Interlaboratory Data Management Software

Transcription

1 Interlaboratory Data Management Software

2 AN EFFECTIVE TOOL FOR EVALUATING LABORATORY PERFORMANCE The Randox Acusera range of quality controls is of the most accurate, stable and consistent on the market. As true third party controls, they are not designed or optimised for use with a specific reagent or instrument manufacturer, providing a true, unbiased assessment of laboratory performance. The use of internal quality controls is only the first step in improving analytical performance. The ability to interpret data and effectively monitor performance is essential in establishing and maintaining reliability, accuracy and precision. Randox s Acusera 24 7 is an Internal Quality Control (IQC) and peer group reporting package, designed primarily to complement and support the Acusera range of quality control sera. However, it can be used to monitor the performance of any internal quality control. An effective IQC and peer group reporting scheme like Acusera 24 7 will help improve your laboratory s analytical performance, help meet regulatory requirements and most importantly ensure the accuracy and reliability of patient test results. Acusera 24 7 enables laboratories to monitor analytical performance, access peer group reports and compare results with other laboratories using the same quality controls, method and instrument. Peer group data is updated every 24 hours giving you access to the most up-to-date information available. This is unique to the Randox Acusera 24 7 service. Acusera 24 7 web eliminates the need for local installation, reduces the need for frequent back ups and the amount of support necessary from on site IT staff, making it ideal for use in laboratory chains and groups. 2

3 WHY PARTICIPATE IN A PEER GROUP REPORTING PROGRAMME LIKE ACUSERA 24 7? Receive reliable information from a trustworthy source Acusera 24 7 peer group statistics are generated every 24 hours from up to 20,000 independent labs worldwide. This large number of participants ensures an extensive database of results for many analytical methods, assures validity and therefore increases confidence in your results. Identify any trends, system errors or reagent issues as soon as they arise Acusera 24 7 will allow you to detect and identify errors in your laboratory system thus minimising expensive repeats and unnecessary troubleshooting. By comparing your IQC results with peer group data you can identify problems that otherwise may have gone unnoticed and assess if shifts in QC recovery are unique to your laboratory. Access to peer group data may even alert you to future issues before they are encountered in your laboratory. QC multi-rules help minimise false rejections and maintain high error detection. Improve EQA/PT performance by eliminating any undetected bias Randox Acusera 24 7 is designed to support and complement your current EQA/PT scheme. External quality assessment is not performed on a daily basis but periodically, either bi-weekly or monthly with RIQAS, or less frequently with other EQA/PT schemes. Errors can occur at any time or at any point in the testing process and may go undetected until you receive your next EQA report. You may identify a problem when you receive your EQA report but when did the issue occur? 1 day ago, 1 week ago or just after your last EQA sample was tested? A well maintained internal quality control programme supplemented with a peer group reporting scheme like Acusera 24 7, is necessary to establish and maintain reliability, precision and accuracy. Acusera 24 7 can even provide comparison data for parameters that are unavailable in your current EQA programme. Have confidence in assigned target values Together with data extracted from over 20,000 participants on RIQAS (Randox International Quality Assessment Scheme), the Acusera 24 7 programme provides immediate confidence in assigned target values. Help your laboratory gain accreditation and meet regulatory requirements Laboratory managers are under increasing pressure to closely monitor laboratory test results and assure their quality due to growing demands from higher authorities for national and international accreditation. ISO states that laboratory management should monitor EQA results and implement corrective actions in situations were quality control criteria is not fulfilled. Good internal quality control procedures including peer group reporting and interlaboratory participation can help meet such requirements. Get an independent perspective Often manufacturers use the same raw materials in their reagents, quality controls and calibrators. As such there is an increased risk that a shift in patient results will go unnoticed as QC results appear fine. The combination of Randox third party quality controls and Acusera 24 7 peer group reporting software can reduce the potential for bias and provide a true assessment of analytical performance. Access peer group data 24 hours a day, seven days a week With Randox Acusera 24 7 peer group data is uniquely updated every 24 hours giving you access to the most up-to-date information available. This is extremely useful when troubleshooting performance issues and resolving them as soon as they occur. In addition to this, participation in a peer group reporting scheme may also improve EQA/PT performance as your results are more likely to compare well to other laboratories participating in the same scheme. 3

