BD EpiCenter™- Integrating Technology

Informatics

History

• Launch of BD EpiCenter October 2000

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What did we achieve so far? • Amount of installations – More than 600 EpiCenter installations in Europe • Connected instruments – Almost 1000 instruments are connected • Connections to LIS companies – EpiCenter is connected to more than 50 different LIS systems • Software releases – Approx. two software releases per year including new features

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What is BD EpiCenter ? – Microbiology Data Management Software designed to • Improve the microbiology testing process • Enhance microbiology result quality • Conduct statistical / epidemiological analysis – BD EpiCenter Software can be directly interfaced to • BD BACTEC™ • BD MGIT™ • BD Phoenix ™ • BD INNOVA ™ • Bruker Biotyper™ • and the LIS system Informatics

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Microbiology Challenges

Analyze

Availability of skilled microbiologists

Maldi-Tof BACTEC

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Control Costs: Staff & Patient management

Enhance Communicate Workflow Monitor

• Expertized Results • Customizable Expert Rules • Reporting & Epidemiology

Changing microbiology and greater complexity

Integrate

EpiCenter

Physician/Patient need for rapid microbiology

Phoenix MGIT

• Proactive Alerts • Alert Distribution • Multi-User Access • LIS Reporting

Manual LIS

Monitor & Integrate

Clinical Relevance

Lab Efficiency

• How can EpiCenter help you? – Monitor BD instrument platforms in real time, from any location in or outside the institution – Anywhere, anytime access to Instrument Status, Test Status, Test Details, Patient History. – Reduces bottlenecks with access and data entry from multiple locations across the laboratory. – EpiCenter provides a single interface to Laboratory Information Systems (LIS) for all instruments

– Comprehensive Reporting across Patient, Specimen and Test data – Patient Test History – Integrate data from multiple platforms and manual tests (E-Test, Kirby-Bauer) to a single microbiology-focused database

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FX Multiple Workgroup* Integration EpiServer Room A

Workgroup #3* Hospital Local Area Network (LAN)

EpiClient #1 Room B

Workgroup #1

EpiClient #2 Room C

Workgroup #2*

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EpiCenter Integration

Hospital Network

Lab Information System (LIS)

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EpiCenter Integration MALDI-TOF ID from positive BD BACTEC™ blood cultures in minutes, using the Bruker MALDI Sepsityper™ kit. ID to the … and Biotyper traced back Organisms from MALDI ID automatically integrated source, a positive BD can be linked to BD into EpiCenter database BACTEC™ bottle Phoenix™ susceptibilities…

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Microbiology Challenges

Analyze

Availability of skilled microbiologists

Maldi-Tof BACTEC

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Control Costs: Staff & Patient management

Enhance Communicate Workflow Monitor

• Expertized Results • Customizable Expert Rules • Reporting & Epidemiology

Changing microbiology and greater complexity

Integrate

EpiCenter

Physician/Patient need for rapid microbiology

Phoenix MGIT

• Proactive Alerts • Alert Distribution • Multi-User Access • LIS Reporting

Manual LIS

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Analyze & Communicate

Clinical Relevance

Lab Efficiency

• How can EpiCenter help you? –

Optimize Technician Result Review

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Ready to use reports for MALDI, Phoenix and BACTEC systems

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Expert systems for automated result evaluation & correction Proactive Alert Generation from user-defined criteria

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Improved Quality of Results

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Provide Quality Assurance and Result Consistency

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Deliver Meaningful Information in a Timely Manner for faster Clinical Decision Making

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Supporting a paperless workflow Workflow reports, Surveillance reports, Epidemiology Reports, Performance Reports

Automatically analyze test result data in context of patient and specimen attributes Implement lab-specific quality assurance protocols using advanced customizable expert rules Communicate results directly to LIS systems Message distribution of alert messages to the correct person or location, using hospital network and e-mail

Flexible custom reports allow sophisticated epidemiological analysis of microbiology data

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Workflow Efficiency •

How can EpiCenter help you?

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Workflow optimization in pre-analytical activities, test automation and post analytical investigations.

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Front End support for Laboratory Workflow – Remote Instrument Management – Technician Efficiency – Automated Communication – Reporting Tools

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Back End support for Managers – Better Data Analysis and Faster Reporting – Provides data to address performance improvements – Serve internal customers better

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Epicenter – LIS interface •

Fully Bi-directional Interface – Using ASTM protocols

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Real time communication

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Customisable uploads and downloads – You decide what and when

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Epicenter – LIS interface •

Download from the LIS to the EpiCenter system: – Patient and specimen demographic records – Isolate information – Test orders (and results) – LIS can also download request for specific information to Epicenter that would cause EpiCenter to upload the requested information.

