IMMULITE/Dimension/Stratus CS Control Migration
What is the Siemens Quality Control Material Migration project?
Siemens Healthcare Diagnostics and Bio-Rad Laboratories, Inc. have expanded their global joint marketing agreement under which Bio-Rad will sell its quality control products and Unity™ Quality Control (QC) data management solutions to Siemens IMMULITE® Immunoassay Systems, RIA, Dimension® Integrated Chemistry Systems, and Dimension Vista® Intelligent Lab System customers. This move extends clinical laboratorians access to consistent control materials and data management tools within the Siemens laboratory systems portfolio which, until now, only included the ADVIA® Chemistry and ADVIA Centaur® Immunoassay systems.
Through this agreement, all Siemens Immunoassay and Chemistry systems can now use the same portfolio of Bio-Rad and Siemens controls. This reduces the number of controls that your laboratory must manage. In conjunction with this, three IMMULITE and RIA controls, CON6, Tumor Marker, and Cardiac will be discontinued and inventory is expected to be depleted by April 1, 2012 (Dimension Control Info Tab, Table 1). Specific DADE® controls used with Dimension and Dimension Vista systems will also be discontinued. The list of DADE® controls that will be discontinued, as well as the expected inventory depletion dates, is provided in the Dimension Control Info tab, Table 1.
What is Siemens' history with Bio-Rad?
The Siemens/Bio-Rad joint marketing agreement was a first in which an instrument manufacturer and a third-party control manufacturer worked together for the benefit of the customer. Traditionally, instrument manufacturers have their own controls for internal processes and external assay qualifications. While customers understand the benefits of third-party controls, they frequently have to utilize the instrument manufacturer’s controls when validating and troubleshooting assays and instrumentation. Customers are forced to choose between a quality control system that is not connected to the assay calibrators, and a control system that has been validated by the instrument manufacturer.
The Siemens/Bio-Rad expanded agreement continues to overcome this traditional and cumbersome paradigm. During 2011, Siemens validated Bio-Rad labeled controls on our IMMULITE systems and incorporated them into our manufacturing, installation, and troubleshooting processes. Siemens customers are able to purchase controls from a company which specializes in controls and InterLaboratory Quality Control (ILQC) solutions, and still follow the instrument manufacturer’s recommendations for quality.
Through this expanded agreement, Siemens recommends that customers partner with a company whose quality control products are used in 70% of the marketplace and that has one of the world’s largest quality control comparison groups.
Siemens customers are able to join with an excellent quality control manufacturer that is committed to expanding their options for quality products and management.
What are Portfolio Quality Control Materials?
For the first time, with the new Bio-Rad extended agreement, Siemens is able to offer customers the same commercially available quality control materials for our portfolio of ADVIA, Dimension, and IMMULITE instrument platforms.
Will all IMMULITE/RIA QC materials be migrated to Bio-Rad commercially available controls?
Only three IMMULITE and RIA controls: CON6, Tumor Maker (TMCO) and Cardiac Marker (CC) controls - will be migrated. Siemens proprietary controls will still be manufactured and sold by Siemens. For the most up-to-date list see Tables 1, 2 and 3 under the IMMULITE Control Information section.
What about Dimension, Dimension Vista, and Stratus CS systems customers using DADE® Controls?
Siemens Dimension, Dimension Vista, and Stratus CS systems U.S. customers have been primarily using thrid-party control materials and Siemens-labeled controls for which there is not a third-party control available or where a Siemens labeled control is required for regulatory reasons. This will continue.
However, the majority of Siemens Dimension, Dimension Vista, and Stratus CS systems customers outside of the US have either All Inclusive (consumables supplied by Siemens at a fixed price) or Cost Per Result (CPR, a fixed price for each reported result) contracts in which control materials are provided. Bio-Rad controls will be substituted for the DADE® controls or the Thermo-Fisher (MAS) controls in these contracts.
The Dimension/Stratus Control info tab provides lists of DADE discontinued controls as well as the Dimension, Dimension Vista, and Stratus CS controls that will continue to be available.
What are the Siemens-labeled controls that will still be manufactured and sold by Siemens?
For the most up-to-date list of Siemens-labeled IMMULITE, RIA, Dimension, Dimension Vista, and Stratus CS controls, see tabs above.
What are Portfolio Data Management Solutions?
By collaborating with Bio-Rad, Siemens customers will be offered the same QC data management services for our portfolio of ADVIA, IMMULITE, Dimension, Dimension Vista, and Stratus CS instrument platforms.
What is Bio-Rad's Unity™ InterLaboratory Peer Data Management Reporting Program?
Bio-Rad's Unity™ InterLaboratory Peer Data Management Reporting Program is a database in which participating quality control users worldwide (over 15,000 Siemens customers) can report and compare QC results. This helps to increase confidence in proficiency results by identifying trends or shifts that may occur between proficiency surveys, and reduce costs.
How do I enroll in Bio-Rad's Unity™ InterLaboratory Peer Data Management Reporting Program?
How soon will Siemens customers be expected to migrate to the Bio-Rad controls?
Customers can start migrating to Bio-Rad controls immediately.
CON6, TMCO, and CC will be discontinued and inventory is expected to be depleted by April 1, 2012.
Specific DADE® controls will also be discontinued. Expected inventory depletion dates for the these controls are provided on the Dimension Control tab above, Table 1.
Is there a plan to convert the All Inclusive and CPR contracts?
Yes, each Siemens Country Commercial Organization will manage the conversion of their All Inclusive and CPR contract customers. This will be completed by March 2012.
What about new All Inclusive and CPR contracts?
Effective immediately, every new All Inclusive and CPR contract will be written to designate Bio-Rad controls instead of IMMULITE and RIA CON6, Tumor Marker (TMCO) and Cardiac Marker (CC) controls or DADE controls or the Thermo-Fisher (MAS) controls
Who will investigate control complaints?
The Siemens/Bio-Rad partnership will ensure Siemens customers are fully supported by either Siemens, Bio-Rad, or both to address their needs.
Why is Siemens making this change?
Based on extensive customer research, Siemens determined that customers want to use the same quality control materials and data management solutions across multiple Siemens platforms to improve workflow in the laboratory. The Bio-Rad collaboration achieves this goal by leveraging the expertise of a company whose quality control products are used in 70% of the marketplace and that has one of the world's largest quality control comparison groups.
If Bio-Rad does not have a specific representative in a/my country how can they be contacted?
How do I convert to Bio-Rad controls?
To proceed with your control conversion, please contact your local Bio-Rad representative or distributor. Siemens recommends that you allow sufficient time for the conversion.
How will I troubleshoot my QC, when the Siemens controls are no longer available?
Your local Bio-Rad Customer Service Center will assist you. Additionally, through participation in Bio-Rad’s Unity InterLaboratory Program, you may access the Bio-Rad website at www.qcnet.com to locate the data appropriate for your lot of Bio-Rad control. In addition, you can continue to contact Siemens for questions related to Siemens products and services.
To view the Siemens/Bio-Rad brochure, worldwide Bio-Rad contact information, and information on equivalent Bio-Rad controls, go to: www.siemens.com/diagnostics-controlbrochure
I have more questions on the migration, whom can I contact?
Contact your local Siemens or Bio-Rad representative, who will be happy to help you.