4 The Acusera 24 7 software is designed to be used as an extension to your laboratory s internal quality control procedures. Participation in an interlaboratory or peer group reporting programme is becoming increasingly compulsory in countries worldwide. It is encouraged by ISO and other accrediting bodies as it allows laboratories to assess relative accuracy when they are unable to measure trueness. In other countries where participation is not yet compulsory, there is a general drive towards it, as it is considered to be highly beneficial and cost effective. Good quality assurance is vital in reducing errors and ensuring confidence in patient results. A quality assurance package should incorporate all aspects of quality. Randox Laboratories Limited offers quality management solutions for: Internal Quality Control (control sera) - Acusera QC Peer Group Reporting Acusera 24 7 software External Quality Assessment RIQAS ISO outlines the requirements for quality and competence in medical laboratories; it concludes that clinical laboratories should participate in interlaboratory comparisons such as those organised by external quality assessment schemes, monitor results closely and implement corrective actions in situations were quality control criteria is not fulfilled. Good internal quality control procedures including peer group reporting and interlaboratory participation can help meet such requirements. 4

5 ACUSERA 24 7 WEB OVERVIEW Easy to set up No local installation required Eliminates the need to frequently update or back up software Different levels of user access Exceptional connectivity Acusera 24 7 connects directly to your instrument, LIS or middleware enabling automatic data import and eliminating the need to manually enter data Capture and analyse QC data economically from laboratory instruments not connected to the LIS using our connectivity solution Acusera 24 7 Connect Configurable to respond to QC data coming simultaneously from a variety of sources in a range of formats Advanced statistical analysis Set fixed means and/or SDs based on cumulative data, data from a particular time period or peer group data Enter expected responses for qualitative/ semiquantitative results Simple and intuitive user interface Upon opening the programme a dashboard interface is automatically displayed, visually showing any QC tests which have fallen outside performance limits in the last seven days The on-screen summary of results displays data for each QC run including SDI and rule violations in addition to cumulative and monthly stats for each lot of control in use Results that fall outside acceptable limits of performance are displayed in orange for alert and red when rejected allowing quick and easy identification Add comments and actions for each individual QC run to enable advanced data review Multi-lingual software Acusera 24 7 is available in several languages including English, Spanish, Italian, French, Portuguese, Chinese, Polish, Korean, Russian and Slovakian Quick and easy configuration Simplified configuration and set up All settings are automatically saved meaning you only have to programme once Customised user defined settings for analytes, instruments and reagent manufacturers Interactive charts Interactive Levey-Jennings and Histogram charts allow users to zoom in and look at specific data points in depth Combine multiple lots of control and/or multiple parameters on one easy to interpret chart to determine if the same trends are seen with more than one control or parameter Add actions or comments for advanced data review Comprehensive reports A comprehensive range of report formats is available with many more in development for exceptional data analysis and review Secure audit trail report Allows reconstruction of the course of events leading to creation, modification or deletion of a record Helps meet regulatory requirements Affiliate group reports enable lab groups or chains to directly compare their results with each other Inter-laboratory functions An extensive range of interlaboratory reports are available including the laboratory comparison report, performance summary charts and peer group statistics Unrivalled peer group review Peer group data is uniquely updated every 24 hours giving users rapid access to the most up to date information available 5

6 ACUSERA 24 7 REPORTS AND CHARTS Participation in Acusera 24 7 provides you with access to the following detailed charts and reports: Dashboard Page 7 On Screen Summary of Results Page 8 Interactive Levey-Jennings Charts Page 9 Interactive Multi Levey-Jennings Charts Page 10 Interactive Histogram Charts Pages Laboratory Performance Overview Page 13 Peer Group Statistics Page 14 Audit Trail Report Page 15 Laboratory Comparison Report Page 17 Exception Report Page 18 6

7 DASHBOARD INTERFACE The unique dashboard interface provides a rapid indication of poor performance The dashboard interface is a pre-defined homepage that is automatically displayed each time a user logs onto the software. The dashboard instantly brings any QC tests which have fallen outside the user-defined performance limits in the last seven days to the user s attention and provides an indication of any poor performing tests that require further investigation. 7

