IQA Cryopreservation Panel Procedure
Contents
1. 2012 Frontier Science Foundation Page 5 of 12 Date Modified 31 Jan 2012 IQA Cryopreservation Panel Procedure Assay Module Prior to shipping the samples to the IQA lab each aliquot must be resulted in the Assay module Completing the Cryopreservation Data Entry Screen To open the Assays module go to Tasks Assays on the menu bar or click the Assay AI button on the LDMS toolbar Assay Selection Preview Results Assays Assay Selection Criteria _ Frequently Used Assays last 360 days Review Edit New Run Not Setup Al Open Cultures Select Assay l Terminate Unterminate CE i All Closed Cultures iret EPE TAEA ENUI SOC uns Not Pertormed Not Terminated Nr SO Cultures T Design All Cultures search DNA PCR Previous Runs Found E Immunology Run Date Description Al P24 Antinen x Specimen Search Criteria Search Filters Specimen Received Date Field Add Filter gt i f Use Dates D Op eta 1 Received Date Fm x Value Clear AI To 27Jan 2012 Specimens Found 123456 33212000008 9500673 01 27 Jan 2012 EDT 27an 2012 0 00 123456 332V12000008 ASSO0673 02 27 Jan 2012 BLD CEL EDT 2 Man 2012 000 123456 332V12000008 A9500673 03 27 AJan 2012 BLD CEL EDT 27Aan 2012 0 00 123456 332712000008 __A35006 3 04 _ 27 Jan 2012 BLD CEL EDT 2 Jan 2012 0 00 Records Found 4 Records Selected 0 Unselect All Select All Empty Grid Add t2. Indicate the most current CD 4 absolute number Indicate the viral load copies ml e The Viral Load field is optional e The CD4 field is optional even for positive HIV status 8 Enter data or select responses for each of the fields 9 Click the Add button on the LDMS toolbar to save the record 10 Click the Report El button on the LDMS toolbar to print a patient report 11 Use the VCR buttons to scroll to the next record to result 12 Repeat steps 8 11 for the remaining samples Shipping Module Once the aliquots have been resulted in the Assay module the last step is to create a Shipping diskette and Manifest Report to send with the frozen aliquots to the IQA lab Creating a Shipping Diskette and Manifest Report To open the Shipping module go to Tasks Shipping on the menu bar or click the Shipping a button on the toolbar To create a shipping diskette and Manifest Report 1 Click the Setup Shipment tab to search for your samples 2 Select IQA from the Group box 2012 Frontier Science Foundation Page 7 of 12 Date Modified 31 Jan 2012 10 11 12 13 14 15 16 17 18 19 20 21 IQA Cryopreservation Panel Procedure Select Received Date from the Type box and enter the received date into the ID box Click the arrow button to move the criteria into the query grid Click the Execute L 2 button on the LDMS toolbar Select two aliquots from each blood donor by clickin
3. import or click Cancel to abort the import If you would like the aliquots never to appear in the bulk add list of the Storage module click Yes on the message box If you want the specimens to appear in the bulk add list click No on the message box If the condition of the samples is something other than what appears in the import screen click Yes on the message box The Adjust Conditions dialog box appears Select the aliquots that should be changed by clicking on each select the new sample condition from the box and click OK If the condition of the aliquots are satisfactory click No The Success dialog box appears Click YES to import the associated test Assay information Select the appropriate temperature for the shipment and click OK Click OK The Shipping Batch message box appears Click OK in the dialog box that displays the importing process was completed successfully Click OK to acknowledge the Shipment Batch number A message will appear indicating that the Storage module must be run separately for the imported specimens Click OK to complete the import process Note Your imported IQA samples will automatically show up in Specimen Management with the imported box checked the imported date the Cryopreservation test ordered and the sending labs results available in the Assay Module Assay Module After the samples have been imported and tested you must enter the results for each aliquot in the Assay module Com