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Upload from the EpiCenter to the LIS: – Test results (both manual and instrumented tests) – Isolate information – Demographic records – Epicenter can also upload requests for specific information to the LIS that would cause the LIS to download the requested information.

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The Value of BD EpiCenter™ Data Management •

Monitor and Integrate – Seamless Integration of MALDI Biotyper, Phoenix & BACTEC results

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Analyze and Communicate – Leverage EUCAST and Lab-Specific Expert System – Automated Quality Assurance – Automated Result Review support – Automated alerts directed to responsible HCP

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Workflow Automation – Front end support for more efficient sample processing – Improved Sample Integrity – Rapid ID and Automated Critical Alerts to speed up intervention – Back end Data Analysis Flexibility (e.g. Real-time Antibiogram)

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EpiCenter Modules •

EpiCenter RTU (ready to use) – – –

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EpiCenter PLUS – – –

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Additional ability to create custom reports using tools included in the system Store and report additional data from other test methods Epidemiology and Surveillance filter package

EpiCARE – –

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stand alone or interfaces BD instruments to the LIS system Expert System including interpretation rule and recommendations from EUCAST, CLSI and SFM Predefined report menu

Open expert system allowing creation of customized rules Automated alerting reporting and modification of results provided by the PHX system

Multi-User –

Ability to deploy EC on multiple computers using the existing facility network

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Sentinel

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Barcode Label Printing

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Enables lab to send alerts to clinicians using EC workstations or via e-mails, mobile phones,…

Offers the opportunity to print barcode labels for BD or non-BD consumables

TB eXiST –

2nd line drugs AST testing for Mycobacteria

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BD EpiCenterTM – EpiCARE Module Clinical Application Rule Editor • advanced EpiCenter module • allows to build customized rules • based on isolate results • „IF ... THEN ... ELSE“ structure

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BD EpiCenterTM – BD Sentinel Module @ Message Distribution Module “Sentinel” • only with EpiCARE module • to send system messages (alerts) to specific EpiCenter workstations in-/outside the lab • different sound files can be configured • send alert email to specific persons (via defined rule) • ... may be sent to multiple email addresses • generate reports on a specific printer on the LAN

Hospital LAN server

EpiCenter client

client

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BD EpiCenterTM … Helps to Speed Up Your Sepsis Time-To-Report BACTEC Room

TB Lab

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EpiCenter Client

EpiCenter Server

Lab Network (TCP/IP)

Blood Culture/Varia Lab

Gram stain / Rapid ID EpiCenter Client

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Lab Manager

EpiCenter Client

Video 1 Video 2

Communicate Automated Alerts

Hospital Network

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BD EpiCenterTM – Solutions for the Customer Needs ID/AST

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New ID / AST Offer What • Full ID/AST solution integrating BD Phoenix™ and Bruker microflex™ via BD EpiCenter™, optionally using the BD Phoenix AP™. • Six Sigma and Lean approach. • Full EUCAST compliance.

How • Co-Marketing agreement between BD and Bruker Daltonics. • Direct instrument interface between BD EpiCenter™ and the Bruker MALDI Biotyper software. • Full integration of MALDI ID and BD Phoenix™ AST into the BD EpiCenter™ BDXpert™ system. • The Bruker Biotyper, BD Phoenix™ and BD BACTEC™ integration via BD EpiCenter™ provides the most complete state-of-the-art system for all microbiology laboratories.

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BD EpiCenterTM – EUCAST European Committee on Antibiotic Susceptibility Testing • organized by ESCMID and european national breakpoint committees • agreed on a model for harmonizing breakpoints in Europe • wt MIC‘s accessible via internet for specific drug / bug combinations • based on European data collection

www.eucast.org Informatics

Implementation of EUCAST standard in the BD Phoenix™ / BD Epicenter™ System • Monitoring of EUCAST committee activities initiated as of 2005 • Release of first set of EUCAST compliant panels in Nov 2008 • Release of complete EUCAST standard breakpoints and rules April 2009 • Current software incorporates April 2010 EUCAST update • BD is committed to release yearly updates of all the standards included in the BDXpert System (EUCAST, CLSI, SFM) • Current portfolio of EUCAST compliant panels includes 14 Gramnegative and 7 Gram-positive panels.

