Validation of Data Collection 4.0 software for DNA 3500 Genetic Analyzers

Background
The Iowa DCI Crime Laboratory, located at 2240 S. Ankeny Blvd., Ankeny, IA 50023, seeks to contract with a vendor for validation services within its forensic DNA section. The goal is to validate and implement ThermoFisher’s Data Collection 4.0 (DC 4.0) software on the 3500 Genetic Analyzer, which produces Short Tandem Repeat (STR) DNA data used in crime laboratories. This validation will encompass both caseworking and databasing sections of the lab and must meet all instrument parameters.

Work Details
The contractor will be responsible for:
- Conducting a comprehensive validation of DC 4.0 software on the 3500 Genetic Analyzer, ensuring compliance with FBI QAS for Forensic DNA Testing Laboratories (2020), FBI QAS for DNA Database Testing Laboratories (2020), ISO/IEC 17025:2017, and ANAB Forensic Testing and Calibration AR 3125:2019.

- Providing all necessary DNA samples for the validation study, including known buccal or blood samples, mock casework samples (including sexual assault type samples), mixtures, FTA color change reference samples, and NIST 2391c.

- Performing functional testing, reliability testing, regression testing, precision and accuracy studies, sensitivity studies, specificity studies, and assessing analytical thresholds due to DC 4.0.

- Analyzing Globalfiler and PowerPlex Fusion DNA profiles using Genemapper ID-X v1.6 data analysis software.

- Delivering a complete validation write-up that includes a summary of data generated during the validation process.

- Providing training to Iowa DCI Crime Laboratory staff through validation reviews and practical training sessions.

Period of Performance
The contract period will commence upon award and is expected to be completed within a timeframe that aligns with the laboratory's operational needs as outlined in the proposal.

Place of Performance
The work will primarily take place at the Iowa Criminalistics Laboratory located at 2240 S. Ankeny Blvd., Ankeny, IA.