Exhibit L_HIV_Lab Submission_Guidelines CDD.pdf

Document #: CC0018.02 Page 1 of 11 Rev. 1 - 08/2015

Center for Disease Detection 11603 Crosswinds Way ● STE #100 ● San Antonio, Texas 78233

(877) 233-1337 ● www.cddmedical.com

PURPOSE

The purpose of this procedure is to provide instructions and guidelines for the collection, preparation and shipping of HIV Specimens from U.S. Navy Submitting Activities to Center for Disease Detection Laboratory.

SCOPE

This procedure applies to all technical personnel responsible for collecting, processing and shipping HIV specimens under the Navy Contract.

SUPPLIED ITEMS

Blood Collection

Figure 1 (16 x 100 Plastic Serum Separator Tube)

Figure 2 (5 mL Screw cap Serum Transfer Tube)

Figure 3 (Pre-printed Barcode Labels)

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Shipping Supplies

Specimen Shipment Boxes

Medium Box – Air 40 (holds 40 tubes) Includes:

Foam Insert

Absorbent Pad

Rubber Band

CONUS Box – Large Box (holds up to 5 Air 40’s)

OCONUS Box – Large Box (holds up to 4 inserts) Includes:

Outer Box

Foam Inserts (6)

Refrigerant Packs

Other Shipping Supplies

Clear plastic Ziploc bags Tamper-Proof Seals

Lab Pak shipping pouch Clear Plastic Sleeves for air bill

Packing Tape

Tamper-Proof Seal

Zip-Lock Bag

Ice Packs

Packing Tape

Air 40 Box

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Computer-generated air bills

DD Form 250 – (OCONUS Only) A printable DD Form 250 in .pdf format is available at:http://www.cddmedical.com/images/DD250%20I nternational%20-%20Navy.pdf

CDC Shipping Permit (OCONUS Only)

ITEMS REQUIRED BUT NOT SUPPLIED

Blood Collection

Needles for use with vacuum collection tubes

Needle Holder (Hub)

Tourniquet

Alcohol Swabs

Adhesive Bandages and/or gauze

PROCEDURES

Sample Collection

Follow local SOP for routine venous blood collection.

Collect blood samples using only the plastic 7mL barrier-gel collection tubes supplied.

Be sure to completely fill the blood collection tube.

If sample shipment will be delayed or you must collect using a different tube than the ones supplied, centrifuge samples and transfer the serum to the screw cap vials (supplied).

Refer to Figure 4 (Volume of Specimen Required for Testing – SST / Pour Off Tube)

Avoid hemolysis. Grossly hemolyzed specimens will be rejected for testing.

Refer to Figure 5 (Hemolysis).

http://www.cddmedical.com/images/DD250%20International%20-%20Navy.pdf http://www.cddmedical.com/images/DD250%20International%20-%20Navy.pdf

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Figure 4 (Volume of Specimen Required for Testing – SST / Pour Off Tube)

Figure 5 (Hemolysis)

Sample Handling

Gently invert sample tubes 4 or 5 times immediately after collection.

Allow samples to fully clot prior to centrifugation.

Centrifuge samples between 30 minutes and 2 hours after collection to minimize fibrin clotting.

Do not refrigerate specimens before centrifugation.

Centrifuge samples @ 1800g for 10 minutes.

None Mild Moderate Gross

Must be filled +/- 10% of the Fill Line

1.5 ml Required

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After centrifugation, allow samples to sit upright at room temperature for 1 hour prior to shipping.

Specimens may be stored refrigerated (2-8 °C) for up to 7 days.

Specimens that cannot be delivered to CDD Laboratory within 7 days of collection must be transferred to the 5.0 mL screw-cap collection tubes and frozen (-20°C).

Do not submit specimens in any other tube than those provided by CDD Laboratory.

Specimens collected in other than the evacuated blood collection tube provided by CDD Laboratory must be transferred to the provided 5.0 mL screw-cap vial before shipment.

Specimens received by CDD in any other tube other than those provided will be rejected.

Sample Tube Labeling

Apply the barcode labels at the top of the sample tube (the end closest to the cap).

Place the barcode so the lettering is in a vertical position (along the length of the tube).

Refer to Figure 6 (Proper Label Placement) for an example.

Figure 6 (Proper Label Placement)

Place the barcode label over the top of the tube manufacturers label to allow enough space for lab personnel to see the sample level and color.

Place the barcode label on the tube so that there are no wrinkles, folds or tears on the barcode itself. Samples received with damaged barcodes will be rejected.

Include at least two unique identifiers (e.g. SSN, Name, DOB, etc.) on specimen tubes to positively identify the samples. Samples received without sufficient labeling will be rejected.

Barcode labels must be completely legible. Barcodes with blanks, smudges or unreadable text will be rejected.

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Package Samples for Shipment (CONUS)

Place centrifuged, bar-coded SSTs or 5ml screw cap serum transport tubes upright in the foam tube holder.

Ensure the absorbent pad is in the bottom of the primary shipping box.

Place the foam tube holder in the primary shipping box.

Close the primary shipping box and secure the lid with a rubber band (provided).

