Consulting and Validation

Consulting

As America’s leading forensic DNA analysis laboratory, capable of testing more than 25,000 databanking samples and 750 forensic cases per month from agencies across the world, Bode has an understanding of the full range of DNA testing needs and maintains some of the world’s leading experts on staff. Bode has several experts who can provide consulting services such as laboratory design and build out; process flow assessments to ensure maximum efficiency in the laboratory; validation of robotics to expedite DNA testing; mentoring of laboratory staff; information technology (IT) solutions for forensic DNA analysis, and assistance in gaining ISO 17025 accreditation.

Individuals on staff available to provide these services include Robert Bever, Ed Huffine, Mike Cariola, Jon Davoren and Robert Griffiths.

Validations

Bode offers validation services customized to meet your laboratory’s needs. Based on your validation objectives, Bode will work with your laboratory to develop a custom validation plan. Whether you are interested in setting up a new laboratory, performing internal validations of a new chemistry or robotic system, or automating a process in your laboratory, Bode’s extensive experience in forensics along with our wide range of technical capabilities will aid your laboratory in meeting your validation objectives.

Bode validation experts provide high quality work that withstands thorough review by the technical leader at Bode, as well as thorough review by auditors to both ISO/IEC 17025:2005 standards and the Quality Assurance Standards for Forensic DNA Testing Laboratories and Convicted Offender DNA Testing Laboratories issued by the FBI Director. All completed validations performed by Bode meet or exceed these guidelines, are well-organized and include working protocols with interpretation guidelines based on the validation.

Bode’s validation services include:

Validation Design – Once your validation objectives have been discussed, Bode will develop a validation plan for your laboratory. The validation plan will incorporate all of the requirements for the internal validation guidelines from SWGDAM. This plan can incorporate multiple site locations.

Script Development – For robotic system validations, Bode will work with your lab to write and/or optimize scripts for your robotic platforms. The scripts will be tested and implemented onto your robotic system.

Validation Lab Work – Bode can either travel to your laboratory to conduct the validation lab work or provide detailed experimental instructions to your laboratory for your analysts to perform the required lab work.

Data Analysis – Bode will complete all of the data analysis of the validation lab work.

Validation Binder - Bode will compile all data and write a final validation report of the overall system validation and provide your laboratory with an organized validation binder for audit purposes, demonstrating compliance with all accreditation guidelines. The validation data and final report will be reviewed internally at Bode to ensure compliance with ASCLD/LAB International requirements as well as the FBI-QAS standards before being sent to your laboratory for final review.

Training - Bode will develop a complete and detailed training plan for DNA analysts. Analysts will also be provided the complete and detailed design plan for the entire validation so they are informed about all aspects of the validation. Following validation completion, competency samples will be sent for all DNA analysts to perform lab work validated. Bode will review results from each analyst and determine successful completion.

Validation Specialists (Applied Research)

In order to quickly and competently validate new procedures as the field of DNA analysis progresses, Bode relies upon an Applied Research section. Bode’s method development, optimization and validation (Applied Research) section provides the staff with the most technically sound and current procedures and technologies. The head of this group is Jon Davoren (MS), Director of Applied Research, who has been involved with developing and optimizing forensic techniques for over 7 years. The other scientists in the department are Kristen Hancock and Heather Cunningham who each have more than 4 years of experience in validation of manual and automated extraction, quantification and amplification systems.

Bode’s validation specialists have validated processes for all aspects of forensic DNA casework including both robotic and manual procedures. Bode has completed over 20 FBI QAS compliant validations in the past three years. Validations include:

Robotics – TECAN, Biomek, Hamilton and Qiagen

Extraction – AB Prepfiler, Qiagen EZ1 and Micro, and Promega DNA IQ

Quantification – Quantifiler Duo, Quantifiler, and QuantifilerY

Amplification – Identifiler, Powerplex16, YFiler and MiniFiler

By partnering with Bode, clients benefit in future years through access to the most current research and approaches to DNA analysis that address the challenges faced by the entire forensic community.

Please contact our Technical Services Department at (866) 263-3773 x 787 for more information on any of the services above.

REQUEST A QUOTE – Please email Technical Service at bode.service@bodetech.com for a quotation.