PRISCA Presentation

PRISCA Prenatal Risk Assessment*
Maternal Fetal Health Screening

Decision Support Tools for Calculating and Reporting of Maternal Screening Results
*Note: Available outside the US Only
Copyright Siemens AG 2009. All rights reserved.
IT Solutions From Siemens
OPENLink OPENLink NOVIUS Lab // TDX* // ServoLab* NOVIUS Lab TDX* ServoLab* EasyLink Informatics System EasyLink Informatics System ADVIA CentraLink ADVIA CentraLink RapidCOMM RapidCOMM Patient Patient Identification Check Identification Check SpecTRACK SpecTRACK EDI EDI GHX GHX
siemens.com/diagnostics siemens.com/diagnostics
Protis* Protis* PRISCA* PRISCA*
RTS RTS eLuminate eLuminate
Sample Management Solutions

* Products only available outside USA
Result Management Solutions
Quality Management Solutions
Instrument Management Solutions
Business Management Solutions
Page 2
Feb-09
Siemens Healthcare Diagnostics / Global Marketing
An Array of Supporting Services and Solutions
eBusiness Informatics PRISCA Cardiac / CQI Specialists
Consulting Industry Scholarships Continuing Education Service and Support
Page 3
Feb-09
Maternal Screening Requires Decision Support Software

ters Parame gram ing Pro es Screen al rang norm merous eeks of 1. Nu ous w for vari n gestatio ction s corre erou tient 2. Num d on pa base factors phics l ts, emogra d lab resu rates Incorpo tory, and 3. his patient d un ultraso lations k calcu tiple ris s 4. Mul rithm next nd algo a ermine ors det nts sk Fact 5 . Ri of patie care steps in
Page 4
Feb-09
PRISCA Integrates Data from Multiple Healthcare Sources to Provide a Consolidated Patient Report
Patient Demographics & Hospitals History

Page 5 Feb-09
Biochemical Laboratory Results
Ultrasound Measurements
2008 Siemens Healthcare Diagnostics. All rights reserved Siemens Healthcare Diagnostics / Global Marketing
PRISCA 4.0
PRISCA 4.0 is a CE certified software application for Maternal Screening Risk Calculation for Trisomy 21, Trisomy 18 and Neural Tube Defects. Feb-09 Page 6 Siemens Healthcare Diagnostics / Global Marketing
PRISCA Support For Siemens Immunoassay Systems
IMMULITE 2500 Immunoassay System
Co
s ng mi
n oo

Page 7 Feb-09
IMMULITE 2000 XPi Immunoassay System
PRISCA Supports First Trimester Screening Approaches Combined with Ultrasound
Measured at 9 weeks to 13 weeks and 6 days

Free -hCG
IMMULITE Systems
Pregnancy Associated Plasma Protein (PAPP-A)
Gestational Age (Crown-Rump Length)
Nuchal Translucency
Page 8
Feb-09
Nuchal Translucency Measurements Gestation 9-13 wks CRL 45-84 mm Mid-sagittal view Image size >75% Neutral position Away from amnion Maximum lucency Calipers on-to-on
Page 9 Feb-09 Siemens Healthcare Diagnostics / Global Marketing
PRISCA Supports Second Trimester Screening Approaches Combined with Ultrasound
Double Test (AFP and hCG)
Triple Test (AFP, hCG, and uE3)

IMMULITE Systems
Quadruple* Test (AFP, hCG, uE3, Inhibin A)
Gestational Age (Crown-Rump Length)
Nuchal Translucency
*Ability to enter Inhibin A results to enable quadruple testing requires PRISCA v 5.0 (in development)
Page 10
Feb-09
Why 1st Trimester or 2nd Trimester Screening?
2nd Trimester
Well-established correction factors Well-established algorithms Extensive databases Risks for Tr21, Tr18 and NTD Specimen stability
1st Trimester
Earlier in pregnancy Higher detection rate with NT Diagnostic Procedure by CVS Correction factors not well established Lacks NTD screen by AFP
Page 11
Feb-09
Summary of screening test performance
2001 2000 YEAR 1999 1998 1990 1980 1970
NT & Nasal Bone & 1st Trim Biochemistry
95%
NT & 1st Trim Biochemistry & 2nd Trim Quadruple Test 95% NT & Maternal Age & PAPP-A & free -hCG Quadruple Test (Triple & Inhibin) NT & Maternal Age Double Test Triple Test Maternal Age 35%
20 30 40 50 60 70 80 90
85%
75% 75%
65%
1st Trimester 2nd Trimester
100
Source: Various Literature Sources
% Detection Rate (5% FPR)

