Your Quality Control Methods Are 50 Years Old. Your Patients Deserve Better.
Dear Laboratory Director / Quality Manager, The statistical QC methods most laboratories rely on today were developed in the 1970s — before modern analyzers, before precision medicine, and before the regulatory landscape you navigate daily. They use unverified assumptions, report meaningless "errors per million results," and cannot tell you whether a patient result is at risk right now. RiskGATOR changes everything.
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. Instead of theoretical sigma values, RiskGATOR reports risk as 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™ |
|---|---|
| ✗Defines acceptable performance as a sigma value based on 1987 industry concepts | ✓Defines acceptable risk as MIRs per year and per failure event — specific to each analyte and clinical setting |
| ✗Based on incorrect formulas with unverified assumptions | ✓Compares estimated risk against given risk criteria (CLSI recommendation) |
| ✗Estimates errors per one million results — no clinical relevance | ✓Estimates probability of harm as one error every 'x' hours, days, weeks, months, or years |
| ✗Assumes QC processes are effective without verification | ✓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 QC principles.
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
Founded by Zoe Brooks and Raymond Gerz — who have collaborated since 2008 — AWEsome Numbers Inc. is on a mission to simplify complex statistical metrics, provide clear insights, and deliver actionable advice to ensure consistent and reliable lab results. Our proprietary algorithms and innovative software empower, educate, and certify lab professionals with the knowledge and tools needed to standardize quality control processes across laboratories worldwide.
Ready to Lead the Paradigm Shift?
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.
