Calidad y Trazabilidad Leica XL SEAP 2017 - Curso de Preanalitica 24 Febrero 2017

Leica Biosystems Our Mission Advancing cancer diagnostics, Improving lives

Because time is of the essence… Consult Biopsy AP Lab Diagnosis Consult Don’t wait another day Aligning and integrating the workflow to enable same day diagnosis

Striving towards Vision24 Enabling clinicians to efficiently provide patients a highly confident diagnosis within 24-hours from biopsy

Beginning to end integration A holistic system-wide approach to the lab Service & Support from beginning to end Biopsy Preanalytics Primary Staining IHC/ISH Imaging Diagnosis 1. Only company to own the workflow from biopsy to diagnosis 3. Enabling control of the lab through IT solutions 2. Dedicated consumables for our instruments

CEREBRO and APiQ software solutions Unleashing productivity and innovation Improved sample tracking and traceability with CEREBRO APiQ unified device management across the lab Manage inventory and control costs with APiQ Data-driven decisions to improve control and productivity

Protect Their Health, and Your Reputation Scanning the item ID actively verifies critical case details and securely links each patient to all case items Active verification warns if operator is linking wrong slide or cassette to a case Documenting the process and chain of custody Track steps as the sample moves through the laboratory Increasing accountability Each scan records who, what, when and where

Impact of Sample Tracking 450 Asset Tracking 400 Wrong Stain 350 Slide Missing (Recut) Slides Mislabelled 300 Cassettes Missing Cassette Mislabelled 250 No entry of Cassette 200 150 100 50 Nov 08 Dec 08 Jan 09 Feb 09 Mar 09 Apr 09 May 09 Jun 09 Jul 09 Aug 09 Sep 09 Oct 09 Nov 09 Dec 09 Jan 10 Feb 10 Mar 10 Apr 10 May 10 Jun 10 Jul 10 Aug 10 Source: John H Sinnard, MD, PhD. Pathology Informatics, Yale School of Medicine, 2010, Pathology Informatics, “Histology asset tracking dashboard: Real-time monitoring and dynamic work lists” , pp 17-18

Impact of Sample Tracking – Reduced Risk Before CEREBRO 3 months using CEREBRO Accessioning Grossing Embedding 6 months using CEREBRO Microtomy Send out Error risk assessment Since installing CEREBRO (Dec 2012), Pathlab laboratories has reported no incidents or issues. They attribute this great result to the consistently great safety and quality control data provided by the CEREBRO system. These results are exceptional in comparison to industry averages presented in the study by Nakhleh et al. 2011. This level of performance is achieved with rigorous procedures and very high standards of quality tracking. Source: Corinne Hill, BSc MSc, Lead for Histology from Pathology Associates Ltd, Pathology Leaders Webinar: Patient Specimen Safety in the Modern Histology Lab, September 12 2013, Online

Powerful, Yet Easy to Use and Learn Add cassettes or slides Edit Case Add Note Add no. of Tissue Un-use and re-use item Print item Counters for grossed and all samples Case information Printed and loaded cassette Container for grossed samples Unread note attached to the cassette Grossed sample Container for loaded cassettes Unloaded routine slide Counters showing loaded and all cassettes Unloaded charged slides for advanced staining

Highly Visual and Informative

Increased Flexibility UNIVERSAL ACCESSIONING GROSSING TISSUE EMBEDDING SECTIONING STAINING SEND-OUT REPORTING Extend tracking to any corner of your laboratory with the Universal workstation. Now you can track specimens at archival, cryosectioning and many other operations PROCESSING ADDITIONAL FIXATION DECALCIFICATION FROZEN SECTION SAMPLE STORAGE SLIDE ARCHIVAL TRACKING REFFERED CASES DELIVERY TO PATHOLOGIST Automated stainers (BOND, H&E, Special) Manual staining and non-connected instruments

