FAQ: Questions Laboratory Professionals are Asking Today
Laboratory quality management is changing. Staffing shortages, increasing workloads, evolving accreditation standards, and growing pressure to reduce diagnostic error are changing how laboratories think about quality. These are some of the questions laboratory professionals are asking—and the same questions that inspired the development of RiskGATOR.
Why is quality control becoming more difficult for clinical laboratories?
Laboratory quality hasn’t become more difficult because the science has changed. It’s become more difficult because laboratories are expected to do more with fewer experienced people. Higher testing volumes, staffing shortages, and evolving accreditation requirements mean every quality decision carries more weight than ever before.
Why isn’t statistical quality control enough anymore?
Statistical QC is excellent at telling you that something changed. What it doesn’t tell you is whether that change puts patients at risk, how urgent it is, or what you should do next. Today’s laboratories need answers that go beyond statistics—they need confidence in their decisions.
How are staffing shortages affecting laboratory quality?
As experienced technologists retire, many laboratories are asking less experienced staff to make increasingly complex quality decisions. That makes consistency more important than ever. Every member of the team should be able to approach quality events with the same confidence and the same decision-making process.
Why do laboratories experience QC alarm fatigue?
When every QC alert seems equally important, it’s easy to spend valuable time investigating events that pose little clinical risk. Over time, that creates frustration, consumes resources, and makes it harder to recognize the few quality events that truly deserve immediate attention.
How can laboratories identify which quality events matter most?
Not every quality event has the same impact on patient care. Laboratory leaders need practical ways to distinguish routine variation from situations that deserve immediate investigation, so time and attention are focused where they’ll make the greatest difference.
How does risk-based quality management improve patient safety?
Instead of asking only, “Did something go wrong?” risk-based quality management asks a more important question: “What could this mean for patient care?” That shift helps laboratories focus their attention on the quality events that matter most.
How can laboratories prepare for ISO 15189 and CLSI EP23?
Accreditation is no longer just about demonstrating statistical control. Laboratories are increasingly expected to show how they identify, evaluate, document, and manage quality risks as part of everyday operations. Having a consistent, well-documented process makes those conversations much easier.
Can artificial intelligence improve laboratory quality management?
Artificial intelligence can help laboratories make sense of large amounts of quality data, identify patterns, and support consistent decision-making. But like any tool, its value depends on the quality of the science behind it—and the people using it.
How can laboratories reduce the cost of diagnostic error?
Every analytical error has the potential to affect far more than a single laboratory result. Repeat testing, delayed diagnoses, unnecessary procedures, and additional healthcare costs all begin with quality decisions made inside the laboratory. Preventing those errors benefits patients, clinicians, and healthcare systems alike.
How does RiskGATOR fit into an existing laboratory workflow?
Most laboratories don’t want to replace the quality processes they’ve already built—they want to make those processes easier, more consistent, and easier to defend. RiskGATOR is designed to work alongside existing laboratory workflows, helping teams make more confident quality decisions using the data they already have.
Why has AWEsome Numbers spent more than 30 years studying laboratory quality?
Long before RiskGATOR existed, one question kept coming up: How can laboratories make better quality decisions? For more than three decades, that question has guided research into Total Error, patient risk, quality management, and decision support. RiskGATOR is the latest chapter in that continuing journey.
What is RiskGATOR?
RiskGATOR® is a Software-as-a-Service (SaaS) platform that layers on top of your existing QC processes to help identify clinically meaningful analytical risk by combining statistical quality control with Total Allowable Error (TEa) and evidence-based quality management principles. Instead of simply detecting statistical rule violations, RiskGATOR helps laboratory professionals determine whether an analytical change has the potential to affect patient care, enabling more informed quality control decisions.
How RiskGATOR Supports Better Laboratory Decisions
RiskGATOR transforms your QC data into actionable insights to improve patient safety, reduce wasted effort and lower healthcare costs.
From QC Data to Risk Intelligence
transforms routine quality control data into meaningful risk intelligence.
✓ Move beyond manual spreadsheet review.
✓ Surface clinically meaningful analytical changes.
✓ Guidance for better laboratory decisions.
Result: Greater confidence that QC data is leading to better-informed risk management decisions.
Earlier Visibility
helps clinical laboratories identify emerging analytical risk earlier.
✓ Detect shifts, trends, and unusual analytical patterns.
✓ Identify reagent lot-related changes before they become larger quality concerns.
✓ Monitor instrument and analyte performance over time with greater clarity.
Result: Earlier identification of analytical issues and faster, more focused investigations.
Built for Clinical Laboratories'
actual clinical laboratory workflows.
✓ Evaluate quality across instruments, analytes, reagent lots, QC levels, and laboratory departments.
✓ Bring greater structure and consistency to routine monthly QC review.
✓ Guide laboratory managers with tools designed around real clinical laboratory workflows.
Result: A quality review process that aligns with how clinical laboratories actually work.
Better Review, Better Confidence
helps standardize quality control review by providing clearer analysis and consistent evidence.
✓ Promote a more consistent and standardized approach to QC analysis.
✓ Present QC findings in a clearer, easier-to-review format.
✓ Compare quality performance across instruments, analytes, and laboratory departments.
✓ Support quality meetings, investigations, and accreditation activities with consistent evidence.
Result: More consistent decisions supported by clearer evidence and stronger documentation.
Human-Centered Intelligence
supports professional judgment with meaningful analysis and evidence, helping laboratory professionals make more informed quality decisions while remaining firmly in control.
✓ Present meaningful analytical evidence to support expert review.
✓ Keep laboratory professionals at the center of every quality decision.
✓ Strengthen confidence without replacing professional judgment.
Result: Laboratory professionals empowered with better information while remaining in control of every decision.
Drive Continuous Improvement
RiskGATOR helps laboratories identify meaningful opportunities for continuous quality improvement by transforming routine QC data into actionable operational insight.
✓ Identify trends that support ongoing quality improvement.
✓ Prioritize improvement initiatives using meaningful laboratory data.
✓ Measure progress over time with greater confidence.
Result: Measurable, continuous improvements in quality, efficiency, and laboratory performance.
From Statistical Insight to Operational Risk Intelligence
Your laboratory already has the data. RiskGATOR helps transform that data into practical, risk-based quality management aligned with today’s quality standards.
Traditional Unverified Statistical QC
VS.
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
RiskGATOR: Verifies Daily QC can detect unacceptable risk in a single run
No breakdown for cause of errors
RiskGATOR: Guides investigation of common faults that cause reduced method accuracy and/or precision
Assumes QC processes are effective
RiskGATOR: Presents intuitive Risk Distribution Graphs and Risk Evaluation Charts
No cost analysis
RiskGATOR: Quantifies avoidable healthcare costs caused by lab errors, evaluates acceptability of cost, and recommends improvement to reduce costs
What Lab Professionals Say
About AWEsome Numbers Inc.
AWEsome Numbers helps clinical laboratories identify clinically meaningful analytical risk using evidence-based quality management principles. The company's flagship SaaS platform, RiskGATOR, combines statistical quality control with Total Allowable Error (TEa) to support safer laboratory decision-making.
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.