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.
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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 reliability of patient results. With the health and safety of patients at stake, laboratories must ensure the results they produce are reliable and reportable.
In addition to the impact on the quality of patient test results, 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 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 an independent 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.
The Unity Real Time quality control data management software solution:
- Facilitates compliance with regulatory and accreditation requirements (e.g. ISO 15189 and CLIA)
- Recommends and helps implement optimum quality control rules when used with Bio-Rad's 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
- Supports qualitative quality control review for Urinalysis, Blood Safety, etc.
- Enables the consolidation of quality control data management into one platform
- Enables participation in the Unity™ Interlaboratory Program for peer comparison
The Westgard Advisor Automatic Rule Selection Tool
The Westgard Advisor add-on module automatically recommends and helps implement 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. This reduces desensitization to false error flags, and ultimately saves labs 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. Various published quality specification values are available in Unity Real Time, including Biological Variation, State of the Art, CLIA (US), RCPA (Australia), RiliBÄK (Germany), GOST (Russia), IPH (Belgium), EMC (Spain), Qualab (Switzerland), IQMH (Canada), SEKK (Czech Republic), SKML (Netherlands), WS/T (China), and Turkey TEa. 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 Advisor 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 Time's 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 accreditation.
Fig 2 – Bench Review process in Unity Real Time
Internal Charts and Reports
Unity Real Time offers several charts and reports to interpret quality control data, including:
Fig 3 – Multiple Levey-Jennings Chart in Unity Real Time
- 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 data from the Unity Interlaboratory Program.
Levey-Jennings (multiple) Chart
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.
- 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.
Unity Interlaboratory Program
Interlaboratory quality control programs are a broader strategy than just running controls and comparing them to expected internal 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-Rad's 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, such as the CAP program or Bio-Rad's EQAS program.
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