CLIA Consultation and Validation

Comprehensive solution for your lab's validation project - reduce launch time by 80% or more.

Why is validation important & why should I care? In short, you want to ensure your lab:

• Achieves accurate, reproducible results
• Complies with regulatory requirements and quality standards

Validation utilizes analytical techniques, processes, and procedures to generate extensive documentation and empirical results. Our validation consultation services adhere to rigorous industry standards such as CAP and CLIA.

However, validating a workflow can be time consuming. From our experience, labs that opt to perform validation themselves often end up paying more for labor & consumables. Inefficiencies and lack of experience can result in as much as a 10-week delay, impacting the lab’s bottom line.

We are here to help. Whether you are aiming to streamline your workflows or seeking to launch a new lab, our experienced specialists are here to take the stress of validation planning & implementation off of you, so that you can focus on what you do best.

The process is simple:

• Personalized Consultation
• Readiness Evaluation
• Validation
• Training
• Launch

Personalized Consultation

Our specialist will reach out to set up an exploratory call. During this step, our goal is to understand your needs and expectations. We will guide you through our product & services, and answer any questions you might have, including but not limited to the following:

• Product features, advantages, and benefits
• Product literature
• Cost per sample
• Billable CPT codes
• Medical reimbursements
• Your investment
• Validation time frame
• Technical support

Readiness Evaluation

After you have agreed to our service, our specialists will reach out and propose a validation plan & site prep list. During this step, our specialists will ensure you have everything ready to move forward. Need consumables? We will ship you a box on the house.

Here is what you can expect:

• Validation plan
• Site prep list
• A shipment of consumables, reagents, and standards needed for validation

Validation

This is where the magic begins. We will dispatch a highly experienced Field Application Scientist to your lab. The dedicated FAS will be onsite and work with your team to set up the new assay.

Here are the common parameters we will be evaluating during the validation:

• Accuracy
• Precision
• Sensitivity (Limit of Detection)
• Clinical Correlation
• Specificity
• Reportable Range

Training

After your new assay is validated, we will give your team proper documentation and technical training to ensure your lab meets regulatory protocols and is producing replicable results.

Our specialists will provide the following:

• Workflow training
• Written SOP
• Validation report
• Training certification

Launch

Congratulations! You are good to go. Our specialist will follow up to provide any technical support needed to ensure continued success.

Ready to reduce your validation costs & timeline? Talk to our specialist.