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MatrixQC is the first Brazilian software designed for the Automated Internal Quality Control for Clinical Laboratories. Integrated to MatrixConnect, it is the only Brazilian solution able to receive, in real time, quality control results processed in automation instruments with no need to fill out spreadsheets or enter these results in other quality control software programs. The integration of MatrixQC into MatrixConnect enables the assessment of control results and decision making on the analytical system automatically and in real time, according to rules defined by the laboratory's quality manager.
Briefly, the flowchart of automated quality control begins with the processing of the control in the instrument. Once the processing is completed, the control result is sent to MatrixConnect via interfacing. MatrixConnect, in turn, redirects this result to MatrixQC. MatrixQC analyzes the result and checks whether any control validation rule previously defined by the quality manager has been violated. In the event of violation of a rule, the system applies measures defined by the quality manager such as sending a message to the quality manager, or even blocking the analytical system before the next production cycle. Finally, once corrective measures are taken and recorded in MatrixQC, the quality manager may completely or partially unblock the analytical system.

This innovative approach to internal quality control is a powerful tool for quality managers. A single software includes analysis tools and allows managers to centralize information, control the process and track actions. It enables quality managers not only to control quality but also to control the production process throughout the laboratory, from their desk or home. Additionally, MatrixQC meets the stringent standards of certifying agencies for clinical laboratories quality, and is essential for obtaining and maintaining a quality certificate.

Below are some of the functionalities which make MatrixQC the most complete and versatile laboratory quality control system available in the Brazilian market. To learn more about the benefits of other Matrix products, please access the descriptions of MatrixStorage and MatrixConnect.

 

Statistics Indicators

MatrixQC has five different work modes as regards the mean and standard deviation (SD):

  • nominal mode: mean and SD are informed by manufacturer ("package insert value”);
  • designated mode: mean and SD are informed by laboratory (for example, based on the laboratory's own studies);
  • fixed points mode: mean and SD are calculated based on the control values of the first n points of a series, where “n” is informed by the laboratory;
  • accumulated mode: mean and SD are calculated based on all the points of the lot;
  • period mode: mean and SD are calculated based on all the points of a certain interest period.

The standards above are simultaneously maintained by MatrixQC and may serve as the basis to control analytes or to run comparative analysis. Statistics tools allow the viewing and comparing of the results of different standards, the viewing of the size of the population considered, and of other statistics indicators such as the coefficient of variation. he standards above are simultaneously maintained by MatrixQC and may serve as the basis to control analytes or to run comparative analysis. Statistics tools allow the viewing and comparing of the results of different standards, the viewing of the size of the population considered and of other statistics indicators such as the coefficient of variation.

Validation rules

One of the most powerful features of MatrixQC is the automatic validation of control results. The logical basis of the validation is the parametrization of Westgard Rules according to the standards of the laboratory and the configuration of these rules in MatrixQC. The system has an intuitive interface which allows the quality manager to define as many rules as necessary, and establish which rules apply to individual analytes.

MatrixQC has no restrictions as to the number of levels per control and dynamically adapts itself to differences between routines. The laboratory's validation rules are defined for Control Groups – the sets of levels of each control – and may be individually configured to include only the results of a certain control level (intra-level), all the levels of the Control Group (inter-levels), or only the points of a run (intra-run).


Automatic Actions

MatrixQC enables the quality manager to define the actions that should be taken whenever a certain rule is violated. Violation alerts may be sent either by e-mail or through pop-up messages over the laboratory's network. The processing of the related analyte may be blocked or the analytical system as a whole may be blocked, thus interrupting production.

Once the whole production, or the processing of an analyte, or the analytical system is blocked only authorized staff with a password that allows the unblocking of the operation may unblock it. MatrixQC records all decisions implemented, either manually or automatically, such as the blocking and unblocking of production. It also allows the recording of actions taken to correct problems.

Additionally, MatrixQC controls how often the control is processed and blocks the analytical system in the event of failure to process a certain control after “x” hours have elapsed from the time the last control has been processed. This prevents production from starting before the control routine has been completed.

Another possibility of automatic quality control available at MatrixQC is the verification of Total Error. This feature enables MatrixQC to automatically prevent the laboratory from working with validation rules which are deemed “too broad”, that is, above a percentage relative to the mean previously defined by the quality manager for each analyte – known as Total Error.

 

Lot Expiration

The expiration of quality control lots is monitored by MatrixQC which sends alerts to the quality manager on the approach of the lot expiration date, thus enabling him to purchase a new lot and begin a new historical series. MatrixQC enables the processing of the new lot in parallel with the lot currently in use.

Operation and Analysis

Many features are included in MatrixQC's operation and analysis module. Its control panel shows a spreadsheet that allows users to view all the points received from each control. Nominal and normalized result controls are shown beside the current mean and standard deviation, rules violated, actions taken, and other data. This panel also allows the cancellation of invalid points, the recording of actions taken and changes in control lots in use, whenever two lots are being processed in a parallel fashion for the same analyte.


A simplified version of the Levey-Jennings Graph may be viewed vertically beside the spreadsheet, or in greater detail by checking the appropriate option. The graph may highlight the values of points, the respective dates and rules violated, and may also be printed. Histograms and Youden Plot are also available.



An exclusive feature, Analysis of the Coefficient of Variation Between Two Simultaneous Periods, allows the detection of changes in the analytical system throughout time, especially variations over configured maximum thresholds.

Results of controls for non-interfaced techniques may also be manually entered to enable the quality control of these routines.

Integration to Bio-Rad's Unity Pro

MatrixQC may also be integrated to Bio-Rad's quality control software Unity Pro. One of the major benefits of this integration is that control results need not be manually entered into Unity Pro – they are automatically transferred by MatrixQC.