8 ON SCREEN SUMMARY OF RESULTS The on screen summary of results provides users with a visual overview of current analytical performance Acusera 24 7 will automatically calculate statistical data, including the mean and standard deviation. Data is presented in an easy to read format allowing any sudden or gradual changes in performance to be identified immediately. The summary provides both monthly and cumulative data and enables comparison to a user defined fixed mean and standard deviation. Each laboratory can set fixed values based on peer group statistics or other values such as the target and range quoted for the particular lot of control material in use. Results which are outside acceptable limits of performance are highlighted in orange for alert and red when rejected allowing for quick and easy identification. The system also provides users with a reason for the poor performance and indicates which rule has been violated. Users may add comments or actions enabling advanced data review. 8

9 INTERACTIVE LEVEY-JENNINGS CHARTS Identify trends, bias and precision problems at a glance using the fully interactive Levey-Jennings charts Two types of Levey-Jennings charts are available, one based on the standard deviation and the other based on percentage deviation. Each chart provides an instant visual indication of whether or not a test is performing well. Using the unique overview bar, laboratory staff can scroll through past data to look at previous trends or zoom in on a specific time period providing them with a more in depth look at performance. The interactive nature of the chart also allows users to add actions or comments, for advanced data review. The date and deviation from the mean is easily displayed by hovering over any of the data points, further information including the actual result obtained can be accessed simply by clicking on each individual data point. Depending on their preference users may choose to hide either the data points or the daily mean line. 9

10 INTERACTIVE LEVEY-JENNINGS CHARTS Combine multiple levels of control and or multiple parameters on the same chart Multiple data sets can be generated by simply combining results from multiple parameters, instruments or lot numbers on one easy to interpret chart. The ability to combine data for multiple levels of quality control on a single Levey-Jennings chart enables users to see if the same bias or the same trends are seen with more than one level of control. Whilst the ability to combine multiple parameters on the same chart enables users to check if the same level of bias or the same trends are seen across different parameters. 10

11 INTERACTIVE HISTOGRAM CHARTS The histogram displays your monthly mean for each parameter allowing any long term trends to be identified and corrected as soon as possible Like the Levey-Jennings chart the histogram can be based on either standard deviation or percentage deviation and provides a visual representation of a laboratory s performance. The histogram chart is extremely useful in identifying both shifts (abrupt changes) and trends (gradual changes over time) in your monthly results. Each bar on the chart represents a single calendar month. Like all charts the interactive nature of the histogram means users can zoom in on a specific month or time period for a more in depth look at performance. 11

12 INTERACTIVE HISTOGRAM CHARTS Display data for multiple levels of control and/or parameters on the same histogram chart Users can choose to display data for multiple levels of control and/or multiple parameters on the same histogram chart. The ability to display multiple data sets on a single chart enables laboratories to determine if the same shift in control values is seen between different levels of control or with more than one parameter. Like the Levey-Jennings charts actual data can be displayed by simply hovering over the bar relating to the month of interest. 12

13 LABORATORY PERFORMANCE OVERVIEW REPORT Performance summary charts allow cumulative and monthly data to be compared to a peer group based on world or affiliate group results The performance summary report highlights potential bias and imprecision issues, displaying your SDI on the y-axis and your CVI on the x-axis. Your laboratory s performance versus your chosen peer group and method peer group are plotted. Your cumulative or monthly results can be compared to world or affiliate group statistics enabling enhanced trouble shooting capabilities. Analytical performance can be quickly and easily interpreted by identifying where your result falls in the shaded region. 13

14 PEER GROUP STATISTICS Using Acusera 24 7 you can select the peer group statistics to which your results are compared Several options are available: All methods Method Method / Reagent Method / Instrument Model Methods / Instrument Model / Reagent Method / Instrument Group Method / Instrument Group / Reagent Peer group data can be customised so that laboratories can compare their performance either to their peers worldwide (world statistics) or to their peers in a selected affiliate group (group statistics). Group coordinators can view the performance of others in their group of affiliate laboratories. The peer group may be changed at any time and data can be viewed on the same screen allowing for easier troubleshooting. Acusera 24 7 peer group data is updated every 24 hours giving you access to the most up to date information available. This service is unique to Acusera

