This is the ninth version of the popular EP Evaluator^® method evaluation software package, first release for DOS in 1991, and for Windows in 1999. Unlike other laboratory statistics programs, EP Evaluator^® was designed by a board-certified clinical chemist specifically to meet the needs of the clinical laboratory ― including connectivity, network support, 21 CFR Part 11 compliance, built-in backup/restore, ability to copy data to/from spreadsheets, and, above all, well-designed professional reports, ready to sign and file. View Sample Reports. View Brochure and Price List.

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CLIA
‘88 CAP JCAHO EE
Online EE9
CLIA EE9
Stnd EE9
Stnd+DC
EE9
Pro

   Accuracy and Linearity

         Clinical Linearity, Calibration Verification and
                  Reportable Range

         Simple Accuracy     Simple Accuracy determines accuracy for those systems where the specimen concentrations are specified as a range.

         CLSI EP6 Linearity CLSI EP6 Linearity - Linearity according to the CLSI model.

   Method Comparison

         Alternate (Routine Quantitative)

         CLSI EP9 Method Comparison   CLSI EP9 Method Comparison: Implements CLSI EP9A. A statistically rugged procedure often used for submissions to regulatory agencies.

         Two Instrument Comparison        Two Instrument Comparison: Compares two instruments without using linear regression. Specifically designed for semi-annual instrument harmonization process.

         Multiple Instrument Comparison

         Qualitative / Semi-Quantitative

         POC Glucose   POC Glucose: Compares POC glucose results to those from a laboratory instrument. Implements both Clarke and Consensus diagrams.

         Hematology Studies   Hematology Studies: Compares both CBC and Diff parameters for multiple instruments. Optionally may assess clinical sensitivity.

   Precision

         Simple Precision   Simple Precision: Calculates simple mean, SD and related statistics. Optionally detects outliers.

         CLSI EP5 Precision CLSI EP5 Precision: A statistically rugged algorithm for calculating within-run, between-run, between-day and total precision.

   Reference Interval

         Establish    Establish: Uses 2 or 3 different approaches to calculate a normal range (central 95% interval). Includes CLSI C28-A.

         Verify    Verify: Verifies normal range.

         ROC Plots    ROC Plots: From test results and gold-standard diagnosis, calculates cut-off values for tests like Troponin. Determines diagnostic effectiveness of test. Implements CLSI GP10.

   Sensitivity

         Limits of Blank (Analytical) *    Sensitivity - Limits of Blank (Analytical): Calculates lowest concentration significantly different from zero.

         Limits of Quantitation (Functional) *    Sensitivity - Limits of Quantitation (Functional): Calculates lowest concentration which is quantitatively reliable.

   Lab Management

         Cost Per Test    Cost Per Test: Calculates cost per test based on costs of supplies, labor, equipment, etc.

         Incident Tracking    Incident Tracking: Tracks lab errors and incidents for quality improvement reasons.

         Inventory Management    Inventory Management: Provides for tracking receipt and dispensation of laboratory supplies.

         Competency Assessment    Competency Assessment will provide for assessing competency through asking questions and tracking various measures of competency assessment for individuals.

   INR

         Geometric Mean and VRI    Geometric Mean and VRI: Calculates geometric mean and verifies reference interval for PT and INR results.

         Method Comparison    Method Comparison: Compares both PT and INR for two methods.

         Manual INR Check    Manual INR Check: Validates the INR calculation.

   Other

         Performance Standards (TEa)    Performance Standards (TEa): Calculates total allowable error from several different criteria.

         Carryover    Carryover: Calculates specimen to specimen carryover.

         CLSI EP10 - Preliminary Evaluation

         Interference (CLSI EP7) *   Interference (CLSI EP7): Determines maximum concentration of a specimen interferent that will produce a clinically acceptable result.

         Six Sigma Metrics   Six Sigma Metrics: Determines if method meets criteria for Six Sigma performance using bias and precision statistics.

         Average of Normals (Checks Bias)   Average of Normals: Tracks median value of all patient results in order to detect changes in method bias.

         Stability   Stability: Assesses the stability of specimens or reagents over time in a specified storage condition.

         Histogram and Descriptive Stats

   Additional Features

         Data Extraction from Instrument Manager™

         Project Management   Project Management: Implements ability to create and manage unlimited new projects and to archive old data.

         Audit Trail and Network Security   DAudit Trail and Network Security: “Professional Version” Features that satisfy 21 CFR Part 11 regulations for audit trail, and limits program or project access via password protection to authorized users.

         Data Capture from Instruments   Data Capture from Instruments: Capability of capturing data directly from interfaced instruments directly into many EE modules.

Required by regulatory legislation or organization

* Evidence can be provided from vendor or laboratory

Implements Eight CLSI Protocols

• EP5-A, Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline
• EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
• EP9-A, Method Comparison and Bias Estimation using Patient Samples; Approved Guideline
• EP12-A, User Protocol for Evaluation of Qualitative Test Performance--Approved Guideline
• C28-A2, How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline
• GP10-A, Assessment of the Clinical Accuracy of Laboratory Tests using Receiver Operating Characteristic (ROC) Plots; Approved Guideline
• EP10-A, Preliminary Evaluation of Clinical Chemistry Methods; Approved Guideline
• EP7-A, Interference Testing in Clinical Chemistry--Approved Guideline

System Requirements

32 bit Windows –Works with Windows 98 and higher, including Vista. Most EE9 features (except serial data capture) will work on Intel Macs if the Crossover program is used.
Processor (CPU) speed: 300 MHz or greater.
Hard disk space requirements: The size of the application before data has been entered is about 30 MB.
Printer output may go to any local or network device supported by an appropriate Windows printer driver.
Networks: Both the executables and the database are installed on the server under the same folder. Access is provided via an icon on user’s desktop. The database engine is included in the executable.