Module 5 FOR 565 writing
docx
keyboard_arrow_up
School
Arizona State University *
*We aren’t endorsed by this school
Course
565
Subject
Information Systems
Date
Feb 20, 2024
Type
docx
Pages
5
Uploaded by shaccount10
1
Module 5: Writing Assignment FOR 565: Lab, Leadership, Policy & Practice Science is continuously evolving and constantly changing when new discoveries are made that can impact society. In crime labs all over our nation, scientists are being equipped with
2
innovative technologies and brought up to date with new methods to help solve crimes. For new methods and equipment to be used, there must be validation. It is important to ensure that they are efficient and cost effective (Vossbrink, 2023). To prepare the lab validation, it’s important to have mock evidence that can be experimented with for a thorough analysis of the new technology. The new technology should be learned and determined if it is cost effective to the laboratory, if it is efficient in cutting time for results, and how reliable it is for the field. The forensic DNA standards to follow are ISO/IEC 17025, SWGDAM, NIST, FBI QAS and CODIS standards. All these standards are essential for running an accredited DNA laboratory and to get access to CODIS and the FBI’s databases. Accreditation is essential for any forensics lab to get customers and to have their analyses allowed in court. SWGDAM standards ensure your lab is using the best practices for DNA analysis (Vossbrink, 2023). ISO/IEC 17025 is an international standard for accuracy and reliability in DNA analysis (Vossbrink, 2023). FBI QAS standards are essential to maintain the highest levels of quality and integrity in DNA analysis and
for access to their database. NIST standards are valuable for its DNA quantitation standards reference material that can be used for validating new DNA instrumentation. CODIS standards are required to be met for each DNA instrument for entry into the CODIS database. By using these standards, the lab is ensured that their new DNA instrument is validated by the best in the industry. The validation of the new robotics DNA extraction instrument is vital to ensuring that reliability and accuracy of producible data. To begin, the laboratory staff must be trained in the operation of the instrument, its specifications, and methodology. The instrument must then be calibrated to support the accreditation parameters (such as ISO/IEC 17025 requirements). These calibrations must only be carried out by appropriately trained and competency tested personnel.
3
The calibration method must then be validated prior to use, and all reference materials should be traceable and tested, with technical records established and documented (ANSI, 2023). The instrument’s performance must be tested under working conditions with repeatability tests to ensure precision, and processing time assessments on its ability to handle different matrices. Control measures must be established for routine performance monitoring with the determination
of acceptable parameters. This should include any reporting limits, limits of detection, purity/yield, potential contamination assessments, laboratory control standards, and calibration standards (Vossbrink, 2023). All validations need to be documented with all protocols, results, and deviations. Additionally, the creation of standard operating procedures (SOPs) must be established prior to any laboratory instrument use. Once these steps are completed, all validation data should be condensed into a report to confirm that the instrument meets all regulatory standards and is approved by a quality control team. Once the instrument is prepared to run, an initial audit should be conducted to review the instrument and analyst’s performance. Through additional audits and calibration checks, there should be enough reliability that the new DNA extraction instrument is able to produce accurate data (ANSI, 2023). To validate any new piece of equipment for chemical or biological analysis, one must use an assortment of samples: Reagent Blank, Extraction Control, Internal Blind Control, and Substrate Control samples. The same can be said for DNA extraction equipment. In order to test extraction accuracy, one must run the extracted samples through analysis machines. (Gima, 1998) (FBI). Reagent Blank samples, which contain only dilution carrier chemicals (reagents), allow the user to clear out the analytical system they are using, reset the values, and ensure no cross contamination will occur from both past tests and the reagents used. Reagent blanks should be
Your preview ends here
Eager to read complete document? Join bartleby learn and gain access to the full version
- Access to all documents
- Unlimited textbook solutions
- 24/7 expert homework help
4
used for each data set present. (Gima, 1998) (FBI). Extraction Control samples are of a known type and concentration. To ensure the extraction process is working properly, these control samples are extracted and typed alongside case evidence. A minimum
of 1 extraction control per case should be used. (Gima, 1998) (FBI). Internal Blind Control samples are of a known type and concentrate to those who are not the validation user. These samples are extracted and used to assess both the equipment (extraction and analytical) and the user’s analytical process. A minimum
of 1 internal blind control per case should be used. (Gima, 1998) (FBI). Substrate control samples, when possible, are taken from the substrate the DNA evidence is found. The substrate control should be taken from an area near
the case sample. It is used to identify possible background DNA information. A substrate control
sample should be taken, where possible, from each potential source of DNA collected. (Gima, 1998) (FBI). Based on the test data of the samples ran, a conclusion of a successful validation is determined. The precision, accuracy, and sensitivity data are to be calculated. The results need to
be repeatable through multiple runs while giving accurate measure. The data is then compared to the original data from the previous DNA extraction method. This is done by using statistical techniques relevant to the data. If it is within the acceptable range compared to the original procedure, it is one step closer towards a successful validation. Once the process is finished, it is to be evaluated and approved by an author. If the validation is successful, it is required to publish
a peer-reviewed publication of the methods and results (QUALITY, 2020). References
5
ANSI National Accreditation Board. (2023). ACCREDITATION REQUIREMENTS FORFORENSIC TESTING AND CALIBRATION
(2023)
. [Accessed September 19, 2023] https://anab.qualtraxcloud.com/ShowDocument.aspx?ID=12371
FBI. The guidance document for the FBI Quality Assurance Standards for Forensic DNA Testing
And DNA Databasing Laboratories (n.d.). https://le.fbi.gov/file-repository/qas-guidance-
document-070120.pdf
Gima, L. (1998). PROTOCOL FOR THE EXTRACTION AND QUANTITATION OF DNA FROM CASE EVIDENCE. DEPARTMENT OF JUSTICE BUREAU OF FORENSIC SERVICES
BERKELEY DNA LABORATORY. https://www.sjsu.edu/people/steven.lee/courses/c3/s1/DOJ
%20Extraction%20Protocol%2098.doc
QUALITY ASSURANCE STANDARDS FOR FORENSIC DNA TESTING LABORATORIES
. swgdam. (2020, July 1). https://1ecb9588-ea6f-4feb-971a-73265dbf079c.filesusr.com/ugd/4344b0_d73afdd0007c4ed6a0e
7e2ffbd6c4eb8.pdf
Vossbrink, Russell. (2023). Module 3: Accrediting Bodies. [PowerPoint slides 1-10]. FOR 565: Laboratory Leadership, Policy, and Practice.
Vossbrink, Russell. (2023). Module 4: Accrediting Standards and Certifications.
[PowerPoint slides 1-12]. FOR 565: Laboratory Leadership, Policy, and Practice.
Vossbrink, Russell. (2023).
Module 5: Validation Studies and Protocol Development.
[PowerPoint slides 1-12]. FOR 565: Laboratory Leadership, Policy, and Practice.