Leader in. prenatal. data management. LifeCycle version 3.2. Brochure not for distribution in the USA

Transcription

1 Leader in prenatal data management LifeCycle version 3.2 Brochure not for distribution in the USA

2 LifeCycle TM version 3.2 Why LifeCycle? Because you can be confident in the reported results LifeCycle is capable of seeking out any possible bias in the medians. It monitors variations of median MoM trends (both by time and by gestational age) and provides users with prompt warnings if any issues arise. Further, it confirms that the MoM correction factors (e.g. smoking, weight and ethnicity) are accurate, and reports detection and false positive rates while checking how the average maternal age affects them. In this way, everything possible is done to assure integrity of the reported results. Because you can configure the software to your population With LifeCycle, all default algorithms and parameters are supported by published literature, but the program allows you to configure the risk calculation parameters to comply with national standards and guidelines. The Medians Tool, which forms part of the product, analyzes median data and proposes updates to the medians or weight correction formulas. Configuration to your population is the basis for good screening performance. Because you can use your data for research All LifeCycle data is stored on a long-term basis. To allow easy access there is a data mining tool to build and save specific queries. It is also easy to export any selected data for further statistical analysis. 2

3 more than a risk calculator Laboratories and clinics often concentrate on the risk calculation when they examine maternal health software products. However, there are many more functions needed to manage an effective maternal health program with software playing a role in each of them. Data entry Sample receiving Ultrasound entry Reporting Audit Risk calculation Results acceptance Workflow control Performance monitoring Outcome entry Instrument interfaces Data import/export and HL7 Quality assurance 3

4 Support all risk assessment strategies LifeCycle will give users the full flexibility of selecting the appropriate risk assessment process that best suits the pregnant mother s situation. Tracking the step-wise process may be a complex task; however LifeCycle provides users the tools to effectively manage this process delivering the desired screening services. All multi-step strategies are supported 1st trimester combined 2nd trimester triple and quad Integrated test Contingent test Stepwise sequential test Combining NT with 2nd trimester biochemistry Repeat measurements of analytes in the 1st and 2nd trimester Stay on track of the process With LifeCycle, users can define cutoffs for samples that indicate increased, borderline and low risks as well as create actions (e.g. request a new sample) for them. Furthermore, LifeCycle can automatically produce lists of outstanding requested patient samples as well as dates when ultrasound visits are scheduled. 4

5 LifeCycle expands the reporting capabilities User-configured texts on the patient report LifeCycle automatically generates user configured text and instructions to the report recipient that provides warnings if the marker profile indicates an adverse obstetrical outcome in addition to Down s syndrome. For example, a clinic may provide the message below if the PAPP-A MoM was less than 0.4. The PAPP-A result is <0.4 MoMs. In addition to Down s syndrome, this may be an indication of adverse obstetrical outcomes. Please follow up the pregnancy with a detailed obstetrical scan. LifeCycle also allows users to add free-text comments to the patient report based on criteria the laboratory deems appropriate. Utilize what-if application to analyze results LifeCycle includes a what-if module that allows users to analyze if markers or key demographic variables are causing the risk to be elevated. Without affecting saved values users have the ability to modify key variables and recalculate the risk in order to evaluate what effect (if any) new values may have on it. 5

6 New add-on product for LifeCycle 3.2 laboratories Ultrasound Software Interface Module Connect LifeCycle to Laboratory Information Systems Now available for LifeCycle 3.2, an Add-On HL7 Interface Module that allows direct communications with ultrasound applications and Laboratory Information Systems as a means to send and receive data. The default configuration provides a link to Astraia, FMF certified ultrasound application; however the module can also communicate with other applications with configuration services available from PerkinElmer. The interface module allows patient information and/or results processed through LifeCycle 3.2 to be sent to an ultrasound application or Laboratory Information System for final risk calculation or reporting. This module provides increased efficiency and flexibility by allowing data to be entered just once, with seamless communication and subsequent utilization by other applications. Features guide Feature Elipse risk calculation engine Configurable risk calculation parameters Benefit Report risks for Down s syndrome (T21), Edwards syndrome (T18), Patau s syndrome (T13), neural tube defects, Turner s syndrome, Triploidy, SLOS and CdLS-Cornelia de Lange syndrome Ability to adapt the software to national recommendations Ability to add new clinically validated markers Ability to change the CRL and other gestation dating formulas Use virtually any equation option to find the optimal estimation of normal medians (e.g. 2nd order log-polynomial for AFP, ue3 and hcg, 4th order log-polynomial for free beta hcg, non-log for PAPP-A, reciprocal for weight correction etc.) Default parameters are based on a published meta-analysis, but can be changed to accord with other publications 6

7 Feature Includes Medians Tool and MoM performance monitoring reports Benefit Calculate and change medians to match the local variations Identify and react quickly to drift in the normal median values Prove confidence in the reported results Outcome follow-up and reports to monitor the detection and false positive rates Validate the risk assessment program. Record details of anomalies or adverse obstetrical outcomes and compare them against the reported risks. Find out reasons for unexpected false positive rates, e.g. average maternal age Responsive and open database design including a query and data mining tool Store and retrieve patient history on a long-term basis Define database queries and exports for advanced statistics and research Step-by-step process control tool Ensure that all daily tasks get followed through Ensure that the requested 2nd samples (e.g. in contingent testing) are received Save time when processing information in batches Sample tracking Have an audit trail of all actions and decisions made Have proof that the process was followed for every patient Multiple entry forms with data validation rules Simplify the data entry process by having a separate entry form for the scientist, data entry clerk and outcome entry Improve the data quality by checking the data before saving Ability to purchase a service to modify the entry forms to match the requisition form HL7 Interface Module (sold separately) Advanced technical flexibility Save time on data entry by utilizing available interfaces that communicate with ultrasound applications and laboratory information systems for easily importing demographic data and exporting results Scalable from a single computer to a multi-user, client-server system Optional multi-site architecture for centralized quality assurance, sharing of information, calculation of medians and other parameters, and performance monitoring from combined data 7

8 LifeCycle has a global support and user network PerkinElmer prenatal software in use. For additional information about PerkinElmer products, please visit our web site: Specific information on Elipse risk assessment engine also available at: All PerkinElmer products may not be available in all countries. For information and availability, please contact your local representative or go to our web site. PerkinElmer, Inc. PerkinElmer, Inc. 940 Winter Street wallac Oy Waltham, MA usa po Box 10 Phone: (800) or Turku, Finland (+1) phone: fax: For a complete listing of our global offices, visit PerkinElmer, Inc. All rights reserved. PerkinElmer is a registered trademark of PerkinElmer, Inc. All other trademarks depicted are the property of their respective holders or owners. PerkinElmer reserves the right to change this document at any time and disclaims liability for editorial, pictorial or typographical errors , May 2011 P printed in Finland