University of Kentucky Hospital Markey Cancer Center Biospecimen Tissue Procurement Shared Resource Facility MDR#3, Room 219; 700 S. Limestone St.; Lexington, Kentucky 40536; ph: (859)323-2618; fax: (859)257-3757 113 Combs; 800 Rose St.; Lexington, Kentucky 40536; ph: (859)323-2916; fax: (859)257-3757 BSTP SRF 317.1 Serial Number Sample Tracking System Page 1 of 7 _________________________________________________________________________________________________________ SUBJECT: SERIAL NUMBER SAMPLE TRACKING SYSTEM HYPERLINKED TABLE OF CONTENTS Table of Contents I. PRINCIPLE (Purpose):..................................................................................................2 II. ROLE:...........................................................................................................................2 III. GLOSSARY, ABBREVIATIONS OR DEFINITIONS:...................................................2 IV. INDICATIONS (Policy): ...............................................................................................2 V. SPECIMENS (Samples): .............................................................................................3 VI. MATERIALS, REAGENTS, EQUIPMENT and SAFETY PRECAUTIONS: ................3 VII. DOCUMENTS, RECORDS and FORMS: ..................................................................3 VIII. RELATED PROCEDURES: ......................................................................................4 IX. QUALITY:....................................................................................................................4 X. PROCEDURE ..............................................................................................................4 XI. EXPECTED VALUES, INTERPRETATIONS/RESULTS/ ALERT VALUES and REFERENCE INTERVALS: .............................................................................................6 XII. METHOD PERFORMANCE SPECIFICATIONS:.......................................................6 XIII. REFERENCES:.........................................................................................................6 XIV. ATTACHMENTS (Appendices, Forms, Labels, Tags, Tables): ................................7 XV. HISTORY BLOCK......................................................................................................7 XVI. APPROVAL BLOCK: ................................................................................................7 June 25, 2012 University of Kentucky Hospital Markey Cancer Center Biospecimen Tissue Procurement Shared Resource Facility MDR#3, Room 219; 700 S. Limestone St.; Lexington, Kentucky 40536; ph: (859)323-2618; fax: (859)257-3757 113 Combs; 800 Rose St.; Lexington, Kentucky 40536; ph: (859)323-2916; fax: (859)257-3757 BSTP SRF 317.1 Serial Number Sample Tracking System Page 2 of 7 _________________________________________________________________________________________________________ I. PRINCIPLE (Purpose): A. This process document describes the purpose and process for assigning Biospecimen Shared Resource Facility (BSTP SRF) tracking serial numbers to all biospecimens. This will help identify each specimen. The purpose of the serial number tracking system is to link each unique sample to the donor in the BSTP SRF database (caTISSUE). II. ROLE: A. It is the responsibility of all BSTP SRF lab personnel who assign, create, and/or affix labels to storage vials to use unique BSTP SRF tracking serial numbers for each biospecimen. III. GLOSSARY, ABBREVIATIONS OR DEFINITIONS: A. Refer to BSTP SRF 97 Glossary, Abbreviations, Acronyms and Definitions. IV. INDICATIONS (Policy): A. The numbering system for the BSTP SRF serial number tracking system will be alpha-numeric. The entries will proceed as A000000-A999999, B000000-B999999 etc., one letter followed by 6 sequential numbers. Once we get to Z999999 the following sequential number will be AA000000. i. These serial numbers will replace the draw and aliquot numbering system currently in place. ii. The date of processing is being removed from the labels. This has been deemed unnecessary because it is recorded in caTISSUE. June 25, 2012 University of Kentucky Hospital Markey Cancer Center Biospecimen Tissue Procurement Shared Resource Facility MDR#3, Room 219; 700 S. Limestone St.; Lexington, Kentucky 40536; ph: (859)323-2618; fax: (859)257-3757 113 Combs; 800 Rose St.; Lexington, Kentucky 40536; ph: (859)323-2916; fax: (859)257-3757 BSTP SRF 317.1 Serial Number Sample Tracking System Page 3 of 7 _________________________________________________________________________________________________________ Collection Protocol Case ID Number Unique Serial Number with matching Data Matrix 2D Barcode. Sample Type B. The purpose of the serial number tracking system is to link each unique sample to the donor in the BSTP SRF database (caTISSUE). C. The serial number tracking system applies to all samples collected, and/or stored by the BSTP SRF. i. All samples for all sites will be assigned a sequential number. If they are later not used, the number is not reused. For example, if 10 labels are printed in advance for Driesler samples but then only 6 are used, the unused 4 labels will be destroyed and the numbers never used. D. The data matrix barcode will reflect the serial number. The barcode allows scanning of each sample type into the database and ensures quality control of the biospecimen inventory. V. SPECIMENS (Samples): A. N/A VI. MATERIALS, REAGENTS, EQUIPMENT