4. the IQA Cryopreservation and Viability Data Entry Screen in the Assay module 3 Delete extra aliquots from the Pending list Shipping Module Importing IQA Samples To open the Shipping module go to Tasks Shipping on the menu bar or click the Shipping Lev button on the LDMS toolbar Shipment Type LDMS Shipping Batch Shipment File Location Shipment No 47 i DEC Global Spec ID Prim Deriv Add DrawTime DrawDate val Vol Condition Test Setup Coordinates 050708000002 G1G00481 03 BLD CEL EDT 08 00 17 Mar 2008 3 5e 06 SAT Satisfactory No 001 001 EA 05008000002 G1G004B1 04 BLD CEL EDT 08 00 17 Mar 2008 3 5e 06 SAT Satisfactory No 002 001 n Continue Cancel To import IQA samples Click the Import tab Select LDMS Shipping Batch from the Shipment Type box Click Shipment File Location Select a drive on your PC Click OK Enter the batch number from the Shipping Manifest in the Shipment No field Click Import The shipping batch information will load into the grid Click on the Shipment QA QC tab to perform QA QC on the batch to be imported QA QC the shipment via barcode scanning or visual inspection CMP ee eS eS YS 2012 Frontier Science Foundation Page 9 of 12 Date Modified 31 Jan 2012 10 11 12 13 14 15 16 17 18 19 20 21 22 IQA Cryopreservation Panel Procedure Click the Import tab Click Continue A message box appears Click OK to continue with the
5. IQA Cryopreservation Panel Procedure IQA Cryopreservation Panel Procedure This document describes how to complete the IQA Cryopreservation and Viability Panel in the LDMS It is divided into two sections sending labs and IQA lab Please follow the instructions below For additional assistance please call LDMS User Support at 716 834 0900 x7311 or via e mail at Idmshelp fsirf org Sending Labs The immunology sending labs are required to perform four steps in the LDMS when preparing the IQA specimens 1 Log the specimen s into the Specimen Management module and assign the Cryopreservation Assay in Test Setup to each aliquot 2 Generate labels for IQA aliquots 3 Result the IQA aliquots in the IQA Cryopreservation and Viability Data Entry Screen in the Assay module 4 Ship the IQA aliquots to the IQA lab using the Shipping module The remainder of the document provides a description of the various modules in the LDMS that must be utilized to complete the above steps Specimen Management Module Entering IQA Specimens To open the Specimen Management module go to Tasks Specimen Mgt on the menu bar or click on the Specimen Management El button on the LDMS toolbar The Entry Tab displays Find OPID Load Spec Date 12 Dec 2007 Exp Date 0 Remote ecd Imported Culture Derivative Rec Date 12 Dec 2007 vf Time _ __ Export ID Roue Enter Specimen ID of Tubes o Primary Type o Delete Sp
6. ecimen Global Spec ID Volume ni i i i Details 650007000013 EEQ0041T 00 BLD C z Aliquots of Aiquots 0 vajo Units l Derivative l Sub Add Der l Other Spec ID Delete Modify Clear Specimen GlobalSpec ID Primam Add Der SubAdd Der Volume Units Cond Other Spec Id Group ID Details 50007000014 EEQO041T 01 BLD HEP CEL wIN A CEL IST v 1Q4 99001 500Y07000014 EEQO041T 02 BLD HEP CEL wIN A v 5000000 00 CEL ST 10499001 50007000014 EEQO041T 03 BLD HEP CEL wIN A Y 5000000 00 CEL IST v 10499001 500007000014 EEQO041T 04 BLD HEP CEL w N 5000000 00 CEL ST 10499001 2012 Frontier Science Foundation Page 1 of 12 Date Modified 31 Jan 2012 IQA Cryopreservation Panel Procedure To enter IQA specimens 1 Select IQA from the Group box Enter the donor number or PID in the ID1 field Enter your labs network affiliation processing method in the ID3 field a For example a laboratory processing PBMC s for the IPREX network would enter IPREX in the ID3 field Select the specimen and received dates from the Spec Date and Rec Date boxes Note Use the Current Date for this exercise Enter the following information above the primary grid e of tubes 1 e Primary Type BLD 7 Click Add The primary loads in the grid 8 Enter the following into the primary grid e Additive ACD EDT or HEP e Volume 20 e Units ML 9 Click on the Primary Details button Enter the Processing Date Processing T
