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BD EpiCenter™- Integrating Technology

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History

October 2000

• Launch of BD EpiCenter

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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

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InformaticsMaldi-Tof BACTEC Phoenix MGIT Manual LIS

Inte

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Microbiology Challenges

Mo

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Enhance Workflow

Physician/Patient need for rapid microbiology

Control Costs: Staff & Patient management

Availability of skilled

microbiologists

Changing microbiology and

greater complexity• Expertized Results

• Customizable Expert Rules

• Reporting & Epidemiology

Analyze Communicate

• Proactive Alerts• Alert Distribution

• Multi-User Access

• LIS Reporting

EpiCenter

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• 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

Monitor & Integrate

Clin

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Lab

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– 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

EpiClient #1

Room B

EpiClient #2

Room CWorkgroup #1 Workgroup #2*

Hospital Local Area Network (LAN)

Workgroup #3*

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EpiCenter Integration

Hospital Network Lab Information System (LIS)

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EpiCenter IntegrationMALDI-TOF ID from positive BD BACTEC™ blood cultures in minutes, using the Bruker Sepsityper™ kit.MALDI Biotyper ID

automatically integrated into EpiCenter database

Organisms from MALDI ID can be linked to BD Phoenix™ susceptibilities…

… and traced back to the source, a positive BD BACTEC™ bottle

InformaticsMaldi-Tof BACTEC Phoenix MGIT Manual LIS

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Microbiology Challenges

Mo

nit

or

Enhance Workflow

Physician/Patient need for rapid microbiology

Control Costs: Staff & Patient management

Availability of skilled

microbiologists

Changing microbiology and

greater complexity• Expertized Results

• Customizable Expert Rules

• Reporting & Epidemiology

Analyze Communicate

• Proactive Alerts• Alert Distribution

• Multi-User Access

• LIS Reporting

EpiCenter

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Analyze & Communicate

– Improved Quality of Results• Automatically analyze test result data in context of patient and specimen attributes

– Provide Quality Assurance and Result Consistency • Implement lab-specific quality assurance protocols using advanced customizable expert rules

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

Clin

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Lab

Effi

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cy• How can EpiCenter help you?

– Optimize Technician Result Review• Supporting a paperless workflow

– Ready to use reports for MALDI, Phoenix and BACTEC systems• Workflow reports, Surveillance reports, Epidemiology Reports, Performance Reports

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

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Workflow Efficiency

• How can EpiCenter help you?

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

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

• 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

• Real time communication

• 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.

• 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

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

• 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)

– 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

• EpiCenter PLUS– 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– 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

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

• Barcode Label Printing– 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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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

BD EpiCenterTM – BD Sentinel Module

server

clientclient

EpiCenter

Hospital LAN

@

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BACTEC Room

Lab Network (TCP/IP)

TB Lab

EpiCenter Server

Lab ManagerBlood Culture/Varia Lab

EpiCenter Client

Gram stain /Rapid ID

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

EpiCenter Client

EpiCenter Client

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Video 1 Video 2

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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 OfferWhat• 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 systemfor all microbiology laboratories.

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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.orgwww.eucast.org

BD EpiCenterTM – EUCAST

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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 Gram-negative and 7 Gram-positive panels.

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Evaluations of Phoenix/Epicenter SystemEvaluations of Phoenix/Epicenter 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

• 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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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

BD EpiCenterTM – Barcode Printing Module

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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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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.

BD and Bruker Daltonics Co-Marketing Advantages

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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.

BD and Bruker Daltonics Co-Marketing Advantages

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BACTEC FX

Direct ID

MALDI

EpiCenter

Phoenix

Direct ASTOptionally viaPhoenix AP

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• MALDI for ID

• Phoenix for AST

• Integrated Informatics via BD EpiCenter™

ID/AST Offer Overview

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:

• Consistency A or B yield the top 1 organism.• Consistency C will yield an “Unspecified” organism.

A: Species Consistency B: Genus Consistency C: No Consistency

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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 eXiSTeXtended 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.

• 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.

• EpiCenter will provide four predefined Blood Volume Statistical Reports.

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

BVM Sample Report – Blood Volume Summary

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– Box Plot of Blood Volume by Ward.

BVM Sample Report – Box Plot

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

BVM Sample Report – Blood Volume Plot of Means

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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 ?