Pro-QCP™: The New Standard for Diagnostic Quality
The first AI-powered Quality Assurance Utility that automates ISO 15189 risk management compliance — saving 50+ hours per risk assessment while measurably improving diagnostic accuracy.
Here’s How it Works
Pro-QCP will guide you step-by-step through a comprehensive risk assessment of your entire diagnostic test process – specific to your particular test method and unique environment – to identify and address your lab’s potential sources of error, to facilitate a continuous quality improvement process, and to generate an inspection-ready Individualized Quality Control Plan (IQCP).
Pro-QCP will also help ensure regulatory compliance and allow you to standardize QA procedures across a variety of test platforms and testing locations:
Pro-QCP will also help ensure regulatory compliance and allow you to standardizev QA proPro-QCP allows you to incorporate your historical performance data into your risk assessment, capture citations to federal and accreditation organization requirements, and embed links within your IQCP to your lab’s specific policies and procedures.
In addition to a comprehensive IQCP, Pro-QCP will generate a Suggestion Report. This report is for internal use and is the basis for a continuous quality improvement program, allowing you to identify and prioritize actions and initiatives that will further mitigate errors over time.
Pro-QCP is a learning program and over time will incorporate new QCP’s that have been field-tested by our community of users. These additions may represent innovative or creative new quality assurance measures or simply proven best practices. When you return to Pro-QCP over time, you should expect to see new QCP suggestions and further opportunities to reduce errors in your lab.
Pro-QCP comes pre-populated with references to your lab’s specific regulatory and accreditation requirements, as well as to the specifications for your particular test platform.
See first hand how Pro-QCP can improve the accuracy of your lab’s test results, drive efficiencies and economies, improve the outcomes of your patients, and help ensure satisfactory regulatory compliance:
Your First Module is Free
No Credit Required
- Choose a Pro-QCP module to trial
- Log in and see how Pro-QCP can improveyour patient outcomes
- Enter the code “IQCP-UPGRADE” at checkout
The Challenge: ISO 15189 Raises the Bar
The New Standard
ISO 15189:2022 transforms laboratory quality management from a minimum, document-based approach to a data-driven, risk-based process designed to continuously improve diagnostic accuracy. This represents the future of operational excellence and patient safety.
Comprehensive risk assessments following CLSI EP-23 Guidelines require approximately 76 hours to perform — time spent gathering documentation, identifying potential errors, cross-checking regulatory requirements, and writing Individualized Quality Control Plans.
The Resource Reality
For lab managers with limited staffing and without formal training in risk management, this presents a significant challenge. Multiply this effort by dozens or hundreds of test platforms in an average lab, and you’re looking at thousands of labor hours just to stay compliant.
The industry needed a breakthrough solution that makes this higher standard achievable for every laboratory and POCT location.
Meet Pro-QCP: Risk Mitigation Made Simple
Pro-QCP is a breakthrough AI-powered quality assurance utility that automates ISO and CLIA risk mitigation compliance. Coined “Risk Mitigation for Dummies,” it provides expert-guided comprehensive risk assessments, suggests effective mitigation strategies, and designs inspection-ready Individualized Quality Control Plans.
Identify Errors
Pinpoints sources of diagnostic error throughout your testing process, from specimen collection to result reporting.
Mitigate Risks
Suggests proven risk mitigation strategies tailored to your laboratory’s unique workflow and requirements.
Improve Quality
Implements a continuous quality improvement process that drives better outcomes over time.
Ensure Compliance
Auto-generates inspection-ready IQCPs aligned with your lab’s specific accreditation requirements.
Here’s How it Works
Pro-QCP will guide you step-by-step through a comprehensive risk assessment of your entire diagnostic test process – specific to your particular test method and unique environment – to identify and address your lab’s potential sources of error, to facilitate a continuous quality improvement process, and to generate an inspection-ready Individualized Quality Control Plan (IQCP).
Pro-QCP will also help ensure regulatory compliance and allow you to standardize QA procedures across a variety of test platforms and testing locations:
Pro-QCP will also help ensure regulatory compliance and allow you to standardizev QA proPro-QCP allows you to incorporate your historical performance data into your risk assessment, capture citations to federal and accreditation organization requirements, and embed links within your IQCP to your lab’s specific policies and procedures.
In addition to a comprehensive IQCP, Pro-QCP will generate a Suggestion Report. This report is for internal use and is the basis for a continuous quality improvement program, allowing you to identify and prioritize actions and initiatives that will further mitigate errors over time.
