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General Quality Control Charts and Reports ​

Description, Purpose and Objective ​

NOTE

The Graphics and General Reports suite is the centralized module for analysis and visual diagnosis of analytical quality in Quattrol. Its purpose is to structure, process and graphically present the behavior and trend of the laboratory's quality control results.

The objective of this console is to offer analysts, bacteriologists and quality managers advanced statistical tools (Levey-Jennings curves, frequency distribution histograms and Peer Group interlaboratory comparisons) that allow them to preview analytical anomalies in real time and export physical or digital reports ready for external accreditation audits.

Context of Use ​

This panel is operated by:

  • Directors and Quality Coordinators: To monthly audit the dispersion of the data, check the consistency against the peer group and certify compliance with the tolerable margins of inaccuracy and bias.
  • Bacteriologists and Technical Personnel: To visually verify if there are systematic (trends) or random derivations that require corrective calibrations.

1. Levey Jennings (Traceability and Trends) ​

Purpose ​

Graphical evaluation of the precision and stability of the analytical system over time. It allows you to identify systematic deviations (shifts from the mean) or random deviations (violations of control limits $\pm 1s, \pm 2s, \pm 3s$) and control the margin of the Maximum Allowable Total Error (ET+).

Tabs and Modalities ​

  • QC Test (Individual): Evaluates the performance of a specific quality control test.
  • CC Group (Consolidated): Generates and superimposes in a single coordinate graph the curves of multiple related tests in the same analytical profile.

Input Parameters ​

  • Date range: Start date and End date selector to limit the history of points evaluated in the graph.
  • CC Test / CC Group😗* Drop-down lists to choose the specific test (includes measurand, instrument, method and control lots) or the control group configured in the system.
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Actions ​

  • Print: Processes the Levey-Jennings curve on screen and generates a physical version or a downloadable PDF document.
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2. Histogram (Frequency Distribution) ​

Purpose ​

Visual representation that groups the quality control results into class intervals, allowing you to evaluate the symmetry of the distribution, the dispersion of the measurements and to visually verify whether the control data follow a Gaussian behavior (normal distribution curve).

Tabs and Modalities ​

  • CC Test: Frequency analysis applied to an individual analytical test.
  • CC Group: Consolidated frequency distribution graph for a set of associated tests.

Input Parameters ​

  • Date range: Time interval for filtering numerical readings.
  • CC Test / CC Group😗* Drop-down field for selecting the test or profile to be evaluated.
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Actions ​

  • Print: Export the frequency graph formatted in high resolution for quality reporting.
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3. Pair Group (Interlaboratory Comparison) ​

Purpose ​

It consists of an external comparative evaluation that contrasts the laboratory's own statistics against a global database of peer laboratories that process under identical analytical conditions, allowing the identification of persistent systematic errors (analytical bias).

Tabs and Modalities ​

  • CC Test: Individual comparison per trial against the peer community.
  • Group CC: Consolidated data plot for a comparative test profile.
  • Levey Jennings - CC Test: Laboratory Levey-Jennings curve overlaid with the statistical limits of means and standard deviations reported by the Pair Group.
  • Levey Jennings - CC Group: Overlay of Levey-Jennings graphs with the Peer Group metrics at the group template level.

Input Parameters ​

  • Date range: Evaluation period for calculating group statistics.
  • CC Test / CC Group😗* Selection of the test or template to be contrasted.
  • Level:* Drop-down menu to define the statistical rigor filter for interlaboratory comparison:
    • Level 1 (Measuring - Batch): Broad comparison level. Compare data sharing the same assay and batch, regardless of the method or equipment.
    • Level 2 (Measuring - Batch - Method): Requires that the peer group coincide in the analyte, physical batch and chemical method used.
    • Level 3 (Measuring - Batch - Method - Instrument): The strictest level of comparison. Requires peer group laboratories to use the exact same manufacturer, analyzer model, control lot, and chemical methodology.
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Actions ​

  • Print: Generates the formal Par Group comparative report and consolidated SDI calculation for quality audits.
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Viewing and Generation of Reports ​

When completing the mandatory parameters (date range, trial or group selection and level if applicable) in any of the sections, the platform immediately renders an interactive preview of the graph at the bottom of the screen.

Once the user verifies the consistency of the interactive graph, they must press the Print button to process and download the official report formatted in high quality.

Interpretation of Clinical Metrics and Peer Group Indicators ​

TIP

Statistical Interpretation Guidelines for the Bacteriologist:

  • Standard Deviation Index (SDI / Z-Score): Quantifies the distance between your laboratory average ($ar{X}{lab}$) and the consensus average of the peer group ($ar{X}$), normalized by the group dispersion ($s_{par}$): $$SDI = \frac{\bar{X}{lab} - \bar{X}{par}}{s_{par}}$$
  • $|SDI| \le 1.0$: Excellent performance; full agreement with the peer analytical community.
  • $1.0 < |SDI| \le 1.5$: Desempeño aceptable; vigilar posibles derivas del reactivo o calibrador.
  • $1.5 < |SDI| \le 2.0$: Alerta metrológica; existe un sesgo incipiente que requiere investigación técnica preventiva.
  • $|SDI| > 2.0$: Unacceptable or out of control performance; clinically significant bias requiring mandatory corrective actions (recalibration, batch change or equipment maintenance).
  • Quotient of Variation Coefficients (CVR): Evaluates the relative imprecision of the laboratory compared to the peer group: $$CVR = \frac{CV_{lab}}{CV_{par}}$$
  • $CVR \le 1.0$: The laboratory is more accurate or the same as the average peer group.
  • $CVR > 1.5$: Excessive imprecision; Greater dispersion than comparable laboratories.

Roles and Permissions Required ​

The entry and use of general graphics and reports is governed by the following security profiles and permissions:

The roles authorized to consult and download these analyzes are Director / Quality Coordinator, Bacteriologist / Analyst and Technical Auditor.

  • Levey-Jennings plots:
    • lv_graphics_read: Allows read access to the Levey-Jennings plot path by trial and group, and viewing the interactive preview.
  • Frequency Histogram:
    • histogram_read: Allows you to load the histogram module and interact with the frequency distribution.
  • Pair Group Charts:
    • peer_group_graphic_read: Allows you to access the peer group interlaboratory comparison module and apply the filters by Level 1, 2 and 3.
  • Common Shares:
    • performance_report_read / report_statistical_read: Authorizes the execution of the Print function to generate and download official quality reports in PDF or physical format.

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