Protecting Patients.
Empowering Lab Professionals.
Saving Healthcare Costs.
RiskGATOR: The Paradigm Shift in Laboratory Risk Management
What is RiskGATOR?
RiskGATOR is medical laboratory risk management software that uses Mathematically-Optimized Risk Evaluation (M.O.R.E.) to replace outdated 1970s statistical quality control methods.It tells you exactly how many patient results could be at risk right now and shows you the simplest ways to protect them—reducing lab errors that lead to incorrect diagnoses, saving time for lab professionals, and cutting unnecessary healthcare costs.
Unlike traditional QC that estimates “errors per million results,” RiskGATOR quantifies risk as Medically Incorrect Results (MIRs) per failure event—giving you actionable insights that improve patient safety, regulatory compliance, and lab efficiency.
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 from 1987 use unverified assumptions that let errors slip through.
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 flagsand 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 Outdated Assumptions to Mathematical Certainty
Laboratory instruments have evolved dramatically since 1975. It’s time quality control caught up.
Traditional Unverified Statistical QC
RiskGATOR: Mathematically-Optimized Risk Evaluation™
Defines acceptable performance as a sigma value based on concepts from industry in 1987
Defines acceptable risk as the number of MIRs per year and per failure event that vary by analyte and clinical setting
Includes unverified assumptions of shifts over time
Compares estimated risk against given risk criteria to determine acceptability (CLSI recommendation)
Based on incorrect formula
Estimates the probability of harm as the likelihood of an analytical process producing one error every ‘x’ hours, days, weeks, months or years
Estimates errors per one million results
Analyzes QC data to advise if an analytical process requires improvement in method accuracy and/or precision
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
Will not detect failure in a single run when sigma is low
Guides correction of Daily QC Process Design to create a process verified to detect failure in a single QC run
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?
Traditional statistical QC from the 1970s uses unverified assumptions and estimates “errors per million results”—a metric that doesn’t tell you when a patient might be harmed. RiskGATOR quantifies risk asMedically Incorrect Results (MIRs) per failure eventand estimates the probability of harm as “one error every ‘x’ hours, days, weeks, months, or years.” This means you know exactly how many patient results are at risk right now and can take action before harm occurs. It meets the CLSI recommendation to compare estimated risk against given risk criteria.
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 flagsby 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 providesRisk Distribution Graphs and Risk Evaluation Chartsthat 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 software still relies on 1970s-era sigma metrics and Westgard rules based on incorrect formulas and unverified assumptions.RiskGATOR is the first software to implement Mathematically-Optimized Risk Evaluation (M.O.R.E.)—a paradigm shift that quantifies actual patient risk, not theoretical error rates. It combines Analytical Process Quality and Daily QC Process Effectiveness into a single intuitive Risk-Based Quality Grade that conveys acceptability of risk and recommended action. This is the future of laboratory quality control.
How much does RiskGATOR cost and is it worth the investment?
RiskGATOR quantifies avoidable healthcare costs caused by lab errorsand 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 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 Paradigm Shift
RiskGATOR is launching to early adopters who want to lead the transformation in laboratory quality management.
Be part of the movement from outdated assumptions to mathematical certainty.
About AWEsome Numbers Inc.
Dedicated to revolutionizing clinical laboratory quality control, Zoe Brooks and Raymond Gerz founded AWEsome Numbers Inc. in 2012.
Our mission is to simplify complex statistical metrics, provide clear insights, and deliver actionable advice to ensure consistent and reliable lab results.
We achieve this using our proprietary algorithms and innovative software, and by empowering, educating, and certifying lab professionals with the knowledge and tools needed to standardize quality control processes across laboratories.
