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.
The Unity Real Time quality control data management software solution:
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:
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:
Fig 3 Multiple Levey-Jennings Chart in Unity Real Time
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:
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.
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