Pro-QCP is a learning program and over time will incorporate new QCP’s that have been field-tested by our community of users. These additions may represent innovative or creative new quality assurance measures or simply proven best practices. When you return to Pro-QCP over time, you should expect to see new QCP suggestions and further opportunities to reduce errors in your lab.
Pro-QCP comes pre-populated with references to your lab’s specific regulatory and accreditation requirements, as well as to the specifications for your particular test platform.
See first hand how Pro-QCP can improve the accuracy of your lab’s test results, drive efficiencies and economies, improve the outcomes of your patients, and help ensure satisfactory regulatory compliance:
Your First Module is Free
No Credit Required
- Choose a Pro-QCP module to trial
- Log in and see how Pro-QCP can improveyour patient outcomes
- Enter the code “IQCP-UPGRADE” at checkout
Expert-Guided Risk Mitigation
The Pro-QCP interface provides a clear, step-by-step approach to designing a superior quality control plan. Starting with a comprehensive risk assessment, the system identifies hazards and potential sources of errors throughout your test process, from patient ID and sample collection to reporting a timely and accurate result on the correct patient record.
As each risk is identified, Pro-QCP assists in developing customized mitigation strategies tailored to your lab’s specific personnel, environment, patient population, and accreditation requirements. This includes suggesting appropriate QC materials, frequencies, process controls, and acceptance criteria as well as creating performance-feedback loops that inform training and competency assessment programs.
Finally, the platform automates the generation of a Suggestion Report and an inspection-ready Individualized Quality Control Plan (IQCP), ensuring full compliance with ISO and CLIA standards and supporting continuous quality improvement.
Proven Performance: The Clinical Evidence
Clinical studies demonstrate how Pro-QCP reduces the time required to perform comprehensive risk assessments from 76 to 26 hours per test platform — a savings of 50+ hours — and how Pro-QCP identifies unaddressed sources of error in even top performing labs.
Calculate Your Time Savings
See how Pro-QCP lowers your regulatory burden.
Manual Assessment
Number of test systems × 76 hours = Your current compliance burden
With Pro-QCP
Number of test systems × 26 hours = Your streamlined process
Hours Reclaimed
Number of test systems × 50 hours = Your total labor savings
The Payoff: Transform Your Laboratory Operations
50+ hours saved per risk assessment with thousands of hours reclaimed annually across multiple test systems
Streamlined inspections with assured compliance for ISO 15189:2022 and CMS IQCP requirements
Performance feedback loops improve quality, inform training programs, and enhance competency assessments
Fewer diagnostic errors, faster turnaround times, and measurably improved patient care
Why ISO 15189:2022 Matters for Your Laboratory
ISO 15189:2022 represents the future of diagnostic quality — a higher, data-driven standard for patient safety and operational excellence. Because laboratory test results inform most medical decisions, they are a critical component in healthcare delivery.
Data-Driven Decisions
Move beyond minimum documentation to evidence-based quality management
Operational Excellence
Achieve higher standards while optimizing resources and workflow efficiency
Improved Accuracy
Measurably enhance diagnostic precision throughout your testing process
Patient Safety
Drive downstream efficiencies and improved clinical outcomes across your healthcare system
Pro-QCP’s expert guidance and workflow optimization makes this higher standard achievable for every laboratory, regardless of size or resources. The system is complementary to all laboratory information systems and offered in modules specific to each major IVD test platform.
Comprehensive Coverage: Industry-Leading Compliance
Pro-QCP is aligned with all major regulatory and accreditation bodies, ensuring your laboratory meets the highest standards across multiple frameworks. Our modules cover hundreds of major IVD test platforms from leading manufacturers.
Regulatory Alignment
Fully compliant with CAP, COLA, TJC, A2LA, ISO, CLSI, and CMS requirements
Platform Coverage
Hundreds of modules currently available, with thousands more targeting each major IVD test platform coming soon
System Integration
Complements and works seamlessly alongside all laboratory information systems without disruption
Aligned With Major Accreditation Orgs
Experience the Future of Lab Quality — Free
Access your first module today and discover how Pro-QCP can save 50+ hours per assessment, improve diagnostic accuracy, and take the guesswork out of ISO 15189:2022 compliance. Join leading laboratories worldwide who are transforming and upgrading their quality management approach.
