Additional Guidance on Standard 8 of the Quality Assurance Standards for DNA Databasing and Forensic DNA Testing Laboratories
August 1, 2022
The Federal Bureau of Investigation’s (FBI) CODIS Unit has been monitoring the interpretation and use of the 2020 Quality Assurance Standards (QAS) since those revisions took effect in July 2020. SWGDAM is also working on proposed revisions to the QAS Guidance Document to clarify the scope of provisions in Standard 8 and recommendations were considered at the recent July 2022 SWGDAM Meeting. As a result of those discussions, it was agreed that the following clarification would be proposed for the next revision of the QAS Guidance Document:
Forensic Standard 8.8.3/Database Standard 8.9.3 are applicable to software used as a component of instrumentation, for the analysis and/or interpretation of DNA data, or for statistical calculations. Studies performed under Standard 8.3 or evaluations performed under Standard 8.5 may be concurrently used as the software testing.
Accordingly, effective August 1, 2022, the FBI’s CODIS Unit is adopting the recommended clarification for Forensic Standard 8.8.3/Database Standard 8.9.3 that only those modifications to software used as a component of instrumentation, for the analysis and/or interpretation of DNA data or for statistical calculations must be evaluated to determine if the modifications result in major or minor revisions to the software and be subject to the testing required by the subsequent substandard.
As a reminder, the provisions of Forensic Standard 22.214.171.124 /Database Standard 126.96.36.199, that software that does not impact the analytical process, interpretation, or statistical calculation, shall require at a minimum, a functional test, is applicable to new software or new modules of existing software.
While these clarifications will take effect August 1, 2022, please keep in mind that your accrediting bodies have software requirements that remain in effect and will be not affected by these clarifications.
Questions relating to this additional guidance for the 2020 QAS Standard 8 should be directed to the NDIS Custodian at email@example.com.