Laboratory Quality Control Management System. A New Approach to Quality Control

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Alaina Richardson
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1 Laboratory Quality Control Management System A New Approach to Quality Control

2 Overview Provide hospitals and reference laboratories with tools to capture Quality Control (QC)/Proficiency Testing (PT) and patient results for QC purposes from diagnostic instruments and manual result entry programs on a daily basis in real/semi-real time. Allow for monthly review of QC data and assessment of instrument performance against quality requirements (Total Allowable Error (TEa)) specified by clients (to meet quality requirements of Biological Variation and/or EQA programs). Automate the QC management process by automatically reading the QC data from instruments and recommending proper QC rules. Copyright (c) LAQC Systems, Inc. All Rights Reserved. 2

3 Overview. Continued Provide a unique service to collect, analyze and compare individual laboratory data immediately with a world wide peer group at the touch of a button over the Internet (commercial QC External Quality Assurance (QAP) and Proficiency Testing (PT) on-line programs). Transfer detail and summary data between a Laboratory and a single QC database in real time over the Internet. Copyright (c) LAQC Systems, Inc. All Rights Reserved. 3

4 Products Daily QC LAQC-DQC : applies Westgard and any user defined QC rules to QC results and builds Levy-Jennings charts. Includes powerful Report Wizard and troubleshooting functions. Expert QC LAQC-EQC : works with summary QC data from a Daily QC program (LAQC or other) and recommends proper QC rules. This includes internal peer comparison and troubleshooting modules. Includes powerful Report Wizard. Automated Link LAQC-AL : an automated LINK" between LAQC-DQC and LAQC-EQC that automates the QC management process in real time. Copyright (c) LAQC Systems, Inc. All Rights Reserved. 4

5 Products. Continued LAQC-Web : web based application for instant access to on-line peer comparison (QAP and PT). Truly real-time peer stats! QC Import Modules/Instrument Interfaces/Middleware: the interface between LIS systems and diagnostic instruments and LAQC PC or Web software. Copyright (c) LAQC Systems, Inc. All Rights Reserved. 5

6 Overall Data Flow Laboratory Instruments Manual Entry Uni-directional Communicator Direct Instrument Interface Bi-directional Middleware Measured Daily QC Data LAQC-DQC Daily QC D a t a Summary QC Data Recommended QC Rules LAQC-EQC Expert QC D a t a Summary QC Data for Peer Comparison Recommended Parameters for LAQC-EQC Peer Comparison (QAP/PT) D a t a LIS LAQC-DQC Database (Intranet) LAQC-EQC Database (Intranet) Peer Database (Internet) LIS Database Processed Daily QC Data Copyright (c) LAQC Systems, Inc. All Rights Reserved. 6

7 Generic multi-site Laboratory Set up Centralized QC Software environment Lab Instruments Patient data All data Interfaces / Middleware QC/ PT data Site A QC Softwar e QC/PT data LIS Lab Instruments Patient data All data Interfaces / Middleware QC/ PT data Site B QC Softwar e QC/PT data On-line Peer Comparison (QAP/PT) Lab Instruments Patient data All data Interfaces / Middleware QC/ PT data Site N QC Softwar e QC/PT data Copyright (c) LAQC Systems, Inc. All Rights Reserved. 7

8 Daily QC LAQC-DQC Used by technologist and managers on a daily basis. Applies QC rules as assigned by either user or LAQC-EQC. Assesses each QC result against Assigned Mean & SD. Auto-approves results according to set protocol. Helps to troubleshoot problematic daily QC. Documents all activities regarding QC. Generates multiple user-definable reports. Copyright (c) LAQC Systems, Inc. All Rights Reserved. 8

LAQC-DQC (QC Summary Report) Copyright (c)

12 Expert QC LAQC-EQC Monthly/Summary review of QC data. Compares Mean & SD imported from LAQC-DQC (or manually entered) to Target & TEa (quality requirements) for each QC sample. Assesses method performance vs. quality requirements. Recommends QC rules based upon method performance. Documents activities and administrative comments. Troubleshoots problematic summary QC. Includes expert functions: Calibration check, Reagent verification, Mean Shift analysis, Problems Solver and Total Error Calculator. Copyright (c) LAQC Systems, Inc. All Rights Reserved. 12

