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

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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

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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

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All rights reserved Siemens Healthcare Diagnostics / Global Marketing .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.

0 PRISCA 4.0 is a CE certified software application for Maternal Screening Risk Calculation for Trisomy 21.PRISCA 4. 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 ! IMMULITE® 2000 Immunoassay System Page 7 Feb-09 IMMULITE® 2000 XPi Immunoassay System IMMULITE® 1000 Immunoassay System Siemens Healthcare Diagnostics / Global Marketing .

All rights reserved Siemens Healthcare Diagnostics / Global Marketing .PRISCA Supports First Trimester Screening Approaches Combined with Ultrasound Measured at 9 weeks to 13 weeks and 6 days Free ß-hCG IMMULITE® Systems Pregnancy Associated Plasma Protein (PAPP-A) Gestational Age (Crown-Rump Length) Nuchal Translucency Page 8 Feb-09 © 2008 Siemens Healthcare Diagnostics.

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 .

Inhibin A) Gestational Age (Crown-Rump Length) Nuchal Translucency *Ability to enter Inhibin A results to enable quadruple testing requires PRISCA v 5. All rights reserved Siemens Healthcare Diagnostics / Global Marketing .PRISCA Supports Second Trimester Screening Approaches Combined with Ultrasound Double Test (AFP and hCG) Triple Test (AFP. and uE3) IMMULITE® Systems Quadruple* Test (AFP. uE3.0 (in development) Page 10 Feb-09 © 2008 Siemens Healthcare Diagnostics. hCG. hCG.

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 Siemens Healthcare Diagnostics / Global Marketing .

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 ß-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) Siemens Healthcare Diagnostics / Global Marketing Page 12 Feb-09 .

percentiles. confidence intervals  Interlaboratory Comparison IMMULITE  Individual lab with all other labs  Tabular and graphical visualisation Report Page 13 Feb-09 Siemens Healthcare Diagnostics / Global Marketing . standard deviations.Shared Database for Quality Management PRISCA E-Mail monthly Typolog merges  Basic statistics  Medians. regressions.

LIS 2. Data transfer from LIS to PRISCAConnect 3. Data transfer to PRISCA 5. Risk calculation 4. Bidirectional link instrument . Results transfer to LIS 4 PRISCA & PRISCAConnect 2 5 3 1 LIS Advantages: Safety Automation Efficiency Page 14 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .PRISCAConnect CE Software – A fully automated solution for risk assessment 1.

 All records without problems move into the OK records grid  Multiple options for validation  Validate OK records and send back to LIS.PRISCAConnect Validation  Newly calculated risks move into the validation grid. Page 15 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .

PRISCAConnect  All other records move to the Problem records grid.  Double-clicking a record gives further details about record Page 16 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .

PRISCAConnect Patient details  Patient details screen supports operator need for additional information during validation or investigation of problem records Page 17 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .

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 Siemens Healthcare Diagnostics / Global Marketing .

PRISCA Software Provides + Easy-to-Use Interface Flexibility Security Quality Control Automation For Your Prenatal Screening Program Page 19 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .

Easy-to-Use Interface Main Input Screen Demographics Ultra sound Biochemistry  1st trimester  2nd trimester Results Page 20 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .

Flexibility Page 21 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .

Flexibility – Selection of a screening protocol Select A Screening Protocol: • 1st trimester • 2nd trimester • Single tests • Combined Page 22 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .

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 Siemens Healthcare Diagnostics / Global Marketing .Flexibility .

Flexibility .Data overview page Searching Sorting Selecting Batch printing Historical reports Page 24 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .

User defined settings Adjustments to Local Conditions Are Possible:  Cut Off levels  Data ranges  Units  Language  Display formats Page 25 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .Flexibility .

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 Page 26 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .

Flexibility .Referring Physicians User-definable list of referring physicians Page 27 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .

Referring Physicians A report layout can be assigned to each of them Page 28 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .Flexibility .

Security – Auto Backup Program Automatic Backup Request During Each Program Termination Page 29 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .

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 Siemens Healthcare Diagnostics / Global Marketing .

Security . Page 31 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .Reports Archive Every printed report is archived automatically… …and can be restored.

Quality Control .Medians  IMMULITE 2000® medians are well established for Caucasian populations.  Page 33 Feb-09 Siemens Healthcare Diagnostics / Global Marketing . Medians can be entered automatically as an initial setup.

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 Siemens Healthcare Diagnostics / Global Marketing .

Page 35 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .Medians – Internal medians Medians can be calulated based on the user‘s 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 Page 36 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .

Quality Control .0 offers a Statistical Module with a Pre-defined List of Reports.  These Reports can be Loaded. Page 37 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .Statistics  PRISCA 4.

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 Siemens Healthcare Diagnostics / Global Marketing .

Statistics  High positive rates for certain physicians might indicate problems in determination of the gestation age – medians… Page 39 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .

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” Siemens Healthcare Diagnostics / Global Marketing .

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 Siemens Healthcare Diagnostics / Global Marketing .

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 Page 42 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .Coming Soon! PRISCA V.

0) PRISCA Connect Shared Database Assessment Automation Quality Management For Your Prenatal Screening Program Page 43 Feb-09 Siemens Healthcare Diagnostics / Global Marketing .PRISCA – Full Suite of Prenatal Risk Assessment Decision Support Software PRISCA Software (Version 4.