interQC Delivering Simplicity in the Quality Control Management for your Laboratory Developed by Vitro

What is Quality Control? Monitors the analytical performance of a laboratory Indicates the reliability of the data obtained Types: Internal Quality Control Internal/External Quality Control External Quality Assurance

Internal Quality Control What is Quality Control? Typically an assayed control with a wide acceptable range, it does not detect evolving trends Provided by: Reagent manufacturer which is designed for a specific kit Independent third party control manufacturer, which is recommended by Accreditation norms It does not show peer to peer comparisons Immediate decisions to accept or reject patient results

Provides proactive assessment and quality control performance review What is Quality Control? Internal assayed or unassayed Quality Control accompanied by an inter-comparison software that provides inter-laboratory, peer to peer comparisons Inaccuracy Imprecision Internal/External Quality Control With the software, the lab can establish their own range and can easily detect evolving trends that can be corrected on a timely basis

External Quality Assurance What is Quality Assurance? Validates lab quality control Only one data point, not representative as with internal/external real time imprecision comparisons Compares the performance of your lab systems versus other participating methods or platforms Provides retrospective assessment and performance review with blinded samples

interQC is the most complete and intuitive quality control software package currently on the market. A Web-based vendor-hosted application providing: Intra (within) lab data comparison Inter (between) lab data comparisons 24 HOURS AND 7 DAYS A WEEK IN REAL-TIME interQC: Quality Control Data Management software. An open software where any manufacturer’s quality controls can be used

As a Web Application, no installation is required. Access from website interQC: Quality Control Data Management software Each user has an unique and secure access. EnterExit Laboratory User Password

interQC: Main Menu New dynamic selector to vary the search combination: By instrument By control By parameter: possibility to visualize internal comparisons between your different instruments

interQC is the most complete and intuitive quality control software package currently on the market. Real-time statistics with one-screen dashboard with internal and external statistical comparisons interQC Software interQC offers: Graphs that aid the laboratorian in data interpretation and decision making Reports that comply with your regulatory requirements Customizable Quality Director Rules that allow you to choose the level of scrutiny for your lab Continual Quality Improvement by recording your corrective and preventative actions Guarantee of your Quality Assurance and Proficiency Testing

interQC is the most complete and intuitive quality control software package currently on the market Real-time statistics with one-screen dashboard with internal and external statistical comparisons interQC Software interQC offers:

Real-Time Statistics Dashboard One-screen dashboard for all the control levels Real-time update of internal statistics Automatic outlier detection TIMELY REVIEW AND DECISION MAKING

Real-Time Statistics Dashboard Peer group comparatives listed in descending order from global users to the most specific instrument group

Real-Time Statistics Dashboard Standard Deviation Index (SDI) real-time comparison of the internal mean to the target mean Coefficient of Variation Index (CVI) - real-time comparison of the internal imprecision (CV%) to the external one (CVu%)

Real-Time Statistics Dashboard The comparative index are color-coded to indicate the degree of acceptable or unacceptable performance of the lab, when compared to your peer groups using the same lot of control SDI: Inaccuracy (Bias) CVI: Imprecision SDI ≥ -1 or ≤ 1 Good ≥ 1 or ≤ 2 Acceptable ≤ -1 or ≤ -2 ≥ 2 or ≤ 3 Warning ≤ -2 or ≥ -3 ≥ 3 Unacceptable ≥ -3 CVI ≤ 1 Good ≤ 1 or ≤ 1,5 Acceptable ≥ 1,5 or ≤ 2 Warning ≥ 2 Unacceptable

Real-Time Statistics Dashboard Control manufacturer’s Package Insert information available for the customer in the same Statistic Dashboard.

interQC is the most complete and intuitive quality control software package currently on the market interQC offers: Graphs that aid the laboratorian in data interpretation and decision making interQC Software Real-time statistics with one-screen dashboard with internal and external statistical comparisons

Wide range of graphs aids the laboratorian in the interpretation of: Internal QC data Real-time comparison to your peer group Graphs Levey-Jennings Control Charts. Standard Deviation Index (SDI) / Coefficient of Variation Index (CVI) Multi-level Evolution Comparative Histogram interQC graphs:

Graphs: Levey - Jennings Tracks trends or mean shifts of your internal controls Compares your internal data points with the external mean in the same graph Reflect all the records completed in the system Internal mean External mean Instrument note

Graphs: Levey - Jennings This graph illustrates a reagent lot number change registered by the laboratorian

Represents the cross point for inaccuracy comparisons (SDI) versus imprecision comparisons (CVI) in all control levels for each analyte (test) Graphs: SDI - CVI L 1 L 2

Visualize if the deviation affects all control levels or just to only one in the same graph Graphs: SDI - CVI L 1 L 2

Compares the internal control mean for all levels with the external control mean most like your lab Graphs: Multi-level

Monitors: Systematic Error Manufacturer’s measurement range Linearity of the system Graphs: Multi-level

Graphs: Evolution Monitors your lab’s monthly mean besides the most specific external mean Shows individual trends Systematic Error Correction during a period of time

Monitors your lab’s Monthly CV besides the most specific external CV Graphs: Evolution Shows individual changes of imprecision Random Error Correction

