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Optimizing Quality Control Data Management


Introduction

Automation continues to gain importance in modern clinical laboratories in step with increasing test consolidation, rising demands from clinicians for rapid turnaround times, and an ever-mounting shortage of licensed medical technologists. Ultimately, the laboratories that implement high-quality automation solutions are better equipped to meet these modern demands.

Within the context of overall laboratory automation (e.g. sample processing robotics, decision management solutions, etc.), the automation of quality control data management is particularly vital due to its impact on the validation of patient results. With the health and safety of patients at stake, laboratories must ensure patients and clinicians that the results they produce are reliable and accurate.

In addition to the impact on the quality of patient care, decisions made based on quality control results have implications on laboratory credibility, operating costs (in terms of repeat testing, delays in turnaround time, etc.), and impact compliance with regulatory and accreditation requirements. Unquestionably, quality control is one of the most important yet often least appreciated activities in the laboratory.

Bio-Rad Laboratories Unity Real Time expert quality control data management solution helps meet the quality demands of the clinical laboratory. The system is a third party software solution that can be easily integrated with existing Laboratory Information Systems (LIS), laboratory instruments and middleware solutions, such as Data Innovations Instrument Manager. With the latter solution, Bio-Rad has partnered with Data Innovations to provide a bi-directional, integrated connectivity solution that offers quality control autoverification.

System Overview

The Unity Real Time quality control data management software solution:

  • Facilitates compliance with regulatory and accreditation requirements (e.g. IS O 15189 and CLIA)
  • Recommends and implements optimum quality control rules when used with Bio-Rads Westgard Advisor add-on module
  • Provides high-quality statistical process control with comprehensive audit trails
  • Facilitates prospective and supervisory quality control data review
  • Provides advanced data analysis charts and reports
  • Enables the consolidation of quality control management into one platform
  • Reduces non-essential retests with Analytical Goals options
  • Enables participation in the Unity Interlaboratory Program for external peer comparison

The Westgard Advisor Automatic Rule Selection Algorithm

The Westgard Advisor add-on module automatically recommends and implements optimal Westgard rules in the Unity Real Time software. By establishing proper quality control design, the module decreases false rejections and helps attain laboratory designated quality goals with the highest error detection rates possible. This reduces desensitization to false error flags, and ultimately saves lab time and money by eliminating unnecessary troubleshooting and repeat testing.

The Westgard Advisor module recommends rules based on the quality specification the laboratory defines for each test and test performance. The quality specification options include +3sd, Biological Variation, CLIA, RCPA, State of the Art, or User Defined values. Since the Westgard Advisor is integrated with Unity Real Time, users can simply apply the suggested rules in Unity Real Time with a single click.

Fig 1 Westgard AdvisorTM in Unity Real Time

Primary Statistical Process Control Tools

Unity Real Time provides flexible options for statistical process control (e.g. Westgard) rules. The system provides 17 different rule options that can be set to reject, warn or off. Laboratories may either manually define the appropriate Westgard rules for each test, or utilize the Westgard Advisor (described above) to optimize the selection of appropriate rules for each test.

The interpretation of Statistical Process Control results is supported by the use of several Unity Real Time features, including two prospective review options:

  • Autoverification is possible with Unity Real Time through a bi-directional interface that communicates rule evaluations to other systems.
  • Laboratories may also use Unity Real Times Bench Review for run-time analysis and Supervisor Review for periodic supervisory data analysis.

Bench and Supervisor Review

Unity Real Time displays all pending results by automatically refreshing displays for both prospective and supervisory review. Bench Review displays all the pending results for a selected range of tests for prospective review. Supervisor Review displays all pending results for periodic supervisory review.

Both displays are color-coded to indicate rule violations (yellow for warnings and red for rejections) to facilitate the identification of problems and improve laboratory workflow. Users can link to Levey-Jennings charts or the complete data history on any test for troubleshooting. Both levels of review are recorded, along with any documented corrective actions, in a local report. This report assists laboratories in meeting the requirements of regulatory agencies to document quality control data review.

Fig 2 Bench Review process in Unity Real Time

Local Charts and Reports

Unity Real Time offers several charts and reports to interpret quality control data, including:

  • Levey-Jennings (single) Chart
    Levey-Jennings charts plot a set of data points against a mean and 3 standard deviation (SD) range. Unity Real Time users have the option to plot against their fixed mean and SD, floating (cumulative) mean and SD, the mean and 3 SD range of another instrument in the lab or against the consensus group dat a from the Unity Interlaboratory Program.
  • Levey-Jennings (multiple) Chart
    The Multi-Levey-Jennings feature of Unity Real Time contains all the same basic features of the single Levey-Jennings chart, but allows users to select several tests to display on a single screen. This provides an easy way to compare tests, such as the same analyte run on two different instruments, similar tests like ALT and AST, or tests on different lot numbers of control material.

    Fig 3 Multiple Levey-Jennings Chart in Unity Real Time

  • Audit Trail Report
    The Audit Trail Report provides a convenient mechanism to track all events that may impact the evaluation of data. Unity Real Time records the previous and current settings, the user, the date and time, and users can be optionally required by the supervisor to enter a comment to explain why a change was made at the time of the change.

Analytical Goals

Analytical Goals options are available in Unity Real Time to provide a feedback mechanism on the performance of the primary statistical process control (e.g. Westgard) rules scheme. Unity Real Time provides the following Analytical Goal options to improve analytical performance and reduce the number of false rejections:

  • Imprecision based upon Biological Variation and State of the Art help the laboratory confine imprecision within defined limits.
  • Medical Relevance can be used to distinguish between statistical error and a medically important change.
  • Total Error based upon Biological Variation, the most robust tool, focuses on process improvement opportunities for imprecision, bias, and total error. When used to its fullest extent, this tool can be instrumental in revealing statistical process control protocols and specifications that are not test-appropriate and simply increase laboratory costs due to unnecessary repeat testing, troubleshooting, and recalibration.

Fig 4 Analytical Goals, Total Error based upon Biological Variation setup dialog box in Unity Real Time

Unity Interlaboratory Program

Interlaboratory quality control programs are a broader strategy than just running controls and comparing them to the intralaboratory expected results. With an interlaboratory comparison program, laboratories submit their data to a central database and receive back reports comparing their results statistically to other laboratories in defined consensus groups running the same or similar tests. In this manner, a laboratory can compare its performance to available consensus groups to determine if its performance is as good as those using the same method. If not, the laboratory knows that it should investigate possible corrections to improve results. With Unity Real Time, Bio-Rads Unity Interlaboratory Program gives the laboratory additional documented confidence that their results are satisfactory, and provides laboratories additional confidence that they will pass blind proficiency surveys offered by external quality assessment programs.

References

  1. Fraser Callum, Biological Variation: From Principles to Practice, AACC Press, Washington DC, 2001 (available at www.aacc.org)
  2. Ricos Carmen et al., Current databases on biological variation: pros, cons and progress, Scandinavian Journal of Clinical & Laboratory Investigation, Vol. 59, No. 7, November 1999, 491-500 (an update is available at www.westgard.com)
  3. 42 CFR (Code of Federal Regulations), Ch. IV (10-1-01 Edition), Part 493
  4. Westgard James O, Basic Planning for Quality, Westgard QC, Inc., 2000
  5. Westgard James O, Basic QC Practices, Westgard QC, Inc., 1998
  6. Petersen Per-Hyltoft et al., Combination of analytical quality specifications based on biological within- and between-subject variation, Annals of Clinical Biochemistry 2002;39:543-550

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