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Evaluations of Phoenix/Epicenter System® System® ECCMID 2009, Helsinki •

EUCAST breakpoints in automated susceptibility testing of Gram-positive bacteria BD PhoenixTM validated. R. Smyth, S. Bengtsson, G. Kahlmeter, G. Babini, E. Montrucchio

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EUCAST breakpoints in automated susceptibility testing of Gram-negative bacteria BD PhoenixTM validated. R. Smyth, S. Bengtsson, G. Kahlmeter, G. Babini, E. Montrucchio

ECCMID 2010, Vienna: – Evaluation of performances of the Phoenix automated system in the antimicrobial susceptibility testing using EUCAST breakpoints (Abstr. 2590). T. Giani, V. Conte, M.M. D'Andrea, G.M. Rossolini* (Siena, IT) – Assessment of the Phoenix system and EUCAST breakpoints for antimicrobial susceptibility testing against contemporary isolates expressing relevant resistance mechanisms (Abstr. 1680). M.I. Morosini, M. García-Castillo*, R. Cantón (Madrid, ES) – Implementation of EUCAST rules in the Phoenix/Epicenter System® Prof. R.Leclercq, Microbiology, University-Hospital Caen, France (presented at the BD booth)

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BD Phoenix AP™

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BD EpiCenterTM – Barcode Printing Module Barcode Printing • print accession barcodes for lab consumables • automatic or manual printout • routing by Specimen Type / Patient Name • batch printout • accession no., patient name, patient ID, specimen type, test name, isolate no • barcode on the specimen lab report • printer and paper can be ordered via BD

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BD Phoenix™ AST 136 Panel • Full 136 wells dedicated to AST only. • Strong combination with MALDI ID. • Phoenix AP ready to prepare the inoculum for the AST 136 panels. • Completing the BD Phoenix™ panel offer: ID/AST, AST 85, AST 136

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BD and Bruker Daltonics Co-Marketing Advantages Workflow ID / AST • The BD EpiCenter™ will enhance the Biotyper workflow, integrate Organism ID with BD Phoenix™ antimicrobial susceptibility results and speed-up result review and reporting.

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BD and Bruker Daltonics Co-Marketing Advantages Direct ID from Pos Blood Cultures • Organisms from positive BD BACTEC™ bottles Identified by the MALDI-TOF Bruker microflex™ can be linked to BD Phoenix™ susceptibility results and interpreted by the BDXpert™ system.

+ BACTEC FX

Direct ID

Direct AST

MALDI

Optionally via Phoenix AP

EpiCenter

Phoenix Informatics

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ID/AST Offer Overview • • •

MALDI for ID Phoenix for AST Integrated Informatics via BD EpiCenter™

Benefit: – – – –

Faster Time to Result Direct ID from pos Blood Culture Lab Efficiency and Economy Huge database (>2000 taxa)

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Sample Workflow – Process Overview

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MALDI Biotyper ID Results on EpiCenter • MALDI ID results automatically transferred to EpiCenter

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MALDI Biotyper ID Results on EpiCenter …Details • Top 10 MALDI ID results displayed read-only on EpiCenter “Test” tab. • Top 1 MALDI ID above the Biotyper Probability Threshold automatically reported as EpiCenter “MALDI Biotyper ID” result. • If no ID is “+” or better then the organism ID is “Unspecified”. • MALDI Quality indicators reported according to Biotyper thresholds.

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MALDI Biotyper ID Results …Consistency Check • If more than one ID is “+” or better, Biotyper evaluates the consistency:  A: Species Consistency  B: Genus Consistency  C: No Consistency • Consistency A or B yield the top 1 organism. • Consistency C will yield an “Unspecified” organism.

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AST Results • Phoenix AST automatically merged to the isolate result in EpiCenter.

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BD EpiCenterTM – Solutions for the Customer Needs TB eXiST

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BD EpiCenterTM – TB eXiST eXtended individual drug Susceptibility Testing • Extended time to test (MGIT AST 4-13 days, TB eXiST up to 56 days) • Extended testing after Growth Control flagged positive • Flexible 2nd line drug choice • Up to 9 concentrations per drug • Launched in Europe 2008 TBeX_GC

TBeX_3_RA_ 10.0

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BD EpiCenterTM – TB eXiST Plot

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BD Blood Volume Monitoring Tool (BVM) •

The implementation of an automated blood volume tracking process is a way to retain in compliance with existing accreditation guidelines while also improving effectiveness in detecting bacteria in blood.

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The EpiCenter BVM Module is designed for use with BD BACTEC FX™ instruments to provide the Customer calculated information on how much blood was drawn prior to incubation of the BACTEC blood culture bottles.

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EpiCenter will provide four predefined Blood Volume Statistical Reports.

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BVM Sample Report – Blood Volume Summary – Data Sheet of means with total number of bottles grouped by Hospital Service, Client ID, Collected by, Specimen type, body site or ungrouped.

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BVM Sample Report – Box Plot – Box Plot of Blood Volume by Ward.

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BVM Sample Report – Blood Volume Plot of Means –

Plot of mean data over time with a 95% confidence interval.

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BVM Sample Report – Graphical Count of Bottles and Volume – Number of bottles collected at each blood volume grouped by Hospital Service, Client ID, Collected By, or ungrouped.

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Questions ?

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