Collection and Shipment Training Training Overview ADC FB GUIDs Kit Review Sample Collection and Processing Sample Shipping Sample Form NCRAD Website Common Nonconformance Issues Questions ID: 1034506
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1. Alzheimer’s Disease Center Fluid Biomarkers StudyCollection and Shipment Training
2. Training Overview: ADC FBGUIDsKit ReviewSample Collection and ProcessingSample ShippingSample FormNCRAD WebsiteCommon Nonconformance IssuesQuestions?
3. Globally Unique Identifier (GUID)
4. Globally Unique Identifier (GUID)Create an account: https://bricsguid.nia.nih.gov/portal/jsp/login.jspOnce you have an account, go to the GUID Tool – Create GUIDTo open the ‘Launch GUID Tool’ you will need to have Java installed on your deviceWhen the GUID Tool is open, you will need all of the following information (ADCFB MOP Appendix A): Complete legal given (first)name of participant at birthThe participant’s middle name, if applicableComplete legal family (last) name of subject at birthDay of birthMonth of birthYear of birthName of city/municipality in which subject was bornCountry of birth
5. ADCFB Kits BiospecimenTotal Blood Volume Collected20 ml30 ml40 ml50 mlPlasmaXXXXBuffy Coat (DNA)XXXXPBMCXXDepending on approved blood volume, sites may choose between four blood collection kits.If desired, sites may also collect and send CSF samples at each annual visitBiospecimenAnnual visitsCSFX
6. Kit Request Modulehttp://kits.iu.edu/adcfb/Ncrad.iu.edu > Tools for active studies > Adcfb > kit request module > kit request system
7. ADCFB Kit Request ModuleEnter emailChoose your site from the drop-down list.The coordinator name and contact information will appear.Verify that this information is accurate and correct if necessary.
8. Indicate the quantity needed of each Specimen Collection KitOnce selected, kit components of the chosen kit will appear at the bottom of the screen**Note: You can order more than one type of kit in a single kit request**
9. Indicate the quantity needed of each Shipping KitIndicate if a Supplemental Kit is neededIndicate if Extra Supplies are needed. If yes, enter quantities.Use Comments to request unlisted or special suppliesEnter the target date for receipt of suppliesClick “Submit” to turn in your request.
10. Specimen Labels
11. Three Label TypesKit NumberSite and PTIDCollection Tube and Aliquot
12. Kit Number LabelsUsed to track patient samples and provide quality assurance – Will be placed on the following locations :Blood Sample and Shipment Notification FormsCryoboxes that house aliquots during shippingOne extra label providedProvided by NCRAD in the kits
13. Site and PTID LabelsSubjects will be identified by their Site and PTIDSites will be responsible for handwriting this onto the provided labelsMust use fine point permanent marker
14. Collection Tube and Aliquot LabelsCollection Tube labels have 4 components:Study name10 digit specimen barcodeSpecimen typeKit number
15. Blood Collection TubesLabel 1: Site and PTID labelLabel 2: Collection Tube labelAll collection tubes will have two labels: The handwritten Site and PTID labelThe collection tube label
16. Labeling Biologic SamplesLabel all collection and aliquot tubes before cooling, collecting, processing or freezing samplesLabel only 1 subject’s tubes at a time to avoid mix-upsWrap the label around the tube horizontally. Label position is important for all tube typesMake sure the label is completely adhered by rolling between your fingersCollection TubeAliquot Tube
17. Collection Tube LabelingEDTA TubeCollection Tube LabelSite and PTID LabelAttach labels to allow a viewing window down the length of the tube to ensure Buffy Coat is visible during processing.Buffy CoatNCRAD LabelManufacturer label
18. Handling/Processing Study Specimens
19. Blood Draw OrderTube Type*Number of Tubes DrawnTube Image 1. NaHep (Green-Top) Tube (10 ml)2 (20 ml)2. EDTA (Purple-Top) Tube (10 ml)2 (20 ml) or 3 (30 ml)*If drawing blood for PBMCs, Sodium Heparin tubes must be the first tubes into which blood is collected. If not, the EDTA tubes will be first.
20. PBMC Collection2 x Sodium heparin (green top) BD Vacutainer® (10 ml)Not processed at site*NOTE*: Must be shipped AMBIENT to NCRAD the day sample is drawn. No Friday Draws.
21. PBMC Preparation (10ml Sodium Heparin Tube x 2)
22. Cryovial Cap ColorsCap ColorSample TypeCap ImagePurplePlasmaBlueResidual (Plasma or CSF)ClearBuffy CoatOrangeCSF
23. Plasma CollectionCreate up to: 7 aliquots (20ml kit) or 10 aliquots (30ml kit)20ml kit:Six 1.5ml aliquots in purple capsOne residual aliquot in blue cap30ml kit:Nine 1.5ml aliquots in purple capsOne residual aliquot in blue cap20ml Kit30ml Kit
24. Buffy Coat CollectionExpected to have a reddish color from the RBCs. Be sure to only place the buffy coat from one EDTA tube into each cryovialCreate up to: 2 buffy coats (20ml kit) or 3 buffy coats (30ml kit)Buffy Coat
25. Plasma/Buffy Coat Collection and Processing: 20 ml
26. Plasma/Buffy Coat Collection and Processing: 30 ml
27. CSF CollectionCreate up to:14 aliquots13 1.5ml aliquots in orange caps1 residual aliquot in blue cap
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29. Packaging Sample Shipments
30. Sample Shipment SummaryCollection TubeDrawn AtSpecimen TypeAliquot VolumeTotal Number of AliquotsShipping Temperature2 Sodium Heparin (Green-Top) Blood Collection Tubes (10 ml)Each visitWhole BloodN/AN/AAmbient2 or 3 EDTA (Purple-Top) Blood Collection Tubes (10 ml)Each visitPlasma1.5 ml plasma aliquotsUp to 10FrozenEach visitBuffy Coat~1.0 ml buffy coat aliquotsUp to 3FrozenSterile ContainerEach visitCSF1.5 ml CSF aliquotsUp to 14Frozen
31. Ambient Shipment Packaging
32. Place the ambient PBMC tubes in the absorbent slots and biohazard bag.Place the bag inside the small shipping box, and then set the refrigerant pack on top of it.Place small shipping box within a provided UPS Laboratory Pak, seal, and place UPS label on outside of package.Ambient Shipment Packaging*Gel packs must be put in a freezer at minimum the night before shipping.