No-Charge Trial
Start with a complimentary module to experience the Pro-QCP difference in your own laboratory environment
Expert Support
Access comprehensive guidance and resources to maximize your efficiency and compliance outcomes
Rapid Implementation
Get up and running quickly with seamless integration into your existing laboratory workflows
Here’s How it Works
Pro-QCP will guide you step-by-step through a comprehensive risk assessment of your entire diagnostic test process – specific to your particular test method and unique environment – to identify and address your lab’s potential sources of error, to facilitate a continuous quality improvement process, and to generate an inspection-ready Individualized Quality Control Plan (IQCP).
Pro-QCP will also help ensure regulatory compliance and allow you to standardize QA procedures across a variety of test platforms and testing locations:
Pro-QCP will also help ensure regulatory compliance and allow you to standardizev QA proPro-QCP allows you to incorporate your historical performance data into your risk assessment, capture citations to federal and accreditation organization requirements, and embed links within your IQCP to your lab’s specific policies and procedures.
In addition to a comprehensive IQCP, Pro-QCP will generate a Suggestion Report. This report is for internal use and is the basis for a continuous quality improvement program, allowing you to identify and prioritize actions and initiatives that will further mitigate errors over time.
Pro-QCP is a learning program and over time will incorporate new QCP’s that have been field-tested by our community of users. These additions may represent innovative or creative new quality assurance measures or simply proven best practices. When you return to Pro-QCP over time, you should expect to see new QCP suggestions and further opportunities to reduce errors in your lab.
Pro-QCP comes pre-populated with references to your lab’s specific regulatory and accreditation requirements, as well as to the specifications for your particular test platform.
See first hand how Pro-QCP can improve the accuracy of your lab’s test results, drive efficiencies and economies, improve the outcomes of your patients, and help ensure satisfactory regulatory compliance:
Your First Module is Free
No Credit Required
- Choose a Pro-QCP module to trial
- Log in and see how Pro-QCP can improveyour patient outcomes
- Enter the code “IQCP-UPGRADE” at checkout
Pro-QCP supports major diagnostic platforms, including….
Frequently Asked
Questions
Can’t find what you are looking for?
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chat with you.
Who is CarePoint Solutions?
Founded in 2012, CarePoint designs, develops and commercializes products that improve the accuracy and reliability of diagnostic testing.
The company’s flagship product, Pro-QCP represents a first-of-its-kind software solution that helps ensure regulatory compliance and implements a continuous quality improvement process for in vitro diagnostic testing.
Visit www.carepointsolutions.com for more information.
Which diagnostic tests are supported?
CarePoint’s goal is to publish Pro-QCP risk assessment modules for all major IVD test platforms. If you don’t see a specific module that you are looking for, let us know and we’ll alert you as soon as it is available.
How flexible is the program?
The program is user-friendly, designed to effortlessly guide you through every step. It tracks your progress in real time, ensuring you can see how far you’ve come and what’s left to complete. The modules are thoughtfully organized into logical sections, providing a clear, step-by-step process to develop IQCPs at your own pace. Additionally, the program features a built-in tour guide to assist you along the way, offering helpful tips and support to ensure a seamless experience.
How will it help me?
- Pro-QCP takes you step-by-step through a comprehensive risk assessment of your entire test process, and documents that for accreditation inspections
- Based on clinical benchmark studies, Pro-QCP will save you up to 50 hours when preparing each individualized quality control plan (IQCP) – almost pays for itself in immediate time savings alone
- Pro-QCP standardizes your QA measures and IQCP’s across test platforms, locations, and throughout your healthcare system
- Pro-QCP will identify sources of error in your unique test process and location
- Pro-QCP will suggest proven practices that can mitigate risks and errors
- Pro-QCP will assess and document your entire test process, from specimen collection through posting patient results to generate a comprehensive and inspection-ready IQCP
- Pro-QCP’s data-driven, outcomes oriented approach will raise confidence in patient test results and drive down-stream efficiencies and economies throughout your healthcare delivery system
- Pro-QCP delivers actionable information to support your continuous quality improvement program
Can I buy Pro-QCP modules with a credit card or
purchase order?
purchase order?
You can subscribe to Pro-QCP with a credit card, check, or purchase order – and gain immediate access to the program.
What if I am dissatisfied with my purchase?
When we say we mitigate risks, we really mean it! If you are not completely satisfied with Pro-QCP, cancel within 30 days and receive a full refund. Your satisfaction is guaranteed.
Do I need to install IQCP software or have a special computer to use Pro-QCP?
If your computer, tablet or phone is connected to the Internet you have everything you need and can use Pro-QCP without installing any software.
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