Validation demonstrates laboratory workflows to be reliable, reproducible, and robust in the laboratory’s own environment.

  • Reliable—results obtained by using this method are accurate and correctly reflect the sample being tested
  • Reproducible—the same or very similar results are obtained each time a sample is tested
  • Robust—successful results are obtained a high percentage of the time with few samples that need to be repeated

The HPS team will work closely with you to develop a clear project plan and deliver an individualized experimental design to suit your needs. In most instances, the necessary Applied Biosystems consumables needed to complete the testing are included with the service. Validation specialists with forensic DNA laboratory experience come to your facility to perform the laboratory work and monitor the results in real-time. Partnering with HPS allows you to focus your resources on continued casework or databasing demands. Before delivering your validation data and report, HPS will analyze the resulting data, develop a detailed report using your data, and perform a detailed technical review.

 

After you have had the opportunity to review the data and report, a teachback training will be delivered. The teachback training will present individualized results and can leverage virtual, in-person, or hybrid formats. We know we’re successful when your laboratory has the knowledge and expertise to implement your newly validated workflow.

Validation and performance checks are part of implementing new methodologies and technologies and are used to assess the functionality of laboratory equipment and instruments. In most instances, validations consist of a larger scope of work and performance checks and performance verifications are scaled down to meet specific requirements dependent on each unique situation.  Please contact our HPS team to discuss your specific validation and performance check needs.

Our HPS validations aim to enable laboratories to comply with ISO/IEC 17025-2005 standards. The final reports that we deliver are designed to address recommended international guidelines and standards, including SWGDAM, NATA, UKAS, KOLAS, and NABL. It is your responsibility to interpret the standards relevant to your laboratory and ensure that the proposed HPS project scope includes studies that meet or exceed those requirements.

 

Our consultative approach to services enables us to meet your specific quality assurance requirements that may be unique to your region. Please contact our HPS team to discuss these further.

Experts will work closely with your state CJIS Security Officer and ABIS vendor to architect a solution that meets your agency’s needs. Discussions will be focused on network infrastructure readiness, RapidHIT ID deployment configurations, data transmission options, and end-to-end workflow verification. During pilot test phase, our project management team will facilitate scheduling, scoping discussions with your agency IT and biometric vendor to enable proper workflow parameters. Once verification testing is completed, your agency will be positioned to submit for FBI’s Approval to Operate (ATO) Rapid DNA in booking stations.

Detailed project planning: Using the project scopes designed to meet your needs, the HPS team develops a detailed experimental design for your project. The experimental design is shared with you and reviewed during pre-service communications to facilitate project readiness. Additionally, the Applied Biosystems kits and reagents that are required for the validation service are included as a deliverable, along with NIST-traceable DNA controls that work to standardize your validation project using trusted samples that exhibit predictable quality and performance.

 

Laboratory work: HPS scientists perform the laboratory wet work at your site, freeing your resources and allowing them more time to focus on continued casework or databasing demands.

 

Data analysis and report writing: Following laboratory wet work, HPS analyzes the resulting data for each validation study. The analyzed data is detailed in a report that is thoroughly reviewed by a project manager for technical accuracy. HPS reports are audit-ready documents that provide a comprehensive overview of the service. The report can serve as the scientific foundation on which your laboratory can begin implementing the technology.

 

Teachback training: Your HPS project may include an individualized, validation-specific teachback training. The training is customized with your project data and presented in a virtual, in-person, or hybrid format. The teachback training program aids in understanding the validation results and helps ensure laboratory competency and troubleshooting capability.

With the adoption of any new technology, it is critical that all users in the lab be thoroughly trained on the instruments, kits, software, and workflows. To address these needs, HPS offers an array of specialized training programs, and our trained forensic applications specialists and field service engineers are available to assist you. We can customize your service package to include training as a total solution for your forensic needs.

The global HPS team of forensic DNA specialists have delivered over 2,000 projects in 57 countries, ranging from small verification testing projects to complete laboratory turnkey solutions and nation-wide laboratory system validations and performance checks. Contact us to find out how our experienced HPS team can help you bring your new workflow online.