Page 12
Feb-09
Shared Database for Quality Management
PRISCA
E-Mail
monthly
Typolog
merges
Basic statistics
Medians, percentiles, regressions, standard deviations, confidence intervals
Interlaboratory Comparison
IMMULITE Individual lab with all other labs Tabular and graphical visualisation
Report
Page 13
Feb-09
PRISCAConnect CE Software A fully automated solution for risk assessment 1. Bidirectional link instrument - LIS 2. Data transfer from LIS to PRISCAConnect 3. Risk calculation 4. Data transfer to PRISCA 5. Results transfer to LIS 4 PRISCA & PRISCAConnect 2 5 3 1 LIS
Advantages: Safety Automation Efficiency

Page 14 Feb-09
PRISCAConnect Validation Newly calculated risks move into the validation grid. All records without problems move into the OK records grid Multiple options for validation Validate OK records and send back to LIS.
Page 15
Feb-09
PRISCAConnect
All other records move to the Problem records grid.
Double-clicking a record gives further details about record
Page 16
Feb-09
PRISCAConnect Patient details
Patient details screen supports operator need for additional information during validation or investigation of problem records
Page 17
Feb-09
PRISCAConnect Provides a New Level of Automation for Maternal Screening Programs

LIS Connectivity for automation of risk assessments Eliminates/minimizes manually entered data Reduces risk of error 1101010010111 Improves lab workflow and efficiency Improves labor efficiency Easy to use in daily routine Allows lab to send results to LIS for printing, archiving, and delivery to clinicians Customized flexibility for reporting CE certification
PRISCAConnect
1101010010111
Automation of Prenatal Risk Assessment Programs
Page 18
Feb-09
PRISCA Software Provides +
Easy-to-Use Interface Flexibility Security Quality Control Automation For Your Prenatal Screening Program
Easy-to-Use Interface Main Input Screen
Demographics Ultra sound Biochemistry 1st trimester 2nd trimester Results
Page 20
Feb-09
Flexibility
Page 21
Feb-09
Flexibility Selection of a screening protocol
Select A Screening Protocol:

1st trimester 2nd trimester Single tests Combined
Page 22
Feb-09
Flexibility - Determing the Gestation age

Gestation Age Determination By: CRL Robinson & Fleming Own table By BPD Hadlock Own table Scan date Sample date Delivery date Conception date LMP
Page 23
Feb-09
Flexibility - Data overview page
Searching Sorting Selecting Batch printing Historical reports
Page 24
Feb-09
Flexibility - User defined settings
Adjustments to Local Conditions Are Possible: Cut Off levels Data ranges Units Language Display formats
Page 25
Feb-09
Flexibility: Variety of Reports
19 Pre-defined Reports Available Different Default Report Settings for Different Doctors May be Assigned Special Reports Possible A Report Language Can Be Assigned to Each Referring Doctor
Flexibility - Referring Physicians
User-definable list of referring physicians
Page 27
Feb-09
Flexibility - Referring Physicians
A report layout can be assigned to each of them
Page 28
Feb-09
Security Auto Backup Program
Automatic Backup Request During Each Program Termination
Page 29
Feb-09
Security Password Access
Two Password Levels Superuser for Unlimited Access Users With Restricted Access Users List Can be Created Last Data Modification Assigned to Logged-In User
Page 30
Feb-09
Security - Reports Archive
Every printed report is archived automatically and can be restored.
Page 31
Feb-09
Quality Control - Medians

IMMULITE 2000 medians are well established for Caucasian populations. Medians can be entered automatically as an initial setup.
Page 33
Feb-09
Medians External medians

