ISBT 128 Labels for CT
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1 ISBT 128 Labels for CT Implementation: System Design, Development, Changes, and Challenges: Part Deux Kathryn M. Bushnell Technical Specialist Cellular Therapy Center
2 WORKSHOP OBJECTIVES Provide information regarding global implementation of ISBT 128 Labeling for CT Products Identify areas of global discussion which influence decisions regarding a formal implementation date Review updates to the ISBT 128 Standard Familiarize the attendee with product code selection through product scenario exercises Discuss specific questions regarding system operation and labeling applications Review an ongoing implementation process to include system design, development, changes, and challenges
3 SYSTEM IMPLEMENTATION A cellular therapy facility will share their experience of ISBT 128 Labeling System design, development and implementation with the audience. Specific components for discussion will include software updates and improvements, label format changes, label examples and implementation target timelines and outcomes. System and Implementation challenges will also be addressed.
4 First An Apology!
5 396 inpatient bed capacity tertiary care center Level 1 Trauma Center NCI Designated Comprehensive Cancer Center Inpatient Oncology Care unit 28 beds, 9 designated for BMT patients
6 Blood and Marrow Transplant Program Cellular Therapy Center Transfusion Medicine Blood Bank Blood Donor Program
7 Implementation process Intro to ISBT128 Outline project timeline Review terminology Map-up the process, identify correct S codes Software Select ISBT128 compliant software Select stand-alone vs. mainframe Validation Validation of the software/printers Validation of the labels stock/content Implement the system Z. Szczepiorkowski 2009
8 Implementation process Intro to ISBT128 Outline project timeline Review terminology Map-up the process, identify correct S codes Software Select ISBT128 compliant software Select stand-alone vs. mainframe Validation Validation of the software/printers Validation of the labels stock/content Implement the system Z. Szczepiorkowski 2009
9 Intro to ISBT128 Outline Project Timeline Jan 2007 ISBT Implementation Plan drawn up. Team members drafted, roles defined Medical Director of Transfusion Medicine LIS Specialist for Transfusion Medicine Transfusion Medicine Safety Officer Transfusion Medicine Supervisor Blood Donor Program Asst Supervisor Cellular Therapy Specialist
10 Intro to ISBT128 Outline Project Timeline Plan called for implementation of ISBT 128 labeling in all DHMC locations concurrent with upgrade to Cerner Millennium LIS. The Conversion of the Cellular Therapy Center to ISBT 128 will occur concurrently with the full ISBT implementation in other Transfusion Medicine Service Sections
11 Intro to ISBT128 Outline Project Timeline ISBT 128 for blood products has been now mandatory for almost a year. Our Blood Bank Software was initially able to only accept ISBT128 labeled blood products but eventually (June 2008) was upgraded to generate ISBT128 labels for blood products. Subsequently, our Blood Donor Program moved to ISBT128 labels (October 2008) with a new release of its software.
12 Intro to ISBT128 Outline Project Timeline May 2010 Full ISBT 128 implementation in the CTC is still pending What happened? Being part of a traditional lab is a blessing and curse. If you are lucky, you get swept along with everyone for improvements. If you are unlucky, you struggle to fit your products into their systems.
13 Intro to ISBT128 Outline Project Timeline ISBT 128 (Blood Bank) ISBT 128 (BDP) ISBT 128 (CTC) Blood products (number / label) Cellular Therapy Products (number) Terminology Number Full label
14 Intro to ISBT128 Review Terminology Standard Terminology for Blood, Cellular Therapy, and Tissue Product Descriptions For Use with Product Description Code Database Version 3.37 May 2010
15 Intro to ISBT128 Map up the Process, Identify correct S codes Codes selected 5/2009 to validate: S1129, S1177, S1186, S1183, S1181, S1167, S1166, S1194, S1196, S1297, S1298, S1134, S1219, S1221, S1188, S1179, S1185, S1299, S1301, S1302 Codes still applicable from those selected: S1129, S1177, S1186, S1183, S1181, S1167, S1166, S1194, S1196, S1297, S1298, S1134, S1219, S1221, S1188, S1179, S1185, S1299, S1301, S1302
16 Intro to ISBT128 Map up the Process, Identify correct S codes Try to weed out the obvious codes that won t apply, e.g. 3 rd party components Other additives Concentration of DMSO (5% or 10%) Storage temperature (-150⁰C or -120⁰C) Products you don t use (MSCs, Pooled Products)
17 Implementation process Intro to ISBT128 Outline project timeline Review terminology Map-up the process, identify correct S codes Software Select ISBT128 compliant software Select stand-alone vs. mainframe Validation Validation of the software/printers Validation of the labels stock/content Implement the system Z. Szczepiorkowski 2009
18 Software Select ISBT 128 Compliant Software Stand alone or LIS integrated label printing Vendors listed on ICCBBA website. Evaluated 2 and went with Digi-trax HemaTrax CT v.2 coming out soon we are a beta test site
19 Software Select ISBT 128 Compliant Software Vendors listed on ICCBBA website for Cellular Therapy Labeling -Chek-Lab, Inc. -Computype, Inc. ** -Data2 Corporation -Digi-Trax Corporation** -HealthCare Products International, Inc. -Inlog International S.A.S. -Mediware Information Systems, Inc. -Medservice Sp. z o.o. -Niceware International, LLC -Pall Medical -Shamrock Scientific Specialty Systems, Inc. -Zebra Technologies Corporation **Exhibitors
20 Software Stand alone vs. primary system Manufacturer A Large Blood Bank Software Company Significant Delays in Introduction of S codes (not yet available) Future updates (likely in July 2009) will have S codes as part of the release Recently dropped blood donor program module Manufacturer X Stand alone label making company Willing to work with the laboratory (beta site) Responsive to identified issues during the implementation process Z. Szczepiorkowski 2009
21 Software HemaTrax CT v.1
22 Software HemaTrax CT v.2
23 Software HemaTrax v.2 Changes Added a tabbed interface instead of switching from form to form. Selecting labels is now done through a dropdown menu.