7. ecimen Management LE button on the LDMS toolbar 1 Click the Browse al button on the LDMS toolbar 2012 Frontier Science Foundation Page 11 of 12 Date Modified 31 Jan 2012 IQA Cryopreservation Panel Procedure 2 Type inthe specimen number of the aliquot 3 Click Run and click on a row to highlight a specimen and then click Select 4 Highlight the specimen in the aliquot grid 5 Right click on the highlighted aliquot and select Test Setup from the menu 6 From the Test Setup screen highlight the Cryopreservation test in the Test Setup grid and click Delete The Delete Test message box appears 7 Click Yes 8 Click Done on the Test Setup screen to return to the Specimen Management screen Note Deleting the test will not remove the specimen record from the LDMS Specimen Management module 2012 Frontier Science Foundation Page 12 of 12 Date Modified 31 Jan 2012
8. g on the rows to highlight them Note Aliquots that were marked as Do Not Store in the Specimen Management module will be highlighted in red Click the Shipment Destination tab and select 213 University of Miami from the Lab box Select a contact from the Contact Person box Select a contact from the Contact Sending Lab box Click the Add button on the LDMS toolbar to batch the shipment In the View Shipment screen select your batch and click Manifest Report If applicable print the Box Map Report Click on the Shipment QA QC tab to perform QA QC on the batch to be shipped QA QC the shipment via barcode scanning or visual inspection Click on the Save button on the LDMS toolbar Click on the View Shipment tab select your batch and select LDMS Shipping Batch from the Shipment Type box Click on the Ship button Click OK to continue or Cancel to view the Storage Report A message box appears Click Yes to ship the batch Select the Shipping Box temperature and click OK Select your disk drive and click OK The success message appears Click OK and note the shipping batch number 2012 Frontier Science Foundation Page 8 of 12 Date Modified 31 Jan 2012 IQA Cryopreservation Panel Procedure IQA Lab LDMS 213 The IQA receiving lab is required to perform three steps in the LDMS when receiving the IQA specimens 1 Import the IQA aliquots into the LDMS using the Shipping module 2 Result the IQA aliquots in
9. ime Processed by Tech Inits and Total Cell Count 10 Enter the following information above the aliquot grid e of Aliquots 4 e Vol 5 e Units CEL e Derivative CEL Note By entering the units of CEL the LDMS will automatically multiply the volume by one million 11 Click Add The aliquots load into the grid 12 Click on the Aliquot Details button Enter the processing information for each aliquot Note If you are resulting and shipping these aliquots to the IQA real time you can utilize the Do Not Store feature This will prevent the aliquots from appearing in your bulk add list in storage These aliquots will also appear highlighted in red in the Shipping module so that you can easily identify those that have been set aside to ship Refer to the Specimen Management chapter of the LDMS User Manual for additional information 13 Click the Add button on the LDMS toolbar The Save Successful message box will appear Note If entering specimens for a patient or donor that has not been entered in your labs database an Enroll dialog box will appear Click Enroll to add the record to the database 14 Click OK A Label Dialog box will appear asking if you would like to generate labels 2012 Frontier Science Foundation Page 2 of 12 Date Modified 31 Jan 2012 IQA Cryopreservation Panel Procedure 15 If you wish to print labels for the aliquots that were just added select the IQA format from the box select the label s