15 AUDIT TRAIL REPORT Providing high-quality statistical process control The audit trail report is a secure; computer generated electronic record showing all events relating to the creation, modification and deletion of an electronic record. The event list contains all auditable events that have been performed including date, time, lot, instrument ID, test, expiry, initials of operator, original value/setting, new value/setting and any comments entered. Regulatory bodies frequently require laboratories to document review of their QC data. Actions, comments and audit trails when used in combination provide laboratories with an effective way of documenting this. 15

16 LABORATORY COMPARISON REPORT The laboratory comparison report is available to laboratory groups or chains and enables results to be compared to those of their peer group and method consensus groups Method, instrument and group statistics are provided for each lot of control in use and each parameter tested. The report includes many vital statistics including the mean, Standard Deviation (SD), Percentage Coefficient of Variation (%CV), Standard Deviation Index (SDI) and Coefficient of Variation Index (CVI). 16

17 EXCEPTION REPORT Allows large laboratory chains or groups to view all analytes that exceed the pre defined SDI/CVR The exception report is ideal for quality control coordinators or laboratory managers who manage multiple laboratory sites or multiple instruments of the same make and model. The report is available on request and lists any analyte that exceeds the specified SDI or CVR warning limits compared to the consensus groups. Any analyte rejected by Acusera 24 7 is also listed for all laboratories within the affiliated laboratory group. Laboratory managers may also choose the frequency of the report. 17

18 FEATURES IN DEVELOPMENT Several new and exciting features are currently in development and will be available soon with Acusera 24 7 Web Analytical goals Imprecision-BV Total Error-BV Medical relevance State of the art QC Statistics Six sigma Total allowable error Total error Data Review Bench and supervisor reports Charts Youden charts Linearity charts Reports Statistical report Supervisor report Operator report Monthly evaluation report Data rejection report Bias and imprecision report Statistical profile report Manufacturer specific report Laboratory histogram report Improved functionality 30 day warning before a QC lot expires Registration and set up Rilibak functionality Westgard advisor 18

19 CONNECTIVITY SOLUTIONS FOR AUTOMATED UPLOAD OF DATA TO ACUSERA 24 7 Acusera 24 7 Connect is a fully automated connectivity solution designed to securely and efficiently import QC data from a laboratory s instrument, LIS or middleware to both Acusera 24 7 Web and Desktop services Eliminates the problems associated with manual data entry and the risks associated e.g. time and transcription errors Laboratories can continue to use standard LIS QC reports. Real time connection Flexible enabling automatic upload from a laboratory s instrument, LIS or middleware. The system is extremely secure capturing only the laboratory s QC data. Lab managers can be confident patient results will not be affected. Similar process to the flow of data to the LIS Analyser Acusera 24 7 Web 24 7 Analyser LIMs/LIS Acusera 24 7 Connect Acusera 24 7 Programme Acusera 24 7 Desktop Analyser Middleware Your Laboratory Process Automation QC Data Management The diagram above demonstrates the flow of QC data from a laboratory s instrument, middleware or LIS. There are three main modes; data top, direct connection and automatic import. Automatic import Ideal for laboratories were an exported QC file containing all required information is currently available from the analyser, LIMs or Middleware. The exported QC file is uploaded directly to Acusera 24 7 Connect. Data tap Ideal for laboratories where an analyser is connected to LIMs however the QC data available is incomplete. The data tap intercepts the transfer of data between the analyser and the LIMs separating the QC data and sending it to Acusera 24.7 Connect. Direct connection Suitable for laboratories with no LIMs connection. In this scenario all analysers will connect directly to Acusera 24.7 Connect. Site requirements: Network Connection QC file must contain date, time, lot number, test, instrument and result Site requirements: LIMs Connection Network Connection Site requirements: Network Connection 19