Graphs: Comparative Histogram Most specific group (instrument) Your Lab Global number of users

interQC is the most complete and intuitive quality control software package currently on the market. interQC offers: interQC Software Graphs that aid the laboratorian in data interpretation and decision making Real-time statistics with one-screen dashboard with internal and external statistical comparisons Reports that comply with your regulatory requirements

interQC is the most complete and intuitive quality control software package currently on the market interQC offers: Reports that comply with your regulatory requirements QC Report QC Summary Statistics Error Causes and Corrective Action Quality Objectives Specifications Reports:

Reports: QC Report

Monthly report: Levey-Jennings Chart Comparative Histogram Statistical Summary ALL IN THE SAME PAGE BY ANALYTE

interQC is the most complete and intuitive quality control software package currently on the market interQC offers: interQC Software Graphs that aid the laboratorian in data interpretation and decision making Real-time statistics with one-screen dashboard with internal and external statistical comparisons Reports that comply with your regulatory requirements Continual Quality Improvement by recording your corrective and preventative actions

interQC is the most complete and intuitive quality control software package currently on the market interQC offers: Continual Quality Improvement by recording your corrective and preventative actions Error Causes and Corrective Actions Identifies, registers and documents error causes and corrective actions Registers and documents any changes taking place with your lab’s systems Facilitates attitude of quality improvement

Error Causes and Corrective Actions Once the lab has rejected a data point, interQC software allows the lab to add an error cause and corrective action

Error Causes and Corrective Actions Errors with associated causes will be clearly differentiated in Levey-Jennings Graphs Without cause With cause

Instrument Notes Register and document any changes in the System by instrument or parameter

Register and document any changes in the System, by instrument or parameter: Change of reagent lot System maintenance Wrong kit detection Instrument Notes

Any change in the System will be clearly visible in the Levey-Jennings graph Instrument Notes

interQC is the most complete and intuitive quality control software package currently on the market interQC offers: interQC Software Graphs that aid the laboratorian in data interpretation and decision making Real-time statistics with one-screen dashboard with internal and external statistical comparisons Reports that comply with your regulatory requirements Continual Quality Improvement through record of corrective and preventative actions Customizable Quality Director Rules that allow you to choose the level of scrutiny for your lab

interQC is the most complete and intuitive quality control software package currently on the market interQC offers: Customizable Acceptability Rules that allow you to choose the level of scrutiny for your lab by parameter Customizable Acceptability Rules Multi-Westgard rules References and laws that establish Maximum Admissible Error by parameter that can be selected as quality objective Biological Variability German Rilibak 2008 USA CLIA

Customizable Westgard Rules Westgard Rules can be configured by the Director specific for each analyte (test)

Customizable Westgard Rules Each rule has a different meaning that will alert the user about the origin of the evolving trend Systematic Random Systematic Random

Customizable Quality Director Rules: What is your laboratory’s Quality Standard? Every Quality Management System is defined by Quality Objectives Some Laws included in interQC establish Maximum Admissible errors that can be fixed as Quality Objective Reachable Quantified Inside some limits: Technical development Clinical significance LAW

First, interQC calculates the laboratory’s random error and systematic error using both internal and external statistics Customizable Quality Director Rules

Next, the Laboratory Quality Director may choose the Maximum Admissible Error to asses for a specific technique

interQC calculates the margin of error between the total error and the Maximum Admissible Error MARGIN OF ERROR Customizable Director Rules: Quality Objectives Calculator Total error Admissible error

Before calculating a director rule to asses the quality level to be established for your lab, it is important to know the stability of the system for a technique Customizable Director Rules: Quality Objectives Calculator

The more rejections observed for a technique, the more unstable the technique Stability Power of detection needed High: Less than 2% rejections Between 25%-50% Medium: Between 2%-10% rejections Approximately 50% Low: Greater than 10% rejections Greater than 90% Customizable Director Rules: Quality Objectives Calculator Therefore, the lab will need to apply a higher power of detection interQC will calculate the rule with the power of detection needed automatically for your laboratory

Keeping in mind all of these parameters, interQC calculates the most specific rule to help your laboratory assess the quality requirements for a specific system and parameter Customizable Director Rules: Quality Objectives Calculator

Customizable Director Rules: Westgard Rules When a data point is accepted by your Director Rule, interQC shows: Westgard rule failed to warn the user Your director rule and acceptability range

interQC is the most complete and intuitive quality control software package currently on the market interQC offers: interQC Software Graphs that aid the laboratorian in data interpretation and decision making Real-time statistics with one-screen dashboard with internal and external statistical comparisons Reports that comply with your regulatory requirements Continual Quality Improvement through record of corrective and preventative actions Customizable Quality Director Rules that allow you to choose the level of scrutiny for your lab Complement to your Quality Assurance and Proficiency Testing

interQC Software interQC is the most complete and intuitive quality control software package currently on the market interQC offers: Complement to your Quality Assurance and Proficiency Testing Integral solution for the Quality control of your systems Assesses the compliance of quality requirements Oriented to continuous improvement

interQC Software Personal customer service for your laboratory from the website Adaptability of the software to your requirements We configure your lab to your specifications