10. ize from the list and click Yes Note To print labels for more aliquots than those on the Entry screen refer to the Generating Labels for IQA section on page 3 Ordering the Cryopreservation Assay via Assign Tests 1 Enter the Assign Tests module via the Tools listing on the LDMS Toolbar Display field categories Shipping M Specimen Storage Available Criteria Drag to selection box to add Selection Criteria Field Lona Description Cateaorv Field Do _ Prot ID2 Prot ID2 Specimen Group y IQA Protocol Type ACTG protocol type dult Ped Specimen 2 IS pecimen Date 27an 2012 Received Date Date specimen was received Specimen Received Time Time specimen was received Specimen SID 1D3 SIDAIDS Specimen Specimen Date Specimen draw date Specimen Specimen ID Identifier for an aliquot or primary specimen Specimen Criteria Sentence Specimen Time Specimen draw time Specimen m Select samples Load From File GlobalSpec ID Group PIDADI Prima Additive Derivative Volume Vol Units Cy 95006 73 01 123456 BLD EDT CEL 500000 CEL pee 49500673 02 123456 BLD EDT CEL 500000 CEL ME 49S00673 03 123456 BLD EDT CEL 500000 CEL 4 49500673 04 123456 BLD EDT CEL 500000 CEL Es Frequently Used Tests hd Assign Selected Test Category TestDescr Min Yol Units Replicates Cultures DNA PCR Immunology Misc P24 Antigen PK Assays Viral Load RNA Click to select
11. o Run To complete the Cryopreservation Data Entry screen Click the plus sign next to the Immunology category Click Cryopreservation Click New Run Not Setup Click Select Assay MN NO Enter the specimen Received Date in the From box or create a query statement in the Filters Criteria tab Note You may generate a pending specimen report from the Filters Criteria tab by clicking the Report button on the LDMS toolbar 6 Click Find Specimens The Specimens Found grid populates with specimens 7 Select the IQA aliquots to be resulted and click Add to Run The Results tab opens 2012 Frontier Science Foundation Page 6 of 12 Date Modified 31 Jan 2012 IQA Cryopreservation Panel Procedure Assay Selection 123456 ID2 m Specimen Type Spec ID 332412000008 Global Spec ID fa3500673 03 IE Date 27 JAN 2012 Run ID 4 _ 2964 PimaJELD Additive EDT Derivative CEL Sub A D N A Were Results obtained on this specimen Indicate HI Status Positive Y Yes C No What was the date of blood separation 27 Jan 2012 Le Indicate original volume of the specimen drawn What was the total cell yield of the specimen after separation Indicate the viability of the specimen before freezing What was the date the specimen was frozen Indicate the number of vials frozen Total viable cell count per vial Method for obtaining cell counts Indicate the volume per vial oa Tech MWC Data Entered by Mwe
12. pecimen before freezing What is the viable cell 100 What was the date the specimen was frozen Ot itiha anie cal envers Indicate the number of vials frozen 4 Comments Total viable cell count per vial 5000000 Data Enard HG ts Manual Automatic Method for obtaining cell counts i 3 AMCE 106 APFR72010 Indicate the volume per vial Assay Tech Data Entered by Indicate the most curent CD4 absolute number Indicate the viral load copies ml 9 Enter data or select responses for each of the fields on the Result screen Note The left side of the result screen displays the sending lab s specimen information These fields are grayed out and the results cannot be changed 10 Click the Save l button on the LDMS toolbar to save the record 11 Click the Report eh button on the LDMS toolbar to print a patient report 12 Use the VCR buitons to scroll to the next record to result 13 Repeat steps 9 11 for all remaining samples Specimen Management Module After the IQA lab s results have been entered for each aliquot tested there may be extra aliquots that have been sent and have been ordered for the Cryopreservation Assay To remove the aliquots from the pending list you must delete the test from the Test Setup tab in the Specimen Management module Deleting Extra Aliquots from the Pending List To open the Specimen Management module go to Tasks Specimen Mgt on the menu bar or click on the Sp