20 GLOSSARY OF TERMS Affiliate group A collection of laboratories or a laboratory chain grouped together on Acusera 24 7 to form a consensus group in order to receive specific affiliate group reports. Bias The term bias refers to the difference between the expected result and an accepted reference value. Coefficient of variation (CV) The coefficient of variation (CV) is the relative standard deviation i.e. the SD expressed as a percentage of the mean. The CV reflects a ratio of the standard deviation to the concentration level, and therefore provides a better estimate of method performance over a range of concentrations. Mean The arithmetic mean is calculated by dividing the sum of all results by the number of results. Your mean is presented as monthly or cumulative. The mean for comparison (MFC) is used to calculate performance statistics depending on the peer group you have chosen. Total error Total error represents the overall error that may occur in a test result due to both the imprecision (random error) and inaccuracy (systematic error) of the measurement procedure. It is commonly defined as; Total error = Bias + ZSD. Where bias is the estimate of systematic error, SD is the estimate of random error and Z is the multiplier that represents the desired confidence level. Total error biological variation Total error biological variation is a powerful tool used to set upper and lower limits of performance for each test based on total allowable error using biological variation data and the laboratories selected performance goals. Trend The term trend is used to describe a gradual change in QC results over time. Peer group A peer group consists of a number of laboratories using the same quality controls, methodology, instrument and reagents. Percentage deviation (% deviation) Your % deviation from the mean comparison. % Deviation = Result- MFC x 100%/MFC Precision Precision refers to the reproducibility of test results and is a measure of how disperse the values are. Shift The term shift is often used to describe an abrupt or sudden change in results. Standard deviation (SD) The standard deviation of a normal distribution is a measure of the scatter or dispersion of observations about the mean in the same units as the observations themselves. The standard deviation quantifies the degree of dispersion of data points around the mean. 20

21 PERFORMANCE STATISTICS Standard Deviation Index (SDI) The standard deviation Index (SDI) expresses the deviation of the participant s result (in SD units) from the mean. The SDI facilitates the comparison of results from different tests at the same time, without having to consider different units or magnitude of change. An average SDI of 1.0 or greater indicates that the test result shows a systematic difference from the group. The Ideal SDI is zero, which would be the case if your result exactly matched the peer group mean. SDI = Mean Peer Group Mean / SD of Peer Group Mean Coefficient of Variation Index (CVI) CVI is an indicator of your precision and is calculated by dividing your CV% by the peer group %CV. The ideal CVI is <1, which is obtained when your %CV is less then that of the peer group. CVI = CV / Peer Group CV 21

22 FAQs What is the speed? The speed depends on the laboratory s local network, internet connection and other activities utilising the bandwidth. How secure is Acusera 24 7? A number of security measures have been introduced since the launch of the new Acusera 24 7 web version. Security features include automatic lock out after several failed log in attempts, encrypted passwords, individual role based accounts and recorded IP addresses. Is any additional software required? Users must have access to a Java applet and have separate connectivity software. How is the web version upgraded? All new Acusera 24 7 releases will be available online automatically. Additional installation of software is not necessary. How much data can be stored? Data storage requirements will depend on the amount of QC data generated by the laboratory. At present approximately four million records required just 8GB of disc space. Users do not need to backup separately as Randox store all data securely. How do I register for the web version? Register interest via All participants will be registered on the host system; web users will be flagged and ed a link to provide administrator access. The administrator will then set up all other users with their access level, username and password. What if I forget my username or password? If an individual with user level or manager level access forgets their username and password they should contact the administrator. If an administrator or group coordinator forgets their username or password they should contact technical support who will verify the administrator and send a new link to the registered account. How often is peer group data updated? Peer group data is updated on a daily basis providing users with the latest performance data for their method or instrument. Is Acusera 24 7 available in any other languages? Yes, Acusera 24 7 is currently available in English, Spanish, Italian, French, Portuguese, Chinese, Polish, Korean, Russian and Slovakian. A unique software selection facility allows users to switch between languages if required. What if the connection goes down? If connection is lost from the laboratories side all data will be transferred to the web once reconnected, the previous session will be remembered. Emergency power generators and dual high speed lines are in place at Randox HQ to ensure 99.8% uptime is guaranteed. Is there a limitation to the number of concurrent users? There is no limitation to the number of concurrent users; different servers are located globally to minimise lag times. How many user levels are available? There are five user levels available; administrator, manager, user, coordinator and technical support. Coordinators will have access to all group data but cannot edit, delete or add any details. 22