33. Frozen Shipment Packaging
34. Frozen Shipment PackagingUse the biohazard bag to package the 25-Slot cryobox
35. Frozen Shipment PackagingPlace 2-3 inches of dry ice in the bottom of the Styrofoam shipping container, then insert the cryoboxes laying upright.Fully cover the cryoboxes with about 2 inches of dry ice in the provided shipper.Each Styrofoam shipper must contain about 45 lbs (20 kg) of dry ice.Fill shipper to the top with dry ice!
36. Frozen Shipping – Dry Ice RequirementsDry Ice label should not be covered with other stickers and must be completed or the shipping carrier will reject/return your package!20Net weight of dry ice in kg
37. Creating Airbills/Scheduling Pickups
38. UPS ShipExecTM Thin Client Website
39. Finding Your Contact InformationOn the right side of the screen, choose the name of your study from the “Study Group” drop down menuThis step must be done 1stOn the left side of the screen, Click on the magnifying glass icon
40. Finding Your Contact InformationOn the right side of the screen, a list of all the site addresses within the study you selected should populateUser can filter the search for their address further by filling in the “Company”, “Contact”, or “Address 1” fieldsHit “Search” when ready.Once you have found your site address, click on the “Select” button to the left of the addressIf any information needs to be updated, please reach out to the NCRAD Coordinator of your study
41. Verify InformationPlease verify that both the shipping information AND study reference are correct for this shipment
42. Entering Shipment InformationAmbient shipmentsEnter the total weight of your package in the “Weight” field, leave the “Dry Ice Weight” field empty!Frozen shipmentsEnter the total weight of your package in the “Weight” fieldEnter the dry ice weight in the “Dry Ice Weight” fieldThe “Dry Ice Weight” field cannot be higher than the “Weight” field (will receive an error message)
43. Need to request UPS Pickup?Click on the “Pickup Request” buttonFill out all fields for the pickup requestEnter in the “Earliest Time Ready” and “Latest Time Ready” in 24-hour formatUsers must schedule pickup minimum 1 hour before “Earliest Time Ready”Choose a name and number that is the best to contact if the UPS driver has questions related to picking up your packageEntering the Room Number and Floor will help the UPS driver locate your packageRoom number field is free textFloor field is numerical onlyHit “Save” when done
44. Shipping PackagesIf all fields in “Ship From” and “Shipment Information” fields are completed, and pickup request is completed (if necessary), click Ship in the bottom right corner of the page
45. Accessing AirbillShipment ReceiptAirbillCheck Pickup Status by going to UPS.com, click on the Shipping, select Schedule a Pickup, and look on the right side of screen to click on “Pickup Request Status”. Enter in the Pickup No. listed on receipt into PRN field and submit
46. Accessing AirbillPrint out the UPS air waybillFold the UPS air waybill and slide it inside the plastic UPS sleeve (NCRAD will provide these in kit requests)Peel the back off the plastic UPS sleeve and stick the sleeve to your package, making sure it is laying as flat as possible along the surface of the package.
47. Reprint Airbills/Voiding ShipmentsTo reprint airbill or void a shipment, click “History” at the top of the ShipExec Thin Client portalIf your shipment doesn’t automatically pop up, enter in the date of shipment and then click “Search”
48. Reprint AirbillClick the print icon to reprint airbill
49. Void ShipmentTo void a shipment, click on the “X” symbol
50. Blood Sample and Shipment Notification Form
51. Blood Sample and Shipment Notification Form
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53. Noncomformance Issues
54. Nonconformance IssuesFields left blank on Blood Sample and Shipment Notification FormLast time subject ate often left blank/unknownIncorrect data reported on Sample and Shipment Notification FormsSample aliquots and collection tubes frozen at an angle/invertedRecommendation: Place aliquots in Argos boxes/tube rack in freezer upright until shipmentRecommendation: Complete Sample Notification forms during the participant study visit as samples are processed.
55. Nonconformance IssuesAll frozen samples for a participant not sent within one shipment box (plasma and buffy coat aliquots should be kept together)Aliquots arriving to NCRAD without labelsSample forms not faxed or scanned to NCRAD the day before shipmentRecommendation: Ship Samples to NCRAD utilizing the Notification Form, by PTID. Do not throw away labels until samples are packed and shipped.Recommendation: No samples should be held ambient for any period of time at the site. Ensure all ambient PBMC samples are shipped by end of the day.Ambient PBMC samples not shipped to NCRAD the day of blood draw
56. Nonconformance IssuesMultiple low volume aliquotsRecommendation: Lay out cryovials in a row and aliquot in order until sample is depleted
57. NCRAD Website
58. NCRAD Website: Helpful Pageshttps://ncrad.org/holiday_closures.htmlhttps://ncrad.org/shipping_address.html
59. Contact Information