Protecting Patients.
Empowering Lab Professionals.
Saving Healthcare Costs.
RiskGATOR: Where Proven QC Science Meets Risk-Based Decision Intelligence
RiskGATOR transforms existing QC data into operational risk intelligence for modern laboratories.
What is RiskGATOR?
RiskGATOR uses Mathematically-Optimized Risk Evaluation (M.O.R.E.) to extend the statistical quality control science that transformed laboratory medicine—adding real-time operational and patient-risk visibility for today’s risk-based laboratory.
Why This Matters to You
RiskGATOR creates a win-win-win for everyone who cares about laboratory quality
Developed by clinical QC experts. Aligned with CLSI EP23A, ISO 15189, and modern risk-based QC principles.
Healthier Patients
Every lab error that reaches a patient can delay treatment, lead to incorrect diagnoses, or cause unnecessary procedures. Traditional QC methods remain essential for detecting analytical variation, but statistical indicators alone cannot always quantify patient impact in real time.
RiskGATOR quantifies the actual probability of harm—estimating how often an analytical process could produce one error every ‘x’ hours, days, weeks, months, or years. This means fewer missed errors, more accurate results, and better patient outcomes.
Result: Patients receive safer, more reliable lab results that lead to correct treatment decisions.
Happier Lab Professionals
Lab professionals spend countless hours investigating false-positive QC flags, repeating tests, and dealing with processes that assume “QC processes are effective” without verification. This creates stress, burnout, and wasted time on problems that don’t actually threaten patient safety.
RiskGATOR reduces false positive QC flags and guides you to focus on real risks. It analyzes QC data to advise if an analytical process actually needs improvement in method accuracy or precision—not just arbitrary sigma values.
Result: Lab professionals reclaim hours each week, reduce stress, and focus on meaningful quality improvements.
Lower Healthcare Costs
Unnecessary QC tests, repeated analyses from false alarms, and lab errors that lead to wrong treatments all waste healthcare dollars that could be used to help more patients. Traditional QC estimates costs but doesn’t optimize them.
RiskGATOR quantifies avoidable healthcare costs caused by lab errors, evaluates the acceptability of error costs, and recommends improvements to reduce expenses. It guides labs to create QC processes verified to detect failure in a single run—eliminating waste.
Result: Healthcare systems save money on QC materials, staff time, and patient care—redirecting resources where they’re needed most.
AWEsome Numbers’ RiskGATOR empowers laboratory staff to work smarter, more efficiently, and faster by turning complex statistics into clear insights. Our innovative software and proprietary algorithms help standardize quality control, reduce errors, and ensure every result is accurate and reliable.
From Statistical Insight to Operational Risk Intelligence
Laboratory instruments have evolved dramatically since 1975. It’s time quality control caught up.
Traditional Unverified Statistical QC
RiskGATOR: Mathematically-Optimized Risk Evaluation™
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
Guides investigation of common faults that cause reduced method accuracy and/or precision
Assumes QC processes are effective
Presents intuitive Risk Distribution Graphs and Risk Evaluation Charts
No cost analysis
Quantifies avoidable healthcare costs caused by lab errors, evaluates acceptability of cost, and recommends improvement to reduce costs
Questions Lab Professionals Ask
How does RiskGATOR improve patient safety compared to traditional QC?
Most QC systems rely primarily on statistical rule performance and aggregate error metrics. RiskGATOR extends those metrics by quantifying analyte-specific patient risk and operational impact in real time.
Will RiskGATOR save time for my lab team?
Yes. Traditional QC generates false-positive flags that waste hours investigating non-issues and repeating tests unnecessarily. RiskGATOR reduces false positive QC flags by analyzing your QC data to determine if an analytical process actually requires improvement in method accuracy or precision. It guides you to focus only on real risks, freeing up your team to do meaningful work instead of chasing false alarms. Labs report reclaiming hours each week and significantly reduced stress.
How does RiskGATOR help meet regulatory requirements?
RiskGATOR meets and exceeds regulatory standards by implementing CLSI’s recommendation that “the ability of QC procedures to detect medically allowable error should be evaluated.” It provides Risk Distribution Graphs and Risk Evaluation Charts that document your QC effectiveness, guides you to create Daily QC Process Designs verified to detect failure in a single run, and generates reports that demonstrate compliance with risk-based quality management requirements from CAP, CLIA, ISO 15189, and CLSI EP23.
What makes RiskGATOR different from other QC software?
Most QC systems rely primarily on statistical rule performance and aggregate error metrics. RiskGATOR extends those metrics by quantifying analyte-specific patient risk and operational impact in real time.
How much does RiskGATOR cost and is it worth the investment?
RiskGATOR quantifies avoidable healthcare costs caused by lab errors and shows you exactly how much money you’re wasting on unnecessary QC tests, false alarms, and patient harm. Most labs find that the software pays for itself within months by reducing QC material costs, staff overtime, and repeat testing. More importantly, the value of preventing even one misdiagnosis or treatment delay far exceeds the investment. Early adopter pricing is available now.
What Lab Professionals Say
What RiskGATOR Does
> Quantifies risk as Medically Incorrect Results (MIRs) per failure event based on simulated failure
> Estimates probability of occurrence of harm as likelihood of analytical process producing one error every ‘x’ hours, days, weeks, months or years
> Compares estimated risk against given risk criteria to determine acceptability (CLSI recommendation)
> Analyzes QC data to advise if analytical process requires improvement in method accuracy and/or precision
> Guides investigation of common faults that cause reduced method accuracy and/or precision
> Presents intuitive Risk Distribution Graphs and Risk Evaluation Charts
> Meets CLSI recommendation that “the ability of QC procedures to detect medically allowable error should be evaluated”
> Guides correction of Daily QC Process Design to create process verified to detect failure in single QC run
> Provides interim QC process to increase number of QC samples tested per run until analytical and QC processes improved
> Guides assignment of QC chart SD to enable range of QC rules from 1-2s to 1-3.5s in software that only supports single 1-2s or 1-3s rule
> Combines Analytical Process Quality and Daily QC Process Effectiveness into single intuitive Risk-Based Quality Grade
> Quantifies avoidable healthcare costs caused by lab errors
> Evaluates acceptability of cost of error
> Recommends improvement to reduce costs
> Reduces false positive QC flags to save lab professional time and reduce burnout
> Guides labs to “identify and select opportunities for improvement and develop, document, and implement any necessary actions” (ISO 15189)
> Guides labs to “direct improvement activities at areas of highest priority based on risk assessments and opportunities identified” (ISO 15189)
Join the Evolution of Quality Control
RiskGATOR is launching to early adopters who want to lead the transformation in laboratory quality management.
Be part of the evolution from statistical insight to operational risk intelligence.
About AWEsome Numbers Inc.
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.
Since beginning their collaboration in 2008, Zoe Brooks, Raymond Gerz, and the AWEsome Numbers team have been dedicated to helping laboratories build on proven QC methodologies while meeting the evolving risk-management expectations of CAP, CLIA, ISO 15189, and CLSI EP23.
Through proprietary algorithms, interactive simulation, advanced analytics, and professional education, AWEsome Numbers translates complex statistical data into actionable operational intelligence—empowering laboratory professionals worldwide to optimize quality control decisions, strengthen patient safety, and implement change with confidence.