LAQC-EQC (Problem Solver Report) Copyright

16 QC Import Modules Daily Data Import Module (DD-IM ): allows extraction of daily data from a variety of LIS systems and instruments. It has a capability of self-configuration for any simple structure Excel/Text format import files. Summary Data Import Module (SD-IM ): allows extraction of summary data from a variety of LIS systems including Meditech, Misys, Cerner and other proprietary LIS systems as well as instruments. It also has a capability of self-configuration for any simple structure Excel/Text format import files. Database Configuration Import Module (DC-IM ): works with any Database Management system and allows the extraction of data from various databases. Copyright (c) LAQC Systems, Inc. All Rights Reserved. 16

24 Benefits 1. Eliminates the need to enter data on paper forms or into a PC program. 2. Electronic transfer of QC data at any time on user defined schedule minutes, hours, days, weeks, months and years. 3. Transfer thousands of QC data points within seconds. Copyright (c) LAQC Systems, Inc. All Rights Reserved. 24

25 Benefits. Continued 4. Significant cost and time savings for laboratory. 5. Ability to meet CAP/ OLA and other regulatory requirements. 6. Eliminate non value added activities associated with review and printout of QC data. Copyright (c) LAQC Systems, Inc. All Rights Reserved. 25

26 Benefits. Continued 7. Improved understanding of the QC process with focused troubleshooting due to decreased flags. 8. Centralized review of all QC data from all laboratories/instruments. 9. Standardized QC processes on one software system will ensure that all clinical tests are evaluated using common quality requirements and appropriate QC rules. Copyright (c) LAQC Systems, Inc. All Rights Reserved. 26

27 Benefits. Continued 10. Savings in staff time reviewing unnecessary QC flags, printing and reviewing QC charts. 11. Better processes for the documentation of new reagent/calibrator/qc lot numbers and studies. 12. Better information provided to management to respond to and document QC issues more quickly. Copyright (c) LAQC Systems, Inc. All Rights Reserved. 27

28 Benefits. Continued 13. Provide monthly reporting on-line for management. 14. Creation of an internal peer QC review capability. 15. Provision of a mechanism for closer monitoring of QC from remote locations without additional costs. Copyright (c) LAQC Systems, Inc. All Rights Reserved. 28

29 Benefits. Continued 16. Decreased costs for paper storage and technician time spent storing paper. 17. Easy tracking of proficiency testing performance and problem resolution. 18. Removal of expensive interface solutions as required by alternative QC programs. Copyright (c) LAQC Systems, Inc. All Rights Reserved. 29

30 Benefits. Continued 19. Peer report production at any time of the month with a World - Wide peer group. 20. Central administrator access to review QC performance at multiple facilities no need to visit each laboratory site! Copyright (c) LAQC Systems, Inc. All Rights Reserved. 30

31 Work Flow 1. Define labs, instruments, tests, QC samples in LAQC-DQC and/or LAQC-EQC. 2. Import/enter daily QC data to LAQC-DQC. 3. Assign Mean & SD in LAQC-DQC (or update to current observed values). Copyright (c) LAQC Systems, Inc. All Rights Reserved. 31

32 Work Flow. Continued 4. Assign Targets in LAQC-EQC (Internal or external peer average, package insert, current mean). 5. Assign TEa in LAQC-EQC (Biological Variation, Clinical Goals, Proficiency, Internal CV). 6. Import Mean & SD to LAQC-EQC and transfer QC rule recommendations to LAQC-DQC. Copyright (c) LAQC Systems, Inc. All Rights Reserved. 32

33 Work Flow. Continued 7. Update QC rule sets in LAQC-DQC if method within TEa. 8. Investigate & correct parameters if method exceeds TEa. 9. Use LAQC-EQC to assess new reagent lots and calibrations. Copyright (c) LAQC Systems, Inc. All Rights Reserved. 33