is recorded using the data logger lid to confirm that
the cryoport is holding temperature and functioning properly.
a. To use the T-TEC Logger™ on an outbound cryoport:
i. With the provided cable, connect the data-logger to the computer and open the
T-TEC Logger™ tracking system program. Select Menu under USB-COM:4,
then select Start Logger.
ii. Enter: “Recipient, Cryoport #, Date, S” (S is for shipped) on Line 1 of the
comments section.
iii. Set the Logging Interval to 2 minutes for domestic and Canada shipments.
Select 5 minutes for all international shipments.
iv. Wait a minimum of 1 hour.
v. Reconnect the data-logger to the computer and open T-TEC Logger™
software. Under Menu select Stop Logger.
vi. Under Menu select Download Data. Save the pdf to the Shared Drive
(RESQualman G Drive > BCR > BCR Cryoport Data > Year > Month) using
the “Recipient, Cryoport #, Date, S” naming format. Once saved, open and
view the temperature graph to ensure that the probe is working properly.
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vii. If the cryoport and logger are functioning properly, then restart the logger
following the steps above but substituting the “S” for shipped with an “R” for
received in the T-TEC™ comments section.
b. To Use the Libero™ Data Logger on an outbound cryoport:
i. Remove the data-logger USB from its bracket and simultaneously press the
Transit and Arrived buttons until the screen says “Conf” (configure). Insert the
logger into a USB port on the W230 shipping computer and open the Libero™
Configuration Utility program, selecting either the gear icon or Device >
Configuration.
ii. In the left hand column, select Description and enter: “Recipient, Cryoport #,
Date, S”. Enter the same for the .pdf file name. **Note: This field has a
character limit; the file name may need to be shortened.
iii. In the left hand column, select Logging and set the interval length to 2 minute
for domestic shipments and Canada, and 5 minutes for international shipments.
Maintain all other default start options and select “Apply”.
iv. Remove the USB and replace the logger in the cryoport bracket. Depress the
Transit button on the logger until the temperature displays.
v. After one hour, stop the logger by holding the Arrived button until the screen
display changes from “Transit” to “Arrived”. Remove the logger from the
bracket and insert into the USB computer port.
vi. Open the .pdf to view the temperature graph and ensure that the probe is
working properly. Save the file to the Shared Drive using the “Recipient,
Cryoport #, Date, S” naming format.
vii. If the cryoport and logger are functioning properly, restart the logger following
the steps above but substituting the “S” for shipped with an “R” for received in
the Libero™ Configuration Utility “Description” section.
c. If the cryoport is not holding an acceptable temperature and the data logger is the
suspected issue, then the one-hour test is repeated using a new logger.
d. If a temperature of -185°C or below was not maintained for at least one hour, then
the cryoport CANNOT be used to ship, and a note is entered on the Cryoport and
Data Logger Incident spreadsheet on the BCR SharePoint (REX/BPC/TCGA-BCR
> Shared Documents > Logistics > Cryoport and Logger Issues). If the cryoport is
suspected to be malfunctioning, then it is taken to Biomedical Engineering and
another cryoport is selected for the shipment. The one hour temperature test is
repeated on the new cryoport.
5. Returning specimens to sites:
a. If not provided by the CO representative, generate a shipping manifest from
LabVantage (refer to BCR-SOP-A005, LabVantage User Manual).
i. A copy of this manifest is emailed to the designated Clinical Outreach (CO)
representative and shipment confirmation is requested.
ii. Once shipping address confirmation is received, an airbill can be created, and
the newly generated tracking number added to the manifest. The updated
manifest is saved on the BCR SharePoint (Shared documents > Logistics >
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Shipping Logs > Return of Specimens) and a copy is emailed back to the CO
representative.
iii. A hard copy of the manifest is used by Logistics for QC purposes and will also
be included in the outbound package.
b. Pull specimens from freezer and place in a properly filled cryocart.
c. After the manifest has been confirmed by the CO representative, two technicians
must verify that the specimens pulled match what is on the manifest.
d. Place samples into 9x9 specimen boxes and load them into a cryoport rack. Then
insert the rack into the prepared outbound cryoport.
6. Creating FedEx airbills for cryoports:
a. Domestic Shipments
i. Go to “Ship” > “Create Shipment”.
ii. In the “To” section, enter the address and contact information. Verify address
and contact information from Clinical Outreach Coordinator before shipping a
package (refer to BCR-SOP-C030 Customer Relationship Management (CRM)
Software in Clinical Outreach).
iii. In the “Package & Shipment Details” section, enter the following:
(a) Weight: 51 lbs.
(b) Declared value: 2000 U.S. Dollars
(c) Service Type: Priority Overnight
(d) Package Type: Your Packaging
iv. In the “Billing Details” section, enter the following:
(a) Bill transportation to: BCR-662, FedEx Account # 491048662
(b) Your reference: Project, Destination, Outbound Cryoport
v. In the “E-mail Notifications” section, expand the “Edit” link. Enter an email
address for the shipper and the receiver. For both, select “Tendered”,
“Exception” and “Delivery”.
vi. In the “Complete your Shipment” section, click “Ship” then print the receipt
and airbill.
vii. Create an inbound airbill following the steps outlined above ensuring that the
BCR address is used for the destination and your reference: Project, Site,
Inbound Cryoport.
b. International Shipments
i. Go to “Ship” > “Create Shipment”.
ii. In the “To” section, first select the “Country/Location” to which you are
shipping. Then enter the address and contact information. Always verify the
address and contact information from Clinical Outreach Coordinator before
shipping a package, if applicable (refer to BCR-SOP-C030, “Customer
Relationship Management (CRM) Software in Clinical Outreach”).
iii. In the “Package & Shipment Details” section, enter the following:
(a) Weight: 51 lbs.
(b) Declared value: $25
(c) Service Type: International Priority
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a. The tracking numbers are e-mailed to the BCR Logistics group for verification.
Once verified they are e-mailed out to the relevant BCR departments.
b. Two Logistics technicians must review and initial that the shipment information is
correct. For Molecular analyte shipments the Plate ID section is filled in and
reviewed by one Logistics technician and one Molecular technician.
10. Add the following information for all cryoport shipments to the whiteboard before
taking an outbound cryoport to the dock: ship date, destination, estimated arrival date,
comments, tracking number, and shipper initials.
11. Physically take the cryoport to the designated FedEx pick-up location for shipment.
Track the package as specified in section II.B.4 above.
II. REFERENCES
None
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Figure 1 Figure 2
Figure 3
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Signatures
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