24 Implementation process Intro to ISBT128 Outline project timeline Review terminology Map-up the process, identify correct S codes Software Select ISBT128 compliant software Select stand-alone vs. mainframe Validation Validation of the software/printers Validation of the labels stock/content Implement the system Z. Szczepiorkowski 2009
25 Validation Validation of the Software/Printers Validation plan drafted 5/2009
26 Validation Validation of the Label Stock/Content Storage for 1 week in a liquid nitrogen freezer (Label A) Storage for 1 week in the 37 0 C CO 2 incubator (Label B) After 30 minutes in a 37 0 C water bath (Label C) Storage for 48 hours at C (Label D) Storage for 24 hours at C (Label E)
27 Validation Validation of the Label Stock/Content
28 Validation Validation of the Label Stock/Content Results Label Stock Validation for Manufacturer X-CT ISBT Labeling System Label A Label B Label C Label D Label E Is the label firmly attached to the bag with no evidence of peeling? yes yes yes yes Yes Is all of the handwritten information clearly visible on the bag? yes yes yes yes Yes Is all of the handwritten information present in a non-smudged condition? yes yes yes yes No Is there any evidence of portions of the written information flaking off the label? no no no no No If you run your finger over the handwriting does it remain clear and unaltered without evidence of smudging or flaking? no no no no No Is all the printed information on the label present in a non-smudged condition? yes yes yes yes yes Is there any evidence of any of the printed information flaking off the label? no no no no no If you run your finger over the printed information does it remain clear and unaltered without evidence of smudging or flaking? yes yes yes yes yes Can the following barcode be read correctly? yes yes yes yes yes DIN W W W W W ABORh Type Product code (HPC, Apheresis with Citrate at RT) <S <S <S <S <S
29 Validation Implement the System Cerner Millennium v.18 has cellular therapy terminology. We were set to implement upgrade and the lab postponed it. Without the upgrade we can t implement ISBT 128 labeling.
30 Validation Implement the System CT labs not required to print ISBT labels yet ISBT terminology is required by FACT and AABB >350 Codes already generated for CT products users have the ability to request new codes
31 Small Cell Therapy Group Survey 1. Are you using ISBT 128 labels for cellular therapy products? NO 2. Which Vendor did you choose? DIGITRAX 3. Any specific reasons why you went with one company over another? BLOOD BANK PREFERENCE AND WHAT WAS AVAILABLE TO WORK WITH OUR LIS 4. Which label sizes do you use? BB USES THE 4 x 4. I HAVE 4x4 AND 1.5x1.5 LABELS IN WAITING. I HAVE NOT FOUND VIAL LABELS YET 5. Do you use the label for cryovials? NO 6. How did you validate the labels? VISUAL CONFIRMATION WITH A REQUIRED DATA CHECKLIST (IN BB) 7. Did you discover any major issues during validation of the system? THERE ARE A TON OF ISBT CATEGORIES FOR CELLS. IT WAS HARD TO NARROW DOWN TO WHAT I WILL BE USING
32 Small Cell Therapy Group Survey cont. 1. Are your labels tied in with a Laboratory information system? If so, which one and what version are you running? YES WE ARE ON SUNQUEST Do you use label verification with your LIS? IT IS NOT INTEGRATED WITH SUNQUEST YET. OUR DIGITRAX IS FREE STANDING 3. If you aren't using ISBT 128 labels yet - what is the reason? IT TOOK SO LONG FOR ICCBBA TO PUBLISH THE LIST OF CT PRODUCTS THAT OUR CONTRACT WITH DIGITRAX EXPIRED FOR CELL THERAPY. WE ARE NOW WAITING A BUDGET RENEWAL OF THIS COST. NOT SURE HOW LONG BEFORE WE MAY BE APPROVED IN THIS CURRENT ECONOMIC CLIMATE. ALSO, WE ARE NO LONGER AN NMDP COLLECTION SITE SO SHIPPING PRODUCTS IS NOT AN ISSUE WHICH WAS PARTIALLY SUPPORTING MY REQUEST FOR THE SYSTEM. 4. Is there anything in particular you would like addressed in the ISCT presentation? WHAT ISSUES ARE HOLDING UP THE NATIONAL ARC FROM GOING FORWARD?
33 Helpful Links Small Cell Therapy Lab Google Group ICCBBA Cellular Therapy Home Page
34 Thanks! Zbigniew Ziggy M Szczepiorkowski, MD, PhD, FCAP Miriam Fogg Leach, MSAI, MT(ASCP)SBB, BSIS,QLI Jeff Dragoo, Sales Engineer, Digi-Trax Corporation
35
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