Configure CEREBRO to Your Tracking Needs Skip existing or add new tracking steps Accession Gross Decal Process Embed Section Stain Release Diagnose Archive Order Scan & track Print Order Scan & Scan & Scan & match track Scan & track track Print Order Scan & Scan & Scan & Scan & Scan & match track track track track Print

Accessioning Works seamlessly with or without LIS feed Associate lab-specific unique ID to case Structure cases via panels Option to print request forms and container labels Option to batch print slides, slide labels and/or cassettes 17” touch screen PC with keyboard and mouse, barcode scanner, label printer, choice of printing options

Grossing Scan container to start printing cassettes or use batch printed cassettes Scan cassette to verify correct “loading” of tissue View/set the number of tissue pieces loaded View/add notes and special instructions Option to assign samples to temporary storage Option to assign blocks to tissue processing basket for easy tracking of processing step Compact 12” touch screen PC, barcode scanner, flexible mounting arm, choice of printing options

Tissue Processing Scan the processor and select the processing desciption Scan the basket to assign all cassettes to the run in one go or scan individual cassettes in or out of the run as needed CEREBRO checks the protocol description against the cassette and warns about potential mismatch View/add notes and special instructions Counters to show completed/remaining work Compact 12” touch screen PC, wireless barcode scanner, flexible mounting arm

Embedding Scan cassettes to embed Number of cassettes per case displayed View/add notes and special instructions on screen Counters to show completed/remaining work Work within the context of tissue processing basket Compact 12” touch screen PC, barcode scanner, flexible mounting arm Summary of the embedding module main features In summary, you scan your cassettes to embed. The number of cassettes for that case is displayed with any associated notes or instructions. A counter shows that progress of that case through embedding. This workflow gives security to confirm that you have the correct sample.

Sectioning Scan cassette to start printing slides (or slide labels) or use batch printed ones Scan slide to verify correct tissue “loading” View/add notes, special instructions and number of tissue pieces loaded Counters show completed/remaining work Option to assign sectioned blocks to temporary storage Option to assign slides to rack for tracking of manual staining step Compact 12” touch screen PC, barcode scanner, flexible mounting arm, choice of printing options

Staining with Connected Instruments Connect CEREBRO to Leica BOND and 3rd party instruments Eliminate redundant data entry and related errors No re-labeling or sorting needed Instrument uses the barcode to link it to the staining information from CEREBRO Skilled staff freed for more valuable tasks Maximize your laboratory’s workflow efficiency Customizable uni- or bi-directional HL7 messaging interface based on available instrument interfacing options

Staining Station Track manual staining and non-connected instruments Scan a tray to assign all slides to the run, alternatively scan individual slides in or out of the run as needed CEREBRO checks the protocol assignment against the slide and warns of any potential mismatch View/add notes and special instructions Counters show completed/remaining work Compact 12” touch screen PC, wireless barcode scanner, flexible mounting arm

Send-out Visual representation of slide status within a case Rapid assignment to a pathologist Simultaneous slide release across multiple cases View/add notes and special instructions Use case history for troubleshooting 17” touch screen PC with keyboard and mouse, barcode scanner, flexible mounting arm Summary of Send-Out feature set. In summary, there is strong visual representation of slide status within a case, rapid assignment of cases to a pathologist, and send out across multiple cases, including partial cases. That concludes the overview of the 5 key clients for the CEREBRO product, moving through the workflow from end to end, accessioning to sign out.

Universal Station Track virtually any step in the workflow Potential application include: Tracking non-standard workflow such as additional fixation or decalcification Sample storage and disposal after grossing Block and slide archival Slides and blocks sent for referral 12” compact touch screen PC, barcode scanner, flexible mounting arm

Administration System configuration module Tests, test panels Tissue, procedure, section, processing descriptions Cassette and slide types Containers and locations Label designer Users and access rights LIS Connectivity configuration CEREBRO admin, laboratory/IT admin. Only a single instance is required Included in every installation 58

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