Manual of Standard Operating Procedures

Materials

• Biospecimens
• Up to 4x Biospecimen Bags, Small (Provided With Each Kit)
• Up to 4x Biospecimen Kit Forms
• 1x Dry Ice, 20 lbs (Not Provided)
• 1x Dry Ice Label (Provided)
• Up to 4x Ziploc Bag, Large (Provided)
• Up to 4x Therapak™ Aqui-Pak™ Absorbent Sleeves (Provided)
• 1x FedEX Return Labels (Provided with Initial Kit Delivery)
• 1x UN3373 Labels (Provided)
• 1x Insulated Shipping Box with Outer Cardboard Box, Suitable for Dry Ice (Not Provided)
  • Recommended: Insulated Foat Shipping Kit, ULINE, Cat. # S13392 (12 x 12 x 11.5 Inches)
• Up to 4x Replacement Kit Forms (If Needed During Collection)

Procedure

1. Inform the central lab of the upcoming shipment via the kit request and submission portal or by email if the portal is inaccessible, DS-Biorepository@cuanschutz.edu.
2. Acquire dry ice pellets (15-20 lbs) and pour about 1/3 of it into the Styrofoam shipping container.
   • A box of approximately 12x12x11.5 inches is recommended for returning samples from four collection kits. Ensure the package will accommodate enough dry ice to keep the samples frozen during travel.
3. Ensure all biospecimens from one kit have been consolidated into the large Ziploc bag the kit was shipped in.  
   • Keep samples on dry ice to ensure they don’t thaw.
   • Ensure large loose tubes, such as saliva, tongue swab, PAXgene^® DNA, PAXgene^® RNA, and 15 mL conical of plasma were placed in the absorbent sleeves provided with the collection kits.
     • These should be placed inside the medium biospecimen bag.
   • Transfer Buffy coat samples into the small biospecimen bag containing the CyTOF^®-ready samples, RBC matrix tubes, and plasma matrix tubes.
   • Return all samples into the larger, large Ziploc bag and seal.
4. Place a maximum of four large bags of biospecimens (4 kits) in the insulated shipping box and bury them under the dry ice and cover them with the remaining dry ice, until the container is full.
   • Do not tape the Styrofoam box shut. As dry ice sublimates, the CO2 gas will increase the internal pressure of the package and can injure those handling the package.
5. Place the Styrofoam container inside a rigid cardboard box.
6. Place copies of the completed biospecimen kit forms for each kit on top of the Styrofoam box and tape the outer cardboard box closed with packing tape.
   • Ensure any replacement kit forms used are attached to their corresponding biospecimen kit forms.
7. Attach the return shipping, UN3373, and dry ice labels to the box.
   • Ensure the dry ice sticker has been filled out with shipping details and dry ice weight.
8. Attach FedEX shipping label from step 1 to the outside of the box and drop the package off at the nearest location that accepts shipments containing dry ice.

Materials

• Biospecimens
• Up to 10x Biospecimen Bags, Small (Provided)
• Up to 10x Biospecimen Kit Forms (Provided)
• 1x Dry Ice for Combing Samples (Not Provided)
• 1x Dry Ice for Shipping (Provided by World Courier)
• 1x Dry Ice Label (Provided)
• 1x Insulated Shipping Box Suitable for Dry Ice (Provided by World Courier)
• Packing Tape
• 1x Rigid Cardboard Box (Provided by World Courier)
• Up to 10x Replacement Kit Forms (If Needed During Collection)
• 1x Shipping Labels (Provided by World Courier)
• Up to 10x Therapak™ Aqui-Pak™ Absorbent Sleeves (Provided)
• 1x UN3373 Labels (Provided)
• 1x World Courier Customs Invoice Form (Provided)
• 1x World Courier Order Form (Provided)
• 1x World Courier Quote Questionnaire (Provided)
• Up to 10x Ziploc Bag, large (Provided)

Procedure

1. Email the DS-Biorepository, DS-Biorepository@cuanschutz.edu, to notify the central lab of your intent to ship and to request the following shipment forms (also available online):
   • World Courier Customs Invoice Form
   • World Courier Order Form
   • World Courier Quote Questionnaire
2. Request an updated quote from World Courier.
   • Fill out the Quote questionnaire and return it to usquotes@worldcourier.com. Be sure to CC Roxanna.martinez@worldcourier.com and the DS-biorepository
   • Quotes are only good for 30 days and a new quote will need to be issued with each shipment.
3. Submit the shipment request to World Courier.
   • Email the completed quote, the order form, and the customs invoice to NewOrder@worldcourier.com and CC roxanna.martinez@worldcourier.com and DS-Biorepository@cuanschutz.edu.
   • A job number will be assigned to the shipment and World Courier will provide an “OK to Send” notification to the collection site.
   • A job number will be assigned to the shipment and World Courier will provide an “OK to Send” notification to the collection site.
4. Once given the “OK to Send” status, World Courier will work with the collection site to schedule a pickup over the next 2-3 weeks.
   • Shipments should be scheduled for Monday or Tuesday to avoid weekend deliveries.
5. The day before or day of shipment combine biospecimen from a single kit together into one large and place at -80°C until World Courier is ready to package the samples for shipment.
   • Record the Kit IDs included in the anticipated shipment and confirm the number of each biospecimen to be returned per participant.
   • Keep samples on dry ice to ensure they don’t thaw.
   • Ensure large loose tubes, such as saliva, tongue swab, PAXgene^® DNA, PAXgene^® RNA, and 15 mL conical of plasma were placed in the absorbent sleeves provided with the collection kits.
     • These should be placed inside the medium biospecimen bag.
     • It is likely that these steps were already completed after sample collection (see Biospecimen Collection).
   • Transfer buffy coat samples into the small biospecimen bag containing the CyTOF^®-ready samples, RBC matrix tubes, and plasma matrix tubes.
     • Cryopreserved buffy coat should not be stored long-term (>2 weeks) at -80°C. For this reason, unlike the other biospecimens, the buffy coat cannot be pre-assembled in the return kit immediately after biospecimen collection.  
   • Return all samples into the large Ziploc bag the kit came in, seal it, and keep at -80°C until shipment.
6. On the day of shipment, assemble sample shipments in the shipping materials provided to sites.
   • World Courier may provide a 2-hour window for shipment pickup.
   • During this time, a courier will arrive on site with packing materials and dry ice.
     • The collection site staff must pack the return samples. World Courier will not handle the samples directly but will wait outside for receipt of packed shipping boxes.
   • Bury 10 filled kit bags, in the insulated shipping box under the dry ice provided by World Courier.
   • Place the insulated shipping box in the external cardboard shipping box.
   • Ensure that copies of the kit biospecimen forms and replacement kit forms, if needed, are included with the shipment. These may be placed between the insulated shipping box and the outer cardboard box.
   • Ensure the UN3373, dry ice, and shipping labels are affixed to the outer shipping box. These should be provided by World Courier.
   • Close and seal the outer shipping container with packing tape.
7. Transfer the assembled shipment to the courier and provide any updates on tracking information to the DS-Biorepository through email at DS-Biorepository@cuanschutz.edu.