13. pleting the Cryopreservation Data Entry Screen ET To open the Assay module go to Tasks Assay on the menu bar or click on the Assay button on the LDMS toolbar To complete the Cryopreservation data entry screen 1 SR a Click on the plus sign next to the Immunology category Click Cryopreservation Click New Run Not Setup Click Select Assay Enter search criteria in the specimen search grid 2012 Frontier Science Foundation Page 10 of 12 Date Modified 31 Jan 2012 IQA Cryopreservation Panel Procedure 6 Verify that the IQA Review check box is selected by default it will be selected and click Find Specimens The specimens found grid will populate with specimens meeting the above entered search criteria 7 Select specimens to add to the run 8 Click Add to Run TYPE3 5146 ID3 NOSID 24 Wk gt m Specimen Type Spec 1D 500 05001 587 Global Spec ID CEQ00327 01 Spec Date 15 JUN 2005 Run ID 12410 Primary BLD Additive aCD Derivative ICEL Sub A D N A Were Results obtained on this specimen T Yes C No Specify reason v Indicate HIY Status J What was the date of blood separation Das cn towed 57 Jan 2012 Le Indicate original vol f th i d es DOCS CORPS ERP DER EE Indicate the viability of the sample after What was the total cell yield of the specimen after separation thawing ox 1086 E Jxus Indicate the total viable cell count Indicate the viability of the s
14. the Specimen field category Add the following data items to the Selection Criteria e Group IQA e Specimen Date Current Date Execute to populate the Select Samples grid Highlight the four specimens Click on the sign next to Immunology and highlight Cryopreservation Click Assign Selected Test A message box appears LOU 2012 Frontier Science Foundation Page 3 of 12 Date Modified 31 Jan 2012 IQA Cryopreservation Panel Procedure Are you sure You are about to assign the Cryopreservation test to 4 specimens This operation cannot be undone Are you sure you wish to do this Yes No 8 Click Yes The Success message appears Labels Module Generating Labels for IQA me IQA Immunology Quality Assurance Format 10A Barcode Barcode Content LOMS Standard bee oo Meow BES tem Row Gol LaserLabell2 11 5 x CryoLabels top margin 20 Additiv Laser Label13 1 5 WE Labels top margin 45 Clinic ID Laser Label 14 lee 68 ET Acro j l Culture Label Bae ID Barcode Labell 1 x Z 75 Siva Bea Notch on Left ci Rd face Barcode Label 2 iE 1 75 Zebra printer Notch on Left ATOUP Barcode Label 3 7 8 1 75 Zebra printer Black Mark Harve st D ate Barcode Label6 275 1 Bra dy 1344 Horizontal E D 1 PID Barcode Label 7 i 75 x 1 Brady 300 MYP Horizontal Font 6 L Protocol Barcode Label 9 _ 1 75 x 93 Zebra printer Horizontal D 3 SID Barci od Labe TU LEF po ee 300 MVP Hori
15. zontal Font 3 Barcode Label 11_ 5 Brady ai IP Vertical Barcode Label 12 2 75 x L Brady 1 344 Horizontal Barc ade Label 13 ZAM To ton bottom J J J ns Le Miwim 00 00 00 Ce UAN Alignment Label Manufacturer DPID Other Specimen ID Primary Received Batch No Received Date ship Batch No Spec Date 1 ee Ji 1i mi mn on Barcode Label 15 Barcode Label 16 28 x Brady 300 MVP 3 Labels Across LabXpert XSL 125 461 IIIS Sissi 1 ms Barcode Label 14 14 1 ne Brady 3 300 MVP E t Search From a File PER Global Specimen Import File Search Criteria ES i Field 1 Received Date 20120127 Operator 2 Modify Value 27 Jan 2012 L Delete To generate IQA labels 1 Inthe Labels module select IQA from the Group box the appropriate format from the Format box and the appropriate label size from the grid 2 Enter the Received Date in the Field box and the current date in Value Click Add to populate the search criteria grid 3 Click the Execute button on the LDMS toolbar 4 Click the Print button on the Report toolbar Below is an example of an IQA label created in the LDMS 2012 Frontier Science Foundation Page 4 of 12 Date Modified 31 Jan 2012 IQA Cryopreservation Panel Procedure
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