Place the primary shipping box into the clear Ziploc bag.

Fold the top of the bag until it is flush with the primary shipping box.

Place a strip of the tamper evident security tape over the bag opening ensuring that the entire end is covered.

Place the sealed specimen box into the FedEx Lab Pack. (One Air 40 per lab pack).

Place an itemized list of contents (CHCS or MRRS roster / shipping list or DD250) inside of the FedEx Lab Pack.

NOTE: Place the DD Form 2923 (Privacy Act Data Cover Sheet) on top of the paperwork to ensure that all PII is covered. Refer to Figure 8.

Seal the lab pack by removing the plastic adhesive strip and pressing the edges of the lab pack together.

For sites using the CONUS box to submit specimens to CDD, place the sealed primary shipping boxes in the large outer shipping container (CONUS box) Each CONUS box holds up to 5 Air 40’s.

Use newspaper and/or packing peanuts to cushion the contents and prevent shifting during transit.

Seal the CONUS box using the packaging tape provided. Be sure to seal the top and bottom of the box along with all 3 seams.

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Printing the Shipment Air Bill

Log on to the CDD Website to print the air bill.

Click on the link below or type the address into your web browser.

https://dodweb.cddmedical.com/mil-label/request?command=signon.create

At the login prompt, enter in your site ID, login, and password that were provided by CDD then click submit.

Verify that the correct site is listed in the ‘Name’ field.

Use the dropdown arrow next to “Shipping Labels” to select the number of labels to create for the shipment. Create one label for each Lab Pak or CONUS box to be shipped.

Click ‘Retrieve Labels’. After a few moments the labels will generate and a screen showing printer settings will appear.

Click the “Download” link to retrieve the air bill for printing.

Select “Open” when prompted to Open or Save the air bill. The image will appear.

Click Print.

Once air bill is printed fold the page in half.

Place folded air bill in the plastic FedEx sleeve provided by CDD.

Peel wax paper from back of plastic sleeve and affix the plastic sleeve containing the air bill on the exterior of the lab pack or the CONUS box.

Each package submitted must have its own air bill. DO NOT DUPLICATE

AIR BILLS!

NOTE: The air bill program is designed to generate “Saturday Shipping Labels” when used on Friday. Be sure to generate air bills for Friday shipments on Friday. If a package shipped on Friday is not labeled for Saturday delivery, the specimens will not be delivered to CDD until the following Monday.

https://dodweb.cddmedical.com/mil-label/request?command=signon.create

Document #: CC0018.02 Page 8 of 11

Package Samples for Shipment (OCONUS)

Place centrifuged, bar-coded SSTs or 5ml screw cap serum transport tubes upright in the foam tube holder.

Place the foam insert into the clear Ziploc bag.

Fold the top of the bag until it is flush with the foam insert.

Place a strip of the tamper evident security tape over the bag opening ensuring that the entire end is covered.

OCONUS boxes require assembly. Six pieces of foam are required for each box.

Assemble OCONUS box. Tape the bottom of the box using the CDD supplied packaging tape on all three seams.

Place the sealed foam insert into the insulated shipping container (OCONUS). The OCONUS box holds up to 4 foam inserts and 3 refrigerant packs. Use newspaper and/or packing peanuts to cushion contents and prevent shifting during transit.

OCONUS specimens must be shipped with refrigerant ice packs. Place all 3 CDD-provided refrigerant ice packs between the primary shipping boxes.

Seal box using the packaging tape CDD provided. Place packaging tape on all 3 seams.

Fill out the required data on the International Air Waybill. Please refer to Figure 7 (Example International Waybill) for help.

o Section 1: Date Shipped o Section 3: Total Packages – Always indicate just one package.

o Section 3: Total Weight – Always indicate 5 lb (pounds).

o Section 3: Commodity Description o Section 9: Sender’s Signature

Fill out the required data on the DD 250 o Section 3: Date Shipped o Section 11: Your site address o Section 17: # of specimens sent o Section 21 a: Date and Sign

Place the completed International Air Waybill and 3 copies of the DD250 (PR0009.04.A DD250 for International Shipping) in the clear plastic waybill sleeve.

Place the copies of the DD250 behind the International Air Waybill.

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Peel the wax paper from back of plastic sleeve.

Affix the plastic sleeve containing International Air Waybill and DD250 copies to the exterior of the OCONUS box.

Each OCONUS package submitted must have its own International Air Waybill. DO NOT DUPLICATE WAYBILLS!

Affix the CDD provided CDC permit to the exterior of the box next to International Air Waybill.

REFERENCES

IATA Dangerous Goods Regulations 49 Code of Federal Regulations

DEFINITIONS

CDC Centers for Disease Control and Prevention CDD Center for Disease Detection CONUS Continental United States OCONUS Outside Continental United States SST Serum Separator Tube UIC Unit Identification Code RCF Relative Centrifugal Force

RECORDS

None

ATTACHMENTS

PR0009.04.A DD Form 250 for International Shipping

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IMAGES

International Waybill

Figure 7 (Example International Waybill)

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Figure 8 (DD Form 2923 - Privacy Act Data Cover Sheet)