Release 11 - The Standard for Quality Assurance software designed to evaluate and measure the clinical laboratory performance and provide clear, concise, 'inspector-ready' reports to meet all CLIA '88, CAP, JCAHO  and COFRAC requirements.  EP Evaluator® was designed by a board-certified clinical chemist specifically to meet the needs of the clinical laboratory and is used by more laboratories and more invitro diagnostics (IVD) companies than any other software of its kind. 

Additional Information
 

 
 

 


Version Comparisons

  CLIA
‘88
CAP TJC COFRAC  EE
Online
EE
CLIA
EE
COFRAC
EE
Stnd
EE
Pro
   Accuracy and Linearity                      
         Clinical Linearity, Calibration Verification and
              Reportable Range                               
   check mark check mark  check mark check mark  
         Simple Accuracy    question mark     check mark check mark check mark      
         CLSI EP6 Linearity   question mark          
         Trueness   question mark            
   Method Comparison                                          
         Alternate (Routine Quantitative)    question mark   check mark check mark check mark
         CLSI EP9 Method Comparison    question mark   check mark check mark        
         Two Instrument Comparison       check mark   check mark check mark check mark
         Multiple Instrument Comparison   check mark   check mark check mark check mark    
         Qualitative / Semi-Quantitative  check mark   check mark check mark    
         POC Glucose  check mark    check mark check mark        
         Hematology Studies  question mark   check mark check mark        
   Precision                                                                         
         Simple Precision  check mark check mark check mark check mark check mark
         CLSI EP5 Precision  check mark check mark check mark check mark        
   Reference Interval                             
         Establish   check mark check mark check mark check mark check mark    
         Verify   check mark check mark check mark check mark check mark
         ROC Plots   check mark            
   Sensitivity                                              
         Limits of Blank (Analytical) *   check mark check mark check mark check mark check mark  
         Limits of Quantitation (Functional) *   check mark check mark check mark check mark      
   Lab Management                  
         Cost Per Test   check mark              
         Incident Tracking   check mark              
         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.              
   Coagulation                  
         Geometric Mean and VRI   Geometric Mean and VRI: Calculates geometric mean and verifies reference interval for PT and INR results.              
         PT/INR Method Comparison   Method Comparison: Compares both PT and INR for two methods.              
         Manual INR Check   Manual INR Check: Validates the INR calculation.            
         Factor Sensitivity (FS)  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.       check mark  
         CLSI EP10 - Preliminary Evaluation  CLSI EP10 - Preliminary Evaluation: Determines linearity, precision, accuracy, carryover and drift, using 50 results assayed over 5 days.        
         Interference (CLSI EP7) *  Interference (CLSI EP7): Determines maximum concentration of a specimen interferent that will produce a clinically acceptable result. check mark      
         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.       check mark    
         Histogram and Descriptive Stats  Histogram and Descriptive Stats: Calculates a variety of statistical parameters for a dataset that describe the mean (or central tendency) and SD (dispersion).              
   Additional Features                  
         Composite Reporting  Data Extraction from Instrument Manager™: Capability of extracting data directly from instrument Manager via ODBC directly into many EE modules.            
         Data Extraction from Middleware  Data Extraction from Instrument Manager™: Capability of extracting data directly from instrument Manager via ODBC directly into many EE modules.                
         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.                

  Required by regulatory legislation or organization   Optional by regulatory legislation or organization
   
Items in red indicate changes in EE Release 11
   * 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 

  Operating System

Windows XP (32-bit)
Windows 7 (32-bit and 64-bit)
Windows Server 2008 (64-bit)

   Memory A minimum of 128 MB of RAM for the application
   Hard Disk

Minimum of 200 MB for non-network, single user implement
Minimum of 1 GB for networked, multi-user  implementation

   Other

Monitor (1024 x 768 minimum resolution), Keyboard, Mouse and
local or networked Printer
Adobe Acrobat Reader or compatible program