External medians can be entered manually Defined as regression constants Constants can be calculated With 3rd party products (SPSS, Excel) With Shared Database
Page 34
Feb-09
Medians Internal medians Medians can be calulated based on the users database Within certain date ranges Taking exclusion criteria into account Displaying percentiles and regression curves.
Medians Internal medians Tabular view of median calculation: Regression Percentiles Medians
Number of measurements
MoMs
Quality Control - Statistics PRISCA 4.0 offers a Statistical Module with a Pre-defined List of Reports. These Reports can be Loaded.
Page 37
Feb-09
Statistics
Control of the Median MoMs is an Early Warning System if There is a Shift in the Medians that needs Investigation
Page 38
Feb-09
Statistics
High positive rates for certain physicians might indicate problems in determination of the gestation age medians
Page 39
Feb-09
Statistics
Statistical reports are user configurable Example: We want to investigate the development of the mean maternal age. We select: Parameter = Age at delivery Date = (desired date range) Graph type = vertical bar Group = Monthly Calculation method = mean
Page 40 Feb-09
Click on RUN
Data export If Built-In Statistics Do Not Meet All of Your Needs? Patient data can be exported to MS EXCEL MS Word MS ACCESS SPSS Within certain date ranges With user definable columns For Special Investigation
Page 41
Feb-09
Coming Soon! PRISCA V. 5.0*

Correction for nasal bone assessment Added 2nd Trimester Quadruple Test More Flexible Center-Specific Medians Improved NT Sonography Quality Control More Flexible Determination of Gestational Age Shared Database Module Option
For Your Prenatal Screening Program

* In development
PRISCA Full Suite of Prenatal Risk Assessment Decision Support Software
PRISCA Software (Version 4.0)
PRISCA Connect
Shared Database
Assessment
Automation
Quality Management
For Your Prenatal Screening Program


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PRISCA Prenatal Risk Assessment*

Maternal Fetal Health Screening

*Note: Available outside the US Only

Copyright Siemens AG 2009. All rights reserved.

IT Solutions From Siemens

Protis* Protis* PRISCA* PRISCA*

RTS RTS eLuminate eLuminate

Sample Management Solutions

Result Management Solutions

Quality Management Solutions

Instrument Management Solutions

Business Management Solutions

Siemens Healthcare Diagnostics / Global Marketing

An Array of Supporting Services and Solutions

eBusiness Informatics PRISCA Cardiac / CQI Specialists

Consulting Industry Scholarships Continuing Education Service and Support

Siemens Healthcare Diagnostics / Global Marketing

Maternal Screening Requires Decision Support Software

Siemens Healthcare Diagnostics / Global Marketing

Patient Demographics & Hospitals History

Biochemical Laboratory Results

PRISCA Support For Siemens Immunoassay Systems

IMMULITE 2500 Immunoassay System

IMMULITE 2000 Immunoassay System

IMMULITE 2000 XPi Immunoassay System

IMMULITE 1000 Immunoassay System

Siemens Healthcare Diagnostics / Global Marketing

PRISCA Supports First Trimester Screening Approaches Combined with Ultrasound

Measured at 9 weeks to 13 weeks and 6 days

Pregnancy Associated Plasma Protein (PAPP-A)

Gestational Age (Crown-Rump Length)

PRISCA Supports Second Trimester Screening Approaches Combined with Ultrasound

Double Test (AFP and hCG)

Triple Test (AFP, hCG, and uE3)

Quadruple* Test (AFP, hCG, uE3, Inhibin A)

Gestational Age (Crown-Rump Length)

Why 1st Trimester or 2nd Trimester Screening?

Siemens Healthcare Diagnostics / Global Marketing

Summary of screening test performance

2001 2000 YEAR 1999 1998 1990 1980 1970

NT & Nasal Bone & 1st Trim Biochemistry

1st Trimester 2nd Trimester

Source: Various Literature Sources

% Detection Rate (5% FPR)

Shared Database for Quality Management

Siemens Healthcare Diagnostics / Global Marketing

Advantages: Safety Automation Efficiency

Siemens Healthcare Diagnostics / Global Marketing

Siemens Healthcare Diagnostics / Global Marketing

All other records move to the Problem records grid.

Double-clicking a record gives further details about record

Siemens Healthcare Diagnostics / Global Marketing

PRISCAConnect Patient details

Siemens Healthcare Diagnostics / Global Marketing

PRISCAConnect Provides a New Level of Automation for Maternal Screening Programs

Automation of Prenatal Risk Assessment Programs

Siemens Healthcare Diagnostics / Global Marketing

PRISCA Software Provides +

Easy-to-Use Interface Main Input Screen

Demographics Ultra sound Biochemistry 1st trimester 2nd trimester Results

Siemens Healthcare Diagnostics / Global Marketing

Siemens Healthcare Diagnostics / Global Marketing

Flexibility Selection of a screening protocol