Quality Control Management

Raise quality and increase profitability

Comprehensive Quality Control Plan, Using Six Sigma Process

Lab Connections specializes in seamlessly integrating Six Sigma principles into your laboratory’s operations, ensuring a smooth transition with minimal interruption.

Our approach begins with a comprehensive assessment of your lab’s current processes, pinpointing areas that need improvement without overwhelming your staff. We then offer customized, practical training programs designed to teach key Six Sigma concepts and methodologies tailored to your lab’s unique needs.

Our support extends to project selection, providing guidance on manageable projects that align with your lab’s goals, as well as ongoing project support for data analysis and problem-solving. We also assist in managing cultural and organizational changes associated with Six Sigma adoption, ensuring buy-in from your staff.

Through our expertise, we help you establish key performance indicators, implement a culture of continuous improvement, seamlessly integrate Six Sigma principles into your lab systems, and simplify documentation and reporting processes.

The result is a laboratory that embraces Six Sigma with confidence, improving quality, reducing costs, and enhancing efficiency while minimizing disruptions.

Continuous Monitoring and Analysis

Review of QC data daily, weekly, and monthly

Generate analysis report of lot-to-lot comparison data following the onboarding of new lots and shipments of reagents, in order to verify parameters of statistical means and standard deviations are set appropriately

Reports from new lots will be sent to Management for final approval

Determine from a survey of data if systematic and random errors were evaluated correctly and troubleshooting was properly performed

Provide reports to management of necessary corrective actions, or corrective education

Provide necessary support and education for QC evaluation and troubleshooting to reduce costly wasted time and materials

By making this critical shift, labs can increase profitability, enhance operational efficiency, and ensure the accuracy and reliability of laboratory test results.

Lab Connections is your partner in modernizing QC processes, delivering cost-effective solutions, and keeping your lab at the forefront of quality assurance.

Quality Benchmarks & Improvements

At Lab Connections, our commitment to quality is reflected in our comprehensive set of quality benchmarks. We prioritize accuracy, ensuring that our services and products consistently meet specified accuracy standards and deliver reliable results.

Efficiency is at the core of our operations as we continually streamline processes to reduce waste, enhance productivity, and minimize costs, guaranteeing optimal value for our clients.

Timeliness is a key element of our service, and we take pride in delivering within agreed-upon timeframes and deadlines.

Customer satisfaction is paramount, and we actively measure and improve it through feedback and surveys, tailoring our services to meet our clients’ evolving needs. Regulatory compliance is non-negotiable, and we diligently ensure adherence to industry-specific regulations and standards. We’re committed to error reduction, implementing robust strategies to minimize errors and defects.

Our dedication to continuous improvement is ingrained in our culture, allowing us to evolve our processes and services continually. Data security and privacy are paramount, and we take stringent measures to protect sensitive information and maintain compliance with data security regulations. We maximize resource utilization, efficiently managing personnel, equipment, and materials to optimize our operations.

Finally, our commitment to sound financial health and profitability underpins all our endeavors, ensuring our ability to provide enduring quality and value to our clients.

Quality Control Audit

We provide expert level assistance with Quality Control Design. A comprehensive QC plan is integral to the modern lab. The accuracy of machine-derived patient data depends on the effectiveness of the processes used to measure, analyze, correct errors and document the course of action.  QC education and teamwork offers confidence that providers are getting the right answers for their patients.

Systemic bias can creep into processes, causing a shift in accuracy that can be painful to track down and decipher at a later date. 

Without proper controls, this shift may not be detected in a timely manner, causing a large amount of errored information to be released unintentionally.

This can result in:

  • Patient harm
  • Inappropriate care
  • Financial loss due retesting and unnecessary patient care

This method of in-depth analysis and correction of procedure leads to fewer errored results and fewer wasted resources.

We can also help identify inaccurate or inefficient QC procedures, which can result in a large amount of wasted expense in QC material, reagents and labor.

Holistic Approach to the QC Question

We approach the QC question with a broad view to evaluate how all the pieces of the puzzle come together by providing:

  • Education in Quality Control Design and practices
  • Supplying effective and systematic troubleshooting tools for QC errors
  • Ongoing support for 3rd Party Quality Control Management Systems
  • Calibration verification oversight
  • Integration of effective Look-back procedures
  • Middleware verification and optimization
  • Yearly competencies

Sample QC Scope of Work

Case Studies

Case Study: Quality Improvements

Quality improvements were achieved through collaboration between the Lab Connections team and Laboratory Staff, verifying the accurate transmission of patient results to healthcare providers and fostering staff confidence in delivering precise diagnostic testing. Statistical analysis of the Six Sigma metric, coefficient ratio, and standard deviation index from peer evaluations were employed to measure the progress […]

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Case Study: Calculated Cost Reduction

Lab Connections is pleased to announce that, with our guidance and collective efforts alongside lab management we have successfully demonstrated a marked improvement in quality while simultaneously realizing a reduction in operating costs over the period of February 1st to April 30th, 2023. This accomplishment has resulted in a measured cost reduction of $4900 in […]

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Free Consultation

We invite you to reach out to us through this form or call 417-622-8433. Whether it’s workflow inefficiencies, quality control concerns, or compliance hurdles, we’re here to provide solutions. 

Sample QC Scope of Work

Education and processes implemented to ensure that QC management and regulatory requirements are met:

  • Generate assessment of quality benchmarks and process improvements to facilitate test performance in a safe manner
  • Evaluate test mapping in third party QC providers software, to ensure all parameters are appropriately configured for Lab data collection
  • Examine past QC reports for exclusions to determine where errors are occurring or have occurred with the goal of preventing future exclusions or outliers to increase reputability of data and test results
  • Conduct a retrospective QC analysis of all analytes processed on Lab Analyzers to verify that control ranges are properly established for each test, adjusting the standard deviation (SD) and mean to reflect the variability of the Labs performance.
  • Set temporary mean and SD in the event data is corrupted.
  • Train staff on how to effectively analyze QC data and familiarize them with a flowchart developed by Lab Connections experts for resolving QC errors.
  • Analyze Lot to Lot comparison data on QC material to determine that statistical mean is set appropriately for each assay
  • Apply QC multi-staged strategy by combining the Westgard QC rules with the Six Sigma Metric. Allowing for the potential of realizing a >95% confidence in error detections while reducing the chances of a false error event (causing an erroneous rejection) down to <5%.
  • Evaluate volume of patient testing in conjunction with the Six Sigma Metric to determine the frequency of QC events
  • Perform weekly review of: Levey-Jennings charts, coefficient of variation between the mean and SD  to look for imprecision,  investigate performed corrections for random and systematic errors, and compare/contrast the chart data post-correction
  • Formulate and write policies and procedures for appropriate QC troubleshooting processes
  • Create procedures for calibration verification including Allowable Total Error and Medical Decision Levels as approved by Clinical Laboratory Improvement Amendments (CLIA) Proficiency Testing Related to Analytes and Acceptable Performance; Correction
  • Work with the Lab Scientists to make sure the steps needed to maintain Gold Standard objectives for patient care are understood and practiced