23 ACUSERA 24 7 SOFTWARE AND CONNECTIVITY SOLUTIONS Randox offers two different solutions for participation in the Acusera 24 7 inter-laboratory data management programme. Acusera 24 7 Web eliminates the need to install and update software locally in your laboratory making it ideal for group installations while our Acusera 24 7 Desktop is suited to laboratories that do not have access to the internet or have a limited internet connection. The table below is designed to help you determine which solution is best for your laboratory. Type of Solution Acusera 24 7 Web Acusera 24 7 Desktop Web service (internet based) Desktop Software Platform Hosted by Randox Installed on PC Requirements Internet Connection (For Peer Group Stats) Connectivity Java applet Reports and Charts Summary of results Audit Trail Report Interactive Charts Levey Jennings Chart Multi Levey Jennings Chart Histogram Multi-Histogram Chart Youden Charts Due 2012 Linearity Charts Due 2012 Performance Summary Charts Peer Group Statistics Statistical Report * Supervisor Report * Operator Report * Bias and imprecision report Data rejection report * Manufacturer specific report * Monthly evaluation report * Affiliate Group Reports Analytical Goals Imprecision Biological Variation Due 2012 Total Error Biological variation Due 2012 Medical Relevance Due 2012 State of the Art Due 2012 Data Analysis * Show data points exceeding SDI, CVR, Bias%, TE, TEB% + Sigma * Evaluation mean and SD Use of % instead of fixed SD * Use of floating statistics to set a fixed mean or SD * Enter expected responses for qualitative/semi-quantitative results * QC statistics Six Sigma Due 2012 Total Allowable Error Due 2012 Total Error Due 2012 Registration and setup RiLiBAK functionality * Westgard Advisor * * Coming soon Please contact us if you would like further assistance or help deciding which solution is best for your laboratory 23

24 The Acusera range of third party controls covers over 300 routine and specialised parameters. Accurately target values Randox controls have the most accurately assigned target values and ranges available. This is made possible through access to a unique database of over 20, 000 independent laboratories. Unrivalled stability Randox lyophilised controls have a shelf life of up to four years eliminating the problems associated with changing lot number and enabling long term QC monitoring. The extended working stability of many controls means they will meet and often exceed stability expectations. Convenient and easy to use Many controls are available in liquid and liquid ready to use formats eliminating variability due to reconstitution errors. Highest quality material The Acusera range of lyophilised controls contain no added preservatives or stabilisers which can cause interference. Furthermore all controls for use with antibody based methods are made from 100% human serum providing a matrix similar to the patient sample. Consolidation With the Acusera range of multi-analyte controls you can dramatically reduce costs and the number of controls used in your laboratory by replacing multiple instrument specific controls with a single multi-analyser product. Most consistent material Adherence to strict manufacturing processes keeps variation between lots to a minimum. Clinical Chemistry Immunoassay Urine Chemistry Urinalysis Lipids Cardiac Immunology/Proteins Controls offering Coagulation Blood Gas Diabetes Therapeutic Drugs Toxicology Speciality/Research RANDOX INTERNATIONAL QUALITY ASSESSMENT SCHEME RIQAS is the largest global EQA scheme with over 20, 000 participants in more than 100 countries worldwide. Global accreditation to ISO/IEC Reduced parameter and reporting options available Comprehensive yet user friendly reports Reports available within hours of final submission date Blind samples covering clinically relevant concentrations Extensive analyte menu enabling significant programme consolidation Programmes offering Blood Gas Liquid Cardiac Cardiac Maternal Screening Clinical Chemistry Serology (EBV) Coagulation Serology (HIV-Hepatitis) Glycated Haemoglobin Serology (Syphilis) Haemataology Serology (ToRCH) Human Urine Specific Proteins Immunoassay Therapeutic Drugs Immunoassay Speciality I Urinalysis Immunoassay Speciality II Urine Toxicology Lipids Randox Laboratories Limited, 55 Diamond Road, Crumlin, County Antrim, BT29 4QY, United Kingdom T +44 (0) F +44 (0) E marketing@randox.com I LT244 JUN 12