and SAFETY PRECAUTIONS: A. Brady Printer BP-1344 June 25, 2012 University of Kentucky Hospital Markey Cancer Center Biospecimen Tissue Procurement Shared Resource Facility MDR#3, Room 219; 700 S. Limestone St.; Lexington, Kentucky 40536; ph: (859)323-2618; fax: (859)257-3757 113 Combs; 800 Rose St.; Lexington, Kentucky 40536; ph: (859)323-2916; fax: (859)257-3757 BSTP SRF 317.1 Serial Number Sample Tracking System Page 4 of 7 _________________________________________________________________________________________________________ VII. DOCUMENTS, RECORDS and FORMS: A. Serial Number Tracking Form B. Codesoft 7 Premiere C. Lab Computer A626688 VIII. RELATED PROCEDURES: A. N/A IX. QUALITY: A. The BSTP SRF laboratory will keep track of the last number used by saving the last number used in the Brady label template, as well as recording the last number used in the serial number tracking log located beside the Brady printer. The printer software has a shared variable function, which will allow the number to be shared with all protocols. X. PROCEDURE and CALCULATIONS: A. Open Codesoft 7 Premier i. Start menu ii. Codesoft 7 iii. Codesoft 7 Premier B. Open Label Template i. From Codesoft 7 Premier, click File. ii. Open iii. Desktop\labelTemplates\serial Barcode 2010\ iv. Select the specific protocol label template. June 25, 2012 University of Kentucky Hospital Markey Cancer Center Biospecimen Tissue Procurement Shared Resource Facility MDR#3, Room 219; 700 S. Limestone St.; Lexington, Kentucky 40536; ph: (859)323-2618; fax: (859)257-3757 113 Combs; 800 Rose St.; Lexington, Kentucky 40536; ph: (859)323-2916; fax: (859)257-3757 BSTP SRF 317.1 Serial Number Sample Tracking System Page 5 of 7 _________________________________________________________________________________________________________ v. Open protocol. C. Print-while in Codesoft 7 Premier. i. File ii. Select printer iii. Select Brady Printer Model 1344 LPT 1: iv. Click “OK”. v. File vi. Print vii. Labels in the series (How many unique labels do you need?) viii. Copies of each label (This will duplicate serial numbers.) ix. Click “OK”. x. If you need to change the Barcode Prefix, do it at this screen. xi. Click “OK”. xii. Save changes made to template before exiting. D. Change Participant ID i. Click once in participant ID field. ii. Change to correct participant ID. E. Fill in BSTP SRF 317.2 Serial Number Tracking Log i. Fill in the last serial number printed under “Last Number Used” field. ii. Write in the name of the protocol the serial number was assigned under “Protocol” field. iii. Initial and Date. June 25, 2012 University of Kentucky Hospital Markey Cancer Center Biospecimen Tissue Procurement Shared Resource Facility MDR#3, Room 219; 700 S. Limestone St.; Lexington, Kentucky 40536; ph: (859)323-2618; fax: (859)257-3757 113 Combs; 800 Rose St.; Lexington, Kentucky 40536; ph: (859)323-2916; fax: (859)257-3757 BSTP SRF 317.1 Serial Number Sample Tracking System Page 6 of 7 _________________________________________________________________________________________________________ F. Printing labels for Chain of Custody forms. i. Follow steps A-E. ii. Print the appropriate number of no-code labels, (Example: Four for the necessary paperwork, one for the red top tube, and one for the purple top tube) and then all the necessary coded labels. G. What to do if the last serial number is unknown to ensure duplicate serial numbers are not created. i. Refer to the database and recent Chain of Custody Forms to find a range of the last few numbers used. ii. If you are unsure to within 10 serial numbers add 100 to the last known serial number, and document this in BSTP SRF 317.2 Serial Number Tracking Log. iii. If you are unsure to within 50 to 100 serial numbers add 500 to the last known serial number, and document this in BSTP SRF 317.2. iv. If you are unsure of anything more than 100 serial numbers add 1000 to the last known serial number, and document this in BSTP SRF 317.2. v. If you cannot find enough information to find a range of the last serial number used move up one character in the prefix of the serial number, and document this in BSTP SRF 317.2. a. If last known range was somewhere between A000000 and A006000 serial number will be B000000. XI. EXPECTED VALUES, INTERPRETATIONS/RESULTS/ ALERT VALUES and REFERENCE INTERVALS: A. N/A XII. METHOD PERFORMANCE SPECIFICATIONS: A. N/A June 25, 2012 University of Kentucky Hospital Markey Cancer Center Biospecimen Tissue Procurement Shared Resource Facility MDR#3, Room 219; 700 S. Limestone St.; Lexington, Kentucky 40536; ph: (859)323-2618; fax: (859)257-3757 113 Combs; 800 Rose St.; Lexington, Kentucky 40536; ph: (859)323-2916; fax: (859)257-3757 BSTP SRF 317.1 Serial Number Sample Tracking System Page 7 of 7 _________________________________________________________________________________________________________ XIII. REFERENCES: A. N/A XIV. ATTACHMENTS (Appendices, Forms, Labels, Tags, Tables): A. N/A XV. HISTORY BLOCK Replaces: Changes: Previous SOP number / revision; List the location and brief description of changes in this revision. For new procedures record “New”. XVI. APPROVAL BLOCK: Written by: Jesse Yannelli Approved by: __________________________ Director or Co-Director Date: 01/08/2010, 10/25/12 Date: ______________________________ Annual Review Medical Director: Date version removed from manual: Date procedure retired: June 25, 2012 Date:
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