Your QC Foundation Is Proven. Today’s Risks Demand Greater Visibility.
Dear Laboratory Director / Quality Manager, The statistical quality control methods that transformed laboratory medicine remain foundational to quality practice. Today’s laboratories, however, operate in a far more complex environment—facing tighter regulatory expectations, faster analytical systems, increased operational variability, and greater accountability for patient outcomes. RiskGATOR helps laboratories build on proven QC science with real-time operational risk intelligence aligned with modern standards.
Introducing RiskGATOR: Mathematically-OptimiZed Risk Evaluation™
RiskGATOR is the first medical laboratory software to implement M.O.R.E. Quality™ (Mathematically-OptimiZed Risk Evaluation) — a scientifically rigorous framework aligned with CLSI EP23A, ISO 15189:2022, CAP, and CLIA. Building on established analytical metrics such as sigma, RiskGATOR translates QC performance into Medically Incorrect Results (MIRs) per failure event and estimates the probability of patient harm as "one error every 'x' hours, days, weeks, months, or years." You will know exactly how many patient results are at risk — and exactly what to do about it.
| ❌ Traditional Statistical QC | ✅ RiskGATOR: M.O.R.E. Quality™ |
|---|---|
| ✗Reports rule violations without quantifying patient impact | ✓Quantifies patient impact before results are reported |
| ✗Assumes statistical performance equals clinical safety | ✓Verifies clinical risk in real time |
| ✗Estimates errors per one million results — no clinical relevance | ✓Estimates probability of harm as one error every 'x' hours, days, weeks, months, or years |
| ✗QC rule performance does not directly verify daily detection capability | ✓Verifies Daily QC can detect unacceptable risk in a single run |
| ✗No breakdown for cause of errors — no root cause guidance | ✓Guides investigation of common faults causing reduced method accuracy and/or precision |
| ✗No cost analysis — healthcare waste goes unquantified | ✓Quantifies avoidable healthcare costs caused by lab errors and recommends improvements |
A Win-Win-Win for Everyone Who Cares About Laboratory Quality
Developed by clinical QC experts Zoe Brooks and Raymond Gerz — who have collaborated since 2008 and founded AWEsome Numbers Inc. in 2011 — RiskGATOR is aligned with CLSI EP23A, ISO 15189:2022, and modern risk-based extensions of proven QC science.
RiskGATOR Delivers Value Across Your Entire Laboratory Team
🏛 Laboratory Directors & QC Managers
- Easily meet compliance goals with comprehensive audit trails and automated reporting
- Save countless hours through automated analysis and standardized reporting workflows
- Generate regulatory-ready documentation with a single click
- Demonstrate quality improvements with data-driven metrics and trend analysis
- Implement ISO 15189:2022 and CLSI EP23A requirements with confidence
📋 Laboratory Managers
- View problem methods at a glance with intuitive dashboards
- Review and assign automated action plans with clear accountability
- Proactively identify risks before they impact patient results
- Track resolution progress with real-time status updates
- Receive automated alerts before issues become problems
👩🔬 Supervisors
- Provide front-line staff with clear, step-by-step action plans for each method
- Improve communication with easy-to-understand reports and visual indicators
- Ensure consistent procedures across all shifts and team members
- Monitor team performance and identify training opportunities
🧪 Front-Line Staff
- Easily troubleshoot issues with step-by-step guidance
- Save time by following easy-to-understand instructions and predefined actions
- Access method-specific procedures and QC requirements instantly
- Clearly understand the connection between QC and patient care
Everything You Need to Manage Laboratory Risk Effectively
RiskGATOR combines intelligent analytics, cloud collaboration, and actionable insights in one platform.
Fully Aligned with Regulatory Standards
"I was genuinely impressed by the platform's depth of capability, particularly its ability to consolidate complex risk data into clear, actionable insights. The combination of strong analytics, practical usability, and thoughtful design makes it a powerful solution for organizations looking to strengthen their risk management approach."
Is RiskGATOR Right for Your Laboratory?
We are looking for laboratories that are ready to lead the transformation in quality management. Ideal Beta participants include:
- Clinical and hospital laboratories currently performing manual QC evaluation or using legacy statistical QC software
- Laboratories seeking to implement ISO 15189:2022 risk management requirements
- Laboratory directors and quality managers committed to reducing medically incorrect results and false positive QC flags
- Laboratories experiencing high rates of false-positive QC flags and wasted staff time
- Organizations seeking to quantify and reduce the healthcare cost impact of lab errors
- Forward-thinking leaders who want to influence the next generation of laboratory quality management software
Dedicated to Revolutionizing Clinical Laboratory Quality Control
AWEsome Numbers was founded on a simple belief: the statistical quality control science that transformed laboratory medicine remains essential—but today’s laboratories require greater operational visibility, stronger risk-based decision making, and clearer alignment with modern global standards…
Ready to Extend Proven QC with Risk Intelligence?
Join the laboratories that are defining the future of clinical quality management. Get access to RiskGATOR and experience M.O.R.E. Quality™ for yourself.